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.

 

 

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FDA Releases Outcomes of Refrigerated Dips and Spreads Sampling Program

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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.

 

 

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House Appropriations Bill Highlights Support for Restructuring of FDA

By Food Safety Tech Staff
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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.

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IFT Rebrands Quality Management Division to Highlight Food Safety Focus

By Food Safety Tech Staff
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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.

 

 

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

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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

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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.

 

World Food Safety Day 2023

Celebrating World Food Safety Day

By Food Safety Tech Staff
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World Food Safety Day 2023

Wednesday, June 7 is World Food Safety Day. The annual event was established in 2018 by the United Nations General Assembly to raise awareness and inspire action to help prevent, detect, and manage foodborne risks.

This year’s theme is “Food Standards Save Lives,” which highlights the role of established food safety practices and standards to ensure food safety and quality.

The Food and Agriculture Organization of the UN (FAO) in collaboration with the World Health Organization (WHO) is calling on countries, companies, and educational institutions to further adoption of safe food practices. Following are this year’s calls to action:

Policy makers

Make safe food an easy choice by shaping public support for programs, such as food aid, school feeding and other publicly owned food outlets.

Focus on establishing a robust national food safety system and ensure it complies with food safety standards.

Encourage and engage in multisectoral collaboration at the local, national, regional, and global levels.

Food businesses

Engage employees, suppliers and other stakeholders to grow and develop a food safety culture.

Comply with national and international food standards.

Educational institutions and workplaces

Promote safe food handling.

Engage with families and involve them in food safety activities.

Support food safety education.

 

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FDA Launches Webpage on Equivalence and Food Safety

By Food Safety Tech Staff
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On June 5, the FDA published a new webpage dedicated to equivalence—the process of determining whether a foreign regulatory counterpart’s food safety controls achieve at least the same level of public health protection as measures required by U.S. law—for food safety.

As the FDA explains, equivalence is a right and an obligation for all members of the World Trade Organization (WTO). All members must accept the sanitary or phytosanitary measures of the other members as equivalent, even if these measures differ from their own or from those used by other members trading in the same product, if the exporting member objectively demonstrates to the importing member that its measures achieve the importing member’s appropriate level of sanitary or phytosanitary protection.

This means that a foreign regulatory authority is not required to develop and implement the same exact procedures and food safety controls that FDA requires, but rather that it must objectively demonstrate how its food safety controls meet at least the same level of public health protection achieved by U.S. measures. Likewise, for food exported from the United States, foods produced in compliance with U.S. regulations may be permitted entry into foreign markets based on a positive equivalence determination.

The webpage explains how equivalence is determined, the current equivalence determinations, and how regulatory authorities can submit a formal request for equivalence for FDA-regulated food products.

 

 

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FDA Announces Proposed Framework for Post-Market Review of Chemicals Added to Food

By Food Safety Tech Staff
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The FDA is seeking to enhance its approach to post-market review of chemicals added to—as well as those that come in contact with—food products. Robert M. Califf, M.D., Commissioner of Food and Drugs, and Susan Mayne, Ph.D., Director of the Center for Food Safety and Applied Nutrition, at the FDA, released a statement on May 26, outlining the agency’s intent to enhance surveillance and scrutiny and improve processes to identify potentially dangerous chemicals as new information comes to light.

As part of its “more modernized, systematic reassessment of chemicals with a focus on post-market review,” the FDA is focusing on new approaches to mine data and prioritize substances for in-depth review based on risk.

The enhanced approach to post-market regulation of food chemical safety shared by Drs. Califf and Mayne offers a proposed framework to systematically reassess chemicals post-market, which includes:

·      Expanding tools and methods used when conducting safety reviews and assessments of chemicals in food and substances that come into contact with food to keep pace with scientific advances and technological innovations

·      Updating processes to identify, evaluate, prioritize and communicate new and evolving information to determine if reassessment of a chemical by the FDA is warranted

·      Continuing to monitor the food supply to ensure that chemicals in food are present at levels that are not a risk to public health

They are seeking greater funding as well as additional staff to establish the proposed ongoing post-market monitoring framework. “This, combined with additional authorities to require industry to share new data and information, would allow the FDA to prioritize based on risk and better target our resources toward chemicals that we think warrant in-depth post-market review,” the statement reads.

The agency plans to engage stakeholders and provide opportunities for public comment and other stakeholder feedback about the framework through public meetings, webinars, and other engagements, and will share more information in the coming months.