The Keynoter newspaper in the Florida Keys reported
that plans to release genetically engineered mosquitoes in Key West “
remain on indefinite hold.”
This came after an announcement by the Florida Keys Mosquito Control
District that this controversial experiment “will only take place once
all necessary regulatory and ethical approvals have been obtained, from
regulatory agencies at both federal and state level, based on the
results of independent, rigorous, scientific review.”
FKMCD and its director, Michael Doyle, should be applauded for not
rushing ahead with this experiment before receiving federal and state
approval, or before these genetically engineered mosquitoes and their
possible risks are independently and properly assessed.
The debate over which federal and state agencies would oversee the
release of genetically engineered mosquitoes in the U.S. has been filled
with confusion but is starting to become a bit clearer. Ever since the
USDA stated back in November 2011 that
it will not regulate the release of genetically engineered mosquitoes in the Florida Keys,
as originally expected, FKMCD and Oxitec (the creators of the GE
mosquito) have been scrambling to find a federal agency that will take
the lead. It appeared the federal agencies were playing a game of
regulatory “hot potato,” each one passing on taking the leading role.
But just last week,
Oxitec stated in a Bloomberg article
that it has “opened an investigational new animal drug file with the
Food and Drug Administration.” While this might sound wonky and
bureaucratic, it is actually a telling move on the part of Oxitec -- one
that starts to clarify if – and how - these genetically engineered
mosquitoes will be regulated in the U.S.
In January 2009
the
FDA came out with Guidance 187 which stated that the agency would
regulate genetically engineered animals as “new animal drugs.” This idea originated in the Reagan administration and its’
Coordinated Framework for the Regulation of Biotechnology,
which stated that the U.S. didn’t need any new laws to regulate
biotechnologies or their products --instead old laws could be
interpreted in order to accommodate new technologies.
And so the FDA decided to use laws originally written to approve new
animal drugs (think: vaccines for cattle, antibiotics added to chicken
feed) to regulate the use of genetically engineered animals, and now
insects. The FDA’s twisted logic reads like this: drugs change the
composition and function of an animal; the genes inserted into an animal
also change their composition and function; so
ipso facto GE animals are new animal drugs. If this sounds like something out of a Kurt Vonnegut novel to you, you are not alone.
We have been fighting this wacky interpretation of how GE animals should be regulated for years. The
FDA
is also trying to approve a genetically engineered salmon, which would
be the first-ever GE food animal, as a “new animal drug” as well.
Yes, a fish we are supposed to eat is being approved as a new animal
drug. And this classification makes even less sense for GE mosquitoes.
There are two overarching problems with using new animal drug laws to
approve genetically engineered mosquitoes. First, classifying a
genetically engineered mosquito as a ‘drug’ is the regulatory equivalent
of trying to fit a square peg into a round hole. These GE mosquitoes
aren’t the same thing as, say, a new animal feed additive; an additive
can’t reproduce in the wild, bite humans and spread disease, or fly to
another part of town. Therefore the questions regulators would need to
ask regarding risks are entirely different. So while the FDA might be
able to determine the risks of an animal feed additive, that doesn’t
mean it can do the same for GE mosquitoes.
The FDA does not have the necessary expertise to judge the mosquitoes’ environmental effects
and has a poor track record of collaborating with other agencies that
could provide scientific and technical analysis. This is not the fault
of the FDA, necessarily, since we can’t expect veterinary medicine
experts to understand insect ecology. But it does mean our regulatory
system has failed to keep up with new technologies and the current
system is broken.
The second broad problem is the lack of transparency around new
animal drug applications. As we have unfortunately learned through
the
FDA’s process for approving the GE salmon under these same laws, the
public has little knowledge or input into the agency’s decisions; the FDA had the GE salmon application for over 10 years before it even announced the existence of the application
and
when it did, it was only because the application was close to final
approval. The public only received information that the GE salmon
company and the FDA deemed was not “confidential business information.”
With the current process, the FDA could approve these GE mosquitoes
for release as an “investigational new animal drug” and the public would
not know, nor would it have any data, until the decision has already
been made. “Independent, rigorous, scientific review” cannot happen in
secret, behind closed doors. That would be bad science, bad policy, and
would set a bad precedent for how GE insects are regulated.
The indefinite delay of genetically engineered mosquitoes in the
Florida Keys is a victory for the grassroots organizations in the Keys,
but unfortunately it may only be temporary. Now that we know Oxitec has a
file open with the FDA to approve its mosquitoes as an investigational
new animal drug, approval could come at any time and the public would
have no warning or input.
Using antiquated laws that are ill-equipped to deal with novel risks
posed by GE insects would set a dangerous precedent here in the U.S. and
abroad and should not be allowed to continue. The time has come to
actually write laws that address the novel risks posed by genetically
engineered animals and insects, and to develop proper risk assessment
models to measure the dangers.
The only way to stop this experiment outright is for the Florida Keys
Mosquito Control District to announce it has cancelled its plans to
release genetically engineered mosquitoes or for the FDA to stand up for
the Keys residents and reject this application. If not, don’t expect
this issue to disappear any time soon.
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