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Food Safety Modernization Act

Enacted by Congress in 2011 as a law of general applicability

• Establishes a national standard for food safety risk mitigation and response across the food supply chain
• Designated the U.S. Food and Drug Administration (FDA) with regulatory authority

FDA Published 7 Main Rules:

• Produce Safety
• Sanitary Transportation of Human & Animal Food
• Foreign Supplier Verification Program
• Accreditation of 3rd Party Auditors & Certification Bodies
• Preventive Controls for Human Foods & Preventive Controls for Animal Foods
• Prevention of Intentional Contamination / Adulteration

Managing Supply Chain Relationships

Understanding where you are in the supply chain can promote resilience in your distribution channels

The Food Safety Modernization Act generally only requires you to assess

• All Nodes 1 Link Up
• All Nodes 1 Link Down

Supply chain mapping is your first step at acknowledging the Traceability of an agriculture product.

Proposed Rule on Food Traceability

Traceability – the ability to track how a food product is produced; moves, is sold, or otherwise distributed; and is altered (processed or manufactured, if applicable) along the food supply chain.

The importance of record-keeping cannot be understated:

• Good records affirm proactive food safety activities and reduce economic harms associated with a recall.
• On September 23, 2020, FDA has published a proposed rule listing Key Data Elements (KDEs) across Critical Tracking Events for foods identified on a Food Traceability List

Food Traceability List
FDA developed a Risk-Ranking Model for foods requiring additional tracing based on micro-biological food-borne illnesses. This list refers to single ingredient foods and any recipe containing these foods as ingredients.

Critical Tracking Events
Nodes or areas of activity that trigger traceability records:

• Growing
• Receiving
• Creating
• Transforming
• Shipping

Key Data Elements
Information necessary in record-keeping across critical tracking events

Critical Tracking Events

• Growing: On-farm production of foods on Food Traceability List (FTL)
• Creating: Making or producing of a food on the Food Traceability List through manufacturing or processing using only ingredients not on the FTL
• Transforming: An event in the food’s supply chain changing a food on the Food Traceability List, its package, and/or its label, such as by combining ingredients or processing food  
• Shipping: An event in a food’s supply chain in which a food is arranged for transport from a defined location to another defined location
• Receiving: An event in a food’s supply chain in which a food is received by a customer (other than a consumer) at a defined location after being transported from another defined location

Key Data Elements

Growing

Link Traceability Lot Code to…Growing area coordinates

FTL Foods:

• Shell eggs
• Cucumbers
• Herbs
• Melons
• Leafy greens
• Peppers
• Sprouts
• Tomatoes
• Tropical tree fruits

Additional for Sprout Growers

Grower of Seed for Sprouting

• Location identifier & description
• Associated Seed Lot Code
• Date of harvesting

Seed Processor/Conditioner

• Location identifier & description
• Associated Seed Lot Code
• Date of Conditioning/Processing

All Seed Packinghouse(s)

• Location identifier & description
• Associated Seed Lot Code
• Date of Conditioning/Processing

Seed supplier

• Location identifier & description
• Taxonomic name of seeds
• Growing Specs
• Volume
• Type of Packaging
• Antimicrobial Treatment
• Associated Seed Lot Code
  • Master lot & sub-lot codes

Sprouter

• Any New Lot Code
• Date of Receipt by Sprouter
• Sprout Traceability Lot Code(s)
• Associated Date(s) of Production

Shipping

Link Traceability Lot Code to…

• Entry number(s) assigned to the food (if imported)
• Quantity and unit of measure of the food
• Traceability product identifier & description of the food
• Lot Code Generator’s location identifier, description, and POC
• Shipment location’s identifier and location
• Date/time of shipment
• Reference record type(s) and number(s) for shipment documents
• Transporter’s name

Shipper must keep above records. Shipper must also transmit above records except reference record type & number & transporter’s name.

Additional if Shipper is a Farm:

• Statement that shipper is a farm
• Originator of Food (if not shipper)
  • Location identifier & description
• Harvester of Food (if not shipper)
  • Business name
  • POC
  • Phone number
  • Date/Time of Harvesting
• Cold Storage (if not shipper)
  • Location identifier & description
  • Date/time of cooling
• Packer (if not the shipper)
  • Location identifier & description
  • Date/time of packing

Creating

Link Traceability Lot Code to…

• Location identifier & description
• Date “creation” completed
• Traceability product identifier & description of food
• Quantity and unit of measure
• Reference record type(s) and number(s) relating

FTL Foods:

• Soft cheeses
• Nut butter
• Fresh-cut Fruits & Vegetables
• Ready-to-eat deli salads

Transforming

Link Traceability Lot Code to…

• Traceability product identifier & description
• Quantity of each traceability lot of the food used in transformation
• New traceability product identifier and description for food produced in transformation
• Quantity and unit of measure of food produced through transformation (e.g., 100 tanks, 200 lbs.)
• Reference record type(s) and number(s) for records relating to transformation

Manufacturing/Processing an FTL Food to make  Another Food Product.

Receiver

Link Traceability Lot Code to…

• Location identifier & description from immediate previous source (not the transporter)
• Entry number assigned to the food (if imported)
• Location identifier & description of where the food was received
• Date/time the food was received
• Quantity and unit of measure of the food (e.g., 6 cases, 25 returnable plastic containers)
• Traceability product identifier & product description
• Location identifier, description, and POC for traceability lot code generator
• Reference record type(s) and reference record number(s), e.g., invoice number or bill of lading, for receipt of food
• Name of transporter who transported the food to the receiver

Additional Considerations for First Receivers:

First Receiver: First person (other than a farm) who purchases and takes physical possession of a food on the FTL

First Receivers except from Fish Vessel:

• General
  • Traceability lot code
  • Location identifier & description of food originator
• From Food Harvester
  • Business name
  • Phone number and POC
  • Date/time of harvest
• From Food Cooler (if applicable)
  • Location identifier & description
  • Date/time of cooling
• From Food Packer
  • Location identifier & description
  • Date/time of packing

First Receivers after Fishing Vessels:

• General
  • Traceability lot code
  • Harvest date range
  • Locations for trip (National Marine Fisheries Service Ocean Geographic Code or geographical coordinates)

Only foods that are originated can have a first receiver:

• Grown
• Raised
• Caught
• Harvested, i.e., eggs

If the traceability lot code has not been previously established, they would need to develop one, linking all KDE records to this traceability lot code.

Full Exemptions

Growers:

• <$25K average annual sales during past 3 yrs.
• <3K Laying hens with respect to shell eggs produced
• Food on the FTL sold direct to consumer
• Food produced & packaged on farm*
• Food identified as Rarely Consumed Raw by FDA
• Food produced for personal consumption

Creators/Transformers:
Note: When met, these exemptions extend to all Critical Tracking Events

• Food on FTL receives commercial processing (“kill step”) that reduces presence of microorganisms of public health significance
• All eggs on farm receive a treatment as outlined in the Egg Safety Rule

Shipping:

• Transporters of FTL foods exempt from shipping record requirements

Food Access Points:

• 501(c)(3) Non-profit Food Establishments
• Non-food establishments like apartments or offices that hold food

NOTE:  Commercial markets may still require enterprises maintain these records.

For food produced and packaged on farm, the packaging must:

• Be intact until it reaches its consumer.
• Keep the integrity of the product
• Stop the product from being contaminated or adulterated in transit

The labeling must provide:

• The name of the farm business
• The full address of the farm
• A business phone number

Partial Exemptions

Commingling Raw Agricultural Products Post-Harvest, Pre-Processing not subject to PSR
Exempt entities that must register through FDA’s Food Facility Registration System must maintain records identifying…

• Immediate previous source of food
• Immediate subsequent recipient of food

Retail Food Establishments purchasing FTL directly from a farm
Only need to establish and maintain record for 180 days including information on…

• Name and address of farm sourcing the food

Farm to School and/or Farm to Institution
Only need to establish and maintain record for 180 days including information on…

• Name and address of farm sourcing the food

Fishing vessels
Entities that must register through FDA’s Food Facility Registration System must maintain records identifying…

• Immediate previous source of food
• Immediate subsequent recipient of food

FDA solicited comments for whether small Retail Food Establishments with less than 10 full-time equivalent employees would be exempt or partially exempt from this rule.

• Commingling means products are mixed post-harvest but pre-processing. FDA provides the example of shell eggs mixed from separate farms under different management before packing.

Critical Tracking Events Across Supply Chain

FDA published examples of where CTEs fall on supply chain…

Seafood:

• Fishing Boat
• Seafood Processor
  • 1st Receiver
  • Receiver
  • Shipping
• Distributor
  • Receiver
  • Transforming
  • Shipping
• Restaurant
  • Receiver

If the traceability lot code has not been previously established, they would need to develop one, linking all KDE records to this traceability lot code.

