Food Safety: FDA Coordinating with Stakeholders on New Rules but Challenges Remain and Greater Tribal Consultation Needed
Published: 2016-05-19T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.
section_title: What GAO Recommends
paragraphs: 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.

section_title: Letter
paragraphs: According to the Centers for Disease Control and Prevention (CDC), the  U.S. food supply is one of the safest in the world. Nevertheless,  foodborne illness remains a costly, common public health problem. Two  independent studies published in 2012 estimated the cost of foodborne  illness in the United States. According to a September 2013 bulletin from  the U.S. Department of Agriculture’s (USDA) Economic Research  Service, the study that used the more conservative approach estimated  the cost to be $14.1 billion per year. CDC data indicate that as a result of  foodborne illness, roughly 1 in 6 Americans (or 48 million people) get sick  each year, 128,000 are hospitalized, and 3,000 die. As reflected in figure  1, CDC data also show that the number of reported multistate foodborne  illness outbreaks is increasing. This is notable because multistate  outbreaks constitute a small proportion of total outbreaks but affect  greater numbers of people. For example, according to CDC data, 3  percent of reported outbreaks from 2010 to 2014 were multistate, but they  were associated with 11 percent of illnesses, 34 percent of  hospitalizations, and 56 percent of deaths. CDC cites several potential  contributors to the increase in reported multistate outbreaks, including  greater centralization of food processing practices, wider food distribution,  and improved detection and investigation methods.
The safety and quality of the U.S. food supply, both imported and  domestic, are governed by a highly complex system stemming from at  least 30 federal laws that are collectively administered by 15 federal  agencies. The federal agencies with primary responsibility for food safety  oversight are USDA’s Food Safety and Inspection Service (FSIS) and the  Department of Health and Human Services’ (HHS) Food and Drug  Administration (FDA). FSIS is responsible for the safety of meat, poultry,  and processed egg products. FDA is responsible for virtually all other  food.
The federal food safety system is supplemented by states, localities,  tribes, and territories, which may have their own laws and agencies to  address the safety and quality of food. In all, more than 3,000 nonfederal  agencies perform the great majority of government food safety activities.  Among other things, these agencies investigate and contain illness  outbreaks; conduct illness surveillance and monitor the food supply for  contamination; inspect restaurants, grocery stores, and food processing  plants; and take regulatory action to remove unsafe or unsanitary  products from the market.
For several decades, FDA has taken steps to leverage the food safety  work of nonfederal food safety agencies. For example, since the early  1970s, FDA has contracted with numerous state agencies to perform food  safety inspections and investigations. However, over the years, we and  others have identified challenges FDA faces in surveilling and inspecting  the nation’s approximately 154,000 food facilities and more than 2 million  farms. Many of these reports have called on FDA to take greater  advantage of the food safety capabilities of nonfederal agencies.
In January 2011, the FDA Food Safety Modernization Act (FSMA) was  signed into law, representing the largest expansion and overhaul of U.S.  food safety law since the 1930s. FSMA mandated, among other things,  that FDA take steps that when taken, would better integrate its food  safety oversight with that of states, localities, tribes, and territories.
Several of these steps relate to three new prevention-oriented rules  required by FSMA, one governing the growing, harvesting, packing, and  holding of produce, widely referred to as the produce safety rule, and the  others governing the production of human and animal food, respectively,  widely referred to as the preventive controls rules for human and animal  food because they focus on preventing contamination. For the purposes  of this report, we refer to these three rules as the rules on produce,  human food, and animal food.
Among other things, FSMA directed or encouraged FDA to coordinate in  the following three areas:
Rule development. FSMA directed FDA to coordinate with state  departments of agriculture in publishing the produce rule. FDA’s  rulemaking is also subject to other laws and executive orders  requiring consultation with states, localities, and tribes.
Rule implementation. FSMA authorized and encouraged FDA to  leverage states, localities, tribes, and territories in conducting  examinations, testing, and investigations under FSMA rules. For  certain rules, FSMA mandated that FDA coordinate implementation.
Regulator training. FSMA directed FDA to administer training and  education programs for state, local, tribal, and territorial food safety  officials relating to the regulatory responsibilities and policies  established by FSMA.
You asked us to review issues pertaining to 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.
To address our objectives, we reviewed relevant federal laws and  regulations, including FSMA and the Federal Food, Drug, and Cosmetic  Act, that prescribe FDA’s coordination with nonfederal agencies on the  FSMA-mandated rules on produce, human food, and animal food. We  also reviewed other federal law and policy that prescribe FDA’s regulatory  consultation requirements, including HHS’s tribal consultation policy, as  well as our past work on key features and issues to consider when  implementing collaborative mechanisms. We reviewed relevant  documentation, such as transcripts of public meetings regarding the rules;  the text of the proposed, supplemental, and final rules, including the rule  preambles and relevant documents referenced in each of the rules; and  FDA documents related to rule development, implementation, and  training, such as implementation and training plans.
To obtain the perspectives of nonfederal officials on FDA’s rulemaking,  implementation, and training efforts, we took three steps. First, we  reviewed all public comments from state, local, tribal, and territorial  governments, and from associations representing those entities, that  were submitted in response to relevant FDA rulemaking dockets. We  conducted a content analysis of these comments to identify themes  related to coordination challenges faced and opportunities for  improvement. Second, we interviewed representatives of selected  associations of state, local, tribal, and territorial food safety officials to  obtain their views on the identified challenges and opportunities, as well  as their views on steps taken by FDA related to rule development,  implementation, and training. Appendix I presents a more detailed  description of our methodology, and appendix II lists the associations we  interviewed. Third, we visited California—the state with the nation’s  largest agricultural and food production sectors—where we met with state  and local officials to discuss their programs on produce and human and  animal food. We also attended relevant food safety conferences and  conducted more than 50 interviews with knowledgeable FDA and HHS  officials and other stakeholders, including representatives of industry;  public interest groups; and other relevant groups, such as the  International Food Protection Training Institute, Food Safety Preventive  Controls Alliance, Partnership for Food Protection, and Produce Safety  Alliance.
We conducted this performance audit from March 2015 to May 2016 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.
subsections: section_title: Background
subsections: section_title: FSMA-Mandated Rules on Produce, Human Food, and Animal Food
paragraphs: Prior to FSMA, FDA focused on reacting to foodborne illnesses after they  occurred. FSMA marked a historic turning point by requiring that FDA  focus on preventing rather than reacting to foodborne illnesses. FSMA did  so, in part, by requiring a number of new rules that together provide a  framework for preventing foodborne illness across the food safety system.  Of these rules, those on produce, human food, and animal food took aim  at the entities in the earliest stages of the farm-to-fork continuum (see  illustration of that continuum in fig. 2): the farms that grow and facilities  that process food for human and animal consumption.
Produce is an important part of a healthy diet but is susceptible to  contamination from numerous sources, including agricultural water,  animal manure, equipment, and agricultural workers. Because produce is  often consumed raw without processing to reduce or eliminate  contaminants, steps to prevent contamination are key to ensuring safe  consumption. Prior to FSMA, there were no enforceable national  standards for on-farm practices related to produce safety. FDA and others  had taken several actions to address produce safety, including issuing  guidance documents and letters to industry, but in spite of these efforts,  produce-associated foodborne illnesses occurred regularly. According to  FDA, from 1996 through 2010, produce accounted for 42.3 percent of all  outbreak-related illnesses linked to FDA-regulated foods.
The FSMA-mandated rule on produce established the first enforceable  national standards for on-farm growing, harvesting, packing, and holding  of domestic and imported produce. Among other things, the rule  established standards related to agricultural water quality; the use of soil  amendments, such as raw manure; the use of domesticated animals;  intrusion by wild animals; worker training, health, and hygiene; and  sanitation of equipment, tools, and buildings. The rule also established  standards specific to sprouts, which are especially vulnerable to  contamination because of the warm, moist, and nutrient-rich conditions  needed to grow them. The rule included several exemptions. For  example, it does not apply to produce that is rarely consumed raw, such  as asparagus and black beans; produce that is to be consumed on farm;  or produce that is to undergo commercial processing, such as refining  produce into sugar or distilling it into wine, that adequately reduces  contaminants of public health significance. In addition, the rule does not  apply to farms that have an average annual value of produce sold during  the previous 3-year period of $25,000 or less.
subsections: section_title: The Human Food Rule
paragraphs: Processing of food for human consumption is an important part of the  global food industry. New and innovative food products are created daily  in response to advances in science and technology as well as consumer  demand. For example, ready-to-eat, refrigerated, and heat-and-serve  foods are more popular than ever. Contamination of processed foods can  come from a wide range of sources, including raw ingredients, processing  equipment, and shipping containers. Once contamination occurs, it can  spread widely because of mass production and global supply chains. For  processed foods that require little to no preparation before consumption,  contaminants can be especially dangerous because consumers may not  take steps such as cooking to reduce or eliminate the hazard.
