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7/9
2009
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4th International Conference for Food Safety and Quality
(November 3-4)
Key speakers



ISO22000:2005 Training Course
(November 5-6, 2009)


click here for more information

Video: Vice President Biden: Food Safety Working Group Key Findings


Administration Urged to Boost Food Safety Efforts
Source of Article: http://voices.washingtonpost.com
By Jane Black and Ed O'Keefe Updated 4:11 p.m. ET
The Obama Administration today took a first step towards overhauling food safety regulations that have been blamed for a steady stream of food safety outbreaks and product recalls.
The new proposals, recommended by a working group President Obama created in March, emphasize prevention, enforcement and improving the government's response time to food safety outbreaks.
"There are few responsibilities more basic or more important for the government than making sure the food our families eat is safe, Vice President Joseph Biden said at a White House news conference where he was joined by Health and Human Services Secretary Kathleen Sebelius and Agriculture Secretary Tom Vilsack. "American families have enough to worry about today. They should not have [food safety] as a concern."
Fears about food safety has been spurred by a series of national outbreaks of salmonella and E.coli in products as varied as peanuts, pistachios, spinach, tomatoes, peppers and, most recently, cookie dough. The complex and sometimes bizarre division of labor among the 15 federal agencies that oversee inspections is also a concern: The Food and Drug Administration is responsible for fresh eggs while the Department of Agriculture is responsible for egg products. Cheese pizzas are inspected by the FDA while meat-laden pepperoni pies go to the USDA.

The administration outlined a variety of measures to prevent the spread of salmonella, a bacteria that causes more than 1 million illnesses each year in the United States. The FDA issued a final rule to reduce the contamination in eggs, which the agency estimates will help reduce the number of foodborne illnesses associated with the consumption of raw or undercooked contaminated eggs by 79,000 or about 60 percent. It also will save more than $1 billion annually, Sebelius said.
The regulation has been a long time coming. President Bill Clinton first proposed similar regulations in 1999.
The USDA's Food Safety and Inspection Service (FSIS) also committed to develop new standards to reduce the prevalence of salmonella in turkeys and poultry by the end of the year. It will also establish a salmonella verification program with the hopes that 90 percent of poultry establishments will meet the new standards by the end of 2010.
Both agencies also announced plans to tackle E.coli. FSIS will step up enforcement at meat processing plants and increase sampling that tests for the pathogen especially for ground beef. The FDA, which is responsible for fresh produce, will by the end of the month issue guidance on ways to reduce contamination in the production and distribution of tomatoes, melons and leafy greens.
The proposals also included new staff positions that will help agencies coordinate with one another. The FDA will hire a deputy commissioner for foods to oversee and coordinate its efforts on food, including food safety. FSIS will hire a new chief medical officer position to report to USDA's undersecretary for food safety.
On the whole, food safety advocates were pleased with the new initiatives. "We are coming out of a phase, just like in the financial sector, where the government was loathe to regulate," said Caroline Smith DeWaal, food safety director for advocacy group Center for Science in the Public Interest. "Tougher controls earlier in the food chain will result in fewer recalls and fewer outbreaks."
"Part of the problem with how we currently deal with foodborne illness cases is we wait until people get sick and die and then we announce an outbreak," said Bill Marler, a veteran food safety litigator who writes an active blog about the issue. "It seems that the focus here is a bit on preventing it before we have sick and dead people as opposed to counting the bodies after salmonella or E. Coli is out of the barn."

Such changes are long overdue, advocates agree. Many key food safety regulations were inspired by the publication of Upton Sinclair's "The Jungle" in 1906. "While the law hasn't changed dramatically since then, our world has changed dramatically since then," Biden said. "It's not unusual for us to snack on vegetables from South America and pick up some fruit from the South Pacific and then go have dinner with beef from Brazil."
¡°Today¡¯s announcement signals an important break from our past policy of making piecemeal changes to outdated laws," said Sen. Richard Durbin (D-Ill.) "These changes are a fundamental step towards comprehensive food safety reform.¡±
Still, many key changes will be left to Congress, including the controversial issue of giving federal agencies the authority to recall tainted products if a manufacturer refuses. This would also make it easier for consumers to find out where recalled food was sold.
Several bills have been introduced to tackle this and other issues not included in the working group's recommendations. Reps. Henry Waxman (D-Calif.) and John Dingell (D-Mich.) want to give FDA the authority to recall tainted food, to "quarantine" suspect food, and to have the ability to impose civil penalties and increased criminal sanctions on safety violators. Rep. Rosa L. DeLauro (D-Conn.) has proposed separating the agency's food safety responsibilities by establishing a new Food Safety Administration. In the Senate, Durbin hopes to give the agency a larger budget with more inspectors and stronger regulatory tools.

More E. coli sampling, salmonella program among Obama panel recommendations
Source of Article: www.meatingplace.com
by Ann Bagel Storck on 7/7/2009

A Food Safety Working Group created by President Obama in March on Tuesday announced recommendations that include new standards to reduce salmonella in poultry and increased E. coli sampling in beef products, among other actions.
The recommendations are centered around three core food safety principles, the group said:
Preventing harm to consumers is our first priority.
Effective food safety inspections and enforcement depend upon good data and analysis.
Outbreaks of foodborne illness should be identified quickly and stopped.
E. coli and salmonella prevention
By the end of July, the group stated in a report, USDA's Food Safety and Inspection Service will issue improved instructions to its workforce on how to verify that establishments that handle beef are acting to reduce the presence of E. coli. Also by the end of July, FSIS will increase its sampling to find this pathogen, focusing largely on the components that go into making ground beef, the group said.
By the end of the year, FSIS will develop new standards to reduce the prevalence of salmonella in poultry. The agency will also establish a salmonella verification program with the goal of having 90 percent of poultry establishments meeting the new standards by the end of 2010.

