Your Ignorance, Their Bliss

The Gourmet holiday issue, overwhelmingly dominated by cookie recipes and seasonal food, also contains an surprising piece, Your Ignorance, Their Bliss,”by Michele Kayal. “If Congress passes the National Uniformity for Food Act, many state-required food regulations will be replaced with less stringent ones set by the FDA. Can this really be a good idea?” See: http://www.epicurious.com/gourmet/toc.

The article’s point: The Food and Drug Administration, already facing added duties in protecting the national food supply against acts of terrorism, could have to take over the duties of food labeling and standards from individual states. The National Uniformity for Food Act would replace stronger state food labeling and safety standards with weaker, federally mandated rules. Moreover, the rules would need to be researched and imposed by an agency whose resources have been increasingly cut back, even as its duties have expanded.

A chart with the piece tells the story of the incredible shrinking FDA:

BUDGET

2003: $47.6 million

2006: $30 million

2007: $25 million

FULL-TIME EMPLOYEES

2003: 950

2006: 881

2007: 817

Thanks to James Norton and the “The Grinder” for the lead on this story.

Neal D. Fortin

www.iflr.msu.edu

Pasteurized milk: Built Ford Tough

Pasteurized milk: Built Ford Tough
Brae Surgeoner, Commentary from the Food Safety Network (Nov. 22, 06) www.foodsafetynetwork.ca.

In May 1943, Edsel Bryant Ford, son of auto magnate Henry Ford, died at the age of 49 in Detroit, of what some claimed was a broken heart.
Biology, however, decreed that Ford died of undulant fever, apparently brought on by drinking unpasteurized milk from the Ford dairy herd, at the behest of his father's mistaken belief that all things natural must be good.

Scores of consumers across North America have adopted what they believe to be a simple approach to good health including the consumption of raw, unpasteurized milk; many are willing to pay between $4.50 and $20 a gallon for what they perceive as the creamier taste and finer flavor.
In the U.S., 28 states permit the sale of raw milk under varying restrictions, but in

Canada, it has been prohibited under the Food and Drug Regulations since 1991. In an article published in 2005 concerning Canada’s rising black market for raw milk, a producer who agreed only to be interviewed if his identity was concealed, told a CTV reporter, “What we're providing is milk at its purest. I would say customers beg for the milk. It’s not even asking. They beg for the milk.” He further claimed that some of his customers drove upwards of 200 kilometers to buy his raw milk products – mostly city dwellers.

On Tuesday, health and law enforcement officials raided Michael Schmidt’s biodynamic farm near Durham, Ontario, armed with a search warrant and power to confiscate his computer hard drives, his milk equipment, and milk products. All of this part of an investigation into Schmidt’s distributing raw unpasteurized milk products.

Schmidt is no stranger to controversy. In 1994, the Owen Sound Health Unit raided his farm, seizing $800 worth of unpasteurized dairy products – charges were laid under the Health Protection and Promotion Act. Yet, for 12 years now Schmidt has continued to sell his raw milk. His clientele includes 120 families in the Toronto area - about 200 kilometers away.

This past September, two children who drank raw milk from a Whatcom County dairy in Washington State became ill with E. coli O157:H7. At the same time, four children, including two 8-year-olds in San Diego County, California were hospitalized with E. coli infection after consuming raw milk products. Despite this, raw milk advocates are adamant that if drinking raw is milk wrong, they don’t want to be right.

Health authorities cannot continue to turn a blind eye to such a defiant attitude. In December 2005, 18 people in Washington and Oregon, including six children were infected with E. coli O157:H7 after drinking an unlicensed dairy’s raw milk – two of the kids almost died. Closer to home, four cases of E. coli linked to unpasteurized milk were reported to Ontario health officials in April 2005; in this case, from an individual who routinely sold raw milk from the back of a vehicle parked in the city of Barrie. There are too many other such cases to mention. Additional outbreaks are listed at: www.foodsafetynetwork.ca/en/article-details.php?a=2&c=6&sc=35&id=384

Raw milk drinkers believe the pasteurized milk found on grocery store shelves lacks the essential enzymes and nutrients necessary to absorb calcium -- yet research shows this is simply not the case. The only things lacking in pasteurized milk are the bacteria that make people -- especially kids -- seriously ill. Adults, do whatever you think works to ensure a natural and healthy lifestyle, but please, don't sneak around and break the rules to impose your dietary regimes on your kids.