Prior to FSMA, FDA had issued various regulations to protect against  contamination of processed foods. For example, FDA required  processors to meet Current Good Manufacturing Practice requirements  (CGMP), which established minimum standards for processing of human  food. Among other things, the standards covered food industry personnel;  operations and equipment; plants, grounds, and facilities; and  warehousing and distribution. However, an FDA work group reported in  2005 that it was unclear whether the CGMPs—last updated in 1986— adequately addressed new food safety challenges, including more  sophisticated and increasingly automated technologies and newly  recognized contaminants. In addition to requiring processors to meet  CGMPs, FDA required processors of certain food products, such as  seafood and juice, to have programs in place to prevent contamination  through, among other things, monitoring, recordkeeping, verification of  monitoring practices, and corrective actions. However, no such  requirements applied comprehensively across the food processing  industry.
The FSMA-mandated rule on human food revised existing requirements  for processors in a number of ways. Two key revisions were updated  CGMPs and the establishment, for the first time, of requirements for  contamination prevention programs (known as preventive control  programs) across much of the industry. Among other things, under the  preventive control programs required by the rule, food processors must  develop and implement written plans that identify and evaluate known or  reasonably foreseeable food safety hazards; specify the steps, or  controls, that will be put in place to significantly minimize or prevent the  hazards; specify how the controls will be monitored, verified, and  corrected, as needed, to ensure that they are working; and maintain  records documenting these actions. The rule included several  exemptions. For example, it does not apply to seafood or juice processors  (which are subject to separate preventive control regulations) or to farms.
section_title: The Animal Food Rule
paragraphs: Animal food is made for a variety of species, including animals from which  humans obtain food, pet animals, and laboratory animals. The safety of  animal food is important not only for the health of animals, but also for the  health of humans. For example, contaminated food fed to livestock can  cause harm both to the livestock and to humans that consume the  livestock. In addition, contaminated food fed to pets can cause harm both  to the pets and to humans that come in contact with the food or with items  the food has touched. For example, from 2006 to 2008, 79 people in 21  states were reported ill from handling pet food manufactured in a  Pennsylvania facility that was contaminated with Salmonella.
Prior to FSMA, the regulation of animal food focused on specific safety  issues. For example, FDA had an animal food sampling program focused  on, among other things, tracking levels of contaminants, including  Salmonella and Escherichia coli, and investigating possible sources of  contamination. In addition, FDA had a program aimed at protecting  against Bovine Spongiform Encephalopathy (commonly known as mad  cow disease) and had issued CGMPs for medicated animal feed.  However, in 2010, an FDA-led work group issued a report identifying  gaps in the regulation of animal food products, including the lack of  federal regulations to fully address all aspects of producing safe animal  food. The FSMA-mandated animal food rule was designed to fill that gap.  Like the human food rule, it established two sets of requirements—one  relating to CGMPs and one to preventive control programs. The animal  food rule established CGMPs applicable across the animal food industry  and mandated preventive control programs for animal food processors.  Also, like the human food rule, the animal food rule included several  exemptions. For example, it does not apply to farms.
section_title: Implementation Timeline
paragraphs: As reflected in figure 3, FDA’s implementation of FSMA’s mandate for  new rules on produce, human food, and animal food spans several years.  With the rules finalized in 2015, industry compliance with the rules is  scheduled to come due between 2016 and 2020, with compliance dates  phased in based on business size and other factors.
section_title: Requirements for Coordination on Rule Development, Rule Implementation, and Regulator Training
paragraphs: In addition to shifting FDA’s focus to preventing rather than reacting to  foodborne illnesses, FSMA also called on FDA to work with nonfederal  agencies in carrying out the new law. Among other things, FSMA directed  or encouraged FDA to coordinate on rule development, rule  implementation, and regulator training.
Rule development. In its rulemaking processes, FDA is subject to  laws and executive orders that require consultation. These include the  Unfunded Mandates Reform Act of 1995 (UMRA) and Executive  Orders 12866 and 13563, which direct all federal agencies to provide  for meaningful and timely input from state, local, and tribal officials  during rule development. They also require that this consultation  occur before promulgation of proposed rules. Moreover, FSMA  specifically required FDA to coordinate with state departments of  agriculture in publishing the proposed produce rule. Further, in  recognition of the unique government-to-government relationship  between the federal government and Indian tribes grounded in the  Constitution, separate requirements apply to consultation with tribes.  Specifically, Executive Order 13175 requires federal agencies to have  an accountable process to ensure meaningful and timely input by  tribal officials in developing federal policies that have tribal  implications. In January 2005, HHS adopted a tribal consultation  policy formalizing this requirement. Under that policy, no agency  within HHS 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.
Rule implementation. FSMA authorized and encouraged FDA to  leverage states, localities, tribes, and territories in conducting  examinations, testing, and investigations on FDA’s behalf for  determining compliance with all FSMA food safety provisions,  including those related to the rules on produce, human food, and  animal food. For the produce rule, FSMA went further in actually  requiring FDA, as appropriate, to coordinate with states and localities  in enforcing and ensuring compliance with the rule. In fact, FSMA  required that the final produce rule provide for coordination of  enforcement activities by state and local officials.
Regulator training. FSMA required FDA to administer training and  education programs for state, local, tribal, and territorial food safety  officials relating to the regulatory responsibilities and policies  established by FSMA.
section_title: History of Calls for Food Safety Integration
paragraphs: The concept of an integrated food safety system has been in existence  for several decades. The concept was first formally articulated by the  Association of Food and Drug Officials in 1998, when the association  described a vision for food safety integration across all levels of  government. Also in 1998, the National Academy of Sciences issued a  report calling for a more integrated food safety system. In September  1998, FDA, in cooperation with other federal and nonfederal agencies,  hosted a meeting of food safety officials from all 50 states (referred to as  a 50-state meeting) to examine the idea of integration. Around the same  time, FDA established the National Food Safety System project to  strengthen partnerships among federal and nonfederal agencies to better  ensure safe food and respond to outbreaks. The project had some  successes until about 2002, when the project was put on hold because of  a lack of funding, according to several sources, including FDA.
In November 2007, FDA renewed its focus on integration in its new Food  Protection Plan. In that plan, FDA presented a strategy for protecting  the U.S. food supply against intentional and unintentional contamination  and recognized the importance of leveraging the resources of nonfederal  agencies, among others, in doing so. As part of FDA’s effort to implement  its new plan, FDA hosted its second 50-state meeting in August 2008. At  that meeting, participants reflected on accomplishments made since the  initial 50-state meeting 10 years earlier and concluded that despite  progress in some areas, many obstacles to integration remained.  Outcomes of that meeting included creation of an FDA-state collaborative  mechanism, the Partnership for Food Protection (PFP), to implement  recommendations made at the 2008 meeting.
In April 2009, a study funded by the Robert Wood Johnson Foundation  and led by George Washington University recognized progress that had  been made toward integration and made several recommendations to  further strengthen collaboration and partnerships, among other things.  Three months later, the White House Food Safety Working Group—which  was created in 2009 and stopped meeting after about 2 years—submitted  a report to the President identifying food safety integration as a priority.  In September 2009, FDA again embraced the concept of an integrated  food safety system by publishing a vision statement for achieving  integration. In June of the following year, the National Academy of  Sciences issued a second report on food safety, supporting, among other  things, an integrated food safety system and describing remaining steps  necessary to facilitate such integration. Two months later, FDA, under  the auspices of the PFP, hosted the third 50-state meeting, with  subsequent 50-state meetings held in August of 2012 and 2014.
section_title: Current Examples of Food Safety Integration
paragraphs: Food safety integration is seen today in a number of collaborations  among food safety officials across levels of governments. These include  the following:
State cooperative programs for milk, shellfish, and retail food  safety. FDA works with nonfederal regulatory agencies to ensure the  safety of milk and raw molluscan shellfish, as well as the safety of  food served in retail establishments. Regulatory responsibility and  authority in these areas lies primarily with state, local, tribal, and  territorial governments. However, FDA provides assistance to these  nonfederal governments through three cooperative programs: the Milk  Safety Program, the National Shellfish Sanitation Program, and the  Retail Food Protection Program. These programs are governed by  memorandums of understanding that FDA entered into with the  National Conference on Interstate Milk Shipments, the Interstate  Shellfish Sanitation Conference, and the Conference for Food  Protection, respectively, which represent the nonfederal regulatory  agencies. Under these cooperative programs, FDA provides  guidance, training, certification, and other technical assistance. This  includes promoting the adoption, implementation, and enforcement of  the FDA Grade “A” Pasteurized Milk Ordinance, the National Shellfish  Sanitation Program Model Ordinance, and the FDA Model Food  Code, each developed by FDA in collaboration with state and local  food safety agencies.
