September 02, 2011 | By John Mandler and Rhyddid Watkins
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Biotechnology: The Debate, and the Litigation, Continues

Scrutiny impacts several major U.S. crops, export markets.

The United States Department of Agriculture defines agricultural biotechnology as “a range of tools, including traditional breeding techniques, that alter living organisms, or parts of organisms, to make or modify products; improve plants or animals; or develop microorganisms for specific agricultural uses. Modern biotechnology today includes the tools of genetic engineering.” The breath and variety of the plants, animals and other products currently available on the market that fit this definition is truly impressive, especially considering the relatively short time since biotech products were introduced, and their relatively high cost of development. 

Since biotech seeds first appeared on the market approximately 15 years ago, debate has raged on topics ranging from environmental impact to labeling and proper use and just about everything in between. What’s interesting though, is despite the length of time that biotechnology has been used in the U.S. and around the world, the large percentage of acreage utilizing the technology and the dramatic impact on the U.S. crop production industry, scrutiny of the use of biotechnology in food production has remained steady.  Increasingly, those who challenge the introduction of biotechnology have turned to litigation to challenge the regulatory approval and use of biotech products. Cases challenging regulatory approval of biotech alfalfa and sugar beets have made headlines over the past year. So 15 years later, where are we really when it comes to use and the regulatory process for the approval of biotech plant products?  We’ll take a quick look at some of the current issues facing the industry, including the animal feed industry and international markets, and review some of the most recent litigation.

Use of Biotech Crops

Biotechnology has already had a significant impact on several major U.S. crops including, corn, soybean, cotton, canola, sugar beet, alfalfa, papaya, and squash. According to the National Agricultural Statistics Service, between 85% and 95% of the corn, cotton, soybeans, and sugar beets grown in the United States are genetically engineered (GE). 

While the first GE crops were developed with goals of reducing use of chemicals such as insecticides or herbicides and for specific related traits, companies are now looking towards developing GE crops resistant to environmental conditions. This could expand the land available for agricultural growing purposes, as well as potentially reduce yield losses that occur each year due to drought or other inclement weather. Other crops are also being developed with the goal of enabling animals to more effectively use the nutrients found in animal feed.

Considering the amount of corn, soybeans, alfalfa and other crops that are used in the feed industry, biotech has had a major impact on the U.S. feed industry. There continue to be a number of challenges though, that face the industry as a whole, but particularly the feed industry.

Rules, Regulations and Legal Challenges

Exports

International acceptance of GE crops continues to be one of the major challenges facing the industry.  As noted above, the majority of biotech crops are grown in the U.S. Europe maintains a strict, and slow, approval process for biotech crops, and currently allows only a few varieties. They have a zero tolerance policy for the presence of unauthorized GM material in food, and a “technical zero” of 0.1 percent for the presence of unauthorized material in imported feed. This presents challenges to those exporting feed products to Europe, as not only must feed and grain be segregated, in most cases, to keep GE and non-GE feed crops separate, but a distinction must also be made between approved and non-approved GE crops. 

But other issues may lead to more questions for feed exporters, such as concern over cross-pollination and the potential for unapproved (or any) genetic material to be detected in what was designated as a GE-free crop. The essentially zero tolerance for the presence of unauthorized material severely limits the feed that can be exported. This is causing some in the EU to call for an increase in the speed of authorizing GM products for use in animal feed, as there is a real concern over a feed shortage in parts of the EU.

What does this mean for exporters? Here are a few items to keep in mind. First, grain segregation is key. Ensure you have systems and regulations in place to keep GE feed and grain segregated from non-GE feed and grain, if you source or store both.  If you are receiving grain from growers, knowing what is coming in and when is key to ensure proper storage. Second, understand your supply chain. Know where your feed and feed ingredients are sourced from, and work with the suppliers to ensure that records are properly kept and where appropriate, that refuges were properly used if GE crops were grown nearby. Third, evaluate your testing protocol. If you are exporting grain and feed products to Europe, ensure that you have proper protocols in place to test for the presence of GE organisms in the feed and that you maintain the proper documentation to support those results.

For growers, recordkeeping is likely going to be of even more importance, as the feed and grain industry is seeing increased regulation, not just on the GE plant issue. Ensure that you are maintaining the necessary records so that your buyers can verify the type of seed used, and also that proper planting guidelines were observed, if necessary. While grain traceability is difficult, and is currently not required, increased regulation is continuing to make traceability more of a necessity than an option likely down the road.

