Animal Drug Availability Act (ADAA) of 1996

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

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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
  FDAs 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.

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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

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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

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ADAA Impact on Animal Drug Review

• Section 6 Feed Mill Licenses
• Establishes a new system for licensing feed mills

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ADAA Path to Passage

• 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

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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

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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.

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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

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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

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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.

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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)

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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

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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

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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)

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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)

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ADAA Chronology

• 09/28/96 Presented to the President
• 10/09/96 Signed Became Public Law

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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.'

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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)

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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)

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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)

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Import TolerancesCongressional Intent

• the billpermits FDA to set import tolerances
  for drugs used in other countries (Senator
  Lugar)

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Import TolerancesCongressional Intent

• 09/24/96 House Commerce Committee issued its
  report on ADAA (Report 104-823)
• It contained two references to import tolerances

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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)

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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.

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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)

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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.