National standards for oversight of retail food, manufactured  food, and animal food. FDA has developed national regulatory  program standards for oversight of retail food, manufactured food, and  animal food. These standards—the Voluntary National Retail Food  Regulatory Program Standards, the Manufactured Food Regulatory  Program Standards, and the Animal Feed Regulatory Program  Standards—serve as guides for nonfederal agencies in the design  and management of food safety regulatory programs, helping to foster  consistency across programs and their continuous improvement. The  retail program standards were first released in 1999, the  manufactured food program standards in 2007, and the animal feed  program standards in 2014. As of January 2016, 682 nonfederal  agencies, including state, tribal, territorial, and local agencies, were  enrolled in the retail standards; 42 state agencies in 40 states were  implementing the manufactured food standards; and 21 state  agencies in separate states were implementing the animal feed  standards.
Federal-state collaborative mechanisms for foodborne illness  surveillance and outbreak response. FDA is involved in a number  of collaborative mechanisms focused on foodborne illness  surveillance and outbreak response. For example, FDA co-chairs the  steering committee of the Food Emergency Response Network, which  integrates the nation’s food-testing laboratories at the federal and  nonfederal levels to better respond to emergencies involving  biological, chemical, or radiological contamination of food. In addition,  FDA coordinates the Electronic Laboratory Exchange Network, a web- based information network that allows federal and nonfederal food  safety officials to compare, share, and coordinate laboratory analysis  findings. FDA also collaborates with other federal and nonfederal  agencies through mechanisms including the National Antimicrobial  Resistance Monitoring System, which tracks whether foodborne and  other bacteria are resistant to the antibiotics used to treat and prevent  the spread of illness; PulseNet, which connects cases of foodborne  illness to potential outbreaks; and the Foodborne Diseases Active  Surveillance Network, which estimates the number of foodborne  illnesses, monitors trends in incidence of specific foodborne illnesses  over time, and attributes illnesses to specific foods and settings,  among other things. In addition, since 2008, FDA has awarded  cooperative agreements to states to develop rapid response teams  aimed at, among other things, creating integrated and sustained  response capabilities for food emergencies.
These and other collaborations illustrate the progress that has been made  toward food safety integration. However, prior to FSMA, a key limitation to  full integration was the lack of a statutory mandate to integrate. In 2010, 1  year before FSMA was signed into law, the National Academy of  Sciences reported that it agreed with the recommendations of the George  Washington University-led study published the prior year. The study  found that the most fundamental prerequisite for achieving integration  was high-level political commitment to that goal and accountability for  achieving it. The study noted that the absence of an integration mandate  did not by itself preclude collaboration, as evidenced by the extensive  collaboration that already existed, but it meant that in the end officials  were not fully empowered and accountable for integrating their food  safety efforts. Accordingly, the study’s first recommendation was for a  congressional mandate and accountability at the federal level for building  an integrated food safety system. In January 2011, FSMA was signed into  law, providing such a mandate by requiring FDA to take steps that when  taken, would better integrate its food safety oversight with that of states,  localities, tribes, and territories.
section_title: FDA Took Steps to Meet Its Regulatory Consultation Responsibilities but Did Not Consult Early with Tribes
paragraphs: 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. FDA stated  that it met its requirement under FSMA to coordinate with state  departments of agriculture in publishing the proposed produce rule;  representatives of state agriculture departments had varying views on the  quality of the coordination. FDA did not fully meet its responsibility to  consult with tribes throughout all stages of development of the proposed  rules.
Unfunded Mandates Reform Act of 1995. Agencies are to develop a process to  permit elected officers of state, local, and tribal governments (or their designees) to  provide meaningful and timely input into the development of regulatory proposals  containing significant intergovernmental mandates. Before promulgating any  proposed or final rule that may result in the expenditure of $100 million or more  (adjusted for inflation) in any 1 year by state, local, or tribal governments in the  aggregate or by the private sector, agencies must prepare a written statement  including, among other things, a description of the extent of the agency’s prior  consultation with state, local, and tribal governments and a summary and evaluation  of those governments’ comments and concerns.
Executive Order 12866. Each agency shall provide the public meaningful  participation in the regulatory process. Before issuing a notice of proposed  rulemaking, each agency shall seek the views of those likely to be affected, including  state, local, and tribal officials.
Executive Order 13563. Before issuing a notice of proposed rulemaking, each  agency should seek the involvement of those likely to be affected and those expected  to be subject to the rulemaking (including, specifically, state, local, and tribal officials).
Executive Order 13175. Each agency shall have an accountable process to ensure  meaningful and timely input by tribal officials in the development of regulatory policies  that have tribal implications. Agencies are to consult with tribal officials early in the  process of developing proposed regulations.
subsections: section_title: FDA Took Steps to Meet Certain Regulatory Consultation Responsibilities
paragraphs: 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. To accommodate  broader audiences, FDA made 7 of these meetings accessible via live  webcast and posted transcripts of 12 and recordings of 9 to its website  following the meetings.
FDA also opened dockets in the Federal Register requesting information  to inform its rulemaking. For example, in February 2010, while FSMA  was still being debated in Congress, FDA opened a docket requesting  information about, among other things, coordination of produce safety  practices and federal, state, local, and tribal government statutes and  regulations related to produce safety. Additionally, in response to  stakeholder requests, FDA extended its initial 120-day comment period  for each of the three proposed rules to about 300 days for the produce  and human food rules and to about 150 days for the animal food rule. By  the close of these periods, FDA had received about 36,000 comments on  the produce rule, more than 8,000 on the human food rule, and more than  2,400 on the animal food rule. In December 2013, FDA announced that  based on extensive stakeholder input, FDA planned to make significant  changes to key provisions of the produce and human food rules. In March  2014, FDA made a similar announcement regarding the animal food rule.  Accordingly, in September 2014, FDA published supplemental proposed  rules for each, providing an approximately 75-day comment period. In  response, FDA received more than 2,400 comments on the produce rule,  more than 1,300 on the human food rule, and more than 140 on the  animal food rule.
section_title: FDA Stated That It Met the Requirement to Coordinate with State Agriculture Departments; State Representatives Had Varying Views on the Quality of the Coordination
paragraphs: FDA stated that it met its requirement under FSMA to coordinate with  state departments of agriculture in publishing the proposed produce rule.  In the preamble to the proposed rule, FDA stated that it met the  requirement and referenced in support a memorandum in the docket file.  In the memorandum, FDA listed 13 meetings held from February 2010 to  May 2012 and also listed 24 state departments of agriculture. FDA  indicated in the memorandum that each of the listed departments was  represented during at least one of the 13 meetings. FDA did not,  however, provide detailed information in the memorandum regarding the  specific attendees or the extent or nature of the discussions, making it  difficult to assess whether the requirement was met.
We contacted officials from 8 of the listed state departments of  agriculture. These officials confirmed that one or more representatives  from each of their departments attended at least one of the meetings  referenced by FDA. All of these officials agreed that FDA met the FSMA  requirement to coordinate with state departments of agriculture, but they  had varying views on the quality of FDA’s coordination. Specifically,  officials from 2 departments characterized the quality as very good, 3  characterized it as good, 2 characterized it as moderately good, and 1  characterized it as very poor. Officials from one of the departments that  characterized the coordination as very good explained that FDA was very  open to discussing states’ concerns. One of the officials that  characterized the coordination as moderately good stated that FDA did  not seek as much input from states as the official would have liked. The  official that characterized the coordination as very poor noted that states  had many outstanding concerns that had not been addressed, including  the produce rule’s complexity and compliance costs.
We also interviewed officials from two associations that represent state  departments of agriculture. According to one of these associations, FDA  was more willing to discuss its general intent for the rule than has  previously been FDA’s practice, which the association said was helpful,  but this did not constitute coordination. The other association said that  FDA coordinated well with it, holding monthly meetings with the  association since FSMA’s enactment.
section_title: FDA Did Not Fully Meet Its Tribal Consultation Responsibilities
paragraphs: FDA did not fully meet its tribal consultation responsibilities. In particular,  FDA did not consult with tribes throughout all stages of development of  the proposed rules, as is directed under the HHS tribal consultation policy  for all rules with tribal implications where the federal government does not  provide the funds necessary to pay the direct compliance costs incurred  by tribes. The FSMA mandate that FDA develop rules on produce and  human and animal food had several tribal implications. For example,  FSMA authorized and encouraged FDA to leverage tribal agencies,  among other nonfederal agencies, in conducting activities to determine  compliance with all FSMA food safety provisions. Other potential  implications included 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.
