On Nov. 5, the U.S. Food and Drug Administration (FDA) hosted a two-hour webinar with American Indian tribes to discuss FDA’s proposed rules on the Food Safety Modernization Act (FSMA). During the webinar, FDA emphasized that it will work with tribes to implement FSMA regulations. However, tribes remain concerned and frustrated with FDA’s failure to…
Tribal Consultation: Time For FDA To Recognize Sovereignty Principles
The U.S. Food and Drug Administration (FDA) has seemingly created an untimely protocol of not complying with Executive Order 13175 and the meaningful principles of tribal consultation and sovereignty. In 2013, FDA has proposed three regulations that have substantial direct effects on tribal food businesses and economies without evidence of meaningful tribal consultation. This is…
FSMA Rules Pose Unique Hardships for Tribal Communities
The proposed Food Safety Modernization Act (FSMA) regulations have sparked debates about the costs of compliance and other impacts on small- to medium-sized producers. But American Indian tribes face notably unique challenges under the new rules. Recently, the U.S. Food and Drug Administration (FDA) hosted a two-hour webinar to consult with tribes on FSMA. In…
FDA's Proposed Produce Rules Disregard Tribal Sovereignty and Federal Case Law
On Sept. 16, Food Safety News published an article by Kelly Damewood entitled, “FDA Finally Addresses Tribes on FSMA,” which stated that the U.S. Food and Drug Administration (FDA) has not engaged in formal consultation with tribes regarding their proposed produce safety rules as part of the Food Safety Modernization Act (FSMA). Formal…