FSMA News
When the Food Safety Modernization Act was originally passed in 2011, it included a direction from Congress for the US Food and Drug Administration (FDA) to propose additional recordkeeping requirements to enable better traceability through the food chain.
They were instructed to make their proposed rule technology-agnostic, and to include traceability features that go beyond the "one-step-forward, one-step-back" that was implemented as part of the Bioterrorism Act of 2002.
This Proposed Rule for Food Traceability would apply to all firms that manufacture, process, pack, or hold foods on the Food Traceability List unless otherwise specified in one of the exemptions.
You do not need to be covered by another part of FSMA to be affected by this proposed rule.
The Proposed Rule for Food Traceability is published in the federal register and is open for comment. On that site you’ll also find publicly submitted comments they’ve received so far.
The current extended deadline for comment is February 22, 2021.
As of this writing, they have received a total of less than 300 comments through the online portals. The Proposed Produce Safety Rule received somewhere around 18,000 comments.
We will explain key features of the Proposed Rule for Food Traceability in sections. We will also provide tips for submitting effective comments at the end. Please don’t hesitate to contact us with any questions at 207-764-2100 or leah.cook@maine.gov.
The draft rule proposes that the person/business who makes the food assigns it a traceability lot code. That traceability lot code will then show up on every document in the food chain until it’s received by the final business that will sell it or serve it direct to the consumer. It cannot be changed or replaced by later parties unless that party is creating or transforming it into a new item on the Food Traceability List.
The name and contact info for the lot code generator—the person/business who creates and assigns the lot code to the food—has to appear on the records throughout the entire food chain. This is to allow the FDA investigators to jump from the end of the food chain as far upstream as they can in one step when time is of the essence to prevent more foodborne illness or deaths.
Along the way, there are critical tracking events when information has to be generated, sent onward, or kept, and there are key data elements that are the pieces of information that have to be included in those records. Those key data elements differ depending on which activities you’re doing in the supply chain.
Each farm/business will need to create program records that serve as a master key to understanding and connecting the different pieces of an operation’s traceability program.
And finally, this overall model applies to foods that are on the Food Traceability List, or made with ingredients on the List. It does not apply to certain types of sales or operations.
The FDA has proposed an initial list of foods that would be subject to this Proposed Rule. Foods on the list were selected based on a data-driven risk matrix that considered:
- Frequency of outbreaks and occurrences of illnesses
- Severity of illnesses
- Likelihood of contamination
- The potential for pathogen growth, with consideration of shelf life
- Manufacturing process contamination probability and industry-wide intervention
- Consumption rate and amount consumed
- Cost of illness
It is not intended to be a static, one-and-done final list. Foods may be added or removed to reflect changes in outbreak incidence, changes in industry, and current science.
The foods proposed for the Food Traceability List include:
- Cheeses, other than hard cheeses
- Shell eggs
- Nut butters
- Cucumbers (fresh)
- Herbs (fresh)
- Leafy greens (fresh and fresh-cut)
- Melons (fresh)
- Peppers (fresh)
- Sprouts (fresh) – (does not include microgreens)
- Tomatoes (fresh)
- Tropical tree fruits (fresh)
- Fresh-cut fruits and vegetables
- Finfish, including smoked finfish
- Crustaceans
- Bivalve mollusks
- Ready-to-eat deli salads (does not include meat salads)
The traceability requirements of the proposed rule would apply to both foods on the Food Traceability List and foods made with ingredients on the List.
Critical tracking events are the times in the food chain when traceability tasks need to be done. The tasks vary depending on which event is happening. The FDA has established 5 types of critical tracking events:
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Growing—when you are cultivating and harvesting the fruit, vegetable, or other applicable food.
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Receiving*—when you are taking physical delivery of foods.
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Transforming—when you change the form of a food on the List, its package, or labeling. (Ex: processing, commingling, repacking, etc.)
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Creating—when you are processing or manufacturing a food on the list using only ingredients that are not on the List. (Ex: slicing apples, making soft cheese from milk and salt, making peanut butter, etc.)
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Shipping—when you arrange for shipment and delivery of foods.
*First Receivers are the first entity in the food chain to receive the food after the farm (or harvesting operation for things like fish or eggs). The proposed rule makes this distinction to provide a clear starting point for the traceability chain, in recognition that there may be multiple harvesting, cooling, and packing steps that are part of the growing operations.
