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U.S. Department of Health and Human Services

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Safety & Health

Risk-Based Initiatives at the Center for Veterinary Medicine

Risk-Based Initiatives
at the
Center for Veterinary Medicine

 

Barry Hooberman
Office of Surveillance & Compliance
FDA Center for Veterinary Medicine

AFSS Public Meeting - Risk-Based Initiatives - Slide 1

Slide 2

Why a Risk-Based Approach?

  • Risk assessment is a logical process for collecting, organizing and analyzing information to inform a risk decision (“science-based decision making”).
  • Risk assessment approach is also a forecasting process for the prevention of illnesses/adverse health risks.
  • Eases the interactions between decision makers, stakeholders, and the public
AFSS Public Meeting - Risk-Based Initiatives - Slide 2

Slide 3

What is Risk Ranking?

Risk assessments provide the “facts” for risk analysis.

Risk, Risk Assessment, Risk

AFSS Public Meeting - Risk-Based Initiatives - Slide 3

Slide4

Risk Ranking

The risk management decisions about which risks to manage first are value-laden decisions.

Risk

Values

Risk
Risk

Risk Management

Risk
Risk

Costs

Risk
AFSS Public Meeting - Risk-Based Initiatives - Slide 4

Slide 5

Risk Assessment Poses Four Simple Questions:

What can go wrong?
Hazard Identification

What are the consequences?
Consequence Assessment

How can it happen?
Exposure Assessment

What is the likelihood it would go wrong?
Risk Estimation

AFSS Public Meeting - Risk-Based Initiatives - Slide 5

Slide 6

Compliance Programs

  • BSE/Ruminant Feed Ban
  • Illegal Drug Residues in Meat, Poultry, Seafood and Other Animal Derived Foods
  • Medicated Feeds
  • Drug Process (cGMP)
  • Animal Feed Contaminants
  • BIMO (Good Laboratory Practices, Sponsor/Monitor, Clinical Investigators)
  • Pre-approval New Animal Drug Inspections
AFSS Public Meeting - Risk-Based Initiatives - Slide 6

Slide 7

BSE/Ruminant Feed Ban

  • Number and sites planned for FY.
  • Sites are risk-ranked relatively, based on site hazard(s) and violation history.
  • Site Go/NoGo decisions made annually and ranked list is delivered to ORA for FY work planning.
AFSS Public Meeting - Risk-Based Initiatives - Slide 7

Slide 8

BSE Site Scoring

  • Last inspection date
  • Last inspection Decision: Type of firm inspected
  • Does the firm handle feed or feed ingredients that are intended for the feeding of ruminant animals?
  • Does the firm receive feed or feed ingredients that contain or may contain prohibited material (PM)?
AFSS Public Meeting - Risk-Based Initiatives - Slide 8

Slide 9

BSE Site Scoring

  • Is the received product containing prohibited material intended ONLY for further distribution?
  • Does the firm manufacture or process products containing prohibited materials?
  • Does the firm manufacture, process, blend, repackage, or transport BOTH products containing prohibited materials AND products containing only non-prohibited materials?
AFSS Public Meeting - Risk-Based Initiatives - Slide 9

Slide 10

Drug Residues

  • Number of inspections planned for FY; sites are decided weekly.
  • Weekly violation reports are generated.
  • Site Go/NoGo decisions made weekly and conveyed to ORA for near term scheduling.
AFSS Public Meeting - Risk-Based Initiatives - Slide 10

Slide 11

Drug Residues

  • Rank violations from past year(s) according to defined risk criteria
  • For unique violators, filter out duplicate violations, keeping most egregious
  • For a budget-limited number of inspections, determine from the risk ranking scores a threshold for the past year(s) violators
  • Use this threshold to assist with future Go/NoGo weekly inspection decisions for incoming violations
AFSS Public Meeting - Risk-Based Initiatives - Slide 11

Slide 12

Drug Residues

Hazard:
Residue Toxicity (RT)

  • Acceptable Daily Intake (ADI)
  • Drug not approved for food animals
  • AMDUCA-prohibited drug
  • Human Carcinogen

Likelihood of Exposure:
Firm Violation Frequency (VF)

Exposure Level:
Tolerance Exceedance (TE)

AFSS Public Meeting - Risk-Based Initiatives - Slide 12

Slide 13

Medicated Feeds

Factors were identified to be used in assessing risk score:

Facility risks

  • Inspection data /classifications
  • Establishment type
  • Time since the last cGMP inspection
  • Number of inspections conducted over a given time

Product Risk

  • Category of Drugs
AFSS Public Meeting - Risk-Based Initiatives - Slide 13

Slide 14

Drug cGMP Inspection Site Selection Risk Factors

Inherent Product/Process Risk
 Factors
  1. Profile Class
  2. Subclass
      Represents the container type,method of application, use, market class, or type of product.
  3. Process Indicator Code (PIC)
 Inherent Facility Risk
 Factors
  1. Size (Sales)
  2. Establishment Type
  3. Last District Decision
 
Complacency Risk
 Factor
  Time Since Last Inspection
 
  Total Score
AFSS Public Meeting - Risk-Based Initiatives - Slide 14

Slide 15

Across Programs?!#%

  • WORK IN PROGRESS
AFSS Public Meeting - Risk-Based Initiatives - Slide 15

Slide 16

Program “Characterization”

 

COMPLIANCE PROGRAM“Resource Allocation”
“Surveillance”“For Cause”
 
BSEMostly ~95%
 
Some ~ 5%
Feed Contaminants
 
Mostly ~95%
 
Some ~ 5%
Feed Manufacturing GMPs for medicated feeds made from Category II Type A Medicated Articles and certain Category I Type A liquid and free choice feeds
 
Mostly ~90%
 
Some ~10%
 
Drug Manufacturing GMPs
 
MostlySome
 
Drug Tissue Residues
 
None
 
All
Post-Market Drugs and DevicesNone
 
All
AFSS Public Meeting - Risk-Based Initiatives - Slide 16

Slide 17

Program “Characterization”

 

COMPLIANCE PROGRAMKnown Hazards?Range of Hazards
BSEKnownNone
High
Feed ContaminantsAlmost all knownVery wide
Low to high
Feed Manufacturing GMPs for medicated feeds made from Category II Type A Medicated Articles and certain Category I Type A liquid and free choice feedsMostly knownWide
Low to High
Drug Manufacturing GMPsMostly knownVery wide
Low to high
Drug Tissue Residues Wide
 
KnownMedium to high
Post-Market Drugs and DevicesUnknownSmall
Medium to high
AFSS Public Meeting - Risk-Based Initiatives - Slide 17

Slide 18

Challenges

  • Comparing programs with different objectives; e.g., compliance vs. surveillance.
     

    • Some of the programs are based on existing, observed health effects and not risks (which estimate the probability of health effects).
    • For some programs it is difficult to predict what the hazards will be in the coming year, which makes comparing risks a highly uncertain process.
  • Characterizing programs which encompass wide ranges of potential hazards and risks.

    • Comparison based on “riskiest” hazards, the midpoint in the range of risks, or a risk metric based on a distribution of estimated risks? 
AFSS Public Meeting - Risk-Based Initiatives - Slide 18

Slide 19

Challenges

  • Finding appropriate metrics for characterizing hazards/health effects and exposure that are common to all the programs.

    • In some programs, the metric for hazard characterization may simply be related to the severity/likelihood of illness associated with a particular chemical, whereas in other programs the hazard characterization is a function of past violations or other facility/process variables. 
AFSS Public Meeting - Risk-Based Initiatives - Slide 19

Slide 20

Solutions

  • Please feel free to fill in!!!!! 
AFSS Public Meeting - Risk-Based Initiatives - Slide 20

Slide 21

Animal Feed Contaminants

  • The Animal Feed Safety System (AFSS):
    To develop and implement a comprehensive, risk-based, preventive animal feed safety system that minimizes, reduces or eliminates the risks to animal and human health that can arise from animal feed
AFSS Public Meeting - Risk-Based Initiatives - Slide 21

Slide 22

How Will Ranked Risks Be Used for AFSS?

