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Who is protecting pets?

Polluted Pets: Who is protecting pets?

April 17, 2008

The Toxics Substances Control Act (TSCA) is the cornerstone in our system of health protections for industrial chemical exposures. Passed in 1976, it is the only major public health and environmental law in the U.S. that has never been updated. It allows nearly all industrial chemicals on the market and in consumer products with no mandate for safety testing, and with no requirement that companies prove their products are safe for children and others who are vulnerable before they are sold. The result of this weak law is a body burden of industrial chemicals found in every member of every household in this country, pets and people alike.

Congress and public health agencies attempt to hold together the threadbare safety net provided by TSCA with a series of other programs and laws targeted at particular kinds of exposures, including laws and regulations that provide some oversight on the safety of drugs, pesticides in food, cosmetics, and food additives. But even with this hodgepodge of programs, we’ve seen recent glaring evidence of safety gaps, with potential health risks from exposures that include everything from antifreeze in toothpaste (FDA 2007b) and lead and asbestos in children’s toys (CDC 2007, 2008), to cancer-inducing chemicals in cosmetics and personal care products (EWG 2007; Brody 2007; Darbre 2006; Irigaray 2007) and unregulated contaminants in overseas-produced food and drugs (Armstrong 2008).

As weak as the system of protections is for people, it’s even weaker for pets. Public health agencies have little authority and few resources to ensure that products produced for pets are safe (FDA CVM 2007a).

A massive pet food recall in 2007 brought attention to the most urgent issues in pet food safety such as regulations, ingredients and additives in commercial foods and accountability of pet food manufacturers to government agencies and to the general public (AVMA 2007). Illnesses and deaths of pets caused by melamine-contaminated food have contributed to a loss of public confidence in pet food safety, raising many questions about the role of the government in this important area (FDA 2008).

Basic common sense suggests that commercially distributed pet food should be held to the same health and safety standards as human food. Indeed, the FDA Center for Veterinary Medicine (CVM) describes its mission as a “consumer protection organization [that fosters] public and animal health by approving safe and effective products for animals” (FDA CVM 2000a). In this position, CVM is “responsible for the evaluation, approval and/or surveillance of animal drugs, food additives, feed ingredients, and animal devices” (FDA CVM 2000b). These public statements indicate that, similar to the FDA's Center for Food Safety and Applied Nutrition (CFSAN) which oversees 80% of food intended for human consumption in the United States (FDA 2002), the CVM is in a position to provide leadership, oversight, and targeted regulations in order to assure the safety of pet food. However, the current reality falls far short of this worthy goal. When it comes to the presence of dubious food additives, chemical pollutants or untested ingredients in pet food, pets and pet owners are still largely on their own.

For human food, the FDA CFSAN regulates food additives, colorants, and chemical contaminants in food such as pesticide residues. Together with CFSAN, other government agencies oversee the safety of human food supply, including the Food Safety and Inspection Service of the U.S. Department of Agriculture, Environmental Protection Agency, and state and local governments. Even with this system, food additives and preservatives that may pose health risks are sometimes approved for use in human food (FDA 1993, 2007c). Recent studies, for instance, demonstrate links between attention deficit/hyperactivity disorders and common food additives (McCann 2007; McCann 2008). The adequacy of health protections for food additives has been called into question many times (Barrett 2007). But food manufactured for pets falls outside of even this flawed system.

Significantly less stringent oversight is applied to pet food compared to food standards for people. Unlike their role in human food safety, FDA and USDA are doing and are required to do close to nothing for pet food safety under the current laws and regulations. Some standards and mandates for government oversight of pet foods do exist (FDA CVM 2007a; Syverson 2007a, b). In practice, these regulations have massive gaps. To draw a comparison, for human food additives companies need to submit an application to obtain pre-clearance approval from FDA. Provisions for the similar pre-clearance mechanism for pet food additives are defined in Title 21 Code of Federal Regulations (CFR) subchapter on animal drugs, feeds, and related products. Such a petition should contain a description of the chemical identity, manufacturing process and controls, human food safety data, target animal safety data, product labeling, and in some cases an environmental assessment. For some additives, tolerance limitations need to be established in order to ensure their safety. Yet despite having the power to do so, the CVM does not scrutinize manufacturer’s practices with regard to pet food additives. As described on the CVM website (FDA CVM 2007a):