For each of these supply chain events, there are key data elements that need to be carried over, created, or kept.
The draft rule proposes that each operation maintain a set of records that serve partly as a navigational aid and partly as a master data list. The program records include:
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A description of reference records, including:
- Which kinds of records contain the required information (invoices, Bills of Lading, Receiving Records, etc.).
- An explanation of where to find the required information on those records.
- A description of how those reference records link together, if applicable.
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A list of all foods on the Food Traceability List that you ship, including the:
- Traceability lot identifier for each item.
- Traceability lot description for each item.
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A description of how you assign traceability lot codes for:
- Foods you originate.
- Foods you create.
- Foods you transform.
- Foods you’re the First Receiver for if they don’t come in with a lot code.
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Any other information needed to understand your traceability system.
These program records provide investigators and regulators a key to understanding how different documents link together, and can allow operations to use abbreviated information on actual shipment documents if they can be referenced to master data lists in the program records.
Records have to be kept as true copies for at least 2 years after they are created and must be provided to the FDA within 24 hours of a request. You can use existing records to satisfy any of these requirements provided they meet the general record requirements, as with all the other parts of FSMA.
There are times when operations must provide the FDA with an electronic sortable spreadsheet within 24 hours that includes the required traceability information for the foods and date ranges specified in the FDA’s request.
You'd have to provide this spreadsheet when necessary to help the FDA prevent or limit a foodborne illness outbreak, implement a recall, or investigate a credible threat to public health. This requirement is explicitly technology based, but also proposes that the FDA will withdraw the request for such a spreadsheet when necessary to accommodate a religious belief of a person requested to provide it.
The FDA has identified the pieces of information that are critical to performing swift tracebacks in the event of outbreaks or investigations. For each critical tracking event—growing, receiving, transforming, creating, or shipping—each operation has to create, pass on, or keep these key data elements.
Traceability lot code – a descriptor (can be a combination of letters and numbers) assigned to a lot of food produced during a period of time in a single physical location.
Ex: FF-GH-01-2752021
Traceability lot code generator - the name, point of contact, and phone number of the entity that created and assigned the lot code.
Ex: Farmer Fields, Inc, Francis Farmer, 207-222-2222
Location identifier - can be a code used to designate the location name, if master program records link the location identifier with the location description.
Ex: GH-01 = Greenhouse #1 at Farmer’s Fields, Inc.
HF-05 = Home Field #5 at Farmer’s Fields, Inc.
Location description - the business name, physical location name, primary phone number, and complete physical address.
Ex: Farmer’s Fields, Inc.
Greenhouse #1
207-222-2222
432 Main Street
Riverfield, ME 04000
Harvester information - if not harvesting yourself, this includes the business name, point of contact, and phone number of the harvester, and the dates and times it was harvested.
Ex: Hank’s Harvesters, Henry Higgins, 207-444-4444
Harvested: 10:00 am, 8/7/2023
Cooler information - if not cooling the product yourself, this includes the location identifier and location description of the place where product was cooled, and the dates and times it was cooled.
Ex: The Cooling Company
Route 1 Cooler (CC-RT1)
207-555-5555
12 US Route 1
Greenport, ME 04111
Cooled: 11:00 am, 8/7/2023
Packer information - if not packing the product yourself, this includes the location identifier and location description of the place where product was packed, and the dates and times it was packed.
Ex: Perfect Packing Services, Inc.
Packhouse 3 (PPS-PH3)
207-777-7777
37 Oak Grove Road
Hilldale, ME 04222
Packed: 8:00 am, 8/8/2023
Quantity and Units of Measure (U/M) - how many units of foods were shipped, and what are the units of measure.
Ex: 6 cases
25 returnable plastic containers (RPCs)
200 lbs
Traceability product identifier - can be a unique identification code you assign to designate a specific product. SKUs and UPCs are common examples of these.
Ex: TOM-CHERRY-25 = 25 lb carton of Cherry Tomatoes
123456 789012 = 8 oz containers of Queso Fresco cheese
Traceability product description - a description of the food that includes the category code or term, category name, and the trade description. You can use your own category codes or industry category systems. Trade descriptions for single-ingredient foods include brand name, commodity, variety, packaging size & style. For multi-ingredient foods they include brand name, product name, packaging size, and packaging style.
