Tag Archives: FDA

Recall

Packaging Process Breakdown Causes Eataly Recall

By Food Safety Tech Staff
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Recall

Eataly USA has recalled its Eataly Artichoke Spread due to undeclared walnuts. A customer who is allergic to walnuts suffered a “light” allergic reaction after consuming the spread.

“The customer declined to fill out the Eataly incident form and just wanted to bring the seriousness of what happened to our attention.” – FDA

After investigating further, it was discovered that the issue was caused by a temporary breakdown in the packaging process, FDA stated in a safety recall.

The product was distributed at the company’s popular New York City Eataly Flatiron location.

Eggs

Rose Acres Recalls Eggs, FDA Investigating Salmonella Link

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Eggs

Rose Acre Farms has voluntarily recalled eggs from its farm in Hyde County, North Carolina following an investigation by FDA, CDC and other agencies involving Salmonella illnesses. FDA testing determined that eggs produced from this farm are connected to 22 cases of Salmonella Braenderup infections; the CDC is confirming illness information with state health departments.

The exact amount of eggs recalled totals 206,749,248.

The eggs are sold under several brand names, including Coburn Farms, Country Daybreak, Food Lion, Glenview, Great Value, Nelms, and Sunshine Farms, as well as restaurants.

FDA is advising restaurants and retailers that they should not sell or use any recalled shell eggs. In addition, they should take measures to avoid cross-contamination of the food processing environment and equipment by washing and sanitizing display cases and refrigerators regularly, washing and sanitizing cutting boards, surfaces and utensils, and washing hands with hot water and soap after any cleaning or sanitation process. Consumers are advised not to eat the recalled eggs.

A full list of the recalled eggs are available on FDA’s website.

Stephen Ostroff, 2016 Food Safety Consortium

Blockchain Transformational, Says Ostroff. FDA Updates on Pathogens, FSMA, WGS and More

By Maria Fontanazza
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Stephen Ostroff, 2016 Food Safety Consortium

Stephen Ostroff, M.D. deputy commissioner for foods and veterinary medicine, sounds excited about the promise of blockchain. He also continues to enthusiastically wave the flag for whole genome sequencing (WGS) in solving foodborne illness cases. At the recent GMA Science Forum, Ostroff shared his usual update on incidents involving pathogens, agency progress in inspections and FSMA, and what the future holds.

The 2018 Food Safety Supply Chain conference features a Blockchain panel discussion | June 12–13 | Learn morePathogens

“There’s been essentially zero change in incidents of pathogens, and in some [cases there have been] increases—despite the fact that we’ve been doing quite a bit to improve the profile of food safety in the United States,” said Ostroff. This isn’t the first time that Ostroff pointed to the fact that foodborne illness is resistant to change, but he still emphasized the disappointment that industry is “way off” from the Healthy People 2020 target rate for pathogens established by the government. “None of these are close to where we thought we would be,” he said, referring to the government’s established target rates for Campylobacter, E.coli O157, Listeria, Salmonella, Vibrio and Yersinia.

Ostroff has previously pointed to improved diagnostics and surveillance systems as being partially responsible for a lack of improvement in the number of foodborne illness cases (due to higher detection rates), but during this particular presentation he brought attention to culture independent diagnostic tests (CIDTs)—which he said are having a “major impact on data collected in FoodNet.” CIDT is relatively new and is more rapid than the culture method, but it doesn’t allow for subtyping or antimicrobial resistance testing.

According to Ostroff, CIDTs have major implications for folks who work in food safety. The overall incidence of infection with foodborne pathogens is not decreasing, and the use of CIDTs makes assessment of trends difficult. CIDTs appear to be finding infections previously undiagnosed or unrecognized. In addition, they could affect the agency’s ability to monitor FSMA impact measures.

Inspections

The agency continues to look at inspection data from both the perspective of the number of inspections and their outcomes. During FY 2017, there were 1253 domestic and 146 foreign inspections. For FY 2018, there have already been 1610 domestic inspections to date.

Enforcement Discretion

In January, FDA issued new enforcement discretion for certain provisions in four FSMA rules. This included resolving issues related to the “farm” definition, requirements for food contact substances under FSVP, and certain written assurances in place for the Preventive Controls (human and animal) rule until FDA comes up with a practical solution to issues raised by stakeholders, Ostroff said.

