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EPA Comment Page

Re: Release of Genetically Engineered Mosquitoes

The Institute for Responsible Technology and the individuals listed at the bottom urge the EPA to reject the experimental release of genetically engineered mosquitoes in California. Additionally, to reject the two-year extension of the experimental release conducted in Monroe County, Florida, as requested by Oxitec.

When Oxitec began releasing genetically engineered (GE) mosquitoes by the millions (in Brazil, Panama, Malaysia, the Cayman Islands, and Florida), it guaranteed that their GE insects would quickly die out after they stopped the releases. In written documentation and public testimony, Oxitec scientists assured the world that their transient GE varieties would never alter the genomes of natural mosquitoes. They were wrong.

Three years after Oxitec’s Brazilian release, an independent follow-up study identified a large number of “hybrid” mosquitoes, whose genomes carried DNA from both the GE insects and the local natural variety. It was unknown if these insects—new to nature—would be harder to kill with insecticides, more likely to transmit disease in their bites or have a survival advantage to increase their numbers over time.

However, what was certain is that Oxitec was wrong, and they inadvertently changed nature’s gene pool with unpredictable consequences.

Introducing GE mosquitoes should never be treated as a local, containable event. It’s a global issue that can impact public health and the environment. With long-term and potentially irreversible consequences, the decision to release engineered insects into the wild should be preceded by the most exhaustive independent scrutiny, using state-of-the-art scientific tools and inputs from a host of experts.

Instead, we have an EPA travesty. A non-transparent assessment based on cherry-picked data gathered and submitted by Oxitec alone—the very company that stands to benefit from approval. The scope of Oxitec’s investigations remains scandalously small, while the company’s track record is filled with false representations and failures.

Below we present 7 ways the EPA’s assessment is inadequate. Together, they demonstrate the need to overhaul the approval process for genetically engineered insects and, in the meantime, reject this request for continued releases.  

  • EPA Assessments Are Biased To Favor Industry

Whistleblowers recently accused the agency of putting corporate interests ahead of public health protection. Those familiar with EPA’s history were not surprised. Investigators and employees have long declared them “captured by industry.”

We make no assertions that any individual at the EPA acted inappropriately in the Oxitec assessment. Instead, we believe it serves as a glaring example of how important agency policies have a built-in industry bias, which puts the public and environment at risk.

  • Important data is hidden from the public
  • Confidential business information 

By labeling data “confidential business information,” Oxitec conceals relevant test results from the public.

  • Hiding results from the current mosquito trial

EPA is asking for public comments and preparing its own decisions on whether to extend the Florida trial for two years and start other trials in California without ever making the results of the current mosquito trial available.

  • Withholding California county names

Without justification, EPA is withholding the list of 12 counties being considered for the GE mosquito release. This prevents reviewers from analyzing relevant data about counties’ ecosystems, endangered species, use of tetracycline in agriculture (see below), and prevalence of the mosquito-borne diseases that the GE insects are designed to reduce.

  • The EPA relies on Oxitec to conduct studies and cherry-pick data

EPA relies on companies to conduct or commission their own studies on the products being assessed. Investigations confirm that companies often design their research and cherry-pick results to force a conclusion of safety.

Explicit examples of such manipulation surfaced through internal Monsanto documents made public from the recent Roundup trials. Although Monsanto was obligated to submit adverse findings to EPA, they not only withheld data, they secretly ghost-wrote scientific articles claiming opposite conclusions. EPA used these forged documents in their review and approval of glyphosate.

When Monsanto submitted data showing that Roundup was barely absorbed into human skin, they failed to tell EPA that the human cadaver skin they used was first baked and then frozen—before Roundup was applied. When the researchers first tested Roundup on normal cadaver skin, the absorption rates were much higher than EPA’s allowable levels, so that data was withheld.

These are just recent examples from decades of evidence showing that EPA is being “played.” Yet no amount of outrageous activity, not even the jailing of Industrial Bio-Test executives—the lab that defrauded the EPA and FDA by conducting bogus safety tests for chemical and pharmaceutical companies—has dislodged the agency’s reliance on company data.

