Safely Feeding America
Source : http://www.foodsafetymagazine.com/magazine-archive1/junejuly2016/safely-feeding-america/
By Mitzi D. Baum, M.Sc.
One day in 1969, retired businessman John van Hengel met a desperate mother rummaging through grocery store garbage bins to find food for her children. Van Hengel met the woman while he was volunteering at his local soup kitchen. She told van Hengel there should be a place where, instead of being thrown out, discarded food could be stored for people to pick up—similar to the way banks store money for future use. That mother’s wisdom gave birth to a new industry that feeds the hungry.
After that encounter, van Hengel established St. Mary’s Food Bank in Phoenix, AZ, as the first food bank in the United States. In its initial year, St. Mary’s distributed 275,000 pounds of food to people in need. Word of the food bank’s success quickly spread, and by 1977, food banks had been established in 18 cities across the country. As the number of food banks continued to increase, van Hengel saw the need for a network organization to help them grow and coordinate. In 1979, he and other partners founded a national organization for food banks called Second Harvest. The network changed its name in 2008 to Feeding America.
Today, Feeding America is the nation’s largest domestic hunger-relief organization—a powerful and efficient network of 200 food banks across the country. As food insecurity rates hold steady at the highest levels ever, the Feeding America network of food banks has risen to meet the need. The network feeds 46 million people at risk of hunger, including 12 million children and 7 million seniors annually.
Feeding America and its partners not only lead in hunger-relief efforts, but they also lead the hunger-relief community in providing safe food. The rapidly changing product mix from shelf-stable to perishable foods flowing into food banks compels the network to develop increasingly sophisticated food safety practices so that such products reach the consumer safely. Accordingly, Feeding America is working hard to help its member food banks continuously improve their food safety acumen (see “Food Safety in the Feeding America Network,” p. 64). This important work reflects our commitment to establish, maintain and sustain robust standards that carefully steward our donors’ resources to provide safe food to the people we serve.
Taking a Giant Step Forward
Feeding America is fortunate to have an enduring relationship with Cargill. Over the years, Cargill has been generous in its support for both Feeding America’s national office and our member food banks across the country. In 2012, our partnership with Cargill took a significant step forward when Feeding America started thinking more critically about the future of food safety. With the Food Safety Modernization Act (FSMA) moving forward, Feeding America saw the need for the network to be well prepared for the final FSMA rules. We asked Cargill to help this effort through funding for staffing, educational summits and third-party food safety audits. Cargill understood the importance and urgency of our proposed food safety strategy and got the program off the ground with a 2-year grant.
Third-party food safety audits were new to the network and participation was voluntary. Although progress was slow at first, early adopters of the auditing program soon recognized and communicated the benefits of participation. These benefits include: 1) better depth of understanding of their food banking operations; 2) increased efficiencies in their operations through written Standard Operating Procedures; 3) improved staff training; 4) improved management of pest control operator relationships; and 5) higher operational standards and results. After the first year of training audits, a handful of early adopters started scored audits, which they passed with high scores. Notwithstanding this incremental success, it was clear we needed to do more to encourage the rest of the food banks to engage in the program. As the initial grant period ended, Feeding America approached Cargill with another idea. We wanted to focus on providing resources to achieve a holistic shift in food bank food safety culture. Our vision went beyond auditing and deeper than the food bank level. We wanted to provide educational opportunities and resources to our 60,000 agency partners (soup kitchens, shelters and pantries)—the end of the supply chain. Cargill endorsed the concept with a generous 3-year grant to support the enhanced food safety initiatives we envisioned. Once Cargill said yes, we quickly got busy.
Building the Foundation
We developed a multifaceted approach to reinforce the food safety programs that already existed in the network. Our challenge was to provide the same opportunities and information to each food bank while avoiding a cookie-cutter approach that ignored each food bank’s unique situation, knowledge base and resources. We overcame this challenge with five specific action items.
1. Provide dollars to support improvements. Initially, we created a considerable amount of conversation to get food banks to participate in the third-party auditing program—seizing every opportunity to discuss it. There was a lot of trepidation within the network about our chosen vendor’s distribution center standard and how it would impact operations. Many of the food banks wondered if the application of a food manufacturing standard even made sense. Thus, we faced a great deal of pushback, and understandably so. Who wants another audit? In an effort to respond to this anxiety, we sought to incentivize participation by providing grants. We developed a request for proposals so the network could access grant dollars specifically for food safety improvements. The key eligibility requirement was that the food bank applicant had to be actively participating in the program by having completed a training audit within the last 12 months. The grant dollars would be utilized to correct any issues identified in the food bank’s third-party audit report. The grants quickly became very competitive and created a buzz about the food safety program within the network. Activity in the program soared. It became so well socialized that within 1½ years, we achieved over a 90 percent voluntary participation rate in the network.
2. Free education and training for the network. We decided that we needed to create a forum or summit to deliver specific information regarding our vendors’ distribution center standard. We developed our Food Safety Summit (FSS) to bring network staff together to learn the critical elements of the new standard. The FSS was initially for those food banks that self-identified as needing additional education and training in food safety, but it became a training opportunity for all network food banks. The FSS takes place at a food bank that passed a scored audit and is a 2-day, intensive drill-down of the new distribution center standards by a qualified instructor from the audit vendor. The FSS also includes a complete warehouse walk-around to illustrate examples of how the new standards should be implemented. These summits were a success and greatly advanced our education and training plan. As we had hoped, the FSS provided a safe environment for people to learn and ask questions among peers, thereby creating an atmosphere that encourages team building, networking and sharing of best practices. Funds from the Cargill grant allowed Feeding America to provide training for more than 250 individuals from all 200 food banks. Now the fundamental issue—lack of understanding of the expectations of the new distribution center standard—no longer existed.
3. More free education and training. With the success we achieved with the FSSs, we wanted to continue building on the education-and-training component. We needed data from the network to determine where we should focus our limited resources and what type of training was necessary. After consulting with Walmart’s vice president of food safety, Frank Yiannas, we decided to undertake a food safety risk assessment. We enlisted our consultants, Deloitte & Touche, to help with this evaluation. The team decided to conduct the assessment during food banking’s busiest month of the year, December, when the food banks would be already stressed and any weaknesses in the system would become immediately apparent. We completed the risk assessment, and results identified high-risk areas of Hazard Analysis and Critical Control Points (HACCP) and food defense. Once we exposed these high-risk areas, we then started working on reducing them.
The first thing Feeding America did was to offer free certification classes for HACCP, Seafood HACCP and Food Defense to food bank network staff. The training strengthened the network’s already growing food safety knowledge, allowed the individual food banks to have staff with the depth of knowledge necessary to manage all types of foods and helped fill the gaps identified. We also provided food safety webinars that focus on these and other relevant network topics and provide additional opportunities to discuss common food safety challenges that exist at food distribution centers. These outreach efforts provided the network with a greater understanding of the many aspects that are key for moving food safely through their facilities.
4. Education for the end of the supply chain. As we expanded the network’s food safety knowledge, we knew we had to provide substantive education for the 60,000 agency partners. To do so, we needed to develop a comprehensive food safety curriculum. Accordingly, in October 2012, Feeding America began a partnership with the National Restaurant Association to create a customized curriculum for the hunger-relief community. Two years later, in August of 2014, we introduced the ServSafe® Food Handler Guide for Food Banking to the network (see “ServSafe® Food Handler Guide for Food Banking”). The book is 46 pages, filled with images that are relatable to the intended audience (food bank staff, partner agency staff and volunteers), offers opportunities to “apply your knowledge” in each chapter and includes a final quiz and a certificate of completion. The network’s desire for the book was so great that we distributed more than 10,000 copies within 10 months. The book is currently in its second printing.
5. Focus on TCS foods. The network’s capacity to access retail stores across the country increased exponentially in a few short years and quickly became one of the largest food streams. As a result, we needed to develop food safety guidelines for temperature controlled for safety (TCS) foods and other perishables. To meet this challenge, Feeding America released the Retail Food Safety Guidelines in March 2014 for the network to provide appropriate guidance for handling TCS foods and produce. This comprehensive guide, in conjunction with the ServSafe® Food Handler Guide for Food Banking, provides basic food safety concepts and instruction about safe handling practices and how to implement and execute them.
As Feeding America continues to reinforce the foundation of food safety across its food bank network, the search for new food streams remains ongoing (see “Getting Involved”). The food bank network has been focused on food waste reduction for over 35 years—keeping safe, nutritious foods out of the landfill and getting it onto the table. Recently, “food waste reduction” has become a buzz phrase—a part of the food industry vernacular. Like Feeding America, food manufacturers, the U.S. Environmental Protection Agency and the U.S. Department of Agriculture (USDA) are working toward reducing food waste. With all of these stakeholders focused on the same issue, communication and cooperation are imperative. The following success stories highlight the positive impact collective action has on food recovery and food waste reduction.
In 2012, Feeding America began working with the USDA-Food Safety Inspection Service (FSIS) to discuss food donation opportunities that were available but unattainable under USDA regulations. Our initial discussions focused on how food banks could accept bulk protein donations and distribute such product to hungry people. Opportunities for bulk protein donations were available, but most agency partners cannot store or distribute large, frozen bulk proteins. Additionally, most do not have the appropriate facilities to break down the product into smaller, consumer-size packages. Food banks have the facilities to accomplish this task; however, most do not have a USDA inspector on-site. After continued conversations and information sharing, FSIS determined that food banks could repack bulk proteins by utilizing a retailer exemption. The exemption was predicated on the food banks only distributing repackaged product directly to the end consumer through one of three channels: through a food bank-owned/operated pantry; an on-site meal provider/soup kitchen; and/or a mobile pantry food distribution. The retailer exemption has allowed the food bank network to exponentially increase protein donations, reducing food waste and landfill.
Building on the initial progress achieved with FSIS, we continued the dialogue with a focus on food items that are considered economically altered/misbranded (e.g., meat patties that were labeled as 3.4 ounces but were actually 3.2 ounces). This type of product was available for donation because it did not meet the donor’s commercial specifications. The process to facilitate this type of donation can be lengthy, and donors do not want product sitting in their facilities for up to 90 days while they wait for USDA approval to change the product label. Feeding America provided requested information to FSIS and, in turn, it developed Directive 7020.1, which was enacted on January 26, 2016.
This directive addresses economically altered/misbranded meats by stipulating that: 1) this type of product can be donated “as is” without applying for temporary label approval and without a “Not for Sale” statement on each package; 2) a temporary label approval and “Not for Sale” package statements are needed if product ingredients include allergens (any of the Big 8); and 3) meat processed in the U.S. and packed in foreign-language packaging for export can be donated. This directive has allowed the food bank network to access thousands of pounds of protein that were destined for landfill due to labeling issues.
Opportunities to redirect food from landfills to reduce food waste are abundantly available. Consider recalled foods. Feeding America looked at the rise in food recalls over the past 3 years and the circumstances for the recalls. The data showed that recalls were often due to labeling issues. With this information, an opportunity to divert recalled product from landfill that a manufacturer still had in its possession could be achievable. These recalled products are wholesome but do not meet labeling requirements for distribution; they did not have any potential biological contamination issues. These recalled products could feed food-insecure people.
