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Surprising New Food Safety Act Enforcement Tools
by Caroline Smith DeWaal | Jan 31, 2011

Editor's note: This is the second in a series of articles from Center for Science in the Public Interest Food Safety Director Caroline Smith DeWaal on the implementation of the FDA Food Safety Modernization Act. In the second installment, DeWaal looks at several new enforcement tools - suspension of registration and records access - that emerged from lessons learned from the Bioterrorism Act of 2002.

The effort to modernize the Food and Drug Administration's (FDA) food safety program began in the late 1990s, following several very large outbreaks linked to raw oysters and imported berries. One outbreak involved berries tainted with Hepatitis A that were processed into a dessert served by the school lunch program, and underscored for consumers our vulnerability. That outbreak sickened over 250 consumers in five states, many of whom were school children.

The first bill titled, "The Consumer Food Safety Act of 1998," was filed in April of that year by Representative Frank Pallone, with 29 cosponsors, including both Representative Henry Waxman and Representative Rosa DeLauro. While it was a relatively simple bill compared to what finally passed Congress late last year, the legislation contained many of its essential elements, including both registration and process controls.

In 2001, when Congress was grappling with the aftermath of the attack on the World Trade Center, concerns were raised by then-Secretary of Health and Human Services Tommy Thompson that our food supply could become a target. In fact, Thompson told Congress that he was most concerned about food as a target because inspections were not adequate. In response, Congress included a number of food provisions in the Bioterrorism Response Act of 2002, along with $100 million for improvements in inspection and counterterrorism programs. The agency was given authority to register domestic and foreign facilities, detain suspect food items, require prior notice on all imported food shipments, and also required "one up/one down" traceability.

The FDA Food Safety Modernization Act significantly improves the registration provision and adds records access requirements that will be critical to preventing future outbreaks. While registration of food facilities doesn't sound like a program that will give teeth to the new FDA Foods program, in fact, when coupled with suspension, it gives FDA a powerful new enforcement tool. To understand why, let's back up and look at the history of the issue.

Prior to 2002, FDA inspectors went into the field not knowing who exactly they should be inspecting. An Inspector General report once noted that FDA inspectors would refer to the Yellow Pages of the local phone book to find food plants in an area. The registration provision was adopted by Congress in order to give the agency a comprehensive list, with names, addresses and contact information for the food plants under its jurisdiction. While the 2002 Bioterrorism Act provided a first step for registration, its implementation by FDA was lackluster, and the database of food plants soon became out-of-date.

The initial registration provision under the Bioterrorism Act required registrants to "notify the Secretary in a timely manner of changes to [registration] information," and required FDA to compile and maintain an up-to-date list of registered facilities. The new Act is more specific and requires food facilities to re-register between October and December of each even numbered year beginning in 2012.

Authority to suspend the registration of a food facility is perhaps one of the most important enforcement tools the new law grants FDA. It allows the agency to effectively shut down a food facility that is associated with an outbreak of serious foodborne illness. A facility under suspension cannot import, export, or ship food until the business takes corrective action. This provision becomes effective no later than 180 days after enactment of the law or earlier, if regulations are issued by FDA. The new authority artfully shifts the legal burden between industry and the agency to create incentives for businesses to comply with food safety requirements, while giving the agency real teeth to address non-compliance. To keep FDA from overreaching, the authority to suspend a facility resides with the Commissioner, and businesses are provided an opportunity to contest the suspension within two days of its issuance.

The Commissioner can reinstate the registration when the evidence shows that adequate grounds do not exist for its continuation. Thus, a facility can submit a corrective action plan for FDA's approval, and once approved, it can begin shipping product again. Suspension authority will be an effective enforcement tool if properly implemented. This provision gives FDA a significant new tool to go along with its broad responsibility to protect the public from unsafe food.

Another treasure in the Act is the records access provisions. To gain access to corporate records under the 2002 Bioterrorism Act, FDA needed evidence of adulteration as well as a serious risk to health or life. It also required that record requests be in writing. This delayed access to critical corporate records during outbreak investigations like one involving peanut butter and led the agency to ask Congress to relax the adulteration requirement. Additionally, the Bioterrorism Act only allowed FDA to access records for the food under investigation, preventing inspectors from following leads to other food lines within the same facility.

