7 Biotechnology Law Report 116 (March-April 1988)

Hotel in Washington, D.C. The conference drew over 300 biotechnology executives andgovernment offieals from 15 different countries, including France, Japan, The Ne-therlands Germany and Canada.

The meeting marked the debut of the ABC affinity discussion groups whichunited representatives from different countries who have common product interests andgeographical markets. The groups were designed to serve as a foundation forsubsequent communication and business relationships.

Conference speakers covered fundamental issues such as biotechnology financing,patents, regulation, business, trade, and politics. Among the numerous speakerswere: FDA Commissioner Frank E. Young; Dr. Henry I. Miller, Special assistant tothe Commissioner; Rep. John Dingell (D-MI); Dr. David. C. Pope, assistant directorof the Bureau of Biologies; I.L. Pep Fuller, U.S. Trade Representative and director,Chemical and Advanced Technology Policy, Executive Office of the President; and JohnF. Guion, senior vice president, NASDAQ Company Services, who gave the keynoteaddress.

Speaking on "Harmonization of U.S., Japanese and European Patent Law: FutureProspect or Faint Hope," Michael K. Kirk, assistant commissioner for External Af-fairs, U.S. Patent Office, made mention of a comparative study of patent practies inthe field of biotechnology related mainly to microbiological inventions conducted bythe European Patent Office, the Japanese Patent Office, and the U.S. Patent Office.The text of that study appears at <BLR 777> infra.

The meeting also provided ABC with the opportunity to recognize severalindividuals who have made outstanding contributions to the biotechnology industry.Dr. Frank Young and Dr. Henry Miller of the FDA received awards for their efforts toestablish an enlightened, educated regulatory climate.

Philip Abelson, deputy director for Science magazine, was honored for bringingclarity, objectivity and timeliness to biotechnology journalism. Also receivingawards were Anthony Irving, ABC board member and Samuel Ronel of InterferonSciences.

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{BLR 771} BLR BIBLIOGRAPHY: Biotechnology - Environment - Regulation.

BIOTECHNOLOGY AND THE ENVIRONMENT: INTERNATIONAL REGULATION.By Jeffrey N. Gibbs, Iver P. Cooper and Bruce F. Mackler. 1987. pp 339. StocktonPress, 15 East Street, NY, NY 10010. $160.00.

Reviewed by Joanne P. Will

Biotechnology, defined by the authors define as "any technique that uses livingorganisms to make or modify products or to improve plants or animals for specificuses", has created diverse markets for its products.

The health care industry now has biotechnology derived drugs and vaccines. Thechemical industry has benefitted from genetically engineered organisms that can

produce chemicals and plastic. Biotechnology derived agricultural products includepesticides and crops that resist drought, cold and insects.

However, along with this burgeoning biotechnology market comes the concern for

7 Biotechnology Law Report 117 (March-April 1988)

proper environmental regulation of these products.BIOTECHNOLOGY is an excellent reference book on the environmental regulation of

biotechnology in the United States and eleven other countries. It is readily under-standable by those with minimal experience in enviromental regulatory law, yetcomprehensive enough for those with experience in the field. The book is an worth-while addition to a legal or scientific library.

Chapter 1 provides a concise overview of biotechnology and its applications andthe enviornmental problems presented by it.

MAJOR EPA STATUTES

The next three chapters discuss the three major statutes administered by EPA:the Federal Insecticde Fungicide and Rodenticide Act (FIFRA), which confers upon theEPA the power to regulate pesticides; the Toxic Substances Control Act (TSCA), a

complex statute which gives the EPA jurisdiction over chemicals; and the Clean WaterAct, which gives the EPA authority to regulate the discharge of wastes from biotech-nology industries into navigable waters.

Especially helpful is the section on Genetically Engineered Pesticides inChapter 2, because it contains case histories illustrating how the law has beenapplied.

USDA PROGRAMS

Chapter 5 deals with the USDA. Although the USDA does not have general author-ity for the protection of the environment, they must respond to environmental con-cerns in accordance with the National Environmental Policy Act (NEPA). NEPA re-

quires all federal agencies to file environmental impact statements for any federalaction.

The USDA has three major programs for reviewing the environmental impact ofagricultural biotechnology. The book concisely explains the functions of the Agri-cultural Recombinant DNA Research Committee (ARRC), the Committee on Biotechnologyin Agriculture (CBA), and the National Biological Impact Assessment Program (NBIAP).The interrelation of the three programs is also discussed.

NIH AND FDA

The next chapter discusses The National Institutes of Health Guidelines forRecombinant DNA research. The section interpreting the guidelines is particularlyuseful.

Chapter 7 discusses the FDA and the statute it administers, the Federal FoodDrug and Cosmetic Act. As does the USDA, the FDA must file an encironmental impactstatement. The impact of NEPA on the FDA is well highlighted by a case history onbovine growth hormone.

The following chapter neatly ties the discussions of Chapters 2-7 together.

Chapters 9 and 10 deal with the NEPA and the Endangered Species Act (ESA).These two chapters provide excellent overviews of two general environmental statuteswhich impact on the biotechnology industry.

7 Biotechnology Law Report 118 (March-April 1988)

Chapter 11, 12, and 13 provide concise overviews of the important issues oftransportation, local regulation, and product liability of biotechnology derivedproducts. The authors state that the biotechnology industry will "face implicitregulation in the form of suits by private parties."

INTERNATIONAL REGULATION

Chapter 14-24 provide concise overviews of the environmental regulation ofbiotechnology in the United Kingdom, Austrailia, Austria, Canada, Denmark, FederalRepublic of Germany, France, Ireland, The Netherlands, New Zealand, and Switzerland.

Chapter 25 discusses the international environmental regulation of biotechnol-ogy and the two major players, the Organisation for Economic Cooperation and Devel-opment (OECD) and the European Economic Community (EEC). The chapter is necessarilybrief because one could fill a volume on the OECD and the EC involvement in envi-ronmental regulation.

The last chapter is a thoughtful discussion of the need for environmentalregulation of biotechnology for the dual purpose of protecting the environment andpermitting new and promising products to be tested and marketed.

The authors also provide a postscript at the end of the text to update eachchapter. This illustrates how biotechnology is constantly evolving.

This book will be useful to attorneys and regulatory personnel working in thebiotechnology area, as well as scientists developing and testing biotechnologyproducts.

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{BLR 772} Personnel Changes - Biotechnology Lawyers.ON THE MOVE:

GREENLEE ESTABLISHES FIRM

Lorance L. Greenlee recently announced the establishment in Boulder, Colorado,of Greenlee and Associates, P.C., a firm specializing in patent, trademark andcopyright matters.

Greenlee was formerly vice president and chief patent counsel at AgrigeneticsCorporation. He received a B.A. in chemistry from the University of Colorado, aPh.D. from Duke University and a J.D. from the University of Utah.

WINNER JOINS GREENLEE

Also with Greenlee and Assoiates is Ellen P. Winner. She was formerly a patentattorney with Agrigenetics and junior partner at Sheridan, Ross and Mclntosh.

Ms. Winner received a B.A. in chemistry from Blake College and a J.D. from theUniversity of Denver.

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