1. the proposed produce safety and preventative control rules (21 CFR Parts 16 and 112)
2. the approval of genetically engineered salmon for market purposes (Docket Number FDA-2011-N-0899) and
3. elimination of artificial trans fats in foods (Document Number: 2013-26854).

FDA’s blatant and continuing disregard for presidential administrative directives is a cause for tribal concern and immediate action. President Bill Clinton signed Executive Order 13175 in 2000 promulgating consultation and coordination requirements with tribal governments because of the foundational governing principles supported by federal case law and policy. President Obama affirmed Executive Order 13175 in November 2009 in order to further the objectives of federal agencies working cooperatively and inclusively with our nation’s first sovereigns. The expressed purpose of Executive Order 1317 requires tribal consultation and coordination on policies that have substantial direct effects on tribes. Policies as defined in Executive Order 13175 “refers to regulations, 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.” HHS adopted its own detailed tribal consultation policy that applies to all divisions, including FDA. FDA states on its website that it is responsible for “the protection of public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, medical devices, most of our nation’s food supply.” FDA either does not consider the promulgation of food regulations or regulation affecting tribal food sources, processes or economic ventures as having direct substantial impacts on tribes. FDA Rule (21 CFR Part 16 and 112)-Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption is perhaps one of the most apparent rules that will have substantial direct impact on tribes. The rules squarely challenge years of litigation between federal agencies and tribes over the proposed regulation of water quality within tribal lands, civil regulatory authority of tribes over their own affairs, and inclusion of tribal nations as sovereign governments. The proposed rules will put many tribal food and agricultural businesses out of business not because tribes cannot comply with the heightened standard of food safety, but because the costs of compliance for rural farmers is severely underestimated. For example, in tribal communities where the cost of living is even higher than most rural communities, the cost of complying, becoming exempt, or attempting to get guidance on the rules would be expensive. Tribes are completely ignored or not considered in the proposed produce safety rules variance provisions, the one place where it would be fairly simple to insert the word tribe next to state as an affirmation to tribal nations of the government-to-government relationship that Executive Order 13175 stresses. Moreover, complying with the proposed produce safety rules would place tribes in the precarious position of ignoring the long-standing battle between federal agency regulation and tribal civil regulatory authority. Yet, FDA’s one tribal consultation webinar, held on Nov. 5, 2013, which occurred 10 days before final comments were due on the rule, was simply inadequate tribal consultation. The webinar included a PowerPoint presentation. Unfortunately, FDA did not adequately provide information and subverted tribal concerns to the prospective arena of “implementation issues” rather than rule development. More adequate tribal consultations provide tribal government participation and administrative comment (just as with other sister federal agencies or programs) prior to the proposed rule being noticed for public comment. FDA Rule citation-Environmental Assessment and Preliminary Finding of No Significant Impact Concerning a Genetically Engineered (GE) Atlantic Salmon.  There were no tribal consultations on the FDA action that approved GE salmon despite the significant direct and indirect impacts from the rule on tribes. FDA, as a federal agency with the legal requirement to protect tribal trust resources, must recognize the essential spiritual, legal, economic, emotional, social, and political attachments that tribal nations have to salmon because it is declared in the federal law in the court case US v. Washington, 384 F. Supp 312 (1974). In US v. Washington, the US Supreme Court stated, “The right to fish for all species available in the waters from which, for so many ages, their ancestors derived most of their subsistence is the single most highly cherished interest and concern of the present members of plaintiff tribes, with rare exceptions even among tribal members who personally do not fish or derive therefrom any substantial amount of their subsistence.” Since the 1974 decision, several tribes have developed robust subsistence and commercial fishing operations that have greatly improved respective tribal economies and regions. Additionally, the current tribal management of the fisheries is evidence of the sophistication and the necessity to include tribal knowledge in protecting and supporting reserved tribal water