4/6/2017 Introduction Guide to US Food Laws Eggs are regulated by both FDA and USDA and Regulations Eggs are also regulated at the state and federal levels SECONDEDITION Chapter 12 PatriciaA.Curtis FDA shares safety of eggs with Food Safety Egg Laws and Ispection Service (FSIS)within the USDA Regulations FDA has jurisdiction over establishments that sell or serve eggs or use them as ingredients (shell eggs) FSIS oversees the safety of liquid,frozen, and driedegg products,domestic and imported,and the safe use or disposal of WILEY Blackwell damaged and dirty eggs(egg products) History History Egg Grading Manual historical overview Egg Grading Manual historical overview Farmer Products Inspection Act of 1917 Egg Products Inspection Act of 1970 (EPIA) -original authority of establishing grades and uniformity of standards and grades grading service for voluntary use -federal standards preempt state standards states were required to amend their laws to Agricultural Marketing Act of 1946 conform to the federal laws contains the authority under which the Federal Food,Drug and Cosmetic Actof 1938 present egg grading service is performed -prevents the shipment of adulterated or misbranded foods authorizes the development of standards eggs fall under this authority
4/6/2017 1 Chapter 12 Egg Laws and Regulations Introduction • Eggs are regulated by both FDA and USDA • Eggs are also regulated at the state and federal levels • FDA shares safety of eggs with Food Safety Ispection Service (FSIS) within the USDA - FDA has jurisdiction over establishments that sell or serve eggs or use them as ingredients (shell eggs) - FSIS oversees the safety of liquid, frozen, and dried egg products, domestic and imported, and the safe use or disposal of damaged and dirty eggs (egg products) History Egg Grading Manual historical overview • Farmer Products Inspection Act of 1917 - original authority of establishing grades and grading service for voluntary use • Agricultural Marketing Act of 1946 - contains the authority under which the present egg grading service is performed - authorizes the development of standards History Egg Grading Manual historical overview • Egg Products Inspection Act of 1970 (EPIA) - uniformity of standards and grades - federal standards preempt state standards - states were required to amend their laws to conform to the federal laws • Federal Food, Drug and Cosmetic Actof 1938 - prevents the shipment of adulterated or misbranded foods - eggs fall under this authority
4/6/2017 History History Surveillance Inspections Surveillance Inspections EPIA also controls the disposal of undergrade EPIA authorizes inspection of shell egg handlers eggs to prevent their getting into consumer to control the disposal of restricted eggs channels -Shell egg handlers include firms that grade and -These eggs are defined as"restricted"eggs pack eggs for consumer,commercial distribution and hatcheries Checks and dirty eggs are moved to egg -Quaterly visits are made to each producer/packer breaking plants where they are processed -yearly visits are made to hatcheries All other restricted eggs must be disposed of -Visits are conducted by state or federal shell egg in a means that prevents use in human food surveillance inspectors maybe denaturing with color dye Records must be maintained History History State Laws State Laws 1919,the first state laws were enacted in New york was the first state to enact a law South Dakota,Iowa,and Illinois requiring that eggs be labeled by quality and Earliest regulations prohibited the sale of size inedible eggs New york egg producers hoped that Since then,all 50 states maintain egg laws consumers would be pay more for higher that regulate labeling,grading.and marketing quality of eggs EPIA provision concerning standards,grades Inspection of eggs at retail outlets is the and labeling help to ensure free movement of resposibility of the states eggs in interstate commerce and eliminate features that create barriers
4/6/2017 2 History Surveillance Inspections • EPIA also controls the disposal of undergrade eggs to prevent their getting into consumer channels - These eggs are defined as ”restricted” eggs - Checks and dirty eggs are moved to egg breaking plants where they are processed - All other restricted eggs must be disposed of in a means that prevents use in human food maybe denaturing with color dye History Surveillance Inspections • EPIA authorizes inspection of shell egg handlers to control the disposal of restricted eggs - Shell egg handlers include firms that grade and pack eggs for consumer, commercial distribution and hatcheries - Quaterly visits are made to each producer/packer - Yearly visits are made to hatcheries - Visits are conducted by state or federal shell egg surveillance inspectors - Records must be maintained History State Laws • 1919, the first state laws were enacted in South Dakota, Iowa, and Illinois • Earliest regulations prohibited the sale of inedible eggs • Since then, all 50 states maintain egg laws that regulate labeling, grading, and marketing of eggs • Inspection of eggs at retail outlets is the resposibility of the states History State Laws • New York was the first state to enact a law requiring that eggs be labeled by quality and size • New York egg producers hoped that consumers would be pay more for higher quality • EPIA provision concerning standards, grades and labeling help to ensure free movement of eggs in interstate commerce and eliminate features that create barriers
