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Cloned food postponed
By Lorraine Heller
Source of Article:
17/12/2007 - Food from cloned animals looks likely to take longer than expected to enter the American food supply, following the passage of a provision in the Senate's Farm Bill that requires more testing.
The amendment, which was included in the Farm Bill (H.R. 2419), calls for a rigorous review of the human health and economic impacts of introducing cloned foods.
Advanced by Senators Barbara Mikulski and Arlen Specter, amendment 3524 was designed to address concerns that the US Food and Drug Administration's (FDA) risk assessment of the controversial technology was flawed.
FDA in December issued its assessment of the available scientific evidence surrounding cloning, which concluded that there were no additional safety risks posed by the technology when compared to other assisted reproductive technologies currently in use in US agriculture.
However, fierce opposition from scientists, health groups, consumer advocacies and even industry sparked a heated debate, which culminated in the proposal of an amendment to the 2007 Farm Bill.
The US Senate on Friday passed the 2007 farm bill, The Food and Energy Security Act, by an overwhelming majority of 79-14.
According to the Center for Food Safety (CFS), a public interest group at the forefront of the fight against cloning, "the FDA's flawed and cavalier approach to cloned food and its potential impacts called for a truly rigorous scientific assessment".
At a time when the FDA has repeatedly failed the public, this amendment will ensure that the American consumer is considered before any special interest," said Joseph Mendelson, legal director of CFS.
The amendment requires that two rigorous studies be performed before the FDA is able to issue a final decision on food from clones.
It directs the National Academy of Sciences (NAS) to convene a blue-ribbon panel of leading scientists to review the FDA's initial decision that food from cloned animals is safe.
The amendment further requires the NAS to study the potential health impacts of cloned foods entering the nation's food supply, including the possible health effects of lessened milk consumption as a result of consumer avoidance of cloned food.
The bill also directs the United States Department of Agriculture (USDA) to examine consumer acceptance of cloned foods and the likely impacts they could have on domestic and international markets.
"I believe in science, in research, and in a transparent process. Before we allow cloned animals into our food supply, we must know more about it. When something is this new, unclear and uncertain, we need to be sure," said Senator Mikulski.
"Just because something has been created in a lab, doesn't mean we should have to eat it. If we discover a problem with cloned food after it is in our food supply and it's not labeled, the FDA won't be able to recall it like they did Vioxx - the food will already be tainted. We have been down this road before with product safety - the FDA has a credibility crisis," she said.
Requiring more research would also go a long way in allaying consumer concerns about cloning.
A recent national survey commissioned by the International Food Information Council (IFIC), found that 50 percent of American consumers have an unfavorable view of cloning, while 28 percent remain neutral.
And a recent survey by the Consumers Union found that 89 percent of Americans want food from cloned animals to be labeled.
It is now up to the Senate and House Agriculture Committees to agree on the provisions of the final bill during conference, which will take place in early 2008.

FDA to Back Food From Cloned Animals
Move Would Defy Congress's Wish for Delay
(Washington Post, DC)
By Rick Weiss
Having completed a years-long scientific review, the Food and Drug Administration is set to announce as early as next week that meat and milk from cloned farm animals and their offspring can start making their way toward supermarket shelves, sources in contact with the agency said yesterday.
The decision would be a notable act of defiance against Congress, which last month passed appropriations legislation recommending that any such approval be delayed pending further studies. Moreover, the Senate version of the Farm bill, yet to be reconciled with the House version, contains stronger, binding language that would block FDA action on cloned food, probably for years.
With a conference committee poised to finalize the farm bill in the next few weeks, that left the FDA a potentially narrow time frame within which to act if it wanted to settle the issue in sync with America's major meat-trading partners.
New Zealand and Australia have released reports concluding that meat and milk from clones are safe. Canada and Argentina are reportedly close to doing the same.
And although European consumers are generally uncomfortable with agricultural biotechnology, the European Union's food safety agency is expected to endorse the safety of meat and milk from clones in a draft statement that could be released within the next week.
"The science seems to be leading them and us to the same conclusion," said a U.S. trade official, speaking on the condition of anonymity because U.S. policy is technically still under review.
The FDA has hinted strongly in the past year that it is ready to lift its "voluntary moratorium" on the marketing of milk and meat from clones and their offspring, saying that the science led them to that decision. Multiple studies compiled by the agency have shown that the chemical composition of those products is virtually identical to that of milk and meat from conventionally bred animals. And studies in which rodents were fed food from clones have found no evidence of health effects.
But public opinion has been negative on the issue, with some saying that not enough safety studies have been conducted and others concerned about the health of the clones, which are far more likely than ordinary farm animals to die early in life.
As of yesterday, the FDA would neither confirm nor deny that it is close to releasing its so-called final risk assessment. Spokeswoman Julie Zawisza said the agency had received a lot of feedback -- about 30,500 comments -- on its draft risk assessment, released in December 2006. That document found no "food consumption risks or subtle hazards" associated with meat or milk from clones or their offspring.
The agency has not revealed how many comments were in favor or opposed.
Clones are genetic replicas, typically made from a single skin cell of a desirable animal. A handful of U.S. companies have pushed for marketing approval, saying the technology will make products from the tastiest beef cattle, leanest pigs and most generous milk producers more widely available to consumers.
"Thousands of data points, hundreds of peer-reviewed journal articles and two reviews by the National Academies have all said the same thing," said Mark Walton, president of ViaGen, an Austin-based cattle cloning company that provided many of the animals that independent researchers studied for the FDA. "There is nothing left to review."
Walton emphasized that for now, because clones are so expensive to make, they will be used almost entirely as breeding stock to produce conventional offspring for market. Scientists largely agree that although some clones harbor genetic peculiarities of uncertain relevance, their sexually produced offspring are healthy and normal.
But even Walton concedes that eventually both clones and their offspring will find their way to market. And as word spread through back channels in recent days that the FDA was poised to give a green light, opponents expressed surprise and anger.
"The FDA has been on the Hill on bended knee asking for more money, yet they are willing to turn around and thumb their nose at the appropriators," said Carol Tucker Foreman, of the Consumer Federation of America, referring to the omnibus spending bill that called for a delay. "The president signed that bill and it is in effect, and they are acting like it doesn't exist."
Margaret Mellon of the Union of Concerned Scientists, an advocacy group, said she had read the entire 678-page draft risk assessment and found it to be "long on assumptions and short on data, and especially short on the data that are directly relevant to food consumption safety."
Of particular concern, she said, was that even though the vast majority of clones die either before birth or soon after, those that survive are deemed normal. She said the FDA should withhold approval at least until it has a regulatory plan in place that will give it an ability to track food from clones and watch for human health impacts.
Others have called for mandatory labeling so consumers can avoid products from clones.
The FDA has said that lacking any safety concerns, it will not demand such labels. But last month, the two largest U.S. farm animal cloners, ViaGen and Trans Ova Genetics of Sioux Center, Iowa, announced a voluntary plan under which cloned animals would be registered and segregated from the conventional meat processing streams. If accepted by regulators, it could allow some food distributors to label their products as "clone free."
The Agriculture Department has also declared that meat from clones cannot be deemed organic. 1-05-08