To better understand the potential for this type of food recovery, Feeding America conducted a research study, “Acquisition of Recalled Foods Due to Labeling Issues to Alleviate Food Insecurity in the United States.” Our research found that a diverse group of respondents (n = 72) from academia, regulatory, food manufacturing, food retail outlets, food industry advocacy groups and industry consultants all agreed that food products recalled due to labeling/misbranding issues could be relabeled to reflect the actual contents of the product and be distributed. The study validated the concept.
Feeding America has had multiple opportunities to pilot this concept with both dry and temperature-sensitive product. In each case, Feeding America created a protocol—approved by the donor and regulators—to meet the needs for distribution, specific directions were communicated to recipient food banks and the protocol executed. In total, Feeding America food banks have diverted over 100 truckloads of wholesome, nutritious recalled product from landfill. The network has the capability to manage this type of product, and it is becoming a solution for donors.
On March 22, 2016, Starbucks announced its new FoodShare program with Feeding America as its partner. All of Starbucks’ 7,600 corporately owned and operated locations will donate their leftover, unsold ready-to-eat meals to Feeding America’s member food banks. The FoodShare program is the result of Starbucks’ vision to reduce food waste, have a philanthropic impact nationally and locally, and combat food insecurity. Working closely together, Starbucks and Feeding America identified a specific protocol to safely pick up, deliver and distribute the products without breaking the cold chain. A pilot program commenced in the fall of 2015. We identified the Critical Control Points and analyzed the process to determine any potential gaps that could threaten the safety of the donations. Discerning potential risk for both parties in the development, implementation and execution of the process was imperative. The process relied on open communication between the two organizations. If either party had any level of discomfort with the protocol, it was discussed and appropriate solutions were developed and implemented. By testing and tweaking the protocol with a laser focus on food safety, each organization’s commitment to food safety was evident, and this, ultimately, contributed to the partnership announcement. FoodShare is expected to be to scale within 5 years.
Moving Forward in Step with Our Donors and Partners
When I began working at Feeding America in 1996, the collaborative efforts described above seemed impossible—scenarios that we dared to dream. Feeding America was a grass-roots network of food banks doing their best to feed those in need. The food banks did not handle fresh produce in those days because they simply did not have the capacity. Food banking was, essentially, distribution of dented cans. The Feeding America national office was small, with only 39 employees, but we were mighty.
Since then, the Feeding America network has accomplished an extensive amount of work in a short time. Now we focus on continuous improvement and seek to build on our foundation. The advancements in food safety training, education and established programs are made possible by the success achieved in our partnerships and the generosity of our donors and partners. We will continue to work with our colleagues in the food industry to learn and grow, and utilize industry best practices to inform our operations and ultimately feed hungry families. As a network, we are committed to ensuring the safety of the food and grocery products distributed by our 200 member food banks and 60,000 agency partners. We will continue safely Feeding America.
Mitzi D. Baum, M.Sc., is the managing director of food safety for Feeding America.
Letter From The Editor: Food safety should generate jobs now
Source : http://www.foodsafetynews.com/2016/06/letter-from-the-editor-food-safety-should-generate-jobs-now/#.V2dBoE5pCUl
By Dan Flynn (June 19, 2016)
Until recently, I did not really know or care what the so-called Millennial Generation did or did not do. I figured they’d figure it all out on their own — eventually.
After all, we are talking about a generation that was born before the year 2000, and now they are inching up in age. Every year puts some experience in the bag for them.
Lately, however, I’ve been worried about them. I once worked for a Canadian editor who warned me about not mixing up “years of experience” with the same year of experience that is just being repeated.
Living a sort of Ground Hog Day existence sounded like fun in the movies, but it if you’ve been living what we use to call a “holding pattern,” it cannot be fun and in the long run it must be depressing no matter how tricked out that parental basement is that you’ve been living in.
Certainly, not all millennials are idle. I have nieces and nephews that are among them, who’ve managed to get good careers going. But they all know friends who haven’t. And listening in on their conversations recently set me thinking and doing some comparing and contrasting.
What were the realities, then and now? Those of us who graduated from colleges in the 1970s were confronted with two inescapable facts.
The first, which seemed most important at the time, was our unwilling entry in the nation’s lottery for an all expense paid trip to Southeast Asia. Many went to Vietnam and did not come back. Many of those who did return went on to be among our generation’s best leaders.
The second was the insidious impact of inflation. From 1972 to 1980, the consumer price index doubled. In three of those eight years, annual inflation topped 12 percent. It taught us to spend those first checks we earned out of college right away because the money was going to be worth less the longer we waited. It meant it was hard to get traction. It turned us into a generation of spenders, not savers.
With the all volunteer military, millennials at this point do not have to worry how they might look in jungle green or “desert camo,” but even with that little difference between our time and theirs, I would not want to be going through what too many of them are experiencing. College debt and no decent job prospects in an economy that seems barely alive. We have not seen so much as 3 percent GNP growth since I don’t know when.
Only Howard Shultz makes out from this. Well-educated baristas are wonderful for him, but their talents are being wasted by this economy.
Even with the Vietnam lottery detail, I would take what we had over repeating the same year of idleness or under-employment that so many of the millennials have had to deal with. We did a lot in those years when inflation was eating us alive. We always had the sense were moving forward.
At this point, you are thinking “what does this have to do with food safety?” Actually it’s simple.
What I am going to simply call the “food sector” of the economy takes 12 percent of household spending, accounts for 10 percent of U.S. employment, and 12 percent of U.S. manufacturing jobs. The “food sector” is now under the Food Safety Modernization Act (FSMA), the most sweeping reforms ever for the industry. We know compliance comes with a cost. Somewhere along the way the Congressional Budget Office came up with $500 million as the cost of preventing future foodborne poisoning, but it will probably cost more.
The “food sector” at the moment is filling up every webinar, continuing education class, community college and university summer program dealing with FSMA compliance. Nothing against teaching old dogs new tricks, but why not also use this moment to hire some new folks too.
Turing the economic burden of FSMA into opportunities would be a win-win because of what I think the millennials can bring to the table. The old dogs are eventually going to retire. Why not bring people in now so they can be “present at creation?”
One thing for certain, if new people are hired for food safety, they won’t be the ones resisting change.
Food fraud: EU warns Italy to stop treating squid with hydrogen peroxide
Source : http://barfblog.com/2016/06/food-fraud-eu-warns-italy-to-stop-treating-squid-with-hydrogen-peroxide/
By Doug Powell (June 19, 2016)
Michael Ramsingh of Seafoodnews.com reports European trade officials have warned Italy to stop soaking its squid in hydrogen peroxide (H2O2) and shipping it to markets around the EU.
Italian officials were notified by the EU Commission’s Ministry of Health that soaking squid in H2O2 currently violates specific food safety regulations. The practice is legal in the Italian market but is not approved in other member countries.
“The use of this substance as a food additive, therefore, is not authorized in the EU,” the Commission said in a statement. “The Member States have the responsibility to enforce effectively the Union legislation concerning the food chain, which also includes rules applicable to the use of food additives.”
H2O2 is used to treat squid to increase its marketability since it whitens the product on display. The treatment does not pose a health risk for consumers. However, the practice is considered dubious since it is nearly impossible to tell a treated squid product with a non-treated item, which makes it difficult to verify the actual freshness of the item.
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Follow the money: Reducing risk vs. increasing costs
Source : http://www.foodsafetynews.com/2016/06/follow-the-money-reducing-risk-vs-increasing-costs/#.V2c6Gk5pCUl
By Jim Mann (June 16, 2016)
Healthcare providers, caregivers, researchers and suppliers gathered at the 43rd annual meeting of the Association for Professionals in Infection Control & Epidemiology (APIC) in Charlotte, NC, June 11-13. The theme was “Inspiring Innovation in Infection Prevention” and attendees discussed how evidenced-based research can resolve the recurring riddle of risk versus budgets for both foodservice and skilled nursing facilities.
Motivating innovations in foodborne outbreak prevention was an unstated goal but an important byproduct of the meeting. All hospitals and nursing homes prepare and serve food for the most vulnerable populations. The CDC attributes Healthcare Associated Infections (HAIs) as the cause of death for 99,000 hospital patients annually and 380,000 in nursing homes. The year-to-date reference point is carried to the state level at this website: http://handwashingforlifehealthcare.org/healthcare-deaths
Personnel from the Handwashing For Life Institute were unsuccessful in attempts at APIC to locate peer reviewed estimates on the percentage of these deaths due to the food preparation, delivery and feeding of the patients and residents.
Busting myths about gloves, hot water and hand sanitizers
Deep dives into measuring new factors in infection transmission exposed flaws in food handling and overall patient protection systems. Sessions challenged such basics as “To Glove or Not To Glove” and busted many a myth. Deborah Burdsall presented findings she has discovered in her doctoral work on this topic at the University of Iowa.
Research illustrates that we in the USA are overusing gloves but under-changing them when a clean, gloved-hand is most essential in protecting the at-risk population. Glove use and misuse is deeply psychological and thus very difficult to align behaviors with the science and the guidelines of the FDA or CDC.
Caregivers at the annual meeting attended sessions starting as early as 5:30 a.m. where they were challenged to think about the advantages of washing hands with cool water after years of guidance under the Model Food Code to use hot water. Evidenced-based research shattered the myth that alcohol hand sanitizers can the hands, causing Irritant Contact Dermatitis (ICD). Poorly formulated soaps, particularly those which are not easily rinsed, are the culprits. Formulation matters.
Sometimes more money means fewer infections, which means money saved
High-tech challenges were also on the menu. Much of the meeting content recognized that the majority of unresolved issues in patient safety required behavior changes and changes of culture, from the boardroom to the caregiver. Most all require significant investment but offer greater savings in lower infection rates.
Two specific technologies were well represented and integrated from the show floor through to educational sessions and in an array of poster presentations. Electronic Hand Hygiene Monitoring (EHHM) and ultraviolet (UV-C) surface disinfection are both problem-solving advancements but both require a strong business case to initiate. HAI costs are well documented and their reduction often has a payback within the first year. But getting started is still a hard sell in some corporate settings.
The growth of ultraviolet in killing resistant pathogens was summarized by Gunner Lyslo, founder and CEO at Surfacide LLC. He said UV-C is a good example of applied innovation. It is an evidence-based technology that not only is effective in reducing pathogens in patient rooms but more importantly is improving patient outcomes. Documented performance directly connected to lowering HAIs is driving the current surge of usage.
The Affordable Care Act incentivizes higher performance with its scale of reimbursements from the punitive to the positive rewards for outstanding outcomes. This innovation is quickly becoming the standard, Lyslo said. According to APIC 2016 keynote speaker Dr. William Rutula from University of North Carolina Health System, “If you don’t have these systems, you should have them in your capital budget.”
Overwhelming innovation, underwhelming implementation
Innovation can drive behavior change but effective and enduring solutions start with leadership in realistic risk assessment and the early engagement and empowerment of the program creators, implementers and maintainers.
