"Food Czar" to Help FDA Solve Many Problems

[Econ101]

FAQs About Melamine Contamination



Compiled by the U.S. News library staff

Posted 5/3/07



What is melamine?



Melamine is an organic compound that, when combined with formaldehyde, produces a fire- and heat-resistant resin. Melamine is used to make plastics including floor tiles, whiteboards, and kitchenware. Melamine was considered non- or minimally toxic until veterinary scientists determined that it was the cause of possibly thousands of dog and cat renal (kidney) failures and deaths after pet food was contaminated with the industrial chemical. Melamine has also been recently discovered in livestock feed that more than a million hogs and chickens are believed to have eaten.



How did melamine get into the animal food supply?



FDA officials believe the pet food and livestock feed were produced usingcontaminated wheat gluten and rice protein that were sold to a U.S. pet food maker by two Chinese companies. U.S. officials believe the companies added melamine to the grains to boost the protein content–and the price–of the wheat gluten and rice protein.



Should people worry about eating food made from animals that ate the melamine-contaminated feed?



No. Melamine is unlikely to pose a threat to humans even if small amounts of it are found in the American food supply, according to toxicologists monitoring for the industrial chemical in food. The FDA reports that only a small portion of what was fed to the poultry and hogs was tainted and would most likely have been excreted before the animals were slaughtered for human consumption. Also, human diets are more varied than dog and cat diets. Because pets tend to eat the same products every day, while humans consumedifferent foods, only a small portion of a human diet might contain the contaminated products.



What steps is the federal government taking to protect the American food supply?



The FDA has announced that it has created a senior position to supervise the agency's regulation of food safety. The assistant commissioner of food safety–the "food safety czar"–will set up a food safety strategy so the FDA can head off a crisis before it occurs.



The FDA will also begin testing six imported food ingredients–wheat and corn glutens, rice, soy proteins, corn meal, and rice bran–for melamine. In addition, the agency plans to test a variety of foods and animal feed to determine the extent of the melamine contamination.



Congress has started investigating how the FDA polices food imports. Legislative proposals include the creation of one food safety agency.



How will consumers be affected by the melamine contamination?



Since many pet food brands were recalled because of the melamine contamination, pet food owners are opting to buy organic and premium pet food, with some opting to make their own pet food.



Before the current crises, consumers were more likely to buy Chinese-manufactured wheat and rice byproducts because they were cheaper than U.S.-manufactured products. Now, since the onset of the contamination, there is a renewed interest in the U.S. wheat and rice byproduct industry, which has not been affected by the contamination.



Sources:

Associated Press

Chemical & Engineering News

Chicago Tribune

New York Times

U.S. Food and Drug Administration

Washington Post

wiseGEEK.com



usnews.com



Contaminant confirmed in FDA tests

Melamine found in nearly 400 of 700 samples of pet food additives. All lots traced to Chinese exporters.



By JENNIFER MANN

The Kansas City Star

May. 04, 2007



The Food and Drug Administration said Thursday that of 700 tests of wheat gluten and rice protein concentrate, almost 400 revealed a contaminant believed to have killed thousands of pets.



The substance found, melamine, is used to make plastic and fertilizer and was first discovered in pet food in February. The FDA said all of the positive tests have been traced to 92 lots of wheat gluten and rice protein that came from two previously identified Chinese exporters. All lots from the two Chinese firms were traced back to pet food manufacturers, a dozen of which have now initiated recalls.



There have been allegations that the Chinese mix melamine with wheat gluten to make it appear to be a higher-protein, and thus better-grade, food ingredient.



The FDA reiterated Thursday that melamine consumed by humans is unlikely to have any detrimental health effect. Human consumption occurred when some of the tainted pet food was sold to feed mills for hogs and chickens before it was discovered to have been tainted with melamine. That feed was fed to 2.7 million broiler chickens and approximately 400 hogs that have been processed and likely consumed.



"Based on what we know on the levels of melamine and the dilution effect, the likelihood of any ill effects is very remote," said David Acheson, assistant commissioner for food protection at the FDA.



The agency said it is presently visiting both human and pet food manufacturers that have protein concentrates such as wheat gluten and rice protein imported from China and testing those ingredients for melamine. Acheson said the FDA doesn't yet have any results from those tests.