  • Decide how risks from contaminants can best be prevented or controlled:
     

    • Do limits for higher-risk contaminants need to be identified?  If yes, which contaminants?
    • Do analytical methods for higher-risk contaminants need to be developed?
    • What process changes can feed manufacturers  make to reduce risks from contaminants?
    • What surveillance/sampling programs are needed to ensure compliance with contaminant limits?
      For internal use only
AFSS Public Meeting - Risk-Based Initiatives - Slide 22

Slide 23

AFSS Risk Ranking Model

  • Goal:
The AFSS Relative Risk Model is a tool for ranking relative risks of feed contaminants to aid FDA in setting priorities for allocating its resources in a risk-based manner
AFSS Public Meeting - Risk-Based Initiatives - Slide 23

Slide 24

What is Risk?

Risk is a function of hazard and exposure

Risk = Hazard x Exposure

 

 Health Consequences

Severity
(skin irritation/off-feed to death)
+
Potency
(amount to cause illness)
 

Routes
(how are we exposed)
+
Likelihood
(improbable to common) 

AFSS Public Meeting - Risk-Based Initiatives - Slide 24

Slide 25

Framework of the AFSS
Risk Model

 

Hazard A
Hazard
Hazard B
 
 
Hazard C
 
Ingredient 1

 

Ingredient 2
 
Ingredient 3
Feed Ingredients &Sources (AAFCO, CFR, other)
 
 
Mill: Mix
  
 
 
 
Mill: Heat
  
Manufacturing Processes
 
 
Distribution
 
  
 
 
 
Animals
 
  
 
 
 
 
Humans 
Population(s)
AFSS Public Meeting - Risk-Based Initiatives - Slide 25

Slide 26 

Contaminants

 

Plant Origin
Animal Origin
Mineral Origin
Microbial Origin
Misc. Origin
Grains
A, B, D
Mammalian Protein meals
B, C, D, E, F
P, Ca, Na
D
Yeast & single cell protein
C, D
Human food waste
A, C
Oilseeds
A, B, D
Poultry meals
B, C, D, E
Trace element premixes
D
 
Animal manure
B, C, D
Molasses
B, D
Aquatic animal meals
B, C, D
Non-nutritive adsorbents
D
 
 
Roots & tubers
A, B, D
Fats & Oils
 
 
A = Mycotoxins
B = Agricultural chemicals
C = Microbial pathogens
D = Metals
E = Drug residues
F = TSEs
 
 
 
 
Forages
A, B, C, D
 
 
Roughages
A, B, C
Fats & oils
B
 
AFSS Public Meeting - Risk-Based Initiatives - Slide 26

Slide 27

Feed Contaminants Program

Pesticides
Malathion, chlorpyrifos-methyl, pirimiphos-methyl, methoxychlor, diazinonp

Elements
Cadmium, lead, mercury

Mycotoxins
Aflatoxins, fumonisins, deoxynivalenol, zearalenone, ochratoxin Ap

Microbes
Salmonella enterica, E. coli O157:H7p

Dioxins and PCBs

AFSS Public Meeting - Risk-Based Initiatives - Slide 27

Slide 28

Ingredients: Contaminant Levels

Data may be available for some or all of the following:

  • Specified ingredients
  • Starting materials for ingredients

    • Modifying contaminant levels for processing steps associated with a specific ingredient
  • Complete feed (mixed feeds, feed supplements, etc.)

    • May be used to check or validate exposure estimates
AFSS Public Meeting - Risk-Based Initiatives - Slide 28

Slide 29

What You Are About to Hear

  • Phares Okelo
       The Risk-Ranking Model
  • Jerry Rushin
       The Risk-Ranking Model – Application to Microbial Pathogens
  • Barry Hooberman
       A Risk-Ranking Model – Application to Chemical Contaminants 
AFSS Public Meeting - Risk-Based Initiatives - Slide 29