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CDC: Foodborne Illness Numbers Down
by Dan Flynn | Apr 16, 2010
Since the bad old days of the late 1990s, federal food safety officials say the incidence of the best-known foodborne illnesses have been cut back. Shigella is down 55 percent, E. coli O157 is down 41 percent, Campylobacter is down 30 percent, and Salmonella is off by 10 percent.
Those were among the positive findings of the "Preliminary Foodnet Data on the Incidence of Infection with Pathogens Transmitted Commonly Through Food--10 States, 2009" as published in the Morbidity and Mortality Weekly Report (MMWR).
MMWR is published by the federal Centers for Disease Control and Prevention (CDC) in Atlanta and FoodNet is a data-sharing project involving ten states and the federal government.
The most dramatic reductions are found when 2009 was compared with the 1996-1998 period. Dr. Chris Braden, who heads up CDC's foodborne disease unit, said incident rates are mostly stable in more recent years. Braden's comments came in a telephone conference with reporters.
"We can say that since FoodNet began surveillance in 1996, Campylobacter, Listeria, Salmonella, Shiga toxin-producing Escherichia coli (STEC) O157, Shigella, and Yersinia, six of the pathogens we track, have all declined," he said.
Federal food safety officials from the Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), and CDC say more needs to be done to protect the public from foodborne pathogens.
Foodborne illness costs Americans $152 billion a year, according to a recent study by Georgetown University and the Pew Chartable Trusts. CDC blames foodborne illness for 76 million illnesses and 5,000 deaths annually in the U.S.
Vibrio infections, associated with eating raw or undercooked shellfish, increased by 85 percent from the late 1990s period used as a baseline. Most of those illnesses are from bad oysters and while the number is a small percentage of total foodborne illness, serious illnesses and even death can result.
The ten states that are involved in FoodNet have a population of about 46 million people or about 15 percent of the total U.S. population.
The full report is available online at For more information about FoodNet, please visit

Debate Over Antibiotic Use Continues
by Helena Bottemiller | Apr 19, 2010

Discussion on the link between antibiotic resistance in humans and the routine, subtherapeutic use of antibiotics in food animal production rolls on. For the past several weeks, congressional staff working on food, agriculture, and health issues have heard from both both sides of the debate with a series of briefings on the issue.
The uptick in discussion on Capitol Hill comes in the wake of a February CBS Evening News broadcast criticizing the widespread use of antibiotics in animal agriculture. The meat industry has been actively pushing back against the criticism, partly fueled by concern it could build momentum for legislation that would ban the subtherapeutic use of antibiotics in animal feed in an effort to curb growing antibiotic resistance in humans.
Consumer and public health groups, however, have been trying to capitalize on growing consumer awareness of antibiotic use to build just that momentum. "We're excited this message is getting out," Robert Guidos, vice president of public policy and government relations for the Infectious Diseases Society of America (IDSA) told Food Safety News.
Congresswoman Louise Slaughter (D-N), the only microbiologist serving in Congress, authored the Preservation of Antibiotics for Medical Treatment Act, commonly known as PAMTA, to address what she believes is a growing threat to public health.
The bill would require that the U.S. Food and Drug Administration (FDA), deny any new animal antibiotic drugs unless the federal government is certain the drugs will not contribute to antimicrobial resistance. The bill would also ban the routine, or nontherapeutic, use of antibiotics in food-producing animals.
"I cant stress enough the urgency of preventing the current stock of antibiotics from becoming obsolete," Slaughter told an audience of Hill staffers last Wednesday in a briefing sponsored by scientific and public health groups, including the Union of Concerned Scientists (UCS), the Pew Charitable Trusts, and the American Public Health Association (APHA).
"Resistant bacterial infections increase health care costs by $4 to 5 billion each year, a staggering amount. Seven classes of antibiotics certified by the Food and Drug Administration are considered to critical to humans," said Slaughter, adding that every day 38 people needlessly lose their lives to resistant infections.
"Make no mistake, the bill would not infringe in any way, on the use of the drugs to treat a sick animal," added Slaughter. "It simply prohibits their non therapeutic use unless the drug companies can prove the drugs do not promote antimicrobial resistance."
Further fueling the discussion, an Op-Ed titled "Cows on Drugs" by former FDA commissioner Donald Kennedy appeared in the New York Times Saturday. Kennedy called on Congress to pass PAMTA, which he believes is 30 years overdue."We don't have the luxury of waiting any longer," he wrote.
The meat and feed industry, as well as the American Veterinary Medical Association (AVMA), remain vehemently opposed to such a ban, and are actively engaging growing criticism. In a recent letter to CBS, several industry groups responded to the critical coverage, which they called "reckless and one-sided."
"In fact, antibiotics are given to livestock strategically, when animals are sick, susceptible or exposed to illness. Modern livestock production facilities provide animals with an environment designed to keep them safe, healthy and comfortable," read the letter, signed by over a dozen groups, including the American Meat Institute, the National Pork Producers Council, and the Association of Veterinarians in Turkey Production.
"Also, there's no proof that antibiotic use on farms significantly increases resistant bacteria in humans. Since antibiotics have been used in livestock for half a century, if there was going to be an epidemic of resistance related to antibiotic use in agriculture, it would have occurred by now. The fact that it has not means that antibiotic use in animals is not a major risk to human health," said the letter.
In its response, CBS said it respectfully disagreed and stood by the coverage. "Our reporting found decades of research in this country and abroad which link antibiotic resistance in humans to the use of antibiotics in food animal production."
"The challenging thing about this issue of antibiotic resistant organisms in agriculture, and being spread by food, is that it is no longer a question of science," said Maryn McKenna, author of Superbug, a book about the drug resistant staphylococcus aureus epidemic, who presented on the Hill last week.
"The scientific questions--does this happen, is agricultural antibiotic use causing it to happen, does it pose a threat to human health--have all been answered, and in each case the answer is Yes," said McKenna. "The questions that have to be answered now are questions of politics, economics and competing commercial interests, and those are much, much stickier."