CVM has used regulatory discretion and not required food additive petitions for substances that do not raise any safety concerns. In this case, we ask the company to submit the information needed to list the ingredient in the Official Publication of the Association of American Feed Control Officials (AAFCO). This ingredient definition process is done to conserve agency resources, as food additive approval is time-consuming. CVM reviews the data to ensure the ingredient has utility and can be manufactured consistently to meet product specifications. Although ingredients used under regulatory discretion are still unapproved food additives, we agree we will not take regulatory action as long as the labeling is consistent with the accepted intended use, the labeling or advertising does not make drug claims, and new data are not received that raise questions concerning safety or suitability.

As a result, companies are not required to notify FDA before they use a chemical additive in pet food, as they are for human food. Instead, pet foods can legally contain unapproved food additives whose safety has not been adequately examined by scientific experts. This state of affairs puts the health of pets into a version of a hit-or-miss game.

Several case studies of toxic chemicals in commercial pet foods illustrate the problems inherent in this lack of regulation. Antioxidant preservative ethoxyquin is a controversial additive that is currently allowed at levels up to 150 parts per million (ppm, equivalent to microgram of additive per gram of food) in animal feeds and canned pet food, as described in 21 CFR section 573.380 (FDA 1996a). Presence of ethoxyquin in dog food has been linked to numerous adverse effects in dogs, such as liver, kidney, thyroid and reproductive dysfunction, teratogenic and carcinogenic effects, allergic reactions, and skin and hair abnormalities (Dzanis 1991). Although FDA acknowledges that 150 ppm levels of ethoxyquin may be hazardous for lactating female dogs and puppies, no action has been taken by the agency beyond a request to the pet food industry that ethoxyquin in complete dog foods be voluntarily lowered to 75 parts per million (FDA 1997; FDA CVM 2007b). At the moment, pet owners cannot know what levels of this additive may be found in a can of pet food; they can only hope that the levels are less than what could harm their dogs.

It is relatively easy for a manufacturer to include a chemical ingredient in pet food. Any food additive that has been cleared by the FDA under the extensive "Generally Recognized As Safe" (GRAS) category is permitted. So far so good. However, if a company wishes to add a new, untested chemical substance into pet food, it merely needs to notify the voluntary AAFCO organization. Under current standards, that is sufficient - no FDA notification is required. In contrast to the wide range of permitted animal food additives and all the potentially present unapproved food additives, EWG analysis found only one chemical prohibited by FDA from use in pet food. Water-retaining additive propylene glycol has been used as an ingredient in soft-moist pet foods (FDA 1996b). Propylene glycol causes inactivation and clumping of hemoglobin in the red blood cells of cats, thereby causing anemia and other adverse effects in cats consuming the substance at levels that used to be commonly present in soft-moist food (Christopher 1989). Current regulations expressly prohibit the presence of propylene glycol in cat foods. Nevertheless, this is just one ingredient among many whose safety or even quantity in pet food is not adequately studied and publicly available.

As the government, general public and the media are well aware, even with all the standards in place for human food safety, the agencies and companies make huge mistakes and leave gaps that put human health at risk. So, we can readily imagine how unreliable the safety of food supply is for dogs and cats where there is almost no oversight from the government at all. Indeed, this is exactly what happened in the melamine crisis of 2007. Congressional hearings that followed the crisis revealed blatant gaps in pet food safety in the United States. Not only has there been no adequate monitoring system for the chemical composition of pet foods, but there was also a huge delay in companies’ response to the crisis. Nearly three weeks passed between the first report of cat illness (received by the Menu Foods on February 22, 2007) and the date when Menu Food notified FDA of the problem and initiated the recall (March 15, 2007). This long delay resulted in a lot of preventable illnesses and even deaths of many pets (Burns 2007a).

