July 27-30, 2015 104th Annual Meeting of the Poultry ...animalnutrition.dupont.com/fileadmin/user_upload/... · controls as required by § 507.40(a)(1); 6) The written corrective

July 27-30, 2015 104th 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

Food Safety Modernization Act:Preparing for Compliance at the Feed Mill

Henry Turlington, PhDDirector, Quality & Manufacturing Regulatory Affairs

American Feed Industry Association

2015 PSA Annual Meeting

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.2012 U.S. Pet Ownership & Demographics Sourcebook

U.S. Feed Production by Species

* Does not include dog & cat food

FSMA LawSEC. 103. 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. 418. 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.

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 1 yr. after publication Businesses not considered VSB or SB

Compliance Deadlines

New Law Applies To

All Ingredient Processing All Feed Manufacturing Pet Food

Feed & Ingredient Imports Transportation

Food Safety Modernization Act

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.

CGMP’s and Preventive Controls for Animal Food

Food Safety Plan• Hazard Analysis• Risk-Based Preventive Controls• Supplier Verification Program• Recall Plan• Monitoring Procedures • Corrective Actions• Verification Procedures• Records

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


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 do not control hazards.

• Failure to follow CGMP’s seldom leadsto a animal food safety risks.

Current Good Manufacturing Practices (CGMP’s)

CGMP’s

Process C

ontrols

Personnel

Maintenance

Pest C

ontrol

Buildings/S

ite

Ingredients

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

§ 225.1 - Current good manufacturing practice. § 225.10 - Personnel.

Subpart B--Construction and Maintenance of Facilities and Equipment § 225.20 - Buildings. § 225.30 - Equipment. § 225.35 - Use of work areas, equipment, and storage areas for other manufacturing and storage purpose.

Subpart C--Product Quality Control § 225.42 - Components. § 225.58 - Laboratory controls. § 225.65 - Equipment cleanout procedures.

Subpart D--Packaging and Labeling § 225.80 - Labeling.

Subpart E--Records and Reports § 225.102 - Master record file and production records. § 225.110 - Distribution records. § 225.115 - Complaint files.

Subpart F--Facilities and Equipment § 225.120 - Buildings and grounds. § 225.130 - Equipment. § 225.135 - Work and storage areas.

Subpart G--Product Quality Assurance § 225.142 - Components. § 225.158 - Laboratory assays. § 225.165 - Equipment cleanout procedures.

Subpart H--Labeling § 225.180 - Labeling.

Subpart I--Records § 225.202 - Formula, production, and distribution records http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/

CFRSearch.cfm?CFRPart=225


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

• Buildings • Processes, including workspaces and employee 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

• Laboratory assays • Product information (labeling)• Specifications (ingredients, products,

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


• 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.

CGMP ACTIVITIES

Ingredient Receiving

Bulk Ingredient Storage

Bagged Ingredient Storage

Micro Ingredient Weigh‐Up

Macro Ingredient Weigh‐Up

Packaging

Blending

Pelleting

Distribution

Finished Product Storage

Rework

Process Flow Diagram

What CGMP activities should be implemented to help control processes?


CGMP Activities

• What is being done?• How is it to be done?• Who is doing it?• How frequently shall it be completed?• Documentation requirements


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


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; pre-

operational inspections

• Validation = to authenticate; confirm that the correct process is being used.– Is the right process being used?– Examples: justification; theoretical; scientific

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.

SUBPART C: Hazard Analysis and Risk-Based Preventive Controls• 507.31 Food safety plan.• 507.33 Hazard analysis.• 507.36 Preventive controls.• 507.37 Supplier program.• 507.38 Recall plan.• 507.39 Preventive control management components.• 507.40 Monitoring.• 507.42 Corrective actions and corrections.• 507.45 Verification.• 507.47 Validation.• 507.49 Verification of implementation and effectiveness.• 507.50 Reanalysis.• 507.51 Modified requirements that apply to a facility solely engaged in the storage of

packaged animal food that is not exposed to the environment.• 507.53 Requirements applicable to a qualified individual and a qualified auditor.

FSMA: Proposed Rule for Animal Food

“I’ve had a HACCP plan for years.

So, I’m ready for FSMA – right?”

Food Safety Modernization Act (FSMA) requires more than HACCP

“Why am I not ready?”

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.

Food Safety Plan• Hazard Analysis• Risk-Based Preventive Controls• Supplier Verification Program• Recall Plan• Monitoring Procedures • Corrective Actions• Verification Procedures• Records

§ 507.30 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 § 507.33(a)(2);2) The written preventive controls as required by § 507.36(b);3) The written supplier program as required by § 507.37(a)(2).4) The written recall plan as required by § 507.38(a)(1); 5) The written procedures for monitoring the implementation of the preventive

controls as required by § 507.40(a)(1);6) The written corrective action procedures as required by § 507.42(a)(1); and7) The written verification procedures as required by § 507.49(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.

Subpart C Hazard Analysis and Risk-Based Preventive Controls

As defined in the proposed FSMA – Current Good Manufacturing Practices and Hazard Analysis Risk-Based Preventive Controls for Food for Animals, 2014

Hazard Identification and Analysis

Qualified individual means a person who has successfully completed training in the development and application of risk-based 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.


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.

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.


National Advisory Committee on Microbiological Criteria for Foods (NACMCF), 1998(Proposed FSMA Animal Food Rule, 2014)

FSMA: § 507.33 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.



(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



(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.



(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 pathogenswhenever 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.


FSMA: § 507.33 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;


FSMA: § 507.33 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.


