Adulteration for FDA Foods

Food Safety Crash Course: FDA and USDA Food Safety Regulations American Conference Institute’s FDA & USDA Compliance Boot Camp: FDA and USDA Food Safety Regulations Kristin R. Eads (Faegre Baker Daniels LLP) October 2, 2013 Who Regulates What? • USDA: – Meat, if > 2% cooked / 3% raw – Poultry, if > 2% cooked – Most dried, frozen, or liquid egg products – Catfish • TTB: – Beer, wine, liquor (most) • FDA: – Everything else • State / Local Governments: – Foods prepared and served in restaurants or grocery stores, etc. – Special oversight of milk products under Pasteurized Milk Ordinance 2 Big Picture Differences Between FDA and USDA • FDA: – Pre-FSMA, no minimum inspection frequency/years between inspections – Reactionary – FSMA shifts focus from reaction to prevention • USDA: – Continuous inspection • Harvest facilities: inspectors examine each animal pre-harvest and post- harvest (carcass) • Further processors: inspectors need not be present at all times, but visit often – On-site – Daily interactions (Memos, NRs, etc.) 3 Adulteration for FDA Foods 4 FDCA Definition of “Food” • Food is “food” – Broadly defined as “articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” 21 U.S.C. § 321(f) • Some categories of food are further defined – Infant formula, dietary supplements (with some exceptions), foods for special dietary use, medical foods, and animal feeds • Broad definition captures articles that are not traditionally understood as food – e.g., food contact articles such as certain processing equipment, food packaging, and components of food packaging The Baseline Standard: Adulteration • Adulterated if: – Contains any poisonous/deleterious substance which may render contents injurious to health • If NOT an added substance, not adulterated if quantity is not ordinarily injurious to health – Consists of filthy, putrid or decomposed substance or otherwise unfit for human food – Prepared, packaged or held under insanitary conditions – Product (whole or in part) of diseased animal or animals that died by means other than slaughter – Intentionally subjected to radiation unless use conformed to regulation/exemption – Container composed of poisonous/deleterious substance which may render contents injurious to health – Valuable constituent abstracted therefrom or substituted (economic adulteration) 6 The Baseline Standard: Adulteration (continued) • Other adulteration standards – Unapproved color additives: deemed “unsafe” as a matter of law regardless of whether there is a safety issue – Dietary supplements • When they present “a significant or unreasonable risk of injury” under the labeled/ordinary conditions of use • Prepared, packed or held in conditions that do not meet GMP regulations – Confections: Tootsie Pops v. Kinder Eggs • “partially or completely embedded therein any nonnutritive object… [except when] such object is of practical functional value….” – Port shopping • Product offered for import that has previously been refused admission (unless compliance affirmatively demonstrated) Filthy. Putrid. Decomposed. • Statute prohibits any amount of filth in food except where courts have found level is trivial • Small amounts of filth (insect parts, excreta) are unavoidable • Enforcement discretion • Defect action levels – Regulating insect and rodent filth, mold, rot – OK? NOT OK? 8 Examples of Filthy/Putrid A. Metal fragments and debris on peanuts B. Not yet packaged but ready to eat potato chips containing scent and traces of urine from mouse, dog, and cat C. Hazelnut packages containing mouse pellets; feathers; human, mouse, dog, and cat hair; and gnaw marks on bags D. Peanuts, flour, and rice packages containing rodent fecal matter, urine stains, and rodent nesting 9 Insanitary Conditions • Food is adulterated if it has been “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” • Focus is on plant conditions, not product itself • May provide basis for enforcement, even where product itself has not been shown to be adulterated • May lead to a recall extending back months or years – e.g., PCA • Aggressive enforcement is an industry concern – e.g., routine environmental positives = insanitary conditions 10 Examples of Insanitary Conditions A. Employee touched the front of his visibly soiled pants and then handled ready to eat tortillas B. FDA found dead rodent, rodent pellets, and other signs of rodent activity C. FDA watched 2 employees drop raw cookie dough on a water- covered floor and return that dough to processing counter for baking D. FDA found bagel maker was not cleaning mixers or conveyer belts so crusted, leftover dough would be on machines at the end of every day E. FDA environmental swabbing found