The Packer | Food Safety News

FDA Seeks to Mesh Public and Private Food Safety Accountability

The Packer — Mon, 20 Oct 2014 05:02:21 +0000

(This article by Tom Karst, national editor of The Packer, was first published Oct. 19, 2014, and is reposted here with his permission.) ANAHEIM, CA—The last word on food safety regulations for the produce industry won’t be written next year, even though the Food and Drug and Administration (FDA) has committed to publish final versions of the produce safety and preventive controls rule for food facilities next year. FDA officials speaking at an Oct. 17 Fresh Summit workshop on food safety regulations said the process of refining and educating growers and industry will continue for years and they urged industry leaders to continue their dialogue with the agency. FDA has been working with the produce industry in a collaborative way on food safety since the late 1990s, said Michael Taylor, deputy commissioner for foods and veterinary medicine for FDA. He credited both the Produce Marketing Association (PMA) and other industry groups in that process. Even though some of the final food safety regulations will be on the books next year, Taylor said it won’t be all over then. “We’ve got to see this as a long process,” he said. Taylor urged further dialogue and input from industry on the recently issued supplemental rules that are open for comment until mid-December. Taylor said the recently issued supplemental rules addressed microbial standards for agricultural water, clarification of operations subject to the produce safety rule, relaxation of raw manure rules and changes in qualified exemptions from the produce safety rule. The exemption issue is controversial, he said, with some groups favoring no exemptions and others favoring more exemptions. FDA has found room for some exemptions , but he said smaller producers not subject to the rule are still subject to existing adulteration standards in food law. “At the end of the day, all growers are accountable for food safety,” Taylor said. “The question is, how do we get there?” Looking ahead toward implementation of the food safety regulations, Taylor said that the agency is committed to education before regulation. “Most people want to make (food safe), what they need is clarity about what is expected,” he said. Taylor noted that many leaders attending the standing-room-only session have contributed to produce safety standards already in place. Other growers need help to achieve acceptable food safety standards, and Taylor said FDA is committed to help those growers as part of the agency’s compliance strategy. The process, aided by a recent cooperative agreement between FDA and state departments of agriculture, will be a long-term project that will extend a decade or longer, he said. At the same time FDA and states will collaborate on public oversight, Taylor said that most of the verification and accountability of new food safety rules will come from private sources such as third-party audits. Meshing that private oversight with public oversight will be an important test of making the produce safety rules effective, he said. Samir Assar, director of the produce safety staff at FDA, addressed changes in water testing language and raw manure regulations in the recently released supplemental rulemaking. PMA’s Bob Whitaker, chief science and technology officer, and Jim Gorny, vice president for food safety and technology, moderated the panel including FDA officials and industry panelists Walter Ram, vice president of food safety, The Giumarra Companies, Los Angeles, CA; Courtney Parker, vice president of salad quality and global food safety, Chiquita Fresh Express, Salinas, CA, and Mike Villaneva, technical director, California Leafy Green Marketing Agreement, Sacramento, CA. In the question-and-answer period, Parker asked FDA about the science behind the mandate to test agricultural water for generic E. coli. Assar said that generic E. coli is a good indicator for fecal contamination, but he said the agency was open to science that would suggest another standard that could be more appropriate. Villaneva said there is grower confusion about its new testing scheme for water, and Assar acknowledged that growers will need technical assistance and guidance to perform the water tests. Ram questioned how FDA will evaluate the significance of a positive Listeria test at a distribution center for produce, and Assar said the context of the find is important. “It could lead to the conclusion there is a public health issue,” he said. Parker asked if FDA would be investing in research projects on produce safety such as the proper science necessary for the application of raw manure. Taylor suggested that FDA will have little budget to support research projects, but he added that the agency could be engaged in helping to advise the direction of research projects funded by USDA or other agencies.

Food Safety Regulations Will Change Industry, Brackett Says

The Packer — Thu, 28 Aug 2014 05:02:52 +0000

(This article by Tom Karst, national editor of The Packer, was first published Aug. 26, 2014, and is reposted here with permission.) The U.S. Food and Drug and Administration’s new food safety regulations aren’t the only changes facing fresh produce marketers, but the coming rules likely will be the most far-reaching, Robert Brackett believes. In a talk called, “Food Safety Issues on the Horizon: Thinking Differently,” Brackett, a former FDA official and now vice president and director of the Institute for Food Safety and Health at the Illinois Institute of Technology, spoke to attendees of the U.S. Apple Association’s Apple Crop Outlook and Marketing Conference on Aug. 22 in Chicago.

