The StarLink Scandal and Biofuels: Recommendations for Amendments to the EPA’s Giant Reed and Napier Grass Ruling

By Kaitlin C. Straker, A. Bryan Endres, Elise C. Scott, & Alison Gomer

I. Introduction

The risks and benefits of emerging biology-based technology have engendered significant debate, particularly regarding the scope of the Environmental Protection Agency’s (EPA) biotechnology-related regulations.[1] Critics charge that federal regulation of biotechnology has been minimal and influenced by industry at the expense of precautionary environmental and health protection.[2] They warn that previous negative experiences with pesticides concerning harmful effects on human safety and the environment should caution regulators against allowing unfettered development and marketing of novel technologies.[3]

Moreover, the EPA’s patchwork and ad hoc regulatory approach[4] lacks clarity and consistency which fuels the debate and can have costly consequences.[5] For example, the EPA’s regulatory oversight of biotechnology, specifically pesticides incorporated through genetic engineering of seeds, relied on a novel interpretation of the Federal Insecticide, Fungicide, Rodenticide Act (FIFRA)[6]—an act passed a decade[7] before the invention of genetic engineering[8] and intended to regulate application of pesticides. The EPA’s regulation of feedstocks intended for biofuels involves a similar twisting of regulatory authority under the Clean Air Act.[9] The EPA’s new regulations under the Clean Air Act require the agency to carry out Weed Risk Assessments (WRAs), an area normally left to the USDA and its Animal and Plant Health Inspection Service (APHIS)[10] under the Plant Protection Act.[11]

This Article examines the EPA’s role in bioenergy regulation, and the agency’s past attempts to control genetically engineered plants. Part II of this Article discusses the Clean Air Act’s authority over plants intended for bioenergy. Part III of this Article reviews the history of the EPA’s regulation of genetically engineered corn, and Part IV of this Article recommends a regulatory innovation based on the lessons learned.

II. Bioenergy Feedstock Regulation

The Renewable Fuel Standard (RFS),[12] part of the Energy Independence and Security Act,[13] directed the EPA to develop and implement regulations to increase biofuel use through a series of escalating mandates.[14] From a compliance perspective, fuel retailers must blend in certain percentages of biofuels to achieve the overall RFS mandate.[15] Renewable Identification Numbers (RINs) associated with biofuel production ensure a reduction in life-cycle greenhouse gas (GHG) emissions associated with the feedstock’s production and processing.[16] The EPA evaluates each potential bioenergy feedstock as part of this GHG calculation.[17] Feedstock pathways meeting the required GHG reduction will qualify for RINs and thus blending to meet the RFS mandates.[18]

In 2012, Chemtex Group and BP Biofuels North America petitioned the EPA[19] to approve Arundo donax (giant reed)[20] and Pennisetum purpureum (napier grass),[21] and though initially approved,[22] the EPA later rescinded its decision[23] based, in part, on public concern related to the potential for these crops to escape cultivation and become invasive.[24] In July 2013, the EPA finalized a revised rule that approved the biofuel pathways for napier grass and giant reed.[25] This revised ruling imposes a unique requirement on fuel producers to ensure the feedstocks used to generate biofuels do not become invasive outside of cultivation.[26] The rationale behind this Clean Air Act requirement is that additional GHG emissions would result from eradication activities in the event of an invasion.[27] The EPA’s ruling also poses a regulatory challenge to fuel producers, who are responsible for feedstock production practices instead of the feedstock grower—the party actually implementing those practices.

