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.
Elizabeth Fawell interprets the FSMA Produce Safety rule for growers and others who meet the FDA Farm definition at the Almond Board’s Food Quality and Safety Symposium in June.
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 the Almond Board has engaged to help the California Almond industry interpret the new rules.
“Partnering with ABC, 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 Almond Board of California (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 whether they are considered a “farm” by FDA, which subsequently impacts which FSMA rules may apply to their operation.
The key factors influencing whether an operation may be considered a farm are:
- 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 the consumption in the U.S., and this rule applies only if the facility has more than $10 million in sales.
Produce Safety Rule
In a second presentation, Fawell provided an explanation and interpretation of the Produce Safety rule for California Almonds, while encouraging growers to read the entire rule for a more in-depth understanding of the requirements. “The Produce Safety rule is not just relevant to growers,” she said. “It applies to growers who meet the definition of a farm, and if you are a huller/sheller or processor/handler who meets the definition of a farm, then you would have to comply with the Produce Safety rule." This rule applies to food intended for consumption in the U.S., whether grown here or imported, and it also applies to produce that is going to be exported. “This is particularly relevant to the almond industry,” Fawell added.
There are two exemptions: growers with sales less than $25,000, and produce that will receive a commercial-processing kill step. However, she said, “In order to be exempt from the Produce Safety rule, you must have written documentation from the customer that the kill step will be applied.” In certain cases, the ABC mandatory program for Salmonella reduction on almonds may provide sufficient assurances and thus qualify growers for an exemption. The Almond Board expects further clarification from FDA on this in the near future.
The Produce Safety rule has several subparts addressing agricultural water, biological soil amendments of animal origin, worker health and hygiene, equipment, tools and buildings, domesticated and wild animals, and harvesting and packing.
Most of these requirements are very similar to good agricultural practice (GAP) standards, according to Fawell, with ag water testing requirements likely to pose a significant challenge. The rule requires water to be “safe and of adequate sanitary quality” for its intended use such as irrigation, water used for prepping crop sprays and water used in harvesting, packing and holding activities, including hand washing.
Water sources must be tested and meet microbial standards for the intended use, and either treated or subjected to other corrective measures. Recordkeeping of these activities will be essential; in fact, a lot of the FSMA rules require documentation.
If subject to the new rules, growers would have inspections. “It’s a new era to have a new set of regulatory requirements, even if you have been experiencing GAP audits, which are for business or commercial purposes rather than an inspection to determine compliance with a set of rules and to enforce an action if you do not comply,” said Fawell. “Be sure you have your records available for inspection.”
Fawell’s presentations as well as those by other speakers at the Food Safety Symposium are available at Almonds.com/FoodSafetySymposium.
For more information, contact Tim Birmingham, director of Quality Assurance and Industry Services, at tbirmingham@almondboard.com