Process Flow Diagram: Complete Swine Feed

(1) (3) (4)

Ingredient/ Processing Step

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

C None

P None

B BSE contamination Regulatory requirement (CFR589.2000)

Supplier approval process; Delivery verification form

C None

P Bone, other foreign materials Physical harm to the animal if consumed

Supplier approval process; Receiving procedures; screens/magnets

B None

C Mycotoxins (aflatoxins) CPG Sec. 683.100 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

C Mycotoxins (aflatoxins) CPG Sec. 683.100 Action Levels for Aflatoxins in Animal Feeds

Supplier approval; Ingredient specifications; ingredient receiving SOP’s; Sample testing

P Foreign materialsPhysical harm to the animal if

consumedSupplier approval process; Receiving

procedures; screens/magnets

Packaging Materials

Ingredient: Grain Products

Ingredient: Plant Protein Products

(2)

Identify known or reasonably foreseeable animal food

safety hazards (B, C, P)

FOOD SAFETY PLAN FOR COMPLETE SWINE FEEDTABLE 1. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS

Ingredient: Animal Protein Products

Hazard Analysis & Preventive Controls

What is the likelihood the hazard will lead to serious consequence if not controlled?

Hazard Analysis: Severity & Probability

FREQUENT (A)

LIKELY (B)

OCCASIONAL (C)

RARE (D)

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.

URGENT (II)Danger and sickness may be severe, but it is not imminent

or immediate.

SIGNIFICANT (III) Sickness or injury may

occur, but impact is reversible.

MINOR (IV)

Sickness or injury is minor.

IV-A .

IV-B .

IV-C .

IV-D Minor

II-A .

II-B .

II-C .

II-D .

III-A .

III-B .

III-C MODERATE

III-D .

RISK ASSESSMENT CHART

I-A CRITICAL

I-B .

I-C .

I-D .

ProbabilityCode

Severity Code

(1) (5) (6) (7) (8) (9)

Ingredient/ Processing Step

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

B None

C None

P None

B BSE contamination Castastrophic (I) Rare (D) Moderate (I-D) No

C None

P Bone, other foreign materials Significant (III) Occasional (C) Moderate (III-C) No

B None

C Mycotoxins (aflatoxins) Urgent (II) Occasional (C) Moderate (II-C) No

P Foreign materials Significant (III) Occasional (C) Moderate (III-C) No

B None


P Foreign materials Significant (III) Occasional (C) Moderate (III-C)

B None


Packaging Materials

Ingredient: Grain Products

Ingredient: Plant Protein Products

(2)

Identify known or reasonably foreseeable animal food

safety hazards (B, C, P)

FOOD SAFETY PLAN FOR COMPLETE SWINE FEEDTABLE 1. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS

Ingredient: Processed Grain By Products

Ingredient: Animal Protein Products

HARPC Risk Assessment

What How Frequency WhoRecordsIngredient or Process

Control

Significant Hazard

(Number)Parameters

MonitoringCorrective Action Verification ActivitiesSignificant Hazard

FOOD SAFETY PLAN FOR COMPLETE SWINE FEEDTABLE 2. PROCESS PREVENTIVE CONTROLS

Significant Hazards: Preventive Controls

What How Frequency Who

Verification Activities RecordsIngredient and Supplier Significant Hazard

Significant Hazard

(Number)Parameters

MonitoringCorrective Action

FOOD SAFETY PLAN FOR COMPLETE SWINE FEEDTABLE 3. SUPPLIER VERIFICATION FOR SIGNIFICANT HAZARDS FROM INGREDIENTS OR RAW MATERIALS

Preventive Controls “WHEN” a Supplier & Ingredient represent a Significant Hazard

• 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

Preventive ControlsSubpart C

Significant Hazards

Significant Hazards

(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.

§ 507.55 Records Required (Subpart C)

As defined in the proposed FSMA – Current Good Manufacturing Practices and Hazard Analysis Risk-Based Preventive Controls for Food for Animals, 2014.

• 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

Additional Records Accessible to FDA

• Recipes• Financial data• Pricing data• Personnel data (excluding training records)• Research data• Sales data other than shipment data regarding traceability

Records that FDA Cannot Access

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.

What’s next?FSMA: Proposed Rule for Animal Food

Anticipate and Prepare“Remain calm and carry on”

August 31, 2015FDA Deadline


GOAL: Develop a proactive program to

reduce potential animal food safety risks

-vs-a reactive approach to

failures or nonconformities

More Quality & Food Safety Certifications

RESULT: More facilities will obtain 3rd party certifications for quality & food safety that support

compliance with FSMA requirements

BENEFIT: Certified facilities are considered lower risk

“NEEDS”

“WANTS”

Safe Feed/Safe Food

Regulatory compliance

Quality & food safety cultureDrive continuous improvement

Meet or exceed customer requirements

“NEEDS”

“WANTS”

Safe Feed/Safe Food


Safe Feed/Safe Food Certification

•Internationally recognized program that aligns with FAMI‐QS•Designed for feed additives and premixes

International Safe Feed/Safe Food

•GFSI recognized program that meet FSMA regulatory requirements•Designed for pet food manufacturers or ingredient suppliers

FSC32 Manufacture of Pet Food

•GFSI recognized program that meet FSMA regulatory requirements•Designed for feed manufacturers

FSC34 Manufacture of Animal Feeds

•Fundamentals for compliance with FSMA•Designed for North American feed manufacturers

FSC36 Safe Feed/Safe Food

Current Safe Feed/Safe Food Certification Programs

Safe

Feed

/Safe Food

What Should You Do?

www.safefeedsafefood.org

AFIA Four Promises of Membership Value

Documents

July 27-30, 2015 104th Annual Meeting of the Poultry ...animalnutrition.dupont.com/fileadmin/user_upload/... · controls as required by § 507.40(a)(1); 6) The written corrective