In 2011, the increased public awareness of food pathogens contributed in large measure to the passage of the Food Safety & Modernization Act (FSMA), which put into place a far more rigorous set of regulations surrounding food safety than had ever existed. In recent years, equipment cleaning processes employed by the food and beverage industry have come under even more increased scrutiny. This is the result of the widespread publicity around pathogen outbreaks in commercially processed food, including E. coli found in Californian romaine lettuce in 2018, and the presence of Listeria in Blue Bell ice cream in 2015. A drive toward more efficient food production coupled with the increased awareness of food pathogens has led the food processing industry to shift its focus to the equipment cleaning processes—specifically cleaning equipment surfaces that come into direct contact with food.

Designing a Clean-in-Place System

Figure 1. Electric fluid heater.

Image Credit: M.G. Newell

There are two basic approaches used in cleaning food processing equipment. The first, clean-out-of-place (COP), is used for cleaning pieces of equipment and utensils that can be easily removed from the production line and disassembled for cleaning (e.g., beaters used in mixers). The second approach, called clean-in-place (CIP), is employed in aseptic and other processing operations where the interior surfaces of the food processing line, such as tanks and piping, cannot be easily reached and disassembled for cleaning. CIP cleaning is the more difficult of the two cleaning processes, and typically involves specialized CIP systems, employing fluid pumps and heaters.

In a CIP system, cleaning fluids are typically heated to increase their cleaning efficiency. Depending on the application, a few different cleaning agents may be used, including hypochlorites, peracetic acid, ozone-enriched water, and acid anionic. The cleaning fluid is circulated through the CIP system in a prescribed manner to regulate the flow, mixing, temperature, time, and mechanical force used with the cleaning agent to achieve maximum results.

Historically, steam-based heat exchangers were used to heat cleaning fluids used in CIP applications in the food and beverage industry. In recent years, the trend has been to use electric fluid heaters (often in-line types) that may be easily incorporated into CIP skids (see Figure 1). These electric fluid heaters provide the flexibility needed for designing into different types of CIP systems, and are ideally suited for lower process flows.

In selecting a fluid heater for CIP applications, there are several critical factors to consider, including:

• Sanitary Design
  • Components such as the heating element, valves and gaskets, used in the construction of the heater eliminate possible locations for contaminants to thrive in the heater.
  • Wetted surfaces in the heater should be constructed of 316L electropolished stainless steel, as it presents an extremely smooth surface to the cleaning fluid.
• Dead Leg Eliminating
  • Eliminate any areas outside of the regular fluid flow path that could harbor pathogens.
  • Non-threaded design fittings provide a smoother surface with few nooks and crannies.
• Fluid Drainability
  • Cleaning fluids should be completely drained from the system after use.
  • An input on the bottom of the heater should allow for complete gravity draining of the heater.
• Temperature Control
  • Maintaining an accurate fluid temperature is essential for the efficiency of the cleaning process.
  • Temperatures may fluctuate more readily in steam-powered heat exchangers than electrically powered fluid heaters, leading to inconsistent cleaning results.

While fluid heaters are at the heart of the clean-in-place process, there are other considerations to be taken into account when designing an ideal CIP system. First, engineer your system for efficient operations. Easy access to the cleaning equipment is also important, especially during FDA inspections.

Most important, though, is a CIP line that’s designed for maximum cleaning against microbial agents. With this in mind, use the proper tanks for the cleaning agents. Fluid tanks should have smooth and continuous welds, be self-draining, and their interior surfaces should be round or tubular, not flat, with no ledges or recesses that could harbor contaminants.

Then, identify and use the proper cleaning agents for your particular application. Hypochlorites are ideal for cleaning stainless steel surfaces that come into direct contact with food. Peracetic acid can be used against all microorganisms and may be applied with either cool or warm water. Acid (anionic) is an effective cleaning agent for removing hard water films or milk stone (found in dairy operations). Finally, ozone-enriched water kills microbes as effectively as chlorine without the hazardous side effects that come with chlorine’s use, and has been approved by the FDA for use on food contact surfaces.

Your CIP system must also be designed for the correct fluid flow rate to ensure cleaning “turbulence” and thorough cleaning results. The fluid flow rate through the CIP system’s process piping should be greater than or equal to 5 feet per second. The flow rate is a function of the pump size—ideally, it should be able to produce a flow rate that’s at least four times greater than that required during cleaning operations, so selecting the proper fluid pump for your CIP system is critical.

Finally, your CIP system needs to be engineered with the proper connections between the component pieces. Avoid creating lively dead areas that are outside of the cleaning agent process flow. These too are ideal locations for pathogen growth.

Even the most carefully designed CIP system will need to be monitored on an ongoing basis once it’s in use to ensure that it’s working as intended. “Automation” does not equal “automated process control.” Several items in the CIP system need to be checked on a regular basis, including cleaning chemical concentrations, pH levels, and pump/metering device performance. Also, check the water chemistry on a periodic basis. Hard water can precipitate on surfaces and clog holes, compromising fluid flow and coverage. A well-designed and well-maintained CIP system will ensure that your food-processing line is operating at maximum efficiency, and delivering results that will minimize the likelihood of food pathogen problems.

Cartee is director of marketing and business development at M.G. Newell. Reach her at mimi.cartee@mgnewell.com. Nhan is marketing coordinator at Heateflex. Reach her at pnhan@heateflex.com.

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The ongoing recall of cumin and cumin-containing foods due to undeclared peanuts or almonds is almost certainly the result of purposeful economically motivated adulteration (EMA), food safety experts believe. Since late last year, food agencies in the U.S., Europe, and Canada have been tracking and reporting what the FDA calls the “largest recall of an allergen in spice.” About 700 different products have been recalled by more than 40 manufacturers and retailers in the U.S. alone since late last year.

“Although we don’t know who the bad guys are yet, it appears clear the motivation for the incident is economic gain, and that’s clearly food fraud,” says John Spink, PhD, director, Food Fraud Initiative, Michigan State University. David Acheson, MD, founder and CEO of The Acheson Group and a former FDA associate commissioner for foods, agrees. “I am 80 percent-plus confident that this is deliberate contamination. I can’t explain it otherwise,” he says.

One of the first companies to voluntarily recall products was Adams Flavors, Foods & Ingredients of Gonzales, Texas, which late last year declared it had been notified by a third-party supplier that one of its spice ingredients contained peanut proteins. Goya Foods subsequently recalled many of its black beans and black bean soup products while Whole Foods recalled more than 100 different products sold in its stores nationwide.

“This is likely to be one of the largest allergen recalls ever because spice mix becomes part of a sundry of products and the multiplier effect—the domino effect—is inevitable,” Craig W. Henry, PhD, vice president of business development for the Americas, Decernis LLC, tells Food Quality & Safety.

The geographic source of the adulteration is thus far unknown, but speculation centers on Turkey and India, the latter producing three-quarters of the world’s cumin supply. Higher-than-normal temperatures there have decimated the current cumin crop, with yields expected to be 40 percent to 50 percent less than those of past harvests. Prices have skyrocketed as a result. Dr. Acheson and others believe that suppliers there have added ground peanut shells and almond husks to “bulk up” ground cumin. “Adding just 1 percent peanut shells at zero cost is essentially a profit of $350 to $400 on a sale of 10 tons of ground cumin,” Dr. Acheson says. “Not a bad margin at zero cost for the grinder to put in their pocket.”

Recent laboratory testing of cumin samples has found a range of contamination. Tests performed by Neogen Corp. found contamination levels ranging from zero to 4.6 parts per million (ppm) total peanut to more than 5,000 ppm, or 0.5 percent, says Tony Lupo, director of technical services. Other labs have found even higher levels. “When they back calculate the peanut content in the cumin itself based on the inclusion rate in the recipe, it can be concluded that the cumin contained greater than 100,000 ppm or 10 percent,” Lupo tells Food Quality & Safety magazine. “Such levels, even when diluted in finished foods, are still well above published reference doses for many peanut allergic individuals.”

“Cumin is very commonly added to foods,” says Cary Sennett, MD, PhD, president and CEO of the Asthma and Allergy Foundation of America. There is no requirement that cumin or other spices be specifically identified on product labels. “Exposure to even a trace amount of peanut can be life-threatening to those who are allergic,” Sennett said in a statement.

The FDA has received eight reports from peanut-allergic consumers who reported mild to potentially severe symptoms after eating foods that contain the affected cumin, says agency spokesman Noah J. Bartolucci. But because the information is self-reported, FDA is unable to vouch for its accuracy or completeness. Nevertheless, “the current recall is the largest recall of an allergen in spice,” Bartolucci tells Food Quality & Safety magazine. FDA issued a consumer advisory in February cautioning people with peanut allergy to consider avoiding products containing ground cumin or cumin powder.

The U.K.’s Food Standards Agency (FSA) is also investigating peanut- and almond-tainted cumin. Chris Elliott, professor of food safety and director of the Institute for Global Food Security at Queen’s University Belfast, who last year led the U.K.’s horsemeat scandal investigation, said it was too early to draw firm conclusions. But, he noted, “whenever there’s a crop failure you always have to look to see what is the potential fraud that is behind that,” Dr. Elliott told The Independent newspaper. “This time the crop failure is cumin and it does seem to be that there has been fraud going on.”

The contamination in Europe has expanded beyond cumin to also include paprika. FSA and food safety agencies in Denmark, Sweden, and Norway have issued warnings that a taco seasoning spice mix made by Santa Maria UK contains undeclared almond. Lab testing revealed that paprika in the spice mix is the most likely cause. The company issued a recall. Back in the U.S., the Giant Food Stores supermarket chain in late January removed Szeged Hungarian Paprika from its shelves due to possible peanut contamination. There is no indication that the cumin and paprika cases are linked.

Intentional adulteration of spices is far from uncommon. Saffron, the world’s most expensive spice, has been found adulterated with glycerin, sandalwood dust, the yellow dye tartrazine, barium sulfate, and borax, according to a January 2014 report by the Congressional Research Service. Ground black pepper has been contaminated with added starch, papaya seeds, buckwheat, flour, twigs, and millet. Vanilla extract, turmeric, star anise, and chili powder are also prone to fraud, the report says.