Brae Surgeoner is a research assistant with the Food Safety Network at the University of Guelph.
bsurgeon@uoguelph.ca www.foodsafetynetwork.ca

South Korea will follow OIE risk standards for beef, may allow bone-in beef in 2007

South Korea will follow OIE risk standards for beef, may allow bone-in beef in 2007, Pete Hisey, Meatingplace.com (22.nov.06)

South Korea promised to reconsider its restrictions on U.S. beef if the World Organization for Animal Health (OIE) formalizes a change in risk standards when it meets in May 2007. Last May, the organization said it was considering changing the methods for determining the safety of beef in view of the spread of bovine spongiform encepthalopathy from those based on prevalence of the disease in a market and the age of animals meant for export to an overall risk assessment of each market.

That assessment would be made on variables such as strength and longevity of a ruminant-to-ruminant feed ban, slaughter and processing procedures, surveillance testing plans and the like. If the OIE were to decide to switch to such a standard, South Korea said it would be willing to reconsider its import standards, the Korea Herald reported. That would presumably mean an end to a 30-month rule on age and a ban on bones, since most bones are not considered to be specified risk materials. The latter is a key consideration for the United States, since two-thirds of shipments to South Korea prior to the BSE crisis were bone-in beef ribs, used in barbecue rib dishes, which are a national favorite.

A russian roulette of food poisoning in American states

A russian roulette of food poisoning in American states
Thomas Hargrove, Scripps Howard News Service (Nov. 21, 06)
http://www.shns.com/shns/g_index2.cfm?action=detail&pk=FATALFOOD-11-21-06
More than 50,000 people, according to this story, got sick or died from something they ate in a hidden epidemic that went undiagnosed by the nation's public health departments over a five-year period. An investigation by Scripps Howard News Service was cited as finding that Americans play a sort of food-poisoning Russian roulette depending on where they live. Slovenly restaurants, disease-infested food-processing plants and other sources of infectious illness go undetected all over the country, but much more frequently in some states than others.
Scripps studied 6,374 food-related disease outbreaks reported by every state to the federal Centers for Disease Control and Prevention from Jan. 1, 2000, through Dec. 31, 2004. The causes of nearly two-thirds of the outbreaks in that period were officially listed as "unknown."
The findings translate into an alarming potential for tragedy. If health officials are unable to connect illness to food, victims who might eat from the same poisoned source cannot be warned. If food is known as the culprit, but the specific disease lurking within is not diagnosed, the victims may get even sicker or die without proper treatment.
The poor track record of so many state labs also raises chilling questions about their ability to spot or deal with a food-borne terrorist attack.
Families of children who got sick during the five-year period in the study tell heart-rending stories of heroic efforts they made to convince the medical establishment they were victims of food illness. Todd Nelson, a Continental Airlines pilot and father of a 19-month-old girl who died of E. coli, was quoted as saying, "My daughter's death would have been listed just as a 'stroke' and swept under the rug. But I wanted to know what my daughter really died of. And I wanted somebody to blame."
The Nelson family believes Ana Leigh Nelson ate infected hamburger meat from a popular Minnesota restaurant in 2002. The family demanded further private tests that confirmed a rare strain of E. coli and then demanded that the medical examiner change her death certificate to correctly report death from complications of food poisoning. The study found that Kentucky, Oklahoma and Nebraska are virtually blind to outbreaks of food sickness, rarely detecting that scattered illnesses have common food causes.
In Alabama, Florida and New Jersey, the cause of food poisoning is almost never found, even when it is known that dozens or hundreds of people became violently ill or died from something they ate, according to the Scripps study. Alabama was the worst in the nation, diagnosing only 5 percent of its reported outbreaks. Alabama State Epidemiologist John Lofgren was quoted as saying, "It's a real struggle. We've never identified a virus at the state level." After learning of the study's findings, Kentucky officials ordered changes to their disease-reporting system. "We really hadn't been categorizing food- and waterborne outbreaks," admitted Kentucky Epidemiologist Kraig Humbaugh.
During the five-year period studied, Florida reported only seven people sickened by E. coli outbreaks, a suspiciously low number for a state of its size. The story goes on to say that although the Scripps study found that the quality of the nation's network of public health departments varies alarmingly, there were some bright spots. Wisconsin, Minnesota and Hawaii do a good job of diagnosing disease outbreaks.
Wisconsin came out on top in the study by diagnosing the cause of 90 percent of its food-poisoning cases. Wisconsin also was the first state to detect and report September's deadly E. coli outbreak from infected raw spinach grown in California and shipped nationwide. The outbreak killed at least three people and sickened at least 199 others.
But the study found little to celebrate overall since most outbreaks go undiagnosed. Federal officials and public health experts agreed with the findings and conclusions of the Scripps study. Tom Skinner at the CDC's Atlanta headquarters after reviewing some of the study's findings, was quoted as saying, "Our surveillance systems were designed to ring a bell when there is a problem. Are they perfect? Absolutely not. Could they be better? Absolutely yes. We've already come a long way, but certainly, we can do better than this."
Skinner offered no explanation when asked why the CDC didn't warn underperforming states and local health departments.
Ewen Todd, director of the Food Safety Policy Center at Michigan State University, was quoted as saying, "The CDC, like most government agencies, is pretty conservative. Why would they want to rock the boat? It takes someone who is independent to say: 'This is crazy.' "
Todd agreed that the quality of public health is erratic in the United States and that the state health programs are especially poor in the South, adding, "Our laboratories are pretty good. But, overall, the whole public health system is not working very well. There are no national standards for the surveillance and reporting of food illnesses."

