\u201cAn EA\/EIS should be done to see if there is any lasting problems,\u201d said Hubert Olipares in an email last December, com menting on a plan by Mera Pharmaceuticals, Inc., to discharge into the ground effluent from its planned genetically modified algae farm at the Kona facility of the state Natural Energy Laboratory of Hawai\u2018i Authority. He noted that state law requires such effluent to be disinfected before being discharged, in this case, into lava rock.<\/p>\n
\u201cAnyway, it is not good laboratory prac tice\u201d to do otherwise, he wrote. Olipares, a bio-safety officer at the Univer sity of Hawai\u2018i, had been asked for his com ments on the project by Amy Takahashi of the Department of Agriculture\u2019s Plant Quar antine Branch. But his recommendation that the department require an environmental assessment or a more thorough environmen tal impact statement went unheeded.<\/p>\n
At the time, Takahashi was processing Mera\u2019s application to the DOA for a permit to import a genetically modified strain of the alga Chlamydomonas reinhardtii,<\/i> which it planned to grow outdoors in large plastic bags and tubes at NELHA. The algae would be piped underground from the bags, called photobioreactors, to a centrifuge at an indoor processing facility. The processed algae would then be frozen and shipped to California, where the company planned to extract hu man proteins to be used in drugs to treat the herpes simplex virus. Effluent from the grow ing process would be disinfected and dis\u00adcharged into the rough a\u2018a lava on which the NELHA complex sits.<\/p>\n
Olipares\u2019 brief email is easily lost in the reams of documents on file at the Depart ment of Agriculture regarding Mera\u2019s appli cations to import several strains of genetically engineered algae. But it indicates that the department had been advised early on that, at the very least, the company\u2019s waste discharge practices should be subject to the state\u2019s envi ronmental review process.<\/p>\n
Instead, DOA staff chose to review envi ronmental concerns on its own, using its algae and plant experts, and relying heavily on representations by employees of Mera and its partner, Rincon Pharmaceuticals, Inc. It was a decision that would come back to haunt the department and its board nearly a year later.<\/p>\n
A Novel Idea<\/i><\/b>
\nOn October 29, 2004, Mera Pharmaceuti cals\u2019 Miguel Olaizola applied to import a genetically engineered strain of C. reinhardtii<\/i> known as Hsv8, which produces a human antibody against the herpes sim plex virus. Nowhere in the United States has genetically engineered algae been used to grow pharmaceuticals outside a labora\u00ad tory setting. Under Mera\u2019s proposal, the algae would be grown at NELHA in photobioreactors, which would sit in a plastic-lined bath of cool, chlorinated seawater. The DOA\u2019s Plant Quarantine Branch ac cepted Mera\u2019s application as complete on December 24.<\/p>\n
Early on, Plant Quarantine\u2019s microorgan ism specialist Takahashi requested informa tion regarding any possible federal oversight of algae engineered to produce drugs. By Febru ary 17, Mera had obtained oral reassurances from the U.S. Department of Agriculture\u2019s Animal Plant Health Inspection Service and the Environmental Protection Agency, \u201crec ognizing that they do not regulate the growth of our transgenic organism,\u201d according to an email to Takahashi from Scott Franklin, vice president of technology development for Rincon Pharmaceuticals, Inc. in La Jolla, Cali fornia.<\/p>\n
The EPA has oversight of pesticides and organisms not regulated by the Food and Drug Administration. But because Mera\u2019s algae is being used to grow FDA-regulated pharmaceu ticals, not pesticides, the EPA\u2019s Flora Chow stated in an email to Franklin that the \u201cexpres sion products are excluded from [EPA] jurisdic tion.\u201d<\/p>\n
And according to the USDA, Franklin said, because C. reinhardtii doesn\u2019t fit that agency\u2019s pharmaceutical definition, and because Mera is not seeking a permit to release the organisms into the environment, the algae is not regulated by the USDA.<\/p>\n
On February 22, Keith Webber, acting di rector of the FDA\u2019s Office of Biotechnology Products also informed Franklin that until his company submitted an Investigational New Drug (IND) application, the FDA has no au thority to oversee Mera\u2019s operations \u201cunless, of course, you plan to uses the residual bioengineered algal material as a component of food or animal feed, in which case you would need clearance from FDA\u2019s Center for Food Safety and Nutrition or Center for Veterinary Medicine, respectively.\u201d<\/p>\n
