Defending Food Safety : Food Safety Defense Lawyer & Attorney : National Food Industry Counsel : National Food Regulatory Lawyer and Attorney, FDA Lawyer and Attorney. USDA Lawyer and Attorney : Gass Weber Mullins Law Firm

After failing to pass a  vote in the House of Representatives on Wednesday (July 29), the Food Safety Enhancement Act of 2009 (H.R. 2749) returned to the House floor for a second vote on Thursday (July 30).  

On the second try, the Dingell-Waxman bill, designed to modernize the FDA’s food safety authority, passed by a vote of 283 - 142. Click on the following link for a summary of the legislation.

Key provisions of the bill include the following:

• Inspections: Food and Drug Administration inspections of food facilities would increase from about once every 10 years to at least annually for high-risk facilities and at least once every three years for facilities deemed a low risk. FDA inspectors will have access to company records.

• Registration: Food processors, importers and other food handlers must register annually with the FDA and pay a yearly fee of $500 for each food facility.

• Recalls: The FDA could mandate the recall of tainted foods, instead of relying on food makers to pull items voluntarily.

• Safe practices: For the first time, the FDA could set standards for safe production of food on farms, as well as require food manufacturers to meet safety standards.

The 132-page bill now goes to the Senate where Illinois Democrat Dick Durham is waiting with his own bill.   Any differences between the House and Senate versions will likely be resolved by Conference Committee. Reportedly, President Obama already endorsed the House bill before Thursday’s successful vote.

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According to FSIS, King Soopers has announced a voluntary recall of various ground beef products after learning the products could potentially be linked to an ongoing Salmonella outbreak. The possible association is being investigated by the Colorado Department of Health.

Approximately 466,236 pounds of ground beef chubs, tray packs and patties (processed in Denver, Colorado) are affected by the voluntary and precautionary recall. The products were processed on various dates between May 23, 2009 and June 13, 2009, and bear Establishment Number "EST. 6250." In turn, the ground beef chub products bear a use-by/sell-by date between "05/31/09" and "06/21/09;" the tray packs of ground beef bear a use-by/sell-by date between "06.02.09" and "06.23.09;" and the ground beef patty products bear a use-by/sell-by date between "06.01.09" and "06.22.09." The products were distributed to retail establishments in Colorado, Kansas, Missouri, Nebraska, New Mexico, Utah and Wyoming. The products (produced in Denver, Colorado). Click on the following link to view the FSIS Recall Release.

The specific products subject to recall include:

• 1-pound chubs of (93/7) ground beef. Each package bears the identifying case code "69558."

• 1 - 1.25-lb. tray packs of (96/4) ground beef. Each package bears the identifying case code "67164."

• 1 - 1.25-lb. tray packs of (96/4) ground beef. Each package bears the identifying case code "67664."

• 1 - 1.25-lb. tray packs of (93/7) ground beef. Each package bears the identifying case code "67663."

• 1 - 1.25-lb. tray packs of (93/7) ground beef. Each package bears the identifying case code "67163."

• 2.5 - 3-lb. tray packs of (93/7) ground beef. Each package bears the identifying case code "67654."

• 6-pack trays of (93/7) ground beef patties. Each package bears the identifying case code "67106."

• 4-pack trays of (93/7) ground beef patties. Each package bears the identifying case code "67115."

As a result of an ongoing investigation into an outbreak of Salmonella Typhimurium DT104 potentially associated with ground beef, the Colorado Department of Public Health notified FSIS of the problem. Epidemiological investigations, and a case control study, conducted by Colorado Department of Health and CDC determined that there may be an association between the fresh ground beef products and 14 illnesses reported in Colorado.

Although the FSIS has no reason to believe that the products are still available for sale in commerce, the agency is nevertheless advising consumers that may have purchased the fresh ground beef between May 23 and June 23, 2009, and who may still have the products in their freezers, to look for and discard any potentially affected products.

As always, FSIS also reminds consumers that thoroughly cooking raw beef products to an internal temperature of 160 degrees will destroy any pathogens that may be present, and will render the products safe.

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Researchers at the University of Arkansas have discovered some new ways to greatly inhibit the presence of pathogens in food.

According to a recent study, infusing chicken meat with a combination of organic acids (acetic, citric, lactic, malic and tartaric) and select plant extracts (from grape seeds and green tea) can drastically reduce the amounts of E. coli O157:H7, Listeria monocytogenes and Salmonella Typhimurium that may be present.

