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Safety & Health

Welcome - 2008 FDA AFSS Meeting

FDA & CENTER FOR VETERINARY MEDICINE

Slide 1

  • THE ANIMAL FEED SAFETY SYSTEM TEAM WELCOMES YOU TO OUR 4th ANNUAL PUBLIC MEETING.
     
AFSS 5th Anual Public Meeting - Slide 1

Slide 2

Welcome

Bernadette Dunham, D.V.M., Ph.D.
Director, Center for Veterinary Medicine

The 5th Animal Feed Safety System Public Meeting
May 14, 2008
Gaithersburg, Maryland
 

AFSS 5th Anual Public Meeting - Slide 2

Slide 3

Animal Feed Safety System

The AFSS program is aimed at protecting human and animal health by ensuring that animal feed is safe. 

AFSS covers all Agency activities:

  • pre-approval of additives for use in feed
  • establishing limits on feed contaminants
  • providing education and training
  • conducting inspections
  • taking enforcement for ensuring compliance with Agency regulations
     
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Slide 4

Animal Feed Safety System

AFSS includes oversight of:
  • labeling, production, distribution and administration of all feed ingredients and mixed feeds at all stages of manufacture, distribution, and use, whether at commercial or non-commercial establishments
AFSS 5th Anual Public Meeting - Slide 4

Slide 5

AFSS Background

  • Initial public meeting - September 2003.
  • Collected information about rules and processes used by the feed industry and by government regulators to enhance feed safety.
  • Team identified “gaps” where the system could be strengthened.
  • The first “Framework” document was presented in April 2005 for public comment.
AFSS 5th Anual Public Meeting - Slide 5

Slide 6

FDA & CENTER FOR VETERINARY MEDICINE

  • THE ANIMAL FEED SAFETY SYSTEM TEAM WELCOMES YOU TO OUR 4th ANNUAL PUBLIC MEETING.
     
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Slide 7

DRAFT AFSS Framework Document 3rd Edition April 2008

Comments by George Graber
For the 5th Animal Feed Safety System Public Meeting
May 14, 2008
Gaithersburg, Maryland
AFSS 5th Anual Public Meeting - Slide 7

Slide 8

Today

  • Cover major feed/food safety events
  • Highlight main features - AFSS Framework, 3rd edition
  • Present the Framework’s 6 Components and 14 Gaps
  • Take comments and questions
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Slide 9

Major Events

  • Melamine Pet Food Incident
  • FDA Amendments Act of 2007
  • FDA’s Food Protection Plan
  • Interagency Food Import Strategy Plan
  • U.S. and China Memorandum of Agreement
     
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Slide 10

Greater Expectations By…

  • Feed manufacturers
  • Animal producers
  • Packers
  • Consumer
  • Regulatory agencies
  • Congress
     
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Slide 11

Pet Food and Melamine

Outcomes from melamine contamination
  • cat and dog illnesses/deaths
  • front-page national news
  • massive economic fallout
  • industry changes
  • congressional oversight hearings
  • FDAAA of 2007 – mandated new regulations & enhanced programs
     
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Slide 12

FDA Amendments Act of 2007

  • Title X (Food Safety) requires “by regulation” for pet food in 2 years (September 2009):

    • ingredient standards
    • processing standards
    • labeling standards, nutritional and ingredient information
  • In consultation with stakeholders (docket opened and public meeting)
     
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Slide 13

Other Provisions

  • In 1 year, FDA must establish pet food early warning surveillance, notification system

    • identify adulteration
    • notify veterinarians, other stakeholders during recall
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Slide 14

“Reportable” Food

  • Law requires FDA to develop “reportable” food registry

    • reasonable probability of causing adverse health consequence
  • CVM will identify reportable animal foods
  • Must be done in 1 year
     
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Slide 15

FDA’s Food Protection Plan (FPP)

  • Announced November 2007
  • New framework to identify and counter potential hazards in food and feed
  • Requires cooperation among all our food and feed safety partners (Federal, state, local, tribal, and foreign gov’ts, industry, academia, consumers and Congress)
     
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Slide 16

FPP’s 3 Core Elements

  • Prevention

    • Build safety in from the start
  • Intervention

    • Verify prevention and intervene when risks are identified
  • Response

    • Respond rapidly and appropriately
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Slide 17