Yes, APIC sees the R in ROI as “return” but also as lives saved. The I is for “investment,” but they are looking to “innovation” to accelerate patient safety initiatives. ROII, or I squared, Return On Investments in Innovation, is a call for all to learn business speak when trying to improve care. Business drives the care.
Let’s all learn the language. Neither infection prevention nor quality assurance arguments are effective funding factors by themselves. They both require evidence converted to revenue.
All foodservice and care providers in general are risky businesses, getting riskier as the government amps up its array of penalties as a more efficient way to “motivate” compliance rather than adding more facility auditors. Scientific advancements, such as Whole Genome Sequencing, contribute to the rising risk as tracking the infection back to its source of infection is getting faster and more accurate.
Progress in risk modeling, including quantitative risk assessment, is making it easier to build better business cases to invest in enhanced patient care and foodservice innovations. University of Arizona’s Kelly Reynolds presented one such powerful advancement: “Once we find the pathogens, it is important to quantify the risk and identify the effective interventions. Our team is continuously enhancing these decision support models.”
Make your business case:
1.Measure your risk and opportunity.
2.Set your standards.
4.Train to the standards.
5.Motivate with evidence-based outcomes.
USDA continues citation focus against inhumane treatment
Source : http://www.foodsafetynews.com/2016/06/usda-meat-inspectors-continue-inhumane-treatment-enforcement-focus/#.V2c6X05pCUl
By Dan Flynn (June 16, 2016)
Twenty of 27 administrative actions USDA’s Food Safety and Inspection Service took against America’s largest meat and poultry plants during the government’s second quarter were for the inhumane treatment of animals during slaughter.
Three of the other administrative actions against the large plants were for violating sanitation performance standards, two were for Hazard Analysis and Critical Control Point (HACCP) variations, and two were for other reasons.
Those other reasons were both for violating control action by repeatedly removing U.S. retained tags. The violators were JBS Swift and Co. in Louisville, KY, and Foster Poultry Farms in Fresno, CA.
Information on the large plant administrative violations is contained in Food Safety and Inspection (FSIS) Enforcement Report for the second quarter of the government’s fiscal year, Jan. 1 to March 31. Large plant inhumane handling violations were also prominent in the first quarter report.
The uptick in inhumane treatment violations by large plants first turned up in the report for the first quarter when 13 of 18 large plants were written up for the violation.
USDA’s inspection service is on the job at about 800 livestock slaughter operations that produce upwards of 150 million head of livestock annually. In addition, there are about 3,000 FSIS-regulated poultry establishments that slaughter about 9 billion birds a year.
Beyond those 1,100 slaughter establishments, FSIS also regulated meat and poultry packing and processing at another 5,100 facilities.
Inhumane handling led to the Swift Pork Co. in Worthington, MN, being suspended briefly twice and Tyson Fresh Meats Inc. in Logansport, IN, three times. These include both actions that either occurred or were pending during the quarter.
The pattern for FSIS regulated small plants stands in contrast with the large plants when it came to second quarter administration actions. The more numerous small plants were cited for inhuman treatment 16 times during the period, just 16.5 percent of the total violations compared to 75 percent for the large plants.
FSIS sent Letters of Warning over inhumane treatment to:
•Beltex Corp. in Fort Worth;
•Dakota Pack in Estherville, IA;
•H&B Packing Company in Waco, TX;
•J.F. O’Neill Packing Co. Inc. in Omaha;
•JH Routh Packing Co. in Sandusky, OH;
•West Michigan Beef in Hudsonville, MI.; and
•Yosemite Meat and Locker Service in Modesto, CA.
Several warning letters also went to companies where suspensions were imposed.
During the period, FSIS took 75 administrative actions against small plants for either HACCP or sanitation violations, representing more than 77 percent of the total. Frequently those actions are addressed on the small day when an FSIS inspector brings up the problem with plant management.
Meat and poultry producers and processors may operate only when USDA inspectors are available to provide continuous inspection and oversight inside their facilities.
During the quarter, FSIS caught three firms operating when USDA inspectors were not present. they were Pedro’s Tamales in Lubbock, TX, ENA Meat Packing Inc. in Patterson, NJ, and the Golden Gate Meat Co. in San Francisco.
FSIS’s very small plants (it does not have a medium category) make up its largest group and 106 were subject to administrative actions during the second quarter. FSIS wrote them up for a total of 190 administrative actions.
HACCP and sanitation issues accounted for almost 70 percent of the actions, while inhumane treatment during slaughter came in second at 25 percent.
Production at U.S. meat and poultry plants was down slightly during the quarter. The number of livestock carcasses inspected by USDA during the period was 36.31 million, down from 38.13 million during the first period. Poultry production came in at 2.237 billion birds, down a tad from 2.246 billion.
USDA inspectors condemned 51,504 livestock carcasses, down from 52,080 in the first quarter. However, higher numbers of poultry were condemned in the second quarter — 10.88 million versus 8.94 million in the first quarter. The report did not say if the higher condemnation rate is due to more poultry plants switching over to the new pathogen-based poultry inspection rule.
In addition, FSIS’s Office of Investigation, Enforcement, and Audit (OIEA) detained 1.129 million pounds of meat, poultry and eggs during the quarter, up from 590,420 pounds in the previous quarter.
The Office of Field Operations (OFO) at FSIS in three actions in the Raleigh district also detained 263,704 pounds of regulated product. There were no OFO detentions made during the first quarter.
Five businesses — Fry’s Food in Fountain Hills, AZ; Gold Gate Meat Company in San Francisco; Krasdale Foods in the Bronx, NY; the Market on Broadway in Pittsburgh; and Safeway in Wheat Ridge, CO — were targets of Prohibited Activity Notices by OFO.
In addition, OFO issued 295 Notices of Warning during the period, up from 185 during the first quarter.
USDA follows a progressive discipline system of regulation, Withdrawal or Denial for Unfitness is among its most severe measures because without USDA inspection, meat and poultry cannot be sold as human food.
On March 1, USDA filed to remove inspection service from John H. Lake, owner of Lake’s Farm Raised Catfish Inc. in Dundee, MS, because of his two felony convictions for DUI. Lake subsequently agreed to a USDA order to ensure compliance with FSIS statutory and regulatory requirements by imposing certain ethics and others measures on the company.
Eric and Kurt Amstutz, co-owners of Tanks Meat Inc. of South Elmore, OH, also agreed to a USDA order after their convictions for offering for sale meat that was not inspected. They will be subject to the provisions of a standards of conduct policy and program.
No new criminal actions were taken during the quarter.
Customs officers to ensure safety of imported food
Source : http://www.business-standard.com/article/economy-policy/customs-officers-to-ensure-safety-of-imported-food-116061500377_1.html
By Nitin Sethi New Delhi (June 16, 2016)
Instead of appointing full-time technically qualified and trained food safety officials, the Food Safety and Standards Authority of India (FSSAI) has made customs officials responsible for ensuring the safety of imported food across 125 points of import and clearance as an additional task. The move, which contradicts FSSAI’s own regulations, has been made as part of government’s push for ease of doing business.
In March 2016, these custom officials were designated as what the FSSAI Act calls "authorised officers". Besides undertaking all other custom duty related tasks, they are now additionally in-charge of supervising, taking samples, sending these to labs, reviewing the lab results and approving the safety of all imported food products coming into India against the set standards for more than several thousand products and ingredients that FSSAI approves.
Their appointment comes in contrast to the regulations FSSAI passed this January. Under these norms the FSSAI mandated that the technical qualifications and training of those posted at customs to check safety of imported should match that of ‘food safety officers’ as prescribed by law.
Under the regulations, at the time of joining, Food Safety officers - a category of specialised officers enshrined in the law - are supposed to “have a degree in food technology or dairy technology or biotechnology or oil technology or agricultural science or veterinary sciences or bio-chemistry or microbiology or a Masters in chemistry or degree in medicine from a recognised university”. The officer can also have an equivalent/recognised qualification notified by the Centre, and he or she has to complete the mandated training before joining the post.
But the custom officials were not individually identified and checked against these qualifications before the additional charge of food safety was handed over to them. The examiners, superintendents, inspectors and appraisers at these 125 locations were appointed in their ex-officio positions instead. They were also not trained to handle import of food products under the law at the time of handing them this additional charge.
FSSAI responding to detailed queries sent to its Chief Executive Officer by Business Standard said, “The technical qualifications apply only where FSSAI appoints its own (full time) authorised officers at these locations. Obviously not for the custom officials.” It justified the move in entirety as essential for ensuring safety of imported food in India.
“Their appointment was decided in consultation with the department of customs. The basic idea and premise was to give the ease of doing business and facilitate the importer,” FSSAI added. Business Standard reviewed documents that show the discussion on these and other processes to ensure ease of business for food importers was held with the finance ministry through 2015.
The decision to appoint customs authorities as part time handling food safety instead of specialised full-time officers comes after years of having allowed custom officials to clear food imports in violation of the law, as the government had not appointed specialist safety officers on most of these locations.
Though the law came into place in 2011, by mid-2015 the FSSAI had appointed only five officers to manage 16 importing locations, its record show. In May 2015, the FSSAI admitted on record that custom officers were permitting import of food on their own, even where FSSAI had its specialists posted and at times even those consignments that had been barred by FSSAI.
But, when Business Standard asked FSSAI how much food products had been imported in the previous three years from locations that did not have trained and qualified food safety officials, the agency said that data was not available with them.
Documents show that in 2015 the finance ministry pursued the case for a single window clearance mechanism for food imports and simplifying the process. The FSSAI responded, “It appears that FSSAI may take some time to expand its presence at the major ports of import. Keeping in view that the imports cannot be blocked at all other locations all of a sudden, it is proposed that the names and designations of the officers of the Customs department may be made available to the FSSAI so that they are formally notified as the ‘authorised officers’ under the FSSAI Act, 2006.” In 2015, the intent to expand the network of trained officials was reflected. That changed in 2016.
A plan to expand the FSSAI’s reach across the country was quietly shelved earlier this year when the government set aside its original draft cabinet note to have a Rs 1,750-crore centrally sponsored scheme for FSSAI and states to ensure food safety. The plan for FSSAI to move out of enforcement of the food safety law was instead set in motion. In January 2016, upon instructions, the chairman of FSSAI wrote in an internal note, “We need not provide personnel for import clearances since this work could be transferred to the customs department. We would, however, have to review whether appeals on import related issues would lie with us or with the designated customs authority and provide for the same in our regulations.”
FSSAI responded to Business Standard queries to say, “Custom officers were anyway drawing the samples (mandatory for all consignments of food imports). Now they shall have the legal force to ensure safety of all food that is imported under the FSSA.” Appointing trained specialists of FSSAI, the agency said, would become ‘cumbersome’.
The US, EU and many other developed and developing countries, including those in Africa have dedicated food safety officials across their importing points. In fact the US food safety officials carry out checks of food safety on their own as well as through third party certification even at the manufacturing units of the exporting countries. A hard application of sanitary and phyto-sanitary standards and conditions by developed countries has many times lead to disputes with exporters, including with India.