The pet food problem was discovered in February by Canadian-based Menu Foods when 13 cats died after a taste test. While only 16 deaths have been officially confirmed, the FDA estimates thus far that about 2,000 cats and about 2,000 dogs have died from eating the contaminated pet food. The agency has received over 17,000 calls on the issue and is still logging calls.



Menu Foods, which on Thursday expanded its recall of approximately 100 brands and labels of pet food for the fourth time, said it received the tainted wheat gluten from Las Vegas-based ChemNutra.



ChemNutra says it received the wheat gluten from Xuzhou Anying Biologic Technology in China, although the purchase order lists the shipping company as Suzhou Textiles Silk Light Industrial.



The New York Times reported Thursday that the general manager of Xuzhou had been detained for unknown reasons. The FDA declined to comment on that report or to elaborate on any progress being made by the agency in its investigation in China.



There also have been reports that it is common practice for some Chinese firms to ship food labeled as nonfood items in order to evade officials and inspection. The FDA is sending a team to China to investigate.



"We need to see what comes out of this investigation in China," Acheson said. "Clearly, this whole episode has raised questions we had not previously been thinking about."



Meanwhile, legislation passed Wednesday by the Senate to strengthen the FDA's ability to police food was stripped of its most important element — the ability to require recalls.



The FDA said it doesn't comment on pending legislation.



Sen. Richard Durbin, an Illinois Democrat who proposed the legislation, said earlier this week that the authority to require recalls is important.



"I think if you ask any consumer across America, they would think it would be obvious," Durbin said. "The government should have that power."



Durbin's office said Wednesday that the issue will be taken up later this year.



The legislation provides for an early warning notification system, uniform standards for pet food, improved regulation of imported foods and better record keeping.



"This is a huge step forward," Durbin's office said in an e-mail.



kansascity.com

 

[PORKER]

Senator Schumer: 2.5 Million Contaminated Chickens In Indiana Expose Enormous Loophole In Food Safety
Fri, 05/04/2007 - 10:51 — admin

Currently No Way to Trace Poultry Contaminated by Feed -- Without Tracking, No Way of Knowing if Contaminated Chickens Were Sold to Consumers in Recent Months; Schumer to Reintroduce Bill that Creates Tracking System to Trace Meat and Poultry to Source in Case of Contamination or Outbreak of Disease
May 2, 2007 -- WASHINGTON - With news that at least 2.5 million chickens in Indiana may have been exposed to contaminated feed, Senator Charles E. Schumer today announced his plan to reintroduce the Meat and Poultry Traceability Act, a bill that would require the Secretary of Agriculture to be able to trace all meat and poultry back to the farms or slaughterhouses where they were raised or slaughtered. Schumer also wrote to Dr. Andrew von Eschenbach, the Commissioner of the Food and Drug Agency, asking him to take urgent action on investigating feed and feed lots at farms to ensure that animals are not being fed contaminated food.

"In this case, we have been lucky so far that no one has suffered health problems from eating chicken that were given contaminated feed, but we can't rely on luck next time. In the case of an outbreak of disease or contamination in our meat and poultry supplies, we've got to be able to trace all products back to the farms or slaughterhouses they came from in order to stop an outbreak from harming consumers," Schumer said.

Schumer will re-introduce the Meat and Poultry Products Traceability and Safety Act to improve the safety of meat and poultry products by enhancing the ability of the U.S. Department of Agriculture (USDA) to retrieve the history, use and location of meat and poultry products through a recordkeeping and audit system or registered identification. If meat from a diseased cow were to spread, currently there is no comprehensive system in place from farm to retail to track meat products throughout the country. Schumer's legislation would allow for a meat and poultry trace-back system to be set up by USDA so that, in cases where a health safety issue arises because of the presence of a food-borne pathogens or disease, such as Mad Cow, E. coli, or salmonella, the meat can be traced from the farm to slaughter to retail, at each point along the food-supply chain. This would help prevent other contaminated meat or diseased animals from entering the food-supply chain, and assist in recall.

Schumer also signed on as a cosponsor to the Pet and Human Food Safety Amendment, an amendment that is expected to pass today. Introduced by Senators Ted Kennedy and Dick Durbin in response to the recent outbreak of contaminated pet food, the amendment will also strengthen food safety standards.

According to the Centers for Disease Control and Prevention (CDC), each year food borne pathogens such as Listeria, E. coli, Salmonella, and Campylobacter are responsible for over 76 million illnesses, more than 300,000 hospitalizations, and 5,000 deaths.

In addition, Schumer sent a letter to Commissioner von Eschenbach of the U.S. Food and Drug Administration (FDA), the agency in charge of monitoring animal feed. In the letter, Schumer urges the FDA to step up its efforts to monitor feed supplies at farms to prevent a repeat of this frightening episode. Senator Schumer's letter to Commissioner Eschenbach is below.


May 2, 2007

Dr. Andrew C. von Eschenbach
Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. von Eschenbach,

I write to you today to urge the U.S. Food and Drug Administration (FDA) to do everything within its power to more proactively investigate meat and poultry farms so to further protect animals from ingesting tainted feed that could then negatively impact human consumers.

As you are aware, earlier this week, the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) discovered that byproducts from pet food manufactured with contaminated wheat gluten imported from China were used in chicken feed on some farms in the state of Indiana. It is believed that chickens from approximately 30 broiler poultry farms have ingested the contaminated chicken feed, potentially tainting millions of chickens. While USDA and FDA officials state that they do not believe the contaminated feed poses a risk to human consumers, the situation remains alarming.

While I applaud the USDA and the FDA for the steps that they have taken to begin this investigation into the contaminated chicken feed, I believe that the FDA has the power to prevent situations like this from occurring in the future by proactively investigating farms to inspect feed and feed lots. As you know, the FDA has monitored the feed that the nation's animals eat for many years. Until this point, it has utilized its authority in monitoring the nation's feed by inspecting and investigating farms only after an outbreak or incident. However, according to 21CFR11.19, the FDA has the authority to institute special regulations, if necessary, to cover the inspection of "excluded operations", such as meat and poultry farms before an incident. I urge you to consider instituting these special regulations to allow for FDA inspection of farms in relation to animal feed before an incident.

Thank you for your consideration.

Sincerely,

SENATOR Charles E. Schumer

 

[PORKER]

The FDA - operating on a $1.5 billion 2007 budget - argues it can navigate efficiently through this alphabet soup, continuously cross-checking with other agencies and sharing the burden of monitoring an entire nation's food supply.

Critics of the FDA, however, say the agency that began with a single chemist has burgeoned into a regulatory monolith so large it has grown overly bureaucratic and inefficient.

On average, Americans spend 25 percent of their budgets on products regulated by the FDA. In addition to most food products, the agency also watches over human and animal drugs, medical devices, microwave ovens, cell phones, lasers, magnetic resonance imaging machines, cosmetics and animal feed.

But the FDA's broad oversight results in a see-sawing of resources, said Joseph Mendelson, legal director for the Center for Food Safety, a non-profit public interest and environmental organization.

"The FDA is overwhelmed with pharmaceuticals and biologics to the extent that it ends up giving the agency an institutional bias to those issues as opposed to the food issues," Mendelson said.

From ports to farms, inspection rules vary

The division of responsibilities among agencies has resulted in spotty inspections of American food establishments and a porous defense at U.S. ports, critics say.

"The FDA is lacking inspectors domestically, it's lacking on-farm controls, its lacking at imports. You name it, it's not there," DeWaal said. "The agency is really a shell that has the responsibility but not the wherewithal to actually improve food safety."

DeWaal provided an example of a frozen pizza factory.

"The USDA will inspect the pepperoni pizza line every day. The FDA will inspect the cheese pizza line every five to 10 years. It would be very easy for the pepperoni pizza inspector to walk over and check the cheese pizza line, but today they're not allowed to," DeWaal said.

The same problem exists at U.S. ports, DeWaal said. In 2006, the FDA inspected only 1.06 percent of all imported foreign foods.

Although the partnerships between the FDA and other agencies are intended to smother food-borne illness like a blanket, they instead create gaps in the structure, DeWaal said. While inspectors may be at the scene of a suspect food shipment or facility, because their jurisdiction is limited, they cannot conduct a full inspection.

