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1 Introduction Setting the Context What Characterizes an Effective Preventive Food Safety System? In his workshop introductory remarks, Ned Groth explained that, while planning this workshop, Forum members developed a set of key cri- teria for an effective preventive food safety strategy or system. A protective food safety system should be: â¢ systematic (i.e., from farm to table); â¢ isk-based (i.e., with set priorities and established risk management r practices); â¢ transparent and participatory; â¢ cost-effective; and â¢ minimally disruptive of trade (which is an obligation of all coun- tries regardless, as per the SPS Agreement). These criteria served as a framework for the dayâs discussion. The first three criteria in particular figured prominently during the course of the workshop, with an emphasis on: â Edward Groth III, PhD, is a Consultant with Groth Consulting Services, Pelham, NY. â The SPS Agreement is the World Trade Organization (WTO) Agreement on the Applica- tion of Sanitary and Phytosanitary Measures, adopted in 1994, which allows members to take appropriate and scientifically based measures to protect public health as long as they do so in a manner that minimally disrupts trade.
MANAGING FOOD SAFETY PRACTICES FROM FARM TO TABLE â¢ he need for more transparent and effective communication among t all stakeholders and the need for all farm-to-table stakeholders to participate in food safety management; â¢ he need to consider the global scope of the farm-to-table food t production process; and â¢ he need for science- and data-based decision making when attempt- t ing to improve the safety and lower the risks of food production. Cost-effectiveness and the obligation to minimally disrupt trade were mentioned during the course of the workshop discussion but were not elaborated on to nearly the extent that the other criteria were. Is Food Safety Solvable? Also in his opening remarks, Groth emphasized that progress can be achieved and that even very difficult food safety problems are solv- able. As an example, he told an anecdotal story about some shipments of shrimp from Southeast Asia being refused entry into the United States and European Union (EU) a number of years ago because of the detection of unacceptable levels of chloramphenicol residue. The refused entries had a devastating effect on shrimp export throughout Southeast Asia. Over the last five years, however, the Vietnamese shrimp industry has made a terrific comeback, despite initial problems in educating the thousands of low-tech and largely illiterate shrimp farmers about what they needed to do to correct the problem. Largely through technical assistance provided from several European countries, the Vietnamese government has developed a surveillance, monitoring and analytical capacity that simply did not exist at any level five years ago. Today, the United States and EU account for almost half of all Vietnamese shrimp exports. A handful of other success stories were told elsewhere during the course of the dayâs discussion. For example, at one point during the dayâs discussion it was noted that many developing countries that one might not necessarily expect to have sophisticated food safety systems in place are nonetheless able to meet the very high EU import standards. It was sug- gested that perhaps this is because of direct working relationships between exporting and importing countries and the agencies therein. Grothâs introductory remarks were followed by Taylorâs keynote ad- dress: Institutional Roles in Risk-Based Management. A key message of â Chloramphenicol is an antibiotic that is typically administered only as a last resort treat- ment for difficult-to-treat bacterial infections in humans. U.S. federal regulations prohibit its use in food-producing animals or animal feed products, however, due to its unpredictable effects in some human patient populations.