Illness traceback and response
The Food Safety Working Group also announced several actions aimed at managing foodborne illness outbreaks more effectively and sharing information in an emergency. These actions include:
Within three months, FDA will issue draft guidance on steps the food industry can take to establish product tracing systems to improve national capacity for detecting the origins of foodborne illness.
Within three months, federal agencies will implement a new incident command system to address outbreaks of foodborne illness.
Within six to 12 months, FSIS will improve collaboration with states by increasing the capacity of its public health epidemiology liaison program to state public health departments through additional hires and expanded outreach.
CDC will work with states to evaluate and optimize best practices for aggressive and rapid outbreak investigation, and will launch a new system to facilitate information-sharing and adoption of best practices within 12 months.
The federal government will enhance foodsafety.gov to better communicate information to the public and include an improved individual alert system allowing consumers to receive food safety information, such as notification of recalls. Agencies will also use social media to expand public communications. The first stage of this process will be completed in 90 days.
New positions at FSIS and FDA
The group also announced that within the next three months, USDA will create a new position, chief medical officer, at FSIS. This position, which will report to the under secretary for food safety, is designed to enhance USDA's commitment to preventing foodborne illness.
This month FDA will create a new position, deputy commissioner for foods, to oversee and coordinate its efforts on food, including food safety. This position will be empowered to restructure and revitalize FDA's activities and work with FSIS and other agencies in developing a new food safety system.

Food Safety Video
Basic Food Safety - Part 2: Holding Time and Temperatures

FSIS, JBS Swift ? ¡°Where is the Beef?¡± Would you Mind Telling the Public Where the E. coli Beef is BEFORE the 4th of July?

Source of Article: http://www.marlerblog.com/
The good/bad thing about hitting 50ish, and litigating food poisoning cases for 16 years, is the institutional memory that I have developed regarding bad food and bad commercials.
Coming days before the 4th of July barbeque's, JBS Swift Beef Company expanded the approximately 40,000 pounds of ¡°assorted beef primals¡± recalled on June 24 to include another approximately 380,000 pounds of ¡°assorted beef primals" due to E. coli O157:H7 contamination. Somewhere between 18 and 24 Illnesses have been reported in what is believed to be Arizona, California, Colorado, Florida, Illinois, Michigan, Minnesota, Nebraska, Oregon, South Carolina, Tennessee, Utah and Wisconsin? As reported by the Food Safety and Inspection Services (FSIS):
The beef products were produced on April 21, 2009 and were distributed both nationally and internationally. Each box bears the establishment number "EST. 969" inside the USDA mark of inspection as well as the identifying package date of "042109" and a time stamp ranging from "0618" to "1130." However, these products were sent to establishments and retail stores nationwide for further processing and will likely not bear the establishment number "EST. 969" on products available for direct consumer purchase. Customers with concerns should contact their point of purchase.
The recalled products include intact cuts of beef, such as primals, sub-primals, or boxed beef typically used for steaks and roasts rather than ground beef. FSIS is aware that some of these products may have been further processed into ground products by other companies. The highest risk products for consumers are raw ground product, trim or other non-intact product made from the products subject to the recall.

So, where is the recalled beef?
On August 18, 2008 after years of hand wringing, the FSIS finally put public health before ¡°proprietary¡± business interests when it made the following rule:
9 C.F.R. ¡× 390.10 Availability of Lists of Retail Consignees during Meat or Poultry Product Recalls
The Administrator of the Food Safety and Inspection Service will make publicly available the names and locations of retail consignees of recalled meat or poultry products that the Agency compiles in connection with a recall where there is a reasonable probability that the use of the product could cause serious adverse health consequences or death.

The full rule can be reviewed at: http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2005-0028F.pdf

The Bottom Line:
The FSIS is now supposed to make available to the public names and locations of retail consignees (grocery stores, etc.) of meat and poultry products recalled by a federally-inspected meat or poultry establishment if the recalled product has been distributed to the retail level. The rule will only apply to Class I recalls (like the JBS Swift ones). The information is supposed to be posted on the FSIS website, generally within three (3) to ten (10) working days, following the announcement of the recall.
So, where is the recalled beef?

FSIS and JBS Swift reveal partial distribution of E. coli Tainted Meat
Source of Article: http://www.foodpoisonjournal.com/
Posted on July 2, 2009 by Suzanne Schreck
More than a week after JBS Swift initiated a nationwide recall of E. coli-tainted meat, the USDA¡¯s Food Safety and Inspection Service (FSIS) and JBS Swift have taken the necessary steps of alerting consumers as to which retail outlets received the beef. After an initial recall of 41,280 pounds on June 24, JBS Swift expanded the recall to include an additional 380,000 pounds on June 28. Now the entire April 21 production run of beef primal from the JBS Swift Greeley, Colorado plant is being recalled. The retail outlets listed by FSIS and JBS Swift are:

Price Chopper stores
Hannaford stores in ME, NH, VT, MA, and NY
Stop & Shop stores in ME, MA, RI, CT, NH, northern KY, Southeastern IN, western TN, and AR
Kroger stores in MS and IL
Food 4 Less stores in the Chicago area
Fry¡¯s stores in AZ
Smith¡¯s stores in AZ, UT, and other Western states
Costco
The CDC announced on July 1 that 23 people in 9 states had been infected with the genetic fingerprint of E. coli O157:H7 associated with the outbreak. Twelve people were hospitalized and two suffered hemolytic uremic syndrome (HUS), a complication of E. coli O157:H7 infection that can lead to kidney failure. Illnesses have been reported in the following states: California (4), Maine (1), Michigan (6), Minnesota (1), New Hampshire (1), New Jersey (2), New Mexico (1), New York (1) and Wisconsin (6).

Consumers need to know that the meat they have in their homes may be contaminated with a deadly pathogen. Following is a list to date of individual store recalls that came out before the FSIS/JBS Swift release. Our hope is that you will help us spread the word.

