For the past three years, California almond producers have been striving to meet the demands of the Food and Drug Administration’s (FDA) Produce Safety Rule, which was finalized in 2016 as part of the Food Safety Modernization Act (FSMA). Since the rule’s passing, the Almond Board of California (ABC), the Almond Alliance of California and other groups have walked alongside almond growers and huller/shellers to help them determine how the Produce Safety Rule applies to them, provide resources, and host training workshops where growers could learn more about what they needed to do to be in compliance.
ABC's Tim Birmingham said the FDA ruling takes into consideration the almond industry's long history of food safety and controls already in place.
Then, on March 27, 2019, FDA issued a final Guidance Document, announcing the use of enforcement discretion for certain commodities covered under the Produce Safety Rule – including almonds. In the Guidance Document, FDA states, “We will not expect entities growing, harvesting, packing, or holding these commodities to meet any of the Produce Safety Regulation requirements.” In simple terms, as long as the Enforcement Discretion remains in effect, almond growers and huller/shellers are no longer subject to Produce Safety requirements. FDA has indicated that they will explore this topic further and consider pursuing rulemaking to address the unique circumstances of almonds.
The ramifications of this Guidance and use of Enforcement Discretion for almonds are immense. “This is big deal for almonds. The notice effectively tables the Produce Safety Rule’s requirements for almonds while FDA considers additional rulemaking, taking into consideration our long history of food safety and controls already in place,” said Tim Birmingham, director of Quality Assurance and Industry Services at the Almond Board.
Brian Dunning, chair of ABC’s Almond Quality and Food Safety committee, said “This is a monumental achievement for our industry and a tribute to the extensive investments in food safety that the almond industry has made that started long before the enactment of FSMA. With this recent announcement by FDA, our industry can now remain focused on the food safety issues that are most relevant without unnecessarily spending our valuable resources to just comply with a regulation."
How We Got Here: ABC, Others’ Work with FDA
During the rulemaking process, ABC remained engaged with FDA, educating on industry practices and providing comments on draft rules along the way. When the final Produce Safety Rule was published, ABC was concerned that the rule did not take into account the fact that almonds were already subject to controls for pathogens such as Salmonella. Recognizing this, ABC continued to work with FDA, hosting and participating in a number of meetings and tours to educate FDA on industry food safety practices, including the mandatory pasteurization program. “We are pleased that FDA has recognized the unique situation of almonds and is considering pursuing rulemaking to address for the long term,” said Birmingham.
“We’ve worked closely with food producers to implement FSMA’s Produce Safety Rule… As part of this collaborative process, we’ve received important feedback on the application of this rule from stakeholders of certain commodities, including hops, wine grapes, pulse crops and almonds,” said FDA Commissioner Scott Gottlieb, M.D., in FDA’s press release announcing the ruling. “Given the nature of these specific commodities, and the low risk that these products pose because of the way that they’re processed and consumed, we do not expect producers of these commodities to comply with the Produce Safety Rule.”
Almond Board Pasteurization Program: 12 Years, 0 Salmonella Outbreaks
In 2001 and 2004, Salmonella outbreaks were intensifying across the food industry and raising concerns about food quality and safety. One of the biggest questions for the California almond industry during this uneasy time was determining the true level of risk associated with the product. The easy answer seemed to be that risk should be low: conventional wisdom suggested that low moisture foods, such as nuts and seeds, did not pose a threat since the microorganisms of concern could not grow in these products. But conventional wisdom was not enough – hard evidence was needed to prove a low level of risk.
The Almond Board engaged food safety experts, USDA and research partners to take a holistic approach to the problem and to identify potential risks and develop strategies to control and prevent outbreaks. This collaboration among experts ultimately resulted in the creation of the Almond Board’s mandatory pasteurization program for Salmonella reduction. To date, almonds are the only tree nut with a mandatory pasteurization program and defined performance criteria accepted by FDA.
“The health and wellbeing of almond consumers matters deeply to everyone in the California almond industry. We’re not afraid to tackle food safety challenges head-on, aided by the expertise of our partners, and we’re proud of our pioneering best practices,” said Birmingham.
Extensive discussions with industry, university and government experts also lead to the implementation of best practices, including the Good Agricultural Practices (GAPs) for growers and Good Manufacturing Practices (GMPs) for processors, as well as updated HACCP guidelines and Pathogen Environmental Monitoring (PEM) resources.
Today, because of the Almond Board’s forward-thinking approach to food safety, drive to get ahead of potential problems and hard work in creating resources to help the industry produce the greatest possible product, the California almond industry has now gone 12 years without any Salmonella recalls and outbreaks.
ABC’s mandatory pasteurization program did well in positioning the California almond industry to comply with FSMA standards because it proactively, voluntarily created and implemented many programs that are already in line with FSMA requirements. Today, those programs are the reason that almond growers and handlers can breathe a little easier when considering FDA’s food safety regulations.
“FDA’s recent Guidance Document is a great win for the industry, and the fact that almonds are specifically called out and listed in the notice indicates that FDA has confidence in our systems and recognizes the effectiveness of the almond pasteurization program,” said Birmingham.
Building on Past Successes for Future
From 2007 to 2017, ABC has invested more than $5 million in food quality and safety research and education. This research has been translated into toolkits, online tools and shared at workshops, and the Almond Board will continue to provide the industry with resources to understand and comply with food safety standards.
“We will continue to be proactive in the food quality space, evaluating the industry’s current practices and engaging in research to improve how we understand and threats to food safety,” said Birmingham.
If you have further questions about FDA’s March 2019 Guidance Document, please contact Tim Birmingham at tbirmingham@almondboard.com. You are also encouraged to attend the Almond Board’s Almond Quality and Food Safety Symposium on Wednesday, June 12, where you’ll hear from top food safety and regulatory experts on issues impacting your operation. Learn more at Almonds.com/UpcomingEvents.
