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Microalgae Raise Flags

Regulatory agencies scramble to evaluate the risks of engineered algae and other synthetic biology products

by Britt E. Erickson
October 19, 2015 | A version of this story appeared in Volume 93, Issue 41

A micrograph of microalgae.
Credit: Solazyme
Biotech companies are tweaking oil-producing microalgae to create alternatives to petroleum-based products.

Microalgae are grabbing headlines for their ability to produce oils that can be used to make chemicals, industrial lubricants, transportation fuels, edible oils, high-protein “superfoods,” antiaging creams, and other goods. In many cases, these single-cell microorganisms are genetically engineered to enhance the properties of the oils and to boost production.

The Environmental Protection Agency has seen a significant rise this year in the number of applications from firms hoping to market products in the U.S. derived from engineered algae and other microorganisms. And because of new gene-editing tools, the agency is expecting to face a deluge of such applications in the near future.

Advances in genetic engineering have provided scientists with tools to easily manipulate the genetic material of microorganisms. Researchers are moving beyond replacing just one gene in an organism into a realm commonly referred to as synthetic biology. They can now replace a few key genes in a metabolic pathway, or chemically synthesize entire gene sequences that alter how proteins are encoded.

EPA has the authority to regulate these modified microorganisms under the Toxic Substances Control Act, a 1976 law that governs commercial chemical production in the U.S. Manufacturers must notify EPA 90 days prior to commercializing biotech microorganisms for any use that falls under the jurisdiction of TSCA. Many products, however, do not fall under TSCA, including pesticides, drugs, foods, and cosmetics.

Companies that are developing products with genetically modified microorganisms, including algae, say it is difficult to navigate the complex U.S. regulatory landscape. At the same time, consumer and environmental advocacy groups are raising concerns about gaps in federal oversight that allow some products to enter the market without being evaluated for potential environmental, health, and safety risks.

In July, the White House directed EPA, the Food & Drug Administration, and the U.S. Department of Agriculture—the three federal agencies with jurisdiction over biotechnology—to overhaul the current regulatory system. That system, called the Coordinated Framework for Regulation of Biotechnology, was put in place in 1986 and last updated in 1992.

“This call for a new era of federal oversight is a long overdue acknowledgment that rules and regulations over technologies like synthetic biology are severely inadequate, leaving the public, the environment, and economy at risk,” said Tim Schwab, a food researcher with the advocacy group Food & Water Watch.

Schwab presented his comments late last month at an EPA workshop focused on the health and safety data needed for the responsible development of engineered microalgae. EPA is updating guidance for industry that focuses on those needs. That guidance will then be incorporated into a broader EPA document that evaluates advances in biotechnology since 1997.

“Addressing these research needs may directly or indirectly support EPA’s evaluation of such products under TSCA, as well as more broadly help advance the responsible development and application of synthetic biology,” EPA said.

Many of the discussions at the meeting centered on whether EPA should regulate the end product of biotechnology or the process itself. Current regulations focus on the end product.

Some companies advocated for both. “We need to clearly define the organism used to produce a particular product, and then we need to define the process by which that product is produced,” said Peter J. Licari, chief technology officer of Solazyme, an algal oil firm. “We use microalgae. However, we don’t use open ponds or photobioreactors,” he noted. Solazyme cultivates its microalgae in the dark in stainless steel industrial fermentors.

“EPA has had regulations in place for decades covering microbial industrial fermentation, making everything from enzymes to citric acid,” Licari pointed out.

Others at the meeting worried that EPA lacks the expertise and resources to thoroughly review every engineered microorganism being developed. “Companies with large synbio programs, including those producing algal biofuels, may be considering dozens or hundreds of variants of their products,” said Jaydee Hanson, policy director for the International Center for Technology Assessment, an advocacy group.

Other environmental advocates raised concerns about the unintentional release of engineered microalgae into the environment. “Synbio organisms escape unintentionally from laboratories, biorefineries, and production vats through faulty containment systems and/or human error,” said Dana Perls, food and technology campaigner for Friends of the Earth. “The impacts of release could include genetic contamination of wild species, disruption of natural ecosystems, facilitation of harmful algal blooms, and release of chemical and biological pollutants,” she said.

But industry representatives at the meeting defended their containment approaches. In some cases, algae are engineered to rely on compounds added to a bioreactor for growth. Those compounds are not readily available in the environment, so if the algae are put in the environment under natural conditions, they die quickly, said Patrick Ahlm, assistant director of government and regulatory affairs at Algenol. This biotech firm is commercializing algal technology for producing ethanol and other biofuels.

Ahlm emphasized that Algenol thoroughly characterizes its algae, which includes a full genome sequence analysis. The company also demonstrates that its algae lack the potential to produce toxins and confirms with liquid chromatography-mass spectrometry that the algae are not making them, he said. Algenol also worked with the Florida Department of Agriculture & Consumer Services to show that gene transfer between its modified algae and native algae doesn’t occur and that its algae are noninvasive.

Ahlm and other representatives of the biotech algae industry emphasized the benefits of their technologies, including the ability to use captured carbon dioxide emissions to produce sustainable fuels and other products.

“We apply genetic engineering technology to some of our microalgae when we are seeking significant performance benefits such as safety, sustainability, or health advantages,” Solazyme’s Licari pointed out. For example, he said, “we developed an oil with a higher flash point to improve the safety of lubricants as well as a more sustainable alternative to palm oil.”

Environmental groups, meanwhile, questioned why EPA is working on updating biotechnology guidance documents under TSCA, an outdated law that nearly everyone agrees needs modernized.

TSCA “was not designed for assessing the novel risks associated with new biotechnologies,” Food & Water Watch’s Schwab said. “EPA should be collaborating with other federal agencies to comprehensively develop a new framework that follows the precautionary principle and offers holistic, systematic review of all of the relevant risk dimensions associated with new biotechnology products.

“If a company markets its engineered algal oils as an industrial lubricant,” Schwab added, EPA would review the product under TSCA. “But if the company markets a similar or even identical oil for use as a food, TSCA does not apply.” Food products fall under the purview of FDA, which has a voluntary notification process that does not require an environmental safety assessment, he added.

EPA acknowledges that the field of synthetic biology is evolving quickly and that microalgae are just a sliver of the biotechnology space. “We recognize that we have a responsibility as part of the federal government to foster dialogue on biotechnology more broadly,” said Jeff Morris, a deputy director at EPA’s Office of Pollution Prevention & Toxics.

To that end, EPA representatives plan to join FDA and USDA officials later this fall at the first of three meetings intended to gain public input on updating biotechnology regulations across the federal government.  


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