Title 21, Food and DrugsRelease 119-110

§2201 Performance Standards

Title 21 › CHAPTER 27 — FOOD SAFETY MODERNIZATION › SUBCHAPTER I — IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS › § 2201

Last updated Sep 22, 2026|Official source

Summary

The Secretary must work with the Secretary of Agriculture and, every 2 years, look over health data and other relevant information to find the most important contaminants in food. That review includes studies about toxins and disease patterns, current food safety practices, and advice from expert committees like the Food Advisory Committee. When needed to lower the chance of serious illness or death to people or animals, to stop food adulteration under section 342 of this title, or to prevent food from spreading disease under section 264 of title 42, the Secretary must issue contaminant-specific, science-based guidance or rules. Those must apply to products or product groups, separate human food from animal food when appropriate, and not be written for individual facilities. The Secretary must coordinate with Agriculture to avoid duplicate guidance and must review and update the guidance or rules from time to time.

Full Legal Text

Title 21, §2201

Food and Drugs, Source: USLM XML via OLRC

(a)In general
The Secretary shall, in coordination with the Secretary of Agriculture, not less frequently than every 2 years, review and evaluate relevant health data and other relevant information, including from toxicological and epidemiological studies and analyses, current Good Manufacturing Practices issued by the Secretary relating to food, and relevant recommendations of relevant advisory committees, including the Food Advisory Committee, to determine the most significant foodborne contaminants.
(b)Guidance documents and regulations
Based on the review and evaluation conducted under subsection (a), and when appropriate to reduce the risk of serious illness or death to humans or animals or to prevent adulteration of the food under section 342 of this title or to prevent the spread by food of communicable disease under section 264 of title 42, the Secretary shall issue contaminant-specific and science-based guidance documents, including guidance documents regarding action levels, or regulations. Such guidance, including guidance regarding action levels, or regulations—
(1)shall apply to products or product classes;
(2)shall, where appropriate, differentiate between food for human consumption and food intended for consumption by animals other than humans; and
(3)shall not be written to be facility-specific.
(c)No duplication of efforts
The Secretary shall coordinate with the Secretary of Agriculture to avoid issuing duplicative guidance on the same contaminants.
(d)Review
The Secretary shall periodically review and revise, as appropriate, the guidance documents, including guidance documents regarding action levels, or regulations promulgated under this section.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Secretary, referred to in text, probably means the Secretary of Health and Human Services.

Statutory Notes and Related Subsidiaries

Short Title

Pub. L. 111–353, § 1(a), Jan. 4, 2011, 124 Stat. 3885, provided that: “This Act [enacting this chapter and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amending section 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacting provisions set out as notes under section 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title] may be cited as the ‘FDA Food Safety Modernization Act’.”

Reference

Citations & Metadata

Citation

21 U.S.C. § 2201

Title 21, Food and Drugs

Last Updated

Sep 22, 2026

Release point: 119-110