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February 28, 2002 Edited for Typographical Errors, March 1, 2002 Food and Drug Administration/Center for Veterinary Medicine Report on the risk from pentobarbital in dog food The low levels of exposure to sodium pentobarbital (pentobarbital) that dogs might receive through food is unlikely to cause them any adverse health effects, Food and Drug Administration scientists concluded after conducting a risk assessment. During the 1990s, FDA's Center for Veterinary Medicine (CVM) received reports from veterinarians that pentobarbital, an anesthetizing agent used for dogs and other animals, seemed to be losing its effectiveness in dogs. Based on these reports, CVM officials decided to investigate a plausible theory that the dogs were exposed to pentobarbital through dog food, and that this exposure was making them less responsive to pentobarbital when it was used as a drug. The investigation consisted of two parts. First, CVM had to determine if dog food could contain residues of the drug. Second, if residues were found, the Center had to determine what risk, if any, the residues posed to dogs. In conjunction with this investigation, the Center wanted to determine if pet food contained rendered remains of dogs and cats. How pentobarbital can get into dog food Because in addition to producing anesthesia, pentobarbital is routinely used to euthanize animals, the most likely way it could get into dog food would be in rendered animal products. Rendered products come from a process that converts animal tissues to feed ingredients. Pentobarbital seems to be able to survive the rendering process. If animals are euthanized with pentobarbital and subsequently rendered, pentobarbital could be present in the rendered feed ingredients. In order to determine if pentobarbital residues were present in animal feeds, CVM developed a sophisticated process to detect and quantify minute levels - down to 2 parts per billion of pentobarbital in dry dog food. To confirm that the methods they developed worked properly, CVM scientists used the methods to analyze dry commercial dog foods purchased from retail outlets near to their Laurel, MD, laboratories. The scientists purchased dog food as part of two surveys, one in 1998 and the second in 2000. They found some samples contained pentobarbital (see the attached tables). Dogs, cats not found in dog food Because pentobarbital is used to euthanize dogs and cats at animal shelters, finding pentobarbital in rendered feed ingredients could suggest that the pets were rendered and used in pet food. - 2 - CVM scientists, as part of their investigation, developed a test to detect dog and cat DNA in the protein of the dog food. All samples from the most recent dog food survey (2000) that tested positive for pentobarbital, as well as a subset of samples that tested negative, were examined for the presence of remains derived from dogs or cats. The results demonstrated a complete absence of material that would have been derived from euthanized dogs or cats. The sensitivity of this method is 0.005% on a weight/weight basis; that is, the method can detect a minimum of 5 pounds of rendered remains in 50 tons of finished feed. Presently, it is assumed that the pentobarbital residues are entering pet foods from euthanized, rendered cattle or even horses. Finding levels of pentobarbital residues in dog food Upon finding pentobarbital residues in dog food, the researchers undertook an assessment of the risk dogs might face. Dogs were given known quantities of pentobarbital for eight weeks to determine if consumption of small