AFLATOXIN RISK MANAGEMENT IN TEXASotscweb.tamu.edu/OTSC-Present/2010/Mycotoxin NCGB-tjh.pdf ·...
Transcript of AFLATOXIN RISK MANAGEMENT IN TEXASotscweb.tamu.edu/OTSC-Present/2010/Mycotoxin NCGB-tjh.pdf ·...
OFFICE OF THE TEXAS STATE CHEMISTTexas Feed and Fertilizer Control Service Agriculture Analytical Service
AFLATOXIN RISK MANAGEMENT IN TEXAS
&
PURSUIT OF A ONE SAMPLE STRATEGY
Tim Herrman
PhDProfessor and Director
Presented Nov. 16, 2010, for theNation Corn Producers Association
Mycotoxin
Working Group
OFFICE OF THE TEXAS STATE CHEMIST
Office of the Texas State Chemist
HistoryThe 26th Texas Legislature (1899) enacted the first Fertilizer Control Law and placed responsibility for its administration in the Division of Chemistry The 29th Legislature (1905) enacted the first Feed Control Law and located the responsibility for carrying out its statutory requirements with the Director, Texas AgriLife Research In 1984, the Texas Feed and Fertilizer Control Service (TFFCS) and the Department of Agricultural Analytical Services were combined to establish the Office of the Texas State Chemist (OTSC)
OFFICE OF THE TEXAS STATE CHEMIST
Mycotoxin regulation in TexasThe Texas Agriculture Code, Chapter 141 (Texas Commercial Feed Control Act) exempts grain (§141.002(c)(2)) or whole seed that does not contain toxins or chemical adulterants. Grain or seed exceeding the 20 ppb aflatoxinaction level is adulterated and subject to the Texas Commercial Feed Control Act. The Texas Feed and Fertilizer Control Service is the state regulatory agency responsible for administering TAC 141 and this agency is part of the Office of the Texas State Chemist (OTSC), which is in Texas Agrilife Research
OFFICE OF THE TEXAS STATE CHEMIST
OFFICE OF THE TEXAS STATE CHEMIST
MissionWhy the organization exists
Customer FocusIdentify and satisfy the customer
according to the Mission
Internal ProcessesHow to achieve outputs to
satisfy customers
Knowledge and DataInformation and skills needed
to complete internal processes
Financial ResourcesMeans of acquiring and
distributing funding to
support the other perspectives
Application of aBalanced Scorecardto align resources,data, and internal processes with the OTSC mission thatis customer focused
OFFICE OF THE TEXAS STATE CHEMIST
Mission Objective #1: Enforce compliance measures to protect consumers and enhance agribusiness. Measure #1: Percentage of completed corrective actions. Description: This measure reports the percentage of
identified licensing, product registration, labeling, consumer complaints, and sample violations that require corrective actions defined below:
OFFICE OF THE TEXAS STATE CHEMIST
MissionWhy the organization exists
Customer FocusIdentify and satisfy the customer
according to the Mission
Internal ProcessesHow to achieve outputs to
satisfy customers
Knowledge and DataInformation and skills needed
to complete internal processes
Financial ResourcesMeans of acquiring and
distributing funding to
support the other perspectives
Application of aBalanced Scorecardto align resources,data, and internal processes with the OTSC mission thatis customer focused
OFFICE OF THE TEXAS STATE CHEMIST
OFFICE OF THE TEXAS STATE CHEMIST
OFFICE OF THE TEXAS STATE CHEMIST
MissionWhy the organization exists
Customer FocusIdentify and satisfy the customer
according to the Mission
Internal ProcessesHow to achieve outputs to
satisfy customers
Knowledge and DataInformation and skills needed
to complete internal processes
Financial ResourcesMeans of acquiring and
distributing funding to
support the other perspectives
Application of aBalanced Scorecardto align resources,data, and internal processes with the OTSC mission thatis customer focused
OFFICE OF THE TEXAS STATE CHEMIST
Science based annual work planScience based sample analysis scheduleServe as risk managersIncludes monitoring of human-animal hazards
MycotoxinsMicrobiological contaminantsHeavy metalsDioxinBSE contract and grant w/FDA
OTSC Adoption of a Science-based Approach to Risk Management
OFFICE OF THE TEXAS STATE CHEMIST
Aflatoxin Annual Plan of WorkProducts Samples per Area Total Samples
New crop corn 36 504
Bulk corn & screenings
15 210
Deer Corn 10 140
Grain Sorghums 3 42
Peanut meal 1 14
Dry dog food 5 70
Total 70 980
OFFICE OF THE TEXAS STATE CHEMIST
Biological and Other Chemical Hazards FFCS Annual Plan of Work
Products Samples per Area
Total Samples
SalmonellaRendered animal protein, oilseed meals, animal feeds, vegetable
refuse
36 504
DioxinFats, Fish meal, minerals and
mineral premixes, binders, citrus pulp
8 112
