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Restaurants Pose Twice the Risk of Foodborne Outbreaks as Homes, CSPI Data Show

Raw Milk is Disproportionately Responsible for Milk-Related Outbreaks

Outbreak data show that Americans are twice as likely to get food poisoning from food prepared at a restaurant than food prepared at home, according to the Center for Science in the Public Interest. The nonprofit food safety watchdog group analyzed “solved” outbreaks of foodborne illness over a 10-year period—those outbreaks where both a food and a pathogen were identified by investigators—and found that 1,610 outbreaks in restaurants sickened more than 28,000 people. In contrast, 893 outbreaks linked to private homes caused nearly 13,000 cases of foodborne illnesses. Unfortunately, fewer and fewer outbreaks were solved by public health officials over the 10-year period, leaving a lot of important information undiscovered in the data.

Raw-milk proponents may find another of CSPI’s findings disquieting: Of 104 outbreaks of illness linked to milk, 70 percent were caused by raw milk. In other words, although less than one percent of consumers drink raw milk, they bear 70 percent of the burden of illnesses caused by milk-borne outbreaks.

“Pasteurization of milk is one of the most important public health advances of the last 100 years, sparing countless people from infections and deaths caused by Salmonella, E. coli, and Listeria,” said CSPI senior food safety attorney Sarah Klein. “Consumers should avoid raw milk, and lawmakers should not expand its availability.”

CSPI also documented a trend of decreased reporting of foodborne illness outbreaks. States reported 42 percent fewer outbreaks to the Centers for Disease Control and Prevention in 2011 than they did in 2002. Fewer reported outbreaks, though, doesn’t necessarily mean that fewer Americans are getting sick. The recent recession, influenza pandemics, and post-9/11 bioterrorism investments have all diverted state public health budgets and attention away from identifying outbreaks and figuring out their causes.

“Underreporting of outbreaks has reached epidemic proportions,” said CSPI food safety director Caroline Smith DeWaal. “Yet the details gleaned from outbreak investigations provide essential information so public health officials can shape food safety policy and make science-based recommendations to consumers. Despite the improvements in food safety policy in the past decade, far too many Americans still are getting sick, being hospitalized, or even dying due to contaminated food.”

Fresh produce, seafood, and packaged foods regulated by the Food and Drug Administration were responsible for more than twice as many solved outbreaks as meat and poultry products, which are regulated by the U.S. Department of Agriculture. The FDA Food Safety Modernization Act, signed into law in January 2011, was designed to give the agency the authority it needs to conduct more frequent inspections of food processing facilities, particularly higher-risk ones. But the agency has been slow to finalize a number of complex regulations—and Congress, in turn, has been unwilling to provide sufficient funds for the FDA to bring the reform law into full effect, says CSPI.

CSPI’s Outbreak Alert! database includes 7,461 unique and solved outbreaks of foodborne illness that occurred from 1990 through 2011. The report issued today examined the 3,933 outbreaks that occurred in the most recent 10-year period. Those outbreaks sickened 98,399 people. The CDC estimates that 48 million people are sickened annually, of which 128 thousand are hospitalized and 3,000 die.

Click here to read the CSPI 2014 Outbreak Alert.

NIOSH Takes Exception to FSIS Over Worker Safety

April 7, 2014

The Honorable Alfred V. Almanza
Administrator, Food Safety and Inspection Service
U.S. Department of Agriculture
1400 Independence Ave., S.W.
Washington, D.C. 20250

Dear Mr. Almanza:

I am writing to express a concern of the National Institute for Occupational Safety and Health (NIOSH) about misinterpretations by the U.S. Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS), of findings from a NIOSH evaluation of a poultry processing plant.[1]

At the request of USDA/FSIS, NIOSH agreed to evaluate the effects of waivers of line speed restrictions on employee health, with a focus on musculoskeletal disorders and acute traumatic injuries. USDA/FSIS required that establishments that were to be granted waivers for regulatory line speeds under the Salmonella Initiative Program (SIP) cooperate with a NIOSH investigation.[2]

The July 13, 2011 Federal Register Notice announcing the SIP stated in pertinent part:

“FSIS also recognizes that evaluation of the effects of line speed on food safety should include the effects of line speed on establishment employee safety. To obtain preliminary data on this matter, FSIS has asked the National Institute for Occupational Safety and Health (NIOSH) to evaluate the effects of increased line speed as part of the SIP waiver program. NIOSH has stated its willingness to evaluate the effects of increased production volume on employee health, with a focus on musculoskeletal disorders and acute traumatic injuries. NIOSH’s activities may ultimately include observation of work processes and practices; collection of company payroll, personnel, and injury and illness records; interviews with plant managers, supervisors, and employees; health surveys of employees; and videotaping and measurement of specific aspects of job tasks. NIOSH will prepare a report based on its findings of short-, intermediate-, and long-term effects from the process modifications. NIOSH will make recommendations as needed. FSIS will use any available data from NIOSH activities to inform its decisions as it moves forward with planned regulatory reform. FSIS will require that establishments granted waivers for regulatory line speeds under SIP cooperate with NIOSH.”

Based on USDA/FSIS’ stated concern about the effect of waivers of line speed restrictions on employee safety, NIOSH agreed to conduct an evaluation through its Health Hazard Evaluation (HHE) Program when it received a request from an establishment in response to the SIP.

The first poultry processing plant to request an evaluation from NIOSH based on the SIP was a poultry processing plant in South Carolina. In its evaluation of the plant before any production line speed changes had occurred, NIOSH investigators found an alarming 42% prevalence of carpal tunnel syndrome (CTS) in exposed workers. The CTS risk, confirmed by a nerve conduction study, was not unexpected considering the repetitive and forceful motions required by exposed workers to process poultry. In addition to noting the alarming prevalence of CTS in exposed workers, NIOSH made 31 health and safety recommendations to prevent CTS, other musculoskeletal disorders, and traumatic injuries in new workers, and to limit further physical damage to those workers who were already affected by CTS.

When NIOSH returned to the plant only a short time after modification of the plant’s production lines, NIOSH observed a continuing high prevalence of musculoskeletal symptoms. Given what NIOSH observed upon its second visit relative to changes made to the production lines, NIOSH would not have expected to find an increase or a decrease in musculoskeletal symptom prevalence.

First, the amount of intervening time (10 months) between the first and second visits was not sufficient to result in a change in health status. Second, as NIOSH discovered during the second visit, the manner in which the plant had modified the production lines resulted in no change in exposure to repetitive and forceful motions for any individual worker. Third, NIOSH also found that most of its 31 recommendations, including NIOSH’s primary recommendation to redesign the jobs to reduce the risk of CTS due to forceful and repetitive motions, and to address the alarming prevalence of CTS found on its first visit, had not been implemented.

NIOSH was quite surprised by the FSIS/USDA Administrator’s blog entry of March 27, 2014.[3]

First, the FSIS Administrator’s blog entry stated that NIOSH “…made several recommendations to improve worker safety at this facility, but slowing the evisceration line speed was not among them.” This statement is misleading. Line speed affects the periodicity of repetitive and forceful movements, which are key causes of musculoskeletal disorders. Many of the NIOSH recommendations address the design of job tasks to minimize these factors.

Second, the Administrator’s blog entry of March 27, 2014 stated that NIOSH found that “…the increase in evisceration line speed was not a significant factor in worker safety.” The truth of the matter is that the HHE Report draws no such conclusion. In fact, NIOSH investigators found during their second visit that the changes made by the plant to production line speed did not result in an increase in production volume for the individual worker or the plant, but actually resulted in a reduction of the number of birds processed from 180 to 175 birds per minute. Therefore, no conclusion can be drawn regarding the effect of line speed changes and health status.

Third, the Administrator’s blog entry of March 27, 2014 generalized the findings from the plant to the poultry industry as a whole even though the NIOSH HHE Report states that “[T]his plant may not be representative of other poultry processing plants.”

In sum, no conclusion can be drawn from this one HHE regarding the effect of line speed changes on worker health.

NIOSH regrets that USDA/FSIS did not provide NIOSH with an opportunity to review and comment on the Administrator’s blog entry prior to its posting. A NIOSH review could have assisted USDA/FSIS in better understanding the findings from the HHE at the South Carolina poultry processing plant.

