FDA Defies Consultation Regs: No Tribal Input on Food Safety Rules

The Food and Drug Administration failed to meet its responsibility to consult with American Indian tribes as it developed new food safety regulations.
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The federal Food and Drug Administration failed to meet its responsibility to consult with American Indian tribes as it developed new food safety regulations and, when challenged, made only an extremely superficial effort to remedy the lapse.

“Without early consultation, tribes are unable to provide input at a time when it is most likely to have a meaningful impact on FDA’s decision making,” according to the GAO report, “Food Safety: FDA Coordinating with Stakeholders on New Rules but Challenges Remain and Greater Tribal Consultation Needed” (GAO-16-425).

Ensuring the safety of the U.S. food supply is the responsibility of dozens of federal, state, local and tribal agencies. The Food Safety Modernization Act (FSMA) of 2011 was the first major expansion and overhaul of federal food safety law in nearly 100 years. The act significantly increases the FDA’s food safety authorities and responsibilities.

FMSA mandated that FDA write rules for the safe growing, harvesting, holding, processing and transport of food consumed by humans and animals with the aim of preventing food-borne illnesses. The agency held 13 public meetings on its proposed rules and allowed for extended comment periods, but did not meet the requirement to consult with tribes before publication of the rules.

FDA’s responsibilities to tribes are clear. “No agency within HHS [U.S. Health and Human Services Department, of which FDA is a part] may promulgate any regulation with tribal implications unless either the federal government provides the funds necessary to pay the direct costs incurred by the tribes or the agency has consulted with the tribes throughout all stages of the process of developing the proposed regulation,” reads the report.

The new FDA rules have several implications for tribes. Among the most important are “the effect of compliance costs on the sustainability of tribal businesses, the effect of produce rule requirements on traditional farming practices, questions regarding who would be responsible for ensuring compliance on tribal lands, and the effect of water standards on tribal water rights,” according to the report.

But instead of consulting with tribes before the rules were promulgated, FDA’s first formal tribal consultation occurred 1 month after publication of the proposed rule on animal food and 10 months after publication of the proposed rules on produce and human food.

Even when the National Congress of American Indians wrote to FDA after the rules were published stressing the need for tribal consultation, FDA responded only by setting up a couple of webinars for tribes and holding face-to-face meetings with just four tribes. Informational webinars, however, do not constitute the government-to-government consultations required by law.

FDA defended its actions to GAO investigators by saying that it had held public informational meetings that tribes could have attended, but, wrote GAO, “meetings for the general public are not consistent with the government-to-government relationship and dialogue called for … and at least one federal court has made that assertion.”

There is still time to remedy the situation, said Janie Simms Hipp, director of the University of Arkansas School of Law’s Indigenous Food and Agriculture Initiative. “FDA could still go in and conduct tribal consultations, since the new rules will be phased in over time [between 2016 and 2020].”

Food safety regulations are an issue that needs “to be front and center for our Indian producers and our economic development around food,” said Hipp, pointing out that food safety regulations need to be written that are specific to the unique legal environment on Indian lands and that training to meet food safety requirements must take into account the realities of tribal food production.

Hipp suggested that a centralized food training center for tribal producers might be a solution, or that tribes could work together to develop their own food safety regulations. “The best way forward is to work intertribally to build out certification and knowledge to move food around [safely],” she said. She cites the work of Columbia River Inter-Tribal Fish Commission as a possible model. “No way would tribes ever put unsafe food on anybody’s plate.”

FDA in February published a draft tribal consultation policy and has opened a docket to receive public comments. In this report, GAO notes, however, that the draft policy does not explicitly provide for early consultation with tribes and recommends HHS make sure that FDA’s policy does include early consultation for rules with tribal implications and that the FDA develop a timeline for finalizing the policy.