Food Safety Regulation and FDA: Ensuring Public Health

Exceptional service. Dykema delivers. Food Safety Regulation Mitchell Hamline Food Law Seminar November 29, 2016 David P.Graham California | Illinois | Michigan | Minnesota | Texas | Washington, D.C. www.dykema.com

What Is Food Safety? How do consumers view food safety? Increasing broad definition and long term risk view clear and accurate labeling clear information on ingredients and sourcing no artificial ingredients and less processing high nutritional content 2 Exceptional service. Dykema delivers.

What Is Food Safety? (cont.) Regulatory view of safety High risk means generally high short term pathogenic or toxic risks Safety regulations focused on eliminating short term risks Labeling regulations based on disclosing potential long term health effects except allergens 3 Exceptional service. Dykema delivers.

Definition of Food "The term food means (1) articles used for food and drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article." Food does not include anything that comes from food Includes animal feed 4 Exceptional service. Dykema delivers.

FDA Mission Promote public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products . . . Protect public health by preventing adulteration and misbranding 5 Exceptional service. Dykema delivers.

FDA Jurisdiction Food except, USDA regulated meat, poultry and egg products USDA if 3% meat or poultry FDA live animals intended to be used for food Bottled water, ice and cosmetics Joint FDA and USDA jurisdiction over food additives 6 Exceptional service. Dykema delivers.

FDA Jurisdiction (cont.) The Federal Food & Drug Act of 1906, 21 U.S.C. 1-5 (Pure Food and Drug Act) After processing USDA and FDA have joint jurisdiction over distribution of meat and poultry up to the retail establishment FDA governs retail establishments Alcohol Department of Treasury (TTP) under FAAA, 27 U.S.C. 201 et seq. 7 Exceptional service. Dykema delivers.

Statutory Background 1906 Federal Food and Drug Act Pure Food and Drugs Act (Originally drafted in 1875) 1938 Food, Drug and Cosmetic Act ("FDCA") Basic legal framework for food, drugs, cosmetics, tobacco and medical devices 2011 Food Safety Modernization Act Regulatory Pillars are Adulteration and Misbranding 8 Exceptional service. Dykema delivers.

Parallel State and Local Laws Addressed local markets in urban centers Religious practices Cultural norms Adulteration-focused Development of local boards of health in cities, counties and states in 19th Century FDA and USDA partner with state agencies to regulate food safety 9 Exceptional service. Dykema delivers.

Food, Drug, and Cosmetic Act of 1938 (FDCA) 21 U.S.C. 301 et seq. Food standards of identity required "to promote honesty and fair dealing in the interest of consumers" 401 Imitation food must be labeled as such Defined "misbranding" 21 U.S.C. 343 which included a false or misleading label "in any particular" Defined adulteration and primarily concerned with safety and keeping adulterated food off market 10 Exceptional service. Dykema delivers.

Food Safety - USDA Wide Ranging Jurisdiction includes: Farm and Foreign Agricultural Services; Rural Development (including housing) Food, Nutrition Services Food Safety Inspection Services (PSIS) Animal, Plant Health Inspection Services (APHIS) National Organic Program (NOP) Forest Services National Resources Conservation 11 Exceptional service. Dykema delivers.

Food Law - USDA USDA Agencies include: Agricultural Marketing Service (AMS) Strategic assistance marketing Agricultural products in domestic/international markets Oversees Egg Inspections; National Organic Program Animal and Plant Health Inspection Services (APHIS) Health and care of animals/plants their productivity and competition Includes Supplemental Nutrition Assistance Program; Women Infants and Children food supplement program 12 Exceptional service. Dykema delivers.

Food Law USDA (cont.) Food and Nutrition Services Provides hunger relief, nutrition education and agricultural support Partners with communities and governments Includes Supplemental Nutrition Assistance Program; Women Infants and Children food supplement program 13 Exceptional service. Dykema delivers.

Food Law USDA (cont.) Food Safety and Inspection Services (FSIS) Provides inspection services for meat, poultry, egg & egg products, and catfish Looking for wholesome plant and product, correct labeling and packaging Coordinates U.S. involvement/participation in the Codex Alimentarius Commission Codex is United Nations international standard setting organization for food safety and public health 14 Exceptional service. Dykema delivers.

Foreign Agricultural Services Assists with foreign market access for U.S. agriculture 15 Exceptional service. Dykema delivers.

Food Law - USDA Primary food laws enforced by USDA Federal Meat Inspection Act 21 USC 601 et seq Poultry Products Inspection Act 21 USC 451 et seq Egg Products Inspection Act 21 USC 1031 et seq Perishable Agricultural Commodities Act 7 USC 499a et seq Organic Foods Production Act of 1990 7 USC 6501 et seq 16 Exceptional service. Dykema delivers.

Food Law USDA (cont.) Essential Points of Laws Specified Business Entities or Individuals Affected Food and/or Food Sources Affected by the Laws Food Safety, Sanitation and Labeling Record Keeping Violations, Penalties and Due Process 17 Exceptional service. Dykema delivers.

USDA - FMIA Products covered: Cattle, sheep, swine, goats, horses, mules and other equines Businesses covered: "Official establishment" - a registered facility where on-site USDA- authorized inspections are maintained over processes Meat Brokers buyer, sellers and negotiator of products Renderers Animal Food Manufacturers NOT PRODUCERS 18 Exceptional service. Dykema delivers.

USDA FMIA (cont.) Primary Focus: "Adulterated" Meat or meat food substance: bearing or containing any poisonous or deleterious substance which may render meat or meat food product injurious to health contains added poisonous or deleterious substance when animal was alive containing unapproved or unsafe food additives, color additives or pesticide chemicals 19 Exceptional service. Dykema delivers.

USDA FMIA (cont.) (FMIA) Inspections: Required for meat examination pre- and post- slaughter Looking for evidence of disease, inhumane slaughter techniques Also applies to post-slaughter meat and meat products, carcasses and parts Inspectors mark/label - approval or condemnation - of meat, carcasses and parts Under supervision of an inspector FD&CA labeling standards apply No "false or misleading" labels right to appeal inspector's determination 20 Exceptional service. Dykema delivers.

USDA FMIA (cont.) Take place at establishments for slaughtering, meat-canning, salting, packing, rendering, non-retail storage and handling facilities Inspectors have access at any time to: examine establishment for sanitary conditions look at meat for adulteration or improper labeling 21 Exceptional service. Dykema delivers.

USDA FMIA (cont.) Inspector authority: Can refuse to inspect premises if any owner is: A convicted felon Convicted of multiple violations of food law. Can administratively detain adulterated or misbranded food for human use Can seize and/or condemn animal(s) or carcass or parts which are adulterated, misbranded or in violation of the FMIA laws. 22 Exceptional service. Dykema delivers.

USDA FMIA (cont.) Can enjoin operation of establishment or refuse to inspect due to violations Can cite owner or establishment for minor violations Due process is available to owner Can extend inspections to reindeer and dairy exports 23 Exceptional service. Dykema delivers.

USDA FMIA (cont.) Violation penalties include: Seizure and condemnation of violative product Destruction of product at owner's expense Injunctions Fines and imprisonment 24 Exceptional service. Dykema delivers.

USDA Poultry Products Inspection Act (PPIA) Similar Regulatory Regimen to FMIA Exemptions to requirements and inspections : Retailers which cut up poultry for consumers Slaughter, processing and handling required by "recognized religious dietary laws" i.e. Kosher, Halal Poultry raised, slaughtered by owner for exclusive personal, family or employee use Custom slaughter of owner's poultry for owner's use 25 Exceptional service. Dykema delivers.

USDA PPIA (cont.) Slaughter, processing of poultry raised by poultry producer on producer's premises for local distribution (products must be fit for human food; limit 20,000 poultry/year) Pizzas containing poultry products if those products are prepared, inspected and passed in cured/cooked RTE form and served in non-profit institutions Adulteration and misbranded requirements still apply to above 26 Exceptional service. Dykema delivers.

USDA MPIA and PPIA Regulations HACCP ( 417) Hazard Analysis and Critical Control Points Required for all "official establishments" Objective: Food safety and sanitation processes for avoidance of adulteration Analyze establishment for food safety hazards that can occur Before, during and after entry of food product into establishment 27 Exceptional service. Dykema delivers.

USDA MPIA and PPIA Regulations Recall Establishment must prepare and maintain procedures for recall of meat, meat food, poultry or poultry products they produce or ship, including: recall determination how recall will be effected Upon establishment "belief or reason to believe" that a product is adulterated or misbranded, establishment must contact FSIS within 24 hours of that knowledge All records relating to recalled product production, HACCP plans, SSOPs, and other standard requirements must be made available for FSIS review and copy 28 Exceptional service. Dykema delivers.

USDA Food Safety Inspection Service (FSIS) MISSION: The Food Safety and Inspection Service (FSIS) is the public health agency in the U.S. Department of Agriculture responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged. http:// ww.fsis.usda.goviwpsiportal/informationaliaboutisi s 29 Exceptional service. Dykema delivers.

USDA Egg Products Inspection Act (EPIA) Products covered: Shell eggs of domesticated chickens, turkeys, ducks, geese or guinea Egg Products dried, frozen, liquid eggs, with or without added ingredients. Exceptions: Products with relatively small proportion of egg or not considered by consumers to be egg products Freeze-dried, imitation or substitute egg products, cake mixes, noodles 30 Exceptional service. Dykema delivers.

USDA Perishable Agricultural Commodities Act (PACA) Law passed in 1930 Actions leading to law: Unfair or discriminatory business and finance practices affecting perishable commodity growers and others Fraudulent or deceptive marketing of fruits and vegetables Flooded markets and wrongful destruction of food Consumer deception 31 Exceptional service. Dykema delivers.

USDA Perishable Agricultural Commodities Act (PACA) (cont.) Directed by USDA Agricultural Marketing Service (AMS) Function: Administer programs that facilitate efficient, fair marketing of U.S. agricultural products, including food, fiber, and specialty crops 32 Exceptional service. Dykema delivers.

USDA PACA Products covered Fresh fruit and vegetables Perishable Agricultural Commodities (PAC) Including those frozen or packed in ice Shipped in interstate or foreign commerce 33 Exceptional service. Dykema delivers.

USDA PACA (cont.) Businesses covered Commission Merchants Receive PAC for sales on commission or for or on behalf of another Dealers Buyers or sellers of wholesale or jobbing quantities Can include retailers who sell direct to consumers DOES NOT INCLUDE: produce selling own product buyers for retail sales <$230,000/year to a limited extent, buyers of PAC for canning or processing 34 Exceptional service. Dykema delivers.

Food Safety Modernization Act 35 Exceptional service. Dykema delivers.

Overview Relates to FDA regulation primarily Covers approximately 80% of all food consumed Designed to build a "scientifically/risk based food borne illness preventative regime Increases FDA's access to records Registration requirements 36 Exceptional service. Dykema delivers.

FSMA at a Glance Inspection Resources Records Inspection Funding Foreign Supplier Verification Employee Protections Laboratory Accreditation Registration of Facilities Voluntary Qualified Importer Program Jurisdictions/ Authorities Integrated Lab Networks Preventive Controls Import International Agreements Certification Surveillance Performance Standards Prior Notice Mandatory Recall Budgetary Effects Food Defense Capacity of Admin. Detention of Food Foreign Gov.. Sanitary Transportation Inspection of Foreign Facility 3rdParty Auditor Accreditation Smuggled Food Training of Officials Allergy Management Improving RFR Port Shopping 37 Exceptional service. Dykema delivers.

Overview Facility Registration FDA Inspections Increased Access to Records Hazard analysis and risk-based prevention controls Additional Record keeping Regulations FDA mandatory recall authority Imported foods and foreign food suppliers Employee whistleblower protections 38 Exceptional service. Dykema delivers.

Overview (cont.) Proactive vs. Reactive Focus on prevention More Requirements Inspections Recordkeeping Imports More FDA Authority Response Rulemaking/Guidance Programs 39 Exceptional service. Dykema delivers.

FDA Inspections Section 201 Based on Scientifically determined "Risk Profile" Must target "high-risk" facilities FDA must report annually to Congress on inspections Effective immediately but subject to appropriations 40 Exceptional service. Dykema delivers.

FDA Inspections (cont.) Domestic Facilities High-risk facilities Once in first five years, then once every three years Non-high risk facilities Once in first seven years, then once every five years States may inspect more often 41 Exceptional service. Dykema delivers.

FDA Inspections (cont.) Foreign Facilities FDA must inspect at least 600 within one year Then, for five years, inspect at least twice as many as the previous year 19,200 facilities by 2016 42 Exceptional service. Dykema delivers.

Mandatory Recall Authority Section 206 "Reasonable probability that an article of food is adulterated or misbranded and will cause serious adverse health consequences or death" FDA to provide opportunity for "responsible party to cease distribution" If not, FDA will order stoppage and notify chain of distribution Allows for a hearing within 2 days 43 Exceptional service. Dykema delivers.

Administrative Detention of Food Section 207 Standard changes to allow for detention of food is FDA reasonably believes an article of food is adulterated or misbranded Lower than current standard "threat of serious adverse health consequences. . . . " Could apply to labeling violations 44 Exceptional service. Dykema delivers.

Whistleblower Protection Section 402 No discrimination or retaliation against: Employees engaged in manufacturing processing, packing, transporting, distributing, receiving, holding or importing food For making a disclosure protected by the Act, including reports of violations Whether at employee's initiative or in ordinary course of duties 45 Exceptional service. Dykema delivers.

What FSMA Does Not Do No registration fees or additional civil fines (exception: failure to comply with recall order) No criminal penalties Food Safety Accountability Act. S. 216 Up to 10 years for knowingly contaminating food supply with intent to mislead, defraud or endanger consumers No full pedigree traceability No single, unified food safety agency 46 Exceptional service. Dykema delivers.

Industry Trends Driven by FSMA Software-as-a-service to document program management, organize work flows and distribute notifications for corrective and preventative actions Increased availability of risk assessment tools Intersection of mobile devices and electronic recording keeping and verification Increased demand for more effective and frequent training 47 Exceptional service. Dykema delivers.

Industry Trends Driven by FSMA (cont.) Targeted monitoring and verification activities Availability of new self-assessment tools for updating food safety systems Dedicated staff to support compliance efforts More communication on FSMA food safety related topics as regulations have rolled out 48 Exceptional service. Dykema delivers.