Not suprisingly, even better results were obtained when the expirimental technique was coupled with small amounts of irradiation.  In this regard, the researchers believe that a combination of organic acids and plant extracts, coupled with very small amounts of irradiation, could ultimately provide the optimal amount of protection against a wide range of food-borne illnesses.

According to Navam Hettiarachchy, a UA food science professor who supervised the project, "we want to determine the least amount of plant extracts that we can use, and the least amount of irradiation dosage, to get the best inhibitory effect."

Although research is continuing, Hettiarachchy has confirmed that at least one poultry company has expressed interest in the project. In turn, to achieve the maximum food safety benefit, Hettiarachchy also remains "hopeful that, with time, the public will become aware of irradiation processing so that they accept [the technology]." 

Although we'll leave it to others to interpret those tea leaves, we will, at the very least, continue to report on new developments. 

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Tanimura & Antle (located in Salinas, California) has announced a voluntary recall of various romaine lettuce products following a finding of Salmonella in a random sampe taken by the Wisconsin Department of Agriculture. Immediately after being informed of the positive test result, the company initiated comprehensive trace-back efforts, and was able to contact all customers within hours. Those buyers have been told to destroy the lettuce.

The recalled lettuce, which had been distributed to retail, foodservice and wholesale customers in 29 states, was harvested between June 25 and July 2, 2009. The specific products affected by the recall include cartons of bulk and wrapped lettuce with a lot code 531380. Click here to view a copy of the Company Press Release.

According to Tanimura & Antle, the affected products were distributed to the following states: Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Nebraska, New Hampshire, New Mexico, Nevada, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Wisconsin and Wyoming.

Chief executive officer Rick Antle stated that Tanimura & Antle practices strict food safety guidelines. Additionally, despite the lettuce being past its shelf life, he cited an "abundance of caution" in issuing the recall. "We will continue to review opportunities for improvement," Antle said. “Although the recalled product is well beyond the 14-16 day shelf life, we are voluntarily issuing this recall because we want to ensure that we minimize even the slightest risk to public health.”

To date, there have been no reports of illness associated with the lettuce. Moving forward, the company also stated that it will continue to update its website with more information. Consumers with questions, or who need information, may call Tanimura & Antle at 1-877-827-7388.

AUGUST 3, 2009 UPDATE:

On August 3, 2009, Tanimura & Antle expanded the geographic scope of its original recall to include product distributed to all 50 states.  Although the volume of cases from the single recalled lot (which is identified above) has not changed, the company recognizesd the possibility that some customers may have distributed the romaine in states beyond the original 29 -- thus, prompting the expansion. Click on the following link to view a copy of the Updated Recall Release.

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Anyone associated with the food industry appreciates the critical importance of sanitation, the most basic and important aspect of which is proper hand washing.

Notably, eighty percent of all illnesses and infections are transported by touch. In turn, according to the World Health Organization, an individual who washes their hands often is 24 percent less likely to acquire a respiratory illness, and 45 percent to 50 percent less likely to get a stomach bug.

Fortunately, with each passing moment, science and technology lead to new innovations which enhance our knowledge of food-borne illness, as well as our ability to combat it. One of these innovations, while currently being used only in hospitals, may potentially have wide-ranging applications in the food industry as well.

The system, known as Hygreen, enables companies to monitor and keep track of hand washing. It is currently being tested in the Neuro-Intensive Care Unit of Shands, at the University of Florida Medical Center. The units require an employee to simply run their hands beneath a wall mounted sensor which can detect the presence and level of soap on the individual’s hands. If the employee’s hands are clean, a green light turns on.

Conversely, if the sensor detects low levels of cleanliness, or that too much time had elapsed between hand washings, a badge worn by the employee will vibrate softly. The badges and sensors communicate wirelessly with a computer which logs the collected information and can monitor compliance.

"I do wash my hands more often," said nurse Carrie McGirr, R.N., who volunteered to help test the HyGreen system. "It's a fairly simple process to learn."

While seemingly basic, proper hand washing requires one to follow certain basic guidelines which should be both trained and enforced.

Put simply, one should scrub vigorously with water and soap until lather appears, making sure to get between fingers and fingernails. This should be done for at least 20 seconds. Briskly dry with a towel.

While better than nothing, the popular sanitizing hand gels have been shown to be far less effective than hand washing. The reason for this is simple. When you use a hand sanitizer, the bacteria and viruses have no where to go so they remain on your hands. Conversely, when you use soap and water the germs are washed down the drain. A vigorous drying with a towel will ideally get rid anything that washing left behind.

