FDA Tells Senator Robert Byrd They Don’t Care Pet Food Violates Federal Law

Senator Robert Byrd took the questions of one concerned pet owner to the FDA.  Four months later, the FDA responded.  Make sure you are sitting down before you read what Stephen Mason, Acting Assistant Commissioner for Legislation of the FDA told Senator Byrd.

Back in November 2008, many concerned pet owners across the United States stopped from their busy lives to write their Representatives in Congress regarding pet food; specifically explaining that the FDA allows the laws of the Federal Food, Drug, and Cosmetic Act to be violated with pet food.  More than 50 different elected officials of Congress received a letter; each received the same letter, which carefully detailed the undeniable evidence.  Some of the elected Representatives didn’t even bother to respond to their constituent, however most responded with such political jargon it was clear they had never read the letter sent to them.  Out of over 50 Representatives in Congress, only one bothered to ask the FDA to respond.  Senator Robert Byrd of West Virginia sent our letter to the FDA asking for a response.

The evidence presented to Congress was serious.  Briefly, the Federal Food, Drug, and Cosmetic Act laws state that food (which is defined as anything consumed by humans and animals) cannot contain a diseased animal nor an animal that has died other than by slaughter.  The Federal laws also state all foods must be honestly labeled.  Despite Federal Law, pet foods are allowed to include rendered diseased animals and euthanized animals.  Despite Federal Law, pet foods are allowed to make “unqualified claims” on the label.  The FDA is solely responsible for allowing pet food to violate Federal Laws; an FDA policy allows dog food and cat food to be the dumping ground for useless waste such as dead on arrival animals, diseased animals, and euthanized animals.  This FDA policy could be the first time in U.S. history a policy takes precedence over Federal Law.

The following is the FDA’s response to Senator Byrd dated April 8, 2009….(To read and/or view a photo copy of the FDA letter, click here for page one, click here for page two.  To read a copy of the exact letter sent to members of Congress including the evidence, click here..  To read all the responses received from Congress, click here.)…

The Honorable Robert C. Byrd
United States Senate
Washington, D.C. 20510-6025

Dear Senator Byrd:

Thank you for the letter of November 24, 2008, on behalf of your constituent, Ms. XXX of XXX West Virginia.  Ms. XXX expressed concern that the Food and Drug Administration (FDA or the Agency) is ignoring the Federal Food, Drug, and Cosmetic Act (FD&C Act) when it does not prevent processed pet food products that contain tissues from animals that died otherwise than by slaughter from being shipped and sold in interstate commerce.  Ms. XXX expressed three main concerns regarding FDA’s interpretation of the FD&C Act and FDA’s policies and practices related to pet food.

Ms. XXX first concern is the use in pet food of any animal-derived ingredients that result from animals that died otherwise than by slaughter, regardless of the manner of the animal’s death, the condition of the tissues derived therefrom, or the subsequent methods used to process those tissues.  The FD&C Act requires that pet foods, like human foods, be pure and wholesome, contain no harmful or deleterious substances, and be truthfully labeled.  FDA’s Compliance Policy Guides (CPGs), some of which are quoted by Ms. XXX, address the use of feed ingredients derived from animals that may have died otherwise than by slaughter.  Based on the CPGs and other guidance, FDA does not object to (or take action against) feed ingredients or animal feed products that are or contain ingredients derived from animals that died otherwise than by slaughter, provided that the products are not otherwise in violation of the law.  In order to be considered allowable feed ingredients, the animal or tissues derived from these animals must: 1) be undecomposed; 2) not contain toxins or chemical substances that may cause the feed product to be considered adulterated under section 402 of the FD&C Act; and 3) be processed in such a manner, generally by heating during rendering, extrusion or canning, that ensures the elimination of harmful microorganisms.

Ms. XXX second concern is that some of the animals that have died otherwise than by slaughter may be pets euthanized by lethal injection with pentobarbital.  Ms. XXX can access additional information on this topic on FDA’s Web site at http://www.fda.gov/cvm//FOI/DFreport.htm.  FDA previously investigated this issue and our Center for Veterinary Medicine’s (CVM) scientists developed a test to detect dog and cat DNA in the protein of dog food.  All samples from the most recent dog food survey 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 method employed for these tests can detect a minimum of 5 pounds of rendered remains in 50 tons of finished feed.

It is assumed that the pentobarbital residues are entering pet foods from euthanized, rendered cattle or horses, not euthanized pets.  It is possible that animals which have died otherwise than by slaughter may have been euthanized with pentobarbital.  It should be noted that FDA has never indicated that such animals are acceptable for use in animal feed, and the Agency has informed industry stakeholders that animals euthanized with pentobarbital should not enter the feed supply.  Such animals would be considered to contain toxins or chemical substances that may cause the resultant feed product to be considered adulterated under section 402 of the FD&C Act and thus they would not meet one of the criteria for discretionary use of an animal that has died otherwise than by slaughter to be used as animal feed.

