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Tribes Frustrated with FDA’s Failure to Consult Them on FSMA Rules

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 consult with them before developing regulations that will have far-reaching impacts on their communities.

“[The] webinars conducted by the FDA have been small steps to including tribes, collectively the largest agriculturalists in the U.S., into the discussion of FSMA and its potential effects on tribes. But there is still a long way to go,” says Raymond Foxworth of First Nations Development Institute.

Michael Taylor, the deputy commissioner for Foods and Veterinary Medicine at FDA, led the webinar. He responded to most questions posed by tribal representatives with assurances that FDA is committed to helping tribes implement FSMA.

“We want to have an ongoing dialogue about some of the implementation issues,” said Taylor in his opening remarks.

But tribal representatives, such as A-dae Romero of the Cochiti Pueblo, say that their communities are not merely concerned about implementation of FSMA.

“FDA says these issues are about implementation, but Indian law is about a recognition of a relationship between the federal government and tribes,” says Romero. “And FDA has not honored that relationship during the development stage of these rules.”

She adds, “Tribes will face many unique challenges and hardships under the current proposed rules. If we don’t get tribes inserted into the language of FSMA now, who knows what is going to happen at the implementation stage?”

Tribes want more formal consultation 

Tribal representatives are especially frustrated with FDA’s lack of efforts to meet the consultation requirements of Executive Order (EO) 13175. EO 13175, signed by President Clinton in 2000 and reaffirmed by President Obama in 2009, requires federal agencies to consult with tribes when it promulgates regulations with tribal implications.

And the U.S. Department of Health and Human Services (HHS), FDA’s parent agency, has a consultation policy to implement EO 13175, which states: “Before any action is taken that will significantly affect Indian Tribes it is the HHS policy to the extent practicable and permitted by law, consultation with Indian Tribes will occur.”

So far, FDA’s recent webinar has been the only formal step to tribal consultation on FSMA rules. FDA and the National Congress of American Indians (NCAI) co-hosted two webinars on the proposed Produce Safety Rule this past spring. But these webinars were informational and did not constitute compliance with the EO 13175 consultation requirement.

“Meaningful consultation will mean different things to different tribes and their members, but face-to-face meetings with tribes are certainly a critical component of formal consultation,” says Janie Simms Hipp, director of the University of Arkansas School of Law Indigenous Food and Agriculture Initiative, and former senior adviser for tribal relations to Thomas Vilsack, Secretary of the U.S. Department of Agriculture (USDA).

“Not only are local and regional face-to-face meetings more informative, but also some tribal members cannot attend short webinars because they either lack reliable Internet or the short, generalized time frame of a webinar will not allow the deeper discussion necessary to fully consult on the rules,” Hipp explains.

Romero points out that HHS has a consultation policy, which FDA should have followed.

“It’s own consultation policy requires more than a two-hour webinar,” Romero says.

Additionally, Hipp, who organized and implemented tribal consultation for USDA when it initiated rulemaking for the 2008 Farm Bill, stresses the importance of working with tribes before a rule reaches the public comment stage. Otherwise, an agency is limited in how it can respond to tribal input.

She notes that agriculture is the second-largest employer in Indian Country. Without tribal participation at the development stage of rulemaking, FDA cannot adequately address FSMA’s significant and unique economic, social, and jurisdictional impacts on Tribal governments.

Hipp also points out that, while FDA has not met with tribes, FDA staff has met with other groups of producers, such as Amish farmers, in the period leading up to the publication of the Produce Safety Rule.

And, more recently, FDA published rules on animal feed and the use of transfats in foods. These rules were also published without tribal consultation despite their effects on tribal food and feed operations, she says.

Tribes extend invitations to FDA

Despite their frustrations, tribal representatives are eager to work with FDA as the implementation of FSMA progresses. So they have extended invitations to FDA to help set up face-to-face regional meetings.

During the recent FDA webinar, Joanie Buckley of the Oneida Tribe of Indians of Wisconsin invited Taylor to Oneida, WI.

Buckley emphasized, “We need you physically in our backyard … If we’re really going to drill down on this, we need to have you face-to-face.”

In response to requests for meetings, Taylor responded, “[W]e definitely will have some face-to-face engagement. We just have to figure out what’s the right, efficient way to do that for all of us to accomplish the task.”

Notably, HHS has already organized efficient, meaningful consultations to implement other laws. For instance, HHS has initiated formal consultation to implement the Affordable Care Act, which passed one year before FSMA. Under its consultation policy, HHS created a separate advisory committee and held regional, face-to-face meetings around the U.S. Also, HHS has published reports on its progress, approach, and commitment to tribal consultation on the Affordable Care Act.

But neither HHS nor FDA has initiated formal tribal consultation on FSMA other than the recent two-hour webinar. Tribal representatives clearly expect more from FDA as FSMA rulemaking progresses.

“The silence and exclusion of tribal authority and regulatory power in the Act is clear, so now they must engage in thoughtful and meaningful consultations with tribes, not just webinars, to acknowledge and respect the sovereign powers of tribes,” Foxworth says.

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