Who is Affected?

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 the proposed FSMA rules. Some businesses may not be affected at all, some may be affected by one rule, and some may be affected by both rules.

To learn about the FSMA, 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 confusion in determining if they might be impacted by these rules. If you are uncertain, you are not alone! These rules 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.

Download our “Am I Affected?” flowchart to help determine if your business may be subject to the proposed Produce or Preventive Controls Rules!

Scroll down for detailed text to help you determine whether you may be affected by the Produce Rule or Preventive Controls Rule.

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!

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

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.

Farms are likely to fall into one of four categories: 1) exempt from the Produce Rule, 2) subject to less extensive modified requirements under the Produce Rule, 3) subject to full requirements of the Produce Rule but with extended time to come into compliance, or 4) subject to full requirements of the Produce Rule without extended compliance time.

Download our “Am I Affected?” flowchart to help determine if your business may be subject to the proposed Produce or Preventive Controls Rules!

1. Exempt from the Produce Rule

You may be fully exempt from the Produce Rule (also referred to as eligible for the ‘de minimis exemption’) if you sell under a certain amount of fresh produce or if you do not grow anything that is covered by the proposed rules:

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)

Review FDA’s list of covered produce to determine if the products you grow are covered or not. Keep in mind that this list may change.

(b) For the purpose of this part and subject to the exemptions and qualified exemptions therein, covered produce includes all of the following:

(1) Fruits and vegetables such as almonds, apples, apricots, aprium, asian pear, avocados, babaco, bamboo shoots, bananas, Belgian endive, blackberries, blueberries, broccoli, cabbage, cantaloupe, carambola, carrots, cauliflower, celery, cherries, citrus (such as clementine, grapefruit, lemons, limes, mandarin, oranges, tangerines, tangors, and uniq fruit), cucumbers, curly endive, garlic, grapes, green beans, guava, herbs (such as basil, chives, cilantro, mint, oregano, and parsley), honeydew, kiwifruit, lettuce, mangos, other melons (such as canary, crenshaw and persian), mushrooms, nectarine, onions, papaya, passion fruit, peaches, pears, peas, peppers (such as bell and hot), pineapple, plums, plumcot, radish, raspberries, red currant, scallions, snow peas, spinach, sprouts (such as alfalfa and mung bean), strawberries, summer squash (such as patty pan, yellow and zucchini), tomatoes, walnuts, watercress, and watermelon; and

(2) Mixes of intact fruits and vegetables (such as fruit baskets).

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

2. Subject to Modified Requirements

If you are not eligible for a full exemption from the rules, you may be eligible for less extensive and less costly modified requirements under the Produce Rule (also referred to as “qualified exempt”). There are two main ways by which a produce operation may be eligible for these modified requirements:

• If the produce you grow will undergo additional commercial processing that kills harmful microorganisms, then the produce is not covered, but you are still subject to the recordkeeping requirements and the compliance and enforcement requirements of the Produce Rule.
• If your farm on average over the previous 3 years has less than $500,000 in gross annual sales (not just produce or covered produce, but ALL food) AND the majority of the food you sell is sold directly to a “qualified end-user,”* then you must:

1. • 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 (That is, FDA reserves the ability to revoke your “qualified exempt” status in certain circumstances).

*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.

3. Completely Subject to the Produce Rule with Extended Compliance Time

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. However, producers who do not fit the modified requirement guidelines above but who do meet other criteria are eligible for additional time to bring their businesses into compliance as follows:

• If you have, on average over the previous 3 years, less than $500,000 in gross annual sales of produce (not covered produce, not all food, but all produce), then you have 3 years before you are required to fully comply with the Produce Rule (and 5 years to comply with the water standard).
• If you have, on average over the previous 3 years, less than $250,000 in gross annual sales of produce (not covered produce, not all food, but all produce), then you have 4 years before you are required to fully comply with the Produce Rule (and 6 years to comply with the water standard).

4. Completely Subject to the Produce Rule without Extended Compliance Time

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.

Preventive Controls Rule – Are You Affected?

Farms and food businesses are likely to fall into one of five categories: 1) exempt from food facility registration, and therefore not covered by the Preventive Controls Rule, 2) have to register as facilities, but exempt from the full requirements of the Preventive Controls Rule, 3) have to register as facilities, but subject to less extensive modified requirements under the Preventive Controls Rule, 4) subject to full requirements of the Preventive Controls Rule, but with extended time to come into compliance, or 5) subject to full requirements of the Produce Rule without extended compliance time.

Download our “Am I Affected?” flowchart to help determine if your business may be subject to the proposed Produce or Preventive Controls Rules!

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.

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
  • Except field coring (e.g. removing the core of lettuce in the field), which is considered harvesting.
• Canning
• Coating with things other than wax/oil/resin
• Drying/dehydrating to create a distinct commodity
  • Except if you dry/dehydrate without doing any additional processing (e.g. drying herbs, or drying grapes to make raisins), then that activity falls is considered a “farm” activity and not a facility activity.
• Artificial ripening
• Cooking
• Pasteurizing/homogenizing
• Infusing
• Distilling
• Salting
• Smoking
• Grinding/milling
• Freezing
• Slaughtering animals or post-slaughter operations

Read our issue page on “Do I Operate a Farm or 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 (HARPC); 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)?

1. Not Covered by the Preventive Controls Rule

If you are a farm or a retail food establishment, then you are exempt from the requirement to register as a food facility, and therefore are not a facility subject to the Preventive Controls rule.

However, as described above and in more detail on our Do I Operate a Farm or a Facility page, some farms may also be considered facilities, and would therefore have to register with FDA and be subject to the Preventive Controls Rule.

Visit our page on direct marketing under the Preventive Controls Rule for more information on the retail food establishment exemption.

2. Facilities 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)

3. Facilities Subject to Modified HARPC Requirements

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

1. A very small business (defined as less than $1 million in total annual sales of human 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
   3. 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
   3. 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.

Very small businesses also have three years to come into compliance with the rule.

4. Facilities Subject to the Complete HARPC Requirements, but With Extended Compliance Time

Unless a facility qualifies for the exemptions or modified requirements above, then it is subject to the complete HARPC requirements. However, small businesses (less than 500 employees) have two years to come into compliance with the full requirements.

5. Facilities Subject to the Complete HARPC Requirements, without Extended Compliance Time

All other facilities subject to the full HARPC requirements have one year to come into compliance with the rule.

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.