| - Wed, 22 Feb 2012 01:59:07 -0800
An Oklahoma woman has sued Taco Bell, alleging that contaminated food it served caused her to become very ill with Salmonella infection.
The 22-year-old Cleveland County resident said in her complaint that she ate at a Taco Bell restaurant on Nov. 3, 2011. Two days later, on a Saturday, she began suffering from painful abdominal cramps and multiple bouts of diarrhea, including while she was attending a University of Oklahoma football game.
After developing bloody diarrhea the following day, she was treated at an emergency clinic and later had to seek medical attention several more times as her condition continued to worsen.
The woman's symptoms persisted for about two weeks, causing her to miss several days of work.
A stool specimen tested positive for the outbreak strain of Salmonella Enteritidis, which the Centers for Disease Control and Prevention (CDC) said infected at least 68 individuals in 10 states.
Outbreak cases were confirmed in Texas, where 43 people were sickened, and in Oklahoma, where 16 people were infected. Kansas reported two outbreak cases while Iowa, Michigan, Missouri, Nebraska, New Mexico, Ohio and Tennessee each reported one.
Although the CDC has identified the likely source of the widespread outbreak only as "Mexican-style fast food restaurant Chain A," both the Oklahoma State Department of Health and the Michigan State Department of Health disclosed that the suspect food was traced to Taco Bell.
The woman is being represented by the law firm Beeler, Walsh & Walsh in Oklahoma City and by the law firm Marler Clark in Seattle. Marler Clark sponsors Food Safety News.
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| - Wed, 22 Feb 2012 01:59:06 -0800
An Iowa woman has filed suit against the Jimmy John's Gourmet Sandwich chain after suffering from a severe E. coli O26 infection, and alleging that her illness was caused by a sandwich made with contaminated raw sprouts.
In a complaint filed in the Iowa District Court for Polk County, the 27-year-old Des Moines resident says she ate a Turkey Tom sandwich with sprouts at a Jimmy John's store in West Des Moines on Jan. 3, 2012.
On Jan. 5, she awoke with severe abdominal cramps and later in the day, at work, began suffering from bouts of diarrhea. Over the weekend her symptoms worsened dramatically and she began defecating blood.
She saw a doctor, but continued to get sicker and was referred to a specialist on Jan. 11, who ordered a colonoscopy and treated her for severe dehydration. She was rushed to the emergency department of Jan. 12. She says her acute, painful and debilitating illness lasted for three weeks.
A stool specimen confirmed that she had been infected with E. coli O26, and later that the bacteria was indistinguishable from the outbreak strain linked to sprouts served on Jimmy John's sandwiches. The woman was confirmed by the Centers for Disease Control and Prevention to be one of at least 12 people sickened in five states in an outbreak linked to Jimmy John's sandwiches.
Raw sprouts served at Jimmy John's Gourmet Sandwich restaurants have been associated with multiple foodborne illness outbreaks, including In recent days franchise owners and customers have said the chain is dropping raw sprouts from its menu.
The woman is being represented in her lawsuit by the Des Moines law firm Wandro, Baer & McCarthy and the Seattle law firm Marler Clark, which sponsors Food Safety News.
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| - Wed, 22 Feb 2012 01:59:05 -0800
After decades of consideration, the Environmental Protection Agency has released a final assessment on the health impact of dioxins, for the first time setting a toxicological threshold for non-cancer risks posed by exposure to the chemicals.
The food industry had been concerned that EPA would set exposure recommendations below what some Americans are already exposed to via their diet, which could cause some people to radically change their eating habits. But the report released by EPA instead touted the reductions in dioxin exposure. According to the agency air emissions of dioxins have decreased 90 percent since the 1980s.
"Today's findings show that generally, over a person's lifetime, current exposure to dioxins does not pose a significant health risk," said EPA on Friday. "Most Americans have low-level exposure to dioxins. Non-cancer effects of exposure to large amounts of dioxin include chloracne, developmental and reproductive effects, damage to the immune system, interference with hormones, skin rashes, skin discoloration, excessive body hair, and possibly mild liver damage."
The agency said consumers should not be worried about exposure: "Most Americans have low-level exposure to dioxins. Most dioxin exposure occurs through the diet with small amounts of exposure coming from breathing air containing trace amounts of dioxins and from inadvertent ingestion of soil containing dioxins. While we all likely have some level of dioxin in our bodies, the levels are low and findings show that low-levels of exposure do not pose a significant health risk."
Dioxins are released into the air during certain industrial processes, like cement production and are also naturally occurring. According to new government data, air releases of dioxin rose 10 percent between 2009 and 2010. Dioxins are ingested by food animals, via grazing and contaminated feed, and are bioaccumulated -- a reality that has concerned regulators and public health authorities because dioxins are linked to reproductive and developmental problems, immune system damage and cancer.
The World Health Organization (WHO) estimates that 90 percent of human exposure to dioxins is via food, particularly meat, dairy, fish and shellfish. The food industry worries that the EPA reassessment would have recommended an exposure threshold that is lower than the level of exposure many Americans already face through their daily diet.
The EPA's new assessment sets a reference oral dose -- more information here: http://www.epa.gov/iris/subst/1024.htm
According to one advocacy groups, some Americans may be close to the reference dose.
"The key finding of EPA's new report is that EPA has published a reference dose for dioxin and that the daily intake of dioxin in food is close to this level," said Mike Schade, a spokesman for the Center for Health, Environment & Justice. "It shows that the average background exposure of the American public to dioxin in food is very close to or above the EPA new reference dose."
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| - Wed, 22 Feb 2012 01:59:03 -0800
Stealth - the act or characteristic of moving with extreme care and quietness, especially so as to avoid detection
- Collins English Dictionary - Complete and Unabridged © HarperCollins Publishers 1991, 1994, 1998, 2000, 2003
About 10 days ago, I complained about an unpublicized Class I recall, which was described in FDA's Weekly Enforcement Report dated February 8, 2012. The recall involved 114 tons of cut leaf "curly" spinach from Tiro Tres Farms, Eagle Pass, TX. The offending spinach was recalled by the manufacturer after the product was found to be contaminated with E. coli O157:H7.
I received some comments - and some flak - about my article, so I decided to see whether this was a one-time incident or whether there have been other Class I recalls about which we consumers were never informed. The following recalls were gleaned from FDA Weekly Enforcement Reports dated on or after November 2, 2011.
- Nicho Produce Co., Inc. (Edinburg, TX): A CUT ABOVE produce items. Thirty-three (33) different items, including shredded, cut, sliced, diced or cubed salad greens, vegetables and fruits, most of them packed in 5-lb bags. Products were recalled due to potential contamination with Listeria monocytogenes. This was an FDA-initiated Class I recall, announced by letters dated December 9th and 19th, 2011, and involved 9,829.5 "pieces" distributed in Texas.
River Ranch Fresh Foods LLC, (Salinas, CA): River Ranch and Hy-Vee bagged salads and coleslaw with Best if Used by date of 4 NOV 2011. Product was recalled after FDA found two environmental sub samples positive for Listeria monocytogenes. This was an FDA-initiated Class I recall that was subsequent to an earlier public recall of Farmers Market and Hy-Vee brands of bagged salads, also produced by River Ranch. This stealth recall involved 588 cases of bagged salads, which were distributed to Indiana, Iowa and Canada.
Rio Queen Citrus, Inc. (Mission, TX): TexRio Tomatoes, packed in 20-lb bulk boxes, imported from Mexico. Notification of the company-initiated Class I recall was by telephone on November 25, 2011. Two hundred forty-three (243) boxes were recalled because the tomatoes were potentially contaminated with Salmonella. Distributed to Texas and Missouri.
Four Seasons Produce, Inc. (Ephrata, PA): Farm Wey labeled cantaloupes, Lot #32773301 & 32773302, manufactured by Farm-Wey Produce, Inc. (Lakeland, FL). Four Seasons recalled 1,064 cases (15/case) on November 19th by email, telephone and fax after being informed by New York State that the melons were potentially contaminated with Salmonella. The recalled cantaloupes were distributed to New York, Pennsylvania, Puerto Rico and Bermuda.
Combs Produce, LP (Dallas, TX): Natures Harvest Grape Tomatoes, recalled by email on November 25, 2011 due to potential contamination with Salmonella. Approximately 400 cases were distributed to Oklahoma and Texas.
Supreme Protein (Manasquan, NJ): Supreme Protein Chocolate Caramel Cookie Crunch (0.71 oz/20g bars; Lot B11272A October 2012), manufactured by Belmont Confections Inc. (Youngstown, OH). The firm initiated a recall by email, letter and telephone on October 11, 2012 of 473 bars, because the product was potentially contaminated with Salmonella. The recalled bars were distributed nationwide.
These are just a few examples from less than 4 months' worth of FDA Enforcement Reports. For brevity and simplicity, I limited myself to Class I microbiological hazards, and did not include undeclared allergens, foreign material contamination (i.e., metal, glass, etc) or undeclared/unapproved additives.
I was taken to task for my February 9th stealth recall 'rant' by Jim Prevor of the Perishable Pundit in his February 15th item "Food Safety, Recalls And Why Consumers Don't Always Need Notification." What were his gripes, and how do they stack up in light of what I have found?
Prevor theorized that the E. coli O157:H7-contaminated spinach was not destined for direct retail sale; therefore, he concluded, there was "...no need to notify consumers."
But, USDA's Food Safety and Inspection Service routinely publicizes recalls of products that are destined strictly for the institutional market. Why should FDA not do likewise?
Prevor also suggests that the recall was not publicized to avoid worrying or confusing consumers, who would not differentiate between the recalled (curly) spinach from Texas and the unaffected (flat leaf) baby spinach from California and Arizona. He concludes that avoiding a public announcement was the responsible path, to prevent crushing "countless farmers and processors".
Sorry, Jim, but how does that justification extrapolate to the "Branded" products I've cited above - especially those that were sold in retail-sized packaging bearing lot number identification and/or expiration dates?
Finally, Prevor ends his article with the following statement:
One suspects that the decision to not announce recalls when the announcement would not enhance public health is motivated by the desire to protect another value: Maintaining viable farms, industries, jobs, etc.
Interesting. I always thought that the primary responsibility of FDA was to protect public health.
FDA relies on consumers and consumer advocates to help it carry out its broad mandate. The agency has no choice - it cannot afford to inspect more than a tiny fraction of food producers and processors in the USA. But, like it or not, the flip side of this dependency is the need to keep consumers informed. Naive consumers, or those who are ignorant of existing recalls, are more likely to become casualties than collaborators.