Given the tribal implications and the fact that the federal government did  not provide the funds necessary to pay the direct compliance costs  incurred by tribes, FDA should have consulted with tribes before  publishing the proposed rules. Instead, the first formal consultation took  place 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. As reflected in figure 4, the proposed rules on produce and human  food were published in January 2013, with an initial comment period set  to end in May 2013. As of April 2013, FDA had conducted no direct  outreach to tribes. On April 4, the National Congress of American Indians  wrote a letter to FDA stressing the need for tribal consultation. On April  24, FDA announced that it would extend the comment period for the  proposed produce and human food rules; the comment periods were  ultimately extended to late November 2013. FDA’s formal efforts to  consult with tribes began with a letter sent by mail in mid-August 2013 to  all federally recognized tribes, notifying them of FDA’s intent to prepare  an environmental impact statement for the produce rule and inviting  consultation on that statement. In mid-September 2013, FDA sent  another letter to all federally recognized tribes, notifying them of a 2-hour  consultation webinar on the FSMA rules to be held with all interested  tribes in early October 2013. FDA subsequently rescheduled the  webinar for early November 2013, the month after FDA published the  proposed rule on animal food. Starting in April 2014, FDA also held four  in-person consultations with some tribes. According to FDA, attendees  were tribes that had requested consultation or that had responded to FDA  invitations to consult.
FDA acknowledged that its official tribal consultation did not begin prior to  promulgation of the proposed rules but noted that it held public meetings  at which tribes could have provided input. However, meetings for the  general public are not consistent with the government-to-government  relationship and dialogue called for in Executive Order 13175 or the  HHS tribal consultation policy, and at least one federal court has made  that assertion. FDA also stated that tribal consultation can be initiated  when either the agency or tribes identify potential tribal implications but  that no tribal concerns were brought to FDA’s attention until the spring of  2013. FDA stated that once it was notified of tribal concerns, the agency  began taking steps to formally consult with tribal leaders and did so  before the final rules were drafted. The HHS tribal consultation policy  does allow for identification of potential tribal implications by either an  agency or tribes but places the onus on the agency to initiate the  consultation and to ensure that it occurs in a timely manner. Moreover,  early consultation is clearly emphasized in the HHS tribal consultation  policy. In fact, the requirement that consultation occur “throughout all  stages” of the rulemaking process was specifically added to the HHS  policy when it was revised in December 2010. According to HHS, this  change was made to ensure that tribal concerns are heard and that  responses are given in a timely manner whenever possible.
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. A  senior HHS official told us that each agency within HHS that does not  have its own consultation policy, such as FDA, follows the HHS policy.  However, the HHS policy establishes a minimum set of requirements and  expectations—including collaboration with tribes on meeting development  and reporting on consultation outcomes—and directs agencies to  establish their own processes to ensure compliance with those directives  and expectations, which FDA has not done. We discussed this issue with  FDA officials several times from July 2015 through February 2016. On  each occasion, these officials stated that they were in the process of  developing a draft tribal consultation policy but did not have a timetable  for finalizing the policy. On February 29, 2016, FDA released its draft  tribal consultation policy and published a notice in the Federal Register  inviting comments through May 31, 2016. FDA also sent the draft by  mail to all federally recognized tribes and notified the tribes of a  teleconference to be held on April 21 to provide an overview of the draft  and to hear comments and answer questions about it.
We reviewed the draft policy and noted that unlike the HHS policy, it did  not explicitly provide 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. For example,  whereas the HHS policy discusses consultation “throughout all stages of  the process of developing the proposed regulation,” the draft FDA policy  removes “proposed” from this statement. According to FDA officials, they  did not intend to exclude early consultation and instead consider early  consultation to be implicitly included in the phrase “throughout the  process of developing the regulation.” However, without early consultation  explicitly provided for—as it is in the HHS policy—there is a risk that it  may not occur. According to FDA, the most frequent comment made by  tribes and tribal organizations on the FSMA rules, generally, was that  FDA should have done more to consult with the tribes when the proposed  FSMA rules were being drafted. FDA’s draft tribal consultation policy does  not explicitly ensure that this concern will be addressed in future  rulemaking. Courts have found that early consultation is important  because, by the time an agency has published a proposed rule, the  agency has already narrowed down and largely determined the regulatory  approach it plans to take. Going forward, the final rule is required to be  a logical outgrowth of what the agency has previously proposed.  Consultation before publication of a proposed rule allows for input at a  time when it is most likely to have the greatest impact on the agency’s  decision making and also allows for public comment and discourse on the  results of that input.
In addition, as of February 2016, FDA still did not have a timetable for  finalizing its tribal consultation policy. Our body of work has shown that  timetables with milestones and interim steps can be used to show  progress toward implementing efforts or to make adjustments to those  efforts when necessary, and that without defined tasks and milestones, it  is difficult for an agency to set priorities, use resources efficiently,  measure progress, and provide management a means to monitor this  progress. Developing a draft tribal consultation policy and releasing it for  comment are good first steps, but without setting a timetable with  milestones and interim steps, it will be difficult for FDA to set priorities,  use resources efficiently, measure progress, and provide management a  means to monitor this progress in finalizing the policy. FDA therefore risks  continued delays in establishing a process to ensure meaningful and  timely tribal consultation. As a November 2009 presidential memorandum  on tribal consultation states, “istory has shown that failure to include  the voices of tribal officials in formulating policy affecting their  communities has all too often led to undesirable and, at times,  devastating and tragic results. By contrast, meaningful dialogue between  Federal officials and tribal officials has greatly improved Federal policy  toward Indian tribes. Consultation is a critical ingredient of a sound and  productive Federal-tribal relationship.”
section_title: FDA Has Begun to Develop Plans for Coordinated Rule Implementation and Is Working to Overcome Challenges
paragraphs: 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. Through our  discussions with officials from FDA and from associations representing  nonfederal food safety officials, we identified numerous challenges that  FDA is working to overcome in its development of plans for coordinated  implementation. The associations we interviewed also identified a number  of opportunities to improve coordinated implementation of the rules, some  of which FDA has taken steps to implement.
subsections: section_title: FDA Has Begun to Develop Plans for Coordinated Implementation
paragraphs: 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. To develop plans  for FSMA implementation, FDA established a variety of work groups,  including one on the produce rule, formed in December 2012, and one on  the human and animal food rules, formed in January 2013. FDA charged  these work groups with, among other things, developing strategies to  coordinate implementation with nonfederal agencies. FDA also  established a separate state strategy work group in May 2015 to focus on  a broad range of issues related to nonfederal agency involvement in  FSMA implementation. These issues include under what mechanisms  FDA should provide funding to nonfederal agencies for work done to  implement FSMA-mandated rules, how to coordinate FDA and nonfederal  agency inspections and compliance activities under the FSMA-mandated  rules, how best to share information between FDA and nonfederal  agencies, and how to maintain the competency of FDA and nonfederal  agency investigators.
To obtain the input of nonfederal agencies, each of these FDA work  groups includes at least two nonfederal representatives. According to  FDA officials, these nonfederal representatives are selected based on  recommendations by the PFP. FDA officials told us that these nonfederal  representatives are able to share the views of their respective agencies,  in addition to the views of associations to which the representatives  belong. For example, several nonfederal representatives are members of  the Association of Food and Drug Officials (AFDO), which is made up of  state, local, and territorial food safety officials. Therefore, the nonfederal  representatives are able to obtain input from AFDO and its members and  convey that input to the FDA work group.
FDA has also obtained input from nonfederal agencies in other ways. For  example, in September 2014, FDA awarded a 5-year cooperative  agreement to the National Association of State Departments of  Agriculture (NASDA), which represents the commissioners, secretaries,  and directors of the state agriculture departments in all 50 states and four  U.S. territories. Under this cooperative agreement, NASDA is, among  other things, developing a plan that will outline processes for state  agriculture departments to consider as they develop regulatory programs  for the produce rule, with applicability to the other FSMA-mandated rules  as well. The plan will describe processes for information sharing,  regulator training, funding, and dispute resolution, among other things.  According to FDA officials and NASDA representatives, FDA meets with  NASDA periodically to discuss and provide technical assistance on  various aspects of the plan. FDA officials and NASDA representatives  told us that NASDA intended to present a preliminary draft of its plan to its  members in March 2016.
