The recent recall of cat and dog food has raised broad concerns about food safety, oversight of pet food, and manufacturing practices. At an April 12 Senate hearing, veterinarians and other witnesses offered their perspectives on the issues.
The experts said no one could have foreseen that melamine, which has uses as a fertilizer in Asia and in the production of plastics, might contaminate the wheat gluten that is an ingredient in certain pet foods—or that melamine or an accompanying agent might contribute to kidney failure in cats and dogs. In hindsight, though, some legislators believe regulations and response still could have been better.
"There are a lot of questions to ask, and we need answers," said Sen. Dick Durbin of Illinois, who called for the hearing. "That's why we're here today—to learn who's inspecting pet food manufacturing plants, what goes into that food, and whether we need to update our food safety system to protect pets and human health."
During the hearing, the senators also sought more details about the recall from representatives of the Food and Drug Administration.
Dr. Stephen F. Sundlof, director of the FDA Center for Veterinary Medicine, testified that the agency had tracked the major shipments of the suspect wheat gluten from China but continued tracing the ingredient pound by pound. An interplant transfer led Menu Foods to recall certain products from an Ontario plant almost a month after the manufacturer initially recalled products from plants in Kansas and New Jersey.
Steven Solomon of the FDA Office of Regulatory Affairs, who has been leading the field investigation, testified that the agency has visited hundreds of stores in the United States to ensure that retailers are removing all the products that multiple manufacturers have recalled.
Food safety system
Many of Sen. Durbin's inquiries about the recall related to the structure of the national food safety system, which divides jurisdiction for human and animal foods among multiple government bodies. He has introduced legislation to establish a single agency that would consolidate these responsibilities.
Early in his line of questioning, Sen. Durbin asked whether the FDA has the legal authority to issue a mandatory recall.
"We don't have that mandatory authority," Dr. Sundlof said. "We have other measures that we can use to make sure that contaminated product doesn't get into the market, such as seizure of product, if we need to go that far."
Then, Sen. Durbin referred to his experience working in a meat-packing facility in East St. Louis when he was in college. Inspectors from the Department of Agriculture were always on the scene, Sen. Durbin said. He inquired about the frequency with which the FDA inspects manufacturers of pet food.
Dr. Sundlof said the FDA has inspected about 30 percent of U.S. manufacturers of pet food in the past 3 1/2 years. Most of the inspections were to check for proper labeling of certain beef products to prevent the spread of bovine spongiform encephalopathy.
"But there have been many that were for other reasons," he said. "Some of them were just routine inspections. Others were for cause."
Dr. Sundlof said the FDA bases the level of inspection on the risks from products, partly because of limitations on resources, and pet food traditionally has been very safe.
"I think what's happened with pet food contamination is an indication that we are not dedicating the most basic resources to this endeavor," Sen. Durbin replied.
Later, Sen. Robert Byrd of West Virginia asked whether the FDA has screening systems for ensuring that harmful substances do not contaminate pet foods.
Dr. Sundlof said the Food, Drug, and Cosmetic Act requires manufacturers to produce food that is safe, is wholesome, does not contain contaminants, and bears the proper labels. The manufacturers are responsible for ensuring that the ingredients are free of contaminants. The FDA inspects companies occasionally to determine whether they are complying.
"They are supposed to maintain records of the ingredients that they received, and those records contain information about the analysis of the products," Dr. Sundlof said. "In this case, we do know that the Xuzhou Anying company from China did supply certificates of analysis to the U.S. importer."
Dr. Sundlof said the certificates indicated that the Chinese company tested for a number of contaminants, including pesticides. The company did not test for melamine, which the FDA would not normally consider as a possible contaminant.
Oversight of pet food
Dr. Sundlof and Solomon both noted during their testimony that the FDA works with states to inspect manufacturers. Solomon said many states operate under contract, while others maintain cooperative agreements with the FDA. Solomon added that many states follow the same standards as the FDA does.
