July 9, 2021
Today, the FDA issued the draft FDA Oversight of Food Products Covered by Systems Recognition Arrangements: Guidance for Food and Drug Administration Staff that addresses how the agency plans to adjust its regulatory oversight activities for covered foods imported from countries that have been determined to produce similar food safety outcomes through an FDA assessment.
For covered food products imported from a country with an active Systems Recognition Arrangement (SRA), the draft guidance details adjustments to FDA’s regulatory oversight activities including:
- In-country food establishment inspections
- Automated screening and risk targeting and review of imported food
- Examination and sampling of imported food
- Relevance of importer verification programs
- Regulatory compliance actions
Systems recognition, a voluntary partnership between the FDA and a foreign regulatory counterpart or competent food safety authority, allows the FDA to leverage regulatory partners’ food safety systems, reallocate resources in a more risk-based manner, and improve and expand information sharing on food safety issues. FDA has signed SRAs with participating agencies in Australia, Canada, and New Zealand, and is in the initial phases of assessing the European Union.
Systems Recognition advances the FDA’s New Era of Smarter Food Safety initiative and reflects the agency’s larger effort to take a risk-based approach to food safety, consistent with the FDA Food Safety Modernization Act (FSMA) and with the agency’s Strategy for the Safety of Imported Food.
This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments electronically on Regulations.gov.
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2019-D-1997.
For additional information: