COMPLIANCE DATES. Preventive Controls. CGMP Compliance Date. Business Size. Business other than Small and Very Small employees

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2 COMPLIANCE DATES Business Size CGMP Compliance Date Preventive Controls Compliance Date Business other than Small and Very Small employees Sept. 19, 2016 Sept. 18, 2017 Small Business Sept. 18, 2017 Sept. 17, 2018 Very Small business Less than $ 2.5 million in sales Including market value of the feed Sept. 17, 2018 Sept. 17, 2019

3 SMALL BUSINESS SEPTEMBER 18, 2017

4 FSMA IN A NUTSHELL PREVENTION - STEPS TO MAKE SURE THAT ANIMAL FOOD IS SAFE FOR ANIMALS AND WILL NOT LEAD TO HARM TO HUMANS PREVENT CONTAMINATION OF ANIMAL FOOD, ANIMAL FOOD CONTACT SURFACES AND ANIMAL FOOD PACKAGING RESPONSE- TRACEABILITY AND ABILITY TO ACCOMPLISH A RECALL

5 KEEP IT SIMPLE, KEEP IT REAL YOUR PROGRAM MUST BE IMPLEMENTABLE. INVOLVE YOUR EMPLOYEES MAKE SURE WHAT YOU PUT IN WRITING IS ACHIEVABLE.

6 FSMA-REGULATIONS FOR FEED MILLS 1. PREVENTIVE CONTROLS FOR ANIMAL FOOD - CGMPS, HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS, ANIMAL FOOD SAFETY PLAN, SUPPLY CHAIN PROGRAM. 2. SANITARY TRANSPORTATION RULE 3. FOREIGN SUPPLIER VERIFICATION RULE

7 CGMPS - REGULATORY CURRENT GOOD MANUFACTURING PRACTICES THE THINGS YOU DO TO PRODUCE QUALITY ANIMAL FOOD THAT IS SAFE. FDA DEVELOPED REGULATIONS FOR CGMPS UNDER FSMA.

8 CGMPS NOT AN ENTIRELY NEW CONCEPT WHETHER YOU ARE A LICENSED MEDICATED FEED MILL OR NOT, YOUR FIRM IS ALREADY SUBJECT TO CERTAIN CGMPS.

9 CGMPS LICENSED MEDICATED FEED MILLS GENERAL PROVISIONS GENERAL ISSUES AND PERSONNEL CONSTRUCTION AND MAINTENANCE OF FACILITIES PRODUCT QUALITY CONTROL DRUG COMPONENTS, LABORATORY CONTROLS, EQUIPMENT CLEANOUT PROCEDURES, PACKAGING AND LABELING RECORDS AND REPORTS

10 CGMPS NON LICENSED MILLS FACILITIES AND EQUIPMENT PRODUCT QUALITY ASSURANCE LABELING RECORDKEEPING

11 FSMA CGMP CATEGORIES- SUBPART B PERSONNEL PLANT AND GROUNDS SANITATION WATER SUPPLY AND PLUMBING EQUIPMENT AND UTENSILS PLANT OPERATIONS HOLDING AND DISTRIBUTION HOLDING AND DISTRIBUTION OF HUMAN FOOD BY PRODUCTS FOR USE AS ANIMAL FOOD.

12 LOOK FAMILIAR? THE FSMA REGULATORY CGMPS ARE BASED, AT LEAST IN PART, ON THE CURRENTLY REQUIRED CGMPS

13 SOME SIGNIFICANT DIFFERENCES LICENSED VS. NON LICENSED FEED MILLS LESS PRESCRIPTIVE DOCUMENTATION FOR NON LICENSED MILLS TRAINING SPECIFIED FOR LICENSED MEDICATED MILLS ONLY REQUIRED SCHEDULE FOR LAB TESTING (ASSAYS) - LICENSED MILLS

14 SUBPART B PERSONNEL PERSONAL HYGIENE AND CLEANLINESS CONTROL OF PERSONAL ITEMS LIKE JEWELRY AND CLOTHING AND EVERYONE S PERSONAL FAVORITE OTHER PRECAUTIONS AS NEEDED TO PROTECT AGAINST CONTAMINATION OF ANIMAL FOOD, ANIMAL FOOD CONTACT SURFACES OR ANIMAL FOOD PACKAGING MATERIALS

15 IMPLEMENTATION STEPS CLEANLINESS CLOTHING HAND WASHING PRACTICES RESTRICTIONS ON JEWELRY AND OTHER POSSESSIONS SEPARATE STORAGE AREAS FOR CLOTHING