Oversight of Food Imports

FDA continues to take a risk-based approach to FSVP and overseas inspections. Part of these efforts includes the agency’s systems recognition program where it looks at other mature food safety systems around the world to recognize countries that have programs similar to the United States. Thus far FDA has recognized Australia, Canada and New Zealand food safety systems; It is currently in the process of evaluating European Union members.

Intentional Adulteration Rule

The International Adulteration rule continues to be a hot topic of discussion, especially as it relates to associated costs. FDA is actively working on putting out a draft guidance that will discuss how to conduct vulnerability assessments, along with its interpretation of the rule, according to Ostroff. Part one of the draft should be out “in the very near future”, he said. He added that the agency is trying to be flexible with the rule and although food defense is an important component of food safety, companies should never do anything in the context of food defense that could pose a food safety risk.

Whole Genome Sequencing

WGS provides more precise identification at a genetic level and helps expedite recognition and response time for nearly all current foodborne illness and outbreak investigations. “It’s the new normal—it’s here and it’s here big time,” said Ostroff, adding that the GenomeTrakr network has more than 167,000 isolates sequences in the database and is becoming more and more powerful. “It’s amazing what this tool can do,” he said, citing two recent cases involving strains of Salmonella in papayas and kratom.

Blockchain

“I think blockchain can be really transformational in the world of food safety,” said Ostroff, calling it “traceability on steroids without question”. He thinks the technology could also be useful in addressing food fraud and economically motivated adulteration, and provide more consumer transparency. Right now the FDA is looking very closely at blockchain in context of traceability and FSMA.

Recall

FDA Orders Mandatory Recall of Triangle Pharmanaturals Kratom Products

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Recall

Earlier this week the FDA ordered a mandatory recall for all Triangle Pharmanaturals food products that contain powdered kratom as a result of Salmonella contamination. The mandatory action was issued because the company “refused to cooperate with FDA despite repeated attempts to encourage voluntary recall,” FDA stated in a release.

For more than a month, FDA has been investigating a multistate outbreak of Salmonella infections that were linked to products containing kratom, a plant native to Thaland, Malaysia, Indonesia and Papua New Guinea. Over this period of time, there have been several voluntary recalls by companies that provide products containing kratom: PDX Aromatics, Tamarack, Inc., and NutriZone LLC. All of these recalls were due to positive Salmonella product sample results.

Triangle Pharmanaturals, however, was not responsive to FDA’s requests to issue a voluntary recall, even after samples of products manufactured by the company tested positive for Salmonella. “In the course of investigating a multi-state outbreak of salmonella infections linked to kratom products in conjunction with local officials, FDA investigators were denied access to the company’s records relating to potentially affected products and Triangle employees refused attempts to discuss the agency’s findings,” FDA stated.

“Under the FDA Food Safety Modernization Act, the FDA has the authority to order the recall of certain food products when the FDA determines that there is a reasonable probability that the article of food is adulterated or in violation of certain allergen labeling requirements and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals.” – FDA

As of March 14, the CDC reported that 87 people were infected with outbreak strains of Salmonella in 35 states; 27 people have been hospitalized. And as of April 2, 26 different kratom-containing products have tested positive for Salmonella.

FDA is advising consumers to avoid kratom and all kratom-containing products, which have been sold in several forms, including leaves, tea, pills, capsules and powder. “There is no FDA-approved use for kratom and the agency has received concerning reports about the safety of kratom, including deaths associated with its use,” the agency stated.

FDA

FDA Releases 2017 Retail Food Program Standards

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FDA

FDA has released the 2017 edition of the Voluntary National Retail Food Regulatory Program Standards. These retail program standards offer recommendations for designing and managing retail food regulatory programs, help regulatory agencies pinpoint areas of improvement for the programs, and enable effective strategies for inspections and foodborne illness prevention.