The appointment of unqualified custom officials for food safety comes as part of a larger package of the reform through the single window process. In January regulations for safety of imported foods were revised without mandatory public consultations. FSSAI is empowered to use emergency provisions to bypass consultations when there is an ‘urgency concerning food safety and public health’. But, the agency used the emergency provisions of the law for ease of food import business.
These new regulations also introduced eased norms for testing of imported food products through a ‘Risk based Import clearance System’. While the rules have been applied to ease testing, the system is still a work in progress, FSSAI noted in its April 2016 newsletter.
In contrast, the FSSAI had recorded some reservations against this risk-based system in 2015. The FSSAI had told the finance ministry, “It is clear from the above provisions, in particular section 47(5) that the FSSAI does not have the enabling powers to put in place a Risk-based Import clearance system.” But it also suggested that regulations subordinate to the law could be put in place to overcome the limitations of the law. It told the finance ministry, “As a regulator the FSSAI is as much concerned about facilitating the ease of imports, for which, it is proposed to frame ‘Import regulations’ and make enabling provisions in the regulations in this behalf.”
FSSAI justified this move in its response. “We say that there is nothing provided in the act itself which denies us the right to introduce the risk based sampling. At that point we said that we shall have an enabling provision and that has been provided in the (new) import regulations.”
While FSSAI in one part of its response had said it did not have data on total volume of food products imported without its approval in previous years, in another part of the response it also claimed that almost 90% of the imports came in from two ports at Chennai and Mumbai that it has specialists deployed at.
This raises the questions of why government did not designate the rest of 10% imports to be also routed through these ports and instead deploy officials at 125 other custom locations. FSSAI claimed in its response that India had all kind of importers – big and small – and some of them preferred other locations.
Contradicting the FSSAI claim, the DG of Commercial Intelligence and Statistics data says that in February-March 2016 the total food item imports from across the country were worth Rs 20,198 crore while those coming through Chennai and Mumbai were only Rs 2,364 crore -
FSSAI’s April 2016 newsletter said FSSAI cleared food products worth only Rs 7,111.91 crores during the two month period.
FSSAI said it now has 21 of the key entry points for imported food covered by few officials. It also said that with the single window online clearance system in place it was anyway able to monitor all imports. But the task of taking samples from consignments and checking them physically for labelling, ingredients and safety through lab tests now lies with the custom officials doubling up as food safety officers at 125 custom points.
Why Sourcing Local Food Is So Hard for Restaurants
Source : https://hbr.org/2016/06/why-sourcing-local-food-is-so-hard-for-restaurants
By Nicole Torres (June 15, 2016)
As globalization has created longer and increasingly complex food supply chains, there has been a concomitant surge in demand for locally-sourced food. Some companies have ridden this wave. Chipotle, for example, differentiated itself from other restaurants by building a brand around a promise of fresh and local ingredients. But after the chain was linked to outbreaks of E. coli, norovirus, and salmonella last year, its emphasis on local sourcing was called into question.
It turns out that a shorter supply chain doesn’t necessarily mean a less complicated one; in fact, working with smaller local producers can bring its own set of challenges, particularly when it comes to food safety testing and preparation. Chipotle has ramped up efforts to improve food safety since then, reportedly hiring two leading food safety experts and investing $10 million in helping smaller suppliers meet their updated safety standards.
I recently spoke to Professor John Quelch, who teaches at Harvard Business School and at Harvard’s T.H. Chan School of Public Health, about the major challenges of local sourcing, how companies can manage them, and what food supply chains will look like in the future. He has written a case study about food safety testing and is the author of All Business Is Local. Our conversation has been edited for length and clarity.
HBR: Chipotle emphasized a shorter supply chain and sourcing from local growers. However, you’ve made the point that even though there are fewer intermediaries between supplier and restaurant, its operations can actually end up being more complex and fragmented, and therefore harder to control for safety. How can this be?
QUELCH: Chipotle is sourcing from multiple suppliers around the country. Comparatively speaking, a company like McDonald’s or KFC sources all of its chicken from maybe five or six large suppliers, such as Tyson Foods and other companies. Tyson chickens would be shipped direct from their plants frozen or refrigerated to McDonald’s or KFC distribution centers and outlets nationwide. McDonald’s or KFC might have their own inspectors on-site at the largest chicken farms and processing centers. They would also impose strict quality controls in each supplier’s plants, and testing procedures would also be laid down.
Chipotle aimed to differentiate itself from other quick-serve restaurants on the basis of using local ingredients and local sourcing of its products. The implication was, “Our food is fresher, we’re not going to be shipping ingredients from one side of the country to another.”
However, local sourcing adds complexity, increases risk and fragments the supply chain. Even if you have a standard quality control procedure for all of your sources, you’re not going to be able to monitor them on-site at every location. You’re going to have to put your trust in the suppliers to live up to the expectations laid down in the quality control guidelines.
Why isn’t that sufficient when it comes to local suppliers?
Companies like Tyson have decades of experience in testing and making sure their products are safe. They’re producing massive quantities in a single plant. If there’s a food safety problem, it’s going to risk the shutdown of a significant portion of their production capacity and that can have serious profit consequences. As a result, their sophistication and experience in terms of food testing is very good.
Of course, there are many concerns over how they treat animals at their plants. These are legitimate concerns from an animal rights point of view. But in terms of public health, these companies have a lot at stake financially and reputationally if any one of their plants has to be taken offline because of a food safety problem.
On the other hand, most local suppliers lack substantial experience in testing their products. They don’t have as much as experience with USDA inspection procedures and their own internal inspection systems may not be as well-developed and operationally as reliable as those at the Tysons of the world. And they are often not large enough to justify a customer placing an individual inspector on-site or even in organizing regular inspections.
Do you have any advice to offer companies like Chipotle that want to source more of their ingredients from these smaller suppliers but don’t have the resources to control for safety?
Number one: If you are doing local sourcing, you have to bake into your cost structure a higher percentage of sales allowance for food safety and ingredient testing than if you are sourcing nationally from a few big suppliers. Obviously, that can have a bearing on your retail price, but, in general, consumers expect to pay more for locally-sourced products, particularly if they have other attributes, such as being organic or natural.
For example, if you dine at a farm-to-table restaurant, you expect to pay a little bit more even though the supply chain is shorter. You realize that the industrial efficiency of the Tyson chicken plant that results in pretty low prices is not going to be replicated at a friendly local organic farm. Nor would you want it to be. Fortunately for suppliers and retailers, interested consumers expect to pay higher prices for the locally sourced, farm-to-table product.
Number two: We now have a number of very competent independent food testing companies, such as the NutriSciences Company, which I recently wrote a case study about, to whom you can outsource your requirements. You should use those. You should not, as a small supplier or as a regional restaurant, feel as though you have to develop the food testing internally.
Shouldn’t advancing technologies, in agriculture and operations, also be able to help here?
Yes. First, the regulatory authorities both in Europe and the U.S. are requiring more sophisticated scientific tests. This is another reason for outsourcing because only the large food safety testing consulting firms have the resources to invest in the latest equipment needed to run the more sensitive scientific tests that are now required.
The second answer relates to tracking particular food products from the source. The Food Safety Modernization Act, the FSMA, which President Obama signed in 2011, put more focus on preventing food safety problems by testing ingredients at the point-of-origin rather than testing finished products. These days, many ingredients are joined together in a single food product from so many sources all over the world that, in the case of a problem, it can be difficult and time-consuming to identify which ingredient was the culprit. Chipotle, to my knowledge has still not identified the ingredient that was the source of its problem.
It is now possible, through technology, to tag the steak you buy in the supermarket from the specific animal and farm it originated from, and track it through the food chain so that, if there is a problem with the meat source, it should be traceable fairly quickly.
Supply chain transparency, especially when it comes to provenance, has definitely become a big deal over the past couple of years.
Say a quick serve restaurant chain proves to be the common source of illness among a group of consumers, you want to hone in on the source as fast as possible; otherwise, the rest of your supply chain will be in jeopardy and at risk of shutdown pending discovery of where the problem started. This represents a huge business risk. So investing in a tracking system is essential.
Companies and regulators are doing a lot here. For example, the Irish Food Board has been investing in tracking technology—and they now require food companies to have traceability systems in place—because they’re trying to justify a premium price of Irish meat and other Irish foods on the basis of the implicit reliability and reduced risk of it having this tracking system in place.
Will tomorrow’s food companies, and other companies in general, be increasingly global, increasingly local, or some hybrid of the two?
As in many other categories, you will see a blend of global and local. There will continue to be a passion and a demand among a minority of consumers for locally produced, farm-to-table food—that trend will continue. The more people who have the disposable income to be able to pay the price differential, and the more informed consumers become, the more that trend will grow.
Of course, some consumers will not be able to afford the higher price of local organic food for every meal. But when they enjoy a special meal, they may prefer to go out to a farm-to-table restaurant or have the organic chicken at home. In other words, it’s not an either/or proposition. It’s a matter of the balance between the local and the global that will be selected by each household.
It’s worth mentioning the recent news regarding the attempted takeover of Monsanto by Bayer, that’s a response to the increased competition in the overall chemical/agricultural fertilizer space prompted by DuPont’s merger with Dow.
Are we seeing greater consolidation in the industry?
Many consumers are price sensitive, and they are looking for safe food at a reasonable price. To the extent that global mergers and acquisitions can add to the efficiency of the food supply and deliver competitive price points to consumers, they will support those companies.
What you’re seeing is that, at every stage of the supply chain, there’s increased consolidation. So if Bayer and Monsanto merge and Dow and DuPont merge, then further down the line, you can expect more mergers of food processing companies that make the branded products that are closer to the end consumer. They’ll want to consolidate their buying power, so that they don’t get shortchanged when they have to pay higher prices to the new, larger consolidated companies back up the supply chain. In economics, this is called countervailing power, whereby mergers at one stage in the value chain prompt mergers at the next stage and the preceding stage.
What are the biggest challenges and opportunities companies are facing today when it comes to their operations in supply chains?
One thing we have not touched upon is the issue of sustainability in the global supply chain — and here I’m referring to the degree to which a company follows policies that are not only conducive to environmental protection, but also take account of the health, welfare and safety of the workers at the farms that supply the suppliers that supply you.
For example, look at the palm oil industry. There are not only environmental concerns and health related concerns associated with palm oil as a product, but there are also supply chain-related concerns around the welfare of workers who are in the fields in Malaysia harvesting the palm oil. Increasingly, consumers of all kinds (but especially Millennials) are becoming concerned about these considerations — the environmental and sustainability footprint of the brands which they purchase at the grocery store.
This presents an opportunity for local sourcing companies, because they don’t have to explain themselves to the same degree, and at the same time, an added challenge for large multinational companies that are sourcing globally.
If Flour is Contaminated with E. coli Can You Still Use It?
Source : https://foodpoisoningbulletin.com/2016/if-flour-is-contaminated-with-e-coli-can-you-still-use-it/
By Linda Larsen (June 14, 2016)
The news about the General Mills flour E. coli O121 outbreak and the massive recall of their products has tapered off recently, with the exception of information that the FDA found E. coli O121 bacteria in an open bag of General Mills flour in the home of a patient sickened in this outbreak. The case count still stands at 38 sickened in 20 states, and the recall has not been updated.
