Baby Bottle

Stratified Sampling Increases Cronobacter Identification in Infant Formula

By Food Safety Tech Staff
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Baby Bottle

A new study, published in the Journal of Food Protection, found that spacing out samples over time, called “stratified” sampling, is better at catching risky pathogens like Cronobacter in powdered products, such as infant formula, than randomly sampling from the product as it is being produced. In addition, the study found that that while taking more samples of a product generally increases the chance of catching the pathogen, there is a point after which it is unlikely that additional sampling will increase safety.

The new paper “Simulation Evaluation of Power of Sampling Plans to Detect Cronobacter in Powdered Infant Formula Production” used computer models to simulate sampling and testing finished formula, to determine the efficacy of current national and international guidelines for testing programs, and find solutions to improve detection of Cronobacter in these types of products.

All efforts were based on detecting a realistic hazard, here defined by testing samples from Cronobacter-contaminated batches produced in Europe in the 2010s, using the most current data available. The paper found that safety plans with 30 or more grab samples had a very high probability of detecting the hazard. And that there was a point of diminishing returns, such that very high sample numbers—for example, testing every can produced—would not be meaningfully more powerful.

“This shows that existing sampling and testing guidance is powerful, at least for the one hazard profile our team had access to for the study,” said project lead Matthew J. Stasiewicz of the University of Illinois Urbana-Champaign. “This also highlights the need for additional research and data-sharing efforts into patterns of contamination in current infant formula production, so that sampling and testing can be better matched to current needs.”

“In additional to analyzing scenarios we found relevant, we built a web app that allows industry stakeholders to simulate various sampling scenarios and gain deeper understanding of the effectiveness of sampling plans specific to their plants. With this knowledge, producers can proactively address risks and optimize current sampling practices,” added Minho Kim, lead author.

 

bioMerieux IMV Awards

bioMérieux Recognized with Nine Clinical Laboratory Awards

By Food Safety Tech Staff
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bioMerieux IMV Awards

IMV has recognized bioMérieux with nine IMV ServiceTrak Clinical Laboratory Awards in the categories of Immunoassay, ID/AST and Blood Culture excellence. IMV, part of Science and Medicine Group, is a market research and business intelligence provider to the laboratory diagnostic industry. The IMV ServiceTrak Clinical Awards are presented each year to manufacturers with the highest satisfied responses, representing the best in customer satisfaction, performance and service.

bioMérieux was honored as the best in the following categories:

Immunoassay:

  • Best Service
  • Best Customer Satisfaction
  • Best System Performance

ID/AST:

  • Best Service
  • Best Customer Satisfaction
  • Best System Performance

Blood Culture:

  • Best Service
  • Best Customer Satisfaction
  • Best System Performance

“We are thrilled that bioMérieux has received significant recognition and multiple awards from IMV ServiceTrak for the sixth consecutive year,” said Dan Biondo, Vice President, Customer Support Operations, bioMérieux. “Our commitment to deliver innovative diagnostic systems, service and customer satisfaction further supports the successful activation of antimicrobial stewardship efforts, as well as bioMérieux’s essential role in the betterment of public health.”

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Partially Hydrogenated Oils in Foods No Longer GRAS

By Food Safety Tech Staff
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On August 8, The FDA issued a direct final rule reflecting its June 2015 final determination that the use of partially hydrogenated oils (PHOs) in foods is no longer Generally Recognized as Safe (GRAS). The FDA had established January 1, 2021, as the final compliance date to remove PHOs from the food supply. This action addressed artificial sources of trans fat, with the understanding that trans fat will not be completely removed from the food supply because it occurs naturally in meat and dairy products and is present at very low levels in other edible oils.

The direct final rule:

  • Revises regulations to no longer include PHOs as an optional ingredient in the standards of identity for peanut butter and canned tuna
  • Revises FDA GRAS affirmation regulations to no longer include partially hydrogenated forms of menhaden and rapeseed oils
  • Revokes the regulation for partially hydrogenated fish oil as an indirect food substance
  • Revokes pre-1958 authorization for using PHOs in margarine, shortening, and bread, rolls and buns.

The direct final rule will be effective on December 22, 2023.

Wiping down table

EPA Draft Guidance on Virus Claims for Antimicrobial Products

By Food Safety Tech Staff
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Wiping down table

In July, EPA released the draft guidance “Evaluation of Products for Claims against Viruses,” which proposes how registrants of antimicrobial products with sanitizing claims could add claims that these products are effective against viruses. The guidance, once finalized, would expand the availability of antimicrobial products that are effective against viruses such as SARS-CoV-2.