Specifically, the agency requires fuel producers, not growers, utilizing napier grass or giant reed to submit a Risk Mitigation Plan (RMP) that specifies invasion prevention procedures and record-keeping.[28] Essential documents in a RMP include the agreements with the feedstock growers and other intermediaries involved in harvest, transport, or storage of the biomass.[29] Incorporated within these agreements should be the assignment of rights, duties, and liability associated with the RMP or potential spread of the feedstock.[30] In addition to submitting copies to the EPA, the agency requires a third party auditor to monitor compliance.[31]

Researchers note that because this rule requires a close, communicative relationship between the biomass grower and fuel producer prior to the sale of biomass for conversion to biofuel, the EPA is oversimplifying the agricultural supply chain.[32] The agency assumes a direct relationship between the feedstock grower and ultimate fuel producer. It is difficult, however, even in this initial stage of industry development to trace feedstocks on a producer-by-producer basis, and as this industry expands into a commodity-based supply chain, traceability will be increasingly difficult. Moreover, the rule, as written, could eventually keep farmers without a pre-existing relationship with a fuel producer out of the bioeconomy.[33]

III. Previous Biotechnology Regulation: Bt Corn Example

Under FIFRA,[34] the Federal Food, Drug, and Cosmetic Act (FFDCA),[35] and the Toxic Substance Control Act (TSCA),[36] the EPA obtained authority to regulate pesticides and ensure a given pesticide would not produce negative consequences for the environment, human safety, or non-target species.[37] With the invention of genetically engineered plants containing pesticide activity, the Presidential-level working group charged with determining the regulatory policy for biotechnology concluded the existing laws were adequate to meet the needs of new biotechnology inventions.[38] Accordingly, the EPA’s responsibility for regulating pesticides expanded to include regulating genetically modified crops containing pesticide activity through a reinterpretation of its FIFRA authority.[39]

Starting in the mid-1990s, the EPA began approving genetically engineered Bt corn[40] as a plant pesticide[41] (now referred to as plant incorporated protectants).[42] In 1998, the EPA registered a particular variety of Bt corn, StarLink,[43] for industrial uses and animal feed.[44] The EPA amended StarLink’s registration several times, and in 2000, the EPA added conditions, which imposed unique requirements on seed manufacturers to help prevent commingling with other corn varieties intended for human consumption.[45] Specifically, seed manufacturers were tasked with ensuring that corn grown within 660 feet of StarLink could not be used for human consumption and required the creation of grower agreements negotiated between the seed manufacturer and the farmer, which mandated a twenty percent refuge[46] of non-Bt corn be planted to prevent insect resistance.[47]

During this time, concern regarding under-regulation of novel genetically engineered crops led the organization Genetically Engineered Food Alert[48] to test foods for the presence of foreign DNA, and in September 2000, the group discovered taco shells that contained StarLink corn.[49] The discovery led to a flurry of negative media coverage, and Aventis, StarLink’s manufacturer, voluntarily requested a revocation of its pesticide registration for StarLink to prevent further sales and scandal.[50] As an additional mitigation strategy, Aventis developed the StarLink Enhanced Stewardship (SES) Program to prevent further contamination; the program provided a twenty-five cent per bushel incentive for growers to allow StarLink and corn grown within the 660 foot buffer to be handled through the program, a separate five to ten cent per bushel payment for non-StarLink corn accidently mixed with StarLink, and free DNA testing kits to growers and grain elevators.[51] Aventis paid out a reported $130 million through the SES program by 2004.[52] Despite the SES program, Aventis faced litigation.[53] Non-StarLink corn farmers brought a class action suit against Aventis for the consumer backlash against the corn market, which the company eventually settled for $110 million plus interest.[54] Consumers of the commingled corn who claimed they suffered an allergic reaction from the consumption of StarLink also brought a suit against Aventis that settled for a reported $9 million.[55]

Following the StarLink incident, when the EPA extended registrations for non-StarLink variety Bt corn in October 2001, they included additional requirements for the Bt corn seed manufacturers.[56] The revised registration rules require seed manufacturers to:

  • prepare and induce seed users to sign grower agreements which contractually bind growers to plant the proper refuge;
  • create and execute educational programs for growers about refuges and insect resistance;
  • create a remedial action plan to implement if resistance is discovered;
  • hire an independent third party to survey and measure the degree of compliance by growers;[57] and
  • submit annual reports to the EPA on grower agreements, sales, compliance, and education.[58]

