NSAC's Blog

What the New FDA Rule Means for Farms: Part 1

December 1, 2020

The image shows crops and a hoop house on a farm. Photo credit: USDA.
The image shows crops and a hoop house on a farm. Photo credit: USDA.

Almost a decade ago, the National Sustainable Agriculture Coalition (NSAC), along with thousands of farmers, asked Congress to make sure the new food safety measures in the Food Safety Modernization Act (FSMA) worked for sustainable and organic farmers. Farmers were particularly concerned with the FSMA provisions around extensive traceability and recordkeeping. Fortunately, Congress listened to NSAC and the farmers who requested a number of exemptions and scale-appropriate requirements be added to this FSMA section.

Recently, the Food and Drug Administration’s (FDA) released the proposed rule for Food Traceability which includes an number of these important FSMA components, including farm-specific exemptions. However, while farmers can celebrate many practical provisions in FDA’s new proposed rule, there are still some areas of concern that small farms and food businesses, in particular, should prepare to take action on once again.

The deadline for farmers and organizations to comment on the proposed Food Traceability rule is January 21, 2020. NSAC will share deeper analysis and takeaways for your proposed comment in future blog posts.

What is the Rule?

The proposed rule establishes additional traceability recordkeeping requirements for businesses who manufacture, process, pack, or hold foods on FDA’s Food Traceability List (FTL), as required by Section 204(d) of FSMA.  The Food Traceability proposed rule is not the first FDA rule to require traceability recordkeeping for some entities, but the new post-FSMA rule expands FDA’s traceability recordkeeping requirements. FDA hopes the new rule will allow them to quickly and effectively determine the cause of a foodborne illness outbreak.

The proposed rule only applies to certain types of food and entities. The foods FDA proposes to regulate under this new rule includes:

  • Cheeses, other than hard cheeses (soft ripened or semi-soft cheeses, and fresh soft cheeses that are made with pasteurized or unpasteurized milk);
  • Chicken shell eggs;
  • Nut butter (all types of tree nut and peanut butters; does not include soy or seed butters);
  • Cucumbers;
  • All fresh herbs;
  • Leafy greens, including fresh-cut leafy greens (includes lettuce, (e.g., iceberg, leaf and Romaine lettuces), kale, chicory, watercress, chard, arugula, spinach, pak choi, sorrel, collards, and endive);
  • All melons (i.e. cantaloupe, honeydew, and watermelon); 
  • All peppers;
  • Sprouts;
  • Tomatoes;
  • All types of tropical tree fruit (i.e. mango, papaya, mamey, guava, lychee, jackfruit, and starfruit);
  • Fruits and vegetables (fresh-cut) (except for any produce that is classified as rarely consumed raw by the Produce Safety Rule);
  • Finfish, including smoked finfish (i.e. cod, haddock, Alaska pollack, tuna, mahi mahi, mackerel, grouper, barracuda, and salmon; except does not include siluriformes fish, such as catfish);
  • Crustaceans (i.e. shrimp, crab, lobster, and crayfish);
  • Mollusks, bivalves (i.e. oysters, clams, and mussels; does not include scallop adductor muscle);
  • Ready-to-eat deli salads (i.e. egg salad, potato salad, pasta salad, and seafood salad; does not include meat salads).

If a business manufactures, processes, packs, or holds any of the above listed food items, they must comply with the proposed rule, unless they are exempt.

Who is exempt from the Proposed Rule?

The rule exempts a number of food items and entities, including some exemptions that were required by FSMA. This post focuses only on the exemptions that apply to sustainable farms and food businesses, but check out this FDA handout for additional information on other exemptions. The exemptions below will hopefully support sustainable agriculture and food systems, but note also where we mention a few remaining concerns:

  • Food a farm sells directly to consumers. NSAC advocated for an amendment to FSMA that exempts farm products from the proposed rule if they sell the food directly to consumers. FDA included this exemption in the proposed rule, as required by FSMA, exempting these food sales from cumbersome recordkeeping requirements.
  • Food produced on a farm if the packaging prevents contamination and the label on the product sold to the consumer includes the business phone number, address, town, state, zip code, and country for the farm. NSAC also advocated for this requirement in FSMA, because labels that preserve the identity of the farm on a product are fully traceable. FDA included this FSMA text in the proposed rule as well.

    However, NSAC is concerned about whether or not the proposed rule will be practical for all products that meet the general FSMA language. In the preamble to the proposed rule, FDA states what is allowable packaging to “prevent future contamination,” including language that states FDA will not exempt a product in clamshells with holes or cardboard boxes.
  • Rarely consumed raw produce.  NSAC appreciates FDA’s exemption of produce that is exempt from the produce safety rule because it is on the rarely consumed raw list.
  • Maybe retail food establishments with no more than 10 employees at each establishment (not the entire business). FDA is considering either a full or partial exemption for retail food establishments with 10 or fewer full-time employees at a retail establishment, but this limitation does not apply to an entire business, if the business has multiple retail locations. A retail food establishment’s primary business is to sell food directly to consumers. This could include community supported agriculture (CSA) programs, online sales, grocery stores, restaurants, etc.

    NSAC applauds FDA for considering this exemption, even though technically it was not included in FSMA. FSMA did require scale appropriate options for businesses, and we encourage FDA to consider what might be an appropriate expansion of the definition, similar to other FSMA rules.
  • Businesses who are originators of food who grow, raise, harvest, or catch food, and sell no more than $25,000 annually for the previous 3-year period average. This exemption includes all farmers that are exempt from the produce safety rule because their previous 3-year annual sales average is not more than $25,000, adjusted for inflation.

