With the addition of the Intentional Adulteration rule, there are now seven rules that will have some impact on California Almond processors once the compliance periods begin, some as soon as this September, which is the case for large handlers, who have more than 500 employees and are subject to Preventive Controls. But which rules will impact a specific operation requires a close look at the categories and the qualifications that place an individual or company into a specific category.
Are you an almond grower, a huller/sheller, a handler or a manufacturer? You may be surprised to learn that all four of these categories could also be considered a “farm” under the Food Safety Modernization Act (FSMA) rules.
This distinction is important in knowing which rules you will need to follow under FSMA, according to Elizabeth Fawell, counsel, Hogan Lovells, the consulting firm that Almond Board of California (ABC) has engaged to help the California Almond industry interpret the new rules.
“Partnering with Almond Board, we wanted to determine how we best figure out and communicate to the almond industry which of the FSMA rules apply to different types of operations,” she said in her talk at the 18th Annual Food Safety Symposium, presented by ABC in June this year in Modesto.
FSMA Rules that Apply
Fawell and her colleagues at Hogan Lovells developed a decision tool for almond industry members to determine which FSMA rules apply to their operation.
The key factors influencing the type of operation are:
- Location (proximity to an orchard)
- Ownership structure
- Company size
- Activities performed (growing, hulling/shelling, handling, manufacturing)
“It’s the activities that you engage in that matter,” Fawell said. “Engaging in multiple activities can change the obligations you have and which rules you must comply with.”
For example, if you’re a huller/sheller or a processor or handler, you might also be a farmer. “One of the things that is most confusing is that depending on what you do, you may be regulated under the Produce Safety rule for some of your activities and under Preventive Controls for other activities,” she explained.
The Preventive Controls for Animal Food rule applies to the almond industry for hulls that are used as an animal feed. An exemption from this rule would only be made if the hulls are consumed on the farm where the almonds are grown. Growers who meet the “farm” definition are also exempt if they do not engage in the processing of hulls.
The Intentional Adulteration rule, which was just finalized in May, applies primarily to facilities, as defined by FDA. A facility engages in manufacturing, processing, packing and holding product for consumption in the U.S., and this rule applies only if the facility has more than $10 million in sales.
The decision tool can be found in Fawell’s presentation at Almonds.com/FoodSafetySymposium, where all presentations from this year’s symposium are also available.
FSMA and GFSI
Speaker Richard Stier, addressing processors in the symposium audience, suggested that if they participate in third-party audits, they are “really close” to being in compliance with the Preventive Controls rule. “How does GFSI [Global Food Safety Initiative] dovetail with FSMA?” he asked. “You can bolt on new requirements to everything you’ve already done. Whatever audit scheme you use, you will have to add on to be compliant,” said Stier, a consulting food scientist who is also a member of Almond Board of California’s Technical Expert Review Panel (TERP).
Essentially, for those who have developed, implemented and maintained a food safety program, under GFSI, this will fulfill most of the FSMA requirements, he noted. “You will have to reassess that plan and figure out where you don’t fit, and my guess is the lack of fit is probably going to be in the validation documents up front and your verification program.” However, Stier added, GFSI auditors will check to see if you comply with all FSMA rules.
Changes in Hazard Analysis
Hazard Analysis Critical Control Point (HACCP) plans processors have in place will be relevant, but there are some subtle differences in the new rule, according to Dr. Linda Harris, microbial food safety specialist and now chair of the Department of Food Science and Technology at UC Davis. Dr. Harris has been working with the almond industry for 15 years.
Under the Preventive Controls rule, your Hazard Analysis must:
- Have written documentation, including documentation of your thought process. This has to be prepared by or under a Preventive Controls Qualified Individual — someone who has participated in the PCQI training, such as is offered by ABC.
- Identify and evaluate known or reasonably foreseeable hazards in the food you produce.
- Determine if any of the hazards require a preventive control.
“This is a little bit different from what we have been doing with HACCP,” Harris said, adding that a Hazard Analysis has to be done as a team by people at all levels of your operation and is based on collaboration and cooperation by a very broad range of individuals — someone from sanitation, someone from maintenance, for instance — people who are out there in the trenches.
She continued, “Without a solid Hazard Analysis, everything else you have to do in your food safety plan starts to unravel because this is truly the foundation.”
Your HA has to look at biological, physical and chemical hazards; the latter includes allergens, aflatoxins, pesticides and — in a departure from traditional HACCP — there is a specific mention of radiological hazards and an emphasis on allergens.
“The rule says specifically you have to look at food allergen preventive controls, sanitation preventive controls, supply chain preventive controls, and you have to have a recall plan,” stated Harris.
Hazard Analysis Resources
Dr. Harris presented resources for preparing a Hazard Analysis, which can be seen in her presentation, “Hazard Analysis of Almonds: Resources to Help You Conduct the “Almond Hazard Analysis.” These include past outbreaks, recalls, scientific literature, historical information from your own data, analyzing your own data, and including that analyzed data into your hazard analysis.
Additional resources are warning letters published by FDA, Forms 483, which are reports of findings after an FDA inspection, Extension publications and data from the Almond Board. Data submitted to FDA by tree nut groups, including the Almond Board, are published on the FDA website as “Assessment of the Risk of Human Salmonellosis Associated with the Consumption of Tree Nuts: Request for Comments, Scientific Data and Information.” This document summarizes a lot of data Almond Board of California has created, and puts it in terms of risk assessment and hazard analysis, according to Harris. “This is a valuable document to download and use in your hazard analysis,” she said.
Another resource is a USDA-funded project conducted by UC Davis that developed a list of documents of “everything I know that pertains to tree nuts,” she added. “It contains a spreadsheet of every outbreak, every recall, every survey done on tree nuts and any data we have on survival.”
At the conclusion of Dr. Harris’ presentation, Tim Birmingham, director of Quality Assurance and Industry Services at the Almond Board, announced an additional PCQI training session will be held Nov. 2–4, at which many of these resources will be made available. Further details about the training session will be announced later. For more information on PCQI training or Hazard Analysis resources, contact Birmingham by email or phone him at (209) 343-3222.
