July 27-30, th Annual Meeting of the Poultry Science Association Louisville, Kentucky. Presented at:

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1 July 27-30, th Annual Meeting of the Poultry Science Association Louisville, Kentucky Presented at: From Egg to Plate The Influence of Gut Health Symposium Presentations distributed by DuPont with express written permission from the Poultry Science Association

2 2015 PSA Annual Meeting Food Safety Modernization Act: Preparing for Compliance at the Feed Mill Henry Turlington, PhD Director, Quality & Manufacturing Regulatory Affairs American Feed Industry Association

3 U.S. Animal Production It's estimated that 70 million dogs and 74 million cats are owned in the United States. Approximately 37% of all households in the US have a dog, and 30% have a cat U.S. Pet Ownership & Demographics Sourcebook

4 U.S. Feed Production by Species * Does not include dog & cat food

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6 FSMA Law SEC HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS. (a) In General - Chapter IV (21 U.S.C. 341 et seq.) is amended by adding at the end the following: `SEC HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS. `(a) In General - The owner, operator or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food manufactured, processed, packed or held by such facility, identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 or misbranded under section 403(w), monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice.

7 Very Small Business 3 yrs. after publication Less than $2.5 million total annual sales Small Business 2 yrs. after publication Employ fewer than 500 persons & do not qualify for exemption Other Businesses Compliance Deadlines Businesses not considered VSB or SB 1 yr. after publication

8 New Law Applies To All Ingredient Processing All Feed Manufacturing Pet Food Feed & Ingredient Imports Transportation

9 Food Safety Modernization Act

10 Food Safety Modernization Act CGMP s and Preventive Controls for Animal Food Proposed rule applies to facilities that manufacture, process, pack, or hold animal food and are required to register as a food facility under section 415 of the FD&C Act. This rule does not apply to farms that manufacture food for their own animals or other food facilities not required to register. New CGMP s Hygienic personnel practices and training Facility operations, maintenance, and sanitation Equipment and utensil design, use, and maintenance Processes and controls Warehousing and distribution Holding and distribution of human food by-products for use in animal food Food Safety Plan Hazard Analysis Risk-Based Preventive Controls Supplier Verification Program Recall Plan Monitoring Procedures Corrective Actions Verification Procedures Records

11 Current Good Manufacturing Practices (CGMP s) CGMP s are often associated with a Quality Management System (do not always have performance controls) CGMP s are more general and may apply throughout the operation. CGMP s programs deal indirectly with animal food safety issues while HACCP plans deal solely and directly with animal food safety issues. CGMP s CGMP s do not control hazards. Failure to follow CGMP s seldom leads to a animal food safety risks. Process Controls Personnel Maintenance Pest Control Buildings/Site Ingredients

12 Current Good Manufacturing Practices (CGMP s) TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER C--DRUGS: GENERAL PART 225 CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Subpart A--General Provisions Current good manufacturing practice Personnel. Subpart B--Construction and Maintenance of Facilities and Equipment Buildings Equipment Use of work areas, equipment, and storage areas for other manufacturing and storage purpose. Subpart C--Product Quality Control Components Laboratory controls Equipment cleanout procedures. Subpart D--Packaging and Labeling Labeling. CFRSearch.cfm?CFRPart=225 Subpart E--Records and Reports Master record file and production records Distribution records Complaint files. Subpart F--Facilities and Equipment Buildings and grounds Equipment Work and storage areas. Subpart G--Product Quality Assurance Components Laboratory assays Equipment cleanout procedures. Subpart H--Labeling Labeling. Subpart I--Records Formula, production, and distribution records

