Tag Archives: food safety

Food Safety Agencies Introduce New Model to Better Identify Foodborne Illness Sources

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FDA, CDC and the USDA’s FSIS have jointly released a report on the new method for analyzing outbreak data to identify better foods that are responsible for illness related to four major foodborne bacteria.

Titled “Foodborne Illness Source Attribution Estimates forSalmonella, Escherichia coli O157 (E. coliO157), Listeria monocytogenes (Lm), and Campylobacter using Outbreak Surveillance Data,” the report was produced by the Interagency Food Safety Analytics Collaboration (IFSAC).

FSTNewsNewModelforOutbreaks For the new model, IFSAC analyzed data from nearly 1,000 outbreaks that occurred between 1998 and 2012, excluding those that involved multiple pathogens, those for which no food vehicle was identified, and those attributed to food containing multiple ingredients, to assess which categories of foods were most responsible for making people sick with Salmonella, E. coli O157, Listeria, and Campylobacter.

The pathogens were chosen because of the frequency or severity of the illnesses they cause, and because targeted interventions can have a significant impact in reducing them. Some of the findings include:

  • More than 80 percent of E. coli O157 illnesses were attributed to beef and vegetable row crops, such as leafy vegetables.
  • Salmonella illnesses were broadly attributed across food commodities, with 77 percent of illnesses related to seeded vegetables (such as tomatoes), eggs, fruits, chicken, beef, sprouts and pork.
  • Nearly 75 percent of Campylobacter illnesses were attributed to dairy (66 percent) and chicken (8 percent). Most of the dairy outbreaks used in the analysis were related to raw milk or cheese produced from raw milk, such as unpasteurized queso fresco.
  • More than 80 percent of Listeria illnesses were attributed to fruit (50 percent) and dairy (31 percent). Data were sparse for Listeria, and the estimate for fruit reflects the impact of a single large outbreak linked to cantaloupes in 2011.

The new model using data from the resulting 952 outbreaks differs from previous methods by using a categorization of foods updated to align with the regulatory framework of FDA and FSIS. The model focuses more on recent outbreaks by giving less weight to data from 1998 through 2007, and decreasing the bias that potentially results from very large outbreaks.

“This suggests interventions designed to reduce foodborne salmonellosis need to include a variety of approaches,” IFSAC’s report states. “For [Listeria monocytogenes], the limited number of outbreaks and wide credibility intervals dictate caution in interpreting the attribution percentages for fruit and dairy,” the report notes.

The report also noted that “Lm outbreaks have been frequently linked to the Dairy category, specifically with the consumption of soft cheeses by pregnant women and persons with weakened immune systems. Although the wide credibility interval for the Fruit category substantially limits interpretation, the analysis does suggest vigilance in seeking unrecognized sources of outbreaks and illnesses in this food category.”

Top Reasons for Warning Letters

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Drug residues, inadequate food safety and HACCP programs for seafood, and nutrition content mislabeling were leading causes of FDA issuing recent warning letters.

The U.S. Food and Drug Administration (FDA) sent warnings to three beef producers, one pork producer, a seafood processor and a biscuit manufacturer in its latest round of warning letters.

Some of the beef producers and dairy farms received warning letters for drug residues found in their meat:

  • Oak Hill Farms of Seward, PA, received a warning letter for selling a bob veal calf in July 2014, testing of which revealed neomycin, a drug that has no acceptable tolerance level.
  • Schneider Dairy of Westphalia, MI, was found to have sold a dairy cow for slaughter in February 2014 that contained more than 10 times the tolerance level for for desfuroylceftiofur, marker residue for the drug ceftiofur. FDA also found that the dairy failed to maintain complete drug treatment records and lacked clear directions from its veterinary clinic on using the drug.
  • Stonegate Farms, sold a cow for slaughter in July 2014 that was found to have 13 times the tolerable level of penicillin in its kidneys and nearly 100 times the tolerable level of sulfadimethoxine in its liver. That dairy also failed to maintain complete treatment records of its cattle, according to FDA.
  • Poeppelman Pork of Yorkshire, OH, was also found to have sold an animal for slaughter with excessive levels of drugs in its tissues. In February 2014, the pork producer allegedly sold a pig for slaughter that was found to have penicillin in its kidneys. FDA’s letter noted there is no tolerance level of penicillin in swine.