Heavy MetalsFish meal, minerals and mineral
premixes
5 56
Prohibited Mammalian Protein
29 406
Total 49 1078
OFFICE OF THE TEXAS STATE CHEMIST
OTSC Risk Management Approach
OFFICE OF THE TEXAS STATE CHEMIST
MissionWhy the organization exists
Customer FocusIdentify and satisfy the customer
according to the Mission
Internal ProcessesHow to achieve outputs to
satisfy customers
Knowledge and DataInformation and skills needed
to complete internal processes
Financial ResourcesMeans of acquiring and
distributing funding to
support the other perspectives
Application of aBalanced Scorecardto align resources,data, and internal processes with the OTSC mission thatis customer focused
OFFICE OF THE TEXAS STATE CHEMIST
OFFICE OF THE TEXAS STATE CHEMIST
MissionWhy the organization exists
Customer FocusIdentify and satisfy the customer
according to the Mission
Internal ProcessesHow to achieve outputs to
satisfy customers
Knowledge and DataInformation and skills needed
to complete internal processes
Financial ResourcesMeans of acquiring and
distributing funding to
support the other perspectives
Application of aBalanced Scorecardto align resources,data, and internal processes with the OTSC mission thatis customer focused
OFFICE OF THE TEXAS STATE CHEMIST
OTSC Factoids2009 2010 2011
Total Budget $5,478,709 $5,488,347 $5,370,823
Feed Tonnage 17,487,064 16,815,374 -
Total Personnel 55 FTE 54 FTE 53 FTE
Feed Reserve 46% 44% 45%
Estimated market value of Texas fertilizer, animal feed and pet food ~ $10 billionOTSC receives about $500,000 in grants each year from FDA and USDAReasons for personnel reduction: increased efficiency gained from automation and new instrumentation
OFFICE OF THE TEXAS STATE CHEMIST
Risk Communication
Risk Assessment
Scientific inputs
Risk Management
Decisions involvingPolicy and values
Generic components of risk analysis
Source: FAO -Food Safety Risk Analysis
OFFICE OF THE TEXAS STATE CHEMIST
Fungal Toxins
Fungus ToxinAspergillus flavus & A. parasiticus
aflatoxin
Fusarium species tricothecenesF. Verticillioides fumonisinsF. Graminearum zearalenonePenicillium verrucosum
ochratoxins
Claviceps ergot
OFFICE OF THE TEXAS STATE CHEMIST
Mycotoxicoses of AnimalsToxin General Effect Susceptable Species
Aflatoxin Liver damage including cancer, decreased milk & egg product,
Young animals, dogs, fish, poultry, dairy cattle
Fumonisin Equine leukoencephalo- malacia, porcine pulmonary edema
Horses, rabbits, swine, breeding animals
Tricothecenes Necrosis and hemorrhage in digestive tract, depressed blood regeneration
Monogastric animals pigs, chickens and turkeys, then ruminants
Ochratoxin Kidney damage, liver damage, and intestinal necrosis and hemorrhage
Swine, turkeys and chickens decreased productivity
Mycotoxin: CAST report No 139 url
OFFICE OF THE TEXAS STATE CHEMIST
Aflatoxin action levelsppb Product Description
20 Corn, peanut products, cottonseed meal, and other animal feeds and feed ingredients intended for dairy animals, for animal species or uses not specified above, or when the intended use is not known
20 Corn, peanut products, and other animal feeds and feed ingredients, but excluding cottonseed meal, intended for immature animals
100 Corn and peanut products intended for breeding beef cattle, breeding swine, or mature poultry
200 Corn or peanut products intended for finishing swine of 100 pounds or greater
300 Corn and peanut products intended for finishing (i.e., feedlot) beef cattle
OFFICE OF THE TEXAS STATE CHEMIST
Fumonisin advisory levelsppm Product Description
5 Equids and rabbits (no more than 20% of diet)**
10 All other species or classes of livestock and pet animals (no more than 50% of diet)**
20 Swine and catfish (no more than 50% of diet)**
30 Breeding ruminants, breeding poultry and breeding mink* (no more than 50% of diet)
60 Ruminants >3 months old being raised for slaughter and mink being raised for pelt production (no more than 50% of diet)**
100 Poultry being raised for slaughter (no more than 50% of diet)**
OFFICE OF THE TEXAS STATE CHEMIST
DON advisory levels for animalsppm Product Description
1 finished wheat products, e.g. flour, bran, and germ, that may potentially be consumed by humans. FDA is not stating an advisory level for wheat intended for milling because normal manufacturing practices and additional technology available to millers can substantially reduce DON levels in the finished wheat product from those found in the original raw wheat. Because there is significant variability in manufacturing processes, an advisory level for raw wheat is not practical.