16 EMPLOYEE TRAINING AND EXPECTATIONS ESTABLISH YOUR CGMPS AND MAKE SURE EMPLOYEES UNDERSTAND AND FOLLOW THEM. TRAINING AND FOLLOW UP

17 PLANT AND GROUNDS GR0UNDS ELIMINATE OR CONTROL POTENTIAL PEST HARBORAGE AREAS LIKE HIGH WEEDS, EQUIPMENT STORAGE, TRASH CONTAINERS AND OUTDOOR STORAGE OF ANIMAL FOOD. MAINTAINING EXTERIOR AREAS LIKE DRIVEWAYS, YARDS, PARKING AREAS SO THAT THEY DO NOT CONSTITUTE A SOURCE OF CONTAMINATION IN AREAS WHERE FOOD IS EXPOSED. PROPER DRAINAGE IN AREAS THAT COULD CREATE HAZARDS TO ANIMAL FOOD.

18 PLANT AND GROUNDS PLANT ADEQUATE SPACE AROUND EQUIPMENT AND OTHER BUILDING AREAS FOR CLEANING, EQUIPMENT MAINTENANCE AND PEST CONTROL. DRIP AND CONDENSATE DOES NOT CREATE A SOURCE OF CONTAMINATION ENSURE ADEQUATE VENTILATION AS NEEDED TO PREVENT CONTAMINATION LIGHTING ADEQUATE TO DO WORK AND PROTECTED TO PREVENT CONTAMINATION BY GLASS BREAKAGE

19 AUDIT THE PLANT AND GROUNDS DO A THOROUGH INSPECTION OF THE FACILITY AND ASK YOUR EMPLOYEES TO DETERMINE IF THERE ARE ANY AREAS OF THE PLANT WHERE CLEANING AND MAINTENANCE CANNOT BE DONE PROPERLY AUDIT AREAS FOR VENTILATION, DRIP CONDENSATE AND LIGHTING. WALK THE GROUNDS TO IDENTIFY ISSUES RELATING TO STORAGE, DRAINAGE AND PEST HARBORAGE

20 PREVENTIVE MAINTENANCE PROGRAM A PLAN A SCHEDULE OF ROUTINE MAINTENANCE A MEANS TO ACCOMPLISH THE SCHEDULE MANPOWER ROUTINE REVIEW OF MAINTENANCE ACTIVITIES - DOCUMENT

21 SANITATION BUILDINGS AND EQUIPMENT KEPT CLEAN A HOUSEKEEPING PROGRAM ANIMAL FOOD CONTACT AND NON CONTACT SURFACES OF UTENSILS AND EQUIPMENT CLEANED AND MAINTAINED WHEN EQUIPMENT IS WET CLEANED IT MUST BE THOROUGHLY DRIED BEFORE USE CLEANING COMPOUNDS SAFE FOR INTENDED USE CONTROL OF USE OF TOXIC MATERIALS USED FOR CLEANING AND MAINTENANCE USE AND PROPER IDENTIFICATION AND STORAGE

22 SANITATION - CONTINUED STORAGE OF FERTILIZERS AND PESTICIDES IN AREAS AWAY FROM WHERE FOOD IS MANUFACTURED, PROCESSED OR EXPOSED PEST CONTROL TRASH STORAGE AND HANDLING

23 HOUSEKEEPING PROGRAM THE FIRST THING TO DO. HAVE A HOUSEKEEPING PLAN HAVE A SCHEDULE IMPLEMENT THE SCHEDULE ONE OR MORE COMPETENT PERSONS MUST OVERSEE THE PROGRAM DOCUMENTED INSPECTIONS A PLANT OPERATIONS CGMP.

24 WATER SUPPLY AND PLUMBING WATER SUPPLY WATER SUPPLY AND WATER SOURCE ADEQUATE WATER AT SUITABLE TEMPERATURE AND SUITABLE PRESSURE WATER THAT CONTACTS ANIMAL FOOD, ANIMAL FOOD CONTACT SURFACES AND ANIMAL FOOD PACKAGING MATERIALS SAFE FOR INTENDED USE WATER REUSED IF IT DOES NOT CONTAMINATE FEED

25 WATER SUPPLY AND PLUMBING PLUMBING ADEQUATE SEWERAGE OR OTHER SYSTEMS TO DISPOSE OF LIQUID WASTE ADEQUATE, ACCESSIBLE AND CLEAN TOILET FACILITIES FOR EMPLOYEES ADEQUATE HAND WASHING FACILITIES

26 INSPECT YOUR WATER SUPPLY AND PLUMBING SYSTEM INSPECT CORRECT ANY DEFICIENCIES DOCUMENT YOUR INSPECTION AND ANY CORRECTIONS TEST THE WATER SUPPLY AT LEAST ANNUALLY INSTRUCT EMPLOYEES TO REPORT ANY ISSUES

27 EQUIPMENT AND UTENSILS ALL PLANT EQUIPMENT AND UTENSILS CLEANABLE AND PROPERLY MAINTAINED DESIGNED, CONSTRUCTED AND USED APPROPRIATELY TO AVOID ADULTERATION OF ANIMAL FOOD BY NON FOOD GRADE LUBRICANTS, FUEL, METAL FRAGMENTS OR ANY OTHER CONTAMINANTS EQUIPMENT INSTALLED TO FACILITATE CLEANING AND MAINTENANCE

28 EQUIPMENT AND UTENSILS - CONTINUED ANIMAL FOOD CONTACT SURFACES MUST BE: MADE OF MATERIALS THAT WITHSTAND THE ENVIRONMENT OF THEIR USE. MADE OF NON TOXIC MATERIALS MAINTAINED TO PROTECT ANIMAL FOOD FROM BECOMING CONTAMINATED

29 EQUIPMENT AND UTENSILS - CONTINUED ALL EQUIPMENT USED FOR ANIMAL FOOD PRODUCTION MUST BE DESIGNED CONSTRUCTED AND MAINTAINED IN A WAY TO PROTECT AGAINST CONTAMINATION FREEZERS AND COLD STORAGE COMPARTMENTS THAT HOLD ANIMAL FOOD MUST BE FITTED WITH AN ACCURATE TEMPERATURE MEASURING DEVICE. ACCURATE INSTRUMENTS AND CONTROLS USED FOR MEASURING, REGULATING OR RECORDING RELATED TO CONTROLLING OR PREVENTING GROWTH OF UNDESIREABLE MICRORGANISMS.

30 EQUIPMENT AND UTENSILS - CONTINUED COMPRESSED AIR OR OTHER GASES MECHANICALLY INTRODUCED INTO ANIMAL FOOD OR USED TO CLEAN ANIMAL FOOD CONTACT SURFACES ARE USED IN SUCH A WAY AS TO PREVENT CONTAMINATION

31 EQUIPMENT AND UTENSIL STEPS DESIGNATE EQUIPMENT AND UTENSILS FOR USE IN ANIMAL FOOD PRODUCTION ACTIVITIES ONLY WHEN FEASIBLE. ESTABLISH A CLEANING SCHEDULE FOR UTENSILS AND EQUIPMENT WHEN PURCHASING NEW EQUIPMENT, MAKE SURE IT IS DESIGNED TO HOLD UP TO THE ENVIRONMENT, HAS SMOOTH SURFACES FOR MATERIAL FLOW AND CAN BE CLEANED AS NEEDED. ESTABLISH SAFE USE PROCEDURES FOR COMPRESSED AIR CLEANING

32 PLANT OPERATIONS MANAGEMENT OF THE ESTABLISHMENT MUST ENSURE THAT: ALL OPERATIONS ARE CONDUCTED IN ACCORDANCE WITH THE FSMA CGMPS ANIMAL FOOD IN ALL FORMS IS PROPERLY IDENTIFIED ANIMAL FOOD PACKAGING MATERIALS ARE SAFE AND SUITABLE. THE OVERALL CLEANLINESS OF THE PLANT IS UNDER THE SUPERVISION OF ONE OR MORE COMPETENT INDIVIDUALS ASSIGNED RESPONSIBILITY FOR THIS FUNCTION

33 PLANT OPERATIONS MANAGEMENT OF THE ESTABLISHMENT MUST ENSURE THAT: PLANT OPERATIONS DO NOT CONTRIBUTE TO CONTAMINATION OF ANIMAL FOOD, ANIMAL FOOD CONTACT SURFACES OR ANIMAL FOOD PACKAGING MATERIALS CHEMICAL, MICROBIAL AND EXTRANEOUS-MATERIAL TESTING PROCEDURES ARE USED WHERE NECESSARY TO IDENTIFY SANITATION FAILURES OR POSSIBLE ANIMAL FOOD CONTAMINATION ANIMAL FOOD THAT HAS BECOME ADULTERATED IS REJECTED, DISPOSED OF OR IF APPROPRIATE, TREATED OR PROCESSED TO ELIMINATE ADULTERATION ANIMAL FOOD MANUFACTURING STEPS ARE PERFORMED IN A WAY THAT MINIMIZES THE POTENTIAL FOR GROWTH OF UNDESIRABLE MICROORGANISMS.

