FDA Logo

FDA CFSAN Announces Priority Guidances for Remainder of 2023

By Food Safety Tech Staff
No Comments
FDA Logo

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  • Draft Guidance on Dietary Supplement Master Files
  • Draft Guidance on Low-Moisture Ready to Eat Foods (including infant formula)
  • Draft Guidance on Action Levels for Arsenic in Food Intended for Babies and Young Children
  • Draft Guidance on Action Levels for Cadmium in Food Intended for Babies and Young Children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.

 

FDA Logo

FDA Update on Cyclospora Research, Prevention and Response

By Food Safety Tech Staff
No Comments
FDA Logo

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.

 

USDA Logo

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

By Food Safety Tech Staff
No Comments
USDA Logo

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
No Comments
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.

FDA Logo

FDA Publishes New FAQs and Tools for the Food Traceability Rule

By Food Safety Tech Staff
No Comments
FDA Logo

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.

 

 

FDA Logo

FDA Releases Outcomes of Refrigerated Dips and Spreads Sampling Program

By Food Safety Tech Staff
No Comments
FDA Logo

The FDA has released the results of a March 2021-January 2022 routine sampling program of ready-to-eat (RTE) refrigerated dips and spreads to test for Listeria monocytogenes and Salmonella spp.

The goal of the testing program—launched as part of the FDA’s risk-based approach to food safety, as outlined in the FDA Food Safety Modernization Act (FSMA)—is to identify common factors or patterns related to the contamination of RTE dips and spreads. The data collected helps the FDA develop guidance and update program priorities, including sampling assignments and the prioritization of surveillance inspections.

Out of the 747 samples, four were detected to have a human pathogen.

Pathogen Findings: Salmonella

The agency detected Salmonella Havana in one hummus sample collected from a retail establishment in Kingsburg, California. The FDA performed Whole Genome Sequencing (WGS) analysis on the organism and determined that it did not match any known human illnesses and was not linked to any other product or environmental samples.

Pathogen Findings: Listeria monocytogenes

The FDA detected Listeria monocytogenes in three dips and spreads samples—two cheese samples, one cheese and pepper sample—collected from a retail establishment in Colorado Springs, Colorado. All three of the samples were produced by the same manufacturer. WGS analysis on the organisms determined they did not match any known human illnesses and were not linked to any other product or environmental samples.

The agency also detected two subspecies (i.e., Listeria welshimeri, Listeria innocua) of non-pathogenic Listeria spp. in three samples—two collected from retail establishments and one from the manufacturer/processor. Since these samples were non-pathogenic, they were not analyzed by WGS.

The agency noted that the findings suggest that Salmonella spp. and L. monocytogenes were not widespread in the multi-commodity RTE dips and spreads collected nationwide, though it cautioned against making inferences more broadly about the contamination or potential for contamination of RTE dips and spreads based solely on this testing assignment’s findings. “The presence of contamination in the samples suggests the risk of contamination still exists. For example, from FY2017 through FY2022, there were a total of 22 recalls of dips and spreads due to potential Salmonella or L. monocytogenes contamination; of these hummus and cheese dips and spreads make up 64% of the recalls (10 hummus recalls, 4 cheese dips and spread recalls),” the agency stated.

 

 

U.S. House of Reps seal

House Appropriations Bill Highlights Support for Restructuring of FDA

By Food Safety Tech Staff
No Comments
U.S. House of Reps seal

The U.S. House of Representatives’ Committee on Appropriations has directed the FDA to unify its food program under a Deputy Commissioner for Foods and highlighted additional priorities for the agency related to cell-cultured meat products, allergen labeling and quantitative pathogen testing.

In its recent bill appropriating funds for the USDA, FDA and related agencies for fiscal year 2024, the committee laid out its priorities for these agencies, including:

Human Foods Program Restructuring. The Committee directed FDA to unify the foods program under an expert, empowered Deputy Commissioner for Foods with full line authority over CFSAN, the food and feed-related activities of the Center for Veterinary Medicine (CVM), and all food-related components of the Office of Regulatory Affairs, including inspection and compliance, food-related laboratories, import oversight, State partnerships, training, and information technology.

Allergen Labeling. The Committee stated that it is concerned about the increase in the diagnosis of food allergies to new and emerging food allergens not currently required to be labeled. The Committee urged the Center for Food Safety and Applied Nutrition (CFSAN) to identify potential future food allergens that would require labeling on food packaging and to implement the required process toward labeling on packaged foods.

