FDA Proposes Additional Record Keeping for High-Risk Foods, Including Imports

Required by Section 204(d) of FSMA, the proposed requirements “would establish traceability recordkeeping requirements for persons who manufacture, process, pack, or hold foods that FDA has designated as foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health,” FDA said. “The requirements are intended to help us rapidly and effectively identify recipients of these foods to prevent or mitigate a foodborne illness outbreak and to address credible threats of serious adverse health consequences or death as a result of such foods being adulterated … or misbranded,” it said.

Requirements Apply to High-Risk Foods

FDA’s proposed rule would, as directed by FSMA, apply the enhanced record-keeping requirements to certain foods it has identified as being of high risk. Foods that contain the high-risk foods as ingredients would also be covered by the proposed new requirements, FDA said. FDA’s proposed Food Traceability List of foods covered by the new traceability requirements is as follows:

• Cheeses, other than hard cheeses -- Includes all soft ripened or semi-soft cheeses, and fresh soft cheeses that are made with pasteurized or unpasteurized milk
• Shell eggs -- Shell egg means the egg of the domesticated chicken
• Nut butter -- Includes all types of tree nut and peanut butters; does not include soy or seed butters
• Cucumbers -- Includes all varieties of cucumbers
• Herbs (fresh) -- Includes all types of herbs, such as parsley, cilantro, basil
• Leafy greens, 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, collards, and endive
• Melons -- Includes all types of melons, such as cantaloupe, honeydew, and watermelon
• Peppers -- Includes all varieties of peppers
• Sprouts -- Includes all varieties of sprouts
• Tomatoes -- Includes all varieties of tomatoes
• Tropical tree fruits -- Includes all types of tropical tree fruit, such as mango, papaya, mamey, guava, lychee, jackfruit, and starfruit
• Fruits and Vegetables (fresh-cut) -- Includes all types of fresh-cut fruits and vegetables
• Finfish, including smoked finfish -- Includes all finfish species, such as cod, haddock, Alaska pollack, tuna, mahi mahi, mackerel, grouper, barracuda, and salmon; except does not include siluriformes fish, such as catfish
• Crustaceans -- Includes all crustacean species, such as shrimp, crab, lobster, and crayfish
• Mollusks, bivalves -- Includes all species of bivalve mollusks, such as oysters, clams, and mussels; does not include scallop adductor muscle
• Ready-to-eat deli salads -- Includes all types of ready-to-eat deli salads, such as egg salad, potato salad, pasta salad, and seafood salad; does not include meat salads

FDA developed this list partially based on input received from a request for comments issued in 2014 (see 14020318). FDA will publish a final Food Traceability List on its website when it issues its final rule. FDA will then periodically review the list to determine whether revisions are appropriate, under procedures outlined in its new regulations, FDA said.

Record Keeping Required for Key Points in Supply Chain, Including Some Importers

The proposed rule would require the establishment of records containing “key data elements” (KDEs) for different “critical tracking events” (CTEs) of any listed food’s supply chain. The requirements would apply to any entity that manufactures, processes, packs, or holds foods on FDA’s Food Traceability List. FDA would also require general records on the traceability program of each covered entity. Paper records would be acceptable in most cases, though FDA encourages entities to maintain their records electronically.

Data elements vary by CTE. For each of these critical tracking events, similar, but different, record-keeping requirements would apply. Data elements that would have to be recorded would include information on the food, location information, lot codes, and entry numbers for foods that have been imported. The specific data elements would vary based on whether the entity is a grower, receiver, first receiver, creator, transformer or shipper of the food.

Traceability program records also required. FDA also would require general records about the overall traceability program of entities that manufacture, process, pack or hold foods. This would include a description of reference records, a list of listed foods that are shipped, a description of how traceability lot codes are assigned, and other information needed to understand data in an entity’s records.

Shippers must provide information to downstream entities. In order to avoid situations wherein downstream entities in the supply chain are unable to provide records required by FDA, shippers of covered foods would be required to send some records to the immediate subsequent recipient of the food (other than the transporter), including the lot code and other information on the food and information on the originator of the food.

Importers May Be Subject if Performing Covered Activities, Including ‘Holding'

While the proposed rule does not specifically list requirements for importers, FDA does have the authority to refuse admission to importers for violations of these record-keeping requirements by importers who are subject to them because they manufacture, process, pack or hold the food, the agency said. “We believe that many, but not all, persons who transport, distribute, receive, or import food also ‘hold’ food, as we propose to define holding,” FDA said.

On the other hand, importers that do not physically possess food would not be “holding” the food under the proposed rule’s definition. “A person who coordinates the import of a listed food but never takes physical possession of the food would not be subject to the rule, while a person who imports a listed food they physically possess would be subject to the rule unless an exemption applied,” FDA said. “For example, some firms buy food produced in foreign countries, arrange for the importation of the food into the United States, and sell the food to other U.S. firms without ever taking physical possession of the food; such firms would not be subject to the rule,” it said.

Importers may be designated to keep records. But importers and brokers, even if they only arrange for the importation and never physically hold the food, may maintain tracing information of the food on behalf of a downstream entity, such as a cold storage facility that receives imported produce. “We propose to allow persons subject to the proposed rule to designate an individual or firm who will establish and maintain tracing records on behalf of the person, although the person subject to the rule would remain responsible for meeting … requirements. This would enable firms who hold imported foods to enter into agreements with importers of record, brokers, and others to keep required tracing records for the foods on their behalf,” FDA said.

Exemptions Apply for Transporters, Small Farms; Modified Requirements Requests

FDA is proposing a plethora of exemptions from the proposed new record-keeping requirements. Small farms and shell egg producers would not be subject to the rule, nor would foods that receive certain types of processing or produce that is rarely consumed raw. Entities that apply a “kill step” would not have to maintain records for the subsequent shipping of the rule. Transporters of food would also be exempt.

FDA is also proposing to establish procedures whereby entities subject to the requirements could request modified requirements or an exemption for a specific food or type of entity, “on the grounds that application of the requirements to that food or type of entity is not necessary to protect public health,” FDA said. “In addition, the proposed rule includes procedures for requesting a waiver of one or more of the requirements for an individual entity or a type of entity on the grounds that having to meet the requirements would impose an economic hardship.”

Implementation Two Years After Final Rule

FDA is proposing that the new requirements take effect two years after the effective date of the final rule, which would come 60 days after the final rule is published.