Warning !!! Danger This location is contaminated with Toxicodendron radicans Exposure may be harmful to your health
POISON IVY
The Food Environment l we each eat ~ 1200 lbs of food a year l children eat more fruits and vegetables l total food business is >$700 billion ($340 billion at home and $360B in food service) l ~ 12,000 new product introductions yearly l Government and educators are encouraging greater consumption of fruits and vegetables for improved health (Food Pyramid) l Greater interest in fresh foods - less processing
FOOD SCARES l MSG l artificial sweetners l Alar in apples l Cyanide in grapes
Food Safety Issues
Safety Issues l microbial toxins and pathogens l pesticides l environmental contaminants l migration from packaging materials l intentional or unintentional additives l animal drugs (antibiotics) l biotechnology products l tampering
Shakespear ÒMuch ado about nothingÓ or the problem of finding the presence of and assessing the risk of potential chemical and biological hazards present at infinitely
Federal Structure l Congress ➨ committees investigate issues ➨ companies and organizations lobby for viewpoint ➨ Congressional Record ➨ passes bills ➨ overides veto of President
Federal Structure ¥ President Ð vetoes or signs bill. Becomes an Act (Law or Statute) US Code Ð assigns carrying out law to Departments, Agencies and Commissions Ð these agencies propose Federal regulations- more depth
History l 1906 Pure Food and Drug Act l 1906 Meat Inspection Act l 1947 FIFRA 86 Stat 975; 7 USC Sec 136 l 1938 Food Drug and Cosmetic Act l 1954 - Miller Pesticide Amendment 68 Stat 511 required pre-market testing & tolerance setting (Sec 408 of FFDC Act) l 1958 Food Additives Amendment premarket testing of additives and and Delaney Clause (zero tolerance for carcinogens) l 1967 - Wholesome Meat Act 21 USC 672; Pub L 90-201 pre-emption of States rights l 1996 Food Quality and Protection Act
FTC FTC President President CPSC EPA EPA USDA USDA HHS HHS Customs Treasury Treasury BATF FSIS FDA FDA
Regulatory Procedure l must follow Administrative Procedures Act l 701 (a) notice and comment l 701(e) allowance for administrative hearing ➨ food additives ➨ pesticide tolerances ➨ food standards
61 FR 46716 61 FR 46716
FR Parts l Summary l Background l Comments l Conclusions l Economic Impact l Paperwork Reduction l Environmental Impact l CFR Parts
Code of Federal Regulations final steps after FR l 9 CFR Meat l 21 CFR Food l 40 CFR EPA l 61 CFR Federal Trade Commission 21 CFR 100.80 21 CFR 100.80
Steps to Overturn Regulation l give info during notice and comment period, FDA must respond l ask for administrative hearing if 701(e) reg l after promulgated go to CCA ➨ arbitrary ➨ capricious ➨ ripe for adjudication
FDA Other Material l InspectorÕs Operations manual l Regulatory Procedures Manual l Compliance Policy Guides Manual (CPGM) l none have exact legal definitions but are processes and legal notices of policy
Courts l only come into play when there is a challengeto thre law based on the Constitution l Three levels ➨ District ➨ Circuit Court of Appeals ➨ Supreme Court l job is to interpert the law when conflict exists l Supreme Court ➨ grants certiorari ➨ A political process
Government Sanctions under FD&C Act l Seizure l Injunction l Criminal - no intent necessary ➨ US v Park - vicarious responsibility ➨ US v Hata - objective impossiblity ➨ US v Starr - sabotage l warning letter l Recalls - not mandatory
Food Drug and Cosmetic Act l 402(a)(3) - a food is adulterated if it consists in whole or part of filthy, putrid or decomposed substances or is otherwise unfit for food filth is common definition - animal hairs, feces insects and parts etc
Case Study l US v 133 Cases Tomato Paste 22 F Supp 515 (1938) ➨ Harbor City Canning ships tomatoes from California to Philadelphia ➨ tomatoes processed in July 1935 had corn ear worms, plant did no pre- inspection ➨ worms broken upon canning so could not see them , also no taste and not injurious to health
US v 133 Cases Tomato Paste 22 F Supp 515 (1938) l Court ruling: ➨ filth has common meaning ➨ must have protection of aesthetic sensibilities of consumers ➨ processed worms constitute filth even though undetectable to eye ➨ would only allow if small enough to be de minimus ➨ level was above what FDA used as regulatory action level which was unpublished ➨ Courts asked FDA to publish
US v Lazere 56 F. Supp 30; 1944 l filthy bakery l kids playing on flour with cat l numerous flies l testimony that filth is nutritious and therefor does not make food unfit l witness ate processed mouse l Court said must protect aesthtic sensibilities
