Docket Management
Docket: 02D-0324 - Draft Guid.: Drugs, Biologics & Medical Devices Derived from Bioengineered Plants
Comment Number: EC -43

Accepted - Volume 9

Comment Record
Commentor Dr. Dermot Hayes Date/Time 2003-01-10 10:45:20
Organization Plant Science Institute at Iowa State University
Category Academic

Comments for FDA General
1. General Comments Dockets Management Branch (HFA-305) Food and Drug Administration 5600 Fishers Lane, Room 1061 Rockville MD 20852 Re: Docket No. 02D-0324: Guidance for Industry: Drugs, Biologics and Medical Devices Derived From Bioengineered Plants for Use in Human and Animals These comments are offered by the leadership of the Public Policy Task Force of the Plant Sciences Institute at Iowa State University. The Task Force initiates, coordinates and communicates activities in the areas of economics, sociology, risk and business as they relate to agricultural biotechnology. Quality and safety of the food supply In commenting on FDA guidance on biopharmaceutical crops, it is important to state that maintaining the quality, safety and public confidence of the food supply is of paramount importance to Iowa. Agriculture and related industries generate almost a quarter of the state’s total industrial output. Iowa and Iowa State University are committed to developing the scientific safeguards, and the educational response, needed to ensure public confidence in the quality and safety of the food supply. In keeping with this commitment, we support the efforts to promote the development of biopharmaceutical crops while safeguarding our precious agricultural resource. Promoting biopharmceutical crop opportunities in Iowa Public and private efforts are well underway in Iowa to promote the development, production, and processing of pharmaceutical crops. We believe that these crops present a great opportunity for our state and represent a potentially enormous benefit to Iowa’s future economy. The main issue should be the adoption of effective, science-based methods that ensure that pharmaceutical crops can be produced in a safe, responsible, and well-managed manner that safeguards our environment, quality of life and valuable agricultural resources. The proposed FDA/USDA guidance, in its present form, is well intentioned but may unnecessarily impede the development of pharmaceutical crops in Iowa, as well as in other places in the country. Sections of the guidelines may also adversely affect the perception of all biotechnology products with our international customers. Iowa State University has expertise in several critical research areas relating to biopharmaceutical crops. Currently, the only public research program in the nation working in the area of plant-based vaccines is located at Iowa State University — a program that has worked closely with USDA-APHIS on containment and biosecurity measures. Iowa State also hosts a Plant Transformation Facility, the world’s largest public-sector facility for the production of transgenic corn. In addition, an Iowa industry, government and university consortium has made plans to establish a biopharmaceutical protein purification facility (biologics manufacturing facility) at the Iowa State University Research Park. Containment and traceability Containment of plant-made pharmaceuticals and guarding against the adventitious presence of these products in food and feed supplies is the major challenge in developing this industry. However, many strategies for containment have been extensively studied and developed for the seed production industry and in seed quality assurance programs. Clearly, other strategies need to be revisited, refined or adopted to new levels of stringencies required for biopharmaceutical crop containment. We are confident that USDA-APHIS, with proper support, can exercise diligent regulatory oversight over containment issues. They have worked interactively and successfully with groups in Iowa and Iowa State in developing safe and effective procedures for containing these crops. We also support research to develop technological fixes for the containment and traceability of biopharmaceutical crops through the use of alternative hosts, visible markers, more effective male sterility or terminator strategies and so forth. We are confident that the combined use of different containment strategies — both physical and biological — will reduce the risk of contamination to acceptable levels. We very much oppose the strategy of banning the production of outcrossing biopharmaceutical crops in geographical areas in which they are grown for food and feed production. We think that such a strategy discriminates against economic development in the Corn Belt and hinders the development of effective containment strategies. We have already learned a great deal about containment from the experience of various groups in the area, and the investment in the infrastructure to make this technology safe and effective in the Midwest will not occur without the appropriate private sector incentives. Our experience suggests that the economic harm caused by such a ban would greatly outweigh the negligible risks associated with the production of these crops under current guidelines. Science-based Risk Analysis Approval for production of plant-made pharmaceuticals should be based on science-based risk analysis. FDA needs to conduct, or request from the applicant, studies to define and evaluate the risks associated with production of each pharmaceutical crop. The National Research Council has established procedures for accomplishing science-based risk analysis. Hazards to human health and the environment need to be identified through examination of the probability of risks in every step of the process -- from seed production to end-use. Once identified, the significance of risks should be assessed and plans developed to manage them. Communicating the risks to decision-makers and the public is a crucial step, because public perception of risk often is much more significant than the technical possibility of risk. The overall risk, a statistical sum of each individual risk from the planting of seed to the processing by end users, should be the measure used by the FDA, along with other relevant data and information submitted in support of the product, to determine whether approval is granted. Iowa State University through the Office of the Vice Provost for Research has recently established a Containment Task Force to conduct risk analysis at the various levels of biopharmaceutical crop production and to identify steps where research will reduce risks. Zero Tolerance and Setting of Thresholds We contend that a zero-tolerance standard for contamination of food and feed crops by biopharmaceutical crops is not scientifically defensible. Biopharmaceutical products differ in the risks they pose to food and feed supplies, and the containment required needs to be evaluated on a product-by-product basis. Thresholds of tolerance should be defined for each biopharmaceutical product so that the potential impacts of each can be examined. It should not be assumed that all products have similar effects on human or animal health or the environment. It should be recognized that certain products may be potentially harmful while others may be relatively benign. Certification While we believe that federal regulatory agencies have developed effective strategies for biopharmaceutical containment, certification systems will be key to ensure that those strategies are implemented. Standard operating procedures, verification practices and identity-preservation programs can be implemented through process management and certification programs developed through the demonstrated expertise of institutions like Iowa State University, Iowa Crop Improvement Association, and various commodity groups. In addition, state and federal regulatory agencies need sufficient personnel and resources to provide effective inspection and enforcement. Public confidence will rely on a combination of private sector initiatives and strong regulatory agency actions when problems arise. Public-supported research and education An independent, publicly-funded institute is needed to coordinate the research and education activities on genetically modified agricultural products. Congress has called for authorization of such an institute in the new Farm Bill. At Iowa State University, a Biosafety Institute for Genetically Modified Agricultural Products (BIGMAP), has been initiated to provide unbiased, science-based and socially-justifiable evaluation of the risks and benefits of these products. The Institute aspires to fulfill a role for genetically engineered products similar to the Underwriters Laboratory, conducting its work in a transparent manner that builds public trust in the technology and the evaluation process. A well-informed public makes better choices about food, nutrition and health. Public dialog about issues surrounding the growing of pharmaceutical crops and the rules that will guide their production will lead to more informed public policy decisions. The recent (Nov. 21, 2002) open forum held at Iowa State University on the proposed FDA/USDA guidelines is an example of the kind of education and discussion needed. Dermot Hayes Leader, Public Policy Task Force Plant Sciences Institute Iowa State University Stephen H. Howell Director, Plant Sciences Institute Iowa State University Manjit Miisra Director, Seed Science Center Plant Sciences Institute Iowa State University

EC -43