The proposal was reviewed by the RAC at its June 1, 1984, meeting. The RAC 
with no negative votes recommended approval of the proposal. 
On September 14, 1983, a lawsuit was filed (Foundation on Economic Trends, et al. 
v. Margaret M. Heckler et al., Civil Action Z/83-27 1 4 in the United States District 
Court for the District of Columbia). On May 16, 1984, Judge John Sirica issued a 
preliminary injunction in this case. The injunction was partly affirmed and partly 
vacated by the Appeals Court in a decision of February 27, 1985. Although the 
preliminary injunction specifically does not apply to proposals voluntarily 
submitted to the NIH (as is the case with the Agracetus proposal), the Director, 
NIH, decided that before he would approve the Agracetus proposal an 
Environmental Assessment should be prepared. 
On April 29, 1985, Mr. Allen J. Dines, Director, Business Development, Agracetus, 
forwarded to the NIH both additional details concerning the proposed field test 
and a draft environmental assessment. That draft EA was revised by the NIH to 
produce this EA. 
On July 8, 1985, Mr. Allen J. Dines sent a letter to the NIH indicating that the 
proposal already recommended for approval by the RAC had also been submitted 
for review to the Animal and Plant Health Inspection Service (APHIS) of the U.S. 
Department of Agriculture. Mr. Dines included with his letter a copy of a 
June 14, 1985, letter to him from James W. Glosser, Acting Administrator, APHIS, 
which states that: "Based upon our review of your proposal, we have determined 
that your genetically engineered tobacco plant does not present a plant pest risk. 
Therefore, your proposed field testing would not be subject to further regulation 
by USDA, APHLS, under the Plant Pest Act." 
Environmental Assessment 
Page 1 1 
[ 481 ] 
