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By Richard F. Stier
It seems that each and every day when we pick up a newspaper, watch television or surf the Internet, we are faced with a new food recall, an announcement about foodborne illness or something about the horrors of processed foods. It is to the point that many consumers in the United States believe that our food supply is inherently unsafe. Therefore, the question is “How safe is our food?” and “What should be done to improve the situation?” assuming that it needs improvement.
Am I qualified to comment? Having worked in hundreds of food plants on five different continents, I have seen all kinds of processing operations and their associated food quality and safety systems. I can honestly say that after a few weeks in Asia or Africa, I cannot wait to get home and cease worrying about what I am going to eat next. However, we deviate from the point.
How safe is our food supply? My personal belief is that it is extremely safe, the Centers for Disease Control and Prevention estimates of 76 million illnesses and 5,000 deaths aside. I have never been in a food plant that acknowledged that their goal was to make people sick, although I have been in facilities where I would not eat what they produced after seeing the operations. However, I have also never been in a plant where I could not find one or more areas that could be improved. Most operators welcome audits and want to do better. They understand that safe food equals good business. Moreover, even though I feel that the food supply is extremely safe, I believe that the industry as a whole can do better.
I do not believe that increased regulation and more testing are the answers. In this country, the United States government mandates Hazard Analysis and Critical Control Points (HACCP) for meat and poultry, seafood and juice. I can envision a future (probably nearer than farther) where this program will be mandated for all food and ingredient processing industries. Even though HACCP is not mandated by the government for all processors, the food business has driven industry-wide implementation. You want to sell ingredients to a processor or food chain? You better have a HACCP program. You want to sell your finished goods to a supermarket? You better have HACCP in place. The problem lies in whether processors really understand what they are doing when they implement the system. There are far too many HACCP programs that are poorly developed and managed. The biggest failing is in the supporting or prerequisite programs. Most food poisoning outbreaks are caused by a breakdown in sanitary operations in some way, shape or form. The problem can be poor cleaning, improper maintenance, poor air handling, bad plant design or allowing situations where cross-contamination can occur. Third party audits are often so proscriptive and under such severe time constraints that even very competent people cannot devote the necessary time and effort to really looking for problems. One colleague, Mr. Don Graham, who is a member of the Food Safety Magazine editorial board, tells his clients that he will not work with them unless he is allowed the time to do a proper assessment. Many years ago, I talked with a fellow who worked as an industry consultant on the East coast. He told me a story about how he went into one plant and found himself a nice perch above the production lines that allowed him to see almost the whole operation. The plant manager saw him in his perch and, after several hours, came over and invited him to come down. The manager was not pleased because he felt that the consultant was sitting on his ass and not doing what he had been paid to do. The consultant proceeded to show the manager several pages of observations that he had made, which shut him up rather quickly. The bottom line is that identifying problems takes time and effort as well as money. Processors must make a commitment to improvement.
So, what about testing? Consumer groups are constantly harping on the government for not testing enough. Testing has a role, but it is certainly not the best means to ensure food safety. There are times when I feel that we (government and industry) forget the past and how our food safety systems have evolved. HACCP was created to ensure the production of safe foods for the space program, but one of the driving factors was the realization that to adequately test products to ensure safety, the amount of sampling and testing required was not only prohibitively expensive, but would leave little food to use in the program. Statistically, it simply does not compute. One of the key findings from the National Academy of Sciences Report from 1985, which truly jump-started HACCP, was the following:
“Testing of finished products was not an effective means of protecting the consumer and assuring the foods were free of microorganisms of public health significance.”
This was the exact same conclusion that the scientists from Pillsbury, the National Aeronautics and Space Administration and the United States Army Laboratories in Natick, MA had reached 25 years earlier. If a company develops and implements a good food safety system based on HACCP and makes the commitment to maintain it, the foods they manufacture should be safe. Microbiological testing is a means to verify that the system is working, but I would put more faith in a properly designed system than in end product testing.
How do we do better if we are not going to test or rely on government regulation? The key is a company commitment to food safety. This means that top management must support food safety and establish that mentality throughout the company, which means getting marketing, sales, accounting and others on board. But, how does one get the non-scientists to support the program? One means is to show them what can happen if the company fails in their public duty to ensure safe foods. One way to do this is to invite someone such as Bill Marler to the company’s annual sales or business meeting. Listening to him can be a real epiphany. If your people do not walk out of that meeting committed to the production of safe food, you should consider bringing in a new group.
Richard F. Stier has been involved in food safety and HACCP since 1981. He currently consults on food safety, sanitation and quality systems and has worked with companies throughout the world. He is a member of the Food Safety Magazine editorial board.