Maker of Tainted Dog Food to Pay $3.1M
Source of Article:
COLUMBIA, S.C. (AP) ? A company that made contaminated pet food that killed dozens of dogs nationwide will pay $3.1 million in a settlement with pet owners, an attorney said Friday. The pet food, which contained a mold called aflatoxin, was produced at Diamond Pet Foods' plant in South Carolina. The company will set up a fund to reimburse pet owners for the loss of their dog, veterinarian bills and the cost of any unreturned contaminated food, said attorney Jim Andrews, who represented a Knoxville, Tenn., family that sued the company. Diamond Pet Foods, based in Meta, Mo., acknowledged that workers at its Gaston, S.C., plant failed to follow internal testing procedures to ensure its products were safe. The company made the acknowledgment after the Food and Drug Administration released a report showing the company has no record of test results for 12 shipments of corn in 2005, when grain tainted with the deadly fungus slipped into the plant. The company contends it did nothing illegal, according to the settlement. Mark Schell, Diamond's assistant general manager, did not immediately return a telephone message. Aflatoxin, a naturally occurring chemical that comes from a fungus sometimes found on corn and in other crops, can cause severe liver damage. The contaminated pet food was sold in 23 states. Diamond recalled about 20 varieties of dog and cat food when a New York veterinarian said in December 2005 that she had linked a dog's death to the company's food. The 2005 recall is unrelated to the contamination problem that prompted recalls of more than 100 pet-food brands in early 2006. In that case, investigators traced pet deaths to a toxic chemical, melamine, that had been added during manufacturing in China.
On the Net:
Diamond Pet Food Settlement:
Diamond Pet Foods:

So, what's the Beef with the New California Raw Milk Safety Rules?
Posted on January 4, 2008 by Food Poisoning Attorney
Source of Article:
I posted a few days ago that Claravale Farm of Paicines and Organic Pastures of Fresno have sued the State of California for setting standards for the quality of raw milk.
I was curious what the ^beef ̄ was really all about. According to the State of California, ^the new standard sets a maximum amount of coliform bacteria at no more than 10 bacteria per milliliter (mL) in milk sold raw to the consumer, the same limit required for pasteurized milk. This level is consistent with both national and international public health and food safety requirements as reflected in standards set for pasteurized dairy products by the U.S. Food and Drug Administration, the United States Department of Agriculture (USDA), the Canadian Food Inspection Service, and the European Economic Community (EEC). It is also the same standard currently used for raw milk sold for direct consumption in several western states, including Nevada, Arizona, Utah, Idaho, and Washington. ̄
The State also suggested the following for reducing the risk of bacteria being in the raw milk:
? Properly managing manure, bedding, housing and pastures to prevent cows from arriving overly dirty at the milking parlor.
? Washing the udders and teats of cows, and ensuring they are clean and dry prior to milking.
? Ensuring the hands of milkers are clean and dry
? Use of an appropriate commercially available pre-milking teat sanitizer to further reduce the amount of bacteria contacting milking equipment.
? Milking any cows with infected udders last, and ensuring such milk is properly excluded from milk intended for consumption.
? Ensuring all equipment throughout the entire milking system is properly cleaned and sanitized after each milking.
? Ensuring detergents and sanitizers are used at effective concentrations, and that adequate amounts and temperatures of hot water are utilized.
? Establishing and adhering to a maintenance schedule for milking equipment to ensure proper operation and to replace worn out inflations, hoses, gaskets and other parts that can harbor coliform bacteria.
? Providing sufficient refrigeration to ensure milk is properly cooled and stored at 45 degrees or below.
? Ensuring the milk products plant where the raw milk is handled and finally packaged for the consumer is also properly constructed, clean and sanitary. Bottles of raw market milk must be mechanically capped to avoid contamination from workers¨ hands.
So, the rules seem to work in other states and other parts of the world? I certainly hope the State of California does not cave to pressure from the raw milk folks, who seem to spend as much time or more on the internet blogging and making Youtube videos as they do milking. Perhaps Arnold, ^The Governator, ̄ will call and ask me to come in to assist in the defense of the State? On the other hand, perhaps I should just stay out of the fight, let the raw milk people win and continue to provide me with work? I¨ve always wanted to own land in Fresno and Paicines. Perhaps I can give up my "Batman" title for "Bill the Barbarian?"

Food Safety and Quality Related Job Openings
NIR/Analytical Services Manager ? Land O¨Lakes, Inc. - Shoreview, MN
Sanitation Manager ? Malt-O-Meal - Northfield, MN
Food Safety Consultant - Agricultural Consulting Services, Inc. ? Rochester, NY
Quality Control Supervisor - Channel Fish Co. ? Boston, MA
Food Safety Programs Director ? Food Marketing Institute - Crystal City, VA
Food Chemist/ Nutritional Chemist ? EMSL Analytical, Inc. - Indianapolis, IN
QA/QC Manager - Carl Buddig and Company ? South Holland, IL

Food Safety and Quality Related Job Openings

Short- and Long-term Effects of Bacterial Gastrointestinal Infections
Anders Ternhag,* Anna Torner, Ake Svensson,哂 Karl Ekdahl,*」 and Johan Giesecke*」
*Karolinska Institute, Stockholm, Sweden; Swedish Institute for Infectious Disease Control, Solna, Sweden; Stockholm University, Stockholm, Sweden; and 」European Centre for Disease Prevention and Control, Stockholm, Sweden
Source of Article:
Suggested citation for this article:

During 1997?2004, microbiologically confirmed gastrointestinal infections were reported for 101,855 patients in Sweden. Among patients who had Salmonella infection (n = 34,664), we found an increased risk for aortic aneurysm (standardized incidence ratio [SIR] 6.4, 95% confidence interval [CI] 3.1?11. within 3 months after infection and an elevated risk for ulcerative colitis (SIR 3.2, 95% CI 2.2?4.6) within 1 year after infection. We also found this elevated risk for ulcerative colitis among Campylobacter infections (n = 57,425; SIR 2.8, 95% CI 2.0?3.. Within 1 year, we found an increased risk for reactive arthritis among patients with Yersinia enteritis (n = 5,133; SIR 47.0, 95% CI 21.5?89.2), Salmonella infection (SIR 18.2, 95% CI 12.0?26.5), and Campylobacter infection (SIR 6.3, 95% CI 3.5?10.4). Acute gastroenteritis is sometimes associated with disease manifestations from several organ systems that may require hospitalization of patients.

Bacterial gastrointestinal infections continue to cause illness and death and contribute to economic loss in most parts of the world, including high-income countries that have developed surveillance and control programs. The symptoms of acute bacterial intestinal infection are usually mild to moderate, and spontaneous remission occurs (1), but in some cases, the disease can cause rapid deterioration of a patient's condition.

An episode of acute enteric infection involving extraintestinal organs can also lead to complications and trigger chronic disease. Complications include irritable bowel syndrome (2), reactive arthritis (3), hemolytic uremic syndrome (HUS) (4), and Guillain-Barre syndrome (GBS) (5). There may be other, perhaps unusual and less documented, late effects of acute enteric infections, such as inflammatory bowel disease (6).

In Sweden, there is no active follow-up on reported cases of bacterial enteric infection in terms of disease outcome or long-term complications. During the 8-year period 1997?2004, >100,000 persons with acute gastrointestinal infection were reported within the national surveillance program for communicable diseases. We present a retrospective cohort study of these patients to investigate the association between exposure to a bacterial pathogen and the risk for autoimmune illness, gastrointestinal complications, and extraintestinal infectious disease.

Materials and Methods
Participants comprised persons with intestinal infection (nontyphoidal Salmonella spp., Campylobacter spp., Yersinia enterocolitica, Shigella spp., or enterohemorrhagic Escherichia coli [EHEC]) reported to the Swedish Institute for Infectious Disease Control during 1997?2004. We collected data on age, sex, date reported, and country of infection and used social security numbers for identification. This identification number was used to link our cohort of cases (those with short-term complications occurring within 3 months or long-term effects within 1 year after infection) to the Swedish Hospital Discharge (covers all hospital in Sweden) and Causes of Death registers. Ethics permission was obtained from the Ethical Committee, Karolinska Institute. Discharge diagnoses must be reported to the register; therefore, any study using this register is, in practice, population based. The Hospital Discharge Register was validated by using a diagnosis of acute myocardial infarction; underreporting was <1%, main diagnosis was missing for <1% of cases, and correct diagnosis was made for 86% (7).

We calculated the follow-up time for each case as person-time from reported date of infection to an event, death, or study termination. Person-years were then compared with a Swedish standard population of 5-year age groups to calculate the expected number of cases for each disease. Standardized incidence ratios (SIRs) were constructed by dividing the observed number of cases with the expected number of cases. Ninety-five percent exact confidence intervals (CIs) were calculated under the assumption that the number of observed cases were Poisson distributed. CIs that do not overlap 1 indicate that the number of observed cases is significantly different from the number of cases expected in a population cohort of similar age and sex distribution. The described method is called indirect standardization, and interpretation of results is similar to relative risk interpretation, i.e., comparing the risk for disease in an exposed cohort to the risk for disease in an unexposed cohort.

We previously estimated standardized mortality ratios (SMRs) for Salmonella ( and Campylobacter infections (9) and showed that country of infection (domestic or abroad) was an effect modifier; i.e., the SMR differed substantially between these 2 strata and no pooled SMR could be calculated. The underlying factor for this interaction was probably that the term abroad served as a proxy for healthiness or a healthy traveler effect. For our present analysis, we divided the cohort into 2 strata on the basis of country of infection (Sweden or abroad), but no statistical significant interaction was evident. We concluded that crude SIRs irrespective of country of infection could be estimated. All analyses were conducted by using SAS statistical software, version 8.2 (SAS Institute, Inc., Cary, NC, USA).

Demographic data on the 101,855 study participants and frequency counts for infectious agents are summarized in Table 1. Campylobacter spp. caused the most cases, 57,425 (56%). The second most frequent pathogen was Salmonella spp., the causative agent in 34,664 cases (34%); distribution of serovars is shown in Table 2. Of all cases of gastroenteritis, Yersinia spp. accounted for 5,133 (5%) cases; Shigella spp. 3,813 (4%); and EHEC 820 (<1%).

Table 3 shows the number of reported case-patients with specific diseases within 3 months of an episode of bacterial gastrointestinal infection, along with expected number of cases and SIRs. Not surprisingly, the highest risks were found for HUS after EHEC infection and GBS following campylobacter infection. Although SIRs were quite elevated, absolute risks were more moderate; among 820 cases of EHEC infection, we found 13 episodes of HUS (1.6%), 57,425 cases of campylobacteriosis, 13 cases of GBS (0.02%), 5,133 cases of Yersinia infection, and 9 cases of reactive arthritis (0.2%). The risk for aortic aneurysm among patients with salmonellosis was significantly higher than expected (SIR 6.4, 95% CI 3.1?11.. The absolute risk for bacteremia/sepsis was 0.02% for case-patients with Campylobacter infection and 0.03% for those with salmonellosis. For many complications, we did not find any statistically significant elevated risks. Other complications that we had hypothesized to be associated with gastrointestinal infections could not be shown. Only a few cases were found within 3 months, contributing to imprecise estimates of SIRs.

Within 1 year of acute bacterial gastrointestinal infection, case-patients with Yersinia enteritis were at increased risk for reactive arthritis (SIR 47.0, 95% CI 21.5?89.2), Salmonella infection (SIR 18.2, 95% CI 12.0?26.5), and Campylobacter infection (SIR 6.3, 95% CI 3.5?10.4) (Table 4). The risk for ulcerative colitis was elevated among patients with salmonellosis (SIR 3.2, 95% CI 2.2?4.6) and, to a lesser extent, among patients with campylobacteriosis (SIR 2.8, 95% CI 2.0?3.. Of the 29 patients in our salmonellosis cohort who had ulcerative colitis, 13 (44%) had first experienced ulcerative colitis during the 10-year period before the acute infection. Among patients with campylobacteriosis, we found 42 with ulcerative colitis, of whom 18 (43%) had received a diagnosis of ulcerative colitis in the 10-year period before the infection. We did not find any increased risk for Crohn's disease in the same group of patients. We did not find any elevated risk for many of the rheumatologic diseases included in the present study in any of the participants. The distribution of Salmonella serotypes among patients with aortic aneurysm, reactive arthritis, and ulcerative colitis in our cohort did not differ in any substantial way from the whole salmonellosis cohort (Table 5), although the number of patients was rather small.

