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Tribes Still Troubled by FDA’s ‘Inadequate’ Consultation Policy

With less than 30 days notice, the U.S. Food and Drug Administration (FDA) finally set a date for face-to-face consultation with American Indian tribes and pueblos on its proposed rules under the Food Safety Modernization Act (FSMA).

On March 27, FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor sent a letter to tribal and pueblo leaders informing them of a consultation to be held on Wednesday, April 23, from 8:30 a.m. to 11 a.m. MDT at the Indian Pueblo Cultural Center in Albuquerque, NM.

FDA’s stated agenda includes a discussion of seven proposed FSMA rules and its intent to create an Environmental Impact Statement (EIS) for the Produce Safety Rule. Additionally, FDA officials indicated that they would answer questions and hear feedback on all seven proposed rules.

Concerns over Notice and Agenda for April Meeting

Over the past 10 months, tribal representatives had asked FDA for face-to-face consultation on FSMA rules. But now that FDA has finally set a date, some representatives are dismayed by the meeting’s short notice as well as the expansive amount of material agency officials propose to cover in a single meeting.

“A two-and-a-half-hour meeting in one location to digest and consult on hundreds of pages of rules is wholly inadequate,” said 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 Secretary of Agriculture Thomas Vilsack.

A-dae Romero, an attorney specializing in food and agricultural law and a member of the Cochiti Pueblo, also expressed concern over the content and length of the meeting. She noted that, according to FDA’s stated agenda, a substantial amount of the two-and-a-half-hour meeting is devoted to background and explanations of the proposed rules, leaving little time for feedback and questions.

“The amount of information that FDA proposes to cover with over 24 different tribes in New Mexico (and possibly other tribes from other states) is appalling,” said Romero.

In addition to the April 23 meeting in New Mexico, FDA plans to conduct a consultation with the Navajo Nation on April 22, FDA spokesperson Catherine McDermott told Food Safety News. Doyle Forrestal from Region VIII of the U.S. Department of Health and Human Services confirmed that a consultation meeting is scheduled for April 22 in Window Rock, AZ, at the Navajo Museum.

Implementation and Formal Consultation Issues

Romero and Hipp emphasized that tribes are deeply troubled by FDA’s apparent reluctance to comply with formal consultation requirements.

Executive Order (EO) 13175 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.”

Despite EO 13175 and HHS’s consultation policy, FDA has only held one formal FSMA consultation thus far, which was a two-hour webinar held last November.

“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,” Hipp said.

FDA has also held several phone calls, webinars and meetings since developing FSMA rules. But both Romero and Hipp noted that these meetings do not constitute formal consultation.

“FDA is a subsidiary of HHS. So is its sister agency, the Indian Health Service (IHS), which has a very good template for formal Tribal Consultation. But, for some unknown reason, FDA is choosing not to follow a well-established Tribal Consultation Policy of HHS,” Romero said.

In addition to the lack of face-to-face consultation, Hipp pointed out that FDA did not attempt to consult with tribes during the development stage of its proposed rules.

“What would have been more appropriate is for FDA to have planned consultation immediately after FSMA was enacted and coordinate a comprehensive approach to meeting their obligations. They didn’t do so, and we are now at a juncture where ‘hurry up and check the box’ is their approach,” she said.

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