Are U.S. regulators dropping the ball on biocrops.
By Carey Gillam, ReutersApril 16, 2010
COLUMBIA, Mo. - Robert Kremer, a U.S. government microbiologist who studies Midwestern farm soil, has spent two decades analyzing the rich dirt that yields billions of bushels of food each year and helps the United States retain its title as breadbasket of the world.
Kremer's lab is housed at the University of Missouri and is literally in the shadow of Monsanto Auditorium, named after the $11.8 billion-a-year agricultural giant Monsanto Co. Based in Creve Coeur, Missouri, the company has accumulated vast wealth and power creating chemicals and genetically altered seeds for farmers worldwide.
But recent findings by Kremer and other agricultural scientists are raising fresh concerns about Monsanto's products and the Washington agencies that oversee them. The same seeds and chemicals spread across millions of acres of U.S. farmland could be creating unforeseen problems in the plants and soil, this body of research shows.
Kremer, who works for the U.S. Department of Agriculture's Agricultural Research Service (ARS), is among a group of scientists who are turning up potential problems with glyphosate, the key ingredient in Monsanto's Roundup and the most widely used weed-killer in the world.
"This could be something quite big. We might be setting up a huge problem," said Kremer, who expressed alarm that regulators were not paying enough attention to the potential risks from biotechnology on the farm, including his own research.
Concerns range from worries about how nontraditional genetic traits in crops could affect human and animal health to the spread of herbicide-resistant weeds.
Biotech crop supporters say there is a wealth of evidence that the crops on the market are safe, but critics argue that after only 14 years of commercialized GMOs, it is still unclear whether or not the technology has long-term adverse effects.
But whatever the point of view on the crops themselves, there are many people on both sides of the debate who say that the current U.S. regulatory apparatus is ill-equipped to adequately address the concerns. Indeed, many experts say the U.S. government does more to promote global acceptance of biotech crops than to protect the public from possible harmful consequences.
"We don't have a robust enough regulatory system to be able to give us a definitive answer about whether these crops are safe or not. We simply aren't doing the kinds of tests we need to do to have confidence in the safety of these crops," said Doug Gurian-Sherman, a scientist who served on a FDA biotech advisory subcommittee from 2002 to 2005.
"The U.S. response (to questions about biotech crop safety) has been an extremely patronizing one. They say 'We know best, trust us,'" added Gurian-Sherman, now a senior scientist at the Union of Concerned Scientists, a nonprofit environmental group.
The World Health Organization has not taken a stand on biotech crops generally, simply stating "individual GM foods and their safety should be assessed on a case-by-case basis."
And while many scientists around the world cite research they say shows health and environmental risks tied to GMOs, many other scientists say research proves the crops are no different than conventional types.
With a growing world population and a need to increase food production in poor nations, confidence in the regulatory system in the leading biotech crop country is considered critical.
"One of the things that we think is important to do is to have regular reviews and updates of our strategies for regulating products of biotechnology," said Roger Beachy, a biotech crop supporter who was appointed last year as director of the National Institute of Food and Agriculture.
"We want to look carefully to see that they are logical and science-based but still maintain the confidence of the consumer to ensure that the projects that are developed and released have the highest level of oversight," added Beachy.
So far, that confidence has been lacking. Courts have cited regulators for failing to do their jobs properly and advisers and auditors have sought sweeping changes.
Even Wall Street has taken note. In January, shares in Monsanto fell more than 3 percent amid a rush of hedging activity during a morning trading session after a report by European scientists in the International Journal of Biological Sciences found signs of toxicity in the livers and kidneys of rats fed the company's biotech corn.
Monsanto has said the European study had "unsubstantiated conclusions," and says it is confident its products are well tested and safe.
Indeed, farmers around the world seem to be embracing biotech crops that have been altered to resist bugs and tolerate weed-killing treatments while yielding more. According to an industry report issued in February, 14 million farmers in 25 countries planted biotech crops on 330 million acres in 2009, with the United States alone accounting for 158 million acres.
A common complaint is that the U.S. government conducts no independent testing of these biotech crops before they are approved, and does little to track their consequences after.
The developers of these crop technologies, including Monsanto and its chief rival DuPont, tightly curtail independent scientists from conducting their own studies. Because the companies patent their genetic alterations, outsiders are barred from testing the biotech seeds without company approvals.
Unlike several other countries, including France, Japan and Germany, the United States has never passed a law for regulating genetically modified crop technologies. Rather, the government has tried to incorporate regulation into laws already in existence before biotech crops were developed.
The result is a system that treats a genetically modified fish as a drug subject to Federal Drug Administration oversight, and a herbicide-tolerant corn seed as a potential "pest" that needs to be regulated by USDA's Animal Plant Health Inspection Service (APHIS) before its sale to farmers.
The process is also costly and time-consuming for biotech crop developers, which might need to go through three different regulators before commercializing a new product.
Nina Fedoroff, a special adviser on science and technology to the U.S. State Department, which promotes GMO adoption overseas, said even though she is confident that biotech crops are ultimately safe and highly beneficial for agriculture and food production, an improved regulatory framework could help boost confidence in the products.
"We preach to the world about science-based regulations but really our regulations on crop biotechnology are not yet science-based," said Fedoroff in an interview. "They are way, way out of date. In many countries scientists are much better represented at the government ranks than they are here."
Agriculture Secretary Tom Vilsack, a former governor of top U.S. corn producing state Iowa, also said he recognizes change is needed. The USDA is in fact developing new rules for regulating genetically modified crops but the process has dragged out now for more than six years amid heavy lobbying from corporate interests and consumer and environmental groups.
"There is no question that our rules and regulations have to be modernized," Vilsack told Reuters. "The more information you find out, the more you have to look at your regulations to make sure they are doing what they have to do. There are some issues we are still grappling with."
Fourteen years after commercialization of the world's first biotech crop, the trio of U.S. regulatory agencies charged with overseeing biotech crops . USDA, the Environmental Protection Agency, and the U.S. Food and Drug Administration . are under attack on several fronts.
The USDA is most directly in the line of fire after a string of federal court decisions found its officials acted illegally or carelessly in approving some biotech crops.
In one recent case, a federal court banned the sale of a herbicide-tolerant alfalfa engineered by Monsanto until the government more thoroughly evaluates its safety.
U.S. District Court Judge Charles Breyer of the Northern District of California ruled that the USDA violated federal law in allowing unrestricted commercial planting of "Roundup Ready" alfalfa . a key livestock fodder . without a solid review.
Breyer ordered the USDA to prepare an environmental impact statement that explores potential negative consequences that critics say could include contamination of non-GMO alfalfa fields. The spread of herbicide-tolerant weeds is also a concern and is a mounting problem that has been reported across the United States in many key farming areas.
Monsanto has appealed the ruling and the U.S. Supreme Court will hear the case on April 27, marking the first time the high court has taken up biotech crop concerns.
Meanwhile, the USDA recently completed its Environmental Impact Statement and took public comments on the report through early March. The department has yet to issue a final report.
In a similar case, a federal court found that sugarbeets altered to be "Roundup Ready" were approved without adequate USDA evaluation.
U.S. District Court Judge Jeffrey White said the government's decision to deregulate Roundup Ready sugar beets "may significantly affect the environment" and he encouraged growers to "take all efforts, going forward, to use conventional seed."
Judge White declined to immediately ban all GMO sugarbeet plantings, but said he would consider a permanent injunction at a hearing on July 9.
Andrew Kimbrell, executive director of the Center for Food Safety, which filed the sugarbeet lawsuit, said the court actions should be a "wakeup call" for the U.S. government.
"They will not be allowed to ignore the biological pollution and economic impacts of gene-altered crops. The courts have made it clear that USDA's job is to protect America's farmers and consumers, not the interests of Monsanto," he said.
The USDA, EPA and FDA say they work hard to ensure that crops produced through genetic engineering (GE) for commercial use are properly tested and studied to make sure they pose no significant risk to consumers or the environment.
But a November 2008 report by the Government Accountability Office, the investigative arm of the U.S. Congress, cited several problems. Among the shortcomings mentioned in the report is a lack of a coordinated program to determine whether the "spread of genetic traits is causing undesirable effects on the environment, non-GE segments of agriculture, or food safety."
