Initial Contaminant Levels in Swine Feed Ingredients Karen B. Ekelman, PhD Presented To: Animal Feed Safety System Public Meeting Gaithersburg, Maryland May 22, 2007
|  |
Slide 2 Initial Contaminant Levels in Swine Feed Ingredients - Outline - Introduction
- Feed Contaminants Program Data
- Pesticides - Microbes - Elements - Dioxins - Mycotoxins - PCBs - Initial contaminant levels in ingredients for starter, grower and finisher swine feeds
|  |
Slide 3 Initial Contaminant Levels in Swine Feed Ingredients 1. Introduction |  |
Slide 4 Ingredients: Initial Contaminant Levels Cont. A | Cont. B | Cont. C | Contaminants | | | | | Ingredient 1 | Ingredient 2 | Ingredient 3 | Feed Ingredients | | | | | | Mill: Mix, Heat, etc. | | Manufacturing Processes | | | | | | | Finished Feed | | | | | | | | | Animals | | | | | Humans | Population(s) |
|  |
Slide 5 Ingredients: Initial Contaminant Levels - Challenge #1: Lack of data!
- For chemicals – Feed Contaminants Program, published data, expert opinion
- Data are particularly limited for elements
- For microbes – Feed Contaminants Program, published data, expert opinion
- Little or no data on levels of microbes in many feed ingredients and feeds
- Data on % of feeds and feed ingredients containing microbes are generally limited to Salmonella and E. coli O157:H7; much less data are available for other microbes of interest
|  |
Slide 6 Ingredients: Initial Contaminant Levels - Challenge #2: Data are not always available for the ingredient!
- For example - Soybean meal
- Microbes – Plant products and byproducts
- Mycotoxins – Soybeans and soybean byproducts
- Pesticides – Soybeans and soybean byproducts
- Dioxins, PCBs – Soybean meal
- For example – Spray-dried blood cells vs. Choice white grease
- Microbes – Animal products and byproducts
- Mycotoxins – Animal products and byproducts
- Pesticides – Animal products and byproducts
- Dioxins, PCBs – Animal fats
|  |
Slide 7 Initial Contaminant Levels in Swine Feed Ingredients 2. FDA CVM Feed Contaminants Program Data |  |
Slide 8 Feed Contaminants Program (FCP) - Sampling and
inspection program for non-drug, non-BSE-related hazardous contaminants in feed and feed ingredients - Current FCP was
published in 2005 - http://www.fda.gov/
cvm/Documents /7371-003.pdf
| FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL | | SUBJECT: FEED CONTAMINANTS PROGRAM | IMPLEMENTATION DATE: December 13, 2005 | COMPLETION DATE: 9/30/2010 | DATA REPORTING | | PRODUCT CODES | PRODUCT ASSIGNMENT CODES (PACs) | Industry Codes 54,69,70,71,72 | 71003A - Pesticides/Industrial Chemicals 71003B - Elements 71003C - Mycotoxins 71003E - Microbes 71003G - Dioxins |
|  |
Slide 9 Feed Contaminants Program (FCP) - Pesticides
- Malathion, chlorpyrifos-methyl, pirimiphos-methyl, methoxychlor, diazinon
- Elements
- Mycotoxins
- Aflatoxins, fumonisins, deoxynivalenol, zearalenone, ochratoxin A
- Microbes
- Salmonella enterica, E. coli O157:H7
Dioxins and PCBs
|  |
Slide 10 Feed Contaminants Program – Pesticides - FDA conducts routine, annual surveillance for levels of pesticides in animal feeds
- Feed ingredients and mixed feeds
- From 1989 - 2005, approximately 500 – 600 samples per year; since then, approximately 200 per year
- Data for AFSS swine feed model example are from 2000 - 2006
- Routine surveillance results are summarized each year by district and food commodity but not by individual pesticides; these annual reports will soon be available on CVM’s web page
|  |
Slide 11 Feed Contaminants Program – Pesticides Domestic Surveillance Feed Samples With Pesticides, 1992 to 2002 |  |
Slide 12 Feed Contaminants Programs – Pesticides Means Pesticides Levels For Domestic Feeds Samples, 1992 - 2003 |  |
Slide 13 Feed Contaminants Program – Elements (Heavy Metals) - Very limited surveillance of elements in feed and feed ingredients
- Some samples are collected in response to investigations (e.g., 2003 pet food investigation)
- Data used for the AFSS swine feed example are from 2000 – present (2007)
- Some data are available for:
- Cadmium
- Selenium
- Nickel
- Lead
- Copper
- Iron
- Arsenic
- Zinc
- Mercury
- Chromium
|  |
Slide 14 Feed Contaminants Program – Mycotoxins - Routine, annual surveillance for levels of 5 mycotoxins in animal feeds
- Aflatoxins, fumonisins, deoxynivalenol, zearalenone, and ochratoxin A
- Approximately 200 – 250 samples of feed ingredients and mixed feeds per year since 1994
- For AFSS swine feed example, will use data from 1994 - 2004
- Results are summarized annually by district, food commodity and mycotoxin and will soon be available on CVM’s web page; a publication is also planned.