When President Obama took office, he promised "transparency" in his administration. I grant that the workings of FDA, USDA and other US agencies are more open than those in many - perhaps most - other countries. Nevertheless, the President's promise raised the bar for FDA. At the very least, there should be a consistent - and transparent - policy guiding the agency's decisions on when and how to release information about recalls. This is especially true for FDA-initiated recalls.
Speaking as a consumer, and as a food safety microbiologist with more than 30 years of experience - several of them with Canada's food safety regulatory agency - I strongly believe that all Class I recalls should be posted promptly on the government's food safety website.
Consumers deserve - and should demand - no less.
------------------------Reposted, with permission, from the Feb. 19, 2012 eFoodAlert.
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| - Wed, 22 Feb 2012 01:59:03 -0800
After a five-month battle with listeriosis from eating contaminated cantaloupe, 68-year-old Mike Hauser of Colorado died Tuesday morning, the Denver Post reported.
Hauser's death brings the number of adult fatalities to 34 in the outbreak traced to Listeria-tainted cantaloupes grown and packed by Jensen Farms and distributed by Frontera Produce. The outbreak, which sickened at least 146 people in 28 states, was the deadliest involving foodborne infection in nearly 100 years.
Four more outbreak victims have died since the final investigation update from the Centers for Disease Control and Prevention, which attributed 30 deaths and one miscarriage to listeriosis infections caused by the Colorado cantaloupes.
In addition to Mike Hauser, fatalities not included in the CDC's count are Paul Schwarz of Missouri, Sharon Jones of Colorado, and Dale Braddock of Nebraska.
Hauser was a retired podiatrist.
Investigators from the Food and Drug Administration and Colorado public health officials have said hard-to-clean equipment and pooled water in the packing plant, in addition to condensation on cantaloupes moved to cold storage, were among the factors contributing to the lethal outbreak.
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| - Wed, 22 Feb 2012 01:59:01 -0800
Raw milk and raw milk products are 150 times more likely than their pasteurized counterparts to sicken those who consume them, according to a 13-year review published by the Centers for Disease Control and Prevention on Tuesday. States that permit raw milk sales also have more than twice as many illness outbreaks as states where raw milk is not sold.
The CDC study, published online in Emerging Infectious Diseases, reviewed dairy-related outbreaks between 1993 and 2006 in all 50 states, during which time the authors counted 121 dairy-related illness outbreaks resulting in 4,413 illnesses, 239 hospitalizations and three deaths.
Despite raw milk products accounting for approximately one percent of dairy production in the U.S., raw milk dairies were linked to 60 percent of those dairy-related outbreaks. In addition, 202 of the 239 hospitalizations (85 percent) resulted from raw milk outbreaks. Thirteen percent of patients from raw milk outbreaks were hospitalized, versus one percent of patients from pasteurized milk outbreaks.
Seventy-five percent of the raw milk outbreaks occurred in the 21 states where the sale of raw milk was legal at the study's onset in 1993. Today, 30 states permit the sale of raw milk, while another seven are considering raw milk legislation changes this year.
The study found that individuals under the age of 20 accounted for 60 percent of those affected by raw milk outbreaks, compared with 23 percent associated with pasteurized products. Children were also more likely than adults to become seriously ill from pathogenic bacteria in raw milk.
The differences in illness severity between raw and pasteurized milk are largely due to the pathogens present in each: People sickened from raw milk typically ingest injurious bacteria -- most commonly Salmonella or Campylobacter -- whereas pasteurized milk outbreaks more often result from "relatively mild" pathogens such as norovirus, according to the CDC.
This is the first comprehensive federal-level update to raw milk statistics of this kind since 1998, when the Center for Food Safety and Applied Nutrition released a similar review of raw milk outbreaks spanning from 1973 to 1992. That study found that 46 raw milk outbreaks occurred during the review window, with 40 of them in states with legal raw milk sales.
At the time, the 1998 study concluded that "consumption of raw milk remains a preventable cause of foodborne illness." Similarly, Tuesday's CDC study suggested that "stronger restrictions and enforcement should be considered."
"It's really helpful to have these numbers updated as interest in raw milk increases through activist groups," said Michele Jay-Russell, Ph.D., program manager of the Western Center for Food Safety at University of California Davis.
"I wouldn't say the statistics are surprising, but it's helpful to know that, unfortunately, things have not really changed since the last report," she added. "Despite being in the 21st century, raw milk continues to make people sick."
The study comes on the heels of one of the largest raw milk outbreaks in U.S. history. As of Tuesday, 77 people in four states have been sickened in a Campylobacter outbreak linked to raw milk from Your Family Cow dairy in Pennsylvania that began in late January. At least nine of the victims from that outbreak have been hospitalized.
Many of those who are ill in that outbreak are children. "Parents who have lived through the experience of watching their child fight for their life after drinking raw milk now say that it's just not worth the risk," said Dr. Barbara Mahon, co-author of the CDC study, in a news release.
Since January 2007, the end of the study's review window, there have been at least 56 additional foodborne illness outbreaks associated with raw milk. Between 2010 and 2011, raw dairy products were linked to 21 outbreaks and 201 illnesses, while pasteurized dairy products caused two outbreaks and 39 illnesses.
According to Jay-Russell, nearly all instances of outbreaks from pasteurized dairy occur because of contamination after the pasteurization process.
This year, Indiana, New Jersey, Iowa, Idaho, New Hampshire, Kentucky and Wisconsin have all considered changes to their raw milk sales laws. The majority of the bills under review would either permit the sale of raw milk where currently illegal, or remove certain restrictions on its sale in states where it's already permitted.
Federal law restricts the transport of raw milk across state lines for sale, though consumers are free to travel across state lines to purchase milk and take it home, and there is no law against consuming unpasteurized milk.
The push for loosened raw milk sales rules across many states runs counter to the best scientific recommendations the CDC and Food and Drug Administration can make based on the available data, Jay-Russell said. Many raw milk proponents argue that raw milk provides nutrients and numerous health benefits negated by the pasteurization process, while many food scientists say there's no credible scientific evidence for any of those claims.
"It's [the CDC and FDA's] charge to look at the health statistics and inform the public and help policy makers create policy that makes sense," Jay-Russell said. "But there's a push-back. Some groups don't want government influence over food, so it makes it a much more political debate than a scientific one."
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| - Tue, 21 Feb 2012 07:53:00 -0800
A study published today in MiBio lends further weight to the growing theory that using animal antibiotics in livestock contributes to drug resistance among human bacteria.
Methicillin-resistant Staphylococcus aureus, or MRSA, is a strain of Staph that's resistant to methicillin - the drug most commonly used to treat Staph infections.
Using a detailed DNA mapping technique, researchers at the Translational Genomics Research Institute (TGen) in Arizona were able to trace one of these superbugs - MRSA CC398 - to its origins, discovering that the human strain of this bacteria developed its drug resistance in animals rather than in people.
Often referred to as "pig-MRSA" or "livestock-associated MRSA," the strain is known to affect humans who have been exposed to live animals, such as farmers or veterinarians. But this study found that CC398 was originally a human bacteria, susceptible to antibiotics, before it spread to animals and then back to people. By the time it returned to humans it had picked up two souvenirs: resistance to methicillin and resistance to tetracycline - a drug often used to treat Staph infections in patients allergic to the penicillin class of antibiotics, which includes methicillin.
Because both tetracycline and penicillins are commonly administered to food animals, the study finds that it is likely that the use of these drugs in livestock gave this Staph bacteria the exposure it needed to develop resistance to these drugs.
In 2010, Tetracycline - used to promote growth and prevent the spread of disease - comprised over 42 percent of all antibiotics administered to food-producing animals in the United States. That year 12,328,520 pounds of the drug were given to animals, while just over 100,000 pounds of the drug are sold for human use. And while over 1.9 million pounds of penicillin were sold for animal use in 2010, approximately 1.5 million pounds are distributed for human use.
Both of these drugs are crucial for treating human Staph infections, says Dr. Lance Price, lead author of the study and Director of TGen's Center for Food Microbiology and Environmental Health.
"Methacyline's a really good antibiotic for treating these kinds of infections," he told Food Safety News in an interview. "But a substantial portion of the population is allergic to penicillin and they need alternative drugs like tetracycline. But 69% of the staph we see is resistant to tetracycline."
Price says that animal feeding operation provide the perfect setting for the growth of antibiotic-resistant bacteria. According to the Centers for Disease Control and Prevention, MRSA is easily transmitted in settings where factors it calls the "5 Cs" are present: crowding, frequent skin-to-skin contact, compromised skin (cuts or abrasions), contamination or lack of cleanliness.
"A CAFO (Concentrated Animal Feeding Operation) is the place where these 5 Cs are most prevalent," says Price. "And the single worst thing you could do is add antibiotics to that environment. It's the cocktail for creating superbugs."
Once these superbugs are created, there's no telling where they can go, Price says. While most cases of CC398 come from direct contact with livestock, some human cases cannot be traced to live animals, raising the question of where they came from. Other humans? Contaminated meat?
Several studies have shown MRSA to be prevalent on our meat and poultry. A study published in the Journal of Food Protection in October of last year found Staph bacteria in 29 percent of grocery store ground meats. And a study led by Price released earlier that year discovered Staph on almost one half of grocery store meats and poultry after putting samples in a bacteria enrichment broth to make Staph more detectable. Half of these contaminated meats were carrying a multi-drug resistant strain of Staph.
Price says the transmission of MRSA from meat to humans is an area that needs more research.
"There is definitely drug-resistant Staph in our food supply and probably in high concentrations. We still don't know whether it's a good route of exposure for people," he explains. "I think that's something we've really got to dedicate some research to."
For now though, Price says the upshot of his research is that antibiotics should be saved for treatment, not growth or prevention.
"We should be using antibiotics prudently, both in human antibiotics and animal production," he notes. "We should only be using them to treat infections - and it should be a last resort - because we're heading towards a time when our antibiotics won't work anymore, and we have to do everything we can to preserve the ones we have."
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| - Tue, 21 Feb 2012 01:59:03 -0800
Michael Taylor, with major accomplishments in food safety for two Democratic Presidents, is nevertheless finding himself the target of a petition seeking his removal.
And as if the old adage needed more proof that political movements always end up eating their own, Mr. Taylor's nemesis is MoveOn, the left-of-center group that got its start trying to retain President Clinton after his sexual liaison with Monica Lewinsky.
Taylor, currently deputy commissioner for foods at the U.S. Food and Drug Administration (FDA), did not get on MoveOn's bad side for anything as nefarious as that.
He did however do a 15-month stint as vice president for public policy for Monsanto, leaving the corporation that has been called one of America's ten most innovative companies, in January 2000. If Taylor's obituary were written now, it's not his short time at Monsanto that would get much attention. It would be his two longer periods of public service. At USDA during the Clinton Administration, he was the top administrator for the Food Safety and Inspection Service that first banned E. coli O157:H7 from beef.
And at FDA, he put his skills with Congress to work to get the Food Safety Modernization Act passed by Congress and he now in charge of implementation.
Still, a loose coalition of genetic engineering (GE) opponents, raw milk advocates, organic farmers and the like has voiced objections to Taylor since he joined the Obama Administration. They point to other stints in Taylor's resume where they claim he had ties to Monsanto.
A petition went up months ago, but only after MoveOn adopted Taylor's removal as a pet cause has the effort "gone viral." It has so far collected about 420,000 signatures.
Now, however, some of the nation's best known food safety and consumer advocates are trying to see if they can get MoveOn to back down.
"We acknowledge that Monsanto symbolizes a lot of things that many people (including some of us) don't like about modern, industrial agriculture. But Mr. Taylor's résumé is not reducible to his work at that company," the signers wrote MoveOn.
"It is far more relevant that in the Clinton Administration he headed the Food Safety and Inspection Service at the U.S. Department of Agriculture, where he stood up to the meat industry and fought for strict controls that help keep E. coli and other pathogens out of meat and poultry. Since joining the Obama Administration, Taylor has been working extraordinarily hard to transform the FDA from a reactive agency that chases down foodborne‐illness outbreaks after people fall ill, to a proactive public‐health‐based agency focused on preventing foods from becoming contaminated in the first place."
"We are confident that his leadership, formerly at USDA and now at FDA, has and will continue to reduce the number of Americans sickened, hospitalized, and killed by foodborne pathogens."
Signing on to the public letter are:
-Michael F. Jacobson, Ph.D., Executive Director Center for Science in the Public Interest
-Shaun Kennedy, Director, National Center for Food Protection and Defense Director, Partnerships and Programs, College of Veterinary Medicine Assistant Professor, Veterinary Population Medicine University of Minnesota
-William D. Marler, Esq. Marler Clark, The Food Safety Law Firm
-J. Glenn Morris, M.D., Director, Emerging Pathogens Institute University of Florida
-Michael Rodemeyer, Lecturer, Department of Science, Technology and Society University of Virginia, Former Executive Director, Pew Initiative on Food and Biotechnology
-Donald W. Schaffner, Ph.D., Extension Specialist in Food Science and Professor Director of the Center for Advanced Food Technology Rutgers University
-Deirdre Schlunegger Chief Executive Officer STOP Foodborne Illness
-Carol L. Tucker‐Foreman, Distinguished Fellow, The Food Policy Institute Consumer Federation of America, Former Assistant Secretary of Agriculture
On the other side, Atlanta' s Frederick Ravid is the author of the petition calling for Taylor's removal. He posted it on SignOn.org in August. MoveOn sent it out on Feb. 6 to its five million members, spiking sign-ups.
Taylor's supporters have pointed out that Ravid 's claims that biotech foods contribute to various types of cancers are without scientific merit.
Taylor has removed himself from making any policies having to do with GE foods.
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| - Tue, 21 Feb 2012 01:59:02 -0800
Continuing her charge against the subtherapeutic use of antibiotics in food animal production, Congresswoman Louise Slaughter (D-NY) sent a letter late last week to more than 60 of the leading fast food companies, meat producers, and grocery stories asking them to release details on their antibiotic use policies.
Slaughter specically asked the companies to breakdown what percentage of the food they sell is raised "without any antibiotics," raised with antibiotics only for "therapeutic reasons," or raised with "routine use of antibiotics" -- information that consumers often have no way of knowing. The list of companies that received the letter was varied, including: Burger King, Cargill, YUM! Brands, Costco, Bon Appetit Management Company, Kraft, McDonald's and Whole Foods.
"Very simply, consumers have a right to know what's in their food," said Slaughter. "It's like that old commercial, 'where's the beef?' We just want to know, 'what's in the beef?' The US is facing a growing public health crisis in the form of antibiotic-resistant bacteria, and information about how these companies are contributing to its rise or resolution should be available to consumers."
Antibiotic-resistance is not just an issue that rallies sustainable agriculture advocates -- who have long argued against drug use in food animal production -- the issue is increasingly tied to foodborne illness outbreak headlines.
Last year, the United States had the most outbreaks ever of antibiotic-resistant Salmonella tied to meat and poultry, according to Slaughter's office. Last summer, the largest Class I meat recall on record was initiated after Cargill ground turkey was linked to a nationwide drug-resistant Salmonella Heidelberg outbreak tied to 136 illnesses and one death.
"Decades of research has shown that the practice of routinely feeding antibiotics to swine, cows, and chickens harms human health by contributing to diseases that fail drug treatment," the letter continued. "A National Academy of Sciences report stated that 'a decrease in the inappropriate use of antimicrobials in human medicine is not enough [to slow the increase in antibiotic resistance]. Substantial efforts must be made to decrease inappropriate misuse in animals and agriculture as well."
The most recent estimates show around 80 percent of all antibiotics sold annually are used in food animal production.
The only microbiologist serving in Congress, Slaughter challenged companies to tout examples of lessening antibiotic use.
"There are some who would have us believe that we must pump our food up with antibiotics to keep prices low and affordable," she said. "But the food industry has proven success stories and leaders who understand the benefits that come from raising and serving antibiotic-free meat. It is not incompatible for us to have healthy and affordable food."
The letter asks companies to respond in detail to Congresswoman Slaughter's office by June 15.
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| - Tue, 21 Feb 2012 01:59:01 -0800
In a story last summer for Food Safety News, I looked to see if the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) recalls were biased toward any one day of the week. This inquiry followed what seemed to be several late Friday recall announcements, including a nationwide recall of contaminated ground turkey implicated in a multistate outbreak of Salmonella infection.
That Friday recall and others raised questions about whether the timing of recall notices could potentially leave consumers uninformed about unsafe food over a weekend.
That preliminary look did not show any significant differences in the daily publication of recall notices, but with the close of 2011, I decided to take a longer look.
This more comprehensive look included recalls going back to 2005 for USDA and Food and Drug Administration (FDA) monitored foods. The USDA data also detailed whether there was a specific pathogen found in the foods (or epidemiologically linked to an outbreak), if any illnesses were associated with the recalled item, and the class of the recall as designated by the USDA's Food Safety and Inspection Service (FSIS). The FDA does not specify classes in its recall notices, so only the first two categories could be assessed.
The conclusions of this more detailed analysis show a different story from the earlier one.
USDA-FSIS Recalls
On the USDA front; from 2005-2011 there were more recalls announced on Fridays than would be expected by random chance (p<.001). Indeed, 2006, 2007, 2009, 2010 and 2011 all had significantly higher numbers of recalls on Fridays (p<.05).
The total number of Class I recalls on Fridays were also higher from 2005-2011 (p=.003). Class I recalls, by definition, are for dangerous or defective products that could cause serious health problems or deaths.
While on a per year basis, only 2006 and 2011 have significantly higher number of Class I recalls on Fridays than expected, 2007 and 2009 are very nearly significantly higher (p=.055 and p=.062, respectively).
The red line indicates the expected number of recalls if equally distributed throughout the week. A proportion significantly higher than expected of p<.01 indicated by *.
In addition, if weekend recall dates are excluded, the pattern holds for total recalls with a greater number on Fridays than other weekdays (p=.002). For Class I recalls, there was no significant difference in the number of Friday recalls compared with the number expected for weekdays, but there were still more alerts published on that day than any other day of the week (p=.086).
The red line indicates the expected number of recalls if equally distributed throughout the week. A proportion significantly higher than expected of p<.01 indicated by *.
There was no trend in any day of the week having more pathogen or illness related recalls than any other day in the seven years analyzed. This was true when only weekdays were analyzed, as well. This indicates that recall notices related to outbreaks of foodborne illness and due to specific pathogens found in food have been evenly spaced throughout the week.
While this is the case, when taken as a whole there were more Class I and Class II recalls on Fridays than would be expected. The significance of this difference for Class I recalls was eliminated when analyzing only weekdays, but held true for Class II notices, perhaps showing a propensity for putting out more urgent recalls on Fridays.
One particularly interesting finding was an observable pattern in an increasing number of Class II and Class III recalls during the time period studied, while Class I recall numbers remained relatively static. There was a significant difference in the number of Class II recalls starting in 2008 the percentage that Class II recalls make of the total number of recalls has continued to increase (P<.05). Class III recalls remain rare and, as such, there is little statistical power in any observations made.
The increasing number of Class II and slightly Class III with the stagnant number of Class I led to an overall increase in the number of recalls per year by the USDA from 56 in 2005 to 108 in 2011.
FDA Recalls
The previous article on this topic did not evaluate FDA recalls. This oversight has been amended this time around, and the findings are similar to those for FSIS recalls.
A glance at the total recalls per day chart shows that between 2005 and 2011 a significantly higher number of recalls were issued on Fridays than would be expected (P<.01).
The red line indicates the expected
number of recalls if equally distributed throughout the week. A
proportion significantly higher than expected of p<.01 indicated by
*.
This holds when excluding the weekends that had so few recalls.
The red line indicates the expected
number of recalls if equally distributed throughout the week. A
proportion significantly higher than expected of p<.01 indicated by
*.
The FDA data again points to a bias toward publishing recall notices on Fridays over other days of the week and, if anything, the tendency is more pronounced with this agency than with the FSIS. Indeed, recall announcements related to foods testing positive for pathogens and those associated with illnesses were also more common on Fridays, compared to the whole week or just the work week, a trend not seen in FSIS recalls.
Fridays have consistently seen significantly more than an expected number of recall notices for both the whole week and weekdays only for the entire seven years examined. However, due to the low number of recalls related to illnesses in all the years, statistical tests cannot be performed on a per year basis. This is also true of pathogen-related recalls prior to 2009.
There was again a pattern of certain types of recalls increasing over the years, as well as the overall number of FDA recalls increasing. The total number of recalls in 2005 was 145 and this reached a max of more than 800 because of multiple peanut butter-related recalls in 2009. Excluding that outlier, there was still a steady increase in the number of FDA recalls from 2005 to the end of 2011.
Why Fridays?
This tendency toward releasing recall statements on Fridays, more than on other days of the week, is likely not intentional but could be problematic, because people who do not consume media over the weekend might be less likely to be informed in a timely manner and, as a result, could eat recalled food. On the other hand, Friday recall notices may be the result of a sense of urgency to get make the information public before the work week ends.