Yamahide Shokuhin, a seafood processor and exporter in Miki-shi, Japan, was cited for having inadequate HACCP plans. The company was also found to have “significant deviations” from requirements, including a number of incomplete food safety plans for its dried shaved bonito product.

NP Foods Ltd., headquartered in Riga, Latvia, was cited for having several wafer and biscuit products that were mislabeled, all related to incomplete nutritional information. The company also failed to include the common or usual name of the foods on the labels in English.

In each letter, FDA requested that the companies provide written responses detailing steps taken to bring the facilities into compliance with food-safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence. The companies are given 15 working days from receipt to outline specific steps they have taken to come into compliance with the law.

Dietary Supplements: Verifying Label Claims “By Input” Unacceptable

By Tara Lin Couch, Ph.D.
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FDA issued more than 400 Warning Letter citations for inappropriate specifications in dietary supplement during 2013 and 2014. Many of these violations were due to a failure to have Finished Product Specifications, but recent citations have also noted that using solely the input of a dietary ingredient for verifying the strength “By Input” is unacceptable.

The FDA regulations dictated in 21 CFR 111, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, require that each batch of a finished dietary supplement product must meet quality requirements for identity, purity, strength, composition, and limits of potential contaminants.

Criteria used to establish that these requirements are met are supposed to be provided in a Finished Product Specification developed by the dietary supplement company. FDA issued more than 400 Warning Letter citations for inappropriate specifications in 2013 and 2014. Many of these violations were due to a failure to have Finished Product Specifications at all, but recent Warning Letters have also noted that using solely the input of a dietary ingredient for verifying the strength “By Input” is unacceptable.

The input of a dietary supplement alone is not a scientifically valid analytical test method for determining the strength of a dietary ingredient in a finished product. Chemical testing of the ingredient should be accomplished whenever possible. If that is not possible due to the unavailability of a scientifically valid test method, the testing may be exempted provided dietary ingredient raw material testing, in-process testing, other finished product testing, process controls, and additional information can support that the strength of the dietary ingredient can be verified without testing, as allowed in 21 CFR 111.75(d)(1).

The incoming dietary ingredient raw material must be verified to meet quality requirements for identity, purity, strength, and the lack of potential contaminants. Warehouse controls must then ensure that the material is held in a condition in which its quality is not altered. The material must be formulated at an appropriate amount, with sufficient overage, to meet the label claim while taking into account manufacturing variability. This is dictated in an approved Master Manufacturing Record (MMR). Once executed, the Batch Production Record (BPR) must document that the correct amount of the dietary ingredient was actually dispensed into the product during manufacture. Established in-process examinations and tests are then used to verify that the batch is uniformly mixed and meets the unit dosage weight and weight variation requirements. Variations on weight cannot exceed the overage amount to ensure that even the smallest dosage unit still complies with the label. In-process chemical tests can also be employed to verify the amount of a dietary ingredient. This can be particularly beneficial if the reason a dietary ingredient is exempted from testing is because of matrix interferences or instrumental quantitation limits.

Other finished product testing can also be used to support that an exempted ingredient is present in the product at the correct, labeled amount. Test results from chemically similar ingredients that are determined to be as expected suggest that the exempted ingredient is also present at expected levels because these ingredients will tend to react the same way during manufacture, especially if both ingredients are introduced and processed in the same step. Results obtained from finished product testing of other ingredients whose concentrations are associated with the exempted ingredient may also support that the exempted ingredient is present as expected.