34 PLANT OPERATIONS RAW MATERIALS AND INGREDIENTS INSPECTED TO DETERMINE SUITABILITY SHIPPING CONTAINERS INSPECTED TO DETERMINE IF CONTAMINATION HAS OCCURRED RAW MATERIALS CLEANED AS NECESSARY RAW MATERIALS AND OTHER INGREDIENTS, INCLUDING REWORK STORED TO PREVENT CONTAMINATION IF SUSCEPTIBLE TO CONTAMINATION WITH MYCOTOXINS OR OTHER NATURAL TOXINS ARE EVALUATED AND USED IN A SAFE MANNER.

35 PLANT OPERATIONS MANUFACTURING, PROCESSING, PACKING AND HOLDING OPERATIONS THAT PREVENT THE GROWTH OF HARMFUL MICROORGANISMS AND CONTAMINATION GRINDING, MIXING, PELLETING AND COOLING WORK IN PROGRESS AND REWORK FILLING, ASSEMBLING AND PACKAGING

36 PLANT OPERATIONS A FEW SPECIFICS SUPPLIER APPROVAL PROGRAM WRITTEN PROCEDURES (CGMPS AND SOPS) SAMPLE RETENTION AND INSPECTION PROGRAM RECALL PLAN

37 HOLDING AND DISTRIBUTION ANIMAL FOOD HELD FOR DISTRIBUTION SAFE CONTAINERS HELD IN A WAY TO PREVENT CONTAMINATION FROM TRASH PROPERLY LABELED SHIPPING CONTAINERS INCLUDING BULK VEHICLES EXAMINED PRIOR TO USE TO PROTECT AGAINST CONTAMINATION ANIMAL FOOD THAT IS RETURNED MUST BE ASSESSED TO DETERMINE PROPER DISPOSITION UNPACKAGED BULK ANIMAL FOOD HELD TO PREVENT CROSS CONTAMINATION WITH OTHER ANIMAL FOOD

38 HOLDING AND DISTRIBUTION HUMAN FOOD BY PRODUCTS ANIMAL FOOD HELD FOR DISTRIBUTION CONTAINERS HELD IN A WAY TO PREVENT CONTAMINATION FROM TRASH PROPERLY IDENTIFIED SHIPPING CONTAINERS INCLUDING BULK VEHICLES EXAMINED PRIOR TO USE TO PROTECT AGAINST CONTAMINATION

39 SUBPART C HAZARD ANALYSIS AND RISK- BASED PREVENTIVE CONTROLS FOOD SAFETY PLAN HAZARD ANALYSIS PREVENTIVE CONTROLS

40 HAZARD IDENTIFICATION HAZARD IDENTIFICATION MUST CONSIDER KNOWN OR REASONABLY FORESEEABLE BIOLOGICAL, CHEMICAL, AND PHYSICAL HAZARDS THESE COULD OCCUR NATURALLY, BE UNINTENTIONALLY INTRODUCED, OR BE INTENTIONALLY INTRODUCED FOR ECONOMIC GAIN

41 HARPC HAZARD ANALYSIS AND RISK- BASED PREVENTIVE CONTROLS WHERE DO YOU START? HACCP YOU ALREADY HAVE IDENTIFIED MOST OF THE HAZARDS GENERIC HAZARD ANALYSIS FOR THE INDUSTRY - AFIA/NGFA WITH THE UNIVERSITY OF MN SHOULD BE AVAILABLE LATER THIS FALL AT LATEST. ASSEMBLE A TEAM TO IDENTIFY THE LIKELY HAZARDS

42 HAZARD CATEGORIES - FSMA BIOLOGICAL CHEMICAL INCLUDING RADIOLOGICAL PHYSICAL REMEMBER YOU ARE IDENTIFYING KNOWN OR REASONABLY FORESEEABLE HAZARDS.

