FSMA Exemptions and Requirements for Sanitary Food Transport
Food haulers, take note: the FDA’s proposed Food Safety Modernization Act (FSMA) rule on sanitary transportation of human and animal food is now final.
The rule advances the effort to protect foods from farm to table by keeping them safe from contamination during transportation. The goal is to prevent food safety risks during transportation, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads and failure to properly protect food.
The FSMA rule establishes new requirements in these four areas:
- Vehicles and transportation equipment
The design and maintenance of vehicles and transportation equipment must ensure that they do not cause transported foods to become unsafe. They must be suitable and adequately cleanable for their intended use and capable of maintaining temperatures necessary for the safe transport of food.
- Transportation operations
This includes the measures taken during transportation to ensure food safety, i.e., adequate temperature controls to prevent contamination of ready-to-eat food from touching raw food. This also includes the 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 is required when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport. This includes the training of carrier personnel in sanitary transportation practices and documentation of the training.
This includes the maintenance of records of written procedures, agreements and training required of carriers.
The rule primarily applies to shippers, receivers, loaders and carriers who transport food throughout the United States by motor or rail vehicle, whether or not the food is affiliated with interstate commerce. It also applies to shippers in other countries who ship food to the United States directly by motor vehicle, rail vehicle, ship or air, and arrange for the transfer of the intact container onto motor or rail vehicle for transportation within the U.S. to be consumed or distributed. It will be enforced by FDA authorities.
When does my company need to comply?
The FDA recognizes that small businesses in particular may need more time to comply with the new requirements.
- Small businesses
Businesses other than motor carriers who are not also shippers and/or receivers that have fewer than 500 employees and motor carriers with less than $27.5 million in annual receipts need to comply two years from publication of the final rule.
- Other businesses
Companies not fitting the “small business” description have one year to comply after the final rule publication.
Which companies qualify for exemption?
The following businesses may be exempt from the rule:
- Shippers, receivers or carriers engaged in food transportation operations that have an annual gross profit of less than $500,000.
- Transportation activities performed by a farm.
- Transportation of food that is transported through the United States to another country.
- Transportation of food that is imported for future export and that is neither consumed nor distributed in the United States.
- Transportation of compressed food gases (carbon dioxide, nitrogen or oxygen authorized for use in food and beverage products) and food contact substances.
- Transportation of human food byproducts transported for use as animal food without further processing
- Transportation of food that is completely enclosed by a container except a food that requires temperature control for safety.
- Transportation of live animals, except molluscan shellfish.
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