INTRODUCTION Taylorâs talk was that food safety is as much an institutional challenge as it is a scientific, business, or regulatory challenge. The âgood newsâ with respect to food safety, Taylor said, is that policy makers are âgetting it.â Food safety is on the radar screen and, in fact, Americans are at a turning point in their history with respect to having the opportunity, means, and political will to improve our food safety system. But institutional roles and responsibilities still need to be clarified, institutional capacity needs to be strengthened (so each institution can meet its responsibilities), barriers to information exchange and collaboration need to be broken down, and new mechanisms for collaboration need to be created. In short, even with the increased policy focus on food safety, far more work needs to be done in order to foster an institutionally integrated, systems-based approach to food safety. Taylorâs emphasis on the institutional nature of the challenge of food safety was a major underlying theme of the remainder of the work- shop presentations and discussions. Organization of the Workshop and This Report The remainder of the workshop was organized around three major sessions: 1. essons learned from recent outbreaks and other past experiences L in a range of foods (i.e., from minimally processed to highly pro- cessed) and under a range of regulatory frameworks (i.e., from reliance on good agricultural practices, or GAPs, to the use of very strict low-acid canned food regulations), as well as lessons learned from scientific research on consumer behavior. In addition to the respective roles of industry and government and the need for more transparency and collaboration between these two sectors in par- ticular, other major topics of discussion during this session included the essential role of science in the development of safe food pro- duction systems and the need to make data-based decisions when designing such systems; the argument that testing and audits are verification, not preventive measures; and how research has shown that consumer education by itself are not a sufficient preventive measure against foodborne illness. 2. The range of strategic approaches to improving food safety that is being considered or has already been implemented. These ap- proaches range from the technological (e.g., advances in molecular detection technologies) to changes in how the public and private sector can or should interact. In addition to the continued discus- sion on the respective roles of industry and government and the need for more collaboration between the two sectors, other major
MANAGING FOOD SAFETY PRACTICES FROM FARM TO TABLE topics of discussion during this session included the global nature of the U.S. food supply and the critically important role of risk- based supply chain management; and the reality that, while new testing technologies are becoming available, again, testing is not preventionâthere is a need to better utilize the technological tools and knowledge already in place. This session ended with what was arguably the most conceptual presentation of the day: Julia Caswellâs âbig pictureâ examination of different publicâprivate sector combinations and strategies used elsewhere and in the U.S. and the need to consider whether this country should adopt a more comprehensive approach to food safety management rather than relying on its current reactive, risk-by-risk approach. 3. Future steps toward improving and ensuring the safety of our food supply. This session involved a four-person panel with represen- tatives from industry (Cargill Inc.), a consumer advocacy group (Center for Science in the Public Interest) and two regulatory agen- cies (Center for Food Safety & Applied Nutrition [CFSAN] and the Food Safety and Inspection Service [FSIS]). Each panelist was asked to provide some perspective on what they had heard during the course of the previous sessions. The issue of the respective roles of industry and government and the need for more privateâpublic sector cooperation and coordination again figured prominently throughout the session. The panelists offered opinions and insights into how this might be achieved, for example whether the forma- tion of a single unified food safety agency could be an option. There were starkly contrasting views on the practicality and po- tential of such an agency, with both regulatory agency representa- tives strongly opposed to the notion and the consumer advocacy representative and some audience members in favor. Both regula- tory agency representatives and the private industry representative briefly described some recent or pending food safety measures being implemented or planned by their respective institutions. An- other major topic of discussion was the challenges that stem from the increasingly global nature of our food supply chain, such as ensuring that agricultural suppliers are adhering to good sanitary practices. â CFSAN is one of six product-oriented centers within the U.S. FDA. In conjunction with FDA field staff, CFSAN is responsible for promoting and protecting public health by ensuring that the U.S. food supply is safe, sanitary, wholesome, and honestly labeled and that cosmetic products are safe and properly labeled. â The FSIS is the public health agency in the USDA responsible for ensuring that the Nationâs commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged.
INTRODUCTION This workshop report is organized around these three sessions, with Chapters 2, 3, and 4 summarizing the presentations and discussions of the first, second, and third sessions, respectively. A paraphrased summary of Taylorâs keynote presentation follows. Keynote Address: Institutional Roles in Food Safety Risk-Based Management Presenter: Michael Taylor Michael Taylor began by remarking that regulators and industry often think about food safety as a scientific, business, or regulatory challenge. He argued that there is another way to think about food safety: as an in- stitutional challenge. In fact, it is practically unavoidable to look through the institutional lens when deliberating an effective farm-to-table risk-based approach to food safety. Food safety success depends on the behaviors of many different types of institutionsâfor example, how institutions interact with each other and whether and how institutions are incentivized to do certain things. How institutions work well together, or not, and share data, or not, significantly impacts outbreak management success and the timeli- ness, or lack thereof, in resolving food safety problems. The extent to which institutions work well together is particularly im- portant with multi-state outbreaks, where not just the federal government but also the governments of multiple states are responding. Taylor pointed to the Salmonella Saintpaul outbreak, which involved 40-plus states, as an example of the vital role that institutions play in outbreak response situa- tions. Not only are multiple levels of government involved in these types of situations (i.e., federal, state, and local governments), but within each level there are multiple institutions: â¢ t the federal government level, there are the Centers for Disease A Control and Prevention, or CDC (playing the âepi roleâ), and both the FDA and USDA (playing distinct regulatory roles). Together, these agencies play key roles in national coordination, traceback, and risk communication. â This section is a paraphrased summary of Michael Taylorâs keynote address. â Michael Taylor, JD, is a Research Professor at George Washington University, Washington, DC. â The Salmonella Saintpaul outbreak began in April 2008, with the first cases reported to the CDC by the New Mexico Department of Health in May. Within weeks, the outbreak ex- panded to include 43 states, the District of Columbia, and Canada. By the end of August, the outbreak appeared to be over. JalapeÃ±o and Serrano peppers grown in Mexico were identified as the main source of contamination.