    While FDA was not required in FSMA to include this exemption, NSAC applauds FDA’s efforts to ensure small and new businesses are not overly burden with the new proposed rule. NSAC encourages FDA to consider other FSMA exemptions for both produce farms and food facilities under the FSMA preventive controls rule, as they consider this and other exemptions.
  • Transporters of food. FDA also decided to exempt anyone who is a transporter, which is anyone who possesses or controls a food item on the FTL, only to transport the food, for example, by road, rail, water, or air.
  • Shell egg producers with less than 3,000 laying hens.
  • Nonprofits that are 501(c)(3) organizations.

Who is partially exempt or maybe exempt from the Proposed Rule?

The proposed rule also includes a number of practical partial exemptions, some of which NSAC advocated for. Listed below are several partial exemptions that are applicable to sustainable agriculture. For information on all exemptions and partial exemptions visit FDA’s resources here.

  • Farm to School or Institution sales. Any product produced on a farm and then sold directly to a school or institution is only required to keep the name and address of the farm that sold the food to them. They are otherwise exempt from the long list of records other businesses must keep in the rule, beyond the farm name and address associated with the food item on the FTL.

    However, if a farm product is first sold to a food hub, and then sold to a school or institution, those sales would not meet this partial exemption (but could meet other exemptions, if applicable). NSAC looks forward to further discussions with FDA and USDA around the farm to school partial exemption we advocated for during the FSMA process.
  • Farm sales directly to retail food establishments. Any food produced by a farm and sold directly to a retail food establishment by that farm applies for a partial exemption, which only requires the retail food establishment to maintain a records of the name and address of the farm for that product on the FTL. NSAC pushed for this partial exemption in FSMA for farm to grocery store sales, and we are encouraged to see FDA apply this exemption to all retail food establishments, including multi-farm CSAs and restaurants.
  • Commingled raw agricultural commodities from farms, that are not produce.  Any item on the FTL that is harvested, but not yet processed, and not a produce item covered by the produce safety rule, is eligible for a partial exemption when products from multiple farmers are combined together. The exemption applies to any business that commingles these products. However, if the business is required to register as a food facility, they must keep records of the immediate previous source and immediate subsequent purchaser of the food. NSAC also asked Congress to add this exemption into FSMA.
  • Retail Food Establishments with no more than 10 employees. FDA is considering a partial exemption for these entities, that would still require them to complete all the same record keeping requirements as other businesses, with one exception. NSAC will encourage FDA to move forward with a complete exemption for small retail food establishments to ensure the requirements in FSMA that the rule be “scale-appropriate and practicable for facilities of varying sizes,” are fulfilled.

Proposed Rule Takeaways

Overall, NSAC is grateful FDA is attempting to establish a proposed traceability rule that will ensure future recalls and messaging on food borne illness outbreaks are not overly broad. As FDA mentioned in the preamble to this proposed rule, overly broad public messaging on an outbreak, which implicates an entire food item, such as romaine lettuce, is detrimental to producers whose products are not implicated in the outbreak area and are still safe to eat. We hope this proposed rulemaking will ensure FDA is able to conduct tracebacks to a specific business in a timely manner, instead of issuing an overly broad outbreak statement. 

We also appreciate FDA’s efforts to create a rule that is scale-appropriate to the different business sizes, including the new exemptions added to ensure small businesses are exempt or able to receive a partial exemption. If it were not for the farmers and sustainable food advocates that pushed for some of the farm product and direct to consumer or retailer sales exemptions, this rule could have been detrimental to small, sustainable, organic, and diversified farm operations. 

However, the impact of this rule could still be significant for small, sustainable farms – the proposed rule requires businesses to keep extremely detailed records, even on some of the exempt farm products mentioned above. For example, for farm products that are exempt because of their product’s label, the first purchaser of the food is still required to keep very detailed farm records of that product, regardless of any exemption. Farms may inadvertently be required to keep and send these records to purchasers as a result. We will provide more information on this concern in Part 2 of this post.

Sustainable farm operations may also be affected by FDA’s requirements regarding the packaging necessary for the exemption for food produced on a farm with the proper labeling information. As mentioned above, some commonly used containers that are recyclable, are not allowed to be used for this exemption. The examples FDA provides on what packaging is acceptable for this exemption are expensive, resource intensive, and may not be possible for many farmers. For example, FDA recommends that to meet this exemption, farms individually wrap each cucumber in sealed plastic wrap, with the appropriate labeling. NSAC is concerned about the waste, environmental impact, and costs this will create for small and mid-scale sustainable farms.  

NSAC will also further analyze the FTL, and hopes FDA will move forward with a final list that primarily focuses on the varying risks associated with a food product’s production systems and practices.

In Part 2 of this series, we will analyze the proposed rule as it relates to non-exempt businesses, including non-exempt farms, food hubs, restaurants, grocery stores (including food cooperatives), and wholesalers.

Please consider commenting on how the rule might impact your farm, food business, or supply chain. Check our blog for future posts with more detailed comment information for farmers, food businesses, and organizations who want to comment on this proposed rule.

Categories: Carousel, Food Safety, Local & Regional Food Systems

One response to “What the New FDA Rule Means for Farms: Part 1”

  1. […] more about the history of the proposed rule, and if you are exempt from the rule, visit the Part 1 post here. This blog will focus on proposed compliance requirements if you are not exempt from the rule, and […]