Our data confirm the elevated risk for complications and long-term sequelae after an episode of acute bacterial gastroenteritis. We have presented new estimates of the absolute and relative risk for well-described complications such as HUS after EHEC infection, GBS after an episode of Campylobacter enteritis, and reactive arthritis after Yersinia enteritis. Another complication that we have been able to verify is aortic aneurysm after an episode of salmonellosis. Perhaps more unexpected, the risk for ulcerative colitis was elevated in the cohort of patients with salmonellosis and campylobacteriosis. The distribution of Salmonella serovars was the same among patients with and without complications. The finding of no major difference in the distribution of Salmonella serovars between the group of patients with and without complications indicates that factors other than Salmonella serovar alone determine the risk for complications.

Compared with other studies, our new estimate of the risk for HUS after EHEC infection is lower than previously reported (10,11). An explanation of our lower estimates could be that we used only International Classification of Diseases (ICD) codes specific for HUS. Several of these cases may in fact be classified under nonspecific ICD codes that also include a large proportion of cases unrelated to HUS. However, had we included them in the analysis, any association with the infections would have been diluted. Our estimate of risk for GBS and campylobacter are in line with a study in England that showed a risk of <2/10,000 that GBS will develop in a patient with campylobacteriosis (12). These results are also in line with a previous study in Sweden (13). All estimates of complications in this study are based on discharge data from the Hospital Discharge Register; this means that minor complications that either were not presented to any doctor or were handled only by general practitioners were not available for this analysis. At the population level, reactive rheumatologic symptoms associated with infection are typically mild and transient (14). This is probably the reason why our estimate of reactive arthritis after Yersinia infection is quite low, although similar low risks have been reported elsewhere (15).

In patients with atherosclerotic disease, or in those with preexisting aneurysms, transient bacteremia with nontyphoidal Salmonella infection can result in vascular infections (16?1. Most of these aneurysms described previously have been localized in the subrenal segment of the abdominal aorta (17). Salmonella spp. in these patients can invade the arterial intima and cause a localized endothelial infection that results in an aneurysm or the enlargement of a previously existing aneurysm. This may explain the association between Salmonella infection and aortic aneurysm in this study.

Our findings of an elevated risk for ulcerative colitis in the cohort of patients with salmonellosis and campylobacteriosis need further study. In another large cohort study, an association between acute gastroenteritis and inflammatory bowel disease was identified (n = 43,013), where the incidence rate for ulcerative colitis was 40 per 100,000 person-years, a doubling of the risk for those unexposed to infection (19). We do not know why an episode of infectious gastroenteritis could contribute to the initiation or exacerbation of ulcerative colitis. Seasonal variation in the onset of ulcerative colitis, and reports that excessive childhood infections are associated with higher risk for ulcerative colitis, may support the hypothesis that infections could be triggers of disease (20). From this study, we cannot say whether there is a causal relationship between Salmonella and Campylobacter infections and relapse of disease in patients with known ulcerative colitis, or whether the infection could trigger ulcerative colitis in susceptible persons. We cannot entirely rule out that the findings are an artifact, resulting from an increased number of medical examinations and stool cultures in a group of patients with diarrhea because of a known or unknown inflammatory bowel disease. More study is needed to confirm or refute our findings.

Because irritable bowel syndrome is diagnosed and treated at hospital in only a minority of patients, our estimates are probably too low. Many studies have not used a control group but reported only the numbers and percentages of patients who had irritable bowel syndrome after gastroenteritis (21); 1 study with controls estimated a relative risk of 11.9 (CI 6.7?21) after 1 year of follow-up (22).

Our study has some limitations. Perhaps the most serious one is the selection bias of patients entering the gastroenteritis cohort. Only a small fraction of all patients with Salmonella infection, for example, seek medical care, have a stool sample taken, and are eventually reported to national surveillance (23). This could have an effect on the results, especially if we are collecting data on those with the most severe disease; disease severity itself affects complications and sequelae. Another limitation is the lack of information on confounding factors among study participants, especially coexisting illnesses such as malignant disease or immunodeficiencies of any cause. Such coexisting illnesses could perhaps increase to some extent the risk for complications (6), but our results on the effect of disease from gastrointestinal infections would not have changed. Although the quality of the Swedish Hospital Discharge Register is quite good, there is always a general problem of reliability in registry-based epidemiologic research.

In conclusion, we studied the risk for complications 3 months and 1 year after acute bacterial gastroenteritis and found disease manifestations from several organ systems that required hospitalization of patients. These findings are a reminder of, and could be an argument for, the usefulness of existing control programs targeted to control bacterial enteric disease.

This study was approved by the Regional Ethical Committee, Karolinska Institute, Stockholm, Sweden.

Dr Ternhag is a resident physician at Karolinska University Hospital and a PhD student at Karolinska Institute, Department of Medical Epidemiology and Biostatistics, Sweden. His research interests are in infectious disease epidemiology, registry-based research, and long-term prognosis of infectious diseases.

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Table 1. Distribution of infectious agents, age and sex for 101,855 study participants, Sweden, 1997?2004
Table 2. Most frequent serotypes isolated among study participants with nontyphoid Salmonella infection, Sweden, 1997?2004
Table 3. Complications associated with gastroenteritis, 3 months postinfection, among 101,855 patients with bacterial gastrointestinal infection, Sweden, 1997?2004
Table 4. Complications associated with gastroenteritis, 1 year postinfection, among 101,855 patients with bacterial gastrointestinal infection, Sweden, 1997?2004
Table 5. Salmonella serotypes among patients with aortic aneurysm, reactive arthropathies, and ulcerative colitis, Sweden, 1997?2004

Suggested Citation for this Article
Ternhag A, Torner A, Svensson A, Ekdahl K, Giesecke J. Short- and long-term effects of bacterial gastrointestinal infections. Emerg Infect Dis [serial on the Internet]. 2008 Jan [date cited]. Available from

Comments to the Authors
Please use the form below to submit correspondence to the authors or contact them at the following address:

Anders Ternhag, Karolinska Institute, Department of Medical Epidemiology and Biostatistics, Box 281, SE-171 77, Stockholm, Sweden; email:

E. Coli Threat to Leafy Greens Demands More Safety Regulations, Research
Date Published: Monday, January 7th, 2008
Source of Article:
Several years ago, the Dole Fresh Bagged Spinach E. coli outbreak highlighted the difficulty of keeping the food borne pathogen out of fresh produce. Since then, the growers of leafy greens in California have taken steps to keep their crops safe from E. coli contamination. But despite the danger E. coli can present to consumers, federal regulators have, for the most part, allowed growers to self-regulate. Many question whether or not steps the industry voluntarily takes will be enough to prevent another leafy green E. coli outbreak in the future.
In September 2006, bagged fresh baby spinach sold by the Dole Food Company was linked to an E. coli outbreak that was blamed for the deaths of three people and illness in 200 others. Health officials traced the source of that E. coli contamination to a cattle ranch adjacent to the California field where the spinach was grown. It is believed that runoff from the ranch that was contaminated with cattle feces made its way into the spinach field. Since then, several other recalls of E. coli contaminated lettuce and other greens have made headlines.
Recently growers and processors in California¨s Central Valley formed a safety group, and 118 companies have signed on to the California Leafy Green Handler Marketing Agreement. Safety precautions covered by the agreement include testing the water supply monthly for E. coli and keeping animals off farmland. But signing onto that agreement is strictly voluntary, although once growers do sign on, they are legally bound to adhere to the standards. The US Department of Agriculture (USDA) is considering implementing a national version of those industry-developed standards that followed the E. coli outbreak and now govern California farmers and leafy green handlers. While the USDA is weighing both voluntary and mandatory standards, it has been reported that the agency favors a voluntary program that allows flexibility.
But many consumer advocates are saying that whether they are voluntary or mandatory, the new leafy green standards are inadequate. While the new standards could reduce the risk of runoff from cattle pastures contaminating fields with E. coli, they do little to address the risk of E. coli from deer, pigs, birds, rodents and garden slugs. What¨s worse, very little research is being done to determine how likely these other potential E. coli sources might be to contaminate fields. Research is needed to perform quantitative risk assessments, to prioritize the actual risks and to devote the necessary resources to minimize or eliminate them. While some of this work is being done ? The Center for Produce Safety at the University of California Davis was recently formed with industry and government money to better understand E. coli risks much more research in this area is needed.

A Safe and Bountiful Harvest: How to Ensure America's Food Safety
by Daniella Markheim
Backgrounder #2096

Source of Article:

Recent food scares have increased public scrutiny of and debate about the effectiveness of America's food safety system. E. coli in ground beef and California spinach, salmonella in jars of peanut butter, and tainted pet food, ginger, and garlic from China are just some of the unsafe domestic and foreign products that have made it through the food safety system and onto dinner tables and the evening news. Not surprisingly, in January 2007, the U.S. Government Accountability Office identified America's food safety system as a high-risk area needing special oversight and reform.[1]

Both Congress and the Administration are actively trying to do just that. Congress will consider a wide range of policy and regulatory reforms in the weeks ahead, in addition to a new action plan proposed by the Presi?dent's Interagency Working Group on Import Safety.

With U.S. households and businesses expected to demand more and more food imports, most of the new ideas focus on ensuring that the system has the capacity to monitor and protect families from an influx of foreign food. Yet a review of past product recalls clearly demonstrates that policymakers need to be mindful that Americans are just as likely to be harmed by products made in the United States.

Congress and the Administration can best improve U.S. food safety by implementing reforms that follow an unbiased, science-based approach to food safety that allows market forces and competition to weed out unsafe producers. Injudicious regulations and restrictions that discriminate between food producers or erect unfounded, protectionist, non-tariff barriers to trade would do little to bolster U.S. food security, would likely violate international trade agreements, and would harm America's economic relations with developing countries.

Food Safety Today

Americans are shopping the world's grocers like never before, importing almost $75 billion of fresh fruit, vegetables, and other food products for direct consumption or further processing in 2006.[2] Imports accounted for 80 percent of seafood and nearly 50 percent of all non-citrus fruits consumed domestically.[3] International trade allows families to sample tastes from around the world while keeping food prices down through competition.

However, Americans do not rely on foreign pro?ducers to keep themselves well fed; most U.S. pan?tries are stocked mainly with products purchased from domestic producers. Food expenditures exceeded $1 trillion in 2006.[4]

Most of this food--whether produced at home or imported from abroad--is perfectly safe. Market competition and consumer choice provide the incentives that drive producers to supply high-quality products in return for market share and profits. While markets are the best defense against tainted food, there is still some risk that unsafe products may reach America's kitchens--accidents can happen.

Thus, as a complement to the market, govern?ments implement food standards, testing require?ments, and inspection procedures in an attempt to reduce the risk of harm to zero. The U.S. government may be able to do more to catch the occasional tainted product by restricting and controlling the market with costly regulations, but only at great expense to con?sumers and companies. High food prices and less food will not bolster America's food security.

Instead, government should take a balanced approach to food safety by keeping markets free and limiting the scope and cost of government interven?tion to establishing minimum accepted quality stan?dards and implementing science-based methods of detecting tainted domestic and foreign products before they reach U.S. consumers. Even though the focus of legislative reform is currently on import safety, domestic food sources should face compara?ble government scrutiny.

An Ad Hoc System. The federal food safety sys?tem has evolved on an ad hoc basis, typically in response to particular health threats. This has resulted in a fragmented and complex regulatory environ?ment. Fifteen agencies implementing more than 30 laws and interagency directives collectively share the responsibility of keeping America's food safe.[5] The Food Safety and Inspection Service (FSIS) in the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) in the Department of Health and Human Services dominate the system. The FSIS manages the food safety system for all meat, poultry, and egg products, while the FDA is responsi?ble for virtually all other food products.

The Customs and Border Protection (CBP) agency in the Department of Homeland Security also plays a role in the food safety system, although food safety is only a portion of its "twin goals" of anti-terrorism and trade facilitation. The CBP was established to regulate the flow of goods and people through 326 official ports of entry, and its field agents and data gathering via the National Targeting Center aug?ment U.S. food inspection capacity.[6] Through this center, the Automated Targeting System (ATS) fil?ters cargo information received from exporters before shipments arrive and assesses the relative risks of incoming cargos before distributing that information to the correct inspection branches--or at least the ones with which it can communicate.[7]

The ATS has become the heart of the risk-assess?ment component of the food safety system. Regret?tably, while FDA computers can communicate with the ATS, FSIS computers remain out of the loop. Without real communication among authorized agencies, opportunities to leverage shared data and promote a more effective and efficient food safety process are lost.

Misallocated Resources. While the FSIS and FDA share the primary responsibility for food safety, each agency employs different inspection proce?dures, imparts various levels of regulatory burden on producers, and works within a different budget. Moreover, while the FSIS is responsible for roughly 20 percent of U.S. imports, which involve a rela?tively small number of domestic and international firms, it receives nearly 65 percent of the funding for food safety and has a larger staff when on-site audit teams are taken into consideration.

The FDA, which is responsible for the remain?ing 80 percent of imported food, receives only around 25 percent of federal food safety funding.[8] This misallocation of resources makes the FDA's job far more difficult. Misplaced funding and understaffing underlie many (but not all) of the procedural problems confronting the FDA and U.S. food safety system.

Two Food Safety Systems. The U.S. food safety regulation, monitoring, and enforcement process is both complex and nontransparent. Food safety reg?ulations for imports vary by product and country of origin, and the procedures used to implement the regulations vary by agency. Comparing FSIS opera?tions with FDA operations illuminates some of the weaknesses that undermine effective oversight of U.S. food safety and demonstrates that procedural and structural factors influence the system's perfor?mance as much as funding does.

The FSIS System. The FSIS determines import eli?gibility based on the general equivalence of the for?eign country's regulations with U.S. standards and on satisfactory on-site audits conducted by the FSIS. An on-site audit team evaluates the systemic regula?tory procedures in a country, but it does not inspect food or certify individual firms. Instead, individual firms apply to their own government for certifica?tion, thus placing the burden of responsibility and oversight directly on the foreign government.[9]

This approach limits the scope of the agency's portfolio but restricts market access to just 34 coun?tries deemed to have equivalent standards.[10] Restraining imports certainly keeps the agency from being spread too thin, but product prices are higher and domestic products are no safer as a result.

Once imports reach the U.S., the CBP compares shipping information that it received in advancefrom exporters with the cargo that arrives. In addition to the shipper's name and address, the documentation must provide more specific information, such as the grower and the product code, in accordance with the Bioterrorism Act of 2002.[11] The USDA's Animal and Plant Health Inspection Service assesses animal health and public health requirements.[12]

Then the FSIS takes over. Seventy-four import inspectors stationed at 33 major ports inspect cargo at roughly 135 import inspection centers. Inspec?tors enter shipment data into an Automated Import Information System (AIIS), a computer database that facilitates record keeping and coordination among ports.

Of the products under FSIS control, 100 percent must be visually inspected for certification docu?ments, proper labeling, and overall condition. The AIIS generates a random sampling of cargo for fur?ther inspection, ensuring that testing spans a wide range of products regardless of volume or origin. Cargo shipments that make the in-depth inspection list are then subjected to further testing, including laboratory analyses for microbiological contamina?tion, chemical residues, food chemistry, and species identification. Products that fail to meet U.S. stan?dards are refused entry into the U.S. market.[13]

The FDA System. In contrast to the restrictive FSIS process, the FDA system is more open but far less transparent. Import requirements are estab?lished individually on a firm-by-firm basis rather than through a cooperative process with the export?ing country. The full burden of determining com?pany eligibility falls squarely on the FDA and the particular company.[14]

Rather than acknowledge some value in foreign standards that could limit the number of firms that the FDA would need to evaluate, the agency looks at every firm. For example, China's Inspection and Quarantine Agency has approved only about 12,700 of the country's 450,000 food producers to produce for export. However, rather than use China's assessment to set a more manageable foun?dation from which to start, the FDA has instead decided to try to certify all 450,000 firms.[15] In all, hundreds of thousands of firms from 150 different countries interested in sending food products to the U.S. market must certify with the FDA that their products comply with U.S. standards--an impossi?ble task for even the best-funded agency.

While this approach may give the impression that the FDA is closely monitoring food safety stan?dards, in reality, the understaffed, underfunded FDA is largely overwhelmed by the sheer number of both domestic and foreign firms falling under its purview. In an attempt to cope, the FDA targets "high-risk" imports and countries and relies on an "import alert" list that tracks firms with repeated safety offenses. This approach to keeping food safe is one of the few available to the resource-poor agency, but the opportunity for tainted food to slip through the system remains. Even "low-risk" prod?ucts can be contaminated, and any producer can cut corners on safety procedures, whether that pro?ducer is in China, France, or the U.S.

Additionally, FDA port inspections are random and far less frequent than inspections under the FSIS process: The FDA inspects only 1 percent of the imported food that it regulates.[16] In 2002, Con?gress granted the FDA the authority to commission other agencies to conduct import inspections in its absence. As of September 2007, the FDA had com?missioned more than 9,900 CBP officials to fill this role.[17] In practice, CBP has become the default inspector at many ports of entry because FDA field inspectors are stationed at only 90 of more than 300 ports.[18] While some ports lack appropriate inspec?tions staff, 18 are staffed by both the FSIS and the FDA.[19] In a food safety system in which resources are stretched thin, such redundancies only further tax the system.

Recalls. If an unsafe product makes it through the system unnoticed, then companies are encour?aged to recall the tainted product voluntarily. Nei?ther the FSIS nor the FDA has the authority to issue mandatory recalls, with the exception of the FDA's power to announce a mandatory recall for unsafe baby formula. Yet in practice, companies move quickly and voluntarily to remove unhealthy prod?ucts. In a competitive, open market, companies cannot afford to lose consumer confidence or the accompanying profits. The more effectively markets are allowed to work, the better markets will weed out harmful products.

Government Proposals for Fixing the System

Poor interagency coordination and communica?tion, insufficient resources, and complex, nontrans?parent rules and processes have combined to threaten the food safety system--and weaken con?sumer confidence--to the point that even domestic industry is adding its voice to the call for more effec?tive regulation and oversight.[20] Domestic food pro?cessors and retailers are looking to federal oversight to streamline and standardize firm-specific regula?tions for both domestic and foreign producers. Sim?plifying and clearly publicizing food safety standards would enable all firms to spend less on compliance and would reduce importers' uncertainty over the safety of the foreign products on their shelves.

Industry pressure, coupled with the Bush Administration's and Congress's intent to strengthen the food safety system, makes some degree of reform seem inevitable. In an executive order on July 18, 2007, President George W. Bush ordered an Interagency Working Group on Import Safety to examine the issues and propose a comprehensive strategy for bolstering the food safety system. The Import Safety Action Plan was released on Novem?ber 6.[21] The plan shares many of the ideas outlined in myriad congressional proposals for reform, espe?cially with regard to shifting the process toward a more preventative approach to food import safety that guards against harmful products before they even reach the border.

Legislators are considering options for reform that include:
Implementing a complete structural overhaul of the system to form a unified agency to oversee food safety,
Imposing import fees to fund increased FDA inspections,
Requiring countries and/or foreign firms to be certified before exporting to the U.S.,
Restricting the number of ports eligible to re?ceive imports,
Banning imports from any foreign company that is unwilling to give U.S. inspectors access to facilities,
Expanding product safety research and develop?ing more rigorous scientific testing protocols,
Granting the authority to order mandatory recalls of tainted products,
Improving communication and data sharing among agencies,
Increasing penalties for violations of food safety regulations, and
Tracing products through the production and import process.[22]
While some of these proposals have merit, some clearly cross the line between reducing the threat of unsafe food products and simply erecting protec?tionist barriers to trade. Moreover, given America's history of food contamination, a focus on foreign producers would be misguided. In 2007, the FDA issued more than 310 recalls and announcements, of which more than 260 were for domestic products and roughly 50 were for foreign goods. The USDA has issued 38 recalls, all of which involved domestic meat products.[23] Clearly, limiting food imports will not solve America's overall food safety concerns but would instead create new obstacles to ensuring U.S. food security.

Discriminating between foreign and American firms or among America's trade partners could result in violations of commitments and rules underpinning freer trade through the World Trade Organization and bilateral trade agreements. Countries might respond to U.S. protectionism by imposing retaliatory fees and import restraints on U.S. goods, harming the U.S. food industry and agriculture sector.

Even if great care is taken to ensure equal treat?ment of domestic and foreign firms under any new rules and procedures, domestic producers would not face the costly import fees or restrictions on port access that would confront foreign firms. In response, foreign firms would likely pass the higher costs of exporting to the U.S. market on to U.S. food processors, retailers and, ultimately, consumers. U.S. retailers would be forced to choose between selling fewer, more expensive imports and selling substitute domestic goods that appear to be com?petitive because of import barriers.

The Import Safety Action Plan

The President's preventative approach to food safety blends the current, unworkable FDA practice of picking and choosing between "high-risk" and "low-risk" countries and firms with the FSIS tactic of imposing trade restrictions on sources from countries without U.S.-style food regulations and standards. Such a system may seem appealing; how?ever, current practice clearly demonstrates how dif?ficult it is for agencies to identify "high-risk" companies in a vast, ever-changing economic land?scape, and market restrictions only add to the cost of food without any guarantee of improved safety.

Producers of "high-risk" goods from specific countries would face mandatory certification. Under agreements with these specific countries, firms would have to demonstrate that their prod?ucts fully comply with FDA regulations before they could export food to the U.S. market. In addition, voluntary certification would be encouraged for other foreign companies interested in gaining expe?dited access to the U.S.[24] The names of foreign and domestic certified producers and products would then be made publicly available, providing consum?ers and businesses greater access to information regarding product safety.[25] Although certification does not guarantee improved product safety, U.S. consumers and retailers would be far more likely to select a certified producer over an uncertified pro?ducer, which would effectively make voluntary cer?tification "mandatory" for many firms.

The report never explicitly defines the criteria for what constitutes a "high-risk" product or country. Developing countries without U.S.-style food safety protections and controls would intuitively float to the top of the list for requisite action. The plan com?pensates such "high-risk" developing countries by providing technical and other assistance to adopt a U.S.-style regulatory infrastructure and eventually reverse their categorization as high-risk exporters. However, tainted food can come from any firm and any location, and the list of recalls of domestically produced food proves that U.S. regulations are no guarantee against harmful food. Requiring countries to adopt American rules will not necessarily make imports any safer. Nonetheless, until "high-risk" countries are reclassified, firms in these countries would be unable to ship food products to the U.S.

As already proven under the current system, the U.S. can neither fully inspect and analyze every food import nor afford to certify every foreign firm wishing to export goods to America. Yet targeted certification is by definition discriminatory and would risk breaking international trade agreements. Moreover, company certification--both mandatory and voluntary--would likely impede competition and trade, harming producers and consumers alike. This aspect of a "preventative" approach to mitigat?ing failures in the food safety system runs real risks of increasing the costs of trade in food without a comparable increase in food safety. Overall, the plan and other reform proposals fail to balance the high cost of a more intensive regulatory system with the modest health and safety benefits likely to accrue.

How Free Markets and Competition Defend Against Unsafe Food

While the food industry is starting to look to the government to develop more transparent rules and standards, a competitive market environment is what motivates firms to produce and offer safe food for America's families. Recent food scares have made food processors and retailers ever more diligent in searching out and eliminating unsafe processes and products. No company, domestic or foreign, wants to be at the center of the next food recall. For instance, this year's E. coli outbreak in California spinach cost the industry an estimated $37 million to $74 million in monetary damages and an inesti?mable amount in consumer confidence.[26]

When a recall is needed, firms are generally quick to remove tainted products voluntarily. Even companies with the best and safest food processing and handling procedures have accidents. The faster contaminated products are removed from stores and household cupboards, the faster company rep?utations can be restored and exposure to legal action reduced. This works with international sup?pliers as well.

China's rapid response in addressing the recent "crisis" in food and product safety clearly demon?strates the market's power to promote the produc?tion of safer foods. To shore up its reputation with consumers and governments around the world, China is stepping up efforts to police food quality. The country has restricted or even stopped export?ing some products, such as garlic and ginger, until safety requirements are met. China has also recently signed an agreement with the U.S. on food and feed import safety that should improve the level of coor?dination and communication between the two countries.[27] These actions reflect China's awareness that, if the flow of tainted products does not cease, consumers in America and around the world will become extremely wary of buying anything "Made in China."

Important Guidelines for Reform

Regrettably, the President's plan and many of the ideas circulating in Congress go too far in restricting imports without bolstering America's food security. Curtailing or stopping imports--most of which are perfectly harmless--will not make the food on U.S. grocery shelves any safer, just more expensive and less available in quantity and variety.

Free markets and consumer choice act together as the first defense against unsafe products. How?ever, the government can take steps to bolster con?fidence in the integrity of the food safety system. Specifically, Washington should:

Work with industry to establish and clearly communicate transparent, standardized sci?ence-based regulations and standards. Reducing the cost and complexity of America's standards will not weaken them. The easier and less costly U.S. regulations are to understand and implement, the more likely it is that firms will comply with them.
Avoid the current process that focuses agency resources primarily on "high-risk" countries and firms. Tainted food can come from even the safest of countries and producers. Likewise, companies and farms with a sullied history of complying with food standards can improve. All food products, whether produced in the U.S. or abroad, should face the same inspection and test?ing requirements. Collecting and analyzing information about a country's regulatory equiva?lence to the U.S. and producers' compliance with America's food standards can be useful in estab?lishing better inspection and monitoring proce?dures at or within the border but should not serve as the central focus of the food safety sys?tem. In a dynamic, open economy, regulatory agencies would be hard-pressed to keep up with the ever-changing list of "high-risk" and "low-risk" producers.
Avoid discriminatory treatment of food im?ports. Tariffs, fees, port restrictions, unwar?ranted inspections, and pre-certification for companies--mandatory or "voluntary"--all func?tion as non-tariff barriers to trade. Implementing these approaches to food safety would likely vio?late international trade commitments, raise food prices at home, and harm America's economic relations with developing countries without signif?icantly improving food safety in the U.S.
Ensure that agencies use efficient processes to fulfill their mission objectives effectively. While a preventative approach to stopping tainted imported food before it arrives at the U.S. border is emotionally appealing, no amount of funding will enable agencies to evaluate and monitor every foreign food producer--or even just the "high risk" producers--and the products that they sell. Inspections at the U.S. border remain the best proxy for conducting individual plant inspections around the world.