Indeed, processes within the regulatory agencies may be causing an inordinate number of recall notices to be issued on Fridays. Such factors could include laboratory procedures to find contamination in samples, communication delays between the lab, regulators and the companies voluntarily recalling their products, and the general timeline of work in the offices. These, along with other processes, including political pressures, could lead to significantly more recalls on Fridays.
Importantly, recalls are initiated by private companies once the potential for hazard is found. The company distributing or producing the food recalls the products in coordination with the regulatory agency, but the company is ultimately responsible for when the recall is initiated.
It could take days before information regarding potential hazards makes it from a lab or other area of initial discovery, through the regulatory agency to the producer, and then for a recall alert to be issued. Thus, the high number of Friday recalls could be seen as an attempt to get the information out before the weekend, while people are still likely to be tuned into the news.
While the causes leading to the high number of Friday recalls cannot be determined with this small look into the past few years, what can be seen is a potential for lack of communication between the consumer and the food regulators. Easy access to information regarding potentially dangerous foods should be an issue of primary importance for both the USDA and FDA, and these agencies can work to ensure that the information is not going out when people are less likely to get it.
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| - Mon, 20 Feb 2012 01:59:03 -0800
The International Food Protection Training Institute (IFPTI) is currently accepting applications for the 2012-2013 "Applied Science, Law, and Policy: Fellowship in Food Protection" program.
This program is "designed to provide a select group of future leaders from the state and local food protection community with an intense professional development experience focused on critical thinking, problem solving and decision-making skills."
The fellowship is intended for state, local, tribal, and territorial food regulatory professionals in the journey (2-5 years experience) and technical (5-10 years experience) profession levels.
The Fellowship in Food Protection is a series of three week-long training sessions that will be held at IFPTI in Battle Creek, Michigan over the course of one year beginning in August, 2012.
The sessions are divided in the following subjects: 1) Applied Law, 2) Compliance, 3) Policies & Strategies, 4) The Impact of Science, 5) Food Systems Control Applications, and 6) Prevention, Intervention, and Response. The Fellows will also complete research projects during the course of the year and will present their findings at the annual AFDO Conference.
The program overview and applications are available online on the Fellowship page. IFPTI will reimburse all appropriate program-related travel expenses including airfare, hotel, and meals.
Application deadline is March 1, 2012. Notification and confirmation of selected participants is May 15, 2012.
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| - Mon, 20 Feb 2012 01:59:02 -0800
The local food ordinance movement that began in a handful of small towns in Maine has found its way to California. On Jan. 24, 2012, farmer Pattie Chelseth introduced a "Local Food and Community Self-Governance" ordinance to the Board of Supervisors in El Dorado County in the historic Gold Country of the Sierra Nevada Mountains.
The ordinance, referred to as a "food sovereignty proposal," was met with support from the five-member Board and those in attendance.
Raw Milk and Cow Shares
Chelseth's interest in a local food ordinance began last year after she was issued a cease and desist order from the California Department of Food and Agriculture for operating a cow-share that consisted of two cows and 15 owners. Under a cow share arrangement, people pay to become part owners (the purchase of "shares") of a cow. The shareholders pay the farmer to board and care for the cow, and as part of their ownership, they're entitled to a share of the raw milk.
California law permits sales of unpasteurized milk from farms and in retail stores, provided that the dairy is licensed and inspected. Some, including Chelseth, argue that cow shares fall outside of such regulation because the milk isn't being sold -- the shareholders already own the cow.
The California Department of Food and Agriculture disagrees. The agency considers cow shares to be commercial transactions, and subject to the public health regulations that govern dairy production in California.
Introducing the Local Food Ordinance
Like the Local Food and Community Self-Governance ordinances passed in Maine, the El Dorado County ordinance would exempt from state or federal licensure and safety inspection transactions that occur in the Placerville area directly between a producer and a consumer, when the food is for home consumption.
Unlike the ordinances passed in Maine, the El Dorado County version includes five subsections that address the right to own livestock, the right to contract for care and production of such livestock, the right to the products of that livestock, the right to contract for specialty food items (such as baked goods and jams), and the right to participate in private food clubs.
Nearly six months after Chelseth held a meeting on her farm to discuss the creation of a local food ordinance, the El Dorado County Board of Supervisors took up the issue.
In Chelseth's remarks to the board, she quickly reviewed recent court holdings and documents that assert consumers do not have a fundamental right to produce and consume the foods of their choice or a fundamental right to own and use a dairy cow or dairy herd, and that a cow-share contract does not fall outside the scope of state regulation (see the Wisconsin decision for the most recent example).
She then cited the county's history of "noble pioneers and hearty farmers" and asked the board to be a pioneer and beacon for what she called citizens' "right to choose."
Support and Concerns
The board members each expressed support for the ordinance as well as some concerns. While supporting local producers would be beneficial to the area's economic development, and restore authority around local food production to the producers, board members also noted their desire to proceed cautiously and thoughtfully in drafting and passing this kind of ordinance.
Supervisors Ray Nutting and Ron Briggs shared their personal experiences of watching the agriculture and food system change and dealing with the laws as they stand today. Nutting expressed strong support for the ordinance, saying that the board would do whatever it could, within the limits of the California and U.S. Constitutions, to bring the laws and policies in line with the goals of the ordinance.
The board underscored that it was "on the same page" as Chelseth in wanting to enact the ordinance, but also needed to address some of the legal issues raised in this ordinance. Briggs noted that the legal issues were not insurmountable and that the board would work with Chelseth to create a better ordinance.
Supervisor Jack Sweeney suggested first creating a unified resolution asking the state and federal governments from interfering in what they consider an entirely local issue. Sweeney said the board needed to address the potential conflicts with the U.S. and California constitutions in order to prevent the supervisors from violating their oaths of office and from getting the county into significant legal trouble. "We don't want to be anarchists," he said. "We just want to have our home foods."
In the end, the supervisors passed a motion directing Briggs and Norma Santiago "to prepare a resolution of general support to bring back to the Board of Supervisors for adoption."
Although El Dorado County did not pass the ordinance that night, it appears from the discussion at the meeting and the momentum these types of ordinances are gaining around the country, that it may not be long before El Dorado County declares its "rights" to local food self-governance.
To see video of the ordinance discussion at El Dorado County Board of Supervisor meeting on Jan. 24, 2012, click here (note: after you click, the link will ask if you want to open the minutes of the meeting before it proceeds to the video page).
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| - Mon, 20 Feb 2012 01:59:01 -0800
Or is the first "sproutbreak" in four years the reason?
Jimmy John's Gourmet Sandwich franchise owners and customers are being told the chain is permanently dropping sprouts from the menu.
Jimmy John's restaurants are currently associated with a five-state outbreak of the rare O26 strain of E. coli. It is the fifth outbreak involving sprouts traced back to Jimmy John's franchises since 2008.
While there has been no public comment by Jimmy John's since the outbreak was announced February 15, a Kirkville, MO franchise owner says "Jimmy himself" has ordered all sprouts permanently removed from the menu.
"Jimmy decided he was tired of the negative press from it and he thinks sprouts aren't necessary for Jimmy John's to rock," franchise owner Will Aubuchon told the Daily Express in Kirksville, MO.
And Linda DeGraaf, a Jimmy John's customer from Omaha who was sickened in the 2009 outbreak, was told by a corporate email that sprouts have been dropped. "We no longer serve sprouts because supplies are too inconsistent," wrote a Jimmy John's spokeswoman.
After a 2010 outbreak, founder Jimmy John Liautaud switched the sandwich chain to clover sprouts after Salmonella illnesses were associated with alfalfa sprouts. At the time, he said clover sprout seeds were smoother and would be easier to clean.
Jimmy John's is not alone among sandwich chains that have decided sprouts are too risky. The 230-unit Jason's Deli dropped sprouts for at least the balance of 2012 as a food safety concern. And the current O26 outbreak prompted the seven-state Erbert and Gerbert's Sandwich Shops to drop sprouts.
Jimmy John's recent history includes five major outbreaks associated with spouts. Only the latest involves E coli O26.
Briefly here's the history of each of those incidents, including the latest ongoing event:
2011 - E. coli O26
On February 15, the Centers for Disease Control and Prevention (CDC) announced an ongoing investigation into illnesses linked to consumption of raw clover sprouts at Jimmy John's restaurants.
Twelve are sickened in five states. Among the 11 ill persons with information available, 10 (91 percent) reported eating at a Jimmy John's sandwich restaurant in the 7 days preceding illness. Ill persons reported eating at 9 different locations of Jimmy John's restaurants in 4 states in the week before becoming ill.
One Jimmy John's restaurant location was identified where more than one ill person reported eating in the week before becoming ill. Among the 10 ill persons who reported eating at a Jimmy John's restaurant location, 8 (80 percent) reported eating a sandwich containing sprouts, and 9 (90 percent) reported eating a sandwich containing lettuce.
Currently, no other common grocery stores or restaurants are associated with illnesses. Preliminary traceback information has identified a common lot of clover seeds used to grow clover sprouts served at Jimmy John's restaurant locations where ill persons ate.
FDA and states conducted a traceback that identified two separate sprouting facilities; both used the same lot of seed to grow clover sprouts served at these Jimmy John's restaurant locations. On Feb. 10, 2012, the seed supplier notified sprouting facilities that received this lot of clover seed to stop using it. Investigations are ongoing to identify other locations that may have sold clover sprouts grown from this seed lot.
2010 (December) - Salmonella Newport
Sprouters Northwest of Kent, WA, issued a product recall after the company's clover sprouts had been implicated in an outbreak in Oregon and Washington. At least some of the cases had consumed clover sprouts while at a Jimmy John's restaurants. Seven were sickened.
At about the same time, a separate Salmonella outbreak was linked to Tiny Greens Organic Farm, and Jimmy John's, involving alfalfa sprouts served at Jimmy John's restaurants.
2010 (Dec) - Salmonella I4,[5],12:i:-
A second outbreak involving Jimmy John's was reported Dec. 17, 2010 by the Illinois Department of Health. Many of the Illinois cases reported eating alfalfa sprouts at various Jimmy John's franchises in an outbreak that sickened 140.
Four days later, on December 21, Jimmy John Liautaud asked all of his franchises to remove sprouts from the menu as a "precautionary" measure.
On December 23, the Centers for Disease Control revealed that outbreak cases had been detected in other states and that the outbreak was linked with eating alfalfa sprouts while at a "nationwide sandwich chain."
On December 26, preliminary results of the investigation indicated a link to eating Tiny Greens' Alfalfa Sprouts at Jimmy John's restaurant outlets. The FDA subsequently advised consumers and restaurants to avoid Tiny Greens Brand Alfalfa Sprouts and Spicy Sprouts produced by Tiny Greens Organic Farm of Urbana, Illinois. Spicy sprouts contained alfalfa, radish and clover sprouts.