MANAGING FOOD SAFETY PRACTICES FROM FARM TO TABLE â¢ t the state and local government level, there are the public health A labs, health departments, and food inspection agencies, all of which not only must interact with each other but also with the various federal institutions. State and local governments typically work on the frontline during outbreak responses and play critical roles in early detection. â¢ dded to these is the obviously central role that the private food A industry plays, including food producers, processers, and retailers. Not only are private companies critical sources of information, they are also responsible for managing the recalls. â¢ inally, there is the public, which includes the press as well as out- F break victims and other citizens. The latter serve as the ultimate measure of the effectiveness of any food safety system or strategy. While certain institutions may seem to have particular primary roles (e.g., the federal government is responsible for national coordination), multiple institutions from these different sectors typically work together on most activities. For example: â¢ hen conducting hazard identification and analysis, while the W responsibility falls first and foremost on private industry, clearly both the federal government regulatory groups (including CDC, FDA, and USDA) and government and academic research groups play important roles as well. â¢ ikewise with developing and implementing interventions: while L this is primarily an industry responsibility, the Agricultural Re- search Service (ARS) and other research organizations are active in this area as well. â¢ etting food safety standards is primarily a government activity, S with the FDA, USDA, and state and local agencies all involved, Codex, the International Organization for Standardization (ISO) and other international standard-setting bodies also play a role. In- creasingly, food companies and retailers are also setting food safety standards through purchase specifications and other means. â¢ inally, while verifying and enforcing compliance has traditionally F been perceived of as a government role, the private sector partici- â Codex is the Codex Alimentarius Commission (CAC), an intergovernmental organization jointly run by the Food and Agricultural Organization (FAO), and the World Health Organiza- tion (WHO). Codex is responsible for compiling the standards, codes of practice, guidelines, and recommendations of the Codex Alimentarius, an international set of food standards often referred to as the âCodex standards.â
INTRODUCTION pates as well (i.e., through commercial purchasers and third party auditors). All of these various mixed responsibilities across all of these areas of food safety and risk management highlight the reality that institutions are highly interdependent in outbreak response and other food safety situa- tions. Effective institutional interaction is critical to their success. This is true no matter what the situation isâwhether it is a traceback, outbreak investigation, or prevention activity. The reality is that there is an enormous number and diversity of institu- tions with widely divergent perspectives and capacities working on the same problems. This poses a tremendous challenge. Precisely because of their divergent perspectives and capacities, most institutions have a tendency to work within a particular set of traditional practices. Taylor referred to a recent examination of the food safety information infrastructure, an effort supported with funding from the Robert Wood Johnson Foundation,10 which concluded (among other findings) that institutions tend to focus only on their particular role in the system and fail to consider how they can work cooperatively and collaboratively with other institutions and address food safety as a systems-level problem. This âstovepipeâ way of working impedes information-sharing and collaboration. Taylor emphasized that much more work is needed to foster an integrated, systems-level approach to food safety. Taylor also emphasized, however, that it is enormously gratifying that âpolicy makers at the legislative level are getting this.â He pointed to sev- eral signs that the issue of food safety is on the public policy radar screen: â¢ DAâs Food Protection Plan and the Bush administrationâs Import F Safety Action Plan, both of which are focused on forging bet- ter interaction between government and industry in order to im- prove risk management of both imported and domestic food safety systems-level problems. â¢ earings for the 110th Congress on the Salmonella Saintpaul out- H break, which Taylor noted were particularly noteworthy with re- spect to how members of both sides of the aisle âreally dug into what was going on at the institutional level in terms of the interac- 10â The project, âExploring Opportunities to Improve the Nationâs Food Safety Information Infrastructure,â was sponsored by the Food Safety Research Consortium (FSRC), a collabora- tion among seven research institutions. The goal of the project was to address issues relating to how food safety data are collected and shared. The FSRC issued a report on the project findings in May 2008.
