Tag Archives: ORA

June 27, 2023

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

By Food Safety Tech Staff

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.

June 20, 2023

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.

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.

January 31, 2023

From the Editor’s Desk

FDA Proposes Redesign of Human Foods Program

By Food Safety Tech Staff

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On January 31, Robert M. Califf, M.D., MACC, FDA Commissioner of Food and Drugs shared a proposal for a unified Human Foods Program that would combine the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR) and certain functions of the Office of Regulatory Affairs (ORA) under one leader.

The new model was proposed in response to the findings of an external evaluation of the FDA Foods program conducted by an expert panel of the Reagan-Udall Foundation and a separate internal review of the agency’s infant formula supply chain response completed last year.

The Reagan Udall evaluation identified several concerns, including lack of communication, lack of a clear vision and mission, lack of a clear, overarching leader, and siloed workers within the FDA’s Human Foods program. The panel also found that the FDA Human Foods program was ill defined with multiple agencies, including CFSAN, OFPR and OVA, working independently of each other, often with separate leadership and little sharing of information. It recommended creating a new Federal Food Administration under HHS that would operate parallel to, rather than under the auspices of, the FDA.

In his statement announcing the proposal for a more unified Human Foods program, Califf highlighted the issues identified by these independent reviews, including problems with the current culture, structure, resources, and authorities in the FDA Human Foods program.

“Today I am announcing a new, transformative vision for the FDA Human Foods Program. I am also announcing a transformative vision for the Office of Regulatory Affairs (ORA, the FDA’s field-based operations) to support the FDA organization as a whole. The proposed structures for both groups will have clear priorities that are focused on protecting and promoting a safe, nutritious U.S. food supply that more quickly adapts to an ever-changing and evolving environment,” said Califf.

The “Vision for a Reimagined Human Foods Program” includes the recommendation to create a Human Foods Program under a single leader who reports directly to the Commissioner. Under this plan, the functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR), as well as certain functions of ORA will be unified into a new organization called the Human Foods Program.

“The FDA will conduct a competitive national search for a Deputy Commissioner for Human Foods, who will oversee the Program. The person in this position will report directly to me and will be charged with leading a unified Human Foods Program that keeps the foods we regulate safe and nutritious, while ensuring the agency remains on the cutting edge of the latest advancements in science, technology, and nutrition,” said Califf. “The Deputy Commissioner will have decision-making authority over policy, strategy, and regulatory program activities within the Human Foods Program, as well as resource allocation and risk-prioritization.”

Other key elements of the proposed new Human Foods Program include:

Creation of a Center for Excellence in Nutrition that prioritizes the agency’s ongoing efforts to help American consumers make more informed food choices, including by working with industry to offer healthier, more nutritious food products.
Establishment of an Office of Integrated Food Safety System Partnerships that will focus on elevating, coordinating and integrating the FDA’s food safety and response activities with state and local regulatory partners to more effectively meet the vision of an Integrated Food Safety System in the FDA Food Safety Modernization Act of 2011.

The proposed program would also include the establishment of a Human Foods Advisory Committee made up of external experts who will advise the agency on challenging and emerging issues in food safety, nutrition and innovative food technologies.

“Finally, there will be an emphasis on strengthening our enterprise information technology and analytical capabilities to fulfill the promise described in the New Era of Smarter Food Safety and support the improvement in workflow that will accompany these changes,” said Califf. “This area of focus will support the work of the Human Foods Program by enabling more facile communication, more efficient operations and enhanced empirical risk algorithms to guide the priorities of the program and the work in the field.”

To execute this new plan, the FDA has formed an Implementation and Change Management Group that will be charged with developing a detailed plan for implementation of the newly organized agency. “While details of this proposal continue to be developed, CFSAN, ORA, and OFPR will continue to operate under their current structures, with my direct oversight. I look forward to providing additional public updates by the end of February on our progress, organizational design and timeline,” said Califf.

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