The United States vs. E. Coli, et al.

The United States vs. E. Coli, et al.
16.nov.06, The Legal Television Network
Henry I. Miller, http://tinyurl.com/ty2y7

Can the feds combat the germs? Since the first reports of an outbreak of E. coli-related illnesses traced to fresh, bagged spinach, this deadly strain of bacteria has led to three deaths and approximately 200 illnesses nationwide. According to the federal government, food poisoning linked to these and other microorganisms afflict 76 million Americans and claim 5,000 lives.

This new biological enemy isn't linked to Al Queda. Yet, while cases of food poisoning normally fall within the province of the Food and Drug Administration and Center for Disease Control, these germs are now under investigation by the FBI.
With billions of germs lurking within our borders, the G-Men may need to add a few more agents.

Federal officials investigating the spinach outbreak have narrowed their search to a handful of ranches in California’s Salinas Valley and appear to be focusing on wild hogs as the cause of contamination. The outbreak seems to be over and Popeye’s favorite food is making its way back onto store shelves and restaurant menus. But will consumers buy it? Americans may want their spinach back, but they also want an answer to an important question: On whom can we rely to protect us from future outbreaks of contamination and food-borne illness?
First, it’s clear we can’t rely on growers of fresh produce to protect us 100 percent of the time. Modern farming operations – especially the larger ones -- already employ strict standards and safeguards designed to keep food free of pathogens. And most often they work: Americans’ food is not only the least expensive, but also the safest, in the history of humankind.

However, there is a limit to how safe we can make agriculture, given that it is an outdoor activity and subject to all manner of unpredictable challenges. If the goal is to make a field 100 percent safe from contamination, the only solution that guarantees this is to pave it over and build a parking lot on it. But we’d only be trading very rare agricultural mishaps for fender-benders.

It has also become painfully clear that we can’t rely on processors to remove the pathogens from food in every case. This most recent outbreak of illness demonstrated that our faith in processor labels such as “triple washed” and “ready to eat” must be tempered with at least a little skepticism. Processors were quick to proclaim the cleanliness of their own operations and deflect blame toward growers. But all of those in the food chain share responsibility for food safety and quality.

