Food Law


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General Comment

The FDA proposed regulations for Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption on January 16, 2013. The following links provide detailed information about the proposed regulation.



Observations and Comments


Incidents from the past decade in which adulterated fresh fruits and vegetables reached consumers underpin Congress' reaction in FSMA of extending food laws to include the handling of fresh/raw fruits and vegetables.  Generally, USDA is responsible for production agriculture (such as standards and grades for fruits and vegetables) and FDA is responsible the processing sector.  However, the boundary between these jurisdictions becomes less clear when the processing occurs on farms, such as packaging fruits and vegetables for the fresh market.  Congress clarified when it enacted the FSMA that FDA (in collaboration with USDA and other agencies) will be responsible for overseeing the production and packaging of fresh/raw fruits and vegetables, including packaging that occurs on farms.


U.S. food law focuses on reducing the risk that food is adulterated when it reaches the consumer.  The legal system also recognizes that the adulteration does not occur only in the step immediately preceding the consumer, but that food can become unsafe anywhere in the processing or handling channel.  Congress has not granted the FDA or the USDA authority to regulate the safety of agricultural commodities on farms even though the commodities ultimately lead to the final food product.  Congress has instead directed FDA and USDA to focus their food safety regulatory authority on food processing.  The thought process is that food processors will have the opportunity to remove unsafe agricultural commodities from the food system during the processing stages.

However, all food is not subject to processing.  Some foods, for example, will be consumed as fresh or raw agricultural commodities, such as fruits and vegetables.  For those foods, unsafe items must be removed from the food system by some strategy or practice other than food processors.  Accordingly, standards for handling fresh or raw agricultural commodities will primarily be enforced on the farm if this is one of the last steps before the food is made available to the consumer.

The FSMA completes the Congressional mandate that food processors must develop and implement hazard analysis, risk-based preventive controls, whether this mandate is in the form of HACCP for seafood, juice, meat or poultry, or Hazard Analysis for all other processed foods.  However, Congress has NOT mandated Hazard Analysis for handlers of fresh or raw agricultural commodities even though produce is NOT subject to further processing prior to reaching the consumer.  Instead, Congress has mandated specific practices be followed by producers and handlers of fresh or raw agricultural commodities.

  • Some of the farm production practices (such as irrigation water and biological soil amendments) on farms producing fresh/raw fruits and vegetables for sale to consumers are now regulated by FDA, according to the FSMA.
  • Non-farm food processors are subject to Hazard Analysis (21 USC 350g); on-farm raw agricultural commodities processors are subject to specific produce handling practices (21 USC 350h). 
    • Are non-farm raw agricultural commodities processors subject to Hazard Analysis or specific handling practices?
    • My assumption is that a raw agricultural commodity handler who is NOT a farmer is subject Hazard Analysis (21 USC 350g), but I need to confirm that assumption.
    • Although I cannot find any statement that explicitly confirms this assumption, 21 USC 350h and associated regulation focus on growing, etc.  This suggests that a non-farm processor is subject to 21 USC 350g; not 21 USC 350h.  Furthermore, 21 USC 350g is based on facility registration; a non-farm food processor aligns with facility registration, and not with 21  USC 350h.  I believe that a non-farm raw agricultural commodity handler is subject to 21 USC 350g, not 21 USC 350h.




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