Gretchen Goetz | Food Safety News

Study: Chlorine Dioxide Gas Offers Hope for Sprout Sanitation

Gretchen Goetz — Mon, 01 Dec 2014 06:01:22 +0000

Chlorine dioxide gas may be an effective tool for combating Salmonella on sprouts, according to a new study. Researchers at Rutgers University and the U.S. Department of Agriculture’s Agricultural Research Service (ARS) have found that chlorine dioxide gas is more effective at killing Salmonella on bean sprouts than chlorine wash — the industry-preferred decontamination technique. The scientists found that the chlorine dioxide gas was able to reduce the presence of Salmonella on bean sprouts by 99.999 percent, compared to a 99-percent reduction achieved with chlorine wash. Sprouted seeds have a long, and poor, contamination record. The warm, moist environment in which they are grown also provides the perfect growing conditions for pathogenic bacteria, most commonly Salmonella, E. coli or Listeria. Since 1995, at least 51 outbreaks in the U.S. and Canada have been linked to sprouts. Of those outbreaks, 39 were linked to Salmonella. The largest known E. coli outbreak in history was linked to radish sprouts in Japan in 1996. At least 8,500 people were sickened and 12 died in that outbreak. National sandwich chain Jimmy Johns permanently dropped sprouts from its menu in 2012 after a series of outbreaks were linked to sprouts served at its restaurants. Just last week, the U.S. Centers for Disease Control and Prevention said it is investigating an ongoing multistate outbreak of Salmonella Enteritidis in the Northeast linked to bean sprouts. As of Nov. 24, 68 people in 10 states were known to have been sickened. While the sprouted seed industry has been searching for a surefire way to sanitize its product, cleaning sprouts is tricky because the food is sensitive and any harsh treatment could affect its color or taste. Sprouts are also harder to treat because, as with other fresh produce, the porous, uneven surface of sprouted seeds provides many places for bacteria to tuck themselves away. “There are areas we don’t see,” Dr. Bassam Annous, ARS research microbiologist and lead author of the paper, explained in an interview. “They look smooth, but really, if you go into the micro level, it looks like mountains and valleys.” In these valleys, bacteria can be harder get at with aqueous sanitizers because they are protected by trapped air molecules. “It becomes harder to kill because it’s living in a protective environment now,” he said. This is where, according to Annous, gas can be more effective than aqueous sanitizers because it is able to penetrate these protective air bubbles and expose bacteria. Water-based solutions, on the other hand, cannot penetrate these areas. Annous likened it to a wine bottle. If the bottle is full of air, the air must be forced out in order for it to fill with wine. The researchers found that applying the chlorine dioxide gas to sprouts in a tumbler was more effective than applying it to stationary sprouts laid out on the bottom of the chamber into which the gas is funneled. This way, the gas could reach all sides of the sprouts. The sprouts used in the experiment were exposed to Salmonella in a manner meant to imitate what contamination would be like in the real world, Annous said. The scientists used Salmonella strains collected from patients during three past U.S. sprout-related Salmonella outbreaks to make sure that the types of Salmonella they were using were indeed the type that could cause widespread Salmonella illnesses in humans. They soaked the sprouts in a cocktail of the three Salmonella strains for five minutes and then let them sit overnight so the Salmonella grow and develop biofilm, a protective layer that shields the bacteria and provides it with nutrients. The sprouts were then treated with either chlorine wash or chlorine gas, either in a tumbler or not, and for varying degrees of time. The chlorine wash achieved a 2-log, or 99-percent, reduction in Salmonella levels, as opposed to the 3-, 4- and 5.5-log, or 99.99-percent, reductions achieved by the chlorine dioxide gas. Longer exposure times and being in the tumbler contributed to the highest log reductions. “It gets the job done,” said Annous of the chlorine dioxide gas. Chlorine wash is currently the recommended best treatment for reducing sprout contamination. The International Sprout Growers Association requires a treatment of chlorine wash and adherence to good manufacturing practices (GMP) in order for growers to be certified by its voluntary quality assurance program. Other options for sanitizing sprouts include heat treatment of seeds, treatment with ozone, a highly reactive form of oxygen, or irradiation. All of these methods significantly reduce, but do not eliminate, pathogens from sprouts, according to the U.S. Food and Drug Administration’s sprout safety recommendations. When asked whether or not chlorine gas treatment would be expensive for the industry to implement, Annous said it would be cost-effective in the long run. While it would be expensive to buy and install the necessary equipment, the cost would go down after implementation. Plus, he noted, “It’s a lot cheaper than recalling your product, shutting down your plant and going through litigation if, god forbid, there’s an outbreak.” Annous said he’s working on another research project to design a sealed bag that will release chlorine dioxide gas to treat a sprout once it’s been packaged, thus providing a kill step after the final stage of production. Evidence shows that sprouts carrying bacteria are most often contaminated in the seed phase, according to FDA. But improper handling during or post-growing has also contributed to contamination. Annous is also working with other researchers to use chlorine gas to sanitize seeds before sprouting. While the bean sprouts used in this study could be treated with gas after sprouting because they are white, he said that green sprouts, such as alfalfa sprouts, would be bleached by the process. However, a seed is much tougher, and treating a green sprout in its seed phase will not compromise its color once it grows. The other authors of the paper include Kit L. Yam and Vara Prodduk of Rutgers, The State University of New Jersey, Department of Food Science, and Linshu Liu of USDA ARS Dairy and Functional Food Research Unit.

Chicken ‘Juice’ Helps Campylobacter Thrive in Kitchens, Study Finds

Gretchen Goetz — Mon, 24 Nov 2014 07:04:20 +0000

The liquid that comes off of a defrosting chicken provides a safe harbor for Campylobacter, according to a new study. Chicken “juice” from a defrosted bird turns a surface into a protein-rich environment in which Campylobacter can form a protective biofilm, reported a study from the Institute of Food Research. This biofilm helps bacteria attach to things and survive tough conditions. The researchers used strains of Campylobacter jejuni, the form of the bacteria that causes 90 percent of Campylobacter foodborne illness infections, for the study. While all Campylobacter usually has trouble living outside its natural environment, a chicken’s gut, chicken juice turns a formerly unfriendly surface into one that attracts Camplyobacter biofilm, found the researchers. “This film…makes it much easier for the Campylobacter bacteria to attach to the surface, and it provides them with an additional rich food source,” said Helen Brown, a PhD student at IFR, funded by the Biotechnology and Biological Sciences Research Council. Brown’s studentship is co-funded by Campden BRI, in a statement. While other types of molecules from animals, such as bovine serum proteins or milk, either slow or inhibit biofilm formation, the liquid expelled by chicken enhances it, according to the paper. “This study highlights the importance of thorough cleaning of food preparation surfaces to limit the potential of bacteria to form biofilms,” said Brown. Researchers designed the experiment to imitate conditions in an industrial kitchen, putting chicken juice on stainless steel surfaces. While the presence of chicken broth increased Campylobacter attachment and growth, the concentration of chicken broth didn’t make a difference. More concentrated broth did not help Campylobacter biofilm to attach and grow. Chicken broth also evened the playing field for different strains of Campylobacter. Strains that have no flagella, or tail, usually attach to surfaces and form biofilms more easily, but chicken broth made it easier for strains without flagella to attach to surfaces too, according to the study. The researchers said their findings point to a need for more research on animal juices and bacteria. “This highlights the need for future studies to not only investigate the link between chicken or pork soil and surface conditioning but also assess the effect of other meat exudates on biofilm formation,” reads the paper’s conclusion. The study was published ahead of print Sept. 5 in Applied and Environmental Microbiology.

Pharmacopeial Convention Publishes Guidance for Combatting Food Fraud

Gretchen Goetz — Wed, 19 Nov 2014 07:02:10 +0000

The U.S. Pharmacopeial Convention (USP) Monday released a comprehensive plan to combat food fraud for monetary gain. The USP said the new guidance is designed to help food manufacturers and regulators pinpoint which food ingredients are most likely to be adulterated by a supplier, and to advise the best way to prevent this act — officially known as economically motivated fraudulent adulteration of food products (EMA). EMA can be especially tricky to fight since it’s hard to predict where to find it, explained Dr. Jeff Moore, senior scientific liaison for USP, a nonprofit organization that sets food and medicine safety standards, in a statement Monday. “The output from implementing this tool provides users with a basis for making informed, vulnerability-based decisions on how to deal with EMA within their organizations,” said Moore. The goal of the plan is also to help regulators identify what food fraud control measures have been taken and to “track the source of food fraud should it occur,” according to Moore. The document targets a specific type of food fraud — substituting non-authentic or substandard ingredients for real ones or removing authentic ingredients without the knowledge of the buyer for economic gain. Economically motivated food fraud can not only harm the food manufacturer — who is paying more for a substandard good — but can also harm the consumer. For example, if an ingredient is labeled as one thing but is actually another, consumers allergic to the unlabeled ingredient are at risk of a reaction. EMA is an issue both industry and regulators have recently become more determined to recognize and address. In October 2011 the Government Accountability Office recommended that FDA formally define EMA and and publish guidance on the problem. FDA subsequently created the Workgroup on Economically Motivated Adulteration. The agency is currently seeking comments on the topic to help finalize its rule. The federal Congressional Research Service (CRS) said in a report on EMA January of this year that Congress has “not addressed food fraud in a comprehensive manner.” It pointed out that food fraud is not defined as the responsibility of one single agency, but said the problem is “broadly addressed through various food safety, food defense, and food quality authorities as well as border protection and import authorities across a number of federal agencies.” Research defining the scope of food fraud is relatively new, but has started to grow in the past few years. “Economic adulteration and counterfeiting of global food and consumer products is expected to cost the industry $10 to $15 billion per year,” estimated the Grocery Manufacturer’s Association of America in a 2010 report. A 2013 study published in the Journal of Food Protection identified 137 unique incidences of EMA sine 1980. Seafood fraud was the most common type, with 24 incidences, followed by dairy (15), fruit juices (12), oils and fat (12), grain products (11), honey and other natural sweeteners (10), spices and extracts (8), wine and other alcoholic beverages (7), infant formula (5), plant-based proteins (5) and other food products (28). The goal of the USP tool is to help food producers formulate a fraud protection plan tailored to specific ingredients and to calculate those ingredients’ specific risk for adulteration. “The use of a framework such as the Guidance on Food Fraud Mitigation could offer manufacturers an opportunity to analyze their portfolio of ingredients and decide where to dedicate resources to protect the integrity of their food supply chains,” said Markus Lipp, Ph.D., senior director of food ingredients at USP, in an email to Food Safety News. The USP guide offers a step-by-step outline for identifying vulnerabilities in the supply chain and keeping fraudulent ingredients out. It also offers a way to predict the impact should EMA occur. The level of fraud risk for an ingredient, said Moore, depends on many variables. “The vulnerability of food ingredients to EMA varies according to several factors, from the size and reach of the supply chain for a particular ingredient (the longer the supply chain, the greater the opportunity of EMA at any point) to geopolitical factors (the Guidance has the example of vanilla and the lack of availability because of political unrest in Madagascar, one of the few producers of vanilla beans), or market-driven demand for a particular ingredient (one example was when guar gum started being used by the natural gas industry, which raised prices and exposed guar gum to adulteration where it didn’t exist before),” said Lipp. The components of the plan include:

1. Identify the fraud vulnerabilities of an ingredient based on factors such as its fraud history, the buyer’s testing frequency, the relationship with the seller, and that ingredient’s supply chain.

2. Potential impacts assessment: identify how economic adulteration of a certain ingredient could impact public health and company profit or, on the regulatory side, confidence in regulatory officials.

3. Develop an appropriate mitigation strategy, bringing the ingredient’s vulnerability to an appropriate level based on its potential impacts on food safety and economics.

The tool also provides real-life examples of economically motivated food fraud, how it was discovered and how it’s being prevented going forward. EMA vulnerabilities must be continuously assessed, according to the guidance. Changes in any of the factors (e.g., economics surrounding the ingredient, change in supply chain, change in geopolitical status for a region) may all indicate the need for an updated vulnerability characterization,” reads the document. Lipp said USP also submitted the guidance to FDA this week, arguing that EMA should be considered its own category of food protection, and should not be lumped into the category of “preventive controls,” where it is currently filed with the agency. See past Food Safety News coverage of economically motivated food fraud: Tests Show More Honey Isn’t Honey Seafood Fraud: A Threat to Your Health, or Just Your Pocketbook?

