Produce Safety Rule

 

Food Safety Modernization Act (FSMA)

FSMA is the most sweeping reform of food safety laws in over 70 years. Signed January 4, 2011, by President Obama, FSMA aims to create an integrated food safety system and improve the quality of food products to the public by reducing foodborne illness. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

On November 27, 2015, the FDA published the final rule for Produce Safety.

FSMA Overview

The seven major FSMA regulations are the:

Produce Safety Rule Main Components

The key elements to the Produce Safety Rule and additional resources are listed below.  Please note that the Rule covers both open air farms and insulated greenhouses. For more information, attend a PSA Grower Training Course. If you are a covered non-exempt farm you are REQUIRED BY FEDERAL LAW to have at least one person on the farm who has taken a PSA Grower Training Course.

  • Employee qualifications and training.
    Farm workers who handle produce and/or food contact surfaces must have certain training, including the importance of health and hygiene.
    – Produce Safety Alliance Grower Trainings
  • Worker health and hygiene.
    Workers can carry, introduce and spread contamination to fresh produce so it’s critical to have training in place for employees and visitors.  Farms must also implement worker practices such as, washing hands after using the restroom and notifying their supervisor when they are ill.
  • Agricultural water used during growing, harvesting, packing and holding.
    Water is a potential source of contamination if it’s not monitored or used appropriately. The Produce Safety Rule addresses production water (e.g. irrigation) and post-harvest water (e.g. rinsing) standards. 
    – Agricultural Water Assessment Builder – FDA
    – Tips for sampling piped water – Western Center for Food Safety
    – Making Sense of Rules Governing Chlorine Contact in Postharvest Handling of Organic Produce – UC Davis
    – For more information, please see our FAQ page or the Resource page or visit FDA’s Standards for the Growing, Harvesting Packing and Holding of Produce for Human Consumption: What You Need to Know about the FDA Regulation: Guidance for Industry – Small Entity Compliance Guide
  • Biological soil amendments.
    Appropriate use of raw manure and compost minimizes the risk of contamination.
    – Food Safety on the Farm: Good Agricultural Practices and Good Handling Practices—Manure and Municipal Biosolids – University of Florida Extension
  • Domesticated and wild animals.
    Produce growing areas must be visually monitored for signs of animal intrusion and workers must not harvest produce that is likely contaminated (e.g. don’t harvest melons with bird poop on them).  Farms are not required to exclude animals from their fields or destroy animal habitat.
  • Equipment, Tools and Buildings.
    The Produce Safety Rule establishes standards related to the use and sanitation of equipment, tools and buildings to prevent contaminating produce.
  • Record Keeping.
    Certain records are required by the Produce Safety Rule.  In general, records should be accurate, legible, and indelible; dated and signed by the person who performed the activity; and should be created at the time of the activity. Records should be keep for at least two years.
    – Templates for record keeping – Produce Safety Alliance
  • Sprouts.
    Sprouts have specific requirements because of their susceptibility to contamination.  Contact the Sprout Safety Alliance if you are a sprout grower.
    – Sprout Safety Alliance

Microorganisms of Public Health Concern

All the categories of the Produce Safety Rule listed above (Worker Health and Hygiene, Agricultural Water, Biological Soil Amendments, Domesticated and Wild Animals, Equipment, Tools and Buildings) have been found to be potential sources of contamination of covered produce from previous outbreaks. Outbreaks of what? There are 3 main Microorganisms of Public Health Concern, E. coli, Listeria and Salmonella. All are bacterial in nature, smaller than what can be seen with the naked eye, and can make you sick 

Escherichia (E) coli – Naturally is found in your intestine, in those of animals, and in surrounding water and soil. While most live and go about their daily lives without much harm to you, some strains are pathogenic and can cause, diarrhea, UTI, respiratory illness, pneumonia, and kidney failure. The greatest concern for food outbreaks is O157:H7, a shiga toxin-producing E.coli that can lead to the more severe symptoms.

Listeria monocytogenes – Naturally is found in soil, water, and animal digestive tracts. This bacteria can survive and multiply even when refrigerated, making it a real threat in air conditioning drips, standing water, and sprout production. Infection with the bacteria (a disease called listeriosis) can result in fever, muscle aches, nausea, vomiting and diarrhea and potentially death.

Salmonella – Naturally is found in the intestines of animals or infected humans and, while often associated with eggs and other meat based outbreaks, contamination on produce can also occur. Infection with Salmonella can result in diarrhea, fever, abdominal cramps, and bloody stool.

Produce Safety Rule Compliance Dates

For those farms not exempt from the Produce Safety Rule, there are different regulatory compliance dates depending on the provision and the size of the farm’s business.

Business Size Compliance Dates for Sprouts Compliance Dates for Most Produce Water Related Compliance Dates1 Compliance Date for Qualified Exemption Labeling Requirement Compliance Date for Retention of Records Supporting Qualified Exemption
All other businesses (>$500K) 1/26/17 1/26/18 1/26/23 1/1/2020 1/26/16
Small businesses
(>$250K–500K)		 1/26/18 1/28/19 1/26/24
Very small businesses
(>$25K–250K)		 1/28/19 1/27/20 1/26/25

1 According to the Proposed Rule issued on 9/13/17, Compliance dates for Subpart E, Agricultural Water, allow an additional four years. The final water rule has been released and compliance with growing/production water requirements is expected for large farms in April of 2025, with smaller and very small farms to follow. Compliance with harvest and post-harvest water requirements is expected to follow the dates as displayed above.

Compliance dates for covered activities, except for those involving sprouts are:

  • Exempt from the regulation—Less than $25,000 in annual average produce sales for the preceding three years, adjusted for inflation* (Average 3 Year Value for 2021-2023: $31,9252).
  • Very small businesses—Greater than $25,000 but less than $250,000 in annual average produce sales in the preceding three years; “Very Small” farm, produce regulation compliance start date January 27, 2020.
  • Small businesses—Greater than $250,000 but less than $500,000 in annual average produce sales in the preceding three years; “Small farm”, produce regulation compliance start date January 28, 2019.
  • Large businesses—Greater than $500,000 in annual average produce sales in the preceding three years; “All Others”, produce regulation compliance start date January 26, 2018.
  • Qualified Exemption— Average annual monetary value of all food sold during the preceding 3-years was less than $500,000, adjusted for inflation* (Average 3 Year Value for 2021-2023: $638,491), and sales to qualified end-users during such period exceeded the average annual monetary value of the food sold by such farm to all other buyers.

* Click here to see inflation adjusted values.