WASHINGTON — The Food and Drug Administration’s nascent Human Foods Program, which will be a combination of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response and certain aspects of the Office of Regulatory Affairs (ORA), came into greater focus on June 27 when the agency made several proposals for breaking up the ORA.

“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,” said Robert M. Califf, MD, FDA commissioner. “Earlier this year the FDA announced steps to modernize and streamline our food program, including field operations, to address these mounting challenges.

“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.”

Specifically, the ORA’s mission will be defined as conducting investigations, inspections and imports for all FDA-regulated products with assignments planned in partnership with the HFP. Compliance functions currently managed by the ORA will be managed within the HFP and each product centers’ existing compliance functions.

The eight human and animal food laboratories currently managed by the ORA will be merged into the HFP. The newly merged labs will then be partnered with the four labs currently in CFSAN to form a unified lab network within 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’s director to coordinate on research priorities, according to the proposal.

Certain functions of the Office of Operations’ Office of Security and Emergency Management will be transitioned to the ORA. They include 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.

“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,” Dr. Califf said. “We will continue to evaluate and make adjustments as we work closely with experts throughout the agency to revamp and enhance our field operations."

Joseph Scimeca, senior vice president of regulatory and scientific affairs for the International Dairy Foods Association (IDFA) said the organization agrees with the agency’s “continued focus on breaking down silos, unifying its food program and emphasizing that the deputy commissioner for the human foods program will be responsible for coordinating closely with the FDA lead for the animal foods program and the office of regulatory affairs. We appreciate the commissioner reiterating that the deputy commissioner will have full responsibility for setting the strategic direction of HFP and for formulating and executing the program’s budget.”

Scimeca added: “IDFA applauds the changes announced relative to ORA, particularly the refocusing of the office on inspections and outbreak investigations while also addressing duplication of efforts and overhead. We encourage FDA to reassign cooperative programs staff — particularly those that oversee the Grade A dairy program — to the Human Foods Program.”

Sarah Gallo, vice president of product policy for the Consumer Brands Association, said the group supports the proposal.

“We are pleased the FDA is taking bolder action to make meaningful and lasting change by answering informed industry and stakeholder calls to unite and elevate the Human Foods Program and fully authorize the deputy commissioner with control over its strategic direction,” she said. “This includes complete authority over the budget, as well as the responsibility to execute a common mission throughout all components, including the animal foods program. We are also encouraged that the FDA plans to address areas of duplication and refocus the Office of Regulatory Affairs on its core business, inspections and investigations.”