In the U.S.A., the Food and Drug Administration, the Environmental Protection Agency, and the Department of Agriculture hosted a "Conference on Scientific Issues Related to Potential Allergenicity in Transgenic Food Crops". The goal of the Conference was to foster a dialogue among scientists on food allergy and new varieties of food crops developed by gene transfer to assess current information regarding what makes a substance such as a protein a food allergen and what means are available to assess allergenic potential.
The group of thirteen invited scientists included Dr. Robert Aalberse, Univ. of Amsterdam, The Netherlands, Dr. Martin Chapman, Univ. of Virginia, Dr. Peter Day, Rutgers, Dr. Kenneth Frey, Iowa State Univ., Dr. Michael Kemeny, Guy's Hospital, London, Dr. T.P. King, Rockefeller Univ., Dr. Yoichi Kohno, Chiba Univ., Japan, Dr. Samuel Lehrer, Tulane Univ., Dr. Dean Metcalf, NIAID/NIH, Dr. Marshall Plaut, NIH, Dr. Richard Raybourne, CFSAN/FDA, Dr. Steven Taylor, Univ. of Nebraska, and Dr. John Yunginger, Mayo Clinic.
The invited scientists presented and discussed papers on plant breeding and biotechnology, allergenic foods, exposure and allergenic response, T cell and B cell antigenic determinants, in vitro and in vivo diagnostics, and animal models. The scientists noted that allergenic reactions to foods occur in a small percentage of the population, but nevertheless, affect a significant number of individuals. Life threatening reactions are a rare occurrence, and most allergic reactions to foods can be attributed to less than a dozen foods. Methods are available to assess allergenic potential for proteins that are derived from sources to which consumers have reacted and for which serum is available, but it may be useful to establish a serum bank. There are no direct methods to assess potential allergenicity of proteins from sources that are not known to produce food allergy. Although, some assurance can be provided to minimize the possibility that a new protein will cause an allergic reaction by evaluating its similarity with characteristics of known food allergens (i.e. whether the new protein has a similar protein sequence, is resistance to enzymatic and acid degradation, is heat stable, and is of the appropriate molecular size), no one factor is predictive. Glycosylation of the protein was not considered a useful parameter for predicting allergenic potential.
A transcript of the proceedings (Docket No.94N-0053; document TR-1) is available from FDA by making a written request to the Freedom of Information Staff (HFI-35), Food and Drug Administration, Room 12A-16, 5600 Fishers Lane, Rockville, MD 20857.