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.

 

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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.

Written Plan

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 tbirmingham@almondboard.com.

To access ABC’s food safety documents, go to www.AlmondBoard.com/Growers or www. AlmondBoard.com/Handlers.

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