H.R.3200 - Food Amendments and the Animal Drug Availability Act of 1996104th Congress (1995-1996)
Summary: H.R.3200 — 104th Congress (1995-1996)
Introduced in House (03/29/1996)
TABLE OF CONTENTS:
Title I: Food Amendments
Title II: Animal Drugs
Food Amendments and the Animal Drug Availability Act of 1996 - Title I: Food Amendments - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to state the mission of the Food and Drug Administration.
(Sec. 102) Modifies requirements regarding label claims of a relationship between a nutritional ingredient and a health-related condition.
(Sec. 104) Prohibits construing FDCA provisions relating to misbranding or food additives to require a separate disclosure of a method of production or an ingredient other than in the statement of ingredients, unless necessary to protect the public health.
(Sec. 105) Allows certain labeling and additive (including color additive) petitions to be submitted to an accredited person and deems the person's recommendation to be a decision of the Secretary of Health and Human Services unless the Secretary makes certain findings. Provides for accreditation.
(Sec. 107) Allows an additive in feed for food-producing animals, and allows approval of a new animal drug, if the additive or drug presents a small risk (currently, if the additive will not adversely affect the animals and if no residue will be found in food from the animal).
(Sec. 108) Prohibits States and subdivisions from having any requirement for a human food, a drug or biological product, or a cosmetic of the type authorized or required under the adulteration, misbranding, or new drug provisions of the FDCA, subject to exception and waiver.
(Sec. 109) Directs the Secretary to regularly meet with other countries regarding reducing regulation and seeking reciprocal arrangements.
(Sec. 110) Prohibits the Secretary from relying on statements that have not been promulgated in accordance with Federal rulemaking requirements to require any action to be taken to satisfy an FDCA requirement.
(Sec. 111) Amends the FDCA and the Federal Trade Commission Act to remove or repeal provisions regulating the sale, public eating place serving, and advertising of colored oleomargarine or colored margarine. Repeals related definitions.
Title II: Animal Drugs - Amends the FDCA to revise the definition (for new animal drug provisions) of "substantial evidence." Modifies requirements regarding approval of supplemental applications. Exempts use in a minor species and the minor use of a drug from provisions prohibiting approval if there is a lack of substantial evidence that the drug will have its purported effect. Revises requirements regarding combination drugs.
(Sec. 202) Reduces the period for approval of new animal drug applications.
(Sec. 203) Empowers applicants to declare that a review impasse exists. Sets forth a dispute resolution process.
(Sec. 204) Revises requirements regarding drug residues and tolerances.
(Sec. 205) Regulates animal feed drugs that are limited by approved applications to use under the supervision of a licensed veterinarian (veterinary feed directive drugs) (VFDDs).
Deems animal feed with a new animal drug unsafe unless its labeling, distribution, holding, and use (currently, its labeling and use) conform to specified FDCA requirements.
Allows withdrawal of approval for certain VFDD recordkeeping violations.
Adds to the prohibited acts list the refusal to permit record access as required by VFDD provisions and the failure to maintain records or make reports as required by VFDD provisions.