The Ripple Effects of Flawed Agbiotech Regulation

The modern techniques of genetic engineering—also known as biotechnology, recombinant DNA technology, or genetic modification (GM)—offer plant breeders the tools to make old crop plants do spectacular new things. In about three dozen countries worldwide, more than 17 million farmers are using genetically engineered crop varieties to produce more consistent yields with lower inputs and reduced environmental impact. Most of these new varieties are designed to be resistant to pests and diseases that ravage crops or to be resistant to herbicides so that farmers can more effectively control weeds while adopting more environment-friendly no-till farming practices and herbicides.

Over many millennia, there has been a virtually seamless continuum of genetic improvement of crops using increasingly sophisticated techniques. The modern era of genetic engineering emerged during the 1970s as part of this progression of technologies. Thus, because genetic modification has been with us for centuries, the term “genetically modified organism” and its abbreviation “GMO”—commonly used nomenclature—are unfortunate, confusing choices of terminology. “GMO” is often used arbitrarily to mean organisms containing genes transferred across species lines when accomplished (only) by recombinant DNA techniques, but this usage ignores the fact that genetic modification has been achieved using many technologies and that recombinant organisms are not in any way a meaningful “category.”

Since the first market introduction of crops engineered with molecular techniques in 1994, farmers have found that the new varieties reduce overall costs, deliver important environmental benefits, and increase per-acre profitability. Although farmers who choose these genetically engineered seeds find them worth their higher prices, many are eagerly awaiting the expiration of the patents on popular biotech traits in the next few years, hoping that prices will fall.

The patent on Monsanto’s Roundup Ready soybean trait (herbicide-resistance)—the most widely adopted crop biotechnology product in the world—and the patents covering another 22 biotech traits and processes are expected to expire over the next decade. Such patent expirations should make it possible for plant breeders to sell “generic” versions of these seeds, resulting in greater competition and lower prices.

Unfortunately, a quirk in the way biotech crops are regulated in the United States and other countries poses several challenges that may make it difficult for breeders to develop a generic seed industry.

Regulators treat these important products as though they pose uniquely worrisome risks, in spite of a longstanding consensus in the scientific community that the newer techniques are essentially an extension of more primitive ones. Federal regulation discriminates against the most precise and predictable techniques for genetic improvement, requiring endless, redundant case-by-case reviews of plants crafted with those techniques. By contrast, the testing and commercialization of similar seeds and crops made with less precise, less predictable techniques are usually subject to no regulation at all.

Re-registration | Federal regulators’ approach to biotech oversight violates two fundamental principles of regulation: similar things should be regulated in similar ways, and the degree of oversight should be proportional to the expected degree of risk. Regulators have, in fact, turned the second principle on its head, with more precisely and predictably crafted products subjected to the most expansive and costly regulatory requirements.

Both biotech and non-biotech crop varieties can be, and routinely are, patented. But when the intellectual property rights protecting biotech plant traits expire, prospective generic breeders need to ensure that growers and end users have legal permission to sell the seeds and to grow and sell the harvested crops, respectively. A complicating factor is that the genetic constructs of most biotech seeds—known as “transformation events,” or simply “events”—must be periodically “re-registered” for commercial sale by regulatory authorities in the United States and abroad. In key markets, this can be a lengthy, expensive, and politically unpredictable process that requires access to the proprietary testing data held by the original developers of the approved events.

For example, a common bacterium called Bacillus thuringiensis (or Bt) produces proteins that are toxic to certain insects but safe for humans and other animals. When one or more of the Bt genes that express this protein are inserted into a specific corn variety, it makes the corn plant insect-resistant, reducing the need to spray chemical pesticides. But each time one of these genes is spliced into a different corn variety, that insertion creates a new “transformation event” that must be approved and re-registered separately. U.S. farmers can choose from more than 15 different transformation events of corn and dozens more of soy, rice, cotton, canola, and several fruits and vegetables. However, in order to export any of these crops, each event must be Winter 2012–2013 | Regulation | 9 re-registered repeatedly in various foreign countries as often as every three to five years.

