AFLATOXIN RISK MANAGEMENT IN TEXAS

Transcription

1 AFLATOXIN RISK MANAGEMENT IN TEXAS & PURSUIT OF A ONE SAMPLE STRATEGY Tim Herrman PhD Professor and Director Presented Nov. 16, 2010, for the Nation Corn Producers Association Mycotoxin Working Group OFFICE OF THE TEXAS STATE CHEMIST Texas Feed and Fertilizer Control Service Agriculture Analytical Service

2 Office of the Texas State Chemist History The 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)

3 Mycotoxin regulation in Texas OFFICE OF THE TEXAS STATE CHEMIST The Texas Agriculture Code, Chapter 141 (Texas Commercial Feed Control Act) exempts grain ( (c)(2)) or whole seed that does not contain toxins or chemical adulterants. Grain or seed exceeding the 20 ppb aflatoxin action 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

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5 Mission Why the organization exists Customer Focus Identify and satisfy the customer according to the Mission Internal Processes How to achieve outputs to satisfy customers Application of a Balanced Scorecard to align resources, data, and internal processes with the OTSC mission that is customer focused Knowledge and Data Information and skills needed to complete internal processes Financial Resources Means of acquiring and distributing funding to support the other perspectives

6 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:

7 Mission Why the organization exists Customer Focus Identify and satisfy the customer according to the Mission Internal Processes How to achieve outputs to satisfy customers Application of a Balanced Scorecard to align resources, data, and internal processes with the OTSC mission that is customer focused Knowledge and Data Information and skills needed to complete internal processes Financial Resources Means of acquiring and distributing funding to support the other perspectives

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10 Mission Why the organization exists Customer Focus Identify and satisfy the customer according to the Mission Internal Processes How to achieve outputs to satisfy customers Application of a Balanced Scorecard to align resources, data, and internal processes with the OTSC mission that is customer focused Knowledge and Data Information and skills needed to complete internal processes Financial Resources Means of acquiring and distributing funding to support the other perspectives

11 OTSC Adoption of a Science-based Approach to Risk Management Science based annual work plan Science based sample analysis schedule Serve as risk managers Includes monitoring of human-animal hazards Mycotoxins Microbiological contaminants Heavy metals Dioxin BSE contract and grant w/fda OFFICE OF THE TEXAS STATE CHEMIST

12 Aflatoxin Annual Plan of Work Products Samples per Area Total Samples New crop corn Bulk corn & screenings Deer Corn Grain Sorghums 3 42 Peanut meal 1 14 Dry dog food 5 70 Total OFFICE OF THE TEXAS STATE CHEMIST

13 Biological and Other Chemical Hazards FFCS Annual Plan of Work Products Salmonella Rendered animal protein, oilseed meals, animal feeds, vegetable refuse Dioxin Fats, Fish meal, minerals and mineral premixes, binders, citrus pulp Heavy Metals Fish meal, minerals and mineral premixes Prohibited Mammalian Protein Samples per Area Total Samples Total

14 OTSC Risk Management Approach

15 Mission Why the organization exists Customer Focus Identify and satisfy the customer according to the Mission Internal Processes How to achieve outputs to satisfy customers Application of a Balanced Scorecard to align resources, data, and internal processes with the OTSC mission that is customer focused Knowledge and Data Information and skills needed to complete internal processes Financial Resources Means of acquiring and distributing funding to support the other perspectives

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17 Mission Why the organization exists Customer Focus Identify and satisfy the customer according to the Mission Internal Processes How to achieve outputs to satisfy customers Application of a Balanced Scorecard to align resources, data, and internal processes with the OTSC mission that is customer focused Knowledge and Data Information and skills needed to complete internal processes Financial Resources Means of acquiring and distributing funding to support the other perspectives

18 OTSC Factoids 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 billion OTSC receives about $500,000 in grants each year from FDA and USDA Reasons for personnel reduction: increased efficiency gained from automation and new instrumentation

