Rule development. Rule implementation. FDA Took Steps to Meet Its Regulatory Consultation Responsibilities but Did Not Consult Early with Tribes

FDA took numerous steps to meet its responsibilities under UMRA and  Executive Orders 12866 and 13563 to ensure meaningful and timely input  from the public and stakeholders during development of the FSMA- mandated rules on produce, human food, and animal food. Among other  things, as reflected in table 1, FDA held 13 public meetings from April  2011 through October 2015 related to these three rules. We also interviewed officials from two associations that represent state  departments of agriculture. FDA Did Not Fully Meet Its Tribal Consultation Responsibilities

FDA did not fully meet its tribal consultation responsibilities. Under the HHS tribal consultation policy, each agency within HHS must  establish its own tribal consultation policy, which should include an  accountable process—one that among other things, measures and  reports on the results and outcomes of the agency’s tribal consultation  performance—to ensure meaningful and timely input by Indian tribes. FDA therefore risks  continued delays in establishing a process to ensure meaningful and  timely tribal consultation. Consultation is a critical ingredient of a sound and  productive Federal-tribal relationship.”

	FDA Has Begun to Develop Plans for Coordinated Rule Implementation and Is Working to Overcome Challenges

FDA has begun to develop plans to ensure compliance with the FSMA- mandated rules on produce, human food, and animal food through  coordinated implementation with nonfederal agencies. FDA charged  these work groups with, among other things, developing strategies to  coordinate implementation with nonfederal agencies. FDA is taking various steps to overcome these challenges. According to FDA officials, the agency is currently developing a new  system, called the Observation Corrective Action Reporting system  (OCAR), that will serve as a platform through which users can access  information housed in existing FDA information systems related to  industry compliance. FDA Has Begun to Develop and Administer Plans for Regulator Training and Is Working to Overcome Challenges

FDA has developed a plan for training regulators on the FSMA-mandated  human and animal food rules and has begun to administer that plan. FDA Has Begun to Develop a Regulator Training Plan on the Produce Rule

As of February 2016, FDA had begun to develop, but not to administer, a  plan for training regulators on the FSMA-mandated produce rule. Number of Regulators to Be Trained

Officials from FDA and several of the associations we interviewed  discussed challenges related to the thousands of regulators who must be  trained. Specifically, FDA officials  stated that they plan to administer training in 2016 to regulators in areas  with the highest concentrations of large businesses, for which compliance  is due first. FDA then plans to administer training in 2017 to regulators in  areas with the highest concentrations of small businesses, for which  compliance is due later. Finally, FDA plans to administer training in 2018  to regulators in areas with the highest concentrations of very small  businesses, for which compliance is due last. For example, just as most nonfederal agencies lack legal authority to  conduct on-farm inspections related to produce, according to some  association representatives, most nonfederal agencies have no regulatory  structure for overseeing produce. Conclusions

The safety and quality of the U.S. food supply are governed by a highly  complex system involving more than 3,000 nonfederal agencies at the  state, local, tribal, and territorial levels. FSMA mandated, among other  things, that FDA take steps that once taken, would better integrate its  food safety oversight with that of nonfederal agencies. FDA has  begun to develop such a policy and issued a draft in late February 2016. Without early consultation, tribes are unable to  provide input at a time when it is most likely to have a meaningful impact  on the agency’s decision making. Moreover, FDA has not established a  timetable to guide the policy’s finalization. Recommendations for Executive Action

To help ensure meaningful and timely consultation with Indian tribes on  future rulemaking, we recommend that the Secretary of Health and  Human Services direct the Commissioner of the FDA to take the following  two actions: make certain that FDA’s tribal consultation policy explicitly provides  for early consultation with tribes on all rules with tribal implications  where the federal government does not provide the funds necessary  to pay the direct compliance costs incurred by tribes, including before  promulgation of proposed regulations, and develop a timetable, with milestones and interim steps, for finalizing  FDA’s tribal consultation policy. Appendix I: Objectives, Scope, and Methodology