GAO Finds Fault With Government Tests for Pesticide Residues

Gretchen Goetz — Mon, 10 Nov 2014 07:02:20 +0000

Government agencies in charge of monitoring food for pesticide residues must step up their testing programs, said the Government Accountability Office in a new report. While data collected by these agencies has shown low levels of pesticide residue violations in the past few years, shortcomings in sampling methods mean some residue violations may be going undetected, according to the report, published Friday. GAO recommended that the agencies report shortcomings in their methodology to make the significance of their findings clear. Three government agencies — the U.S. Food and Drug Administration, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) and USDA’s Agricultural Marketing Service — are responsible for testing the U.S. food supply for pesticide residues. FDA’s and FSIS’s findings are used to enforce the residue tolerance levels set by the Environmental Protection Agency, while AMS’ data is used to give EPA an idea of dietary exposures to pesticides from year to year. In its report, GAO found that both FDA and FSIS should disclose the limitations of their testing programs in their pesticide residue reports, in accordance with best practices set forth by the Office of Management and Budget. FDA should also examine the possibility of making its sampling program statistically significant, recommends the report. FDA’s sampling program is not statistically valid, the study found, because it targets foods that have already been shown to have higher residue levels in the past rather than selecting samples completely at random. This means that findings of pesticide residues, or a lack of residues, cannot be extrapolated to reflect a greater trend. Without a random sampling method, FDA, which is responsible for testing all produce, dairy products, seafoods and spices, cannot determine the overall incidence of pesticide residues in bigger populations of foods, such as domestic or imported foods, or a certain commodity. The report also found that FDA’s new tool for identifying foods that might be more likely to carry high levels of pesticides is flawed because it relies on multiple sources of information. In addition, FDA does not test for many pesticides for which EPA has set tolerance levels, found GAO, a fact it said the agency should disclose in its reports. In its review of FSIS’s testing, GAO said the agency, responsible for animal products, does have a statistically sound sampling method. GAO noted that FSIS dramatically reduced the frequency of its residue testing between 2000 and 2009, over which time the number of samples collected dropped from 8,000 to under 1,900 per year. Since 2010, however, that number has started to climb up again as FSIS works with EPA to expand its testing capabilities. GAO also noted that, like FDA, FSIS does not test for all pesticides with established tolerances. After updating its equipment to be able to test for more pesticides, FSIS is now testing for 85 of the 207 substances on EPA’s priority list. Both FDA and FSIS should disclose which pesticides for which they are not testing, despite the fact those chemicals have established tolerance levels, said GAO. The report generally praised AMS’s residue testing program. While the agency has some minor problems with its methodology, according to GAO’s findings, it has a robust sampling program that provides “valuable information on the incidence and level of pesticide residues in food.” GAO acknowledged that the bulk of the pesticide monitoring task falls to FDA. The agency is responsible for monitoring residues in approximately $400 billion worth of domestic foods and $50 billion in imported foods. In response to GAO’s study, FDA said it is expanding its pesticide testing program, but that its top priority is preventing human illness from microbiological contamination in these same foods, so that is where it allocates the bulk of its resources. FDA also noted that implementing a statistically valid sampling program would require significantly more resources, and that it uses data from AMS too identify problem foods to assign certain commodities to a higher risk category. History of Pesticide Residue Testing In 1996, the Food Quality Protection Act mandated that the Environmental Protection Agency reassess all existing tolerance levels for pesticides used on food that had been approved for use before November of 1984. By 2007, EPA had completed 9,721 reassessments, which are now used to determine whether detected pesticide residues are at safe levels. Since the reassessments, the use of certain pesticides, such as organophosphate insecticides, which were shown to be toxic at high levels, have decreased significantly. U.S. farming operations used an estimated 684 million pounds of conventional pesticides in 2007, the most recent year for which data is available. GAO noted that it’s difficult to associate the amount of pesticides used with the risk to human health, since they constitute such a wide variety of chemicals in varying amounts. “We were unable to find publicly available estimates of the overall toxicity or risk associated with the use of agricultural pesticides in the United States,” note the authors.

Nonprofits Sue FDA Claiming Agency Hasn’t Proven Safety of Animal Growth Drug

Gretchen Goetz — Fri, 07 Nov 2014 05:03:16 +0000

A trio of food safety and environmental advocacy groups Thursday filed suit against the U.S. Food and Drug Administration, saying the agency has not sufficiently proven that ractopamine, a drug fed to pigs, cattle and turkey, is safe for animals, humans who eat them, or the environment. Ractopamine, a beta-agonist, increases the rate at which animals convert feed to muscle by mimicking the body’s stress hormones. It is typically fed to livestock in the weeks before slaughter to promote weight gain. The FDA approved ractopamine for use in pig feed in 1999, but since that time the potential affect of the drug residue on humans and on the environment has come into question. Several governments, including the European Union, China and Russia have banned the import of ractopamine-fed pigs, saying they don’t know enough about the drug’s safety to approve it in food animals. Now three concerned groups — Center for Food Safety, the Center for Biological Diversity and the Sierra Club — are claiming that FDA, after approving 11 new uses for the drug, has not done enough to test the potential harmful effects of ractopamine on people, animals and the environment. The FDA has not conducted the environmental assessments needed to prove that the drug is safe for the humans, plants and animals living around farms where it’s used, says the complaint, filed with the United States District Court of Appeal for the Northern District of California. This failure to conduct a proper assessment, they argue, is a violation of the National Environmental Policy Act. “FDA is basing controversial drug approvals on incomplete and inadequate environmental analyses,” said Paige Tomaselli, senior attorney for Center for Food Safety in a press release Thursday. “These drugs in our food supply impact the environment, thousands of farm workers, millions of consumers, and billions of animals. FDA cannot continue to abdicate its responsibility to do its job.” Ractopamine was first approved for use in pigs in 1999 under the brand name Paylean. FDA found that its manufaturer, Elanco, a division of Ely Lilly, sufficiently proved its safety in animals and for human exposure at the doses at which it would be used. Later on, the drug was approved for use in cattle (as Optaflexx) in 2003, and for use in Turkeys (as Topmax) in 2008. But the group that filed the Thursday complaint against the agency says more research needs to be done to keep up with the widespread and new uses of the drug — now given to 60 to 80 percent of pigs raised for food — and to track its effects on the environment. Ractopamine is excreted through animal feces, so if enough survives in the feces, it can be spread through fertilizer in fields, and could from there run off into water. The complaint says Topmax was unlawfully approved, as were subsequent ractopamine-based combination drugs, because the agency did not consider all possible repercussions for the environment when approving these new uses of the compound. Elanco has acknowledged the “potential leaching into the soil and groundwater from confinement areas” and the fact that the drug may enter waterways, a fact the complaint says necessitates more thorough research into its effects on these ecosystems and the people and animals in them. The groups also claim that there is insufficient research on the danger of ractopamine to humans. They cite one particular study, the only one conducted directly on humans, presented as part of Elanco’s safety tests to FDA, pointing out that one six male subjects were tested. However, the study’s author notes that this small human test was done only to determine which animal better reflected the human metabolization of the drug. In its report on the toxicology of ractopamine, FDA says that exposure to the drug for humans can lead to heightened heart rate and a higher systolic blood pressure. Over time, exposure to the drug can lead to abnormal heart rhythms, tremors, nervousness and metabolic problems. The drug is safe, however, says the agency, since the residues left in animals after slaughter don’t reach harmful levels. In tests of ractopamine residues in muscles, kidneys and liver, levels were in the parts per billion range, falling well below the concentration of acceptable daily intake (.25 parts per million in muscles, .75 ppm in liver and 1.5 ppm in kidney and fat). The groups who filed Thursday’s lawsuit say more must be known about human exposures to ractopamine now that the drug has expanded uses and a larger presence in the environment. To read more about the controversy of ractopamine safety, see past Food Safety News coverage: FDA Petitioned to Lower Ractopamine Limits for Meat, Review Health Impacts Codex Adopts Ractopamine Limits for Beef and Pork Animal Drug Used Widely in US Meat the Subject of Trade Dispute

Berkeley Puts First Soda Tax on the Books

Gretchen Goetz — Thu, 06 Nov 2014 06:33:50 +0000

The city of Berkeley, CA became the first municipality in the country to approve a tax on sugar-sweetened beverages Tuesday. Measure D, a proposal to levy a 1-cent-per-ounce tax on sugary drinks and syrups, passed easily, with 75 percent of voters approving it. Only a 50 percent majority was needed to push the measure through. Meanwhile in San Francisco, the city’s much larger neighbor across the Bay, a proposal to charge 2 cents per ounce on sugary drinks failed to get the two-thirds majority it needed to pass. San Francisco’s pro-soda-tax coalition had decided to aim for the two-thirds majority so that, if the measure was passed, the tax money collected could be earmarked for specific purposes, specifically nutrition and physical education programs. Berkeley’s soda tax will go to the city’s general fund. Despite the San Francisco tax’s defeat, voters showed that a majority of them support such a levy on soda, with 54.5 percent favoring the proposal. Berkeley’s new drink tax will apply to soft drinks and juices with any amount of added sugar, however low. Exempted from the tax will be sweetened milks, creamers, alcoholic drinks, infant formula and juices with only natural sugar content. The proposed rule was meant to be easy for voters to swallow, and therefore could only apply to drinks that are unequivocally bad for kids, said the writers of the measure. “We exempted milk products because they have nutritional value,” explained Martin Borque, executive director of the Berkeley-based Ecology Center, and a leader of the Yes on Measure D movement, in a press conference Wednesday. “We don’t like sugar-sweetened milk necessarily and had some internal dialogue about that.” At the same time, writers of the measure didn’t want to make concessions within the categories of drinks they decided to include, which is why drinks with lower amounts of added sugars will still be subject to the tax. In the lead-up to the election, Berkeley and San Francisco became proxies for the bigger nationwide battle between big soda and health advocates pushing to raise prices on sugary drinks. The election was the most expensive in Berkeley’s history. In that city alone, the beverage industry spent $2.4 million on the No on D campaign, according to Berkleyside.com. On the other side, former New York Mayor Michael Bloomberg, who ran an unsuccessful campaign to impose a soda tax in the Big Apple, poured $657,000 into supporting Measure D in the weeks preceding the election. About half of that money went to commercials run during the World Series, in which the Giants, the Bay area’s home team, played. The other half went directly to the Vote Yes on Measure D campaign. And in San Francisco and Berkeley combined, beverage giants spent over $12 million on anti-tax campaigns through the American Beverage Association California PAC, according to MapLight, a nonpartisan research center that tracks money in politics. The Coca-Cola Company was the biggest spender, contributing $5.8 million, with Pepsico close behind at $4.4 million, followed by Dr. Pepper Snapple Corp. at $1.8 million, Red Bull at $140,000 and Sunny Delight at $39,000. Bloomberg’s foundation decided not to invest in the San Francisco Yes campaign, as it felt the two-thirds majority would be too hard to overcome, said Howard Wolfson, Bloomberg’s senior advisor. Berkeley: anomaly or sign of a turning tide? The mood was high among the winners Wednesday. “It was a really exciting night last night to be in Berkeley,” said Josh Daniels, co-chair of the Vote Yes on Measure D campaign and president of the Berkeley Unified School District Board, at Wednesday’s press conference. “It was an incredible victory, a resounding victory.” “It’s a landmark day for our kids’ health, not just Berkeley but across the country,” seconded Martin Borque, executive director of the Berkeley-based Ecology Center, a group that advocates for healthy, sustainable urban living. But whether the pro-soda-tax movement will indeed sweep the country remains to be seen. So far, 30 other municipalities have voted down proposals to levy a tax on sugary drinks. And after all, Berkeley is a liberal bastion even within a blue state. Will public health activists in more conservative cities and states around the country be able to convince voters to give the government more control over what they eat and drink? “Let’s not forget that Berkeley is proud of being the most liberal city in America and, based on polling of Americans at-large, far from representative of the rest of the country,” said the American Beverage Association in a statement Wednesday. “So despite what the proponents of the tax may be stating, yesterday’s news in no way portends a trend.” Borque, exec. dir. of Berkeley’s Ecology Center, points out that, while voters in Berkeley may be overwhelmingly liberal, many of them still face the same diet-related health challenges as people in regions all across the country. Because of this, a soda tax could be just as relevant in Berkeley as in the rest of the country. “Well many people may think, ‘Oh, California, everyone’s skinny and healthy,’ that’s clearly not the case,” said Borque, pointing to statistics that show otherwise. A 2013 report on the health status of Berkeley residents revealed that 40 percent of ninth graders in the Berkeley Unified School District were overweight. The mortality rate among African Americans in Berkeley was double that of the mortality rate among Whites, and the second leading cause of death in the city was poor diet/inactivity. But ABA has argued that a soda tax will only hurt poor people by increasing their grocery prices, and that sugary drinks are only a small contributor to the problem of obesity in America compared to other caloric foods. This is likely the argument it will continue to make in other municipalities that might try to introduce a soda tax. Proponents of soda taxes, on the other hand, point to studies that drinking soda directly contributes to weight gain and weight-related diseases like diabetes, as well as research showing that a tax on soda could prevent thousands of deaths from weight-related diseases each year. The Berkeley Vote Yes on Measure D campaigners said they made a concerted effort to make sure poor and minority communities in Berkeley felt the soda tax was in their best interest and to deny ABA’s claims that it would hurt them. “We knew that we wanted to get in there so that big soda couldn’t get in there and use our groups against us,” said Carol McGruder, co-chair of the African American Tobacco Control Leadership Council and public policy and advocacy chair of the Berkeley NAACP. “Sometimes they don’t really talk about what the tax is they just say it’s a regressive tax and it hurts poor people.” When a soda tax came up for a vote in Richmond, CA in 2012, it was opposed by the NAACP branch there. McGruder said this was because the soda industry courted the organization. Still, ABA said that the defeat of a soda tax in San Francisco and of a tax on beverage containers in Massachusetts, shows that consumers don’t want their drinks to get any more expensive for the cause of public health. “If politicians in this country want to stake their reputation on what Berkeley has done, then they do so at their own risk,” said ABA in its statement. “Voters across the country sent a strong message in yesterday’s elections – and it wasn’t a plea for more taxes.” Consumer health advocates disagree, saying it’s the beverage industry that will be delving into its pockets in the future. “Coca cola, PepsiCo, and the American Beverage Association can no longer count on spending their way to victory,” said Michael F. Jacobsen, executive director of the consumer health watchdog Center for Science in the Public Interest (CSPI), which contributed $15,000 to the Yes on Measure D campaign. “But they better keep their checkbooks out: We expect that cities, towns, and state legislatures all over the country are taking a close look at what happened in Berkeley and many will be readying similar campaigns to tax soda in the years to come.” Wolfson, Bloomberg’s chief advisor, says he has no doubt the win in Berkeley will inspire other cities. “I am 100 percent confident that this effort will engender significant interest from local leaders in other municipalities around the country who will be interested in pursuing similar policies.” One thing is certain: while Berkeley won a battle Tuesday, the war over soda taxes will rage on.