In late 2015, when we interviewed officials in the FDA work groups  developing plans for coordinated implementation of the FSMA-mandated  rules on produce and human and animal food, each group expected its  work to continue through roughly 2020, when the final compliance dates  under the rules come due. Each had few details to share about the  specific role nonfederal agencies will ultimately play in rule  implementation. In broad terms, each FDA work group emphasized that  FDA cannot implement the rules alone and that successful  implementation will require the assistance of nonfederal agencies.
section_title: FDA Faces Numerous Challenges Related to Coordinated Implementation and Is Working to Overcome Them
paragraphs: Through our discussions with officials from FDA and from associations  representing nonfederal food safety officials, we identified numerous  challenges that FDA faces in developing plans for coordinated  implementation of the FSMA-mandated rules on produce, human food,  and animal food. FDA is working with nonfederal agencies to overcome  these challenges. Appendix II lists the associations we interviewed.
subsections: section_title: Nonfederal Agency Resources
paragraphs: Officials from FDA and nearly all of the associations we interviewed said  that nonfederal agencies generally do not have the resources to take on  new responsibilities for implementing the FSMA-mandated rules.
Representatives of several associations told us that nonfederal agencies  are concerned that these new responsibilities represent an unfunded  mandate. They said that nonfederal agencies are generally unwilling to  assist FDA with implementation of the FSMA-mandated rules until  dedicated federal funding is first made available. One association  representative explained that since the last recession, state legislators  have generally been unwilling to even discuss new responsibilities for  federal initiatives, regardless of their merits, unless the federal  government commits to long-term funding of any costs incurred.
To address this issue, FDA, through its state strategy work group and in  coordination with NASDA and other stakeholder groups, is exploring  funding mechanisms to provide nonfederal agencies with resources for  carrying out new responsibilities related to implementation of the FSMA- mandated rules. FDA officials told us that for the produce rule, this  mechanism may be in the form of a cooperative agreement that would  provide flexibility to nonfederal agencies by adjusting their funding  amounts based on their level of involvement and the types of activities  they undertake to implement the rule. This could include funding for start- up costs incurred in developing new regulatory structures for overseeing  produce. FDA officials said that for the human and animal food rules, the  initial funding mechanism may continue to be contracts, which FDA has  used since the 1970s to reimburse nonfederal agencies for inspections of  processed food facilities. As of December 2015, FDA had not made any  final decisions regarding funding mechanisms. However, in March 2016,  FDA issued a federal funding opportunity announcement making  available $19 million for cooperative agreement awards to assist  nonfederal agencies in implementing the produce rule.
section_title: Inventories of Businesses Subject to the Rules
paragraphs: FDA officials discussed challenges related to developing inventories of  businesses that will be subject to the rules on produce, human food, and  animal food. According to FDA officials, such inventories are essential to  coordinated implementation because they allow FDA and nonfederal  agencies to allocate resources and assign inspection responsibilities,  among other things. FDA’s existing business inventory data are drawn  from information provided by businesses required to register with FDA.
Farms, however, are not required to register. According to FDA officials,  the lack of a registration requirement for farms limits the available data  that it can use to inform its implementation of the produce rule. Human  and animal food businesses are required to register with FDA. However,  the information provided by these businesses generally does not include  key data needed to inform implementation of the FSMA-mandated human  and animal food rules, such as annual business sales or total number of  employees, which influence business compliance dates under the rules.  In addition, FDA officials said that nonfederal agencies generally do not  collect inventory data in a uniform and consistent manner, which limits  their ability to share and benefit from one another’s data. Moreover, FDA  officials said that inventory data can be out of date because new  businesses are frequently established and existing ones relocate or shut  down.
FDA is working to address these inventory challenges in several ways.  For example, FDA is working with NASDA to develop farm inventories  and is exploring potential data sources maintained by other government  and private sector entities. To help promote consistency in data collection  across FDA and nonfederal agencies, FDA has also worked with the PFP  work group on information technology to develop a dictionary of common  data elements. To help keep inventory data up to date, FDA officials told  us that they are working with nonfederal agencies on ways to share one  another’s data. FDA officials noted that business inventories will never be  perfectly accurate or current and that they must be consistently updated  and verified through in-person inspections.
section_title: Varying Legal Authorities
paragraphs: Representatives of most of the associations we interviewed said that  nonfederal agencies’ varying legal authorities pose challenges to  coordinated implementation of the FSMA-mandated rules. For example,  some association officials noted that because there were no pre-FSMA  national standards for on-farm practices related to produce safety and  because many states base their food safety statutes and regulations on  federal law, most nonfederal agencies lack authority under state law to  conduct on-farm inspections related to produce. These agencies  generally must seek such authority from their legislatures. Some  association officials stated that for each of the new FSMA-mandated  rules, some jurisdictions will have adopted them by reference through  language in their state law that automatically adopts federal rules, but  other jurisdictions do not have such language and must revise their  agencies’ existing legal authorities. Consequently, the resulting  authorities are likely to vary considerably across jurisdictions. Moreover,  the process of revising legal authorities can take many years. One  association representative explained that some state legislatures do not  meet each year and most do not operate year-round. As already  discussed, representatives of most associations said that nonfederal  agencies are generally unwilling to assist FDA with FSMA implementation  until dedicated federal funding is first made available and therefore may  not seek new authority until that occurs.
FDA is taking various steps to overcome these challenges. For example,  as already discussed, FDA is exploring funding mechanisms to provide  nonfederal agencies with additional resources for carrying out new  responsibilities related to FSMA implementation. In addition, FDA has  entered into a cooperative agreement with AFDO, the Association of  State and Territorial Health Officials, and the National Conference of  State Legislatures to catalogue state food safety authorities, track  changes in those authorities, and gauge state legislators’ willingness to  modify legal authorities in response to the new FSMA-mandated rules,  among other things. Further, under its cooperative agreement with FDA,  NASDA is working with AFDO to develop a model produce rule that  states can adopt. The model rule is intended to help expedite the process  of drafting new legal authorities and to promote consistency in those  authorities across jurisdictions. FDA’s national regulatory program  standards for oversight of manufactured food and animal feed will also  help to foster consistency of laws because participant agencies are  required to identify areas in which their legal authorities differ from federal  authorities. Until the requisite nonfederal authorities are obtained, FDA  officials told us that they are able to commission some nonfederal officials  to conduct certain implementation activities under federal authority.
section_title: Varying Regulatory Structures
paragraphs: Representatives from most of the associations we interviewed said that  varying nonfederal agency regulatory structures also pose challenges to  coordinated implementation of the FSMA-mandated rules. For example,  according to our analysis, state and local governments generally carry out  food safety responsibilities through separate departments of agriculture  and public health. However, some states’ and localities’ food safety  authority resides in another department—such as a department of  consumer protection—or in a university-affiliated body. In addition,  regulatory activities—including inspections—may be housed in different  departments across jurisdictions or shared by more than one. For  example, in Georgia, inspections of human food facilities are the  responsibility of the state department of agriculture, but in West Virginia,  this responsibility is shared by the state departments of agriculture and  public health. According to FDA and association officials, this variation in  regulatory structures makes coordinated implementation difficult because  there is no one-size-fits-all approach that FDA can use with each  jurisdiction. Instead, FDA must tailor its approach to the unique  circumstances of each. In addition, the variation makes it more likely that  implementation activities will be carried out inconsistently across  jurisdictions.
To address these challenges, FDA is taking various actions to promote  uniformity of regulatory programs across jurisdictions. These actions  include promoting FDA’s national regulatory program standards for  oversight of manufactured food and animal feed. These standards serve  as guides for agency managers in the design and management of food  safety regulatory programs, helping to foster consistency across  programs and continuous improvement of participating agencies. In  addition, as is discussed in greater detail below, FDA is working to  develop and administer training for regulators across jurisdictions to help  promote consistent implementation of the FSMA-mandated rules.
section_title: Volunteer Status of Nonfederal Participants
paragraphs: FDA officials discussed challenges related to the status of nonfederal  participants in work groups focused on planning for FSMA  implementation. They explained that the nonfederal participants serve in  these roles on a voluntary basis, in addition to fulfilling their primary duties  at their respective agencies. Therefore, these participants have limited  time to devote to work group activities. Participation in work group  activities is further strained by limited resources at the participants’  respective agencies. In addition, FDA officials stated that some  nonfederal officials are prohibited from using their agencies’ or federal  resources to travel outside their home states to attend periodic in-person  meetings. FDA officials also explained that there are a number of  nonfederal officials with the expertise needed by the various work groups,  but many cannot participate for various reasons, such as competing  demands on their time. Therefore, the same nonfederal officials are  frequently asked to participate in a number of different groups, further  limiting their ability to contribute to each.