Finally, the number of other finished product ingredient tests that are performed is important. If all other test results are determined to be within specification, it indicates that the product was manufactured according to the MMR and there is no reason to expect anything different from an exempted dietary ingredient.

Dietary supplement companies that are compliant with all parts of 21 CFR 111 will already be performing these activities. A procedure that summarizes the overall process of verifying the addition of a dietary ingredient can then be created and used as the test method reference on the Finished Product Specification. A separate document that describes the details of test exemptions per product should also be generated. The actual result obtained should be acquired from the completed batch production record.

The “By Input” approach is no longer relevant.

This article originally appeared in EAS-e-News February 2015 issue.

Canadian Poultry Products Recalled for Lack of Import Inspection

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The products subject to recall bear the establishment number “Canada 591”. These products were shipped to retail locations in Washington.

Sunrise Poultry Processors of Lethbridge, Alberta, is recalling approximately 2,705 pounds of poultry products that were not presented at the U.S. point of entry for inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The following poultry items, produced on Feb. 2, 2015, are subject to recall:

  • 40-lb. bulk cases of “Sunrise Poultry CHICKEN THIGHS.”
  • 25-lb. cases of “Sunrise Poultry CHICKEN THIGHS BONELESS.”
  • 25-lb. cases of “Sunrise Poultry BONELESS CHICKEN BREAST.”
  • 2.5-lb. cases of “Sunrise Poultry CHICKEN WHOLE FRYER.”
  • 4-lb. cases of “Sunrise Poultry CHICKEN WHOLE FRYER.”
  • 3.25 to 3.75-lb. cases of “Sunrise Poultry CHICKEN WHOLE FRYER.”

The products subject to recall bear the establishment number “Canada 591”. These products were shipped to retail locations in Washington.

The problem was discovered when the import facility reported to FSIS that product with an estimated date of arrival of Feb. 4, 2015, had not been received at that location.

FSIS and the company have received no reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.

Australia Could Ban Raw Milk Sale

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While the sale of raw milk is already banned for human consumption in all states and territories in the country, raw milk is still sold as ‘bath milk’ or ‘cosmetic milk’ with a disclaimer, but it is knowingly being consumed by people who argue the bacteria in raw milk are beneficial to health. Raw milk cheese gets a pass.

A national ban on the sale of raw milk is looming after state and territory leaders agreed consumers need protection from the dangers posed by unpasteurized milk.

The Australia and New Zealand Ministerial Forum on Food Regulation, attended by ministers responsible for food regulation, raised their ‘extreme concern’ about the consumption of unpasteurized cow’s milk that is sold as ‘bath milk’ with a disclaimer ‘not for human consumption.’ The forum found urgent action was required at a national level and are asking for “a joint public health, food safety and consumer law solution that will deliver a consistent approach across all Australian jurisdictions,” Australian newspaper The Herald Sun reports. 

Last month Premier Mike Baird vowed to work with other state and territory leaders to stop health food stores selling the potentially deadly product. His move followed Victoria’s tough action on producers of raw milk following the death of a Victorian child and the hospitalization of four other children in December. The children suffered severe complications as a result of food poisoning sourced to raw milk consumption.

The sale of raw milk is already banned for human consumption in all states and territories but raw milk is sold as ‘bath milk’ or ‘cosmetic milk’ with a disclaimer, but it is knowingly being consumed by people who argue the bacteria in raw milk are beneficial to health.

Now under new regulations, Victorians who give family members raw milk to drink face fines of $60,000.

As of Sunday, a strong bittering agent will be put into unpasteurized milk to deter people from consuming it, according to the state’s minister for consumer affairs, Jane Garrett. More than 100 protesters gathering outside Garrett’s Brunswick office and vowing they would continue drinking milk in what they describe as its “purest form.” Meanwhile, specialist cheese makers are welcoming a decision by the New Zealand and Australian health ministers to allow a wider range of cheeses to be made from raw milk. The decision was made at a meeting of the ministers in Auckland. The new rules require that the raw milk cheese does not support the growth of disease-causing bacteria, and that there is no rise in the level of those during processing.

