Produce Safety Rule

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule)

The FDA Food Safety Modernization Act (FSMA) Produce Safety rule was finalized November 27, 2015.   The rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. Information about the rule and the implementation of the rule can be found on the FDA web site.

Compliance Dates

Compliance dates for covered activities, except for those involving sprouts, after the effective date of the final rule are (not including sprouts—see below):

  1. Very small businesses, those with more than $25,000 but no more than $250,000 in average annual produce sales during the previous three year period: four years (November 2019)
  2. Small businesses, those with more than $250,000 but no more than $500,000 in average annual produce sales during the previous three year period: three years (November 2018)
  3. All other farms: two years (November 2017)
  4. The compliance dates for certain aspects of the water quality standards, and related testing and recordkeeping provisions, allow an additional two years beyond each of these compliance dates for the rest of the final rule

Compliance dates for modified requirements for farms eligible for a qualified exemption are:

  • For labeling requirement (if applicable): January 1, 2020
  • For retention of records supporting eligibility for a qualified exemption: Effective date of the final rule
  • For all other modified requirements:
    - Very small businesses, four years after the effective date of the final rule
    - Small businesses, three years after the effective date of the final rule


Compliance dates for covered activities involving sprouts after the effective date of the final rule are:

  • Very small businesses: three years (November 2018)
  • Small businesses: two years (November 2017)
  • All other farms: one year (November 2016)

Exemptions

The rule does not apply to: 

  • Produce that is not a raw agricultural commodity.
  • The rule provides an exemption for produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance, under certain conditions.
  • The following produce commodities that FDA has identified as rarely consumed raw: asparagus; black beans, great Northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts
  • Food grains, including barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds (e.g. cotton seed, flax seed, rapeseed, soybean, and sunflower seed)
  • Produce that is used for personal or on-farm consumption
  • Farms that have an average annual value of produce sold during the previous three-year period of $25,000 or less

 

The rule also provides a qualified exemption and modified requirements for certain farms.

  • To be eligible for a qualified exemption, the farm must meet two requirements:

- The farm must have food sales (all food, not produce alone) averaging less than $500,000 per year during the previous three    years; AND  
- The farm’s sales to qualified end-users must exceed sales to all others 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 disclosing 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. 

Fact sheet

KEY REQUIREMENTS: Final Rule on Produce Safety 

Other important links:

Produce Safety Alliance (PSA)

The Produce Safety Alliance is a collaboration between Cornell University, FDA, and USDA to prepare fresh produce growers to meet the regulatory requirements included in the FSMA Produce Safety Rule.  The PSA has a listserv that you can join in order to keep updated on the regulation and training opportunities. Go here to sign up.

Sprout Safety Alliance:  

The U.S. Food and Drug Administration is working with the Illinois Institute of Technology’s Institute for Food Safety and Health (IIT IFSH), who will administer the Sprout Safety Alliance (SSA), a public-private alliance, similar to the Produce Safety Alliance, but focused on sprouts.  SSA will provide a core curriculum, training and outreach programs for sprout producers and other stakeholders.  The Alliance is supported by FDA and its goal is to enhance the industry's understanding and implementation of best practices for improving sprout safety and to help the industry meet requirements outlined by the FSMA Produce Safety Rule.