“My instincts are that this is a real EMA situation,” Dr. Acheson says. “My advice to all those using cumin—and other spices that could be part of this EMA thinking—is to start testing incoming ingredients for allergens.” He also recommends companies seek to trace back their spice supply chains as far as possible. But “the tracebacks that I have personal knowledge of go a certain distance back and every vendor says they don’t have peanuts or almonds in their facility. So we don’t know where they came from,” Dr. Acheson tells Food Quality & Safety.

Agres is a freelance writer based in Laurel, Md. Reach him at tedagres@yahoo.com.

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Three federal agencies have developed a new method for analyzing the foods from 17 broad categories responsible for foodborne illness outbreaks from 1998 to 2012 that were caused by Salmonella, E coli O157, Listeria monocytogenes, and Campylobacter. The pathogens were selected because of the frequency or severity of the illnesses they cause and because targeted interventions can have a significant impact in reducing them. The CDC has estimated that these four pathogens cause 1.9 million cases of foodborne illness in the U.S. each year.

The Interagency Food Safety Analytics Collaboration (IFSAC), a partnership that includes the CDC, the FDA, and the USDA’s Food Safety and Inspection Service (FSIS), issued the report in February in conjunction with a public meeting about the new method. The report, “Foodborne Illness Source Attribution Estimates for Salmonella, Escherichia coli O157 (E. coli O157), Listeria monocytogenes (Lm), and Campylobacter using Outbreak Surveillance Data,” states that more than 80 percent of E. coli O157 illnesses were attributed to beef and vegetable row crops, such as leafy vegetables. Illnesses attributed to Salmonella were broadly attributed across many food categories, although 77 percent were related to seeded vegetables, such as tomatoes, and eggs, fruits, chicken, sprouts, beef, and pork.

About 66 percent of Campylobacter illnesses were attributed to dairy, with most of those outbreaks related to raw milk or cheese produced from raw milk; 8 percent of Campylobacter illnesses were attributed to chicken. Fifty percent of Listeria illnesses were attributed to fruit and 31 percent to dairy. Due to limitations in outbreak data and uncertainty in the estimates, IFSAC recommends caution in interpreting certain findings, such as estimates for Campylobacter in dairy and Listeria in fruits. IFSAC suggests that the results be used with other scientific data for risk-based decision making.

David Goldman, MD, MPH, assistant administrator for the Office of Public Health Science at FSIS, says that most of the food industry regulated by FSIS is aware of the pathogens and food combinations that have historically led to illness. This “point-of-consumption attribution model” developed by IFSAC analyzes the type of food that was consumed by the affected individual and the pathogen that led to the illnesses. “We don’t know the places where the contamination took place, whether on the farm, in the processing plant, in transit, or in the kitchen.”

According to Christopher Braden, MD, director of the Division of Foodborne, Waterborne, and Environmental Diseases at the CDC, “industry realizes that when we are talking about a food category, that gives them some information about where they should focus. Then they need to go in and see where the hazards really exist among the different foods within those categories.”

Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest, says that even though she is pleased to see IFSAC “making some progress and engaging stakeholders, I am also concerned that the project is moving too slowly to provide meaningful information for FSMA implementation.” She says the expert panel convened at the public meeting should “provide information on the top hazards linked to food commodities.”

Holliman is a veteran journalist with extensive experience covering a variety of industries. Reach her at kathy.holliman@gmail.com.

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Serious illnesses linked with consumption of nonpasteurized milk have increased in recent years, with most caused by Campylobacter spp. Although reports of illness associated with raw milk are publicized, interest in nonpasteurized milk continues, along with an increase in the number of states where its sale is legal or where access to raw milk is possible through cow-share programs.

The CDC’s Emerging Infectious Disease Journal reported in January that outbreaks associated with raw milk increased from 30 during 2007-2009 to 51 during 2010-2012. The number of outbreaks during that six-year period is four-fold higher than the number reported from 1993 to 2006. After Campylobacter spp., the most common pathogens found in raw milk were Shiga toxin-producing E. coli, Salmonella enterica serotype Typhimurium, and Coxiella burnetii. In 59 percent of outbreaks, at least one patient was younger than age 5. In addition to young children, people who are elderly or immunocompromised are most susceptible to these pathogens.

Also in January, the European Food Safety Authority’s Panel on Biological Hazards issued a report concluding that raw milk can contain several harmful bacteria such as Campylobacter, Salmonella, and Shiga toxin-producing E. coli. That group advised that even with good hygiene practices at farms and maintenance of the cold chain, the risk of infection cannot be eliminated. The group advised boiling raw milk before consumption.

This year, incidences of contamination have been reported in Arlington, Wash., where testing showed presence of Campylobacter in raw milk from a local farm, and in East Berlin, Pa., where the milk tested positive for the bacteria.

Consumption of nonpasteurized milk is currently advocated by its supporters as the “ultimate whole food” that contains high levels of calcium, beneficial bacteria, more vitamins, and other healthful qualities that are destroyed when the milk is pasteurized. According to the Northeast Organic Farming Association, buying this milk “is good for your family’s health, good for the farm and good for the environment.”

That position, however, is opposed by major health organizations in the U.S., according to Real Raw Milk Facts, a group of scientists that has compiled information on the key health and safety issues associated with nonpasteurized dairy products. The American Academy of Pediatrics supports a ban on the sale of raw milk and milk products because of the threat of disease and the evidence that pasteurization does not alter the nutritional value. This point of view is shared by the American Medical Association and other similar organizations.

