Who is Affected?


Food safety affects all of us. Everyone – from the farmer to the processor to the consumer – has a role in ensuring safe food. As required by the Food Safety Modernization Act (FSMA), FDA has issued a proposed – draft – set of rules that authorize new regulations at the farm level for:

  • Standards for produce production (Produce Rule), and
  • Food safety measures for facilities that process food for human consumption (Preventive Controls Rule).

If you operate a business that grows and sells fresh produce – and/or processes, packs, manufactures, or holds food – you should read the following information, as your business may be affected by these proposed rules. Some businesses may not be affected at all, some may be affected by one rule, and some may be affected by both rules.

IMPORTANT: these proposed rules are not yet final, which means they are not yet law. To learn about the FSMA timeline, read NSAC’s FSMA Overview and Background.

The information included below is intended to help individuals gain a better understanding of whether or not their business operation may be impacted by the proposed rules. Farmers and business owners nationwide are reporting tremendous confusion in determining if they might be impacted by these rules. If you are uncertain, you are not alone! One major concern about these draft rules is that they are complex and confusing for producers.

For Producers and Processors, Start Here:

  • Do you grow, harvest, pack, or hold (store) fruits or vegetables? If yes, you may be affected by the Produce Rule.

  • Do you process, manufacture, pack, or hold (store) human food? If yes, you may be affected by the Preventive Controls Rule.

  • Do you BOTH grow, harvest, pack, or hold (store) fruits or vegetables AND process, manufacture, pack, or hold (store) human food? If yes, you may be affected by BOTH the Produce Rule and the Preventive Controls Rule.

  • Are you a food hub, CSA farm, on-farm processor, or direct marketer? We also have special guidance available for these operations.

For Consumers

If you’re a consumer, these rules could, over the long term, impact the kind of food you are able to find and purchase in your community.  The proposed rules may also increase the costs of purchasing fresh fruits and vegetables. Ultimately, we want to ensure a safe and affordable food supply, strong on-farm conservation of natural resources, and thriving family farms and small value-added farm and food businesses. That translates into fresh, healthy food for communities across the country, from the farmers’ market to the grocery store to the school cafeteria! As a concerned consumer, you absolutely have a say in these proposed rules and should speak out! We will share guidance for consumers on making comments later this spring – sign up to your left for updates.

Please note: these rules DO NOT affect home gardeners who grow food for personal consumption.


FSMA baby tomato

Produce Rule – Are You Affected?

If you grow, harvest, pack, or hold produce, you may be subject to part or all of the Produce Rule when it becomes final. The current distinctions are based off of the proposed rule and may change in the final rule. Farms are likely to fall in one of three categories:  1) exempt from the Produce Rule, 2) subject to modified requirements under the Produce Rule, or 3) subject to full requirements of the Produce Rule.

Exemptions from the Produce Rule

Produce that is NOT covered by the Produce Rule includes:

  • Produce grown for personal or on-farm consumption
  • Produce that is rarely consumed raw (e.g, potatoes, turnips, winter squash)
  • Produce that is not in its raw or natural state (i.e., produce that receives additional processing and that would be subject to the Preventive Controls rule)

You are NOT covered by the Produce Rule if the average annual monetary value of the food you sold during the previous 3-year period is no more than $25,000.

Modified Requirements

A number of operations will be subject to modified requirements through the Produce Rule. There are two mains ways by which a produce operation is subject to modified requirements.

  1. If the produce will undergo additional commercial processing that kills harmful microorganisms, then the produce is not covered but you are subject to the recordkeeping requirements and the compliance and enforcement requirements of the Produce Rule.
  2. If your farm on average over the previous 3 years has less than $500,000 in gross annual sales AND the majority of the food is sold directly to a “qualified end-user,”* then you must:
    • Provide the name and complete address of the farm where the produce was grown on either a food packaging label or on a sign at the point of purchase;
    • Comply with the compliance and enforcement requirements of the Produce Rule; and
    • Be subject to the provisions regarding the withdrawal of your status as a partially covered (“qualified exempt”) operation.

*A “qualified end-user” is a consumer, or a restaurant or retail food establishment that is located in the same state as the farm that produced the food, or not more than 275 miles from that farm.

Completely Subject to the Produce Rule

You are completely subject to the requirements of the Produce Rule if you grow, harvest, pack, or hold produce that is usually consumed raw and you do not fall under the categories for exemptions or modified requirements.


FSMA orange packing line banner

Preventive Controls Rule – Are You Affected?

