21 U.S.C. § 2201 — Performance standards
submitted 15 years ago by Pub. L. 111-353 to r/title-21-FOOD-AND-DRUGS · 241 words · no verdicts yet
Performance standards is governed by the rules in this section. It requires or permits the actions and conditions stated below, including the listed exceptions. (a) In general The Secretary must, 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 rele...
(a) In general The Secretary must, 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 must 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) must apply to products or product classes; (2) must, where appropriate, differentiate between food for human consumption and food intended for consumption by animals other than humans; and (3) must not be written to be facility-specific. (c) No duplication of efforts The Secretary must coordinate with the Secretary of Agriculture to avoid issuing duplicative guidance on the same contaminants. (d) Review The Secretary must periodically review and revise, as appropriate, the guidance documents, including guidance documents regarding action levels, or regulations promulgated under this section.
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.
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—
shall apply to products or product classes;
shall, where appropriate, differentiate between food for human consumption and food intended for consumption by animals other than humans; and
shall not be written to be facility-specific.
The Secretary shall coordinate with the Secretary of Agriculture to avoid issuing duplicative guidance on the same contaminants.
The Secretary shall periodically review and revise, as appropriate, the guidance documents, including guidance documents regarding action levels, or regulations promulgated under this section.
Source credit: (Pub. L. 111–353, title I, § 104, Jan. 4, 2011, 124 Stat. 3899.)
- 2011Enacted · Pub. L. 111-353 · 124 Stat. 3899
A history note hasn’t been published yet. The record shows enactment by Pub. L. 111-353 on 2011-01-04.
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