19 Generic components of risk analysis OFFICE OF THE TEXAS STATE CHEMIST Risk Assessment Risk Communication Risk Management Scientific inputs Decisions involving Policy and values Source: FAO -Food Safety Risk Analysis

20 Fungal Toxins Fungus Aspergillus flavus & A. parasiticus Toxin aflatoxin Fusarium species tricothecenes F. Verticillioides fumonisins F. Graminearum zearalenone Penicillium ochratoxins verrucosum Claviceps ergot

21 Mycotoxicoses of Animals Toxin General Effect Susceptable Species Aflatoxin Fumonisin Tricothecenes Ochratoxin Liver damage including cancer, decreased milk & egg product, Equine leukoencephalomalacia, porcine pulmonary edema Necrosis and hemorrhage in digestive tract, depressed blood regeneration Kidney damage, liver damage, and intestinal necrosis and hemorrhage Young animals, dogs, fish, poultry, dairy cattle Horses, rabbits, swine, breeding animals Monogastric animals pigs, chickens and turkeys, then ruminants Swine, turkeys and chickens decreased productivity Mycotoxin: CAST report No 139 url

22 ppb Aflatoxin action levels Product Description OFFICE OF THE TEXAS STATE CHEMIST 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

23 Fumonisin advisory levels ppm 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)**

24 ppm OFFICE OF THE TEXAS STATE CHEMIST DON advisory levels for animals 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 recommendations

25 Preharvest Research Objective Priority Priority Stakeholder Issues/Needs Identification and characterization of medium Identify atoxigenic fungi strains mycotoxigenic fungi OFFICE OF THE TEXAS STATE CHEMIST identify resistance high medium Need atoxigenic products Exploit fungal genomics non-toxigenic strains high Improved sampling of corn and sorghum Management 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 technology Host plant resistance, characterization federal insurance program (planting late is still high and selection of plant traits 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 Lack of incentives to minimize practices to reduce peanut breeding to develop resistance high aflatoxin Post Harvest Research Objective Feed lots not regulated Sampling and detection for mycotoxins high Loop holes in law Lack of investment by commercial seed companies in individual kernel mycotoxin high host resistance to mycotoxins in TX Economics of developing resistance (2%) seed sales sampling designs and probability high and 1/3 has problem individual kernel spectral analysis high Lack of uniformity between states on surveilllance Detoxification using binding agents and enterosorbent clays medium high Dairy feed problem with corn shipped from midwest Feed manufacturers having trouble getting low mechanisms for binding 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 establishing a faculty appointment Regulatory approaches to mitigating mycotoxin hazards in TX targeted surveillance verification of sampling, testing, records monitor mycotoxin nationally high low high

26 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 of the 15 th Edition of AOAC Sampling of Animal Feed Procedure.

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29 Risk Management Agency: Loss Adjustment Manual OFFICE OF THE TEXAS STATE CHEMIST

30 Sampling Statistics OFFICE OF THE TEXAS STATE CHEMIST Mean x= x + x + x x n n i where: x = mean = x + x + x... = individually measured value (x ) n x n = number of measurements Variance S 2 1 n = 2 x n-1 i i=1 h ( xi ) i= 1 n 2 1= 1 [14 - (6) 2 ] 2 3 Standard Deviation Coefficient of Variation s = s 2 % CV = s x x = 1 50% = 1 x 100 2

31 Sampling Statistics s 2 c(s) = acb where a and b are constants and C is the estimated concentration Using regression analysis, the relationship between sampling variance and aflatoxin concentration is s 2 c(s) =11.361C ppb aflatoxin s 2 c(s) = x = 1036 Standard deviation sqrt of the variance = 32 Coefficient of variance = s μ x 100 = 32 Johansson et al Testing shelled corn for aflatoxin, Part I: Estimation of variance components AOACI 83(5)

32 Sampling Statistics: sample size OFFICE OF THE TEXAS STATE CHEMIST s 2 c(s) = (1.13/ns) x C0.98 where ns is the sample size in kg Example 1: 1.13 kg (2.5 lbs) 100 ppb aflatoxin s 2 c(s) = 1 x x = 1036 cv = 32 Example 2: 4.54 kg (10 lbs) s 2 c(s) = (1.13/4.54) x x = cv = 16 Example 3: 9.08 kg (20 lbs) cv = 11.35