a strain of listeria in multiple areas of a facility 11 Action Levels • Substances presenting health hazards – Naturally-occuring poisonous/deleterious substances not adulterants, unless present at levels sufficient to render injurious to health – FDA sets action levels – Examples: • Aflatoxin: – 300 ppb in corn for beef cattle – 20 ppb in feed for dairy cows – 0.5 ppb in milk • Mercury: 1 ppm in fish • Also lead, DDT, PCBs, etc. 12 Action Levels • Substances not presenting health hazards – FDA sets food defect action levels – Not about safety, but quality – Commodity-specific – Examples: • Chocolate: – Insect filth: 60+ insect fragments per 100g – Rodent filth: 1+ rodent hair(s) per 100g • Pitted dates: – 5%+ dates are rejects (moldy, insects, excreta, sour, dirty) – 2+ pits or fragments per 100 dates • Tomato paste: 45%+ mold in six subsamples 13 Economically Motivated Adulteration (EMA) • Food/Feed is deemed adulterated if: – Any valuable constituent omitted in whole or part – Any substance substituted – Damage or inferiority concealed in any way – Any substance added to increase bulk or weight or reduce quality or strength or appear better than it is • 2007: Melamine in wheat gluten leads to numerous pet deaths and massive recalls • However, EMA does not need to be associated with a risk to health 14 Simple and Sophisticated EMA • Simple adulteration – Addition of inert material to add fill weight • Maltodextrin • Antioxidant extraction • Moisture • Sophisticated adulteration – Deliberate substitution with selected ingredients specifically designed to manipulate tests to “enhance” ingredient quality • Premium orange juice • Melamine • Olive oil 15 EMA Indicators Q: What indicators can suggest potential EMA? • High-value, easy to disguise, homogenous product (liquids in particular), bulk product • Availability of “cheaper” materials, with standards that make the detection of substitution very difficult – E.g., olive oil, fruit juice, honey, sugar • Ingredient shortages and tough economic conditions providing financial incentive for EMA • Certain countries, such as China, present greater risk of EMA – E.g., melamine-contaminated wheat gluten 16 Microbial Pathogens • Some are worse than others… • E. coli O157:H7 • Salmonella spp., e.g. – Enteritidis – Heidelberg – Typhi (typhoid fever) • Listeria monocytogenes • Shigella spp. • Campylobacter jejuni • Clostridium botulinum (botulism) • Norovirus • Vibrio spp. • B. cereus 17 Adulteration for USDA Foods 18 USDA Basics • FMIA, PPIA, and EPIA • Adulteration standard essentially identical • Key difference: some of those same pathogens are not adulterants in certain USDA-regulated products • Raw vs. Ready To Eat (RTE) – Certain pathogens in raw product not an adulterant – RTE not meant to be cooked; similar to FDA-regulated foods 19 E. coli O157:H7 • First infamous outbreak was E. coli O157:H7 in 1993 in the Northwest (undercooked hamburgers at Jack in the Box chain) • 1994: USDA requires testing for E. coli O157:H7 in ground meat product. Positive product is adulterated. – Withstood challenge by industry in W.D. Texas in 1994 • Current standard: – Intact cuts: not adulterant – Ground or trim product: adulterant – Cubes or similar non-intact: adulterant – Blade or needle tenderized, or injected: adulterant 20 Non-O157 STEC Testing • Through early 2012, no other E. coli variants were adulterants • In response to petition, FSIS now requires testing of six other serogroups of Shiga toxin-producing E. coli (STECs) • FSIS determined they are adulterants of non-intact raw beef products and product components under FMIA • See SHIGA TOXIN-PRODUCING ESCHERICHIA COLI IN CERTAIN RAW BEEF PRODUCTS, 76 Fed. Reg. 58157 (Sept. 20, 2011) • Effective March 2012 for beef trimmings – Later for raw ground beef 21 Salmonella • NOT an adulterant in raw meat or poultry – Supreme Beef Processors case • Normal cooking processes destroy organism and therefore presence itself does not render the product “injurious to health” • But – Statute allows USDA to regulate characteristics of raw materials that are “prepared, packed or held” at the plant – including presence of certain pathogens of concern such as Salmonella Heidelberg – “Insanitary conditions” such that product “may have been rendered injurious to health” include presence of Salmonella in meat or environment that could cross- contaminate • Performance standards – USDA and plants perform testing; if above base-line, USDA can pull inspection • Multidrug Resistant Salmonella (MRS) as emerging issue (will they be adulterants?) 22 Campylobacter • Most common pathogen in poultry • Not adulterant in raw product • Subject to performance standards, like Salmonella

Load more