WASHINGTON, Aug. 11, 2014 – The National Grain and Feed
Association (NGFA) is asking the Food and Drug Administration (FDA) to make
“significant changes” in its proposed rules implementing the sanitary food
transportation provisions of the Food Safety Modernization Act (FSMA).
The proposed rules establish certain criteria, including
conditions, practices, training and record-keeping for the sanitary
transportation of food. NGFA submitted its suggestions for the proposed rules
during a comment period that ended July 31. It’s not known when FDA will
release its final rules.
President Barack Obama signed FSMA into law in January 2011.
The law is considered the most sweeping reform of the food safety laws in more
than 70 years. In addition to a rule on sanitary transportation under the act,
the FDA has also proposed: preventive control requirements for human and animal
food, standards for produce safety, a Foreign Supplier Verification Program for
importers, a program for the accreditation of third-party auditors, and focused
mitigation strategies to prevent intentional adulteration of the food system.
The rules regarding sanitary food transportation would apply
to shippers, carriers and receivers transporting agricultural commodities,
food, feed and feed ingredients, and other agricultural products by truck and
rail.
NGFA praised the agency for not applying the proposed rules
to barge and vessel transportation, as well as for not prescribing specific
sanitation practices for clean-out of rail and truck transportation conveyances
and equipment. “This gives shippers, carriers and receivers the flexibility to
continue to utilize appropriate sanitary transportation practices that have
evolved over time,” the group noted.
NGFA also said it supports FDA's decision not to restrict
access for human and animal food to certain classes or types of rail or truck
conveyances or transportation equipment.
However, the association asked FDA to grant three additional
exemptions:
--for transfers of human and animal food between facilities
operating under the ownership of the same legal entity, such as the same parent
or corporate entity. Intra-company transfers typically involve the use of
dedicated fleets of trucks or rail cars to move agricultural and food products
between a company's own facilities, NGFA said.
--for dedicated rail and truck transportation conveyances
and transportation equipment used to haul the same type of human or animal food
on a continual basis.
--for transportation of live food animals. Although NGFA
supported a tentative conclusion from the FDA to exempt transport of live
food-producing animals from regulations, it suggested adding that specific
exemption to this section of the rule. Transportation of live animals is
subject to the jurisdiction of USDA’s Food Safety and Inspection Service.
NGFA also said it had asked FDA to make other changes to its
proposed rules, including the following:
-Clarify the definition of “shipper” so that the requirement
to notify carriers of any special clean-out procedures and to keep records
applies to the party that loads a shipment, not to brokers or third-party
logistics operators who arrange for the transportation to be provided.
-Modify the proposed requirement that carriers identify the
previous three loads hauled in bulk trucks or rail cars. The NGFA said such a
requirement is excessive and unnecessary.
-Eliminate the proposed recordkeeping requirement that
electronic records be kept in a manner that complies with the agency's “onerous
and costly” Part 11 rules that stipulate computer validation.
-Eliminate the proposal to exempt from the regulations those
shippers, carriers and receivers that have less than $500,000 in total annual
sales. NGFA said size-based exemptions are inappropriate for food safety.
Instead, the association recommended that the agency provide small entities
with additional time to comply with final regulations before enforcement
begins.
-Clarify the
definition of “transportation equipment” to apply only to those items (such as
containers, totes and pallets) that actually are loaded onto a truck or
railcar, or devices (such as pumps, fittings, hoses and gaskets) that are
integral and affixed to the transportation conveyance.
-Delete the proposed requirement that convenient
hand-washing facilities be provided for vehicle operators unless human contact
with the food poses a hazard of causing the food to become adulterated or unfit
for human or animal consumption.
FDA has also proposed a regulatory exemption for truck
transportation of raw agricultural commodities by farms. NGFA recommended that
the agency develop guidance on good transportation practices.
“Such guidance should stress the importance of cleanout
procedures in non-dedicated farm transportation conveyances and equipment used
to haul raw agricultural commodities and other products, and provide practical,
realistic and effective sample clean-out procedures for such conveyances,” NGFA
told FDA.
Additionally, NGFA emphasized that FDA’s regulations should
not undermine the legal responsibility for rail carriers and truck transporters
to provide clean conveyances and transportation equipment.
“This legal obligation is reasonable because the carrier or
other provider of the transportation conveyance is in the best position to
monitor the use of transportation conveyances and equipment, know the contents
of the previous load(s) hauled, and implement prudent and effective clean-out
procedures to protect product safety,” NGFA said.
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