GCB Bioenergy (2012) 4, 127–129, doi: 10.1111/j.1757-1707.2011.01134.x
LETTER
New hope for dedicated genetically engineered bioenergy feedstocks? A. BRYAN ENDRES University of Illinois, Energy Biosciences Institute, Urbana, IL 61801, USA
Abstract The unique regulatory requirements and costs of genetic engineering (GE) are likely to inhibit commercialization of dedicated bioenergy crops due to the relatively small current market. Two recent regulatory approvals for GE plants, however, may signal a shift in policy and an opening of a door to a streamlined federal regulatory pathway for commercialization for non-food plants. The change, however, may shift regulatory battles from the federal to the state and local level, as each state has independent authority to regulate plants under respective noxious weed/plant protection statutes. This previously dormant state regulatory power could result in even more complex barriers to commercialization of GE bioenergy crops–replacing the regulatory delays embedded in the federal system with regulatory chaos at the state and local level. Keywords: agriculture, biotechnology, genetic engineering, regulation Received 20 September 2011 and accepted 20 September 2011
Genetic engineering (GE) has the potential to accelerate the development of dedicated bioenergy crops, from more readily saccharified lignocellulose and dropin-fuels, to pest resistance and decreased nitrogen requirements. However, the unique regulatory requirements and practical costs of this particular route to genetic improvement are likely inhibitory to the commercialization of material for what is currently a small market. The United States regulates the field testing and commercialization of genetically engineered (GE) plants under a 1986 tri-agency agreement knows as the Coordinated Framework for the Regulation of Biotechnology (51 Fed. Reg. 23302, 2006). This complex system envisioned oversight by the USDA to prevent introduction of agricultural pests and noxious weeds under its Plant Protection Act (PPA) authority, the EPA to regulate plant incorporated protectants through its Federal Insecticide, Fungicide, and Rodenticide Act regulatory powers, and the FDA to ensure the safety of food and feed products via its general jurisdiction under the Federal Food, Drug, and Cosmetic Act. Despite the agencies’ overall track record of regulatory success, several commentators have decried this multistep, multiagency regulatory system as terribly inefficient and imposing undue regulatory burdens on the development of GE crops, both in terms of time and cost (Hancock, 2003; Bradford et al., 2005; Johnson et al., 2007; Strauss et al., 2010). Recent agency actions regarding Correspondence: A. B. Endres, tel. + 217 344 7255, fax + 217 244 5933, e-mail:
[email protected]
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two GE plants, however, have opened the door to a potentially streamlined regulatory pathway toward commercialization for certain nonfood plants, which largely bypasses the Coordinated Framework’s oversight process. This may provide a route for the more rapid development and commercialization of dedicated bioenergy crops enhanced through GE. On the other hand, taking advantage of this potential regulatory loophole may engender additional criticism from interest groups concerned about potential invasiveness of novel bioenergy crops or other groups with generalized opposition to GE, thereby potentially jeopardizing broad-based public support for bioenergy. Congress enacted the PPA to prevent the spread of disease and invasive plants by controlling plant movement and release within interstate commerce. One preventative strategy adopted by the statute is to regulate the distribution of potential plant pests. Although in agriculture a pest means an animal that damages a crop, under the PPA a different definition is used. PPA implementing regulations define a plant pest as any organism which can directly or indirectly injure any plant or product derived from a plant. USDA’s Animal and Plant Health Inspection Service (APHIS) has responsibility for administering the PPA and the attendant regulations. With the development of GE plants, regulatory oversight fell to APHIS under the premise that GE plants are potential plant pests. For well over a decade, APHIS treated all new GE plants as regulated articles, subject to extensive field trials designed to assess whether the product was, in fact, a plant pest. 127
128 A . B . E N D R E S After successful field trials, plant developers could petition APHIS to deregulate a variety based on field testing results that demonstrated the plant was not a potential plant pest. For commodity agricultural purposes, deregulation was a necessary precursor to commercialization as an APHIS deregulation determination allowed the sale, distribution, and postharvest disposition of the new plant variety without further APHIS oversight. The path to deregulation, however, was time consuming, costly, and inserted regulatory risk into the plant development process (Jaffe, 2006). Accordingly, biotechnology proponents advocated for a substantial relaxation of the regulatory review process. In 2007, APHIS sought public comments for a revised regulatory approval and segregation/isolation mechanism. This proposal, however, has yet to move forward in the rulemaking process and appears permanently stalled. As a result, most in the biotech industry resolved themselves to working within the existing regime for the foreseeable future and most of the multiple GE advances demonstrated in the laboratory or controlled field environments are unlikely to move forward to commercialization. However, recent APHIS decisions on the regulatory status of two GE plants, may have opened the door to a potentially streamlined regulatory pathway toward commercialization for certain nonfood crops; a procedure which largely bypasses the Coordinated Framework’s oversight process. From a legal perspective, APHIS’s implementing regulations for the PPA define a regulated article as any organism produced through GE, but only if either the donor, recipient, vector or vector agent is listed a plant pest in the regulation or the APHIS Administrator has reason to believe it is a plant pest. Accordingly, APHIS’s jurisdiction under the PPA extends only to regulated articles–not every plant altered through GE. In 2008, APHIS, in response to a petition filed by New Zealand Crop and Food Limited, determined that a GE Petunia (Petunia) genetically modified via an Agrobacterium tumefaciens-mediated plant transformation to alter the flower color was not a regulated article because neither the recipient, donor, vector, nor vector agent was a plant pest. As a nonregulated article, APHIS lacked jurisdiction to subject the GE Petunia to the PPA’s regulatory process (i.e., field testing followed by a petition for deregulation). Moreover, as a nonfood/feed plant, the GE Petunia avoided FDA review under the Federal Food, Drug, and Cosmetic Act. And, as the novel plant did not encompass a plant incorporated protectant or alter a use of a pesticide, the EPA lacked jurisdiction under its pesticide safety statutes. In sum, the GE Petunia avoided the Coordinated Framework’s federal regulatory process.
