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A Prescription for Smart Government Rulemaking

Scientist typing Editors’ Note: Now more than ever, the question of science’s influence on government policy is drawing into sharper focus. Writer Travis Bernardo takes a look in this blog post at how scientists can get involved with the rulemaking process.

Imagine the rising din of buzzing wings. Millions of mosquitoes flitting about in dense swarms on a small island.

Now imagine an equally cacophonous sound: the dissent of the residents living on that island.

Over the next two years, up to fourteen million mosquitoes will likely be released in Key Haven, a small island-bound community in Monroe County, FL. This particular strain of Aedes aegypti—dubbed OX513A by its maker, the U.K. biotech firm Oxitec—has been genetically engineered as a molecular weapon to combat mosquito-borne pathogens such as the dengue, yellow fever and Zika viruses.

OX513A mosquitoes produce nonviable offspring under experimentally controllable conditions. By releasing large numbers of (non-biting) males in the wild, the company believes that the transgenic insects will be able to overwhelm and thereby thin out local mosquito populations. This idea has been borne out in a number of field trials; a release of 3.3 million mosquitoes in Grand Cayman, for example, reduced the wild population by around 80 percent in a matter of months. Trials are now being held in several countries, including Brazil—a hot spot for Zika—and the company hopes to show similarly positive findings in Florida, where Zika infections are on the rise.

Academic opinions on OX513A are mixed. Scientists generally believe that genetically modified organisms are safe, but many are skeptical that this insect will be effective in population control. Some are also hesitant to condone the release of transgenic mosquitoes without a better understanding of the environmental risks. (Excellent coverage of the academic discussion can be found here.)

Notwithstanding skepticism from some corners of academia and from many of the island’s residents—vocal opposition prompted a non-binding voter referendum in which Key Haven gave OX513A a thumbs down— the trial will almost certainly go forward. That’s because it received full approval from the U.S. Food and Drug Administration (FDA) in August. The agency’s decision to green-light the trial is effectively the final word on the matter, barring an unlikely protracted legal battle.

This raises an important question: When the FDA and similar agencies make decisions on public health issues that are intertwined with science, do the larger scientific and medical communities wield any influence?

Private Scientists and Public Clout

American civics reminds us that not all government bodies are designed to express the people’s will directly. Indeed, only one third of the federal government—the legislative branch—is actually voted into office. It’s true that we elect the president, but that’s a singular exception: the executive branch is populated almost entirely by political appointees and (to a much larger extent) career hires who are never subjected to an election. Executive agencies, which today play a dominant role in the final policies that stem from legislation, are therefore only indirectly accountable to the public—at best.

Nevertheless, scientists working outside government can help ensure that regulators operate through a scientifically informed process. In fact, there’s a mechanism in place specifically designed to address this quandary. It’s a somewhat wonky, and certainly less-appreciated, feature of the executive branch called “notice and comment.”

In brief, here’s how it works. When an agency such as the FDA announces a new regulation, the announcement is placed in the Federal Register, the official compilation of all federal regulations. A comment period then commences on the day of the announcement, usually lasting for 60 days. During this period the agency accepts any and all comments from the public. After the comment period ends, the agency reviews any posted commentary and generates its final decision on the proposed regulation.

A Meaningful Impact

Regulatory decisions often draw thousands of comments; the ruling on Oxitec’s mosquito field trial (docket no. FDA-2014-N-2235) drew more than 50,000 of them.

The problem? Most comments are thin on substance. This limits their usefulness to regulators, who use the comment period to collect empirical data that might have been overlooked. In essence, they’re asking the public to help them uncover substantive data. Substance is, of course, a scientist’s bread and butter. Deep knowledge of a subject, advanced communication skills, methodical attention to detail, an instinct to stay rooted in facts—these are all attributes that will naturally produce a noteworthy and useful public comment. This means that scientists are uniquely positioned to register an impact on public policy by weighing in on executive regulations.

Draft rules and comments for pending regulations can be found at regulations.gov. Each has a unique docket number, and on a rule’s main docket page you can find all publicly available documents, a place to post comments and a docket-tracking feature to provide regular email updates.

Public attention to OX513A emerged only recently, but the field trial was the result of a prolonged regulatory process spanning many months. Environmental assessments, and even blueprints detailing the Oxitec mosquito’s genesis, were readily available for public consumption. So wherever he or she stood on the issue, every scientist in the country had an opportunity to weigh in on the decision.

Looking beyond this mosquito’s fate, it’s clear that the government’s regulatory bodies will need to be continually held accountable to empiricism. This is especially true as a new administration in January raises the possibility of significant changes in policy priorities. However this cabinet shakes out, though, we remain at a point where scientific innovation will continue to push the boundaries of executive policy.

And for the broader scientific community, the notice-and-comment period is a tailor-made opportunity to help shape those boundaries.

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