Robert Brackett

Besides new food safety legislation and regulation in the U.S. and other countries, Brackett identified macro changes that include globalization of food trade and production, a rising world population, climate change, diminished land availability, urbanization, global economic shifts and instant communication. The fallout from these changes will bring increased imports of food, a need for standardized regulations between countries, more biotechnology, higher food prices and increased chances of fraud, he said. Brackett said economic growth in developing countries will fuel rising consumer expectations and stronger demand for fruits and vegetables, meat and processed foods. Changes in developed countries, including the U.S., include aging populations, increased reliance on medicine and the emergence of chronic conditions that could lead to health issues such as obesity, heart disease and diabetes, he said. This means a substantial part of the U.S. population is at risk from problems with the safety of the food supply. “At least 20 percent to 25 percent of the population is at risk and should watch what is in their foods,” he said. At-risk populations include the very young, the very old, those taking medicines and others who may be allergic to food. Brackett said that 17 percent of the U.S. population is 60 or older, and 4 percent of the population is 80 years old or older. Nearly two-thirds of the population is overweight, and 44 percent of Americans are taking one or more prescription medicines. New tools online New epidemiological tools will help identify pathogens, and scientists will be able to trace foodborne illness outbreaks easier, he said. “We will have tools to allow FDA and (the Centers for Disease Control and Prevention) to find out where outbreaks occur much more accurately and sooner than they have in the past,” he said. Brackett said researchers will have new molecular testing tools, which will allow better attribution of where problems exist. Next-generation genome sequencing will allow scientists to take a bacterium sample and complete the sequence of the whole genome quickly and cheaply. That type of test used to take as long as a year, but now Brackett says it costs about $100 and several tests can be completed in a day. The technology will allows scientists, for example, to isolate the place on a packing line where a food safety problem was introduced, he said. “It is a level of resolution we have never had before on foodborne pathogens,” he said. In the future, handheld equipment for genome sequencing of pathogens may be common, he added. Another reality of today’s world is consumer engagement in social media, Brackett said. Whereas the public response to Alar on apples was significant in 1989, a similar event in 2014 would be much more magnified because of social media, he said. “The response would be in hours, not days or months,” he said. Misinformation could also be multiplied by false reports on social media, he said. Brackett also noted the growth of private-label foods by retailers, Brackett said. Those situations will cause suppliers and retailers to look at mutually dependent partnership arrangements, he said. “If there is a foodborne illness issue, you both could go down,” he said. Private audit standards higher than government standards are also continuing to be imposed on suppliers, he said. The Global Food Safety Initiative aims for a harmonized set of standards across the globe, he said, though acceptance of that standard is not universal. Food safety systems are under review and change is happening not only in the U.S., but also in China, New Zealand and Canada. Food safety expectations With the Food Safety Modernization Act, Brackett said FDA is supposed to have a partnership with the industry. The new regulations will have a broad prevention mandate and accountability for food suppliers, he said. “You have to be accountable to FDA inspections that you have prevented something from happening,” he noted. Imports will have an oversight that is much stricter than in the past. “Something that was always stated — farm-to-table food safety — it truly is farm-to-table food safety responsibility because we will have FDA investigators on the farm,” Brackett said. Brackett said “preventive controls” regulations require firms such as fresh-cut apple processors to employ good manufacturing practices. “I call it HACCP (Hazard Analysis and Critical Control Point) on steroids because these preventive controls are much broader than you have had in the past,” he said. Eventually, the preventive control regulation may require supplier verification for domestic suppliers, just as FDA will require for import suppliers. The produce safety rule — applicable to apple growers — will address firms that grow , harvest, pack and hold produce. The regulations will include requirements about water quality, sanitation of equipment, standards for soil amendments and risks posed by specific processes and commodities, he said. Brackett said the produce safety rule will make it much more difficult for companies which may grow a variety of commodities. The one part of food safety regulations with the most teeth, Brackett said, is records access for investigators. Certain records must be available to government investigators upon request, he said. The rules under the Foreign Supplier Verification Program will have a big effect on the industry, he said. The regulation will put the responsibility on importers to confirm that fresh produce imports are grown with the same safety standards as in the U.S. “The importer of record must prove that to investigators,” he said. FDA will employ a computer program to help the agency decide which categories of imported food will receive the most scrutiny, he said. Implications for fresh produce suppliers are several, Brackett said. Companies must develop food safety plans and be able to prove to FDA that procedures are in place to reduce the risk of foodborne illness. The industry will be asked to get ahead of possible food safety issues, to figure out what could go wrong and prevent it from occurring. “Ultimately, hopefully there will be safer food and more confidence in the regulatory system and the food industry,” Brackett said. Brackett said private audit standards will become more important. After he spoke, one apple shipper asked if the number of third-party audits could be reduced through harmonization. “It’s moving that way, but I think it will be quite some time before we get a harmonized audit system,” Brackett said.

