Tag Archives: human foods program

By Food Safety Tech Staff

The U.S. Food and Drug Administration’s reorganization implementation involving the creation of a unified Human Foods Program (HFP), adoption of a new model for its field operations and other significant modernization efforts are scheduled for Oct. 1, 2024, notably enhancing the agency’s ability to oversee and protect the human food supply and other products the FDA regulates.

Lead by Jim Jones, Deputy Commissioner for Human Foods at FDA, the reorganization establishes the HFP by realigning the functions of the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response, as well as key functions from the Office of Regulatory Affairs (ORA) under one program.

Additionally, the restructuring of ORA will enable the field operations unit to focus on inspections, investigations and imports as its core mission. The FDA is changing the name of ORA to the Office of Inspections and Investigations (OII) to better convey the organization’s role as the frontline of the FDA, which provides real time insights and science-based evidence necessary to ensure the safety and quality of products Americans depend on.

Jim Jones will Keynote the Food Safety Consortium Conference, October 20-22 in Washington DC. During this session Mr. Jones will delve into the agency’s recent reorganizational changes, key regulatory policy priorities, and commitment to stakeholder transparency. Doug Stearns, Deputy Associate Commissioner of Regulatory Affairs, will discuss how these changes will shape investigations and inspections for both domestic and foreign facilities. Attendees will gain valuable perspectives on regulatory shifts, emerging challenges, and collaborative opportunities shaping the landscape of food safety and compliance. Discover how the new Deputy Commissioner’s strategic vision will drive innovation, enhance public health outcomes, and foster trust within the food industry. Attendees will have the opportunity to gain deep insights into emerging challenges, innovative strategies, and collaborative approaches to advancing food safety.

June 27, 2023

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

By Food Safety Tech Staff

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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.

February 28, 2023

FDA Provides Update on Restructuring of Human Foods Program

By Food Safety Tech Staff

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The FDA announced that it has begun a national search for a new Deputy Commissioner for Human Foods and has provided an update on its proposed restructuring of the agency’s Human Foods Program and Office of Regulatory Affairs (ORA).

The Deputy Commissioner for Human Foods will report directly to the FDA Commissioner. As part of its search criteria, the agency notes that it is focused on identifying a candidate that has the expertise to provide leadership over the FDA’s nutrition and food safety programs (including programs aimed at preventing and responding to chemical, microbial, and other hazards).

“The ideal candidate will have executive-level and real-world experience sufficient to lead the newly envisioned Human Foods Program and its vast remit. This individual will also have clear line of authority over the proposed Human Foods Program, which would include the existing components of the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), and certain human foods-related components of ORA,” said the FDA in its statement released on February 28.

In terms of the proposed restructuring of the Human Foods program, the Deputy Commissioner will be charged with setting strategic direction for food inspections and have authority over program resource allocation. To achieve these goals, the agency has started the process of:

Assessing specific functions of ORA, CFSAN and OFPR to be unified into a new Office of Integrated Food Safety Systems Partnerships that will engage with state, local, tribal, and territorial food safety regulatory partners. The assessment will also include how best to enhance connectivity with international food safety partnership programs.
Analyzing inspection and compliance functions that sit within both ORA and program offices across the agency to determine opportunities to streamline operations and clarify decision-making authority at each step of the inspection process as well as integrate new automation and information technology (IT) support. The new processes will enable ORA and program personnel to function as a multidisciplinary team, eliminating sequential steps, immediately bringing the best expertise to bear on the problem at hand, and speeding decisions.
Determining how best to empower the Deputy Commissioner for Human Foods and leaders of other programs, along with the Associate Commissioner for Regulatory Affairs, to oversee program and field resource allocation, including publicly mapping the budget to functional activities to provide clarity on resource allocation.
Ensuring seamless coordination across the FDA and state-operated food laboratory operations by evaluating the foods laboratory programs, including the relationships, roles, and responsibilities among CFSAN, CVM, ORA and state-operated laboratories.
Improving the FDA’s ability to conduct risk prioritization to deliver the highest public health benefit by performing an extensive evaluation of how the Human Foods Program accomplishes risk management, particularly risk prioritization, given the multitude of demands and the scarce resources, and how this can be used to guide dynamic work planning and resource allocation.
Planning for greater enterprise transformation of certain ORA IT functions, which will be coordinated with the FDA’s Office of Digital Transformation (ODT). This move builds on the existing project to create an enterprise-wide platform for managing inspections and compliance activities. ODT will drive upgrades to FDA-wide IT systems.
Evaluating training programs, including for FDA investigators, to see how they can best serve the needs of both the FDA, regulatory partners and regulated industry. This will include assessing whether some training functions or roles should be unified into the Human Foods Program and other product programs.

This vision will include moving cosmetics regulation and color certification functions out of CFSAN and into the Office of the Chief Scientist to better align the expertise of the agency’s cosmetics subject matter experts with the Chief Scientist and to leverage the FDA’s areas of expertise across the agency as it works to implement the Modernization of Cosmetics Regulation Act of 2022.

“Our proposal specifically tackles issues identified in two independent evaluations of our food programs, one conducted by the Reagan-Udall Foundation and an internal evaluation of the agency’s infant formula response. We’ve heard loud and clear that the current resource distribution and operational model between the FDA’s regulatory programs and field operations are siloed and there’s too much duplication. We intend to fix this and strengthen both the regulatory programs and field force,” said FDA Commissioner Robert M. Califf, M.D. “Both subject matter experts in the programs and the expertise of our investigators in the field will see more interaction as part of multidisciplinary teams that have clarity on who is in charge of making decisions.”

The FDA is seeking to finalize its proposal this Fall. It will then undergo a thorough review before advancing to Congress for a 30-day notification period where members may raise any concerns that the FDA may need to address. Afterwards, the FDA will issue a Federal Register Notice, provide notification to and engage, as needed, in negotiations with the Unions for impacted staff, prior to initiation of the new proposal. The FDA emphasized that it will continue to engage with stakeholders throughout this process.

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