Presentations

Joint JIFSAN/SRA/RAC Smposium
USDA/APHIS
4700 River Road
Riverdale, MD 20737
Conference Center Rooms C&D
September 30, 2003

Summary of the meeting

8:00 – 8:30 am Registration  
8:30 – 8:40 am Introductory Remarks Robert Buchanan, FDA/CFSAN
8:40 – 8:50 am Welcome Elizabeth Calvey,
FDA/CFSAN/JIFSAN

Morning Session: Peer review of Risk Assessments and Related Activities: what it is, what it can do, and what are some pitfalls?

Moderator: Janell Kause, FSIS/USDA

8:50 – 9:15 am Introduction: What is peer review?
abstract
presentation  		 Heather Douglas, U. Puget Sound
9:15 – 9:40 am OIRA guidance on information quality and peer review Margo Schwab, OIRA
9:40 – 10:05 am Peer review – challenges raised by OMB's guidelines
abstract
presentation  
OMB Press Release		 Leslie Hushka, ExxonMobil
Biomedical Sciences

10:05 – 10:25 am		 BREAK
10:25 – 10:50 am Strengths and limitations of regulatory peer review
abstract
presentation  		 Heather Douglas, U. Puget Sound
10:50 – 11:15 am Developing EPA's peer review program
abstract
presentation  		 Dorothy Patton, Consultant
(formerly EPA)
11:15 – 11:40 am Evolution of EPA’s peer review program
abstract
presentation  		 Jeff Morris, EPA/ORD
11:40 – 12:00 noon Questions and answers period  

12:00 – 1:00 pm		 LUNCH

Afternoon Session: A. Peer review needs of FDA/CFSAN, FDA/CVM and USDA/FSIS

Moderator: Mary Bartholomew, FDA/CVM

1:00 – 1:25 pm Federal review of risk assessments
abstract
presentation  		 Jim Schaub, USDA/ORACBA
1: 25 –1:50 pm CFSAN’s needs for peer review of risk assessments
abstract
presentation  		 Robert Buchanan, FDA/CFSAN
1:50 – 2:15 pm USDA/FSIS' needs for peer review of risk assessments
abstract
presentation  		 Carol Maczka, USDA/FSIS
2:15 – 2:40 pm The role of the RAC in the peer review of CVM’s risk assessments
abstract
presentation  		 Barry Hooberman, FDA/CVM
2:40 – 3:05 pm The economic benefits of economic peer review
abstract
presentation  		 Richard Williams, FDA/CFSAN
3:05 – 3:30 pm Questions and answers period  

3:30 – 3:45 pm		 BREAK

Afternoon Session: B. Panel Discussion and Closing Comments

Moderator: Mohamed Modarres, U. Maryland

3:45 - 4:45 pm Panel discussiona Panel membersb
4:45 - 5:00 pm Wrap-up and closing comments
presentation		 Don Schaffner, Rutgers U.


aPossible questions to be addressed by the panel members and discussed include:

  • What does ‘peer’ review really mean in a practical sense?
  • What are the key components of a peer review process?
  • What value does peer review of risk assessments provide to different organizations?
  • How should peer review be conducted? Who should participate? What work products should be subjected to peer review?
  • How should different organizations respond to the results of a peer review?

bPanel members:

Robert Buchanan, FDA/CFSAN
Phil Deshong, U. Maryland
Leslie Hushka, ExxonMobil
Dorothy Patton, Consultant (formerly EPA)
Caroline Smith DeWaal, Consumer Science in the Public Interest
Carol Maczka, USDA/FSIS