If you are involved in the production of fresh produce, you have likely heard about FDA’s Food Safety Modernization Act (FSMA). President Obama signed FSMA into law in 2011, granting FDA the authority over preventive and risk-based standards for growing, harvesting, packing, processing, and distributing domestic and imported food for humans and animals. The Produce Safety Rule (PSR) is one of seven foundational rules enacted by FSMA and the one most directly affecting produce growers. PSR’s primary focus is preventing biological safety hazards (i.e, microorganisms that cause human illness) in the growing, harvesting and post-harvest handling of fresh fruits and vegetables.
Much of the language and terminology presented here is taken directly from the FSMA-PSR as published in the Federal Register. The complete rule and guidance documents can be found on the FDA FSMA Website: http://www.fda.gov/Food/GuidanceRegulation/FSMA/.
Must You Comply with FSMA-PSR?
The first question any producer must answer is whether they meet the regulation’s definition of a “farm”. The two lengthy definitions of a “farm” provided in the PSR are intended to distinguish owner-operated production sites and off-site packing locations from commercial facilities. 1.) A Primary Production Farm (PPF) is a farm operating under one management in one general physical location (does not have to be contiguous) devoted to the growing of crops, the harvesting of crops, the raising of animals, or any combination of these activities. 2.) A Secondary Activities Farm (SAF) is an operation not located on the PPF that is devoted to harvesting, packing, and or holding raw agricultural commodities (i.e, produce in its raw or natural state), provided that the PPF that grows, harvests, or raises the majority of raw agricultural commodities harvested, packed, or held by the SAF owns, or jointly owns a majority interest in the SAF. If you do not meet the FDA’s definition of a PPF or SAF, then you are not covered by the FSMA-PSR; however, you might be subject to one of the other six foundational rules, such as the FSMA-Preventive Controls Rule.
While all growers should be aware of the food safety risks on their farm, some may be excluded from the rule or eligible for an exemption. FDA has provided a flow diagram for determining whether produce from your farm is excluded from the rule, qualifies for an exemption, or is subject to the rule (below, http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM472499.pdf).
Exclusions. The following are not subject to the PSR, including:
- Farms with ≤$25,000 in produce sales (on average for the last three years)
- 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; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts
- Food grains, including barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds (e.g. cotton seed, flax seed, rapeseed, soybean, and sunflower seed)
- Produce grown for personal or on-farm consumption
- Produce that is not a raw agricultural commodity
Exemptions. If you are not excluded from the rule according to the above criteria, you may be eligible for a qualified exemption under the following circumstances, provided appropriate documentation and other conditions are met:
- The produce undergoes commercial processing to reduce the presence of microorganisms of public health significance (i.e., there is a “kill step”).
- If your farm has food sales (not just produce sales) averaging less than $500,000** per year during the previous hree years; and the farm’s sales to qualified end-users exceed sales to all others combined during the previous three years (i.e., more than 50%). A qualified end-user is either (a) the consumer of the food or (b) a restaurant or retail food establishment that is located in the same state, the same Indian reservation as the farm, or not more than 275 miles away.
***Proving eligibility for the qualified exemption requires three years of sales records to support the exemption. Business size determines compliance date as well as when you need to begin collecting sales records (Table 1).
***Farms receiving a qualified exemption must also prominently display their farm name and address on produce labels or at the point of purchase.
Contamination of fresh produce from human pathogens generally occurs via these primary sources: humans, animals, water, soil, and/or the surfaces of equipment, tools and buildings. The FSMA-PSR addresses each of these sources and establishes science-based minimum standards for the industry to follow in the growing, harvesting, packing and holding of covered produce. Compliance dates for standards vary according to business size and for different parts of the rule (see Table 1 below). For example, standards specific to the sprout industry must be implemented earlier than other types of covered produce. Growers also have two additional years to comply with water regulations beyond their compliance date.
Table 1. FSMA-PSR compliance dates by business size.
In addition, the FSMA-PSR requires at least one supervisor or responsible party from each farm subject to the rule to complete food safety training from a FDA-approved standardized curriculum before their compliance date. Currently, the Produce Safety Alliance (PSA)(producesafetyalliance.cornell.edu) offers the only FDA-approved grower training course to satisfy this requirement. The PSA course educates growers on preventing biological safety hazards from contaminating produce on the farm by assessing produce safety risks, implementing produce safety practices (i.e., Good Agricultural Practices (GAPs)), monitoring practices, using corrective actions, and maintaining records. Growers interested in attending a PSA grower training workshop can find registered classes at the following link: https://producesafetyalliance.cornell.edu/training/grower-training-courses. Additional classes will be offered as more trainers become certified to teach the workshops.