Holliman is a veteran journalist with extensive experience covering a variety of industries. Reach her at kathy.holliman@gmail.com.

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A recent clinical trial found that feeding peanut products to infants who are at high risk of developing peanut allergies was safe and actually led to an 81 percent reduction in developing peanut allergies. Published in The New England Journals of Medicine, the study was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and was conducted by the NIAID-funded Immune Tolerance Network.

The study, called Learning Early About Peanut Allergy (LEAP), had researchers comparing two strategies to prevent peanut allergies—consumption or avoidance of dietary peanuts—in infants who were at high risk of developing peanut allergies because they already had egg allergies and/or severe eczema. More than 600 high-risk infants between 4 and 11 months of age were assigned randomly either to avoid peanuts entirely or to regularly consume at least 6 grams of peanut protein per week. Both regimens were continued until the children reached age 5. Participants were monitored throughout this period with recurring visits with health care professionals.

Researchers then conducted a supervised, oral peanut food challenge with the 5-year-olds. They found an overall 81 percent reduction of peanut allergies in children who began early, continuous consumption of peanuts compared to those who avoided peanuts.

Over the years, the food industry has been searching for ways to reduce peanut allergic reactions. “For a study to show a benefit of this magnitude in the prevention of peanut allergy is without precedent,” says NIAID director Anthony S. Fauci, MD. “The results have the potential to transform how we approach food allergy prevention.”

Prior to this latest study, parents were told to avoid allergenic foods for their young children. “While recent studies showed no benefit from allergen avoidance, the LEAP study is the first to show that early introduction of dietary peanut is actually beneficial and identifies an effective approach to manage a serious public health problem,” says Daniel Rotrosen, MD, director of NIAID’s Division of Allergy, Immunology and Transplantation.

However, pediatric specialists are concerned that parents are getting the wrong message regarding the safety of letting their children eat peanuts to prevent them from developing peanut allergies. The American College of Surgeons released an advisory that warns parents and caregivers about the risks of giving nuts to babies and infants, acknowledging that while The New England Journal of Medicine study did address these worries, much of the mainstream news coverage of the research has not.

“It is important that parents realize that exposure to peanut antigen in babies at-risk for allergy should take place in a physician’s office where the babies can be carefully monitored,” according to the advisory. “An appropriate trial should include the eating of smooth peanut butter while monitored and NOT the eating of peanuts!”

A follow-up study called LEAP-On will ask all LEAP study participants to avoid consuming peanuts for one year. These results will determine whether continuous peanut consumption is required to maintain children’s tolerance to peanuts.

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A garbage disposal can make food handling jobs a lot easier—having an simpler solution to dispose of all your food scraps and leftovers can make your establishment’s routine more efficient.

If you want to maintain a garbage disposal and ensure it serves you for a long time, it’s essential to take proper care of it as even the most durable and powerful disposals have their limits, which if ignored, over time can cause them to break down.

But how do you take care of a garbage disposal?

There aren’t any complex rules, but the following are some general do’s and don’ts that can make garbage disposal maintenance a lot easier.

Do make sure to use it often enough. When left unused, the garbage disposal can succumb to older leftovers forming strong and hard to clear obstructions.

Don’t over pour grease. Of course, there will inevitably be some grease with leftovers, but don’t make pouring grease into the disposal your primary option.

Do grind hard materials. While some say that you shouldn’t do it, why have a garbage disposal if you don’t use it for anything hard like bones or fruit pits? Doing this also has the added benefit of cleaning the inside walls and keeping it cleaner.

Don’t dispose of too many starchy foods. Banana and potato peels, or almost any peels for that matter, are not good matches with a garbage disposal if you want to use it for a long time. The starchiness of many vegetable and fruit peels can quickly form a thick and sticky paste, which can make cleaning the blades next to impossible. That doesn’t mean you can’t do it, just try to limit them, and if you have to do it often, make sure you clean it often as well (see below).

Do clean your blades with ice cubes. You should put a healthy dose of ice cubes down the garbage disposal at least once or twice per month—the smashed ice pieces will reach all the parts of the disposal, including hard-to-reach areas. This is probably the most effective way to clean a garbage disposal.

Don’t put glass, cigarette butts, and shells in the disposal. Glass or shells will inevitably damage it, sometimes even beyond repair, while cigarette butts will contaminate it with toxic chemicals and make it smell terrible, which will be very difficult to get out.

Do use lemons to take out nasty smells. Take a lemon, or even an orange/grapefruit, and run it through the garbage disposal—the acids will not only clean the walls, but will also kill any unwanted odors, as well as give the garbage disposal a nice, fruity smell that can last for quite some time.

Maintaining a garbage disposal that serves your industry needs for a long time is not easy—the stress that it has to withstand when dealing with various food scraps can, over time, make it less functional or break it altogether. Therefore a certain list of guidelines must be followed in its maintenance—regular cleaning, as well as limiting or completely avoiding running some materials through the garbage disposal are required to ensure its longevity.