10 grains and grain by-products (on an 88% dry matter basis) and 30 ppm in distillers grains and brewers grains (on an 88% dry matter basis) destined for ruminating beef and feedlot cattle older than 4 months and ruminating dairy cattle older than 4 months, with the added recommendations that the total ration1 for ruminating beef and feedlot cattle older than 4 months not exceed 10 ppm DON, and the total ration for ruminating dairy cattle older than 4 months not exceed 5 ppm DON. For chickens, 10 ppm DON with the added recommendation that these ingredients not exceed 50% of the diet of chickens.
5 Grains and grain by-products destined for swine with the added recommendation that these ingredients not exceed 20 percent of their diet.
5 Grains and grain by-products destined for all other animals with the added recommendation that these ingredients not exceed 40 percent of their diet.
June 29, 2010 Nonbinding recommendationshttp://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/NaturalToxins/UCM217558.pdf
OFFICE OF THE TEXAS STATE CHEMIST
Preharvest Research Objective Priority Priority Stakeholder Issues/NeedsIdentification and characterization of mycotoxigenic fungi
medium Identify atoxigenic fungi strains
identify resistance high medium Need atoxigenic products Exploit fungal genomics non-toxigenic strains high Improved sampling of corn and sorghumManagement practices for mycotoxin high Management of crop to reduce mycotoxins Build a database low high Need improved host resistance develop an early warning system low high More rapid detection technology practices to reduce mycotoxins high med-low Improved remediation technologyHost plant resistance, characterization and selection of plant traits
high federal insurance program (planting late is still allowed, shouldn't be after March 15)
characterize commercial corn hybrids high Policy issues related to insurance develop corn germplasm high Insurance allows farmer to keep grain
peanut breeding to develop resistance high Lack of incentives to minimize practices to reduce aflatoxinFeed lots not regulated
Sampling and detection for mycotoxins high Loop holes in law
individual kernel mycotoxin high Lack of investment by commercial seed companies in host resistance to mycotoxins in TX
sampling designs and probability high Economics of developing resistance (2%) seed sales and 1/3 has problem
individual kernel spectral analysis high Lack of uniformity between states on surveilllanceDetoxification using binding agents and enterosorbent clays
medium high Dairy feed problem with corn shipped from midwest
mechanisms for binding Feed manufacturers having trouble getting low mycotoxin grain from midwest
Verify effectiveness high Need public corn breeders working on aflatoxin
criteria for approving binding agents
Storage management to control mycotoxins build an educational outreach program high establishing a faculty appointment lowRegulatory approaches to mitigating mycotoxin hazards in TX
high
targeted surveillance verification of sampling, testing, records monitor mycotoxin nationally
Post Harvest Research Objective
OFFICE OF THE TEXAS STATE CHEMIST
SAMPLING: Office of the Texas State Chemist Field Procedures
Samples must be obtained by a procedure which yields a representative sample using procedures of AOAC International or procedures that are determined dependable through research and/or investigation. Refer to Section 965.16 of the 15th
Edition of AOAC “Sampling of Animal Feed – Procedure.”
