FDA Has Added Few Details on the Resources and Strategies Required to Implement Its Food Protection Plan

In light of the federal government’s long-term fiscal challenges, it is critical  that agencies can justify the needed resources and develop effective,  efficient strategies to achieve their mission. We testified in January 2008  that, while FDA officials had acknowledged that implementing the Food  Protection Plan would require additional resources, FDA had not provided  specific information on the resources it anticipates the agency will need to  implement this plan to improve its oversight of food safety. For example,  the Food Protection Plan proposes to enhance FDA’s information  technology systems related to both domestic and imported foods which  the Science Board report suggests could cost hundreds of millions of  dollars. At that time, FDA officials stated they would provide specific  information on how much additional funding would be necessary to  implement the Food Protection Plan when the President’s budget was  publicly released in the coming weeks.
In its fiscal year 2008 budget, FDA received approximately $620 million for  food protection, an increase of about $56 million over fiscal year 2007, and  directed $48 million of that amount toward implementing the Food  Protection Plan, according to FDA. FDA requested approximately $662  million for food safety for fiscal year 2009, an increase of about $42 million  over fiscal year 2008. According to the Department of Health and Human  Services’ budget justification, FDA plans to direct the $42 million to  strategic actions described in its Food Protection Plan. As shown in table  1, the plan outlines spending on all three core elements of the Food  Protection Plan––a total of about $21 million for prevention, about $34  million for intervention, and about $23 million for response for fiscal years  2008 and 2009. FDA also reported that, in fiscal year 2008, the agency  intends to hire nearly 1,500 full time equivalents (FTE), including  approximately 730 to fill vacant positions. Of these, 161 will be new FTEs  funded by congressional increases dedicated to food safety activities. In  addition, in fiscal year 2009, FDA plans to hire 94 new FTEs for food safety  activities.
Furthermore, in May 2008, FDA’s Commissioner of Food and Drugs  provided his professional judgment in response to a congressional request  of FDA’s immediate resource needs to implement key initiatives across the  core elements of the Food Protection Plan. The Commissioner called for  an additional $125 million for food protection in fiscal year 2008 beyond  the $48 million that FDA had already allocated for implementing the Food  Protection Plan in this fiscal year. According to the Commissioner, this  increase will allow FDA to address some of the plan’s strategic actions,  such as identifying and targeting the greatest threats from intentional and  unintentional contamination and conducting more risk-based inspections.  The Commissioner’s assessment also calls for 250 additional FTEs to  accomplish the goals of the Food Protection Plan. After the Commissioner  provided his assessment of FDA’s resource needs, the Senate passed an  Iraq War Supplemental that included an additional $119 million for food  safety to be available through fiscal year 2009. In addition, on June 9, 2008,  the Department of Health and Human Services announced that the  Administration is amending its fiscal year 2009 budget request to include,  in part, a $125 million increase for food safety. This amount would add to  the $42 million increase originally proposed in the fiscal year 2009 budget  justification (see table 1) and appears to be consistent with the  Commissioner’s professional judgment response. To accompany this  amendment, FDA has posted information on steps it is taking to invest in  its transformation in areas such as domestic medical products, import  products, and domestic food safety.  For example, under transforming  domestic food safety, FDA reports that it issued final fresh cut produce  guidance to limit contamination of fresh-cut fruits and vegetables.  In  addition, FDA conducted inspections and took action against processors  of low acid canned foods that were deviating from required standards.
In addition, in January 2008, we testified that the Food Protection Plan  does not discuss the strategies it needs in the upcoming years to  implement this plan. When we asked FDA for more specificity on the  strategies for implementing the plan, FDA officials told us that they have  internal plans for implementing the Food Protection Plan that detail  timelines, staff actions, and specific deliverables. More recently, a senior  level FDA official provided us with an estimate of 5 years for fully  implementing the plan. However, FDA has not provided us with timelines  for the various strategies described in the plan. For example, under the  plan’s strategic action 2.3—to improve the detection of food system  “signals” that indicate contamination (see table 1)—FDA has recently  identified three additional action steps with deliverables that will be  needed to identify, develop, and deploy new screening tools and methods  to identify pathogens and other contaminants. However, FDA could not  provide us with an estimate of how long it would take to implement these  steps or the overall strategic action. Without this type of information, we  are not able to assess whether FDA’s estimated 5-year time frame is  feasible.