The new law gives FDA clear authority to access a facility's written food safety plan, together with monitoring and test results, during its regular inspections of the food plant. These records must be made available to "a duly authorized representative of the Secretary upon oral or written request." This will greatly aid the FDA in improving the effectiveness of its inspections. No longer will the agency be doing a simple inspection, reflecting only its findings during the time inspectors are in the plant. Through a random review of records for different days or even weeks, FDA can transition to conducting inspections that reflect activities in the plant over a longer time frame. And during an investigation of an outbreak, the FDA Food Safety Modernization Act provides clear authority to expand an inquiry to other food lines within a facility, provided there is a reasonable belief the food processed on them is affected in the same way as the food under investigation.

The FDA never realized the full benefit of new authorities to oversee and enforce food safety laws it gained in the 2002 Bioterrorism Act. The Food Safety Modernization Act takes lessons learned from a decade of outbreak investigations to give the agency tools for protecting public health. The agency will need to move forward rapidly on regulations to put muscle in and reap the full value of these tools.

Food-borne bacteria causes difficult-to-treat heart infections
Published: Thursday, Jan 27, 2011, 15:21 IST
Place: Washington, DC | Agency: ANI

Scientists have found that particular strains of a food-borne bacteria are able to invade the heart, leading to serious and difficult-to-treat heart infections.The bacteria Listeria monocytogenes is commonly found in soft cheeses and chilled ready-to-eat products, according to researchers at the University of Illinois at Chicago College of Medicine.

For healthy individuals, listeria infections are usually mild, but for susceptible individuals and the elderly, infection can result in serious illness, usually associated with the central nervous system, the placenta and the developing fetus.About 10 percent of serious listeria infections involve a cardiac infection, according to Nancy Freitag, principle investigator on the study. These infections are difficult to treat, with more than one-third proving fatal, but have not been widely studied and are poorly understood.Freitag and her colleagues obtained a strain of listeria that had been isolated from a patient with endocarditis, or infection of the heart.They found that when they infected mice with either the cardiac isolate or a lab strain, they found 10 times as much bacteria in the hearts of mice infected with the cardiac strain. Further, the researchers found that while the lab-strain-infected group often had no heart infection at all, 90% of the mice infected with the cardiac strain had heart infections. Freitag's team used molecular genetics and cardiac cell cultures to explore what was different about these two strains.The results suggest that these cardiac-associated strains display modified proteins on their surface that enable the bacteria to more easily enter cardiac cells, targeting the heart and leading to bacterial infection.The study appeared online in the Journal of Medical Microbiology.

FDA recalls Merrick product - salmonella risk for people and pets
Source :
By Valerie Heimerich, (31, Jan, 2011)

Merrick Pet Care has announced that it is recalling one of their pet food items because of possible salmonella contamination. Merrick products are carried in over 40 Sacramento area retail stores.
On Friday a U.S Food and Drug Administration press release identified the recalled product as Jr. Texas Taffy, a dog treat.
Adults or children may be at risk if they have touched a contaminated pet product or any surface on which the dog treat may have been placed.
The impact of salmonella on pets and people can include vomiting, abdominal pain and bloody diarrhea.
But the list of illnesses for humans exposed to salmonella is much longer and more serious. These include but are not limited to the inflammation of heart chambers and valves, arterial infections and eye and urinary problems.
For details on impacted item and lot numbers, click here.
No illnesses have been reported to date. Anyone who has purchased the Merrick Jr. Texas Taffy is being urged to return the unused portion for a full refund.
If you found this story informative or enjoyable, click on the "subscribe" button above. You will receive free email alerts (and no spam!) when additional articles by Val Heimerich are published. Ms. Heimerich welcomes your comments, questions and suggestions; feel free to post a comment on this article or email her at

