“Let me just start with the comment that it’s been a very, very busy time at CFSAN. There are a number of things coming up,” including a push to finalize the last of the seven final rules related to the foundation of the Food Safety Modernization Act as well as finalizing rules related to gluten-free labeling, the Nutrition Facts label and serving sizes and the Generally Recognized as Safe process, CFSAN’s Director Susan Mayne told attendees at the Grocery Manufacturers Association Science Forum in Washington, DC, April 19.
The division also hopes to push out guidances to support the GRAS rule, the Nutrition Facts labeling rule, FSMA in general, nutrition labeling on menus and finalize the 2014 draft food consumption advice concerning methlymercury in fish, she added.
As if that weren’t enough, she also said the division is pushing forward on work related to chemical contamination in food, reducing the risk of food borne pathogens and educating consumers about the safety of genetically engineered ingredients.
She recognized that this is an aggressive list and acknowledged that some of this work will overflow into coming years, but based on her initial 15 months in her current position with the agency she is confident that CFSAN is doing everything it can to carry out its mission of translating scientific knowledge into action to protect and promote public health.
As support for her faith in the division, she lauded it for its diverse and significant accomplishments achieved in “just the last five weeks or so,” including the publication of the final guidance on how to reduce acrylamide in certain foods, the final rule on Bovine Spongiform Encephalopathy, the proposed rule to limit inorganic arsenic in infant rice cereal, the final FSMA rule for ensuring food safety during transport and the approval of the additive petition for folic acid fortification in corn masa flour.
Final rules on the horizon
A top priority for CFSAN in the remainder of 2016 is finalizing the last of the foundational FSMA rule – the Focused Mitigation Strategies to Protect Food Against Intentional Adulteration rule, which it proposed in December 2013 to comply with a court-ordered deadline.
The rule is aimed at preventing potential acts of terrorism through the food supply, and requires food facilities to write defense plans to address vulnerabilities such as bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling and ingredient mixing, to name a few.
Mayne said CFSAN is on track to publish this last final rule by the previously estimated target date of May 2016, at which point the division will be “fully engaged in the implementation phase of FSMA.”
To support implementation, she added that CFSAN is “working very hard on education, outreach and technical assistance on these FSMA rules,” which she recognizes is “creating some angst for the industry.”
She added: “We are trying to do all that we can to make ourselves available for questions that you may have as we work though the implementation part of FSMA. … We literally get hundreds of queries that come into our technical assistance network and which we respond to as quickly as we can” although some take longer than others as they require talking with subject matter experts to develop detailed, thoughtful answers.
In addition to supporting industry, CFSAN is aggressively training its staff and reaching out to international players so they understand the division’s goals and what is required of companies, she said.
The GRAS process
Beyond FSMA, Mayne said CFSAN is on target to finalize by August a final rule related to the GRAS process. The deadline was set as part of a consent decree for a lawsuit brought by the Center For Food Safety which alleged FDA unlawfully exempted GRAS substances from regulation as food additives under a proposed rule from 15 years ago that was never finalized.
Following that rule, Mayne said FDA will publish several additional guidances, including one that will explain what it means for a substance to be GRAS. This guidance will allow people who are considering the GRAS process to go to one place where they can find out what GRAS means, how FDA interprets GRAS status and what kind of documents they need, Mayne said.
The second guidance would address GRAS Panels and conflicts of interest, she added.
Gluten-free and Nutrition Facts
A less controversial final rule on the horizon is the gulten-free labeling for fermented and hydrolyzed foods, Mayne said.
CFSAN also “is working very hard to finalize” rules updating the Nutrition Facts label and serving sizes and related regulations such as nutrient content claims, Mayne said.
On a similar note, Mayne said, CFSAN hopes to soon release findings from the 2014 Health and Diet Survey that it conducted, which includes information on how consumers read labels.
Menu labeling, methylmercury in fish
In addition to the guidances needed to help industry comply with these new rules, Mayne said CFSAN soon hopes to publish final menu labeling guidance, which she recognized “many of you in industry are very much looking forward to getting.”
Likewise, CFSAN is working closely with the Environmental Protection Agency to respond to public comments on the 2014 draft food consumption advice concerning methylmercury in fish.
“The important thing here is that we know that seafood and fish is an important part of a healthy diet for pregnant women, but we want to make sure that they don’t consumer seafood that is high in mercury. So, we put out the 2014 draft consumption advisory that we need to finalize right now,” Mayne said.
In addition, the division will start reviewing public comments on how to define natural and is reviewing a petition to update the definition of healthy for use on packaging.
Contaminant and pathogen reduction priorities
CFSAN also has its hands full reducing the risk of chemical contaminates in food and the risk of food borne pathogens, Mayne said.
While she celebrated the recent regulation accomplishment related to arsenic levels in rice, she said the division still needs to update the 2002 risk analysis framework and update the Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food (also known as the Red Book) following a meeting held by FDA in 2014 to gather feedback from stakeholders.
In terms of reducing food borne pathogen outbreaks, Mayne said CFSAN is reviewing feedback from a recent advisory committee meeting on the risk of listeria in ready-to-eat foods.
The agency also plans to release initial data related to a pilot sampling program in which CFSAN sampled raw milk cheese age fermented for at least 60 days, sprouts and avocados for microbial contaminants and pathogens.
“We’ve also been engaged in conversations with stakeholders in regards to compliance around raw milk cheese to really ensure that raw milk cheese continues to be consumed safely,” she said.
The final hot topic area that Mayne said CFSAN is actively address is that of labeling genetically engineered foods.
She noted that the agency recently published final guidance on labeling food with genetically engineered crops and Aqua Advantage salmon, but that just like industry and other stakeholders it is waiting with bated breath to see how legislators will handle GMO labeling.
Regardless of legislative changes though, CFSAN is moving forward with education efforts to help consumers better understand the safety of genetically engineered ingredients, Mayne said.
Reflecting on CFSAN’s accomplishments to date, as well as its laundry list of priorities, Mayne stressed that CFSAN also is juggling several other priorities which might change the timing on some of these goals. However, she emphasized, she and the agency are doing the best they can to advance food safety.