NIOSH conducts health hazard evaluations with the aim of improving the health and safety of American workers. NIOSH supports USDA/FSIS’ recognition “that evaluation of the effects of line speed on food safety should include the effects of line speed on establishment employee safety.”

NIOSH would be pleased to assist USDA/FSIS in accurately characterizing the results of the HHE conducted at a poultry processing plant in South Carolina. Please contact the NIOSH Chief of Staff, Frank Hearl, at 202.245.0625 if NIOSH can be of assistance.

Thank you.

Sincerely,

John Howard
Director

Cc:
Adam Tarr, Chief of Staff, FSIS, USDA
Frank Hearl, Chief of Staff, NIOSH, CDC, HHS
Lucero Ortiz, Chief of Staff, OSHA, DOL

PDF Version: LetterApril72014.pdf 

[1] Musolin K et al. Evaluation of Musculoskeletal Disorders and Traumatic Injuries Among Employees at a Poultry Processing Plant. Available at http://www.cdc.gov/niosh/hhe/reports/pdfs/2012-0125-3204.pdf 

[2] 76 Federal Register 41186 (July 13, 2011) Seehttps://www.federalregister.gov/articles/2011/07/13/2011-17625/salmonella-verification-sampling-program-response-to-comments-on-new-agency-policies-and

[3] See http://blogs.usda.gov/2014/03/26/food-safety-and-worker-safety-can-improve-in-poultry-facilities/#more-50820

FDA Shutters Seattle Smokehouse Due to Listeria

The U.S. Food and Drug Administration recently ordered Jensen’s Old Fashioned Smokehouse Inc., a processor of smoked fish products in Seattle, Wash., to stop processing, preparing, packing, holding and distributing any food at or from its facility.

The order follows the FDA’s analysis of environmental samples collected during its most recent inspection of the company’s facility, which confirmed the presence of Listeria monocytogenes (L. mono) in the facility, including in food processing and storage areas.

Jensen’s Old Fashioned Smokehouse Inc. is subject to a consent decree of permanent injunction, which was entered by the United States District Court for the Western District of Washington in 2001. Under the terms of the consent decree, the company agreed to comply with requirements to control food safety hazards and ensure that its products are not adulterated. 

The findings of the FDA’s most recent inspection establish that food in the company’s facility is adulterated and led the FDA to issue the order to cease operations under the terms of the consent decree.In order to resume operations, Jensen’s must meet several requirements, including thoroughly cleaning and sanitizing the facility and hiring an expert to develop a Sanitation Standard Operation Procedure and an environmental microbial monitoring program for L. mono. Jensen’s must also test representative samples of all vacuum-packaged smoked fishery products on hand at the company for L. mono and provide the results to the FDA.

Jensen’s processes smoked fish products and distributes or sells them in its retail store, online and through other businesses in Washington, Oregon and California.

L. mono can cause a serious illness called listeriosis, which can be fatal, especially in certain high-risk groups. These groups include older adults, people with compromised immune systems and certain chronic medical conditions (such as cancer) and unborn babies and newborns. In pregnant women, listeriosis can cause miscarriage, stillbirth and serious illness or death in newborn babies, though the mother herself rarely becomes seriously ill. To date, no illnesses have been reported to the FDA associated with Jensen’s smoked seafood products.

Why are Chicken Pet Treats Recalled for Salmonella, but Chicken for Human Consumption Not?

On November 4, 2013, Bailey’s Choice recalled its 5 oz. packages of chicken treats because they had the potential to be contaminated with Salmonella.  The potential for contamination was noted after routine testing by the Georgia Department of Agriculture (GDA) revealed the presence of Salmonella in some 5 oz. packages of chicken treats.

Over the last year the CDC reported a total of 481 persons infected with seven outbreak strains of Salmonella Heidelberg in 25 states and Puerto Rico and an earlier total of 134 persons infected with the outbreak strain of Salmonella Heidelberg in 13 states.  Although FSIS issued a Public Health Alert following the second outbreak announcement, no recall was issued despite the chicken products being linked to Foster Farms.

Salmonella is an organism that 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 (i.e., infected aneurysms), endocarditis and arthritis.

Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Salmonella outbreaks. The Salmonella lawyers of Marler Clark have represented thousands of victims of Salmonella and other foodborne illness outbreaks and have recovered over $600 million for clients.  Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation.  Our Salmonella lawyers have litigated Salmonella cases stemming from outbreaks traced to a variety of foods, such as cantaloupe, tomatoes, ground turkey, salami, sprouts, cereal, peanut butter, and food served in restaurants.  The law firm has brought Salmonella lawsuits against such companies as Cargill, ConAgra, Peanut Corporation of America, Sheetz, Taco Bell, Subway and Wal-Mart.

Microbial Testing Now Required for Infant Formula

Today, the U.S. Food and Drug Administration published an interim final rule to further safeguard the health of infants fed infant formula in the United States. The rule, which sets standards for manufacturers to produce safe infant formula that supports healthy growth, is accompanied by two draft guidance documents for industry.

“Many families rely on infant formula as either the sole source of nutrition or an integral part of an infant’s diet through 12 months of age,” said Michael R. Taylor, the FDA’s deputy commissioner for Foods and Veterinary Medicine. “The FDA sets high quality standards for infant formulas because nutritional deficiencies during this critical time of development can have a significant impact on a child’s long-term health and well-being. This rule will help to prevent adulteration in infant formula and ensure infant formula supports normal, physical growth.”

While breastfeeding is strongly recommended and many mothers hope to breastfeed, only 75 percent of infants in the United States start out being breastfed. By age three months, two-thirds or 2.7 million U.S. infants rely on infant formula for some portion of their nutrition. The interim final rule applies only to infant formulas represented for use by healthy infants without unusual medical or dietary problems.

The interim final rule amends the FDA’s quality control procedures, notification, and record and reporting requirements for manufacturers of applicable infant formula products. The rule, in part, will ensure that infant formula contains all federally required nutrients. The interim final rule also establishes current good manufacturing practices specifically designed for infant formula, including required testing for microbial contamination. This microbial testing includes testing representative samples of finished products to prevent the distribution of infant formula products contaminated with the pathogens Cronobacter and Salmonella. The interim final rule also establishes quality factor requirements to support healthy growth.

Companies currently manufacturing infant formula in the United States already voluntarily conduct many of the current good manufacturing practices and quality control procedures included in the interim final rule. Following publication of the rule, the FDA will be accepting and reviewing comments on issues or information not previously considered.

The two draft guidance documents published today provide industry with additional information related to the interim final rule. One draft guidance document addresses the manufacture of infant formula products made for infants with unusual medical or dietary problems. For example, these infant formulas might be made for infants who are born extremely premature and have special dietary needs. This type of formula is not the subject of this interim final rule. The draft guidance provides information about the manufacture of such formulas in relation to the requirements for current good manufacturing practices, quality control procedures, the conduct of audits, and records and reports that apply to the infant formulas covered by the interim final rule.

The other draft guidance document explains how manufacturers of currently and previously marketed infant formulas can demonstrate that their products meet the quality factor requirements of the interim final rule.

The FDA is accepting comments from the public on the interim final rule for 45 days at www.regulations.gov (Docket Number FDA-1995-N-0036).

New York Comptroller Critical of Failure in Food Safety Inspections

The Department of Agriculture and Markets is not keeping up with the demands of its inspection schedule, allowing thousands of food manufacturers, supermarkets, bakeries and other food-related businesses to operate without updated inspections, according to an audit released today by State Comptroller Thomas P. DiNapoli. The backlog has allowed hundreds of new establishments to start serving the public without the required initial inspection.

“Food safety is critical for the health and well-being of New Yorkers, but the Department of Agriculture and Markets is quickly falling behind in its responsibilities to make sure what the public is eating is safe,” DiNapoli said. “The department needs to take immediate steps to maximize its resources and address the backlog of past-due inspections.”

The department’s Division of Food Safety and Inspection is responsible for inspecting more than 31,000 establishments including food manufacturers, wholesale bakeries, beverage processors, food warehouses, refrigerated warehouses, retail food stores, slaughterhouses, fish processors, rendering/disposal plants and food transportation services. From April 1, 2011 through June 4, 2013, it received 5,724 consumer complaints for investigation, and inspectors obtained 3,894 food samples for testing to identify potential violations of food safety.

DiNapoli’s auditors found that as of June 4, inspections that were due for almost 5,000 establishments had not been completed. Another 439 new establishments did not yet have a required initial inspection completed prior to opening for business.

A random sample of 45 of the new establishments found that license applications had languished for an average of six months. Nineteen of those businesses (42 percent) were already preparing food without the required inspection. They included fish markets, delis and convenience stores.

The food safety division’s staff of 82 inspectors is as much as 37 percent below the level recommended by the U.S. Food and Drug Administration. To meet the requirements dictated by potential hazard ratings for existing establishments, inspectors would need to conduct 30,000 to 36,000 inspections annually, including re-inspections, or about 2.2 inspections per day by each inspector. However, between April 1, 2011 and June 4, 2013, inspectors completed an average of only 1.7 inspections per day each.

By adjusting schedules and work practices for greater efficiency, more time could be allocated to conducting inspections, auditors concluded, thereby bringing the division closer to meeting its targets.

Auditors found most consumer complaints are investigated timely and confirmed the department’s food sampling program is a nationally recognized leader in the field.DiNapoli recommended the department:

· Establish performance measures for food inspection activities, including department-wide policy governing such things as work scheduling and time allowances for local travel.
· Establish procedures to further prioritize and ensure timely completion of inspections of new establishments.
· Increase efforts to provide coordinated real-time access to data among divisions and obtain training on how to use that data to monitor performance, including activities such as inspections and complaint response.

Ag & Market officials agreed with DiNapoli’s recommendations and have taken some steps to implement them. For a copy of the report, visit: http://www.osc.state.ny.us/audits/allaudits/093014/13s27.pdf

What do Stephen Colbert and Salmonella have in common? Pistachios

Wonderful Pistachios announced today that Stephen Colbert, Emmy-award winning host and executive producer of Comedy Central’s “The Colbert Report,” will star in two Super Bowl spots for the brand. This will be Wonderful Pistachios’ second consecutive Super Bowl appearance and will kick-off a new, full-year agreement with Mr. Colbert under the campaign theme, “Get Snackin’, Canada.”

According to a recently released FDA Warning Letter, in early 2013 ARO, a pistachio producer not affiliated with Wonderful Pistachios, was associated with three Reportable Food Registry (RFR) reports that detailed positive Salmonella findings detected in two shipments of raw pistachios.  In addition, according to the letter, a cluster of salmonellosis infections reported from January through May 2013, were investigated by local, state, and federal public health and regulatory agencies. Epidemiological data from the outbreak investigation coupled with results of FDA inspection findings and analyses from product and environmental samples collected from ARO’s processing facility indicate that pistachios were the likely source of the Salmonella outbreak.

During the May 21st through May 24th, 2013 inspection, environmental samples were collected from various locations within ARO’s processing facility and analyzed. The analysis revealed the presence of Salmonella enterica serotype Senftenberg (S. senftenberg) in seventeen (17) subsamples.

During the FDA inspection, investigators observed the following significant violation:

a.         An employee in the roasting room was observed repeatedly touching the bottom of shipping boxes that were resting on the floor and then touching roasted, ready-to-eat, pistachios without washing or sanitizing hands.

b.         Maintenance personnel were observed entering and exiting the hand sorting room through a door that opens directly to the outside of the facility. Apparent bird droppings were observed on the floor of the outside areas where maintenance personnel were observed working and entering the hand sorting room.

c.         Inside the hand sorting room, two buckets containing floor sweepings of pistachios, dust, and debris, were observed near the hand sorting production lines. During the inspection, ARO stated that the buckets of floor swept pistachios would be reworked into finished product.

d.         The movement of employees from the outside of the facility (where apparent bird droppings were observed) into the hand sorting room may introduce contaminants into the facility and contaminate finished food, particularly based on the practice of reworking pistachios from the floor.

Why does FSIS close a plant for cockroaches but not Salmonella?

Lynne Terry of the Portland Oregonian broke the story tonight that the U.S. Department of Agriculture Food Safety Inspection Services suspended poultry processing at one of the biggest Foster Farms plants in California over “egregious” unsanitary conditions.