Fish Markets Get Botulism Warning
Source :
By Dan Flynn, (28, Jan, 2011)
Oregon's 121-year old Newman's Fish Markets Inc. received a warning letter last Dec. 7 from the U.S. Food and Drug Administration (FDA) over violations at its seafood processing facility in Portland.
It concerns Newman's hot smoked, vacuum-packed, refrigerated salmon; sturgeon; escolar; tuna and black cod.
FDA said fish processors must have seafood Hazard Analysis and Critical Control Point (HACCP) plans for hot smoked, vacuum-packed, refrigerated sturgeon to control the food safety hazard of Clostridium botulinum and environmental chemical contaminants.
During an inspection last July 29, FDA said it watched Newman's smoke a batch of fish that included sturgeon. Company managers told the inspector they would freeze the vacuum packaged products to prevent the formation of deadly botulism.
Newman's said it was planning to use stickers to urge consumers to keep the packages frozen and to thaw them under refrigeration right before use. FDA said Clostridium botulinum is a "reasonability likely hazard" for vacuum packaged fish, especially those that lack clear labeling.
FDA expressed similar concerns about Newman's smoked salmon.
The agency said Newman's must conduct or have conducted for it a hazard analysis for each kind of fish and fishery product that it produces to determine whether there are food safety hazards that are reasonably likely to occur and to have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur.
The plan must address "any biological, chemical, or physical property that may cause the food to be unsafe for human consumption."
Newman's HACCP plan for hot smoked black cod does not list the food safety hazard of Clostridium botulinum at the "Refrigerated Storage" control point.
Newman's Sept. 7 response included a revised HACCP plan for hot smoked, vacuum-packaged refrigerated escolar and tuna, but for not black cod.
The seafood processors' revised HACCP plan for escolar and tuna does not identify the hazard of histamine formation. FDA said the company eliminated "brining" as a control.
"Although the formation of Clostridium botulinum may not be a significant hazard for this product if it is labeled to be held frozen and thawed under refrigeration immediately before use, histamine formation is considered a food safety hazard that is reasonably likely to occur at the "brining" CCP, the warning letter said.
FDA said Newman's lacked monitoring procedures for minimum salt content, and ratio of brine to fish. The agency also said Newman's does not list "the critical control point of thawing for controlling the food safety hazard of histamine formation. According to your hazard analysis you are controlling this hazard through refrigeration and icing."
FDA gave Newman's 15 working days to respond to its concerns.
Newman's was founded in Eugene, OR in 1890.

Do not eat Salmonella Cilantro
Source :
By Bill Marler, (29, Jan, 2011)

Dr. Mark Horton, director of the California Department of Public Health (CDPH), today warned people not to eat certain fresh cilantro distributed by Tanimura & Antle, based in Salinas, because the cilantro may be contaminated with Salmonella. To date, no illnesses have been reported.
The suspected cilantro was available at retail locations in California from January 14 through today. The cilantro was sold in bunches containing a white twist-tie printed with blue lettering. The twist-ties contain the words "Produce of USA, Cilantro #4889" and have a blue Tanimura & Antle logo adjacent to the UPC code 33383 80104.
Symptoms of Salmonella infection include fever, abdominal cramps, and diarrhea which may be bloody. Most infected people recover within a week. Some may develop complications that require hospitalization. Infants, the elderly, and people with weakened immune systems are at highest risk for more severe illness. People who develop symptoms of Salmonella infection after consuming cilantro should consult their health care provider.
While the contaminated cilantro may no longer be available in retail stores, CDPH is concerned that consumers may still have some in their homes. Consumers in possession of this contaminated cilantro should not eat it.

Improper Food Handling Breeds GI Outbreaks at Schools
Source :
By , (28, Jan, 2011)

TORONTO-Proper and frequent hand washing by food handlers is key to keeping food-borne illnesses at bay in schools, according to a new study published in the Journal of School Health.
Researchers at Ryerson University examined reports published between 1998 and 2008 to identify a number of factors, including the cause of a gastrointestinal outbreak, how the infection was transmitted, the number of children affected, mortality rates, and control and prevention measures. Of the 121 outbreaks cited in the reports 51 percent involved bacterial infections, 40 percent involved viral infections and 9 percent involved by one or more parasites. In almost half of the cases, transmission was identified as being food-borne (45 percent), followed by person-to-person (16 percent), waterborne (12 percent) and via animal contact (11 percent).
The researchers found that the risk of food-borne illness was reduced when food handlers practiced effective hand-washing and received food-safety training and certification. Student-training programs on hand hygiene and enhanced cleaning and disinfection of schools also were effective strategies.

Research hails chitosan antimicrobial coating potential in curbing Listeria
Source :
By Rory Harrington, (28, Jan, 2011)