OFFICE OF THE TEXAS STATE CHEMIST
OFFICE OF THE TEXAS STATE CHEMIST
OFFICE OF THE TEXAS STATE CHEMIST
Risk Management Agency: Loss Adjustment Manual
OFFICE OF THE TEXAS STATE CHEMIST
% CV = sx
x 100
s = s2
( )S
1n -1
x
n2
i=1
n ii 1
h
= −
⎡
⎣
⎢⎢⎢⎢
⎤
⎦
⎥⎥⎥⎥
∑∑=xi
2
2
x=x x x ... x
nx
n
where: x = mean x x x ... individually measured value (x n = number of measurements
1 2 3 n i
1 2 3 1
+ + + +=
+ + =
∑
)
Mean
Variance
Standard Deviation
Coefficient ofVariation
1 + 2 + 33
1= 1 [14 - (6)2 ]2 3
1 = √1
50% = 1 x 1002
Sampling Statistics
OFFICE OF THE TEXAS STATE CHEMIST
Sampling Statisticss2
c(s) = aCb where a and b are constants and C is the estimated concentrationUsing regression analysis, the relationship between sampling variance and aflatoxin concentration is
s2c(s) =11.361C0.98
100 ppb aflatoxin
s2c(s)
= 11.361 x 91.2011 = 1036Standard deviation sqrt
of the variance = 32
Coefficient of variance = s ÷
μ
x 100 = 32
Johansson et al. 2000. Testing shelled corn for aflatoxin, Part I: Estimation of variance components AOACI 83(5)1264-1269
OFFICE OF THE TEXAS STATE CHEMIST
Sampling Statistics: sample sizes2
c(s) = (1.13/ns) x 11.361C0.98
where ns is the sample size in kgExample 1: 1.13 kg (2.5 lbs)100 ppb aflatoxin s2
c(s) = 1 x 11.361 x 91.2011 = 1036cv = 32
Example 2: 4.54 kg (10 lbs)s2
c(s) = (1.13/4.54) x 11.361 x 91.2011 = 256.859cv = 16
Example 3: 9.08 kg (20 lbs)cv = 11.35
OFFICE OF THE TEXAS STATE CHEMIST
Chain of custody from field to lab
OFFICE OF THE TEXAS STATE CHEMIST
Aflatoxin Analysis in Corn:
AOAC 977.16 - Sampling for Aflatoxins(Preparation for Sample Procedure)
OFFICE OF THE TEXAS STATE CHEMIST
Sampling and Sample Preparation10 pound sample collected
Entire sample ground and subdivided by Romer Mill
5 pound portion further ground by RetschMill with 1.5 mm screen
Sample passes through a number 20 sieve
OFFICE OF THE TEXAS STATE CHEMIST
Sample Grinding
OFFICE OF THE TEXAS STATE CHEMIST
Sample Grinding
OFFICE OF THE TEXAS STATE CHEMIST
Confirmation Analysis (HPLC)50 grams extracted with 70 % methanol
Aflatoxins first analyzed using Neogen ELISA test kit
Aflatoxins quantitated by PHRED (Photochemical Reactor for Enhanced Detection) fluorescence after separation on high performance liquid chromatography
OFFICE OF THE TEXAS STATE CHEMIST
OTSC Aflatoxin Analyses
OFFICE OF THE TEXAS STATE CHEMIST
Analysis Accuracy and Reproducibility Contested Samples from 2010 Corn CropOTSC TVMDL Eurofins Avg Dev RSD
648 550 660 46 0.071305 260 350 30 0.0985.5 5.3 6 0 0.048110 82 103 11 0.099574 586 750 76 0.132372 317 325 23 0.061
1340 1093 1157 96 0.07125 23 26 1 0.044
0.078
N = 24
OFFICE OF THE TEXAS STATE CHEMIST
Analysis Accuracy and Reproducibility HPLC with Aflatoxin Test Kits
A B CELISA Avg 47 329 577
RSD 0.06 0.09 0.08
Aflatest Avg 47 375 585RSD 0.07 0.04 0.08
HPLC Avg 52 378 580RSD 0.06 0.05 0.06
N = 90
OFFICE OF THE TEXAS STATE CHEMIST
Analysis Accuracy and Reproducibility Gulf Country vs OTSC
GC OTSC OTSC-GC RSD
Greenville 23 417 487 70 0.144Sherman 13 481 530 49 0.093
Greenville 487 166 0.34Sherman 530 140 0.26
Composite sample (ppb)
Individual Sample (ppb)
Facility Sample No
N = 72
OFFICE OF THE TEXAS STATE CHEMIST
Mean STD RSDGreenville 515 139 0.33Sherman 449 308 0.34
Probing sample (ppb)
Comparison between one probe and 10 probesperformed by OTSC field staff at two locations
N = 144
OFFICE OF THE TEXAS STATE CHEMIST
OFFICE OF THE TEXAS STATE CHEMIST
Post Harvest BMPs