Although the EPA’s prior requirements included grower agreements,[59] after the StarLink incident, the public and the EPA realized additional post-approval monitoring and requirements were required to ensure comprehensive information was given to and carried out by growers.[60]

Although some critics may see the current EPA rule as overbroad stating that the risk of the species becoming invasive is minimal, the overall industry response to the approval of giant reed and napier grass was positive as Chemtex in particular was pleased to move forward with their plan to build a refinery for giant reed in North Carolina.[61] In the interest of avoiding a similar economic and reputation scandal as StarLink, the biotech industry’s response to the increased requirements following StarLink was neutral, and instead the focus was on farmer compliance.[62] Likewise, the suggested amendments define the scope of the RMP more fully and thus help to limit industry liability.

IV. Recommendations

Although the StarLink episode created an opportunity for government agencies to gain more control over biotechnology, an area formerly controlled largely by industry,[63] the EPA’s rule approving napier grass and giant reed fuel pathways does not employ such strict regulation. Similar to the initial Bt corn requirements,[64] the EPA’s rule approving napier grass and giant reed does not include adequate post-approval monitoring for compliance and education.[65] The EPA explicitly states that the fuel producer is expected to exercise a “level of responsibility for and oversight of the feedstock production, harvest, transport and storage that may not normally exist in a buy-sell contract for agricultural products[,]”[66] yet it fails to require educational programs to ensure growers understand their responsibilities, much like the pre-StarLink scandal regulations. Further, comparable to the initial Bt corn regulations, although the EPA requires a copy of the agreement between the fuel producer and grower regarding the RMP and invasion liability,[67] this does not ensure that the grower understands his or her responsibilities or how to implement best management practices.

An economic and reputational incident comparable to StarLink would be damaging to this nascent bioenergy industry. Amending the EPA’s Arundo ruling provides the agency and biofuel industry an opportunity to avoid a possible scandal. The EPA should issue an amended rule that is modeled after post-StarLink Biopesticide Registration Action Documents.[68] Specifically, the rule could require fuel producers to:

  • prepare and obtain feedstock growers’ signatures to contractually bind growers to implement specific best management practices;
  • create and execute educational programs for growers regarding invasive species and preventing invasion;
  • create an explicit remedial action plan to implement if invasion is detected;
  • hire an independent third party auditor to assess compliance by growers, via both surveys and on-farm assessments (in addition to the auditor the EPA already requires to examine the fuel producers compliance); and
  • submit annual reports to the EPA on agreements, compliance, and education.

Although the EPA’s current mechanism for regulating feedstock production requires a relationship between the fuel producer and grower that predates the sale of biomass,[69] a more specific and robust rule could inform growers’ actions before they enter into a relationship with a fuel producer and provide better instruction on avoiding an invasion. Additionally, it would allow tenant farmers to include the specific terms required by the EPA in their leases to demonstrate compliance and facilitate later sales of napier grass or giant reed to a fuel producer.[70] There is also a need to consider improved regulatory regimes based on existing noxious weed/plant pest authorities and common law tort theories to protect the environment in the absence of a relationship with fuel producers seeking RFS certification.[71] For example, growers of giant reed or napier grass that fail to satisfy the precautionary measures required for the RFS could re-direct their feedstocks to the electric power industry that needs substantial quantities of biomass to satisfy state renewable portfolio standards.

V. Conclusion

Biotechnology, including bioenergy, as an emerging medium and market, requires improved, comprehensive regulation to maintain a place in the U.S. and world economies. Bt corn regulation and the StarLink scandal demonstrate the importance of well-defined requirements and provide a potential framework for amending the current EPA approval of napier grass and giant reed. Such amendments will assist the EPA in avoiding a similar scandal due to a patchwork regulatory scheme and instead promote more comprehensive and effective regulations.

 


[1] A. Bryan Endres, “GMO:” Genetically Modified Organism or Gigantic Monetary Obligation? The Liability Schemes for GMO Damage in the United States and European Union, 22 Loy. L.A. Int’l & Comp. L. Rev. 453, 480 (2000).

[2] A. Bryan Endres, An Evolutionary Approach to Agricultural Biotechnology: Litigation Challenges to the Regulatory and Common Law Regimes for Genetically Engineered Plants, 4 Ne. U. L.J. 59, 70 (2012); Aseem Prakash & Kelly L. Kollman, Biopolitics in the EU and US: Race to the Bottom or Convergence to the Top?, 47 Int’l Stud. Q. 617, 624 (2003).

[3] Endres, supra note 1 at 453.

[4] A. Bryan Endres, Coexistence Strategies in a Biotech World: Exploring Statutory Grower Protections, 13 Mo. Envtl. L. & Pol’y Rev. 206, 207 (2006); Lauren D. Quinn et al., Resolving Regulatory Uncertainty: Legislative Language for Potentially Invasive Bioenergy Feedstocks, GCB Bioenergy, available at http://onlinelibrary.wiley.com/doi/10.1111/gcbb.12216/abstract (forthcoming).

[5] See, e.g., D.L. Uchtmann, Starlink—A Case Study of Agricultural Biotechnology Regulation, 7 Drake J. Agric. L. 159, 195 (2002) (discussing the costs of the commingling of StarLink corn not approved for food-use with the food supply); see also Quinn et al., supra note 4 (discussing how the EPA’s eighteen month delay in approval of two species of feedstocks for bioenergy cost the petitioners millions of dollars).

[6] 7 U.S.C. §§ 136–136y (2012).

[7] FIFRA was first passed as P.L. 80-104 in 1947.  However, it was rewritten in 1972 with the Federal Environmental Pesticide Control Act (FEPCA).  Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), U.S. Envtl. Prot. Agency, http://www.epa.gov/oecaagct/lfra.html (last visited Nov. 9, 2014); see also 7 U.S.C. §§ 136–136y (2012).

[8] Coordinated Framework for Regulation of Products of Biotechnology, 51 Fed. Reg. 23,303 (June 26, 1986).

[9] 42 U.S.C. § 7401 et seq. (2012).

[10] About APHIS, U.S. Dep’t Agric. Animal & Plant Health Inspection Service (Sept. 2, 2014), http://www.aphis.usda.gov/wps/portal/banner/aboutaphis.

[11] Plant Protection Act, Pub. L. No. 106-224, 114 Stat. 438 (2000).

[12] Regulation of Fuels and Fuel Additives: Renewable Fuel Standard Program, 83 Fed. Reg. 23,900 (May 1, 2007).

[13] Energy Independence and Security Act of 2007, Pub. L. No. 110-140, 121 Stat. 1492.

[14] 40 C.F.R. §§ 80.1100–80.1167 (2013).

[15] Regulation of Fuels and Fuel Additives: Renewable Fuel Standard Program, 83 Fed. Reg. 23,900 (May 1, 2007).

[16] 40 C.F.R § 80.1426 (2013).

[17] Id.

[18] Id.

[19] Fuels and Fuel Additives: Approved Pathways, U.S. Envtl. Prot. Agency, http://www.epa.gov/otaq/fuels/renewablefuels/new-pathways/approved-pathways.htm (last visited Nov. 9, 2014).

[20] Arundo donax is a tall perennial reed-like grass and is among the largest of the grasses, growing to a height of 8 meters.  This species is believed to be native to freshwaters of eastern Asia, but has been cultivated throughout Asia, southern Europe, northern Africa, and the Middle East for thousands of years and has been planted widely in North and South America and Australasia in the past century.  It was intentionally introduced to California from the Mediterranean in the 1820s in the Los Angeles area as an erosion control agent in drainage canals, and was also used as thatching for roofs of barns, sheds, and other buildings.  Gary Bell, Plant Invasions: Studies from North America and Europe 103–113 (J.H. Brock ed., 1997).

[21] Napier or elephant grass, is a tropic bunchgrass with high growth and biomass production rates.  Xin-Ming Xie et al., Dynamic Changes of Lignin Contents of MT-1 Elephant Grass and its Closely Related Cultivars, 35 Biomass & Bioenergy 1732 (2011).

