Roger Beachy, PhD, appointed by President Obama in 2009 to be the founding Director of the USDA National Institute of Food and Agriculture where he served until May of this year, testified as a scientist who was involved in the early stages of biotech research. He was a Professor in the Biology Department at Washington University in St. Louis, the Director of the Center for Plant Science and Biotechnology from 1978-1991 and worked with scientists from Monsanto to develop the first genetically modified food crop, a variety of tomato modified for resistance to a virus disease. His concern now is that inventions with a likelihood of success will “continue to be delayed in reaching the marketplace because of regulatory processes that are ill-defined and/or unpredictable, sometimes irrational, and always costly.” The U.S. will increasingly be challenged by Brazil and China who are expected to provide half the new biotech varieties between now and 2015.
Dr. Beachy said that regulations were developed in the 1980s and finalized in 1986 as the Coordinated Framework for Regulation of Biotechnology under then existing authorities of USDA, EPA and FDA because the anticipated hazards were the same as with other types of agricultural innovation. The regulations were appropriate for the new technology, but have not been adapted to the experiences and new knowledge of the past 24 years. With sufficient time, money and patience, $5-25 million and up to ten years, some new technology can make it to the marketplace, but other useful products cannot get through the process to provide benefits to producers and consumers from investments in science and technology.
Four modifications to the regulatory process are suggested by Dr. Beachy. First, “return to a firm commitment to base regulations on science” related to the safety of the product and not to the process by which it was developed. This will reduce the number of tests and the time and cost of regulations. Second, “redefine the basis by which products of biotechnology are subjected to regulatory oversight.” The role of the Animal and Plant Health Inspection Service of USDA should be maintained, but the characteristics and mechanism of products that trigger regulation should be redefined.
Third, “identify categorical exemptions that can streamline and reduce burdens for products/characteristics experience has shown to be safe.” Existing technologies and products would be reviewed to determine which technologies can have reduced oversight. Fourth, “distinguish between real and perceived risks and focus on those that are real.” Congress needs to provide legislation to consider the opportunity costs of regulatory policies that discourage innovations that reduce risks of conventional agricultural practices. This could include how the National Environmental Policy Act (NEPA) of 1969 is applied to agriculture.
NEPA as it applies to agricultural biotechnology was explored in an article in the summer 2011 issue of Regulation magazine by Henry I. Miller, a physician, fellow at the Hoover Institution and founding director of the Office of Biotechnology at the Food and Drug Administration, and Gregory Conko, senior fellow at the Competitive Enterprise Institute. Under NEPA, agencies are required to consider the effects on the “human environment” of “major actions” they take. Actions with no significant impacts require only a brief Environmental Assessment, but significant impacts require an Environmental Impact Statement on every conceivable effect requiring hundreds of pages. Roundup Ready alfalfa and sugar beets were tied up in court over the initial USDA Environmental Assessments and court requirements to do Environmental Impact Statements.
Any changes in U.S. regulations for biotech crops will be closely watched by the rest of the world, particularly in developing countries where interest in biotech crops has increased, but regulatory structures remain undefined. Testifying at the subcommittee hearing was Dr. Calestous Juma, Professor of the Practice of International Development and Director of the Science, Technology and Globalization Project at Harvard University. He said the U.S. is a role model with “its commitment to using a science‐led regulatory system for determining the approval of new products.” In addition to increasing agricultural productivity, biotechnology has the potential to create more nutritious crops like rice with additional amounts of vitamin A that could improve human health and increase productivity from healthier workers. African countries now have more interest in biotech crops than any time in the last 20 years. Dr. Juma concluded, “The impact of their dedication will be limited unless they are able to benefit from prior knowledge and expertise accumulated in other countries. This is where the United States can serve as a role model in the use of biotechnology in agricultural transformation and science‐based approaches in regulation.” Kenya, Dr. Juma's country of birth, has just approved importing biotech corn for food uses and the planting of biotech seed corn.
Dr. Beachy asked the subcommittee to consider the unintended consequences of overly stringent regulations of biotech crops. These include creating the perception that the technology is unsafe and causing many developing countries to be reluctant to adopt the technology. He noted, “It (the regulatory process) has adapted poorly in response to the proven safety record and absence of adverse affect on the environment or on animal and human health of GE crops. It has not adapted to changes that have further enhanced the safety of the technologies; and it has not adapted to the needs of the market. The system needs attention, modification, and improvement if the U.S. and global agriculture communities and its consumers are to benefit from the investment in past and current science and technology that can impact agriculture and agriforestry.”