Ms. XXX third concern is that FDA endorses mislabeling (i.e., misbranding) of pet foods by supporting a model regulation developed by the Association of American Feed Control Officials (AAFCO).  Ms. XXX specific complaint is that AAFCO Model Regulation PF7(a) is in violation of section 402 of the FD&C Act because it provides for “(…) an unqualified claim, directly or indirectly (…).”  Ms. XXX alleges that an unqualified claim, whether direct or indirect, is false and misleading and thus in violation of section 402(a) of the FD&C Act.  FDA’s position is that if an unqualified claim is true, then it is neither false nor misleading and thus not in violation of the FD&C Act.

Thank you for contacting us concern this matter.  If you have further questions or concerns, please let us know.

Sincerely,

Stephen R. Mason
Acting Assistant Commissioner for Legislation
Department of Health & Human Services
Food and Drug Administration
Rockville MD 20857

The FDA response acknowledges (in paragraph two) that “pet foods, like human foods, be pure and wholesome, contain no harmful or deleterious substances, and be truthfully labeled.”  Yet one sentence following this acknowledgement the FDA states ‘policy’ allows animals that have died other than slaughter into pet foods.  The FDA developed several stipulations for approval of dead animals processed into pet foods, however the FDA does not require any renderer to provide evidence these stipulations are followed.

Stipulation number one states the animal cannot be decomposed.  Science clearly explains that decomposition starts the instant an animal dies.  Unlike animals processed for human foods by slaughter, livestock animals that die prior to slaughter in holding areas or on farms can take hours (if not days) to be rendered.  From the moment these animals die, regardless if they are euthanized or pass due to a disease or illness, their bodies are decomposing.  Many of these animals bodies lie in the hot sun, fall in animal feces, and are covered with insects for hours prior to removal for rendering.  The FDA stipulation the livestock animal must be “undecomposed” is unrealistic and impossible to achieve.   Any first year medical student or first year veterinary student understands how quickly the body decomposes, any farm hand or slaughter house worker can attest to the hours that pass before dead animals are removed; this as well should be clear to the Veterinarians at the Center for Veterinary Management of the FDA.

The second stipulation explained in the FDA letter, “not contain toxins or chemical substances that may cause the feed product to be considered adulterated under section 402 of the FD&C Act”.  Many animals that die prior to slaughter are denatured with “kerosene, fuel oil, or used crankcase oil” according to FDA regulations (Sec. 381.95 Disposal of condemned poultry products http://www.cfsan.fda.gov/~lrd/9CF381.html).  The denaturing agents (kerosene, fuel oil, used crankcase oil) cover the dead livestock animal to clearly mark they are not suitable for processing into human foods.  The FDA tells Senator Byrd that no toxins or chemical substances are processed into pet foods, yet their own regulations instruct slaughter facilities to denature dead animals with toxic chemicals.  Stipulation number two implies the FDA has the interest of quality pet food in mind; however the truth is far from that.  Again, it should be clear to the Veterinarians at the CVM that kerosene, fuel oil, or used crankcase oil IS toxic when consumed

Stipulation number three requires that the dead, decomposing livestock animals, treated with kerosene or fuel oil are cooked sufficiently to destroy harmful microorganisms.  It is challenging to imagine a pet food being “pure and wholesome” when meat ingredients are cooked long enough to destroy harmful microorganisms of decomposing animals covered in fuel oil.

Paragraph three is nothing more than the FDA dancing around the issues.  In 2000 and 2002, the FDA tested and published information regarding pentobarbital in dog food (cat food was not tested).  The ‘Report on the risk from pentobarbital in dog food’ still exists on the FDA website;  http://www.fda.gov/cvm/FOI/DFreport.htm.  The FDA testing, as stated in their letter, did not find any dog or cat DNA.  However, what Mr. Mason neglected to mention, was that the FDA testing also did NOT find any DNA of cattle or horses either.  No animal DNA was detected; thus their testing did not prove or disprove that euthanized dogs and cats are rendered into pet foods.

The next paragraph states the FDA does not allow, and would prohibit dog foods and cat foods that would contain a pentobarbital euthanized animal in pet food.  Yet, in 2002 when the Risk of Pentobarbital in Dog Food report was published, including the names of numerous popular pet foods that tested positive for pentobarbital, the FDA did not recall any of these pet foods or fine the manufacturers for violation of the FD&C Act.

The final paragraph of the FDA response to Senator Byrd is the most absurd.  “FDA’s position is that if an unqualified claim is true, then it is neither false nor misleading and thus not in violation of the FD&C Act.”  Mr. Mason neglected to state the FDA’s position if an unqualified claim is not true.

Senator Robert Byrd should be commended for being the ONLY Representative of Congress that bothered to take pet food concerns to the FDA.  However, the FDA clearly misled the Senator.  Their cleverly worded response proves the FDA considers the profits of industry to be of more importance than the ‘pureness and wholesomeness’ of pet foods.  The truth remains, the FDA allows Federal Law to be violated.  Dead, diseased, disabled, and dying animals processed into pet foods are far from what the law demands; pure and wholesome food.  The agency of the United States that was designed to protect the safety of foods for humans and animals is letting us all down.

Wishing you and your pet(s) the best,

Susan Thixton
Pet Food Safety Advocate
Author, Buyer Beware
Co-Author Dinner PAWsible
TruthaboutPetFood.com
PetsumerReport.com

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