Following a great public outcry and congressional investigation, legislation was passed in September 2007 to protect the health of both animals and humans (Food and Drug Administration Amendments Act 2007; Nolen 2007). The new legislation amends the Federal Food, Drug, and Cosmetic Act to require companies to immediately notify FDA of any food contamination problems. It also requires the Secretary to establish: (1) processing and ingredient standards for pet food; (2) update standards for pet food labeling; and (3) set in place an early warning system to alert the public about unsafe pet food. Although bought at a high cost of needless animal suffering, this Act has the potential to increase the safety of pet food – if the FDA issues appropriately strict rules and regulations and ensures ongoing oversight and surveillance of pet food manufacturing practices. In the meanwhile, more gaps than standards are evident as the lack of government supervision over pet food and other pet products continues to put companion animals at risk over and over again. In the absence of government oversight, the safety of products intended for pets is almost completely within the purview of the manufacturers themselves.

The pet food industry, as represented by the manufacturers’ association known as the Pet Food Institute (PFI), is largely self-regulating. However, as the melamine crisis clearly demonstrated, this model of voluntary compliance and internal setting of manufacturing criteria has not functioned successfully. The only organization that reviews standards on pet food is the Association of American Feed Control Officials (AAFCO). AAFCO has no regulatory authority, although it publishes a code, known as Model Pet and Specialty Pet Food Regulation. As stated on the CVM website, AAFCO responsibility for the pet food products is necessary “because FDA has limited enforcement resources that are focused on human food safety issues” (FDA CVM 2007a). Yet, would it not be better for pets and their owners, more secure, and more scientifically defensible if the FDA itself issued binding pet food regulations instead of relying on a voluntary organization to provide guidelines and suggestions to the industry? For example, for years cat owners have worried about the presence of ash in cat food because of its potential links to kidney problems and chronic renal failure (Hughes 2002). Within the ash, there is calcium, magnesium, calcium, potassium and other trace minerals; greater quantities of ash are produced when low quality meat parts are included in pet food. On its website, FDA states that ash per se is not related to the incidence of feline lower urinary tract disease (FDA CVM 2007c). However, a pet owner cannot help but wonder how high can be the levels of ash that a pet food manufacturer can legally include in a product? Who is setting these levels and has their safety being adequately demonstrated?

Another issue of significant concern is the safety of pet products, such as pet toys, pet beds, and pet clothing, and numerous other products developed and marketed for pets. There are no government standards in this area, leaving the industry group itself, the American Pet Product Manufacturers Association, to adopt whatever manufacturing practices it wishes. As a result, pet toys can contain endocrine-disrupting and asthma-inducing phthalates and pet beds and clothing may have toxic flame retardants in them. Nobody is looking and nobody bears legal responsibility – hardly a situation that inspires confidence in pet owners.

Again, a comparison between products for human use and products for pets points out how the lack of safety standards endangers the health of pets. The Consumer Product Safety Commission (CPSC) oversees the safety of human products. This agency is entrusted by the Congress “to protect the public against unreasonable risks of injuries and deaths associated with consumer products" (CPSC 2007). Specifically, the Consumer Product Safety Act sec. 31 (2) (A) states that the CPSC, with the assistance of a Chronic Hazard Advisory Panel, has the authority to review whether a substance in a product may be a carcinogen, mutagen, or a teratogen. When such a determination is made, the Panel needs to report an estimate of the probable harm to human health that will result from exposure to the substance. This process allows CPSC to issue rules and regulations under the Federal Hazardous Substances Act that will ensure safety of consumer products from chemical contaminants.

In contrast to CPSC control over products for human consumption, it has no power over products for pets. In a letter to EWG, CPSC stated: “The Commission does not have the authority to require labeling that warns of dangers to animals.” Instead, only a “personal” injury or illness of a human consumer can constitute grounds for CPSC action. Thus, as EWG found out, reports of hundreds of deaths of pet birds due to Teflon cookware falls outside the interests of this regulatory agency (EWG 2003b).

All these examples point in a single direction: food and products for pets receive hardly any government oversight, standards, or regulations. This situation puts the health of pets into danger.

Pets are sentinels for the urgent need for a system of health protections that requires companies to prove their products are safe before they are sold. Modernizing public health laws now more than 30 years old is a critical step to protecting the health of all members of American households, whether they walk on two legs or four.