FDA Outlines FSMA Import Safety Mandates, Lists Completed Provisions

(The FSMA was enacted on January 4, 2011 as Public Law No. 111-353. The law provides FDA with new enforcement authorities to help it achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. The law also gives FDA new tools to better ensure the safety of imported foods and directs FDA to build an integrated national food safety system in partnership with State and local authorities. See ITT’s Online Archives or 01/04/11 news, 11010426, for comprehensive BP summary of the law.)

FSMA is Historic as It Creates New System of Import Oversight, Food Safety, Etc.

FDA states that the FSMA is a historic law as it involves a new system of import oversight, the creation of a new food safety system, includes a broad prevention mandate and accountability, and emphasizes partnerships, among other reasons.

Congress Has Given FDA Authority to Use Preventive Controls More Broadly

FDA notes that comprehensive preventive controls for food and feed facilities is not new, but Congress has given FDA explicit authority to use the tool more broadly. Preventive controls would be used in regards to produce safety standards, intentional adulteration standards, and transportation.

With Preventive Controls, FDA Can Consider New Ways to Inspect

More mandated inspections are a part of the FSMA, but with preventive controls in place, FDA can consider new ways to inspect. New tools include: (i) mandatory recall; (ii) expanded records access; (iii) expanded administrative detention; (iv) suspension of registration; (v) enhanced product tracing; and (vi) third party laboratory testing.

Most Groundbreaking Shift of FSMA Involves Import Safety

FDA notes that current reliance on port-of-entry inspections cannot handle increases in imported food. However, FDA states that import safety is the most groundbreaking shift in the FSMA as, among other things, it requires food from abroad to be as safe as domestic food. Importers are now responsible for ensuring that their foreign suppliers have adequate preventive controls in place. Additionally, FDA can rely on third parties to certify that foreign food facilities meet U.S. requirements and can require mandatory certification for high-risk foods. The FSMA also provides expedited review for importers in the voluntary qualified importer program.

FSMA Contains 10 Import Safety Mandates

The following are import safety mandates contained in the FSMA:

• Section 301: Foreign supplier verification program. Requires importers to verify their suppliers use risk-based preventive controls that provide the same level of protection as U.S. requirements.
• Section 302: Voluntary qualified importer program. Allows for expedited review and entry; facility certification required.
• Section 303: Certification for high-risk food imports. FDA has discretionary authority to require assurances of compliance for high-risk foods.
• Section 304: Prior notice of imported food shipments.Requires information on prior refusals to be added to prior notice submission.
• Section 305: Capacity building.FDA is mandated to work with foreign governments to build food safety capacity.
• Section 306: Inspection of foreign food facilities. Can deny entry if FDA access for inspection is denied.
• Section 201: Targeting of inspection resources.Increased inspection of foreign as well as domestic facilities.
• Section 307: Accreditation of third-party auditors. FDA can rely on accredited third parties to certify that foreign food facilities meet U.S. requirements.
• Section 308: Foreign FDA offices. Establish offices in foreign countries to provide assistance on food safety measures for food exported to the U.S.
• Section 309: Smuggled Food. In coordination with the Department of Homeland Security, better identify and prevent entry of smuggled food.

Third-Party Certification Programs Can be Required for High-Risk Foods, Etc.

Third-party certifications are a tool for importers to obtain needed assurances to meet their obligations for the foreign supplier verification program (section 301). They are also a way for importers to participate in the voluntary qualified importer program to expedite movement of food through the import process (section 302). Third-party certifications can also be required by FDA to accompany high-risk foods (section 303).

Implementation Underway, But Many Challenges Remain

Implementation of the FSMA is already underway, however, FDA notes that there are many challenges. FDA has an enormous workload, which include 50 new rules, guidance documents, and reports within three years with tight deadlines. Therefore, changes won't appear overnight -- building the new food safety system will be a long-range process and implementation will require resources.

8 FSMA Provisions Have Been Completed as of August 1

The following are provisions of the FSMA, of which implementation has been completed as of August 1, 2011:

• Fees (section 107)
• New dietary ingredients (section 113)
• Anti-smuggled food strategy (section 201)
• Suspension of registration of food Facilities (section 102)
• Prior Notice of imported food shipments (section 304)
• Administrative detention of food (section 207)
• Consumer-friendly web search for recalls (section 205)
• Guidance to Seafood Industry on food safety hazards (section 103)

The updated list of completed provisions and more information is available here.

(See ITT's Online Archives or 08/01/11 news, 11080114, for BP summary of FDA announcing the fiscal year 2012 fee rates for certain import restrictions, domestic and foreign facility reinspections, etc. mandated in the Federal Food, Drug, and Cosmetic Act, as amended by the FSMA.

See ITT's Online Archives or 07/19/11 news, 11071915, for BP summary of FSMA frequently asked questions on suspending registration, food tracking, etc.

See ITT's Online Archives or 07/06/11 news, 11070612, for BP summary of the FSMA's anti-smuggling strategy for imports and guidance on new dietary ingredients in supplements.

See ITT's Online Archives or 07/08/11 news, 11070716, for BP summary of the FDA's authority under the FSMA for ordering administrative detention of food and to suspend the registration of food facilities taking effect.

See ITT's Online Archives or 05/05/11 news, 11050516, for BP summary of prior notice for imported food as required by the FSMA.)

FSMA: Overview presentation is available here.

FSMA: Focus on Imports presentation is available here.