WASHINGTON — As Congress considered measures to address mounting concerns over human and pet food safety, Dr. David Acheson, the Food and Drug Administration’s newly appointed assistant commissioner for food protection, revealed during a telephone news conference May 8 that what was thought to be wheat gluten and rice protein concentrate contaminated with melamine in China and subsequently used to manufacture some pet foods in the U.S. and Canada was in fact wheat flour. The contaminated pet foods caused the death of hundreds or even thousands of cats and dogs.
"We have discovered that these products, labeled wheat gluten and rice protein concentrate, are, we believe, mislabeled, and that they actually contain wheat flour that is contaminated with melamine and melamine-related compounds," Dr. Acheson said.
Dr. Acheson emphasized the contaminated wheat flour mislabeled by Chinese manufacturers or exporters as wheat gluten and rice protein concentrate was not used as an ingredient in food products meant to be directly consumed by humans.
"We are not talking about a new set of ingredients," he said. "These are the ones we have been tracking since the beginning of this situation. We’ve just taken the analysis of those products a little further."
At the same time, Dr. Acheson and Dr. Kenneth Petersen, assistant administrator for field operations at the U.S. Department of Agriculture, who appeared with Dr. Acheson at both the teleconference on May 8 and before a hearing of the House Committee on Agriculture on May 9, gave details of how contaminated pet food scraps found their way into domestic swine and poultry operations and fish farms.
Dr. Acheson and Dr. Petersen referred to a five-agency study that concluded pet food scraps contaminated with melamine and melamine-related compounds were consumed in such small volumes by affected poultry and swine that risk to human health from consuming the animals was "very low." As a result, 20 million chickens that were on voluntary hold pending the safety determinations and that tested negative for containing detectable levels of melamine were allowed into normal processing channels. Fifty thousand pigs that consumed some of the pet food scraps, assuming they, too, tested negative for melamine contamination, were expected to be sent to slaughter and into food marketing channels soon. The investigation into the use by fish farms of feed manufactured in Canada that included mislabeled and contaminated wheat flour was under way.
In response to a question on how the F.D.A. determined the adulterated ingredient was wheat flour, Dr. Acheson said, "It was a combination of assays that were done to determine this. That first assay involved something called stereoscopic light microscopy and polarized light microscopy, and this essentially characterizes the product initially and is just sophisticated direct visual microscopy. That was followed by a type of chromatography that looked specifically at levels of starch, and it was based on those two assays that the forensic chemistry center was able to determine that the levels of starch that we found in these products were such that it made it very likely that it was wheat flour."
Congress demands answers
House Agriculture Committee members on May 9 peppered Dr. Acheson and Dr. Petersen with questions concerning the ability of the U.S.D.A. and especially the F.D.A. to guarantee the safety of the rapidly expanding volume of imported food and food ingredients. They were especially critical of China’s record in relation to the safety of its food exports and asked if Chinese authorities were cooperating in the melamine contamination investigation. Dr. Acheson assured them the Chinese were cooperating.
Several pointed out the F.D.A. inspects only about 1% of imported food. Dr. Acheson said the current imported food inspection system was risk-based, with resources directed at foods thought to pose the most risk, as it would never be possible to inspect all imports.
He said his responsibility in the new post of assistant commissioner for food protection was to develop an overarching strategy for protecting the safety of food, both imported and domestically produced. The strategy would give greater emphasis to prevention but also enhance the F.D.A.’s ability to intervene and respond to instances or patterns of food adulteration. He said if the strategy required requesting Congress for additional authority for the F.D.A., the agency would do so. He also said current authorities may be "tweaked" to provide for better performance. Several members of the committee questioned whether the F.D.A. had sufficient resources to meet public expectations for food safety. Dr. Acheson assured them if the F.D.A. determined it required more resources, it would ask for them.
Some committee members raised the issue of country-of-origin labeling as a means to exert greater control over the safety of meat and other products imported into the U.S. It was pointed out in view of the recent revelation that farmed fish in the U.S. and Canada were fed melamine-contaminated feed, and that adulterating feed ingredients with melamine was not uncommon in China, consideration should be given to testing catfish, eel and similar products imported from China for the contaminant. Dr. Acheson said F.D.A. inspectors soon will have the means required to test such imported fish for melamine.
Committee members also expressed concern over how the F.D.A. interfaces with foreign food safety agencies with regard to inspecting food before it is exported to the U.S. Dr. Acheson pointed out it was not feasible to the F.D.A. to inspect the more than 150,000 food manufacturing establishments that are registered to export products to the U.S. Instead, the F.D.A. must work with foreign governments as well as foreign food exporters and U.S. importers on methods to ensure the safety of food shipped to the U.S.
