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| [Code of Federal Regulations] |
| [Title 21, Volume 2] |
| [CITE: 21CFR112] |
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION
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| PART 112 | STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION |
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Subpart Q - Compliance and Enforcement
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Sec. 112.192 What is the applicability and status of this part?
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(a) The failure to comply with the requirements of this part, issued under section 419 of the Federal Food, Drug, and Cosmetic Act, is a prohibited act under section 301(vv) of the Federal Food, Drug, and Cosmetic Act.
(b) The criteria and definitions in this part apply in determining whether a food is:
(1) Adulterated within the meaning of:
(i) Section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in that the food has been grown, harvested, packed, or held under such conditions that it is unfit for food; or
(ii) Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;
or
(2) In violation of section 361 of the Public Health Service Act (42 U.S.C. 264).
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Sec. 112.193 What are the provisions for coordination of education and enforcement?
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Under section 419(b)(2)(A) of the Federal Food, Drug, and Cosmetic Act, FDA coordinates education and enforcement activities by State, territorial, tribal, and local officials by helping develop education, training, and enforcement approaches.
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Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271.
Source: 80 FR 74547, Nov. 27, 2015, unless otherwise noted.
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