The agency said in a suspension notice that the company’s plant in Livingston, California is infested with live cockroaches, posing a public health threat.

The suspension comes after USDA/FSIS investigations of three Foster Farms plants in central California, including the one in Livingston, over two nationwide Salmonella outbreaks reported in July and December 2013 that sickened more than 550 people.

The question I have is why does USDA/FSIS have the authority to shutter a plant for cockroaches but not for poisoning 550 with Salmonella?

As I said to USA Today – tonight:

Seattle food safety lawyer Bill Marler found it odd that USDA “has the power to shut a plant down when they found cockroaches but doesn’t have the power to shut them down when they poison hundreds of people with antibiotic-resistant salmonella.”

In two outbreak in 2013 at least 550 sickened and it could be 38.5 times that.*

In the second Foster Farms outbreak of 2013, the CDC reports a total of 416 individuals infected with the outbreak strains of Salmonella Heidelberg have been reported from 23 states and Puerto Rico. Most of the ill persons (74%) have been reported from California. The number of ill persons identified in each state is as follows: Alaska (1), Arkansas (1), Arizona (18), California (310), Colorado (9), Connecticut (1), Delaware (1), Florida (4), Idaho (4), Illinois (1), Kentucky (1), Louisiana (1), Michigan (3), Missouri (5), North Carolina (1), Nevada (10), New Mexico (2), Oregon (10), Puerto Rico (1), Texas (10), Utah (2), Virginia (3), Washington (16), and Wisconsin (1).

Epidemiologic, laboratory, and traceback investigations conducted by local, state, and federal officials indicate that consumption of Foster Farms brand chicken is the likely source of this outbreak of Salmonella Heidelberg infections.

An earlier outbreak of Salmonella Heidelberg linked to Foster Farms was first announced February 14, 2013.  That outbreak sickened 134.  The current outbreak was first announced October 8, 2013 when the number of ill was only 278.  It is now 418.  At that time FSIS threatened Foster Farms with removing inspectors because sanitary conditions at its three facilities were so poor that they posed a “serious ongoing threat to public health.”  FSIS officials had found a “high frequency of Salmonella Heidelberg positives and specifically a high frequency of one or more outbreak strains” in the three plants. The letters also cited “fecal material on carcasses” and “findings of poor sanitary dressing practices, insanitary food contact surfaces, insanitary non food contact surfaces and direct product contamination” at the plants.  See Notices of Intended Enforcement: ONETWO and THREE that FSIS sent to Foster Farms.

Neither Foster Farms nor FSIS have recalled any chicken despite illnesses beginning in February and continuing through the end of November.

See also Consumer Report’s chicken testing and the Pew Charitable Trusts, FSIS’s Weakness in Salmonella Regulation.

If you want a little insight into the legal history of Salmonella as a non-adulterant, read these:

FSIS’s and Foster Farms’ Reason for NOT Recalling Salmonella Chicken: “Shit Happens!”

Butz, Supreme Beef and FSIS’s Salmonella Policy – A Bit(e) of History

And, why some meat with Salmonella gets recalled and some not:

Why does the FSIS like Foster Farm’s Salmonella better than Cargill’s Salmonella?

*According to the CDC, for every one person who is a stool-culture confirmed positive victim of Salmonella in the United States, there a multiple of 38.5 who are also sick, but remain uncounted. (See, AC Voetsch, “FoodNet estimate of the burden of illness caused by nontyphoidal Salmonella infections in the United States,” Clinical Infectious Diseases 2004; 38 (Suppl 3): S127-34).

Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Salmonella outbreaks. The Salmonella lawyers of Marler Clark have represented thousands of victims of Salmonella and other foodborne illness outbreaks and have recovered over $600 million for clients.  Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation.  Our Salmonella lawyers have litigated Salmonella cases stemming from outbreaks traced to a variety of foods, such as cantaloupe, tomatoes, ground turkey, salami, sprouts, cereal, peanut butter, and food served in restaurants.  The law firm has brought Salmonella lawsuits against such companies as Cargill, ConAgra, Peanut Corporation of America, Sheetz, Taco Bell, Subway and Wal-Mart.