13 Current Good Manufacturing Practices (CGMP s) 21CFR Part 225 (Medicated Feed Mill License) PAS 222 HACCP Pre-Requisites (NACMCF) Personnel Site and associated utilities Facilities Processes, including workspaces and employee Buildings facilities Personnel Equipment Supplies of air, water and other utilities Production Equipment Use of work areas, equipment, and storage areas Supporting services, including waste disposal Control of Raw Materials Quality control of medicated components Suitability of equipment (cleaning, maintenance, etc.) Cleaning and sanitation Laboratory controls Management of ingredients Production and quality controls Equipment cleanout procedures Management of medications Environmental Monitoring Labeling Measures for the prevention of contamination Chemical Control Master record file and production records Sanitation Pest Control Distribution records Pest control Allergen Management Program Complaint files Personnel hygiene Glass Control Rework Receiving, Storage, and Distribution 21CFR Part 225 (No Med. Feed Mill License) Product withdrawal procedures Product Tracing and Recall Buildings and grounds Warehousing and transportation Formulation Equipment Formulation of products Complaint Investigation Work and storage areas Specifications for services Labeling Quality control of medicated components Training and supervision of personnel Training Specifications (ingredients, products, Laboratory assays Product information (labeling) packaging) Equipment cleanout procedures Food defense, biovigilance and bioterrorism Personal hygiene Labeling Formula, production, and distribution records Many common areas across different sources for CGMP s

14 Current Good Manufacturing Practices (CGMP s) CGMP ACTIVITIES Prepare a Process Flow Diagram. Identify the areas where CGMP activities are needed. Organize and prioritize the areas of need. Prepare documents to support CGMP s.

15 Process Flow Diagram Ingredient Receiving Bulk Ingredient Storage Macro Ingredient Weigh Up Bagged Ingredient Storage Micro Ingredient Weigh Up What CGMP activities should be implemented to help control processes? Blending Rework Packaging Finished Product Storage Pelleting Distribution

16 Current Good Manufacturing Practices (CGMP s) CGMP Activities What is being done? How is it to be done? Who is doing it? How frequently shall it be completed? Documentation requirements

17 Current Good Manufacturing Practices (CGMP s) CGMP Activities Personnel Training Facility Maintenance & Housekeeping Pest Control Program Traceability & Product Identification Product Rework Procedures Product Recall Plan Product Storage & Rotation Procedures Process Controls, Monitoring & Verification

18 Current Good Manufacturing Practices (CGMP s) Verification and Validation of CGMP s Verification = the act or process of confirming something has occurred. Is the process operating as intended? Examples: direct observation; records review; testing; preoperational inspections Validation = to authenticate; confirm that the correct process is being used. Is the right process being used? Examples: justification; theoretical; scientific

19 EXAMPLES: Verification and Validation Procedures CGMP's Verification Procedures Validation Procedures Foreign Material Control Magnet checks/records; Screening checks/records FDA Choking limits; Customer requirements; Equipment Owner's Manual Employee Handbook (Rules and Regulations) Written tests; direct observation of work Regulatory Compliance; Job Description Requirements Rework Records/Documentation Regulatory Compliance (F&DC Act) Ingredient Specifications Sample testing; Certificate of Analysis Scientific Data No definitive correct answers depends upon your processes and facility.

20 FSMA: Proposed Rule for Animal Food SUBPART C: Hazard Analysis and Risk-Based Preventive Controls Food safety plan Hazard analysis Preventive controls Supplier program Recall plan Preventive control management components Monitoring Corrective actions and corrections Verification Validation Verification of implementation and effectiveness Reanalysis Modified requirements that apply to a facility solely engaged in the storage of packaged animal food that is not exposed to the environment Requirements applicable to a qualified individual and a qualified auditor.

21 I ve had a HACCP plan for years. So, I m ready for FSMA right? Food Safety Modernization Act (FSMA) requires more than HACCP

22 Why am I not ready? Food Safety Plan Hazard Analysis Risk-Based Preventive Controls Supplier Verification Program Recall Plan Monitoring Procedures Corrective Actions Verification Procedures Records HACCP Principles Conduct a Hazard Analysis Identify CCP s, if any Establish Critical limits Establish a system to monitor CCP s Establish Corrective Actions when monitoring fails Establish verification processes Establish documentation.

23 Subpart C Hazard Analysis and Risk-Based Preventive Controls Requirement for a food safety plan. a) You must prepare, or have prepared, and implement a written food safety plan. b) One or more qualified individuals must prepare, or oversee the preparation of, the food safety plan. c) The written food safety plan must include: 1) The written hazard analysis as required by (a)(2); 2) The written preventive controls as required by (b); 3) The written supplier program as required by (a)(2). 4) The written recall plan as required by (a)(1); 5) The written procedures for monitoring the implementation of the preventive controls as required by (a)(1); 6) The written corrective action procedures as required by (a)(1); and 7) The written verification procedures as required by (b). d) The food safety plan required by this section is a record that is subject to the requirements of subpart F of this part. As defined in the proposed FSMA Current Good Manufacturing Practices and Hazard Analysis Risk-Based Preventive Controls for Food for Animals, 2014

24 Hazard Identification and Analysis Qualified individual means a person who has successfully completed training in the development and application of riskbased preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA, or is otherwise qualified through job experience to develop and apply a food safety system. Responsibilities include: Preparation and oversight of the animal food safety plan. Validation of Preventive Controls. Review of records. Re-analysis of the animal food safety plan as warranted. As defined in the proposed FSMA Current Good Manufacturing Practices and Hazard Analysis Risk-Based Preventive Controls for Food for Animals, 2014

25 Hazard Identification and Analysis Hazard means any biological, chemical, (including radiological) or physical agent that is reasonably likely to cause illness or injury in animals or humans in the absence of its control. National Advisory Committee on Microbiological Criteria for Foods (NACMCF), 1998 (Proposed FSMA Animal Food Rule, 2014) Significant hazard means a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing or processing, packing, or holding of animal food would, based on the outcome of a hazard analysis, establish controls to significantly minimize or prevent the hazard in an animal food and components to manage those controls (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the control. As defined in the proposed FSMA Current Good Manufacturing Practices and Hazard Analysis Risk-Based Preventive Controls for Food for Animals, 2014

26 FSMA: Hazard Analysis (a) You must: (1) Identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of animal food manufactured/processed, packed, or held at your facility to determine whether there are significant hazards; and (2) Develop a written hazard analysis. As defined in the proposed FSMA Current Good Manufacturing Practices and Hazard Analysis Risk-Based Preventive Controls for Food for Animals, 2014

27 FSMA: Hazard Analysis (b) The hazard identification must consider: (1) Hazards that include: (i) Biological hazards, including microbiological hazards such as parasites, environmental pathogens, and other pathogens; (ii) Chemical hazards, including radiological hazards, substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and nutrient imbalances; and (iii) Physical hazards; and As defined in the proposed FSMA Current Good Manufacturing Practices and Hazard Analysis Risk-Based Preventive Controls for Food for Animals, 2014

28 FSMA: Hazard Analysis (b) The hazard identification must consider: (2) Hazards that may be present in the animal food for any of the following reasons: (i) The hazard occurs naturally; (ii) The hazard may be unintentionally introduced; or (iii) The hazard may be intentionally introduced for purposes of economic gain. As defined in the proposed FSMA Current Good Manufacturing Practices and Hazard Analysis Risk-Based Preventive Controls for Food for Animals, 2014

29 FSMA: Hazard Analysis (c)(1) The hazard analysis must include an evaluation of the hazards identified in paragraph (b) of this section to assess the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls. (2) The hazard evaluation required by paragraph (c)(1) of this section must include an evaluation of environmental pathogens whenever an animal food is exposed to the environment prior to packaging and the packaged animal food does not receive a treatment that would significantly minimize the pathogen. As defined in the proposed FSMA Current Good Manufacturing Practices and Hazard Analysis Risk-Based Preventive Controls for Food for Animals, 2014

30 FSMA: Hazard Analysis (d) The hazard evaluation must consider the effect of the following on the safety of the finished animal food for the intended animal: (1) The formulation of the animal food; (2) The condition, function, and design of the facility and equipment; (3) Raw materials and ingredients; (4) Transportation practices; (5) Manufacturing/processing procedures; (6) Packaging activities and labeling activities; As defined in the proposed FSMA Current Good Manufacturing Practices and Hazard Analysis Risk-Based Preventive Controls for Food for Animals, 2014