|  |
Slide 15 Feed Contaminants Program – Mycotoxins - Results: FY05 256 samples (229 domestic, 27 import)
- 4 samples exceeded guidance, 7 samples were positive with no official guidance
MYCOTOXIN | ANALYZED | POSITIVE | ABOVE GUIDANCE |
|---|
Aflatoxins | 201 | 13 | 2 (> 20ppb) | Fumonisins | 93 | 46 | 2 (> 5ppm) | Ochratoxin A | 17 | 3 | 3 (No guidance levels) | Zearalenone | 8 | 4 | 4 (No guidance levels) | Deoxynivalenol | 6 | 2 | 0 | Total | 325 | 68 | 11 |
|  |
Slide 16 Feed Contaminant Program - Mycotoxins - Distillers dried grains with solubles (DDGS) collected as part of routine surveillance sampling, 1999 – 2004, and as part of a special assignment during FY 2007 where 40 total samples are scheduled for collection.
FEED INGREDIENT CATEGORY | YEAR(S) | TOTAL SAMPLES | % AFLA. + |
|---|
DDGS from corn | 2007 | 11 | 0% | DDGS | 1994 - 2004 | 37 | 0% | Corn and corn by-products | 1994 - 2004 | 1471 | 19.44% |
|  |
Slide 17 Feed Contaminants Program – Microbes - Routine, annual surveillance of feed and feed ingredients for Salmonella and E. coli O157:H7
- About 200 samples collected per year, 1999 – present; data used for swine feed model example are from 1999 – 2003
- Plant- and animal-origin feed ingredients, mixed feeds, pet foods and pet treats
- Results reported as positive or negative; # of microbes per gram of sample is not determined
- Each Salmonella isolate is characterized by serotype, genetic fingerprint, and antimicrobial susceptibility pattern
- Results are summarized each year and will soon be available on CVM’s web page
|  |
Slide 18 Feed Contaminants Program – Microbes - Routine surveillance results are summarized each year and will soon be available on CVM’s web page
FEED
| # SAMPLES - SALMONELLA | % POSITIVE | RANGE % POSITIVE |
|---|
Pet Treats (1999 - 2004) | 355 | 24.79% | 11% to 100% | Animal-origin Feeds and FIs (2001 - 2004) | 100 | 72.00% | 67% to 80% | Plant-origin Feeds and FIs (2001 - 2004) | 91 | 7.69% | 5% to 11% | Mixed and Complete Feeds (2001 - 2004) | 235 | 10.64% | 8% to 13% |
|  |
Slide 19 Feed Contaminants Program – Microbes - Special surveillance assignments
- Heat-treated and non-heat-treated swine feed (FY 05)
- Direct-human-contact feeds (pet foods/treats) (FY 06)
SAMPLE DESCRIPTION | # SAMPLES | # POSITIVE FOR SALMONELLA | # POSITIVE FOR E. COLI O157:H7 |
|---|
Swine Feed | 31 | 4 | 0 | Heated Swine Feed | 15 | 0 | 0 | Non-Heated Swine Feed | 16 | 4 | 0 |
|  |
Slide 20 Feed Contaminants Program - Dioxins and PCBs - Special assignments almost every year since 1998, approximately 1000 total samples
- Goal has been to obtain information about the background levels in feeds and feed ingredients
- Sample collection and analysis also in response to specific dioxin-related issues (ball clay, zinc oxide, etc.)
