food contaminants. 3 To aid in these tasks, the law strengthens foodborne illness surveillance systems and authorizes agency rulemaking to enhance food traceability. 4
The law also increases the frequency of FDA inspections, including those of foreign facilities, while requiring periodic renewal registrations and establishing user fees
for reinspection and recall-related costs. 5 FDA will be required to target its inspectional resources on high-risk facilities, in accordance with known safety risks of the facility, compliance history and rigor and effectiveness of the facility’s hazard analysis
and risk-based preventive controls. 6 The new law also tightens industry recordkeeping
requirements and grants FDA new authority to inspect company records, mandate
product recalls and quarantine food for which FDA has “reason to believe the article
is adulterated or misbranded.” 7 Moreover, FDA must establish laboratory accreditation standards for laboratories conducting food testing while working with other federal agencies to form an integrated consortium of food testing laboratory networks. 8
Under the law, FDA is required to conduct analyses
and compile reports to assess the safety of the food supply and to recommend improvements to security and to
work cooperatively with other agencies to carry out its
responsibilities to strengthen food safety oversight. For
example, FDA must conduct a vulnerability assessment
and promulgate regulations to protect against intentional adulteration of food. 9 In a separate provision,
FDA must coordinate with the United States Department of Agriculture (USDA) to draft a National Agriculture and Food Defense Strategy to enhance preparedness
of the nation’s food system, improve detection, ensure
efficient response to agriculture and food emergencies
and secure production after an agriculture or food emergency. 10 Moreover, together with the Department of
Homeland Security and USDA, FDA must submit a report to Congress identifying programs and practices intended to promote the safety and supply chain security
of food and to prevent foodborne illness and other
food-related hazards. 11 The law also requires FDA to implement standards and administer training and education for state, local, territorial
and tribal food safety officials relating to regulatory responsibilities under the Federal
Food, Drug and Cosmetic Act, 12 and establishes five Integrated Food Safety Centers
for Excellence to serve as resources to respond to foodborne illness outbreaks. 13
Major portions of the law are also devoted to increasing the scrutiny of food imported into the U.S. from abroad. These new provisions authorize FDA to require that
food imports be accompanied by certifications of compliance with U.S. food safety
standards. Foods that are subject to these requirements will be refused admission if
they are not accompanied by the proper documentation. 14 The law also permits FDA
to determine whether international food safety programs and standards are adequate
to ensure that food imported into the U.S. is as safe as similar products manufactured,
processed, packed or held domestically. 14 Importers will be required to implement risk-based foreign supplier verification programs for most of their imported foods, and
FDA must establish a voluntary qualified importer program to certify participating importers and provide for expedited review and importation of food. 15 FDA will also establish international offices to provide assistance to foreign governmental entities to
ensure the safety of food exported by those countries to the U.S. and accreditation
standards for third-party auditors for the purposes of conducting inspections. 16
“The new law
changes
dramatically
the legal
framework for
regulating
food safety in
the U.S.”
Administrative Initiatives