At the IAFP Conference in Toronto, Tajah Blackburn of EPA, Veronica Moore of FDA and Lee-Ann Jaykus of North Carolina State University, looked at the goals of EPA in proposing changes to registration and labeling of sanitizers that make viral claims, noting that the agency’s focus is on viruses transmitted by food. In particular, EPA is concerned with viruses known to be resistant to the most commonly used physical cleansers and disinfectants, and environmentally persistent viruses.

Under federal law, all antimicrobial products that claim to kill pathogens like viruses and bacteria on surfaces must be registered with EPA before they can be sold or distributed in the U.S. EPA primarily classifies antimicrobial products as sanitizers, disinfectants, and/or sterilants based on the product performance, test methods used to demonstrate efficacy, and microorganisms tested. Many products are registered with EPA as both sanitizers and disinfectants because they have undergone testing to support both claims.

The EPA noted in its announcement of the new draft guidance that products registered with only sanitizing claims may contain lower amounts of active ingredients and may have shorter contact times compared to products registered as disinfectants. Certain types of sanitizers can be used in food service and food processing facilities on surfaces such as dishes and utensils. Historically, EPA guidance has addressed the addition of claims against bacteria—but not against viruses—to products registered only with sanitizing claims.

Based on the proposed guidance, if laboratory data indicate that a product registered only with sanitizing claims meets EPA’s criteria for efficacy against viruses, the product could include claims against viruses on its label. New virucidal claims for sanitizers would rely on the same performance and testing standards currently used to assess products efficacy against viruses, such as disinfectants. If the draft guidance is finalized, it could lead to changes in the FDA Food Code to reflect new labeling regulations, said Blackburn.

EPA proposes to pilot this draft guidance over seven years to allow enough time to assess the outcome. Based on the outcomes, the agency will determine whether the guidance should be modified, terminated or made permanent.

The draft guidance is available for public comment (docket EPA-HQ-OPP-2023-0288) at regulations.gov.

 

 

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FDA Announces Public Meeting on Modernizing Food Recalls

By Food Safety Tech Staff
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The FDA Center for Food Safety and Applied Nutrition (CFSAN) is hosting a free hybrid public meeting entitled “Modernizing Food and Drug Administration Recalls Listening Session” on September 29, 2023, from 9:00am-5:00pm ET.

Join the discussion on “Recalls Trends, Regulation and Lessons Learned,” a Panel Discussion with FDA at the Food Safety Consortium, October 16-18

The listening session will provide an opportunity for stakeholders to share information and feedback about topics related to recall modernization, for FDA-regulated products. The FDA is inviting comments from all interested stakeholders and has identified the following examples of topic categories of the type of information the agency is interested in obtaining:

  • General recall preparations / contingency planning
  • Creating successful recall strategies, including methods to reach underserved communities
  • Initiating a recall
  • Strategies for public warning, including press releases, social media, and other communication tools
  • Increasing efficiency and effectiveness of recall information exchange
  • Ensuring effective recalls
  • Terminating a recall
  • Strategies for reducing recall recurrence for similar situations

The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Avenue, Bldg. 31, Rm. 1503A (the Great Room), Silver Spring, MD 20993. Virtual registration is also available.

Registration is required to attend in person or virtually.

 

Rochester Midland

Peak Rock To Acquire Rochester Midland Corporation

By Food Safety Tech Staff
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Rochester Midland

An affiliate of private investment firm Peak Rock Capital has signed a definitive agreement to acquire Rochester Midland Corporation (RMC), in partnership with RMC’s founding family and management team.

Founded in 1888, RMC is a leading supplier of specialty chemical products and value-added services across water energy, food safety, facility hygiene and other applications. The company works with thousands of businesses worldwide across diverse end markets including food and beverage, healthcare, packaging and facility services. RMC is headquartered in Rochester, New York, with additional facilities in the U.S., Canada and U.K.

“RMC represents an exciting opportunity to invest in a supplier of mission-critical services that enable customers to operate safely and efficiently. We look forward to helping the company accelerate its growth trajectory while pursuing complementary acquisitions to extend RMC’s production capabilities, geographical presence, and service offerings,” said Jordan Campbell, Managing Director of Peak Rock.

 

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USDA FSIS To Host Virtual Public Meeting on Cyclospora Cayetanensis in Produce

By Food Safety Tech Staff
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The USDA Food Safety and Inspection Services (FSIS) and the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) will be holding a virtual public meeting on August 30, 2023, from 11 a.m.-1 p.m. ET to discuss and vote to adopt NACMCF’s recent report on Cyclospora cayetanensis in produce. Written comments must be submitted by August 25, 2023. The committee will also provide an update on the Cronobacter spp. in powdered infant formula charge.