The unrenewed expiration of the registration of any transformation event in an important export market could result in entire bulk shipments containing even relatively small percentages of that crop being rejected by the government of an importing country. Such an occurrence would have tremendous negative economic effects that would ripple throughout the food supply chain. This means that as long as biotech traits must be re-registered every few years, those who sell or buy genetically engineered seeds will have to bear the burden of meeting these ongoing stewardship obligations and will experience some degree of uncertainty and financial risk. The heightened costs associated with re-registration could erase a substantial portion of the economic gains ordinarily associated with patent expirations and the subsequent development and sale of generic products.

The re-registration requirement cannot be justified scientifically and is needlessly complex. For 30 years, there has been broad agreement among plant scientists that using genetic engineering to develop new plant varieties presents no new or unique risks compared to conventional breeding using techniques such as hybridization or irradiation mutagenesis. Scientific bodies around the world, ranging from the U.S. National Academy of Sciences to the United Nations’ Food and Agricultural Organization, have concluded that there is no scientific justification for regulating the use of genetic engineering techniques, as opposed to regulating certain traits that may be associated with heightened risk. Thus, there is no justification for subjecting all genetically engineered crop plants to special pre-market approvals or to periodic re-registration.

Agency fiction | Adding further cost and complexity to re-registration is the required resubmission of—or legal access to—the original safety testing data submitted for the initial approval, along with whatever new testing and monitoring information regulatory authorities may require. Governments treat the data in approval applications as confidential business information or protected trade secrets because the data often contain information about the innovator’s development and production processes, quality control and management programs, and other details that would be of significant value to potential competitors.

When considering approval applications from developers of generic versions of innovator products, regulators generally are not permitted to rely on data in the innovator’s application to evaluate the follow-on products. However, while there are good reasons why regulators should maintain the confidentiality of an innovator’s data, there is no good reason for regulatory regimes to require follow-on producers to have access to the original developer’s proprietary data in the first place. After all, regulators need not evaluate a dossier submitted for re-registration of a biotech transformation event de novo. For a biotech event to have been granted market approval in the first place, regulatory scientists would have already examined submitted data and arrived at a judgment that the product is safe enough for commercial use. In other words, one can rely on a principle of transitivity that says that if the application for the original product was evaluated and approved for marketing on the basis of submitted data, and the follow-on product contains the same transformation event, the follow-on product is equivalent to the original product and should be approved.

The simplest solution to this problem is for governments to eliminate the unjustifiable, unnecessary re-registration requirement. Alternatively, regulatory agencies should, at the very least, eliminate the legal fiction that agency scientists have not already examined the original data and reached the conclusion that the product is safe for consumers and the environment. In other words, there should be no need for breeders to submit or have access to original safety data when seeking a re-registration. There appears to be little political support, however, in either the United States or abroad, for the reform of biotech crop regulation. Regulators are resistant to relinquishing their perks, budgets, and bureaucratic empires. As a workaround of the flaws in the regulatory system, seed breeders and the biotechnology industry have begun to cooperate on a voluntary, contractual arrangement that will help to address some of these problems. Under the terms of this “Accord Agreement,” participating developers will agree to maintain registrations for their transformation events for a limited time after the expiration of the patents. Developers and generic breeders would then be able to make binding contractual agreements to share needed regulatory data and to hand off longterm regulatory stewardship obligations, thereby facilitating a seamless transition to the post-patent regulatory regime.

Private contractual arrangements that would permit postpatent generic versions of biotech crop varieties should begin to address some of the regulatory and legal challenges that stand in the way of a seamless transition to a post-patent generic seed industry. But any wholly private effort can at best be expected to ameliorate the problem rather than to solve it entirely because the existing regulatory requirements—which defy both sound science and common sense—must still be met. The continuing presence of discriminatory regulation will make it difficult for small breeders (particularly public sector breeders and small firms in less developed countries) to take advantage of off-patent traits. The ripple effects of a quarter-century of flawed agbiotech regulation have been wide, deep, and damaging.