What is the FSMA Produce Safety Rule?
The Produce Safety Rule is part of the FDA Food Safety Modernization Act (FSMA) that was passed by President Obama on January 4, 2011. This regulation focuses on setting the first-ever federal regulatory standards for the production, harvest, and handling of fruits and vegetables, in an effort to prevent microbial contamination and reduce foodborne illnesses associated with fresh produce. The Produce Safety Rule was made available publicly on November 13, 2015 and was published in the Federal Register on November 27, 2015.
What does the FSMA Produce Safety Rule cover?
The Produce Safety Rule, outlined in Section 105 of FSMA, establishes science-based minimum standards for safe production and harvesting of fresh fruits and vegetables. These standards are based on a foundation of Good Agricultural Practices (GAPs).
The rule is divided into several parts, including standards for:
- Worker health, hygiene, and training
- Agricultural water, both for production and post-harvest uses
- Biological soil amendments (e.g., compost, manure)
- Domesticated and wild animals
- Equipment, tools, buildings, and sanitation
- Production of sprouts*
* The Sprout Safety Alliance, based at the Illinois Institute of Technology, is developing a core curriculum, training and outreach programs for stakeholders in the sprout production community to enhance the industry's understanding and implementation of best practices for improving sprout safety, and requirements for sprout producers included in the FSMA Produce Safety Rule.
The FDA has a brief summary of the key requirements for the final Produce Safety Rule available on their website.
Will my farm be subject to the regulation?
If you grow, pack, process, or sell fresh produce, this regulation may apply to you. Review § 112.1—112.7 of the regulation to determine if your farm and the commodities you grow are subject to the regulation. You can also refer to the FDA’s factsheet on coverage, exclusions, and exemptions to help you determine whether you are subject to the regulation.
Here are a few key exemptions and exclusions:
- The rule does not apply to certain specified produce commodities that are rarely consumed raw. You can find the list of produce covered by the regulation in § 112.2.
- The rule does not apply to produce that is used for personal or on-farm consumption, or that is not a Raw Agricultural Commodity (RAC).
- The rule provides an exemption for produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance (e.g., via a “kill step”) as long as certain disclosures are made and written assurances are received, with appropriate documentation.
- The rule does not cover produce farms that have an average annual value of produce sold during the previous 3-year period of $25,000 or less.
- The rule provides a qualified exemption and modified requirements for farms that meet two requirements: (1) the farm must have averaging less than $500,000 per year during the previous 3 years; and (2) the farm’s sales to qualified end-users must exceed sales to others.
A qualified end-user is either: (1) the consumer of the food or (2) 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. Instead, these farms are 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 to display the same information at the point-of-purchase. These farms are also required to establish and keep certain documentation (See § 112.7).