A 2014 report, funded by the Department of Energy and the Alfred P. Sloan Foundation, concluded that “the U.S. regulatory agencies have the adequate legal authority to address most, but not all, potential environmental, health and safety concerns” posed by organisms engineered using synthetic biology. The report also identifies two key challenges faced by the EPA, FDA, and the USDA’s Animal and Plant Health Inspection Service (APHIS) in the regulation of these organisms.
- New technologies, like synthetic biology, used to develop genetically engineered organisms increasingly place them outside of APHIS’ authority to review. Last updated in the mid-1980s, the USDA regulations are outdated and often do not apply to modern engineering. This could allow several synthetically engineered plants to make it to field trials or commercial production without passing any regulatory review.
- The rise of synthetic biology will cause a flood of new and diverse genetically engineered products and microbes that could easily overwhelm the EPA’s Biotechnology Program. New technologies have made production faster and cheaper. This could lead to delays, inadequate reviews due to backlog or insufficient expertise/training, and legal challenges.
The report was released shortly after the Glowing Plants Kickstarter campaign of 2013 that exposed loopholes and challenges to the regulation of synbio. A small, independent group of “bio-hackers” set out to modify firefly DNA, enabling it to work in the common mustard weed in hopes of producing plants that would glow in the dark. They designed and then ordered the re-engineered sequence from an online company that prints DNA and injected it into seeds using a special tool called a gene gun. For a small donation, the company agreed to send out packets of the modified seeds as a thank you. They were able to raise close to a half-million dollars from over 6,000 random donors. This resulted in the promise to distribute hundreds of thousands of unregulated and newly engineered seeds across North America (the European Union has tighter restrictions, so the company does not plan to send seeds there). A new organism would be introduced into the eco-system with no third party review or government regulation.
The seeds were not intended for human consumption, so the FDA did not get involved. The EPA decided that it was not under their jurisdiction; therefore, the USDA should handle the regulation of the plant. However, since the genes were injected using a gene gun, a new technology not mentioned in the thirty-year-old guidelines, the USDA declared it was unable to regulate the development and distribution of the glowing plant. The Reagan-era guidelines still in effect regulate organisms that use viruses and bacterial pathogens to deliver the newly engineered genes into plants. New technologies, like the gene gun, have made these methods obsolete, thus leaving a large loophole in regulation that has allowed several companies to by-pass the USDA.
How is synthetic biology regulated?
Synthetic biology is currently virtually unregulated, unassessed, and unlabeled. It is governed by the same set of laws, regulations, and policies established in the 1986 White House Office of Science and Technology Policy (OSTP) publication of the Coordinated Framework for the Regulation of Biotechnology. The Coordinated Framework stated that the existing regulatory bodies (FDA, EPA, and APHIS) and existing federal laws appeared adequately capable of regulating the products of biotechnology. It outlined the agencies’ principal responsibilities and noted that any gaps in regulation should be addressed in a coordinated effort by the agencies. It also acknowledged that the technology would continue to grow and advance, and the agencies would need to evolve along with the technology. This open-ended evolution of the agencies caused some issues. There were disagreements over the appropriate levels of regulation of genetically modified organisms. Recombinant DNA technology was seen by some to be identical to the cross-breeding techniques used for centuries, while others felt it created genetic changes that were highly unlikely to ever occur in nature and should be more closely regulated.
In 1992, OSTP issued a statement to clarify the developing regulations of the agencies pertaining to the genetically modified organisms intended for environmental release. The statement outlined the government’s policy of oversight “based on the risk posed by the introduction” of an organism and not on the process or technique used to produce the organism. The fact that an organism was produced by cutting and pasting DNA strands from different hosts could not be cited as a reason for evaluating it. Only the final product, if found to be a potential risk, could initiate oversight.
This policy leaves the advancement of synthetic biology and the creation of novel DNA and organisms outside the purview of government regulation, oversight, or monitoring, even if it could have significant unintended environmental or health consequences.
APHIS: Authority to regulate plant pests, plant health, and animal health and welfare. The authority to regulate GE field trial crops and deregulate crops for commercial use is based on the use of plant pests to genetically alter the crop. New genetic engineering technology, like CRISPR, does not trigger the plant pest test and, therefore, is not reviewed by APHIS.
FDA: Authority to regulate food, food additives, human and animal drugs. Since FDA oversight only monitors the end product, not how it was made, several synthetically derived compounds are Generally Recognized as Safe (GRAS) on the basis that they mimic an existing compound and so are exempt from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements. It is unclear how the FDA will address novel compounds that do not have natural comparisons.
EPA: Authority to regulate pesticides as well as GE microbes as “new chemical substances” under the Toxic Substances Control Act (TSCA). The large influx of new chemical substances will cause a backlog to the understaffed EPA.
Lack of Disclosure
The fact that technology is moving faster than the speed of government regulation is not the only reason so many engineered yeast by-products are making it to market. Watchdog groups that monitor emerging technologies are having trouble gathering information on these organisms. Companies developing many of these products hide behind claims of “proprietary information” to mask the full results of the tests and studies they have conducted. Much of the research on synbio products is the property of the companies that are developing them. The public is assured of their safety, but since the research involves trade secrets, the results of the studies cannot be disclosed and there is no opportunity for third party assessment. Referred to as Confidential Business Information (CBI), U.S. law states that the “data necessary to ensure the safe use of GMOs can be withheld from public peer review.” In a consumer climate that is demanding more transparency in food production, proprietary information is keeping many in the dark.