Deregulation Litigation

The past year has seen a rise in litigation related to genetically modified crops as advocacy groups continue to push for increased regulation and federal oversight of GE crops. Two major cases involved the use of Round-Up Ready Sugar Beets and Alfalfa.

Both lawsuits involved USDA’s decision to deregulate, or partially deregulate, the crop in question. Deregulation is essentially USDA’s determination that the crop is safe to plan and in many cases, growers may start using that GE plant with little to no restrictions. As part of the deregulation process, USDA first does an initial environmental assessment, accompanied by a plant pest risk assessment. If USDA determines the GE plant/trait in question has no significant impact, it can move it to deregulated status. However, if USDA determined there is a likelihood of significant environmental impact, it must complete a more thorough environmental study. In many cases, USDA has the option to partially-deregulate the plant/trait while it completes the second study.

The deregulation process is often hotly contested by environmental, pro-organic, and often even some consumer groups. This was most definitely the case when it came to alfalfa and sugar beets.

Alfalfa, an important feed crop, became the first GE crop considered in a case before the U.S. Supreme Court. This case, Monsanto v. Geertson, involved a challenge to USDA’s decision to partially deregulate GE alfalfa. In June 2010, the Court held that courts could not prevent USDA from partially deregulating GE crops while it completed the final studies. This set important precedent, as it clearly established that USDA has the role of determining what restrictions should apply to GE plants at every state of the regulatory process. In early 2011, USDA fully deregulated GE alfalfa. With this decision, farmers are free to plant and move GE alfalfa without further oversight by USDA, now bound only by restrictions set by the seed company. USDA’s decision has now spawned further litigation, which remains unresolved.

A similar issue was the focus of a case involving GE sugar beets, Center for Food Safety v. Vilsack. This case out of California closely followed the Supreme Court’s alfalfa decision, as the court considered USDA’s decision to deregulate GE sugar beets. The court held that USDA had abused its discretion by not conducting the secondary environmental study, vacated the decision to fully deregulate the plant, and referred the case back to USDA for further consideration and review. Shortly thereafter, in early 2011, USDA partially deregulated GE sugar beets, allowing farmers to continue to grow and distribute the crop under certain restrictions. USDA’s decision again led to more  litigation, this time from both environmental groups opposing the plant, who contend the restrictions are insufficient, and GE supporters, who contend the restrictions are too burdensome. This round of litigation is still on-going, and is likely a sign of things to come as USDA moves forward considering the deregulation of additional GE crops.

100% Natural?

Recent lawsuits have also been filed challenging the labeling claim of “100% Natural” when the product in question contains oils derived from genetically modified plant materials. Class action lawsuits were filed in July 2011 in New York, California and New Jersey alleging various causes of action including fraud and misrepresentation, claiming that products were falsely labeled 100% natural when the oils contained within were derived from GE plants.

While these cases involve human food products, not animal feed, the potential for trickle-down impact on the feed and grain industry is clear. These type of claims, if successful, could expand to other types of food products, including meat. While this may have little practical effect on demand for GE feed and grain in the long-run, a bigger impact may be felt in increased demand for record-keeping, testing and segregation practices on feed and grain products as a whole, as companies attempt to insulate themselves from these types of lawsuits. Either way, this remains an issue to watch as we are seeing increased focus on a number of types of labeling and consumer fraud lawsuits in the food industry.   

What is on the Horizon?

USDA has adopted a stance of “co-existence” when it comes to GE crops, meaning that it believes that it is possible for GE, non-GE and organic crops to coexist in today’s agricultural landscape. As we can see from just the few examples of ongoing litigation discussed above, not everyone agrees. It is likely that we will continue to see increased litigation related to USDA’s deregulation decisions of GE crops, as well as newer legal arguments, such as that seen in the debate over what can be called “natural”. While there are calls for the EU to speed up the process for approval of GE plants, particularly in the seed industry, that appears unlikely to happen in the near future.

With the demand for food, fuels and medicines constantly increasing and biotech companies developing new plants resistant to environmental conditions, proponents of both conventional and GE seed are likely to have plenty of opportunities to challenge APHIS’s restrictions. As we’re seeing with the GE-related natural lawsuits, even after deregulation, the path is not necessarily free and clear for GE-plant products and those who produce and use them.

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