On Jan. 14, 2011, it was revealed that the FDA had isolated Salmonella serotype I4, [5], 12:i: - from a water runoff sample collected from Tiny Greens Organic Farm; the Salmonella isolated was indistinguishable from the outbreak strain. The several FDA inspections of the sprout growing facility revealed factors that likely led to contamination of the sprouts.
2009 - Salmonella Saintpaul
Jimmy John's, which the CDC at the time identified at "Restaurant Chain A" was caught up in one of the largest recent sprout-related outbreaks.
A total of 256 were sickened in an outbreak first reported in February by the, Nebraska Department of Health and Human Services. Officials there identified six isolates of Salmonella Saintpaul. Although this is a common strain of Salmonella, in the previous year only three cases had been detected in Nebraska and only four subtypes of this outbreak strain had been identified in the entire USA.
Alfalfa sprout consumption was found in a case study to be significantly related to illness. The initial tracebacks of the sprouts indicated that although various companies had distributed the sprouts, the sprouts from the first cases originated from the same sprouting facility in Omaha.
Forty-two of the illnesses beginning on March 15 were attributed to sprout growing facilities in other states; these facilities had obtained seed from the same seed producer, Caudill Seed Company of Kentucky. The implicated seeds had been sold in many states.
On April 26, the FDA and CDC recommended that consumers not eat raw alfalfa sprouts, including sprout blends containing alfalfa sprouts. In May, FDA alerted sprout growers and retailers that a seed supplier, Caudill Seed Company of Kentucky, was withdrawing all alfalfa seeds with a specific three-digit prefix.
CDC also reported many illnesses occurred at "Restaurant Chain A," which was later identified as Jimmy John's.
2008 - E coli O157:NM
An outbreak of E. coli O157:NM in Colorado's Boulder and Adams counties, including the University of Colorado, was linked to the consumption of alfalfa sprouts from Jimmy John's franchises in the area.
The sickened, including several UC students, experienced symptoms of bloody diarrhea and cramping with O157 determined to be the cause. A total of 28 illnesses were associated with the outbreak.
In addition, the environmental investigation identified Jimmy John's food handlers in Boulder, CO who worked while infected with E. coli. The health department investigation found a number of critical food handling violations, including inadequate hand washing. The 14 isolates from confirmed cases were a genetic match to one another. |
| - Sun, 19 Feb 2012 01:59:03 -0800
Jimmy John's Gourmet Sandwich franchises like to be known for "freaky fast delivery," promising customers quick response.
But the promise does not apply to the news media after foodborne illness outbreaks involving Jimmy John's.
Since the February 15 report by the Centers for Disease Control and Prevention (CDC) about a five state outbreak of the rare O26 strain of E. coli associated with clover sprouts served by its sandwich restaurants, Jimmy John's has opted not to respond at all to media inquiries.
Jimmy John Liautaud, founder of Jimmy John's, has not responded to an invitation to respond to questions from Food Safety News. The invitation was sent to his private email address, which was provided by one of Jimmy John's former advertising and public relations agencies.
After previous outbreaks involving Jimmy John's, the franchise restaurant chain also dodged the media. In January 2011, however, Liautaud did respond to multiple outbreaks involving alfalfa sprouts served by Jimmy John's restaurants with an announcement the chain was switching to clover sprouts.
But since this new warning by CDC about the E. coli O26 outbreak involving clover sprouts from Jimmy John's, the chain has gone back to the silent strategy. One of its competitors, Erbert and Gerbert's Sandwich Shops, has for the time dropped sprouts from the menu.
"The decision to pull the sprouts from our system-wide menu is being made to protect the health of our guests," said E&G's Chief Executive Officer Eric Wolfe. "We value the well-being of our customers and felt removing all sprouts from our menu and sandwich line was the best way to eliminate the risk.
Until they were pulled, alfalfa sprouts were served at E&G's restaurants in Wisconsin, Minnesota, North Dakota, South Dakota, Colorado, George and Texas.
CDC's initial case count for the latest Jimmy John's-connected outbreak totaled 12. Two have been hospitalized.
The sickened were in Iowa (5), Missouri (3), Kansas (2), Arkansas (1), and Wisconsin (1).
All the victims, so far, have been female, ranging in age from 9 to 49 with a median age of 25. None have died.
CDC identified a common lot of clover seeds used to grow the clover sprouts served on Jimmy John's sandwiches.
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| - Sun, 19 Feb 2012 01:59:02 -0800
There are no words that cause raw milk advocates more heartburn than these: "The Congress shall have Power ...To regulate Commerce with foreign nations, and among the several States, and with Indian Tribes."
It was this section of the United States Constitution - the Interstate Commerce Clause - that as recently as this week tripped up an Amish dairy farmer who was legally milking cows in Pennsylvania, but selling illegally the District of Columbia and its Maryland suburbs.
But issues surrounding the Interstate Commerce Clause have spilled over to affect more than just raw milk since the time the Constitution was ratified. The Clause also affects other foods, as well as food safety.
Sick chickens, wheat and pasteurized milk are among the food issues that have piled up around the Interstate Commerce Clause - also known as Article I, Section 8 - and have even made their way into Supreme Court cases in disputes over when it applies.
Maybe if the U.S. constitution had set up a special panel of experts on business and the economy, we'd have a uniform and consistent series of cases ruling on when the Commerce Clause applies and when it does not.
But instead of these rulings being made by experts, people in robes who may or may not know how to balance their own checking accounts make them.
Because of this, our system produces decisions that often leave the reader of history with a case of whiplash from going back and forth.
My favorite among the many decisions involving the Interstate Commerce Clause and food is, by far, the "sick chicken case" of 1935.
It was that sick chicken that brought down the National Recovery Administration. The NRA required businesses to display "the Blue Eagle" to show that they were adhering to the organization's various codes.
Four chicken guys from Brooklyn, however, did not go along with the NRA's clueless attempts at making the market go up.
The Schechter Poultry Corporation was a poultry wholesaler supplying chicken to New York City wholesalers.They were eventually charged with 60 counts of violating the NRA Live Chicken Code. They pled not guilty, but were convicted.
On appeal, however, the U.S. Supreme Court ruled the Live Poultry Code was unconstitutional because it regulated intrastate commerce. The convictions were overturned.
Instead of just cutting his losses from the inept NRA with its scheme for lowering retail chicken prices in New York City, then-President Franklin Roosevelt subsequently went ballistic with plans to "pack" the court.
So that was the "sick chicken" case, so named for the NRA violation that had some connection to poultry health.
The Roosevelt administration then continued to attempt to impact prices through yet another law - the 1938 Agricultural Adjustment Act - which limited how much wheat individual farmers could plant.
Wheat grower Roscoe Filburn did not contest how much he could grow and sell into interstate commerce. He did, however, think that how much wheat he grew strictly for his own use was not subject to government jurisdiction.
So, when he was found and fined for growing excess wheat, he contested it all the way up to the U.S. Supreme Court. It was just seven years after the sick chicken case. Filburn lost.
The production quotas were found to comply with the Interstate Commerce Clause and the court went with the logic that if a farmer is allowed to grow his own chicken feed, demand for chicken feed will be down. So, growing your own could have a big impact on interstate commerce.
Some historians say that in the time between these two cases, during which Roosevelt threatened to double the size of the court with more favorable appointments, the President had whipped the court into doing his will. Of course by 1942, the war was on and the government's power to dictate production had more urgency.
The sick chicken and wheat cases are just the first two on a long list of interstate commerce cases involving food, and sometimes food safety.
Baldwin, Hood, and Dean are among the names of three early cases involving milk and state laws to discriminate against out-of-state products.
The result of the Baldwin case was basically that if a state is going to isolate some part of its economy, it better have a pretty good reason for doing so. Regulating food prices is not part of a state's role.
In Dean, Milwaukee dairies challenged the city of Madison's law prohibiting the sale of milk produced more than five miles from the center of the city.
Indeed, it was our old friend the Interstate Commerce Clause that was relied upon in the 1941 case of Edwards v. California. In Edwards, a state law preventing poor people from other states from entering California was ruled unconstitutional.
All that human talent was part of interstate commerce, and was found to fall under the power of Congress to regulate.
Some, including many raw milk advocates from the comments I read, believe that the Commerce Clause has been used far too broadly to regulate societal functions that the founding fathers never would have considered to be "interstate commerce."
A case not involving food or food safety, but regulation of school grounds, was found to be too much of a stretch even for Congress.
But I think it's clear that when it comes to food and food safety, the Commerce Clause clearly gives Congress the power. And it is the Congress that should get any credit or blame.
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| - Sun, 19 Feb 2012 01:59:01 -0800
Does the CDC like tacos more than sandwiches? Or, is it hopefully something else?
First, let's be clear, confidential patient information should never be disclosed absent the patient agreeing to it. And, second, a report should not be issued if there is no outbreak linked to a product and/or manufacturer. However, once an outbreak is tied to a particular product or manufacturer, the public has a right to know what or who is poisoning them, yes, even if the risk has passed for the moment. Consumers need to be able to make market decisions based upon safety records of the suppliers of food to them and their families.
I know, I have been harping on this transparency thing over the last few weeks after the CDC, once again, failed to name the "Mexican-style fast food restaurant chain, Restaurant Chain A" for the second time in two, and arguably three, Salmonella outbreaks that were eventually tied to Taco Bell.
Then the CDC announced another outbreak, an apparently ongoing outbreak: "This investigation is ongoing, but preliminary results of the epidemiologic and traceback investigations indicate eating raw clover sprouts at Jimmy John's restaurants is the likely cause of this outbreak."
"Investigation Announcement: Multistate Outbreak of Shiga Toxin-producing Escherichia coli O26 Infections Linked to Raw Clover Sprouts at Jimmy John's Restaurants:"
The CDC reported a total of 12 persons infected with the outbreak strain of STEC O26 reported from 5 states. The number of ill persons identified in each state is as follows: Iowa (5), Missouri (3), Kansas (2), Arkansas (1), and Wisconsin (1).
A few weeks earlier the CDC announced this outbreak: "This particular outbreak appears to be over"), as a final report "Investigation Announcement: Multistate Outbreak of Salmonella Enteritidis Infections Linked to Restaurant Chain A:"
As of January 19, 2012, a total of 68 individuals infected with the outbreak strain of Salmonella Enteritidis have been reported from 10 states. The number of ill persons identified in each state with the outbreak strain was as follows: Texas (43), Oklahoma (16), Kansas (2), Iowa (1), Michigan (1), Missouri (1), Nebraska (1), New Mexico (1), Ohio (1), and Tennessee (1).
