FDA Commissioner Hamburg to Step Down

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Hamburg, one of the longest-serving FDA commissioners in the modern era, told Reuters in an interview that her decision was prompted by the heavy demands of the job and the sheer length of time she has held the position.

Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration (FDA), who for almost six years has overseen public health initiatives ranging from tobacco control and food safety to personalized medicine, disease control and drug approvals, is stepping down, Reuters News Agency has reported.

Hamburg, 59, is one of the longest-serving FDA commissioners in the modern era. She was nominated by President Barack Obama and confirmed by the U.S. Senate in May 2009 and last year was named the world’s 51st most powerful woman by Forbes.

Hamburg, one of the longest-serving FDA commissioners in the modern era, told Reuters in an interview that her decision was prompted by the heavy demands of the job and the sheer length of time she has held the position. “This is a very challenging job full of opportunities to make a huge and enduring difference,” she said, “but it is 24/7 and there are really really difficult decisions to make.”

Late last month, the agency named Dr. Robert Califf, a prominent cardiologist and researcher from Duke University, to oversee its drug, medical device and tobacco policy. Reuters adds that Califf may be a potential successor to Hamburg.

A long-time public health official with extensive experience fighting AIDS and tuberculosis, Hamburg, who graduated from Harvard Medical School, previously served at the National Institutes of Health before becoming New York City’s health commissioner.

Click here to read the Reuters article.

Funding Critical for FSMA, Says FDA’s Taylor

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In an FDA blog, the Deputy Commissioner for Foods describes that work must be done right now to ensure that FSMA rules are implemented smoothly and effectively in late 2016 and 2017, and lists several areas in need of additional funding that, through FSMA, will transform the food safety system into one that prevents hazards instead of just responding to them.

President Obama’s FY 2016 budget request would provide an additional $109 million for FSMA implementation. In the current fiscal year, FDA received an additional $27.5 million. And at this juncture as Congress considers the funding that will help transform all the plans and preparations for FSMA into protections that will greatly reduce the number of illnesses caused by contaminated foods and greatly increase consumer confidence in the safety of our food supply, this additional investment would be critical for the success of FSMA and its implementation, writes Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine.

In an FDA Voice blog, Taylor describes that work must be done right now to ensure that the FSMA rules are implemented smoothly and effectively in late 2016 and 2017, and lists the areas in need of additional funding that, through FSMA, will transform the food safety system into one that prevents hazards instead of just responding to them.

  • Approach to food safety inspections and compliance will be fundamentally different. FDA will deploy inspectors who are specialized in specific food commodities, rather than covering a broad range of FDA-regulated products. Backed by technical experts, they will assess the soundness and performance of a facility’s overall food safety system. Achieving this will require a major reorientation and retraining of more than 2,000 FDA inspectors, compliance officers and other staff involved in food safety activities.
  • For vast majority of food producers want to comply and keep their products safe. FDA will be issuing guidance documents that will be essential to helping industry meet FSMA requirements. Funds are needed now for FDA to recruit additional experts who can ensure that guidance development is based on the best science and knowledge of industry practices.
  • Education and technical assistance to help farmers, processors and importers—especially small businesses—implement the new standards. FDA would use a large portion of these resources to provide financial support to state agencies and public-private-academic collaborative entities, such as the Produce Safety Alliance and the Preventive Controls Alliance. FDA has also joined with the U.S. Department of Agriculture’s National Institute of Food and Agriculture (NIFA) in providing grants that will fund food safety training for small, sustainable and organic farm owners and food processors.
  • State partnerships. There are more than 3,000 state, local and tribal government agencies involved in food safety. To align state programs with FDA’s new facility inspection and compliance approach, the agency will provide states with funds for inspector training, information sharing capacity with FDA and other states, state laboratory coordination, and inspector certification programs, and these preparations must be accelerated in 2016.
  • Modernize how we ensure the safety of imported foods. The Foreign Supplier Verification Program will require a substantial regulatory development process, increased staffing and the training of more than 400 investigative and compliance personnel within FDA to enforce the regulation. It will also require extensive training and technical assistance for importers.