Similarly, while FDA’s Food Protection Plan recognizes the need to  partner with Congress to obtain 10 additional statutory authorities to  transform the safety of the nation’s food supply, FDA’s congressional  outreach strategy is general. When we asked FDA officials if they had a  congressional outreach strategy, FDA officials told us that they had met  with various congressional committees to discuss the Food Protection  Plan. When asked if they had provided draft language to congressional  committees on the various authorities, FDA officials explained that they  only provided technical assistance, such as commenting on draft bills, to  congressional staff when asked.
FDA appears to be refining its implementation plan over time. Most  recently, in June 2008, FDA provided us with a draft work plan that it  characterizes as a dynamic document that changes on a daily basis to  implement the Food Protection Plan. While this draft work plan provides  more information on the action steps and deliverables to achieve the core  elements, we continue to have concerns about FDA’s lack of specificity on  the necessary resources and strategies to fully implement the plan. For  example, as part of the plan’s strategic action 1.1—to promote increased  corporate responsibility to prevent foodborne illnesses (see table 1)—FDA  has identified a goal of analyzing food import trend data and focusing  inspections based on risk, and the draft work plan shows six deliverables,  such as analysis of import data sets and an import risk ranking, associated  with this goal. However, the timelines for these deliverables are unclear. In  addition, the agency plans to dedicate a total of $673,000 to this goal in  fiscal years 2008 and 2009, and FDA officials told us that the agency  considers this funding to be a down payment toward achieving this goal.  However, it is unclear what the total cost will be to meet this goal. While  the work plan provides some basic information, more specific information,  such as estimated resources needed to implement the various strategies— the core elements, goals, and deliverables—as well as the overall plan and  timeframes for implementing the strategies, are needed to assess FDA’s  progress in implementing the plan or in acquiring the resources and  authorities it needs.
Anticipating the cost of the overall plan is important because, while some  activities, such as meeting with industry experts to discuss corporate  responsibility, may be accomplished within one budget cycle, others, such  as the establishment of an FDA field office in China will likely require a  long-term commitment of agency resources. From the information we  have obtained on the Food Protection Plan, it is unclear what FDA’s  overall resource need is for implementing the plan. The overall resource  need could be significant. For example, if FDA were to inspect each of the  approximately 65,500 domestic food firms regulated by FDA, at the  Commissioner’s May 2008 estimate of $8,000 for a domestic food safety  inspection, it would cost approximately $524 million to inspect all of these  facilities once. Similarly, if FDA were to inspect each of the 189,000  registered foreign facilities (which includes facilities that manufacture,  process, pack, or hold foods consumed by Americans) at the  Commissioner’s estimated cost of $16,700 per inspection, it would cost  FDA approximately $3.16 billion to inspect all of these facilities once.   These figures underscore the need for FDA to focus safety inspections  based on risk.
Ultimately, a results-oriented organization needs to take a long-term view  of the goals it wants to accomplish and describe them in a strategic plan.  To facilitate congressional oversight, strategic plans should discuss (1)  long-term goals and objectives for all major functions; (2) approaches to  achieve the goals and objectives, and in particular the required resources  including human capital and information technology; (3) a relationship  between the long-term goals and the annual performance goals; and (4) an  identification of key factors that could significantly affect achievement of  the strategic goals. Such discussions in the Food Protection Plan could  help clarify FDA’s organizational priorities to the Congress, other  stakeholders, and the public.
Lastly, when we testified before this subcommittee in January, we  reported that FDA planned to keep the public informed of their progress  on implementing the Food Protection Plan. In addition, in March 2008,  FDA officials indicated that a progress report on actions taken to  implement the Food Protection Plan would be issued in April 2008. In May,  FDA officials told us that they had prepared a draft progress report, but as  of June 4, 2008, FDA had not made this report public. FDA officials told us  that the progress report is still being cleared by the Department of Health  and Human Services, and they could not provide us with the report until it  was cleared by the department. Instead, FDA officials provided us with a  broad overview of FDA’s actions and, subsequently, provided us with a list  of accomplishments drawn out of numerous public documents. For  example, FDA issued a Federal Register Notice to solicit stakeholder  comments on the implementation of the Food Protection Plan as part of a  broad outreach plan.
We have noted that public reporting is the means through which the  federal government communicates the results of its work to the Congress  and the American people. Such reporting is in the public interest and  promotes transparency in government operations. While it is important to  show what progress has been made, having such information in a  consolidated document at a readily accessible location reassures Congress  and the public that actions have been taken.

