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. The PDA Bureau of Food Safety & Labs has a cooperative agreement with FDA to complete the produce farm inspections in Pennsylvania.
An On-Farm Readiness Review, or OFRR, is a voluntary program and consists of a non-regulatory, pre-inspectional visit. The goal of an OFRR is to walk through your operation, step-by-step, and see what you’re doing right, what you need to improve, and problem-solve with trained professionals, any modifications that may be necessary to meet the new food safety requirements. This is a confidential service, and best of all, it’s at no cost!
For more information or to schedule an On-Farm Readiness Review, please call the Pennsylvania Department of Agriculture at 717-787-4315.
Produce not covered
by the Produce Rule:
Rarely eaten raw, all
other products are covered

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:
- The farm must have food sales averaging
less than $500,000 per year adjusted for inflation during the previous three
years; and,
- 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.
- 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.
- 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