OFFICE OF THE TEXAS STATE CHEMIST Texas Feed and Fertilizer Control Service Agriculture Analytical Service
OTSC Statistically Derived Risk-Based Plan-of-Work
Susie DaiAssistant Research Professor
Mary SasserManager Field Operations
K.M LeeAssociate Scientist
Tim HerrmanProfessor, State Chemist and Director
OFFICE OF THE TEXAS STATE CHEMIST
Outline
Who are we? Sampling: Risk Management What ? Why ? How?
Regulatory Science
OFFICE OF THE TEXAS STATE CHEMIST
OFFICE OF THE TEXAS STATE CHEMIST
Where do We Receive the Authority
Texas Commercial Feed Control Act
Texas Agricultural Code
Chapter 141
Agricultural Analytical Service Three teams
Feed and Fertilizer Control Service Field investigators Registration Compliance
OFFICE OF THE TEXAS STATE CHEMIST
Office of the Texas State Chemist, Texas Agricultural Experiment Station, Texas A&M University System
Sample Chain of Custody
Sample Received
Sample Information Stored
Official Sample
Official Feed Seal Placed on Sample
Information Entered
Sample Shipped
Sample Prepared for Analysis
Reports Mailed to Manufacturer
Analytical Results to FFCS Each analytical result
must be surrounded by sample integrity. Without proof of the sample chain of custody, an analytical result is just a number.
Texas Commercial Feed Control Act
Texas Agriculture Code
Chapter 141
OFFICE OF THE TEXAS STATE CHEMIST
Risk = Probability x Consequence
Risk Probability Consequence
= X
Risk: A characteristic of a situation or action wherein two or more outcomes are possible, the particular outcome that will occur is unknown, and at least one of the possibilities is undesired.
OFFICE OF THE TEXAS STATE CHEMIST
What is Our Sampling Plan
Codex Alimentarius Animal Feed Taskforce: "Guidelines on application of risk assessment for feed" and a “list of hazards in feed”
OFFICE OF THE TEXAS STATE CHEMIST
What is Our Sampling Plan
Biological Bacterial
(Salmonella, Brucella)
Endoparasites (Toxoplasma and Taenia spp.)
Prions
Chemical Mycotoxin (aflatoxin,
fumonisin, ochratoxin, DON, T-2)
Industrial contaminants (Dioxin and PCB)
Heavy metals Drug residue Pesticide residue
OFFICE OF THE TEXAS STATE CHEMIST
Communication for Plan-of-Work
January: administrative planning
April: development & implementation
October: mid-year review
OFFICE OF THE TEXAS STATE CHEMIST
Why: AFRPS Standard 8 Planning and Resources
Requirement Summary Documented work
plan to support its inspection and sample collection
Conduct an evaluation of resource needs to complete inspection and sample collection projections
Evaluate resources to fully implement AFRPS
Program Elements Work plan to include:
inspection projections, sample, timeframe
Resources including adequate staff, equipment and funding
Conduct a review of resources required to implement the AFRPS including IT, funding, staff, equipment and other.
OFFICE OF THE TEXAS STATE CHEMIST
Why OTSCPlan of Work
FDA Plan-of-Work Inspection-based
Facility inventory Risk ranking Samples to support
inspection as evidence Rely upon states to
conduct the majority of inspection (60-70%)
OTSC Plan-of-Work Sample-driven
Targets coverage of all establishments in state
Directs inspections based on violation history
Builds into the POW FDA inspections
OFFICE OF THE TEXAS STATE CHEMIST
How ?
Plan of Work Attributes: Scalable including the ability to adjust sample numbers based
on state-wide tonnage, shifts in the use of different ingredients, and weighted by establishments risk factor and tonnage.
Adaptable including continuous updating subject to quarterly review.
Assessable such that conformance to the plan is possible real time.
Automated using project management software. Differentiates between investigational, surveillance and
monitoring sample collection. Transitional to facilitate process-control regulatory oversight
including one-sample-strategy and HACCP adoption. Portable to enable field investigators to perform work at any
point in the state and avoid duplication.
OFFICE OF THE TEXAS STATE CHEMIST
What: Three Components Economic Sampling Plan of
Work Feed Hazard Sampling Plan of
Work Investigational Plan of Work
OFFICE OF THE TEXAS STATE CHEMIST
Component 1Economic Sampling Plan of Work: Why?