FDA Establishes Definition of 'Gluten-Free' for Food Labels

Gretchen Goetz — Mon, 05 Aug 2013 05:27:14 +0000

The U.S. Food and Drug Administration on Friday issued a set of standards for food manufacturers wishing to label a product “gluten-free.” The agency set a limit of 20 parts per million for the amount of gluten that may be present in foods marketed as gluten-free. The rule also extends to foods labeled “free of gluten,” “without gluten” or “no gluten.” FDA’s final rule on gluten-free labeling comes six years after the agency published its proposed definition of gluten-free in 2007 and 9 years after Congress requested a universal definition of gluten-free from the agency in the Food Allergen Labeling and Consumer Protection Act (FALCPA). The push for a standard definition for the term “gluten-free” has been spurred by an increase in the number of people diagnosed with celiac disease over the past few years. Celiac disease prevents a person from being able to absorb nutrients after eating gluten. An estimated 1 percent of Americans are thought to have the condition, although 83 percent of cases currently go undiagnosed. “Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life,” said Margaret Hamburg, commissioner of FDA, in a comment on the new rule. “The FDA’s new ‘gluten-free’ definition will help people with this condition make food choices with confidence and allow them to better manage their health.” Sales of gluten-free foods have been on the rise recently, reaching $2.6 billion in 2010. That figure is estimated to hit $5 billion by 2015. FDA said it chose 20 ppm rather than 0 ppm as the limit because current scientific methods can’t detect levels of gluten below 20 ppm. “In addition, some celiac disease researchers and some epidemiological evidence suggest that most individuals with celiac disease can tolerate variable trace amounts and concentrations of gluten in foods (including levels that are less than 20 ppm gluten) without causing adverse health effects,” the agency stated in its Q & A on the new rule. The amount of 20 ppm of gluten in food can be visualized by picturing 2 grains of salt in a piece of bread. Celiac awareness advocates praised the release of the rule. “For years, gluten-free labels have gone unregulated, putting our gluten-free community in danger,” Alice Bast, president of the National Foundation for Celiac Awareness, said in a statement Friday. “We applaud the FDA for finally publishing a standard definition of gluten-free.” The new rule applies to all FDA-regulated foods and drinks, including dietary supplements.

Preventive Controls: Daunting for Some, Standard Procedure for Seafood

Gretchen Goetz — Mon, 05 Aug 2013 05:01:35 +0000

The concept of “preventive controls” is an anxiety-producing one for many FDA-regulated food companies right now as the agency prepares to issue a final rule that will make hazard-prevention measures mandatory for processing facilities. As Food Safety News reported last week, trepidation is especially high among smaller firms, which are balking at potential costs of meeting the new requirements. But for the seafood industry, which has been under a mandatory preventive controls plan for almost two decades, the new rule triggers memories rather than fear. The message coming from this industry is: “We were able to do it, and you can, too.” Seafood is one of only two types of food that the U.S. Food and Drug Administration requires a preventive control plan to process (the other is juice). These plans, known as HACCP (hazard analysis and critical control points), bear a close resemblance to those that will be required of other industries under the FDA’s new rule, known as HARPC (hazard analysis and risk-based preventive controls). Both systems focus on identifying points in processing where hazards may compromise food safety and implementing preventive measures at those points. But while some in the fresh produce industry are daunted by the new HARPC regulations (one processor called it “the end of many small- and mid-size farms”), the seafood industry says it has been there, done that, and that it came through the experience as a stronger sector. “The complaints we’re hearing from the other industries as they look at these preventive measures are almost identical to what we heard from the seafood industry when HACCP was introduced,” says Dr. Steve Otwell, a seafood specialist with the University of Florida Sea Grant and national coordinator of the Seafood HACCP Alliance. “Surprisingly, HACCP has been accommodated, has been implemented in the seafood industry, and it has not had the financial consequences that some feared. ” The costs of implementing HARPC have been put at approximately $701 million for the first year and then $472 million annually, according to estimates from the White House Office of Management and Budget. It’s these numbers — and the complexity of a HARPC plan itself — that have processors of other FDA-controlled foods, especially smaller ones, worried. How seafood came to adopt HACCP early The fact that the majority of seafood-processing firms are small or medium in size prompted the seafood industry to request HACCP regulation back in the early 1990s, according to Kenny Lum, president of the Seafood Products Association, which provides processing assistance to Northwest seafood companies. At that time, Lum says, European buyers were beginning to require preventive control plans of their American suppliers, while American consumers were expressing concerns about seafood safety and quality. The industry wanted to implement HACCP to prove to its customers that all seafood processors were producing high-quality, sanitary products. “Industry had a concern because there are a lot of very small operators, so we really wanted to have sort of a regulatory safety net that everybody needed to operate under,” Lum explains. A long and winding road Just because the seafood industry asked for it doesn’t mean the road to HACCP implementation was a smooth one. At first, processors were overwhelmed by the new rules. In January 1999, two years after FDA’s HACCP rule for seafood had gone into effect, the agency published a Q & A document to help processors with the challenges they were facing. “A large number of questions have been raised by the seafood industry, regulators, consumers, and others about interpretation of the regulation,” FDA stated in the introduction to its Q & A document. The Q & A was intended as a supplement to another document FDA wrote to help seafood processors comply with HACCP: the “Fish and Fishery Products Hazards and Controls Guide,” or “The Guide,” now in its 4th edition and published in 2011. Otwell says The Guide has become a crucial tool in helping seafood processors navigate HACCP. “It has really turned out to be a seafood safety bible,” Otwell says. “Everybody, whether I’m in China, the United States, Florida or Massachussetts, everybody can go to the same book of recommendations.” “That’s what helps us through those challenges, particularly small processors,” Lum says of The Guide. “It gives us a format.” Education crucial to alliance As helpful as The Guide has been for seafood processors, both men agree that HACCP implementation would not have been successful without the educational efforts that accompany it. That education comes in large part from the Seafood HACCP Alliance, a collaboration of academics, government agencies and industry formed in 1995 to provide HACCP training and support to seafood processors. “Training is the essential part of HACCP — making sure that even the small processors, since they’re going to be subject to regulation, go through the training,” says Lum. In order to make this education happen, industries now coming under HARPC are going to have to work with university extension programs and government agencies to develop a training support system that’s accessible to all processors, says Otwell, who is the national coordinator for the Seafood HACCP Alliance. “[Cost] should not be a hurdle. Education should be available for everybody to help this thing happen and cost should not be an impediment,” Otwell says. “If people have not accounted for educational delivery, that imposes a pretty heavy cost.” “The Seafood HACCP Alliance is a model that everybody else is trying to follow, but we came up with it at a time when the universities were funded to do these sorts of educational things. Now things have gotten tougher. Budgets across the United States are tighter, so the delivery’s going to be a little more difficult.” That’s why Otwell says that it’s crucial for government, universities and the industry come together to figure out an education plan for the new preventive controls. An ever-evolving process Despite the fact that seafood has been making friends with HACCP since FDA issued its final rule in 1995 (two years before it was implemented), the industry still faces difficulties associated with these standards. “It continues to be a challenge for small processors as well as new processors coming into the business,” Lum says. “Sometimes it just becomes overwhelming and they just decide maybe they’ll do something else. Maybe manufacturing toys or something,” he jokes. But for those willing to get serious about HACCP, the tools are there to help them. One key to ensuring that HACCP stays effective — and not prohibitively expensive — is flexibility in the rules, he says. While FDA’s HACCP rule says seafood processors can adjust regulations to fit their businesses if they can prove that what they’re doing is just as effective, he says many processors, especially smaller ones, lack the resources and knowledge to put together the data needed to make these changes. For example, while HACCP requires processors to record storage temperatures every 30 minutes, for some firms, such as those in very cold climates, this might be unnecessary since years of records will show that temperatures never fluctuate that quickly. Processors need to know how to present this type of data to FDA in order to get a change in process approved, Lum explains. Adapting the HACCP rule is something Otwell says FDA could work on, both for the benefit of inspectors and processors. “Inspectors get put into situations where they have to make judgment calls but don’t have information,” Otwell notes. “There needs to be some way of constructive exchange so that it can be shared across the wider community.” This is something he suggests FDA work on with other industries as it moves forward with the preventive controls rule. Looking toward the future Although the seafood industry will not be subject to the new HARPC rule, it continues to evolve its HACCP plan. One aspect that will be important going forward is translating HACCP into other languages so that foreign processors are on the same page, Otwell says. New estimates have found that 90 percent of seafood consumed in the U.S is imported. Because of this, a big part of HACCP compliance now is making sure that foreign suppliers understand and incorporate these preventive controls into their food safety culture, he says. “So if you’re going to get the training across, not only does the language have to be there, but you’ve got to be mindful of how they learn and their cultures,” Otwell points out. “And it’s different in different locations. So looking back over the past 15 years, that’s one of the lessons there from the seafood alliance that the other groups could pay attention to.” Lum says he hopes pathogen interventions for ready-to-eat foods such as tuna and oysters will get more attention. While processes such as irradiation for oysters have been approved, they are not currently required under seafood HACCP. “That’s really one of our focuses is this very category of minimally processed ready-to-eat foods because we believe we can build risk assessment models and put in the interventions,” Lum says. What do other industries have to look forward to? Otwell says mandatory preventive controls help everyone get on the same page. “One thing that was dramatic [about HACCP for seafood] – it changed the whole knowledge base and the whole language of communication. Before HACCP came along, people didn’t talk about sanitation control procedures. Now everybody can communicate and compare things. [HACCP] definitely raised attention and awareness, and if you’re aware and you get into a more preventive mode, obviously you’re going to have some impact.”

Cyclospora Case Count Rises to 418

Gretchen Goetz — Fri, 02 Aug 2013 01:49:23 +0000

At least 418 people in 16 states are now known to have been sickened with cyclospora infections between mid-June and mid-July, according to updated numbers from state health departments as of the end of the day Thursday. This latest case count marks a 40-case jump from the 378 illnesses reported by the Centers for Disease Control and Prevention Wednesday. While health officials have determined that the 146 cases in Iowa and the 81 in Nebraska are part of the same outbreak — which is thought to be linked to bagged salad mix — investigators in the 14 other affected states have yet to determine whether cyclospora illnesses reported to their health departments during the same time period are part of that outbreak. The latest total case count of 418 includes the 397 cases reported by CDC in an update Thursday, along with an additional 19 cases in Texas — reported to Food Safety News Thursday by a representative from the Texas Department of State Health Services, one additional case in Georgia that was counted by the Georgia Department of Public Health Thursday, according to a GDPH spokesperson, and one more case reported by Iowa Thursday. Christine Mann of the Texas DSHS told Food Safety News that the majority of cases still being reported in that state are coming from the Dallas/Ft. Worth area, and that the most recent illness onset was in mid-July. “We haven’t found a common source of exposure in this outbreak but we’re still investigating and looking at all of our leads,” said Mann. The situation in Texas is echoed in the other states whose illnesses haven’t been linked to the outbreak in Iowa and Nebraska. Health officials in these states have to determine whether their cyclospora illnesses are linked to other cases within the same state, and then, if so, whether the cases could be part of the larger outbreak in the Midwest. Nancy Nydam of the Georgia DPH said the number of cases in Georgia still isn’t above the state’s yearly average of approximately 10 cases. “[The four cases] fall within the parameters and the time range, but annually we see 10 cases a year. “We’re only at four, so we’re not close to getting crazy about this because it falls within our normal range,” Nydem said. Florida, which has the fourth-highest number of cyclospora cases reported in the mid-June-July period — behind Iowa, Texas and Nebraska — said its number of illnesses remained at 25 as of the end of the day Thursday. The current counts of illnesses by state are as follows: Iowa (146), Texas (132), Nebraska (81), Florida (25), Wisconsin (9), Illinois (4), New York (6), Georgia (4), Kansas (2), Louisiana(2), Missouri (2), Arkansas (1), Connecticut (1), Minnesota (1), New Jersey (1) and Ohio (1).