However, Webber continued, most IND applicants can claim a \u201ccategorical exclusion\u201d from the provisions of the National Environ mental Policy Act that would otherwise require environmental disclosure. If the FDA finds that extraordinary circumstances are associated with the application, it may deny the exemption. Mostly, the FDA defers to the USDA when it comes to potential releases of bioengineered organisms into the environment.<\/p>\n
\u201cIf they are not requiring a \u2018release permit\u2019 for your operations, then we would not, either,\u201d Webber wrote.<\/p>\n
According to a March 22 email from Takahashi to her boss Neil Reimer, the feds were not the only ones lacking adequate rules for this project. The email indicates that under the state\u2019s rules, a project such as Mera\u2019s would not necessarily require Board of Agri culture approval.<\/p>\n
\u201cAs we agreed, I would forward the Chlamydomonas request for Board approval. However, when I worked on the Chlamy domonas request on Sunday, March 13th, I had difficulty phrasing the title, which I normally draft based on the authority. I be lieve that the risk level for Chlamydomonas needs to be determined as a high-risk species to establish our authority for seeking Board action,\u201d she wrote. (A note: The rest of the email, when reviewed by Environment Hawai\u2018i, had been redacted by the depart ment, citing \u201cattorney-client privileged com munication.\u201d)<\/p>\n
As the DOA wrestled with Mera\u2019s algae import request, on April 7, Olaizola asked Takahashi to expand Mera\u2019s permit applica tion to include seven other substrains that had been transformed to express molecules that could aid in reducing inflammation, tumor growth, and possibly even fight cancer.<\/p>\n
The Process<\/i><\/b>
\nBecause of the unprecedented nature of the request to grow genetically engineered algae in an outdoor setting, Takahashi inundated Olaizola and Franklin with questions about the algae over the next two months.<\/p>\n
At the same time, the BOA\u2019s Subcommit tee on Algae, which is made up of several of Hawai\u2018i\u2019s algae experts, had reviewed Mera\u2019s application and recommended approval of the Hsv8 strain, but were not finished review ing the seven others. Despite the unanimous recommendations for approval, some sub committee members expressed concerns that such a large operation increased the risk of a possible escape of these strains into the sur rounding environment.<\/p>\n
Responding to these concerns, Olaizola emailed Takahashi, \u201cIn principal, Chlamydonomas could be dispersed along with contaminated water or wet soils. We do not believe that this is a concern at our facility in Kailua-Kona as we are surrounded by hot lava fields where open fresh water bodies are non-existent.\u201d<\/p>\n
Simultaneously with the staff review of the applications, Bruce Steel, chief executive of ficer of Rincon, was working to win over Ted Liu, an ex officio member of the Board of Agriculture who would vote on the project. Liu, director of the state Department of Business, Economic Development, and Tourism, was sold on the idea: DOA records include an email Liu had sent Steel stating, \u201cI assure you that we will do all we can to support this venture and partnership. I will call you to discuss.\u201d<\/p>\n
On May 4, the Board of Agriculture\u2019s Advisory Committee on Plants and Animals also unanimously approved Mera\u2019s request to import the Hsv8 strain and gave conditional approval of the seven other strains of GM algae pending favorable recommendations from the algae subcommittee, but not before grilling Steel, Olaizola, and Franklin about their drugs, Mera\u2019s facility, and the possible effects genetically engineered organisms might have. They assured the committee that any spilled algae would be killed by either bleach or seawater, that no horizontal gene transfer or algae blooms would occur if the algae somehow escaped, and that the proteins housed within the algae were non-toxic to humans.<\/p>\n
Committee members also asked how the facility could be monitored for an escape of the algae, which has the potential to become airborne. On May 11, Olaizola followed up with an email to Takahashi. He wrote, \u201c[I]f accidental release would occur (and assuming that our decontamination procedures would somehow fail) and if it survives, it could be expected that it might attempt to establish itself in one of our [nearby] Haematococcus [another type of algae] cultures, the only source of fresh water for several hundred yards around. Our Haematococcus cultures are microscopically observed every two days. So if Chlamydomonas would actually escape and survive, we would be able to detect it by microscope observation. If we, in fact detect it, our intention is to immediately decon taminate the culture that it is found in.\u201d<\/p>\n