BJ's Wholesale Clubs in Connecticut, Massachusetts, Maine, New Hampshire, New York, Ohio and Rhode Island ? beef cuts and vacuum-packed primal cuts
Bloom and Food Lion Stores in Georgia, South Carolina and Virginia ? beef cuts and ground beef
Costco ? steaks, ribs, ground beef (PDF)
Food 4 Less ? ground beef, 15% (PDF)
Fry's Food and Drug Stores ? ground beef (PDF)
Hannaford Bros. Co. ? beef cuts and ground beef (PDF)
Kroger ? ground beef (PDF)
Price Chopper ? ground beef and beef loin bottom sirloin steaks
Roundy's Supermarkets, Inc., including Pick 'n Save, Copps and Rainbow stores ? beef cuts and fresh ground beef
Smith's Food and Drug Stores ? ground beef (PDF)
Smith's Food and Drug Stores in Arizona, Idaho, Montana, Nevada, New Mexico, Utah and Wyoming ? beef cuts and ground beef (PDF)
Stop & Shop Supermarket Company ? ground beef
WinCo Foods, LLC Stores in Idaho and Oregon ? boneless bottom round roast, steak, carne asada, ground beef

CDC acts to expedite foodborne data sharing
Source of Article: http://www.cidrap.umn.edu/
Maryn McKenna Contributing Writer
Jul 7, 2009 (CIDRAP News) ? At the same time that the Obama Administration inaugurates new safety and enforcement standards for the agencies overseeing food production in the United States, one of those agencies?the Centers for Disease Control and Prevention (CDC)?is taking steps to improve the flow of data revealing food-safety problems.
Last month, the CDC released one of its periodic reports disclosing statistics on foodborne disease outbreaks in the United States. But in a break from agency tradition, the report did not summarize and compare 2 or more years' worth of numbers.
Instead, it presented just 1 year's worth, for 2006, in an unusually granular breakdown of outbreaks by disease-causing organism?the first step in a program to push outbreak analysis out more quickly, said CDC scientist Ian Williams, PhD.
"Our hope is to get data out there for people to actually use it," said Williams, chief of the OutbreakNet team in the CDC's Division of Foodborne, Bacterial and Mycotic Diseases. "In reporting systems, there is always a lag time because data has to be aggregated, cleaned, and verified?but for any year we hope to have something out by the following fall."

Data for 2007 and then 2008 will be published soon, Williams said.
The report, titled "Surveillance for Foodborne Disease Outbreaks?United States, 2006," and published in the CDC's bulletin Morbidity and Mortality Weekly Report (MMWR), points up vulnerabilities in the food-safety system that may be more visible because they are not contrasted with other years' data. Among them: by etiology, a high percentage of outbreaks caused by norovirus (54%) followed by Salmonella (18%); and by food, a high percentage traced to leafy vegetables and fruits and nuts (17% for leafy vegetables and 16% for fruits and nuts, or 33% all told).
Such single-point reporting may be a weakness of the new system, because it cannot establish trends in the way that multi-year analyses do, said prominent food-safety attorney Bill Marler of Seattle. "It you looked just at 2006, you would think that produce is a terrible risk, but in 2007 and 2008 there were fewer outbreaks in produce and many more in meat," he said.

Marler and other food-safety advocates, though, applauded the move to get data out to the field more quickly.
"We have been asking for years to get this kind of data out more succinctly and earlier," said Donna Rosenbaum, executive director of the nonprofit organization Safe Tables Our Priority (STOP). "To put out a single-year data set is a move in the right direction."
The greatest hole in the safety net exposed by the report, though, is the large number of outbreaks for which there are no data. In 2006, 48 states reported 1,270 outbreaks (defined as two or more cases of similar illnesses linked to a common food).
But among those 1,270 outbreaks, officials could confirm a causative agent for only 621 (49%), and a causative food in only 528 (42%). In an additional 263 outbreaks (21%), an organism or chemical was suspected, but not confirmed. The new analysis confirming those percentages "will help us get a sense of where there are holes in the system and where we need to put more effort," Williams said.
In addition to two states that reported no foodborne outbreaks at all, 12 reported none due to viral illnesses, despite the sharp rise in norovirus cases in other areas?findings that the CDC acknowledged are due to the differences in funding, lab resources, and other public-health infrastructure from state to state. (In 2006, for instance, a number of state laboratories began receiving materials that allowed them to perform diagnostic tests for the presence of norovirus.)

The data show other holes as well: chief among them, the vast number of foodborne illnesses that are presumed to happen in the United States each year but are never reported in a manner that allows them to be analyzed. Up to 76 million Americans are believed to suffer foodborne illness each year, according to previous CDC estimates; the 2006 data, though, cover only 27,634 cases among the 1,270 outbreaks that year.

"It is very concerning to us how few cases are identified and analyzed," Rosenbaum said. "Some people do suffer transient illness and get well quickly, but others suffer long-term consequences and tremendous economic loss, and have no one to hold accountable.

"Even when people do seek care and attempt to get a (lab) culture confirmation for their illness, unless there is a second, third or fourth case in the community, it is very unlikely there is going to be an investigation."

Slow progress in reducing foodborne illness was a theme in the administration announcements Tuesday, covering sweeping changes to egg safety rules. And it has been touched on in earlier CDC reports, such as an April 10 MMWR disclosing that "fundamental problems with bacterial and parasitic contamination are not being resolved."

That paper, from a sister CDC project to OutbreakNet known as FoodNet, found that for certain disease organisms, improvements in foodborne illness plateaued in 2004, and predicted that the United States would not hit 2010 goals for reducing those illnesses.

Some smaller outbreaks are never analyzed by public health, and some illnesses that look like individual cases may be part of larger or multi-state outbreaks that are not recognized, the CDC's June report said.

Outbreak News
07/08. An Iowa Child Hospitalized with HUS: Is JBS to Blame
07/08. Hong Kong: 13 ill in suspected food-poisoning cases
07/08. Food Poisoning In San Carlos Caused By Nestle Cookie Dough
07/07. Michigan Health Department Links E. coli O157:H7 Cases to JBS Swift Beef
07/07. North Dakota Salmonella Outbreak Traced to Unlicensed Caterer
07/07. Health officials see salmonella outbreak in Caldwell County
07/07. USDA links bad beef to state
07/07. 97 students sickened over suspected food poisoning in north China
07/07. Malaysia: 40 Pupils Down With Food Poisoning
07/07. UK: 40 police officers hit by food poisoning
07/07. Ukraine: President orders prosecutors to investigate mass food poisoning of children
07/02. Multistate Outbreak of E. coli O157:H7 Infections Linked to Eating Raw Refrigerated, Prepackaged Cookie Dough
07/02. Multistate Outbreak of E. coli O157:H7 Infections Associated with Beef from JBS Swift Beef Company
07/02. E. coli outbreak hospitalizes 12 people
07/02. 95 People Stricken - Nestle and JBS Swift ? Time to Take Care of Your Customers
07/02. Six Michigan Victims in JBS Swift E. coli O157:H7 Outbreak
07/02. 97 students sickened over suspected food poisoning in north China
07/01. E. coli Outbreak Investigation Tries to Solve Mystery by Turning Focus to Nestle Flour Supplier
07/01. CDC Reports 72 E. coli O157:H7 Illnesses in 30 States Linked to Nestle Cookie Dough
07/01. Holiday from hell for Broadstairs family

Overhaul of Food Safety Rules in the Works
(Washington Post, DC)
By Jane Black and Ed O'Keefe
The Obama administration took its first step yesterday toward overhauling food safety regulations that have been blamed for a steady stream of food recalls and related illnesses.
The new proposals, recommended by a working group that President Obama created in March, emphasize prevention, enforcement and improving the government's response time to such incidents.
"There are few responsibilities more basic or more important for the government than making sure the food our families eat is safe," Vice President Biden said at a White House news conference, where he was joined by Health and Human Services Secretary Kathleen Sebelius and Agriculture Secretary Tom Vilsack. "American families have enough to worry about today. They should not have [food safety] as a concern."
Fears about food safety have been spurred by outbreaks of salmonella and E. coli illness from products as varied as peanuts, spinach, tomatoes, pistachios, peppers and, most recently, cookie dough.
Fifteen federal agencies oversee food inspections in a complex and sometimes bizarre division of labor: The Food and Drug Administration is responsible for produce, while the Agriculture Department is responsible for meat. Cheese pizzas are inspected by the FDA, while pepperoni pies go to the USDA.

The administration outlined a variety of measures yesterday to prevent the spread of salmonella, a bacterium that causes more than 1 million illnesses each year in the United States.
Among them is a final rule, issued by the FDA, to reduce the contamination in eggs. About 142,000 Americans are infected each year with Salmonella enteritidis from eggs, the result of an infected hen passing along the bacterium. About 30 die.
The FDA will now require that egg producers test regularly for salmonella and buy chicks from suppliers who do the same. Eggs, which must be refrigerated by wholesalers and retail stores, will have to be refrigerated on the farm and during shipment, as well. About half the egg industry is following similar guidelines voluntarily.

The agency said that will help reduce the number of related food-borne illnesses by an estimated 79,000 a year, or about 60 percent. The new requirements will cost producers about $81 million a year, and add about 1 cent to the cost of a dozen eggs, FDA Commissioner Margaret Hamburg said. Sebelius said it will save the nation about $1.4 billion a year in medical expenses.

Such a regulatory change has been a long time coming. President Bill Clinton proposed similar action in 1999, but it was never implemented.

The USDA's Food Safety and Inspection Service (FSIS) also committed to developing new standards by the end of the year to reduce salmonella in poultry. The office will also establish a salmonella verification program, with the hopes that 90 percent of poultry establishments will meet the new standards by the end of 2010.

Both agencies also announced plans to tackle E. coli. FSIS will step up enforcement at meat processing plants and increase sampling that tests for the pathogen, especially in ground beef. By the end of the month, the FDA, which is responsible for fresh produce, will issue guidance on ways to reduce contamination in the production and distribution of tomatoes, melons and leafy greens.

The proposals also included adding staff positions to help agencies coordinate with one another. The FDA will hire a deputy commissioner for foods, and FSIS will hire a new chief medical officer, who will report to USDA's undersecretary for food safety.

On the whole, food safety advocates were pleased with the new initiatives. "We are coming out of a phase, just like in the financial sector, where the government was loath to regulate," said Caroline Smith DeWaal, food safety director for the advocacy group Center for Science in the Public Interest. "Tougher controls earlier in the food chain will result in fewer recalls and fewer outbreaks."

Bill Marler, a longtime food safety litigator who writes a blog about the issue, said: "Part of the problem with how we currently deal with food-borne illness cases is we wait until people get sick and die, and then we announce an outbreak. It seems that the focus here is a bit on preventing it before we have sick and dead people, as opposed to counting the bodies after salmonella or E. coli is out of the barn."

Still, some advocates cautioned that new programs must be carefully crafted to avoid doing more harm than good. Some proposals, such as the efforts to establish a product tracing system and salmonella prevention guidelines for fresh produce, remain vague.

It brings "to mind the old saying about the devil being in the details," said Wenonah Hauter, executive director of the Washington-based nonprofit Food & Water Watch. The government "must take care to avoid one-size-fits-all standards that cater to the largest industrialized producers and processors of food."

Many key changes will be left to Congress, including the controversial issue of giving federal agencies the authority to recall tainted products if a manufacturer refuses. This would make it easier for consumers to find out where recalled food was sold.