- Expensive sample collection and analysis by the GC-MS “gold” standard method compared to biological methods (e.g., CALUX)
- Results reported as PPT TEQs (parts per trillion toxicity equivalents) for 10 dioxin and 7 furan congeners; recently, results also reported for 3 dioxin-like PCB congeners
- Congener patterns can help trace sources of contamination
- Results will be posted on CVM’s web page; several publications are also planned.
|  |
Slide 21 Feed Contaminants Program - Dioxins and PCBs - 1998 – anti-caking agents (ball clay)
- 2000 – animal fats, fish meal, meat and bone meal, deodorizer distillates, molasses
- 2001 – milk products, wood products, minerals, complete feed, vitamins, oilseed meals
- 2002 – minerals, forage, grains
- 2003 – minerals (in response to 2 contamination incidents)
- 2004 – animal and plant fats and oils used in animal feeds
and in clays used to bleach/filter these fats/oils - 2005 – rendered mammalian and poultry fats, yellow grease
and filtering and bleaching agents - 2006 – anti-caking agents, feed ingredients or bedding containing wood or wood products, and feed ingredients contacting or containing soil
|  |
Slide 22 Feed Contaminants Program - Dioxins and PCBs - Results: Levels of dioxins in grains, grain by-products, and forages were consistently low and significantly below the EU limit for these products (0.75 ppt TEQ)
PRODUCT | SAMPLES | RANGE (ppt TEQ) |
|---|
Grains | n = 93 | 0.00 - 0.034 | Grain by-products | n = 49 | 0.00 - 0.074 | Forages | n = 10 | 0.00 - 0.046 |
|  |
Slide 23 Feed Contaminants Program - Dioxins and PCBs - Results: Levels of dioxins in fish meal and fish oil samples were low and below the EU limit for dioxins in these products (1.25 ppt TEQ D/F for fish meal, 6 ppt TEQ D/F for fish oil), except for menhaden fish meal and fish oil.
|  |
Slide 24 Ingredients: Initial 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 will be presented by Drs. Benjamin and Okelo
- Complete feed (mixed feeds, feed supplements, etc.)
- Information on how to use contaminant levels in feed to check or validate some aspects of the risk ranking model will be discussed by Dr. Hooberman
|  |
Slide 25 Ingredients: Initial Contaminant Levels DIET INGRED. | INGREDIENT CATEGORY FOR CONTAMINANTS |
|---|
SALMONELLA | METHOXYCHLOR | AFLATOXINS | DIOXINS |
|---|
Corn | Plant products & byproducts | Corn | Corn & corn byproducts | Corn | Spray-dried whey | Animal products & byproducts | Animal products & byproducts | Animal products & byproducts | Milk & milk byproducts | Soybean meal | Plants products & byproducts | Soybeans & soybean byproducts | Soybean & soybean byproducts | Soybean meal |
|  |
Slide 26 Initial Contaminant Levels in Swine Feed Ingredients 3. Contaminant Levels in Ingredients for Starter, Grower and Finisher Swine Feeds |  |
Slide 27 Point Estimates vs. Distribution Measures - Examples today use point estimates of data, usually the mean
- Model will use all available data, not just means:
- Median vs. mean; range
- Sample distributions and estimated population distributions
- May incorporate “static” representations of the distributions
- May use some method of random, iterative sampling from the distribution (e.g. Monte Carlo)
|  |
Slide 28 Starter Swine Feed – Example Ingredient | Salmonella (% positives) | Aflatoxins (PPB) | Dioxins (PPT TEQ D/F) |
|---|
Category | % Pos | Category | % Pos | Mean | Category | % Pos | Mean |
|---|
