On Sept. 16, Food Safety News published an article by Kelly Damewood entitled, “FDA Finally Addresses Tribes on FSMA,” which stated that the U.S. Food and Drug Administration (FDA) has not engaged in formal consultation with tribes regarding their proposed produce safety rules as part of the Food Safety Modernization Act (FSMA). Formal tribal consultation, she explained, is triggered through Executive Order 13175, when an agency’s rules have substantial direct effects on tribes or effects on the relationship between tribes and the government.
Federal case law states that federal regulations apply to tribes unless one of three exceptions exists: 1) tribal self-government function, 2) if federal regulations applied would abrogate treaty rights, or 3) Congress did not intend for the law to apply to tribes. The exceptions aside, FDA’s proposed safety rules will not only have substantial effects on tribes and their relationship with the federal government, but also disregard existing federal Indian Law.
There are many problematic points within FDA’s proposed rules, but the three most troubling provisions for tribes are the issues of enforcement, regulation of agricultural water, and variances.
Generally, federal case law states that a trusting relationship exists between tribes and federal government. This relationship is not new. It has been well established for decades. This relationship, typically, does not include the state unless there is some contractual relationship between the tribe and the state that specifies state limitations within the realm of tribal jurisdiction. Local governments have none or very little direct or indirect authority within the federal/tribal relationship.
FDA has traditionally not been an enforcement agency; instead, it relies on state partners to carry out its enforcement roles. The same holds true for its sister food-safety agency, the U.S. Department of Agriculture (USDA). As FDA itself reported in its cost justification for user fees associated with FSMA, FDA has fewer than 3,000 full-time employees to do field work such as inspections. With such a small field employee base and a huge unappropriated directive to overhaul food-safety regulations, FDA will presumably contract out to state and local county health departments to ensure compliance with, and enforcement of, the proposed produce safety rules. This contractual agreement would be between FDA and local and state governments – with no input from tribes.
Tribes have extensive experience serving as contractual partners with federal agencies to carry out federal policies on tribal lands. Tribes’ ability to work closely with FDA in the enforcement of these rules on tribal lands would merely be a logical extension of their other health, safety, and welfare responsibilities already in place through federal contracts to enforce or implement policy on tribal lands by and through other federal agencies. However, FDA is not contemplating such relationships within these rules, and, as there has been no opportunity for consultation, this process is not now currently under way.
Tribal regulation of surface water has been adjudicated quite extensively for the past 20 years through the Clean Water Act Section 518(e) and the Safe Drinking Water Act. (See City of Albuquerque v. Browner, 865 9th Cir. 733 (1993) and Montana v. U.S. EPA (137 F.3d 1135, 1138 (9th Cir. 1998)). The Ninth and Tenth U.S. Circuit Courts of Appeal have affirmed a tribe’s treatment as a state in order to implement its own water standards enforceable against Indians and non-Indians alike, even if the tribal standards are higher than that of the state and local government. The U.S. Environmental Protection Agency (EPA), as an agency of the federal government, must ensure that those regulation standards are met. However, FDA proposes to enforce a national EPA standard on recreational water on all agricultural waters, whether they are surface or ground water, if used in the production, manufacturing, and processing of produce.
First, the microbial standards meant to detect pathogens that can make people sick are based on a developing science (microbial source detection) and are not well-established in the science as yet.
Second, tribal regulation of water has already been adjudicated and confirmed, but FDA is silent as to tribal regulation of water quality and establishment of water-quality standards. FDA has failed to address this important issue in the proposed produce rules, and it is required to do so pursuant to the federal policy regarding tribal consultation when federal action has a direct effect on the tribal/federal relationship.
Finally, FDA explains that it has promulgated these proposed rules through authority from FSMA, the added provisions in the Food, Drug, and Cosmetic Act (Section 419), and the Commerce Clause (Article 1, Section 8, cl. 3 of the U.S. Constitution). The Commerce Clause reads, “The Congress shall have Power: To regulate Commerce with foreign Nations, and among the several States, and with the Indian tribes.” The regulations will affect commerce with Indian tribes. In addition, the FD&C and FSMA only allow for variances (exemption or modification of the proposed rules for an entire area) from the proposed produce rules for states and foreign governments. The implicit or explicit exclusion of tribes from one of the most important provisions in the proposed produce rules is the most telling glimpse into FDA’s relationship with tribes in the implementation of these rules. Tribes have just been flatly excluded.
While FDA’s two-hour tribal consultation webinar is scheduled for Oct. 7, 2013, at 2:30-4:30 p.m. EST and comments on the proposed produce safety rules close in slightly more than one month, tribes, along with the federal government as their trustee, need to be sounding the alarm for the very real implications that these rules may have on tribal communities and existing and planned tribal food and agriculture businesses, as well as tribal governments as sovereign entities.
Some critics may argue that there may not be very many tribal businesses subject to the proposed rules, but any tribe knows that the unintended consequences of federal regulation can lead to major concerns in the future. Federal regulatory history has demonstrated to tribal communities that any small chip at existing sovereignty tribes claim is one too many. And these regulations will have a real and chilling effect on tribes creating new or expanding existing food and agriculture businesses.© Food Safety News