Legislators are also considering several bills to tackle issues not included in the working group's recommendations. Reps. Henry A. Waxman (D-Calif.) and John D. Dingell (D-Mich.) want to give the FDA the authority to recall tainted food, to "quarantine" suspect food, and to have the ability to impose civil penalties and increased criminal sanctions on safety violators. Rep. Rosa DeLauro (D-Conn.) has proposed separating the agency's food safety responsibilities by establishing a new Food Safety Administration. In the Senate, Richard J. Durbin (D-Ill.) hopes to give the agency a larger budget with more inspectors and stronger regulatory tools. 7-08-09

U.S. narrows salmonella warning to Mexican jalapenos
Source of Article: http://www.chiroeco.com/
WASHINGTON (Reuters) - U.S. health officials urged consumers on Friday to avoid only raw jalapeno peppers from Mexico, narrowing an earlier warning against eating any fresh jalapenos amid an outbreak of salmonella illness.
The Food and Drug Administration now believes jalapeno and serrano peppers grown in the United States are not connected to the nearly 1,300 salmonella cases reported since April, Dr. David Acheson, FDA associate commissioner for foods, told Reuters in an interview.
Investigators seeking the source of the outbreak have been probing clusters of illnesses in various locations.
"All the ones we have been looking at have been traced back to Mexico," Acheson said.
Officials are trying to pinpoint a particular region or farm as the source of the contamination, which came from a strain known as Salmonella stpaul, he added.
Investigators had focused early in the probe on tomatoes as a possible culprit. Last week, regulators lifted their warning on tomatoes not because they were cleared from suspicion, but because any that could have been contaminated would have spoiled and been discarded by that time.
"Available data does not exonerate tomatoes at this point," Dr. Ian Williams of the Centers for Disease Control and Prevention said.
Enrique Sanchez, the director of Mexico's National Sanitation and Farm Food Quality Service, called the decision "arbitrary" and said it could have an "enormous" harmful impact on the local jalapeno industry.
"The FDA is taking a decision without scientific proof," Sanchez told Reuters. "In Mexico there is no outbreak reported by the health ministry that indicates, not even suspiciously, that there is a salmonella outbreak in Mexico."
Mexican officials will conduct their own investigation, said Marco Antonio Sifuentes, a spokesman for
the Mexican agriculture ministry. Mexico says the Salmonella stpaul strain has not been detected in the country.
"We have said it so many times that we're tired of repeating it. There does not exist one single case of Salmonella stpaul in Mexico," Sifuentes said.
The agriculture ministry said it has seen no scientific evidence from U.S. authorities that the tainted jalapenos originated in Mexico.
"In the case of tomatoes, the FDA made a serious error. Now they are committing another big mistake because of their incompetence," Sifuentes said.
The FDA's Acheson said U.S. officials were working closely with Mexican authorities on the investigation.
Food safety experts say finding the outbreak's source has been difficult because people had trouble recalling what they had eaten before they became ill and the produce had been discarded by the time inspectors could follow up.
Serrano peppers have also been scrutinized as a possible source. The FDA still advises the elderly and people with weak immune systems to avoid eating raw serrano peppers from Mexico, Acheson said.
On Monday, the FDA said a single jalapeno pepper at a Texas distributor was contaminated with the strain of salmonella detected in the outbreak. That pepper originated in Mexico. The FDA said on Friday it had determined the contamination did not originate at the Texas distributor.
The latest salmonella illness was reported to have occurred on July 10, bringing the total to 1,294, Williams said.
Cases have been reported in 43 states, the District of Columbia and Canada, and 242 people have been hospitalized.
Salmonella poisoning, which causes diarrhea, fever and abdominal cramps is very common, with 40,000 cases and 400 deaths each year in the United States alone.


Job List
07/08. Q & Food Safety Mgr North America ? West Chester, PA
07/08. QA / Food Safety Manager (Central) ? Dallas, TX
07/08. QA / Food Safety Manager (East) - Orlando, FL
07/08. QA / Food Safety Manager (West) ? Irvine, CA
07/08. Food Safety Consultant ? Cresskill, NJ
07/07. Quality Mgt Spec - Food Safety ? Minneapolis, MN
07/07. Food Safety Mgr - Downers Grove, IL
07/07. Consumer Safety HACCP Seafood ? Tampa, FL
07/02. Q Mgmt Specialist - Food Safety ? Reston, VA
07/02. Food Product Safety Manager - Alabama
07/02. Food Safety/QA Client Coordinator ? Chicago, IL
07/01. Laboratory Tech - QA and Food Safety ? Barrington, IL
07/01. Quality Management Specialist? Albuquerque, NM
07/01. Food Safety Compliance Manager ? Totowa, NJ

FDA¡¯s Pistachio ¡®Warning¡¯: The Other Side Of The Story
Source of Article: http://www.perishablepundit.com/#4
July 1, 2009
Although our coverage of the recent issues with pistachios and salmonella has been extensive, we haven¡¯t felt it necessary to mention every one of the now 664 recalls, though these continue to drip-in as various repackers continue to announce recalls. Then, for the first time in memory, we received a ¡°warning¡± notice from the FDA advising that consumers not eat the product of a specific company:

FDA WARNS CONSUMERS NOT TO EAT CALIFORNIA PRIME PRODUCE AND ORANGE COUNTY ORCHARDS BRANDS OF PISTACHIOS
Products linked to the previous recall by
Setton Pistachio of Terra Bella Inc.

The U.S. Food and Drug Administration is warning consumers not to eat California Prime Produce and Orange County Orchards brands of pistachios repacked by Orca Distribution West Inc., Anaheim, California, Orca received and repacked pistachios recalled by Setton Pistachio of Terra Bella Inc., Terra Bella, Calif.

The pistachios may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (infected aneurysms), endocarditis and arthritis.

The FDA visited Orca as part of its audit checks to follow up on Setton Pistachio¡¯s recall. The FDA found that products subject to Setton Pistachio¡¯s recall had been repacked and distributed by Orca under the California Prime Produce and Orange County Orchards brands. Orca has not made a public announcement regarding these products. Therefore, the FDA is issuing this press release to alert consumers so that they can take appropriate action.

The products were distributed to retail locations in airports and hotels nationwide. The California Prime Produce and Orange County Orchards brands of pistachios were packaged in clear 6 ounce flexible plastic Ziploc bags, UPC Number: 8 10826 01116 2 with Sell By Dates of 7/30/09 and 8/30/09.

Consumers who have purchased these products are urged not to eat them. They can also report problems, including adverse reactions, to the FDA district office consumer complaint coordinator in their area of the country.