Super Bowl Food Safety

By Sangita Viswanathan
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Despite all the excitement surrounding the big game, party hosts should be cognizant of potential lurking dangers in their food. No one wants to get sick off a few wings, jalapeno poppers, and mozzarella sticks – An interview with PURE Bioscience’s CEO, Hank Lambert.

With the Super Bowl this weekend, fans around the country are beginning to plan for their big parties, deciding who to invite and what food they’ll be serving. Some rough estimates predict that football fans, on an average will consume 2400 calories, just during the game.

Despite all the excitement surrounding the big game, party hosts should be cognizant of potential lurking dangers in their food. No one wants to get sick off a few wings, jalapeno poppers, and mozzarella sticks.

Hank Lambert, CEO of PURE Bioscience, Inc. spoke to Food Safety Tech about how costs can keep their food safe and precautions that can be taken to prevent Super Bowl fans from getting sick from the food.

PURE Bioscience develops and commercializes proprietary antimicrobial products based on patented, stabilized ionic silver, and Silver Dihydrogen Citrate (SDC). “The product is a food contact disinfectant that is effective in killing a broad range of pathogens, including norovirus (in 60 seconds). We are non-toxic compared to others that are ammonium or chlorine based, tasteless/ odorless and non-corrosive (with an EPA level 4 toxicity or lowest toxicity label),” describes Lambert.

Lambert warns that norovirus is particularly dangerous during this season, and is a risk at home entertaining as much as it is in a public restaurant or cruise ship. Following food handling and prep guidelines is always critical and Lambert provides a few tips to ensure this:

  • Ensure that hands are properly cleaned between preparing and serving, between handling raw and prepared foods. Proper hand washing by itself, can help halve half the risk of any foodborne illness, he points out.
  • Ensure food prep surfaces are cleaned, so that any cross contamination can be avoided. For instance after prepping raw chicken, make sure you properly wash and sanitize the surface before cutting veggies or cheese on it.
  • Keep raw and cooked foods separate, starting at the grocery store keep your chicken wings for instance in a separate bag from the carrots or celery or dip to minimize risk of cross contamination, and follow this at home in the refrigerator and during prep.
  • Cook your foods thoroughly. For instance, poultry (wings or tenders), make sure it’s cooked to internal temp of 165 F to kill potential bacteria.
  • Keep the foods at safe temperatures, whether it’s in the refrigerator (40 F or below) when storing or serving them to ensure bacteria won’t grow. Don’t leave prepared food out for more than two hours out at a time, Lambert mentions guacamole served in large bowls, left sitting out for hours at such parties. “Serve in a small bowl, refrigerate the rest, and replenish when needed to maintain safe temperatures,” he advises.

Another rule to remember: “If you have someone at home or a guest is sick, they should not be handling food or around food. Even if you think you are feeling better, you could still be shedding norovirus or other germs when you sneeze, perspire etc., for up to three days after you feel better. So be thoughtful of other guests,” Lambert cautions.

So which traditional Super Bowl foods are the most prone to food-borne illnesses? “A common culprit is often chicken products, which, if not cooked to proper internal temperature, carry the risk of spreading Salmonella. Raw vegetables can also be a leading cause if not properly washed, or if they have been cross contaminated,” lists Lambert.

So while you are reveling in your Super Bowl Party this weekend, eat safe and may the best team win!

Lawmakers Introduce Bill for Single “Food Safety Administration”

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Food safety oversight is currently split up among 15 agencies in the Departments of Health and Human Services, Agriculture, and Commerce. The Safe Food Act of 2015 introduced in both houses of Congress on Wednesday, aims to consolidate all the authorities for food safety inspections, enforcement and labeling into the Food Safety Administration.

