Risk-Based Initiatives
at the
Center for Veterinary Medicine
Barry Hooberman
Office of Surveillance & Compliance
FDA Center for Veterinary Medicine |  |
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
|  |
Slide 3 What is Risk Ranking? Risk assessments provide the “facts” for risk analysis. Risk, Risk Assessment, Risk |  |
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 |
|  |
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 |  |
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
|  |
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.
|  |
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)?
|  |
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?
|  |
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.
|  |
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
|  |
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) |  |
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
|  |
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 |
|  |
Slide 15 Across Programs?!#% |  |
Slide 16 Program “Characterization” | COMPLIANCE PROGRAM | “Resource Allocation” |
|---|
| “Surveillance” | “For Cause”
|
|---|
| BSE | Mostly ~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
| Mostly | Some
| Drug Tissue Residues
| None
| All | | Post-Market Drugs and Devices | None
| All |
|  |
Slide 17 Program “Characterization” | COMPLIANCE PROGRAM | Known Hazards? | Range of Hazards |
|---|
| BSE | Known | None
High | | Feed Contaminants | Almost all known | Very 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 feeds | Mostly known | Wide
Low to High | | Drug Manufacturing GMPs | Mostly known | Very wide
Low to high | Drug Tissue Residues Wide
| Known | Medium to high | | Post-Market Drugs and Devices | Unknown | Small
Medium to high |
|  |
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?
|  |
Slide 19 Challenges |  |
Slide 20 Solutions - Please feel free to fill in!!!!!
|  |
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
|  |
Slide 22 How Will Ranked Risks Be Used for AFSS? |  |
Slide 23 AFSS Risk Ranking Model 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
|  |
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) |
|  |
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) |
|  |
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 | |
|  |
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 |  |
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
|  |
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
|  |
