Environmental Law in biotechnology in agriculture.

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Environmental Law in biotechnology in agriculture.

Post by Admin on Wed Mar 04, 2015 7:33 pm

Environmental Law
Agricultural Biotechnology, The Environment, And Health
By Blake A. Biles
Plants that are genetically modified by “modern” biotechnology are known as “plant LMOs” (Living Modified Organisms) and can have a range of agricultural, pharmaceutical, and industrial end uses. Agricultural biotechnology (ag biotech) encompasses plant LMOs that are tied to the production of human food and/or animal feed. Numerous parties have an interest in, or are otherwise affected by, the commercialization of ag biotech products. This gives rise to a wide range of potential disagreements and disputes.

The genetic modification of plants usually involves the production of new plant proteins. Consequently, evaluations of potential adverse health impacts focus on allergenicity (virtually all food allergens are proteins) and protein toxicity. Typically, if a bioengineered food product shows no increased allergenicity or other toxicity when compared to a “safe” conventional counterpart, scientists may conclude that the bioengineered product is safe for general consumption.

Potential adverse environmental impacts of plant LMOs include longterm effects of gene flow (in the field) between transgenic and conventional plants (including the possible depletion/ elimination of heritage or native plants); the creation of “superweeds” that are resistant to insects, unfavorable ambient conditions, or synthetic pesticides; adverse impacts on “non-target” organisms (e.g., other plants, butterflies); and, more generally, negative impacts on biodiversity. However, considerable work remains before there will be broad scientific consensus as to analytic and assessment principles and protocols.

The commercial “value chain”—the parties who are involved in bringing commercial ag biotech products from invention to market—include the technology providers, seed companies, farmers/growers, commodity companies, and food processors. Downstream parties include wholesalers and business purchasers of the finished products, grocery and other retail stores, and individual consumers. Other significant factors include lending organizations, consumer and environmental public interest groups, and government agencies. Together, these constitute a broad and diverse mix of organizations that may identify legal issues associated with achieving their goals and resolving problems that arise along the way.

In addition to the commercial and regulatory controversies that typically arise, ag biotech brings to the table at least three elements that compound and magnify legal disputes: (1) an evolving and controversial technology that implicates consumer products and choice; (2) health and environmental considerations that are not easily defined and resolved on a consensus basis; and (3) economic and political dimensions presented in an international framework that affects businesses and individuals throughout the world.

At the intergovernmental level, strong disagreements among developed nations have been manifested in trade negotiations that may lead to more formal dispute proceedings. The resolution of differences between developed and developing nations is perhaps even more significant to the long-term success of ag biotech because such differences often implicate both financial and social welfare considerations. Thorny and contentious issues of access and benefits-sharing often conflict with the need for commercial entities to protect their intellectual property in the transgenic products and to obtain profits. Moreover, national political and economic interests might weigh against the use of ag biotech products in a way that adversely affects large segments of indigenous populations.

Given this disparate mix of parties and issues, a U.S. lawyer who advises a client involved in ag biotech would do well to develop a basic grasp of the economic and political big picture, even though the client’s requests for legal assistance typically focus on particular regulatory and/or commercial matters. In this regard, health and environmental regulatory schemes around the world are in a profound state of flux. In a sense, they all seek to address the types of risk considerations that government officials have faced in regulating the development and commercialization of conventional foods, drugs, pesticides, and chemical products: (1) risk assessment; (2) risk management; and (3) risk communications.

National ag biotech regulatory schemes often are structured around three basic elements. First, the products covered may include plant LMOs, products containing plant LMOs, and products derived from plant LMOs. Second, the activities covered typically encompass experimental work, testmarketing activities, and full-scale commercialization. Third, the particular regulatory measures may include one or more of the following: analytical testing; health and/or environmental effects testing and evaluation; quality and/or content specifications; labeling requirements; certification obligations; premarket review or product registration; restrictions upon sale, distribution, use and/or disposal; and record keeping and reporting requirements. For the practitioner who is asked to advise concerning specific regulatory programs, it is useful to dissect such programs along these three lines as they apply to a client’s particular situation.

In the United States, statutory authority for the oversight of ag biotech products and activities is shared among the Department of Agriculture, the Environmental Protection Agency (EPA), and the Food and Drug Administration. In light of this overlapping jurisdiction, the government issued in 1986 a “Coordinated Framework for the Regulation of Biotechnology,” a comprehensive policy statement for the regulation of genetically modified organisms (GMOs, which include plant LMOs) and products derived from GMOs. Products created using genetic engineering are presumed to be as safe as their conventional counterparts unless evidence indicates otherwise. Thus, federal oversight of GMOs, and of products derived from GMOs, is based on existing statutes and regulatory authorities relating to conventional products; special review or treatment, based on the fact that a product was created using biotechnology, is not required.

A variety of potential liabilities may face clients depending upon their interests in particular ag biotech products. The most significant adverse consequences involve tangible commercial losses and harm to product reputation. First, the core U.S. regulatory provisions involve government review and/or approval of activities that occur at various points in the value chain. Therefore, regulatory noncompliance typically may result in the inability to produce, distribute, and sell both a company’s noncompliant regulated product and others’ products that are affected by it. This may include otherwisecompliant grain that has been contaminated by noncompliant grain, and processed food products that are derived from plant LMOs. Further, recalls and injunctive measures can be quite expensive and severely damaging to a product’s future value.

Second, failure to comply with regulations may enhance exposure to both contract and tort liabilities. Commercial contracts typically contain terms warranting that the products and services being sold comply with applicable statutory/regulatory requirements. In addition, general commercial warranties may be interpreted to include warranties of regulatory compliance. Persons who are found to have violated government requirements may face liability to persons who are in privity downstream, where such noncompliance materially affects the latter’s own commercial activities and financial returns.

Third, persons may bring tort claims based on a number of theories. Plaintiffs may find their cases easier to prosecute in the event of the defendants’ regulatory noncompliance, because many courts will conclude that noncompliance constitutes per se negligence. Even absent such a finding, potential tort liability is a major concern to parties in the ag biotech value chain because of the large number of downstream persons potentially involved with ag biotech products. However, because there has not been a showing to date of adverse impacts on humans or the environment, for the foreseeable future successful tort actions most likely will be grounded in property and other commercial damages.

Finally, the major challenges to proponents of agricultural biotechnology lie outside the United States— particularly the inability of U.S. business interests to gain significant access to non-U.S. markets, due either to restrictive or nonexistent regulatory frameworks, or to the lack of meaningful capacity by government officials to manage such frameworks as do exist. Lawyers’ involvement in addressing these concerns lies primarily in the policymaking and institution- building arenas, which in turn provide the frameworks within which the various parties’ obligations and liabilities will be established.


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