Recognizing the cost-savings potential of this regulatory loophole, Scotts Miracle-Gro, genetically engineered a new ‘Round-up Ready’ variety of Kentucky Bluegrass (Poa pratensis L.). Specifically, the plant developer genetically engineered the grass to express an enzyme, 5-enolpyruvylshikimate-3-phosphate synthase, derived from thale cress (Arabidopsis thaliana) to provide glyphosate tolerance. Kentucky Bluegrass is not listed as a plant pest and no organisms used as the source for genetic material (i.e., thale cress, rice or corn) are considered plant pests. Moreover, biolistics, the method used to genetically engineer the Kentucky Bluegrass, did not involve a plant pest. Because the developer used no plant pests or unclassified organisms to perform the GE, APHIS concluded in July 2011, that it had no reason to believe the resulting GE product was a plant pest. Therefore, the agency lacked jurisdiction under the PPA to regulate the novel plant. As another in the expanding line of glyphosate tolerant plants, the Kentucky Bluegrass will avoid the lengthy environmental review process (and inevitable litigation) experienced by herbicide tolerant alfalfa and sugar beets. (Endres, 2011). In the alfalfa and sugar beet experience, specific aspects of the APHIS environmental review under the National Environmental Policy Act and the accompanying court litigation focused on the cumulative impact of glyphosate tolerant plants. But APHIS’ jurisdiction-based decision in the Kentucky Bluegrass case sidesteps this precarious regulatory hurdle. Whether the approvals for GE Petunias and Kentucky Bluegrass signal a shift in overall agency regulatory philosophy or are two isolated events remains to be seen. But what is clear at this point is that scientists seeking to enhance dedicated bioenergy crops such as Miscanthus or poplars through GE may have a simplified pathway through what previously has, in effect, been a costly and time consuming regulatory barrier. And to the extent these grasses do not include plant incorporated protectants, or have residual uses as food or forage, they may avoid EPA and FDA review, as well. In sum, GE bioenergy crops could forego the Coordinated Framework process entirely. The Coordinated Framework, although perceived by many in the biotechnology industry as onerous, is not the only regulatory obstacle. The noxious weed provisions of the PPA may trigger USDA scrutiny outside of the regulated article rules applicable to GE plants. In fact, several interest groups have filed suit against the USDA challenging the agency’s concurrent finding that GE Kentucky Bluegrass is not a noxious weed. There is, however, a downside. Potential battles may loom at the state and local level, as each state (and © 2011 Blackwell Publishing Ltd, GCB Bioenergy, 4, 127–129
N E W H O P E F O R G E B I O E N E R G Y F E E D S T O C K S ? 129 within some states, each county) may independently declare a plant a noxious weed under respective state noxious weed/plant protection statutes. With the exception of a few California counties, most states to date have deferred regulatory action with respect to GE plants in reliance on a comprehensive environmental and safety review at the federal level. (Endres, 2006). But to the extent a new wave of GE plants circumvent federal oversight under the Coordinated Framework, states may decide to assert their previously dormant regulatory authority. For example, the Oklahoma Agricultural Biotechnology Act requires a permit from the State Board of Agriculture before moving or releasing any GE organism (2 Okl. St. Ann. § 11-40). The Oklahoma statute, however, has an exemption for those organisms in which there is an application for ‘regulatory approval from the appropriate federal agency’. Would plant developers foregoing regulatory review under the Coordinated Framework now have to seek approval before the Oklahoma State Board of Agriculture? Will other states implement similar safety and environmental review processes? If states were to decide to regulate, given the absence of a Federal requirement, more complex barriers could arise. States could unilaterally prohibit the distribution, transportation or planting of varieties approved in other jurisdictions. There is the potential therefore to replace the regulatory delays embedded in the federal Coordinated Framework with regulatory chaos at the state and local level. Although few in the biotechnology industry would point to the European Union’s system of GE plant regulation as a model for emulation in the United States, it is important to note that in the early 1990s, the European biotechnology industry supported EU-level legislation in order to establish a standardized and predictable system. (Grossman & Endres, 2000;
© 2011 Blackwell Publishing Ltd, GCB Bioenergy, 4, 127–129
Balter, 1991). Circumventing the Coordinated Framework, therefore, may have some short run benefits, but the potential exists for an even more complex and disjointed process to evolve in its place at the state and local level. And, without the protective cover of federal approval, a single environmental or safety incident could turn the relatively unsophisticated public perception of GE (McHughen, 2007) against the industry. Accordingly, in this new environment of regulatory freedom, precautionary environmental and safety stewardship measures at the industry-level, such as those advocated by the Biotechnology Industry Organization’s affiliate Excellence Through Stewardship®, warrant particular attention.
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