FDA issues proposed rule to determine safety and effectiveness of antibacterial soaps

The U.S. Food and Drug Administration today issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market.
Today’s action is part of a larger, ongoing review of antibacterial active ingredients by the FDA to ensure these ingredients are proven to be safe and effective. This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings.
Millions of Americans use antibacterial hand soap and body wash products. Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water. Further, some data suggest that long-term exposure to certain active ingredients used in antibacterial products—for example, triclosan (liquid soaps) and triclocarban (bar soaps)—could pose health risks, such as bacterial resistance or hormonal effects.
“Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”
The widespread consumer use of antibacterial products, the accumulated scientific information and concerns raised by health care and consumer groups have prompted the FDA to reevaluate what data are needed to classify the active ingredients in consumer antibacterial products as “generally recognized as safe and effective” or GRASE.  Under the proposed rule, manufacturers who want to continue marketing antibacterial products will be required to provide the agency with additional data on the products’ safety and effectiveness, including data from clinical studies to demonstrate that these products are superior to non-antibacterial soaps in preventing human illness or reducing infection.
“While the FDA continues to collect additional information on antibacterial hand soaps and body washes, we encourage consumers to make an educated choice about what products they choose to use,” said Sandra Kweder, M.D., deputy director, Office of New Drugs at CDER. “Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others.”
Consumers should continue to be diligent about washing their hands. If soap and water are not available, an alcohol-based hand sanitizer that contains at least 60 percent alcohol should be used.  More information on appropriate hand washing from the CDC may be found here.
Almost all soaps labeled “antibacterial” or “antimicrobial” contain at least one of the antibacterial ingredients addressed in the proposed rule. The most common active ingredients in antibacterial soaps are triclosan and triclocarban. Some soaps labeled “deodorant” may also contain these ingredients.
The proposed rule does not require the antibacterial soap products to be removed from the market at this time. When the proposed rule is finalized, as previously stated, either companies will have provided data to support an antibacterial claim, or if not, they will have to reformulate (remove antibacterial active ingredients) or relabel (remove the antibacterial claim from the product’s labeling) these products in order to continue marketing. The proposed rule is available for public comment for 180 days, with a concurrent one year period for companies to submit new data and information, followed by a 60-day rebuttal comment period.
For more information:

Salmonella “Action Plan” Quietly Released by FSIS

The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) today released its Salmonella Action Plan that outlines the steps it will take to address the most pressing problem it faces–Salmonella in meat and poultry products. An estimated 1.3 million illnesses can be attributed to Salmonella every year.

“Far too many Americans are sickened by Salmonella every year. The aggressive and comprehensive steps detailed in the Salmonella Action Plan will protect consumers by making meat and poultry products safer.” said Under Secretary for Food Safety Elisabeth Hagen.

The Salmonella Action Plan is the agency’s strategy to best address the threat of Salmonella in meat and poultry products.  The plan identifies modernizing the outdated poultry slaughter inspection system as a top priority. By focusing inspectors’ duties solely on food safety, at least 5,000 illnesses can be prevented each year.

Enhancing Salmonella sampling and testing programs is also part of this comprehensive effort,  ensuring that these programs factor in the latest scientific information available and account for emerging trends in foodborne illness. Inspectors will also be empowered with the tools necessary to expeditiously pinpoint problems.  With more information about a plant’s performance history and with better methods for assessing in-plant conditions, inspectors will be better positioned to detect Salmonella earlier, before it can cause an outbreak.

In addition, the plan outlines several actions FSIS will take to drive innovations that will lower Salmonella contamination rates, including establishing new performance standards; developing new strategies for inspection and throughout the full farm-to-table continuum; addressing all potential sources of Salmonella; and focusing the Agency’s education and outreach tools on Salmonella.

These efforts will build upon the work that USDA has done over the past several years. In 2011, USDA strengthened the performance standards for Salmonella in poultry with a goal of significantly reducing illnesses by 20,000 per year.  And through the Salmonella Initiative Program, plants are now using processing techniques designed to directly reduce Salmonella in raw meat and poultry.  Thanks to these innovative technologies and tough policies, Salmonella rates in young chickens have dropped over 75 percent since 2006.

Learn more about the Salmonella Action Plan.