The GAO took the FDA to task for not requiring companies like Monsanto and other GMO developers to notify the agency before selling new products, relying on only voluntary notice. It recommended the FDA publicize the results of food safety assessments of genetically engineered crops and advised the three agencies to develop a risk-based strategy to monitor use of GE crops.
But more than a year later, most of the recommendations remain unimplemented, according to Lisa Shames, director of the natural resources and environment arm of the GAO.
"We can only influence agencies to take action. We can't compel them to," she said.
Since 1987, the USDA has overseen genetically modified organisms through the Animal and Plant Health Inspection Service. APHIS's Biotechnology Regulatory Services (BRS) regulates GE organisms based on "plant pest risk."
Monsanto and other biocrop developers must petition APHIS to grant their genetically altered organisms "nonregulated status" . that is, permission to grow these plants without official oversight. To win approval, the companies must demonstrate that their tests show the new varieties do not pose a risk to plant health.
"APHIS grants nonregulated status only when it determines that the new genetically engineered variety is unlikely to pose a plant pest risk," said USDA spokesman Michael Pina, who labeled the current regulatory system "strong."
USDA has said it wants to make changes that ensure safety while making the process more transparent to the public, and more efficient and easier for the companies developing the technologies to navigate.
Still, the USDA has been formally debating regulatory changes for more than six years and issued proposed new rules in fall 2008, allowing public comment through last summer, as it must under the law.
The proposed overhaul drew more than 15,000 comments, many of them expressing fears that the regulatory changes as laid out would not address key concerns.
In one public comment, physician Amy Dean, a board member for the research and education group American Academy of Environmental Medicine which is seeking a moratorium on GM food, said the proposed changes would "significantly weaken or eliminate oversight of GM crops."
And Robert Peterson, a Montana State University scientist and leader of the university's "biological risk assessment" program, told regulators that while he agreed with some of the proposed regulatory changes, he thought the agency's risk assessment protocols were "fundamentally flawed."
"Recent research reveals that the approach advocated by APHIS is not scientifically sound and can lead to bad decisions," Peterson said.
At the FDA, genetically engineered organisms are treated much the same as foods from all other plant varieties.
GE developers are not required to consult with FDA on safety issues, and the agency sees no need now for risk-based monitoring efforts for GE crops because there are no current safety concerns, FDA spokeswoman Rita Chappelle said.
The agency stressed that the burden for ensuring safety lies with the companies. "Manufacturers have an obligation to ensure that their products continue to be safe each and every day," Chappelle said.
At the EPA, officials also say the burden of proof is with the corporate developers of the technology. And they say they have at least 20 scientists conducting comprehensive analyses for the products that come before the agency, such as BT corn and BT cotton, which are altered to protect the plants against pests. The agency also routinely seeks outside advice from experts who sit on its scientific advisory panels.
Over the last several months, the EPA has also started allowing more public input into its review of new products.
"Transparency and open government is a major priority of the Obama administration. We are adding a significant amount of public participation," said Keith Matthews, acting director of the U.S. Biopesticides and Pollution Prevention Division.
Further to its mission of environmental protection, EPA officials said the agency reviews products every 15 years for adverse effects. EPA senior policy advisor Bill Jordan said glyphosate, the popular weed-killing chemical, could come under review soon.
"We have an ongoing responsibility to make sure products that are in the marketplace continue to meet the safety standards of the pesticide law," he said. "We have a program called registration review. Sometime soon we'll be getting to glyphosate. I would expect that we would look at emerging research on its environmental effects and see whether that leads us to change the terms and conditions of registration or limit its use in some way."
Concerns about genetically altered crops and the lack of broad testing hit a boiling point last year. In February 2009, 26 leading academic entomologists . scientists specializing in insects . issued a public statement to the Environmental Protection Agency complaining that they were restricted from doing independent research by technology agreements Monsanto and other companies attach to every bag of biotech seed they sell. The agreements disallow any research that is not first approved by the companies.
"No truly independent research can be legally conducted on many critical questions regarding the technology," the scientists said in their statement.
University of Minnesota entomologist Ken Ostlie, who co-authored the statement, said some of the concerns involve corn engineered to resist corn rootworm pests. Biotech corn crops in Minnesota, Iowa, and parts of Wisconsin and South Dakota harvested last fall showed damage and disease, and some fear the biotech corn could sicken livestock.
"We don't know if something is going on with the plant and the technology or with the insect. We just know things didn't work the way they were supposed to," said Ostlie. "It would be nice to have independently verifiable information going into EPA's decision-making beyond just what the company provides."
Christian Krupke, an entomologist at Purdue University, said the technology engineered into the plants has many benefits, but more research is needed on effects.
"We are all fans of this technology. The problem is we are not getting access to ask the questions that need to be asked that maybe the companies don't want to ask," Krupke said.
A backlash against biotech crops has swept many countries. India became one of the latest hot spots in February when biotech opponents created such an uprising that the Environment Minister, Jairam Ramesh, blocked the release of a genetically modified eggplant made by Monsanto.
India already allows planting of altered cotton, but Ramesh said there was not enough public trust to support the introduction of a GM food crop until more research was done.
Among the critics of the engineered eggplant was Tiruvadi Jagadisan, a former managing director of Monsanto's India operations.
In an interview with Reuters, Jagadisan, who worked with Monsanto for 18 years, said he believed there were "very many legitimate concerns about the safety of GM food crops for humans, animals and the environment." He said Monsanto did not give "accurate information to the public" about its eggplant.
"No extensive tests have been done to assess the effect of consuming GM crops on future generations," Jagadisan said, an assertion common among critics, but one Monsanto has repeatedly denied.
Monsanto called Jagadisan's assertions "baseless" and said India's regulatory regime requires "extensive and rigid crop safety assessments, following strict scientific protocols."
The state department's Fedoroff, a supporter of Monsanto's technology, called the incident "one little setback" to gaining worldwide acceptance of biotech crops.
She said with rising food prices and population growth, biotech crop technology will become increasingly important, and criticisms of Monsanto and its technology were unfair.
"They've certainly made mistakes but they've done a whole lot more good than harm. They are investing more in crop improvements than our government is," she said.
Back in his USDA laboratory, Kremer's assigned government work is focused on general soil quality. As a side project in support of that research, he has spent the last several years studying soil and plant growth tests that appear to show ravaged root systems in biotech "Roundup Ready" plants.
The crops have been subjected to glyphosate applications and on the surface appear to be impervious to the weed-killing treatments as the genetic alteration allows. But the roots seem to tell a different story.
"This is supposed to be a wonderful tool for the farmer ... but in many situations it may actually be a detriment," Kremer said. "We have glyphosate released into the soil which appears to be affecting root growth and root-associated microbes. We need to understand what is the long-term trend here," he said.
The development of crops engineered to tolerate glyphosate spurred a surge in use of the chemical . an extra 383 million pounds were sold from 1996 to 2008, according to a report released by The Organic Center (TOC), the Union for Concerned Scientists (UCS) and the Center for Food Safety (CFS).
Monsanto says the chemical binds tightly to most types of soil, is not harmful and does not harm the crops.
But some scientists say there are indications of increased root fungal disease as well as nutrient deficiencies in Roundup Ready crops. They say manganese deficiency in soybeans in particular appears to be an issue in key farming areas that include Indiana, Michigan, Kansas and Wisconsin.
Outside researchers have also raised concerns over the years that glyphosate use may be linked to cancer, miscarriages and other health problems in people.
Monsanto says extensive research shows glyphosate is safe for humans and the environment, and has an entire section on its website devoted to refuting the reports. Monsanto says extensive investigation of questions about changes in soil micro-organisms has found no long-term ill effects.
Peering into into his petri dishes, Kremer isn't so sure.
"Science is not being considered in policy setting and deregulation," said Kremer. "This research is important. We need to be vigilant."
REUTERS Reut14:57 04-13-10