amounts of pentobarbital resulted in any physiological changes that could indicate potential effects on health. In short, the scientists wanted to find the level of pentobarbital dogs could be exposed to that would show no biological effects. The most sensitive indicator that pentobarbital had an effect is an increase in the production of certain enzymes collectively called cytochrome P450. Virtually all animals produce enzymes as a normal response to metabolize naturally occurring and man-made chemicals in their environment. Barbituates, such as pentobarbital, are especially efficient at causing the liver to produce these enzymes. In dogs, the most sensitive biological response to pentobarbital is an increase in the production of cytochrome P450 enzymes, which is why the scientists chose that as the best indicator of biological effect. If a low level of pentobarbital did not cause a dog to produce additional cytochrome P450 enzymes, then scientists could assume that the pentobarbital at that low level had no significant effect on the dog. In CVM's study, experimental animals were each dosed orally with either 50, 150, or 500 micrograms pentobarbital/day for eight weeks. The results were compared with control animals, which were not exposed to pentobarbital. Several significant pentobarbital-associated effects were identified in this study: 1. Dogs that received 150 and 500 micrograms pentobarbital once daily for eight weeks had statistically higher liver weights (relative to their bodyweights) than the animals in the control groups. Increased liver weights are associated with the increased production by the liver of cytochrome P450 enzymes; 2. An analysis showed that the activity of at least three liver enzymes was statistically greater than that of the controls at doses of approximately 200 micrograms pentobarbital per day or greater. - 3 - But researchers found no statistical differences in relative liver weight or liver enzyme activity between the group receiving 50 micrograms pentobarbital per day and the controls. Based on the data from this study, CVM scientists were able to determine that the no-observable-effect level - which is the highest dose at which no effects of treatment were found - for pentobarbital was 50 micrograms of pentobarbital per day. Adverse health effects unlikely For the purposes of CVM's assessment the scientists assumed that at most, dogs would be exposed to no more than 4 micrograms/kilogram body weight/day based on the highest level of pentobarbital found in the survey of dog foods. In reality, dogs are not likely to consume that much. The high number was based on the assumption that the smallest dogs would eat dog food containing the greatest amount of pentobarbital detected in the survey of commercial pet foods-- 32 parts per billion. However, to get to the exposure level of 50 micrograms of pentobarbital per day, which is the highest level at which no biological response was seen, a dog would have to consume between 5 to 10 micrograms of pentobarbital per kilogram of body weight. But the most any dog would consume, based on the survey results, was 4 micrograms pentobarbital per kilogram of body weight per day. It should be emphasized that induction of cytochrome P450 enzymes is a normal response to many substances that are naturally found in foods. It is not an indication of harm, but was selected as the most sensitive indicator to detect any biological effect due to pentobarbital. Thus, the results of the assessment led CVM to conclude that it is highly unlikely a dog consuming dry dog food will experience any adverse effects from exposures