Regulations l Prior to 1971 FDA kept filth levels secret - only came out in Court cases l 1971 Freedom of Information Act - published info & started regulatory process l 51FR 22480 - final rule 6/19/86 -created new defect action levels and put in CPGM
Regulations l 21 CFR 110.110 ➨ (a) recognition of problem of contamination chance, always will be present even under GMP ➨ (b) level set is necessary and feasible to attain- subject to change publish availability in FR and put in CPGM ➨ (c) no excuse to violate 402 (a)(4) ie donÕt keep filth at maximum ➨ (d) mixing not allowed
Defect Action Levels l milled grain CPGM # 7104.06 ➨ six 50 gram samples ➨ average of 75 or more insect fragments / 50 grams except not for durum or red durum wheat flour ➨ or 1 or more rodent hair per 50 grams l consumer wheat flour ➨ - one rodent pellet / 5 lb bag
Defect Action Levels l based on found levels from early legal actions that US won l later Industry worked with FDA to help determine levels l US v General Foods - machinery mold case - no level so canÕt adjudicate l processed potato history
Poisonous or Deleterious Substances l pathogens l environmental toxins l carcinogens l mutagens l teratogens
Food Drug and Cosmetic Act l 402(a)(1) - a food is adulterated if it contains any poisonous or deleterious substance which may render the food injurious to health ➨ example : pathogens such as E. coli O157:H7 ➨ examples : lead, mercury, radionucleotides
Pathogen Problem l estimated 40 to 80 million illnessses a year l estimated > 9000 deaths ~ 2% of all deaths per year l estimated hospital costs > $3 billion to $23 billion l estimated productivity loss $9 billion l chronic long term illnesses possible
Pathogens l no regulations setting standards for maximum amount l based on this zero tolerance ie may be injurious to health ie one organism can lead to problem for some one l actual action level based on ability to determine, eg 1 Listeria / 25 g l ? should level be set higher
Food Drug and Cosmetic Act l 402(a)(1) - however if not added, the food is not adulterated if the quantity would not ordinarily render injurious to health ➨ example -selenium ➨ example - solanine
l US v Seabrook Int'l. Foods 501 F Supp 1086 (1980) ➨ Court granted summary judgment to FDA for three shipments of shrimp containing Salmonellae ➨ Court ruled that salmonellae are added substances due to human intervention so 1st clause applied Òmay renderÓ thus any amount injurious otherwise if not added then can set Òde minimusÓ based on not ordinarily injurious ➨ under may render injurious ruling government can set maximum amount which can be zero ➨ less burden of proof for US - donÕt have to show injurious to health at that level, only that it may render injurious
Question ? What level is tolerable, if any? What do we do about environmental contaminants?
FD&C Act Section 406 Tolerances for poisonous or deleterious substances in food l UNSAFE UNDER 402(a) (1) UNLESS ➨ required in production ➨ cannot be avoided in GMP ➨ Secretary shall promulgate regulations limiting level
REGULATIONS 21CFR 109 Tolerances For Unavoidable Contaminants in Food or Packaging ¥ EPA first established acceptable levels for delisted pesticides and FDA would accept tolerance for processed food and publish in 21 CFR
REGULATIONS 21CFR 109 Tolerances For Unavoidable Contaminants in Food or Packaging ¥ FDA began working on these for environmental compounds but only one promulgated PCBÕs (took 10 years) ¥ under 701(e) forced to do in hearing process ¥ Court case by case basis began to lead to confusion
Natick Paperboard v Weinberger 525 F. 2nd 1103 1st CCA 1975 l paperboard with PCB contamination l FDA seized whole output on basis > 10 ppm PCB which was tolerance l PCBs can migrate from packaging l PCB s are an unsafe additive therefore subject to 409 and 406 l but Court ruled only paper destined for food use can be seized
Case Studies l US v Anderson Seafood 447 F Supp 1151 (1978) 622 F 2d 157 (1978) l US seized fish with >0.5 ppm mercury l charged under 402(a)(1) 1st clause l District Court ruled Hg not added so 1st clause applies as set too low l Don't have to show intervention of man ie Hg is unintentionally added so 2nd clause does not apply l appeal by US to Circuit rejected so FDA had to raise to 1 ppm see 44 FR 3990 January 1979 (this creates a case by case problem)
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