The Food and Drug Administration (FDA) has issued a final rule that establishes new requirements aimed at ensuring that the transportation of food is free from contamination throughout the supply chain from farm to table.
The new rules, which were required by the Food Safety Modernization Act (FSMA), take effect for some companies on April 6, 2017, but the vast majority of covered motor carriers -- those having less than $27.5 million in annual receipts -- would have until April 6, 2018 to comply. The extra year also applies to businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons.
Many companies will not have to worry about the new rule at all, however. The rule exempts:
Carriers, shippers and receivers that have less than $500,000 in annual revenue
Farms transporting their own food
Transportation of food that is completely enclosed by a container unless the food requires temperature control for safety
Transportation of live food animals, except molluscan shellfish
Transportation of human food byproducts transported for use as animal food without further processing
Transportation of food that is transshipped through the United States or is imported for future export and not consumed or distributed in the U.S.
Transportation of compressed food gases (such as carbon dioxide, nitrogen or oxygen authorized for use in food and beverage products), and food contact substances, such as coatings, plastics, paper and so on.
Most of those exemptions were not part of FDA's initial proposed rule.
In addition to these exemptions, FDA said it intends to publish waivers for carriers, shippers and receivers that hold valid permits and are inspected under the National Conference on Interstate Milk Shipments (NCIMS) Grade A Milk Safety program. The waiver would apply only when Grade A milk and milk products are being transported.
Waivers also would be granted to food establishments such as restaurants, supermarkets and home grocery delivery operations that already hold valid permits by a regulatory agency to deliver food directly to customers.
For motor carriers, shippers and receivers not lucky enough to qualify for an exemption or waiver, the new rule requires various steps to reduce risks associated with problems such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads and failure to protect food. FDA has established requirements for vehicles and transportation equipment, transportation operations, records, training and waivers.
Vehicles and transportation equipment
The design and maintenance of vehicles and transportation equipment must prevent the food transported from becoming unsafe. For example, equipment must be suitable and adequately cleanable for their intended use and capable of maintaining temperatures necessary for the safe transport of food.
Motor carriers, shippers and receivers must take various steps during transportation to ensure food safety, such as adequate temperature controls; preventing contamination of ready to eat food from touching raw food; protection of food from contamination by non-food items in the same load or previous load; and protection of food from cross-contact – i.e., the unintentional incorporation of a food allergen.
Training of carrier personnel in sanitary transportation practices and documentation of the training is required when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport. FDA plans to develop an online course that would meet the training requirements and make it available before the first compliance dates go into effect.
Record-keeping requirements cover written procedures, agreements and training. The required retention time for these records depends upon the type of record and when the covered activity occurred, but does not exceed 12 months.
Key changes from the proposed rule
The longer list of exempt operations is one of the biggest changes in the final rule from the version FDA initially proposed, but there are other important changes, including:
Flexibility for shippers and carriers to agree to a temperature monitoring mechanism as opposed to mandatory use of a temperature indicating or recording device during transport. In addition, carriers must demonstrate maintenance of requested temperature conditions only upon request and not after every single shipment
A focus solely on practices that create safety risks rather than those that affect quality but don't make food dangerous to consume
Addition of "loaders" – people who physically load food onto a motor or rail vehicle – as a covered party
Clarification of the relevance of intended use (human food vs. animal feed, for example) and stage of production (raw materials vs. finished product, for example)
Primary responsibility for determining appropriate transportation operations resting with the shipper, who may use contractual agreements to assign those responsibilities to others
A halt to the sale or distribution of food until safety is verified if any covered person or company in the transportation chain becomes aware of a possible failure of temperature control or any other condition that might render a food unsafe
For more information
The most complete source of information is the final rule as published in the Federal Register, but most questions likely would be answered by materials on the FDA FSMA website.
Also, FDA has scheduled an April 25 webinar on the new rule. For details on the session, which will be held at 11 a.m. Eastern, click here.
Finally, for any questions not easily found in published documents, FDA has launched the FDA FSMA Food Safety Technical Assistance Network. Questions submitted online or by mail will be answered by information specialists or subject matter experts.