FDA Lifts Ban on Mexican Cucumbers Linked to 2013 Salmonella Outbreak

Gretchen Goetz — Wed, 24 Jul 2013 07:21:50 +0000

The U.S. Food and Drug Administration will no longer detain cucumbers from the Mexican growers whose products were linked to an outbreak of Salmonella earlier this year. The agency removed the two cucumber suppliers from its import alerts list this week, meaning that their products can no longer be “detained without physical examination.” The cucumbers were placed on the list April 23, 2013 after they were named as the likely source of an ongoing outbreak of Salmonella Saintpaul that would eventually sicken 84 people in 18 states. The implicated cucumbers were imported by Tricar Sales of Rio Rico, AZ , and supplied to that company by Daniel Cardenas Izabal and Miracle Greenhouse, both of Culiacán, Mexico. “Reviewing shipping records, with assistance from its partner state agencies, FDA traced cucumbers eaten by seven people who were made sick during the outbreak to the importer and further, to the suppliers, Daniel Cardenas Izabal and Miracle Greenhouse,” said FDA in its outbreak report. While evidence pointed to the Mexican cucumbers as the outbreak source, tests on samples of the cucumbers and facilities where they were grown and processed came up negative for Salmonella. However by the time public health officials identified the cucumbers as the likely outbreak source, the potentially contaminated cukes would no longer be on the market. The outbreak lasted from mid-January through the end of April, with the last case beginning April 28. Tricar Sales was founded as a U.S. distributor for crops generated by Daniel Cardenas Izabal in 1952.

Salmonella Outbreak Linked to N.C. Holiday Inn Sickened 100, Final Report Says

Gretchen Goetz — Tue, 23 Jul 2013 19:05:27 +0000

The Salmonella Typhimurium outbreak linked to a Holiday Inn in North Carolina ultimately sickened at least 100 people this May, the North Carolina Division of Public Heath reported this week. The bacteria was linked to the All American Grill at the Holiday Inn Bordeaux in Fayetteville, NC, according to the final outbreak report, issued by NCDPH July 19. Health officials in Cumberland County first alerted the state health department of a Salmonella outbreak that had sickened an estimated 15 people on May 15. All of the ill people had reported eating at the Holiday Inn Bordeaux in the days preceding illness. The case count would eventually expand to 88 — the number reported May 28. Now, in its final outbreak report, NCDPH says 100 Salmonella illnesses were ultimately linked to the outbreak. That final count included 25 cases confirmed by laboratory testing and an additional 75 suspected cases. Of those sickened, 29 were staff members at the hotel. Victims ranged in age from 17 to 81 years old. The first illnesses began May 1, 2013 and the last reported illness onset was May 17, 2013. The strain of Salmonella Typhumurium responsible for the outbreak was one that’s unique to North Carolina, according to the report. While the specific vehicle of the bacteria was not identified, health officials found a series of sanitation violations that might have led to contamination. “Interviews with managerial staff and observation of food preparation identified multiple opportunities for Salmonella contamination, including improper water temperatures and the absence of hand washing supplies in some areas,” the final report notes. “Other potential food safety issues that were identified included bare hand contact with ready to eat foods, temperature violations, and a dishwasher in one kitchen that was not operating effectively as described by staff members.” Health officials speculate that various foods and surfaces in the restaurant kitchen were cross-contaminated, which would explain why they were unable to identify the specific source of the bacteria.

FDA to Evaluate Risk of Salmonella in Tree Nuts

Gretchen Goetz — Thu, 18 Jul 2013 05:03:30 +0000

The U.S. Food and Drug Administration Wednesday announced its plan to assess the risks of Salmonella contamination associated with tree nuts. The aim of the risk assessment, described in a filing by FDA, is twofold: to determine the current risk to public health associated with eating tree nuts and to evaluate the success of Salmonella interventions currently being used on tree nuts or that could be applied in the future. “The need for a risk assessment is underscored by outbreaks of human salmonellosis linked to tree nuts over the past decade, by product recalls, and by Salmonella isolation from tree nuts during surveys,” said FDA’s Center for Food Safety and Applied Nutrition in its announcement of the plan. “In recent years, contamination with Salmonella has been found in almonds, cashews, pistachios, pine nuts, Brazil nuts, macadamia nuts and walnuts, among other types of tree nuts destined for human consumption.” The results of the assessment will be used to inform public policy on nut safety and to help guide nut producers on best practices, according to FDA. Salmonella contamination in tree nuts has led to a series of outbreaks and recalls over the past dozen years. Just last week, two California companies supplied by ARO Pistachios — also of California — recalled pistachios processed over an 8-month period after Salmonella was detected in samples of the nuts. Raw whole almonds were identified as the source of an international Salmonella Enteriditis outbreak that sickened 157 people in Canada and 11 in the U.S. in 2000-2001. Then, two years later, Salmonella Enteriditis, again linked to whole raw almonds, sickened 29 people in 12 states and one Canadian province. The California company whose product was tied to this outbreak ultimately recalled 13 million pounds of raw almonds. In 2011, Turkish pine nuts were the source of a multistate outbreak of Salmonella Enteriditis that sickened 43 people in 5 states between August and October. “These outbreaks, published reports of Salmonella in tree nuts destined for human consumption, and recalls emphasize the need to assess the risk of salmonellosis associated with tree nuts intended for human consumption, and to evaluate the appropriate risk based preventive controls needed to reduce the risk of human salmonellosis,” says FDA in its filing. The agency is seeking input from industry, scientists and other stakeholders. It will present the plan during a webinar on Monday, July 22 at 12 p.m. EST. The document describing the assessment will be available for public comment in the Federal Register beginning today.

Another Hospitalization Linked to Multistate Hepatitis A Outbreak

Gretchen Goetz — Thu, 11 Jul 2013 20:43:55 +0000

While the case count in the multistate hepatitis A outbreak linked to frozen pomegranate seeds has been leveling off over the past week, new information on illnesses continues to trickle into the Centers for Disease Control and Prevention. Today that included a report of one more hospitalization, one less case in New Mexico, and one more case in California. The number of people who’ve been hospitalized as a result of their infections now stands at 63. In total, 143 confirmed cases have been reported among people who ate an organic frozen berry mix containing pomegranate seeds from Turkey that are believed to be the source of the virus. Illness onset dates range from March 31 through June 24 of this year. Health officials say the outbreak appears to be ending, but cases could still crop up among people who might have had the berry product — distributed by Townsend Farms of Fairview, OR and sold at Costco stores in western states — in their freezer and not discarded it. “Newly discovered cases have tapered off quite a bit. However, we may see a few more cases come in because it is a frozen product,” said CDC spokesperson Darlene Foote in an emailed statement to Food Safety News. The potentially contaminated pomegranate seeds were also sold in two other products: at Harris Teeter stores in a berry mix also made by Townsend Farms and as “frozen pomegranate kernels” distributed by Scenic Fruit of Gresham, OR. Neither of these products have been linked to illnesses to date. For more information on the products recalled in connection with this outbreak, see the CDC’s outbreak page. The updated numbers of illnesses by state are as follows: Arizona (21), California (70), Colorado (28), Hawaii (8), New Mexico (5), Nevada (6), Utah (3), and Wisconsin (2). All patients were exposed to the virus in western states. The individuals who fell ill in Wisconsin ate the frozen berry product while in California.

Norovirus Outbreak in NW Wyoming 'Tapering Off' After Sickening over 200

Gretchen Goetz — Wed, 03 Jul 2013 05:01:52 +0000

In addition to cameras, a group touring Yellowstone National Park last month brought an unwanted visitor to the area in the form of a foodborne virus. Many members of the group arrived complaining of gastrointestinal symptoms, which were later determined to have been caused by norovirus. The virus, which is transmitted via the fecal-oral route spread to others in the park, eventually sickening more than 100 employees and 50 visitors in mid to late June. At least 50 illnesses were also reported among employees at neighboring Grand Teton National Park. As of Tuesday, however, no new norovirus cases had been reported in the area in over a week, a Yellowstone spokesperson told Food Safety News. She did not know where the tour group that introduced the virus had begun its trip. The National Park Service said it has taken extra measures to prevent the spread of infection, including increased cleaning and disinfection of all public areas such as stores, gift shops, restaurants, and lodging facilities. Employees who were potentially infected were isolated until they have been symptom-free for at least 72 hours. While the outbreak appears to be “tapering off,” she said, it’s still important to take precautions to prevent the spread of norovirus, the most common cause of gastrointestinal illness in the U.S., when visiting the park. “Wash your hands. That’s the biggest thing,” she advised. “People tend to forget to wash their hands with soap and water before they eat, especially on vacation. They’re touring and then walk into the restaurant and don’t think of going to the restroom first to wash their hands. “People tend to rely on hand sanitizer, but it just isn’t as effective against norovirus as plain old soap and water.” A woman who visited the park this week said there are still signs in park restrooms informing park visitors of the outbreak and advising them to practice good hand hygiene to avoid the spread of illness. A representative from the Wyoming Department of Health told Food Safety News that the Department’s epidemiologists are monitoring the outbreak in case it spreads beyond the parks into neighboring counties.

11 Years of Data Show Poultry, Fish, Beef Have Remained Leading Sources of Food-Related Outbreaks

Gretchen Goetz — Fri, 28 Jun 2013 07:04:11 +0000

Between 1998 and 2008, poultry, fish and beef were consistently responsible for the greatest proportion of foodborne illness outbreaks, according to a new government analysis. Experts at the Centers for Disease Control and Prevention reviewed the 13,405 food-related outbreaks reported during this time period, identifying 3,264 outbreaks that could be attributed to a specific food category. Fish and poultry remained responsible for the greatest share of these outbreaks over these 11 years — accounting for about 17 percent of outbreaks each — followed closely by beef, which was responsible for 14 percent of outbreaks. Eggs, on the other hand, played an increasingly smaller role as outbreak sources – accounting for 6 percent of outbreaks in 1998-1999 and for just 2 percent in 2006-2008. This trend was largely due to a decrease in the amount of Salmonella outbreaks linked to eggs, according to the report authors. Leafy greens became a more common outbreak source, responsible for 6 percent of outbreaks in 1998-1999 and 11 percent by 2008-2009. Dairy also grew as an outbreak source, rising from 4 percent in the beginning of the period studied to 6 percent by 2006-2008. The researchers also looked at the leading pathogen-food combinations that caused outbreaks during the 11-year window, finding that histamine in fish was the most common outbreak source, followed by ciguatoxin in fish, Salmonella in poultry and norovirus in leafy vegetables. “You see the same combinations of pathogens and foods repeatedly,” said Hannah Gould, epidemiologist in the Division of Foodborne, Waterborne, and Environmental Diseases at CDC’s National Center for Emerging and Zoonotic Infectious Diseases and lead author of the report. “It’s good to keep tracking that and now to have a method to continue to look at changes over time,” Gould commented in an interview with Food Safety News. The authors note that the number of outbreaks linked to these commodities should not be confused with the number of illnesses caused by these foods, as outbreaks result in varying numbers of illnesses. While poultry was responsible for the largest share of illnesses (17 percent) between 1998 and 2008, leafy greens were the next greatest cause of illness, accounting for 13 percent of the 67,752 illnesses attributed to an outbreak food source. The pathogen/commodity pairs responsible for the most outbreak-related illnesses were norovirus and leafy vegetables, which led to 4,011 illnesses of the 67,752 linked to a designated commodity category. The pathogen/commodity pairs responsible for the most deaths were Listeria in poultry (16 deaths), Salmonella in fruits or nuts (14 deaths), and E. coli in leafy greens (7 deaths). The team also looked at food preparation, finding that restaurants and delis accounted for the vast majority (68 percent) of the places where outbreak-linked foods were prepared. Private homes were the next most common place of preparation, at 9 percent, followed by catering or banquet facilities (7 percent). “That’s something interesting that we talk about here more than we usually do,” said Gould, referring to the location data, which CDC doesn’t often report in its reviews of foodborne illness data. Outbreaks after 2008 What about outbreaks that have occurred since 2008? Have these trends continued or have they changed in the past few years? “Leafy greens and norovirus continues to be a problem and norovirus has been the number one cause of outbreaks in our data for years and years and years and has remained that way,” said Gould. Gould also led an analysis of foodborne illness outbreaks that occurred between 2009 and 2010 — published in January of this year — which found that during that period, beef, dairy, fish, and poultry were associated with the largest number of foodborne disease outbreaks. That report also showed that unpasteurized dairy products are the leading cause of dairy-related outbreaks, accounting for 81 percent of the outbreaks linked to dairy during that time period. Gould said the 1998-2008 report shows that the incidence of raw dairy-related outbreaks has been growing over this time. “Outbreaks caused by dairy went up as well, and that seems to be caused by an increasing number of outbreaks due to unpasteurized milk,” she said. The data used for this report comes from CDC’s Foodborne Disease Outbreak Surveillance System, which was started by CDC in 1973 and went online in 1998. The authors chose 1998-2008 as their reporting period because the format of the database changed starting in 2008, when it became the National Outbreak Reporting System. Although this new report may appear similar to one CDC released in January titled “Attribution of Foodborne Illnesses, Hospitalizations, and Deaths to Food Commodities by Using Outbreak Data, United States, 1998-2008,” the two are very different. The January report offers an estimation of total U.S. illnesses linked to various food sources. Though it is based on data from the Foodborne Disease Outbreak Surveillance System, the figures in that report are extrapolated based on national foodborne illness estimates, while this June report looked only at outbreaks reported to CDC. The complete results of the 1998-2008 data analysis can be found in CDC’s Morbidity and Mortality Weekly Report. Editor’s note: An earlier version of this article incorrectly identified the period analyzed by this report as 20 years. The article has been updated to reflect the correct time period of 11 years.