31 FSMA: Hazard Analysis (d) The hazard evaluation must consider the effect of the following on the safety of the finished animal food for the intended animal: (7) Storage and distribution; (8) Intended or reasonably foreseeable use; (9) Sanitation, including employee hygiene; and (10) Any other relevant factors. As defined in the proposed FSMA Current Good Manufacturing Practices and Hazard Analysis Risk-Based Preventive Controls for Food for Animals, 2014

32 Process Flow Diagram: Complete Swine Feed

33 Hazard Analysis & Preventive Controls FOOD SAFETY PLAN FOR COMPLETE SWINE FEED TABLE 1. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS (1) (2) (3) (4) Ingredient/ Processing Step Identify known or reasonably foreseeable animal food safety hazards (B, C, P) Justify listing the identified animal safety hazard in column 2 What CGMP's are applied to significantly minimize or prevent the animal food safety hazard? B None Packaging Materials C None P None Ingredient: Animal Protein Products B C BSE contamination None Regulatory requirement (CFR ) Supplier approval process; Delivery verification form P Bone, other foreign materials Physical harm to the animal if consumed Supplier approval process; Receiving procedures; screens/magnets B None Ingredient: Grain Products C Mycotoxins (aflatoxins) CPG Sec Action Levels for Aflatoxins in Animal Feeds Supplier approval; Ingredient specifications; ingredient receiving SOP s; Sample testing P Foreign materials Physical harm to the animal if consumed Supplier approval process; Receiving procedures; screens/magnets B None Ingredient: Plant Protein Products C Mycotoxins (aflatoxins) CPG Sec Action Levels for Aflatoxins in Animal Feeds Supplier approval; Ingredient specifications; ingredient receiving SOP s; Sample testing P Foreign materials Physical harm to the animal if consumed Supplier approval process; Receiving procedures; screens/magnets

34 Hazard Analysis: Severity & Probability What is the likelihood the hazard will lead to serious consequence if not controlled? RISK ASSESSMENT CHART Probability Code FREQUENT (A) LIKELY (B) OCCASIONAL (C) RARE (D) Severity Code Immediate danger to health and safety of the animal or humans. Probably will occur in time if not corrected, or probably will occur one or more times. Possible to occur in time if not corrected. Unlikely to occur; may assume hazard will not occur. CATASTROPHIC (I) Imminent and immediate danger of death or severe sickness. I-A CRITICAL I-B. I-C. I-D. URGENT (II) Danger and sickness may be severe, but it is not imminent or immediate. II-A. II-B. II-C. II-D. SIGNIFICANT (III) Sickness or injury may occur, but impact is reversible. III-A. III-B. III-C MODERATE III-D. MINOR (IV) Sickness or injury is minor. IV-A. IV-B. IV-C. IV-D Minor

35 HARPC Risk Assessment FOOD SAFETY PLAN FOR COMPLETE SWINE FEED TABLE 1. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS (1) (2) (5) (6) (7) (8) (9) Ingredient/ Processing Step Identify known or reasonably foreseeable animal food safety hazards (B, C, P) What is the Severity Code for the animal food safety hazard? What is the Probability Code for the animal food safety hazard? What is the Risk Assessment Code for the animal food safety hazard? Is the animal food safety hazard a significant hazard? (Yes or No) Significant Hazard Number Packaging Materials B C P None None None B BSE contamination Castastrophic (I) Rare (D) Moderate (I-D) No Ingredient: Animal Protein Products C None P Bone, other foreign materials Significant (III) Occasional (C) Moderate (III-C) No B None Ingredient: Grain Products C Mycotoxins (aflatoxins) Urgent (II) Occasional (C) Moderate (II-C) No P Foreign materials Significant (III) Occasional (C) Moderate (III-C) No B None Ingredient: Plant Protein Products C Mycotoxins (aflatoxins) Urgent (II) Occasional (C) Moderate (II-C) No P Foreign materials Significant (III) Occasional (C) Moderate (III-C) B None Ingredient: Processed Grain By Products C Mycotoxins (aflatoxins) Urgent (II) Occasional (C) Moderate (II-C) No