Goal: GMP compliance of firms
OFFICE OF THE TEXAS STATE CHEMIST
Different Firms
What and How:
OFFICE OF THE TEXAS STATE CHEMIST
What and How Different Firms
Different
Inspection
Frequencies
OFFICE OF THE TEXAS STATE CHEMIST
How: Violation History as a Determinant for Inspectional Frequency
OFFICE OF THE TEXAS STATE CHEMIST
Results
2008 2009 2010 2011 2012 20135%
10%
15%
20%
25%
30%
25%21%
24%20%
17%13%
Sample Violation History for TexasFeed Industry
Fiscal Year
Sam
ple
Viol
ation
Hist
ory
(%)
Source: Office fo the Texas State ChemistFY 13: 9/1/2012-4/25/2013
2008 2009 2010 2011 2012 20135%
10%
15%
20%
25%
30%
21% 20% 20%17% 16%
14%
Sample Violation History for TexasFertilizer Industry
Fiscal Year
Sam
ple
Viol
ation
Hist
ory
(%)
Source: Office fo the Texas State ChemistFY 13: 9/1/2012-4/25/2013
OFFICE OF THE TEXAS STATE CHEMIST
Component 2:Feed Hazard Sampling Plan of Work
OFFICE OF THE TEXAS STATE CHEMIST
Component 2:What: Feed Hazard Sampling Plan of
Work
OFFICE OF THE TEXAS STATE CHEMIST
nppzp /)ˆ1(ˆˆ 2/
n
zn
z
n
ppz
n
zp
22/
2
22/
2/
22/
1
4
)ˆ1(ˆ
2ˆ
)/()~1(~~ 22/2/ znppzp
• Wald interval
• Wilson interval
• Agresti-Coull interval
where, n : sample size; Z/2 : (1 - /2) 100th percentile of the standard normal distribution
p : observed sample portion;
22/
22/ 2/
:
zn
zT
~𝒑 (T : observed sample frequency)
Why: Binomial Probability Statistics
OFFICE OF THE TEXAS STATE CHEMIST
Sample size (n)
where, N : population (a total number of feed products)
e : acceptable error
Z/2 √ 𝑝 (1−𝑝)𝑛
(n: average sample size of the past 3 years)
)1()1(
)1(2
2/2
22/
ppzeN
Nppzn
Sample Population
Sample Distribution
Violation Rate (Contamination)
SamplingSample size (n)
Presentation of the Population
Why: How Many Samples We Need to Take for this Sample Category?
OFFICE OF THE TEXAS STATE CHEMIST
• p (violation rate) : 0.297
• Product: corn products (aflatoxins)
Lower limit Upper limit
Wilson interval 0.2766 0.3189
• 95% confidence intervals
• N (population) : 50,000 • Z/2 : 1.96
• Estimated sample sizes
675 (minimum) 732 (maximum)
• e (acceptable error) : 0.034
How: Representative Sample Numbers to Estimate the Whole Population
Conclusion from Statistics: Taking ~700 corn samples can estimate the aflatoxin contamination in the whole corn industry in TX
OFFICE OF THE TEXAS STATE CHEMIST
How : POW Total Work Load
Work Plan Summary
Complete list of investigator’s feed & fertilizer facilities
Newly registered firms
Economic feed & fertilizer projections
Economic mycotoxin projections
Funded project projections
Regulatory inspections
One Sample Strategy
Equipment list
Contact lists
OFFICE OF THE TEXAS STATE CHEMISTComponent 3
Inspections Work Plan
OFFICE OF THE TEXAS STATE CHEMIST
Alignment of OTSC POW with AFRPS
OFFICE OF THE TEXAS STATE CHEMIST
Alignment of OTSC POW with AFRPS
OFFICE OF THE TEXAS STATE CHEMIST
National View of POWWhat, Why and How
USDA FSIS
OFFICE OF THE TEXAS STATE CHEMIST
Global View of POW: What, Why and How
New Zealand
EU
France CODEX
Regulatory Science Graduate Curriculum
Advancing the
science
of creating tools,
standards,
and practices to
improve the
protection and
compliance
of food systemsregsci .tamu.edu
SCSC 635Comparative Global
Standardsin Food Systems
SCSC 634Regulatory Science:
Principles & Practices in Food Systems
Globalization and standards Principles of standards development Regional food laws and regulations Impact of food law and regulations on
trade, food security and food protection
Emerging field of regulatory science
Food law and policy
Risk analysis
Conducting a risk assessment
Current issues and problems
Fall
regsci .tamu.edu
AGEC 638Special Topics in
Managerial Economics forRegulatory Science
SCSC 636Regulatory Science
Methodologyin Food Systems
Economic impact of regulations
Financial principles and practice for investments in compliance and oversight
Cost-benefit analysis of regulations governing the food industry
Statistically derived risk-based POW
Compliance Strategies
Inspectional Techniques for food systems
Crisis response & incident command
Spring
regsci .tamu.edu
SCSC 629/VTMI 629Laboratory Quality Systems
Validity & reliability of laboratory data
Laboratory process control
Quality assurance procedures, tools and methods
Laboratory management
Summer
regsci .tamu.edu
OFFICE OF THE TEXAS STATE CHEMIST
OFFICE OF THE TEXAS STATE CHEMIST Texas Feed and Fertilizer Control Service Agriculture Analytical Service
END
Acknowledgements:
APHL – Feed and Food Subcommittee
FDA – Texas Feed Safety and Inspection CAPS
Texas A&M AgriLife Research
Top Related