FDA is working to address this challenge through its state strategy work  group. Specifically, the state strategy work group has conducted outreach  to the PFP and associations representing food safety officials to identify  additional officials that are qualified, able, and willing to participate. In  addition, FDA said that the funding mechanism it is exploring to  compensate nonfederal agencies for work done to implement the produce  rule may also cover expenses related to participation in FDA work groups.
section_title: Paperwork Reduction Act
paragraphs: FDA officials told us that the time and effort required to comply with the  Paperwork Reduction Act (PRA) poses a challenge to FDA’s ability to  collect information from nonfederal agencies on a timely basis to inform  policy decisions. FDA officials said that developing coordinated  implementation plans frequently requires such information. To save time,  FDA has taken advantage of the Office of Management and Budget’s  (OMB) fast-track clearance process, which OMB established in 2011 to  expedite certain information requests. In addition, FDA officials told us  that they leverage surveys conducted by associations representing  nonfederal food safety officials with whom FDA has cooperative  agreements. FDA officials said that viewing these survey results can help  FDA avoid duplication of work and overburdening of nonfederal agencies.  However, FDA officials said that because they cannot control the design  and reporting mechanisms of these surveys, the information gleaned from  them is often incomplete and of limited use to FDA. We have previously  found that other federal agencies also reported difficulties in complying  with PRA requirements.
section_title: Stakeholders Identified Opportunities to Improve Coordinated Implementation
paragraphs: The associations we interviewed identified a number of opportunities to  improve coordinated implementation of the FSMA-mandated rules, some  of which FDA has taken steps to implement. Several of these  opportunities are consistent with our prior work on key features and  issues to consider when implementing collaborative mechanisms.
subsections: section_title: Clarifying Roles and Responsibilities
paragraphs: Officials from several of the associations we interviewed agreed that FDA  should engage in discussions with nonfederal agencies regarding the role  each will play in implementing the FSMA-mandated rules. Officials from  most of these associations also said that these discussions had already  begun to occur. Several association officials further noted that FDA had  made clear that it plans to have nonfederal agencies conduct the majority  of inspections under the FSMA-mandated rules on produce, human food,  and animal food, but that FDA had not provided details regarding how this  would occur, particularly in light of the many challenges that must be  overcome before nonfederal agencies can begin implementation  activities. As we discussed earlier in this report, FDA is aware of and  working to overcome the challenges to coordinated implementation of the  rules. In addition, FDA officials have stated that they intend to continue  their discussions with stakeholders throughout FSMA implementation to  ensure that all participants understand and carry out their roles in food  safety. Our prior work on interagency collaboration has found that all  collaborative mechanisms, regardless of complexity and scope, benefit  from clarifying roles and responsibilities.
section_title: Regular Communication
paragraphs: Officials from all of the associations we interviewed agreed that FDA  should foster regular communication with nonfederal agencies to help  ensure well-coordinated implementation. Officials from several of these  associations said that FDA is in the process of doing so. For example,  most association representatives commended FDA for its willingness to  hold outreach sessions and send FDA officials to association meetings to  share information. Several of these association representatives noted that  FDA had improved its efforts to communicate with stakeholders since  FSMA’s enactment. For example, FDA has initiated regular conference  calls with nonfederal officials to ensure early identification and resolution  of critical issues and increase communication. According to FDA officials,  the agency intends to continue communicating with stakeholders  throughout implementation of the FSMA-mandated rules to ensure that all  participants understand and carry out their roles in food safety. Our prior  work on interagency collaboration has found that frequent communication  among collaborating agencies is a means to facilitate working across  agency boundaries and to prevent misunderstanding.
section_title: Comprehensive Funding Mechanism
paragraphs: Officials from nearly all of the associations we interviewed agreed that  FDA should develop a comprehensive funding mechanism to reimburse  nonfederal agencies for activities undertaken to implement the FSMA- mandated rules. Officials from most of the associations said that this  funding mechanism should take the form of a cooperative agreement  rather than a contract. In the past, FDA has used contracts to reimburse  nonfederal agencies for activities undertaken to implement pre-FSMA  regulations. Some association representatives explained that contracts  are generally awarded on a short-term basis to compensate for a narrow  set of activities—such as per inspection—and therefore do not provide  sufficient coverage for the numerous, long-term activities nonfederal  agencies must undertake to implement the new FSMA-mandated rules.  These activities include obtaining new legal authorities and establishing  appropriate regulatory structures, where necessary, and hiring, training,  and retaining new staff. Several association representatives explained  that cooperative agreements would be a more appropriate funding model  to cover these varied activities and assure nonfederal agencies of the  continued financial support they will need for successful implementation.  As we discussed earlier in this report, FDA officials are exploring funding  mechanisms to provide nonfederal agencies with resources for carrying  out new responsibilities related to implementation of the FSMA-mandated  rules. Furthermore, in March 2016, FDA issued a federal funding  opportunity announcement making available $19 million for cooperative  agreement awards to assist nonfederal agencies in implementing the  produce rule.
section_title: Information-Sharing System
paragraphs: Officials from most of the associations we interviewed agreed that FDA  should develop a system to rapidly share information with nonfederal  agencies related to industry compliance. Currently, FDA uses an  information-sharing system known as the Field Accomplishments and  Compliance Tracking System, through which nonfederal agencies that  conduct inspections for FDA enter data through a web portal. Internally,  FDA has a variety of other information systems that house data related to  industry compliance; however, the various systems are not connected to  one another. This means that FDA staff must frequently access and  analyze data from multiple systems to answer questions about industry  compliance.
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. In addition, they said OCAR will include a portal  through which FDA and nonfederal regulators can access and enter  information before, during, and after an inspection. According to FDA  officials, regulators will be able to use OCAR before an inspection to  access information regarding a business’s compliance history, past  recalls, and results from samples taken during prior inspections, among  other things. Regulators may also use the system to access resource  materials, including training videos and fact sheets. FDA officials said that  regulators will use OCAR during an inspection to enter data regarding a  business’s compliance with relevant rule requirements. According to FDA,  OCAR will also include an industry portal through which businesses can  access their inspection reports and input information regarding corrective  actions. FDA officials said that OCAR will result in numerous benefits,  including improved data quality; data analysis; and information sharing  between FDA, nonfederal regulators, and industry. FDA expects OCAR to  be fully operational by 2019; however, numerous steps remain before that  can occur. Our prior work on interagency collaboration has found that  information-sharing websites, integrated electronic reporting processes  and procedures, and negotiated data-sharing arrangements are valuable  in enhancing and sustaining joint activities.
section_title: Process to Address Questions regarding the Rules
paragraphs: Officials from most of the associations we interviewed agreed that FDA  should establish a process to quickly answer questions from industry and  regulators regarding the FSMA-mandated rules. Some association  representatives explained that this would help promote consistency in the  way that the rules are understood and implemented. In September 2015,  FDA launched a FSMA Technical Assistance Network, through which  industry, regulators, and the public may submit questions to subject  matter experts at FDA regarding the FSMA-mandated rules. Currently,  inquiries may be submitted to the Technical Assistance Network via on  online web portal or via mail. According to FDA, by 2017—when FDA  plans to begin conducting inspections under the rules—regulators will be  able to contact the Technical Assistance Network during, or in preparation  for, inspections and speak directly with FDA subject matter experts to get  answers to their questions regarding the rules. FDA officials told us that  the Technical Assistance Network will also allow FDA to identify trends in  the type of questions asked, which will indicate areas in which FDA may  need to develop guidance. In addition to the Technical Assistance  Network, FDA officials told us that they plan to establish a Produce Safety  Network, which will station FDA staff at various locations around to  country to provide education and technical assistance, among other  things, to industry and regulators as they implement the produce rule.
section_title: Dispute Resolution System
paragraphs: Officials from all of the associations we interviewed agreed that FDA  should develop a system to promptly arbitrate disputes between industry  and regulators regarding rule interpretation. Several association  representatives explained such a system would be important once  inspections under the rules are under way to help promote consistency in  the way the rules are implemented. As noted earlier, NASDA is  developing a process for dispute resolution as part of the regulatory  program plan it is drafting under a cooperative agreement with FDA. FDA  officials stated that they agree in principle with the need for an arbitration  system, but that they will not make any final decisions regarding  implementation of such a system until they have reviewed NASDA’s  proposal. They stated that NASDA plans to convene a work group to  develop this proposal and that the work group will include FDA  representatives. However, the work group has not yet been established.  In the meantime, FDA officials told us that in 2015, they hired an  ombudsman in their Office of Regulatory Affairs to serve as an  independent arbiter of disputes between FDA, industry, and nonfederal  regulators on a variety of regulatory issues, including those related to the  FSMA-mandated rules.