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By Mark Mansour
In the aftermath of health care reform legislation, and in the midst of a potentially massive financial industry overhaul, the Senate will soon confront a major food safety bill.
The House voted 283–142 in late July 2009 to pass the Food Safety Enhancement Act of 2009 (HR 2749). The Senate Health, Education, Labor and Pensions (HELP) Committee in mid-November of last year approved the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (S 510), although the measure has yet to reach the full Senate floor because of that body’s more sclerotic nature.
What happened to get us to such a pivotal and climactic point in food safety-related legislation, and what would these bills—the most dramatic changes to the food safety regime in decades—mean to food companies large and small?
The Food Drug and Cosmetic Act is three-quarters of a century old, having functioned well with periodic amendment. Until several years ago, FDA was viewed as the gold standard in the realm of global regulation. Within the space of 10 years, however, the U.S. Congress is considering dramatic changes in the manner in which it regulates foods.
What happened is a function of several concurrent events, the cumulative effect of which has been the placing of an unusual strain on a system that once was viewed as the best in the world. Perhaps most important is that, in the span of a decade, the size and scale of global food imports exploded. During that same period, FDA and the U.S. Department of Agriculture (USDA) have functioned with relatively unchanged economic resources, while retirements at all levels of these agencies, combined with a relatively slow influx of new talent, taxed the agencies’ capacities for managing a growing workload. At the same time, new technologies taxed the capacity and response time of the regulatory and rulemaking system
More dramatic, over the course of several short years, outbreaks of foodborne illnesses involving spinach, lettuce, peanut butter, peppers, pet food and meat have shocked the public, Congress and the agencies, leaving many wondering whether large-scale changes were needed. Although in direct response numerous bills were introduced at both the federal and state levels (at one time, 2 years ago, nearly 400 separate bills were pending in Congress and legislative and municipal bodies around the country), the lack of a consensus in Congress left these initiatives to die session after session.
The Congressional elections of 2006 and the national election of 2008 changed the equation entirely, providing renewed energy to proponents of sweeping (as opposed to incremental) change. These political changes have strengthened the hand of those calling for more dramatic changes in the food regulatory system. Whether or not it was the final straw may be debated, but the massive peanut butter recall last year, which exploded to encompass virtually all peanut products manufactured over the course of the past 2 years, shared headlines for days with the debate over the stimulus package. The same was the case with the pistachio recall of 1 year ago.
After several pending proposals were considered and ultimately merged, the House passed HR 2749. The bill covers food only, with other FDA-regulated products expected to be covered under separate legislation later.
The perception of an inability by FDA and exporting countries to stem the tide of tainted products entering the U.S. made legislative action inevitable. Already, FDA had taken its cue from Congress and throughout 2008 was cautioning industry in speeches and presentations that it would be held accountable for its products, as well as ingredients purchased from suppliers and from those suppliers’ suppliers.
The House bill encompasses a suite of major changes, the highlights of which are as follows:
1) Create an up-to-date registry of all food facilities serving American consumers and requires all facilities operating within the U.S. or importing food to the U.S. to register with the FDA annually;
2) Generate resources to support FDA oversight of food safety, requiring payment of a registration fee per facility that would generate revenue for food safety activities at the FDA. The registration fee would be waived for small businesses and facilities that solely serve as warehouses;
3) Prevent food safety problems before they occur, requiring foreign and domestic food facilities to have safety plans in place to identify and mitigate hazards; safety plans would be subject to review by FDA inspectors and third-party certifiers.
4) Increase inspections by requiring FDA to establish a risk-based schedule for inspecting foreign and domestic food facilities and set a minimum inspection frequency of once every 4 years; refusing, impeding or delaying an inspection would be cause for suspension of registration and for barring entry into the U.S.;
5) Require food imports to demonstrate safety, requiring foreign food manufacturers to be certified as meeting all U.S. food safety requirements by third parties accredited by FDA; uncertified facilities would be prohibited from exporting to the U.S.;
6) Create a fast-track import process for food meeting security standards, directing FDA to develop voluntary security guidelines for imported foods; importers meeting the guidelines would receive expedited processing;
7) Require safety plans for fresh produce, directing FDA to issue regulations for ensuring the safe production and harvesting of fruits and vegetables;
8) Improve traceability by significantly expanding FDA traceback capabilities in the event of an outbreak of foodborne illness by filling the loopholes in the current requirements in the Bioterrorism Act of 2002; includes farms and restaurants in the traceback requirement (under current law, these two entities are exempted); uses electronic records and lot numbers;
9) Require country-of-origin labeling and disclosure for processed food labels to indicate the country in which final processing occurred; requires food manufacturers to identify the country of origin for all ingredients on their Web sites; requires country-of-origin labeling for all produce;
10) Expand laboratory testing capacity, requiring any testing done to meet certain safety requirements to be performed only by a laboratory accredited by the FDA; require laboratories to send any test results to FDA;
11) Provide FDA new authority to issue mandatory recalls of tainted foods; strengthen fines imposed on food facilities that fail to comply with safety requirements;
12) Advance food safety science by directing the Secretary of Health and Human Services to include food in an active surveillance system to assess more accurately the frequency and sources of human illness; the Secretary is also directed to identify industry and regulatory approaches to minimize hazards in the food supply;
13) Make “generally recognized as safe” (GRAS) determinations public, requiring publication of the request for a GRAS decision and FDA’s determination; and
14) Allow FDA to charge a fee to domestic firms requiring export certificates.
