-- Creates an up-to-date registry of all food facilities
serving American consumers: Requires all facilities operating
within the U.S. or importing food to the U.S. to register with the
-- Generates resources to support FDA oversight of food
safety: Requires registered facilities to pay an annual
registration fee of $1,000 in order to generate revenue for food
safety activities at the FDA; requires registered facilities to
pay for FDA’s costs associated with reinspections and food
recalls; allows FDA to charge a fee to domestic firms requesting
export certificates for exported food.
-- Prevents food safety problems before they occur: Requires
all facilities operating within the U.S. or importing food to the
U.S. to implement safety plans that identify and protect against
food hazards. FDA would have the authority to specify minimum food
safety plan requirements and to audit food safety plans.
-- Requires safety plans for fresh produce: Directs
FDA to issue regulations for ensuring the safe production and harvesting
of fruits and vegetables.
-- Increases inspections of food facilities:
Sets a minimum inspection frequency for all registered facilities.
High-risk facilities would be inspected at least once every six
to 18 months; low risk facilities would be inspected at least once
every 18 months to three years; and warehouses that store food would
be inspected at least once every three to four years. Refusing,
impeding, or delaying an inspection is prohibited.
-- Improves traceability of food: Enhances FDA’s
ability to trace the origin of tainted food in the event of an outbreak
of foodborne illness. FDA would be required to issue regulations
that require food producers, manufacturers, processors, transporters,
or holders to maintain the full pedigree of the origin and previous
distribution history of the food and to link that history with the
subsequent distribution history of the food; and to establish an
interoperable record to ensure fast and efficient traceback (current
law permits facilities to hold a record in any format — paper
or electronic — making efficient tracing of foods difficult
for FDA). Prior to issuing such regulations, FDA would be required
to conduct a feasibility study, public meetings, and a pilot project.
-- Enhances the safety of imported food: As an
additional layer of protection, FDA can 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. Third party certifying entities must meet strict
requirements to protect against conflicts of interest with the firm
-- Expands laboratory testing capacity: Requires
FDA to establish a program to recognize laboratory accreditation
bodies and to accept test results only from duly accredited laboratories.
Gives FDA the ability to require laboratories to send test results
-- Provides strong, flexible enforcement tools:
Provides FDA new authority to issue mandatory recalls of tainted
foods. Strengthens criminal penalties and establishes civil monetary
penalties that FDA may impose on food facilities that fail to comply
with safety requirements.
-- Creates fast-track import process for food meeting
security standards: Permits FDA to develop voluntary security
guidelines for imported foods. Importers meeting the guidelines
would receive expedited processing.
-- Enhances the safety of infant formula: Enhances
FDA’s ability to assure the safety of new infant formulas
before they go on the market.
-- Advances the science of food safety: Directs
the Secretary to include food in an active surveillance system to
assess more accurately the frequency and sources of human illness.
The Secretary is also directed to identify industry and regulatory
approaches to minimize hazards in the food supply.
-- Enhances FDA’s ability to block unsafe food from
entering the food supply: Strengthens FDA’s authority
to administratively detain unsafe food products. Grants FDA “quarantine”
authority under which the agency may restrict or prohibit the movement
of unsafe food products from a particular geographic area.
-- Directs FDA to assess the use of carbon monoxide in
certain foods: Requires FDA to conduct a safety review
of the use of carbon monoxide in meat, poultry, and seafood products.
-- Enhances transparency of GRAS program: Requires
posting on FDA’s website of documentation submitted to FDA
in support of a “generally recognized as safe” (GRAS)
-- Requires country-of-origin labeling and disclosure:
Requires all processed food labels to indicate the country
in which final processing occurred. Requires food manufacturers
to identify the country of origin for all ingredients on their websites.
Requires country-of-origin labeling for all produce.
-- Creates an up-to-date registry of importers:
Requires all importers of drugs, devices, and foods to register
with the FDA annually and to pay a registration fee.
-- Requires unique identification numbers for facilities
and importers: To enhance information about FDA-regulated
entities, creates unique identification numbers for all drug, device,
and food facilities and importers.
-- Creates a dedicated foreign inspectorate: Requires
FDA to establish and maintain a corps of inspectors to monitor foreign
facilities producing food, drugs, devices, and cosmetics for American
-- Grants FDA new authority to subpoena records related
to possible violations.
-- Provides protection for whistleblowers that bring attention
to important safety information: Prohibits entities regulated
by the FDA from discriminating against an employee in retaliation
for assisting in any investigation regarding any conduct which the
employee reasonably believes constitutes a violation of federal