Representative David Scott of Georgia asked Dr. Acheson if the risks posed by food imports should encourage consumers to eat more domestically produced food in place of imports. Dr. Acheson said food imports were consumer driven, with consumers increasingly wanting access to year-round supplies of produce and other food products that can’t be provided by U.S. agriculture alone. He pointed out there was a global food market and short of changing consumer behavior, that won’t change.
Representative Colin Peterson, chairman of the agriculture committee, concluded the hearing asking Dr. Acheson and Dr. Petersen their views on proposals for establishing a single food safety agency.
"Simply moving boxes around seldom solves problems," Dr. Acheson said. "However this is approached, it must be approached strategically. It needs to be approached with adequate resources. And it needs to be done carefully. Ultimately, could it (a single food safety agency) work, potentially, at some point, sure, perhaps. But it would have to be done the way I described.
"Right now, the system, with the communication that we have between the various agencies, is working remarkably well," Dr. Acheson asserted. "We have constant interaction, constant communication. And I would worry that simply embarking on a strategy like that could in fact put us back and not bring us forward."
Dr. Peterson agreed, stating, "That has been my concern, too, given the experience we have had with Homeland Security. Hopefully we’ve learned our lessons. But we could put ourselves in a situation where, if we try to do something like this, basically, we’d be out of commission for two years. It probably would make sense to just stop importing food while we’re going through this, because we probably couldn’t guarantee anything during all the commotion that would happen."
In response to the same question, Dr. Acheson said, "The agencies, the U.S.D.A. and the F.D.A., in this situation certainly have complementary authorities. I don’t see many duplicative authorities. So the current situation is an example how the agencies can leverage their individual resources and get their arms around a particular problem. Are there always better ways to do things? Certainly, and I think we’ll always try to find those better ways. But our work seems to be complementary to that of the F.D.A. at this point."
Bills giving F.D.A. mandatory recall authority introduced
WASHINGTON — Senator Richard J. Durbin of Illinois and Representative Rosa DeLauro of Connecticut on May 1 introduced identical bills giving the Food and Drug Administration mandatory food recall authority and establishing new means for certifying foreign governments, food manufacturers and exporters who wish to sell products to the United States. Separately, Senator Durbin on May 2 won 94-0 approval for an amendment to the Prescription Drug User Fee Amendments of 2007 (S.1082) that incorporates certain measures included in his bill that already enjoyed broad bipartisan support.
The bills introduced by Ms. DeLauro (H.R.2108) and Mr. Durbin (S.1274) share the common title Food Safety for Humans and Pets. Ms. DeLauro’s bill was referred to the House Committee on Energy and Commerce, and Mr. Durbin’s bill was referred to the Senate Committee on Health, Education, Labor and Pensions (HELP).
The bills outlined procedures that must be followed by companies or persons with reason to believe they may have introduced an adulterated food into interstate commerce or who were notified by the F.D.A. they had done so. In the event the persons or companies involved failed to follow the specified notification and recall procedures voluntarily, the bills authorize the F.D.A. to recall the food in question and exact penalties for noncompliance.
The bills would require the Secretary of Health and Human Services to establish within two years a system under which a foreign government or foreign manufacturer, importer, distributor or retailer that seeks to export food to the U.S. shall submit a request for certification. To receive certification, the applicant would have to demonstrate its products meet standards for food safety, inspection, labeling and consumer protection "that are at least equivalent to standards applicable to food produced in the U.S." The bills also outline under what circumstances accreditation may be withdrawn or reinstituted and would require routine inspection of food and food animals before they enter the U.S.
The bills also aimed to improve communications during a human or pet food recall and would require the F.D.A. to establish processing and ingredient standards for feed and pet food and updated standards for the labeling of pet food that include nutrition and ingredient information. The bills also sought the establishment of an early warning and surveillance system to identify contaminants of the pet food supply and outbreaks of illness from pet food.
Mr. Durbin introduced and secured approval for some of the measures in his bill that already enjoyed broad support by means of an amendment to S.1082. Mr. Durbin was assured by Senator Edward Kennedy of Massachusetts, chairman of the HELP committee, and Senator Michael Enzi of Wyoming, the committee’s ranking minority member, that the committee would take up the more controversial issues of mandatory food recall authority and foreign establishment certification later.
"With the passage of this amendment, we will make our nation’s food safety system stronger on several fronts," Mr. Durbin said. "We have strengthened regulation of imported food; instituted a better record keeping, tracing and inspection process for human and pet food; put in place an early warning system when outbreaks of contaminated food occur; set uniform standards for pet food, and instituted fines for companies that fail to report problems. There is more work to be done to fix our food safety system, but today we have moved forward to address the growing concerns across our nation."
This article can also be found in the digital edition of Food Business News, May 15, 2007, starting on Page 1. Click