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Produce SAFETY Rule

The FDA data set demonstrates that from 1996 to 2010, approximately 131 produce-related reported outbreaks occurred, resulting in 14,350 outbreak-related illnesses, 1,382 hospitalizations and 34 deaths. These outbreaks were associated with approximately 20 different fresh produce commodities. This is a significant public health burden that is largely preventable.

The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, 2011, enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.

As a key element of this preventive approach, FDA was mandated under FSMA to establish science-based, minimum standards for the safe growing, harvesting, packing, and holding of produce on farms to minimize contamination that could cause serious adverse health consequences or death.   PDA Bureau of Food Safety & Labs has a cooperative agreement with FDA to complete the on-farm audits and inspections on produce farms in Pennsylvania. To assist produce growers in the state we are providing several informational sheets and  templates. If you have any questions, please feel free to contact the staff in the Bureau.

Produce not covered by the Produce Rule:

Rarely eaten raw, all other products are covered



Produce Safety Rule compliance is determined by annual food sales:



Qualified Exemptions:

Farms may be eligible for a qualified exemption and associated modified requirements (§ 112.5, § 112.6). To be eligible for a qualified exemption, the farm must meet two requirements: 

  1. The farm must have food sales averaging less than $500,000 per year adjusted for inflation during the previous three years; and,
  2. The farm’s direct sales to qualified end-users must exceed sales to all buyers combined during the previous three years. A qualified end-user is either (a) the consumer of the food or (b) a restaurant or retail food establishment that is located in the same state or the same Indian reservation as the farm or not more than 275 miles away.
  3. A farm with the qualified exemption must still meet certain modified requirements, including prominently and conspicuously displaying the name and the complete business address of the farm where the produce was grown either on the label of the produce or at the point of purchase. These farms are also required to establish and keep certain documentation. 
  4. While some growers may be exempt or not covered by the Produce Safety Rule, all growers should be prepared to implement food safety practices because they grow food people eat.  Growers may also sell to buyers that require the implementation of food safety practices, including those required in the regulation.

Who and what is exempt:
  •  A farm that has less than an average of $25,000 in produce sales over the last three years
  • Commodities that are rarely eaten raw
  • Produce going to a processor that has a kill step
  • Have less than $500,000 annual food sales and majority of the food (by value) is sold directly to qualified end users