FDA Must Complete FSMA Rules by Mid-2015, Judge Says

Gretchen Goetz — Tue, 25 Jun 2013 14:03:57 +0000

The U.S. Food and Drug Administration must publish all of the regulations required under the 2011 Food Safety Modernization Act by June 30, 2015, a federal judge ruled Friday. Judge Phyllis Hamilton of the U.S. District Court of Northern California rejected FDA’s proposed timeline for completion of the regulations, which outlined “target timelines” of 2015 through 2016 for the publishing of all final rules. “The court finds defendant’s ‘target timeframes’ to be an inadequate response to the request that the parties submit a proposal regarding deadlines that can form the basis of an injunction,” wrote Hamilton in her decision. The ruling marked the latest, and possibly last, phase in the suit brought by the Center for Food Safety against FDA for the agency’s failure to meet several deadlines for the writing of FSMA-mandated rules. In a petition filed August 29, 2012, CFS asked the court to order the completion of the delayed rules. Since that time, FDA has released three of the seven key rules that CFS sited as overdue in its filing, including the proposed rule for produce safety, the proposed rule for preventive controls across the food supply and new requirements for food facility registration. Three other rules have been submitted to the White House Office of Management and Budget, which must approve the proposed rules before they are released. These include new standards for foreign food suppliers, preventive controls for animal feed and standards ensuring the neutrality of third-party audits. A regulation ensuring the safe transport of food, also mandated by FSMA, has yet to be submitted to OMB. On April 13 of this year, Judge Hamilton issued a motion for summary judgment, requesting the parties to submit remedy proposals for new deadlines. While the Court found the deadlines submitted by FDA to be too fluid, it also acknowledged the complexity of FDA’s task and did not require the agency to publish all of its final rules by May 1, 2014, the amended deadline that CFS had proposed. The Court said this date was “overly restrictive” and could also lead to the curtailing of the public comment periods for the rules, a situation the Court wished to avoid. “This is a critical victory for consumers, farmers, and the public health,” said George Kimbrell, CFS senior attorney in a statement. “The Court’s decision will ensure FDA cannot unduly delay these life-saving measures any longer, while also ensuring all interested parties have a meaningful say in their outcome.”

Processing Aids for Fresh Produce: Safety Buffers Between Farm and Table

Gretchen Goetz — Mon, 24 Jun 2013 09:17:25 +0000

Nutrition labels on items in the produce section tend to be short, if not absent altogether. While cereals, soups and sauces come with long lists of ingredients on their packaging, an apple doesn’t need an ingredient list for consumers to know what they’re buying (although it arrived at the grocery store in a labeled package), and the ingredients for bagged salad are only as varied as the different lettuces in the bag. However, more often than not, other substances are at some point applied to the fruits and vegetables available on store shelves in order to kill pathogens or preserve freshness. But unless these substances change the character of the food or are still present in significant amounts by the time they reach the consumer, they are considered a “processing aid,” and do not have to be listed as an ingredient by law. According to the U.S. Food and Drug Administration, processing aids are substances that are added to a food during processing but are either “removed in some manner from the food before it is packaged in its finished form” or “converted into constituents normally present in the food,” or are “present in the finished food at insignificant levels and do not have any technical or functional effect in that food.” For more information about how processing aids are classified, see Food Safety News’ article Processing Aids: What’s Not on the Label, and Why? What processing aids were used on the produce I’m buying? Processing aids used on produce are wide-ranging, from chlorine washes to ozone to organic acids to oils derived from plants such as cinnamon or pine trees. “It’s not always across the board for all commodities and they don’t always use [one processing aid] consistently even throughout the season,” says Trevor Suslow, extension research specialist at the University of California Davis. The challenge for a processor is to find the substance that safely delivers the desired effect (pathogen reduction or freshness preservation) without changing the quality or taste of the food. Items marketed as ready-to-eat, such as bagged lettuce or sliced apples, have almost certainly been treated with at least one processing aid, says Suslow. Indeed FDA recommends the use of antimicrobial agents in its guidance for industry on minimizing microbial hazards for fresh-cut fruits and vegetables. “An initial wash treatment may be used to remove the bulk of field soil from produce followed by an additional wash or washes containing an antimicrobial chemical,” writes the agency. One such ready-to-eat product, bagged lettuce, usually goes through two and often three washing phases, says Suslow. The first wash water commonly contains chlorine or chlorine dioxide, while the second might include an antimicrobial agent such as peracetic acid or acidified sodium chlorite – a combination of sodium chlorite and citric acid. Finding the right balance has been a process for the leafy greens industry, says Suslow, as too much chlorine can leave a lingering odor or flavor on greens, and too little won’t be effective at killing pathogens. “As that industry has grown and matured and gotten some strong negative feedback earlier on about chlorine residual taste or smell, which some of the product certainly had, they’ve really worked at minimizing any carry over,” Suslow explains. Peracetic acid is also applied by apple processors, who may use it on apples in a dunk tank or as a spray. A 2007 study from Washington State University found that peracetic acid could also be used on cherries without changing the quality of the fruit when used at low and medium concentrations. The leading method of cherry sanitization is also a chlorine wash, according to the study. Chlorine washes are common across the produce industry, says Suslow. Table grapes are another example of a type of produce often treated with chlorine. “It can vary, but at least the operations that I’ve had the opportunity to visit, it’s pretty much the same,” he says. “They tend to be rinsed in chlorinated water or ozone and then they take the individual grapes off the stem after that.” Stone fruits, such as peaches and nectarines, which are in season right now, often benefit from a chlorine wash as well, says Suslow. FDA has set specified concentrations for processing aids used in washes so that they are present at safe levels. For example, the concentration of sodium chlorite in acid solutions used on raw agricultural commodities and processed fruits and vegetables must remain between 500 and 1,200 parts per million. Other processing aids may be used to keep produce from spoiling. For example, grapes are often packed with pads containing sulfur dioxide to prevent decaying and the growth of mold. On the flip side, processing aids can also be applied to induce ripening. Ethylene gas, for example, is often applied to bananas to speed up the ripening process before they are distributed to retailers, since bananas are commonly harvested in an unripened state. Processing aids for produce: looking forward One sector that’s recently been looking at different processing aid options is the cantaloupe industry. After two deadly foodborne illness outbreaks linked to these melons – a Listeria outbreak that killed 33 people in 2011 and a Salmonella outbreak that sickened 261 people and killed 3 in 2012 – shook consumer confidence and hurt the industry, processors have been looking for a way to ensure consumers of the safety of their product. Processing aids are among the solutions that are being closely examined by the cantaloupe industry, along with brushing, pasteurization and other sanitizing techniques, according to Suslow. An ongoing research project at the Center for Produce Safety is looking at the effectiveness of essential oils — such as those derived from cinnamon bark and pine needles — as antimicrobial agents. “We’re getting promising results,” says Suslow of this research, “and we still have a ways to go.” The trick with these oils, he notes, is to make sure they don’t affect the flavor of the produce to which they’re applied. Another benefit of using essential oils is that they are also organic, a feature that appeals to a growing number of consumers. Will such oils become common as processing aids in the produce industry? That remains to be seen. Suslow says cost is a primary concern, and right now chlorine remains one of the cheapest sanitizing options for produce. Other organic processing aids include lactic acid as an antimicrobial or ascorbic acid (derived from vitamin C) as an anti-browning agent. For an in-depth explanation of organic versus non-organic processing aids, see Food Safety News’ article How Does the Organic Industry Regulate Processing Aids? Another processing aid gaining popularity in the produce industry is electrolyzed oxidized water, which can be generated on-site and is sodium-free. Fresh berries: another approach Of course not all produce items have been treated with processing aids. Such items may be fragile or susceptible to taste alteration, or companies might have found that other food safety precautions adequately minimize pathogens on their products. Kyle Register, a representative for Driscoll’s, which sells fresh berries, says each berry is handled only once, and goes straight from the farm where it’s picked into a clamshell and then to the grocery store. No processing aids are used on these items. Instead, the safety of the berries is controlled through stringent adherence to the company’s Global Food Safety Program, which is modeled on FDA’s good agricultural practices (GAPs) standards and verified by independent audits. This fruit packaged without a processing aid illustrates what Suslow says is the main take-home point when it comes to processing aids for fruits and vegetables: one size does not fit all. In fact, there’s a different size for pretty much every processor, and even the same processor is likely to be exploring new methods. “There are a variety of different processes and it’s hard to track because they often change from visit to visit,” says Suslow.

California Cantaloupe Producers Self-impose Food Safety Rules

Gretchen Goetz — Thu, 13 Jun 2013 07:48:04 +0000

California’s cantaloupe producers will face a new set of food safety rules this season — rules they are imposing on themselves. In an unprecedented move for the state’s produce industry, California cantaloupe handlers have elected to adopt a mandatory food safety plan as part of an effort to restore consumer confidence in the cantaloupe market, which has suffered following two nationwide foodborne illness outbreaks linked to these melons in the past two years. In 2011, a Listeria outbreak that sickened 147 people in 28 states and killed 33 was linked to cantaloupes from Colorado. The following year, Salmonella linked to a farm in Indiana sickened 261 people in 24 states, killing 3. While neither of the outbreaks was linked to California cantaloupes, sales of the melon have dropped significantly nationwide, an effect that has hit the Golden State hard. A full 75 percent of the cantaloupes consumed in the U.S. are grown in California. Now California cantaloupe producers intend to give consumers a reason to trust their product. “Beginning this year, California cantaloupe farmers and shippers of all sizes will be operating under the only mandatory food safety program that requires government audits of all cantaloupe production activities,” said Steve Patricio, a California melon producer and chairman of the California Cantaloupe Advisory Board (CCAB), which represents all of the state’s cantaloupe producers. The new standards for the state’s cantaloupe producers include 156 checkpoints, all of which must be met in order for a handler to pass the program’s audits, which will be conducted by inspectors from the California Department of Food and Agriculture. “CCAB is using government auditors instead of private inspection companies to ensure accountability, uniformity and consistency of audits throughout the California cantaloupe industry,” said Patricio in a Wednesday press release. A list of California cantaloupe handlers subject to these mandatory audits is available on CCAB’s new website, www.californiacantaloupes.com. A copy of the audit checklist and more information about the new cantaloupe food safety program, including the guidance document, can also be found on the site. Earlier this year, a national cantaloupe safety program called the National Cantaloupe Guidance was launched after a year of development by industry, scientists, consumers and regulators. The Guidance offers best practice recommendations for cantaloupe producers. For more background on the California cantaloupe food safety program and the National Cantaloupe Guidance, see Food Safety News’ past coverage: CA Writes Food Safety Standards for Cantaloupes Produce Industry Groups Release Cantaloupe Safety Guidance

Study Links Bacteria in Processed Chickens to Contamination on Farm

Gretchen Goetz — Wed, 12 Jun 2013 06:08:49 +0000

The levels of bacteria in broiler chickens at the processing plant appears to be related to the amount of bacteria found among birds on the farm, according to a new study. Researchers at the University of Georgia, Athens looked at the prevalence and loads of Salmonella and Campylobacter in 55 flocks at a large chicken farm in Georgia and found that high levels of these bacteria on the farm corresponded to high levels on carcasses at the processing plant. Most cases of Campylobacter infection in the U.S. are associated with eating raw or undercooked poultry, according to the Centers for Disease Control and Prevention. A 2011 study conducted by the USDA’s Food Safety and Inspection Service found that of the Salmonella illnesses attributed to undercooked meat, poultry and eggs in the U.S., 48 percent are attributed to chicken, while 17 percent are attributed to turkey. In recent years, studies have found that between 50 and 80 percent of chickens sold at retail are contaminated with Campylobacter, while approximately 15 percent carry Salmonella. A 2010 Consumer Reports study found that, out of 382 chickens bought from more than 100 supermarkets, food stores, and mass merchandisers in 22 states, 62 percent contained Campylobacter, 14 percent contained Salmonella and 9 percent contained both. While previous studies have linked the presence of Campylobacter and Salmonella on the farm to their presence in chickens at processing, this study was the first to examine the relationship between pathogen loads (the amount of the pathogens found) at the farm and at the processing plant. The study reported “a direct linear relationship between the mean Salmonella load…of farm samples and the mean Salmonella load of carcass rinses.” For Campylobacter, loads on the farm were still predictors of loads at processing, but the amount tended to increase exponentionally from farm to processing. “The Campylobacter loads of all four farm sample types were significantly associated with Campylobacter loads of post-chill carcass rinses,” noted the report. Salmonella was detected in farm samples from 96 percent of flocks that also had Salmonella at the processing stage, while Campylobacter was identified among 71 percent of flocks among which the bacteria was also detected during processing. This association between farm and processing plant contamination points to a need to focus on methods to prevent contamination on the farm, according to the researchers. “This study suggests that reducing foodborne pathogen loads on broiler chicken farms would help to reduce pathogen loads at processing, and may ultimately help to reduce the risk of foodborne illness,” said Roy Berghaus, an author on the study in a press release. “This is important because most of our efforts towards reducing foodborne pathogens are currently focused on what happens during processing. Processing interventions are effective but they can only do so much.” For Salmonella prevention, these on-farm practices may include vaccination of breeder hens, treatment of newly hatched chicks with a competitive exclusion product, which prevents colonization of pathogenic bacteria in the gut of the bird, and the use of acidified water during feed withdrawal. However, the researchers point out, no known methods have been effective at reducing Campylobacter among flocks. Thus efforts to prevent the pathogen from entering the birds’ environment through strict biosecurity measures would be the only recourse for combatting Campylobacter on the farm. Post-processing freezing has also been shown to reduce Campylobacter loads, note the authors. The study was published ahead of print in Applied and Environmental Microbiology.