Martinez, a professional blogger and creative content writer, is a marketing manager at Drain Visions. Reach him at immikemartinez@gmail.com.

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Wherever you travel around this country—and even internationally—you will likely hear the same rhetoric from dietary supplement manufacturers. Firms claim they have quality, something that their competitors do not, and they are doing it the right way despite not allowing an external audit for quality and compliance by a third party. When one of us hears this from a company, we typically respond by asking how they know this to be true, and we are left feeling surprised that more dietary supplement firms do not use a quality audit from a third-party certification organization to demonstrate the adequacy of their quality systems, considering its benefits to benchmark continuous process improvement and relatively low cost.

When you look up the word quality, you will find that it is an attribute or defining characteristic that has become the standard as measured against other things of a similar kind. In a world where we group according to the buckets of good, better, and best, quality is the degree or extent along the scale to that asymptote we call perfection, an impossible point we can never reach. Many may not be familiar with the teaching of W. Edwards Deming and his 14 points for continuous process improvement, but they are quality concepts that have passed the test of time. Deming was a U.S. statistician of mathematical physics, and a pioneer of modern quality management. He developed the founding principles of Total Quality Management and the System of Profound Knowledge. Deming introduced the DMAIC and PDC(S)A acronyms, which have been quoted in every quality seminar since the 1980s. DMAIC stands for Define Measure Analyze Implement and Control and PDC(S)A stands for Plan Do Check (Study) and Act. These acronyms and Deming’s 14 points of quality management gave birth to Six Sigma by Bill Smith of Motorola, many of the concepts of ISO9000 series and the ANSI Q90 series standards issued today for quality improvement, and Lean training of the ‘90s.

Keeping Up to Standard

Intrinsic to demonstrating quality for any firm is implementation of an external quality audit and certification to an industry standard. Given the choice available to the industry, there is no shortage of auditors for part 111 current Good Manufacturing Practices (cGMPs), but there is quality and, therefore, value in the services of an audit. The results of a third-party quality audit provide a benchmark assessment of the adequacy of the existing program as it sits statically in the present, and an assessment of weaknesses to drive continuous process improvement into the future.

The Natural Products Association (NPA), formerly the National Nutritional Foods Association, created the first GMP standard for performing quality audits as well as certification in the dietary supplement industry. NPA is committed not only to advocating for the rights of manufacturers, suppliers, and retailers to have a marketplace in which to sell products but also to consumers having access to quality products in order to maintain their health and well-being. NPA has developed a long and diverse array of self-regulatory initiatives and programs, all of which were firsts for the natural products and dietary supplement industry.

To advocate both consumer and industry concerns, associations will typically develop self-regulatory programs or initiatives which demonstrate industry transparency and maturity, and provide the consumer valuable information that can be used to evaluate products. The public and private benefits of industry self-regulation are numerous, and they typically outweigh the costs incurred to industry. First, self-regulatory programs and initiatives may lead to the establishment of product or ingredient standards to ensure quality and safety. In turn, these standards may facilitate the emergence of markets by establishing baseline levels of product quality and safety; result in improved consumers’ understanding; impart brand recognition through seals/marks representing third-party certification; induce brand loyalty; and garner trust of new products.

Standard setting and implementation can be a further benefit to manufacturers by lowering production costs, which can be passed on to the consumer. For example, a standard can be established to assist manufacturers in producing interconnecting or interchangeable parts. Especially in high-tech industries, standards assure a manufacturer that if its product conforms, the product will interconnect with complementary or rival products of similar specifications. But most important in the days of the global marketplace is that industry self-regulation helps consumers evaluate products and services by providing information about the qualities and characteristics of the seller’s products.

Filling a Need

In 2014, NPA’s GMP Certification Program entered its 15th year of verifying for consumers that dietary supplements are manufactured according to the highest standards. Prior to the GMP final rule roll out in 2007, dietary supplement manufacturers were only required to adhere to GMPs for foods (21 CFR Part 110), which were largely enforced by local and state health departments. The association recognized that while food GMPs are certainly significant in regards to controlling general sanitation practices and monitoring sink log records, they did not address product quality with regard to specifications including identity, purity, strength, and composition, as well as incorporating process control and quality control features to prevent mix-up and contamination which could potentially render a product adulterated. NPA in conjunction with some of the other industry trade organizations helped develop a model for the GMP regulations and passed it to the FDA in late 1995. This model served as the basis for the 1997 FDA proposed GMPs in the form of an advanced notice of proposed rulemaking.

Rather than wait for the FDA to finalize the proposed rule, the association began developing its own GMPs to ensure quality. The NPA GMP audit program was launched in January 1999, with the first certifications issued in July of that same year. NPA’s GMP education seminars were also rolled out in 1999. The program has awarded certification to more than 106 member companies, ranging from some of the largest manufacturers to the smallest in the industry, including both domestic and foreign firms, representing more than 45,000 finished products and thousands of raw materials.

When the program was first launched, the goal of the GMP Certification program was to ensure that all elements of the manufacturing process are reviewed so that products meet their intended quality. Third-party on-site inspections of manufacturing facilities cover such areas as filth control and cleanliness of equipment, facility, and grounds, establishment of a quality control unit, test methods, expiration dating, and procedures for storage and distribution. The third-party certification program includes inspections of dietary supplement manufacturing facilities to determine whether specified performance standards on a number of measures—including quality control, cleanliness, receiving, and testing of raw materials—are being met. A member supplier must receive an “A” rating in order to be certified. Those who receive either a “B” or “C” rating must correct deficiencies and submit for a re-audit.

