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.
Dissent over what? Over the next two years, up to fourteen million mosquitoes will be released in Key Haven, a small island-bound community in Monroe County, Florida. Not just any kind of mosquito, though: 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. Pathogens like the dengue, yellow fever, and Zika viruses.
OX513A mosquitoes produce non-viable offspring under experimentally controllable conditions. By releasing large numbers of (non-biting) males in the wild, the company believes that the transgenic insect can be used to overwhelm and thereby thin out local mosquito populations. This idea has been validated 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% in a matter of months. Trials are now being held in several countries—including Brazil, a hotspot for Zika—and the company hopes to show similarly positive findings in Florida, where Zika infections are on the rise.
Academic opinions on the issue are mixed. Scientists generally believe genetically modified organisms (GMOs) are safe, but many are skeptical that OX513A 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 (some nice coverage of the general academic discussion can be found here).
In Key Haven, the reception was not so much hesitancy, but ferocity: local opposition to the trial was so vocal that a temporary postponement was issued, pending non-binding voter referenda that were just held during the recent election. (Monroe county approved the trial, but Key Haven gave it a thumbs down.)
Notwithstanding skepticism from some corners of academia and from many of the island’s residents, the trial will almost certainly go forward. That’s because it already received full approval by the Food and Drug Administration (FDA) back in August. A powerful executive agency, the FDA is authorized to issue far-reaching national regulations on matters of science and medicine. Their decision to green-light the trial is effectively the final word on the matter, barring an unlikely protracted legal battle.
An important question, then: how much say does the public have in controversial public health decisions like this? Further, when the FDA and similar agencies make decisions on issues intertwined with science, does the scientific community hold influence?
Outgrowth of the Executive
Democracies have common expectations embedded in their culture; the most fundamental of these is a general insistence that government responds to the electorate’s policy preferences. While some cynicism about the political system is healthy, representative governance only functions over the long term when it’s perceived to reflect the values of those it serves.
But 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 are only indirectly accountable to the public—at best.
Historically and constitutionally, the executive branch is delimited (at least domestically) to implementing legislation passed by Congress, not generating policy de novo. However, the executive branch now plays a domiant role in the final policies that stem from legislation. There are myriad reasons for this, the greatest perhaps being that the government’s purview has grown rapidly since the early 20th century. Laws passed today tend to be purposely broad and vague, giving administrative experts width berth to construct the detailed and complex regulatory rules that are actually followed on a day-to-day basis.
So the story of OX513A is not an isolated example; rather, it encapsulates the much broader phenomenon that many medical and environmental policies important to scientists are determined not primarily by Congress, but by the regulations and decisions of unelected executive bodies.
Private Scientists and Public Clout
For those of us who value empiricism and use it as a driving force in our lives, we inexorably want to see that our government ‘gets it right’ on policy. Or, at the very least, we hope it uses something approximating an evidence-based approach in its decision-making. But given that executive agencies aren’t directly accountable to voters, can scientists outside of government realistically hope to promote a scientifically-informed process in the issuance of regulations?
Actually, there’s a mechanism in place specifically designed to address this quandry. It’s a somewhat wonky, and certainly lesser-appreciated, feature of the executive branch, called notice-and-comment.
The notice-and-comment has a fairly long history in the U.S. It has its roots in the Administrative Procedure Act (APA) of 1946, a bill born out of the executive expansion of the 1930’s-era New Deal progressivism. The APA provides a formal process for executive rulemaking, and attempts to balance the need for judgment and technical expertise from unelected officials with an opportunity for public representation. As part of this framework, the APA requires (for the most part) that every new rule or rule change include a period to collect input from the public.
In brief, here’s how it works.
When an agency like the FDA announces a new regulation, the announcement is placed on the Federal Register, the official compilation of all federal regulations. A comment period then commences on the day of the announcement, and usually lasts 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.
Making a Meaningful Impact
I know what you’re probably thinking. It’s a sham, right? They don’t really have to listen to public comments if they don’t want to, do they? It’s true that at the federal level, agencies have the discretion to review or ignore publicly submitted comments. There are some academics who thus liken public comment to mere symbolism, a political form of “kabuki theater.” The empirical data in this regard are mixed, and the question is hotly debated in academia, but the bottom line is that there are many documented cases in which public comment made a substantive impact on a new regulation.
Regulatory decisions often draw thousands of comments; the ruling on Oxitec’s mosquito field trial (docket no. FDA-2014-N-2235) drew over 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 actionable empirical data that might have been overlooked. In essence, they’re asking the public to help them uncover substantive data—and as a scientist, substance is your 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.
What this means is that scientists are uniquely positioned to register an impact on public policy by weighing in on executive regulations.
With that said, here are some guidelines to generate an impactful comment. These suggestions were culled from a number of academic sources that looked empirically at the notice-and-comment period over the last two decades.
Find a Rule. Draft rules and comments for pending regulations can be found at regulations.gov. You may have to dig a little, but with the search and browse features you’ll eventually be able to find your rule of interest. Each has its own 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.
Cite empirical data as thoroughly as possible. One of the strongest advantages to having a background in science is that you’re able to draw from the bank of peer-reviewed evidence to support your position. A suggestion or commentary that is heavily annotated with supporting references will be given substantially more weight. (Don’t worry if the end product is a fairly lengthy tome: there aren’t any word limits to a comment.) The other advantage is that your expertise, both in your field and from your broader academic training, allows you to delve into the scientific documents made available to the public during the rulemaking process. This will allow you to critically analyze and comment on data directly pertinent to the regulation in question.
Write Cogently. In addition to being a warehouse of esoteric knowledge, scientists are well-trained in the art of cogent argumentation. Choose your words carefully. One study suggested that cognitive complexity alone makes a public comment more likely to have an impact.
Emphasize any ‘situated knowledge’ you have on a regulation. Some of the most valuable information comes from people with situated knowledge; that is, those who have uniquely useful information stemming from their individual circumstances. A simple example of this would be a comment from a cab driver who’s responding to a municipal rule change on city traffic patterns. Who better to comment than someone on the front lines of a rule? For issues that are scientifically relevant, think about your area of expertise. An entomologist will have a great deal of pertinent information on the release of genetically modified mosquitoes, while physicians and medically-oriented scientists might have a unique perspective on the medicinal value of kratom.
And for the broader scientific community, notice-and-comment is a tailor-made venue to help shape those boundaries.