Case Count Rises to 49 in Hepatitis A Outbreak Linked to Frozen Berries

Gretchen Goetz — Tue, 04 Jun 2013 21:22:24 +0000

The number of hepatitis A infections linked to a frozen berry mix sold nationwide has now climbed to 49, reported the Centers for Disease Control and Prevention Tuesday. That announcement came on the heels of the first formal recall of the implicated product, which was issued by the maker of the berry mix, Oregon-based Townsend Farms, Monday — three days after the outbreak was announced by CDC. In its recall announcement, the fruit company revealed that the product had not only been sold at Costco, which removed the berries from store shelves Thursday, but also at Harris Teeter. This means the product was not only sold in the western United States, where all of the illnesses reported to date have occurred, but also on the East Coast, where Harris Teeter stores are located. States currently affected by the outbreak include Colorado, New Mexico, Nevada, Arizona, Utah, Hawaii, and California. CDC has not released the number of illnesses by state. Patients sickened in the outbreak are between the ages of 2 and 71 years old, a markedly different age range from the one reported in CDC’s last update Monday, in which no one under the age of 25 was known to have been affected. According to CDC, 60 percent of the patients are female. Of the 25 people for whom information is available, 19 (76 percent) report eating Townsend Farms Organic Anti-Oxidant Blend – the name under which the product was sold at Costco – in the week prior to illness. Harris Teeter issued its own recall of the berry mix Tuesday, noting that it had removed the product from store shelves. The berry mix was sold under the name ‘Harris Teeter Organics Antioxidant Berry Blend’ from April 19 until May 7, 2013 in 10 oz. bags marked with UPC 0 72036 70463 4. Bags bear Lot Codes of T041613E or T0401613C and a “BEST BY” code of 101614. Costco called all of its customers known to have purchased the frozen berries on Thursday of last week. Approximately 240,000 customers were notified that they had purchased the implicated product, sold at Costco stores starting in late February of this year, according to Craig Wilson, vice president of food safety at Costco. The frozen berry mix was sold in 3 lb. bags at Costco marked with UPC 0 78414 404448. The recalled codes are located on the back of the package with the words “BEST BY,” followed by the code T012415 sequentially through T053115, followed by a letter. All of these letter designations are included in this recall for this sequence of lot codes. Consumers who purchased the recalled product are urged to discard them or return them to their point of purchase for a full refund. Those who consumed the recalled berry mix within the last two weeks and have not received the hepatitis A vaccine in the past should get the vaccine from their healthcare provider, or contact their local healthcare department if they do not have a healthcare provider. People who ate the recalled product more than 14 days ago will not benefit from the vaccine, but should keep an eye out for symptoms of hepatitis A infection, which include, nausea, abdominal cramps, diarrhea, fatigue, loss of appetite and jaundice, or yellowing of the skin and eyes. Hepatitis A is a virus that affects the liver. The strain of hepatitis A virus (HAV) implicated in this outbreak is rare in the United States, but more common in North Africa and the Middle East.

Looking Upstream: Seafood Traceability in a Global Economy

Gretchen Goetz — Thu, 30 May 2013 07:29:30 +0000

Early this year, the discovery that horsemeat was being substituted for beef in some European foods triggered widespread concern over food fraud in the EU. This substitution, deemed the “horsemeat scandal,” was eventually determined to be affecting around 5 percent of European beef products. But in the U.S., consumers have a different type of fraud to worry about. It is estimated that about one-third of seafood sold by retailers and restaurants in the United States is mislabeled, a problem that can have serious implications for public health. What’s being done to combat this problem? Is an improved seafood traceback system on the horizon? Today, Food Safety News dives into the world of seafood traceability, looking at what can be done – and what’s being done – to trace fish and shellfish from water to plate. The Problem According to the National Oceanic and Atmospheric Administration, 91 percent of the seafood consumed in the U.S. in 2011 was imported. With over 1,500 species of fish and shellfish coming into the U.S. from all over the world and often going through several processing stages, verifying where seafood came from by the time it reaches the consumer can be difficult. Another problem posed by such a complex industry is species substitution, which can be both inadvertent and intentional. A 2012 study from ocean advocacy group Oceana found that, out of 1,200 seafood samples taken from 673 retail locations across the U.S., 33 percent were a different species from the one indicated to the consumer. The most commonly mislabeled fish were snapper, which turned out to be another species 89 percent of the time, and tuna, of which 59 percent of samples collected were actually another fish. Of the “white tuna” the group tested, 84 percent was actually escolar, a fish that is banned in many countries as it can carry toxins that cause gastrointestinal illness when eaten in quantities over a few ounces. Other in-demand fish for whom different species were commonly substituted included cod, grouper, halibut and Chilean seabass. LeeAnn Applewhite, CEO of Applied Food Technologies, which performs DNA testing on seafood, says the species her company finds are mislabeled largely match those Oceana found were mislabeled. “There’s a lot of mislabeling with sushi and sashimi tuna, and then it’s grouper, cod, halibut, salmon, all the higher value species,” said Applewhite in an interview with Food Safety News. “And it’s region-specific.” In other words, different types of fraud are more common to different regions. While grouper and shrimp fraud are more prevalent in Florida, salmon fraud is seen more on the West Coast, where there are more species of salmon to mix up. But, Applewhite pointed out, seafood fraud isn’t always intentional. In fact many times it’s a mistake. “It’s extremely complicated because fishermen go out, and grouper don’t swim in one place all by themselves and cod in another place all by themselves,” she explained. “You have all these species swimming together and they catch thousands of fish on some of the big boats. They look alike, they’re in the same place, and once they’re filleted, nobody can tell the difference.” And once seafood leaves the harbor, it can be even harder to keep track of, explained Dr. Lucina Lampila, Associate Professor and Extension Seafood Specialist in the Department of Food Science at Louisiana State University. “When you’re a very large plant and you start to have lots get commingled, it’s a little dicier,” Lampila told Food Safety News. “There’s still a record of what boat it came from but it can get a little more confusing.” Why it’s dangerous What’s the harm in eating one type of fish instead of another, other than paying for something you didn’t get? For starters, the mislabeling of escolar as tuna creates a health risk, as the former fish is a waxy, oily species that can cause severe gastrointestinal illness, unlike tuna. Another health problem is created when fish containing histidine are mislabeled. Histidine can be converted to histamine over time by enzymes released in the fish. High levels of histamine, an allergen, can cause illness when ingested by humans. In order to prevent the decay that leads to histamine production, histidine fish must be kept at low temperatures. If a histidine-carrying fish, such as tuna or swordfish, is labeled as a fish that doesn’t carry histidines, such as tilapia or grouper, that fish may not be handled in a way that prevents histamine from forming. While it’s less likely that a histamine-producing fish, which usually have dark flesh, will be confused for one that does not produce histamines, Oceana did find some of these substitutions, such as catfish for grouper. “Hazards such as allergenic proteins and scombrotoxin formation are associated with some species but not others, presenting potential food safety risks if the food is not accurately labeled,” notes the U.S. Food and Drug Administration, the agency in charge of regulating seafood sold in interstate commerce. Another hazard that arises from mislabeling seafood is the possibility of unknowingly serving fish from a region that’s been flagged for a health risk. “If an area of the water is closed because of Ciguatera and snapper is caught in that area and then labeled as a species not typically from that area, that’s a health issue,” said Applewhite. Ciguatera is a toxin found in some tropical reef fish. Another area-specific risk is Vibrio bacteria, found in shellfish when water temperatures get too warm. “If the fish is being mislabeled and you’re trying to contain an outbreak, you’d want to know where the fish was harvested and what date and if anyone else had eaten it so the doctors know what kinds of symptoms to look for,” said Kim Warner, Senior Scientist at Oceana and author of the seafood fraud study. “These health concerns are reasons why you’d want a traceability system in place so you can quickly identify the source of the fish.” Some fish, such as tilefish, contain high levels of mercury, and women who are pregnant or breastfeeding are advised to avoid these fish. Substitutions of these species for others can also pose a health risk. Using DNA testing to combat seafood fraud Back in 2000 when LeeAnn Applewhite started Applied Food Technologies (AFT), DNA testing for seafood was virtually nonexistent. The predominant testing method at the time was protein analysis, which requires subjective interpretation of results and is ineffective for cooked foods. “I hated those methods and I knew everything was going molecular,” recalled Applewhite. “So I started writing federal grants to address this.” By 2004 the company had developed the first seafood DNA testing methods to be accepted by FDA. Then in 2005, AFT was asked by two major commercial food suppliers – U.S. Foods and Sysco – to begin DNA testing on the fish they were purchasing. “When we started this in 2005, we were seeing extremely high levels of substitution with catfish,” said Applewhite. “It was actually Vietnamese catfish, not U.S. catfish.” The company also detected high levels of substitution for grouper, snapper and cod — In some cases, 60 percent of fish that was supposed to be one species would be mislabeled. But over the years, AFT has seen a “dramatic drop” in the amount of mislabeled seafood brought to its clients, according to Applewhite. “It’s all down well below 20 percent now.” Since it developed its first DNA tests, the company has expanded its database of DNA sequences to include over 1,500 seafood species from around the world. Before a new species is entered into the system, it is taxonomically validated by a museum of natural history. AFT also does backup testing for FDA, which performs DNA tests on all seafood subject to an import alert. The government has also become concerned with seafood fraud over the past few years. Starting in 2007, after the substitution of toxic pufferfish for monkfish caused a series of illnesses in the U.S., FDA launched its own initiative to validate fish species via DNA testing. Under the agency’s Barcode of Life initiative, it has developed authenticated sequencing for 172 fish species. “Species substitution has been an area of concern for the FDA and within the seafood industry for some time,” said a representative for FDA’s Center for Food Safety and Applied Nutrition in an email to Food Safety News. “As a result of these concerns, the FDA has recently invested in significant technical improvements to enhance its ability to identify seafood species using state of the art DNA sequencing.” The agency said it has been collecting samples to determine where DNA testing efforts could be most effective. “In Fiscal Year (FY) 2012, the FDA conducted surveillance sampling for species substitution at wholesale distributors, gathering approximately 800 individual filets from approximately 100 different lots of fish to verify the accuracy of the labeling utilizing the new DNA testing capabilities,” said the agency. “Once we finish compiling the results, the FDA will have a better idea of where to conduct future sampling and enforcement efforts.” But going forward, many predict that DNA testing will be industry-driven. Craig Wilson, vice president of food safety at Costco, said the company has been DNA testing its incoming seafood for a couple years. “We’re doing a lot of DNA species confirmation and that helps us quite a bit,” Wilson told Food Safety News. While he can’t speak for other companies, Wilson said, “I think more and more people are doing that.” Keeping tabs on seafood To move safe and properly identified seafood from the water to the table not only requires species validation, but also a system that retains information about the origin of a product as it travels through the food supply. The 2009 federal Country of Origin Labeling (COOL) law, enforced by USDA’s Agricultural Marketing Service, dictates that seafood entering the U.S. must be accompanied by a label indicating what country it came from and whether it was farm-raised or wild-caught. However, the rule exempts “processed” seafood – seafood that’s been smoked, boiled, or changed in any way. After seafood is imported, it often makes many more stops before reaching the consumer, making it difficult to track. “A lot of the data is required in fish being imported but it’s not following it through the supply chain,” said Warner of Oceana. “It can go through ten or fifteen different brokers, ten or fifteen cold storages, and they’re handed all differently, and who the heck knows what happens?” said Wilson. “That part for a lot of folks can be incredibly complicated.” After seafood enters the U.S., the only hard and fast law governing its traceability is the Bioterrorism Act. Passed by Congress in 2002, the Act dictates that food processors and handlers must be able to “identify the immediate previous sources and the immediate subsequent recipients of food.” The Act exempts restaurants and farms (including fish farms) from these requirements. While this means seafood handlers must have a record of where they got a shipment of seafood and where they sent it, it does not affect the labeling that accompanies the food. “I know who I got it from and who I sold it to, but we’re calling it different things, so it takes a while to try to map it up into our system to really see where that product is from and where it went,” explained Angela Fernandez, vice president of grocery retail and consumer packaged goods at GS1 US. GS 1 is the global nonprofit organization that started the barcode system now used for all food items at grocery stores around the world. The group now offers a standardized tracing system for the various food industry sectors, including seafood. Fernandez says the level of information passed from one seafood company to another depends on what the purchaser is asking for, and varies greatly from business to business. But overall, she says, the industry seems to be seeking better traceback systems. “This is really where the industry has come to GS 1 and said, ‘Will you help guide us?'” Many in the industry have come to GS 1 to help assess their current traceability systems and see where any breakdowns might exist. “Right now we’re in the middle of doing a proof of concept with some of the large seafood players in the U.S.,” said Fernandez. “They believe that they’re capturing a lot of this information today in a standardized way, so we are currently working with them to map out all of the different processes that are happening with each supply chain role and seeing the information they’re capturing and how they’re capturing it to identify gaps that they have.” Where will the change come from? According to the Food Safety Modernization Act, signed into law in 2011, FDA must improve the traceability of the U.S. food supply in two ways: 1. Run pilot programs to see where traceback information needs to be captured and 2. Implement mandatory record keeping for high risk foods. Whether certain seafoods will be on the list of risky products remains to be seen. The agency is also taking into account the results of two pilot studies on traceback conducted by the Institute of Food Technologists (IFT) – one on tomatoes and one on a frozen Kung Pao-style dish. But how much these results and FDA’s ensuing action will affect the seafood industry is unclear. “We’ll see how far it goes. Certainly IFT recommended that there be traceability and how it could be done, but it’s just kind of a wait and see,” said Lampila. The agency has also indicated its intention to tighten its controls on seafood fraud through increased DNA monitoring. Another option for regulation might come from Congress, where U.S. Representatives Edward Markey (D-MA) and Barney Frank (D-MA) have introduced the Safety and Fraud Enforcement for Seafood (SAFE Seafood) Act. The bill would mandate full traceability for all seafood sold in the U.S. by requiring data about the origin of a seafood product to follow it through every step of the supply chain. However, experts agree that the industry is already moving towards a better traceback system, and that the effort will be a joint one between industry and government. “There’s a traceability industry,” said Warner. “There are people trying out different models. I think the industry will find out what works and what’s the best way to handle this.” One model that won’t work is FDA testing a majority of the seafood coming into the U.S., something for which the agency doesn’t have the capacity. Right now it is estimated that less than two percent of imported seafood is inspected. “The FDA won’t be able to do it, but they can keep you from importing if you don’t have verification and can put some sort of system in place that assures that the verification is accurate,” said Wilson. It’s a matter of a buyer being able to verify the supplier, according to Lampila. “It takes setting up some rules and some oversight and actually FDA encouraging the processor: If you’re going to import, go visit the site and audit yourself or hire another auditor to go in.” And if the vendor is able to verify the origin of his product, he will see a reward from consumers, she said. Some seafood vendors are now listing the exact location, down to latitude and longitude, where seafood was caught, sometimes even naming the boat. “They are doing that and they are getting sales. They’re getting a premium for their product,” said Lampila. “From my perspective, I see the industry wanting to do more than what we anticipate from the regulations, which I think is a good thing,” Fernandez weighed in.