“The FDA encourages government agencies responsible for regulation or oversight of the retail food establishments that sell, serve or vend food directly to the public to enroll in the Retail Program Standards. Enrollment in the Retail Program Standards conveys a jurisdiction’s intent to actively use the Retail Program Standards as a tool to assess and improve its retail food regulatory program.” – FDA

Changes to the 2017 edition of the retail program standards include:

  • Updates to the definition of the training standard
  • Clarifying the standardizing and re-standardizing criteria for food safety inspection officers
  • Aligning program elements between the Retail Program Standard 4 and Retail Program Standard 2 regarding performance elements and competencies
  • Incorporating more methods of communication efforts with industry and the community
  • Consolidating report forms and FDA forms 3519 and 3520 into one FDA Form 3598
FDA

FDA Collaborates with AMA on Foodborne Illness Education

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FDA

FDA and the American Medical Association (AMA) have joined forces to release continuing medical education videos for doctors about foodborne illness. FDA and AMA felt that the globalization of the food supply as well as the growth of foodborne pathogens necessitated more medical education and patient counseling on foodborne illness.

“These changes create a need for physicians to guide patients in protecting themselves from foodborne illness, especially those who are among the most vulnerable to serious consequences and who are most likely to be in a physician’s care: the very young whose immune systems are not yet fully developed; individuals whose immune systems are weakened by pregnancy, age, chronic conditions like diabetes, cancer and HIV/AIDS; and persons with organ transplants taking immuno-suppressive medications,” according to an FDA release.

The two videos, “What Physicians Need to Know About Foodborne Illness: Suspect, Identify, Treat, and Report” and “Preventing Foodborne Illness: Talking to Patients About Food Safety” are available on FDA’s Food Safety and Nutrition Resources for Healthcare Professionals webpage.

Recall

FDA Food Recalls Up Nearly 93% Since 2012

By Food Safety Tech Staff
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Recall

Over the past five years, the food and beverage industry has seen a big increase in the units recalled—a 92.7% spike in FDA recalls and an 83.4% increase in recalled pounds by USDA since 2012, according to Stericycle’s quarterly recall index. The firm cites technological advances in food testing, factory farming and more automation in food production as the main contributors to the high numbers.

During Q4 2017, bacterial contamination and undeclared allergens led the pack in food recall causes. According to Stericycle, back in 2012, about 28% of FDA food recalls were a result of bacterial contamination, while undeclared allergens accounted for 35% of pounds of food recalled by USDA. During Q4 2017, 44% of food recalls (based on units) were from bacterial contamination, followed by undeclared allergens (31%), mislabeling (13%), and quality (10%). Among the top categories for recalls were prepared foods (20%, nuts and seeds (16%), produce (15%) and baked goods (12%). In addition, nearly 50% of the USDA recalled pounds were a result of lack of inspection.

Jim Gorny, CFSAN

CFSAN Announces New Senior Science Advisor for Produce Safety

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Jim Gorny, CFSAN

FDA has created a new position for former FDA member Jim Gorny to serve as the senior science advisor for produce safety at CFSAN. Gorny worked at FDA from 2009 to 2013 as the senior advisor in the agency’s Office of Food Safety at which time he was involved in the development of FSMA. He was previously the vice president of food safety and technology at the Produce Marketing Association.

In his position at CFSAN Gorny will work with a team of produce safety professionals on implementing new science and risk-based requirements that aim to prevent illnesses from contaminated produce. He will serve as the chief advisor to CFSAN Director Susan Mayne on policies and programs associated with produce safety. His responsibilities include stakeholder outreach and engagement, investigations and recalls, research and training.

“I will be working with state regulatory partners and other government agencies at home and abroad to build support for implementation of the produce rule, as well as with industry to help further compliance… I’ll be working to make sure that the people in senior-level management and the field staff, including those conducting foreign inspections, are speaking the same language. – Jim Gorny, FDA

In an interview published on FDA’s website, Gorny discusses his role at FDA, the produce safety rule and how he will be working with industry and key stakeholders, including the farming community.

FSMA

Need Help with Produce Safety and FSMA? FDA Launches New Page

By Food Safety Tech Staff
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FSMA

FDA has launched a FSMA landing page on its website in an effort to provide more information about FSMA and assist in compliance. Links include information about the rules, guidance documents, training and technical assistance, compliance and implementation tools and general background about FSMA.

As the first major compliance date for large farms recently went into effect, the agency also recently updated the Produce Safety page. In an agency news update, it noted that in September 2017, FDA announced that routine inspections would be postponed until Spring 2019 to provide more time for education, outreach and training in 2018.