Fda

  • Posted: May 11th, 2012 - 1:42pm by Doug Powell

    Turtles in the 1960s and 1970s were inexpensive, popular, and low maintenance pets, with an array of groovy pre-molded plastic housing designs to choose from. Invariably they would escape, only to be found days later behind the couch along with the skeleton of the class bunny my younger sister brought home from kindergarten one weekend.

    Maybe I got sick from my turtle.

    Maybe I picked up my turtle, rolled around on the carpet with it, pet it a bit, and then stuck my finger in my mouth. Maybe in my emotionally vacant adolescence I kissed my turtle. Who can remember?

    The U.S. Centers for Disease Control reports there are now 124 confirmed cases of people, primarily kids, infected with outbreak strains of five different Salmonella outbreak strains in 27 states.

    There’s a country-wide love for turtles in 2012, even though the U.S. Food and Drug Administration banned the sale and distribution of turtles less than 4 inches in size as pets since 1975.

    Two new multistate outbreaks linked to small turtles have been identified since the prior update on April 5, 2012. Overall, 5 multistate outbreaks of human Salmonella infection are linked with exposure to small turtles. Results of the epidemiologic and environmental investigations indicate exposure to turtles or their environments (e.g., water from a turtle habitat) is the cause of these outbreaks.

    • A total of 124 persons infected with outbreak strains of Salmonella Sandiego ( and B), Salmonella Pomona (A and B), and Salmonella Poona have been reported from 27 states.

    • Small turtles (shell length less than 4 inches) were reported by 92% of cases.

    • Forty-three percent of ill persons with small turtles reported purchasing the turtles from street vendors.

    • 19 ill persons have been hospitalized, and no deaths have been reported.

    • 67% of ill persons are children 10 years of age or younger.

    • Small turtles (shell length less than 4 inches) were reported by 93% of cases with turtle exposure. Forty-three percent of ill persons with small turtles reported purchasing the turtles from street vendors.

    The number of ill persons identified in each state is as follows: Alaska (2), Alabama (1), Arizona (3), California (21), Colorado (5), Delaware (3), Georgia (3), Illinois (1), Indiana (1), Kentucky (1), Massachusetts (3), Maryland (6), Michigan (2), Minnesota (1), Nevada (4), New Jersey (7), New Mexico (3), New York (24), North Carolina (1), Ohio (2), Oregon (1), Pennsylvania (9), South Carolina (3), Texas (12), Virginia (3), Vermont (1), and West Virginia (1).

    The complete update is available at http://www.cdc.gov/salmonella/small-turtles-03-12/index.html.

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    Cdc, Children, Fda, Pets, salmonella, turtle
  • Posted: May 4th, 2012 - 12:23am by Doug Powell

    As ratings for broadcaster CNN continue a free-fall to nowhere, they’ve come out with a new insight: the 2011 listeria-in-cantaloupe outbreak that killed 32 was preventable.

    So are 99 per cent of all outbreaks.

    CNN Presents on Sunday will feature an in-depth look into the outbreak which, based on a text version appearing on the Intertubes today, is a cut-and-paste job with no new analysis or insight.

    “After a months-long investigation surrounding the outbreak, CNN has found serious gaps in the federal food safety net meant to protect American consumers of fresh produce, a system that results in few or no government inspections of farms and with only voluntary guidelines of how fresh produce can be kept safe.”

    Those gaps have always been there and are still there.

    Dr. James Gorny, the FDA chief investigator who led a team to Jensen Farms in Colorado said, "We had melons from the grocery stores which were positive for Listeria, with the exact same genetic fingerprint as we found in all of the ill individuals. We had ill individuals with that same genetic strain of Listeria. We had food contact surfaces at the packing house of Jensen Farms with the exact same, genetically matched strain of Listeria. So we had lots and lots of evidence that this was ... as definitively as possible, a smoking gun, that this was the source of the contamination. ... The evidence is very, very strong in this case. Some of strongest I've ever seen.

    "What turned the operation upside-down was some significant changes they made. It was a very tragic alignment of poor facility design, poor design of equipment and very unique post-harvest handling practices of those melons. If any one of those things would have been prevented, this tragedy probably wouldn't have occurred."

