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able poisonous and deleterious substances.5 In addition, for food and all other regulated products, the 1938 FDCA added injunction proceedings and mandatory establishment inspection to the enforcement tools included in the 1906 act.6

Since 1938, Congress has occasionally amended the FDCA to further enhance the FDA’s power to accomplish its food safety mission. Notable examples of these amendments include the Food Additives Amendments of 1958, creating a premarket approval system for food additives; the Color Additives Amendments of 1960, creating a premarket approval system for color additives; and the Animal Drugs Amendments of 1968, creating a unified scheme for all aspects of animal drug regulation, including ensuring the safety of animal drug residues in food.7 More recently, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act)8 strengthened the food safety provisions of the FDCA by, among other things, (1) authorizing the FDA to administratively detain food for which there is “credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals,”9 (2) mandating the registration of food facilities,10 (3) giving the FDA access to industry records related to food that “presents a threat of serious adverse health consequences or death to humans or animals,”11 (4) empowering the FDA to require the maintenance of records needed by the agency “to identify the immediate previous sources and the immediate subsequent recipients of food,”12 and (5) requiring prior notice of imported food shipments. Finally, in 2007 Congress added a new section to the FDCA (the Food and Drug Administration Amendments Act of 2007) requiring the FDA to establish a Reportable Food Registry for the reporting of instances in which there is a “reasonable probability that the use of, or exposure to, [a] food will cause serious adverse health consequences or death to humans or animals.”13

Nevertheless, in some other fundamental respects, the law under which

5

FDCA 402(a)(4), 404, 406.

6

FDCA 302, 704.

7

Food Additives Amendment, 72 Stat. 1784 (1958); Color Additive Amendments, 74 Stat. 397 (1960); Animal Drug Amendments, 82 Stat. 342 (1968).

8

Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), HR 3448, 107th Cong, 2nd sess. (FDCA 801(m)).

9

FDCA 304(h).

10

FDCA 415.

11

FDCA 414(a).

12

FDCA 414(b).

13

FDCA 417.



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