to the low levels of pentobarbital found in CVM's dog food surveys. Appendix FDA/Center for Veterinary Medicine Survey #1, qualitative analyses for pentobarbital residue Dry dog food samples purchased in Laurel, MD, area, March - June 1998 KEY---Yes = confirmed for presence of pentobarbital No = failed to confirm for presence of pentobarbital No result = analyses failed quality assurance requirements -Rendered ingredients:-AD = animal digest AF = animal fat BBM = beef and bone meal BT = beef tallow MBM = meat and bone meal NOTES---3-4 ppb = Estimated limit for confirming pentobarbital with highest confidence -ppb = parts-per-billion pentobarbital, by weight (nanograms per gram) ----n = not given or not legible Rendered ingredients (position in ingredient list) Confirmed for the presence of pentobarbital? Brand Name Formulation Name Lot Number Beef Meal(1) yes Nutro Premium 10:19 2AR7JJ Beef Meal(1) yes Nutro Premium 00:512BA7256259101069704 MBM(2) AF(6) AD(7) yes Ol'Roy Krunchy Bites & Bones V033 MBM(2) AF(5) AD(8) yes Ol'Roy Premium Formula with Chicken Protein and Rice V093 MBM(2) AF(5) AD(8) yes Ol'Roy Premium Formula with Chicken Protein and Rice V071 MBM(2) AF(6) AD(9) yes Ol'Roy High Performance with Chicken Protein and Rice V073 MBM(2) AF(6) AD(9) no result Ol'Roy High Performance with Chicken Protein and Rice V073 MBM(2) AF(6) AD(7) yes Ol'Roy Krunchy Bites & Bones V153 MBM(2) AF(5) yes Trailblazer Chunk Premium Quality 029813:30\A/2 MBM(2) AF(5) yes Trailblazer Chunk Premium Quality A5981315\A/R (?) MBM(2) AF(5) yes Trailblazer Bite Size Ration A5889911A\A/1 MBM(2) AF(5) yes Trailblazer Bite Size Ration 030800113\A/2 MBM(2) AF(4) no Pedigree Mealtime 814EL0011E MBM(2) AF(4) no Pedigree Mealtime 816GL154D MBM(2) AF(6) no Pedigree Meaty Chunks with Rice and Vegetables 811FL0027E MBM(2) AF(6) no Pedigree Meaty Chunks with Rice and Vegetables 811FL2211E MBM(2) AF(3) yes Dad's Bite Size Meal 17:42 MBM(2) AF(3) yes Dad's Bite Size Meal 7:12 MBM(2) AF(6) yes Weis Value Chunky and Moist Feb 0599x MBM(2) AF(6) yes Weis Value Puppy Food 99N132 BBM(2) AF(5) no Friskies Come'n Get It 8104LP-61156 BBM(2) AF(6) no Friskies Alpo 8015LP 60501 BBM(2) AF(6) no Friskies Alpo 8096LP-60531 MBM(3) AF(5) AD(6) yes Super G Chunk Style V113 MBM(3) AD(5) AF(6) no Ol'Roy Lean Formula V013 MBM(3) AD(5) AF(6) no Ol'Roy Lean Formula V073 MBM(3) AF(5) no result Richfood High Protein Dog Meal 1R04018 MBM(3) AF(5) no Richfood High Protein Dog Meal 1R03308 MBM(3) AF(5) AD(6) yes Richfood Chunk Style 1R0478 MBM(3) AF(5) AD(6) yes Richfood Chunk Style 3R05088 MBM(3) AF(5) no Richfood Gravy Style Dog Food 3R010598 MBM(3) AF(5) yes Richfood Gravy Style Dog Food 3R06078 MBM(3) AF(5) Beef Dgst(7) no Super G Gravy Style Dog Food V013 Rendered ingredients (position in ingredient list) Confirmed for the presence of pentobarbital? Brand Name Formulation Name Lot Number MBM(3) AF(5) Beef Dgst(7) no Super G Gravy Style Dog Food V093 MBM(3) AF(5) AD(6) yes Super G Chunk Style V003 MBM(3) AF(5) AD(6) yes Super G Chunk Style V113 MBM(3) AF(4) yes Pet Essentials Chunk Style 0-0046-L9 MBM(3) AF(4) yes Pet Essentials Chunk Style D-1106-L9 MBM(3) AF(5) yes America's Choice Krunchy Kibble 3R MBM(3) AF(5) yes America's Choice Krunchy Kibble R MBM(3) AF(5) AD(6) yes Weis Value Crunchy Dog Food 99N052 MBM(3) AF(5) Beef Dgst(7) yes Weis Value Gravy Style Dog Food N092 MBM(3) AF(7) AD(8) yes Weis Value High Protein Dog Food N072 BBM(3) AD(4) AF(5) yes Ol'Roy Meaty Chunks and Gravy K5 0825 BBM(3) AD(4) AF(5) no Ol'Roy Meaty Chunks and Gravy V90051 BBM(3) AF(4) AD(5) yes Ken-L Ration Gravy Train Beef, Liver and Bacon Flavor