The news that bacteria that is “closely genetically related” to the outbreak strain of E. coli O121 that has made people sick is big news. That is an epidemiological link from the product to those who were sickened.
But how many people have really gotten rid of the flour that was part of the recall? How many people decant their flour into another container and no longer have the bag with identifying information? And how many people haven’t heard of the recall and outbreak?
This brings up an interesting question. If flour is contaminated with E. coli bacteria, can you still use it? The answer is yes, you can, but you are taking a risk, especially if anyone in your home is very young, elderly, pregnant, or has a chronic illness. No one can re-sell any product that has been recalled for pathogenic bacterial contamination, so if you see offers of flour on Craigslist or eBay, bring it to the attention of the managers of those sites. Restaurants can’t use the flour, and grocery stores aren’t allowed to sell it. But there is no way to stop consumers from using the flour.
If you are baking or cooking with the flour and it will be cooked to at least 160°F, the foods you make with the flour will be safe. The problem lies in potential cross-contamination.
It only takes 10 E. coli bacteria to make you very sick. A clump of bacteria that size is small enough to float on a speck of flour with lots of room left over. Scooping your measuring cups into the flour, adding it to the bowl, and stirring and beating will spread flour around your kitchen, in minuscule amounts. But a minuscule amount is all it will take to cause a serious illness. The flour can float in the air, you can breathe it in, and it can settle on countertops, cupboard handles, the floor, sink handles, and food. It’s just so easy for bacteria to travel around your kitchen, and you have no way of knowing if there are pathogenic bacteria in those specks of flour.
So the answer is, yes, you can still cook and bake with potentially contaminated flour. But why take the risk? Flour is an inexpensive product and easily replaced. And the physical, monetary, and emotional cost of a serious illness can be incalculable. It’s best to just get rid of the flour, even if you aren’t sure if you bought a package that was recalled.
The symptoms of an E. coli infection include mild fever, serious and painful abdominal cramps, vomiting, and diarrhea that may be bloody or watery. This illness can lead to a serious complication called hemolytic uremic syndrome (HUS) that can cause kidney failure, strokes, and death. If you or anyone you know is experiencing these symptoms, they should see a doctor immediately.
GAO: FDA could improve tool for assessing imported food risk
Source : http://www.foodsafetynews.com/2016/06/127292/#.V2dAKE5pCUl
By News Desk (June 14, 2016)
A computerized tool used by the U.S. Food and Drug Administration to assess the safety risk of food imported into the United States could be more effective, according to a recent analysis from the U.S. Government Accountability Office.
The tool is known as PREDICT and uses open source and other data to identify food shipments that might pose a greater safety risk and ensure that they receive greater scrutiny.
When FDA rolled out the system, the agency explained that PREDICT was designed to “assist entry reviewers in targeting higher-risk shipments for examination. It also expedites the clearance of lower-risk cargo, but only if accurate and complete data are provided by importers and entry filers.”
“PREDICT improves import screening and targeting to prevent entry of adulterated, misbranded, or otherwise violative goods and expedites the entry of non-violative goods. PREDICT uses automated data mining, pattern discovery, and automated queries of FDA databases to determine the potential risk of a shipment. It takes into consideration the inherent risk of a product and also information about the previous history of importers, manufacturers and shippers,” the agency stated.
Computer tools like PREDICT are more important than ever since FDA can only physically examine about 1 percent of all the imported food coming into the U.S. each year, and imports are continuing to grow.
GAO analysts looked at FDA information from 2012-2014 and found that PREDICT was pretty good at flagging for physical examination those imported food items at higher risk of violating either safety regulations or labeling rules.
However, GAO also noted there were two things FDA could do to make PREDICT even more useful. One is to set up a documentation process to identify those open-source data needed, acquire these data, and then determine how PREDICT should use them.
In addition, GAO stated that new rules and other programs set up under the Food Safety Modernization Act (FSMA) will result in more information for PREDICT to use in helping to assess the safety of imported foods.
Validation and Verification of a Food Process
Source : http://www.foodsafetymagazine.com/magazine-archive1/junejuly2016/validation-and-verification-of-a-food-process/
By Eric Wilhelmsen, Ph.D.
For many food products, validating and verifying a process sounds like a simple task if the product has been made for years and is considered very safe. In many of these cases, one immediately thinks about the time and temperature of a cook step. In other cases, one might think there is no process because the product is not heated or subjected to a heat treatment. As we discuss below, even in these cases, there is a process or procedure for making the product that can be validated and verified. In some cases, the cook step has been replaced by an alternative kill step such as ultrahigh pressure treatment or radiation. In others, the drive for fresher, less-processed foods has resulted in many products without a recognized kill step. We will thus consider how to verify and validate any process, including some of these nontraditional processes. Unfortunately, this discussion is not the final answer regarding process validation and verification, because accepted best practices are still evolving and the regulatory framework is not fully in place. It is likely that this discussion will raise more questions than answers.
Before moving on to discuss some examples, it is appropriate to establish the scope of this discussion with some explanatory definitions. First, validation of a process is the collection of knowledge and experience that allows one to know how to produce a safe food product, which must allow identification of the potential hazards and concerns. It must also provide the tools and metrics for monitoring and controlling these hazards and concerns. For this discussion, we will largely ignore the quality aspects that can impact processes. Second, verification is the process by which one can know that a process is operating as designed. For this term, verification is a process because it must be an ongoing effort that monitors the validated process while product is produced. Finally, a food process includes everything that can impact the safety of a food product. A food process extends from field to fork. It must address all reasonable potential hazards.
Due to space constraints, it is impossible to consider all types of food manufacturing processes. A mental walk through the grocery aisles and departments should draw up pictures of the deli, frozen food cabinets, canned aisle, baking supplies, snack foods and many more. Each class of products brings its own manufacturing challenges. Instead of trying to be overly general, some specific products will be considered to illustrate the general approach and stimulate thought. This discussion refers to suppliers and internal efforts as convenient for the narrative. These assignments do not reflect how a product is produced by a particular supplier.
Canned Pineapple Juice—A Traditional Product
To set the stage, we can consider a traditional product, canned pineapple juice. This is a product with a long history of “safe” manufacture, and there is a large body of experience and knowledge regarding the process. As such, one might expect it to be very easy to develop a validated process and establish procedures to verify that the process was done properly. However, I believe that the following discussion of some of the process parameters and control features will dispel the notion that this is a simple process and set the stage for discussing situations where knowledge of a product is more limited and there is greater uncertainty. To be brief, the following narrative about canned pineapple juice will not focus on specific numbers and specifications. It will instead highlight where metrics and standards of performance are needed.
For canned pineapple juice, the key ingredient is generally pineapple juice concentrate to avoid shipping water. The product could be made at the source from pineapple juice, but we need only consider the more common path from concentrate for this discussion. Pineapple juice has a standard of identity whose provisions must be met when the concentrate is diluted to juice. Other attributes also must be considered, including the presence of heat-resistant mold or Alicyclobacillus. High nitrate levels are also important. Nitrate is important as a depolarizer that can cause toxic levels of dissolved tin. Pineapple is a nitrate accumulator, so the fertilization regime is an important factor in determining the nitrate level of the concentrate. One needs specifications or metrics for these parameters to ensure that the canned product is not negatively impacted and ways to ensure that affected concentrates do not enter the process. Obviously, there are numerous quality specifications such as Brix acid, degree of oxidation and levels of insoluble solids that also need to be considered, but these are largely quality aspects that are outside the scope of this discussion. Nevertheless, we have identified concerns that force the verification process to start in the field or at least prior to the processing plant.
The water used for reconstituting the juice will be the largest volume of the product. The product will be heat-processed, but a heat process will not remove all the potential hazards. Heavy metals and various organic materials must be considered. These concerns often motivate processors to use municipal water supplies, where these hazards are presumably managed. However, one should consider the potential for a failure on the part of the water supplier. How can we ensure that such a failure has not happened?
For the primary package, the can, there are also a number of concerns including the integrity and oxygen barrier properties of the pull tape, the absence of thin spots in the tin coating of the steel and the quality of the seams and the side weld. If the oxygen barrier is inadequate, heat-resistant mold spores can grow in areas proximal to the peel tape. Imperfections in the tin coating can lead to spot corrosion and pinholing. Presumably at this point, the tin plate is made with low-lead tin to avoid this reproductive toxicant. Do we simply trust the supplier that all of these concerns are covered, or should we be doing some of our own verification?
The can, concentrate, water and probably vitamin C need to be put together in the portion of the effort that is normally considered a process. There is a blending operation that must ensure the right proportions of all the components. Foreign materials are not appropriate. The materials need to be mixed to homogeneity and kept homogeneous during the filling operation to ensure that the insoluble solids and other components are evenly distributed throughout the production lot. If the operation is continuous, this can be even more difficult. The blended juice should be deaerated to avoid exposing the steel of the can to higher-than-normal detinning. The blended product must then be heated to a steady temperature and delivered to a filler. The appropriate temperature is selected based on a challenge study and perhaps the D- and z-values of a particular organism. Fortunately, pineapple juice is an acid product, avoiding the complications of pressure retorting to control botulism. It is desirable to minimize the extra time that juice is at this elevated temperature but critical that no cans are filled at lower than the target fill temperature. The headspace of the cans must be flushed with steam and/or nitrogen to minimize oxidation and detinning. This is especially important with the reduced tin layers in use today. Finally, the cans must be cooled after an appropriate amount of time to preserve product quality.
After this quick tour of the concerns that must be encompassed by the validation effort to produce this product, we need to remember that for each concern, we wish to have a verification process. We need to somehow monitor and control metrics for each of the concerns or potential hazards mentioned above to ensure that the validated process has been executed. Sometimes, this means ensuring that a best practice is being followed, such as the fertilizer regime to control nitrate in the fruit. Even with this type of control, it is probably prudent to monitor the nitrate level in the incoming concentrates as a secondary check. The nitrate in the concentrate is an analytical check and is not really amenable to continuous assay. It will be important to determine the appropriate number of tests to avoid problems. It may be necessary to test each lot or perhaps each bin, depending on how variable this metric proves to be. A similar process is needed for all of the noncontinuous measurements. This type of reasoning applies to the blending process. It is good to assert that the blending process is under control, but it must be verified as well. The verification should probably include at least vitamin C determinations and Brix. Brix can be monitored as a flow measurement, but vitamin C determinations are best done as discrete measurements.
Some metrics are hard to monitor directly at process. Sometimes, there are indirect measurements that can be followed at the time of process, but for others, time is required. In these cases, it is prudent to have a retain program and confirm the desired product performance has been achieved. Given the 2- to 3-year shelf life of canned pineapple, there are options that can be taken if certain lots should be moved faster through the marketplace. However, it is always better to avoid such issues. Headspace oxygen is an example of this type of concern. Steam pressure and/or nitrogen flow when the can is being sealed are indirect measurements of the process that can be monitored to show that the process is operating as intended. The headspace oxygen is almost immediately consumed by reaction with the product and with the tin of the can during the thermal process. Thus, the damage is done and the headspace oxygen is gone, preventing later analysis. One can measure only the results of excess oxygen: for example, increased levels of dissolved tin and the loss of vitamin C. If the oxygen levels are extremely high, premature color change is also observed.
