Produce Safety Laws and Regulations
The commercial production of uncut fruits and vegetables is regulated by the Food and Drug Administration (FDA) under the Food Safety Modernization Act’s Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human consumption—commonly referred to as the FSMA Produce Safety Rule.
The Food Safety Modernization Act, or FSMA, was passed by Congress in 2011 and significantly amended the Federal Food, Drug, and Cosmetic Act of 1938. This major legislation aimed to shift the focus of FDA’s food safety efforts from responding to foodborne illness outbreaks to preventing them. The law gives FDA authority to require various parties throughout the food chain to take steps to prevent contamination in the food supply.
Of the major regulations under FSMA, the rule that most directly impacts farmers is the Produce Safety Rule, which sets minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. The Rule applies only to raw agricultural commodities and provides some exemptions based on total annual sales in dollars, or for produce that will be processed with a kill-step or is designated as ‘rarely consumed raw’. The general food safety information presented in this Food Safety for Farmers website includes details about how to comply with the Produce Safety Rule.
Click here to visit the FDA website for the FSMA Produce Safety Rule. Includes link to full text, current Guidance, and other information related to the Rule.
Other FSMA rules that may affect farmers are the Preventive Controls for Human Food Rule, which applies to food processing, including when a raw agricultural commodity is cut, peeled, or otherwise changed from its natural state, and the Requirements for Additional Traceability Records for Certain Foods, commonly known as the Traceability Rule, which establishes recordkeeping requirements for certain foods that better allow these products to be tracked throughout the supply chain.
Click here to visit the FDA website on FSMA. The page includes information about all the FSMA rules, including Preventive Controls and Traceability.
State Authority and Regulations
The FDA gave regulatory authority in most US states to state agencies—in Massachusetts, that’s the Massachusetts Department of Agricultural Resources (MDAR). Agency responsibilities include conducting inspections, maintaining an inventory of farms, and providing education and technical assistance on the Produce Safety Rule. Additionally, states may write their own regulations for produce safety. These must be consistent with the federal rule but may also be stricter or contain additional provisions. Massachusetts does have its own codified rules for produce safety—330 CMR 34.00.
FSMA Produce Safety Rule Subparts
The FSMA Produce Safety Rule (PSR) is Part 112 under Title 21 of the Code of Federal Regulations. It is divided into several subparts and identifies the hazard areas listed below. Please visit the following pages for general food safety information on each topic along with relevant FSMA PSR requirements.
- Worker Health, Hygiene, & Training – Subparts C & D
- Agricultural Water – Subpart E
- Soil Amendments – Subpart F
- Wildlife, Domesticated Animals, & Land Use– Subpart I
- Post-Harvest Handling & Sanitation – Subparts K & L
Note that in the FSMA PSR sprouts—recently germinated seeds that are not grown in soil or substrate and are not cut from their roots—are subject to more stringent requirements than other covered produce. Subpart M describes the requirements for sprouts.
The FSMA PSR includes specific definitions that may have different meanings in other contexts. For example, the word “covered”—for the purposes of the Produce Safety Rule…
“Covered farms” are farms that must comply with PSR requirements and do not qualify for an exemption from the Rule.
“Covered activities” are growing, harvesting, packing, or holding covered produce on a farm.
“Covered produce” is produce that is subject to the requirements of the Rule. Generally, it is any raw agricultural commodity that is not produced solely for personal consumption and will not be commercially processed (e.g., with a “kill step”) before sale. The Rule includes an exhaustive list of produce that FDA determined is “rarely consumed raw”; any commodity on this list is NOT covered produce:
Asparagus, beans (black, great Northern, kidney, lima, navy, pinto), garden beets (roots and tops), sugar beets, cashews, chickpeas, cocoa beans, coffee beans, collards, cranberries, dates, dill (seeds and weed), eggplants, figs, ginger, hazelnuts, horseradish, lentils, okra, peanuts, pecans, peppermint, potatoes, pumpkins, sour cherries, sweet corn, sweet potatoes, water chestnuts, and winter squash.
The FDA staggered the rollout of the Produce Safety Rule so that larger farms (by sales dollars) would be subject to inspection first. As of 2023, covered farms of any size are currently eligible for inspection. See the FSMA Compliance Tool below to guide you as to your business’ coverage under the Produce Safety Rule.
FSMA Compliance Tool
Not sure whether you need to comply with the FSMA Produce Safety Rule? Use our compliance tool to better understand which requirements apply to your farm.
Note that this tool does not determine a farm’s final coverage or exemption status. An inspector from the Massachusetts Department of Agricultural Resources (or the appropriate agency in your state) can work with you to make that determination. In general, if you grow, harvest, pack, or hold produce to be sold for human consumption, you should consider your business covered unless and until you can prove your qualification for an exemption and after confirming this status with the regulatory authority.
The FMSA PSR requires that covered farms keep specific records. Templates for required records can be found in the document below. However, in many cases, it is hard to show that your farm is meeting other PSR requirements without keeping records that are not explicitly required by the Rule. Example recordkeeping logs are included in each of the food safety topic pages listed at the top of this page.
Records Required by the FSMA Produce Safety Rule - (Produce Safety Alliance)
Standard Operating Procedures
Developing Standard Operating Procedures (SOPs) can help you and your employees perform covered activities safely and consistently. SOPs are great tools for streamlining protocols on your farm, producing more consistent products, and training new hires. Click here for more information on SOPs.
At least one supervisor or responsible party for a covered farm is required to receive food safety training that is at least equivalent to a standard curriculum recognized by FDA. The Produce Safety Alliance Grower Training is one such standard curriculum. UMass conducts these trainings at least annually and training dates are posted on the UMass Center for Agriculture Upcoming Events page and are announced in the UMass Extension Vegetable Notes newsletter, among other places. To see a full list of all upcoming PSA Grower Trainings , including remote trainings and those conducted in Spanish or held in other states, click here.
Farm Food Safety Plans & Traceability
Although the FSMA Produce Safety Rule does not require covered farms to develop a farm food safety plan, it is encouraged. Development of a plan involves a thoughtful assessment of a farm’s particular risks from the potential hazards identified in the PSR and the tools and protocols it should have in place to mitigate those risks. Food safety plans are common in non-farm food production settings. They help you get organized and implement preventive steps toward food safety.
Traceability refers to the tracking of a product through the supply chain from producer to consumer. Being able to quickly identify a food product in the event of a foodborne illness outbreak or a potential contamination of the food supply is critical for removing the product from the market and preventing illness. The Produce Safety Rule does not address traceability—recordkeeping requirements, including those for some fresh produce covered by the PSR, fall under another FSMA Rule for Food Traceability.
Visit our Farm Food Safety Plans & Traceability page for more information.
If you can't find the information you're looking for on our website, please contact your regional MDAR produce safety expert (contact information can be found here: MDAR Produce Safety Team) or UMass Extension (contact information below).
UMass Extension Educator