4/6/2017 History History Federal Egg Laws Federal Egg Laws Agricultural Marketing Service was FSIS provides a voluntary egg products responsible for administering the EPIA inspection program for a fee for service Federal Crop Insurance Reform and the Voluntary inspection certifies class,quality. Department of Agriculture Reorganization Act quantity,and condition and is used for of 1994 consolidated food safety certification purposes responsibilities in FSIS Inspection of egg products requires Today,after years of redelegating continuous inspection of the processing of egg responsibilities,FSIS oversees all functions products under the Egg Products Inspection Act examination before and after breaking eggs History History Federal Egg Laws Federal Egg Laws EPIA requires all eggs be kept refrigerated 2012,a new bill "Egg Bill"amended the EPIA and contains labeling that states this requirement -required that egg farmers double the space allotted for 270 million hens in the US FDA has authority to ensure this requirement -required housing improvements for better at food manufacturing estalishments animal welfare So far this bill has not been made law
4/6/2017 3 History Federal Egg Laws • Agricultural Marketing Service was responsible for administering the EPIA • Federal Crop Insurance Reform and the Department of Agriculture Reorganization Act of 1994 consolidated food safety responsibilities in FSIS • Today, after years of redelegating responsibilities, FSIS oversees all functions under the Egg Products Inspection Act History Federal Egg Laws • FSIS provides a voluntary egg products inspection program for a fee for service • Voluntary inspection certifies class, quality, quantity, and condition and is used for certification purposes • Inspection of egg products requires continuous inspection of the processing of egg products - examination before and after breaking eggs History Federal Egg Laws • EPIA requires all eggs be kept refrigerated and contains labeling that states this requirement • FDA has authority to ensure this requirement at food manufacturing estalishments History Federal Egg Laws • 2012, a new bill ”Egg Bill” amended the EPIA - required that egg farmers double the space allotted for 270 million hens in the US - required housing improvements for better animal welfare - So far this bill has not been made law
4/6/2017 History History Egg Products Inspection Act(EPIA)of 1970 Egg Products Inspection Act(EPIA)of 1970 Imposes specific inspections on egg products Egg-breaking plants that break,dry,and and shell eggs process shell eggs into liquid,frozen,or dried Gives enforcement authority to USDA and egg products must operate under the FDA continuous inspection program of the USDA Federal or state officials visit egg hatcheries All egg-breaking plants no matter the size are and packers once every 3 months required to operate in this manner Other firms that transport,ship,receive shell eggs may also be checked periodically History History Federal-State Agreements Federal-State Agreements For 70 years,the USDA in cooperation with In the early days of federal-state grading States has conducted a voluntary Federal- consisted of inspecting eggs and poultry State egg-grading service based on purchased by the US Navy to determine -US standards for quality of individual eggs compliance with purchasing specifications US grades and weight classes for consumer Today,voluntary egg grading and certification services are adminstered by Poultry Programs, nest run grades of shell eggs Gradeing Branch of USDA First quality standards were developed in 1925 Graders are either state or federal employees First standards for weights and grade classes Grading service is cooperative agreement between were developed in 1946 the USDA and State dept of Agriculture
4/6/2017 4 History Egg Products Inspection Act (EPIA) of 1970 • Imposes specific inspections on egg products and shell eggs • Gives enforcement authority to USDA and FDA • Federal or state officials visit egg hatcheries and packers once every 3 months • Other firms that transport, ship, receive shell eggs may also be checked periodically History Egg Products Inspection Act (EPIA) of 1970 • Egg-breaking plants that break, dry, and process shell eggs into liquid, frozen, or dried egg products must operate under the continuous inspection program of the USDA • All egg-breaking plants no matter the size are required to operate in this manner History Federal-State Agreements • For 70 years, the USDA in cooperation with States has conducted a voluntary FederalState egg-grading service based on - US standards for quality of individual eggs - US grades and weight classes for consumer - nest run grades of shell eggs • First quality standards were developed in 1925 • First standards for weights and grade classes were developed in 1946 History Federal-State Agreements • In the early days of federal-state grading, consisted of inspecting eggs and poultry purchased by the US Navy to determine compliance with purchasing specifications • Today, voluntary egg grading and certification services are adminstered by Poultry Programs, Gradeing Branch of USDA • Graders are either state or federal employees • Grading service is cooperative agreement between the USDA and State dept of Agriculture
4/6/2017 SD History History A Federal-State Agreements Federal-State Agreements Two main type of agreements Greatest use of the grading program is in the 1.State Trust Fund labeling of individual consumer packages fees charged are collected and held in trust Regulations provide the approval of grade labels by the state used in the program state is periodically paid from the trust fund Grade mark is contained a shield with USDA according to terms of the agreement USDA shielded eggs account for 49%of eggs 2.Federal Trust Fund packed and moved across interstate lines contracts for services are between the USDA All expiration dates are calculated based on date and the individual firms of packaging and may not exceed 30-45 days fees are collected and held in a USDA trust depending on the wordage used History Federal-State Agreements n ORADE A LARGE ECC Other USDA services USDA Contract Compliance stamp used to USDA USDA identify shell eggs that comply with written AA contract requirements "grader samples the product to ensure compliance date of grading or certificate number appears on the stamp as well as plant and grader number
4/6/2017 5 History Federal-State Agreements • Two main type of agreements 1. State Trust Fund - fees charged are collected and held in trust by the state - state is periodically paid from the trust fund according to terms of the agreement 2. Federal Trust Fund - contracts for services are between the USDA and the individual firms - fees are collected and held in a USDA trust History Federal-State Agreements • Greatest use of the grading program is in the labeling of individual consumer packages • Regulations provide the approval of grade labels used in the program • Grade mark is contained a shield with USDA • USDA shielded eggs account for 49% of eggs packed and moved across interstate lines • All expiration dates are calculated based on date of packaging and may not exceed 30-45 days depending on the wordage used History Federal-State Agreements • Other USDA services - USDA Contract Compliance stamp used to identify shell eggs that comply with written contract requirements grader samples the product to ensure compliance date of grading or certificate number appears on the stamp as well as plant and grader number
4/6/2017 History History Federal-State Agreements Federal-State Agreements ·Other USDA services ·Other USDA services USDA Graded for Export stamp used to USDA Officially Certified as Stated on identify egg products packed for export Certificate stamp used on containers of shipments shell eggs that are certified disease free grader samples the product to ensure .grade and size are not referenced compliance certificate number is shown on the stamp a grading certificate accompanies the eggs when delivered certificate number adn plant or grader number also appear in the stamp History Egg Safety Final Rule Implementation Federal-State Agreements In 2009,FDA requires shell egg producers to ·Other USDA services implement measures to prevent Salmonella USDA Certified Pasteurized stamp used to Enteritidis(SE)from contaminating eggs on the farm and from further growth during identify pasteurized eggs storage and transportation grader samples the product to ensure compliance FDA requires producers to maintain records concerning their compliance with the rule -Produced From Shell Eggs stamp is used to FDA requires producers to register with the identify pasteurized eggs from officially FDA graded eggs
4/6/2017 6 History Federal-State Agreements • Other USDA services - USDA Graded for Export stamp used to identify egg products packed for export shipments grader samples the product to ensure compliance a grading certificate accompanies the eggs when delivered certificate number adn plant or grader number also appear in the stamp History Federal-State Agreements • Other USDA services - USDA Officially Certified as Stated on Certificate stamp used on containers of shell eggs that are certified disease free grade and size are not referenced certificate number is shown on the stamp History Federal-State Agreements • Other USDA services - USDA Certified Pasteurized stamp used to identify pasteurized eggs grader samples the product to ensure compliance - Produced From Shell Eggs stamp is used to identify pasteurized eggs from officially graded eggs Egg Safety Final Rule Implementation • In 2009, FDA requires shell egg producers to implement measures to prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm and from further growth during storage and transportation • FDA requires producers to maintain records concerning their compliance with the rule • FDA requires producers to register with the FDA
