Meeting notes

Date: June 19, 2007, 10:00-10:30 AM

Location: EPA (Washington, DC)

Attendance:

Clifford Gabriel (Director, EPA Office of Science Coordination and
Policy)

Melissa Kramer (EPA Office of Science Coordination and Policy)

Jeffrey Barach (GMA/FPA)

Discussion:

Jeffrey Barach outlined his understanding of the April 18, 2007 proposed
rules on PVCP-PIPs and sought confirmation that his understanding was
correct. He asked for clarification of the proposed exemption criteria
and exemption structure which Melissa Kramer provided. 

Dr. Barach explained that the main concerns of GMA/FPA related to food
safety and ensuring continued consumer confidence in the food supply. A
number of scenarios were discussed to consider whether certain types of
PVCP-PIPs would qualify for exemption under the proposed rules. 

Dr. Barach asked how the proposed rules would affect other agencies’
jurisdiction over PVCP-PIPs, and it was explained that the proposals
would not change the number or type of reviews performed by FDA and/or
USDA for plants containing PVCP-PIPs. EPA also explained that under the
proposal the Agency would receive notification of any PVCP-PIPs for
which a developer is claiming an exemption, and the Agency would make
this information available on the U.S. Unified Biotechnology Website
along with the product’s regulatory status at the other regulatory
Agencies.   

No materials were exchanged at the meeting. 