Air dryers, once popular, are seen less and less frequently. They are generally thought to take too long to finish the job of drying, and studies have shown that paper towels are actually more effective at removing dirt and bacteria.

It is possible, however, that they will make a resurgence. At least that’s what the people at Dyson hope. The Dyson AirBlade is similar to other air dryers but it uses room temperature air which is blown out at over 400mph. It is a futuristic looking machine that is supposed to dry hands completely in less than ten seconds.

We are only left pondering, however, whether the AirBlade is strong enough to help open the bathroom door . . .

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Chang Farms (of Whatley, Massachusetts) has announced a voluntary recall of select Soy Bean Sprouts following the discovery of Listeria monocytogenes during FDA product testing.

The affected products were labeled under the Chang Farm Brand as “Soy Sprouts,” and have a “Sell By” date of July 17, 2009. The soy bean sprouts, packaged in 10 lb bags (bulk) and 12 oz plastic bags (retail), were distributed to retail stores and wholesalers throughout Massachusetts, Connecticut, New York and New Jersey. To date, no illnesses have been associated with the consumption of these products. Click on the following link to view a copy of the FDA Recall Release.

According to the FDA, retail stores and wholesalers who have received these products should remove them from shelves. In turn, consumers are being instructed to either discard any affected products, or return them to the place of purchase for a refund.

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The FDA has announced a new regulation which it expects to prevent approximately 80,000 cases of food-borne illness (and 30 deaths) caused each year by Salmonella Enteritidis in eggs.

The final rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (74 FR 33030), requires manufacturers to employ additional preventive measures during the production of shell eggs in poultry houses, and mandates subsequent refrigeration during storage and transportation. Click on the follwing link to view a copy of the FDA Final Egg Rule.  According to the FDA, the implementation of such measures could potentially reduce the number of Salmonella infections from eggs by nearly 60 percent.

“Preventing harm to consumers is our first priority,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “Today's action will prevent thousands of serious illnesses from Salmonella in eggs.”

Salmonella Enteritidis can be found inside eggs that appear perfectly normal. Eggs in the shell can become contaminated on the farm, primarily because of infection in the laying hens. If the eggs are subsequently eaten raw or undercooked, the bacterium can cause illness.

The new rules requires that measures designed to prevent Salmonella be adopted by virtually all egg producers with 3,000 or more laying hens whose shell eggs are not processed with a treatment, such as pasteurization, to ensure their safety.

Producers with at least 3,000 but fewer than 50,000 laying hens must comply within 36 months after the rule’s publication. Producers with 50,000 or more laying hens must be in compliance with the rule within 12 months after its publication in the Federal Register.

Under the rule, egg producers must:

• Buy chicks and young hens only from suppliers who monitor for Salmonella bacteria;

• Establish rodent, pest control, and biosecurity measures to prevent spread of bacteria throughout the farm by people and equipment;

• Conduct testing in the poultry house for Salmonella Enteritidis. If the tests find the bacterium, a representative sample of the eggs must be tested over an 8 week time period (4 tests at 2 week intervals); If any of the four egg tests is positive, the producer must further process the eggs to destroy the bacteria, or divert the eggs to a non-food use;

• Clean and disinfect poultry houses that have tested positive for Salmonella Enteritidis; and

• Refrigerate eggs at 45 degrees Fahrenheit temperature during storage and transportation no later than 36 hours after the eggs are laid.

Egg producers whose eggs receive treatments such as pasteurization must still comply with the refrigeration requirements. Similarly, certain entities such as distributors, packers, or truckers holding or transporting shell eggs also must comply with the refrigeration mandates.

To ensure compliance, egg producers must also maintain a written Salmonella Enteritidis prevention plan and associated records documenting compliance. Producers (except those who have less than 3000 hens or who sell all their eggs directly to consumers) also must register with the FDA. In turn, the FDA will develop guidance and enforcement plans to help egg producers comply with the rule.

The FDA has estimated that the rule would provide $1.4 billion in annual public health benefits, at an annual cost of $81 million to the regulated industry, or less than 1 cent per dozen eggs produced in the United States.

The new rule is part of a coordinated strategy between the FDA and the FSIS. The FDA and the FSIS will continue to work closely together to ensure that egg safety measures are consistent, coordinated, and complementary.

In addition to the new safety measures being taken by industry, consumers can also reduce their risk of food-borne illness by following safe egg handling practices. The FDA reminds consumers to buy eggs that have been refrigerated, to make sure eggs in the carton are clean and not cracked, and to cook eggs (and any foods containing eggs) thoroughly.