4/6/2017 Egg Safety Final Rule Implementation Egg Safety Final Rule Implementation Compliance Dates Salmonella Enteritidis Producers with >50,000 laying hens had to SE is one of the leading causes of foodborne comply by July 9,2010 illness in the US .Producers with>30,000 laying hens had to CDC has identified shell eggs as a primary comply by July 9,2012 source of SE infections Producers who had to only meet refrigeration Two different ways eggs can be contaminated requirements had to comply by July 9,2010 1.SE from the environment contaminates the Producers with fewer than 3,000 hens and sell shell and evantually moves into the egg all eggs directly to consumers were exempt 2.Laying hens can pass SE to the forming egg transovarian Cost More Than Salmonellosis is NOT JUST caused by Poultry 19,336 In fact,meat poultry products were the source of $3.7 Billion Hospitalized only 33%of Salmonella outbreaks from 1998 to 2008 19% in2013 Poultry 679% 1,027,561 378 dairy, eggs, 14%Beef produce patients in Died Pork and 2013 others
4/6/2017 7 Egg Safety Final Rule Implementation Compliance Dates • Producers with >50,000 laying hens had to comply by July 9, 2010 • Producers with >30,000 laying hens had to comply by July 9, 2012 • Producers who had to only meet refrigeration requirements had to comply by July 9, 2010 • Producers with fewer than 3,000 hens and sell all eggs directly to consumers were exempt Egg Safety Final Rule Implementation Salmonella Enteritidis • SE is one of the leading causes of foodborne illness in the US • CDC has identified shell eggs as a primary source of SE infections • Two different ways eggs can be contaminated 1. SE from the environment contaminates the shell and evantually moves into the egg 2. Laying hens can pass SE to the forming egg transovarian
4/6/2017 Pathogenesis of egg contamination by Salmonella Egg Safety Final Rule Implementation Salmonella Enteritidis .In properly managed egg facilities,SE contamination is rare Risk assessment determines the chance of an egg being contaminated as 1 in 20,000 Implementation of programs to reduce contamination reduces that number in properly managed egg facilities 20a1：71-2 Egg Safety Final Rule Implementation Egg Safety Final Rule Implementation Salmonella Enteritidis Required SE Prevention Measures All persons who produce eggs from a farm All shell producers must: operating with 3000 or more hens are subject 1.have and implement a written SE prevention to the egg safety rule plan Exemptions are if the eggs are sold directly to the consumer or they are not produced for 2.obtain young hens that are SE monitored table egg market 3.use biosecurity program refrigeration and registration 4.use a program to control rodents,flies,etc requirements still needed 5.clean and disinfect poultry houses before Persons who transport eggs must comply with new laying hens are added if any test was the refrigeration requirement positive for SE
4/6/2017 8 Pathogenesis of egg contamination by Salmonella Inne Gantois et al. FEMS Microbiol Rev 2009;33:718-738 Egg Safety Final Rule Implementation Salmonella Enteritidis • In properly managed egg facilities, SE contamination is rare • Risk assessment determines the chance of an egg being contaminated as 1 in 20,000 • Implementation of programs to reduce contamination reduces that number in properly managed egg facilities Egg Safety Final Rule Implementation Salmonella Enteritidis • All persons who produce eggs from a farm operating with 3000 or more hens are subject to the egg safety rule • Exemptions are if the eggs are sold directly to the consumer or they are not produced for table egg market - refrigeration and registration requirements still needed • Persons who transport eggs must comply with the refrigeration requirement Egg Safety Final Rule Implementation Required SE Prevention Measures • All shell producers must: 1. have and implement a written SE prevention plan 2. obtain young hens that are SE monitored 3. use biosecurity program 4. use a program to control rodents, flies, etc 5. clean and disinfect poultry houses before new laying hens are added if any test was positive for SE
4/6/2017 Egg Safety Final Rule Implementation Egg Safety Final Rule Implementation Required SE Prevention Measures Documentation All shell producers must: Letter from the supplier 6.shell eggs held or transported must be states purchased young hens meet the refrigerated at or below ambient requirements listed above temperatures starting 36 hours after laying used to show that young hens come from 7.conduct environmental testing for SE when an approved source laying hens are 40-45 weeks old and 4-6 If the producer raises own hens,then they weeks after mold need to provide the documentation 8.conduct egg testing for SE when Maintenance logs,cleaning/disinfection logs, environmental test is positive for SE biosecurity logs will also work Egg Safety Final Rule Implementation Egg Safety Final Rule Implementation Documentation Documentation .Guidance for Industry:Prevention of Guidance for Industry: Salmonella Enteritidis in Shell Eggs During Cleaning and disinfection for larger hen houses Production,Storage and Transportation:FDA that test positive for SE in the environment provides detailed pest control practices if a house tests positive for SE for two disusses rodent control:indexing,use of consecutive flocks,producer should spot cards,fixed sticky tape,moving tape, disinfect before restocking bait traps etc 、 producer should also consider downtime used to show that young hens come from between flocks in that house an approved source