Cross-Cutting Principles

  • Food means human food and animal feed
  • Focus on risks over a food product’s life cycle from production to consumption
  • Target resources to achieve maximum risk reduction
  • Address both unintentional and deliberate contamination of food
  • Use science and modern technology systems, including enhanced IT
     
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Slide 18

Import Safety Action Plan (ISAP)

  • Involved 12 Federal Departments and Agencies - Led by HHS Secretary Leavitt
  • Released November 2007

    • 14 Broad Recommendations
    • 50 Specific Action Steps

      • Short and Long Ter
  • Mirrors Food Protection Plan
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Slide 19

ISAP Building Blocks

  • Advancing a Common Vision
  • Increasing Accountability, Enforcement & Deterrence
  • Focusing on Risks over the Life Cycle
  • Building Interoperable Systems
  • Fostering a Culture of Collaboration
  • Promoting Technological Innovation and New Science
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Slide 20

U.S. and China MOA on Food and Feed Safety

  • Signed December 11, 2007
  • Key points

    • New registration and certification requirements
    • Greater information sharing
    • Increased access to production facilities
    • Greater regulatory cooperation (standards, capacity building)
       
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Slide 21

U.S. and China MOA on Food and Feed Safety

  • Implementation of agreement will begin with designated covered products

    • LACF/AF
    • pet food/treats of animal or plant origin
    • ingredients for food and feed (e.g., wheat gluten)
AFSS 5th Anual Public Meeting - Slide 21

Slide 22

AFSS

  • New title for FDA’s animal feed safety program
  • Modernization initiative began in 2003 with goal to make AFSS more comprehensive and risk-based
  • AFSS Team organized with representation from CVM, ORA, OC and States
  • AFSS Framework – guiding document
     
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Slide 23

AFSS Framework

  • First Draft: February 2005
  • Second Draft: December 2006
  • Third Draft: April 2008
AFSS 5th Anual Public Meeting - Slide 23

Slide 24

Major Changes to Framework Document

  • Added one Component
  • Added 3 new Gaps
  • Gaps and “fixes” should be more easily understood
     
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Slide 25

Purpose and Scope of AFSS

  • FDA’s animal feed program for protection of animal and human health
  • Covers entire spectrum of FDA activities
  • Oversight of labeling, production, distribution and administration of all feed at all stages
  • All commercial and non-commercial feed establishments & all feeders
     
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Slide 26

AFSS – Risk-Based and Preventive

  • It will consist of regulatory and voluntary components.
  • Risk-based decisions by government for deciding on resource assignment and allocation.
  • Feed hazard evaluation by all feed manufacturers to ensure unacceptable risk to animal and human health is controlled.
     
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Slide 27

AFSS Operating Principles (11)

  1. Production, distribution and use of safe animal feed a responsibility of all feed manufacturers
  2. Establishing rules and guidance, and conducting oversight responsibility of gov’t
  3. Rules and guidance provide flexibility
  4. Cooperation among federal and state regulatory agencies
  5. Continued oversight by regulatory agencies
  6. FDA directs resources based on greatest risk
     
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Slide 28

AFSS Operating Principles (11)

  1. Risk-based decisions to decide which feed hazards receive the highest priority
  2. Feed defense measures included
  3. Training is critical
  4. Feed for all animals (food and companion) are covered
  5. All feed establishments are included
     
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Slide 29

Six Components

  1. Ingredients and the Approval Process
  2. Limits for Animal Feed Contaminants
  3. Process Control for the Production of Feed Ingredients and Mixed Feed
  4. Reporting of Unsafe Feed
  5. Regulatory Oversight
  6. Education and Outreach
     
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Slide 30

Within Each Component

  • Description
  • Gaps – needs strengthening or lacking completely
  • How gaps are being addressed
     
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Slide 31

Component A – Ingredients and the Approval Process

The FFDCA provides the authority for FDA to regulate ingredients and additives in animal feed. FDA/CVM uses procedures covered by regulations for controlling many but not all ingredients/additives.
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Slide 32

Component A

  • Gap A1: FDA’s regulations do not provide a complete listing of ingredients permitted in animal feed.
  • Fix: FDA is writing regulation for feed ingredient standards and definitions (FDAAA mandate). CPG on hold for explaining relationship between FDA and AAFCO and for establishing policy to recognize the ingredients defined in the AAFCO OP. MOU between FDA and AAFCO describes process for adding/modifying ingredients in the OP. FDA plans to finalize the GRAS Notification Rule.
     