America is already implementing a system of more rigorous border inspection, but more can be done to make that system more effective in promoting import food safety. Improved data sharing and technical interoperability, increased communication and coordination among agen?cies, and better product testing techniques devel?oped by the private sector would promote effective inspections and testing, bolster food security, and reduce the time that goods sit unsold at the border. While no reform proposal currently provides a plan of attack for improving domestic inspection procedures, this element of the food safety system should not be ignored. Domestic and international food inspection regimes need to be equivalent and science-based.
Give the FSIS and the FDA the authority to order recalls when companies fail to act vol?untarily. This would strengthen the country's ability to recover more quickly from a food scare when a firm does not act responsibly.

America will be served best by reform that main?tains a steadfast commitment to an unbiased, sci?ence-based approach to food safety that allows market forces and competition to weed out unsafe producers. Injudicious regulations and restrictions that discriminate between domestic and foreign food producers or erect unfounded, protectionist, non-tariff barriers to trade will do little to bolster U.S. food security.

Legislating an unwise food safety policy could seriously undermine the primary benefits of inter?national trade--the availability of a wider variety of cheaper products and more effective and efficient resource use as capital and labor shift from less competitive to more competitive industries--and harm U.S. households and the economy as a whole. America's food security depends on sound policies that mitigate the risk that unsafe products could reach U.S. dinner tables without reducing food sup?plies and driving up food prices.

Daniella Markheim is Jay Van Andel Senior Trade Policy Analyst and Caroline Walsh is a Research Assistant in the Center for International Trade and Economics at The Heritage Foundation.


[1]U.S. Government Accountability Office, High-Risk Series: An Update, GAO-07-310, January 2007, at 12, 2007).

[2]U.S. Department of Commerce, International Trade Administration, TradeStats Express: National Trade Data, at (December 10, 2007).

[3]Julie Schmit, "U.S. Food Imports Outrun FDA Resources," USA Today, March 3, 2007, at (December 14, 2007).

[4]U.S. Department of Agriculture, Economic Research Service, "Food CPI, Prices and Expenditures," updated July 2, 2007, at 17, 2007).

[5]Lisa Shames, "Federal Oversight of Food Safety: High-Risk Designation Can Bring Attention to Limitations in the Government's Food Recall Programs," GAO-07-785T, U.S. Government Accountability Office, testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives, April 24, 2007, at (December 12, 2007).

[6]U.S. Department of Homeland Security, Customs and Border Protection, "Ports of Entry," at (December 14, 2007), and L. K., "Targeting Center the Brains Behind Anti-Terror Efforts," U.S. Customs and Border Protection Today, Vol. 3, Nos. 11/12 (November/December 2005), at 14, 2007).

[7]L. K., "Targeting Center the Brains Behind Anti-Terror Efforts."

[8]David M. Walker, Comptroller General of the United States, "Federal Oversight of Food Safety: High-Risk Designation Can Bring Needed Attention to Fragmented System," GAO-07-449T, U.S. Government Accountability Office, testimony before the Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies, Committee on Appropriations, U.S. House of Representatives, February 8, 2007, p. 7, at 14, 2007). The remaining 10 percent of federal spending on food safety is divided between the Environmental Protection Agency and the National Marine Fisheries Service.

[9]U.S. Department of Agriculture, Food Safety and Inspection Service, "Production & Inspection: Importing Meat, Poultry & Egg Products to the United States," Fact Sheet, December 2003, at 14, 2007).

[10]U.S. Department of Agriculture, Food Safety and Inspection Service, "Eligible Foreign Establishments," modified January 3, 2008, at 7, 2008).

[11]Interagency Working Group on Import Safety, "Protecting American Consumers Every Step of the Way: A Strategic Framework for Continual Improvement in Import Safety," September 10, 2007, p. 10, at (December 14, 2007).

[12]U.S. Department of Agriculture, "Production & Inspection."

[13]Mary Stanley, "Importing Meat, Poultry & Egg Products Into the United States," presentation before the Association of Food and Drug Officials 111th Annual Educational Conference, San Antonio, Texas, June 16, 2007, at (December 14, 2007).

[14]U.S. Department of Agriculture, "Production & Inspection."

[15]James Rice, "Food Safety Smarts," The Wall Street Journal, October 23, 2007, p. A2.

[16]Schmit, "U.S. Food Imports Outrun FDA Resources."

[17]Randall Lutter, Deputy Commissioner for Policy, Food and Drug Administration, "Regulation of Imported FDA-Regulated Products," statement before the Subcommittee on Health, Committee on Energy and Commerce, U.S. House of Representatives, September 26, 2007, at 14, 2007).

[18]Marian Burros, "F.D.A. Inspection Lax, Congress Is Told," The New York Times, July 18, 2007, at (December 14, 2007).

[19]Walker, "Federal Oversight of Food Safety," p. 5.

[20]Jane Zhang, "Food Makers Get Appetite for Regulation," The Wall Street Journal, September 17, 2007, p. A2.

[21]Interagency Working Group on Import Safety, "Action Plan for Import Safety: A Roadmap for Continual Improvement," November 6, 2007, at 14, 2007).

[22]Geoffrey S. Becker, "Food Safety: Selected Issues and Bills in the 110th Congress," Congressional Research Service Report for Congress, September 4, 2007, at 14, 2007).

[23]For listings of recalls, see U.S. Department of Agriculture, Food Safety and Inspection Service, "FSIS Recalls," Web site, at 14, 2007), and U.S. Food and Drug Administration, "Recalls, Market Withdrawals and Safety Alerts Archive," Web site, at (December 14, 2007).

[24]Interagency Working Group on Import Safety, "Import Action Plan for Food Safety."


[26]Walker, "Federal Oversight of Food Safety," p. 4.

[27]"U.S., China Sign Import Safety Agreements Covering Food, Feed and Drugs, Devices," Bureau of National Affairs Daily Report for Executives, No. 238, December 12, 2007.

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