On the face of the above two descriptions, the only clear reason to out Jimmy John's and not Taco Bell is that the "Restaurant A" outbreak report was completed and the Jimmy John's report might still be added to. However, I think you could well argue the opposite. During an ongoing investigation, you do not want to introduce bias and telegraph to potential victims where they may or may not have eaten or what they may or may not have eaten. So, perhaps there are other reasons?
According to the CDC, in the Jimmy's John's sprout outbreak, of the 11 ill persons with information available, 10 (91 percent) reported eating at a Jimmy John's sandwich restaurant in the 7 days preceding illness. Eight (80 percent) reported eating a sandwich containing sprouts, and nine (90 percent) reported eating a sandwich containing lettuce (interesting that they called out sprouts and not lettuce).
The "Restaurant A" - Taco Bell outbreak was less definite on a percentage basis. According to the CDC, among 52 ill persons for whom information was available, 60 percent reported eating at "Restaurant Chain A" in the week before illness onset.
Although 60 percent is less that 91 percent (genius right?), the CDC still found that ill persons (62 percent) were significantly more likely than well persons (17 percent) to report eating at "Restaurant Chain A" in the week before illness. The CDC also found that no specific food item or ingredient was found to be associated with illness due to common ingredients being used together in many menu items. However, among ill persons eating at "Restaurant Chain A," 90 percent reported eating lettuce, 94 percent reported eating ground beef, 77 percent reported eating cheese, and 35 percent reported eating tomatoes (so, not a ground beef outbreak?).
Again, on the face of it, having a 91 percent assurance that most of the people recalled eating at Jimmy John's and only 60 percent recalled eating at Taco Bell - I mean "Restaurant Chain A"-- seems like a good rationale to keep the name of the restaurant from the public. But is it? Is 60 percent the cutoff for the CDC to just not name names? Should the CDC have announced the outbreak or even named "Restaurant Chain A" at all?
Or, perhaps it is because in the Jimmy John's outbreak the CDC (or FDA) identified a single seed lot versus no common supplier for "Restaurant Chain A." Honestly, that might cut in favor of naming the seed supplier in the Jimmy John's outbreak and not naming Jimmy John's, and not naming the suppliers in the "Restaurant Chain A" outbreak, but naming "Restaurant Chain A" as Taco Bell.
Damn, this all gives me a headache.
I did find this CDC statement in the "Restaurant Chain A" - Taco Bell outbreak:
Restaurant Chain A, as well as their food suppliers and distributors, were very cooperative in providing extensive information to public health officials as various leads were explored.
Maybe, Jimmy John's did not play nice? Or was it because this is Jimmy John's fifth problem with sprouts. But, then wait, how many times has "Restaurant Chain A" - Taco Bell had issues? Well, unless you read my blog, you would never really know, and that is the problem.
Any other ideas?
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| - Sat, 18 Feb 2012 01:59:04 -0800
"I have long believed that good food, good eating is all about risk. Whether we're talking about unpasteurized Stilton, raw oysters or working for organized crime 'associates,' food, for me, as always been an adventure." -- Anthony Bourdain
In 2006, 205 people in the U.S were sickened and 3 died in an E. coli O157:H7 outbreak linked to baby spinach grown in California. In the aftermath, both the Food and Drug Administration (FDA) and California's Department of Health Services conducted extensive investigations into the outbreak to determine how leafy green produce could become contaminated with a microorganism normally found in the stomach of animals.
While investigators were able to successfully track the contaminated spinach to one specific field in California, and identify potential health risks such as the presence of cattle feces and wild pigs, the investigators had less success identifying the exact method by which E. coli contamination had occurred.
In response, California, the largest producer of leafy green vegetables in the nation with roughly a 75 percent market share, created its own statewide Leafy Green Marketing Agreement. Arizona, the second largest producer of leafy green vegetables with roughly a 15 percent market share, followed suite creating its own statewide program in September of 2007.
Unfortunately, despite the widespread adoption of these voluntary programs at the state level, foodborne illnesses linked to leafy green vegetables continue to be a problem across the country. In 2010, E. coli-tainted romaine lettuce was recalled in 23 states after 19 people became seriously ill in Ohio, New York and Michigan.
Just this last October, the U.S. Food and Drug Administration (FDA) discovered Listeria bacteria during a random sample of romaine lettuce grown in California. And as recently at this past New Year's Eve, "a Texas company recalled 228,360 lbs. -- 114 tons -- of spinach because it tested positive for E. coli O157:H7."
In response to industry interest, the U.S. Department of Agriculture's Agriculture Marketing Service (AMS) published an Advance Notice of Proposed Rulemaking (ANPR) on Oct. 4, 2007 to explore the idea of implementing a national marketing agreement focused on reducing microbial contamination in leafy green vegetables.
AMS received more than 3,500 public comments on the ANPR. On June 10, 2009, the agency received a petition for rulemaking and a request for a public hearing on a proposed National Leafy Green Marketing Agreement (NLGMA). The proposed marketing agreement was submitted to AMS "by a group of producers, handlers, and interested persons representing a cross-section of the national fresh and fresh-cut produce industry."
This initial proposal was designed to operate in a similar manner to voluntary marketing agreements previously implemented in California and Arizona following the 2006 outbreak.
While many in the leafy green industry praised the proposal as a huge leap forward for product safety, the proposal was also met with stiff resistance from many farmers, especially small-scale producers. The new rules also came under attack by consumer food safety advocates who were upset that the proposed rules would essentially allow the industry to police itself.
After taking comments and holding public hearings on the issue, the AMS proposed a revised NLGMA in the spring of 2011. This report provides an overview of how marketing agreements function in general, provides a detailed examination of the latest proposed NLGMA rules, and examines whether criticism for the latest proposed rule is legally and/or factually justified. Marketing Orders and Agreements
The Agricultural Marketing Agreement Act of 1937 (codified at 7 U.S.C. Chapter 26A) provides authority for federal marketing orders administered by the USDA. Under the supervision of the AMS, marketing orders have currently been established for milk as well as numerous fruits, vegetables, and other specialty crops. Not counting milk and the latest NLGMA proposal, there are currently 32 active marketing orders and agreements.
Marketing orders and agreements provide legal tools for agricultural producers, aggregators, processors, manufacturers, and retailers to work together to mitigate financial turmoil in the supply chain. A new marketing order or agreement must be developed by industry representatives, and then proposed to the AMS. The agency will then hold a public hearing and take public comments prior to making a final decision on whether to proceed with a rulemaking.
Prior to a proposed program being implemented, the regulation must be approved in a referendum by a two-thirds or larger majority of producers. Once a marketing order or agreement is approved, local committees appointed by the Secretary of Agriculture provide administration of the program. Marketing orders and agreements are binding on all "handlers" in the geographic area covered by the order. In general, a handler is anyone who receives the commodity from producers, and is responsible for grading, packing, transporting, or placing the farm products into commercial channels.
Marketing orders are distinguished from marketing agreements, in that marketing agreements are binding only on handlers who are signatories of the agreement. Handlers must comply with the grade, size, quality, volume, and other requirements established under the specific program.
Proposed National Leafy Greens Marketing Agreement (NLGMA)
Like all marketing agreements, the proposed NLGMA is intended to be a voluntary program so handlers can choose whether or not they wish to participate in it. Unlike other marketing agreements, the NLGMA has little to do with balancing financial interests in the supply chain, but is focused entirely on providing a legal structure for farmers and handlers to efficiently comply with a new system of national food safety requirements impacting all leafy green vegetables.
While no specifics are given in the proposal, such food safety requirements would be based on the FDA's Good Agricultural Practices (GAPs), Good Manufacturing Practices (GMPs), and the USDA's Good Handling Practices (GHPs).
Under the current proposal, the marketing agreement would be governed by a 26-member Board of Directors appointed by the Secretary of Agriculture. The Board would be responsible for making policy recommendations to the Secretary for final review and approval. Any major changes to the agreement, including the Board's recommended food safety requirements and exemptions, would be sent out for public comment prior to its adoption.
Board members would be apportioned from eight administrative zones, with state's divided into groups based on geographic and climate differences. Each administrative zone would be assigned representation on the Board relative to the amount of leafy green vegetables produced within that zone. For example, administrative zone 1 -- which includes Hawaii and California -- would receive 4 representatives as California produces roughly 75 percent of all leafy green vegetables grown in the country.
In addition, the Board would include 10 designated grower representatives, with two of the 10 grower positions designated for small farmers. No company would be allowed to have more than one representative on the board, even if its operations included multiple farms in different administrative zones.
A Technical Review Committee (TRC) would assist the Board in developing guidelines and procedures. The TRC would consist of members who represent production, handling and food safety experts from each zone (including organic and small business interests), experts from the USDA's agencies, and other federal agencies such as the FDA and EPA. The TRC also would have the authority to work collaboratively with industry stakeholder groups, local and state authorities, and others interested parties whose expertise the TRC might require.
The proposed NLGMA would cover a wide range of fresh leafy green vegetables and their varieties, including: arugula, cabbage, chard, cilantro, endive, escarole, kale, lettuce, parsley, radicchio, spinach, and "spring mix" -- an industry term that describes mixtures of baby lettuces, mustards, chards, spinach, and chicories that vary based on availabilities. These vegetables could be whole or fresh-cut, or in bulk or packaged form. Under the proposed NLGMA, the Board could recommend, subject to USDA approval, the addition or removal of any leafy green vegetable from this definition. Handlers of fresh leafy green vegetables in the 50 states and the District of Columbia, also known as the production area, would be eligible to become signatories. Once becoming a signatory, participants would only handle leafy green vegetables from producers or other handlers that are also in compliance with the NLGMA.
Signatories who handle product imported from outside the United States would be required to demonstrate that those products also meet the requirements of the NLGMA. Compliance by signatories with the terms of the agreement would be mandatory. A signatory would be obligated to participate for no less than one crop year in the program. After the initial year, participants would have the opportunity to withdraw or opt out of the program.
While the program is voluntary for handlers of all sizes, any producer who sells to a handler that is a signatory to the NLGMA would be required to adhere to the marketing agreement. Small farmers participating in farmers markets, CSAs, or other direct sales to consumers may choose not to participate in the marketing agreements, provided they don't sell any of their leafy green vegetables to a signatory handler. Once adopted, all signatory handlers and their growers would be subject to an audit by the AMS Inspection Service. AMS Inspection Service would have the authority to accredit other entities and license their auditors to audit on its behalf, including National Organic Program (NOP) certified agents, FDA inspectors, and third-party auditing services accredited by FDA.
