September 26, 2016 Division of Dockets Management (HFA-305

September 26, 2016 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket #FDA-2016-D-1399-0001, “Procedures for evaluating appearance issues and granting authorizations for participation in FDA advisory committees; Draft guidance for the public, FDA Advisory Committee members, and Food and Drug Administration staff.” Dear Dr. Califf, Food & Water Watch is a national nonprofit advocacy organization. We write today to comment on the FDA’s draft guidance on advisory committee members “appearance” of lacking impartiality (Docket #FDA-2016-D-1399-0001). We present in this comment a case study of one advisory committee’s review of one product, the veterinary medicine advisory committee’s (VMAC) review of AquaBounty’s genetically engineered (GMO) salmon. As previously noted in comments submitted to the FDA by Food & Water Watch,1 the composition of this committee was deeply imbalanced, included members with undisclosed financial conflicts of interest, and otherwise presented “appearance issues,” as FDA called them, that caused the public to question the impartiality of the FDA’s review of GMO salmon. Nearly 2 million members of the public submitted public comments to the FDA in opposition to GMO salmon, citing, among other reasons, the appearance of bias on VMAC.2 Under the Federal Advisory Committee Act (FACA), FDA is required to form “fairly balanced” advisory committees that are not “inappropriately influenced by….any special interest.”3 As this case study indicates, FDA has failed to follow FACA. This case study indicates FDA’s urgent need to dramatically revamp its recruitment of advisory committee members to insure that its work is impartial, balanced, and captures the most relevant expert perspectives that exist on a given subject before the FDA. Though FDA’s draft guidance indicates that it does not speak to financial conflicts of interests, we note that many of the issues that FDA identifies as “an interest or relationship that could cause a reasonable person to question the member’s impartiality” would, by many definitions, constitute a disclosable financial conflict of interest. The agency’s long history of allowing financially conflicted members to participate in advisory boards has undoubtedly eroded public trust in the scientific decision making of the FDA. We advise the FDA to take this opportunity to overhaul its recruitment and vetting of advisory committee members to ensure that the agency has the best, most relevant perspectives. Case Study: 2010 VMAC In September 2010, the FDA announced that the VMAC would be meeting to discuss AquaBounty’s pending animal drug application for AquAdvantage salmon, hereafter called GMO salmon. In addition to the standing committee, FDA invited four temporary members to participate in the VMAC review of GMO salmon, with the agency stating the need for additional “expertise in genetic engineering.”4 Though the scientific community is very divided on genetic engineering, with hundreds of scientists raising safety questions about this controversial technology,5 the FDA invited additional advisory members who have clear ideological positions in favor of GMOs. This included university professors Kevin Wells and Alison Van Eenennaam, both strong advocates of the use of genetic engineering. The one-sided appearance of these appointments was heightened when the media reported that some of the leading scientific experts on GMO fish—who were willing to participate but who happened to be critical of FDA’s review process—were excluded from the process.6 Likewise, a third invited member was a representative from Center for Science in the Public Interest who the FDA said was “highly recognized as a consumer advocate.” 7 The FDA did not mention that this nonprofit group is a prominent supporter of the use of genetic engineering in agriculture.8 The many consumer and environmental groups that are critical or opposed to the use of genetic engineering in agriculture, by contrast, were not invited to participate in VMAC. Alison Van Eenennaam Before the VMAC meeting, Van Eenennaam collaborated with the president of AquaBounty, a representative from the main biotechnology trade association, the Biotechnology Industry Organization, and others on a journal article that enumerated the benefits of AquaBounty’s GMO salmon while discounting the fish’s potential threats to food safety, the environment or the economic viability of fisheries.9 Published months prior to VMAC, the article very clearly presented Van Eenennaam’s clear ideological position in favor of GMO animals, creating an unambiguous “appearance” of Van Eenennaam being an advocate in favor of GMO salmon. Van Eenennaam also came to VMAC with “appearance issues” that, according to many