section_title: FDA Has Begun to Develop and Administer Plans for Regulator Training and Is Working to Overcome Challenges
paragraphs: FDA has developed a plan for training regulators on the FSMA-mandated  human and animal food rules and has begun to administer that plan. As  of February 2016, FDA had begun to develop, but not to administer, a  plan for training regulators on the FSMA-mandated produce rule. Through  our discussions with FDA officials and associations representing  nonfederal food safety officials, we identified several challenges that FDA  is working to overcome in its development and administration of plans for  regulator training.
subsections: section_title: FDA Has Developed and Begun to Administer a Regulator Training Plan on the Human and Animal Food Rules
paragraphs: FDA has developed a plan for training regulators on the FSMA-mandated  human and animal food rules and has begun to administer that plan. The  plan has two components: (1) a series of optional courses aimed at  familiarizing regulators with important background information and key  concepts and (2) mandatory courses focused on the skills, tools, and  knowledge that regulators will need to ensure industry compliance with  the rules.
subsections: section_title: Optional Training on Industry Best Practices
paragraphs: From March 2015 to November 2015, FDA offered six 1-1/2-hour optional  courses via webinar, as shown in figure 5. Rather than focusing on the  specific requirements of the rules—which were not finalized until  September 2015—these courses focused on a range of topics presented  by FDA and industry officials aimed at familiarizing regulators with  industry best practices. The courses included two on food safety culture,  defined as the alignment of values and behaviors with respect to food  safety, from management or owners through to frontline workers. Other  courses focused on the following industry best practices.
Systems thinking. A problem solving approach that views  components of a system in relation to one another and to other  systems, rather than in isolation.
Environmental monitoring. A process used to verify the  effectiveness of controls in minimizing or preventing contamination by  environmental pathogens.
Supply chain management. The identification and control of hazards  associated with raw materials and other ingredients in the supply  chain.
Minimizing allergens risk. Practices to reduce the risk of allergens,  including accurate product labeling and prevention of cross- contamination.
Each of these courses was recorded and made available for subsequent  viewing by FDA and nonfederal officials.
According to FDA, the agency planned to begin providing required  regulator training on the human food rule in May 2016 and on the animal  food rule in June 2016. Under this required training, regulators are first to  take courses developed and administered by the Food Safety Preventive  Controls Alliance (FSPCA) under a grant from FDA. These FSPCA  courses focus on the requirements of the human and animal food rules.  They were designed with an industry audience in mind to help industry  comply with the new rules. However, FDA decided that regulators would  benefit from taking these courses together with industry to ensure that  both groups were receiving the same information and to facilitate learning  from one another.
FDA made the FSPCA courses a prerequisite to subsequent courses for  regulators only, which focus on the skills, tools, and knowledge that  regulators would need to ensure industry compliance with the human and  animal food rules. According to FDA, the regulator-only courses on the  human and animal food rules are scheduled to begin in the summer of  2016 and to continue through the fall of 2018. FDA officials told us that  these courses are being developed by FDA subject matter experts, some  of whom will subsequently train selected FDA and nonfederal officials to  serve as course instructors. Those instructors will then administer the  courses at various locations around the country. FDA officials told us that  they are still working to develop the regulator-only courses, identify  instructors, and finalize details regarding how and where the training will  be delivered.
section_title: FDA Has Begun to Develop a Regulator Training Plan on the Produce Rule
paragraphs: As of February 2016, FDA had begun to develop, but not to administer, a  plan for training regulators on the FSMA-mandated produce rule. At that  time, the draft plan included two components. First, certain regulators  would be trained to conduct on-farm readiness reviews. Second, all  regulators responsible for conducting regulatory inspections and ongoing  compliance and enforcement activities would be trained to perform those  responsibilities.
subsections: section_title: Training for On-Farm Readiness Reviews
paragraphs: According to FDA’s draft plan, regulator training for the on-farm readiness  reviews is to begin with a course developed and administered by the  Produce Safety Alliance (PSA). Like the FSPCA courses, the PSA  course was designed with an industry audience in mind. However, FDA  decided that regulators would benefit from taking the course, along with  industry, to ensure that regulators and industry received the same  information and to facilitate their learning from one another. As with the  FSPCA courses, FDA plans to make the PSA course a prerequisite to  subsequent regulator-only courses. According to FDA’s draft plan, the  regulator-only courses for the on-farm readiness reviews will focus on the  goals of the reviews and regulator roles and responsibilities, among other  things. According to FDA, the agency is working closely with NASDA to  develop this training. As of February 2016, FDA planned to conduct a  pilot of these reviews in the spring of 2017, with training provided in  advance to staff participating in the pilot and subsequently to remaining  staff responsible for conducting these reviews. According to FDA, the pilot  will be coordinated by NASDA in collaboration with FDA and state  representatives.
section_title: Training for Regulatory Inspections and Ongoing Compliance and Enforcement Obligations
paragraphs: Like the training for the on-farm readiness reviews, training for regulatory  inspections and ongoing compliance and enforcement activities is to  begin with prerequisite courses designed for and taken together with  industry. In this case, these prerequisite courses are to be administered  by the PSA and the Sprout Safety Alliance (SSA). Next, FDA plans to  have regulators complete regulator-only courses focused on the skills,  tools, and knowledge regulators will need to conduct regulatory  inspections and ongoing compliance and enforcement activities under the  produce rule. As of February 2016, FDA planned to deliver the training for  regulatory inspections and ongoing compliance and enforcement  activities—including the PSA and SSA courses—beginning in the fall of  2016 for regulators responsible for inspecting sprouts growers, who come  into compliance first, and in the fall of 2017 for remaining regulators. From  the fall of 2016 through the winter of 2019, FDA also planned to develop  and deliver webinars on specific areas of the produce rule, best practices,  and observations from on-farm readiness reviews, among other things.
section_title: FDA Is Working to Overcome Challenges Related to Regulator Training
paragraphs: Through our discussions with officials from FDA and from associations  representing nonfederal food safety officials, we identified several  challenges that FDA is working to overcome in developing and  administering regulator training. Some of these challenges are the same  as those related to developing coordinated implementation plans.
subsections: section_title: New and Updated Training Courses
paragraphs: Officials from FDA and several of the associations we interviewed  discussed challenges related to the need for entirely new and updated  training courses on the FSMA-mandated rules. As previously discussed,  the FSMA-mandated rules marked a major shift in food safety regulation  by, among other things, establishing the first enforceable national  standards for on-farm practices related to produce, establishing the first  CGMPs for the animal food industry, updating CGMPs for the human food  industry, and mandating preventive control programs across the human  and animal food industries. This, in turn, required the development of  entirely new regulator training courses on produce standards and animal  food CGMPs and preventive controls and updated courses on human  food CGMPs. In addition, because the produce industry has not been  subject to routine regulatory inspections to date, FDA officials and  association representatives explained that the produce training courses  will need to train regulators on how to interact with an industry that is  unaccustomed, and potentially resistant, to government oversight.  According to FDA, the agency is taking numerous steps to meet these  challenges, including developing the regulator training plans that we  discussed earlier, which include a focus on “farm etiquette,” describing  key considerations in overseeing the produce industry.
section_title: Number of Regulators to Be Trained
paragraphs: Officials from FDA and several of the associations we interviewed  discussed challenges related to the thousands of regulators who must be  trained. For example, one association representative explained that  compliance with each rule begins to come due roughly 1 year after the  final rule is published, leaving little time for regulators across the country  to receive training on the rule requirements and compliance verification  duties. To reach greater numbers of regulators and reduce attendees’  travel time and cost, FDA officials stated that they are considering  creating training hubs around the country and offering as much online  training as possible. In addition, FDA recognizes that it is not feasible to  train all regulators simultaneously. Therefore, FDA officials stated that  they plan to use a phased training strategy to administer regulator training  in accordance with industry compliance dates. 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.
section_title: Inventories of Businesses Subject to the Rules
paragraphs: According to FDA officials, implementing the phased training strategy that  the agency plans to use is complicated by the business inventory  challenges discussed earlier in this report. Without an accurate inventory  of businesses covered under the rules, FDA is unable to determine when  and where to target its training.
section_title: Varying Legal Authorities
paragraphs: Representatives of most of the associations we interviewed discussed  challenges related to nonfederal agencies’ varying legal authorities. For  example, as we noted earlier in this report, representatives of some  associations stated that most nonfederal agencies lack authority to  conduct on-farm inspections related to produce. However, having such  authority is a prerequisite to hiring regulators to carry out produce  inspections, and hiring regulators must occur before they can be trained.
section_title: Varying Regulatory Structures
paragraphs: Representatives of most of the associations we interviewed discussed  challenges related to nonfederal agencies’ varying regulatory structures.  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. Like legal authority, a regulatory  infrastructure for overseeing produce is a prerequisite to hiring regulators  to carry out produce inspections, and hiring regulators must occur before  they can be trained.
section_title: Conclusions
paragraphs: 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. Integrating food  safety oversight across federal, state, local, tribal, and territorial  jurisdictions is a daunting task that is complicated by numerous  coordination challenges. FDA has demonstrated progress working with  nonfederal agencies to address these challenges, but many hurdles  remain as FDA continues its work to implement the FSMA-mandated  rules on produce, human food, and animal food.