The Kansas Department of Agriculture did inspect the Menu Foods plant in Emporia last year under FDA contract, according to the department, but only as part of the BSE program. The FDA inspected the Menu Foods plant in New Jersey last year as part of the BSE program, according to the agency, but had not inspected the Kansas plant before the recall.
The second set of witnesses at the Senate hearing came from outside the FDA.
Dr. Elizabeth Hodgkins, a feline veterinarian who advocates meat diets, testified about her opposition to the current system for labeling commercial pet foods.
"Pet foods carry both an implicit and an explicit guarantee of safety in the label statement that they carry, conferred by the Association of American Feed Control Officials," Dr. Hodgkins said. "No human food—whether it is fresh produce, meats, or commercially processed and packaged human consumables—is allowed to bear such broad guarantees of wholesomeness and nutritional completeness."
While AAFCO defines which ingredients are safe in general, the label statement does not mean manufacturers of pet food test each batch of ingredients. Dr. Hodgkins added later that she wants to help fix what she sees as a sieve of safety assurances.
Eric Nelson, AAFCO president, testified after Dr. Hodgkins that the current system for feed safety concentrates on post-production controls such as labeling rather than process controls. His association has been working on a model feed safety program to provide more regulatory direction and oversight of all manufacturers of animal food.
The initial steps were providing guidance to industry on best business practices and supporting self-regulation through quality assurance programs, but AAFCO feels these steps have not gone far enough to accomplish the goal of safe animal food. Now the association is developing model process-control regulations for adoption and enforcement by states.
"It would be pure speculation to say that process controls would have prevented this terrible incident from happening. However, the intent of such process controls, as proposed by AAFCO, would be to do just that," Nelson said. "The status quo will not provide the security upon which our citizens rely. The re-establishment of consumer confidence is not going to happen overnight, and it will take great efforts by both industry and those charged with their oversight."
Nelson said the FDA has taken a parallel path to AAFCO by working on modernizing the agency's Animal Feed Safety System, which will incorporate more preventive measures.
Dr. Claudia Kirk, a nutritionist with the University of Tennessee College of Veterinary Medicine, testified that manufacturers of pet food are subject to greater regulatory oversight than is readily apparent. While certain aspects of these regulations require self-monitoring, Dr. Kirk's experience is that most manufacturers are diligent in efforts toward product quality and animal health.
Dr. Kirk said additional government oversight might prevent contamination and limit exposure in some cases. Additional inspections could improve the adherence to quality control and good manufacturing practices, though inspections probably would not have prevented the recent recall.
"If it were mandatory for manufacturers to immediately report significant adverse events to a centralized regulatory agency, earlier investigative action and product withdrawal could occur," Dr. Kirk said. "However, establishing reasonable criteria for when to alert regulators is difficult."
Dr. Kirk said the recall might have moved more quickly with better surveillance of adverse health events in animals and a system for tracking food ingredients.
Duane Ekedahl, executive director of the Pet Food Institute, testified that pet food generally garners high consumer confidence. He cited a Gallup Poll as indicating that pet owners continue to have confidence in the industry, despite the recall. About 80 percent of dog or cat owners said they were not less likely to buy pet food at a store, according to the March 26-29 survey.
Ekedahl also announced the formation of the National Pet Food Commission, which will investigate the recall and recommend steps that industry and government should take to build on existing safety and quality standards.
Toward the end of the hearing, Sen. Durbin asked Ekedahl a series of questions about the accountability of industry and government for food safety.
"The system suggests that you don't have to have a cop standing at your shoulder to do the right thing and to produce a good product—because the marketplace will deal with that," Ekedahl said.
"Well, the marketplace has dealt with it, and a lot of consumers across America aren't going to buy Menu pet food for a long time," Sen. Durbin said.
"That was a foreign contamination of an ingredient that all the regulation in the world would not really have captured," Ekedahl said.
Senator Durbin asked Ekedahl several times whether Menu Foods should have reported sooner that it suspected problems. Ekedahl said he had no direct knowledge of the timing.
The testimony that witnesses submitted in writing is available at http://appropriations.senate.gov/hearings.cfm.