California’s almond growers have been diligent in producing a high quality, safe food product for many years. The Almond Board of California (ABC) worked with USDA and leading food-safety experts to develop a food quality and safety plan designed to provide consumers with the safest possible almonds from California.
This program, which is constantly updated, addresses the entire supply chain, recommending practices that encompass good agricultural practices (GAPs) in orchards, good manufacturing practices (GMPs) in processing plants, and pasteurization which is the final step in the food safety program before California almonds are shipped to customers.
Here is a look at how the ABC food-safety program is likely to mesh with the two proposed food safety rules issued by the Food and Drug Administration (FDA).
The two rules are:
1. Standards for the growing, harvesting, packing, and holding of produce for human consumption (produce safety rule)
2. Current good manufacturing practice and hazard analysis and risk-based preventive controls for human food (GMPs and preventive controls)
Almonds are “produce”
The produce safety rule may directly impact almond growers because almonds and other nuts are considered under the “produce” umbrella by FDA. The produce safety rule will focus on measures to reduce or prevent the potential for microbiological contamination during growing, harvesting, packing, or holding of the food.
Key components to the proposed rule include:
- Qualification and training requirements for workers who handle product or food contact surfaces;
- Agriculture water sanitary quality requirements and verification records;
- Biological soil amendment requirements, including establishment of treatment requirements for soil amendments of animal origin, establishment of treatment requirements, and minimum application intervals for untreated and treated biological soil amendments;
- Establishment of the waiting period between animal grazing and harvest;
- Establishment of requirements related to equipment and tools that contact product, including equipment used in harvest, transport, storage, and buildings; and
- Establishment of requirements related to pest control, hand-washing and toilet facilities, sewage, trash, plumbing, and animal excreta.
Records to document and demonstrate implementation of the key components as outlined above are also required under the proposed rule.
The GMPs and preventive controls proposed rule will impact almond handlers. This rule will update the FDA current good manufacturing practices (cGMP) regulations involving processing, packing, and holding of food for human consumption.
The cGMP updates focus primarily on clarifying requirements to protect against contamination and cross contamination, as well as allergens. In addition, focus will be placed on prevention of contamination of food packaging materials.
The rule also establishes a requirement to develop a written food safety plan. The proposed food safety plan must include:
- Identification of hazards likely to occur in the food, including biological, chemical, physical and radiological hazards;
- Preventive controls, monitoring practices, and corrective actions for identified hazards;
- Verification procedures for identified preventive controls; and
Finally, under the GMPs and preventive controls proposed rule, there will be a requirement for establishing and maintaining records to demonstrate implementation of GMPs and the food safety plan.
Exemptions for small businesses
Both proposed rules will have exemptions based on meeting FDA definitions of small business. On the farming side, the proposed produce safety rule would not apply to farms with an average three-year value of $25,000 or less. For average three-year sales less than $500,000, modified requirements would apply.
In addition, specific products may be exempted from the produce rule if the product receives commercial processing that adequately reduces the presence of microorganisms (a “kill step”).
With the almond industry mandatory program for the reduction of Salmonella bacteria on almonds, it is possible that almonds would be exempted from the produce safety rule. However, almond growers should still be diligent in food safety practices and ensure they are addressing concerns raised by FDA in the produce safety rule as outlined above.
On the handling side, exemptions to the hazard analysis and risk-based preventive controls portion of the rule have been proposed for FDA-defined small business and/or low-risk activities. FDA is seeking comments on the definition of small business, and is considering exemptions for those with average annual sales of less than $1,000,000, $500,000, or $250,000. Exemptions to the current good manufacturing practices component of the rule are not being proposed.
Where will we be a year or two down the road when the final rules have been published and the dust settles? It is clear that almond growers will need to continue to address food safety hazards through the implementation of good agricultural practices and employee training programs.
It is also clear that whether or not almonds will be exempt from the produce safety rule, FDA will consider farming operations in a similar fashion as food processing facilities with more emphasis placed on GMP-type programs at the farm level to ensure sanitary operations.
Undoubtedly this will require more diligence on the part of the almond grower with greater attention to prevention and control of contamination at the orchard level and during the harvest, transport, and storage of almonds.
Almond handlers will be affected primarily by the need to update their current food safety program and practices to conform to the “written food safety plan” requirements specified under the new rule as outlined above.
The ABC Food Quality and Safety Program manual is a valuable resource to help handlers understand some of the key areas that may assist in the development of the food safety plan, including pasteurization, hazard analysis, and critical control points (HACCP), pathogen environmental monitoring, and recall plan development.
Food quality and safety have been a cornerstone of the almond industry for many years, and will continue to be so regardless of the final outcome of the proposed produce safety rule and the GMPs and preventive controls Rule.
So, given the track record of the industry, California almond growers and handlers should be well positioned to address the changes when the dust settles.
Note: For additional information regarding ABC grower and handler food safety programs, please contact Tim Birmingham at firstname.lastname@example.org.
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