Regulatory Guidelines During Field Trials of Biotech Crops

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Field trials are an essential component to improving plant genetics. Long before biotechnology was integral to research, seed companies were testing new materials in a variety of environments to understand and evaluate their performance. Today, field testing remains a vital tool to understand the value and performance of new biotech products. In 1986, the U.S. Government published the Coordinated Framework for the Regulation of Biotechnology establishing the Federal government's oversight of biotechnology products. The framework consists of the U.S. Department of Agriculture (USDA) working with the Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) to ensure the safe development and commercialization of agricultural biotechnology products. In 1987, USDA implemented regulations for biotechnology (7 CFR 340, commonly referred to as APHIS Part 340 regulations) under the authorities of the Federal Plant Pest Act and the Plant Quarantine Act.

While some stakeholders express concerns over the potential for unintentional release of biotech materials into the environment, biotech companies and regulators have a demonstrated record of high success when field testing pre-commercial products.

Pre-commercial products considered for field testing undergo substantial laboratory screening to confirm commercial potential and eliminate undesirable characteristics. Technology providers work through the product development process step by step, and at each decision point, researchers evaluate safety and efficacy. Developers follow proven laboratory processes to establish the value, viability and safety of the product concept. Lab practices adapt as the technology evolves, and practices are standardized, documented and reproduced, and adhere to ISO standards or other scientifically proven protocols. These steps help ensure sound products are considered for field testing.

With the current cost of field testing, researchers will select only the best and most promising pre-commercial materials for evaluation. Field trials start small and grow in size as the product concept is proven and improved.

Within the USDA, the regulatory process is administered by the Animal and Plant Health Inspection Service (APHIS). Its role is to protect agriculture and the environment. Regulations apply to researchers conducting field tests, importing materials into the United States, and transporting materials across state lines.

APHIS manages the permitting and notification processes, defines the conditions for field tests and inspects for compliance. Confinement is required as long as questions of risk remain about the pre-commercial product. The degree of confinement and the redundancy of measures to reduce risk depend on experience with the event, trait or crop. Rigor increases when there is less field experience and lessens as more is known and the product is shown to be safe.

Notification System

When the product is moved outside the laboratory or greenhouse, the USDA must review the relevant information and issue a permit or accept a "notification" for environmental release. Permits and notifications require similarly stringent performance standards for confinement and safety.

Notification is generally used when there is substantial familiarity with the biotech trait or event. Notifications must meet USDA performance standards for transgenic materials to ensure confinement. Companies comply with APHIS guidelines according to their individual circumstances, but attention to the standards remains strict. The APHIS guidelines include standards for field testing, storage, shipping and maintenance. Examples of information required for notification status include use of the plant, species, varieties, proposed location of the test, disposition of adjacent crops and fields, potential for interactions with endangered species, and more. At any time, APHIS can request additional information, and companies must comply.

Introduced in 1994, the notification classification was originally limited to varieties of six common crops. The process was expanded to cover many traits in virtually all crops in 1997. The notification system evolved as a response to the increasing number of field tests resulting from biotech breakthroughs, and applies to those products that are most thoroughly understood.

Permitting Process

A permit requires a more comprehensive review of data and information to support a more detailed environmental assessment. Use and confinement strategies are often more stringent and can require additional, specific safeguards and reporting. When the product includes a plant incorporated protectant (PIP), such as a herbicide tolerance or insect resistance trait, and the test is larger than 10 acres, the EPA also requires an Experimental Use Permit (EUP). When a product is intended for food or feed use, the FDA also reviews.

Deregulation

Since biotech products have been moving through the regulatory system for more than two decades, the accumulated knowledge and experience allows for improvements in regulatory protocols and standards. Because a large percentage of crops - such as corn, soybeans, cotton and canola - have been scrutinized and monitored for many years, APHIS established a deregulation process for well-understood biotech traits. Companies can petition APHIS to request a product be released from further regulatory scrutiny once a significant data set confirms it behaves similarly to its "natural" counterpart and poses no novel safety issues. The USDA has deregulated more than 117 different traits, including herbicide-resistant soybeans, insect-resistant corn and cotton, disease resistant papaya, squash, and more.

The Future of Biotech Plant Regulations

The regulatory system was built to be flexible. As any industry continues to progress, and newer and more beneficial products become available, it is inevitable that regulations and government oversight concurrently advance. In January 2004, USDA announced its intentions to update and strengthen biotechnology regulations for biotech crops. The technology advancement and increase in knowledge about biotechnology-derived products under development suggest that this is an appropriate time to review existing regulations governing the production of agricultural biotechnology products. The first step in the regulatory update is to prepare an Environmental Impact Statement (EIS) on biotechnology regulations. In July 2007, USDA published a draft EIS with a 60-day comment period. After review of the comments, USDA's next step will be to publish proposed changes to its APHIS Part 340 regulations for public comment, before finalizing any new regulations.

With current science- and risk-based regulations in place, the biotechnology industry looks forward to providing farmers and consumers with new and enhanced agricultural biotechnology products such as nutrient-enhanced and healthful grains and oils, plant varieties that are tolerant to extreme environmental stresses and new industrial uses from biotech plant varieties, including increased yields to promote biofuel production. Agricultural biotechnology has the potential to support an eco-efficient world of the future ? a world where more food can be produced while at the same time reducing agriculture's environmental footprint.

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