Many in the industry, especially among smaller manufacturers, have argued that the costs associated with compliance will add significant strain to companies in all sectors who are suffering the effects of a global economic contraction. At the same time, the entire industry is cognizant that it will be extraordinarily difficult to challenge calls for enhanced safety measures.
The Senate version, when it is taken up, may ultimately ease the burden of user fees, but with FDA already arguing for more user fees for generic drug and medical device regulation, it is likely that some form of user fees will be present in any final bill if one emerges now that an election year is in full swing. While there is a consensus that the bill will reach the floor sometime this summer, the precise time and mechanics are not yet certain. Complicating matters has been a push by Sen. Dianne Feinstein (D-CA) to add a ban on bisphenol A to the bill, which is anathema to some sectors of the food industry.
Regardless of how the process ultimately plays out, there already is evidence of significantly more vigorous enforcement of existing law by both FDA and USDA, and with or without legislation, there is every reason to believe that will continue in response to Congressional and public concerns about the safety of the food supply. While there are numerous fragments of statistical support for the proposition that the food supply is as safe as or perhaps safer than it has ever been, in this case, perception is far more important. We are almost certain to see either legislative, administrative or, more likely, both levels of change in the manner in which food is regulated in the near future.
Mark Mansour is a Partner at Bryan Cave LLP.
NEWS:
How safe is the food we get from restaurants, cafeterias and other foodservice providers? A recent study from North Carolina State University—the first study to place video cameras in commercial kitchens to see how precisely food handlers followed food safety guidelines—discovered that risky practices can happen more often than previously thought.
“Meals prepared outside the home have been implicated in up to 70% of food poisoning outbreaks, making them a vital focus area for food safety professionals,” says Dr. Ben Chapman, assistant professor and food safety specialist in the department of family and consumer sciences at NC State and lead author of the paper. “We set out to see how closely food handlers were complying with food safety guidance, so that we can determine how effective training efforts are.”
To get first-hand data on these food safety practices, researchers placed small video cameras in unobtrusive spots around eight foodservice kitchens that volunteered to participate in the study. There were as many as eight cameras in each kitchen that recorded directly to computer files and were later reviewed by Chapman and others. What they found demonstrates the need for new food safety-focused messages and methods targeting food handlers.
“We found a lot more risky practices in some areas than we expected,” Chapman says. For example, most previous studies relied on inspection results and self-reporting by food handlers to estimate instances of “cross-contamination” and found that cross-contamination was relatively infrequent. However, Chapman’s study found approximately one cross-contamination event per food handler per hour. In other words, the average kitchen worker committed eight cross-contamination errors, which have the potential to lead to illnesses, in the course of the typical 8-hour shift.
“Each of these errors would have been deemed a violation under U.S. Food and Drug Administration Food Code inspection guidelines. But more importantly, cross-contamination has the potential to lead to foodborne illnesses and has in recent outbreaks” Chapman says. “And it’s important to note that the foodservice providers we surveyed in this study reflected the best practices in the industry for training their staff.”
The study also confirmed the long-held supposition that more food safety mistakes are made when things are busier in the kitchen. “During peak hours, we found increases in cross-contamination and decreases in workers complying with hand-washing guidelines,” Chapman says.
However, the researchers do more than identify problems in the new paper; they outline solutions that can be applied to the foodservice industry. One suggestion is that food safety training for kitchen staff needs to address the “team-like” nature of a commercial kitchen, rather than focusing on food handlers as individuals. “This study shows us that each food handler is operating as part of a system,” Chapman says, “and the food safety culture of the overall organization—the kitchen and the management—needs to be addressed in order to effect change. For example, the general manager of a restaurant could take steps to highlight the value his or her business places on food safety.”