A Dry Beverage Mix—A Less-Processed Product
Turning our attention to a “nonprocessed” traditional product, let us consider a powdered, fruit-flavored beverage mix. A product of this type is a dry mix of sugars, organic acids, flavors and color components, colloids and perhaps some preservatives. The safety and purity of the ingredients must head our list of concerns. Our suppliers can hopefully convince us that they have done their job correctly. The key checkoff is to know that it is done. If we mix these ingredients under hygienic conditions to avoid contamination, the product should be safe. How do we verify hygienic conditions? Environmental and equipment swabs? Is the product tested directly for pathogens or indicator organisms? The correct answer is probably some mix of all of the above. Fortunately, the low moisture content of a dry powder will not support microbial growth. However, what happens after the product is prepared for consumption? Will the diluted beverage support microbial growth? The question of how do we verify that we have faithfully executed a safe process for this product will take some thought. The tendency to try to just test the product fails to recognize the limited value of negative testing results. As proof of safety, the value of a pathogen test that shows less than some number of colony-forming units (CFUs)/g or a presence/absence test showing no pathogens in a larger sample is of limited benefit on a lot-by-lot basis or for releasing lots. It is not practical to test enough product to show safety. However, in aggregate, such testing can help verify that a process is functioning normally.
A Cold-Brewed Product—A Modern Product?
Moving on, we can consider a much less traditional product, a shelf-stable, cold-brewed beverage. Many of the hazards will be similar to those for the canned juice above. Water is again an important ingredient. However, in this case, it will not receive a thermal process. The material to be extracted must be free of foreign material. And the package must be appropriate. These are the normal hazards of a beverage process and can be addressed in normal ways.
The challenge for this process is addressing the microbial hazards without a thermal process. The most direct avenue for controlling this hazard would be an alternate kill step such as ultrahigh pressure or a chemical treatment. This kill step could be validated with an appropriate challenge study. Such a kill step would make the validation and verification process similar to the canned pineapple juice process in the first example. This process becomes much more interesting to consider if an alternative kill step is not included.
When considering a beverage without a kill step, one must remember that Pasteur was right: Spontaneous generation does not occur. Microorganisms can be killed, removed or excluded. Without a kill step, a process must consider removal and exclusion. For our cold-brewed product, the ingredients and therefore the cold-brewing process can be clean but probably not sterile. This necessitates a removal process or another control mechanism. The common choice is microfiltration, which removes particles as small as the organisms of interest. This filtration process must be verified in some way. This is usually done after a batch has been filtered by demonstrating that the filter is intact. Is filter integrity a pass/not pass test or is it a continuous variable? A processor using this technology must address this verification need. The filter supplier should be very helpful in this area. If the product will not support microbial growth, it is advantageous as a second hurdle.
This sterile-filtered beverage needs to be packaged. A variety of packages and filling systems are available. Any such system must be validated to ensure that it excludes microorganisms. This is challenging because it is hard to prove a negative. One can test and swab and always get negative results, but this will not guarantee that microorganisms have been excluded. Nevertheless, a processor needs both validation and verification of this portion of their process. Here again, the equipment supplier should have metric and verification tools.
Ready-to-Eat Spinach—A Bigger Challenge
To further increase the challenge, we can turn our attention to a product where neither a removal step nor a kill step is available. Value-added produce falls into this category. For this discussion, we will consider washed, ready-to-eat spinach. In this process, we must rely on exclusion to do the heavy lifting. We have limited ability to kill bacteria. This means that the whole process must work in concert.
Given that spinach is the only ingredient in this product, it is important to ensure that foreign matter is not commingled with the spinach at harvest. There is an opportunity to sort out foreign matter at the processing plant, but it is better to prevent such materials from entering the plant. There must be a full working Good Agricultural Practices (GAP) program in place. This science-based program will limit the maximum average level of pathogens that can enter the processing plant by controlling identified and potential causes of infection. All aspects of the GAP program must be verified. Testing programs to monitor the effectiveness of the GAP program are the norm and are expected to detect an extreme breakdown of the program. Most testing programs are N = 60/c = 0 programs where sixty 2.5-g specimens are collected and composited for a presence/absence test. With one sample, this testing will ensure with a 95 percent confidence interval that not more than 5 percent of specimens will exceed 1 CFU/2.5 g of the pathogens of interest to the extent that the sampling represents the lot from which it was taken. Fortunately, GAP programs are largely effective, resulting in very few positive tests and a very low general background for pathogens. However, a strong argument can be made for increasing the preharvest testing in lieu of testing later in the process to reduce the potential maximum average infection level entering the processing facility. The sensitivity of a testing program is tied to the number of grams tested that are used to make each decision. Therefore, lots of tests do not necessarily provide a good program. Multiple tests to make a decision will provide more assurance that an exceptional infection is detected and rejected.
In the processing plant, the spinach is washed and dried before packaging. The wash system has some ability to reduce pathogen load, but its most important role is dirt or grit removal, which must occur without allowing cross-contamination. There are no generally recognized procedures for validating and verifying wash systems. There is no generally recognized procedure for measuring cross-contamination. This is in sharp contrast to the body of knowledge regarding heat penetration and thermal lethality. There are numerous experts to design challenge studies for thermal processes. The measurement of cross-contamination is critical for validating its control. Unfortunately, given the current state of knowledge, it is likely that these procedures will need to be applied to the actual equipment in use, because extrapolation to other systems is beyond our understanding at this time. This may mean developing tests that can be run in actual processing plants where inoculated studies are not a good choice.
In terms of validating a wash system, there are some generally accepted parameters. The sanitizer level and pH are critical for chlorine-based systems. The presence of wash adjuvants can substantially alter the wash system efficacy. Manual dosing of chlorine fails when organic loads exceed the ability of manual dosing to sustain the desired chlorine levels. Automated control and dosing can overcome this limitation and mitigate the impact of organic load. Monitoring pH and chlorine continuously may be necessary to verify that a validated process has been done. However, the chlorine level necessary to control cross-contamination is not defined because there is no standard metric to measure cross-contamination. The idea that cross-contamination should not be detectable is an untenable standard. With most-probable-number procedures and other techniques, detection limits are quite fluid.
There are three candidate approaches for verifying the performance of a wash system with regard to cross-contamination control. Each approach relies on knowledge that is not yet available. The most direct approach is confirming that a wash system controls cross-contamination directly under the most challenging conditions expected to be used and showing that these most challenging conditions are never exceeded. To apply this approach, one needs to measure cross-contamination, a problem as mentioned above, and understand the most challenging conditions. A direct approach for measuring cross-contamination based on using a 1 percent-inoculated contaminant that is distinguishable from the product is showing great promise as an assay for cross-contamination on a research basis but is far from a standard procedure. The most challenging conditions are still far from defined. A second verification concept would be to show that all places in a process line exceed some chlorine level under all operating conditions. This chlorine level is undefined and cannot be defined until there is a standard procedure for measuring cross-contamination. There are some people who argue that 10 ppm is this critical level. However, the data are exceedingly weak. Finally, if one can show that all chlorine levels across a wash system track the level at a control point and then maintain the chlorine level at the control points to some undefined level, this would verify that the wash system is operating as designed. All three of these approaches have scientific merit, but at present, the validation data are lacking to set the control parameters.
Given that this process relies heavily on exclusion, other aspects of the process become more important and challenging. The transportation system for bringing product from the field to the plant is an area of potential concern. The plant environment and personnel are of concern. The validation effort must include these areas so that the verification process can also include them. These will be challenging as we are proving the negative. All concerns and hazards must be addressed.
Finally, we can consider a vertical urban farm where a leafy green is grown in a controlled environment. The process in this case is to exclude pathogenic microorganisms throughout the growing cycle and avoid contamination at harvest. Again, Pasteur was right, so the process should work. However, validation is challenging because it will all be about proving negatives. There is no amount of testing that can prove the system is working. One can achieve a practical validation over time, but there will be lingering doubts. In fact, at some point, it is likely that a pathogen will be found on the product if enough testing is done.
Going back to the basics, the safe manufacture of food products requires diligence and follow-through. It requires recognizing the scope of the process, including all aspects from field to fork. The steps are easy to summarize:
• Identify the hazards or concerns
• Identify the control mechanisms that can mitigate the hazard
• Identify how to confirm that control mechanisms are operating
• Implement the control mechanism and the monitoring systems
Steps 1 and 2 are the validation process. Steps 3 and 4 are the verification process. Unfortunately, as with many things, it is too easy to lose track of the big picture when there are so many details to track. However, this is our job. The food industry is doing it well and is striving to continually do better. Those manufacturers that do not keep up with the rising standards of validation and verification will fail.
Eric Wilhelmsen, Ph.D., is an Institute of Food Technologists-certified food scientist, serving over 30 years in academic and industrial positions. He can be reached at the Alliance of Technical Professionals.
Summer food safety quiz
Source : http://www.hdnews.net/lifestyle/community/summer-food-safety-quiz/article_608b9116-77b7-5dd7-8873-4892670eb83a.html
By hdnews.net (June 14, 2016)
A group of women from the Basilica of St. Fidelis in Victoria asked me to speak about summer food safety at their meeting earlier this week. Instead, I gave them a quiz.
In discussing this summer food safety quiz, we uncovered several mistakes and misunderstandings about food handling safety in the warm summer months.
Take the quiz
How savvy are you about summer food safety? Test your knowledge with this quick quiz.
1. Foodborne illnesses increase during the summer.
True or false?
2. You’re having a cookout and the hamburgers are on the grill. How can you tell if the burgers are done and safe to eat?
A. They have been cooked for at least 4 minutes on each side.
B. A thermometer inserted in the middle of the patties registers at least 160 degrees.
C. They are brown in the middle and no pink is showing.
3. It’s best to rinse meat and poultry under cold running water before cooking.
True or False?
4. It’s a warm sunny day and you’re at a family reunion in the park. Where should you store your cooler?
A. In the trunk of the car away from pests.
B. In the shade of a tree.
C. Beside the picnic table.
D. None of the above.
5. You’re entertaining in the backyard on a very hot day. How long can you leave foods to sit out?
A. 2 hours.
B. 30 minutes.
C. 1 hour.
D. 3 hours.
6. Since only the inside of melons (watermelon, cantaloupe, honeydew melons, etc.) is eaten, their outer rind does not need to be washed.
True or False?
7. You want to make homemade ice cream, and the old family recipe calls for raw eggs. You’ve heard raw eggs might be a risk for Salmonella. What should you do?
A. Use an egg substitute product or pasteurized eggs instead of raw eggs.
B. Cook and chill the milk before adding the eggs.
C. Don’t worry about it. It’s never made anyone sick in the past.
Check your answers
So are you a food safety master, or a food safety disaster? Check your answers.