	FDA’s Proposal to Focus Inspections Based on Risk Can Help Target Scarce Resources

The Food Protection Plan identifies the need to focus safety inspections  based on risk, which is particularly important as the numbers of food firms  have increased while inspections have decreased. In its Food Protection  Plan, FDA has identified some actions to better identify food  vulnerabilities and assess risks. For example, FDA plans to use enhanced  modeling capability, scientific data, and technical expertise to evaluate  and prioritize the relative risks of specific food and animal feed agents that  may be harmful. According to FDA officials, the agency has assigned a  risk-based steering committee to identify models for ranking and  prioritizing risk.
Conducting inspections based on risk has the potential to be an efficient  and effective approach for FDA to target scarce resources, particularly  when the number of inspections has not kept pace with the growth in  firms between 2001 and 2007. Specifically, while the number of domestic  firms under FDA’s jurisdiction increased from about 51,000 to more than  65,500, the number of firms inspected declined slightly, from 14,721 to  14,566. FDA also reported declines in the number of inspections at  overseas firms between 2001 and 2007—even as the United States has  imported hundreds of thousands of different food products from tens of  thousands of foreign food firms in more than 150 countries. Appendix I  has information on the number of FDA inspections of food firms in foreign  countries from fiscal years 2001 through 2007.

	GAO Has Issued Recommendations Intended to Help Leverage Resources and Improve Operations, but FDA Has Implemented Few of Them

FDA has implemented few of our past recommendations to improve food  safety oversight. Our recommendations are designed to correct identified  problems and improve programs and operations. We have made 34 food  safety related recommendations to FDA since 2004 and, as of May 2008,  FDA has implemented 7. For the remaining recommendations, FDA has  not fully implemented them, however, in some cases, FDA has taken some  steps. As shown in table 2, these recommendations fall into two broad  categories: improving monitoring and enforcement processes and  leveraging resources. The planned activities in the Food Protection Plan  could help address several of these recommendations.
In light of the federal government’s long-term fiscal challenges, agencies,  including FDA, need to seek out opportunities to better leverage their  resources. We have made 13 recommendations to help FDA better  leverage its resources since 2004, and FDA has implemented 4 of them. In  a January 2004 report regarding seafood safety, we recommended that,  among other things, FDA make it a priority to establish equivalence  agreements with other countries. We found that such agreements would  shift some of FDA’s oversight burden to foreign governments. FDA did not  concur with this recommendation, and as of May 2008, has not yet  established equivalence agreements with any foreign countries. In the  same report, we recommended that FDA give priority to taking  enforcement actions when violations that pose the most serious health  risk occur; consider the cost and benefits of implementing an  accreditation program for private laboratories; and explore the potential  of implementing a certification program for third-party inspectors.  Although FDA concurred with these recommendations and has taken  some limited action such as requesting public comments on the use of  third-party certification programs, none were fully implemented.  The  Food Protection Plan requests that Congress allow the agency to enter  into agreements with exporting countries to certify that foreign producers’  shipments of high-risk products comply with FDA standards.
Since 2004, we have made 21 recommendations to FDA to improve  monitoring and enforcement processes, and FDA has implemented 3 of  them. For example, in October 2004, we recommended that FDA develop a  sound methodology for district staff to verify that companies have quickly  and effectively carried out recalls. At the time of our review, we found  that FDA was not calculating the recovery rate for recalls. As a result, the  agency did not know how much food was actually recovered, although the  agency told us recovery was an important indicator of a successful recall.  FDA initially commented that we had not demonstrated that weaknesses  in FDA’s recall process resulted in little recovery of food, but as of May  2008, the agency is in the process of conducting a quality management  system review of its recall activities and, once the review is completed, it  will include recommendations for verifying that a company’s recall was  effective, according to FDA.
To conclude, FDA’s release of the Food Protection Plan is a positive first  step toward modernizing FDA’s approach to food safety to better meet the  challenges of an increasingly global food supply and respond to shifting  demographics and consumption patterns. Given that FDA’s resources have  not kept pace with its increasing responsibilities, FDA’s plan to take a risk- based approach to inspections could help FDA make the most effective  and efficient use of its limited resources. However, FDA’s Food Protection  Plan can only be as effective as its implementation, and without specificity  on the resources and strategies needed to fully implement the plan—and  in the absence of public reporting—neither Congress nor the public can  gauge the plan’s progress or assess its likelihood of success in achieving  its intended results. In addition, no one is better poised than FDA to  identify the resources and authorities needed to implement the plan;  therefore, FDA’s capacity to provide such information can be questioned.  Meanwhile, as foodborne illness outbreaks continue, FDA is missing  valuable opportunities to reassure Congress and the public that it is doing  all it can to protect the nation’s food supply.
Mr. Chairman, this concludes my prepared statement. I would be pleased  to respond to any questions that you or other Members of the  Subcommittee may have.