FDA ‘High-Risk’ Designation Would be a Recipe for Disaster

The Packer — Fri, 30 May 2014 05:02:16 +0000

(This May 23, 2014, opinion column by Tom Karst, national editor of The Packer, is republished here with permission.) Is there any way to overcome the distinction of being tabbed by the Food and Drug Administration (FDA) as a “high-risk” food? Perhaps one fanciful marketing tack to consumers would go something like this: “Sure, our much-loved commodity X is called ‘high risk’ by FDA. But, it should be pointed out, it is also ‘high reward’ as well. Big-time phytonutrients and vitamins are on board, along with the risk of Salmonella and E. coli bacteria.” I kid, of course. Having your star-performing fruit or veggie tabbed a “high risk” food is absolutely the worst designation possible for a commodity group or shipper. In that context, I was visiting with one industry leader this week, and he mentioned that the comment period closed May 22 on FDA’s request for industry input on the agency’s methodology for its designation of high-risk foods. In its request for comments, FDA pointed out that the Food Safety Modernization Act (FSMA) requires the designation of high-risk foods. “Specifically, … FSMA requires FDA to designate high-risk foods for which additional record-keeping requirements are appropriate and necessary to protect the public health,” according to the request for comments. The law also requires FDA to publish the list of such foods on the agency’s website at the time when FDA issues final rules to establish the additional record-keeping requirements for high-risk foods. So it is a double whammy. Yes, you are a high-risk food! And, yes, you have extra record-keeping requirements! Former FDA official David Acheson, president and chief executive officer of Frankfort, IL-based The Acheson Group LLC, said in February that the biggest challenge FDA may face is the question of whether a high-risk food can ever be classified as a low-risk food. “Can you get fresh produce, or certain aspects of fresh produce, from a high-risk (list) to a lower risk?” he asked. “That’s part of the challenge.” No one in the food industry, including fresh produce, wants their commodity to be on the list of high-risk foods. FDA plans to publish the list either before or at the same time it issues a proposed rule establishing record-keeping requirements for designated high-risk foods. FDA’s draft approach to identifying high-risk foods uses several criteria to determine a total risk score, according to the notice. However, no commodities were identified as high-risk in FDA’s initial document. Some of the factors that FDA will weigh as it determines which foods are high-risk include outbreak frequency, illness occurrence, severity of illness, the likelihood of microbial or chemical contamination, potential for the food to support pathogen growth, food consumption patterns and the probability of contamination and steps taken during manufacturing to reduce contamination. FDA also will look at health and economic factors, cost of illness and disabilities expected, according to the notice. One of Acheson’s colleagues, Jennifer McEntire, vice president and chief science officer, told me this week that FDA is under no hard deadline to produce this rule, unlike the 2015 deadline for the produce safety rule and other major FSMA regulations. Even so, she said that FDA’s designation of “high-risk” foods is drawing a lot of food industry attention. McEntire thinks that, with the way FDA has proposed its matrix of scoring risk, nearly all commodities could be labeled “high risk.” “How will they draw the line between high-risk and what is not?” she asked. The question of risk methodology on which FDA is currently seeking advice is just a prelude to the main show. Once FDA actually identifies the specific food items that are high-risk, watch out. Fortunes will be spent, I would think, in either keeping commodities off the “high-risk” list or trying to extract them if they are shamed and named. FDA can only solve this by making every food high-risk — or dumping the idea entirely. Since the latter isn’t likely, prepare for the former. High-risk, yes, but consider the rewards!

Cantaloupe at the Crossroads

The Packer — Tue, 04 Sep 2012 08:59:02 +0000

The unwritten rule in the produce industry is that a company should not market its product as safer than a competitor’s. The thinking is that once consumers get it in their heads that a fruit or vegetable is more safe, that means another is less safe, and then maybe they’ll avoid the commodity or category altogether. But what if your company or growing region has a strong food safety record, drafted best practices documents, followed and documented them, and then suffers for the second year in a row as a different region’s product kills consumers? The California cantaloupe industry is understandably upset it’s being found guilty by association to an Indiana salmonella outbreak that has been linked to more than 100 illnesses and two deaths. This isn’t even the first melon recall of the summer, as Burch Farms of Faison, N.C. recalled all its cantaloupe and honeydew in early August because of listeria contamination. No one became ill during that recall. There are some positive signs, as a number of produce associations and independent researchers are working on national commodity-specific guidelines for cantaloupes, which should be published before the end of the year. One can’t help but ask the question: Why did it take a second deadly outbreak to develop national guidelines? The industry, along with the Center for Produce Safety, organized a meeting in January to address the problems and future of cantaloupes after the Colorado outbreak. Cantaloupe grower-shippers need to do something more substantial this time before consumers simply stop buying. Editor’s Note: This opinion piece originally appeared in The Packer on August 24, 2012.