October 16, 2007
Margaret O’K. Glavin
Associate Commissioner
Food & Drug Administration
Rockville, MD
Dear Commissioner Glavin:
During the recent National Association of State Departments of Agriculture (NASDA) Annual Meeting, we discussed the FDA Office of Regulatory Affairs (ORA) Transformation (reorganization) project. We are aware that the agency has temporarily suspended this process; however, since some of the proposed draft plans could have had a detrimental effect on the States / FDA interactions, we wanted you to know of our concerns and our willingness to work with you as you continue to determine effective ways to assure the safety of food and feed in the US. We are also very pleased with the announcement and invitation earlier today to participate in an “ORA Moving Forward” stakeholder process.
Several high profile cases, e. g., most recently, the recall of products potentially contaminated with botulism toxin, the incident of pet food and animal feed potentially contaminated with melamine and the E. coli detection in spinach, have only accentuated the significance these issues have on the public and other stakeholders that we jointly serve. No one can deny that State / FDA interaction is an important aspect of dealing with these issues.
Therefore, as the agency proceeds, either as a result of the Interagency Working Group on Import Safety or this “ORA Moving Forward” process, NASDA believes there is a need for assessments of the effects of proposed changes on other stakeholders. NASDA is willing to work with you on any future plans for reorganizing those parts of the agency that directly affect states’ relations with FDA. We also want you to know how much we value transparency and communications on these important issues.
I also want to thank you for the invitation to the “ORA Moving Forward” meeting on November 6 – 8, 2007. Unfortunately, I will be in China at that time. I will get back to Mr. Barnes as soon as we have determined who will be available to represent NASDA.
If you have questions, please feel free to contact us.
Sincerely,
Roger Johnson
President
NASDA
Commissioner
North Dakota Department of Agriculture
cc: Andrew C. von Eschenbach, M.D., FDA Commissioner
Julie Zawisza, FDA Assistant Commissioner for Communications
Richard Barnes, Director, FDA Federal/State Relations
Bill Northey, Secretary, Iowa DALS
A.G. Kawamura, Secretary, California DFA
Ron Sparks, Commissioner, Alabama Department of Agriculture
Greg Ibach, Director, Nebraska Department of Agriculture
Lester Spell, DVM, Commissioner, Mississippi Department of Agriculture & Commerce