Raw Milk: An Issue of Safety or Freedom.
by Drew Falkenstein | Apr 19, 2010
One need not look far to grasp the scope of this country's food safety problems, and the personal devastation that can happen when somebody is infected by E. coli, Salmonella, Campylobacter, or any other foodborne pathogen.
Stephanie Smith, who, at the time of her illness, was a 19-year-old dance instructor from Cold Springs, Minnesota, suffered an E. coli O157:H7-hemolytic uremic syndrome illness so severe that it left her paralyzed (See Dancer Paralyzed by E. coli Sues Cargill, Dec. 5, 2009). And Linda Rivera, who was sickened from contaminated Nestle cookie dough, was just flown from a Las Vegas Hospital to a long-term rehabilitation center after almost a year-long hospitalization from her own E. coli O157:H7 infection.
But there is one particular food product that has become as much a political issue as it is an issue of food safety. It has been the source of fierce legislative battles throughout the country; an endlessly interesting topic for bloggers and traditional media alike; and the ultimate source of a number of major personal injury cases. It is raw milk--an unpasteurized, back-to-our-roots fluid milk product that, despite its seemingly benign persona, has raised questions about unwarranted and unconstitutional government intrusion into private affairs, and how best to spite the government's regulatory efforts.[1]
The raging debate over raw milk is largely the product of a grassroots campaign aimed at food decentralization, which has gained a much larger voice in the wake of a long list of food poisoning outbreaks linked to mass-produced food products, including Dole baby spinach, Nestle's cookie dough, and countless ground beef, meat, and other widely distributed products.
But the debate over raw milk is different than the debate over safe food generally because the vocal minority that consumes the product, or at least wants to, elects to either ignore the real risks associated with the product, or chooses to consume raw milk knowing full well the risks that it poses. The latter group, in fact, is gaining many more members nationally in the wake of a string of outbreaks linked to raw milk. Thus, at least the debate has crystallized, and now largely involves a vocal group of well-educated consumers who understand the risk, but choose to take it nonetheless.
Whatever the case, the federal government's stand on raw milk is unequivocal. The Food and Drug Administration bans the interstate trade of raw milk entirely; and most states heavily regulate the production and intrastate sale of raw milk, if they permit it at all. But many raw milk proponents feel individually, and very personally, wronged by what they see as governmental meddling in private affairs--some going so far as to call the ability to purchase and consume raw milk a fundamental constitutional right:
According to the founding documents of the United States, personal liberties are self-evident and inalienable rights, not privileges endowed by state health departments, federal bureaucracies, or personal injury lawyers. There is no scientific evidence to justify the singling out of raw milk from among other foods for prohibition or damaging regulation, and there is no legitimate constitutional or philosophical basis on which Americans or anyone else should be deprived of the basic human right to determine what to eat and drink. See
Regardless of whether one believes he should be allowed to eat whatever he wants, there exists no tool to prevent the several states and the federal government from regulating the production and distribution of raw milk. States have the authority in the exercise of their general police powers to enact measures to protect the health, safety, and welfare of their citizens. Brecht v. Abrahamson, 507 U.S. 619, 635, 123 L. Ed. 2d 353, 113 S. Ct. 1710 (1993); see also Sligh v. Kirkwood, 237 U.S. 52, 59-60, 35 S.Ct. 501 (1915) ("The power of the State to . . . prevent the production within its borders of impure foods, unfit for use, and such articles as would spread disease and pestilence, is well established"). This power is bounded only by principles of federalism, generally, and by the protections afforded all persons within a state's borders by the equal protection and due process clauses of the 14th Amendment.
The federal government, in contrast, is one of enumerated powers, meaning that it can act only where it has the constitutional authority to do so. As James Madison wrote,
[t]he powers delegated by the proposed Constitution to the federal government are few and defined. Those which are to remain in the State governments are numerous and indefinite.
The Federalist No. 45, pp. 292-293 (C. Rossiter ed. 1961).
Among the powers specifically delegated to the federal government is the power "[t]o regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes." U.S. CONST. art. I, ¡× 8, cl. 3. The "commerce clause" has, of course, become a particularly potent regulatory enabler that, as a result, has spawned a notoriously complex body of case law. See generally United States v. Lopez, 514 U.S. 549 (1994) (Kennedy, J., concurring). For present purposes, however, it suffices to say that the commerce clause has provided the constitutional authority[2] for a great many landmark legislative and regulatory measures.
The commerce clause unquestionably gives Congress the authority to prohibit the interstate distribution of raw milk, by sale or otherwise, even without resort to the Supreme Court's historically disjointed commerce clause analysis. The reason is that the interstate distribution of raw milk is, in and of itself, "commerce . . . among the several States." As a result, it can be regulated "to its utmost extent." Gibbons v. Ogden, 9 Wheat. 1, 196 (1824). Congress has done exactly this in enacting 21 CFR 1240.61(a), which prohibits the delivery "in interstate commerce [of] any milk or milk product in final package form for direct human consumption unless the product has been pasteurized."
But the more intriguing question is how far Congress's regulatory power actually extends with respect to the manufacture and distribution of raw milk. Is it broad enough to outlaw the sale of raw milk entirely. Stated another way, does the fact that raw milk is produced, and frequently even sold only locally (i.e. not interstate commerce per se) insulate it from Congress's potentially, if not theoretically, apocalyptic reach.
Out of the difficult analytical framework has emerged a line of precedents approving Congress's regulatory efforts, even with respect to intrastate commerce, that has a "substantial economic effect on interstate commerce." See Wickard v. Filburn, 317 U.S. 111, 125 (1942) (emphasis added). "[E]ven if appellee's activity be local and though it may not be regarded as commerce, it may still, whatever its nature, be reached by Congress if it exerts a substantial economic effect on interstate commerce." Id.
Thus, under the Court's current commerce clause analysis at least, the question is ultimately whether local production and distribution of raw milk "substantially affects" interstate commerce. Notably, there have been many seemingly local endeavors that did not harmoniously persist as "merely local" upon Supreme Court scrutiny. See e.g., Wickard, 317 U.S. 111 (1942) (the production and consumption of home-grown wheat); Katzenbach v. McClung, 379 U.S. 294 (1964) (restaurants utilizing substantial interstate supplies); and Heart of Atlanta Motel, Inc. v. United States, 379 U.S. 241 (1964) (inns and hotels catering to interstate guests).
Without predicting the precise boundaries of Congress's power to regulate the production and distribution of raw milk, it suffices to say that it has not come close to exhausting its potential reach by merely enacting 21 CFR 1240.61(a). Again, the shipment of raw milk across state lines is interstate commerce in and of itself, and the power of Congress over that particular species of raw milk distribution is bounded only by an as-yet undefined, and at best highly nebulous, personal freedom to consume raw milk. The better question is how far Congress's reach actually extends into the modes and channels of production and distribution; and the answer is that the power is potentially very broad.
Nevertheless, proponents of raw milk are nothing if not resilient and devoted to their cause. In the face of wide-ranging regulation of their prized product, they continue to seek out creative ways to undermine the opposition, persisting in their mantra that the intrusive efforts of the state and federal governments are acts of unwarranted, legally unjustified bullying.
In this vein, and serving as an implicit acquiescence to the constitutional authority of the states and federal governments to regulate their product, raw milk proponents continue to try to navigate the unfriendly legal waters in which they find themselves. The result of some of their steadfast work are cow-share (or herd-share) agreements, which seek to insulate purveyors of raw milk from state and federal regulation by allowing consumers to purchase shares in a specific cow or herd instead of paying money directly for milk. The logic, of course, is that state and federal regulation cannot reach this conduct because it does not involve the specific sale of raw milk.
I have addressed these agreements before, concluding:
Truly, to call a cow share agreement a species of legal maneuvering may be giving too much credit to an effort that is designed either to flout the law entirely, or at the very least avoid the often stringent requirements associated with licensure. In reality, cow shares are poorly disguised attempts to accomplish something that is, in most states, patently criminal. As a result, when judging whether such conduct constitutes the sale or distribution of raw milk, courts are likely to approach these cases with a healthy dose of realism in determining what the parties' true intent was, whether the forum be civil or criminal court.
See Cow Share Agreements: Fooling Nobody, Food Safety News, Nov. 9, 2009
Many states have confronted cow and herd-share agreements head-on, and most have closed the legislative loophole by specifically outlawing the practice. But not even that has deterred proponents of raw milk; it has, in fact, forced some into ever-more-dangerous, and highly illegal, distributive schemes, including placing a "pet food only" label on raw milk that they know, or have reason to know, will or may be consumed by human beings. Alaska, Colorado, and North Carolina require raw milk to be dyed before being marketed as pet food in order to address this problem specifically.
But, clearly, this type of despicable mislabeling would be illegal in more than just those three states, regardless of the dye requirement. In most states, it would violate consumer protection laws; and additionally would make the job of trial lawyers representing kids who have been sickened by the product a lot easier, as the "pet food only" label is more than an implicit admission that the product is not fit for human consumption and is, as a result, unreasonably dangerous and defective. Punitive damages, in states where they are available, would be sought with gusto.
These and other issues in the raw milk debate are not likely to go away soon; as a result, neither will the outbreaks nor the major personal injuries that can and do occur by consuming this unpasteurized product. In the midst of all this, small-scale farmers and dairies, and other purveyors of raw milk, are well-advised to live with the regulations in place in their home states. From a legal standpoint, there is simply no constitutional argument to be made that state and federal regulations are invalid as a class, and attempts such as the cow-share agreements and "pet food only" labeling that we have witnessed thus far only perpetuate the reality that the exchange is one that the law simply does not permit.
1. At a recent pro-raw milk symposium in Madison, Wisconsin, the keynote presentation, given by dairyman Mark McAfee, was titled "Raw milk as medicine Proudly violating FDA drug laws."
2. Cf. Gonzalez v. Raich et al, 545 U.S. 1, 34 (2005) (Scalia, J., concurring) ("[A]ctivities that substantially affect interstate commerce are not themselves part of interstate commerce, and thus the power to regulate them cannot come from the Commerce Clause alone. Rather as this Court has acknowledged since at least United States v. Coombs, 37 U.S. 71, 12 Pet. 72, 9 L. Ed. 1004 (1838), Congress's regulatory authority over intrastate activities that are not themselves part of interstate commerce [] derives from the Necessary and Proper Clause [set forth at U.S. CONST. art. I, ¡× 8, cl. 18]).

