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Animal Drug Availability Act (ADAA) of 1996

Animal Drug Availability Act (ADAA) of 1996. Legislative History of ADAA and Import Tolerances Jarilyn Dupont Senior Legislative Counsel Food and Drug Administration January 22, 2002. ADAA: Public Law 104-250 Signed into Law 10/09/96.

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Animal Drug Availability Act (ADAA) of 1996

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  1. Animal Drug Availability Act (ADAA) of 1996 Legislative History of ADAA and Import Tolerances Jarilyn Dupont Senior Legislative Counsel Food and Drug Administration January 22, 2002

  2. ADAA: Public Law 104-250Signed into Law 10/09/96 ADAA was designed to increase the number of animal drugs on the market, without compromising FDA’s mission to promote and protect the public health. Culmination of collaboration between FDA, a coalition of animal industry groups, and manufacturers of animal drugs. Passed with strong bipartisan support.

  3. ADAA: Impact on Animal Drug Review Section 2: Evidence of Effectiveness Injects flexibility in the review and approval process by amending the current definition of substantial evidence Section 3: Limitation on Residues Supports “flexible labeling” to permit a range of acceptable or recommended doses to appear on the label

  4. ADAA: Impact on Animal Drug Review Section 4: Import Tolerances Permits the establishment of tolerance levels for drug residues in imported food products of animal origin Section 5: Veterinary Feed Directive Creates a new category of drug approvals

  5. ADAA: Impact on Animal Drug Review Section 6: Feed Mill Licenses Establishes a new system for licensing feed mills

  6. Senate 05/09/95 S. 773 Introduced 12/13/95 S.1477 Introduced 02/21/96 Hearings on S. 1477 03/28/96 S. 1477 Passed Committee 06/20/96 S. 1477 Reported to Senate 09/24/96 Committee Mark-up of S. 773 - Passes Senate (identical to H.R. 2508) 9/28/96 Presented to President 10/09/96 Signed into Law House 10/19/95 H.R. 2508 Introduced 03/29/96 H.R. 3200 Introduced 05/01/96 Hearings on H.R. 3200 09/19/96 Committee Mark-up of H.R. 3200 09/24/96 H.R. 2508 Passes House (identical to S.773) 09/28/96 Presented to President 10/09/96 Signed into Law ADAA: Path to Passage

  7. ADAA: Chronology • S. 773, “ADAA”, introduced 05/09/95 by Senator Nancy Kassebaum & 19 cosponsors - referred to Senate Labor Committee • H.R. 2508, “ADAA”, introduced 10/19/95 by Rep. Wayne Allard & 71 cosponsors - referred to House Commerce Committee

  8. ADAA: Chronology • S. 773 and H.R. 2508, nearly identical. Neither contained an import tolerance provision In floor remarks, sponsors stated the reason for the bill was concern that the animal drug approval process had become “cumbersome and unpredictable” and “increasingly prolonged and complicated”.

  9. ADAA: Chronology • No further official action on S. 773 or H.R. 2508 until 1996 • 12/13/95 S. 1477, “The FDA Performance and Accountability Act” introduced by Senator Nancy Kassebaum & 4 cosponsors Comprehensive Reform bill, contained animal drug reform provisions

  10. ADAA: Chronology • 01/1996 “Reinventing Food Regulations”, National Performance Review - Includes proposal to “…enable [FDA] to focus its reviews on the safety of the drug residue in the imported food product”, among other animal drug initiatives

  11. ADAA: Chronology • 02/21/96 Senate Labor Committee hearings on S. 1477 - Dr. Kessler testified • 03/28/96 S. 1477 Passed Committee • 03/29/96 H.R. 3200, “Food Amendments and the Animal Drug Availability Act of 1996” introduced by Rep. Scott Klug.

  12. ADAA: Chronology • H.R. 3200 was 1 of 3 “FDA Reform” bills. • Title II of H.R. 3200 - “ADAA” (Evidence of Effectiveness and Limitation on Residues verbatim from H.R. 2508 - also picks up provisions from the REGO initiative)

  13. ADAA: Chronology • 05/01-02/96 House Commerce Subcommittee Hearings on the 3 FDA Reform Bills - Dr. Kessler testified • 05/1996 “Reinventing the Regulation of Animal Drugs” National Performance Review

  14. ADAA: Chronology • 05/29/96 One Hour Special Order in House on 3 “FDA Reform” bills • 06/20/96 S. 1477 Reported to Senate • Between 06/96 - 09/96 - Committees, FDA and Industry Coalition working on bills

  15. ADAA: Chronology • 09/19/96 Committee Mark-Up of H.R. 2508 Discharged, included Section 4, Import Tolerance • 09/24/96 H.R. 2508 Reported and Passed the House by Voice Vote - (now identical to S.773)

  16. ADAA: Chronology • 09/24/96 Committee Mark-Up of S. 773 Discharged, included Section 4, Import Tolerance • 09/24/96 S. 773 Passed Senate by Unanimous Consent (now identical to H.R. 2508)

