What is the Produce Safety Rule?
The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, 2011 enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. The law also gives FDA important new tools to hold imported foods to the same standards as domestic foods and directs FDA to build an integrated national food safety system in partnership with state and local authorities.
FDA has finalized seven major rules to implement FSMA, recognizing that ensuring the safety of the food supply is a shared responsibility among many different points in the global supply chain for both human and animal food. The FSMA rules are designed to make clear specific actions that must be taken at each of these points to prevent contamination.
The Produce Safety Rule (PSR) is one of these seven rules to implement FSMA. The PSR establishes, for the first time, science based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables for human consumption. The standards apply to fruits and vegetables normally consumed raw, such as apples, carrots, lettuce, onions, and tomatoes. The PSR does not apply to produce rarely consumed raw (such as winter squash) or produce grown for personal consumption.
The Produce Safety Rule establishes standards for:
- Agricultural Water: Farmers will have to ensure that water that is intended or likely to contact produce or food-contact surfaces is safe and of adequate sanitary quality, with inspection and periodic testing requirements.
- Biological Soil Amendments of Animal Origin: The rule specifies types of treatment, methods of application, and time intervals between application of certain soil amendments — including manure and composted manure — and crop harvest.
- Health and Hygiene: Farm personnel have to follow hygienic practices, including hand washing, not working when sick, and maintaining personal cleanliness.
- Domesticated and Wild Animals: With respect to domesticated animals, the rule requires certain measures, such as waiting periods between grazing and crop harvest, if there is a reasonable probability of contamination. With respect to wild animals, farmers must monitor for wildlife intrusion and not harvest produce visibly contaminated with animal feces.
- Equipment, tools, and buildings: The rule sets requirements for equipment and tools that come into contact with produce, as well as for buildings and other facilities.
- Training: The rule requires training for supervisors and farm personnel who handle produce covered by the rule.
- Sprouts: The rule establishes separate standards for sprout production, including treatment of seed before sprouting and testing of spent irrigation water for pathogens.
Accompanying these standards are certain record keeping requirements that document adherence to the standards, including for training, agricultural water, biological soil amendments of animal origin, and sprouts.
How is Massachusetts Conducting Inspections?
Inspections in Massachusetts will use an "educate before and while we regulate" approach incorporating rule and practice clarification during the inspection process. The focus of any initial visits to the farm will be educational in nature and are designed that a clear understanding of the requirements of the rule is shared between program staff and the farm.
Inspections are assigned on compliance dates for farms covered by the rule starting in June 2019. Initial inspections are for farms that are classified as Large Produce Farms who have an average annual value of produce sold of $500,000 during the previous three years. Farms falling into different categories will receive inspections in consequent years.
Requests for audits will also be supported commencing in June 2019 for all fruit and vegetable farms in Massachusetts, independent of coverage levels, when a request is received.
You can determine your compliance level by using the University of Massachusetts FSMA Compliance Tool below.
How Can I Prepare for a Produce Safety Inspection?
Inspectional visits will be scheduled several days in advance and will take place during the farm's normal working hours of operation. Follow up visits, if required, will follow a similar process. Initial inspectional cycles may require more than one visit to your farm to allow inspectors the ability to be present when different commodities are being grown, harvested, and stored, and will provide a more robust evaluation of compliance under the rule.
During the call to schedule your inspection, your regional inspector will verify farm information and go over what forms and information you may need to have available. They will answer any questions or concerns you may have regarding the process.
Growers are encouraged to prepare for an inspection by completing the following required and recommended steps:
- Attend a Produce Safety Alliance (PSA) Training or equivalent (required)
- Complete your Farm Registration
- Familiarize yourself with the Produce Safety Rule
- Request an on-farm walk-through through the Commonwealth Quality Program (CQP)
Who is the Produce Safety Team?
The Produce Safety Team is divided by regions. Please feel free to contact the staff member assigned to your region with any questions you may have or to schedule a farm service request.
Mobile: (508) 985-8751
South East Region
Mobile: (857) 274-2561
Mobile: (857) 507-6347
Mobile: (857) 274-2531
North East Region
Mobile: (857) 292-1872
Lakeville, MA 02347