[22] Regulation of Fuels and Fuel Additives: Identification of Additional Qualifying Renewable Fuel Pathways Under the Renewable Fuel Standard Program, 77 Fed. Reg. 699 (Jan. 5, 2012); see also Quinn et al., supra note 4.

[23] Regulation of Fuels and Fuel Additives: Identification of Additional Qualifying Renewable Fuel Pathways Under the Renewable Fuel Standard Program, 77 Fed. Reg. 13,009 (Mar. 5, 2012); see also Quinn et al., supra note 4.

[24] Quinn et al., supra note 4.

[25] Regulation of Fuels and Fuel Additives: Additional Qualifying Renewable Fuel Pathways Under the Renewable Fuel Standard Program; Final Rule Approving Renewable Fuel Pathways for Giant Reed (Arundo donax) and Napier Grass (Pennisetum purpureum), 78 Fed. Reg. 41,703 (July 11, 2013) (to be codified at 40 C.F.R. pt. 80) [hereinafter Final Rule]; see also Quinn et al., supra note 4.

[26] Final Rule, supra note 25 at 41,705; see also Quinn et al., supra note 4.

[27] Id.

[28] Final Rule, supra note 25 at 41,709.

[29] Id. at 41,711.

[30] Id.

[31] Id.

[32] Elise C. Scott et al., The Bioenergy Farm Lease, Part 4: Incorporation of Evolving Standards, FarmDocDaily (Nov. 22, 2013), http://farmdocdaily.illinois.edu/2013/11/bioenergy-farm-lease-4-evolving-standards.html.

[33] Id.

[34] 7 U.S.C. §§ 136–136y (2012).

[35] 21 U.S.C. §§ 301–399 (2012).

[36] 15 U.S.C. §§ 2601–2629 (2012).

[37] See Uchtmann, supra note 5, at 184.

[38] Coordinated Framework for the Regulation of Products of Biotechnology, 51 Fed. Reg. 23,303 (June 26, 1986); see Uchtmann, supra note 5, at 169.

[39] See Uchtmann, supra note 5, at 184; see also Endres, supra note 1, at 480.

[40] Bt corn refers to genetically engineered corn that produces toxins derived from the Bacillus thuringiensis bacterium as a means of protection from insect pests.  Richard L. Hellmich & Kristian Allyse Hellmich, Use and Impact of Bt Maize, 3 Nature Educ. Knowledge 4 (2012).

[41] See Plant Incorporated Protectants, U.S. Envtl. Prot. Agency, http://www.epa.gov/oppbppd1/biopesticides/pips (last updated Jan. 2013).

[42] See 40 C.F.R. § 174.3 (2013).

[43] StarLink was a variety of corn engineered to produce the Cry9C protein as a pesticide.  At the time of its registration with the EPA, there was not sufficient data to show if the protein was a human allergen, and StarLink was approved only for animal feed or industry use.  StarLink Corn Regulatory Information, U.S. Envtl. Prot.Agency, http://www.epa.gov/oppbppd1/biopesticides/pips/starlink_corn.htm (last updated Apr. 2008).

[44] Certain Companies; Approval of Pesticide Product Registrations, 63 Fed. Reg. 43,936 (Aug. 17, 1998); see Uchtmann, supra note 5, at 198 (citations omitted).

[45] Uchtmann, supra note 5, at 185–86 (citing U.S. Env’t Prot. Agency, EPA/730/F-00/005, Biopesticide Fact Sheet: Bacillus thuringiensis Subspecies tolworthi Cry9C Protein and the Genetic Material Necessary for Its Production in Corn (Apr. 2000)).

[46] A refuge is an area planted nearby without a certain pesticide (in this case, planted without Bt corn) to conserve alleles in the population that are susceptible to that pesticide and prevent resistance.  A.M. Shelton et al., Economic, Ecological, Food Safety, and Social Consequences of the Deployment of Bt Transgenic Plants, 47 Ann. Rev. Entomology 845, 862 (2002).