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In winter of 2006, William Cunningham, in hopes of obtaining money from the Campbell Soup Company, laced his children’s soup with numerous poisons.

According to the FSIS, "Cunningham then initiated several consumer complaints to FSIS to bolster his claims that certain soup products made his children sick.” Cunningham poisoned the soup with peppers, Prozac, Amitriptyline and lighter fluid, before feeding it to his 18 month old daughter and three year old son. Both were subsequently hospitalized.

In turn, the former dump truck driver called Campbell’s and public health officials attempting to blame the illnesses on the company. After an initial inquiry into the complaints, the FSIS noticed various irregularities, and confirmed there were signs of tampering. FSIS officials then began working in cooperation with the USDA Office of Inspector General, the FDA and local police to present a case to the U.S. Department of Justice. After a thorough investigation, these agencies were able to build a thorough case against Cunningham. Following his recent jury trial and conviction, Cunningham was sentenced to more than one-hundred years in prison.

In a statement issued by the FSIS, the agency extended “its appreciation to all parties involved with the investigation that led to Cunningham's conviction.” Click on the following link to view a copy of the FSIS Statement.  We are grateful for the diligent efforts of all federal, state and local agencies involved to get this one right.

We are also grateful that Campbell's was exonerated – in today’s litigious society, being innocent should count for something. The real victims of this story, however, were not so fortunate. Reports suggest that the children may be afflicted with respiratory problems for the rest of their lives.

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According to FSIS, the Edward S. Miller Packing Company has announced a voluntary recall of approximately 219 pounds of ground beef products that may be contaminated with E. coli O157:H7.

The ground beef products affected by the voluntary recall were produced by the company (located in Montgomery, Illinois) between July 7 and July 10, 2009, and were distributed to consumers and restaurants in northern Illinois. Click on the link to view the FSIS Recall Release.

The specific products subject to recall include:

• 10-pound vacuum-packed bags of bulk "Edward S. Miller Packing Co. Ground Beef." Each bag bears the establishment number "EST. 34342" inside the USDA mark of inspection, and the case codes of "070709," "070809," "070909" or "071009."

• 12- and 15-pound boxes of "Edward S. Miller Packing Co. Ground Beef Patties." Each box bears the establishment number "EST. 34342" inside the USDA mark of inspection and case codes of "070709," "070809," "070909" or "071009."

The problem was discovered through FSIS microbiological sampling. According to FSIS, there have been no reports of illnesses associated with these products. FSIS also reminds consumers that thoroughly cooking raw beef products to an internal temperature of 160 degrees will destroy any pathogens that may be present, and will render the products safe.

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Agriculture Secretary Tom Vilsack has announced the appointment of Jerold R. Mande, M.P.H., as Deputy Under Secretary for Food Safety at the U.S. Department of Agriculture (USDA). In this position, Mande will have responsibility for the Food Safety and Inspection Service (FSIS), the USDA agency which protects public health through food safety and defense by ensuring that the nation's supply of meat, poultry and processed egg products are safe and wholesome.

According to Vilsack, "Jerold Mande brings years of experience in health, nutrition and epidemiology, food safety, and public policy in both government and academia that will greatly serve USDA and the public as we continue to work to protect public health."

Most recently, as Associate Director for Public Policy at the Yale Cancer Center, Yale University School of Medicine, Mande developed a national model to increase support for cancer prevention and control, including diet, exercise, and obesity. He also initiated and helped manage the cancer center disparities program, to improve cancer control and care in underserved populations. He was also a lecturer in public health, and helped train select groups of physicians for careers in public policy.

Prior to this, Mande served on the White House staff as a health policy adviser where he helped lead key food safety, tobacco control and cancer initiatives, including expansion of FoodNet and PulseNet. He was Deputy Assistant Secretary for Occupational Health at the U.S, Department of Labor. He also served as Senior Advisor and Executive Assistant to the Commissioner of the Food and Drug and Administration, where he led design of the Nutrition Facts food label, for which he received the Presidential Award for Design Excellence. Mande began his distinguished career in the U.S. Congress where he was first hired to work on food safety legislation.

Mande holds a Masters Degree in Public Health (M.P.H. Nutrition and Epidemiology) from the University of North Carolina at Chapel Hill and a Bachelor of Science Degree, magna cum laude (B.S. with Distinction in Nutritional Sciences) from the University of Connecticut at Storrs. He also attended the John F. Kennedy School of Government, Harvard University, completing a Program for Senior Managers in Government.

