Information available related to Imports under the FDA Food Safety Modernization Act (FSMA).
About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.
The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, enables FDA to better protect public health by strengthening the food safety system. It gives FDA new tools and authorities to make certain imported foods meet the same safety standards as foods produced in the U.S.
Building a new food safety system based on prevention will take time, and FDA is creating a process for getting this work done. Congress has established specific implementation dates in the legislation. The funding the Agency gets each year, which affects staffing and vital operations, will affect how quickly FDA can put this legislation into effect. FDA is committed to implementing the requirements through an open process with opportunity for input from all stakeholders.
The following are among FDA’s key new import authorities and mandates. Specific implementation dates specified in the law are noted in parentheses:
- Importer accountability: For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. (Final regulation and guidance due 1 year following enactment)
- Third Party Certification: The FSMA establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards. This certification may be used to facilitate the entry of imports. (Establishment of a system for FDA to recognize accreditation bodies is due 2 years after enactment)
- Certification for high risk foods: FDA has the authority to require that high-risk imported foods be accompanied by a credible third party certification or other assurance of compliance as a condition of entry into the U.S.
- Voluntary qualified importer program: FDA must establish a voluntary program for importers that provides for expedited review and entry of foods from participating importers. Eligibility is limited to, among other things, importers offering food from certified facilities. (Implementation due 18 months after enactment)
- Authority to deny entry: FDA can refuse entry into the U.S. of food from a foreign facility if FDA is denied access by the facility or the country in which the facility is located.
- Section 202. Laboratory accreditation for analyses of food
- Section 301. Foreign supplier verification program
- Section 302. Voluntary qualified importer program
- Section 303. Authority to require import certifications for food
- Section 304. Prior notice of imported food shipments
- Section 305. Building capacity of foreign governments with respect to food safety
- Section 306. Inspection of foreign food facilities
- Section 307. Accreditation of third-party auditors
- Section 308. Foreign offices of the Food and Drug Administration
- Section 309. Smuggled food
- FDA Food Safety Modernization Act: Focus on Strategic Implementation of Prevention-Oriented Import Safety Programs
3 Public Meetings
- FDA Food Safety Modernization Act: Prevention-Oriented Import System Regulations and Implementation
March 21, 2016
- Final Rules for Produce Safety, Foreign Supplier Verification Program (FSVP), and Third Party Auditors
- Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies; Washington, DC
September 19, 2013
- FDA hosted an all-day public meeting entitled FDA Food Safety Modernization Act: A New Paradigm for Importers to discuss the implementation of the import safety provisions of the FDA Food Safety Modernization Act (FSMA).
- Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
- Food Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
- Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications
- User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications
- Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards
Draft Guidance for Industry and Food and Drug Administration Staff
- FDA's Voluntary Qualified Importer Program
Draft Guidance for Industry
- Prior Notice of Imported Food Questions and Answers (Edition 3)
Guidance for Industry
- Enforcement Policy Concerning Certain Prior Notice Requirements
Guidance for Industry
- Information Required in Prior Notice of Imported Food
See also Constituent Update: FDA Issues Final Rule, Information Required in Prior Notice of Imported Food