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FDA's Dennis Keefe maps out changes to food additive office

Changes to better position FDA for cell-cultured meat, other innovations

This article is powered by Food Chemical News

Starting May 13, changes will be coming to the FDA Office of Food Additive Safety (OFAS).

As part of a larger FDA reorganization, which was finalized before then-FDA Commissioner Scott Gottlieb left the agency, the OFAS will undergo its first major restructuring since the early 2000s.

According to Dennis Keefe, director of the Office of Food Additive Safety, who spoke to IEG Policy about the reorganization on Thursday (April 11), the changes will streamline OFAS operations and allow the office to respond more efficiently to an increased volume of industry submissions. The restructuring will not change staffing levels, but rather position the office to better address emerging needs related to new tools and technologies, as well as innovations in food production, such as cell-cultured products.

And while it may cause some initial disruptions, the change should ultimately make OFAS more streamlined, effective and proactive, Keefe said.

“The current structure of the office dates back to 2000-2002 when we were [last] reorganized,” Keefe said. “That was part of concerted effort to address some of the problems and challenges the food additives program was having at the time.” But the OFAS, which typically handles 100 to 120 contact notices, about 60 GRAS notices and five to six petitions a year, is now facing different challenges.

“Our workload has changed,” Keefe said. “We clearly are getting more food contact notifications and GRAS notices than petitions now.”

Technological advances have also affected work of the office, as new tools such as predictive toxicology and in vitro studies are beginning to shift risk assessment methodology away from traditional animal feeding studies, while new data streams are starting to require more attention and analysis.

“Informatics is changing. Computational power is changing. So, the dynamic has changed quite a bit for us,” Keefe said.

Creating efficiencies

In response to those changing needs, FDA is moving to restructure the office, which is currently organized by product lines and includes three divisions that respectively handle petitions, contact notifications, and biotechnology and GRAS notice reviews:

  • Division of Petition Review;

  • Division of Contact Notifications; and

  • Division of Biotechnology and GRAS notice review.

The restructuring will replace the current offices with a new, three-division model that will consolidate work on food additives, color additives and GRAS notices under one division, the Division of Food Ingredients, and create a new Division of Science and Technology, which will study specific subject areas and offer targeted support and assistance to all other divisions. The Division of Food Contact Notifications will also experience some changes, but its responsibilities will not change substantially, Keefe said.

“The Division of Food Ingredients is going to be responsible for what some people refer to as direct ingredients,” Keefe said. “The scientific questions we might ask in terms of food safety, they are very similar for food additives and color additives and GRAS notices … and the workload in that space is primarily with GRAS notices ... so, we create some efficiencies there.”

Preparing for emerging challenges, advances in cell-culture technology

The new Division of Science and Technology, on the other hand, will be broken into two branches: one that handles regulatory reviews and the other that focuses on scientific development.

The restructuring will establish teams of staff that work under each of those branches. The regulatory branch will oversee three teams focusing on biotechnology, environmental issues and safety assurance. The scientific development branch, on the other hand, will have two teams that handle informatics and information systems and monitoring.

“We have a biotechnology team, which is responsible for the new varieties of plants, but potentially could be responsible for the new challenges associated with biotechnology, as we begin to think about issues with cultured meat,” Keefe said. “This is a team that would be responsible for these other innovative technologies that are coming.” 

For instance, an ingredient used to produce cultured meat might go through the GRAS process. But the biotechnology team in the new Division of Science and Technology “could be developing the thinking around what’s the decision process that goes through a GRAS notification,” Keefe said. “We are trying to be flexible here in terms of how our thinking can be adaptable to the changes in the technologies,” he said.

The environmental team, on the other hand, will handle all the office’s responsibilities related to the National Environmental Policy Act (NIPA) and will continue to serve not only the OFAS, but also the entire FDA center. “Any of the rulemaking that we do in our program office is subject to NIPA,” Keefe explained. “The food additive petition process, the color additive petition process and the food contact notification program are all subject to NIPA."

The OFAS is also creating a new Safety Assurance Team to work on challenges that may not be immediately related to submissions but could create hurdles for the office in the longer term, Keefe said. The group may develop or revise guidance documents or work on issues related to agency-initiated rulemaking, or other multi-disciplinary problems that the office would like to have the ability to tackle proactively and efficiently, Keefe said.

The teams established under the Scientific Development Branch, on the other hand, will tackle emerging issues related to new data and technology, including information systems and informatics, predictive toxicology and chemoinformatics, Keefe said.

The teams under that branch will oversee data and information systems that the office uses now, including its electronic workflow system for all the petition and notification processes and the OFAS electronic document room, which contains searchable electronic records on previous decisions on specific food ingredients, additives or contact substances.

“We are also developing chemo-information on chemicals that we know are used in food and inventorying that information from our previous reviews,” Keefe said. “We are also trying to develop … predictive tox tools and we need to begin to develop information systems that can make sense of the new data streams that … we expect to be experiencing.”

For example, the new Toxicology in the 21st Century Initiative (Tox21), has brought together several federal agencies in an effort to develop new ways to rapidly test whether substances adversely affect human health. Substances assayed in Tox21 include a range of products including food.

“This is an initiative that FDA is a part of that is being really driven by EPA and they developed … screens, primarily in vitro assays, to screen various steps in toxicological pathways and the EPA has a mandate to look at and prioritize industrial chemicals,” Keefe said.

Information from this new initiative is critical for regulatory agencies, who can use them to make safety decisions. But the Tox21 assays are new for OFAS, and the office needs to have the capacity to analyze and make sense of this information, Keefe stressed. “These are the sorts of data that we are going to see in the future because the science is moving away from animal studies,” he added. “Some of the newer techniques hold promise to get to a quicker decision, so we want to position ourselves to be able to better integrate these new data streams into our decision-making processes.”

For example, the monitoring team that will work under the new Scientific Development branch will be working on data streams that help the agency be better informed about chemicals, ingredients and other food components. That team, Keefe said, has already developed a database from food labels that can monitor trends not only in the nutrition profiles of foods, but also in the ingredients used in those foods.

The team will continue that work with the goal of creating an automated system that can be used along with existing information on food consumption to “in a crude way, monitor dietary exposure and look for red flags or yellow flags in terms of what might be of concern in terms of dietary exposure,” Keefe said. 

But what is the reorganization going to look like in practice? And what effect is it going to have on the agency’s ability to respond to submissions? Keefe answered some practical questions about the reorganization:

Q: How is the restructuring going to affect the workforce at the office?
A. In terms of my FTEs here, that will not change for the office. We are basically working with the people we have in the office now and moving them around. Some of them are moving to different areas ... [so] someone who might have been working in the Food Contact Notification Division might move to one of the other divisions. Obviously, with the creation of the Division and Science and Technology, there are people who were previously working on industry submissions, the petitions and notifications, that are not going to be working on that now, at least not directly.
Q: Does that mean you would have fewer people directly working on petitions and notifications?
A: With the informatics group in the Scientific Development Branch, the individuals that are there were already working on individual projects that related to informatics and information systems. But they were working, if you will, in silos and not integrating. And this way we bring them all together and the data streams can now be integrated and can speak to each other. And we will be in a position to better integrate that information in ways we couldn’t do before. 
Q: With people being moved to the new Division of Science and Technology, are you anticipating disruptions or delays in the OFAS ability to respond to submissions in a timely manner?
A: Let’s be honest, with any organization that reorganizes, there is going to be disruption. I expect there will be some disruption. We are doing everything we can to minimize the disruption, in terms of meeting our statutory deadlines. Meeting those timeframes is our highest priority. Our FTE ceiling is 125 and in 2016, it was 138. So, we have had a reduction. So, by combining the GRAS responsibilities and the petition responsibilities into one division, we are actually creating efficiencies.
Q: How do you feel the reorganization would benefit industry?
A: [The bulk] of our workload in terms of industry submissions are GRAS and FCNs. Those will continue to be a priority for us.  We will continue to meet our deadlines. The new division is not intended to take away from that. In fact, it’s really intended to create efficiencies by consolidating the information systems and integrating them and getting them to support the work of the other two divisions. And, also the new Safety Assurance Team is intended to try to resolve and address challenges that are related to or are emerging from the industry submissions. But when they come in now they tend to disrupt the review of the submissions. 
Q: In FDA’s budget request for FY 2020, the agency has requested increased support to promote innovation, as it relates to new food ingredients. Specifically, the agency has asked for a $3.2 million increase (equivalent to 10 FTEs) in budget authority for the Center for Food Safety and Applied Nutrition (CFSAN) to address an anticipated increase in industry submissions of innovative food ingredients. The request is also calling for a proposed user fee program expected to generate $26.1 million (52 FTEs) to address needs in that area and increase the agency’ scientific review capacity as the need to support novel emerging products continues to grow. Can you speak about how such funding could enhance the work of OFAS?
A: If I were given 10 additional FTEs, I would begin to restore my staff to the levels we were in 2016. If user fees were incorporated or approved, I would expect that the user fees would be targeted to the GRAS program or the food contact notification program, just because typically with the user fee program there is a threshold number of submissions that make a program viable for a user fee approach. I think we passed that threshold with both of those programs. But if Congress were to decide and the president were to agree to user fees for the GRAS program, obviously those funds would then go to support the Division of Food Ingredients. It really depends on where Congress targets the user fees. You could imagine they might target some of the innovative products like cultured meat, I just don’t know. But if you look at the new organization, if Congress were to decide to do something like that, we have specific areas now where those user fee funds could be directed and managed in the new structure.



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