Government and Regulatory Affairs
1997 USDA Amended Biotechnology Regulations

On May 2, 1997, the Animal and Plant Health Inspection Services (APHIS) of the U.S. Department of Agriculture (USDA) published a sweeping amendment to its rules for regulating transgenic plants under the Plant Pest Act. These rules have been used since 1987 for oversight over the field testing of certain plants and microorganisms modified to include genetic sequences from plant pests. Because Agrobacterium is among the listed plant pest genera, this rule has covered almost all transgenic plants that have been field tested in the U.S. for the past 10 years.

This amendment is extremely favorable for companies and academic institutions developing transgenic plants for phytoremediation, agriculture, or other uses. The rule allows almost all transgenic plants, except those where the host plant is a "noxious weed", to be used in research field testing merely upon 30 days advance notice to USDA, without the need for permits and a lengthier review process -- a procedure previously available only for six common food crops. The revised rule also simplifies certain reporting procedures, and makes it easier for a petitioner to extend previously-granted exemptions for certain plant varieties to include closely related variants.

On request, D. Glass Associates, Inc. (DGA) can prepare a report describing this rule and its impact on use of transgenic plants in agriculture and phytoremediation. Such a report would include:

• Historical summary of USDA regulatory efforts, including a discussion of the effect of the regulations on academic and industrial agbiotech activities.
• Summary of the amended rule, including a discussion of the rationale behind the more important portions.
• Analysis of the impact and implications of the amended rule on use of transgenic plants for research and commercial purposes.

The report would be about 20 pages in length, with figures and tables to help explain the rule's provisions. The price of this report is $195. DGA can also present a seminar on biotechnology regulation for key company decision makers, and provide strategic counsel on the impact of this regulation on company plans.

Contact D. Glass Associates for more information on obtaining this report.