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Mike’s Produce, Inc. (d/b/a. Kowalke Family Sprouts) has announced a voluntary recall of all Kowalke Family Sprouts Brand Alfalfa Products with sell-by dates from June 18, 2009 through June 30, 2009.  The recall was announced after the company received notification that a sprout sample (taken from a retail location) had tested positive for Salmonella. 

After being notified of the positive sample, Kowalke Family Sprouts (located in Los Angeles, California) promptly informed the FDA of its actions. It is not clear how Salmonella may have been introduced into the sprouts, and the company is cooperating fully with the agenciy's continuing investigation.

According to reports, Kowalke Family Sprouts met all FDA disinfection, processing, and pathogen testing guidelines. In addition, although the FDA tested for the presence of Salmonella on sprout growing equipment, food contact surfaces, walls, floors, and drains at the Kowalke Family Sprouts facility, all tests results were negative. Despite extensive efforts, the FDA found no Salmonella at the Kowalke Family Sprouts facility.

Even though all environmental samples were negative, and although the alfalfa sprouts tested negative prior to being shipped to retailers, the firm (given the positive retail finding – and, in an abundance of caution) decided to recall all sprouts from the potentially affected lot.

Kowalke alfalfa products are sold in 4 oz, 8 oz, 1 pound and 5 pound clear plastic, clam shell packages. Two other Kowalke products also contain alfalfa sprouts - the Dinner Salad in a 6 oz package and the Onion/Alfalfa Mix in a 4 oz package.

These products were sold to distributors in Los Angeles and to retail stores in Southern California, Nevada, and Arizona. It is possible, however, that the sprouts may have been transported to other states. Click on the following link to view the FDA Recall Release.

To date, no illnesses have been reported from these products.

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The President's “Food Safety Working Group,” chaired by the Secretaries of the Department of Health and Human Services (Kathleen Sebelius) and the Department of Agriculture (Tom Vilsack), was conceived in March 2009 to help modernize our food safety system. In turn, Vice President Biden, Sebelius and Vilsack, have now announced key findings of the Group.

Following numerous meetings, and imput from key stakeholders, the Working Group has recommended a new approach to food safety based on three core principles: (1) prioritizing prevention; (2) strengthening surveillance and enforcement; and (3) improving response and recovery.

"There are few responsibilities more basic or more important for the government than making sure the food our families eat is safe," said Vice President Biden. "Our food safety system must be updated – 1 in 4 people get sick every year due to food-borne illness, and children and the elderly are more at risk. I applaud the Secretaries of HHS and the USDA for tackling this problem head-on, and coming up with key recommendations to ensure the health and safety of our food supply and, with it, the American people."

"Instead of spending their time trying to get kids to eat healthier food, too many parents and families are worrying about whether their food is safe in the first place," said Secretary Sebelius. "In just the past few months since we began work with the Food Safety Working Group, we have seen recalls on everything from spinach to peanut products to now even cookie dough.” According to Sebelius, the Administration believes “that the current system just isn’t working for America’s families, and under the President’s leadership, we are taking action to keep our food supply safe and prevent outbreaks that can impact millions of Americans."

"There isn’t a single American that isn’t impacted by our efforts to protect the food supply," said Secretary Vilsack. "We owe it to the American people to deliver on President Obama’s bold promise to greatly enhance our food safety system, moving our approach into the 21st century, employing the best surveillance techniques available, and ensuring that we are doing all we can to prevent illness before it occurs."

In its announcement, the Working Group outlined specific steps designed to advance its three core principles:

• HHS and USDA are targeting Salmonella contamination by developing tougher standards to protect the safety of eggs, poultry, and turkey.

• To fight the threat of E. coli, USDA is stepping up enforcement in beef facilities and the Food and Drug Administration (FDA) is developing new industry guidance improving protections for leafy greens, melons, and tomatoes.

• The Obama Administration is building a new national traceback and response system including clearer industry guidance, a new unified incident command system, and improved use of technology to deliver individual food safety alerts to consumers.

• Finally, the Administration announced a plan to strengthen the organization of federal food safety functions, including the creation of new positions at key food safety agencies and a continuing oversight role for the Food Safety Working Group.

The Food Safety Working Group is chaired by Secretaries Sebelius and Vilsack, and participating agencies include the FDA, the FSIS, the CDC, the Department of Homeland Security, the Department of Commerce, the Department of State, the Environmental Protection Agency, and several offices of the White House.

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