Our review provides information regarding the Food and Drug  Administration’s (FDA) coordination with nonfederal agencies in relation  to the FDA Food Safety Modernization Act (FSMA)-mandated rules on  produce, human food, and animal food. In particular, the review examines  the extent to which FDA has (1) met its regulatory consultation  requirements in developing the rules, (2) developed plans to coordinate  implementation of the rules, and (3) developed and administered plans for  training regulators on the rules. Review of public comments on FDA rulemaking. Interviews with associations of nonfederal officials.
Why GAO Did This Study

The safety and quality of the U.S. food supply are governed by a complex system involving more than 3,000 federal as well as nonfederal agencies at the state, local, tribal, and territorial levels. In 2011, FSMA mandated that FDA take steps that would better integrate its food safety oversight with that of nonfederal agencies. These steps relate to three new FSMA-mandated rules on produce, human food, and animal food. Among other things, FSMA required FDA to coordinate with nonfederal agencies in the areas of rule development, rule implementation, and regulator training.
GAO was asked to review FDA's coordination with nonfederal agencies on food safety, particularly in relation to FSMA. This report examines—for the rules on produce, human food, and animal food—the extent to which FDA has (1) met its regulatory consultation responsibilities in developing the rules, (2) developed plans to coordinate implementation of the rules, and (3) developed and administered plans for training regulators on the rules. GAO reviewed documentation; analyzed comments from nonfederal agencies on FDA rulemaking; and interviewed officials from FDA, associations of nonfederal officials, and industry, public interest, and other groups.

What GAO Found

The Food and Drug Administration (FDA) took numerous steps to ensure meaningful and timely input from nonfederal officials during development of the FDA Food Safety Modernization Act (FSMA)-mandated rules on produce, human food, and animal food but did not fully meet its tribal consultation responsibilities. Among other things, FDA—an agency within the Department of Health and Human Services (HHS)—held 13 public meetings and offered extended comment periods on the rules. However, FDA did not consult with Indian tribes before publication of the proposed rules, as directed by the HHS tribal consultation policy. Under that policy, each HHS agency is to establish its own tribal consultation policy, which should include an accountable process to ensure meaningful and timely input by tribal officials. FDA has begun to develop such a policy and issued a draft in late February 2016. FDA's draft policy, however, does not explicitly provide for early consultation on all rules with tribal implications. 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. Moreover, FDA has not established a timetable to guide the policy's finalization, without which FDA risks continued delays.
FDA has begun to develop plans to ensure compliance with the FSMA-mandated rules through coordinated implementation with nonfederal agencies and is working to overcome related challenges. For example, according to FDA, insufficient data exist on businesses subject to the rules, making it difficult to assign inspection responsibilities, among other things. In response, FDA is taking steps, such as exploring new data sources. In addition, associations of nonfederal officials that GAO interviewed stated that nonfederal agencies have varying legal authorities and regulatory structures. For example, they stated that most nonfederal agencies lack authority to oversee produce, which is needed for coordinated implementation. In response, FDA is taking steps such as funding the National Association of State Departments of Agriculture's development of a model produce rule that states can adopt. Associations suggested that FDA consider opportunities to improve coordinated implementation, including establishing a system to share information on industry compliance and a process to answer questions from regulators on the rules. According to FDA, it is taking steps to implement these and other suggestions. For example, FDA is developing a new system to allow regulators to access information housed in existing FDA information systems before, during, and after an inspection.
FDA has developed, and begun to administer, a plan for training regulators on the human and animal food rules. As of February 2016, FDA had begun to develop, but not to administer, a plan for training regulators on the produce rule. FDA is working to overcome challenges related to regulator training. For example, one challenge relates to the thousands of regulators who must be trained. FDA plans to, among other things, use a phased training strategy, administering training in 2016 to regulators in areas with the highest concentrations of large businesses, for which compliance is due first; in 2017 to regulators in areas with the highest concentrations of small businesses, for which compliance is due later; and in 2018 to regulators in areas with the highest concentrations of very small businesses, for which compliance is due last.

What GAO Recommends

GAO recommends that FDA (1) make certain that its tribal consultation policy explicitly provides for early tribal consultation and (2) develop a timetable for finalizing the policy. GAO provided a draft of this report to FDA. FDA agreed with these recommendations.