4/6/2017 9 Egg Safety Final Rule Implementation Required SE Prevention Measures • All shell producers must: 6. shell eggs held or transported must be refrigerated at or below ambient temperatures starting 36 hours after laying 7. conduct environmental testing for SE when laying hens are 40-45 weeks old and 4-6 weeks after mold 8. conduct egg testing for SE when environmental test is positive for SE Egg Safety Final Rule Implementation Documentation • Letter from the supplier - states purchased young hens meet the requirements listed above - used to show that young hens come from an approved source • If the producer raises own hens, then they need to provide the documentation • Maintenance logs, cleaning/disinfection logs, biosecurity logs will also work Egg Safety Final Rule Implementation Documentation • Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage and Transportation; FDA • provides detailed pest control practices - disusses rodent control: indexing, use of spot cards, fixed sticky tape, moving tape, bait traps etc - used to show that young hens come from an approved source Egg Safety Final Rule Implementation Documentation • Guidance for Industry: • Cleaning and disinfection for larger hen houses that test positive for SE in the environment - if a house tests positive for SE for two consecutive flocks, producer should disinfect before restocking - producer should also consider downtime between flocks in that house
4/6/2017 Egg Safety Final Rule Implementation Egg Safety Final Rule Implementation Documentation Documentation Envionmental Sampling and Detection of .Refrigeration below ambient temperatures 36 Salmonella in Poultry Houses:FDA hours after laying is required even for producers who pasteurize their eggs ."Within each poultry house,you must sample the environment using a sampling plan appropriate to .Distributors,packers,truckers holding or the poultry house layout" transporting eggs must also comply details how are given in the above A log should be created to monitor the cooler Environmental testing does not serve directly as a temperature and how the eggs moved in and SE prevention measure but instead serves as an out of the cooler indicator of program effectiveness Positive environmental test should be linked to documentation Egg Safety Final Rule Implementation Egg Safety Final Rule Implementation Documentation Documentation Envionmental Sampling and Detection of Salmonella Envionmental Sampling and Detection of Salmonella in in Poultry Houses:FDA Poultry Houses:FDA If any samples are positive,producer has 2 choices ·Testing: Divert the eggs -4 x 1000-egg samples collected and tested Test the eggs -4 tests conducted in 2-week intervals If all negative nothing further is tested If any are positive,all eggs are diverted for treatment to reduce the load of SE until four consecutive egg test are negative test To return to table egg production,1000 eggs must be tested each month for the life of the flock 0
4/6/2017 10 Egg Safety Final Rule Implementation Documentation • Refrigeration below ambient temperatures 36 hours after laying is required even for producers who pasteurize their eggs • Distributors, packers, truckers holding or transporting eggs must also comply • A log should be created to monitor the cooler temperature and how the eggs moved in and out of the cooler Egg Safety Final Rule Implementation Documentation • Envionmental Sampling and Detection of Salmonella in Poultry Houses; FDA • ”Within each poultry house, you must sample the environment using a sampling plan appropriate to the poultry house layout” - details how are given in the above • Environmental testing does not serve directly as a SE prevention measure but instead serves as an indicator of program effectiveness • Positive environmental test should be linked to documentation Egg Safety Final Rule Implementation Documentation • Envionmental Sampling and Detection of Salmonella in Poultry Houses; FDA • If any samples are positive, producer has 2 choices - Divert the eggs - Test the eggs Egg Safety Final Rule Implementation Documentation • Envionmental Sampling and Detection of Salmonella in Poultry Houses; FDA • Testing: - 4 x 1000-egg samples collected and tested - 4 tests conducted in 2-week intervals - If all negative nothing further is tested - If any are positive, all eggs are diverted for treatment to reduce the load of SE until four consecutive egg test are negative test - To return to table egg production, 1000 eggs must be tested each month for the life of the flock