1. True: Yes, foodborne illnesses do increase during the summer, and the reason appears to be twofold.
First, there are the natural causes. Micro-organisms present in the environment grow fastest at temperatures from 90 to 110 degrees. Given the right circumstances, harmful bacteria can quickly multiply in food to large numbers. When this happens, someone eating the food can get sick.
Second, outside activities increase. More people are eating outside at picnics, barbecues, harvest meals and on camping trips. The food safety controls that a kitchen provides — temperature-controlled cooking, refrigeration and washing facilities — are usually not available outdoors.
2. Answer: B. You can’t rely on timing or color to tell that meat is done.
According to USDA research, 1 out of every 4 hamburgers turns brown in the middle before it has reached a safe internal temperature. The only way to be sure food is safely cooked is to use a food thermometer to measure the internal temperature.
Using a food thermometer not only keeps you safe from harmful food bacteria but it also helps you to avoid overcooking, keeping it juicy and flavorful.
3. Answer: False. Rinsing raw meat is not recommended. In fact, you can increase your risk of food poisoning if you do so. Rinsing raw meat or poultry can contaminate your sink and anything your contaminated hands touch (faucet handle, cabinet handle, etc.) It also can splash bacteria onto the countertop and other foods or utensils nearby. Bacteria that might be present on the surface of raw meat or poultry will be destroyed only by cooking to proper temperatures.
4. Answer: B. To keep cold foods cold when outdoors, keep your cooler out of the sun. Place it in the shade, or cover it with a blanket or tarp. A full cooler will maintain its cold temperature longer than one that is partly filled. If it isn’t full, fill the space with plenty of extra ice or freezer packs. Transport the cooler inside your air-conditioned car, not the hot trunk.
5. Answer: C. In hot weather (90 degrees or warmer), don’t leave foods sitting out for more than one hour. Indoors — or at cooler outdoor temperatures — foods should not sit out longer than two hours. Food that is left outside too long might look and taste fine, but can be teeming with harmful bacteria. When in doubt, throw it out.
6. Answer: False. A knife can drag bacteria from the peel or rind to the inside of a melon during cutting. It’s important to wash all produce, even if you plan to peel it.
Also, some people feel the need to wash fruits and vegetables with soaps or detergents before using them. In fact, it’s best not to use cleaning products on produce, since these products can linger on foods and are not safe for consumption. Scrubbing with clean running water is actually the best way to remove bacteria and wash produce safely.
7. Answer: A. Eggs are a standard ingredient in many homemade ice cream recipes. They add flavor and color, prevent ice crystallization, and create that smooth and creamy texture. But using raw eggs is no longer recommended.
Even if you’re using pasteurized eggs or egg substitutes for your ice cream, both the FDA and the USDA recommend starting with a cooked base (also known as a custard base) for optimal safety. This is especially important if you’re serving people at high risk for foodborne illness: infants, older adults, pregnant women and those with weakened immune systems.
How did you score?
Add up the number of correct answers to determine your score.
6 to 7 — Great! Move to the head of the class.
4 to 5 — Not bad. Review your answers to see where you can improve.
Less than 4 — Uh oh. Time to go back to food-safety school.
Contact the Ellis County Extension Office, (785) 628-9430, for more information on safe food handling in the summertime, or see the K-State Research and Extension food safety web page at www.ksre.ksu.edu/foodsafety. There’s lots of helpful information under “Topics of Interest” in the left column.
What’s in This Stuff? An Update on FDA’s Policies and Enforcement Actions Concerning Novel Ingredients in Food and Dietary Supplements
Source : http://www.foodsafetymagazine.com/magazine-archive1/junejuly2016/whate28099s-in-this-stuff-an-update-on-fdae28099s-policies-and-enforcement-actions-concerning-novel-ingredients-in-food-and-dietary-supplements/
By J. Wasserman, Esq., and La Toya C. Sutton, Esq.
In early 2014, we wrote a short article for Food Safety Magazine about two guidance documents the U.S. Food and Drug Administration (FDA) had recently issued, entitled Distinguishing Liquid Dietary Supplements from Beverages and Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements. At the time, we hypothesized that the release of these documents could signal an upcoming wave of enforcement. While there have been some ripples, the predicted tsunami has yet to materialize. However, there have been somewhat-related waves concerning the use of certain novel ingredients in dietary supplements. In this article, we will dive deeper into the details of these guidance documents and discuss some recent FDA enforcement actions in the ingredient space.
Part 1: Liquid Food vs. Supplement Guidance
Distinguishing Liquid Dietary Supplements from Beverages lays out the many factors that FDA will consider when determining whether a liquid product is being represented to consumers as a dietary supplement or a traditional beverage. This distinction is of the utmost importance, since under the Federal Food, Drug, and Cosmetic Act of 1938 (the FD&C Act), a dietary supplement cannot “be represented as a conventional food.” The regulatory requirements that apply to each category of product are vastly different, and ingredients that are allowed to be “dietary ingredients” in dietary supplements may not be legal to use in a conventional food. If a company markets its product in one category, but FDA concludes that it rightly belongs in the other, that company could have a misbranded or adulterated product on its hands and open itself up to government enforcement.
The guidance assigns no particular weight or priority to any of the factors. Instead, as with many other FDA considerations, the sum is greater than any individual parts, meaning that FDA will consider the entire context in which the product is presented to consumers. We will briefly address each factor in the order they appear in the guidance document.
Labeling and Advertising: The first factor is the most traditional consideration and emphasizes that “FDA considers statements and graphics on product labels, labeling, and advertising, including websites and social media, when the agency evaluates the intended use of the product and how it is represented.” FDA notes that graphics can also represent a product as a conventional food.
Product Name: According to the second factor, FDA believes product or brand names that use conventional food terms such as “beverage,” “drink,” “water” or “soda” represent the product as a conventional food. Other terms that generally would be considered to represent a liquid product as a conventional food when used in the product’s name are beverage names such as “orange juice,” “apple cider,” “bottled water,” “iced tea” and “coffee.” The significance of the product name depends on the context in which it is used. On one hand, FDA acknowledges that the mere use of such a term in a product name or brand name may be sufficient to establish that a product is represented for use as a conventional food. However, in other situations, especially when the use of a term is not exclusively associated with describing conventional foods, its use in the product name would probably be evaluated in the broader context of other factors.
Product Packaging: FDA believes that packaging can convey messages about how the product is intended to be used. Packaging characteristics that should be considered include the size, shape, color and design of the packaging, the volume of liquid it holds, whether it is reclosable or designed to be consumed in a single serving, and the similarity of the packaging to packaging used for common beverages.
Serving Size and Recommended Daily Intake: FDA’s position is that liquid products that suggest through their labeled serving size and/or recommended daily intake (RDI) that they are intended to be consumed in amounts that provide all or a significant part of the entire daily drinking fluid intake of an average person in the United States are effectively being represented as conventional foods. Even if a product is not expressly represented as an alternative to a beverage, when the practical result of the labeled serving size and/or total RDI is that the product is used as a beverage or replaces beverages that serve as ordinary sources of drinking fluid, it will be considered to be a beverage.
Recommendations and Directions for Use: Recommendations or directions to use a product for certain uses, such as a “thirst quencher,” can be considered recommendations or directions to use that product as a conventional beverage. In contrast, recommendations or directions to use a liquid product to supplement the diet in a manner consistent with other dietary supplements could be a factor in determining that the product is not represented as a conventional food, even if the packaging is similar to packaging used for beverages.
Marketing Practices: This broad term relates to any marketing practices that favorably compare the product with a category of beverages. This may mean marketing the product as an accompaniment to a meal or based on typical beverage uses like taste, refreshment and thirst-quenching ability. It may also include marketing practices that are less apparent to the consumer, such as the use of metatags that results in the product appearing in the results of an electronic search for conventional beverages, or paying for the product to be displayed in the beverage section of retail stores. FDA does concede that simply recommending that a liquid product be taken with a meal would not generally be considered to represent the product as a conventional food, and promoting a product as a substitute for a beverage would not always represent the product as a conventional food.
Composition: FDA dedicates the most space to discussing this factor, for good reason. The agency’s treatment of this factor makes clear that while it recognizes that there are areas of overlap between the ingredients of some dietary supplements and conventional foods, it does not believe that the overlap was intended to be complete and it pays a considerable amount of attention to the specific regulatory history of the Dietary Supplement Health and Education Act of 1994 (DSHEA) to support its position. Notably, FDA asserts, “Given that some conventional foods are consumed primarily for taste rather than for nutrition or health-related purposes, it would strain common sense to interpret DSHEA as authorizing the creation of a dietary supplement whenever any dietary ingredient is added to any conventional food.” Further emphasizing its stance, FDA states, “Merely adding an ingredient listed as a dietary ingredient in Section 201(ff)(1) of the FD&C Act to a product universally recognized as a beverage does not by itself transform that beverage into a dietary supplement. For example, adding a botanical such as ginkgo to Kool-Aid or nonalcoholic eggnog would not automatically create a product that could be marketed as a ‘ginkgo supplement.’” Finally, the agency reminds marketers that “a dietary ingredient that is lawful for addition to dietary supplements may or may not also be lawful for addition to conventional foods” and vice versa. We will have more on that below.
Other Representations about a Product: This final catchall provision includes statements made in publicly available documents, such as filings with government agencies like the U.S. Securities and Exchange Commission or the U.S. Patent and Trademark Office.
Part 2: Novel-Ingredient Guidance
In this important guidance document, FDA reminds the food industry that the composition of a product matters. It states the dual purposes of the guidance as “to remind manufacturers and distributors of conventional foods about the requirements of the FD&C Act regarding substances added to conventional foods, including beverages” and “to remind dietary supplement manufacturers and distributors that the same requirements apply to certain substances that are added to dietary supplements—namely, those that are not dietary ingredients as defined in Section 201(ff)(1) of the FD&C Act [21 U.S.C. Section 321(ff)(1)].” Thus, unlike most FDA guidance documents, this document provides no new analysis or changes to FDA’s treatment of these products or these issues but instead simply restates many important regulatory principles concerning ingredients in foods and dietary supplements.
The document explains that if a substance is not generally recognized as safe (GRAS) and does not qualify for any other exemptions from the food additive definition, it is a food additive. Food additives require premarket approval, frequently through an industry member-initiated food additive petition, and then, if approved, FDA issues a regulation specifying the conditions under which an additive has been demonstrated to be safe and, therefore, may be used legally. Any unapproved food additive used in a beverage or other conventional food causes the food to be adulterated under the FD&C Act and prevents it from being marketed legally in the U.S.
Turning to the issue of GRAS ingredients, FDA expressed concern that some of the novel ingredients that are being added to conventional foods (including beverages) for their functional effects may cause the foods to be adulterated because while the ingredients may be GRAS in some amounts and for some uses, they may not be GRAS for these uses in foods.
Regarding dietary supplements, FDA noted that dietary ingredients are exempt from the food additive definition. While a dietary ingredient need not be GRAS, it must not cause the product to be adulterated. On the other hand, other ingredients in supplements—fillers, binders, etc.—are not exempted and must be used in accordance with an approved food additive regulation or be GRAS for their intended use.
Part 3: The Impact
Since the release of these guidance documents, there has not been a significant uptick in FDA enforcement against products for issues that seem to be directly related to these documents. There has, however, been some movement in the area.