    But the story of what happened at Jensen Farms, and why no one stopped the sale and shipments of the cantaloupes, also sheds light on serious problems in the nation's fresh produce food safety net, and a voluntary system created by businesses to ensure a quality product, known as third-party audits.

    No kidding.

    Just days before the Listeria outbreak, Jensen Farms paid a private food inspection company called Primus Labs to audit their operation. Primus Labs subcontracted the job to another company, Bio Food Safety, which sent a 26-year-old with relatively little experience to inspect Jensen Farms.

    The auditor was James DiIorio, and he gave Jensen Farms a 96% score, and a "superior" grade. On the front page of his audit at the farm, DiIorio wrote a note saying "no anti-microbial solution" was being used to clean the melons.

    Dr. Trevor Suslow, one of the nation's top experts on growing and harvesting melons safely, was shocked to see that on the audit at Jensen Farms.

    "Having antimicrobials in any wash water, particular the primary or the very first step, is absolutely essential, and therefore as soon as one hears that that's not present, that's an instant red flag," Suslow said. The removal of an antimicrobial would be cause for an auditor or inspector to shut down an entire operation, he said.

    "What I would expect from an auditor," Suslow said, "is that they would walk into the facility, look at the wash and dry lines, know that they weren't using an antimicrobial, and just say: 'The audit's done. You have to stop your operation. We can't continue.'"

    But why just blame the auditors. Who bought these cantaloupes, and where was their internal expertise to assess the audit reports arriving on their desks before, presumably, the melons arrived on their retail shelves.

    "These so-called food safety audits are not worth anything," said Dr. Mansour Samadpour, president and CEO of IEH Laboratories, one of the nation's largest food safety consulting labs for industry. "They are not food safety audits. They have nothing to do with food safety,"

    Samadpour said consumers should have no faith in the current system of farm audits, because farms pay for their own inspections.

    "If this industry is sincere and they want to have their products be of any use to anyone, they should be printing their audit reports on toilet paper," Samadpour said. "People who are commissioning these audits don't seem to understand that they are ... not worth the paper that they're written on."

    So how best to improve the system? Legislation will do little or nothing, the auditing route has regular problems, and food safety is an afterthought in much of the commercial market in the absence of an outbreak. Suggestions? That’s a show I might be interested in watching.

    A preview is below.

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  • Posted: April 22nd, 2012 - 9:31pm by Doug Powell

    The American Cheese Society has a, uh, cheese problem.

    While regulators and retailers reassess the safety of raw milk cheese, ACS declared last week raw milk cheese ”when produced and sold under current FDA guidelines, can be consumed without unnecessary risk.”

    The U.S. Food and Drug Administration began a comprehensive review of the 60-day aging rule in 2009. Officials said the review was done and was awaiting approval before release.

    That was over a year ago.

    The debate focuses on a federal rule that requires cheese made from raw milk to be aged for 60 days before it is deemed safe to eat. Aging allows the chemicals in cheese, acids and salt, time to destroy harmful bacteria. 
Scientists have found, however, that 60 days of aging is an overly simplistic guideline, in part because there are so many types of cheese and different ones may require different safeguards.

    In one 2010 outbreak, 38 people in five states became sick from raw milk gouda made by Bravo Farms of Traver, Calif., and sold through Costco. In another outbreak, eight people in four states were sickened by bacteria traced to soft cheeses made by Sally Jackson, a pioneering cheesemaker in Oroville, Wash.

    In Ms. Jackson’s case, investigators documented unsanitary conditions that could have played a role in making the cheese unsafe. And in the Bravo case, investigators charged the company with packaging cheese for sale before the required 60-day aging was complete.


    The American Cheese Society (ACS) endorses current FDA raw milk cheese guidelines for manufacturers, including:

    • producing cheese in licensed facilities that are routinely inspected on the local, regional, and federal level;
    • producing cheese under the oversight of licensed dairy handlers; and,
    • aging cheese for a minimum of 60 days before it is sold.

    The majority (approximately two-thirds) of ACS members voluntarily exceed these standards by establishing and adhering to a Hazard Analysis & Critical Control Points (HACCP) plan, and following these additional ACS-recommended best practices:

    • taking part in ongoing food safety education;
    • regularly conducting product and environment testing;
    • maintaining accurate and up-to-date records;
    • seeking third party certification;
    • building relationships with local, regional, and federal inspectors; and,
    • adhering to all state and federal regulations and industry standards.

