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What is FSMA?

The FDA Food Safety Modernization Act (FSMA), which was signed into law on January 4, 2011, is the most comprehensive reform of the nation's food safety laws since 1938. Its goal is to better protect public health by shifting US food supply safety efforts from a response to a prevention approach. FSMA is comprised of seven rules that span the entire food supply chain. Of these rules, the one most likely to impact produce growers is the Produce Safety Rule.

This site is intended to answer some of your initial questions about this rule and connect you with helpful resources.

Produce Safety Rule

The Produce Safety Rule establishes a minimum set of food safety standards for farms to follow in order to reduce the risk of microbial contamination during the growing, harvesting, packing, and holding of fresh fruits and vegetables for human consumption.

The Produce Safety Rule is divided into seven parts:

• Training: Establishes training requirements for farm supervisors and personnel who handle produce.

• Health and Hygiene: Growers, and their employees, must abide by certain hygienic practices, such as regular hand washing, to reduce the spread of contamination.

• Agricultural Water: Under the rule, growers must take steps, such as routine water testing, to ensure agricultural water is safe for its intended use.

• Biological Soil Amendments of Animal Origin: The rule addresses the classification, treatment, and application of certain soil amendments, such as raw and composted manure.

• Domesticated and Wild Animals: Requirements include taking measures to reduce risks associated with animals in and around produce fields.
  

• Equipment, tools, and buildings: The rule sets standards for the maintenance of equipment, tools, and other food contact surfaces that come into contact with produce.

• Sprouts: The rule establishes a separate set of standards for sprout producers. For more information, visit the Sprout Safety Alliance website.
  

In addition to these standards, there are requirements to maintain records of certain activities to verify compliance with the rule. More information on record keeping requirements and a set of printable templates can be found here. 

What is DATCP's role?

The Wisconsin Department of Agriculture, Trade and Consumer Protection (DATCP), through a cooperative agreement with the FDA, is responsible for enforcing the Produce Safety Rule in Wisconsin. Before inspections begin, DATCP must work with growers to adopt the rule in a way that makes sense for all growers while ensuring our produce remains safe and wholesome.

Safe Wisconsin Produce is DATCP's program responsible to do just that. We have been working to identify and address the needs of produce growers in Wisconsin who are covered by the Produce Safety Rule. Over the next few years, Safe Wisconsin Produce and its partner organizations, like UW Extension and the Wisconsin Farmers Union, will be working together to make sure growers have access to the resources and training necessary to comply with necessary requirements.           

DATCP will begin on-farm inspections according to the compliance dates outlined below, but prior to inspections, representatives from the Safe Wisconsin Produce team and our partner organizations will be providing On-Farm Readiness Reviews. These voluntary, mock inspections will help growers identify what steps they may need to take to comply with the Produce Safety rule before a regulatory inspection. If you are interested in participating in an On-Farm Readiness Review, or would like more information, please complete our Grower Questionnaire.

Is my farm covered?

Under the Produce Safety Rule, farms will fall into one of three categories:

1) Farms that are exempt from the rule

These farms include those that meet any of the following criteria:

• Have averaged less than $26,632 in gross annual produce sales over the past 3 years

• Only grow produce intended for commercial processing
  

• Only grow produce that is considered to be rarely consumed raw
  

• Only grow produce that will be consumed on the farm (i.e. by family, livestock, etc.)

2) Farms that are eligible for a qualified exemption

These farms are exempt from many of the Produce Safety Rule's requirements, but must still meet two important requirements:

1. Farms must keep records (from the previous three years) to verify their eligibility for a qualified exemption.
   

2. Beginning January 2020, qualified exempt farms must prominently display the name and address of the farm at the point of purchase (with a sign, invoice, etc.) or on a food packaging label.

In order to be eligible for a qualified exemption, farms must meet the following criteria:

1. The farm's gross annual food sales, on average over the past 3 years, are less than $532,645 annually.

2. The majority (greater than 50% by dollar value) of the farm's food sales are to a qualified end-user.
   
   

*A qualified exemption may be withdrawn if necessary in order to protect the public health and prevent or mitigate a foodborne illness outbreak.

3) Farms that are covered by the rule

If a farm does not qualify for any of the exemptions listed above, then it is considered a covered farm, and must comply with the full requirements of the Produce Safety Rule.

If you are uncertain how your farm will be classified under this rule, you can use this self-guided "Am I Covered?" determination tool. This short survey will take less than five minutes, and can help determine if your farm is covered and when compliance begins. If you prefer an offline tool, use the flowchart on the "Is my farm covered by the new federal produce safety rules?" brochure.

Compliance dates

The Produce Safety Rule came into effect on January 26, 2016, and compliance dates for some parts of the rule—such as those related to sprout production—have already taken effect. For all other covered farms, there is a staggered schedule of compliance dates. Generally speaking, the smaller your farm, the more time you will have to meet the requirements of the rule.

Specific compliance dates for covered activities, except those related to sprouts and agricultural water*, are outlined in the table below.

*All farms will have at least two years beyond their respective compliance dates to comply with all requirements pertaining to agricultural water.

What should produce growers do to prepare?

If you are likely to be covered by the rule, we encourage you to begin preparing for compliance by reviewing this website to access available resources and browse upcoming training opportunities.

Farms should also complete the Safe Wisconsin Produce Grower Questionnaire (link below) to receive updates about the implementation of the rule and request information about participating in an On-Farm Readiness Review.

Safe Wisconsin Produce Grower Questionnaire

Produce Safety Alliance Grower Trainings

The Produce Safety Rule requires at least one supervisor or responsible party from every covered farm to receive training under an FDA recognized curriculum. The Produce Safety Alliance Grower Training is the only standardized national training program currently approved by FDA to satisfy this requirement.

Trained and certified staff from the Safe Wisconsin Produce program and its partner organizations are providing Grower Training courses across the state, starting Winter 2018. This one-day course will cover the key areas and requirements of the Produce Safety Rule. More information on the Produce Safety Alliance and Grower Training courses being held outside of Wisconsin can be found here. 

Upcoming trainings in Wisconsin:

Trainings will resume after the 2018 growing season (this will likely be early November).

Previous Trainings

Trainings will be held from 7:30 a.m.-5 p.m. The registration fee is $60 and lunch is included. Please register by mail using this printable form.

• April 3, 2018 - Neville Museum, Green Bay
  
• April 12, 2018 - West Madison Agricultural Research Station, Verona
  
• April 17, 2018 - Clarion Hotel Northwoods Ballroom, Eau Claire
  

FSMA news