“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 modified algae farm at the Kona facility of the state Natural Energy Laboratory of Hawai‘i Authority. He noted that state law requires such effluent to be disinfected before being discharged, in this case, into lava rock.
“Anyway, it is not good laboratory prac tice” to do otherwise, he wrote. Olipares, a bio-safety officer at the Univer sity of Hawai‘i, had been asked for his com ments on the project by Amy Takahashi of the Department of Agriculture’s Plant Quar antine Branch. But his recommendation that the department require an environmental assessment or a more thorough environmen tal impact statement went unheeded.
At the time, Takahashi was processing Mera’s application to the DOA for a permit to import a genetically modified strain of the alga Chlamydomonas reinhardtii, 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 discharged into the rough a‘a lava on which the NELHA complex sits.
Olipares’ brief email is easily lost in the reams of documents on file at the Depart ment of Agriculture regarding Mera’s 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’s waste discharge practices should be subject to the state’s envi ronmental review process.
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.
A Novel Idea
On October 29, 2004, Mera Pharmaceuti cals’ Miguel Olaizola applied to import a genetically engineered strain of C. reinhardtii 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 tory setting. Under Mera’s proposal, the algae would be grown at NELHA in photobioreactors, which would sit in a plastic-lined bath of cool, chlorinated seawater. The DOA’s Plant Quarantine Branch ac cepted Mera’s application as complete on December 24.
Early on, Plant Quarantine’s 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’s Animal Plant Health Inspection Service and the Environmental Protection Agency, “rec ognizing that they do not regulate the growth of our transgenic organism,” according to an email to Takahashi from Scott Franklin, vice president of technology development for Rincon Pharmaceuticals, Inc. in La Jolla, Cali fornia.
The EPA has oversight of pesticides and organisms not regulated by the Food and Drug Administration. But because Mera’s algae is being used to grow FDA-regulated pharmaceu ticals, not pesticides, the EPA’s Flora Chow stated in an email to Franklin that the “expres sion products are excluded from [EPA] jurisdic tion.”
And according to the USDA, Franklin said, because C. reinhardtii doesn’t fit that agency’s 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.
On February 22, Keith Webber, acting di rector of the FDA’s 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’s operations “unless, 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’s Center for Food Safety and Nutrition or Center for Veterinary Medicine, respectively.”
However, Webber continued, most IND applicants can claim a “categorical exclusion” 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.
“If they are not requiring a ‘release permit’ for your operations, then we would not, either,” Webber wrote.
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’s rules, a project such as Mera’s would not necessarily require Board of Agri culture approval.
“As 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,” she wrote. (A note: The rest of the email, when reviewed by Environment Hawai‘i, had been redacted by the depart ment, citing “attorney-client privileged com munication.”)
As the DOA wrestled with Mera’s algae import request, on April 7, Olaizola asked Takahashi to expand Mera’s 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.
The Process
Because 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.
At the same time, the BOA’s Subcommit tee on Algae, which is made up of several of Hawai‘i’s algae experts, had reviewed Mera’s 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.
Responding to these concerns, Olaizola emailed Takahashi, “In 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.”
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, “I assure you that we will do all we can to support this venture and partnership. I will call you to discuss.”
On May 4, the Board of Agriculture’s Advisory Committee on Plants and Animals also unanimously approved Mera’s 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’s 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.
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, “[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.”
With the committee’s 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.
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’s main con cerns revolved around what would happen if the algae were to escape from Mera’s facility.
The DOA staff’s 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’s claims that Chlamydomonas could not travel far and would not survive if it escaped, the algae “can 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… Thus, I worry about this organism being introduced into the native environment.” Brown has studied airborne algae in Hawai‘i extensively and has published several papers on the sub ject.
University of Hawai‘i algae expert Celia Smith offered similar testimony about the algae’s hardiness, adding, “in the scenario of a spill, cells that fall on soil are, in fact, back in their native habitat.”
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.
“The National Academy of Sciences has pointed out that GE-modifications can lead to much more unintended variations com pared to an organism’s 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,” he wrote.
At the meeting, Board of Agriculture mem ber Ben Lindsey admitted that given all the new testimony, he didn’t know enough and, frankly, did not understand enough of the information before him to approve the per mit.
Board member Liu, on the other hand – who had already committed to support the application – said he thought that since the permit had made it through the Board of Agriculture’s review process and had been given the green light from the lower commit tees, the board should also approve the per mit.
“When you’re dealing with science you will never have certainty… I think the debate on this board should be if we vote against it then we don’t believe the procedures… The scope of our inquiry and the basis of our judgment is whether or not those procedures have been put in place,” he said.
Despite Liu’s 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.
Dash for Data
After being deluged at the May 24 meeting with questions about the ramifications of an algae release, Mera and Ricon began several experiments at Ricon’s La Jolla lab to address some of those questions. The experiments, which began shortly after the May meeting, looked at the algae’s ability to grow in seawa ter, anchialine pond water, various concen trations of bleach and salt water, and in the absence of water.
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.
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.
At the June 28 Board of Agriculture meet ing in Kona, Mera claimed its project was “small scale” 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 “large scale” microorganism production as anything greater than 10 liters. In Japan, according to “Biosafety Considerations for Large-Scale Pro duction of Microorganisms,” by Mary Cipriano, anything greater than 20 liters qualifies as large scale.)
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.
Company representatives also pre sented the results of their experiments:
- The algae strain fails to grow and is not viable at salt concentrations greater than 1 percent.
- Three days after inoculation with sea water, none of the strains tested showed signs of growth or vi ability.
- Strains exposed to brackish wa ter were still viable after six days.
- At 70 percent relative humidity, address “the algae survive 1, 10, 100, and 1,000 minutes post drying. After 10,000 minutes, however, we see no viable cells,” a report from Mera states. No data was presented on whether the algae survive between 1,000 minutes (16.6 hours) and 10,000 minutes (6.9 days).
- C. reinhardtii doesn’t form resistant spores or cysts upon drying.
- For a 500-liter system, 400 ml of 12.5 percent bleach solution for 12 hours would be required to kill all of the algae.
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.
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.
But before the board made its vote, Isaac Moriwake, an attorney with Earthjustice, informed the board that it needed to comply with the state’s 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’s claim in executive session, but later chose to dismiss it and approve the permit.
Protest
By 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‘i Nei, filed a petition with the DOA seeking a contested case hear ing.
(Na Maka O Hawai‘i Nei is a broad coalition of environmental and Native Ha waiian groups as well as concerned individu als.)
In its petition, Na Maka members claimed that Mera’s proposal threatened their health and the environment on which they depend for subsistence, gathering, and recreation.
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‘i Nei denying its request. After reviewing the rel evant statutes and rules, Kunimoto wrote, “we have concluded that the [group] is not entitled to a contested case hearing….. [T]he opportunity for hearing for aggrieved persons…pertains to those who are entitled to personalized, written notification of the board’s decision, that is, those whose request involves a Department regulated activity and requires Board approval.”
In her letter, Kunimoto did not identify who “we” were. And in a subsequent appeal of her decision, Na Maka argued that that in itself was an error.
“[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,” states Na Maka’s appeal, filed in First Circuit Court on September 9 by its attorney David Kimo Frankel.
If the majority of the board had not agreed to the denial, that failure “would render any decision announced by the Chairperson of the Board as null and void,” Frankel wrote.
And contrary to Kunimoto’s assertion that only those seeking regulatory approval from the board are eligible for a contested case hearing, Frankel continued, the Board of Agriculture’s rules allow contested case petitions to be filed by “any person aggrieved by a decision or ruling of the board.”
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’s rules under which the permit was approved do not require a contested case be granted.
Overturned!
On a separate front, ‘Ohana Pale Ke Ao, Protect Kohanaiki ‘Ohana, GMO-Free Hawai‘i, and Sierra Club-Hawai‘i Chapter filed on August 2 a complaint in Third Circuit Court against the Board of Agriculture’s decision to approve the impor tation of the seven genetically engineered algae strains without an environmental as sessment.
In their September 12 motion for sum mary judgment, the groups, represented by Moriwake of Earthjustice, argue that the Hawai‘i Environmental Policy Act (HEPA) requires that at the very least an EA be done for all actions that “propose the use of state…lands,” which Mera’s proposal does.
In a declaration supporting the com plaint, Lorrin Pang states, “The applicant’s 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.”
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.
“In 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 …. and provides no data on the hazard of the algae. Instead, the applicants substitute bald assertions about the algae’s safety to humans or the environment.”
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‘i Ocean Science and Technology Park in the 1970s and ‘80s covered any and all activities that might occur on the state’s coastal property.
On October 10, Circuit Court Judge Eliza beth A. Strance sided with the plaintiffs and vacated the Board of Agriculture’s permit approval because it had failed to comply with the state’s environmental review process.
“Strance granted the groups’ request for a judgment declaring that, at minimum, an environmental assessment was required for the project, and that the Board’s approval without such review was invalid,” according to an October 11 press release from Earthjustice.
Calls to the DOA for comment on the ruling were not returned by press time.
Moriwake says that an argument was made during the court hearing that it was NELHA’s responsibility to conduct the EA, but, he says, that is something that NELHA and the BOA need to work out.
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’s case is now moot. No motion to dismiss had been filed by press time.
— Teresa Dawson
Volume 16, Number 5 November 2005