• The proposed rule also would not apply to produce that is used for personal or on-farm consumption, or that is not a raw agricultural commodity.
• The proposed rule would provide an exemption for produce that receives commercial processing that adequately reduces the presence of microorganisms (e.g. a “kill step”) as long as certain documentation is kept.
• The proposed rule would not cover farms that have an average annual value of food sold during the previous three-year period of $25,000 or less.
• The proposed rule would provide a qualified exemption and modified requirements for farms that meet two requirements: (1) the farm must have food sales averaging less than $500,000 per year during the last three years; and (2) the farm’s sales to qualified endusers must exceed sales to others.
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 as the farm or not more than 275 miles away. Instead, these farms would be required to include their name and complete business address either on the label of the produce that would otherwise be covered (if a label is required under the FD&C Act and its implementing regulations) or at the point-of-purchase.
This exemption may be withdrawn in the event of an active investigation of an outbreak that is directly linked to the farm, or if it is necessary to protect the public health and prevent or mitigate an outbreak based on conduct or conditions on the farm that are material to the safety of the produce. As explained in the Preamble, these entities are either exempt from all the requirements of the rule or are subject to a narrower set of requirements.
Summary of the Major Provisions of the Regulatory Action
The proposed rule would establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms. We propose new standards in the following major areas:
• Worker Training and Heath and Hygiene
o Establish qualification and training requirements for all personnel who handle (contact) covered produce or food-contact surfaces and their supervisors (proposed §§ 112.21, 112.22, and 112.23);