Continued Improvements

The NPA GMP program was amended in 2008 to incorporate the requirements introduced in the long awaited FDA cGMPs Finalized Rule for dietary supplements (21 CFR Part 111). The program holds great value for the industry for a number of reasons but none more significantly than reducing exposure to regulatory vulnerability. It is important to note that a product failing to meet the FDA cGMPs is considered a technical adulteration. FDA will not provide help to a manufacturer or distributor to prepare for the GMP inspection, nor will it offer certification.

The objectives of the GMPs from the FDA’s perspective are to provide the general public with unadulterated products that are not misbranded and meet their respective label claims. Thus, those manufacturing firms and distributors that seek to evaluate their state of compliance, have an expert third-party review their facility in preparation for an FDA inspection, or need very skilled and detailed assistance with their quality system to bring it to a state of compliance can use a third-party certifier to address that regulatory need.

To assist firms and present the 815-page GMP Final Rule in a more condensed, palatable form, NPA offers GMP education and training alongside the certification program. The seminar education has expanded to incorporate claims training to highlight the differences between permissible structure/function claims and unauthorized disease claims, New Dietary Ingredients, and requirements of various business models to the GMP Final Rule by former top agency officials.

NPA has recently partnered with UL, which has more than 100 years of experience in the testing and certifying of products. Its name is recognized universally by retailers, consumers, and suppliers of U.S. products, materials, components, and systems. NPA and UL are developing education to train both quality auditors and the dietary supplement industry. One problem with third-party auditing and certification bodies is the lack of transparency displayed so firms can know the true quality of their auditors. NPA and UL are developing unique training in GMPs, Safe Quality Foods, and new changes with the Food Safety Modernization Act designed specifically for auditors. The process in how auditors are qualified to perform quality audits will provide much needed transparency and enable auditors to better think like agency investigators.

Third-party quality audits are a tool that should be used more in the dietary supplement industry as a management tool for determining the effectiveness of one’s quality systems in place. There is no excuse for failing to meet FDA cGMPs. A plethora of resources is available to ensure firms are compliant. Don’t risk falling victim to an avoidable mistake—take advantage of resources that have regulatory experience to help navigate your way through compliance.

Dr. Fabricant is the executive director and CEO of the Natural Products Association. Reach him at Daniel.Fabricant@npainfo.org. Dr. Hilmas serves as senior vice president of scientific and regulatory affairs. Reach him at corey.hilmas@npainfo.org.

The post Supporting Claims of Quality in Supplements appeared first on Food Quality & Safety.

Validity of DNA barcode testing of supplements that contain herbal extracts is being questioned following the New York Attorney General Eric Schneiderman’s order that four retailers in the state discontinue selling their store-brand products, including echinacea, ginseng, garlic, ginkgo, saw palmetto, St. John’s wort, and valerian. DNA barcoding showed that only 21 percent of the store-brand supplements contain the plants listed on the labels and that many products do not contain any DNA from a botanical source.

The attorney general also issued subpoenas requiring that the companies provide support for the health claims printed on the labels of these supplements. The supplements have now been removed from the retailers’ shelves in New York.

Nandukumara Sarma, PhD, director of dietary supplements at U.S. Pharmacopeia (USP), says that DNA barcoding is not the best test for supplements that contain extracts. USP is a scientific, nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and supplements.

“Use of solvents and/or heat during extraction process can degrade—and sometimes destroy—DNA in extracts material. … The presence or absence of DNA in an extract should not be used to confirm the identity of an ingredient in the form of a plant extract,” Dr. Sarma says in a statement. DNA barcoding is a valid and useful technology, but “it is envisioned as a method to be applied mostly to non-extracted plant materials and as a complement to other chemical tests.”

Daniel Fabricant, PhD, CEO of the Natural Products Association, says that chemical analysis or chromatography should be used instead of DNA barcoding. “Once you get an extract, there essentially won’t be any DNA left. All of the products were extracts so we wouldn’t expect there to be any DNA,” he says. Use of DNA barcoding for testing supplements containing herbal extracts is “like using a screwdriver to hammer a nail and then saying the lumber was bad. It’s over-reaching and nonsensical.”

The American Botanical Society (ABS) concurs. “Microscopy and validated chemical test methods, like those found in official pharmacopeias for these seven herbs, should have been conducted to confirm the DNA findings. … We respectfully must question whether an appropriate level of scientific rigor has been applied in this case.”

The ABS has initiated the Botanical Adulterants Program to educate the herbal and dietary supplement industry about ingredient and product adulteration. It is partnering with American Herbal Pharmacopoeia and the University of Mississippi’s National Center for Natural Products Research. The program is focusing on both accidental adulteration of botanical ingredients that can occur due to poor quality-control procedures, and also on intentional adulteration. It hopes to serve as a self-regulation resource so that industry can address these problems through education rather than federal regulation. The program also intends to provide comment and guidance on the strength and/or weakness of different analytical methods used in the industry.