43 EXAMPLES BIOLOGICAL SALMONELLA CHEMICAL AFLATOXINS, MEDICATIONS PHYSICAL FOREIGN MATERIALS

44 HAZARD ANALYSIS EVALUATION OF HAZARDS MUST INCLUDE: CONSIDERATION OF SEVERITY OF ILLNESS/INJURY AND PROBABILITY OF OCCURRENCE IN ABSENCE OF PREVENTIVE CONTROLS CONSIDERATION OF EFFECT OF FACTORS SUCH AS FORMULATION AND PROCESSING OF ANIMAL FOOD, FACILITY, EQUIPMENT, INGREDIENTS, INTENDED USE

45 PREVENTIVE CONTROLS DEMONSTRATE THAT ANY HAZARD YOU IDENTIFY CAN BE CONTROLLED THROUGH YOUR CGMPS. WHEN A SPECIFIC PREVENTIVE CONTROL STEP IS ESTABLISHED TO ELIMINATE OR CONTROL A HAZARD, GREATER DOCUMENTATION IS REQUIRED TO SHOW THAT THE PREVENTIVE CONTROL IS WORKING. DOCUMENTATION FAILURES CAN LEAD TO A CONCLUSION BY FDA THAT THE ANIMAL FOOD IS ADULTERATED AND A RECALL MAY BE NECESSARY IN ADDITION TO A CEASE IN OPERATIONS.

46 SOUNDS COMPLICATED WE SHOULD BE ABLE TO SORT ALL OF THIS OUT ONCE THE GENERIC HAZARD ANALYSIS IS PUBLISHED AND WE RECEIVE GUIDANCE FROM THE FDA THROUGH FORMAL GUIDANCE DOCUMENTS.

47 FOOD SAFETY PLAN PREPARED BY ONE OR MORE PREVENTIVE CONTROLS QUALIFIED INDIVIDUALS (PCQI) CONTENTS INCLUDE: HAZARD ANALYSIS, PREVENTIVE CONTROLS; SUPPLY CHAIN PROGRAM; RECALL PLAN; PROCEDURES FOR MONITORING PREVENTIVE CONTROLS; CORRECTIVE ACTION PROCEDURES AND VERIFICATION PROCEDURES VERY MUCH LIKE A HACCP PLAN

48 SUBPART E SUPPLY-CHAIN PROGRAM MUST BE IMPLEMENTED BY A RECEIVING FACILITY WHEN THE RECEIVING FACILITY HAS IDENTIFIED A HAZARD THAT REQUIRES A SUPPLY-CHAIN-APPLIED CONTROL. A FORMAL WRITTEN PROGRAM BASED ON REGULATORY CRITERIA. DOES NOT REPLACE THE NEED TO PERFORM SUPPLIER APPROVAL ACTIVITIES.

49 SUBPART E SUPPLY-CHAIN PROGRAM SAMPLING AND TESTING OF RAW MATERIALS AND INGREDIENTS, REVIEW OF THE SUPPLIERS RELEVANT FOOD SAFETY RECORDS AND OTHER APPROPRIATE SUPPLIER VERIFICATION ACTIVITIES AS NEEDED. ONSITE AUDITS REQUIRED WHEN THE SUPPLIER IS CONTROLLING AN INGREDIENT HAZARD WHERE THERE IS A REASONABLE PROBABILITY THAT THE HAZARD WILL RESULT IN SERIOUS ADVERSE HEALTH CONSEQUENCES OR DEATH TO HUMANS OR ANIMALS.

50 SANITARY TRANSPORTATION RULE COMPLIANCE DATE MARCH, 2018 FOR SMALL BUSINESSES FOCUSES ON FOUR MAIN AREAS VEHICLES AND TRANSPORTATION EQUIPMENT SUITABILITY TRANSPORTATION OPERATIONS PREVENT CROSS CONTAMINATION TRAINING CARRIERS OF ANIMAL FOOD RECORDKEEPING PROCEDURES, AGREEMENTS (BETWEEN SHIPPER AND CARRIER FOR EXAMPLE) AND TRAINING. ONE YEAR RETENTION REQUIRED

51 STEPS THROUGH CGMP IMPLEMENTATION DEVELOP WORKING HOUSEKEEPING AND MAINTENANCE PROGRAMS EVALUATE THE CGMPS YOUR COMPANY ALREADY FOLLOWS EVALUATE THE NEW CGMPS TO DETERMINE WHAT YOUR COMPANY NEEDS TO IMPLEMENT MAKE A PLAN WITH STEPS TO IMPLEMENT THE CGMPS YOUR COMPANY NEEDS TO FOLLOW. INCLUDE DOCUMENTATION/RECORDKEEPING ACTIVITIES. AUDIT DOCUMENTS AND HOW WELL THINGS ARE BEING IMPLEMENTED REPEAT AS NEEDED, BUT AT LEAST ANNUALLY.

52 QUESTIONS/DISCUSSION