Problems with the 1906 Act

Transcription

1 Problems with the 1906 Act failed to provide clear-cut meanings and specific means for enforcement insufficient funding for enforcement USDA was responsible for testing, but no standards for foods were designated law required proof of intent to deceive or poison; defendants simply pleaded ignorance Differences between 1906 and 1938 Acts prohibited injurious substances (old law prohibited only added injurious substances) prohibits addition of poisonous substances, except where unavoidable (then sets limits) authorized Emergency Permit Control to protect public required label declarations (colors, flavors, preservatives, etc.) required labeling of special dietary foods controls sanitation of processing prohibits use of uncertified dyes prohibits use of deceptive containers authorized factory inspections increased criminal penalties Driving force for change honesty & fairness of manufacturers; competition increased consumer awareness nutrition and health changes in technology improved analytical methods trends (vitamins, healthy foods) change in enforcement priorities - shift to safety cranberry recall (aminotriazole, weed killer that caused cancer in lab animals) thalidomide and birth defects

2 Important Amendments to FDCA of Insecticide, Fungicide, and Rodenticide Act Food Additive Amendment [source of the Delaney Clause - Sec. 409(c)(3)] Color Additive Amendment Fair Packaging and Labeling Act declaration of net quantity (amended for units) Infant Formula Act Nutrition Labeling and Education Act Dietary Supplement Health and Education Act Food and Drug Administration Modernization Act Federal agencies and jurisdiction over foods Numerous! Division of responsibility usually based on law Some responsibility based on policy Food and Drug Administration (FDA) Primary agency with authority over foods No authority over meat & meat products, poultry & poultry products, egg products Formulated foods with 3% meat or 2% poultry Implements many laws including: Tea Importation Act of 1897 Filled Milk Act of 1923 (no longer enforced) Import Milk Act of 1927 FDCA of 1938 as amended Public Health Service Act of 1944 Fair Packaging & Labeling Act of 1966 as amended (regarding foods) FDA scope of authority foods in interstate commerce limited by responsibility of other agencies ingredients in formulated foods processing under GMPs Food and Drug Administration Act of established FDA as permanent agency

3 United States Department of Agriculture (USDA) Several agencies Food Safety and Inspection Service (FSIS) ensures safety, wholesomeness, and labeling of meat, poultry, and egg products implements Federal Meat Inspection Act of 1906, Poultry Products Inspection Act of 1957, and Egg Products Inspection Act of 1970, et al. Deputy Administrator for Inspection Operations domestic inspection of meat, poultry, & egg plants (meat = cattle, sheep, swine, goats; poultry = domesticated birds; eggs = shell eggs of domestic chicken, turkey, duck, goose, guinea) sanitation of plants health of animals inspection before AND after slaughter stamped and released condemned Deputy Administrator for Regulatory Programs pre-market label approval (FDA doesn t require this) food ingredient assessments regulatory compliance issues Deputy Administrator for International Programs ensures wholesomeness of imported meat and poultry products assist US producers in meeting foreign market requirements Agricultural Research Service (ARS) research & technical info to other agencies plant & animal breeding production technology product utilization food safety Food and Nutrition Service (FNS) school lunch programs Women, Infant, and Children (WIC) program Agricultural Marketing Service (AMS) develops grade standards (quality) for meat, poultry, eggs, dairy products, fruits, and vegetables use is voluntary allows for comparisons

4 Federal Grain Inspection Service (FGIS) sets standards for and inspects grains mostly for exported grain Federal Trade Commission has jurisdiction over advertising may take action for false or misleading advertising if advertising accompanies product as labeling, authority may overlap with FDA Bureau of Alcohol, Tobacco, and Firearms division of Treasury Department responsible for alcoholic beverages, except wine beverages of < 7% alcohol < 7% is FDA jurisdiction taxes prohibits harmful residues, ingredients, and additives (may overlap FDA) labeling advertising (may overlap FTC) Environmental Protection Agency (EPA) regulates pesticides determines pesticide safety sets tolerance limits for pesticide residues in foods publishes directions for pesticide use cooperates with FDA FDA/EPA FDA enforces standards and restrictions SET by EPA water defined as food by FDCA FDA controls water used in food processing AND bottled water EPA regulates drinking water Centers for Disease Control (CDC) responds to foodborne disease emergencies directs and enforces quarantines maintain data on foodborne diseases

5 Government Documents Related to Food Laws United States Code (USC) Set of books - 50 Titles (topics) - contains US statutes Foods and drugs covered in Title 21 USC (2 volumes) Titles are divided into sections FDCA in Sections , Title 21 USC Court citation - 21 USC 301 (etc.) FDCA amendments are added as new language or additional sections United States Code Annotated (USCA) Same as USC PLUS short summaries of court cases that relate to interpretation Code of Federal Regulations Set of books - 50 Titles (topics) Contains rules promulgated or amended agencies as published in the Federal Register Updated each year (April 1) Title 21 - Foods and drugs (21 CFR); first 3 volumes deal with food (FDA) 21 CFR 1-99: General regulations for enforcement of FDCA and FPLA; color additives 21 CFR : Food labeling; infant formula; food standards; current GMPs; LACF; etc. 21 CFR : Food additives Title 9 - meat & meat products; poultry & poultry products; eggs (USDA) Federal Register Daily Newspaper of Federal Government used to publish new rules and proposals throughout the year Information added as appropriate to CFR (and USC) each year (April 1) Miscellaneous Documents of importance Compliance Policy Guides Book (volume), broken into chapters containing advisory opinions on numerous subjects Chapter 8 - Fish and Seafood Chapter 20 - Food - General also contains Memorandums of Understanding (MOUs) between FDA and other agencies describe working relationship for overlapping jurisdiction

6 Press Releases Talk Papers FDA Consumer Magazine Food Code Freedom of Information (Act)