PRODUCE LAW: FSMA Produce Safety — what are the obligations of the middle-man?

FDA’s Produce Safety rule under the Food Safety Modernization Act (FSMA) establishes science based minimum standards for the safe growing, harvesting, packaging and holding of imported fruits and vegetables grown for human consumption.

But what responsibilities attach to parties that do not grow, harvest or package, but that simply sell produce from a grower, for example, to an end user? We will discuss here the obligations of the middle-man, which in some cases could be the warehouse that physically receives and holds goods for a downstream customer or in other cases, a broker that is brokering the deal between the grower and end user, but never physically holds product.

As brief background, the regulatory framework of the Produce Safety rule considers various factors related to produce and the farming community, including diverse operations, and a broad range of crops and practices

Rule Covers Farm Production — What About The Middle-Man

The rule covers domestic and imported produce, and produce for human consumption, but exempts produce for personal or on-farm consumption, produce that is not a “raw agricultural commodity”, certain produce that is rarely consumed raw, and farms with produce sales of less than or equal to $25,000 per year. Produce that will be involved in commercial processing, i.e. kill step, or other processes that adequately minimizes hazards are also eligible for exemptions with modified requirements.

The rule establishes standards for produce safety by focusing on conditions and practices that are identified as potential contributing factors for microbial contamination. Standards are established for agricultural water, biological soil amendments of animal origin, worker health and hygiene, equipment, tools, buildings and sanitation, domesticated and wild animals, growing harvesting, packing and holding activities, and sprouts requirements.

But again, what are the obligations for the middle-men, the parties that do not grow, harvest or package produce, and that are not the end-user? This is where the interplay of the FSMA rules, and the broader objective of FSMA to document supply chain safety, takes shape.

Produce Safety Rule Compliance in Seven Steps for Middle-Men

For a person who contracts with a foreign grower, and physically holds or warehouses product to be sold at a later date to a buyer, that person would likely be regarded as the Foreign Supplier Verification Program (FSVP) importer. In this capacity, the person would be required to

(1) Identify all biological, chemical (including radiological) and physical hazards with the imported product

(2) Evaluate and approve the foreign supplier

(3) Determine where the identified hazards would be controlled

(4) Establish written procedures that ensure foods are imported from approved foreign suppliers and that foreign supplier verification activities are conducted for the imported foods

(5) Implement appropriate corrective actions when appropriate

(6) Conduct periodic reviews of their Foreign Supplier Verification Program

(7) Be identified on the entry of each shipment and meet the record requirements.

There are of course various iterations and arrangements that can be developed amongst individuals or entities, which may result in different individuals/parties having different obligations. This could be modified by contract.

Further, their responsibility under FSMA may not end there. It is important to understand that all the seven major regulations and the voluntary qualified importer program work together and one must understand each of them and their effective compliance date to accurately identify responsibilities under FSMA. Compliance dates vary from regulation to regulation and are often dependent upon the size of the entity.