Review the FDA Traceability Rule.
(This rule will apply to some farms)
What is traceback/traceability?
A traceback program allows a farmer to better control the distribution of their product. A strong program will include the following steps:
- Identify a “lot” or a distinct part of the crop harvested during a specific time period. Lots may include a harvested portion of tomatoes from a specific field on a specific day. Smaller operations often define a lot as the portion harvested for an entire day. A larger operation may identify a lot as product harvested in a four hour stretch. When lots are large (several fields or several days of harvested product), it leaves more product subject to a recall if there is a question regarding its safety. It may make traceback more difficult.
- Lots are identified by a unique identification code, which may include numbers, letters and/or dates that identify the product, field and date of harvest. Some larger operations may also identify the harvest crew in the lot code. Lot codes are attached to any boxes or packaging or sometimes directly to the product with a sticker so that the lot code can follow the product from the farm to the buyer.
- A traceback program allows for traceability, or the ability to trace a product one step back and one step forward: back to the field where it was grown and forward to a buyer (where did your product go when it left the farm?) or from a buyer (grocery store, school lunch program) back to the farm. This can benefit the farmer, the buyer and the public health system.
If the buyer identifies a quality problem and reports it to the farmer, the farmer will know exactly when the product was picked and shipped and IF the problem is their fault or that of a shipper or a buyer keeping product on the shelf too long.
If there is the potential of a food borne illness outbreak from a shipment of greens, the buyer can identify where the product came from and the farmer can recall any product from the same lot. In addition, they can do a review of practices to see what might have caused the contamination. Did a worker come to work sick? Was product picked up from the ground? Was the water used to irrigate the product safe?
Who needs a traceback program?
Ideally, every product from every farm should have some type of lot identification whether from farms large or small, whether they sell to distributors, restaurants, grocery stores or directly to the consumer at a stand or CSA.
It is a good business practice to keep records of harvest information and the destination of product. Was it sold at the stand? Via the CSA? To the school lunch program or to the grocery store? If you sell at farmer’s market it a traceback program will tell you which lot (identified by harvest date and harvest location) went to which farmers’ market.
If there are any concerns about quality or safety, knowing what product went where and when can help you to track the problem to the source (field, date of harvest, who harvested the product) and do what you need to fix it.
However, if you are participating in a third party audit program you may be required to have a traceback program in place whether or not you are required by the November 2022 FDA Traceability Rule regarding traceability. Check with the audit program and/or their audit standards to see what is required.
Farms will also be required to have a traceability program if they are not exempted from the FDA Traceability Rule, Requirements for Additional Traceability Records for Certain Foods.
US Food and Drug Administration Rule: Requirements for Additional Traceability Records for Certain Foods
There have been a number of produce outbreaks that, due to the inability to trace the outbreak to its source, consumers were advised to avoid eating spinach or lettuce or raspberries. While it was obvious that not all spinach or lettuce or raspberries were ultimately going to be implicated in the outbreak, because investigators could not pinpoint a source, all product was suspect. In these cases, produce contained no identifying label or code to make tracing back to the source possible.
In an effort to prevent similar situations, the US Food and Drug Administration (FDA) wrote a rule that would require some produce operations to keep records that make traceback possible. Farms growing products listed on the Food Traceablity List will need to have a traceback program unless they fit the criteria for an exemption from the Rule.
To assess your need to comply with the proposed traceability records rule, answer the following questions:
- Do you grow and/or pack foods that appear on the proposed Food Traceability list? If yes, check below to see if you meet criteria for exemptions.
If your product/process/farm operation meets any of these exemptions, you will meet the criteria for being exempted from the rule. If you do not meet exemption requirements and your produce is on the Food Traceability List, you will have to comply.
- Are your annual produce sales $25,000 or less? (If yes, farm is exempt)
- Do you sell directly to consumers (at a farmers' market, roadside stand, through a CSA, or over the internet)? (If yes, farm is exempt)
- Does the food you produce and package on your farm have packaging that remains in place until the food reaches the consumer, that maintains the integrity of the product, and prevents subsequent contamination or alteration of the product AND the labeling of the food that reaches the consumer includes the name, complete address, and business phone number of the farm where the food was produced and packaged?* *Produce packed or packaged in containers such as clamshells with holes, cardboard boxes, vented crates, plastic bags with holes, or netted bags would not be eligible for this exemption because such packaging does not necessarily maintain the product’s integrity and prevent subsequent contamination and alteration. (If yes, farm is exempt)
- Do you grow produce listed as "Rarely Consumed Raw" (RCR) in the Produce Safety Rule? (If yes, farm is exempt)
- Do you sell food directly to a school or institution? *A partial exemption would apply. The school food authority or relevant food procurement entity would be required to establish and maintain for 180 days a record documenting the name and address of the farm that was the source of the food. (If yes, farm is partially exempt)
- Do you sell produce to a facility that applies a kill step (i.e., processing that significantly minimizes pathogens, such as cooking or pasteurization)?* (If yes, farm is exempt)*If a kill step is applied, the farm would not be required to maintain traceback records, as long as they maintain a record documenting the destination of the product to be commercially processed.