The report was requested by the FDA, as the agency seeks more information on the factors that can contribute to C. cayetanensis contamination of domestically grown and imported produce, as well as recommendations for developing an effective prevention and management strategy.

As the report highlighted, cyclosporiasis previously was associated with travel outside of the U.S. or consumption of contaminated imported foods. However, in recent years, the U.S. has seen an increase in cases and positive samples associated with produce, both as raw agricultural commodities, and fresh-cut produce, grown in the U.S. In the last three years, the number of cyclosporiasis cases has increased approximately 300%, often linked to fresh produce consumption, specifically leafy herbs and ready-to-eat salads.

Attendees must pre-register by Friday, August 25, 2023, to receive details on how to access the meeting. During pre-registration, attendees may also express interest in delivering comments during the meeting. Oral comments will be limited to three minutes per speaker. The agenda will be shared on the FSIS Events & Meetings page prior to the event.

 

Different types of food

FDA, USDA and DHS Release Review on Emergent Risks Facing U.S. Food and Agriculture

By Food Safety Tech Staff
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Different types of food

The U.S. Food and Agriculture (FA) sector is facing significant risks that require improved communication and collaboration between industry and government agencies. On July 13, the FDA, USDA and Department of Homeland Security (DHS) released the 120 Day Food and Agriculture Interim Risk Review, which provides a review of critical and emergent risks to the FA sector, as well initial mitigation strategies, factors contributing to risk and proposed actions to address risks.

Risks identified in the review include:

Chemical, Biological, Radiological, & Nuclear (CBRN) Threats. CBRN threats are defined as “hazardous contaminants such as poisonous agents including toxic industrial compounds and materials, toxins, and chemical agents and precursors; natural or genetically engineered pests and pathogens of livestock, poultry, fish, shellfish, wildlife, plants, and insects; and physical effects of nuclear detonations or dispersion of radioactive materials.”

Initial Mitigation Strategies: Prevention of CBRN incidents may be achieved through expanding and enhancing existing physical security and administrative controls, including many food defense mitigation strategies, such as control of entry systems at critical points in production, processing, storage, and transportation, surveillance of critical points, pre-employment screening, and clear marking of employees who are authorized to be at critical points.

Cyber Threats. While these are not new risks, the review notes that as the food industry increases its dependence upon technology, including the move toward automation, precision farming and digital agriculture, the likelihood and severity of a crippling cyberattack increases.

Initial Mitigation Strategies: Some FA sector entities have assessed and mitigated cybersecurity vulnerabilities through entity-specific action, using and applying the National Institute of Standards and Technology Cybersecurity Framework or other actions. Future activities should include the reviewing and securing of interconnectivities between systems. To do this, all FA sector entities, both public and private, must improve their understanding of cyber threats and vulnerabilities and reduce their gaps in protection. Future efforts in cybersecurity in the FA sector should prioritize the sharing of information about cyberattacks, research into cybertheft of food and agriculture intellectual property, FA sector dependency on the energy sector and interdependencies within the FA supply chain. The review also highlights the need for funding for a program to assist small and medium size facilities to increase implementation of effective cyber security mitigations.

Climate Change: Natural disasters and extreme weather events, limited water resources, loss of pollinators and pollinator services, and increased exposure potential to pests and pathogens are among the threats to future agricultural productivity which may be exacerbated by climate change.

Initial Mitigation Strategies: Research on environmental hazards and degradation within the FA sector should include water use, irrigation system improvements, dryland management practices, and crop system utilization. Similarly, research targeting pollinator habitat, how climate change affects pollinators, pollinator forage, and pollination rates as it pertains to crop yield, and current and emerging pests and pathogens that negatively impact the optimal health outcomes of people, animals, plants, and their shared environments to include the health of pollinators is vital to long-term crop sustainability and food security. The use of improved monitoring systems, predictive modeling to inform surveillance, early warning systems, and better control options can help reduce the risk of pest and disease agricultural damage due to climate change.