If EPA relies on the integrity of companies, Oxitec is a poor choice. The company has a history of hiding data and misinforming stakeholders. It  claimed, for example, with an earlier GE mosquito, that no biting females would be released. Millions were.

While they touted success in their Cayman Islands trial and asked to roll out their mosquito program nationwide, a Freedom of Information (FOI) request revealed that their field test was an abysmal failure. The company quietly left the island. Then in 2018, Oxitec submitted Cayman results to the EPA that conflicted with the data obtained in the FOIA documents, misrepresenting the outcome.

Moreover, the company has yet to provide any conclusive evidence that their GE mosquitoes have ever reduced the incidence of mosquito-borne Zika, Dengue, and Chikungunya diseases.

Without independent, in-depth assessments from a variety of experts, the EPA’s approval process remains a façade. 

  • Disregard For Environmental Consequences 

The EPA assessment fails to adequately address:

  • Interactions in the food chain—including the impact on animals that consume GE mosquitoes or larvae;
  • Horizontal gene transfer to other insects, predators, and microbes;
  • The impact of changes in the microbiome;
  • California’s endangered species and unique ecosystems; and
  • The possible shift in insect populations due to displacement of the targeted Aedes aegypti mosquito population.

Because Oxitec’s GE mosquitoes survive in the presence of tetracycline, the EPA also failed to consider the impact of the significant use of these and related antibiotics in agriculture in California counties.

  • Disregard For Human Health Impacts
    1. Oxitec willingly exposed populations in at least five countries to millions of biting GE females without ever conducting a study to see if the GE mosquito saliva—which enters the human bloodstream after a bite—contains new or elevated levels of toxins or allergens.
    2. No human clinical trials and no public health surveillance related to GE mosquito bites exist. The cause of any associated health problems could therefore go unnoticed. It would require a large-scale outbreak of a serious reaction for health authorities to even mount an investigation, let alone consider the mosquito as a potential source.
    3. Tetracycline and related antibiotics are used in rearing the GE mosquitoes, increasing the risk of creating antibiotic-resistant diseases. A petition signed by nearly three dozen physicians in the Florida Keys demanded tests to rule out this danger prior to any release. It was ignored.
  • Disregard For Economic Impact

The introduction of genetically engineered foods and crops has consistently faced significant public rejection worldwide, resulting in lost or reduced markets. GE mosquitoes also have the potential to harm the economy of a region where they are introduced.

  • Impact on tourism in case of an actual health problem

If bites from GE mosquitoes released in Florida or California were found to cause serious health issues, the impact of tourism could be catastrophic, especially if the GE mosquitoes persisted in the environment.

  • Impact of tourism in case of a “misperceived” health problem

Even if the GE mosquito did not cause harm, the misperception that it does can impact the tourist economy. Suppose, for example, that someone develops serious health symptoms at the same time a mosquito bites them. If they blame the mosquito bite, it takes just one viral social media post or one irresponsible headline in a supermarket tabloid to start a scare that could snowball. This threat is exacerbated by the lack of safety testing. No matter how safe GE mosquito bites are, neither Oxitec nor the tourism industry can use data to show that it’s safe. 

  • Lost sales due to contamination 

Oxitec applied for European approval of their GE olive fly but withdrew their application when regulators began to ask important questions. For example, Oxitec was asked about the safety of eating the GE olive fly larvae that would remain inside olives.

Many jurisdictions in the world have zero tolerance for unapproved genetically engineered contamination in food. When unapproved varieties of genetically engineered corn, rice, and flax were found, shipments were rejected, markets were closed, and billions of dollars were lost.

In some cases, export markets closed their doors to all shipments of corn, rice or flax from the entire country where the contamination occurred. If a non-GMO supplier wanted to reestablish trade, the burden of proof was typically on the supplier to sample, test, and sometimes gain third party certification. This can be expensive and time-consuming.