Cell Cultured Meat Labeling. In light of the FDA’s first pre-market consultation for a human food made from cultured animal cells, the Committee stated that it is interested in the internal FDA protocols related to pre-market consultations for cell-cultured protein products, specifically whether or not there are special or unique considerations made for these products in pre-market consultation processes. The Committee requested a report outlining the pre-market consultation process for cell-cultured protein products, noting any special accommodations made to comply with the Formal Agreement between the FDA and the USDA and any agency plans to coordinate with its counterparts at USDA on further action regarding the same products.

FASTER Act. The Committee shared its concerns of reports that companies are circumventing the intent of the FASTER Act by intentionally adding sesame to food products to avoid the cost of preventing cross-contamination. FDA is directed to report on implementation of the FASTER Act, including plans to address this issue and an analysis of whether actions by companies in response to the Act’s passage violated federal food safety rules.

Listeria. The Committee directed FDA to apply a risk-based approach and direct its regulatory efforts toward high risk ready-to eat foods that support the growth of Listeria monocytogenes (Lm). Additionally, the Committee encouraged a regulatory approach that encourages industry to adopt quantitative Lm testing schemes and facilitate robust environmental monitoring programs. The Committee directed FDA to work with industry stakeholders to gather supporting information and data to assist with implementation of this Lm approach to align with other international regulatory standards and restore a level playing field for U.S. food processors in the global marketplace.

IFT logo

IFT Rebrands Quality Management Division to Highlight Food Safety Focus

By Food Safety Tech Staff
No Comments
IFT logo

The Institute of Food Technologists (IFT), a nonprofit scientific organization committed to advancing the science of food and its application across the global food system, has rebranded its Quality Management Division. The newly named Food Safety & Quality Management Division (FSQM)—announced on World Food Safety Day 2023—brings together more than 1,500 members from more than 60 countries to collaborate, network, and share ideas around food safety. IFT chose to rebrand the division to better reflect the overall responsibilities of its members who focus on assurance, quality control, food safety, and food wholesomeness.

IFT’s topical, interest-based groups, known as Divisions, support learning, collaboration, and innovation through the sharing of knowledge via webcasts and podcasts, online forums, and in-person events. In total, the organization hosts 25 Divisions spanning the science of food.

“Rebranding to Food Safety & Quality Management Division communicates to the food community that this Division is a home for those interested in food safety,” added Eric Ewert, Chair of IFT’s Food Safety & Quality Management Division.

 

 

USDA Logo

USDA FSIS Releases New Salmonella Control Guideline for Swine Slaughter and Pork Processing

By Food Safety Tech Staff
No Comments
USDA Logo

The USDA Food Safety and Inspection Services (FSIS) has updated its voluntary guideline for federally regulated swine slaughter and pork processing establishments to control Salmonella in market hogs from pre-harvest through slaughter. The agency announced that it updated the document in response to comments on the previous guideline and to incorporate current, peer-reviewed scientific references related to pre-harvest controls, swine slaughter, processing of pork cuts, and comminuted pork products.

The guideline covers:

  • Pre-harvest controls, including farm rearing, multi-hurdle interventions, transport, and lairage
  • Slaughter controls
  • Best practice recommendations for pork fabrication controls, including processing, packaging, and distribution controls for pork cuts and comminuted pork products.

Download the new guideline here.

 

Conor Kearney

FoodChain ID Announces New CEO

No Comments
Conor Kearney

Conor Kearney has been appointed CEO of FoodChain ID. He succeeds Brad Riemenapp, who led FoodChain ID as CEO for more than five years before his death due to cancer in May. Kearney joined FoodChain ID in 2021 and most recently served as Interim CEO during Riemenapp’s medical leave of absence.

Kearney previously served as the company’s Senior Vice President of Strategy and Operations. Before joining FoodChain ID, he worked for 11 years at Staples, holding multiple leadership roles, and five years at McKinsey & Company. Kearney earned his MBA from Harvard Business School and a bachelor’s degree in Biochemistry and Molecular Biology from Dartmouth College.

“Conor has already had a significant impact on FoodChain ID. His collaborative leadership style and ability to rally the organization to achieve its goals make him the absolute right person to lead FoodChain ID in the next stage of its growth journey,” said Ted Rainaud, Managing Director at Berkshire Partners.

“Brad was a great mentor to me, and I’m committed to continue building on his vision and delivering on FoodChain ID’s mission to make the food supply chain safer and more transparent,” said Kearney.