and fishing rights, which includes the protection of wild fish populations. The preliminary FDA environmental risk assessment (EA) indicated that the approval of AquaAdvantage Atlantic Salmon “will not have any significant impacts on the quality of the human environment of the United States (including populations of endangered Atlantic salmon) when produced and grown under the conditions of use for the proposed action” (p 16). The EA further explained that the AquaAdvantage fish would be raised in Panama but shipped and processed at Prince Edward Island, Canada. In another FDA document entitled, “Preliminary Finding of No Significant Impact,” FDA explains that because the analysis in the draft EA preliminarily indicates that the proposed action will not significantly affect the physical environment of the U.S., FDA, in turn, would not consider the social and economic effects of their rule. There were 13 tribes that submitted comments and official tribal resolutions to FDA regarding the approval of GE salmon. Every single tribe indicated that tribal consultation was not conducted, and each requested consultation. For example, the Yurok Tribe, the largest tribe in California, expressly indicated that “adequate analysis and consultation has not occurred.” It is important to note that federal actions such as this do not further respective FDA/Tribal government-to-government principles. FDA Rule (Document Number: 2013-26854)-Transfat Ban in US Food Supply. FDA recently made a preliminary determination that partially hydrogenated oils (PHOs), the primary source of artificial trans fats in processed foods, are not safe for use in food. FDA is currently in a 60-day public comment period. A final decision would mean that the use of PHOs in food would be phased out over a number of years. Two food sources with some amount of trans fat are microwave popcorn and ground beef, which has naturally occurring trans fat amounts, among other foods. The Lower Brule Sioux Tribe, the owner and operator of Lakota Foods, produces seven million pounds of popcorn each year. The Lakota Foods model has been praised by, among others, South Dakota State University and former Deputy Secretary of Agriculture Kathlen Merrigan, as a successful tribal economic venture. Lakota Foods not only provides jobs in some of the poorest regions and counties in the United States, but has created a thriving tribal economy for the Lower Brule Sioux. Oklahoma and South Dakota are on the list of the top 10 beef-producing states. They are also two of the states with the highest American Indian populations. Within these states, there are numerous beef producers that are either tribally or individually owned. In either case, the tribal cattle production within any given reservation contributes to the respective tribal economies. Increased regulatory costs of input will decrease profits and the amount of money in any economy. Even small amounts of circulating money derived by and for tribal businesses in a tribal economy is integral for the region. The federal and tribal governmental relationship is a founding principle of the U.S. The issue is not whether these FDA policies and rules are right or wrong, but there exist policies, procedures, and law that embody the institutional basis of the long-hardened relationship between the federal government and tribal nations. Ignoring these policies, procedures, and law not only harms tribal nations, but harms America’s government, the foundational institution of the U.S. The spirit and implementation of Executive Order 13175 is vital to our ever-growing nation. This important federal policy has been in existence for more than 13 years, while the principles of a tribal/federal government-to-government relationship have been in existence for much longer than that. President Obama reaffirmed Executive Order 13175. Every federal administrative agency has its own affirmation of Executive Order 13175 through their own tribal consultation policies, including the U.S. Health and Human Services Department, the parent agency of FDA. Most recently, U.S. Attorney General Eric Holder addressed tribes at the 2013 White House Tribal Summit. He said, “Together, through many generations, you and your predecessors have faced down tremendous adversity – standing up to those who once sought to terminate the federal government’s relationships with tribes. You’ve galvanized support for the rights of American Indians to maintain tribal governments – and to have a seat at the table before major reforms are enacted.” Holder did not add, “except in the case of FDA reforms.” FDA’s disregard for tribal consultation not only disregards the established executive orders and spirit of cooperative federal/tribal relationship but federal case law, the HHS tribal consultation policy and constructive inclusion of tribes in federal rule-making is the positive future of our country. It is advisable for FDA to strengthen and uphold tribal consultation and decision-making in their current and subsequent regulatory actions.