Modified Food Safety Bill
Has Lower Registration Fees
The House
Energy and Commerce Committee’s Subcommittee on Health
has approved a modified version of the Food Safety
Enhancement Act of 2009 (H.R. 2749) after lowering the
required registration fees and making certain other
changes. The full committee is expected to consider the
bill June 17, at which time concerns with respect to
criminal and civil penalties, inspection frequency,
effects on small businesses and other issues are likely
to be raised.
According to press reports, the subcommittee-passed bill
includes the following provisions.
Facility Registration - requires all food
facilities operating within the U.S., all importers of
foods, drugs and medical devices, and customs brokers
handling food imports to register annually with the Food
and Drug Administration
Fees - requires registered facilities to pay an
annual registration fee of $500 (down from $1,000 in the
previous version of the bill), caps the registration fee
at $175,000 annually per company, requires registered
food facilities to pay for FDA costs associated with
reinspections and food recalls, and allows FDA to charge
a fee to domestic firms requesting export certificates
for exported food
ID Number - creates unique identification numbers
for all food, drug and medical device facilities and
importers
Increased Inspections - requires high-risk
facilities to be inspected at least once every six to 18
months, low-risk facilities to be inspected at least
once every 18 months to three years, and warehouses that
store food to be inspected at least once every three to
four years
Stronger Enforcement - provides FDA with new
authority to issue mandatory recalls of tainted foods,
increases criminal penalties to a maximum of $100,000
for individuals and $500,000 for organizations,
establishes civil monetary penalties that may be imposed
on food facilities that fail to comply with safety
requirements, strengthens FDA’s authority to
administratively detain unsafe food products, grants FDA
quarantine authority under which it may restrict or
prohibit the movement of unsafe food products from a
particular geographic area, and grants FDA new authority
to subpoena records related to possible violations
Expedited Imports - importers meeting voluntary
security guidelines developed by FDA for imported foods
would receive expedited processing
Country of Origin Labeling - requires all
processed food labels to indicate the country in which
final processing occurred and requires country-of-origin
labeling for all produce (according to Inside US
Trade, the subcommittee removed a provision
requiring food manufacturers to identify the country of
origin for all ingredients on their Web sites)
Foreign Government Certification - FDA would be
able to require food to be certified as meeting all U.S.
food safety requirements by the government of the
country from which the article originated or by certain
qualified third parties
Safety Plans - requires all food facilities
operating within the U.S. or importing food to the U.S.
to implement safety plans that identify and protect
against food hazards and gives FDA the authority to
specify minimum food safety plan requirements and audit
food safety plans
Hazard Mitigation Efforts - directs FDA to
identify industry and regulatory approaches to minimize
hazards in the food supply
Traceability - FDA would have to issue
regulations that require food producers, manufacturers,
processors, transporters or holders to (a) maintain the
full pedigree of the origin and previous distribution
history of the food and link that history with the
subsequent distribution history of the food and (b)
establish an interoperable record to ensure fast and
efficient trace back (according to Inside US Trade,
however, FDA would have to conduct a pilot program
before issuing these regulations and take other steps to
judge their feasibility)
Expanded Lab Capacity - requires FDA to establish
a program to recognize laboratory accreditation bodies
and to accept test results only from duly accredited
laboratories; also gives FDA the ability to require
laboratories to send test results to FDA
Foreign Inspectorate - requires FDA to establish
and maintain a corps of inspectors to monitor foreign
facilities producing food, drugs, medical devices and
cosmetics for U.S. consumers
Infant Formula - enhances FDA’s ability to assure
the safety of new infant formulas before they go on the
market