To confirm GMO contamination, sample materials are often blended and then tested using PCR. If the lab uses methods designed to detect GE mosquitoes, even a tiny amount of contamination can be identified.

EPA can claim that the probability of an actual or perceived health issue, or economic loss due to contamination, is quite low. But EPA hasn’t actually consulted with the businesses in the regions impacted by these events. Most tourist businesses in South Florida remain unaware of the risks to their industry by the GE mosquitoes already released because EPA has refused to engage them in the risk assessment. 

  • Disregard For The Inherent Unpredictability Of Genetic Engineering Technology

When FDA scientists were tasked with proposing assessment protocols for approving GMOs in the early 1990s, the consensus was that genetic engineering introduced a unique set of risks and therefore required safety testing. They stated that GMOs could contain new or higher levels of existing toxins, allergens, and anti-nutrients. The risk was so great, they recommended human toxicological studies.

But the FDA had been instructed by the White House to promote GMOs. Consequently, they created a new position, Deputy Commissioner of Policy, given to Michael Taylor. Taylor was the outside attorney for Monsanto, the soon-to-be GMO giant. Taylor was to oversee the creation of GMO policy, among others.

Based on documents made public by a lawsuit, Taylor’s revisions of the GMO policy statement systematically removed concerns by the scientists. The final published FDA document ultimately declared that the agency knew of no meaningful difference between GMOs and other foods and that no safety testing was required.

After establishing this non-scientific policy, Taylor left the FDA to become Monsanto’s Vice President of Government and Regulatory Affairs.

Tragically, in the 29 years since the FDA policy was enacted, substantial evidence has validated the FDA scientists’ concerns. In fact, the most common result of genetic engineering is surprise side effects. But as FDA microbiologist Louis Pribyl predicted in an internal memo, over time, there was “less concern about safety, because of a false sense of knowing what one is doing and it’s been done hundreds of times before without a problem, why check it now.’”

EPA appears to be operating under this myth of predictability and safety. Thus, they don’t require GMO companies to conduct a thorough evaluation of even the changes in the genome, let alone those in the RNA, proteins, and metabolites. It’s the EPA version of, “Don’t ask, don’t tell.”

In the case of the GE mosquito, these unassessed changes could translate into unpredicted outcomes in all the areas addressed above: environment, health, economy, etc. 

  • Disregard For Safer Alternative Technologies

In parallel with the development of GE mosquitoes, other companies developed and verified effective methods for reducing mosquito populations or rendering mosquitoes incapable of transmitting diseases using a benign bacteria called Wolbachia. The bacteria are already found throughout the insect world and are an example of a tool that does not introduce the unpredictable side effects from genetic engineering, as well as the threat from export markets, the risks of horizontal gene transfer, the potential dangers from a GE mosquito bite, and more.

  • Disregard For The Right To Consent For Human Experimentation

According to the Nuremberg code, “The voluntary consent of the human subject is absolutely essential.” We can guess why this might not go so well when trying to gain consent for releasing GE mosquitoes in someone’s neighborhood:

“The company says that they won’t release any biting female mosquitoes, but they were wrong last time, using an earlier version…

“If females are released, they said that there’s no problem if they bite you, though they never looked for elevated allergens or toxins in the mosquito saliva…

“It’s only temporary unless it isn’t…

“And by the way, if you have dogs that drink from standing water, they’ll likely consume mosquito larvae. And no, there’s no studies on that either.

EPA has no plans for long term monitoring, no assignment of liability in case things go wrong, no way to confirm that the data from Oxitec submitted correct data before the trial, and no way to confirm its claims after. If this were a chemical assessment, it could go very badly. Because this organism that flies, bites, propagates and persists. It could be a disaster.

When EPA began to regulate GMOs in the early 1990s, their assessments were already inadequate. Now the technology has far outpaced those insufficient safeguards. We urge you to protect nature, protect the gene pool, and protect our population by rejecting Oxitec’s proposed trials and by overhauling your GMO regulations in favor of rigorous independent assessments.

Submitted by: The Institute for Responsible Technology