    Shouldn’t any producer of potential risky food comply with food safety basics?

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  • Posted: April 21st, 2012 - 9:19am by Doug Powell

    In 1959, a Nobel Prize-winning physicist challenged his colleagues to use submicroscopic particles to manufacture a wide range of products—an idea that captivated the imagination of scientists and inspired the science fiction movies “Fantastic Voyage” and “Innerspace.”

    Fifty years later, “nano” (small) technology has moved from the science fiction realm to scientific fact, and federal regulators are laying the groundwork for monitoring a new generation of medical devices, drugs, cosmetics, and other products.

    The U.S. Food and Drug Administration is continuing a dialogue on nanotechnology begun in 2011 by publishing proposed guidelines on the evaluation and use of nanomaterials in FDA-regulated products.

    The first draft guideline, “Draft Guidance for Industry, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology” was published in the Federal Register in June, 2011. The FDA is still reviewing and receiving comments on this document from the public.

    In April 2012 the FDA is issuing two new draft guidelines for manufacturers of food substances and cosmetics, which are also open for public comment.

    FDA Commissioner Margaret A. Hamburg, M.D., says the guidelines provide a starting point for the nanotechnology discussion. “Our goal is to regulate these products using the best possible science,” Hamburg says. “Understanding nanotechnology remains a top priority within the agency’s regulatory science initiative and, in doing so, we will be prepared to usher science, public health, and FDA into a new, more innovative era.”

    Nanotechnology—the science of manipulating materials on a scale so small that they can’t be seen with a regular microscope—could have a broad range of applications, such as increasing the effectiveness of a particular drug or improving the packaging of food or altering the look and feel of a cosmetic.

    “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes” describes factors industry should consider when determining whether a significant change in the manufacturing of a food substance affects its identity, safety or regulatory status (such as whether a substance is covered by an existing food additive regulation). A food substance is one that is added to food or to food packaging for purposes that include improving taste, texture, or shelf life.

    This guidance covers “any manufacturing process change that might affect a food substance’s identity, intended uses, or the way it behaves in the body after it is eaten,” says Dennis Keefe, Ph.D., director of the Office of Food Additive Safety.

    Keefe added that nanotechnology now is being studied in food packaging to combat bacteria and detect spoilage, and to improve the bioavailability (the degree and rate at which a substance is absorbed into one’s system) of nutrients, among other applications.

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  • Posted: April 19th, 2012 - 11:07pm by Doug Powell

    It’s like a game show: This Week in Warning Letters from FDA.

    Take your chances, make mistakes, let the U.S. Food and Drug Administration lay out your food failings in public view.

    Seafood was a repeat offender, and some others:

    General Tuna Corporation, based in the Philippines, cited for having a HACCP plan that really sucked;

    Chung's and Son Company of Temple Hills, Maryland, cited for having a HACCP plan that really sucked, your vegetable and shrimp egg roll is adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health;

    Custom Seafood Services Inc. of Seattle, Washington, cited for having a HACCP plan that really sucked, your Dungeness crab sections and King crab legs and claws are adulterated;

    Concept Asia Food Service, another Seattle fish processor with a lousy HACCP plan,
    your sushi roll products, including the salmon roll, eel roll, tai roll, imitation crab roll, and tuna roll, are adulterated

    Sugar Bakers, Inc. of Catonsville, Maryland, you have lousy handwashing trash all over the place, and poor storage choices;

    Panaderia El Angel of Arlington, Washington, a Hispanic bakery, you have serious violations of Good Manufacturing Practices, your products are all adulterated;

    K-Brand Farms of Woodridge, New York, you have serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation regulation (the shell egg regulation), your shell eggs are adulterated; and,

    Societe Fromagere de Bouvron of Bouvron, France, you produce cheese with substandard equipment.

    Join us again next week.

    Your moment of homage, from Second City TV in 1981,

    and, something else.

     

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  • Posted: April 19th, 2012 - 3:52pm by Doug Powell

    The U.S. Food and Drug Administration Reportable Food Registry (RFR) logged 1,153 entries from Sept. 8, 2010 – Sept. 7, 2011, it’s second full year of reporting.

