NSAC's Blog

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WHAT THE NEW FDA RULE MEANS FOR FARMS: PART 2

December 10, 2020

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The Food and Drug Administration (FDA) recently released a food traceability proposed rule which establishes additional traceability recordkeeping requirements for businesses who manufacture, process, pack, or hold foods on FDA’s Food Traceability List (FTL). This post is Part 2 of a two part series on the new FDA Food Traceability proposed rule. To learn 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 some of the issues that might arise for farms and food businesses if the proposed requirements are finalized.

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 around what to comment on in a future blog post.

If you are not Exempt, What Records and Information are you Required to Keep?

If you are not exempt or partially exempt, you might have to comply with the requirements in this proposed rule if they are finalized by FDA. There are varying recordkeeping requirements at each stage of the supply chain.

1. Explain where the required information appears, and how records for different tracing events are linked if applicable (i.e. when you receive a food on the FTL, then when you transform food on the FTL, and finally, when you ship it);
2. A list of foods you ship on the FTL, that includes the traceability product identifier (a unique code) and traceability product description.
   • Descriptions of a food product typically used commercially for purchasing, stocking, or selling includes the category code or term, category name, and trade description.
   • For single-ingredient products, the trade description includes the brand name, commodity, variety, packaging size, and packaging style.
   • For multiple ingredient food products, the trade description includes the brand name, product name, packaging size, and packaging style;
3. A description of how you create lot codes of any food on the FTL you originate, create, or transform; and
4. Any other information needed to understand the data associated with the required recordkeeping requirements.

Recordkeeping is allowed in electronic or paper format, unless FDA requests an electronic sortable spreadsheet containing all the records the business is required to keep under this rule. FDA will request this information to help prevent or address a foodborne illness outbreak, and a business must provide it within 24 hours.

Below are additional recordkeeping requirements, depending on where in the supply chain the food item is packed, held, processed, or manufactured.

Farmers that are Not Exempt

For farmers that grow food on the FTL that are NOT exempt, farmers would also need to keep record of the food’s growing area coordinates, and how the related to the product’s traceability lot code (“lot code”). “Growing area coordinates” are “the geographical coordinates (under the global positioning system (GPS) or latitude/longitude) for the entry point of the physical location where the food was grown and harvested.” There are other specific recordkeeping requirements for sprouts only.

First Business to Receive Food from a Farm

For all businesses that are the first business to receive food grown, caught, harvested, or raised by a farm, there are several required records you must keep. This includes a farm that receives food from another farm, unless the food or entity meets the exemption requirements mentioned in Part 1. 

Required records for these “first receivers” include the following information, which must contain and link to the product’s lot code:

1. The location identifier and location description of the farm the food was caught, grown, harvested, or raised on (this includes a unique code for the farm, and a complete physical address and other key contact information, specifically the business name, physical location name and address, primary phone number, and country of the originator of the food);
2. The business name, point of contact, and phone number of harvester of the food and dates / times of harvesting;
3. If applicable, the local identifier and description of the place where food was cooled; and
4. The location identifier and description of where food was packed and date and time of packing;

If there is no lot code, “first receivers” must create one for the food product. You must link all these records listed above to the lot code.

Businesses that Receive Food, but are not the First to to Receive the Food

If you are the next stop in the food supply chain, and are receiving food from a “first receiver”, then you also have required records to keep as a receiver of the food:

1. Location identifier and location description for the immediate previous source of the food (other than a transporter of the food);
2. Entry number for imported food;
3. Location identifier and description of where food was received, and the date and time the food was received;
4. The quantity and unit of measure of the food (i.e. 6 cases, 200 lbs);
5. The traceability product identifier and traceability produce description of the food;
6. The traceability product identifier and traceability produce description of the food;
7. The reference record types (bills of lading, purchase orders, advance shipping notices, work orders, invoices, batch logs, production logs, and receipts) and reference record numbers (the identification number assigned to a reference record, such as a purchase order number, bill of lading number, or work order number for the documents containing the information specified in 1-6, (e.g. “Invoice #101”)); and
8. The name of the transporter who transported the food to this receiver.

If you Further Process or Manufacture a Food on the List

If you take a food on the FTL and turn it into another product by processing or repackaging the item or combining other food with the item, this is known as transforming the food. Transformation includes “an event in a food’s supply chain that involves changing a food on the Food Traceability List, its package, and/or its label (regarding the traceability lot code or traceability product identifier).” For example, transformation might occur by “combining ingredients or processing a food (e.g., by cutting, cooking, commingling, repacking, or repackaging). Transformation does not include the initial packing of a single-ingredient food or creating a food.” These required records must contain and link to a new lot code for the food produced, the following:

1. For each of the food items on the list used in the transformation process:
   • The lot code(s) for the food;
   • The traceability product identifier and description for foods for each lot code;
   • The quantity of each lot of the food; AND
2. For all food produced through transformation:
   • The location identifier and description for where the food was processed or manufactured and the date of the transformation;
   • The traceability product identifier and description for the transformed food, including the new lot code;
   • The quantity and unit of measure of the food produced for each new lot code; AND
3. Any reference record type and number that includes any of the information above in 1 or 2.