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Slide 33

Component B - Limits for Feed Contaminants

FDA has established limits for some of the more obvious contaminants, but FDA has no systematic approach for determining if or when it must develop limits for known or newly recognized contaminants.
AFSS 5th Anual Public Meeting - Slide 33

Slide 34

Definitions

  • Feed hazard – biological, chemical, or physical agent in, or a condition of, feed with the potential to cause an adverse health effect in humans or animals.
  • Feed contaminant – all potentially toxic or deleterious biological, chemical, or physical hazards inadvertently present in animal feed.
  • Feed contaminants are feed hazards, but not all feed hazards are feed contaminants.
     
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Slide 35

Component B

  • Gap B1: FDA needs a systematic way to distinguish among feed contaminants based on the risk they pose.
  • Fix: CVM is developing a risk-ranking system using modern risk assessment principles. The model is intended for FDA use only to assign resources for enforcement and research.
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Slide 36

Component B

  • Gap B2: FDA does not have a written process that states when conditions require the creation of official regulatory methods for detecting the presence of contaminants in feeds
  • Fix: FDA has developed an internal standard operating procedure (CVM Policy and Procedure Manual 1240.3415) that will trigger method development.
     
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Slide 37

Component C – Process Control for the Production of Feed Ingredients and Mixed Feed

Process Control is a systematic approach for preventing, or eliminating or reducing risks to health of animals and people. cGMP regulations exist for medicated feed and Type A medicated articles.
AFSS 5th Anual Public Meeting - Slide 37

Slide 38

Component C

  • Gap C1: FDA’s current program does not fully address all aspects of feed safety associated with the manufacture, packaging, distribution, and use of all animal feed.
  • Fix: Have begun writing regulations (process control standards) that cover the production, storage and distribution of all animal feed.
     

 

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Slide 39

Process Control Regulations will:

  • Broaden coverage to all feeds/ingredients
  • Prevent contaminations
  • Reduce number of feed recalls
  • Provide equivalency with foreign gov’ts
  • Maintain public confidence
  • Provide uniform regulatory coverage
  • Help focus FDA resources
     
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Slide 40

Process Control Gap C 1

  • Points of consideration in addressing Gap C 1

    • Diversity
    • Flexibility
    • Standards (minimum/baseline)
    • Introduction of Risk
    • Accountability
       
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Slide 41

Process Control Gap C 1

  • Areas of Consideration for Standards

    • Materials entering establishment
    • Material preparation
    • Processing and manufacturing
    • Storage and packaging
    • Labeling
       
AFSS 5th Anual Public Meeting - Slide 41

Slide 42

Process Control Gap C 1

  • Areas of Consideration (continued)

    • Testing
    • Traceability
    • Importing
       
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Slide 43

Component C

  • Gap C2: Strengthening of cGMPs for medicated feeds is needed. Citizen Petition from industry and AAFCO sought to replace the two sets of requirements with a single set .
  • Fix: FDA reply – petition had merit, would propose changes. Became part of AFSS project, number of challenges.
     
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Slide 44

Component D – Reporting of Unsafe Feed

FDA and states collect analytical data on feed. Surveillance by the feed industry, animal producers, veterinarians, academia and the public can be a significant source of adulterated feed situations.
AFSS 5th Anual Public Meeting - Slide 44

Slide 45

Component D

  • Gap D1: The FDA needs to be more proactive with regard to learning about and informing the public about unsafe feed situations.
  • Fix: As required by FDAAA 2007, an early warning and surveillance system and Reportable Food Registry are being developed.
     
AFSS 5th Anual Public Meeting - Slide 45

Slide 46

Component D

  • Gap D2: Not all medicated feed adverse experiences are required to be submitted to FDA.
  • Fix: Revisions to regulation 21 CFR 510.301 were begun, but will likely need to start over (expand reporting requirements and 17 years since original proposal).
     