[47] Uchtmann, supra note 5, at 185–86 (citing U.S. Env’t Prot. Agency, EPA/730/F-00/005, Biopesticide Fact Sheet: Bacillus thuringiensis Subspecies tolworthi Cry9C Protein and the Genetic Material Necessary for Its Production in Corn (Apr. 2000)).

[48] Id. at 182.

[49] Id.

[50] Id. at 187, 192.

[51] Id. at 193–94 (citations omitted).

[52] Kevin O’Hanlon, StarLink Corn Settlement Also to Include Interest, USA Today (Aug. 23, 2004, 5:55 PM), http://usatoday30.usatoday.com/tech/news/techpolicy/business/2004-08-23-starlink-snafu_x.htm.

[53] See, e.g., In re StarLink Corn Products Liab. Litig., 212 F. Supp. 2d 828 (N.D. Ill. 2002).

[54] O’Hanlon, supra note 52; see D.L. Uchtmann, Filing Deadline Extended to July 31: How to File Claims for Compensation from the Non-StarLink Farmer’s Class Action Settlement, Farm Doc (June 4, 2003), http://www.farmdoc.illinois.edu/legal/biotech/instructios03-0604.pdf.

[55] O’Hanlon, supra note 52.

[56] Uchtmann, supra note 5, at 206 (citations omitted); see U.S. Envtl. Prot. Agency, Biopesticide Registration Action Document—Bacillus thuringiensis Plant-Incorporated Protectants (2001), available at http://www.epa.gov/pesticides/biopesticides/pips/bt_brad2/7-coorn.pdf [hereinafter BRAD].

[57] Due to concerns over compliance, in 2010, when the EPA re-registered several brands of Bt corn, they included additional compliance requirements including continued annual surveys as well as on farm assessments.  See U.S. Envtl. Prot. Agency, Biopesticide Registration Action Document—Cry1Ab and Cry1F Bacillis thuringiensis (Bt) Corn Plant-Incorporated Protectants (2010), available at http://www.epa.gov/opp00001/biopesticides/pips/cry1f-cry1ab-brad.pdf.

[58] BRAD, supra note 56.

[59] Uchtmann, supra note 5, at 184–85 (citations omitted).

[60] Id. at 206.

[61] See John Murawski, EPA Approves Arundo Reed for Use in Proposed Sampson County Ethanol Refinery, News & Observer (July 3, 2013) http://www.agbioforum.org/v8n23/v8n23a12-hurley.htm (discussing Chemtex’s plan to build a refinery for giant reed); NC Biofuels Pleased with EPA Approval of Arundo donax, SFN Today (July 11, 2013), http://sfntoday.com/nc-biofuels-pleased-with-epa-approval-of-arundo-donax/ (noting Chemtex’s positive response to giant reed approval).

[62] See Jessica Goldberger, Jeanne Merrill & Terrance Hurley, Bt Corn Farmer Compliance with Insect Resistance Management Requirements in Minnesota and Wisconsin, 8 J. Agrobiotechnology Mgmt. Econ. 151, 152 (2005), available at http://www.agbioforum.org/v8n23/v8n23a12-hurley.htm (comparing their compliance results with several other studies on farmer compliance).

[63] Prakash & Kollman, supra note 2, at 633.

[64] Uchtmann, supra note 5, at 184–84 (citations omitted).

[65] See Final Rule, supra note 25.

[66] Id. at 41,711.

[67] Id.

[68] See BRAD, supra note 56.

[69] See Scott et al., supra note 32.

[70] See id. (discussing how incorporation of the EPA’s regulations into a bioenergy farm lease could facilitate tenant farmers’ entry into the bioeconomy).

[71] See generally James McCubbins et al., Frayed Seams in the “Patchwork Quilt” of American Federalism: An Empirical Analysis of Invasive Plant Species Regulation, 43 Envtl. L. 35 (2013) (discussing shortcomings of regulatory frameworks and proposing a negligence-based liability regime for controlling the introduction and spread of invasive plant species).