    Among the highlights:

    • 225 primary reports – initial reports about a safety concern with a food or animal feed (including food ingredients);
    • 483 subsequent reports from suppliers or recipients of a food or feed for which a primary report had been submitted; and,
    • 174 amended reports to correct or add information to previously submitted reports.

    Reports were received from both domestic and foreign sources.

    The 225 primary reports for Year 2 involved products in 22 commodity categories. Salmonella accounted for 38.2 percent of hazards, Undeclared Allergens accounted for 33.3 percent, and Listeria monocytogenes accounted for 17.8 percent.

    The report notes that the RFR findings have spurred efforts to improve preventive measures in affected commodity areas, both by industry and FDA, and are helping the agency better target its inspection and sampling activities.

    The RFR requires manufacturers, processors, packers and holders (warehousers, distributors, etc.) of FDA-regulated foods/feeds to quickly report to FDA via the online Safety Reporting Portal any foods, feeds or ingredients that could result in serious adverse health consequences to humans or animals. Reportable food submissions provide early warning to FDA about potential public health risks and increase the speed with which the agency and its partners at the state and local levels can investigate the reports and take appropriate follow-up action, including ensuring that the reportable foods are removed from commerce when necessary.

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  • Posted: April 9th, 2012 - 4:49pm by Doug Powell

    A Washington state cheese processor and distributor has agreed to keep its products off the market until they are proven safe for consumption as part of a consent decree of permanent injunction with the U.S. Food and Drug Administration.

    Del Bueno, of Grandview, Wash., which processes a variety of cheeses and distributes them to specialty grocery stores and restaurants, and owner Jesus Rodriguez, agreed to terms of the consent decree entered by U.S. District Judge Lonny R. Suko of the Eastern District of Washington, on April 3.

    Under the consent decree, Del Bueno cannot process or distribute food until it demonstrates that it has developed a control program to eliminate Listeria monocytogenes from its production facility and products.

    Del Bueno must, among other actions, hire an independent laboratory to collect and analyze samples for the presence of Listeria, retain an independent sanitation expert, develop a program to control Listeria for all employees in both English and Spanish, and destroy all food items currently in the facility. Once the company is permitted to resume operations, the FDA may still require the company to recall products or cease production if future violations occur.

    “When a company continues to produce food that presents a risk for consumers, the FDA will take action,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “We will not hesitate to protect the public’s health.”

    FDA and Washington State Department of Agriculture (WSDA) inspections since 2009 have documented numerous deficiencies in Del Bueno’s processing facility. In addition, FDA laboratory testing since 2010 also found Listeria monocytogenes in Del Bueno’s finished cheese products and in the Del Bueno facility. Both the FDA and the WSDA repeatedly advised Del Bueno and its owner of the unsanitary conditions at the facility.

    In 2010, Del Bueno cheese was linked to a case of listeriosis in Washington state. Although no illnesses have been reported in 2012 from Del Bueno products, individuals who have eaten these products and experience any of the symptoms of listeriosis listed above should contact their health care professional.

     

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  • Posted: April 9th, 2012 - 2:56pm by Doug Powell

    Surveys still suck.

    But at least researchers from the U.S. Food and Drug Administration recognize the limitations of self-reported food safety behavior, in this case applied to produce washing practices in the kitchen. From a recent paper in Food Protection Trends:

    “Although washing does not guarantee removal of pathogens if the item has become contaminated, it increases the likelihood that pathogens will be removed, compared with not washing or using washing methods that are not recommended. Soaking and use of any type of cleaner are not recommended washing methods. Soaking does not remove contami¬nants as effectively as rubbing or rinsing produce under running water. Cleaners not meant for produce can introduce chemical contaminants, and produce washes are considered no more effective than water. Unlike other types of produce, almost all bagged, pre-cut let¬tuce in the market place is pre-washed. For bagged, pre-cut lettuce that is labeled as pre-washed, additional washing is not recommended as it is not likely to en¬hance safety and introduces the op¬portunity for cross-contamination of the product with pathogens that may be in the home kitchen. …

    “This study has some strengths and limitations. One of the limitations is that the data are self-reported. We rely on consumers’ ability to both remember what they do and convey it accurately. Self-reporting is also subject to the de¬sire to give socially desirable responses; an observational study of consumer produce washing showed that far fewer consumers actually wash produce than report doing so in surveys. Also, the findings would have been more use¬ful if we had asked consumers why they washed cantaloupes and bagged, pre-cut lettuce. Finally, our survey suffered from the increasingly common problem of low response rates for household sur¬veys, although this does not necessarily bias the survey results. Some of the main strengths of this study are the sampling method, large sample size and weighting strategy, which allows our findings to be representative of the population. This allows us to make comparisons at the population level.