This presents the potential to streamline the audit process facing many producers in today's market, thus improving operations and reducing costs. For example, the proposal would permit the program to evolve whereby an organic producer could include the NLGMA food safety standards as a component of the overall organic system plan and receive a single audit. The proposed NLGMA "would provide the Board authority to establish marketing research and development projects, and or promotional activities, including paid advertising, to assist or promote the efficient adoption, implementation, and marketplace acceptance of the agreement and leafy green vegetables." A Research and Development Committee would assist the Board in carrying out these actions.
The costs of these programs and the audit verification fees would be paid for through assessments of the signatory handlers. The price of these assessments would be recommended by the Board and must be approved by the USDA. These assessments would not be allowed to exceed $0.05 per 24-pound carton equivalent of leafy green vegetables. As assessments are based on the volume of a handler's transactions, large handlers would pay more assessments than small handlers participating in the program.
The AMS believes the proposed NLGMA will have a number of important benefits for producers, handlers, and consumers. "A primary benefit of the proposed agreement is the reduced likelihood of food contamination outbreaks in leafy green vegetables... in the United States."
This would not only benefit consumer health, but also the economic viability of the industry since it is estimated "that a food contamination outbreak could lead to a 10 percent long-term reduction in demand for leafy green vegetables." The 2006 E. coli outbreak alone was estimated to have cost leafy green producers $12 million dollars, and U.S. retailers as much as $63 million in lost profits.
Criticism of the Latest NLGMA Proposal
Both proponents and opponents of the latest NLGMA agree that food safety is a priority that needs to be better addressed by regulation. There is also no question that the most recent NLGMA is a more well thought out and balanced version of the regulation that what was initially proposed in 2009.
Yet, critics of the latest proposal -- including the National Sustainable Agriculture Coalition (NSAC) and the National Organic Coalition (NOC) -- contend that the AMS failed to adequately address at least four main concerns:
- whether the AMS is the proper agency to handle food safety regulation governing leafy green vegetables
- whether a marketing agreement is the proper regulatory tool to carry out national food safety regulations
- whether Congress has already addressed this particular food safety issue with the Food Safety and Modernization Act passed in December of 2010
- whether the NLGMA still unfairly burdens small to medium sized producers who wish to participate in the program
Is AMS the Proper Agency to Oversee Leafy Greens?
Three federal agencies are traditionally involved in U.S. food regulations. In general terms, the USDA is responsible for all issues involving meat, poultry, dairy and eggs. In contrast, the FDA is responsible for all other food and food additives. Finally, the Federal Trade Commission (FTC) is involved in the regulation of food advertising.
The proposed NLGMA even recognizes the FDA's expertise in food safety regulations involving leafy green vegetables as the AMS intends the Board's final food safety regulations to reflect the FDA's published GAPs and GMPs, in addition to the USDA's GHPs. It also makes clear that the AMS intends to follow any existing or new FDA regulations that would impact food safety regulation or audits carried out by the agency.
In contrast, AMS has not traditionally been involved in food safety regulations or their enforcement, even within the USDA. Instead the AMS is involved mainly in assisting producers to market their products. This includes providing standardization, grading and new services for its five commodity programs -- dairy, fruit and vegetable, livestock and seed, poultry, and cotton and tobacco. It also includes overseeing the National Organic Program (NOP) and facilitating both domestic and international marketing efforts for U.S. agriculture. Which is not to say that either USDA as a whole, or AMS in particular, lack expertise when it comes to developing or enforcing new production standards. After all, in addition to developing marketing orders and agreements, AMS is also responsible for helping to create international quality standards for agricultural products.
Its role in overseeing NOP has also provided it the opportunity to implement a farm-based audit program designed to facilitate the needs of both small and large producers. In addition, the USDA as a whole has been heavily involved in the implementation of the Hazard Analysis Critical Control Point system (HACCP) currently utilized in meat, seafood, dairy, and juice production. This flexible system of scientifically based production standards -- designed to reduce microbial contamination during processing -- has been widely adopted by the food industry in Europe and much of the United States.
Thus, while AMS may not be the foremost expert in food safety regulation involving leafy green vegetables, the agency certainly has both the scientific expertise and experienced personnel to carry forth all the provisions proposed under the NLGMA.
Are Marketing Agreements the Proper Regulatory Tool for Food Safety Regulations?
When considering whether it is appropriate to use a marketing agreement to address food safety, it is important to examine how Congress has historically created food safety legislation. Over the past hundred years, Congress has passed many acts to improve food safety in this country, including the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, the Egg Products Inspection Act, the Federal Meat Inspection Act of 1906, the Poultry Products Inspection Act of 1957, and most recently, the Food Safety Modernization Act of 2010.
In almost all cases, these acts did not set forth specific food safety laws, but delegated the responsibility to the FDA or the USDA. This was not an ethical consideration, but a practical consideration as Congress has generally relied on agency expertise to formulate science based standards for the safety of the public. Proponents of using a marketing agreement to enact food safety regulation thus contend that it is simply another example of how an agency can use its scientific expertise to carry out the intent of Congress under the Agricultural Marketing Agreements Act of 1937.
Critics of the recently proposed NLGMA provide two separate reasons why a marketing agreement is the wrong regulatory tool for food safety: (1) it is unethical to make food safety a marketing issue, and (2) Congress never intended marketing agreements to address food safety issues as just another quality issue.
The first question is challenging, as there is neither one set of ethical standards that society adheres to under all circumstances, nor one type of regulatory tool that Congress always uses to address food safety issues. However, in its public comment to proposed NLGMA, NSAC stated the problem as thus: "The members of the National Sustainable Agriculture Coalition have issued a statement containing 16 core principles about food safety. The very first of those principles states: Food safety is noncompetitive and transparent. Everyone who lifts a fork has a right to safe and healthy food, just as they have a right to choose foods based on the qualities most important to them. "Food safety" should not be a competitive marketing food-trait, lest the most vulnerable people end up with access to only the least safe food, or simply fewer choices. Every person has a right to expect the safest possible food, and a right to absolute transparency about its production processes, no matter what they can afford to pay for it. Completely open, public information about what makes a food 'safe' is not negotiable."
While this argument is compelling, it does seem to suggest that the secret goal of the NLGMA is to create a more expensive, less microbial contaminated food, which will then be marketed to consumers as a superior product compared with those leafy green vegetables not produced under the program.
Given that marketing agreements are generally only targeted toward producers and handlers, not consumers, this is more than a little incongruous. The proponents of the NLGMA stated at the public hearing that the promotion and advertising to be conducted under the program would be targeted at those within the leafy green vegetable industry, and not consumers.
There is also nothing in the record that would suggest that the general public would be any more aware of the NLGMA than they are aware of other marketing orders and agreements regulating the sale of milk and other agricultural products. Moreover, even if consumers did believe there were tangible health benefits to eating NLGMA-certified leafy green produce, it would certainly not be any more of a competitive advantage than what is already enjoyed by organic and local food producers who often advertise that their product is healthier and safer than conventionally produced foods. Yet even if it is not unethical, there is still the question of whether Congress ever intended AMS to utilize marketing agreements to address food safety as just another quality issue.
In its public comment to the proposed NLGMA, NSAC stated the problem as thus:
"The House version of what became the 2008 Farm Bill (Food, Conservation, and Energy Act of 2008) authorized the implementation of specialty crop marketing agreements for food safety. Industry sought this amendment precisely because they believed, correctly, that current law did not provide for comprehensive food safety controls via marketing agreements.
After heated debate, the Conference Committee rejected the House provision, precisely based on the argument that marketing agreements are not the right instrument to address food safety concerns and that the Agricultural Marketing Service is not a food safety agency.
Put simply, the leafy green and other specialty crop industry associations lost in their legislative campaign to change the law to provide authority for food safety marketing agreements such as the pending NLGMA. In order to save face, the industry scrambled to get language added to the Conference Report indicating that some marketing orders already issued by USDA have included "quality related provisions intended to enhance the safety of commodities" and that therefore the proposed statutory change was unnecessary.
This "cover your losses" report language flies in the face of the industry's arguments in pursuing the amendment to begin with, and is at any rate irrelevant to the current consideration of the NLGMA. The NLGMA is not a broad marketing agreement that happens to touch on a few quality-related provisions that have some effect on food safety. It is through and through a food safety agreement, period."
While this legislative history may be 100 percent accurate, it does not change the wording of the Act, or the broad delegation Congress originally gave to USDA and AMS to create marketing agreements. In 1937, Congress created the Act to protect farmers from price fluctuations created by market disruptions that impacted interstate commerce.
To accomplish this goal, Congress delegated to the Secretary of Agriculture several important duties, including the powers to: (1) "establish and maintain such orderly marketing conditions for agricultural commodities in interstate commerce as will establish, as the price to farmers, parity prices", and (2) protect producers and consumers from "unreasonable fluctuations in supplies and prices."
Given the detrimental impact of food safety outbreaks on agricultural markets, it is a problem that clearly falls within scope of the Act, regardless of later Congressional hearings and discussions. There is also no language in the Act that would exempt food safety issues from the wide range of other qualities issues covered under the Act. Therefore, the AMS is well within its delegated duties to utilize marketing agreements to address purely food safety related issues. Not because they are a quality issue, but because they directly impact the price of leafy green vegetables in interstate commerce.
Did Congress Already Address This Issue in the FSMA?
There is no question that the Food Safety Modernization Act of 2010 (FSMA) was the most important food safety legislation passed by Congress in decades. The real question is whether Congress fully addressed the food safety issue the NLGMA intended to regulate, thus making the proposed NLGMA conflict with the governing law.
In brief, the FSMA directs the FDA to: (1) develop preventative science based food safety standards for covered facilities, (2) conduct regular inspections of covered facilities to hold them accountable, and (3) require importers to perform supplier verification activities. It also provides FDA with mandatory recall authority and requires enhanced collaboration activities with other state and federal agencies involved in food safety.
Looking at the plain language of both the NLGMA and FSMA, there is some clear overlap when it comes to regulating leafy green vegetable producers and handlers. Under the FSMA, FDA is directed to develop preventative science based food safety standards for these groups and conduct regular inspections. Under the NLGMA, the AMS will be developing preventative science based food safety standards and conducting annual audits. In a best-case scenario, the two sets of rules would be identical and no conflict of law would be created.
Moreover, if the rules drafted under the NLGMA are more stringent than those drafted by FDA, then both systems could mutually exist and complement each other. After all, the NLGMA is a voluntary system so if its handlers and growers want to hold themselves to higher standards than the FDA then who is to complain.
On the other hand, if any of the food safety standards promulgated under the NLGMA are lower than those produced by FDA, than the rules promulgated by FDA would clearly take precedence. This is for two reasons: (1) the FSMA was passed by Congress more than 70 years after the Agricultural Marketing Adjustment Act of 1937, and (2) FSMA is a more clear delegation of Congressional power when it comes to developing science based food safety standards.