All retail food establishments are exempt from keeping records of food they transform if they sell the food directly to consumers. 

If you create a food item on the list

Creating a food on the FTL means you are processing and manufacturing a food that is on the list with ingredients that are NOT on the list (i.e. peanut butter, cheese).

Creators of food must keep records of:

1. The location identifier, description, and date creation of the product occurred;
2. The location identifier, description, and date creation of the product occurred;
3. The quantity of the food; and
4. The quantity of the food; and

These records must be linked to the lot code.

All retail food establishments are exempt from these record keeping requirements if they sell the food directly to consumers.

If you ship food on the list

If you ship food, you must send records with the shipment, that link the lot code to the following information: 

1. The entry number(s) assigned to the food for imported food
2. quantity and unit measure of the food;
3. Traceability product identifier and product description;
4. Location identifier and description and point of contact for the lot code generator;
5. Location identifier and description for the immediate subsequent recipient;
6. Location identifier and descript for the location from which the food was shipped, and the date and time the food was shipped;
7. The reference record types and numbers for the documents containing this information; and
8. The name of the transporter who transported the food from the shipper.

A shipper must also send records to the immediate subsequent recipient of the food that includes all of the information in 1-6.

A shipper must also send records to the immediate subsequent recipient of the food that includes all of the information in 1-6.

1. Statement you are a farm;
2. Location identifier and description of the originator of the food (if not that farm);
3. Business name, point of contact, and phone number of the harvester of the food (if not you), and the date(s) and time(s) of harvesting;
4. Location identifier and location description of the place where the food was cooled (if not by you), and the date and time of cooling; and
5. Location identifier and location description of the place where the food was packed (if not by you), and the date and time of packing.

Proposed Rule Takeaways

NSAC has a few concerns with the proposed rule, including the requirement to provide FDA with an electronic spreadsheet of all required records, if requested, within 24 hours. While NSAC appreciates that required records can be in paper format otherwise, we are concerned about the impact the spreadsheet requirement might have on small and rural businesses that do not have the technology in place to provide an electronic spreadsheet within 24 hours.

NSAC is concerned that any “first receiver” of the product must create a lot code and keep records of detailed farm information, even for products that are required by the Food Safety Modernization Act (FSMA) to be fully exempt from any of the rule’s requirements. For example, a farm product that is exempt because it meets the labeling and packaging exemption should not be a product where businesses throughout the supply chain are required to keep detailed records for that product, especially farm-level records. As a result, buyers most likely will still require exempt farms and small businesses to keep and provide them with these detailed records.

Unfortunately, FDA stated in the rulemaking first receivers must keep all required records, even for exempt products. NSAC encourages FDA to at the very least not require first receivers to keep the required records for food items that are fully exempt under FSMA, and overall, maintain exemptions across the supply chain.

FSMA also stated that FDA could not require businesses to create duplicative records if the information is already recorded by a business. NSAC is concerned this rulemaking will create recordkeeping duplications, in particular for businesses that are required to comply with the already existing FDA recordkeeping requirements based on their authority from the Bioterrorism Act.  FDA must ensure this new rule does not create situations where businesses that must comply with both requirements must now keep duplicative records.

This new rulemaking also requires some businesses to keep “reference records,” which include an explanation of where the required information appears on these already existing records, and if applicable, a description of how reference records for different tracing events are linked (e.g., a purchase receipt, a transformation record, and a shipment invoice). NSAC is concerned about this duplicative requirement, and encourages FDA to comply with the FSMA requirement that this rulemaking “not require the creation and maintenance of duplicate records where the information is contained in other company records kept in the normal course of business.”

FSMA also stated that FDA could not require “a full pedigree, or a record of the complete previous distribution history of the food from the point of origin of such food.” While in most scenarios, the rule does not require this, there is some concern about entities that receive food, but are not “first receivers,” of food, and the requirements around recording information from the original lot code generator.

NSAC appreciates that the proposed rule does not require farms to keep records lengthy records of future supply chain sales. NSAC advocated that the rule only requires farms to keep records of the first point of sale, and FDA has not required farms to keep records beyond that in this proposed rulemaking.

NSAC also pushed for a process in FSMA that would ensure updates to the list are made periodically, and is pleased to see several options in the traceability rulemaking for FDA’s plan to revisit the list. FDA includes options for how both individuals and organizations can request a change in the list in the future, and also how FDA will determine changes to the list in the future. The proposed rule also includes a process to waive the rule requirements for certain businesses and a process to establish modified requirements for other types of businesses and food items.

These proposed requirements will apply to a number of businesses, including food hubs, restaurants, grocery stores, and wholesalers, that are all crucial for fostering a sustainable food system. Please comment on how the rule might impact your farm, food business, or food purchasers, if finalized.

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Categories: Carousel, Food Safety

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