Other steps that can be taken to address food safety concerns include the introduction of new tools and procedures designed to minimize the risk of foodborne illness. New tools could be as simple as installing hand sanitizer units in accessible areas of the kitchen, which may be effective for reducing the likelihood of transfer of some pathogens. New procedures may include overhauling existing food preparation schedules so that cooks face less time pressure during peak hours—and are therefore less likely to make food safety mistakes.
The study, “Assessment of Food Safety Practices of Foodservice Food Handlers: Testing a Communication Intervention” was co-authored by Dr. Douglas Powell and Katie Filion of Kansas State University, as well as Tiffany Eversley and Tanya MacLaurin of the University of Guelph in Canada. The study was published in the June issue of the Journal of Food Protection.
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The Grocery Manufacturers Association (GMA) has issued the following statement by President and Chief Executive Officer Pamela G. Bailey in response to the report by the Institute of Medicine (IOM) and National Research Council report, Enhancing Food Safety: The Role of the Food and Drug Administration:
“We fully support the report’s recommendation that the U.S. Food & Drug Administration should implement a risk-based approach to food safety. By providing the FDA with the resources and authorities the agency needs to help make prevention the focus of our food safety strategies, combined with increased industry resources and vigilance, we can greatly enhance the safety of our food safety system.
“Industry and government both have unique and important roles when it comes to food safety. Currently the FDA Food Safety Modernization Act of 2009 is before the United States Senate. Like the IOM report—and the House of Representative’s bipartisan food safety bill passed last summer—the Senate bill calls for the greater use of risk based approaches and preventative strategies in the protection of our food supply and will provide the FDA with the resources and authorities the agency needs to strengthen and modernize our nation’s food safety system. We strongly urge the Senate to vote on this important, bipartisan bill as quickly as possible.
“Food safety and consumer confidence is the number one priority for the food and beverage industry—we take our responsibility very seriously. Working closely with our partners at the FDA and other federal and state regulatory agencies, we are committed to providing our consumers with the safest foods and beverages possible.”
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The Produce Marketing Association (PMA)’s Chief Science and Technology Officer Dr. Bob Whitaker has been appointed by U.S. Agriculture Secretary Tom Vilsack to the National Advisory Committee for Microbiological Criteria for Food, which provides advice to federal agencies on the microbiological safety of the U.S. food supply. His selection reflects the leadership he has brought to the industry’s food safety efforts since he was hired in 2008 as part of PMA’s commitment to ensuring members have access to the best scientific minds on food safety.
Industry leaders hailed news of Whitaker’s appointment as a landmark for the produce industry and for PMA’s members, and as recognition of Whitaker’s excellent reputation among the national food safety community. Since joining PMA’s staff 2 years ago, Dr. Whitaker has been actively working to bring real-world industry experience and insight to federal government, to positively impact their legislation and regulation of the industry. He has also been actively working to enhance industry’s food safety capability through a variety of industry outreach activities from PMA’s food safety symposia series, to industry presentations to his blog, “Ask Dr. Bob.”
Dr. Whitaker has also brought his leadership to the industry’s food safety research efforts as chair of the Center for Produce Safety (CPS)’s Technical Committee; in two years that group has prioritized industry research needs, and to date has already funded 24 research grants valued at just under $4 million.
“Dr. Whitaker’s appointment by Secretary Vilsack to the NACMF is a true testimony to his technical competency and his many contributions to government, to PMA and to the produce industry in general in the critical areas of food science and food safety,” said Bill Schuler, chair of PMA’s Board of Directors and President and Chief Executive Officer of the Castellini Group of Companies. “His talents are widely recognized, respected and in high demand, and he serves as a great resource for PMA’s membership.”
“This appointment is recognition of Bob’s vast food safety knowledge and industry experience, particularly to the microbiology of produce,” said Joe Pezzini, chair of PMA’s Produce Safety, Science and Technology Committee and Chief Operating Officer for Ocean Mist Farms. “His appointment comes at a critical time as regulation on produce is being developed. Bob represents PMA’s commitment to food safety for the betterment of the industry through his tremendous competency and leadership.”
“I am honored to be invited to join this prestigious group and its work to promote food safety and protect public health,” said Dr. Whitaker. “I look forward to representing PMA, our members and the produce industry as we work toward those goals.”
More details on the committee and the latest appointments can be found at http://www.fsis.usda.gov/News_&_Events/NR_052810_01/index.asp. Background on the committee can be found at http://www.fsis.usda.gov/About_FSIS/NACMCF/index.asp.
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