To date, more than 660 product entries have been included in the FDA¡¯s list of recalled products because of their association with the recall by Setton Pistachio of Terra Bella Inc. For the most updated list of all the recalled products and pistachio products not subject to the recall, please visit: http://www.fda.gov/Safety/Recalls/MajorProductRecalls/ Pistachio/default.htm

Basically, this appeared to be one of the rare cases in which a company was refusing to issue a recall despite FDA pressure. It is such a rare occurrence that we asked Pundit Investigator and Special Projects Editor Mira Slott to find out more:

Jan Caselli
Owner
Orca Distribution West
Anaheim, California

Q: FDA said it released a warning to consumers not to eat California Prime Produce and Orange County Orchards pistachio brands because Orca did not comply with its request to do so. Is this correct, and if so, why did you choose not to issue a consumer alert?

A: This consumer warning was totally vindictive on FDA¡¯s part. We have been vilified by FDA. The FDA press release is erroneously worded to make it appear that Orca did not comply with FDA. I don¡¯t have any recourse. I could hire the best attorney and nothing will change. We are wholesale distributors, and on April 6, I got notified from one of my suppliers, Specialty Commodities, that Orca received 50 pounds of Setton product in January and another 100 pounds in February that could have been contaminated with Salmonella.

It came to our supplier¡¯s attention in their audit with the FDA. At that point, I did my own audit and learned a total of 340 bags were produced from those lot numbers. I immediately contacted our accounts that we sent this product to and they did a full blown recall at the retail level. In fact we not only recalled the 340 bags we believed contained the Setton product but, in an abundance of caution, we recalled all our pistachios that had a sell by date of 8/09 or 9/09 even though many of these came from other sources unrelated to Setton. This was a voluntary recall and still remains that way. I¡¯ve had no reported incidents of illness nor have my customers.

At the end of April, FDA contacted me because they had been given a customer list from Specialty Commodities. I gave my customer list to FDA as they requested. FDA asked me to do a press release and I explained that my customers pulled everything from the shelves. I replaced the recalled product with new product at my own expense. Mind you, I didn¡¯t know the exact origins of those 340 bags in question.

Q: Why not? Don¡¯t you keep records?

A: I place a master order for pistachios from my supplier. I pulled every pistachio from that time frame. FDA implied I intentionally repacked contaminated pistachios. When I sent out product in January and February, I didn¡¯t even know there was a problem. I was only notified from my supplier in April.

Q: Wouldn¡¯t there have been a possibility that some of the products from your shipments could have ended up in consumer homes? Did your customers catch the products early enough in the process where consumers wouldn¡¯t have had a chance to buy them?

A: To clarify, once my supplier, Specialty Commodities, notified me that I had received 150 pounds of Setton product, I notified my customers to pull all product with the sell-by date of 8/09 or 9/09 as those could have contained Setton pistachios. The small amount of Setton product we had received from our supplier was in that period.

Q: What percentage of your pistachios during that period came from Setton?

A: I had received other types of pistachios, not just from Setton. I have another supplier, Garvey Nut & Candy, that does not buy from Setton¡¦ ever. I gave FDA information on all orders that had pistachios and all the ones we recalled. There were pistachios that I didn¡¯t need to recall, another 75 pounds I purchased in January and February in addition to that 150 pounds from Setton.

Garvey Nut & Candy has dealt with the FDA on this issue and assured me I did not receive product from them related to the recall. I pulled everything on the shelf with those sell-by dates regardless.

We use a six-month shelf life on our packages. We took no chances on whose product they may have received, so I instructed them to pull all pistachios shipped during that period. I instructed them to destroy and give me a count of product on hand and we did replacement. My audit says there were a few bags purchased.

Q: For perspective, how many bags did consumers purchase before product was pulled from the shelves? Not to belabor the point, but before this FDA consumer release, how would consumers, who may have purchased product from those January/February shipments, learn that these products were involved in a recall? How many consumers could have been at risk of eating contaminated product?

A: Out of the 340 bags shipped, our records document we recalled and destroyed 272. Potentially there could have been 68, six-ounce bags floating around out there. This is the basis for all the hype. We have no reported incidences of illness. I¡¯m all for protecting our consumers¡¦ my God, I¡¯m in a business where it¡¯s so important to me.

Q: Isn¡¯t it also relevant where these bags were sold and the fact they were travel-size, snacking portions, rather than large packages that might be stored for extended periods in a kitchen pantry? In other words, would it be possible or even likely, especially at this juncture, that any bags unaccounted for in the recall have already been consumed?

A: These are single portion, six-ounce bags. They are sold in hotel lobby shops and airport gift shops in individual serving size. If you had a bag in the pantry, you¡¯d throw it away, but these are the kinds of bags that would be consumed right away. These items would not likely be brought home and stored for future consumption. These products are carried in travel gift shops. They are in one airport, Palm Springs airport, and the rest are hotel lobby gift shops. I handled things correctly, especially in this context.

By the way, FDA said ¡°various airports¡±, when it was only one. People were looking at other airports to see if my products were there.

Here¡¯s little Orca, and they used pictures showing pallets of Setton product. It doesn¡¯t make any sense at all. They showed the boxes, which had nothing to do with our product. That doesn¡¯t help the consumer. We¡¯re wholesalers. When we buy Setton product, we put it in our own package. Consumers don¡¯t see the Setton brand on a retail shelf, they see our brand.

Q: Earlier you pointed out that the pistachio recall was voluntary. Yet, many companies say they feel compelled to abide by FDA¡¯s recommendations for fear of retribution. Are you claiming that FDA¡¯s June 22 news release warning consumers not to eat your brands of pistachios was only done to punish you?

A: I¡¯ve been maligned by the FDA because I said I didn¡¯t know what good it would do to issue a press release. I was cooperative. It¡¯s not like I refused in a belligerent way; I just didn¡¯t see the value in it. What chance would there be of someone having the equivalent of four handfuls of pistachios from January or February? FDA¡¯s actions were way overkill. I was shocked when FDA put out that release.

Of course, if it¡¯s one bag or 1,000 bags that could be tainted, it¡¯s just as important to take action, but it seemed too long in the stream of things to issue a consumer warning that would have any benefit. If this had anything to do with saving someone¡¯s life, I wouldn¡¯t hesitate to do a press release.