Sprouts:

• Seed Grower/Harvester
  • Growing
  • Shipping
• Seed Processor
  • Growing
  • Receiver
  • Shipping
• Seed Packinghouse
  • Growing
  • Receiver
  • Shipping
• Seed Supplier
  • Growing
  • Receiver
  • Shipping
• Sprouter
  • Growing
  • Receiver
  • Shipping
• Distributor
  • 1st Receiver
  • Receiver
  • Shipping
• Grocery Store
  • Receiver

Pepper Poppers:

• Pepper Grower/Harvester
  • Grower
  • Shipping
• On-Farm Cooler
  • Receiver
  • Shipping
• On-Farm Packinghouse
  • Receiver
  • Shipping
• Dairy Farm
  • Soft Cheese Manufacturer
    • Creating
    • Shipping
  • Distributor
    • Receiver
    • Shipping
• Processor
  • Transforming
  • 1st Receiver
  • Receiver
  • Shipping
• Distributor
  • Receiver
  • Shipping
• C-Store
  • Receiver

Blending CTEs with Produce Safety Rule Affirmations

Example: Tomatoes Intended to be Processed with a “Kill Step” to Make Pasta Sauce…

Commercial Composter:

• Tomato Farm
• On-Farm Packinghouse
• Sauce Processor
• Distributor
• C-Store
• Public Water for Irrigation:
  • Affirmations Farm Should  Receive (PSR)
    • Commercial Composter
      • Supplier complied with scientifically valid process
      • Supplier stored compost in a way that minimizes risk of contamination
    • Public Water Source (subject to change)
      • Copy of test results or current certificate of compliance
    • Food Processing
      • Affirmation of commercial processing with “kill-step”

Soil Amendments

• For biological soil amendments of animal origin that are received from a third party, documentation must be provided and kept by the grower to show the process used to treat the soil amendment is a scientifically valid process that has been carried out with appropriate process monitoring and prove that it has been handled in a way that minimizes the risk of contamination (§ 112.60(b)(1)).
  • The documentation must be renewed at least annually (§ 112.60(b)(1)).

• As a best practice, the process should be periodically verified through testing.
• Some suppliers may not have documentation of the treatment process (e.g., certificate of conformance). If they do not, there is no way to know the process they have used. Those subject to the rule must handle these soil amendments the same as they would an untreated amendment, or consider finding another supplier who can supply the appropriate documentation.

Public Water:

• § 112.46(a)(1) and (a)(2) state that if water is sourced from a public water supply (such as municipal drinking water), growers subject to the rule do not need to test the water source as long as they have Public Water System results or a current water supply certificate of compliance that the water meets requirements of the Safe Drinking Water Act, or that it is free of detectable generic E. coli in 100 mL of water.

Commercial Processing with “Kill Step”

• § 112.2(b)
• (b) Produce is eligible for exemption from the requirements of this part (except as noted in paragraphs (b)(1), (2), and (3) of this section) under the following conditions:
• (1) Produce receives commercial processing that adequately reduces the presence of microorganisms of public health significance. Examples of commercial processing that adequately reduces the presence of microorganisms of public health significance are processing in accordance with the requirements of part 113, 114, or 120 of this chapter, treating with a validated process to eliminate spore-forming microorganisms (such as processing to produce tomato paste or shelf-stable tomatoes), and processing such as refining, distilling, or otherwise manufacturing/processing produce into products such as sugar, oil, spirits, wine, beer or similar products; and
• (2) You must disclose in documents accompanying the produce, in accordance with the practice of the trade, that the food is ‘‘not processed to adequately reduce the presence of microorganisms of public health significance;’’ and
• (3) You must either:
• (i) Annually obtain written assurance, subject to the requirements of paragraph (b)(6) of this section, from the customer that performs the commercial processing described in paragraph (b)(1) of this section that the customer has established and is following procedures (identified in the written assurance) that adequately reduce the presence of microorganisms of public health significance; or
• (ii) Annually obtain written assurance, subject to the requirements of paragraph (b)(6) of this section, from your customer that an entity in the distribution chain subsequent to the customer will perform commercial processing described in paragraph (b)(1) of this section and that the customer:
• (A) Will disclose in documents accompanying the food, in accordance with the practice of the trade, that the food is ‘‘not processed to adequately reduce the presence of microorganisms of public health significance’’; and
• (B) Will only sell to another entity that agrees, in writing, it will either:
• (1) Follow procedures (identified in a written assurance) that adequately reduce the presence of microorganisms of public health significance; or
• (2) Obtain a similar written assurance from its customer that the produce will receive commercial processing described in paragraph (b)(1) of this section, and that there will be disclosure in documents accompanying the food, in accordance with the practice of the trade, that the food is ‘‘not processed to adequately reduce the presence of microorganisms of public health significance’’; and
• (4) You must establish and maintain documentation of your compliance with applicable requirements in paragraphs (b)(2) and (3) in accordance with the requirements of subpart O of this part, including:
• (i) Documents containing disclosures required under paragraph (b)(2) of this section; and
• (ii) Annual written assurances obtained from customers required under paragraph (b)(3) of this section; and
• (5) The requirements of this subpart and subpart Q of this part apply to such produce; and
• (6) An entity that provides a written assurance under § 112.2(b)(3)(i) or (ii) must act consistently with the assurance and document its actions taken to satisfy the written assurance.