In fairness to processors, there is ample evidence to suggest that no amount of washing will rid all pathogens from produce. The reason is that the contamination may occur not on the plant, but in it. Exposure to E. coli or other microorganisms at key stages of the growing process may allow them to be taken into the plant and actually incorporated into cells.

Citing this, advocates of food irradiation have stepped forward to claim that their technology can provide the assurance consumers demand and deserve. To be sure, irradiation is an important tool to promote food safety and is vastly under-used, largely due to opposition from the organic food lobby and government over-regulation.

But irradiation is no panacea. Although it quite neatly kills the bacteria, it does not inactivate the potent toxins secreted by certain bacteria such as Staphylococcus aureus and Clostridium botulinum. This is a distinction you’d keenly appreciate should you become infected.
So, if consumers can’t be protected by growers or processors or even irradiation, what can protect them?

There is technology available today that can inhibit microorganisms’ ability to grow within plant cells and block the synthesis of the bacterial toxins. This same technology can be employed to produce antibodies that can be administered to infected patients to neutralize the toxins, and can even be used to produce therapeutic proteins that are safe and effective treatments for diarrhea, the primary symptom of food poisoning.
But don’t expect your favorite organic producer to embrace this triple-threat technology, even if it would keep his customers from getting sick. Why? The technology in question is biotechnology, or gene-splicing -- an advance the organic lobby has vilified and rejected at every turn.
For organic marketers, the irony is more bitter than fresh-picked radicchio. The technology that affords them the best method of safeguarding their customers is the one they’ve fought hardest to forestall and confound.

Perhaps in the wake of at least three deaths and 200 illnesses from the recent E. coli outbreak (and also one of Salmonella typhimurium), the organic lobby will rethink its opposition to biotechnology. Perhaps they will undertake a meaningful examination of the ways in which this technology can save lives and advance their industry.

I’m not betting the farm on it. After all, admitting you’re wrong is hard. Blaming others is easy.
Henry I. Miller, a physician and fellow at the Hoover Institution, headed the FDA’s Office of Biotechnology from 1989 to 1993. Barron’s selected his most recent book, "The Frankenfood Myth..." one of the 25 Best Books of 2004.

Food Allergens Labeling Webcast

The Food Allergen Labeling and Consumer Protection Act (FALCPA) went into effect on January 1st, 2006 requiring food processors to identify, in plain, common language, the presence of any of the eight major food allergens: Milk, Egg, Peanut, Tree Nut, Fish, Shellfish, Wheat, and Soy. The addition of this new regulation along with the existing stringent standards for food safety have left many food processors scrambling to thoroughly understand the impact and how best to achieve compliance.

In this webcast, Catherine Copp, Policy Advisor with the Office of Regulations and Policy at the FDA's Center for Food Safety and Applied Nutrition, will present background details of FALCPA and the FDA's implementation activities, clarify some common misperceptions of FALCPA, discuss the buzz from consumers and the food industry, and provide insight into the FDA's future activities concerning FALCPA. You will also hear from Scot McLeod, Senior Vice President with Ross Systems, who will present case studies on Ross Customers Litehouse Foods, Berner Foods, and ACME Spice and how they’ve addressed the requirements of FALCPA.
Webcast: Addressing the Evolving Requirements for Food Allergen Labeling
Wednesday, December 6; 2pm (EST)

HEALTH COURTS & ADMINISTRATIVE COMPENSATION: OPPORTUNITIES FOR SAFETY ENHANCEMENT

This Forum was webcast live November 8, 2006. An archived webcast will be avaliable for one month at http://cgood.org/healthcare-events-70.html.

“At the Forum on Health Courts and Administrative Compensation, academics, state legislators, lawyers, consumer group representatives, insurance industry leaders, and other interested parties gathered to discuss the potential for new alternatives to medical injury litigation, particularly health courts. Health courts would not only provide more consistent financial compensation to injured patients, but could also help to prevent future medical errors and promote a more reliable system of medical justice—one that both patients and doctors can trust.”

