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EPA Draft Guidance on Virus Claims for Antimicrobial Products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In July, EPA released the draft guidance “Evaluation of Products for Claims against Viruses,” which proposes how registrants of antimicrobial products with sanitizing claims could add claims that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The EPA noted in its announcement of the new draft guidance that products registered with only sanitizing claims may contain lower amounts of active ingredients and may have shorter contact times compared to products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.

 

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USDA Launches “From Learning to Leading: Cultivating the Next Generation of Diverse Food and Agriculture Professionals Program”

By Food Safety Tech Staff
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The USDA National Institute of Food and Agriculture (NIFA) has announced a $262.5 million investment to foster the next generation of diverse agricultural professionals across the nation. This program is funded by President Biden’s Inflation Reduction Act, which aims to lower costs for American families, expand access to markets to producers from all backgrounds and communities, build a clean energy economy and strengthen American supply chains. The $262.5 million investment will provide training and support to more than 20,000 future food and agricultural leaders through 33 project partners.

“Each generation of agricultural professionals faces new challenges as we feed our world’s growing population, and the future generations give me hope that we will rise to the occasion to meet these challenges with opportunity,” said Agriculture Secretary Tom Vilsack. “We need to ensure our youth have the education and training they need to accelerate the development of an agricultural system that is climate-smart, sustainable, profitable and equitable. This historic investment from the Biden-Harris Administration in our nation’s Minority-serving Institutions brings us closer to building a workforce that represents the richness and diversity of all the communities we serve.”

“From Learning to Leading: Cultivating the Next Generation of Diverse Food and Agriculture Professionals Program” (NextGen) will enable eligible institutions of higher learning to build and sustain the next generation of food, agriculture, natural resources and human sciences workforce. This includes efforts to strengthen USDA’s workforce through enhanced educational support, experiential learning and exposure to early career opportunities. Eligible institutions include: 1890 Land-grant Universities, 1994 Tribal Colleges and Universities, Hispanic-serving Institutions (HSI), Alaska Native-serving and Native Hawaiian-serving Institutions and institutions of higher education located in the insular areas, as well as their partners.

“The vision we have at NIFA is to feed and nourish all Americans and create economic opportunity for more American families. Equity and diversity are the two central elements in this vision. One goal of the NextGen program is to identify, inspire and prepare our youth, particularly in underrepresented communities, to be the next generation of hunger fighters and agricultural problem solvers. This is the right thing to do and the right time,” said NIFA Director Dr. Manjit Misra.

Each project will be funded for a period of five years. Examples of awarded projects include:

1994 Tribal Land-grant Institutions

Fond du Lac Tribal and Community College’s project is a collaborative effort between Fond du Lac Tribal and Community College and Leech Lake Community College, bringing together two 1994 Land-grant Colleges to build sustainable educational and experiential systems to prepare Tribal college students to enter agricultural and STEM workforces. ($9 million)

Hispanic-serving Institutions

Luna Community College (LCC), a Hispanic-Serving Institution in Las Vegas, New Mexico, will implement the Luna Initiative for Food, Agriculture, Natural Resources and Human Sciences (FANH)Training and Education (LIFTE) Project, which will address recruitment, enrollment and retention issues of students pursuing academic degrees or noncredit training programs in the Luna Agriculture and Natural Resource Development Center. LIFTE will also expand its training of FANH professionals to increase the workforce required to restore, re-build and re-invigorate forests, farm/range lands and waterways catastrophically damaged during the worst wildfire in New Mexico history, which occurred within LCC’s serving area in the summer of 2022.

1890 Historically Black Land-grant Institutions

North Carolina A&T State University in Greensboro, North Carolina, in partnership with Tuskegee University, University of Arkansas at Pine Bluff, Virginia State University, Florida A&M University, Fort Valley State University, University of Maryland at Eastern Shore, and North Carolina State University will implement the “System Approach to Promote Learning and Innovation for the Next GenerationS (SAPLINGS)” of Professionals and Leaders in Food, Agriculture, Natural Resources, and Human Sciences program with a goal of training 6,134 grade 5-12 students, 326 grade 5-12 educators, and 5,871 college students; reach 980 families; engaging more than 30 partners; and enhancing underrepresented minority student enrollment, retention, and graduation rates at 1890 LGUs to grow the next generation of diverse workers, leaders, and innovators for food, agriculture, natural resources and human sciences (FANH) careers.

To track and report the benefits and impacts of the NextGen program, NIFA is partnering with the Intercultural Development Research Association. In addition to this effort, USDA announced the release of two new public dashboards allowing users to access high-level data about agricultural research funding investments and applicants to track the status of their grant applications.

 

FDA Commissioner Robert M. Califf, M.D.

FDA Updates Proposal for Unified Human Foods Program With New Model for ORA

By Food Safety Tech Staff
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FDA Commissioner Robert M. Califf, M.D.

On June 26, the FDA shared an update on its proposal to create a unified Human Foods Program (HFP), which includes a new model for the Office of Regulatory Affairs (ORA). The changes are based on findings and recommendations of a working group made up of agency officials with expertise in different functional and operational areas that has been working over the past several months to identify additional opportunities to bolster operations within the new HFP and ORA.