Senator Dick Durbin (D-IL) and Representative Rosa DeLauro (D-CT) introduced bills in Congress yesterday with a goal to establish a single, independent federal food safety agency. The aim is to improve food safety for consumers, while also cutting back on the costs of a dispersed system with overlapping responsibilities between agencies, according to Durbin.

 

“What the bill does is remedy the situation,” DeLauro said. “With a single agency, we believe our country will be able to have the ability to detect relatively minor problems before they become major outbreaks.”

The Act would provide the Food Safety Administration with mandatory recall authority for unsafe food, require risk assessments and preventive control plans to reduce adulteration, authorize enforcement actions to strengthen contaminant performance standards, improve foreign food import inspections, and require full food traceability to better identify sources of outbreaks.

DeLauro said the bill builds on the improvements made in FDA’s Food Safety Modernization Act (FSMA).

The federal agencies that would be incorporated into one include:

  • FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM); 
  • The resources and facilities of FDA’s Office of Regulatory Affairs that administer and conduct inspections of food and feed facilities and imports; 
  • The resources and facilities of the Office of the FDA Commissioner that support CFSAN, CVM and inspections;
  • USDA’s Food Safety and Inspection Service;
  • The part of USDA’s Agriculture Marketing Service that administers shell egg surveillance services;
  • The part of USDA’s Research, Education, and Economics mission area related to food and feed safety;
  • The part of USDA’s Animal and Plant Inspection Health Service related to the management of animals going into the food supply; and
  • The part of the National Marine Fisheries Service of the National Oceanic and Atmospheric Administration of the Department of Commerce that administers the seafood inspection program. 

A single food safety agency is not a new concept, and the two lawmakers have sponsored Safe Food Acts five times before, though the most recent was in 2007. In addition, the Government Accountability Office has reported on the need for better coordination of food safety activities over the years.

DeLauro mentioned eggs as an example to show how complicated the current food safety landscape was: “One agency manages the health of hens, another oversees the feed that they eat, another sets egg quality standards but does not test them for Salmonella,” she said. “While still in its shell, the egg is the responsibility of the Food and Drug Administration, but once it’s processed into an egg product, it becomes the responsibility of Food Safety and Inspection Service.”

Durbin and DeLauro are hoping to build bipartisan support for the bills. Current cosponsors of the Senate Safe Food Act include Sens. Dianne Feinstein (D-CA), Richard Blumenthal (D-CT) and Kirsten Gillibrand (D-NY). Cosponsors in the House include Reps. Barbara Lee (D-CA), Louise Slaughter (D-NY), James Langevin (D-RI), Bobby Rush (D-IL), Charles Rangel (D-NY), Jim McDermott (D-WA) and Delegate Eleanor Holmes Norton (D-DC).

115 Sickened: Multistate Outbreak of Salmonella Enteritidis Infections Linked to Bean Sprouts

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So far, 61 outbreaks have been associated with raw sprouts, sickening at least 11,179.

The U.S. Centers for Disease Control reports this outbreak appears to be over.

barfblog-raw-sprouts-Aug-2014A total of 115 people infected with the outbreak strains of Salmonella Enteritidis were reported from 12 states. Twenty-five percent of ill persons were hospitalized. No deaths were reported.

Collaborative investigation efforts of state, local, and federal public health and regulatory agencies indicated that bean sprouts produced by Wonton Foods, Inc. were the likely source of this outbreak.

In interviews, 61 (72 percent) of 85 ill persons reported eating bean sprouts or menu items containing bean sprouts in the week before becoming ill.

In November 2014, Wonton Foods Inc. agreed to destroy any remaining products while they conducted a thorough cleaning and sanitization and implemented other Salmonella control measures at their firm. The firm resumed shipment of bean sprouts on November 29, 2014.

Contaminated bean sprouts produced by Wonton Foods, Inc. are likely no longer available for purchase or consumption given the maximum 12-day shelf life of mung bean sprouts.

