University of Maryland Extension

Produce Safety Rule (PSR)

 

If you grow, pack, process, or sell fresh produce, this regulation may apply to you. The Produce Safety Rule, outlined in Section 105 of FSMA, establishes science-based minimum standards for safe production and harvesting of fresh fruits and vegetables. These standards are based on a foundation of Good Agricultural Practices (GAPs).

What does the Produce Safety Rule cover?

Figuring out what produce is covered by Produce Safety Rule is more easily done by first understanding what is not covered. The rules do not apply to:

-         Produce that is used for personal or on-farm consumption, 

-         Produce that is not a raw agricultural commodity (RAC) (A raw agricultural commodity is any food in its raw or natural state).

-         Produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance (e.g. via a “kill step”) as long as certain disclosures are made and written assurances are received, with appropriate documentation.

-         Produce that is rarely consumed raw. The “rarely consumed raw” list at 21 CFR 112.2(a)(1) is exhaustive.

Any fruits and vegetables - including  mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts, and herbs - that are not explicitly excluded are thereby covered by FSMA. Keep in mind that a crop is still subject to all applicable requirements of the FDCA even if it is exempt from the Produce Safety Rule.

The rule is divided into several parts, including standards for:

  • Food safety training: Section 112.22(c) requires that at least one supervisor from the farm complete food safety training at least equivalent to the standardized curriculum recognized by the FDA. For a list of compliant upcoming PSR Food Safety Trainings, go to the Events page.
  • Worker health, hygiene, and trainingWorker training requirements have two parts: 
    • Health and hygiene training that includes basic food safety principles regarding hand-washing and preventing food contamination. Farmers must exclude any person from working in any operations that may result in contamination of covered produce or food contact surfaces with microorganisms when the person is shown to have, or appears to have, an applicable health condition, until the person’s health condition no longer presents a risk to public health. Farmers are also responsible for ensuring personnel know when and how they must wash hands while working. 
    • Job-specific food safety training -  All personnel (including temporary, part time, seasonal, and contracted personnel) who handle covered produce or food contact surfaces, or who are engaged in the supervision thereof, must receive adequate training, as appropriate to the person’s duties, upon hiring, and periodically thereafter, at least once annually. For example, employees who harvest must be trained how to recognize contaminated produce and how to use harvesting containers and equipment. No certificate is needed, but the farmer must keep records of training dates, topics, and attendees.
  • Agricultural water, for production and post-harvest uses: Agricultural water, as defined in the Produce Safety Rule, is water used in covered activities on covered produce where water is intended to, or is likely to, contact covered produce or food contact surfaces. The general requirement is that all agricultural water must be safe and of adequate sanitary quality for its intended use. There are separate standards for production water (water used during growing activities for covered produce, other than sprouts) and postharvest water ( water used during and after harvest, including during packing or holding activities) to manage the risks of microbial contamination in each stage. Check out the Agricultural Water page for more information on standards and how PSR and GAP standards differ.
  • Biological soil amendments of animal origin (BSAAO): The definition of BSAAO, in 21 CFR 112.3, means any soil amendment which consists, in whole or in part, of materials of animal origin, such as manure or non-fecal animal byproducts. The PSR contains requirements related to the safe use of biological soil amendments of animal origin, including raw manure. The Produce Safety Alliance has a fact sheet on what producers who buy compost or soil amendments from third-party suppliers along with a model Certification of Conformance Form. The Maryland Department of the Environment maintains a list of commercial composters that are inspected and permitted by MDE and which the Department of Agriculture will accept as a verified supplier.
  • Domesticated and wild animals: Farmers must take reasonable precautions to prevent contamination of covered produce, food contact surfaces, and food-packing materials and assess fields used to grow covered produce for evidence of contamination by grazing, domestic, or wild animals. 
  • Equipment, tools, buildings, and sanitation: Subpart L of Part 112 contains requirements for covered farms regarding adequacy of equipment, cleaning and sanitizing of equipment, and storage and maintenance of equipment (see especially 21 CFR 112.123). 
  • Production of sprouts: Because sprouts have frequently been associated with outbreaks of foodborne illness, the PSR includes specific requirements in Subpart M for most sprouts, which are in addition to the other applicable provisions of the PSR. For specific rules and standards, visit the Sprouts Safety Alliance website.


Recordkeeping

Recordkeeping is a large part of complying with the PSR. Records facilitate verification that growers are complying with standards. They also help identify patterns or problems, which are important for growers to recognize and then take steps to minimize the likelihood of food contamination. 

The general recordkeeping standards require records to include:

  • Name and location of the farm;

  • Actual values and observations collected during monitoring activities;

  • An adequate description of the produce applicable to the record (e.g., commodity name, specific variety, or other identifier, such as a lot number);

  • Location of the growing area or other area applicable to the record; and

  • Date and time that an activity was performed or observed.

The records must be taken at the time an activity is performed or observed, must be accurate and legible, and must be dated and signed by the person doing the activity. To ease recordkeeping, check out these Produce Safety Alliance record keeping templates

The Agriculture Law Education Initiative has a video detailing how to keep FSMA compliant records: Produce Safety Rule, FSMA, and Recordkeeping (37:53) by  Sarah Everhart. January 2018.

On-Farm Readiness Reviews

The Maryland Department of Agriculture offers free On-Farm Readiness Reviews (OFRR) to help farmers better understand and meet the requirements of the federal Food Safety Modernization Act Produce Safety Rule. To request a free OFRR, fill out MDA’s request form online.

Useful Resources

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