W20351 BBM(3) AF(4) AD(5) yes Ken-L Ration Gravy Train Beef, Liver and Bacon Flavor W31203 BBM(3) AF(6) no Purina Mainstay U2326-L8 BBM(3) AF(6) no Purina Mainstay U1529-L6 BBM(3) BT(4) no result Purina Dog Chow E1837-L2 BBM(3) AF(6) no Friskies Come'n Get It 8082L9-62159 BBM(3) AF(4) yes Ken-L Ration Gravy Train W12123 BBM(3) AF(4) yes Ken-L Ration Gravy Train W11525 BBM(3) BT(4) no Purina Little Bites U0502L4 BBM(3) BT(4) no Purina Little Bites U1201-L4 BBM(3) AF(5) AD(9) no Heinz Kibbles 'n Bits Jerky L70600 BBM(3) AF(5) AD(9) yes Heinz Kibbles 'n Bits Jerky L2 228 BBM(3) AF(5) AD(9) no Heinz Kibbles 'n Bits 'n Bits 'n Bits L200:38 BBM(3) AF(5) AD(9) no Heinz Kibbles 'n Bits 'n Bits 'n Bits L7 0448 MBM(4) AF(6) yes Weis Value Kibbles Variety Mix Mar 0999z MBM(4) yes Kibble Select Premium Dog Food 11P MBM(4) yes Kibble Select Premium Dog Food 1238 BBM(4) BT(6) no Fieldmaster Fieldmaster C1334-L3 BBM(4) AF(6) no Fieldmaster Fieldmaster U2108-L5 BBM(4) BT(6) no Purina High Pro U1829L6 BBM(4) BT(6) no Purina High Pro U1749-L6 BBM(4) AF(6) no Purina Grrravy U1643-L7 BBM(4) AF(6) no Purina Grrravy U1059-L6 Rendered ingredients (position in ingredient list) Confirmed for the presence of pentobarbital? Brand Name Formulation Name Lot Number BBM(4) AF(6) AD(7) yes Heinz Kibbles 'n Bits Puppy L1-0343 BBM(4) BT(7) Dried AD(10) no Purina Dog Chow Senior U2055L3 BBM(4) BT(7) Dried AD(10) no Purina Dog Chow Senior U0303L4 BT(4) BBM(10) no Purina Kibbles and Cheezy Chews N-0113-L10-E BT(4) BBM(10) no Purina Kibbles and Cheezy Chews N-19-58-L11-W MBM(5) AF(7) yes Champ Chunx Bite Size Dog Food H20054 BBM(5) AF(6) no Purina Kibbles and Chunks N-20-37-L10-E BBM(5) AF(6) no Purina Kibbles and Chunks I-21-10-L10-E BBM(5) BT(6) no Purina Butcher's Blend N1224-L20 BBM(5) BT(6) no Purina Butcher's Blend N-1723-L20 BBM(5) AD(8) no Heinz Kibbles 'n Bits Lean L30906 BBM(5) AD(8) yes Heinz Kibbles 'n Bits Lean L2 1156 BT(5) no Purina Dog Chow U1239-L2 BT(5) no ProPlan Beef and Rice Adult U2053-L2 BT(5) yes ProPlan Beef and Rice Adult U0131 L2 BBM(6) BT(7) no Purina Fit & Trim U0557L3 BBM(6) BT(7) no Purina Fit & Trim U2133-L4 BT(6) yes ProPlan Beef and Rice Puppy E0601-L3 BT(6) yes ProPlan Beef and Rice Puppy E0359 L2 MBM(7) AF(9) no Ol'Roy Dinner Rounds Soft Dry Dog Food 8D30PB1 MBM(7) AF(8) yes Reward Dinner Rounds Dog Food 8C19PA1 MBM(7) AF(8) no Reward Dinner Rounds Dog Food 8D23PB1 Survey #2, quantitative analyses for pentobarbital residue Dry dog food samples purchased in Laurel, MD, area, December 2000 KEY QUANTITATIVE ANALYSES ppb = parts-per-billion pentobarbital, by weight (nanograms per gram) --- = not found above 1 ppb limit of detection a = found in 1-2 ppb range, but not accurately measurable QUALITATIVE ANALYSES yes = confirmed for presence of pentobarbital no = failed to confirm for presence of pentobarbital blank = not analyzed by qualitative method ---- Rendered ingredients:-AD = animal digest AF = animal fat BBM = beef and bone meal BT = beef tallow MBM = meat and bone meal NOTES---1 ppb = Lowest concentration for detecting pentobarbital with some confidence 2 ppb = Lowest concentration for measuring pentobarbital accurately 3-4 ppb = Estimated limit for confirming pentobarbital with highest confidence n = not given or not legible Rendered ingredients (position in ingredient list) Measured (ppb) Confirmed for presence of pentobarbital? Brand Name Formulation Name Lot Number MBM(2) AF(5) BBM(6) AD(8) 10.0 yes Old Roy Puppy Formula, Beef Flavor 0407003 MBM(2) AF(5) AD(8) --- Old Roy Premium Chicken and Rice 0409002 MBM(2) AF(5) AD(8) 32.0 yes Old Roy Puppy Formula, Chicken and