Potential Factors Contributing to Risk

A “potential factor contributing to risk” is defined in the review “as features or operational attributes that render an entity open to exploitation or susceptible to a given hazard.” These include:

  • Food and Agriculture Industry Consolidation
  • Input Shortages, including labor, energy, IT/data, and consumables.
  • Aging and Insufficient Transportation Infrastructure
  • Trade Disruptions
  • Foreign Acquisition
  • Gaps in Preparedness

Proposed Actions

The FDA, USDA and DHS developed a timeline of proposed actions, which includes short-, mid- and long-terms strategies to enhance strategic planning, understanding of FA sector risks, and information sharing and engagement. Next steps include:

Threat Assessment: Identify potential actors and threats, delivery systems, and methods that could be directed against or affect the FA sector. (60 days and annually thereafter)

120-Day FA Risk Review: Identify risks to the FA sector from all hazards, identify activities to mitigate risks categorized as high-consequence and catastrophic, identify steps to improve coordination and integration across the FA sector, inform ongoing development of the Federal Risk Mitigation Strategy. (120 days)

Vulnerability Assessments: Identify vulnerabilities within the FA sector in consultation with state, local, tribal, and territorial (FSLTT) agencies and private sector partners. (180 days)

Risk Assessment: Prioritize by the highest risks for the FA sector, implement benchmarking off of results generated from the CBRN Strategic Risk Assessment Summary. The first draft would focus on CBRN and cyber threats with later iterations to include other threats (e.g., energy disruption, pandemics, catastrophic weather events, consequences of climate change). (365 days)

Risk Mitigation Analysis: This will include high-level actions for mitigating threats, a proposed timeline for their completion and a plan for sharing information. The analysis will identify strategies, capabilities, and areas of research and development that prioritize mitigation of the greatest risks as described in the risk assessment, and include approaches to determine the effectiveness of national risk reduction measures. (545 days)

A Unifying Food and Agriculture Community Architecture

Recognizing the need for improved coordination and communication, and an over-arching framework to direct and maintain a consistent

approach to preparedness and response to high-consequence and catastrophic incidents within the FA sector, the review also includes a proposed “Food and Agriculture Resilience Architecture.”

The proposed Architecture represents an “integrated, whole-of-community and whole-of-government system of stakeholders and capabilities” approach to strengthening the readiness and resilience of FA sector.

 

 

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FDA CFSAN Announces Priority Guidances for Remainder of 2023

By Food Safety Tech Staff
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Infant food safety, including new arsenic and cadmium action levels, are among the new priorities the FDA plans to address before the end of 2023. On July 6, the FDA Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released an updated list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during 2023.

The following guidance topics have been added to the 2023 agenda:

  • Draft Guidance on Dietary Supplement Master Files
  • Draft Guidance on Low-Moisture Ready to Eat Foods (including infant formula)
  • Draft Guidance on Action Levels for Arsenic in Food Intended for Babies and Young Children
  • Draft Guidance on Action Levels for Cadmium in Food Intended for Babies and Young Children
  • Amendment to the Menu Labeling Supplemental Guidance
  • Guidance on Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein.

Public comments on the list of human food and cosmetic guidance topics, including suggestions for alternatives or recommendations on the topics the FDA is considering, can be submitted to www.regulations.gov, using Docket ID: FDA – 2021-N-0553.

The FDA’s list of guidance topics is just one of several resources that the Foods Program routinely shares with stakeholders and partners to inform them of agency priorities. Most proposed and final rules are on the “Unified Agenda of Regulatory and Deregulatory Actions,” which is published by the Office of Information and Regulatory Affairs in the Office of Management and Budget. The Unified Agenda is updated twice a year and reports planned actions by federal departments and agencies government wide. A list of those FDA regulations and guidance documents under Administration review is available on the Office of Management and Budget website.

 

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FDA Update on Cyclospora Research, Prevention and Response

By Food Safety Tech Staff
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The FDA has updated its Cyclospora Prevention, Response and Research Action Plan. The action plan, which was developed in 2021 by the agency’s Cyclospora Task Force, details the FDA’s strategy for reducing the public health burden of foodborne cyclosporiasis in the U.S. and  defines the agency’s priorities for Cyclospora food safety research.

The updated action plan includes refined strategies, a report on accomplishments and three new actions that have been identified by the task force: advancing root cause analyses procedures, building a repository of Cyclospora oocysts that can be used for research and advancing the methods to conduct such research.

This year’s accomplishments cited by the FDA include:

  • Development of a new targeted amplicon genotyping assay for C. cayetanensis that will further aid outbreak and root cause investigations by allowing laboratories to sequence even when low levels of the parasite are detected in the sample.
  • Development of a new fully automated screening assay for the detection of C. cayetanensis in fresh produce, soil and surface agricultural water through a research collaboration between FDA and an independent laboratory.
  • Monthly meetings with stakeholders to discuss food safety, research and share data
  • Technical assistance on research regarding the control of C. cayetanensis on produce and in the environment
  • Expanded laboratory capacity to test for C. cayetanensis through the Food Safety Partnership with Mexico.