Ex:
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Category Code
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Category Name
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Brand Name
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Commodity
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Variety
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Product Name
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Pkging Size
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Pkging Style
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10006162
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Cherry Tomatoes – Round
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Brand ABC
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Tomatoes
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Cherry
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N/A
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25 lb.
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Carton
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Soft Cheese
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Soft Cheese
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Brand XYZ
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N/A
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N/A
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Queso Fresco
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12 x 8 oz.
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Vac. Pack
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Reference record type - the types of records you’re using for that traceability requirement.
Ex: invoices, receiving logs, work orders, batch logs, purchase orders, receipts, bills of lading
Reference record number - identification number assigned to the specific record in question. Usually follows the reference record type.
Ex: BOL 179
Invoice 32463
P.O. 479
Name of the transporter - the business name of the transporter moving the product.
Ex: Tammy’s Trucking, LLC
The key to understanding any regulation is often getting a handle on the definitions. These examples help illustrate what some of these key data elements can look like.
For each critical tracking event in the food chain, this proposed rule lays out what each party would have to do with the key data elements.
Growers* have to assign a traceability lot code and link it to:
- The geographic coordinates to the entrance of the growing area.
Geographic coordinates are used because many fields do not have addresses, and some growers have multiple fields planted in the same crop. Those coordinates do not have to be on documents sent with the product, because the program records should be able to link them to the traceability lot code in-house.
If growers are not doing all parts of their harvesting, cooling, and packing operations themselves, they also need to be prepared to give their First Receiver:
- Statement that they are a farm.
- Harvester’s name, point of contact and phone number, and date & time of harvest.
- Cooling location identification, description, and date & time of cooling.
- Packing location identification, description, and date & time of packing.
*Sprouts growers have to provide a good deal more information to their First Receiver.
Receivers* have to establish and maintain records that link the traceability lot code for the received products to the following:
- Location identifier & location description for immediate previous source.
- Location identifier & location description for where you receive it.
- Date & time you receive the food.
- Quantity & units of measure of foods received.
- Traceability product identifier & traceability product description of the food.
- Location identifier, location description, and point of contact for the traceability lot code generator.
- Reference record type and number where you can find all of the above.
- Name of the transporter who delivered the food to you.
Some of this can live in the master program records and be linked to your receiving logs with abbreviated versions or specific pieces of information. Some of this information needs to be passed forward on subsequent records if shipping products further.
*First receivers who are the first party to take delivery of the product from the farm or harvester may also need to assign a traceability lot code and other required information.
Transformers who process, pack, or commingle products on the Food Traceability List must assign a new traceability lot code to the new lot of product, and establish and maintain records that can link:
- Information on foods used to make the new product, including:
- The traceability lot code of the input products.
- The traceability product identifiers and traceability product descriptions for the input products.
- The quantity of each traceability lot of the foods used in the new product.
- Information on the resulting new product, including:
- Location identifier and description for where you transformed the product.
- Dates when the transformation was complete.
- New traceability product identifier and traceability product description.
- Quantity and units of measure for the food in each new traceability lot code.
- Reference record types & numbers that connect this production information.
Creators who make products on the Food Traceability List entirely from ingredients that are not on the list have to assign a traceability lot code to the product, and establish and maintain records that can link:
- Location identifier and description for where you created the product.
- Dates when the creation was complete.
- Traceability product identifier and traceability product description.
- Quantity and units of measure for the food in each new traceability lot code.
- Reference record types & numbers that connect this production information.
And finally, any shipper of foods on the Food Traceability List has to establish and maintain records that link the traceability lot code to:
- Quantity and unit of measure of the food.
- Traceability product identifier and traceability product description.
- Location identifier, location description, and point of contact for the traceability lot code generator.
- Location identifier and location description for the next receiver.
- Location identifier and location description where you shipped the food from.
- Date and time you shipped the food.
- Reference record types & numbers that connect all of the above.
- The name of the transporter who transported the food for you.
Shippers need to send their customers the information in the bullets marked with an arrow above. If a farm is the shipper, they also need to provide their customers with:
- Statement that they are a farm.
- Harvester’s name, point of contact and phone number, and date & time of harvest.
- Cooling location identification, description, and date & time of cooling.
- Packing location identification, description, and date & time of packing.
The FDA has prepared examples of how this works along the value chain. We encourage you to explore their Supply Chain Examples and other resources.
The intention is that every party would pass forward the traceability lot codes and the traceability lot code generator’s information through the entire food chain.