Chorizo Possible Source of Las Vegas's Firefly Salmonella Outbreak

Gretchen Goetz — Wed, 22 May 2013 20:13:16 +0000

Epidemiologists think they have found the source of a Salmonella outbreak linked to Las Vegas’s Firefly restaurant that is now known to have sickened at least 294 people – almost 100 more illnesses than health officials previously reported. The Southern Nevada Health District announced Wednesday that the outbreak strain of Salmonella had been found in a sample of cooked chorizo collected from the tapas-style restaurant. It is unclear how the chorizo became contaminated, but health officials say the meat likely came into contact with the bacteria at the restaurant, not before it arrived. Nevertheless, “Trace-back efforts have been redirected at the chorizo products due to a small possibility that raw chorizo was contaminated prior to arriving at Firefly,” said SNHD in its third interim outbreak report, issued Wednesday. According to the health department, the bacteria sickened 290 patrons of the restaurant and 4 workers. Of these cases, 73 have been confirmed part of the outbreak by DNA testing. The 221 others are considered probable. The first reported illnesses began on April 22, and the last victim fell ill May 1. All identified victims reported dining at the restaurant between April 21 and April 26. SNHD notes that the case count could change as more illnesses are reported or some are determined not to be connected to Firefly. Health officials submitted the DNA fingerprint of the outbreak strain of Salmonella serotype I:4,5,12:i:- to the Centers for Disease Control and Prevention, which said no other Salmonella cases in the country match those connected to Firefly at this time. John Simmons, Firefly’s head chef, expressed his commitment to learning from this outbreak to avoid another such incident in the future. “While we are anxious to have the final report and a better idea of what may have happened, for me, it was never about the source – it was about making sure I did everything in my power to prevent this from happening again,” said Simmons in a statement Wednesday. “We’ve hired a food safety consultant with over 30 years of experience to double and triple check our methods and we’ll operate in the mode of continuous improvement, constantly upgrading our practices with new technology, new methods, and additional training.”

Court Extends Deadline for FSMA Rules

Gretchen Goetz — Wed, 22 May 2013 05:02:00 +0000

The Center for Food Safety’s tug-of-war with the U.S. Food and Drug Administration over the agency’s delayed food safety rules continued last week as a judge ruled that FDA had more time to come up with a schedule for releasing the outstanding rules. In a ruling yesterday, Judge Phyllis Hamilton of the Oakland U.S. District Court said FDA and CFS now have until June 10 to agree on a schedule for releasing the yet-unpublished food safety rules, mandated by the Food Safety Modernization Act of 2011. CFS filed suit against FDA Commissioner Margaret Hamburg in August of 2012 after the FDA missed a series of deadlines for publishing the regulations mandated by FSMA, which is intended to update the U.S. food safety system by transforming it from a reactive one to a preventive one. After numerous deadlines went by without the release of the mandated rules, CFS went to court to try to force FDA to adhere to these time constraints. In a decision this April, Judge Hamilton ruled that FDA must come up with a new schedule for issuing the proposed rules by May 20. But when FDA sent its updated schedule to the non-profit food watchdog May 15, the group was not happy with the timeline. Since the two parties did not have enough time to discuss these problems before the new timeline was due five days later, they filed a Joint Stipulation for Extension of Time, which Judge Hamilton granted on May 17. According to the order, CFS and the federal food regulatory agency now have until June 10 to agree upon a timeframe for releasing the rules that’s acceptable to both parties. Since CFS filed its complaint last year, FDA has released some of the key FSMA-mandated rules it failed to publish on time, including preventive controls for human food and standards for produce safety, both released in early January. Other rules continue to languish at the White House Office of Management and Budget’s Office of Internal and Regulatory Affairs, which must approve the rules before they are published. FDA attributes some of the delay in its release of the FSMA rules to the hang-ups that come with this part of the process. Among those rules that have yet to be released are the foreign supplier verification program – set to overhaul import safety, an establishment of regulations to ensure the safe transport of food products and a rule ensuring neutrality of third-party audits.

Institute of Medicine: Low Salt Intake May Be Unhealthy

Gretchen Goetz — Thu, 16 May 2013 04:50:17 +0000

Health experts have long promoted one simple, consistent message when it comes to salt intake: cut back. Now, a review from the Institute of Medicine suggests that a diet too low in sodium may actually be unhealthy for those at risk for heart problems. This conclusion was drawn by a committee designated by IOM tasked with reviewing existing research on the effects of sodium intake. After analyzing 39 studies that fit its criteria for review, the committee found that drawing any sort of conclusion about the impact of a low-sodium diet was difficult given the wide range of methodologies used in each study. Despite this variability, the committee said the current body of evidence still shows a positive relationship between salt intake and heart disease. And while the authors were unable to draw a conclusion about the effects of low levels of salt (less than 2,300 mg per day) on the general population, they did find convincing evidence that low sodium intake could lead to adverse effects in patients with mid- to late- stage congestive heart failure. “The evidence on health outcomes is not consistent with efforts that encourage lowerng of dietary sodium in the general population to 1,500 mg/day,” conclude the authors. “Further research may shed more light on the association between lower—1,500 to 2,300 mg—levels of sodium and health outcomes.” The 2010 Dietary Guidelines for Americans, issued by the federal government, recommend limiting daily sodium intake to 2,300 mg for the general population. For those at a higher risk for heart disease, including people over age 51, African Americans and those with high blood pressure, diabetes or chronic kidney disease, the Guidelines recommend consuming 1,500 mg or less per day. But according to the IOM report, this latter recommendation is not backed up by research. Consumer advocacy group Center for Science in the Public interest greeted the study with concern, saying it takes the focus off of the main concern for most consumers: high salt intake. “What the committee failed to emphasize is that most Americans are deep in the red zone, consuming 3,500 to 4,000 milligrams of sodium a day,” said CSPI Nutrition Director Bonnie Liebman. “It’s clear that those excessive levels increase the risk of high blood pressure, heart attacks, and strokes. Whether we aim for 2,300 or 1,500 milligrams a day is irrelevant until we move down out of the red zone.” “The committee was boxed in by a narrow charge to examine only studies that looked at hard endpoints like heart attacks and strokes,” continuted Liebman. “Because of flaws in those studies, the committee did not conclude that low sodium intakes are harmful.” The salt industry, on the other hand, praised IOM for considering the other side of the salt coin. “We are pleased to see that the IOM report has recognized that lowering sodium intake too much may actually increase a person’s risk of some health problems, said Lori Roman, president of the Salt Institute, in a statement Tuesday. “IOM’s recommendation that more study is needed is a positive first step toward a more objective dialog about the complex effects of sodium reduction on overall health.” “There is no scientific justification for population-wide sodium reduction to such low levels and the recognition by the IOM experts that such low levels may cause harm may help steer overzealous organizations away from reckless recommendations,” said Salt Institute Vice President of Science and Research Mort Satin. The full report is available for download here.

Listeria in Onions, Salmonella in Mangoes Topped Last Year's Reportable Foods List

Gretchen Goetz — Wed, 15 May 2013 05:17:43 +0000

Onions recalled for potential Listeria contamination and mangoes recalled for the possible presence of Salmonella were the foods most commonly reported by their manufacturers to the U.S. Food and Drug Administration between September of 2011 and September of 2012, according to a new report from the agency. The U.S. Food and Drug Administration released this latest data from its Reportable Foods Registry (RFR) last month. The Registry is an online forum where companies notify FDA when a food they distribute that may be contaminated or contain undeclared allergens. The majority of products reported to the RFR are subsequent entries, meaning that they contain a food produced by a different company that has been flagged for a health risk. This was the case for both the sliced onions and imported mangoes that topped the list of RFR submissions last year. In July of 2012, Gill’s Onions of California issued a massive recall of sliced onions after samples tested positive for Listeria monocytogenes. According to the RFR report, this finding eventually resulted in 136 submissions to the RFR. Then in August of last year, mangoes imported from Mexican grower Agricola Daniella were recalled after being linked to a multistate Salmonella outbreak that sickened 127 people. The discovery of contamination in the Mexican mangoes led to 107 subsequent entries in the RFR, according to FDA. This year marks the third year FDA has released data from the Registry, which was established by the Food and Drug Administration Amendments Act of 2007. According to the Act, FDA must be alerted of a reportable food via an electronic portal within 24 hours of the company discovering the problem. In total, 1,095 entries were submitted to the Registry between September 8, 2011 and September 7, 2012, or Year 3 of data collection, reported the agency. That number reflected a significant increase from the 882 foods reported during Year 2. The agency says Year 1 was much higher, with 2,240 products reported, because the discovery of Salmonella in a flavor enhancer led to 1,071 subsequent reports to the RFR. Of the Year 3 reports, 224 were primary reports. All but 3 of those primary reports were mandatory industry reports related to a recall in partnership with FDA, while the remaining 3 were voluntary. The number of primary reports has been similar for all three years, said the agency. Data from the RFR is useful not only in identifying products that pose an immediate public health threat, but in identifying types of foods that pose a potential future threat, according to FDA. “We can use the data to identify hazards associated with products for which we have not previously made such an association and thus identify foods for which preventive controls may be needed,” said Deputy Commissioner for Foods and Veterinary Medicine Mike Taylor in the report’s introduction. “The data are also being used to help target inspections, plan work, identify and prioritize risks and develop guidance for industry.”

