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FDA Finally Addresses Tribes on FSMA

Last Thursday, two months before comments close on the Food Safety Modernization Act (FSMA) Produce Safety and Preventive Controls for Human Food rules, the U.S. Food and Drug Administration issued notice of a webinar it will host in October to comply with an executive order mandating consultation with American Indian tribes.

The FDA will host a two-hour webinar with tribal officials on Monday, Oct. 7, 2013, from 2:30-4:30 p.m. (EDT). The primary purpose of the webinar is to consult with tribal officials on the Produce Safety and Preventive Controls for Human Food proposed rules, including FDA’s intent to prepare an Environmental Impact Statement (EIS) for the Produce Safety rule.

“This webinar is being held in response to requests for consultation by tribal officials, and Tribes are invited to share perspectives and any specific questions or concerns about these regulations,” the FDA announcements states.

In 2000, President Clinton set forth consultation and coordination requirements between the federal government and American Indian Tribes in Executive Order (EO) 13175. President Obama issued a Presidential Memorandum reaffirming EO 13175 in November 2009, and the Office of Management and Budget issued guidance documents to help federal agencies comply with that memorandum.

Under EO 13175, federal agencies must consult with tribal officials when they put forward the following two types of rules: 1) rules with tribal implications that have substantial direct compliance costs on Indian tribal governments and are not required by statute, and 2) rules with tribal implications that preempt tribal law.

Policies that have tribal implications are defined as:

“[R]egulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.”

The U.S. Department of Health and Human Services (HHS), FDA’s parent agency, has a consultation policy to implement EO 13175. This policy 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.”

On April 4, 2013, the National Congress of American Indians (NCAI) sent a letter on behalf of their tribal government members to the FDA commissioner requesting compliance with EO 13175 and the HHS consultation policy. FDA did not initiate formal consultation in response to NCAI’s request; rather, it responded with a letter stating FDA would include NCAI’s comments in the rulemaking docket and directed NCAI to FDA’s website for updates and further information.

Before FDA released notice of the October webinar, it responded to questions about whether the agency would engage in consultation by stating that it had held a series of public listening sessions and two webinars but would soon release notice of formal consultation.

The public listening sessions were held between Aug. 12-22 in Oregon, Washington, Maine, New Hampshire and Massachusetts. The FDA states that its tribal liaison sent notifications of the sessions to NCAI, which then distributed the information to tribes. Because FDA does not require registration at all listening sessions, it could not confirm whether any tribal representatives were actually present.

FDA’s two previous webinars with NCAI and other tribal representatives were held in May and the last week of August. Before these webinars were held, NCAI told FDA that they would not constitute official consultation.

According to FDA, a goal of the previous webinars was to “provide interested Tribes and Tribal organizations additional opportunities to express their views, in addition to providing formal comment to the administrative dockets.” The Administrative Procedure Act (APA) requires formal comment to the administrative docket regardless of tribal status when the FDA proposes new regulations. The APA rulemaking procedures are separate from EO 13175, and FDA’s compliance with those procedures is not considered tribal consultation.

When a listener at the August webinar asked FDA how it would meet the consultation requirements of EO 13175, agency officials responded that they had consulted with Mary Hitch from FDA’s Office of External Affairs and Stacy Ecoffey, HHS’s Principal Advisor for Tribal Affairs.

EO 13175, the Presidential Memorandum reaffirming the order, and HHS’s consultation policy do not suggest that an agency may comply with the consultation requirements by consulting with its own staff. HHS’s consultation policy, for example, includes guidelines with mechanisms such as mailings, teleconference, face-to-face meetings, roundtables, annual budget and policy consultation sessions and regular or special consultation sessions. The guidelines are not prescriptive, and the department must use an approach suited for the particular event.

An example of formal compliance with EO 13175 is USDA’s consultation plan after Congress passed the 2008 Farm Bill (the HHS policy does not apply to USDA). USDA created a consultation plan to work with Indian tribes on 70 regulations spanning seven agencies. It then gave 30-45 day’s notice of the entire schedule to all 566 tribal headquarters. The notice announced the location and purpose of the meetings, and it included a CD of the regulations for tribal review beforehand.

Overall, USDA held seven regional meetings where regional groupings of tribes normally meet. It had two days of briefings on the regulations, followed by one-on-one consultations with tribal leaders and their staffs. It also had two webinar briefings, which were followed by regional meetings and more webinars. Finally, USDA recorded every meeting, and it made the transcripts available.

In contrast, FDA will initiate formal consultation on the FSMA Produce Safety and Preventive Controls for Human Food rules by hosting a webinar scheduled a little more than a month before comments close and nine months since the agency first published the rules. FDA gave NCAI less than 30 day’s notice of the webinar, and it intends to cover the entire proposed rules, including the plan to create an EIS for the Produce Safety rule.

FDA also plans to answer questions and receive feedback from tribal governments during this two-hour webinar. However, the agency has not indicated how it will consult with tribes lacking Internet access or the necessary technology to attend a webinar.

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