GRAS substances database

FDA posted their Select Committee on GRAS Substances (SCOGS) Database online. This database allows access to opinions and conclusions from 115 SCOGS reports published between 1972-1980 on the safety of over 370 Generally Recognized As Safe (GRAS) food substances. The database allows users to search for the SCOGS opinion and conclusion, and includes the United States Code of Federal Regulations (21 CFR) citation for those GRAS food substances that have been codified in the CFR. The SCOGS conclusions were made by scientific experts outside of FDA. The complete background of the Select Committee is described in the History of GRAS and SCOGS that is also posted on the site. http://www.cfsan.fda.gov/~dms/opascogs.html.

Neal Fortin has accepted appointment as the Director of the Institute for Food Laws & Regulations

Neal Fortin has accepted appointment as the Director of the Institute for Food Laws & Regulations (IFLR) at Michigan State University. As Director, Professor Fortin will lead the IFLR and its International Food Law Distance Education Certificate Program. IFLR offers region and topic-specific food law courses taught by an international network of food science academic and legal professionals. Students from over 80 countries have participated in these courses via the Internet.

“With globalization increasing,” said Director Fortin, “an understanding of the legal complexities of food regulation is vital to the free trade of food and agricultural products across national boundaries.”

The IFLR International Food Law Distance Education Certificate Program was the 2003 Winner of the Excellence Award in College and University Distance Education from the American Distance Education Consortium (ADEC) under the leadership of its Founding Director Emeritus, Dr. P. Vincent Hegarty. The eight courses offered include an overview course on International Food Laws and Regulations, four region-specific courses—Food Regulation in the United States, European Union, Canada and Latin America—and three topic-specific courses—Codex Alimentarius (The Food Code), OIE (The World Organisation on Animal Health) and the IPPC (International Plant Protection Convention) http://vu.msu.edu/preview/anr-ifl/.
“I am looking forward to working closely with colleagues in academia, agriculture and food industries, and government agencies,” said Director Fortin, “along with the non-governmental organizations important in international food law.”

Before joining the faculty full time, Mr. Fortin was an attorney concentrating in food and drug law, food safety, food labeling, ingredient evaluation, and advertising. Mr. Fortin is also an Adjunct Professor of Law at the Michigan State University College of Law, where he teaches food and drug law, and an Adjunct Professor at the University of Minnesota, School of Public Health, where he teaches a course on nutrition law and policy. Previously, Neal Fortin was manager of the food service regulatory program for the Michigan Department of Agriculture. In this role, he was the primary drafter of the Michigan Food Law of 2000, which streamlined Michigan’s food safety requirements and strengthened and updated food safety standards for changes in science.

Professor Fortin holds a Juris Doctor, Summa Cum Laude, from the Michigan State University College of Law. He holds Bachelor of Science degrees from the University of Michigan and Newman University.We are delighted that Director Fortin will apply his many talents to the administration of the IFLR. Please join us in congratulating Neal Fortin in his new capacity. He can be contacted at 404 Agriculture Hall, by phone at 517-355-8295, or via email at fortinne@msu.edu.

Vitamin A and osteoporosis

Vitamin A and osteoporosis
It has long been known that high doses of vitamin A can cause liver abnormalities. Now researchers are examining an excess intake of vitamin A as a potential risk factor for osteoporosis. Animal, human, and laboratory research suggests an association between greater vitamin A intake and weaker bones. The large doses of vitamin A may impair the ability of vitamin D to promote calcium absorption. The high doses are associated with reduced bone mineral density and increased risk of hip fracture. There is no evidence of an association between beta-carotene intake, especially from fruits and vegetables, and increased risk of osteoporosis.
In the 1970s, FDA considered writing regulations for some mega-dose vitamin products because of their potential health risks. The supplement industry waged a lobbying effort against the FDA’s attempt, and the Proxmire Vitamin and Mineral Amendment of 1976 expressly prohibited the FDA from establishing maximum limits on the potency of any vitamin or mineral.
“Osteoporosis, a disorder characterized by porous and weak bones, is a serious health problem for more than 10 million Americans, 80% of whom are women. Another 18 million Americans have decreased bone density which precedes the development of osteoporosis. Many factors increase the risk for developing osteoporosis, including being female, thin, inactive, at advanced age, and having a family history of osteoporosis. An inadequate dietary intake of calcium, cigarette smoking, and excessive intake of alcohol also increase the risk.” http://ods.od.nih.gov/factsheets/vitamina.asp#h7.