Tracing Listeria monocytogenes in a Commercial Chicken Cooking Plant
By Sharon Durham
April 19, 2010
Incoming raw poultry is the primary source of Listeria monocytogenes contamination in commercial chicken cooking plants, according to a 21-month study conducted by Agricultural Research Service (ARS) scientists and their collaborators at the University of Georgia.
The study¡¯s results will help these facilities more sharply focus their sanitation processes to reduce cross-contamination. L. monocytogenes is a bacterial human pathogen that is sometimes found in fully cooked, ready-to-eat processed meat and poultry products.
By testing a brand-new commercial cooking facility before and after processing began, the research team was able to track sources of contamination. The research team was led by ARS microbiologist Mark Berrang of the Bacterial Epidemiology and Antimicrobial Resistance Research Unit at the agency¡¯s Richard B. Russell Research Center in Athens, Ga.
Because the pathogen is prevalent in the environment and in various forms, there were several potential sources of contamination, including employees, incoming fresh air, raw meat and the surrounding environment.
Potential sources of L. monocytogenes were tested by taking samples of soil and water around and near the facility exterior, and by testing heavily traveled floor surfaces following personnel shift changes. Samples were also collected and tested from incoming air from air vent filters and from monthly swabs of incoming raw meat. The plant was free of L. monocytogenes when first constructed; floor drains in the facility were sampled approximately monthly to determine at what point the plant would become colonized with the bacteria.
Within four months of operation, L. monocytogenes was detected in floor drains, indicating that the organism had been introduced from some outside source. No L. monocytogenes was recovered from any floor samples in the plant entryways, locker room or cafeteria. Likewise, the organism was not detected on air vent filters during the survey. The only tested source found to be consistently positive for L. monocytogenes was incoming raw poultry meat.
Quality assurance in the test plant was exceptional and included an extensive proactive sampling plan to assure food safety. L. monocytogenes can become prevalent in food processing environments; sanitation, biosafety and product sampling protocols are in place in these facilities to prevent shipping contaminated product.
This research was reported in the Journal of Food Protection. Co-authors included ARS microbiologist Richard Meinersmann in Athens, University of Georgia scientist Joseph Frank, and former ARS researcher Scott Ladely.
ARS is the principal intramural scientific research agency of the U.S. Department of Agriculture (USDA). The research supports the USDA priority of ensuring food safety.