With the committee\u2019s approval, the pro posal was then brought on May 24 before the Board of Agriculture. At its meeting in Ho nolulu, DOA staff recommended that it ap prove the importation of Hsv8 and give ten tative approval for import of the other seven strains.<\/p>\n
But this time, unanimous approval was not so easy. The public, through word of mouth, had become aware of the proposal and had flooded the board with testimony opposing the project. The public\u2019s main con cerns revolved around what would happen if the algae were to escape from Mera\u2019s facility.<\/p>\n
The DOA staff\u2019s submittal to the board states that Olaizola had acknowledged that small leaks in the system would not be de tected, especially in pipes that are located underground. According to testimony by University of Texas algae expert R. Malcolm Brown, Jr., contrary to Mera\u2019s claims that Chlamydomonas could not travel far and would not survive if it escaped, the algae \u201ccan grow and reproduce in soils, and living cells can be transported in the air. Either the zygotes, or more often, clumps of vegetative cells or even the gametes which dry out, are perfectly viable and can be recovered\u2026 Thus, I worry about this organism being introduced into the native environment.\u201d Brown has studied airborne algae in Hawai\u2018i extensively and has published several papers on the sub ject.<\/p>\n
University of Hawai\u2018i algae expert Celia Smith offered similar testimony about the algae\u2019s hardiness, adding, \u201cin the scenario of a spill, cells that fall on soil are, in fact, back in their native habitat.\u201d<\/p>\n
Dr. Lorrin Pang, state district health of ficer for Maui, who has worked with the World Health Organization on developing and reviewing new drugs, expressed concerns about the public health threat the algae posed.<\/p>\n
\u201cThe National Academy of Sciences has pointed out that GE-modifications can lead to much more unintended variations com pared to an organism\u2019s natural analog. Whether these variations are harmless or dangerous is unknown at this stage. Effects are hard to predict. That is why medical products produced by GE methods are care fully purified, tested in humans and labeled\/ monitored after marketing,\u201d he wrote.<\/p>\n
At the meeting, Board of Agriculture mem ber Ben Lindsey admitted that given all the new testimony, he didn\u2019t know enough and, frankly, did not understand enough of the information before him to approve the per mit.<\/p>\n
Board member Liu, on the other hand \u2013 who had already committed to support the application \u2013 said he thought that since the permit had made it through the Board of Agriculture\u2019s review process and had been given the green light from the lower commit tees, the board should also approve the per mit.<\/p>\n
\u201cWhen you\u2019re dealing with science you will never have certainty\u2026 I think the debate on this board should be if we vote against it then we don\u2019t believe the procedures\u2026 The scope of our inquiry and the basis of our judgment is whether or not those procedures have been put in place,\u201d he said.<\/p>\n
Despite Liu\u2019s push for approval, the board voted that day to deny the requested permits, with Liu, Alan Gottlieb and Doug MacCluer opposing the motion to deny.<\/p>\n
Dash for Data<\/i><\/b>
\nAfter being deluged at the May 24 meeting with questions about the ramifications of an algae release, Mera and Ricon began several experiments at Ricon\u2019s La Jolla lab to address some of those questions. The experiments, which began shortly after the May meeting, looked at the algae\u2019s ability to grow in seawa ter, anchialine pond water, various concen trations of bleach and salt water, and in the absence of water.<\/p>\n
In a June 8 email to Takahashi, Franklin said the experiments would be complete around June 20, roughly a week before Takahashi planned to present the board with her recommendation on the importation of the seven other transgenic strains.<\/p>\n
In addition to gathering data to present to the board, Mera also decided to scale back its project. Instead of using bioreactors in a range of sizes up to 26,000 liters, the algae would be grown in three bioreactors of 500 liters each, for a total volume of 1,500 liters.<\/p>\n
At the June 28 Board of Agriculture meet ing in Kona, Mera claimed its project was \u201csmall scale\u201d now that it was no longer using the largest bioreactors. (However, the Na tional Institutes of Health Recombinant DNA Guidelines and the Canadian Laboratory Safety Guidelines define \u201clarge scale\u201d micro\u00adorganism production as anything greater than 10 liters. In Japan, according to \u201cBiosafety Considerations for Large-Scale Pro duction of Microorganisms,\u201d by Mary Cipriano, anything greater than 20 liters qualifies as large scale.)<\/p>\n