36 Significant Hazards: Preventive Controls FOOD SAFETY PLAN FOR COMPLETE SWINE FEED TABLE 2. PROCESS PREVENTIVE CONTROLS Ingredient or Process Control Significant Hazard Significant Hazard (Number) Parameters Monitoring What How Frequency Who Corrective Action Verification Activities Records

37 Preventive Controls WHEN a Supplier & Ingredient represent a Significant Hazard FOOD SAFETY PLAN FOR COMPLETE SWINE FEED TABLE 3. SUPPLIER VERIFICATION FOR SIGNIFICANT HAZARDS FROM INGREDIENTS OR RAW MATERIALS Ingredient and Supplier Significant Hazard Significant Hazard (Number) Parameters Monitoring What How Frequency Who Corrective Action Verification Activities Records

38 Preventive Controls Subpart C Requirement for the animal food safety plan (written) Hazard analysis Preventive controls Supplier verification program Recall plan Written procedures for monitoring Correction action program Written verification procedures Records Significant Hazards Significant Hazards

39 Records Required (Subpart C) (a) The owner, operator, or agent in charge of a facility must establish and maintain the following records: (1) The written food safety plan, including the written hazard analysis, preventive controls, monitoring procedures, corrective action procedures, verification procedures, and recall plan; (2) Records that document the monitoring of preventive controls; (3) Records that document corrective actions; (4) Records that document verification, including, as applicable, those related to: (i) Validation; (ii) Monitoring; (iii) Corrective actions; (iv) Calibration of process monitoring and verification instruments; (v) Records review; and (vi) Reanalysis; and (5) Records that document applicable training for the qualified individual. (b) The records that the owner, operator, or agent in charge of a facility must establish and maintain are subject to the requirements of subpart F of this part. As defined in the proposed FSMA Current Good Manufacturing Practices and Hazard Analysis Risk-Based Preventive Controls for Food for Animals, 2014.

40 Additional Records Accessible to FDA Testing results if used to support preventive controls Recall Plan and traceability capabilities Supplier Verification Program (high risk suppliers) Re-assessment records for the Animal Food Safety Plan

41 Records that FDA Cannot Access Recipes Financial data Pricing data Personnel data (excluding training records) Research data Sales data other than shipment data regarding traceability

42 FDA want you to develop an Animal Food Safety Plan that is suitable for your facility and products manufactured. GOAL: Identify hazards that could potentially impact animal food safety and implement preventive controls.

43 FSMA: Proposed Rule for Animal Food What s next? Anticipate and Prepare Remain calm and carry on August 31, 2015 FDA Deadline

44 Food Safety Modernization Act BENEFIT: Certified facilities are considered lower risk More Quality & Food Safety Certifications RESULT: More facilities will obtain 3 rd party certifications for quality & food safety that support compliance with FSMA requirements GOAL: Develop a proactive program to reduce potential animal food safety risks -vsa reactive approach to failures or nonconformities

45 Safe Feed/Safe Food NEEDS Regulatory compliance WANTS Quality & food safety culture Drive continuous improvement Meet or exceed customer requirements

46 Safe Feed/Safe Food NEEDS Food Safety Modernization Act WANTS Safe Feed/Safe Food Certification

47 Current Safe Feed/Safe Food Certification Programs International Safe Feed/Safe Food Safe Feed/Safe Food Internationally recognized program that aligns with FAMI QS Designed for feed additives and premixes FSC32 Manufacture of Pet Food GFSI recognized program that meet FSMA regulatory requirements Designed for pet food manufacturers or ingredient suppliers FSC34 Manufacture of Animal Feeds GFSI recognized program that meet FSMA regulatory requirements Designed for feed manufacturers FSC36 Safe Feed/Safe Food Fundamentals for compliance with FSMA Designed for North American feed manufacturers

48 What Should You Do?

49 AFIA Four Promises of Membership Value