USDA to Award School Food Safety Grant
by Helena Bottemiller | Apr 20, 2010

As part of its initiative to improve school lunch safety, the U.S. Department of Agriculture (USDA) is accepting grant applications from universities to establish a center of excellence for school food safety research. The agency will grant one award of $800,000 for FY 2010 to establish the research center.
The center's mission will be "to provide science-based support to improve the safety of foods provided through the [Food and Nutrition Service] nutrition assistance programs, particularly those served in schools and child care settings," according to USDA.
"The center will be established at a university that has an interdisciplinary group of faculty available to address food safety issues, including but not limited to, expertise in food safety, food microbiology, foodservice management, agricultural production (both livestock and plants), psychology, sociology, research design, and statistics."
The grant is part of a series of initiatives, announced by USDA in early February, to improve the safety and quality of food purchased for the National School Lunch Program and other federal nutrition assistance programs, including new food safety purchasing requirements for its beef suppliers and a thorough review of the entire program by the National Academies of Science (NAS).
The USDA's new policy initiatives were announced in the wake of increased national attention to school lunch safety after a series of USA Today exposes found major gaps in the current system. A recent New York Times article also questioned the efficacy and safety of an ammonia processing technique used in ground beef widely purchased by the school lunch program.
"Nothing is more important than the health and well-being of our Nation's school children," said Agriculture Secretary Tom Vilsack when he announced the food safety initiative. "We must do everything we can to ensure that our kids are being served safe, high quality foods at school. Today's announcement demonstrates our commitment to constantly improving the safety and quality of foods purchased by USDA."
The agency is currently accepting applications. The USDA's formal request for applications, with all the details, is available here.

