December 7, 1998 - Use of Antibiotic Resistant Marker Genes in Transgenic Plants

Food and Drug Administration, Docket No. 98-D-0340
Draft Guidance for Industry: Use of Antibiotic Resistance Marker Genes in Transgenic Plants: Report and Guidance for Industry; Availability
Federal Register Vol. 63: 47505-47506

The American Society for Microbiology (ASM), the largest single life science organization in the world, comprised of more than 42,000 members, appreciates the opportunity to provide written comments on the Federal Register, "Draft Guidance for Industry: Use of Antibiotic Resistance Marker Genes in Transgenic Plants: Report and Guidance for Industry; Availability." The ASM represents scientists who work throughout academic, governmental and industrial institutions worldwide. Microbiologists are involved in research to improve human health and the environment. The ASM's mission is to enhance the science of microbiology, to gain a better understanding of basic life processes, and to promote the application of this knowledge for improved health, and for economic and environmental well being.

The Draft Guidance for Industry: Use of Antibiotic Resistance Marker Genes in Transgenic Plants is lucid and easy to read and understand. The ASM endorses this draft document because we believe it is based on current scientific evidence and knowledge. Moreover, it is not prescriptive; rather, it recommends points to consider in using any antibiotic resistance marker in plants.

The ASM particularly appreciates the analyses and conclusions presented in the FDA Draft Guidance document describing policies and scientific assessments from other countries. ASM recommends that, while taking such matters into account, that FDA base policy decisions on the use of antibiotic resistance marker genes on the best available science, including the facts and analyses cited in its current draft document.

The ASM has several specific comments to make on issues raised in the draft document. For one, ASM agrees that any monitoring of antibiotic resistance marker gene transfers from plants to microorganisms needs to be done at the genetic rather than the phenotypic level. Such monitoring procedures should be capable of distinguishing those marker genes that may have transferred from a plant into microorganisms from any similar antibiotic resistance genes that were already present in the microbial population.

The ASM believes antibiotic resistance genes are widely distributed among microorganisms throughout the environment, particularly among bacteria and fungi that are commonly found on the surfaces and within tissues of plants, whether as benign or disease-causing microorganisms. It would be helpful to consumer groups and to scientists in other specialty areas who may read this document to remind them that any time humans consume fresh produce (e.g. vegetables, fruits, salads), no matter how carefully that food may have been washed, they are also consuming a variety of microorganisms, some of which are certain to carry various types of antibiotic resistance genes.

While these facts are well known, they are not extensively documented and little detailed or quantitative information is available about the environmental distribution of these antibiotic resistance genes. Nonetheless, many consumers and some scientists have the erroneous impression that microorganisms found in nature are universally sensitive to antibiotics and that antibiotic resistance is strictly a man-made phenomenon.

The ASM appreciates the opportunity to comment on this FDA Draft Guidance Document and hopes that these comments will be of assistance to agency officials.