In response to concerns about the impacts of human consumption of the drug-containing algae, company representatives stressed that humans consume antibodies all the time, in their own saliva, and in foods like milk and eggs.<\/p>\n
Company representatives also pre sented the results of their experiments:<\/p>\n
Basically, the companies argued, the algae die in salt water, live a short time in brackish water, and die some time between 16.6 hours and a week without water.<\/p>\n
Despite criticism from members of the public that the experiments were not rigorous and that they suggested the algae could sur vive long enough to be carried some distance, the results were apparently sufficient to satisfy concerns of the Board of Agriculture, al though members Lindsey and Wes Sahara continued to oppose the permit.<\/p>\n
But before the board made its vote, Isaac Moriwake, an attorney with Earthjustice, informed the board that it needed to comply with the state\u2019s environmental review laws before it approved the permit. That meant that an environmental assessment was re quired at the very least, and possibly a full environmental impact statement. After hear ing hours of public testimony mostly against the project, the board discussed Moriwake\u2019s claim in executive session, but later chose to dismiss it and approve the permit.<\/p>\n
Protest<\/i><\/b>
\nBy the time the board took its vote, the project had generated significant public op position. In the days following the June meet ing, a group of more than 20 individuals and organizations represented by Henry Curtis and Kat Brady of Life of the Land, and calling itself Na Maka O Hawai\u2018i Nei, filed a petition with the DOA seeking a contested case hear ing.<\/p>\n
(Na Maka O Hawai\u2018i Nei is a broad coalition of environmental and Native Ha waiian groups as well as concerned individu als.)<\/p>\n
In its petition, Na Maka members claimed that Mera\u2019s proposal threatened their health and the environment on which they depend for subsistence, gathering, and recreation.<\/p>\n
On August 15, Board of Agriculture chair and Department of Agriculture administra tor Sandra Lee Kunimoto issued a one-paragraph letter to Na Maka O Hawai\u2018i Nei denying its request. After reviewing the rel evant statutes and rules, Kunimoto wrote, \u201cwe have concluded that the [group] is not entitled to a contested case hearing\u2026.. [T]he opportunity for hearing for aggrieved persons\u2026pertains to those who are entitled to personalized, written notification of the board\u2019s decision, that is, those whose request involves a Department regulated activity and requires Board approval.\u201d<\/p>\n
In her letter, Kunimoto did not identify who \u201cwe\u201d were. And in a subsequent appeal of her decision, Na Maka argued that that in itself was an error.<\/p>\n
\u201c[T]here is nothing in the record to dem onstrate that the decision of the Board of Agriculture to deny a contested case hearing was taken after six members of the Board had concurred,\u201d states Na Maka\u2019s appeal, filed in First Circuit Court on September 9 by its attorney David Kimo Frankel.<\/p>\n
If the majority of the board had not agreed to the denial, that failure \u201cwould render any decision announced by the Chairperson of the Board as null and void,\u201d Frankel wrote.<\/p>\n
And contrary to Kunimoto\u2019s assertion that only those seeking regulatory approval from the board are eligible for a contested case hearing, Frankel continued, the Board of Agriculture\u2019s rules allow contested case petitions to be filed by \u201cany person aggrieved by a decision or ruling of the board.\u201d<\/p>\n
On October 6, deputy attorneys general David Webber and Deborah Day Emerson filed a motion to dismiss the appeal, on behalf of the Board of Agriculture. They argued that decisions growing out of con tested cases can be appealed to the courts, but that the courts do not have jurisdiction to consider denial of a contested case request. Finally, they told the court that the board\u2019s rules under which the permit was approved do not require a contested case be granted.<\/p>\n
Overturned!<\/i><\/b>
\nOn a separate front, \u2018Ohana Pale Ke Ao, Protect Kohanaiki \u2018Ohana, GMO-Free Hawai\u2018i, and Sierra Club-Hawai\u2018i Chapter filed on August 2 a complaint in Third Circuit Court against the Board of Agriculture\u2019s decision to approve the impor tation of the seven genetically engineered algae strains without an environmental as sessment.<\/p>\n
