Months after the recalls of pet food began in mid-March, developments continued to unfold in response to the adulteration of ingredients from China.
One of the revelations was that the ingredients in question were not wheat gluten and rice protein concentrate, as the labels indicated. Both of the ingredients were actually wheat flour containing melamine and cyanuric acid.
Another revelation was that some of the ingredients went into fish food for industrial aquaculture. The Food and Drug Administration previously traced pet food with the ingredients to hog and poultry operations. The Department of Agriculture released the hogs and poultry for processing after determining meat from the animals posed little risk to human health.
By mid-May, Congress already had held three hearings relevant to the situation. The FDA's new assistant commissioner for food protection, David Acheson, MD, testified about the investigation during a May 9 hearing of the House of Representatives Committee on Agriculture.
On the same day, the Senate passed legislation that included provisions regarding the safety of pet food. In addition, the House and Senate started considering the Human and Pet Food Safety Act of 2007.
The investigation of ingredients containing melamine and cyanuric acid continued in China and the United States. The Chinese facilities that manufactured the ingredients had ceased operations and dismantled equipment, stymieing FDA inspectors. The FDA was detaining vegetable protein products arriving from China and sampling products that had reached U.S. companies.
At a May 8 press conference, Dr. Acheson made a surprising announcement—adulteration is not the only problem with the ingredients from China. They were also mislabeled. The products that were labeled and exported to the United States as wheat gluten and concentrated rice protein were, in fact, found to be wheat flour during the ongoing trace back and trace forward of the original shipments.
Wheat gluten is a component of wheat flour. Dr. Acheson said that, although speculative, there is a plausible reason for the adulteration and mislabeling. Processing flour from whole wheat is simpler than extracting the gluten from wheat flour. Wheat flour contains some ground gluten, he said, but the total protein content of flour is low. The addition of melamine, which is high in nitrogen, could increase the protein reading during testing so that it was consistent with that of wheat gluten.
Cyanuric acid is similar to melamine in that both of the compounds include the triazine structure—consisting of three carbon atoms, three hydrogen atoms, and three nitrogen atoms. The compounds can react to form crystals, which might do damage to the kidneys of animals.
Dr. Acheson said the mislabeling of the wheat flour did not change the findings relative to adulteration with melamine and cyanuric acid, or affect the pet food recalls or the risk assessments involving hogs and poultry unknowingly fed the adulterated product.
"FDA considers this product to be mislabeled, and we're considering possible enforcement actions," Dr. Acheson said.
Dr. Acheson also disclosed that authorities learned that a portion of the mislabeled wheat gluten from China was sent to Canada by U.S.-based ChemNutra Inc. for use in manufacturing fish feed. This product was then imported into the United States for the aquaculture industry. The FDA had issued a hold on the fish and was visiting establishments that received the fish feed, but the agency believes there is no human health risk from consuming them.
Congress continues to hold hearings about the recall of pet food. On May 9, witnesses from the FDA and the USDA Food Safety and Inspection Service testified before the House Committee on Agriculture.
Dr. Acheson testified in part about his position as the first assistant commissioner for food protection. He had been director of the FDA Office of Food Defense, Communication, and Emergency Response.
Dr. Acheson's new job includes developing an agency-wide strategic plan for food safety. He said the FDA faces challenges such as the increased globalization of the food supply, outdated infrastructure relative to increasing complexities of food safety, and difficulties with tracking food rapidly when a problem arises.
"The melamine case we're discussing today illustrates many of these challenges we face—and highlights the need for new scientific and technological approaches to advance food protection," Dr. Acheson said.
The FDA is reviewing food protection in the areas of prevention, intervention, and response. The agency will look at enhancing prevention through stronger science, risk-based controls, and leverage with partners. The FDA will try to improve intervention by applying modern technology to establish a comprehensive food information system. The agency will attempt to enhance response by improving product tracking and laboratory surge capacity.
Dr. Acheson testified that the future of food safety will require different or additional resources. In response to congressional representatives' questions, he said the FDA will never have the resources to inspect all food imports or foreign manufacturers. The agency focuses on risk-based import inspections and on working with other countries to maintain standards for food safety acceptable to the United States.
Dr. Kenneth Petersen, FSIS assistant administrator for field operations, testified that the USDA operates under an equivalence system for imports. Countries must prove they meet U.S. standards for food safety before they can export meat or poultry products to the United States. China does not export meat or poultry products to the United States, though China is eligible to export cooked poultry to this country. China does export fish to this country.
More than one representative spoke in favor of implementing country-of-origin labeling so consumers can discern the source of foods. Dr. Acheson noted that domestically produced foods can cause illness, too.
Representatives also expressed concern that the FDA might not have sufficient authority over imports. In response to questions, Dr. Acheson said the agency does not have the authority to ban an import without evidence of a specific problem.
Congress has been crafting legislation to ensure the safety of pet food. On May 9, the Senate passed a bill to amend the Food, Drug, and Cosmetic Act that included an amendment regarding pet food.
"What we have seen happen over the last several months is a clear indication that our food safety system—as good as it may be—needs to be a lot better," said Sen. Dick Durbin of Illinois when he introduced the amendment, which the AVMA helped draft.
The amendment would require the Department of Health and Human Services to establish the following:
- processing and ingredient standards for pet foods, along with updates to labeling standards
- a surveillance system to identify adulteration of pet food and outbreaks of illness in association with pet food
- a notification network to inform veterinarians during any recall
- an Adulterated Food Registry that would allow HHS to issue alerts for foods following multiple cases of adulteration or outbreaks of illness
The amendment would require an annual report to detail the scope of food imports subject to FDA regulation, the number of FDA inspectors and inspections for food imports, and the findings of these inspections—with information about any enforcement actions.
At press time, the House had not drafted a companion bill. Some provisions of the amendment reappear in separate legislation, the Human and Pet Food Safety Act of 2007, which Sen. Durbin and Rep. Rosa DeLauro of Connecticut introduced in their respective houses of Congress.
The act also would require anyone who has reason to believe that food is unsafe to immediately notify HHS, with civil penalties for failure to notify. Furthermore, the act would grant HHS the authority to order a mandatory recall.
Finally, the act would require HHS to certify that the food safety programs of a foreign government or establishment are at least equivalent to U.S. programs before the government or establishment would be able to export food to the United States.