Holliman is a veteran journalist with extensive experience covering a variety of industries. Reach her at kathy.holliman@gmail.com.

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Food dyes may be useful for more than just giving your cherry Jell-O that vivid red hue. In research described at the annual meeting of the Biophysical Society in early February, a team of food scientists from Rutgers University in New Jersey has found that common food dyes have the potential for use as edible probes of food quality.

Standard fluorescent dyes used as probes in other fields are generally unsuitable for food quality testing, as they are either too toxic for human consumption or too expensive. But the Rutgers scientists say that the edible colors that already either occur naturally in, or are added to, many foods have the potential to act as fluorescent probes.

“Almost every food you eat is fluorescent under some circumstances,” says Richard Ludescher, PhD, a professor of food science at Rutgers. “With a range of applications, we are trying to establish the idea of using molecules that are naturally in or routinely added to food as intrinsic sensors of the quality of the food.”

Sarah Waxman, an undergraduate student in Dr. Ludescher’s lab, presented preliminary findings at the Biophysical Society meeting. The group tested the fluorescent properties of five edible food colors commonly added to food or medications consumed by humans: Allura Red, Sunset Yellow, Brilliant Blue, Fast Green, and a yellow dye called Tartrazine. All five colors fluoresced in a way that was easily distinguishable from the background; they emitted almost no light in pure water, but the light intensity increased when the dyes were added to thicker solutions.

“We’ve established that these molecules respond to viscosity in simple solutions like sugar water and glycerol water,” says Dr. Ludescher. “Next, we need to find out how they respond in more complicated compositions like foods—a pudding, for example. Could we develop a probe for pudding that allows you to measure its viscosity during manufacture?”

The group’s work is supported by funding from the USDA.

Shaw writes frequently about science, medicine, and health while serving as a regular contributor on notable medical publications.

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As 2015 unfolds, federal, state, and local governments will be ramping up their oversight of food growers, producers, and processors in the drive to improve the safety and security of the nation’s food supply system. But with financial and other resources lagging or remaining modest at best, this task promises to become more challenging as the global supply chain expands and imports from China and other questionable countries increase.

All this will continue to put pressure on the private sector to take responsibility for food safety. By the latter half of this year, the FDA will publish final regulations to implement five major provisions of the Food Safety and Modernization Act (FSMA). These include final rules for preventive controls for human food and preventive controls for animal food by the end of August, and final rules for produce safety, the Foreign Supplier Verification Program, and third-party accreditation by the end of October. The FDA in September 2014 had issued proposed minor revisions to the first four of these rules, for example, clarifying definitions of small and very small businesses and outlining activities that would re-categorize a traditional farm into a food facility subject to FDA registration and inspection.

Because many of the proposed new changes had been triggered by earlier comments from industry, the final rules are likely to be very similar the second time around. “We don’t expect to see much change in the final rules, particularly as the re-proposals filled in some of the expected gaps in the preventive control rules around environmental monitoring, supply chain controls, and product testing,” says David Acheson, MD, founder and CEO of The Acheson Group and a former FDA associate commissioner for foods.

“The big challenge in 2015 will be FDA’s obvious lack of resources,” Dr. Acheson says. “What will get expensive for FDA is building the FSMA training programs, the education strategies, and the outreach that the agency needs to do with different countries and industries. Unfortunately those resources will be lacking,” Dr. Acheson tells Food Quality & Safety magazine. “Many small- and medium-sized food companies will be totally clueless about what they need do to comply with FSMA,” he adds. But they will have two to three years to comply with the regulations and thus have some breathing room. Big food companies, on the other hand, have only one year to comply after the final rules are published but because most of them have been preparing, they should be well positioned.

Budget Status Quo

The current fiscal year ends Sept. 30, 2015 and thanks to last December’s enactment of the Consolidated and Further Continuing Appropriations Act, 2015 (HR 83), the Fiscal Year 2015 budgets for FDA, USDA, CDC, and other food-related federal agencies are locked into place. Under the $1.1-trillion “cromnibus” (for “continuing resolution” and “omnibus”) spending bill, FDA’s budget rises to $4.44 billion, a $96.7 million (2.2 percent) increase over Fiscal Year 2014. Of this total, about $2.59 billion comes from public funding, which is $37 million (1.5 percent) more than the agency received last year and $4 million more than the White House had requested. The $1.85 billion balance comes from new and existing industry user fees, imposed mostly on manufacturers of prescription and generic drugs, medical devices, and tobacco products.

FDA’s Center for Food Safety and Applied Nutrition gets $903 million and the Center for Veterinary Medicine receives $147 million. Food safety activities within these and other FDA centers and offices increase by only $27.5 million over the 2014 funding levels (the White House had originally requested an increase of $263 million, the lion’s share of which would have come from user fees). Nevertheless, any increase is vital because the agency estimates it will need $300 million over the next two to three years to fully implement FSMA. Much of this would be used to hire and train more inspectors, improve the agency’s aging IT infrastructure, and partner with and provide cooperative assistance to federal, state, and local government agencies to implement many FSMA regulations.

