Pharmaceutical Research Delayed for Lack of Environmental Review

‘Ohana Pale Ke Ao v. Board of Agriculture, Civil No. 051-144K (Hawaii 3rd Cir. Dec. 16, 2005).

Stephanie Showalter

In October, a Hawaii trial court ruled that the Hawaii Board of Agriculture (Board) must conduct a full environmental review prior to permitting the importation of genetically modified algae. Although the completion of an environmental review is usually prudent, Earthjustice’s victory appears to have had more to do with people’s fear of genetically modified organisms (GMO) than the actual environmental risks presented by the project.

Background
In May 2005, Mera Pharmaceuticals announced that it was partnering with Rincon Pharmaceuticals to test whether microalgae can be cultivated on a large scale for the production of human protein therapies. The San Diego-based Rincon Pharmaceuticals develops recombinant protein therapeutics, such as monoclonal antibodies, using an eukaryotic algae, Chlamydomonas reinhardtii, as a production system. The technology was developed at Scripps Research Institute and “involves introducing the gene sequence responsible for producing a particular human protein into the cells of the algae.”1 The algae will then produce that protein which can be harvested and developed into a drug. Rincon currently produces proteins in the laboratory, but the technology will only be useful to the pharmaceutical industry if production can occur on a commercial scale.

Pharmaceutical companies currently use industrial fermenters to cultivate bacteria from which they produce drugs. Unfortunately, microalgae cannot be cultivated in fermenters because the plants need sunlight. Mera Pharmaceuticals believes it has solved this problem. According to the company’s website it has developed a “closed, controlled system that admits through its transparent walls the light that plants need to grow.” A mixture of algae, nutrients, and freshwater is kept in constant circulation within these “photobioreactors” where computers closely monitor pH, temperature, nutrient levels, and light. The photobioreactors, which must be located outside, resemble small trenches covered in plastic. Mera currently uses this system at its facilities at the Natural Energy Laboratory Hawaii (NELHA), a land-based aquaculture technology park in Kona, Hawaii, to produce dietary supplements.

If the algae-based production system proves successful, it could reduce the cost of producing monoclonal antibodies to $100 to $150 per gram. Today, a gram costs between $1,000 to $1,500 and some drug companies charge as much as $20,000 per patient for some protein drugs.2

Regulatory Framework
Chlamydomonas reinhardtii is included on Hawaii’s “List of Restricted Microorganisms” and a permit is required from the Plant Quarantine Branch (PQB) to import and possess. Mera applied for an importation permit and the PQB determined that the particular GM algal strains Mera sought to import posed an above-moderate risk which triggered a requirement that the Board approve the permit. Several contentious public hearings were held. Opponents seem particularly worried that the algae could escape and become established in Hawaii or cross with native strains of Chlamydomonas.3 Mera and Rincon insist the risks are low (the algae will be enclosed in plastic and not open to the environment) and can be mitigated by containment procedures. The Board eventually granted Mera permission to import seven strains of Chlamydomonas to start field trials at NELHA. No written opinion was issued. Earthjustice, on behalf of a number of citizen groups including GMO-Free Hawaii and the Hawaii Chapter of the Sierra Club, filed suit soon thereafter.

Lawsuit
Earthjustice focused on the fact that the Board had not conducted an environmental review pursuant to the Hawaii Environmental Policy Act (HEPA). HEPA applies to, among other things, actions that “propose the use of state or county lands.”4 HEPA requires the preparation of an environmental assessment (EA) to determine whether an environmental impact statement is necessary. The court held that, at a minimum, an EA should have been prepared because the algae is intended for use at NELHA, a state-owned and -operated facility. Although the record revealed that the Board undertook a detailed assessment pursuant to its importation procedures, the court found no case law to support the Board’s position that this supplemented HEPA review. Two environmental impact statements prepared for NELHA in 1976 and 1985 did consider the production of algae, but the court found that the mass production of GM algae is a “new circumstance which may constitute a different environmental impact.”

Conclusion
The court’s ruling rendered the Board’s approval invalid. The Board will need to prepare at least an EA before re-permitting the project. The additional delay and cost associated with an extensive environmental review seems unnecessary in this case. Mera and Rincon intend to use an existing facility to grow algae in a closed system. Yes, it is genetically modified, but a microalgae production process could result in much-needed new drugs. Opponents of the project voiced generalized concerns related to the use of GM in agriculture rather than focusing on the specific project. This case is a prime example of the need for companies and proponents of new technology to conduct public outreach campaigns. The public is less likely to oppose projects they understand and companies they believe have fully considered the risks.

Endnotes
1. Penni Crabtree, Algae to Antibodies, The San Diego Union-Tribune, May 20, 2005.
2. Id.
3. Dayton Kevin, Modified Algae Project Halted, The Honolulu Advertiser, Oct. 11, 2005.
4. Hawaii Rev. Stat. §343-5(a)(1).