Based on recommendations from the working group and from the external evaluation conducted by the Reagan-Udall Foundation, the FDA is proposing the following additional changes:

  • Establishing ORA’s core mission as conducting investigations, inspections and imports for all FDA-regulated products, with assignments planned in partnership with the HFP and other product programs or Centers. The new Deputy Commissioner for Human Foods will have oversight of all budget and resource allocations for the entire HFP, including ORA resources.
  • Merging compliance functions currently managed within ORA into the HFP and the product Centers’ existing compliance functions to streamline operations and expedite decision-making.
  • Realigning the eight Human and Animal Food laboratories that are currently managed by ORA into the HFP. These eight labs will team up with the four labs in the FDA’s current Center for Food Safety and Applied Nutrition (CFSAN) to form a unified food laboratory enterprise under the HFP. The labs will report to a member of the executive leadership team under the Deputy Commissioner for Human Foods, who will work closely with the Chief Scientist and the Center for Veterinary Medicine (CVM) director to coordinate on research priorities. These labs will remain open and in the same geographic location under the proposal.
  • Transitioning certain functions under the Office of Security and Emergency Management, currently in the Office of Operations, to ORA. This includes the Office of Emergency Management, which activates Incident Management Groups with augmented staffing from relevant Centers and Offices to monitor and manage coordinated responses to emergency situations, such as emergencies involving regulated products like recalls, hurricanes, fires, floods, etc.
  • As previously shared, unifying state and local food safety partnership functions and certain aspects of international food safety partnerships into an Office of Integrated Food Safety System Partnerships in the HFP. This office will report to a member of the executive leadership team under the Deputy Commissioner for Human Foods who will closely collaborate with the CVM director to advance a truly integrated food safety system.
  • Reviewing support functions across ORA and proposing realignment of certain resources and personnel to support these changes. This includes staff and resources in ORA’s Office of Regulatory Management Operations, Office of Information Systems Management, Office of Training, and Office of Communications and Project Management.
  • Prioritizing recruitment, retention and training opportunities for field-based employees with the availability of Title 21 hiring authority to support the agency’s ongoing efforts to increase its inspectional activities domestically and internationally.

“With a human food landscape that is rapidly evolving as consumer preferences, products, and manufacturing processes grow increasingly complex and public health needs increase, the FDA must build a stronger Human Foods Program and Office of Regulatory Affairs. Earlier this year the FDA announced steps to modernize and streamline our food program, including field operations, to address these mounting challenges,” said FDA Commissioner Robert M. Califf, M.D. “Listening closely to feedback provided by employees and stakeholders, our thinking has significantly broadened. We know that in front of us is a once-in-a-generation opportunity to unify our field work with the priorities of program offices and Centers. This is why I’m proposing a number of additional changes to ORA, including moving several of the office’s laboratories and merging its current compliance functions into those of the new HFP and other agency product Centers. These proposed changes are designed to help ensure the most strategic use of resources to meet the demands of our increasingly complex public health mission.”

The agency also provided high-level organization charts to reflect the changes that are being proposed as part of the unified HFP and new ORA model, and announced that it is considering a renaming effort for ORA to more appropriately align its title to the structure and functional duties of the agency’s field operations.

“I believe these proposed changes will result in a new structure that is more nimble, better equipped to prevent and respond to emergencies, like recalls, and enhance the agency’s ability to align inspection resources with our Center and program priorities while also supporting our employees and the public we serve,” said Califf. “We will continue to evaluate and make adjustments as we work closely with experts throughout the agency to revamp and enhance our field operations.”

The FDA noted that it recently began a recruitment effort to fill the position of Associate Commissioner for Regulatory Affairs who will lead ORA through the proposed changes and assist the organizational evolution as envisioned in this proposal if approved. The FDA is also in the final stages of the recruitment process for the Deputy Commissioner for Human Foods and stated that it remains on target to finalize its reorganization proposal, for both ORA and the unified HFP, this fall.

Image: FDA Commissioner Robert M. Califf, M.D.

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FDA Publishes New FAQs and Tools for the Food Traceability Rule

By Food Safety Tech Staff
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The FDA has posted new frequently asked questions and additional tools related to the FSMA Food Traceability Rule to help clarify how the rule applies to specific situations and commodities.

The new FAQs address are largely based on questions received during the FDA’s regular interactions with industry and on questions sent via the Technical Assistance Network, a central source of information for questions related to the FSMA rules, programs, and implementation strategies.

Along with the FAQs, additional tools developed to help further educate and inform industry subject to the Food Traceability Rule are accessible from the FDA’s traceability website, including:

  • Addition of the results for all foods and associated commodity-hazard pairs included in the Risk-Ranking Model for Food Tracing—beyond what appear on the food traceability list
  • Additional description on the Food Traceability List webpage to clarify that “nut butters” include all forms of nut butters—shelf-stable, refrigerated, and frozen products
  • Eight new supply chain examples that illustrate how the rule is applied in different scenarios for different commodities
  • What you need to know about the Food Traceability Rule fact sheets on “Recordkeeping Information for Produce Farms” and “Coverage and Exemption for Produce Farms”
  • Guide to Getting Started with the Food Traceability Rule
  • Additional foreign language translations of the Critical Tracking Event and Key Data Elements interactive tool and supply chain examples.

The compliance date for the Food Traceability Rule is January 20, 2026.