“I don’t believe FDA will have enough resources to pay the states all they need and the states will not have the funding to do it on their own,” Dr. Acheson says. For example, state agencies have traditionally been responsible for inspecting farms while USDA’s Agricultural Marketing Service (AMS) inspects, certifies, and grades agricultural and other farm products. Under FSMA, FDA will have the authority to inspect certain food safety issues on larger farms, a responsibility it would prefer to delegate. “AMS inspectors are trained in food quality and in grading, not in food safety,” Dr. Acheson says. “Someone will have to pay for their training as food safety professionals.”

Last year, public health organizations including the Pew Charitable Trusts, the American Public Health Association, and the Association of Public Health Laboratories pressured lawmakers to increase FDA’s funding for FSMA. Expect to see similar actions this year especially because of worries that the fiscally-minded, Republican-controlled Congress may be reluctant to grant the agency significant additional funding. Indeed, there already are signs of congressional mistrust; the funding bill gives the inspector general at the Department of Health and Human Services (FDA’s parent agency) $1.5 million extra to conduct oversight investigations of the FDA. The bill notes that FDA’s resources have increased by more than 60 percent over the past five years as its responsibilities have grown, but effective oversight has not kept pace.

The real reason appears to be more deep-seated. “During the past year, FDA has informed non-governmental stakeholders of important decisions and announcements before they informed the [congressional] committees,” according to an explanatory statement of the funding bill, which also carries the weight of law. “A collaborative working relationship between the committees and the agency is necessary to ensure efficient and effective implementation of Congress’s funding decisions. These actions jeopardized this relationship. As such, FDA is directed to ensure the committees are notified of major changes to existing policies and any significant developments in its operations prior to providing non-governmental stakeholders such information.”

The funding bill gives the CDC nearly $405 million to respond to the growing threats of emerging and zoonotic infectious diseases. Of this amount, nearly $48 million is dedicated to food safety, an increase of $8 million for the agency to acquire “advanced DNA technology to improve and modernize diagnostic capabilities and enhance surveillance, detection, and prevention efforts at the state and local levels.” CDC labs receive an additional $7.25 million to “establish cutting-edge lab diagnostics to improve rapid identification and detection of emerging pathogens; establish an innovative e-pathology system to speed communication and establish virtual specimen sharing in real time; and increase research capacity and safety in high-containment labs.”

USDA Inspections

The funding bill also allocates slightly more than $1 billion to USDA’s Food Safety and Inspection Service (FSIS). In order to counter economic fraud and improve the safety of the nation’s seafood supply, FSIS, in conjunction with USDA and FDA, “is encouraged to support developing technologies that will provide rapid, portable, and facile screening of food fish species at port sites and wholesale and retail centers,” the explanatory statement says.

As part of its emphasis on prevention of foodborne pathogens, FSIS this year hopes to encourage private facilities to voluntarily develop food defense plans to prevent intentional contamination, with the goal of achieving 90 percent compliance by September 30. FSIS also wants to develop new and enhance existing policies, procedures, notices, and directives to industry to sample, test, and establish new Salmonella performance standards for raw ground chicken and parts, raw beef, and raw pork. It will also direct more than 80 percent of its investigative and enforcement activities on food safety issues. In July, FSIS is expected to finalize recordkeeping regulations that will require all establishments and retail stores that grind raw beef products intended for commerce to maintain records of their suppliers.

China Food Not Welcomed

The 1,600-plus-page funding bill has been criticized because lawmakers inserted a number of amendments of particular interest to them or their constituents that otherwise would not have been passed into law. One of these provisions bars poultry that is processed and cooked in China from being used in the nation’s school lunch and breakfast programs, the Child and Adult Care Food Program, and the Summer Food Service Program. FSIS had previously granted approval to four Chinese poultry processing plans to export cooked chicken to the U.S. so long as the birds had been raised and slaughtered in the U.S., Canada, or Chile. The decision raised red flags, so to speak, among U.S. consumer and other groups because of China’s abysmal food safety record.

Democratic Reps. Rosa DeLauro of Connecticut and Chellie Pingree of Maine, both members of the House Appropriations Committee, had added the amendment to the Fiscal 2015 USDA appropriations bill last spring and congressional leaders included the provision in the omnibus spending bill. “Banning Chinese chicken from school meals is a common-sense step to protect our kids,” DeLauro said in a statement. “China’s food safety record is atrocious, yet last year USDA deemed poultry processed in China to be as safe as poultry processed here. Children are among the most susceptible to foodborne illness. We cannot take unnecessary risks with their health.” China, predictably, was not pleased. China’s Ministry of Commerce spokesman Sun Jiwen urged the U.S. “to take effective measures to correct the erroneous practice and create a favorable environment for the healthy development of Sino-U.S. economic and trade relations.”

Despite this, Washington and Beijing will continue taking steps to improve food relations. Last November, Michael R. Taylor, JD, FDA deputy commissioner for foods and veterinary medicine and point person on FSMA, met with food safety officials in Beijing to discuss improving collaboration. “The legal, regulatory, and technical gaps between our systems are challenging, but we think they can be overcome with sustained effort,” Taylor told a food conference in Shanghai at the time. He also announced that FDA hopes to triple the number of full-time staffers in China who focus on food safety—from four to 12.

Agres is a freelance writer based in Laurel, Md. Reach him at tedagres@yahoo.com.

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