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Demand Tribal Consultation on FDA Food Safety Rules

Your Support Urgently Needed: The FDA Continues to Ignore Tribal Governments
The U.S. Food and Drug Administration’s (FDA) Food Safety Modernization Act of 2010 (FSMA) was signed into law by President Obama on January 4, 2011.  In 2013, the accompanying FDA regulations were released. FDA’s regulations articulate sweeping changes in how agricultural businesses and farmers grow, produce and process specific produce. Most concerning for tribes, tribal producers and tribal food and agricultural businesses are:

  • Provisions that will regulate water standards
  • Provisions that allow for state and foreign government exemptions, but not tribal governments
  • Lack of acknowledgment of regulatory authority of tribes over their own land, people and resources
  • Enforcement of these rules being delegated to state agencies

Since 2013, the FDA has continued to push these rules with little input from tribes and with only nominal acknowledgment of the federal government’s obligation for tribal consultation that is articulated in Executive Order 13175. Only one official tribal consultation listening session was conducted in Albuquerque, New Mexico, on April 23, 2013, with less than 30 days’ notice to tribes. At the close of comments, the FDA received numerous requests by tribes and nonprofit tribal organizations to conduct tribal consultations.

On September 29, 2014, the FDA released supplemental rules in response to the more than 1,000 comments received for the first round of draft regulations. The supplemental rules do not mention tribes, address their concerns, or acknowledge the receipt of the comments that requested tribal consultations. Further, the FDA directed that comments to the supplemental rules be limited and very narrow in scope, and address very specific issues such as soil amendment, water quality standards, and definitions of a farm facility. Again, while the FDA’s supplemental comments offer evidence in meeting their requirements to adhere to Executive Orders 12866 and 13563, there is no mention of the Tribal Consultation Mandate, Executive Order 13175.

FDA has been repeatedly reminded of the obligation for tribal consultation not only by tribes themselves, but also by national organizations like the National Congress of American Indians and First Nations Development Institute. Many questions about relevance, implementation and enforcement of the FDA regulations in Indian Country remain unanswered. The deadline for submission of comments on the supplemental rules will end on December 15, 2014.

Please take action! Contact the FDA quickly and demand full tribal consultation on these and any additional rules stemming from the Food Safety Modernization Act.

Your comments can be emailed to or mailed to this address:

Food and Drug Administration
5100 Paint Branch Pkwy
Wiley Building, HFS-009
Attn: FSMA Outreach
College Park, MD 20740

Here is an example of a letter that you can use, but personalize it for yourself as much as possible:

Re: Docket No. FDA-2011-N-0921, Consultation on Food and Safety Modernization Act, Supplemental Rulemaking for Standards for the growing, harvesting, packing, and holding of produce for human consumption

The purpose of this letter is to provide comments in response to Docket No. 2011-N-0921, Consultation on the Food Safety and Modernization Act, Standards for the growing, harvesting, packing, and holding of produce for human consumption proposed rule.

Because of the potential impacts of this proposed rules on tribal nations and, in general, Indian lands and tribal members, we urge you to consider an extended period of consultation to ensure notice and opportunity for input from tribes and their advisors.  There are over 565 federally-recognized tribes, with diverse histories, needs and policy approaches.  Consultation requires meaningful input from tribes and a true “seat at the table” before the proposed rule is final.

We understand that due to difficulties with the website, the FDA extended the comment period on the final rule. We also understand that FDA has had several meetings, with one tribal consultation meeting in April 23, 2014 in which tribes were given less than 30 days’ notice to attend. However, federal policy pursuant to Executive order 13175 requires the FDA to engage in consultation whenever a proposed rule or policy has tribal implications.  Similarly, U.S. Health and Human Services’ tribal policy lays out a well-planned tribal consultation schedule and process that has not been implemented.
The proposed rule will impact tribal nations, their lands, and their members.  Because FDA failed in efforts to meet the requirements of Executive Order 13175, and its own HHS Tribal consultation policy, we urge you to review the rule expressly to exempt tribal nations, their lands and their members from application of the proposed rule.  Alternatively, we strongly urge FDA to schedule formal consultations with tribal nations and, until such consultation is complete, we urge FDA from enforcing the final rule on tribal nations, their lands, and their people.


(fill in your own name and address here, along with any tribal affiliation or business name as applicable)