FSMA’s mandated steps related to integration touch on areas including  rulemaking. FDA’s rulemaking is also subject to other laws and executive  orders requiring consultation with nonfederal agencies. We found that  FDA took steps to work with nonfederal agencies on developing the  FSMA-mandated rules on produce, human food, and animal food and  developing plans for coordinated implementation of those rules. However,  FDA did not consult with tribes throughout all stages of developing the  proposed rules, as is directed by HHS’s tribal consultation policy for all  rules with tribal implications where the federal government does not  provide the funds necessary to pay the direct compliance costs incurred  by tribes. In particular, FDA did not consult with tribes before publication  of the proposed rules. Instead, FDA’s first formal consultation took place  1 month after it published the proposed animal food rule and 10 months  after it published the proposed produce and human food rules.
Under the HHS tribal consultation policy, each agency within HHS must  establish a tribal consultation policy, which should include an accountable  process to ensure meaningful and timely input by tribal officials. More  than 11 years after establishment of the HHS tribal consultation policy,  however, FDA has not established an agency-level policy. 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 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. 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. Developing a draft policy is a  good first step, but without setting a timetable, with milestones and interim  steps, it will be difficult for FDA to set priorities, use resources efficiently,  measure progress, and provide management a means to monitor this  progress in finalizing the policy. FDA therefore risks continued delays in  establishing a process to ensure meaningful and timely tribal consultation,  a critical element of a sound and productive federal-tribal relationship.
section_title: Recommendations for Executive Action
paragraphs: 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.
section_title: Agency Comments and Our Evaluation
paragraphs: We provided a draft of this report for review and comment to the  Secretary of Health and Human Services. HHS provided written  comments, which are presented in appendix III. In its written comments,  HHS agreed with our recommendations. HHS also provided technical  comments, which we incorporated as appropriate.
We are sending copies of this report to the appropriate congressional  committees, the Secretary of Health and Human Services, and other  interested parties. In addition, the report is available at no charge on the  GAO website at http://www.gao.gov.
If you or your staffs have any questions about this report, please contact  me at (202) 512-3841 or morriss@gao.gov. Contact points for our Offices  of Congressional Relations and Public Affairs may be found on the last  page of this report. Key contributors to this report are listed in appendix  IV.
section_title: Appendix I: Objectives, Scope, and Methodology
paragraphs: 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.
To address all of our objectives, we first identified and reviewed  authorities governing FDA’s coordination with nonfederal agencies on the  FSMA-mandated rules on produce, human food, and animal food. For  each objective, these authorities included FSMA and the Federal Food,  Drug, and Cosmetic Act. For our objective on regulatory consultation,  these authorities also included the Unfunded Mandates Reform Act of  1995; Executive Orders 12866, 13563, 13175, and 13132; the  Department of Health and Human Services’ (HHS) tribal consultation  policy; FDA’s draft tribal consultation policy; and relevant presidential  memorandums and case law. In addition, for our objective on regulatory  consultation, we reviewed our body of work on key implementation  practices, including timetables with interim tasks and milestones.  Moreover, for our objective on coordinated implementation, we reviewed  our prior work on key features and issues to consider when implementing  collaborative mechanisms.
For all objectives, we obtained and reviewed relevant documentation,  including transcripts of and slide presentations from FDA public meetings  related to the three rules; the text of the proposed, supplemental, and  final rules, including the rule preambles; and relevant documents  referenced in each of the rules. For our objective on regulatory  consultation, we also reviewed notices that FDA published in the Federal  Register requesting information to inform the agency’s rulemaking and  records of outreach to nonfederal agencies, including tribes. In addition,  for our objectives on coordinated implementation and regulator training,  we reviewed relevant FDA plans and proposals, as well as cooperative  agreements and grants awarded to stakeholder organizations.  Furthermore, for our objective on regulator training, we reviewed curricula  documents on courses delivered to date.
For all objectives, we also attended relevant food safety conferences and  interviewed knowledgeable FDA officials and other stakeholders,  including representatives of industry; public interest groups; and other  relevant groups, such as the Partnership for Food Protection. In addition,  for our objective on regulatory consultation we interviewed officials from  HHS and eight state departments of agriculture. Moreover, for our  objective on regulator training, we conducted interviews with relevant  training organizations, including the International Food Protection Training  Institute, the Food Safety Preventive Controls Alliance, and the Produce  Safety Alliance. Furthermore, to obtain perspectives of nonfederal officials  on each of our objectives, we took three additional steps.
Review of public comments on FDA rulemaking. We reviewed all  public comments from state, local, tribal, and territorial governments,  and from associations representing those entities, that were submitted  in response to the proposed and supplemental rules on produce,  human food, and animal food. We obtained these comments from  regulations.gov, a website through which the public can search for  and provide comments on federal rulemaking and other dockets that  are open for comment and published in the Federal Register. We  began by downloading from regulations.gov lists of all public  comments on these rules. We then reviewed those lists to determine  which comments were provided by state, local, tribal, and territorial  governments and associations representing those entities. Next, we  conducted a content analysis of these comments to identify themes  related to coordination challenges faced and opportunities for  improvement.
Interviews with associations of nonfederal officials. We  developed a set of closed-ended and open-ended questions based, in  part, on our analysis of public comments. Next, we administered those  questions to representatives of selected associations of state, local,  tribal, and territorial food safety officials to obtain their views on the  identified challenges and opportunities, as well as their views on steps  taken by FDA related to rule development, implementation, and  training. We then analyzed and summarized the association  responses. In all, we interviewed representatives from 10  associations. These associations were selected based on their  participation in the Council of Association Presidents; their  membership in the “Big Seven” associations of state and local  officials; and recommendations received during preliminary  interviews that we conducted with FDA, industry or trade associations,  and public interest groups. We excluded some associations whose  areas of focus were outside the scope of our review. For example,  several associations’ areas of focus were surveillance and outbreak  response, and these associations were therefore unable to answer  questions regarding the FSMA-mandated rules on produce, human  food, and animal food. Appendix II lists the associations we  interviewed.
Site visit. We visited California—the state with the nation’s largest  agricultural and food production sectors—where we conducted  interviews with a range of officials from state and local agencies, and  from university and industry groups, to discuss their programs on  produce, human food, and animal food.
We conducted this performance audit from March 2015 to May 2016 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.
section_title: Appendix II: List of Associations
paragraphs: Appendix II: List of Associations Description  An association of local, state, and federal agencies charged by law to regulate the sale and  distribution of animal feeds and animal drug remedies.
An association representing state, territorial, and local officials from departments of health and  agriculture, whose mission is to advance uniform food and drug safety laws, regulations, and  guidelines.
Council of State Governments  A forum for officials in all three branches of state government whose mission is to champion  excellence in state government to advance the common good.
An association of local health department officials, whose mission is to protect and improve the  health of all people and all communities.
An association of the chief animal health officials in each state, whose mission is to speak with one  voice in matters of animal health science and public policy.
An association representing the commissioners and directors of state departments of agriculture,  whose mission is to support and protect the American agriculture industry while protecting  consumers and the environment.
An organization representing state legislators and their staffs, whose mission is to improve the  quality and effectiveness of state legislatures; promote policy innovation and communication among  state legislatures; and ensure a strong, cohesive voice for state legislatures in the federal system.
An organization of American Indian and Alaska Native tribes, whose mission is to protect and  enhance treaty and sovereign rights; secure traditional Native American laws, cultures, and ways of  life for their descendants; promote a common understanding of the rightful place of tribes in the  family of American governments; and improve the quality of life for Native communities and peoples.
An association of environmental health professionals in the public and private sectors, academia,  and the uniformed services, whose mission is to advance the environmental health and protection  professional for the purpose of providing a healthful environment for all.
U.S. Animal Health Association  An association of state and federal animal health officials and allied organizations, whose mission is  to serve as a national forum for communication and coordination on efforts to prevent, control, and  eliminate livestock diseases.
section_title: Appendix III: Comments from the Department of Health and Human Services
section_title: Appendix IV: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, Anne K. Johnson (Assistant  Director), Cheryl Arvidson, Timothy Bober, Kevin Bray, Ellen Fried,  Megan Kizzort, Armetha Liles, Perry Lusk, Josie Ostrander, Steven  Putansu, and Emmy Rhine Paule made key contributions to this report.