Those are just the highlights; there’s much more to be done. The bottom line is that without investment now, and sustained funding afterwards, there is the risk that the implementation of FSMA will be uneven or even delayed. This would be bad for everyone, including those who must meet the new standards and those who must enforce them. Most importantly, it would be bad for consumers, who want to be sure that the foods they are eating and serving their families are safe.

Click here for the full blog. 

NSF International Strengthens Global Food Division’s European Team

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Global public health organization NSF International has appointed Kevin Swoffer as Technical Director of its Global Food Safety Division. Additionally, NSF promoted Stephen Cox to Global Managing Director, NSF Agriculture and Grace O’Dwyer to Director of Operations for NSF’s Europe Middle East and Africa (EMEA) region.

With nearly 40 years of experience in the food retail and manufacturing sectors, Swoffer has held a number of senior executive positions, including Head of Technical Services at British Retail Consortium, where he was instrumental in developing the BRC series of standards and the Safe and Local Supplier Approval scheme (SALSA). He has also worked at Nestlé UK and Safeway UK in several technical roles, and most recently served as a consultant to a number of global organisations.

“Kevin, Stephen and Grace have a great deal of technical experience in the industry,” said David Richardson, Vice President of NSF International’s Global Food Division’s EMEA region. “I have no doubt our clients will benefit from the changes we have made to our senior management team, adding a unique level of expertise and experience to the services NSF International provides.”

“I have worked with NSF International over many years and welcomed their professional input into standards development and certification services. NSF International has also developed a number of unique solutions to food safety issues. I have long respected their leadership and approach within a very demanding industry,” said Swoffer. “I’m confident we will continue to bring innovative technical services to clients and further enhance our consulting proposition.”

In his role, working as a member of the NSF Technical Services and Consulting Leadership Group, Swoffer will be responsible for developing, implementing and continuously improving services consistent with corporate strategy and meeting the needs of NSF clients. He will provide technical support, advice and guidance to members of NSF teams in the EMEA region.

Swoffer has been involved with the development of food safety standards since 1993. He has authored a number of industry publications including editing the UK Industry Guide to Good Hygiene Practice: Retail Guide, 2nd Edition and writing BRC Product Recall Guidelines. He was appointed as an expert on food quality and safety private standards for UNIDO (United Nations Industrial Development Organization) in 2009 and as the Chairman of the Global Food Safety Initiative (GFSI) Technical Committee in December 2007. He was one of the founding members of the GFSI in 1999 and has been actively involved with GFSI development in recent years. He holds a degree in food science and is a Fellow of the Institute of Food Science and Technology.

Stephen Cox, formerly NSF Agriculture International Development Director, moves to Global Managing Director, NSF Agriculture. In this new role he is developing new services for traditional and emerging agricultural markets in addition to further developing the business’ role. In his earlier role as Business Development & Quality Director for NSF Certification, Cox and his team managed many of the technical and integrity issues for a variety of pre- and post-farm gate assurance standards in addition to liaising with the global network with specific responsibilities for the U.S., Spain, Italy and South Africa.

Grace O’Dwyer has been promoted to the role of Director of Operations EMEA from her previous position as Director of Operations for NSF Agriculture. In her new role, O’Dwyer will focus on developing the European infrastructure of offices, technical expertise and administration support across Europe, the Middle East and Africa. This includes putting in place innovative IT platforms and systems and strengthening operating processes and systems to provide best-in-class customer service support. With a background of technical services provision and business development in the agri-industry, O’Dwyer has significant experience developing customer-led solutions and operating practices in international supply networks.

To learn more about the NSF Global Food Division, visit the NSF Food Safety website.

Four Large Retailers Asked to Stop Selling ‘Mislabeled’ Herbal Supplements

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The New York Attorney General’s office has ordered Walmart, Target, Walgreens and GNC to stop selling “mislabeled” herbal supplements, after independent lab tests of these supplements have revealed that they do not contain ingredients as stated on the labels.