FDA also has mandatory recall authority if food produced under the NLGMA is not sufficient to meet FDA standards. Yet, such an outcome will only occur if the two agencies completely ignore each other's rule making processes, and this seems unlikely since the FSMA clearly directs agencies to work more closely on issues regarding food safety. In response, critics of the NLGMA point out that the FSMA also included the Tester Amendment which exempted qualified facilities--either a very small businesses or those making less than $500,000/yr.--from much of the new regulation. In its public comments, NSAC framed the issue as thus:
"We have sought repeated unqualified assurances from USDA that all of the protections carefully built into the FSMA by Congress to protect the interests of small and mid-sized farms, diversified farming operations, direct market operations, and local food producers would be fully recognized and scrupulously respected under the NLGMA. No such unqualified assurances were forthcoming. In fact, to the contrary, we were told by the Administrator that the ultimate decisions on issues like this would rest with the Review Committee and that while it is assumed that FDA regulations and implementation process will be adopted by the NLGMA, there is a chance these particular issues would be among those that the NLGMA might amend through the process established in the proposed Agreement."
The problem with this line of argument is that the NLGMA is a voluntary system, whereas the FSMA is a mandatory system. As such, the two systems of regulation are not really in conflict as no qualified facilities exempted under the FSMA have to participate in the NLGMA, and those facilities who choose to participate under the NLGMA essentially consent to be bound to USDA-AMS rulemaking.
This will be an important consideration to many small to medium sized operations who will need to balance the economic benefits of participating in the NLGMA, with the increased financial costs associated with annual audits and bringing their operations into compliance.
An Unfair Burden to Small- and Medium-Sized Operations?
As the NLGMA does not contain any specific production standards to date, it is difficult to know with any certainty what its financial costs will be for producers and handlers involved in the program.
In general terms, three financial costs are anticipated for those who wish to participate: (1) the initial costs of bringing one's operation into compliance with the program, (2) the cost of annual audits, and (3) the annual costs of maintaining compliance as the program evolves and changes. These additional costs could potentially be balanced out by increased market stability, and a greater ability for participants to sell product into both domestic and international markets.
Based on cost estimates from a University of California report, AMS estimates "the total one-time modification costs at the farm level" to be "between $1.2- and $3.0 million, and an estimated average range of $14-$34 per acre for modification costs." On top of this initial cost would be annual compliance costs estimated at $2.7- to $4.4 million, or $30-50 per acre.
Of course, these estimates do not include the costs for California and Arizona producers currently involved in state marketing agreements. The producers from these two states are estimated to have spent $6.1- $14.7 million to bring their operations into compliance with their current rules, and spend between $13- to $21.7 million in annual compliance costs.
Annual handler assessments for the program would range between $5.7- to $28.6 million depending upon the whether the assessment was the program minimum of $0.01 per carton, or the program maximum of $0.05 per carton.
Based on these estimates, a hundred acre leafy green vegetable operation in Arkansas would spend between $1,400 to $3,400 in one-time compliance costs and between $3-5000 annually to maintain compliance. Such costs are hardly insignificant for small to medium sized operations, especially for those who might otherwise be exempt from similar regulations under the Tester Amendment of the FSMA.
The only silver lining is that the proposed NLGMA is a voluntary program for handlers to participate in. As such, producers should definitely discuss their financial operations with their handlers to determine whether the economic benefits of participating in the NLGMA would offset their estimated costs.
Will Leafy Greens Producers Support the Agreement?
In drafting its proposed marketing agreement, the NLGMA has provided producers and handlers with one potential tool to help reduce foodborne contamination in their production systems.
Whether it becomes law will ultimately depend upon what changes the agency makes after the latest round of public comments, and whether the proposed marketing agreement will be supported by a 2/3 majority of all leafy green vegetable producers in the nation. The effectiveness of such an agreement is also difficult to estimate, as the Board will need to be appointed and make its recommendation to the Secretary of Agriculture.
This will lead to yet more rulemaking, and additional opportunities for public comment. As such, proponents and opponents of the NLGMA should not expect any final food safety production standards for at least another 18 to 24 months.
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Judd Jensen is pursuing his LL.M. in Agricultural and Food Law at the University of of Arkansas. Prior to returning to law school, he worked in food safety and quality assurance for nearly a decade.
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| - Sat, 18 Feb 2012 01:59:02 -0800
The international organic market just got a little bigger.
Agriculture Deputy Secretary Kathleen Merrigan announced Wednesday that the organic certifying programs in the United States and Europe Union are now considered equivalent. The new partnership between the two largest organic producers in the world means that products certified organic under one certification scheme can be sold as organic in the other without additional certification and paperwork.
Prior to the partnership, producers and companies seeking to trade their organic products both domestically and abroad had to obtain two separate certifications, one from the U.S. and one from the EU. Each certification required its own fees, inspections, and paperwork. By declaring the organic standards equivalent, the partnership eliminates many significant barriers, especially for small and medium-sized organic producers.
In a press release, Deputy Secretary Merrigan noted the new partnership "is a win for the American economy and President Obama's jobs strategy. This partnership will open new markets for American farmers and ranchers, create more opportunities for small businesses, and result in good jobs for Americans who package, ship, and market organic products."
The partnership recognizes that while the certification standards are compatible, there are some differences that need to be addressed. As a general rule, all products that meet the terms of the partnership may be traded and labeled as certified organic produce, meat, cereal, or wine.
The major difference comes in the use of antibiotics. Under the agreement, U.S. apples and pears produced using antibiotics (to control fire blight) may not be exported to the EU, and EU meat and milk derived from animals treated with antibiotics may not be exported to the U.S..
The terms of the partnership require the U.S. and EU to have regular discussions and to periodically review each other's programs to ensure that the partnership agreement is being met.
The international trade implications of this partnership are huge. The combined value of the EU and U.S. organic sectors is valued at $50 billion each year, and growing. Officials at USDA estimate that U.S. organic exports to Europe will triple within three years.
EU Commissioner Dacian Ciolos noted that the partnership "improves transparency on organic standards, and enhances consumers' confidence and recognition of our organic food and products. This partnership marks an important step, taking EU-U.S. agricultural trade relations to a new level of cooperation."
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| - Fri, 17 Feb 2012 11:45:01 -0800
Campylobacter may have struck yet another raw-milk dairy.
Claravale Farm, one of the two state-licensed commercial raw milk dairies in California, is being investigated for the possibility that some of its milk was contaminated with Campylobacter, an infectious disease that can cause serious gastric problems and in some cases can be life-threatening.
Raw milk is milk that hasn't been pasteurized to kill harmful bacteria that may be present in the milk. An ongoing Campylobacter outbreak involving product from a Pennsylvania raw milk dairy has so far sickened at least 77.
Claravale Dairy last week voluntarily stopped distributing to the many stores that sell its products, which include cream and raw cow and goat milk. Its distribution area ranges from the Bay Area all the way down to San Diego. However, as of Feb. 17, the dairy had not yet informed its customers, either through its website or its Facebook page, that it had stopped production.
The dairy, which is owned by husband and wife Ron Garthwaite and Collette Cassidy, did not respond to an e-mail and a phone call request for comment from Food Safety News.
According to the U.S. Centers for Disease Control Prevention, unpasteurized milk can become contaminated if the cow has an infection with Campylobacter in her udder or the milk is contaminated with manure.
Matt Conens, a spokesman for the state's Public Health Department, said the agency is working with local health departments on reported illnesses where raw milk was consumed prior to the onset of illness.
"More than one bacterial agent causing gastrointestinal illness is being investigated, including campylobacter," he said in an e-mail to Food Safety News. But because the investigation is ongoing, the department cannot provide information about the number of reported illnesses or their locations.
Steve Lyle, spokesman for the state's Agriculture Department, said in a Feb. 16 e-mail to Food Safety News that the department is aware of the action taken by Claravale and that tests of the dairy's products are pending. The department is also taking samples from the dairy itself. Results are still several days away, Lyle said, and the department has not taken any regulatory action.
According to information provided by Claravale on a "fact sheet" about raw milk, raw milk can be stored in refrigerators for up to two weeks. This means that customers may still have some of the dairy's raw milk in their refrigerators.
Claravale Farm, located in San Benito, Calif., has been producing raw milk since 1927. As of September 2011, it had a herd of 65 Jersey cows. It has recently added some goats to its operation. Its website touts its milk as being "entirely natural" and unprocessed. Until this investigation by the state, it has not had a problem with foodborne illnesses linked to its milk.
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| - Fri, 17 Feb 2012 01:59:10 -0800
Brown rice syrup used in many organic foods as a substitute for the often-chastised high fructose corn sugar is causing problems of its own with high arsenic levels.
That means danger for those consuming such products as "organic" infant milk formula, cereal bars or high energy foods that contain the organic brown rice syrup (OBRS) as an ingredient, according to a Dartmouth College research team led by Brian Jackson.
Jackson is director of Trace Metal Analysis at Dartmouth's Department of Earth Science.
The team's findings on arsenic in foods containing OBRS were published Thursday in Environmental Health Perspectives, the online peer-reviewed open access journal of the National Institute of Environmental Health Science.
There is "an urgent need for regulatory limits" for arsenic in foods, the researchers say, as there are no current U.S. regulations that set such limits.
After testing 17 infant formulas, 27 cereal bars and three different "energy shot" drinks, the team found levels significantly above the level established for public drinking water.
In 2001, the U.S. Environmental Protection Agency (EPA) - using recommendations from a series of independent panels - set the limit for public drinking water at 10 parts per billion (ppb). The earlier limit, in place since the 1940s, was 50 ppb.
Dartmouth researchers found cereal bars with inorganic arsenic levels raining from 23 to 128 ppb. One of the "energy shot" drinks registered at 84 ppb, and the two others hit 171 ppb. The infant formula came in at 8.6 ppb for dairy-based, and 21.4 ppb for soy-based.
While the cereal bars and "energy shots" returned much higher levels, Jackson is most concerned about the organic infant formulas because these are often a baby's sole source of nutrition.
Rice plants take up arsenic through the soil because the dangerous substance behaves much like silica, which rice needs to grow. Brown rice tends to collect arsenic in higher levels, but amounts vary.
The study's release brought out TV doctors on most major network news shows to warn the public once again that they should not mix up "organic" with "safe."
Others on Jackson's team are Vivien F. Taylor, Margaret R. Karagas, Tracy Punshon and Kathryn L. Cottingham.
Arsenic at levels higher than the EPA drinking water standard have also been found recently in juices popular with children.
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