	Contact and Staff Acknowledgments

Contact points for our Offices of Congressional Relations and Public  Affairs may be found on the last page of this statement. For further  information about this testimony, please contact Lisa Shames, Director,  Natural Resources and Environment at (202) 512-3841 or  shamesl@gao.gov. Key contributors to this statement were José Alfredo  Gómez, Assistant Director; Kevin Bray; Candace Carpenter; Alison Gerry  Grantham; Thomas McCabe; Alison O’Neill; and Barbara Patterson.

Appendix I: Number of FDA Inspections of Food Firms in Foreign Countries, as of December 2007

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Summary:
Why GAO Did This Study

The Food and Drug Administration (FDA) is responsible for ensuring the safety of roughly 80 percent of the U.S. food supply, including $417 billion worth of domestic food and $49 billion in imported food annually. Changing demographics and consumption patterns along with an increase in imports have presented challenges to FDA. At the same time, recent outbreaks, such as E. coli from spinach and Salmonella from tomatoes, have undermined consumer confidence in the safety of the food supply. In November 2007, FDA released its Food Protection Plan, which articulates a framework for improving food safety oversight. In January 2008, GAO expressed concerns about FDA's capacity to implement the Food Protection Plan and noted that more specific information about the strategies and resources needed to implement the plan would facilitate congressional oversight. This testimony focuses on (1) FDA's progress in implementing the Food Protection Plan, (2) FDA's proposal to focus inspections based on risk, and (3) FDA's implementation of previously issued GAO recommendations intended to improve food safety oversight. To address these issues, GAO reviewed FDA documents, such as FDA's operations plan, and FDA data related to the plan. GAO also interviewed FDA officials regarding the progress made. GAO also analyzed FDA data on domestic and foreign food firm inspections. GAO also analyzed the status of past recommendations.

What GAO Found

Since FDA's Food Protection Plan was first released in November 2007, FDA has added few details on the resources and strategies required to implement the plan. FDA plans to spend about $90 million over fiscal years 2008 and 2009 to implement several key actions, such as identifying food vulnerabilities and risk. From the information GAO has obtained on the Food Protection Plan, however, it is unclear what FDA's overall resource need is for implementing the plan, which could be significant. For example, based on FDA estimates, if FDA were to inspect each of the approximately 65,500 domestic food firms regulated by FDA once, the total cost would be approximately $524 million. In addition, timelines for implementing the various strategies in the plan are also unclear, although a senior level FDA official estimated that the overall plan will take 5 years to complete. Importantly, GAO has noted that public reporting is the means through which the federal government communicates the results of its work to the Congress and the American people. FDA officials told GAO that they had prepared a draft report on progress made in implementing the Food Protection Plan, but as of June 4, 2008, FDA told GAO that the Department of Health and Human Services had not cleared the report for release. The Food Protection Plan identifies the need to focus safety inspections based on risk, which is particularly important as the numbers of food firms have increased while inspections have decreased. For example, between 2001 and 2007, the number of domestic firms under FDA's jurisdiction increased from about 51,000 to more than 65,500, while the number of firms inspected declined slightly, from 14,721 to 14,566. Thus, conducting safety inspections based on risk has the potential to be an efficient and effective approach for FDA to target scarce resources based on relative vulnerability and risk. FDA has implemented few of GAO's past recommendations to leverage its resources and improve food safety oversight. Since 2004, GAO has made a total of 34 food safety related recommendations to FDA, and as of May 2008, FDA has implemented 7 of these recommendations. For the remaining recommendations, FDA has not fully implemented them, however, in some cases, FDA has taken some steps. However, the planned activities in the Food Protection Plan could help address several of the recommendations that FDA has not implemented. For example, in January 2004, GAO recommended that FDA make it a priority to establish equivalence agreements with other countries. We found that such agreements would shift some of FDA's oversight burden to foreign governments. As of May 2008, FDA has not yet established equivalence agreements with any foreign countries. The Food Protection Plan requests that Congress allow the agency to enter into agreements with exporting countries to certify that foreign producers' shipments of designated high-risk products comply with FDA standards.