Rice 0415002 MBM(2) AF(5) AD(8) a no Richfood Dog Food Chunk Style 50 09:50 1 MBM(2) AF(6) AD(9) a Old Roy High Performance Chicken and Rice 0417002 MBM(2) AF(5) --- Pedigree Meaty Chunks Mealtime 046DT0117C MBM(2) AF(5) AD(7) a Safeway High Protein 0650 EA MBM(2) AF(6) AD(9) 3.9 yes Richfood High Protein Dog Meal 50 22:34 1 MBM(2) AF(6) --- Pedigree MealTime Large Crunchy Bites 935CK0906E MBM(2) AF(8) AD(9) a no Safeway Puppy food EB2206 MBM(2) AF(6) AD(9) 15.0 yes Weis Total High Energy Chicken and Rice ?17 09:23 2 BBM(2) AF(5) MBM(7) --- Friskies Come and Get it--Beef, Chicken, Liver 0269LP70610 BBM(2) BT(6) AD(8) --- American Fare Bites and Bones C1800 L1 MBM(3) AD(5) AF(6) 3.9 yes Old Roy Lean Formula 0409003 MBM(3) AD(4) AF(5) --- Old Roy Meaty Chunks and Gravy V80333 MBM(3) AF(5) AD(7) --- Safeway Tasty Nuggets EB 22:00 MBM(3) AF(5) Beef Digest(7) 4.5 yes Super G Gravy Style Dog Food n MBM(3) AF(5) AD(6) 16.4 yes Super G Chunk Style Dog Food 0415003 BBM(3) AF(4) AD(5) --- Heinz KenL Ration Gravy Train Beef Liver and Bacon W3 0819 BBM(3) AF(5) AD(9) a Heinz Kibbles N Bits Original, Chicken and Beef L72111 BBM(3) AF(6) AD(8) 25.1 yes Heinz Kibbles and Bits Beefy Bits L22027 BBM(3) BT(4) --- Purina Dog Chow Little Bites C 0202 L2 AF(3) --- Hills Science Diet Senior, 7+, small bites K02350044 AF(3) 8.4 yes Dad's Bite Size Meal Chicken and Rice n BT(3) 11.6 yes PetGold Master Diet Puppy Formulation 11:17 EA MBM(4) AF(6) --- Safeway Small Bites 00:14 EC MBM(4) AF(6) --- Weis Total Pet Kibbles n MBM(4) --- Dad's Kibble Select n BBM(4) AF(6) AD(7) 2.8 no Heinz Kibbles and Bits Puppy L70222 BBM(4) BT(6) --- Fieldmaster Adult C2258L4 BBM(4) BT(5) --- Purina Puppy chow, Beef Flavor C0559 L1 BBM(4) BT(6) --- Purina Kibbles and Chunks Beef Flavor C234 L1 AF(4) --- Neura Special Diet Formulation 300 SM017311:37 Rendered ingredients (position in ingredient list) Measured (ppb) Confirmed for presence of pentobarbital? Brand Name Formulation Name Lot Number AF(4) --- Nature's Recipe Easy to Digest NT B 18:41 AF(4) --- Friskies Alpo Lamb Meal Rice and Barley 0237UA20635 AF(4) --- Pedigree Mealtime with Lamb and Rice 045C50933C AF(4) --- Hills Science Diet Large Breed Adult K07360152 AF(4) MBM(5) AD(6) --- Heinz KenL Ration Choice Blend W4 1947 BT(4) --- PetGold Master Diet Adult Formulation EA 09:25 MBM(5) AF(6) --- American Fare High Protein C0935 L6 BBM(5) BT(7) AD(8) --- Purina Dog Chow Senior 7+ C 2159 L2 BBM(5) BT(6) AD(8) --- American Fare Adult Formulation n BBM(5) BT(7) AD(8) --- Purina One Beef and Rice C 0405 L2 BBM(5) BT(6) --- Purina Butchers Blend N 0751 L20 AF(5) --- Hills Science Diet Large Breed Canine, Puppies 142K51737 AF(5) --- Safeway Lamb Meal and Rice EB1556 AF(5) a Neura Special Diet Formulation 200 SM002714:27 BT(5) AD(9) --- ProPlan Beef and Rice, Adult Formulation V0621L2 BT(5) BBM(6) --- Safeway Kibbles and Munchy Chews F061414 BT(5) BBM(6) --- American Fare Kibbles and Munchy Morsels C1931 L2 MBM(6) AF (7) --- Heinz Reward Dinner Rounds P1 1238 AF(6) BBM(8) --- Friskies Alpo Complete Puppy 0007UA22125 AF(6) --- Nature's Recipe Lifestages Senior Lamb and Rice V80449 AF(6) --- Hills Science Diet Sensitive Stomach K12251603 AF(6) --- Hills Science Diet Sensitive Skin K15350650 AF(6) --- Pedigree Puppy 0420S1702C BT(6) AD(8) --- American Fare Puppy Formulation D 0756 L8 BT(7) --- Safeway Select Adult Dog Formulation (Nutra Balance) E2200L3 BT(7) --- Maxximum Nutrition Lamb and Rice Formula n Meat Meal(7) --- Flavorite Kibbles Dog Food 3104269 February 28, 2001 Edited for Typographical Errors -- March 1, 2002 4 |
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