    “Food Safety practices should be¬gin on the farm and be rigorously ap¬plied along the entire chain so that food products are safe for human consump¬tion without the need for extraordinary measures. Consumers, however, are the critical endpoint along the food supply chain. Educational efforts with respect to product washing should focus on explaining why it is important to wash hard rind produce such as cantaloupe be¬fore cutting, but not rewashing produce that is ready to be eaten.”

    The abstract is below:

    Consumer vegetable and fruit washing practices in the United States, 2006 and 2010
    Food Protection Trends, Vol. 32, No. 4, Pages 164–172
    Linda Verrill, Amy M. Lando 1 and Kellie M. O’Connell
    Vegetables and fruits may become contaminated with pathogens anywhere along the farm-to-plate continuum. Therefore, the FDA recommends that vegetables and fruits that have not already been washed be washed by the consumer before slicing or consuming them. The FDA included in its 2006 and 2010 Food Safety Survey a series of questions about purchasing and washing of strawberries, tomatoes, cantaloupes, and bagged, pre-cut lettuce. The Food Safety Survey is a telephone survey tracking consumers’ knowledge, attitudes and behaviors related to food safety. In 2006, of those who buy these products, 98% wash strawberries, 97% wash tomatoes, 57% wash cantaloupes and 54% wash bagged pre-cut lettuce. Overall, for both years, more women than men wash cantaloupes, and more men than women wash bagged pre-cut lettuce. Cantaloupe washing declined from 2006 to 2010 for men, while lettuce washing increased for women in the same period. Targeted education campaigns should emphasize the importance of washing produce, especially fruits with hard rinds.

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  • Posted: April 6th, 2012 - 1:42am by Doug Powell

    The U.S. Food and Drug Administration has made available on the Internet the second edition of the Bad Bug Book, a handbook of basic information about foodborne bacteria, viruses, parasites, prions, and naturally occurring toxins. In addition to updated scientific information, the book includes five new chapters (on Cronobacter, Enterococcus, Francisella tularensis, phytohaemagglutinin, and venomous fish).

    Although the book is intended primarily for scientific and technical readers, each chapter now also includes a separate section for consumers. The consumer sections are written in everyday language and focus on food safety, including tips on how to reduce the risk of foodborne illness.

    (Don’t pay attention to this; attempts to simplify or dumb down information rarely work; write and present information in a clear, concise and compelling manner).

    Please check the FDA web site periodically, as more chapters will be added. The updated edition of the Bad Bug Book is available on the FDA web site at http://www.fda.gov/Food/FoodSafety/FoodborneIllness/FoodborneIllnessFoodbornePathogensNaturalToxins/BadBugBook/default.htm

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  • Posted: April 5th, 2012 - 12:31am by Doug Powell

    A new report calls on the U.S. Food and Drug Administration to export its regulatory knowhow to improve the safety of imports arriving in the U.S.

    Almost 40 percent of the fruits and nuts and 85 percent of the seafood that Americans purchase come from aboard. More than 80 percent of active pharmaceutical ingredients are imported, and 40 percent of medicines are imported as finished products.

    The report from a committee of the Institute of Medicine of the National Academies says many regulatory agencies abroad lack the legal framework, funding, training, and oversight that have helped to transform the FDA into one of the world’s top-notch regulatory agencies.

    Jim Riviere, a professor of pharmacology at North Carolina State University, Raleigh, and chair of the committee said, "Globalization is not going to reverse. … No matter how much inspection we do, we are always going to find flawed products. We're not saying we need to cut back on inspections, but all resources can't be spent on inspection."

    Instead, the IOM says the onus is on the FDA to help the exporting countries improve their own regulatory systems and supply chains, so that everyone can be more confident that what they're producing is safe.

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