  17. ADAA: Chronology • 09/28/96 Presented to the President • 10/09/96 Signed & Became Public Law

  18. Section 4. Import Tolerance Section 4. Import Tolerances. Section 512(a) (21 U.S.C. 360b(a)) is amended by adding the following new paragraph at the end: '(6) For purposes of section 402(a)(2)(D), a use or intended use of a new animal drug shall not be deemed unsafe under this section if the Secretary establishes a tolerance for such drug and any edible portion of any animal imported into the United States does not contain residues exceeding such tolerance. In establishing such tolerance, the Secretary shall rely on data sufficient to demonstrate that a proposed tolerance is safe based on similar food safety criteria used by the Secretary to establish tolerances for applications for new animal drugs filed under subsection (b)(1). The Secretary may consider and rely on data submitted by the drug manufacturer, including data submitted to appropriate regulatory authorities in any country where the new animal drug is lawfully used or data available from a relevant international organization, to the extent such data are not inconsistent with the criteria used by the Secretary to establish a tolerance for applications for new animal drugs filed under subsection (b)(1). For purposes of this paragraph, 'relevant international organization' means the Codex Alimenterius Commission or other international organization deemed appropriate by the Secretary. The Secretary may, under procedures specified by regulation, revoke a tolerance established under this new paragraph if information demonstrates that the use of the new animal drug under actual use conditions results in food being imported into the United States with residues exceeding the tolerance or if scientific evidence shows the tolerance to be unsafe.'

  19. Import TolerancesCongressional Intent 3 Members and 1 Senator mentioned import tolerances in floor remarks during passage 09/24/96 House and Senate Floor: “Finally, the bill authorizes FDA to establish import tolerances for new animal drugs not approved in the U.S.” (Mr. Bilirakis)

  20. Import TolerancesCongressional Intent “We are pleased that this legislation incorporates FDA proposals included in the Vice President's reinventing Government initiatives,..., and another that will authorize FDA to establish import tolerances for animal drugs not approved for use in the United States.” (Mr. Manton)

  21. Import TolerancesCongressional Intent "In addition, the bill implements two items from the National Performance Review. It would allow FDA to set tolerances for drugs used on farm animals whose meat ultimately is imported into the United States.” (Mr. Deutsch)

  22. Import TolerancesCongressional Intent “…the bill…permits FDA to set import tolerances for drugs used in other countries…” (Senator Lugar)

  23. Import TolerancesCongressional Intent 09/24/96 House Commerce Committee issued its report on ADAA (Report 104-823) It contained two references to import tolerances:

  24. Import TolerancesCongressional Intent A letter from June E. O'Neill, Director of the Congressional Budget Office to Chairman Tom Bliley. Comments regarding import tolerances include: "...The bill would direct the Secretary of Health and Human Services to establish tolerance levels for residues of veterinary drugs in imported animal products intended for human consumption. ... Tolerance Standards. Section 4 of the bill would require that the residues from animal drugs in edible animals imported into the United States meet tolerance standards to be set by the Secretary. These animal products could not be deemed unsafe unless their residue levels exceeded the specified tolerance levels. Under current law, the United States Department of Agriculture monitors residues in imported animal food products, sometimes in consultation with the Food and Drug Administration (FDA). However, this section would place a new formal requirement on the importation of edible animals. Based on information from FDA staff, CBO expects that the tolerance standards set by the Secretary would not differ significantly from current practice. Thus, this provision would not have significant costs for the federal government or the private sector." (Page 11)

  25. Import TolerancesCongressional Intent Section-by-section analysis of the legislation: Section 4 amends section 512(a) to permit FDA to establish a tolerance for residues of an animal drug in human foods, when the drug is not approved for use in the United States but imported food products of animal origin may contain residues of that drug. There are appropriate instances in which food producing animals raised in other countries are treated with animal drugs that are not approved in the United States. For example, the disease or condition treated by the drug does not occur in the United States. There have been concerns about residues of such drugs in food products derived from these animals, imported into the United States.

  26. Import TolerancesCongressional Intent Section-by-Section (continued) This provision authorizes FDA to establish a safe tolerance using criteria similar to those that it would apply in reviewing the human food safety aspects of an animal drug for which approval is sought in the United States. FDA may rely on data generated by the drug manufacturer or on data from a relevant international organization such as the Codex Alimentarius Commission. This is a step in the right direction of international harmonization of regulatory requirements. If an international standard on which FDA relied changes or new information (from either experience or scientific data) shows the tolerance is no longer safe, FDA may change or revoke the tolerance. In addition, section 4 provides that the tolerance may be revoked if information shows use of the animal drug under actual use conditions results in food being imported into the United States with residues exceeding the tolerance” (Page 16 – 17)

  27. ANPR: Import Tolerances 08/10/01 FDA published an Advance Notice of Proposed Rulemaking to solicit comments on establishing drug residue tolerances (import tolerances) for imported food products of animal origin for drugs approved in other countries, but not approved in the U.S.

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