In April 2016, FDA published its final rule for the Sanitary Transportation
of Food (STF). The rule, which became effective on
June 6, 2016, established requirements for shippers, loaders, carriers by motor
or rail vehicle and receivers involved in transporting human (and animal)
food to use documented sanitary practices to ensure the safety of that food.
The goal of the final STF is to prevent practices
during transportation that create food safety risks, such as failure to
properly refrigerate food, inadequate cleaning of vehicles between loads, and
failure to properly protect food.
Pennsylvania Department of Agriculture (PDA) adopts the
new federal regulations as dictated by the Food Safety Act (3 Pa. C.S.A.
§5733(f)) and will enforce all applicable provisions. During inspection of food
establishments subject to this rule, PDA will assess their transportation
operations and practices to make sure required plans are being implemented
properly. PDA will work with and assist these firms to understand and comply
with the new regulations.
The full ruling can be found in the Federal Register.
Who is covered?
With
some exceptions, the final rule applies to shippers, receivers, loaders, and
carriers who transport food in the United States by motor or rail vehicle,
whether or not the food is offered for or enters interstate commerce. It also
applies to foreign shippers who ship food into the U.S. directly by any means
(e.g. motor, rail, ship, air) and arrange for the transfer of the intact
container onto motor or rail vehicle for transportation within the U.S., if
that food will be consumed or distributed in the United States.
Companies
involved in the transportation of food intended for export are covered by the
rule until the shipment reaches a port or U.S. border.
Exemptions
- Shippers, receivers, loaders or
carriers engaged in food transportation operations that have less than $500,000
in average annual revenue;
- Transportation activities performed
by a farm;
- Transportation of food that is
transshipped through the U.S. to another country;
- Transportation of food that is
imported for future export and that is neither consumed or distributed in the U.S.;
- Transportation of compressed food
gases (e.g. cylinders of carbon dioxide, nitrogen used in food and beverage
products), and food contact substances;
- Transportation of human food
byproducts 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 (TCS food).
- Transportation of live food
animals, except molluscan shellfish.
Waivers
In April
2017, the FDA published three waivers for businesses whose transportation operations
are subject to Federal-State or local controls. They include:
Businesses that hold valid permits
and are inspected under the National Conference on Interstate Milk Shipments’
Grade “A” Milk Safety Program, only when engaged in transportation operations
involving bulk and finished Grade “A” milk and milk products.
Businesses that are permitted or
otherwise authorized by the regulatory authority to operate a food
establishment that provides food directly to consumers (including restaurants,
retail food establishments, and nonprofit food establishments), only when
engaged in transportation operations as:
Receivers,
whether the food is received at the establishment itself or at a location where
the authorized establishment receives and immediately transports the food to
the food establishment;
Shippers and carriers in operations
in which food is transported from the establishment as part of the normal
business operations of a retail establishment, such as:
delivery
of the food directly to the consumer(s) by the authorized establishment or a
third-party delivery service or;
delivery of the food to another
location operated by the authorized establishment or an affiliated
establishment where the food is to be sold or served directly to the
consumer(s).
Businesses
that are appropriately certified and are inspected under the requirements
established by the Interstate Shellfish Sanitation Conference’s National
Shellfish Sanitation Program (NSSP), only when engaged in transportation
operations involving molluscan shellfish in vehicles that are permitted by the
State NSSP certification authority.
Compliance Dates
The compliance date for Large
businesses began in April 6, 2017. All other covered businesses will have to
comply with the rule by April 6, 2018.
Key Requirements
The rule identifies shippers
as having the primary responsibility in determining appropriate
transportation operations. Shippers may rely on contractual agreements to
assign some of the responsibilities to other parties. The FDA defines ‘shipper’
as a person (such as the manufacturer or a freight broker) who arranges for the
transportation of food in the United States by a carrier or multiple carriers
sequentially.
The rule requires that shippers
develop and implement written procedures to ensure:
Vehicles and transportation equipment: Vehicles and equipment are
properly designed, maintained and in appropriate sanitary condition to
ensure that it does not cause the food that it transports to become unsafe.
Transportation operations: measures taken during
transportation to ensure food safety, such as adequate temperature controls,
preventing contamination of ready to eat food by raw food, protection from food
contamination by non-food items in the same load or a previous load on the
vehicle, and the protection of food from cross-contact, i.e., the unintentional
incorporation of a food allergen.
Training: Training of carrier personnel in the awareness of potential food
safety problems and basic sanitary transportation practices required by the
rule, and documentation of the training. This training is required when the
carrier and shipper agree that the carrier is responsible in whole or part, for
sanitary conditions during transport.
FDA has developed a free training module for carriers
to help them meet the STF requirements. The online course can be found on FDA website.
Carriers
may elect either to use this module as a means of satisfying the minimum
requirements, to train their own personnel or to acquire training through third
party training vendors and or use.
Records: Maintain records of shipper-to-carrier communication, written
procedures, agreements and training (required of carriers). The required
retention time for these records depends upon the type of record and when the
covered activity occurred, but except for training documentation, does not
exceed 12 months.
The final rule allows offsite storage of all records,
except for the written procedures required, provided that the records can be
retrieved and made available within 24-hours for
regulatory review.