Q: When you asked your customers to destroy product, did you get a dump certificate or another type of official receipt to verify they actually did it?

A: I didn¡¯t get a dump certificate, but I did get a dump list.

Q: The Western Pistachio Association (WPA) was quick to disassociate itself from your company by releasing its own statement June 23 following FDA¡¯s press release: ¡°This is not a new recall. Rather, it is an announcement due to a company that apparently did not comply with the FDA¡¯s original recall requirements¡¦The WPA does not condone any entity that knowingly shipped recalled product or withheld information related to the product recalls¡¦¡± How do you reply to this?

A: I¡¯d like you to make it obvious I did not knowingly repack contaminated product. I learned two months after it had been shipped. The source of the pistachios depends on the supplier I use. One of my suppliers doesn¡¯t even buy from Setton. In those two months -- January and February ? I had received product from Specialty Commodities, and Setton is who they were buying from at the time. They ship me whatever product they have in the warehouse and I don¡¯t care where it originated because I have confidence in my suppliers that I¡¯m getting quality products.

Q: What you receive is not labeled delineating the product¡¯s origins?

A: I receive bulk product from Specialty Commodities, which purchased it from Setton Pistachio. It doesn¡¯t even say Setton on the labeling. By the time Specialty notified me that they had shipped me that product, it was April.

Q: Why the big time lapse from that time forward? FDA didn¡¯t issue its press release warning consumers about your brands until June 22.

A: My customers are supporting me. They saw these reports and starting calling me asking, is this something new? And I said no. I feel like FDA is using me to put out another big blurb disparaging Setton. There had to be another agenda because this action wasn¡¯t done for public health. The implications are nowhere near the facts. I have customers that can stand behind that. These are very large companies that don¡¯t mess around. We don¡¯t use pistachios in any other form except in shell; not in our mixes. There are other major suppliers that utilize Setton pistachios as an ingredient in a wide range of products.

The fact is that FDA didn¡¯t contact me until April 21, and the day they came, I started turning over records. When they came to my door, it was the first time I heard from them. I had all the supporting documents, recall letters and evidence of the replacement shipments. I had already done my business with the pistachio recall and I thought this was all in the past.

I have a cover letter stamped May 20, 2009, from Alonza Cruse, District Director, FDA, that states they¡¯ve completed their investigation and the agency concludes the inspection from April 21 closed under Title 21.

Q: What changed since that time?

A: On June 12, a Friday, the Los Angeles County investigator from FDA with the title of Consumer Safety Officer came back to my facility demanding more information. I was not there at the time. My employees said she barged her way in here to the packing room and demanded employees speak with her. She made them nervous.

My manager took her on a tour of the facilities. According to him, she said that our facility was immaculate and she couldn¡¯t find anything wrong with it, but that¡¯s not why she was there. My employees totally cooperated. She told me she interviewed my manager who said he didn¡¯t have any science background.

I was actually out of the Los Angeles area, but my employees called me to let me know she was there. I asked her, what is the nature of your visit? I thought they were done with the investigation. She said they¡¯ve expanded the recall, and your employees don¡¯t have access to the records I need. I said my customers didn¡¯t inform me of that, but I would fax her all the information she wanted, and she made an appointment for the following Monday (June 15) to meet with me at 1 pm. I pulled all the records and faxed them to her.

A series of unfortunate events followed. Apparently, she called on Saturday to change the time of our meeting to 10 am on Monday. She received everything from me on Friday night, and decided she¡¯d just come earlier instead. I didn¡¯t get the message because I was in the desert at the hospital because my father had a heart attack.

That Monday, I got a call from my employee that she arrived at 10 am. He put her on the phone and I said, I thought our appointment was for 1 pm. I can¡¯t get there for a few hours because of the situation with my father, but she insisted, we have to do the meeting now.

She decided she wanted my customer list of anyone receiving product from September, 2008, to date. I explained that my supplier told me I didn¡¯t receive any of those products until January 2009. It didn¡¯t make sense. I wasn¡¯t buying product from Setton in September 2008. I only got Setton product in small amounts in January and February of 2009.

Q: I¡¯m so sorry to hear the news about your father¡¦ This must have been particularly trying while you were going through such personal trauma.

A: Thank you for your concern. My father is 82, and the surgery was complicated and painful but he survived it. It¡¯s a miracle.

My conversations with the FDA consumer safety officer were frustrating to say the least. She seemed to be a young woman, although she said she¡¯d been with FDA six years. She couldn¡¯t answer even the most basic questions. When I tried to get clarification, she was curt: FDA isn¡¯t obligated to tell you anything, she said.

She also intimidated my employees. At one point she entered the building at lunch time so most employees were out because the operation shuts down from 12 to 1. She took one of my Hispanic workers, having his lunch with another employee, out of his break. He was insulted. She ordered him to show her around the facility, that she had already visited at another time and grilled him about our customers and pistachios, none of which he is savvy to because he is a packer.

Then she pressured him into signing a document, which looked very legal in type, swearing to his statements. The employee phoned me, concerned about this. He put her on the phone. I asked her not to involve my employees. I would meet with her another day. She told me she had a right to be there and to conduct her business however she wanted.

Q: Doesn¡¯t FDA have certain limitations on its legal authority during investigations?

A: My attorney, who deals in FDA cases, said FDA has the right to come into my facility anytime to investigate, but doesn¡¯t have the authority to take workers off of their lunch break and require them to give a tour. And FDA does not have the authority to take photos without my permission, and I asked them not to.

I tried to protect my employees¡¯ and customers¡¯ privacy. She wanted private cell phone numbers and I didn¡¯t think that was necessary. I had already provided her with sufficient contact information for the customers who got product. My customers told me another FDA representative contacted them and supported the fact I did exactly what I was supposed to do.

Q: Media across the country picked up on this story, questioning your company for withholding information from the public about possibly tainted product. Reports also suggested that you consciously sent recalled product that could have been contaminated into the marketplace. What impact is this having on your reputation?