10 MANAGING FOOD SAFETY PRACTICES FROM FARM TO TABLE tion between federal, state, and local agenciesâ and âembraced the need to address these institutional questions in a serious way.â â¢ ending surveillance and outbreak response legislation, including a P bill (Improving Food-borne Illness Surveillance and Response Act of 2008, introduced by then Senator Barack Obama) that would, among other changes, call for an enormous investment in strength- ening state and local capacities to be integrated into a national food safety system. â¢ ending FDA food safety legislation (i.e., the Durbin bipartisan P FDA Food Safety Modernization Act), which like the surveillance and response bill would address other institutional issues. Taylor remarked that it is terrific that food safety, particularly the insti- tutional issues of food safety, is being seriously considered at the national policy and legislative level. It is incumbent upon the food safety community at large, however, to take advantage of this remarkable and unprecedented interest and figure out how to actually achieve better institutional integra- tion. Taylor identified four key elements of successâsteps that the food safety community must take in order to fulfill the vision of a more inte- grated system: 1. Clearly define responsibilities and roles of all institutions for all situations (e.g., outbreaks, prevention). Taylor noted that while there has been progress with respect to HACCP11 implementation and a better understanding of the relationship between company responsibility for having preventive safety plans in place and gov- ernmentâs oversight responsibility, there are still many other role and responsibility issues to be resolved, particularly within and among different government levels and agencies. 2. Build capacity of institutions to meet their responsibilities. This is particularly important with respect to governmental capacity, especially at the state and local level but also at the federal level. The FDA, for example, is under-resourced and has some serious capacity-building to do. Likewise, the Nationâs âepi functionâ is woefully underfunded at all levelsâfederal, state, and local. 3. Break down barriers to information sharing and other collabora- tive efforts among agencies and organizations. 11â Based on a set of seven key principles, HACCP (pronounced âhassipâ), the Hazard Analysis and Critical Control Point, is a systematic harvest-to-consumption approach to the identification, evaluation, and control of food safety hazards.
INTRODUCTION 11 4. Create new mechanisms of collaboration, both between govern- ment and industry and across government. Right now, the mecha- nisms are not in place that would enable these agencies to work together. In conclusion, Taylor opined that regulators, industry, and consumers are at a turning point in the history of food safety. There have been few times that food safety has been on the radar screen at this political level. While there is rightfully considerable focus on getting the science and policy right, change is not going to happen unless there is also an effort to âget the institutions right.â Taylor expressed hope that this workshop discussion would generate ideas that will help us move forward in that direction. Following Taylorâs presentation, there was a question about the roles and responsibilities of the courts with respect to improving food safety. Taylor responded that the courts do play a role as overseers of the gov- ernment and as administrators of the private liability system, as demon- strated by USDAâs experience with the Salmonella performance standard for ground beef, but it is not a central role compared to the one agencies are expected to play, in our government system in implementing laws passed by Congress. This question was followed by a comment by another workshop par- ticipant who suggested that the Department of Homeland Security (DHS) might also have a role to play in improving the food safety system, given its critical existing role in customs and border protection, its management of the National Biosurveillance Integration System (which could serve as a key component of information sharing) and its provision of emergency preparedness grants, including some specifically for food and agriculture (i.e., through the Federal Emergency Management Agency, or FEMA). Taylor agreed. FINDING SOLUTIONS: CONSIDERING OPTIONS Taylorâs keynote presentation set the tone for the workshop: a focus on the roles and responsibilities of institutions, U.S. government and oth- erwise, and the reality that there is still a great deal of work to be done. As he noted in his keynote presentation, food safety is not a new topic of dis- cussion. It has always been an issue, and the global food supply has always had problems. However, food safety is in the national and international spotlight in a way that is has never been before, making now an opportune time to seize on this attention and make some desperately needed changes. The question is, what changes are needed and how should these changes be implemented? More specifically, workshop participants considered:
12 MANAGING FOOD SAFETY PRACTICES FROM FARM TO TABLE â¢ hat can be learned from the science and history of the very safe W thermally processed canned food industry (as Donald Zink dis- cussed) and other food safety success stories? â¢ qually, if not more important, what can be learned from food E safety failures, such as the recent E. coli O157:H7 outbreak in Natural Selection Foods bagged spinach (which Will Daniels dis- cussed) and the more persistent problem of Listeria contamination in ready-to-eat meat products (which Randy Huffman addressed in his presentation)? â¢ hat are some of the strategic approaches that the FDA, USDA, W industry, and other stakeholders have taken or are currently con- sidering (as most of the workshop participants addressed to some extent but which Robert Brackett, Caroline Smith DeWaal, Rich- ard Raymond, Mike Robach, and Stephen Sundlof considered in detail)? â¢ ow about the consumer populationâwhat role can and should H food consumers play in reducing food safety risks (as Christine Bruhn considered)? â¢ an any of the new advanced detection technologies being devel- C oped help the effort, or is the challenge to better utilize already ex- isting and available technologies (as Russell Flowers considered)? â¢ inally, getting back to the original question that Groth posed in F his opening remarks, what can the U.S. government do to facilitate efforts to improve food safety? More generally, how should the public and private sectors interact? Again, this was a question that many workshop participants and audience members addressed to some extent, either in their presentations or during discussion. Of note, more specifically, Julie Caswell asked: Does the United States need to develop a comprehensive joint public-private approach to- ward food safety management and assurance, rather than operating on a risk-by-risk basis? These were just some of the many specifics considered throughout the day. Of note, the two major U.S. food regulatory agencies, FDA and USDA, are housed separately within the executive branch of the U.S. federal government. The FDA is in the Department of Health and Human Services (HHS), whereas USDA comprises its own separate department. HHS also houses the CDC. Much of the discussion summarized in Chapter 4 revolved around fundamental differences in the regulatory approaches of these two separate regulatory agencies.
INTRODUCTION 13 Improving Food Safety: Differences in Opinion Again, the workshop objective was neither to reach consensus nor articulate any conclusions or recommendations. Rather, the goal was to spotlight concerns, consider options, and engage in dialogue on this timely issue. Indeed, one of the major overarching themes of the workshop pre- sentations and discussion was the wide range of opinions and beliefs about those details. As Christine Bruhn observed in the final discussion of the day, âWe have a commonality, and I think we need to grasp that commonality: and that is the desire to make the food supply safer. Where we differ is in some of the details about how to do it.â This was particularly true with regards to the roles and responsibilities of each of the major stakeholders: 1. Government regulatory agencies (i.e., in the United States, the FDA and USDA) 2. Private industry (i.e., food production companies as well as all companies that contribute to any aspect of the food supply chain) 3. The consumer population 4. Academia (and other research institutions) 5. Inter-governmental organizations (e.g., CAC, WHO, FAO) As an example of the varied opinions and beliefs expressed, one work- shop participant was adamant that there should be more governmental oversight on agricultural farms, while others questioned the usefulness of increased oversight. As another example, several participants were enthu- siastic about the notion, or âvision,â of a single unified food safety agency, while others questioned the feasibility and usefulness of such an agency. Despite the contention, there was nonetheless some agreement on the need for more communication, cooperation, and coordination between govern- mental regulatory agencies and private industry. Yet even then, while com- mending USDA on its communication efforts over the past couple of years, panelist Caroline Smith DeWaal commented that the broader issue is not just the need for more communication between regulators and industry but the need for regulatory agencies to communicate more effectively with all stakeholders, including consumers.