Collect a 10 pound sample from incoming grainGrind the entire grain sample using a
Romer or Viking mill before sample reductionReduce sample using a riffler to retain
representative property of the sampleFine grind proportion for analysis to pass
through a 20 mesh sieveUse testing methods approved by either
USDA or AOACI
OFFICE OF THE TEXAS STATE CHEMIST
Impact of Particle Size on Particle Number
Percent through a 20 mesh sieve
Average Particle Size
Standard Deviation
Average Particle Number per gram
55 771 1.65 9,903
65 702 1.63 12,442
75 590 1.67 23,303
85 500 1.71 42,929
50 gram sample with 45% on top of the 20 mesh sieve = 495,150
total particles50 gram sample with 15% on top of the 20 mesh sieve = 2,146,450 total particles
OFFICE OF THE TEXAS STATE CHEMIST
Post Harvest BMPs
Store grain over the action level separately Test incoming unit trainsTest incoming grain from farm storageDo not commingle grain exceeding the
action level with grain below the action level during reclaim Correctly label grain exceeding the action
levelhttp://mycotoxinbmps.tamu.edu/
OFFICE OF THE TEXAS STATE CHEMIST
Sample Reduction for Mycotoxin Analysis
OFFICE OF THE TEXAS STATE CHEMIST
Approved Test KitsCompany Test Kit Range
ppbIdentified Commodities
NeogenCorp
Veratox-AST 5 – 300 Corn, Corn Meal, Corn Germ Meal, Corn Gluten Meal, Corn Meal, Corn/Soy Blend, Milled Rice, Popcorn, Sorghum, Soybeans, Wheat
R- Biopharm
Ridascreen FAST
5 – 300 Corn, Milled Rice, Popcorn, Corn Meal, Cracked Corn, Wheat, Soybean, Corn Germ Meal, Corn Gluten Meal, Corn Soy Blend, Sorghum
Romer FluoroQuant 5 – 300 …
Strategic Diagnostics , Inc.
Myco√ 5 – 300 …
VICAM Aflatest 5 – 300 …
http://mycotoxinbmps.tamu.edu
OFFICE OF THE TEXAS STATE CHEMIST
OTSC Test Kit ValidationGIPSA performance verification on naturally contaminated samples
Three operators will conduct all analyses. All operators shall receive up to two days of training in the use of each test kitIf an observation is a suspected outlier, the available documentation will be reviewed to identify the source of the error and make corrections where possible.
OFFICE OF THE TEXAS STATE CHEMIST
Mycotoxin MitigationAnhydrous ammonia
Procedures in the Texas Administrative Code Chapter 61, Commercial Feed Rules §.61.65
Sequestering agentsThe Office and OTSC Advisory Committee evaluating possible rule change to approve clay bindersPermit, Recordkeeping, Label, Customer formula feed, no change in action levels
OzonationOzone is a powerful oxidant capable of reaction with numerous chemical groups. After 72 hours of ozonation AFB1 level decreased 92.7%. J. M. KING, A. Moustafa, and J. N. Losso. LSU
OFFICE OF THE TEXAS STATE CHEMIST
One Sample StrategyAt the request of stakeholders during the January 11,
2010 meeting in College Station, TX, the director of OTSC began to explore the concept of using a single sample for managing aflatoxin risk at the first commercial collection point.
Firms that choose to participate in the voluntary “One Sample” program will use validated aflatoxin test kits and follow a prescribed sampling pattern, sample size, and amount of material ground tested for aflatoxin, demonstrate performance to analyze aflatoxin using OTSC check samples, use control samples, and follow record keeping procedures. It is the intention of the Service to accept commercial grain elevator results for those firms choosing to participate in voluntary “One Sample” program.