Chitosan-based edible coatings and films have real promise in combating Listeria monocytogenes (LM) in cold-smoked salmon, according to new research.
The study by Haiqiang Chen et al, published in the Journal of Food Science, found that use of chitosan, particularly when used in coatings, was able to inhibit the growth of LM and could potentially be an effective tool for the fish processing sector in efforts to tackle the bacteria.
The group said they launched the project as LM-contamination of ready-to-eat foods, such as cold-smoked salmon, is a common cause of foodbourne illness outbreaks and usually occurs in the post-processing phase. In 2009 the US Department of Agriculture (USDA) estimated that 15 per cent of all smoked fish is tainted with LM.
Chitosan is a natural polymer obtained by deacetylation of chitin, which is the major constituent of the exoskeleton of crustaceans. It is insoluble in water, but soluble in various acidic solvents such as dilute hydrochloric, formic, and acetic acids.
Chitosan efficacy
The aim of the study was to evaluate the performance of chitosan-based edible coatings and films incorporating three generally recognized as safe (GRAS) antimicrobials; sodium lactate (SL), sodium diacetate (SD), and potassium sorbate (PS), against L. monocytogenes on cold-smoked salmon.
Salmon samples were surface-inoculated with a 5-strain cocktail of LM to a final concentration of 4.4 log CFU/cm2 and then either coated with chitosan solutions or wrapped with chitosan films with or without the antimicrobials. The samples were then vacuum packaged and stored at 4C for 30 days.
The scientists found that chitosan coatings, with or without the antimicrobials, consistently showed higher efficacy against LM than chitosan films with the same compositions.
Chitosan films containing 1.2 per cent SL/0.25 per SD or 2.4 per cent per SL, achieved 1.3 log reductions of LM during refrigerated storage period, said the group.
However, chitosan coatings containing 1.2 per cent SL/0.25 per cent SD or 0.15 per cent PS/0.125 per cent SD, were more effective and achieved 2.8 log reductions.
"Our research thus holds great promise to enhance the microbiological safety of RTE fishery products," said the study.

Tips on Keeping Food Safe During Power Outages
Source :
By Natalie Neumann, (29, Jan, 2011)
It's been more than 60 hours since some people in the area have lost power. While this may be too late for some, here are some tips offered by Montgomery County to make sure your food is safe during and following a power outages.
Meat, poultry, fish and eggs should be refrigerated at 40 F and frozen food at or below 0 F, according to the United States Department of Agriculture's (USDA) Food Safety and Inspection Service. Storing food in these temperatures may be difficult with a prolonged power outage.
o Keep the refrigerator and freezer doors closed as much as possible to maintain the cold temperature. A refrigerator will keep food safely cold for about four hours if it is unopened.
o A full freezer will hold the temperature for approximately 48 hours (24 hours if it is half full) if the door remains closed.
o Obtain dry ice or block ice to keep your refrigerator as cold as possible if there is a prolonged power outage.
o Digital, dial or instant-read and appliance thermometers will help determine if the food is at safe temperatures. The refrigerator temperature should be at 40F or below; the freezer, 0or lower.
o To be sure a particular food is cold enough; take its temperature with a food thermometer.
o Never taste food to determine its safety.
o Food may be safely refrozen if the food still contains ice crystal or is at 40F or below. Evaluate each food item separately. Be sure to discard any items in either the freezer or the refrigerator that have come into contact with raw meat juices.
o Food such as meat, poultry, fish, eggs, milk, soft cheeses, butter and leftover cooked meats, casseroles and pizza should be thrown out if they have been held above 40 F for over two hours.

U.S. farmers get approval to plant GMO alfalfa
Source :
By Carey Gillam and Christopher Doering, (28, Jan, 2011)

(Reuters) - The United States said on Thursday farmers could proceed with planting genetically altered alfalfa without any of the restrictions that opponents say are crucial to protect organic and conventional farm fields from contamination.
The decision, closely watched by supporters and protesters around the world for its potential implications on biotech crop regulation, was seen as a boon to biotech crop developers and comes as research into additional biotech crops accelerates.
But opponents of biotech crops were disappointed.
The U.S. Agriculture Department had signaled last month that it might forge a first-ever compromise approval with a range of restrictions for planting, but there were no such conditions in the plan announced Thursday.
The USDA said the decision, made by its Animal and Plant Health Inspection Service, was made after analysis of various economic and environmental factors, and allows GMO farmers to get their crop in the ground this spring.
"After conducting a thorough and transparent examination of alfalfa ... APHIS has determined that Roundup Ready alfalfa is as safe as traditionally bred alfalfa," Agriculture Secretary Tom Vilsack said.
Alfalfa is the fourth-largest U.S. field crop grown, worth roughly $8 billion to $10 billion and grown on about 20 million acres as food for dairy cattle and other livestock.
The decision Thursday to allow planting of genetically altered version comes after years of court battles with opponents.
Developed by biotech leader Monsanto Co to tolerate treatments of Monsanto's Roundup herbicide, "Roundup Ready" alfalfa is preferred by many farmers because it makes killing weeds easier.
But opponents, including conventional and organic farmers, say the biotech alfalfa can easily contaminate their crops because alfalfa is pollinated largely by honey bees, making it difficult to isolate GMO fields from non-GMO strains.
Organic dairy farmers who feed their cows alfalfa say the biotech crop can kill their business.
Opponents also say increased use of herbicide is translating to increased weed resistance, and the rise of "super weeds."
A consortium of opponents led by the Center for Food Safety previously won a court decision against USDA for the government's failure to thoroughly account for the environmental and economic implications of the biotech alfalfa when it approved the crop for the first time in 2005.
A federal court ordered USDA to rescind its approval until the government thoroughly evaluated the impact of the crop.
Vilsack said Thursday the government has now done so, but opponents said they will sue again.