NY Attorney General Eric Schneiderman has sent cease-and-desist letters to all four companies demanding that they stop selling their store-brand herbal supplements because DNA barcoding showed that 79 percent of them either didn’t contain the stated ingredient(s), or were contaminated by other filler materials such as rice and wheat to which some people might be allergic. The companies have been asked to respond by February 9, with information about how their store-brand supplements are processed, according to a NY Times report.

“The topic of purity (or lack thereof) in popular herbal dietary supplements has raised serious public health and safety concerns, and also caused this office to take steps to independently assess the validity of industry and advertising,” the letters stated, adding that “Contamination, substitution and falsely labeling herbal products constitute deceptive business practices and, more importantly, present considerable health risks for consumers.”

Tests were done at the request of the New York AG’s office on the following store-brand supplements: Ginkgo Biloba, St. John’s Wort, Ginseng, Echinacea, Valerian Root, Garlic and Saw Palmetto. Three to four samples of each supplement purchased in different parts of the state were tested. Each sample was tested five times, for a total of 390 tests on 78 samples.

Only 4 percent of Walmart’s supplements (“Spring Valley” brand) actually contained the ingredients listed on the label, while 18 percent did at Walgreens (“Finest Nutrition” brand), 22 percent at GNC (“Herbal Plus” brand), and 41 percent at Target stores (“Up & Up” brand). Only the GNC garlic consistently tested as advertised, according to the AG’s office.

A Walmart spokesperson has said that the retailer is immediately reaching out to the suppliers of these products to learn more information and will take appropriate action. Walgreens agreed to remove the products from its stores across the country, even though only New York was requiring it to do so. GNC confirmed that the products in question had been removed from its store shelves.

Creighton R. Magid is a partner at the international law firm Dorsey & Whitney and head of its Washington DC office, supported Attorney General Schneiderman’s actions and described that “he is taking aim at these herbal supplements not by attacking their efficacy or health risk, which would be more difficult to prove, but by alleging false labeling – something that can presumably be proved with a lab test to establish the actual ingredients.”

“Unless the manufacturers or retailers can show that the ingredients of these products are as shown on the labels – and not merely powdered versions of a junior high lunch – these products will probably start disappearing from store shelves rather quickly,” Magid added.

Metagenomics, Food Safety

Mars Inc. and IBM Research Partner for Food Safety Genome Sequencing Project

By Maria Fontanazza
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Metagenomics, Food Safety

In a novel large-scale collaboration by IBM and Mars, Inc., researchers are harvesting and sequencing the DNA and RNA of simple food samples to determine where anomaly and mutations occur when paired with common organisms or genes, toxins, and heavy metals.

Resulting in a “microbial baseline,” or a benchmark representing normal microbe communities, the index produced from this study will be a gold standard for food and health officials globally to understand what triggers contamination and the spread of disease.

This Consortium for sequencing the food supply chain will study the microbial ecology of foods and their processing environments, and hopes to have a deeper understanding of the populations in these ecologies — bacteria, fungi, viruses, and other microorganisms — and how they interact with each other can then be used to develop new methods for keeping food safe.

“Investigating the genetic fingerprints of food ingredients and their environments will help us unearth genomic keys to healthy food and people,” describes Jeff Wesler, Vice President and Lab Director for IBM Research.

IBMResearchGenomesequecingFeb2015One of the goals of the consortium is to see if there are any actions that food producers can take in respect to microbiomes that can reduce risk and make production safer. And Mars, with more than 130 factories worldwide, can help map the flow of microorganisms into and through the supply chain on a global level. An informatics infrastructure developed in the IBM Accelerated Discovery Lab, a data and analytics hub for IBM researchers and their clients and partners, will help the team parse and aggregate terabytes of genomic data from Mars and apply decades of refined analytics to uncover new insights. Adding relevant weather, transport and other contextual data could help define a targeted breakout, marking on the index a warning for food producers and distributors at the outset of a processing cycle.

Mars and IBM are looking to partner with industry, academics, regulators and some NGOs on the project. For more information, click here.

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.