What the Proposed Rule requires (for those who do not meet exemption criteria above)
The Rule states that farms (unless exempt) that grow, pack and sell the foods that appear on the Food Traceability list must develop, implement and maintain records that contain Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs).
In plain language, this means that at certain points, as a food travels from harvest to customer, farms must keep records so that the food may be traced back to the originating farm/growing area.
Foods/Description
Cucumbers (fresh): Includes all varieties of cucumbers
Herbs (fresh): Includes all types of hers, such as parsley, cilantro basil, etc.
Leafy greens (fresh), including fresh-cut leafy greens: Includes all types of leafy greens, such as lettuce, (e.g., iceberg, leaf and Romaine lettuces), kale, chicory, watercress, chard, arugula, spinach, pak choi, sorrel, endive, etc.
Melons (fresh): Includes all types of melons, such as cantaloupe, honeydew, watermelon, etc.
Peppers (fresh): Includes all varieties of peppers
Sprouts (fresh): Includes all varieties of sprouts
Tomatoes (fresh): Includes all varieties of tomatoes
Fruits and Vegetables, fresh-cut: Includes all types of fresh-cut fruits and vegetables
Records that farms must keep include:
- Location description including:
- Business name
- Physical location/street address, city, state, zip code
- Primary phone number [and email, though not specified in Rule]
- Information regarding suppliers and customers (business name, address, phone number, email)
- A description of your traceback records, including how different records of different critical events (i.e. growing, harvesting, shipping) are linked
- A list of the foods on the Food Traceablity List you grow, harvest, and/or ship, including the traceability identifier and product description for each
- A description of how you develop and assign lot codes you grow, harvest and/or ship
- Any additional information needed to clarify/describe your traceability program
You will need to establish lot codes when you originate (grow and harvest) a food on the Food Traceability List and you will need to keep the same lot code when you conduct all activities associated with the food and original lot code (such as harvest and shipping).
Growing/harvesting
Farms must include the growing area coordinates or geographical coordinates (using GPS or latitude/longitude) for the entry point of the physical location where the food was grown and harvested.
When shipping
If you are a farm, the following information (if applicable) for each traceability lot of the food:
- A statement that you are a farm
The following information should already be part of your Traceability program description. If you are transporting food that you did not grow, harvest, cool and/or pack, then you must include:
- The location identifier and location description of the originator of the food (if not you);
- The 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;
- The 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
- The location identifier and location description of the place where the food was packed (if not by you), and the date and time of packing.
Mock recall
To test the effectiveness of your traceback program, it is recommended that you conduct a mock recall. If your operation sells product off farm, a mock recall will help you to see if you can trace your product one step forward (to a buyer such as a grocery store, produce distributor, or school). To do this, you contact a buyer and tell them you are conducting a MOCK recall. Most buyers will be familiar with this as recall programs have become part of regular food supply business. Ask the buyer to identify a lot of product you have sold to them and to tell you how much has been sold and how much they still have in inventory. Record this information on a mock recall record and put it in your traceback program file. Often this is carried out by email so that a print-off of the email can serve as the record.
Mock recalls also include tracing product one step back. On a farm this means that you also trace that same lot you are tracing forward to the buyer, back to the field, date of harvest, and, perhaps harvest crew if you are tracking that.
Even if you are selling at your farm stand, CSA, or farmers’ market, you should be able to track the product you are selling by traceback code or lot: if a lug of tomatoes is sold Saturday at your market, you should be able to trace it back to the field and date of harvest. You should also keep records of which product when to farmer’s markets, which product (lot) went to CSA distribution and which product (lot) was sold at your farm stand.
For more information regarding the proposed rule, visit these links:
Getting Started with the Food Traceability Rule
Modified Requirements, Exemptions, and Waivers
Critical Tracking Events and Key Data Elements
Electronic Sortable Spreadsheet
Guidance for Industry Frequently Asked Questions about the Food Traceability Final Rule