EPA v. ADVANCED GENETIC SCIENCES, INC.

Case summary

NATURE OF THE CASE: THIS IS THE RESULT OF A HQ-DEVELOPED INVESTIGATION INTO POTENTIAL FIFRA VIOLATIONS BY THE FIRST BIOTECHNOLOGY COMPANY TO APPLY FOR A FIFRA EXPERIMENTAL USE PERMIT (EUP) FOR EXPERIMENTAL ENVIRONMENTAL RELEASE OF A GENETICALLY-ALTERED ORGANISM. EPA CHARGED AGS WITH VIOLA- TING THE EXPERIMENTAL USEPERMIT CONDITIONS AND FALSIFYING INFORMATION IN THE PERMIT APPLICATION. AGS CONDUCTED AN OUTDOOR EXPERIMENT WITH ITS GENETICALLY-ENGINEERED MICROBE FROSTBAN IN VIOLATION OF EPA FIFRA BIOTECHNOLOGY POLICY AND FAILED TO ADEQUATELY REPORT THE EXPERIMENT IN ITS EUP APPLICATION. / ISSUES OF NATIONAL IMPORTANCE: THIS IS THE FIRST CASE EVER FILED BY EPA FOR VIOLATIONS INVOLVING GENETICALLY-ALTERED ORGANISMS. THE CASE WILL TEST THE STRENGTH OF EPA'S FIFRA BIOTECHNOLOGY POLICY AND ITS ABILITY TO ENFORCE VIOLATIONS UNDER FIFRA/ 12(A)(2)(H) AND 12(A)(2)(M). / RECOMMENDED ACTION: AGS PLANS TO FILE AN ANSWER DENYING THE ALLEGATIONS IN THE COMPLAINT AND THEN NEGOTIATE. BECAUSE AGS IS FILING AN ANSWER, EPA MUST BEGIN PREPARING FOR POS- SIBLE TRIAL. REGION-IX, NEIC, AND OPP WITNESSES WILL BE BRIEFED AND THE TAPED INTERVIEW WITH POTENTIAL WITNESS DENNIS BROSTIN TRANSCRIBED. DRAFT SETTLEMENT STRATEGY CALLS FOR A $10,000 CASH PEN- ALTY AND A $100,000 PERFORMANCE BOND RELATED TO THE EUP CONDITIONS. / OTHER PARTIES: FOUNDATION FOR ECONOMIC TRENDS.

Defendants (1)

• ADVANCED GENETIC SCIENCES, INC. (AGS)Named in complaintNamed in settlement

Statutes cited

• FIFRA 14A1 — Fed. Insect, Fung & Rod Act
• FIFRA 12A — Fed. Insect, Fung & Rod Act

Enforcement conclusions (1)

• ADVANCED GENETIC SCIENCES, INC.entered 1986-06-26

  Primary law: FIFRA

  Federal penalty: $13,000

Timeline (4 milestones)

• 1986-03-28Enforcement Action Data Entered
• 1986-03-28Complaint Filed/Proposed Order
• 1986-06-26Final Order Issued
• 1987-01-12Enforcement Action Closed