This Proposed Rule for Food Traceability would apply to all firms that manufacture, process, pack, or hold foods on the Food Traceability List unless otherwise specified in one of the exemptions.
You do not need to be covered by another part of FSMA to be affected by this proposed rule.
There are exemptions to the traceability requirements built into the proposed rule. Some apply to types of businesses and some apply to types of sales.
Exemptions for certain small producers include:
- Farms selling less than $25,000 in produce sales.*
- Shell egg producers with less than 3,000 laying hens.
- Producers with less than $25,000 in food sales.*
- Farms, when the food is sold directly to consumers. (Ex: CSAs, farm stands, farmers’ markets)
*These sales figures are 3-yr averages, adjusted for inflation based on 2019 values.
Exemptions for certain types of foods include:
- Foods that are produced and packaged on a farm
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If the packaging maintains the integrity of the product and remains in place until it reaches the customer, and;
- The label that reaches the customer includes the name, complete address, and business phone number for the farm.
- Produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance.
- Shell eggs when all eggs produced at that farm receive a treatment in accordance with §118.1(a)(2).
- Produce that is Rarely Consumed Raw, as defined in the Produce Safety Rule.
- Some commingled raw agricultural commodities that do not include covered produce as defined in the Produce Safety Rule.
Perforated, netted, or vented boxes, clamshells, cartons, or bags used to package produce would not be considered packaging that maintains the integrity of the product until it reaches the customer.
There are partial exemptions proposed for:
- Farm-to-school and farm-to-institution programs.
- Retail food establishments receiving foods produced on a farm and delivered directly to the store.
- Foods produced through use of fishing vessels.
- Small retail food establishments:
- Option 1: Full exemption for small retailers with 10 or fewer full-time equivalent employees.
- Option 2: Partial exemption from the requirement to produce a sortable electronic spreadsheet for specified products and dates for small retailers with 10 or fewer full-time equivalent employees.
Other exemptions include:
- Transporters.
- Nonprofit food establishments.
- Food for personal consumption.
- Certain entities who hold food on behalf of individuals without being a party to the transaction or being in the business of distributing foods. (Ex: concierges, doormen)
Individual entities can apply for and groups can petition for a waiver from one or more of the proposed traceability requirements. The FDA will consider applications and petitions on the grounds that:
- The application of the rule’s requirements would result in economic hardship for the individual entity or type of entity, based on their unique circumstances.
- A waiver will not impair the ability of the FDA to effectively identify receivers and shippers of foods to prevent or mitigate a foodborne illness outbreak.
- The waiver won’t be otherwise contrary to public interests.
The Proposed Rule for Food Traceability also includes the process to apply or petition for a waiver.
The FDA has requested comments on the Proposed Rule for Food Traceability. We are currently in an extension period for comment, with comments due by February 22, 2021.
They are following a standard rule-making process that includes publishing proposed rules to the Federal Register, opening it for comment, receiving and reviewing all comments, and responding to comments in groups by topics. They then revise the proposed rule before publishing the final regulation.
The FDA is specifically looking for comments on the two options for small retail establishment exemptions and examples of business models that may be incompatible with the proposed rule, with reasons why.
All comments are read and reviewed. If you want to make your comments more effective in this process, we recommend that you:
- Start by comparing your traceability records to the proposed requirements before drafting comments.
- Be specific about what you object to, and why.
- Explain as specifically as you can how the proposed requirements will affect you or your constituency.
- Try to quantify any estimates of the burdens or costs of complying with the regulation.
- If you want the regulations to treat a type of operation differently than other parties in the supply chain, be specific about what factors make traceability different for that type of operation.
- Use arguments, logic, or data that is consistent with established science and outbreak data.
- Propose alternatives that will meet the FDA’s goal of doing faster tracebacks during outbreaks.
- Share any concerns or ideas you have about information handling, privacy, and technology mandates.
This proposed rule is wide reaching and affects the majority of food producers in the US. In a year of unprecedented pressure on farmers and food producers, a longer than standard comment period may be advisable or necessary to allow time for stakeholders to review the proposed rule and submit meaningful comments.
Visit the FDA’s website for the Proposed Rule for Food Traceability to learn more. You can watch the FDA’s public hearings on the proposed rule. You can read the Proposed Rule itself in the Federal Register. And of course, you can submit comments until February 22, 2021.
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