Law professor to head up institute at MSU
People News by Vickki Dozier, Lansing State Journal (Oct. 20, 2006) available at: http://tinyurl.com/ycht4h. Neal Fortin has been appointed the director of the Institute for Food Laws & Regulations at Michigan State University. As director, Fortin will lead the institute and its International Food Law Distance Education Certificate Program. The institute offers region and topic-specific food law courses taught by an international network of food science academic and legal professionals. Students from more than 80 countries have participated in these courses via the Internet.

Before joining the MSU faculty full time, Fortin was an attorney concentrating in food and drug law, food safety, food labeling, ingredient evaluation, and advertising. He is also an adjunct professor of law at the MSU College of Law, where he teaches food and drug law, and an adjunct professor at the University of Minnesota, School of Public Health, where he teaches a course on nutrition law and policy. Previously Fortin was manager of the food service regulatory program for the Michigan Department of Agriculture, where he was the primary drafter of the Michigan Food Law of 2000, which streamlined Michigan's food safety requirements and strengthened and updated food safety standards for changes in science.

E. coli attorney calls on spinach industry to pay victims' medical bills

E. coli attorney calls on spinach industry to pay victims’ medical bills
20.sep.06
from a press release
SEATTLE, WA -- William Marler, a nationally-recognized food safety advocate and attorney, today called on the spinach industry “to do the right thing and immediately pay the medical bills for the victims of this most recent outbreak traced to E. coli-contaminated spinach.” Marler noted that, in other large outbreaks, companies such as Jack in the Box, Odwalla, Chi-Chi’s and Sheetz advanced medical costs for outbreak victims whose illnesses were traced to their food products.
To date, the Food and Drug Administration has reported that 131 people have been confirmed as victims of the outbreak, 20 victims developing hemolytic uremic syndrome (HUS), a potentially lethal complication of E. coli O157:H7 infection. “With such devastating injuries, and so many of them,” Marler continued, “I hope that the people responsible for this outbreak will stop trying to shift the blame or think of more excuses. The FDA has warned the lettuce and spinach industry repeatedly about its problems and deficiencies.” Marler noted that this latest outbreak is the twentieth outbreak since 1995 associated with lettuce or spinach.
Marler’s Seattle-based law firm, Marler Clark (www.marlerclark.com), is representing 31 victims of the outbreak, including twelve people who developed HUS. The firm has filed three lawsuits to date—in Utah, Oregon, and Wisconsin.*
Background: Since 1993, Marler has represented thousands of victims of E. coli, Salmonella, Hepatitis A, Listeria, Shigella, Campylobacter and Norovirus illnesses in over thirty States. In 1998, Marler and his current law partners formed OutBreak, a non profit food safety organization. Marler dedicates one-fourth of his time to travel to food-industry conferences, giving speeches about how to prevent foodborne illness litigation.
US District Court for the District of Oregon Case #306-CV-1313JO, Eastern District of Wisconsin Case #06CV977, and District of Utah, Case #206CB00787BSJ.

Health Claims, Healthy Trends: Navigating the Legal Thicket

Health Claims, Healthy Trends: Navigating the Legal Thicket, Neal Fortin, Food Product Design (June 2006) available at: http://www.foodproductdesign.com/articles/661regs.html.The opportunities to make health claims are far greater than ever before. But do not forget: The area remains a legal thicket. Become fully informed about applicable laws before marketing foods with health claims.

Is a Picture Worth More Than 1,000 Words?

Is a Picture Worth More Than 1,000 Words? The Fourth Amendment and the FDA’s Authority to Take Photographs Under the Federal Food, Drug, and Cosmetic Act, Neal D. Fortin, 1 Journal of Food Law and Policy 239-268 (Fall 2005), also available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=910581.