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Slide 47

AFSS Component E – Regulatory Oversight

Inspections by FDA and States provide a window of assessment regarding an establishment’s compliance with provisions of regulations and document adverse observations. FDA and the States cannot inspect all establishments in the more expansive AFSS.
AFSS 5th Anual Public Meeting - Slide 47

Slide 48

Three Gaps Identified

  • FDA’s inspection obligations not always met on time. (E-1)
  • FDA’s inspection coverage does not give adequate attention to all industry sectors. (E-2)
  • Feed defense to be incorporated. (E-3)

 

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Slide 49

Inspection Obligations Not Always Met On Time (Gap E1)

  • Inventory too large for available inspection resources
  • Working w/ States, via contracts & other arrangements helps, doesn’t cover everything
  • Developing a risk-based mechanism for prioritizing inspections
  • Implemented in FY 08 for FDA-licensed medicated feed mills; will be used for FY 09 BSE inspections
     
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Slide 50

Inspection Coverage Doesn’t Hit All Industry Sectors (Gap E2)

  • Inspections of some industry sectors required by statute, other sectors not mentioned.
  • Industry has diversified since current regulatory system was developed.
  • Transportation is one example of a sector where we have not had much coverage in the past.
  • Risk-based planning allows us to identify sectors & firms most in need of oversight so we can use our resources in a more efficient, effective way.
     
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Slide 51

Address Feed Defense Concerns (Gap E3)

  • CVM works w/ Homeland Security, USDA & other agencies and industry
  • BT registration & recordkeeping are only requirements; guidance for industry being developed
  • Have done vulnerability assessments at a couple of representative firm types
  • Criteria developed for assisting FDA’s Prior Notice Center target feed at higher risk for deliberate contamination
     
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Slide 52

Component F – Education and Outreach

Modifications to feed programs functions and activities necessitate that regulatory staff and impacted parties understand and implement the changes in a timely manner.
AFSS 5th Anual Public Meeting - Slide 52

Slide 53

Component F

  • Gap F1: Timely education and outreach – more a constant than a true gap, although at times a true fix may be necessary.
  • Fix: A plan is being developed for timely and effective implementation of the more expansive AFSS. The plan will help ensure:

    • timely outreach to all stakeholders
    • thorough and timely instruction on implementation
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Slide 54

Component F

  • Gap F2: FDA-licensed medicated feed mills need possession of generic (Blue Bird) labeling as required by regulation 21 CFR 510.10. Must be in a mill’s possession, which FDA has determined means on premises or access to via the internet.
  • Fix: A web-based system is being developed to house the most recently approved Blue Bird label for animal drugs. Being supported by animal drug sponsors.
     
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Slide 55

Component F

  • Gap F3: Assessing and controlling feed hazards must occur along the entire animal feed continuum. The process control regulations will not apply to feeding operations.
  • Fix: Guidance is being prepared to assist animal feeders in ensuring their on-farm practices are consistent with maintaining, storing and feeding safe feed.

 

 

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Slide 56

Component F

  • Gap F4: Public, pet food industry, government agencies, and AAFCO agree that current pet food labeling can be improved to provide more meaningful information to pet owners.
  • Fix: Updated labeling standards are mandated by FDAAA 2007. Congress is requiring regulation that includes standards for nutritional and ingredient information on labeling.
     
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Slide 57

Conclusions

  • The AFSS project is an important component of the Agency’s Food Protection Plan.
  • The 3rd edition of the AFSS Framework Document is posted on the CVM web site.
  • Much has been accomplished, but realize much more needs to be done.
  • Send comments to zoe.gill@fda.hhs.gov

 

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Slide 58

Thank You Comment and Question Time

AFSS 5th Anual Public Meeting - Slide 58

Slide 59

Risk Ranking Method

  • At the 2006 Public Meeting, the AFSS Team presented a method for ranking feed contaminants based upon risk.
  • The approach was explained using swine diet examples.
  • Method determines animal and human Exposure Scoring for chemical and microbiological feed hazards.

 

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Slide 60

Risk Based Approach

The risk based approach:

  • identifies potential hazards;
  • characterizes consequences of hazards;
  • characterizes likely exposure;
  • ranks the risks of hazards as compared with other hazards.
This approach will help us develop the best possible feed safety program.
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Slide 61

Importance of Feed Safety

  • Last year’s melamine pet food contamination case highlighted the importance of feed safety.
  • Feed industry is fast-paced, broad-based, and interrelated.
  • Contaminated product also impacted swine, poultry and fish feed.
  • A well working industry requires the best feed safety system we can develop.
     
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Slide 62

Thank You For Coming

  • Today, we will present our 3rd draft of the AFSS Framework document. It encompasses new requirements from the FDA Amendments Act 2007.
  • Additional information about the risk-based approach that we are developing for compliance activities will be discussed.
  • It is very important that we hear your thoughts and comments.
    Thank you!
     
AFSS 5th Anual Public Meeting - Slide 62