FDA Warns of Botulism Risk from Juice Maker's Products

Gretchen Goetz — Fri, 10 May 2013 22:56:05 +0000

The U.S. Food and Drug Administration is warning consumers not to drink any juice from a New York-based juice maker whose manufacturing processes do not adequately prevent its products from the growth of Clostridium botulinum. According to FDA, carrot and beet juices from Juices Incorporated (aka Juices International and Juices Enterprises) of Brooklyn, N.Y. have the potential to be contaminated with Clostridium botulinum due to food safety insufficiencies in production. FDA filed a complaint for permanent injunction against the company in October of 2010 after the company failed to correct continuing sanitation violations at its facility. A judge ordered the permanent injunction in January of 2011, thus blocking the company from manufacturing or selling product until it corrected its sanitation issues. However, Juices Incorporated failed to comply with the consent decree, prompting a Judge for the Eastern Disctrict of New York to issue an Order to Enforce Consent Decree. Now, FDA reports that “FDA investigators recently confirmed that Juices Incorporated and its owners continue to manufacture and distribute juice products and other beverages.” Juices from the company were recently found in New York City area retail establishments and restaurants, reports FDA. While the company’s carrot and beet juices are the ones that pose a particular botulism risk due to the way they have been produced, FDA is also recommending that consumers avoid any products made by Juices Incorporated, including Ginger Beer Drink, Agony Peanut Punch, Front End Lifter Magnum Punch, Irish Sea Moss, Cashew Punch, Sorrel Drink, Pineapple Twist, Soursop Juice, Corn Punch and any other types of juice the company might have distributed. The carrot and beet juices FDA says are known to pose a botulism risk include:

Carrot Juice Drink
Carrot & Beet Juice Drink
Carrot & Ginger Drink
Double Trouble Carrot Punch
Ginger Beet Juice
Beet Juice Drink

Raw Milk Campylobacter Outbreak on Kenai Peninsula Sickened 31

Gretchen Goetz — Tue, 07 May 2013 08:02:35 +0000

At least 31 residents of Alaska’s Kenai Peninsula were sickened early this year in a Campylobacter outbreak linked to raw milk, according to a report from state health officials. While this outbreak, which lasted from early January to mid-February, appears to be over, the farm whose raw milk caused the outbreak could still be serving contaminated product, according to the document, published by the Alaska Section of Epidemiology (SOE) last week. Between January 8 and February 13, 31 people between the ages of 7 months and 72 years old fell ill with Campylobacter coli infections that were ultimately linked to a cow-share program on the peninsula. Of the victims, two were hospitalized and four developed reactive arthritis, a painful inflammation of the joints caused by bacterial infections that can last up to a year. The SOE report reveals that health officials had identified the cow-share program on the peninsula as the outbreak source by February 14. The following day, SOE and the Office of the State Veterinarian informed the implicated dairy and the public of the problem; however the dairy continued to sell its raw milk products on the Kenai Peninsula and in Anchorage. At that point, 29 cases of Campylobacter coli had been linked to the dairy. The following week, after two more cases were identified, health officials issued an updated health advisory, after which they say the cow share program provided them with a list of its customers that turned out to be incomplete and lacked contact information for most shareholders. On February 22, health officials conducted an environmental investigation at the cow-share operation, collecting samples from cow feces, milk and areas of the farm that come into contact with the milk during production. While the outbreak strain of Campylobacter coli wasn’t isolated from samples taken that day, three separate strains of Campylobacter jejuni were found in samples of cow feces, and Listeria monocytogenes was cultured from a sample of raw milk. Because other pathogenic bacteria were present on the farm, health authorities say its products could still cause illnesses in the future. The SOE report offers the following advice to consumers, healthcare providers and producers of raw dairy items:

– Health care providers should educate families about the risks of consuming raw dairy products. Informational materials are available at http://www.realrawmilkfacts.com/

– Providers should obtain stool cultures in patients with acute GI illness and history of raw dairy consumption.

– Providers should promptly report cases of Campylobacter infections to SOE by calling (907) 269-8000.

– Cow/goat-share operators should maintain current and legible shareholder/distribution records and share these records promptly with health officials if an outbreak is suspected to be linked to their farm.

FDA to Investigate Safety of Added Caffeine

Gretchen Goetz — Tue, 30 Apr 2013 05:00:53 +0000

The U.S. Food and Drug Administration announced Monday that it will reexamine the safety of caffeine added to foods. The decision was prompted by the release of a new caffeinated gum called Alert, manufactured by Wrigley, which hit markets Monday. The last time FDA looked at caffeine as a food additive was in the 1950s when the agency set a limit on the amount of the substance that could be added to colas. Caffeine is on the agency’s list of ingredients that are “generally recognized as safe” (GRAS) when it comprises .02 percent of a cola beverage, but has not been regulated in other contexts. “Today, the market has changed,” said FDA Deputy Commissioner for Foods and Veterinary Medicine in a statement posted on the agency’s website Monday. “Children and adolescents may be exposed to caffeine beyond those foods in which caffeine is naturally found and beyond anything FDA envisioned when it made the determination regarding caffeine in cola.” And while caffeinated gum has just landed on store shelves, artificially caffeinated beverages have been stirring controversy for years, as they have been tied to adverse health effects and even death. Energy drinks are often exempt from the .02 percent limit because they are considered dietary supplements rather than food or drink. Between 2004 and 2012, five people died after consuming Monster drinks, according to data from FDA. During this time period, 21 people experienced “adverse effects” after drinking Red Bull, although no deaths were reported. In Canada, three deaths were reported after the consumption of Red Bull between 2003 and 2012. A death or adverse health effect after consuming a product does not definitively prove that it was caused by the product, but these events have raised questions about the safety of caffeinated beverages. Because so many artificially caffeinated food and drinks have hit the market since the time FDA considered caffeine in cola, “FDA is taking a fresh look at the potential impact that the totality of new and easy sources of caffeine may have on the health of children and adolescents, and if necessary, will take appropriate action,” said Taylor. According to Wrigley, Alert is not targeted towards young people, but is “a new energy product available for adults 25-49 that lets people control the amount of caffeine they want on-the-go.” However, there is no age minimum for purchasing the gum. Each stick of Alert contains 40 milligrams of caffeine – half of the amount found in an 8.4 ounce can of Red Bull energy drink. The federal watchdog organization Center for Science in the Public Interest questioned the safety of Alert, and said the new product stressed the need for regulation of added caffeine. “Could caffeinated macaroni and cheese or breakfast cereal be next?” asked CSPI’s executive director Michael Jacobson in a statement Monday. “One serving of any of these foods isn’t likely to harm anyone. The concern is that it will be increasingly easy to consume caffeine throughout the day, sometimes unwittingly, as companies add caffeine to candies, nuts, snacks and other foods. And that’s on top of the soda, coffee, tea, and energy drinks that are already widely consumed.”

Ginkgo Biloba Linked to Cancer in Rats and Mice

Gretchen Goetz — Fri, 26 Apr 2013 04:39:26 +0000

Ginkgo biloba, the popular dietary supplement purported to have memory-enhancing properties, has been linked to cancer in rats and mice, according to a new government study. After administering ginkgo regularly to rodents over a two-year period, researchers at the National Toxicology Program (NTP) found that the animals were more likely to develop thyroid and liver tumors than those who did not receive the plant extract, or who received low doses. In a shorter three-month trial, rats and mice who were administered ginkgo displayed characteristics that predict tumor growth. “The tumors found in mice were pretty impressive,” said Dr. Cynthia Rider, NTP’s study scientist for ginkgo. “They were among the highest in NTP studies for one of the tumors that doesn’t occur simultaneously all the time in mice,” Rider explained in an interview with Food Safety News. The mice in the three-month study were put into six dosage groups – no ginkgo, 125 mg per kg of body weight, 250 mg/kg, 500 mg/kg, 1,000 mg/kg and 2,000 mg/kg. Doses were administered five times a week. After three months, all mice who had received 250 mg/kg or more had heavier livers than those who had received no extract. Over the course of the two-year study, cancerous tumors developed in all dosed male mice and in female mice who had been given 600 mg/kg or higher. Only some rats in the two-year study developed liver tumors, but higher levels of thyroid tumors were noted among these rodents. How do these results translate into advice for consumers? What dose of ginkgo extract could put a person at risk for cancer, or does the extract cause a risk to humans at all? To answer these questions, more research is required, said Rider. “I think it’s better to leave that part of the interpretation from our perspective and just say that considering the findings, which were positive for carcinogenisis in both the male and female rats and mice, that they may be related.” “Because these supplements are incredibly complex because they’re based on plant materials, we did not do the full toxicokinetic studies that would be needed to make the comparison,” Rider explained. Toxicokinetics is a way of tracking what happens to a substance in the body. So far, another research team at NTP has conducted an analysis of the liver tumors that developed in the mice. The results of that study showed that the liver tumors that grew in mice given ginkgo extract were different from those that arise spontaneously in mice. Researchers reported a “marked differences between these tumors and those arising spontaneously in the B6C3F1 mouse.” What Rider can say about her team’s results is that they show a potential connection between ginkgo and cancer, and that the substance should be looked at to see whether it indeed provides more benefit than potential risk. She points to a 2008 study on the potential effects of ginkgo on memory, for which over 3,000 participants were given either ginkgo extract or a placebo and followed for an average of 6 years, and no difference in memory function was observed between the groups. “If you’re doing your own personal risk-benefit calculation, you might want to consider the human efficacy studies and our studies as well as the variability seen in the marketplace,” said Rider. The American Botanical Council questioned the results of the government research, saying that the ginkgo used in the NTP study did not reflect extracts commonly found in the U.S. “The Chinese ginkgo extract manufactured in Shanghai is not consistent with any compendial botanical and chemical standards for quality as set forth in various official pharmacopeias and does not conform to the well-established chemical profiles, quality, and purity of the leading, clinically tested ginkgo extracts produced by the pioneering Willmar Schwabe Pharmaceuticals of Karlsruhe, Germany, and Indena SpA in Milan, Italy,” said ABC in a statement last week. However, according to Rider, “The Ginkgo biloba extract used in the current studies was procured from a supplier known to provide material to United States companies.” Rider said she and her colleagues found a wide variety of compositions among ginkgo supplements sold in the U.S. This may be due to the fact that ginkgo, as a dietary supplement, is not regulated by the U.S. Food and Drug Administration. With the passing of the Dietary Supplement Health and Education Act of 1994, the responsibility of ensuring the safety of dietary supplements was transferred from FDA to manufacturers. “Dietary supplements do not need approval from FDA before they are marketed,” says FDA on its website. “A firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products,” continues the agency’s Q & A page on dietary supplements. In 1997, a Denver-based company petitioned FDA to include ginkgo biloba in its list of ingredients that are “generally recognized as safe,” or GRAS, and are therefore allowed to be used as food additives. But the company withdrew its request in 2000, and ginkgo has still not been approved for use in foods.

Shellfish Harvest Area in Washington State Closed for Bacteria Hazard

Gretchen Goetz — Thu, 18 Apr 2013 05:02:59 +0000

A section of water in Washington state’s Grays Harbor County has been closed off to shellfish harvest after high levels of bacteria were discovered in the area. The Washington State Department of Health announced Tuesday that waters near Ocean Shores, WA would be closed permanently for the next year, and 11 other harvest areas have been marked as “threatened.” In threatened areas, levels of fecal bacteria are reaching the health department’s safety threshold, and are in danger of rising above it. “If water quality in the threatened shellfish areas gets worse we’ll have to restrict or close harvesting there,” said Bob Woolrich, WSDH’s Growing Area Section Manager. “Having an area listed as ‘threatened’ is a signal to communities to identify and correct pollution problems.” This year, those threatened areas include:

– In Grays Harbor County: Grays Harbor and Pacific Coast

– In Kitsap County: Port Orchard Passage

– In Mason County: Hood Canal 6 (Alderbrook area) and Pickering Passage (McLane Cove)

– In Pacific County: Bay Center and Naselle River

– In Pierce County: Burley Lagoon

– In Thurston County: Henderson Inlet and Nisqually Reach

– In Whatcom County: Portage Bay

Efforts to fix problems in these areas are already underway in some places, according to the health department, and investigations are scheduled to commence soon in others. The warnings were issued as part of WSDH’s annual water quality evaluation of the state’s commercial shellfish harvest areas. “This early warning helps protect the valuable shellfish resources in Washington state,” said Marc Daily, interim executive director of the Puget Sound Partnership, the state agency in charge of ensuring that dollars allocated for Puget Sound recovery are allocated effectively. “Our partners have been successful in taking this information and improving water quality by finding and fixing sources of fecal bacteria from on-site septic systems and farms,” Daily said in a statement Tuesday. “We expect that to continue. Thanks to the combined efforts of the Department of Health, local governments, farmers, conservation districts, private landowners and so many others, Puget Sound is seeing real, measureable improvement.” Go here for a map of Washington state growing areas and their annual reports.