In their September 12 motion for sum mary judgment, the groups, represented by Moriwake of Earthjustice, argue that the Hawai\u2018i Environmental Policy Act (HEPA) requires that at the very least an EA be done for all actions that \u201cpropose the use of state\u2026lands,\u201d which Mera\u2019s proposal does.<\/p>\n
In a declaration supporting the com plaint, Lorrin Pang states, \u201cThe applicant\u2019s argument that these products are safe be cause humans are exposed to antibodies all the time in saliva reveals an even more alarm ing lack of care. Such reasoning is equivalent to arguing that because we are routinely exposed to all kinds of viruses, all viruses (including, for example, Hepatitis B, avian influenza, and SARS) are safe. The question is what risks do these particular products (in tended and unintended) pose. I am not aware of any studies by the applicant or anyone else regarding the health risks of these particular products; speculation does not suffice to jus tify any exposure.\u201d<\/p>\n
The data Mera presented to the BOA was also picked apart in a declaration by Douglas Gurian-Sherman, a genetic engineering ex pert who had worked for the EPA evaluating the safety of microbes and genetically engi neered crops.<\/p>\n
\u201cIn general, risk assessment requires an evaluation of both the hazard of the organism, and the likelihood of exposure (including the amount and frequency of exposure). The data submitted by the applicants address a small part of the possibility of exposure of the Hawaiian environment \u2026. and provides no data on the hazard of the algae. Instead, the applicants substitute bald assertions about the algae\u2019s safety to humans or the environment.\u201d<\/p>\n
Despite the arguments presented by Earthjustice, the deputy attorneys general rep resenting the Board of Agriculture argued that the board needed only to complete its internal review process and that it was exempt from HEPA. They also argued that two environ mental impact statements done by NELHA and the now defunct Hawai\u2018i Ocean Science and Technology Park in the 1970s and \u201880s covered any and all activities that might occur on the state\u2019s coastal property.<\/p>\n
On October 10, Circuit Court Judge Eliza beth A. Strance sided with the plaintiffs and vacated the Board of Agriculture\u2019s permit approval because it had failed to comply with the state\u2019s environmental review process.<\/p>\n
\u201cStrance granted the groups\u2019 request for a judgment declaring that, at minimum, an environmental assessment was required for the project, and that the Board\u2019s approval without such review was invalid,\u201d according to an October 11 press release from Earthjustice.<\/p>\n
Calls to the DOA for comment on the ruling were not returned by press time.<\/p>\n
Moriwake says that an argument was made during the court hearing that it was NELHA\u2019s responsibility to conduct the EA, but, he says, that is something that NELHA and the BOA need to work out.<\/p>\n
As for the contested case appeal, in light of the Third Circuit Court ruling, Frankel says he expects the state will argue that his client\u2019s case is now moot. No motion to dismiss had been filed by press time.<\/p>\n
— Teresa Dawson<\/p>\n
Volume 16, Number 5 November 2005<\/p>\n","protected":false},"excerpt":{"rendered":"
“An EA\/EIS should be done to see if there is any lasting problems,” said Hubert Olipares in an email last December, com menting on a plan by Mera Pharmaceuticals, Inc., to discharge into the ground effluent from its planned genetically … Continued<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[127],"tags":[],"class_list":["post-1536","post","type-post","status-publish","format-standard","hentry","category-november-2005"],"_links":{"self":[{"href":"https:\/\/environment-hawaii.org\/index.php?rest_route=\/wp\/v2\/posts\/1536","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/environment-hawaii.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/environment-hawaii.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/environment-hawaii.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/environment-hawaii.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1536"}],"version-history":[{"count":0,"href":"https:\/\/environment-hawaii.org\/index.php?rest_route=\/wp\/v2\/posts\/1536\/revisions"}],"wp:attachment":[{"href":"https:\/\/environment-hawaii.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1536"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/environment-hawaii.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1536"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/environment-hawaii.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1536"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}