At the heart of trying to understand whether farms will be subject to the Preventive Controls rule is the definition of a “facility.” At this point there is still a lot of confusion about the activities conducted by a farm that might trigger the FDA’s definition of a facility. This is a large gray area in the proposed rules.

Do You Operate a Facility?

You operate a facility if you manufacture, process, pack, or hold food for consumption in the U.S. Many activities fall under the definitions of manufacturing and processing, and the key distinction for FDA seems to be whether you are transforming a product in any way. Manufacturing and processing activities always include:

  • Irradiation
  • Cutting/coring/chopping/slicing
  • Canning
  • Coating with things other than wax/oil/resin
  • Drying that creates a distinct commodity
  • Artificial ripening
  • Cooking
  • Pasteurizing/homogenizing
  • Infusing
  • Distilling
  • Salting
  • Smoking
  • Grinding/milling
  • Freezing
  • Slaughtering animals or post-slaughter operations

For other manufacturing or processing activities, FDA then makes the distinction based off of whether you are conducting the activities on your own agricultural products (“raw agricultural commodities”) or someone else’s agricultural products. This same principle also applies to the definitions of “packing” and “holding.”

For FDA’s discussion of off-farm and on-farm distinctions and how they apply to certain definitions, click here and look at Table 4. Table 4 also discusses the activities that are considered “harvesting,” which would classify the farm as a farm and not a facility.

Read our issue page on “Do I Operate a Facility?” for detailed guidance on what activities do and don’t trigger the “facility” definition for farmers.

Information about Coverage for Facilities

The Preventive Controls rule has two main parts:

  1. New requirements for hazard analysis and risk-based preventive controls; and
  2. Revisions to existing Current Good Manufacturing Practice (GMP) requirements.

Coverage under these two parts must be considered separately because certain facilities are subject to one and not the other.

Are You Covered by the New Requirements for Hazard Analysis and Risk-Based Preventive Controls (HARPC)?

EXEMPT from the New HARPC Requirements:

  • Facilities that manufacture products covered by separate regulations:
    • Juice
    • Seafood
    • Dietary supplements
    • Alcoholic beverages
    • Low-acid canned foods (only with respect to microbiological hazards)
  • Facilities such as grain elevators and warehouses that are solely engaged in storing agricultural commodities (other than fruits and vegetables) intended for further processing
  • Facilities, such as warehouses, that only store packaged foods that are not exposed to the environment and for which refrigeration is not required for safety
  • Facilities that are small or very small on-farm businesses that conduct certain low-risk manufacturing and processing, packing, or holding activities (e.g., making jams and jellies and manufacturing honey and maple syrup; for a list of those proposed low-risk activities, click here)
  • Farms are not covered by the new requirements unless they trigger the “facility” definition (see above)

Facilities Subject to Modified HARPC Requirements

Two main types of facilities are subject to modified HARPC requirements:

  1. A very small business (FDA has not yet settled on a definition for “very small business”; FDA is proposing either less than $250,000, less than $500,000, or less than $1 million in total annual sales of food) must maintain certain records and certify that:
    1. It qualifies for modified requirements, AND
    2. It is implementing and monitoring preventive controls OR complying with applicable non-Federal food safety law and must display a label or sign with the complete business address of the facility at the point of sale.
  2. If the facility on average over the previous 3 years has less than $500,000 in gross annual sales AND the majority of the food is sold directly to a “qualified end-user,”* then the facility must maintain certain records and must certify that:
    1. It qualifies for modified requirements, AND
    2. It is implementing and monitoring preventive controls OR complying with applicable non-Federal food safety law and must display a label or sign with the complete business address of the facility at the point of sale.

*A “qualified end-user” is a consumer, or a restaurant or retail food establishment that is located in the same state as the farm that produced the food, or not more than 275 miles from that farm.

Facilities Subject to the Complete HARPC Requirements

Unless a facility qualifies for the exemptions or modified requirements above, then it is subject to the complete HARPC requirements. To learn more about the HARPC requirements, go to our proposed Preventive Controls Rule page.

Must You Comply with Current Good Manufacturing Practices?

If you operate a facility, you almost certainly must already comply with current Good Manufacturing Practices (GMPs). The only facilities that FDA exempts from current GMPs are facilities such as warehouses and grain elevators that store raw agricultural commodities (including fruits and vegetables) intended for further distribution or processing.

Hang in there!

There is still a lot of confusion about what activities trigger the definition of a facility and the requirements for different facilities. Learn more about the issues and make a comment today!