policies, might qualify as financial conflicts of interest. Van Eenennaam’s name is attached to at least eight patents controlled by the biotechnology company Monsanto, which previously employed her.10 She has conducted research into genetically engineering cows 2 that produce milk with lower amounts of saturated fat—an innovation that, if it were to reach the marketplace, would, presumably, have to go through the same regulatory process as GMO salmon.11 Any reasonable member of the public can see that Van Eenennaam has a professional, if not financial, interest in seeing GMO animals successfully move through the regulatory approval process and into the commercial marketplace. Van Eenennaam’s interest in seeing GMO salmon gain regulatory approval might be heightened because an approval of this fish would set a legal and regulatory precedent, establishing the first-ever GMO animal approved for human consumption. Not only did Van Eenennaam arrive to the FDA with a clear appearance of partisanship, but after she left VMAC, she continued to use her academic platform to promote GMOs, including AquaBounty’s GMO salmon. She collaborated on a laudatory article on GMO salmon in collaboration with an executive of the Biotechnology Industry Organization (BIO), a major biotech trade group whose board of directors included the president of AquaBounty.12 And on at least one occasion, she traveled to an Oregon state congressional hearing to offer favorable testimony about AquaBounty salmon. Her travel expenses were paid by an industry-funded nonprofit, a fact she did not disclose until she was asked directly at the end of her testimony.13 This occurred during the time that FDA was still reviewing AquaBounty’s application. Because Van Eenennaam’s advocacy around GMO animals took place both before and after VMAC, it meant that her activities continued to reflect back on the FDA. That is, during the five years that the FDA reviewed AquaBounty’s application, Van Eenennaam’s role as a prominent GMO proponent continue to shape how the public viewed FDA’s approval efforts, which were based in part on the advice it received from Van Eenennaam. Kevin Wells Wells, at the time he was selected to serve on VMAC, was listed as scientific manager of the biotech company Revivicor, which genetically engineers animals to produce medicine for humans.14 Like Van Eenennaam, if Wells’ transgenic animals were ever to reach the marketplace, they would, presumably, have to go through the same FDA regulatory approval process as GMO salmon. Evidence of Bias on VMAC An analysis of the VMAC hearing’s final discussion indicates that Wells and Van Eenennaam played an outsized role. As just two of 14 members on the panel,15 they offered 25 percent of the comments in the final discussion.16 Predictably, they both were strong advocates of positions favorable to AquaBounty, including that GMO animals should not undergo more regulatory scrutiny than non-GMO 3 animals.17 Their heavy participation served to continually steer the VMAC toward scientific positions that favored an approval for AquaBounty, while also consuming valuable time that could have been spent asking critical questions about AquaBounty and its engineered salmon. Missing Perspectives Throughout its regulatory review of GMO salmon, the FDA and AquaBounty widely cited the work of Dr. Anne Kapuscinski of Dartmouth University, one the world’s leading scientists on environmental issues associated with GMO fish. The agency clearly recognized her expertise leading up to the 2010 VMAC meeting, citing her work more than ten times in the environmental assessment it issued just before the meeting.18 Not only is Kapuscinski an expert, but she also maintains a level of independence, acting as neither an opponent or proponent of the use of GMO fish in aquaculture. Moreover, Kapuscinski was clearly available and interested in participating in VMAC, yet she was not invited. As she noted in a media interview: “It would have been much more scientifically credible to have someone on the committee who has been working on the cutting edge of methods of ecological risk assessment science. Although I would have been one option, there are others they could have considered.”19 Kapuscinski personally attended VMAC as a member of the public, where she offered public comments that were highly critical of the FDA’s review of the science, especially around environmental safety issues. Because she was not an appointed committee member on VMAC, however, her participation in the larger conversation that took place over three days was severely limited. It is difficult to understand why the FDA targeted its recruitment efforts at individuals that favor GMO development—but who have very limited expertise

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