Although this outbreak appears to be over, sprouts are a known source of foodborne illness. CDC recommends that consumers, restaurants, and other retailers always follow food safety practices to avoid illness from eating sprouts.

Be aware that children, older adults, pregnant women, and persons with weakened immune systems should avoid eating raw sprouts of any kind (including alfalfa, clover, radish, and mung bean sprouts).

We count 61 outbreaks associated with raw sprouts, sickening at least 11,179.

How Safe is Consumer Handling of Raw Poultry Products at Home?

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Between 1998 and 2008, 20 percent of Salmonella and 16 percent of Campylobacter foodborne disease outbreaks were associated with food prepared inside the home.

Salmonella and Campylobacter cause an estimated combined total of 1.8 million foodborne infections each year in the United States. Most cases of salmonellosis and campylobacteriosis are associated with eating raw or undercooked poultry or with cross-contamination.

Between 1998 and 2008, 20 percent of Salmonella and 16 percent of Campylobacter foodborne disease outbreaks were associated with food prepared inside the home.

A nationally representative Web survey of 1,504 U.S. adult grocery shoppers was conducted to estimate the percentage of consumers who follow recommended food safety practices when handling raw poultry at home.

The survey results identified areas of low adherence to current recommended food safety practices: Not washing raw poultry before cooking, proper refrigerator storage of raw poultry, use of a food thermometer to determine doneness, and proper thawing of raw poultry in cold water.

Nearly 70 percent of consumers reported washing or rinsing raw poultry before cooking it, a potentially unsafe practice because “splashing” of contaminated water may lead to the transfer of pathogens to other foods and other kitchen surfaces.

Only 17.5 percent of consumers reported correctly storing raw poultry in the refrigerator. Sixty-two percent of consumers own a food thermometer, and of these, 26 percent or fewer reported using one to check the internal temperature of smaller cuts of poultry and ground poultry. Only 11% of consumers who thaw raw poultry in cold water reported doing so correctly.

The study results, coupled with other research findings, will inform the development of science-based consumer education materials that can help reduce foodborne illness from Salmonella and Campylobacter.

Journal of Food Protection, Number 1, January 2015, pp. 4-234, pp. 180-186(7) Kosa, Katherine M.; Cates, Sheryl C.; Bradley, Samantha; Chambers IV, Edgar; Godwin, Sandria. 

Gina Kramer
Food Safety Think Tank

An Introduction

By Gina R. Nicholson-Kramer
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Gina Kramer

This new column on Food Safety Tech is a B2B forum for food safety tech, food manufacturing, food distribution, food retailer service/sales, and chemical and tools manufacturing companies in our industry. One of the important efforts we all have in common in this industry is we must continually identify food safety risk (or gaps) in food manufacturing, distribution, and sales to develop improved systems, methods, chemicals, and tools to fill these gaps and reduce risk. In the near future, many of these efforts will be mandatory due to the new regulatory rules being developed through FSMA.

Food Safety Think TankMy goal for this column is to facilitate new thinking to stimulate innovative solutions in food safety for our industry. I have the experience of leading large chain food sales and food service food safety programs; working with business professionals within our respective food companies and with our vendors, to develop systems and tools to improve food safety.

How can this column be of value to our industry?

  • Follow the column. Subscribe to FST News, and receive notifications of the column in your inbox whenever we post something new.
  • Participate. The column should be more than just a source for useful information; I actually want to start a conversation with you – industry professionals. Respond to column posts and share what you know, ask questions, submit ideas, inform us of gaps you see in food safety, and share your efforts, etc.
  • Contribute. We are actively looking for industry professionals who want to share their work in food safety. Whether it’s benchmarking existing solutions or sharing your research that defines gaps and new opportunities for innovation, we need your contributions. Let’s invoke a broad range of new ideas across a wide range of issues to speed up new or improved tools, reduce cost, improve efficiency, and even develop new business models for food safety solutions. Write to me at Gina@SavourFoodSafety.com. I look forward to hearing from you.