More Governors Make Food Safety Appointments
Source :
By Dan Flynn, (31, Jan , 2011)

The nation's new governors are now all at their posts, and most have already delivered their own "State of State" or budget messages. After last November's election, 29 executive mansion's are held by the GOP, 20 by Democrats, and one by an independent, the former Republican, Rhode Island's Gov. Lincoln Chafee.
With the executive branches of 26 states now under the command of new governors, personnel changes are coming fast and furious. Food safety in state government is often spread across health, agriculture, and consumer portfolios.
Food Safety News continues today with more reports on these important state-level appointments.
Empire state's Gov. Andrew Cuomo has nominated Buffalo native Dr. Nirav R. Shah as the 15th New York State Commissioner of Health.
Dr/ Shah earned both his medical degree and a master's of public health at Yale University's School of Medicine.
He takes over from Dr. Richard Daines, who sought extra taxes on soda pop to fight obesity.
The new commissioner comes to state government from Bellevue Hospital Center in Manhattan.
Vermont's new Democratic Gov. Peter Shumlin picked Dr. Harry L. Chen to be Health Commissioner.
Dr. Chen takes over in Vermont for Dr. Wendy Davis.
Chen earned his medical degree and completed his residency at the Oregon Health Sciences University, where he served a chief resident. He then served on the faculty of the George Washington University Medical Center's Department of Emergency Medicine.
In Vermont, he's served as an emergency physician at the Rutland Regional Medical Center for over 20 years. He was also elected to the Vermont House of Representatives and served on its Health Care Committee. Chen has been active in health care reform.
South Dakota Republican Gov. Dennis Daugaard has named Walt Bones as Secretary of Agriculture.
Bones, with his brothers and nephews, operates a dairy for 2,200 cows and raises cattle and grain on land near Parker, SD that has been in the family since 1879.
He succeeds Jon Farris, who has been South Dakota's acting secretary of agriculture since Bill Even resigned.
SD's Department of Agriculture has programs for plants, eggs, and dairy to protect consumers and maintain integrity of its brands.
Pennsylvania Republican Gov. Tom Corbett has nominated Dr. Eli Avila as Secretary of Health.
Dr. Avila was chief deputy commissioner for the Suffolk County Department of Health Services where he was in charge of more than 1,600 employees and an annual budget of $400 million.
Avila is a lawyer-doctor, having earned his medical degree from the Brown University School of Medicine and his J.D. from St. John's University School of Law. He also has a master degree in public health from the Mount Sinai School of Medicine at New York University.
Avila replaces Everette James, who left state government last October to become a Vice Chancellor at the University of Pittsburg.
Wyoming Republican Gov. Matt Mead has re-appointed Jason Fearneyhough as head of the state Department of Agriculture and appointed Casper City Manager Tom Forslund to head the state Health Department.
FearneyHough has headed up Wyoming's Ag department for the past 18 months. Forslund's appointment means Wyoming has an opening for a new state health officer.
Dr. Brent Sherard currently is both head department head and the state's chief health officer. Being a city manager, and not a medical doctor, Forslund cannot be both the director and health officer.
A department spokesman said it's likely an acting state health officer will be named from the existing staff when Dr. Sherard departs.
Wyoming was recently named as among a handful of state's as getting an "A" from the Center for Science in the Public Interest (CSPI) when it comes to identifying and investigating outbreaks of foodborne illness.
Tennessee Gov. Bill Haslam named Julius Johnson, who has worked for the state Farm Bureau for almost four decades, as Commissioner of the Department of Agriculture.
Johnson is a Tennessee native who was a beef cattle farmer before going on to a career with the Farm Bureau, where he has been chief administrative officer for the past 15 years.
Johnson took over from former Commissioner Terry j. Oliver.

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