In addition, the FDA has limited power over food safety at farms, where the recent E. coli outbreaks originated. The FDA can pressure farmers to follow a list of guidelines, but the safety of produce ultimately rests in farmers' hands.

Reform efforts

A January 2007 report by the U.S. Government Accountability Office - the investigative arm of Congress - listed the status of food safety as part of its High Risk Series report for the first time.

The annual report lists things the government needs to do better. Transforming the way the FDA manages food joins critical U.S. government issues such as Medicaid, NASA's budget and improvements to homeland security. The language in the report mirrors much of the recent criticism aimed at the FDA.

"Any food contamination could undermine consumer confidence in the government's ability to ensure the safety of the U.S. food supply, as well as cause severe economic consequences," the report states. "The current fragmented federal system has caused inconsistent oversight, ineffective coordination, and the inefficient use of resources."

Two U.S. politicians are pushing for legislation this year that will consolidate and streamline the FDA's food regulation power, eliminating what they consider to be unnecessary overlap.

"Last fall, our country experienced a staggering number of recalls and food-borne illness outbreaks," said Rep. Rosa DeLauro, D-Conn., who introduced the Safe Food Act in February. The bill has been referred to the House Committee on Energy and Commerce. "Clearly, the system is broken, and Congress needs to act to protect the public health."

On Feb. 8, for the first time in six years, the House Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies met to confront food safety.

"Food safety threats have evolved since our original food safety laws were enacted," said DeLauro, the new subcommittee chair, at the meeting. "Then, our protections focused on contamination, in sanitation and diseased animals. Today's threats are constantly changing. They are microbial hazards, bacteria, viruses, and it is incumbent upon this subcommittee to ensure our food safety system, and the manner in which it is funded, evolves with those threats."

Manufacturers' representatives endorsed changes, but they and Rep. Jessie Jackson Jr., D-Ill., urged a cautious approach.

"A federal model for oversight of food safety should be addressed as a 21st century challenge," Jackson said, quoting the GAO study. "I only added it should not lead us to an 18th century solution."

Each year, 76 million people become sick, more than 325,000 people are hospitalized and 5,000 people die from food-borne illness, according to the CDC. Harmful food products account for between $10 billion and $83 billion annually in medical expenses.

In conjunction with similar legislation drafted by Sen. Dick Durbin, D-Ill., DeLauro's proposal attempts to peel away the FDA's multi-layered bureaucracy, consolidate its power and reduce the number of food-borne illnesses.

The Safe Food Act would combine the powers of 15 governmental agencies into one Food Safety Administration, eliminating what DeLauro considers conflicts of interest.

"One branch of the U.S. Department of Agriculture inspects meat on behalf of consumers while another helps market it on behalf of producers," her legislation states. "The Center for Veterinary Medicine within the FDA receives fees from the animal drug industry to review and approve animal drugs that can enter the human food supply via meat and poultry."

In addition to consolidating responsibilities, the Safe Food Act would divide food production into categories and assign a set frequency for inspections.

Slaughterhouses, considered Category 1 establishments, would be the most frequently inspected, facing almost continuous observation. Food Safety Administration representatives would visit Category 2 firms, such as a poultry processing plant, daily. At Category 5 firms - food trucks or storage sites - inspectors would check for food safety standards at least annually.

Critics of the FDA say the agency also has less muscle to conduct inspections of foreign food suppliers and distributors at their source. DeLauro's legislation calls for an amplification of resources at U.S. ports.

The bill also calls for the Food Safety Administration to have the authority to seize products suspected of bearing food-borne illness and find those responsible for the outbreak through a "traceback" system.

Current food safety measures

Although the Food and Drug Administration does not comment on pending legislation, an agency spokesman said many of the bill's proposals are already in place. The spokesman said it was agency policy that he not be named.

The FDA focuses its inspections on high-risk threats to the food supply, hoping to stop food-borne illness before it spreads. Because the agency does not inspect every food establishment on a set timetable, it has created the Prior Notice Center as a safety net. The center, which operates 24 hours a day, seven days a week, works with the U.S. Custom Service and Border Protection to contain dangerous foods as well as block them from entering the country.