A: After the news broke, Fox 11, Channel 4, Channel 7, and other media were staked out at my facility here at 7 in the morning. I came in at 8, showing the Fox 11 reporter all my supporting recall documents and my complete customer list, explaining that FDA had contacted them. She told the studio to correct the earlier coverage; that this was not a new recall, and that I never shipped Setton product since early this year.

Local news people were saying to me they were appalled by how my company had been presented, but unfortunately they were not rushing out to air the rebuttal interview. Fox 11 came back at 10 am to do another interview. I had them film in the factory, and they did show it that night, commenting that it had to do with the earlier recall and how we handled it.

The initial negative story got so much hype that it didn¡¯t seem to matter. My Fox LA just continued to have the original bad news story on ? the one they got at 7 in the morning when they didn¡¯t have a chance to get comments from Orca. Later that day, at 8:30 in the morning, Fox 11 did air my interview, which vindicated me. The studio reporter told viewers, you can go eat your pistachios now. But the other stations were just airing the original inaccurate 7 am report. I understand the bad report was repeated again on the next day¡¯s news cycle and had continued to remain on the websites.

At this point, I¡¯m not sure how much damage this may have caused to my business and reputation. My customers are supportive and believe my brands will be OK.

I sense FDA¡¯s actions were an attempt to prove their power. FDA has been heavily scrutinized for how it has handled food safety, and it wanted to show it was doing something. Even if FDA felt compelled to do a press release, they didn¡¯t have to do it in such an inflammatory way, with a headline that implied that all our product should be avoided whenever it was produced. They took this to the fullest, like they were out to get us. I wonder if this FDA woman had a problem with me because I¡¯m a woman in business and I know what I¡¯m doing. She thought she had the right to intimidate my employees and to treat people however she wanted without any recourse. The way she spoke to me was disrespectful. I¡¯m proud of what I do here. I operate my business with integrity, and I believe FDA¡¯s behavior was absurd.

It is actually a very fascinating story with several key points:

First, on the substance of the matter, Jan Caselli is wrong, particularly when you consider that pistachios are a semi-perishable item that can be kept for an extended period. No matter what she did, no matter what her customers did, as long as even one packet reached consumer hands, there is the possibility that the pistachios are sitting in a purse or a pantry. Pistachios are semi-perishable, not a product like spinach that just rots. These consumers certainly should be informed of known risks ? including that these pistachios may be part of the Setton Pistachio recall.

Second, on a food safety basis, Jan Caselli is right: The FDA¡¯s action are absurd. As we mentioned here, the FDA makes the ridiculous assumption that its mere knowledge of a problem with one firm¡¯s production of a product means that this particular product is more dangerous than some competitive product. In fact, discovery of such a pathogen is such a Black Swan Event that its discovery means nothing. You might test that firm¡¯s product for a hundred years and never get another positive or, you might test its competitor¡¯s products and find you receive positives just as frequently or more frequently. In either case, recalls do nothing to enhance food safety.

Add in the fact that this particular repacker sells only small bags at airports and hotel gift shops ? so these are not giant bags or jugs that people are likely to keep for extended periods ? and the fact that FDA issued its ¡°warning¡± almost four months after the last of these baggies were shipped and that there are only 68 bags unacounted for and presumed sold and only a portion of the repacker¡¯s pistachios during the period in question came from Setton ? and the risk from this repacker¡¯s products is exceedingly small. We must have a safe food supply indeed for FDA to bother with such a small matter. Indeed, next time FDA is crying about its lack of resources, we might remember that it sent staff not once, not twice, but three times to this little repacker who sells six-ounce packages in hotel gift shops. If the FDA uses its resources in this way, the FDA will never have adequate resources.

Third, Jan Caselli¡¯s experience with the FDA field office operation adds to the experience we found with the Honduras Cantaloupe matter that local FDA officials are often tyrants. We have been told by leading experts in epidemiology that many border on incompetent and are unable to understand their own epidemiology, so they seem to fall back on bullying tactics. We have suggested that trade associations consider having epidemiologists and attorneys on retainer so that when confronted with a local FDA official, companies have a competent team pre-assembled to help them.

At very least it points to a neglected portion of crisis management programs most of which start with the food safety crisis ? how about the crisis starting when FDA shows up at your door. What to do then?

Fourth, Jan Caselli is quite right about FDA being vindictive. The very headline of its release, ¡°FDA Warns Consumers Not to Eat California Prime Produce and Orange County Orchards Brands of Pistachios,¡± is very different from the actual message in the release: ¡°The California Prime Produce and Orange County Orchards brands of pistachios were packaged in clear 6 ounce flexible plastic Ziploc bags, UPC Number: 8 10826 01116 2 with Sell By Dates of 7/30/09 and 8/30/09. Consumers who have purchased these products are urged not to eat them.¡±

Blaring a blanket headline ¡°not to eat¡± two brands, when the actual advice is very circumscribed, is clearly FDA¡¯s way of saying that companies better obey FDA or FDA will make things much, much worse for the firms that don¡¯t go along..

The problem is, of course, that Congress has, to date at least, specifically elected to not give the FDA the authority to order recalls and FDA¡¯s own regulations state that it will only request a recall in ¡°urgent situations¡± ? a difficult case to make in this situation. The agency can scream ¡°public health¡± all it wants. The odds that by issuing this warning, several months after the event, someone was saved from salmonella are, for all practical purposes, zero.

FDA seems to view the law and its own regulations as not so much a limitation on its powers but as an inconvenience, and it is prepared to come down hard on anyone who thwarts its will, even if it has no statutory or regulatory authority to act in a particular arena.

If FDA is aware of any product that is adulterated, it has authority to seize such food. Normally, it uses that lever to ¡°persuade¡± companies to make recalls. In this case, all the product is long gone and there is nothing for FDA to seize.

Still, in America, just because an agency is powerful, it should not use its powers to threaten law-abiding citizens, and Jan Caselli was well within her rights in deciding not to issue a press release. There is something uncomfortable about FDA officials believing their role so important that they are prepared to go around the plain language of the law to find ways to ¡°punish¡± those who refuse to comply with the desires of the FDA.

Many thanks to Jan Caselli for sharing her story.

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