Produce Safety Rule

Covered facilities that operate under Produce Safety should be aware of the following changes outlined in the Ruling:

This rule deals with safe growing, harvesting, packing, and holding of produce (fruits and vegetables) grown for human consumption and to minimizing the risk of serious adverse health consequences or death from consumption of contaminated produce. This rule is one of the seven rules under the FDA Food Safety Modernization Act (FSMA). These standards do not apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance is eligible for exemption from the requirements of this rule.


Major Provisions of the Rule:

  1. Worker Training and Health and Hygiene
    • Establish qualification and training requirements for all personnel who handle (contact) covered produce or food-contact surfaces and their supervisors;
    • Require documentation of required training and corrective actions;
    • Establish hygienic practices and other measures needed to prevent persons, including visitors, from contaminating produce with microorganisms of public health significance.
  2. Agricultural Water
    • Require that all agricultural water must be safe and of adequate sanitary quality for its intended use;
    • Establish requirements for inspection, maintenance, and certain other actions related to the use of agricultural water, water sources, and water distribution systems associated with growing, harvesting, packing, and holding of covered produce;
    • Establish specific requirements for the microbial quality of agricultural water that is used for certain specified purposes;
    • Require certain records, including documentation of inspection findings, water testing results, scientific data or information relied on to support the adequacy of water treatment methods.
  3. Biological Soil Amendments
    • Establish requirements for determining the status of a biological soil amendment of animal origin as treated or untreated, and for their handling, conveying, and storing;
    • Prohibit the use of human waste for growing covered produce;
    • Establish requirements for treatment of biological soil amendments of animal origin with scientifically valid, controlled, biological, physical and/or chemical processes that satisfy certain specific microbial standards;
    • Require certain records, including documentation from suppliers of treated biological soil amendments of animal origin.
  4. Sprouts
    • Establish scope of applicability of sprout provisions;
    • Establish measures that must be taken related to seeds or beans for sprouting;
    • Establish measures that must be taken for the growing, harvesting, packing, and holding of sprouts;
    • Require testing the growing environment for Listeria species (Listeria spp.) or Listeria monocytogenes (L. monocytogenes) and testing each production batch of spent sprout irrigation water or sprouts for Escherichia coli (E. coli) O157:H7, Salmonella species (Salmonella spp.) and, under certain conditions.

Exemptions From This Rule:

  • Produce that is not a raw agricultural commodity
  • Some product commodities that the FDA has identified as rarely consumed raw
  • Some grains
  • Produce that is used for persona or on-farm consumption
  • Farms that have an average annual value of products sold during the previous three-year period of $25,000 or less
  • 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 during the previous three years; and
    2. The farm’s sales to qualified end-users must exceed sales to all others combined during the previous three years.

Compliance Dates:

Compliance dates vary by covered activities, modified requirements, and activities involving sprouts. For more information please visit: Click Here.

Source: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm