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 – Performance standards released for Campylobacter and Salmonella in chicken/turkey slaughter facilities
23 Listeria monocytogenes
• Hardy bacteria; survives and thrives in cold, wet environments
• Numerous outbreaks in cold cuts and cured meats
• Adulterant in RTE products
• Mandatory compliance guidelines for treatment to avoid LM in RTE foods
• USDA also performs its own verification program of testing
• Testing requirements include both product and environmental
24 Bovine Spongiform Encephalopathy (BSE)
• The so-called “mad cow disease”
• Numerous controls in place: – Verification of cattle age (determines which parts can be used for human food) – Certain high risk material (“Specified Risk Materials”) cannot be used as food, e.g. central nervous system, tongue and dorsal root ganglia, etc. – Nonambulatory (downer) prohibited – No mechanically-separated beef allowed for human food
• Also controls in place at FDA-regulated feed facilities to prevent bone/meat meal from ruminants to be fed to other ruminants
25 USDA’s Other Options
• Even if not adulterant, USDA has enforcement powers it can use • Refusal of inspection (shutdown lines at any time) • Rescind approval of labeling • Withdraw grant of inspection (mark), hold it in abeyance, revoke it, etc. – For instance, failure to maintain sanitary conditions, or to meet the Salmonella/Campylobacter performance standards can result in finding of “insanitary conditions” • Noncompliance Record (NR) • Notice of Intended Enforcement (NOIE) • Food Safety Assessments (FSA) and Comprehensive Assessments
26 USDA Test & Hold
• April 2011: proposed mandatory test-and-hold; went into effect this year • Delay shipping product until negative test results • In past, producers could ship product after testing but before results were verified and then recall • Already practice of big meat and poultry producers – Impact on small and medium-sized processors
27 USDA Test & Hold (con’t)
• Applies to non-intact raw beef products and intact raw beef products that are intended for non-intact use (mechanically tenderized steaks) tested by FSIS for Shiga-toxin producing E.coli and any ready-to-eat products that are tested for pathogens by FSIS. • Goal: quick and accurate results
28 Preventing Adulteration
29 How Do We Prevent Adulteration? (FDA Regulated)
• Big picture: – Pre-FSMA: HACCP – Post-FSMA: Hazard Analysis and Risk Based Preventive Control Plans – cGMPs – SSOPs – Other pre-requisite programs – Supplier Verification
• Other related measures: – Product sampling – Environmental sampling – Recall plans – Robust QA/QC department
30 HACCP – Generally
• HACCP is system for identifying and monitoring potential specific foodborne hazards • Developed in the 1960s to ensure that food in U.S. space program would not make astronauts sick • Designed to replace end product testing – (1) Hazard analysis – (2) Critical control points • FDA requires for seafood and juice • Voluntarily adopted for production of many other FDA-regulated foods
31 HACCP – Basic Steps
• Conduct hazard analysis • Identify critical control points (CCPs) • Establish critical limits for each CCP • Monitor CCPs • Take corrective actions if monitoring shows deviation from critical limit at CCP • Document steps and keep records • Establish procedure for verifying system is working as intended • Periodic reanalysis
32 Hazard Analysis & Risk-Based Preventive Controls (FSMA Section 103)
• Facilities MUST – Evaluate “known or reasonably foreseeable” hazards – Develop a written analysis of the hazard – Identify and implement preventive controls – Monitor effectiveness of preventive controls – Develop necessary corrective actions – Verify effectiveness – Maintain records for 2 years • Reanalysis every 3 years or upon “significant change” that creates “reasonable potential” for new hazard or “significant increase” in previously identified hazard
33 Human Food Preventive Controls Rule
• Released Jan. 2013 • FDA asking for comments on everything • Preventive controls necessary to “S-MOP” hazards (“Significantly Minimize or Prevent”) • FDA avoiding imposing controversial requirements in proposed rule, but wants comments on whether to require some controversial elements in certain situations – Finished product testing – Supplier verification – Environmental sampling
34 What We Know From Human Preventive Controls Rule
• Lots of paperwork (food safety plan, monitoring, validation, corrective actions, etc.) • Closely follows HACCP • Likely will require a trained/certified person at each facility • FDA developing curriculum for training personnel • Long implementation time: – Final rule issuance - likely 1.5 years after proposed rule – Compliance date (enforcement discretion): • 1 year post-final rule issuance for large businesses • 2 years for small, 3 years for very small
35 Current Good Manufacturing Practices (cGMPs)
• Three sets: – Human food (21 CFR Part 110) – Animal feed (medicated feed only, 21 CFR Part 225) – Dietary supplements (21 CFR Part 111)
• Examples: – Plant constructed in manner such that floors, walls and ceiling may be adequately cleaned. – Food contact surfaces should be smoothly bonded (no rough welds) and maintained to minimize accumulation of particles – Proper drainage – Adequate cleaning procedures and substances, etc.
36 How Do We Prevent Adulteration? (USDA Regulated)
• Big picture: – HACCP (regulatory) – SSOPs – Pre-requisite programs – Compliance guidelines and mandatory risk assessments
• Other related measures: – Product sampling – Environmental sampling – Recall plans – Robust QA/QC department
37 USDA “Regulatory” HACCP
• Mandatory for all regulated facilities since 1996 • Still must determine hazards, establish critical limits, control at CCPs, monitor, verify, and keep records of everything • Includes implementation of SSOPs and prerequisite programs • Often called “regulatory” HACCP because some requirements not based on science, but rather FSIS mandate – FSIS involvement in development, review, and critique of HACCP plan – Mandatory reassessments – Prototypical example: ground beef processors are required to verify their supplier is using an intervention against E. coli O157:H7 • Nothing science based about that as a “control” for the beef processor. Even with intervention and testing, E. coli O157:H7 is a hazard reasonably likely to occur, so not a scientifically-valid intervention
38 Slaughter Facility Pathogen Controls / Monitoring
• Preharvest procedures (pens, moving animals, etc.) • Detailed slaughter and processing procedures to minimize chance for contamination (focus on hides, feathers, organs, feet, etc.) • Surface treatments and hot water pasteurization • Temperature control (chilling) • Separate zones for slaughter vs. storage vs. processing vs. cooked product • Cleaning shifts • Environmental testing • Product testing
39 Allergens
40 USDA vs. FDA Allergen Requirements
• FDA regulated foods must disclose (label) the “big 8”: – Milk – Eggs – Fish – Crustacean shellfish – Tree nuts – Peanuts – Wheat – Soy • Strongly encouraged, but not required for USDA foods • Use of “may contain” statements discouraged, but allowed – FDA insists focus should be on use of proper cGMPs to control allergens – E.g. proper cleaning and avoidance of cross-contamination • #2 cause of recalls
41 Handling Adulteration
42 Consequences of Adulteration in U.S.
• FDA can: – Administratively detain / seize food – Make you do a recall – Perform in-depth inspection of your facility – Take your documents – Revoke your facility registration • No registration = illegal to ship product into interstate commerce – Make you pay fines and/or fees – Obtain injunctions – Refuse to allow import of products • USDA: – Inspectors can shut down lines immediately, pull or suspend their inspection, and effectively shut down entire facilities. – Detain food – Strong encourage you to do a recall
43 Reportable Food Registry
• Reportable Food Registry (RFR) launched in 2009 – Report when reasonable probability that use of/exposure to food will cause serious adverse health consequences or death to humans or animals (Class I recall) – “Responsible party” must file report and initiate investigation within 24 hours – May require upstream/downstream reporting – Provides FDA with broad authority to publicize a reported event – Applies to U.S. and imported foods • Except infant formula and dietary supplements – Failure to report is a prohibited act
44 Reportable Food Registry
By internal means or from third party By official notification from another firm Covered facility? Already reported? Test: Required to register under 21 USC § 350d?
Yes No Yes No
Reportable food? FDA may Exempt Test: Reasonable probability of causing death or File amended require you to: serious injury to humans or animals? report, with ID # • Submit report from notification • Investigate cause Yes No • Notify others
1. Adulteration originated with you? Exempt 2. Detected before food left possession? 3. Corrected adulteration or destroyed?
No Yes to all
Within 24 hours 1. Investigate source if possible adulteration originated Exempt with you 2. File report on Reportable Food Registry * FDA may also require you to notify others in the supply chain
Learn of new facts Receive Reportable Food Registry notification from Amend report another firm
fb.us.4389248 Product Recalls / Market Withdrawals
• Class I: – reasonable probability that product will cause serious adverse health consequences or death (SAHCD)
• Class II: – product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
• Class III: – product not likely to cause adverse health consequences
• Market withdrawal: – minor violation, not subject to FDA legal action
46 Recall Powers
• FDA: – Pre-FSMA, mandatory recall authority limited to infant formula • But had a bully pulpit… – Now has mandatory recall authority
• USDA: – No mandatory recall authority – But can withdraw grant of inspection, etc. – Even if not adulterated, USDA can (and will) ask firm to recall where it establishes epidemiological link to cluster of illnesses (e.g. Salmonella Heidelberg in ground turkey)
47 New USDA Reporting Requirement
• 2008 Farm Bill required FSIS to put out several new regs
• May 2012: FSIS releases new requirement for meat & poultry plants, similar to Reportable Food Registry
• Requires notification to FSIS within 24 hours of determining that contaminated or misbranded product has been released into commerce
• Broader than RFR, not just Class I recall standard
• Also now requires plants to have recall plans
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