Corn | Plant products & byproducts | 7.69% (n=91) | Corn & corn byproducts | 19.44% | 47 (n=1471) | Corn | 50% | 0.0091 (n=26) | Soybean meal, 46.5% | Plant products & byproducts | 7.69% (n=91) | Soybeans & soybean byproducts | 4.09% | 8 (n=318) | Soybean meal | 100% | 0.0167 (n=10) | Select menhaden fish meal | Animal products & byproducts | 72% (n=100) | Animal products & byproducts | 1.85% | 110 (n=54) | Menhaden fish meal | 100% | 0.58 (n=22) | Choice white grease | Animal products & byproducts | 72% (n=100) | Animal products & byproducts | 1.85% | 110 (n=54) | Animal fats | 100% | 0.3379 (n=55) |
|  |
Slide 29 Grower Swine Feed - Example Ingredient | Salmonella (% positives) | Aflatoxins (PPB) | Lead (PPM) |
|---|
Category | % | Category | % Pos | Mean | Category | % Pos | Mean |
|---|
Fat (animal) | Animal products & by products | 72% (n=100) | Animal products & byproducts | 1.85% | 110 (n=54) | Animal products & byproducts | 100% | 0.16 (n=2) | Limestone
| All feeds & feed ingredients | 16.55% (n=145) | Minerals, mineral premix | 0% | 0 (n=2) | Minerals, mineral premix | 67% | 2.2 (n=3) | Vitamin premix | All feeds & feed ingredients | 16.55% (n=145) | Vitamin, vitamin premix | 0% | 0 (n=1) | Vitamins, vitamin premix | 0% | 0 (n=0) | Trace mineral premix | All feeds & feed ingredients | 16.55% (n=145) | Minerals mineral premix | 0% | 0 (n=2) | Minerals, mineral premix | 67% | 2.2 (n=3) |
|  |
Slide 30 Finisher Swine Feed - Example Ingredient | Salmonella (% positives) | Chlorpyrifos-methyl (PPM) | Cadmium (PPM) |
|---|
Category | % | Category | % Pos | Mean | Category | % Pos | Mean |
|---|
DDGS
| Plant products & byproducts | 7.69% (n=91) | Corn | 2.16% | 0.037 (n=972) | Plant products & byproducts | 100% | 0.04 (n=2) | Corn
| Plant products & byproducts | 7.69% (n=91) | Corn | 2.16% | 0.037 (n=972) | Plant products & byproducts | 100% | 0.034 (n=2) | Limestone
| All feeds & feed ingredients | 16.55% (n=145) | Minerals, mineral premix | 0% | 0 (n=0) | Minerals, mineral premix | 100% | 1.1 (n=3) | Vitamin premix | All feeds & feed ingredients | 16.55% (n=145) | Vitamins, vitamin premix | 0% | 0 (n=0) | Vitamins, vitamin premix | 0% | 0 (n=0) |
|  |
Slide 31 Initial Contaminant Levels in Swine Feed Ingredients – Next Steps - Adjust initial contaminant levels in swine feed ingredients derived from Feed Contaminants Program data for information available in the published scientific literature
- Except for mycotoxins, little of the data available in the public literature is specifically for feed ingredients/feeds
- Where data are not available, or where data from different sources do not agree, use expert opinion to fill in the gaps or resolve discrepancies
- Problem – Expert opinion is not data
- Can determine how sensitive the risk ranking model results are to assumptions used (e.g., expert opinion); this can help identify the most critical data needed to improve the model’s results
|  |
Slide 32 Next Presentations – Estimated levels of contaminants in swine feed - Estimate levels of contaminants in feed ingredients for which no data are available (e.g. spray-dried blood), based on how processing of the starting material (e.g. animal products and byproducts) is know or predicted to affect the level of contaminants in the ingredient
- Estimate levels of contaminants in swine feeds, based on ingredients used and on how feed processing is know or predicted to affect levels of contaminants.
|  |
Slide 33 Initial Contaminant Levels in Swine Feed Ingredients |  |