Products Represented as Conventional Foods
Shortly after the guidance documents were issued, in March 2014, FDA sent a warning letter to Denwar International BMC Inc. in which it concluded that the company’s line of products, called Lean Slow Motion…Potion, were both adulterated and misbranded. As part of its reasoning, the agency argued that despite using the term “dietary supplement” on the labels, the products were described as beverages elsewhere on the label, compared to other popular beverages on the product website and sold in single-serving, pop-top aluminum cans similar to the packaging of carbonated soft drinks. Further, the letter noted that melatonin, listed as an ingredient in the products, is not subject to any regulation approving its use in food and is not GRAS. In March 2015, FDA issued a similar letter to Bebida Beverage Co. regarding its Koma Unwind Liquid Relaxation product. Again, FDA concluded that the inclusion of melatonin in the product made it adulterated. Furthermore, the packaging and repeated references to the product as a “beverage” indicated that it was not a dietary supplement and therefore misbranded.
In January 2015, FDA issued a warning letter to NYSW Beverage Brands Inc. regarding a number of their dietary supplement products, including VBlast Acai Berry, VBlast Wildberry and VBlast Tropical Punch. Although the letter primarily focused on the company’s noncompliance with dietary supplement current Good Manufacturing Practices regulations, the letter first noted that FDA was not convinced that the products should be considered dietary supplements in the first place. Pointing to the labels of the products, FDA explained that although the products bear “Supplement Facts” panels, the terms “water” and “punch” were used in the statements of identity for the products and the recommended intake was 500 mL, a significant part of the daily fluid intake for the average consumer. The similarity of the products’ packaging to conventional beverage products, such as vitamin waters, was also noted.
Ingredients Not GRAS/Approved for Use in Foods
In July 2015, FDA sent a warning letter to the Ten Ren Tea Company concerning distribution of tea products that were adulterated due to an unapproved food additive. FDA asserted that a number of the tea products manufactured by the company listed stevia leaf as an ingredient. Although certain purified stevia leaf extracts are approved food additives, stevia leaf itself is not GRAS and is not an approved food additive. FDA noted that while it has received inquiries and petitions for the use of whole-leaf stevia or its crude extracts in food, that evidence was insufficient to support a conclusion that those ingredients were safe, and consequently, the products were considered adulterated.
Ingredients Not Allowed in Dietary Supplements
While there has not been much recent FDA enforcement against novel ingredients in conventional foods, there has been significant FDA enforcement against dietary supplements based on ingredients.
For example, in April 2015, FDA issued warning letters to 14 companies regarding a total of 17 dietary supplement products containing DMBA (1,3-dimethylbutylamine) as a dietary ingredient. In the letters, FDA outlines several reasons why a supplement containing DMBA is considered adulterated.
First, the agency maintains that even if the ingredient meets the regulatory definition of a dietary ingredient, it would be considered a “new” dietary ingredient (meaning it had never been used in a supplement before DSHEA was passed in 1994), and consequently, the company would have needed to submit a notification to the agency regarding its safety prior to introducing it into the market. Second, FDA reasons that even if the required notification had been submitted, it was not aware of any safety data establishing that a product containing this ingredient should not be considered adulterated, and had no reason to believe that such support existed. Finally, FDA points out that use of a synthetic version of the ingredient would exclude it from the definition of “dietary ingredient” because it is not a vitamin, mineral, amino acid, herb or other botanical; commonly used as human food or drink; or a concentrate, metabolite, constituent or extract.
A similar set of letters were issued to seven dietary supplement companies about the use of methylsynephrine, also known as oxilofrine or p-hydroxyephedrine, in their products. The ingredient is a known banned substance in most sports due to its performance-enhancing properties. FDA follows the same analysis found in the DMBA letters, ultimately concluding the substance “is not approved as a food additive or prior sanctioned for use in dietary supplements” and “FDA’s review of this substance does not identify a basis to conclude that the substance is GRAS for use in food.”
Another set of warning letters demonstrate the importance of researching the history of any ingredient a company would like to use in its product, including its history of use in clinical studies. If an ingredient has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, and it was not used as a dietary ingredient before such investigation, it cannot be used as dietary ingredient in a dietary supplement.
That seldom-cited provision was the basis for eight warning letters FDA sent in February 2016 to companies that marketed dietary supplements containing cannabidiol (CBD). CBD is one of over 60 compounds found in the cannabis plant that belong to a class of molecules called cannabinoids. Of these compounds, CBD and tetrahydrocannabinol (THC) are usually present in the highest concentrations and are therefore the most recognized and studied. However, unlike THC, CBD is nonpsychoactive and therefore does not cause a “high.” In the 2016 letters, FDA observes that CBD had been studied in an FDA-approved investigatory new drug study and was therefore excluded from use in dietary supplements.
Part 4: What Does This All Mean?
These guidance documents and enforcement actions perhaps show a changing of the guard in terms of FDA’s focus and concern about the use of novel ingredients in foods and dietary supplements. The increasing use of botanicals, synthetic chemicals and other unconventional ingredients throughout the industry has placed these issues at the forefront of the agency’s priorities. Industry members should ensure that their product development process includes a robust regulatory review—both in terms of the appropriateness of the ingredients they intend to use and the representations they intend to make. In other words, know “what’s in this stuff” and ensure that it is all allowed for the type of product you intend to market.
Ivan J. Wasserman, Esq., is a partner in the advertising, marketing and media division of the law firm Manatt, Phelps & Phillips.
La Toya C. Sutton, Esq., is an associate in Manatt’s advertising, marketing and media division.
8. Interestingly, FDA also published its testing results for the products that were the subject of these letters, which showed that many of them did not contain the levels of CBD they claimed to contain.
Researchers try to kill it, use it, and otherwise figure out E. coli
Source : http://www.foodsafetynews.com/2016/06/researchers-try-to-kill-it-use-it-and-otherwise-figure-out-e-coli/#.V2dAhk5pCUl
By News Desk (June 13, 2016)
Summer is usually seen as the peaking season for Escherichia coli, and this summer that may apply not only for recalls and outbreaks, but also research. The Gram-negative, facultatively anaerobic, rod-shaped bacterium commonly found in the lower intestine of warm-blooded organisms is a frequent target of laboratory research that gets published during the summer.
So far we’ve learned University of Alberta researchers believe there is a small percentage of mutant E. coli that are hard to kill with heat. They reported the heat resistant strain survived a 140 degree cooking temperature for 70 minutes, and even higher temperatures than the 160 degree cooking temperature recommended the U.S. Department of Agriculture.
Meanwhile, however, researchers in Singapore created a new antimicrobial material they say is capable of killing E. coli bacteria is 30 seconds. Their work was published in the nano materials journal Small.
The Singapore discovery involves new synthesized chain-like structures of molecules known as chemical imidazolium oligomers. Antibiotics can render the bacteria impotent but leave cell membrane and structures, allowing the bacteria to generate new antibiotic-resistant cells.
The new antimicrobial material could be used in consumer and personal care products to prevent the spread of infectious disease, according to Jackie Y. Yang, executive director of Singapore’s Institute of Bioengineering and Nanotechnology.
Ying said the growth of drug resistance bacteria crates an urgent need for new materials that can kill and prevent the growth of harmful bacteria.
The imidazolium oligomers are a white powder and are soluble in water. Once dissolved in alcohol, it gels spontaneouslly. The researchers believe it could be used in alcoholic sprays to sterilize homes and hospitals.
Finally, a multi-university research project has found that engineered E. coil vesicles can be used as a delivery system for vaccines. The team from Cornell, Iowa, Texas and Georgia published their work in the journal Cell Chemical Biology.
The work involves manipulating the biological machinery of living cell and has focused on using a domesticated lab strain of E. coli to create and deliver vaccines. Using outer membrane vesicles, or OMVs, as vaccine candidates has the advantage that they are potent adjuvants, meaning they would enhance the response to the antigen.
They would most likely be used for the more challenging vaccine targets.
Norovirus: Best way to assess risk?
Source : http://barfblog.com/2016/06/norovirus-best-way-to-assess-risk/
By Doug Powell (June 13, 2016)
The application of quantitative microbial risk assessments (QMRAs) to understand and mitigate risks associated with norovirus is increasingly common as there is a high frequency of outbreaks worldwide.
A key component of QMRA is the dose–response analysis, which is the mathematical characterization of the association between dose and outcome. For Norovirus, multiple dose–response models are available that assume either a disaggregated or an aggregated intake dose. This work reviewed the dose–response models currently used in QMRA, and compared predicted risks from waterborne exposures (recreational and drinking) using all available dose–response models.
The results found that the majority of published QMRAs of norovirus use the 1F1hypergeometric dose–response model with α = 0.04, β = 0.055. This dose–response model predicted relatively high risk estimates compared to other dose–response models for doses in the range of 1–1,000 genomic equivalent copies. The difference in predicted risk among dose–response models was largest for small doses, which has implications for drinking water QMRAs where the concentration of norovirus is low.
Based on the review, a set of best practices was proposed to encourage the careful consideration and reporting of important assumptions in the selection and use of dose–response models in QMRA of norovirus.
Finally, in the absence of one best norovirus dose–response model, multiple models should be used to provide a range of predicted outcomes for probability of infection.
Comparison of risk predicted by multiple norovirus dose–response models and implications for quantitative microbial risk assessment
Nicole Van Abel, Mary E. Schoen, John C. Kissel, J. Scott Meschke
Risk Analysis, June 2016, DOI: 10.1111/risa.12616
Ajuua’s Mexican Restaurant Employees Test Positive for Salmonella
Source : http://www.foodpoisonjournal.com/foodborne-illness-outbreaks/18702/#.V2dA8E5pCUl
By Bruce Clark (June 13, 2016)
The Odessa American reports that Six Ajuua’s Mexican Restaurant employees have tested positive for Salmonella, but officials do not know if they contracted the infection before or after the outbreak was caught by Ector County health officials.
Ector County Health Department Director Gino Solla said the tests for the six employees came to the department Monday, and the number of lab-confirmed tests has increased to 10 since the outbreak was confirmed on June 6. The number of probable cases, he added, was now at 23.
The restaurant, at the request of the health department, closed their doors June 6 after complaints were made by residents. It has since reopened.
Salmonella: Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Salmonella outbreaks. The Salmonella lawyers of Marler Clark have represented thousands of victims of Salmonella and other foodborne illness outbreaks and have recovered over $600 million for clients. Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation. Our Salmonella lawyers have litigated Salmonella cases stemming from outbreaks traced to a variety of foods, such as cantaloupe, tomatoes, ground turkey, salami, sprouts, cereal, peanut butter, and food served in restaurants. The law firm has brought Salmonella lawsuits against such companies as Cargill, ConAgra, Peanut Corporation of America, Sheetz, Taco Bell, Subway and Wal-Mart.
If you or a family member became ill with a Salmonella infection, including Reactive Arthritis or Irritable bowel syndrome (IBS), after consuming food and you’re interested in pursuing a legal claim, contact the Marler Clark Salmonella attorneys for a free case evaluation.
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