ABC Grills Vilsack on Meat Residues
by Helena Bottemiller | Apr 20, 2010
In response to the recent U.S. Department of Agriculture (USDA) Office of the Inspector General (OIG) report, which found that the agencies responsible for monitoring veterinary drug, heavy metal, and pesticide residues are "not accomplishing" their mission, ABC News anchor Ron Claiborne sat down with Agriculture Secretary Tom Vilsack to discuss the findings.
"I think the report was valuable in pointing on some deficiencies that occurred in 2007 and 2008 and we, in 2010, are going try to make sure that we do a better job," Vilsack told ABC News in the interview.
"But, can the public be assured that beef with potentially dangerous substances is not on the market.," Claiborne asked.
"I think that they can because of the focus President Obama has placed on food safety," said Vilsack, noting the creation of the President's Food Safety Working Group (FSWG), which he said is "working hard" to improve the federal food safety system.
In the interview, Claiborne continued to press Vilsack on the issue of consumer safety. "Are inspectors catching all of the beef that may contain potentially dangerous substances, now."
In a typical Washingtonian move, Vilsack artfully dodged the question. "I think they're in the process of improving what they do," he said. "You never have perfection, you strive towards perfection."
"Overall if you take a look at the safety record of what we have today, I think we can assure people that we have a safe and ample supply of food in this country," he added. "What people need to understand and appreciate is that we are taking this report very seriously and we're following up on the recommendations."
What did Vilsack find most alarming about the report. The lack of any concerted recall effort when meat failed residue testing. As Vilsack explains in the interview, FSIS does not have the authority to mandate a company recall of meat found to have excessive levels of antibiotics, heavy metals, or pesticides.
"There's the ability to ask the supplier to recall, but statutorily we do not have the power," he explained. "The power we have is the capacity for us to remove our inspectors from a plant, which effectively shuts down the plant. In terms of mandatory recall authority, we don't have that."
"It's clear when there is a problem with a lab test failing that there should be more aggressive recall efforts, that's clear," he said. "It's also clear we need to do a better job of more frequent testing."
"We are really focused on trying to reassure the consuming public of the safety of food, that's our responsibility," he added. "It's also an effort on our part to make sure that farmers and ranchers are protected, because obviously when there's a food scare it impacts the market."
"It's food safety, it's personal safety, it's health, and it's also protection of the market."

Jim Orchard in Pittsburgh Hospital with Guillain-Barre Syndrome caused by Campylobacter-tainted Raw Milk
Team 4 investigator Jim Parsons reports tonight that 67-year old Jim Orchard drank a bottle of raw milk and is now in intensive care, unable to move.
"They were saying the health benefits, and it was a healthy thing to do, and we like the taste of it," said Orchard's wife, Maureen.
The Orchards purchased their milk from Pasture Maid Creamery in New Castle. They didn't know that state officials told consumers in February 2009 to discard Pasture Maid Creamery's milk because it contained pathogenic bacteria . Campylobacter - and last month, it happened again. The state agriculture department has suspended the milk production permit of Pasture Maid Creamery.
State health officials say approximately 10 people became ill after drinking raw milk from Pasture Maid Creamery. Among them were Maureen Orchard, her husband, Jim, and her daughter. Everyone got well except Jim Orchard, who was diagnosed with Guillain-Barre syndrome, a disorder that attacks the nervous system. He's paralyzed at UPMC Presbyterian hospital.
"Nobody can give you a timeline. With everyone, it's different. And he needs extensive physical therapy, and what that will entail, we have no idea," Maureen Orchard said.
This is exactly what happened to Mari Tardiff during the Alexandre Eco Farms Dairy Raw Milk Campylobacter Outbreak in 2008. On the weekend after Mari drank raw milk, she developed flu-like symptoms, including diarrhea and vomiting. By Thursday, June 12, the food poisoning was overwhelming her body with an amazingly swift force. First her vision blurred. Then her hands went numb. Mari went to an emergency room, and there lab work was done and abdominal X-rays were taken. But doctors could not determine what was wrong. On Friday, Peter took Mari to a neurologist. An MRI was normal but the doctor and radiologist mentioned a frightening possibility . Guillain-Barre syndrome, a potentially fatal inflammatory disorder.
Hours later Mari¡¯s legs were on fire, searing with pain that, ironically, only hot water helped to soothe. Her legs hurt so much that she soon retreated to bed, wrapping her legs in warm towels and a heating blanket. During that night, Mari awoke and realized she could not move. Peter bear-hugged her to lift her to the toilet and then carried her back to bed. In the early hours of the morning, he called for help, which led to an ambulance ride to the small Sutter Coast Hospital, and then a medivac flight to the Intensive Care Unit at the larger, better-equipped Rogue Valley Medical Center (RVMC) in Medford, Oregon. She remained hospitalized for two and one-half months.
Mari was moved to Redding Rehabilitation Hospital and was finally able to come home on November 1, 2008. Today, Mari lives in her family room, which now is equipped with a hospital bed, portable toilet, a Hoyer lift and a stand-up frame, all purchased by the Tardiffs. Using their own resources, they also renovated a downstairs half-bath and laundry room into a handicapped-accessible bathroom and shower. The Tardiffs pay two nurses $10.50 an hour to care for Mari from 7:30 A.M. until 7:00 P.M. five days a week while Peter is at work. Home health physical and occupational therapists also come to the house five days a week.
Mari still works very hard at therapy but it is a slow, painful process. Peter has found it so upsetting that he no longer can watch. Every improvement is celebrated, but he knows how much discomfort and frustration goes into each minute, regained movement. Mari may never walk again. She lost her job, she lost her dreams and plans that she held dear. The illness has been a long, arduous journey for Mari, her family and friends, and while she has made progress, there remains a long way to go:

FSIS Progress Report on Salmonella in Meat and Poultry

Posted on April 21, 2010 by Drew Falkenstein
In 1996, the USDA's Food Safety and Inspection Service established the HACCP (hazard analysis and critical control points) rule to verify that establishments have consistent process control for preventing, eliminating, or reducing the contamination of raw meat and poultry products with disease-causing bacteria like Salmonella, E. coli O157:H7, and campylobacter. The rule, in part, sets performance standards for foodborne pathogens that slaughter establishments, and establishments that produce raw ground products, need to meet.
The FSIS recently released its 2009 progress report for Salmonella, specifically, on raw meat and poultry products:
In calendar year 2009, FSIS analyzed 29,116 verification samples across eight meat and poultry product classes with the following percent positive rate of Salmonella per product class: broilers (7.2%), market hog (2.3%), cow/bull (0.6%), steer/heifer (0.2%), ground beef (1.9%), ground chicken (18.2%), ground turkey (10.7%) and turkey (3.8%).
Sounds like a lot of salmonella, particularly on broilers, ground chicken, and ground turkey. As for broilers, the 7.2% contamination rate is actually a reduction, down from 7.3%, 8.5%, and 11.4% in 2008, 2007, and 2006, respectively. Ditto for ground chicken and ground turkey, though the percentage of those raw products that are contaminated remains quite high. The figure below tracks the incidence of salmonella in raw product over the course of the last decade:

Dingell to Senate: 'Now is the time'

by Helena Bottemiller | Apr 21, 2010

Congressman John Dingell (D-MI), currently the longest-serving member of Congress and a fierce advocate for tougher food safety laws, is again calling out the Senate for stalling on pending food safety legislation to modernize the U.S. Food and Drug Administration.
"Americans are being forced to play a game of Russian roulette with the food they eat," wrote Dingell, in an Op-Ed in POLITICO yesterday. "[L]egislation that could transform the nation's food-safety laws continues to languish in the Senate, while American families are forced to hope for the best and fear the worst."
As Dingell notes, the Senate was widely expected to take up the FDA Food Safety Modernization Act, S. 510, for a vote this week, but Democratic leadership decided to instead focus on financial regulatory reform.
The House passed a similar, but stricter, bill with bipartisan support in July. The Senate version has remained stalled behind other priorities--namely health care reform--since it was unanimously voted out of committee in mid-November. According to Dingell, the legislation would make "the most fundamental changes in our food-safety laws since 1938."
"I know there are many lawmakers, on both sides of the aisle, who care deeply about this," he wrote. "I am appealing to them to move this bill. President Barack Obama has said he wants something done. Now is the time to make it happen."
In the article, Dingell emphasizes the importance of timing amidst a jam-packed legislative agenda. "It is easy to lose sight of the importance of addressing food safety without a major outbreak in the news. And it will be easier to overlook the importance of the issue as we wade deeper into partisan divisions over financial regulatory reform and Supreme Court matters."
"But we delay action on this bill at the peril of the American people. We cannot wait for another outbreak before we act," he added. "To put the Senate's delay to act on similar legislation in perspective, since the bill passed the House, more than 150 food-related safety alerts, market withdrawals and recalls have been issued by the FDA and the food industry."
"There are moments when problems are identified, appropriate solutions crafted and yet no action is taken to remedy the maladies of the American people. These moments are rare and unfortunate."
"The House has taken appropriate action," wrote Dingell. "The longer the Senate delays action, the longer a remedy to a serious problem remains."
The timing of the FDA food safety bill remains uncertain. Meanwhile, the opposition from small, sustainable farmers is growing, and negotiations over the final package of amendments are ongoing.

R-CALF Says Small Plants Need a Break
by Dan Flynn | Apr 21, 2010
The Ranchers-Cattlemen Action Legal Fund, United Stockgrowers of America, known as R-CALF USA, wants the U.S. Department of Agriculture's Hazard Analysis and Critical Control Point abandoned or revamped with an alternative meat inspection protocol.
The Billings, MT-based beef producer organization formally requested the action in a letter to USDA Secretary Tom Vilsack this week. R-CALF USA says recently mandated increased microbial testing is not focused on large slaughter plants, but rather small downstream processors.
."...We are pleased the FSIS is admitting that substantial amounts of hazardous meat currently is shipped into commerce, in spite of the fact that the largest slaughter plants have now operated under HACCP for 12 years," the letter states. "We are dismayed, however, that the agency's increased validation demands are being focused primarily against the processing plants further downstream, the vast majority of which totally depend on meat purchased from upstream, source-slaughter providers...
"...FSIS-style HACCP has resulted in ongoing outbreaks and recurring recalls, which the agency uses as justification for increased microbial testing because HACCP plants ship such a high volume of hazardous raw meat and poultry into commerce bearing the official USDA Mark of Inspection," the letter also states. ..
Central to R-CALF USA's food safety beliefs is that corrective actions must be implemented at the source-slaughtering plant (origin) of contaminated meat, rather than at destination plants, which essentially are powerless over the sanitation conditions at their source-slaughter providers.
R-CALF says it is greatly concerned the agency's increased focus will not only create budgetary concerns that will remove the majority of small plants from federal and state inspection, but also will simultaneously insulate the true source of contaminated meat from adequate agency oversight, virtually guaranteeing ongoing shipment of hazardous meat into commerce. .
."The fact that FSIS strongly recommends the testing of incoming product constitutes an agency admission that the large source-slaughter plants continue to ship large amounts of contaminated/adulterated meat into commerce, (and) R-CALF USA believes the solution to this problem is to detect such meat at the slaughter plant of origin and require corrective actions at the source, not at the destination," the letter states...
Current FSIS guidance will necessitate that plants essentially validate, via testing, not only HACCP plans, and all Pre-Requisite plans, but also a multitude of specialty products, which are the unique niche products that attract consumers to products emanating from small facilities. In stark contrast, large slaughter plants primarily produce carcasses, trimmings, and boxed beef, necessitating only three areas to validate, at most. Small plants, which have substantially less sales revenue and that are dependent on the manufacture and distribution of specialty items, will be burdened with enormous increases in microbial testing expenditures, which their revenues cannot sustain.
The American Association of Meat Processors estimates the initial cost for the increased testing of ready-to-eat products by smaller plants at $12,000 per product line, and $3,600 per product line in future years..
R-CALF USA is concerned that small, inspected plants, which are vital to livestock producers across America, will quickly disappear, eliminating essential services needed by small, local producers. At the same time President Obama and the U.S. Department of Agriculture (USDA) are advocating the "Know your Farmer, Know your Food" program, this agency mandate to increase microbial sampling will further separate consumers from producers because it will result in a lack of processing facilities required to process locally grown livestock. This policy will effectively undercut the stated goals of USDA and will result in an increased dependence on imported meat.. .
"R-CALF USA is concerned that while the agency's mandate for increased microbial testing is focused as close to the consumer as possible (at the downstream plants), such testing is also focused as far away as possible from the source-slaughter plants, which are the origins of enteric bacteria," said R-CALF USA HACCP Committee Chair John Munsell.
"By FSIS admission, the largest plants constitute only 7 percent of all federally inspected plants, but produce 90 percent of our meat. We suggest that 90 percent or more of agency mandated microbial testing must be focused at the source, not the destination of meat products.".
.R-CALF USA would be more willing to endorse this agency mandate for increased microbial testing if such testing would result in safer food. However, since the true origin of contamination with enteric pathogens continues to remain off the agency's enforcement radar, increased testing costs would produce no benefits for public health, while effectively eviscerating America of its small plants. .
."Lastly, R-CALF USA is greatly concerned that FSIS firmly believes our current HACCP system is so ineffective that the agency perceives that greatly increased microbial testing must be implemented for validation purposes, and agency demands for increased testing are symptomatic of an underlying danger, namely the ineffectiveness of FSIS-style HACCP," the letter states. "R-CALF USA respectfully recommends a thorough overhaul of the agency's current HACCP methodology."

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