Blog: Blog

Back To News

The Produce Safety Rule and FSMA

Wednesday, May 10, 2017 | Food and Beverage

The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. It is the most sweeping reform of the United States’ food safety laws in over 70 years. The overall objective of FSMA is to focus on the prevention of food safety issues.

Fred Doan, Account Executive

There are seven primary rules included within FSMA:

  1. Produce Safety Rule
  2. Preventive Controls for Human Food
  3. Preventive Controls for Animal Food
  4. Foreign Supplier Verification Programs
  5. Accreditation of Third-Party Auditors/Certification Bodies
  6. Sanitary Transportation of Human and Animal Food
  7. Prevention of Intentional Contamination/Adulteration

The Produce Safety Rule includes Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.  Produce safety affects every fruit and vegetable grower. Some growers may be subject to the new FSMA Produce Safety Rule, while others receive food safety pressure from buyers. Even if there is no regulatory or market pressure, produce safety is critical to every grower because they produce food that consumers will eat.

It is essential to know that growers are the key to produce safety on the farm, and deciding to do something on the farm is up to them.

Regardless of size, location, or commodities grown, all farms can reduce food safety risks.  Growers know their farm best—their production practices, who works on the farm, and the other details that go into running a successful business.  Those who make significant decisions for the farm and know the day-to-day farm activities need to be involved in assessing food safety risks and developing the farm’s food safety plan.

Actions to reduce food safety risks impact the financial viability of farms and the health and safety of those who consume the produce grown.  The FSMA Produce Safety Rule is the first mandatory federal standard for producing fruits and vegetables in the United States. Before FSMA, growers, packers, and the produce industry were encouraged to follow voluntary guidance such as FDAs 1998 “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables”.

Resource documents are available to help growers and packers determine whether they will be covered or exempt from these regulations. These documents are available on the Produce Safety Alliance website and the FDA’s website.

Produce not covered by the FSMA Produce Safety Rule ((§ 112.2(a)) includes:

  • 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; ginger; hazelnuts; horseradish; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts.
  • Produce that is used for personal or on-farm consumption
  • Produce that is not a raw agricultural commodity (A raw agricultural commodity is any food in its raw or natural state)
  • The definition of produce (§ 112.3) does not include food grains, including barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds (e.g., cottonseed, flaxseed, rapeseed, soybean and sunflower seed).

The rule provides eligibility for an exemption for produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance under certain conditions and with specific documentation requirements (§112.2(b)).

  • Documentation requirements include disclosure statements accompanying produce for further processing and annual written assurances from customers (§§ 112.2(b)(2) and (b)(3)).
  • Farms with an average annual value of produce sold during the previous three-year period of $25,000 (adjusted for inflation) or less would not be covered by the regulation (§ 112.4).
  • Farms may be eligible for a qualified exemption and associated modified requirements (§ 112.5, § 112.6). To be eligible for a qualified exemption, the farm must meet two requirements:
  • The farm must have food sales averaging less than $500,000 per year adjusted for inflation during the previous three years; AND
  • The farm’s direct sales to qualified end-users must exceed sales to all buyers 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 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 specific modified requirements, including prominently and conspicuously displaying 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 specific documentation.
  • While some growers may be exempt or not covered by the Produce Safety Rule, all growers should be prepared to implement food safety practices because they grow food people eat. Growers may also sell to buyers that require implementing food safety practices, including those required in the regulation.


  1. Is my grower/packer operation covered or exempt from coverage by the Produce Safety Rule?
    1. Use This document to help you decide: http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM472499.pdf
  2. What is the guidance for the classification of activities such as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities
    1. file:///C:/Users/Craig%20Doan/Desktop/Produce%20Safety%20Alliance/Draft%20Guidance.pdf
  3. What training is available?
    1. Impact Washington is conducting Produce Safety Alliance -Grower Training courses in Washington state. This class fulfills the FSMA Produce Safety Rule requirement for Produce Growers. The class will be led by a trainer that has attended the PSA lead trainer training and holds the Produce Safety Alliance Lead Trainer Certificate.
    2. Produce Safety Alliance Grower Training Course: Fruit and vegetable growers and others interested in learning about produce safety, the Food Safety Modernization Act (FSMA) Produce Safety Rule, Good Agricultural Practices (GAPs), and co-management of natural resources and food safety. The PSA Grower Training Course is one way to satisfy the FSMA Produce Safety Rule requirement outlined in           §112.22(c) that requires ‘At least one supervisor or responsible party for your farm must have successfully completed food safety training at least equivalent to that received under standardized curriculum recognized as adequate by the Food and Drug Administration.”

Bihn, E, Wall, G, Humiston, M, Pahl, D, Stoeckel, D, Way, R, and Woods, K. 2016. Produce Safety Alliance National Curriculum. Version 1.0 Produce Safety Alliance, Cornell University.


Congratulations are in order as Craig Doan was recently designated as a PSA Lead Trainer based on his extensive education, experiences, and responses to the competency area questions.

As a PSA Lead Trainer, Craig can:

  • Deliver any of the seven curriculum modules during a PSA Grower Training
  • Register for PSA Grower Training Courses with AFDO. The course request form and more information on scheduling courses can be found on the AFDO website
  • Host a training on your own or lead a training team with other PSA Trainers who have attended the PSA Train-the-Trainer Course.

As a PSA Lead Trainer, his name has been added to the AFDO/PSA database and to a listserv that will be used to share information, including new educational materials, as they are added to the PSA website.  In addition, the PSA hosts webinars with produce safety educators to discuss topics relevant to the group. More information about the PSA Educator’s Group, including how to join, can be found on the website.

Talk with an expert