Alexandria, Virginia, USA
October 8, 2012

On behalf of the U.S. seed industry, the American Seed Trade Association submitted comments to the U.S. Food and Drug Administration asking for the inclusion of language in the Guidance that seed production and storage establishments are excluded from both the Federal Food, Drug and Cosmetic Act (FFDCA) Sec. 415 registration and the associated Food Safety Modernization Act (FSMA) regulatory obligations that flow from such registration.

The letter cites Rep. Bennie Thompson (D-MS) commenting during the legislative debate leading up to the passage of the FSMA saying:
"It was never the intent of this legislation to include seed production or storage establishments in the definitions of 'facility,' for purposes either FFDCS Sec. 415 or for the Full-Year Continuing Appropriations Act 2011 (FSMA). In many respects, these establishments are similar to farms, which are exempted from Sec. 415's definition of 'facility.' Nevertheless, earlier lack of clarity as to Congress's intent regarding this matter has led to confusion in an industry that has historically not been subject to regulation by FDA."

Additionally, the letter cites U.S. Senator Tom Harkin (D-IA) addressing the issue in the Senate debate on FSMA saying:
"Mr. President, it is not the intent of this legislation to include the definition of 'facility,' for the purposes of either FFDCS Sec. 415 or for the pending bill, seed production or storage establishments as long as they do not manufacture, process, pack or hold seed reasonably expected to be used as food or feed. Further we note that seeds not used as food or feed have historically not been subject to oversight by FDA."

The comments were filed in early September by ASTA's Andy LaVigne, president and chief executive officer.
 

Website: http://www.betterseed.org/

Published: October 5, 2012