Training. These include the training of carrier personnel in
sanitary transportation practices and documentation of the
training. Such training is required when the carrier and shipper agree that the carrier is responsible for sanitary conditions
Records. These include maintenance of records of written procedures, agreements, and training (required of carriers). The
required retention time for such records depends upon the
type of record and when the covered activity occurred, but
does not exceed 12 months.
The Sanitary Food Transportation Act allows the requirements
of the FSMA rule to be waived if the agency determines that a
waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health.
The FDA announced in the proposed rule that it intends to
publish waivers for:
• Shippers, carriers, and receivers who hold valid permits and
are inspected under the National Conference on Interstate
Milk Shipments (NCIMS) Grade “A” Milk Safety program. This
waiver only applies when Grade A milk and milk products—
those produced under certain sanitary conditions—are being
transported. FDA acknowledges that controls for such transportation operations already exist under the NCIMS program, with state enforcement and FDA oversight.
• Food establishments holding valid permits issued by a relevant regulatory authority, such as a state or tribal agency,
when engaged as receivers, shippers, and carriers in operations in which food is relinquished to customers after being
transported from the establishment. Examples of such
establishments include restaurants, supermarkets, and
home grocery delivery operations. FDA acknowledges that
controls for such transportation operations already exist
under the Retail Food Program, with state, territorial, tribal
and local enforcement, and FDA oversight.
The agency intends to publish these waivers in the Federal
Register prior to the date firms are required to comply with
The FDA also received comments asking for a waiver for
transportation operations for molluscan shellfish for entities
that hold valid state permits under the National Shellfish Sanitation Program. The agency continues to review comments on
this request, and will issue a determination in the near future.
Small businesses. Businesses other than motor carriers who are
not also shippers and/or receivers employing fewer than 500 persons, and motor carriers having less than $27.5 million in annual
receipts would have to comply two years after the publication of
the final rule.
Other businesses. Businesses that are not small and are not otherwise excluded from coverage would have to comply one year after
the publication of the final rule.
AssIstANcE FOR INDUstRy
The FDA FSMA Food Safety Technical Assistance Network
( http://tinyurl.com/jhakysu) provides information to support
industry understanding and implementation of FSMA. Questions
submitted online or by mail will be answered by information specialists or subject matter experts.
The FDA plans to develop an online course that would meet
the training requirements for this rule, and be available before the
first compliance dates go into effect. The agency will also issue
guidance to assist industry in complying with the final rule.