33 Chain of custody from field to lab OFFICE OF THE TEXAS STATE CHEMIST

34 Aflatoxin Analysis in Corn: AOAC Sampling for Aflatoxins (Preparation for Sample Procedure)

35 Sampling and Sample Preparation OFFICE OF THE TEXAS STATE CHEMIST 10 pound sample collected Entire sample ground and subdivided by Romer Mill 5 pound portion further ground by Retsch Mill with 1.5 mm screen Sample passes through a number 20 sieve

36 Sample Grinding OFFICE OF THE TEXAS STATE CHEMIST

37 Sample Grinding OFFICE OF THE TEXAS STATE CHEMIST

38 Confirmation Analysis (HPLC) OFFICE OF THE TEXAS STATE CHEMIST 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

39 OTSC Aflatoxin Analyses OFFICE OF THE TEXAS STATE CHEMIST

40 Analysis Accuracy and Reproducibility Contested Samples from 2010 Corn Crop OTSC TVMDL Eurofins Avg Dev RSD N = 24

41 Analysis Accuracy and Reproducibility HPLC with Aflatoxin Test Kits OFFICE OF THE TEXAS STATE CHEMIST A B C ELISA Avg RSD Aflatest Avg RSD HPLC Avg RSD N = 90

42 Analysis Accuracy and Reproducibility Gulf Country vs OTSC OFFICE OF THE TEXAS STATE CHEMIST Composite sample (ppb) Facility Sample No OTSC- OTSC GC GC RSD Greenville Sherman Individual Sample (ppb) Greenville Sherman N = 72

43 Comparison between one probe and 10 probes performed by OTSC field staff at two locations Probing sample (ppb) Mean STD RSD Greenville Sherman N = 144

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45 Post Harvest BMPs Collect a 10 pound sample from incoming grain Grind the entire grain sample using a Romer or Viking mill before sample reduction Reduce sample using a riffler to retain representative property of the sample Fine grind proportion for analysis to pass through a 20 mesh sieve Use testing methods approved by either USDA or AOACI

46 Impact of Particle Size on Particle Number Percent through a 20 mesh sieve Average Particle Size Standard Deviation Average Particle Number per gram , , , , gram sample with 45% on top of the 20 mesh sieve = 495,150 total particles 50 gram sample with 15% on top of the 20 mesh sieve = 2,146,450 total particles

47 Post Harvest BMPs Store grain over the action level separately Test incoming unit trains Test incoming grain from farm storage Do not commingle grain exceeding the action level with grain below the action level during reclaim Correctly label grain exceeding the action level

48 Sample Reduction for Mycotoxin Analysis OFFICE OF THE TEXAS STATE CHEMIST

49 Approved Test Kits Company Test Kit Range ppb Identified Commodities Neogen Corp Veratox-AST Corn, Corn Meal, Corn Germ Meal, Corn Gluten Meal, Corn Meal, Corn/Soy Blend, Milled Rice, Popcorn, Sorghum, Soybeans, Wheat R- Biopharm Ridascreen FAST Romer FluoroQuant Corn, Milled Rice, Popcorn, Corn Meal, Cracked Corn, Wheat, Soybean, Corn Germ Meal, Corn Gluten Meal, Corn Soy Blend, Sorghum Strategic Diagnostics, Inc. Myco VICAM Aflatest

50 OTSC Test Kit Validation GIPSA 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 kit If an observation is a suspected outlier, the available documentation will be reviewed to identify the source of the error and make corrections where possible.

51 Mycotoxin Mitigation Anhydrous ammonia Procedures in the Texas Administrative Code Chapter 61, Commercial Feed Rules Sequestering agents The Office and OTSC Advisory Committee evaluating possible rule change to approve clay binders Permit, Recordkeeping, Label, Customer formula feed, no change in action levels Ozonation Ozone 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

52 One Sample Strategy At 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.