In addition, the CDC recently began a traceback system under the Food Emergency Response Network. After authorities discover the source of an infected food product, the FDA can take action, ranging from a strongly worded letter to prison sentences for those responsible.

DeLauro has introduced her Safe Food Act several times since the late 1990s. With a Democratic majority and the recent outbreaks of food-borne illnesses, DeLauro said she is hoping for action. Although she does not have an exact estimate on how long a consolidation of food safety agencies would take, she said it could be accomplished for a "minimal cost."

But one former FDA commissioner argues that a consolidated agency is not the answer.

"I know that several very good people in Congress keep thinking that the solution is an organizational or structural issue. I don't think that that's the issue at all," said Dr. Jane E. Henney, who was FDA commissioner from January 1999 to January 2001.

Instead, Henney said she recommended untangling agricultural committees from the FDA.

"The congressional appropriations people sit there, and they're given an allocation of money. So the Department of Agriculture gets funded first, and what's left over, it seems to me, goes to the FDA. So the FDA gets the short shrift of the resource allocation, even though it's got about 80 percent of the food supply to regulate," Henney said.

The history of food regulation

The modern regulatory agency began in 1862 when President Abraham Lincoln appointed Charles M. Wetherill to head the Bureau of Chemistry in the U.S. Department of Agriculture.

Spurred by the slaughterhouse horrors of Upton Sinclair's "The Jungle," President Theodore Roosevelt augmented the responsibilities of the bureau in June 1906 with the simultaneous passage of the Food and Drugs Act and the Meat Inspection Act.

After the deadly "wonder drug" Sulfanilamide killed 107 people in 1937, Congress further strengthened the FDA's role by passing the Federal Food, Drug and Cosmetic Act. The law required companies to prove the safety of new drugs before placing them on the market - a primary FDA responsibility today.

Over the last 20 years, the FDA has evolved rapidly due to political and consumer pressures.

Congress passed the Nutrition Labeling and Education Act in 1990, requiring lists of ingredients and nutritional content directly on product packaging. Words like "low-fat" and "light" were soon visible on supermarket shelves.

In 1997, President Clinton signed the Food Safety Initiative, laying the groundwork for the Food Outbreak Response Coordinating Group. The multi-agency group aims to improve food safety standards and fight food-borne illnesses.

Most recently, after the events of Sept. 11, the Bush administration clamped down on food safety and defense with the Public Health Security and Bioterrorism Response Act of 2002.

The threat of terrorists attacking the food supply has caused the FDA to tighten temperature requirements and strengthen security of food storage.

In addition, the bioterrorism act now requires food manufacturers and distributors - foreign and domestic - to register with the FDA. Companies must also notify the FDA before each individual shipment of a product.

Today, the FDA employs more the 9,000 experts - chemists, physicians, microbiologists, veterinarians, pharmacists and lawyers. A third of its workforce is in the Washington area at the FDA's policy-making headquarters.

The agency's remaining arms extend across the nation through more than 150 field offices and laboratories. The FDA does not develop products on its own, instead sending inspectors to investigate more than 16,000 laboratories a year while FDA scientists research new medical devices, food additives, infant formulas and animal drugs submitted by industry.

Fighting recent budget cuts, FDA critics argue that these inspectors are stretched too far. From 2003 to 2006 the budget for the FDA's Center for Food Safety and Applied Nutrition in the FDA fell 37 percent.

FDA inspectors conducted 4,573 inspections of domestic food processing plants in 2005. During 2007, the agency plans to conduct 3,400 inspections - a more than 25 percent decrease.

The FDA is working with state and local food safety agencies to keep inspections frequent, an agency spokesman said. Combining federal, state and local inspections raised the total for 2005 to 17,730. The FDA expects the 2007 total to rise to 19,137, despite cutting the estimate for its own inspections.

Some critics believe consolidation is already beginning, citing reduced federal funding and job cuts within CFSAN. The government needs to issue a final push of legislation to update and further protect food safety, DeWaal said.

"Some of the work is already being done in the lower levels of the [FDA], but Congress needs to come in and pass a law that modernizes the food laws and bring them together," DeWaal said. "What we don't want is to just have the boxes moved around without a new mission."

Source: Scripps Howard Foundation Wire