Defending Food Safety : Food Safety Defense Lawyer & Attorney : Gass Weber Mullins Law Firm : National Food Product Defense Counsel : Defending Food Safety Blog

The FDA's Reportable Food Registry ("RFR") first went online in September 2009.

Since its inception, numerous questions have been asked regarding the specific circumstances under which a food company is required to inform the FDA about a potentially dangerous food product.

Generally speaking, under the RFR, any food company may have an obligation to inform the FDA – and file a report through the RFR website portal – if the company learns that it has manufactured, received or distributed a potentially implicated food product.

Because the FDA reporting requirements are only triggered under certain defined circumstances, however, a food company uncertain about its reporting obligations under the registry should consider contacting legal counsel to determine the extent and scope of any potential reporting requirements triggered by the FDA rules.

In their current form, the FDA rules extend to any company that is required to submit registration information to the FDA as a manufacturer, processor, packer, or distributor of food. In turn, the rules apply to any food product regulated by the FDA, with the exception of infant formula and dietary supplements which are covered by other regulatory requirements.

Under existing FDA rules, a food company is required to alert the FDA – through the RFR Portal – within 24 hours of becoming aware it has sold and shipped a "reportable food." In turn, a reportable food is defined generally as any food product that has a “reasonable probability” of causing health problems or death in humans or animals. As explained by the FDA, some examples of reasons a food may become reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

In turn, once a food company discovers a problem with a product it has received, manufactured or shipped, and submits a report through the RFR, it will be required to cooperate with the FDA to help determine the cause and contain any potentially affected products. In addition, responsible parties will be required to notify their relevant suppliers, distributors and customers of any potential food safety issues, be ready to submit further data and analysis to the FDA, and initiate their own investigation if the problem is thought to have originated internally.

Notably, however, in addition to other exceptions, the FDA’s reporting requirements apply only to products that have been shipped into commerce. For this reason, a food company is not required to report a problem to the FDA if it was the sole manufacturer of the food product, it discovered the problem internally before the food product was distributed, and it then corrected the problem or destroyed the implicated food.

For additional information on the registry and reporting requirements, please visit www.fda.gov/ReportableFoodRegistry.

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According to the FDA, Basic Food Flavors (of Las Vegas, Nevada) has announced a recall of hydrolyzed vegetable protein (HVP) paste and powder. HVP is a common ingredient used most frequently as a flavor enhancer in many processed foods, including soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips and dressings.

The recall of HVP was announced following the discovery of Salmonella Tennessee in certain product samples, along with other samples reportedly collected at the company’s processing facility. In turn, Basic Food Flavors announced a recall all HVP in powder and paste produced and distributed by the company since Sept. 17, 2009. Click on the following links to view a copy of the FDA News Release and FDA Recall Information.

Although, to date, there have been no reported illnesses associated with the consumption of any food products affected by the recall, the FDA and CDC report that they are currently assessing and closely monitoring the potential risks of illness from affected products.

The FDA is also advising industry that any recalled bulk HVP product should be destroyed or reconditioned according to FDA-approved procedures. Click on the following link for Product Handling And Reconditioning Information. Under the guidelines, FDA is allowing companies to recondition potentially affected HVP if thier processing contains protocols validated to inactivate Salmonella. 

Additionally, according to FDA, companies will not be required to recall any food products containing HVP if the products have validated cooking instructions which are sufficient to inactive Salmonella, FDA is recommending that any down-stream food companies that used HVP as an ingredient in food products which might be eaten by consumers without any further processing or cooking to address the potential risk, however, consider recalling such products. Under new FDA guidelines, certian companies may also have reporting obligations under the Reportable Food Registry.

In any event, additional information relating to potentially affected products can be found at www.foodsafety.gov.

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The FDA's Reportable Food Registry ("RFR") first became active in September 2009. 

In 2007, former President Bush signed into law the Food and Drug Administration Amendments Act (Public Law 110-85). The Act, which amended the Federal Food, Drug and Cosmetic Act by creating a new section 417 (21 U.S.C. 350f), required the Secretary of Health and Human Services to establish a mandatory reporting registry for potentially dangerous foods. The stated purpose of the amendment was to provide FDA with “a reliable mechanism to track patterns of adulteration in food.” Implementation of the new law, however, was delayed while the FDA worked on developing an effective electronic reporting system.

Now that the Reportable Food Registry (“RFR”) is up and running, a food company may be required to alert the FDA (through the RFR Portal) within 24 hours of becoming aware it has received, sold or shipped a "reportable food." According to the FDA, a reportable food is defined as any food product that has a “reasonable probability” of causing health problems or death in humans or animals. 

Because reporting is only required under specific circumstances, however, any company uncertian about its reporting duties should seek legal advice to determine the extent and scope of any reporting requirements under the RFR.

For additional information on the registry and reporting obligations, please visit www.fda.gov/ReportableFoodRegistry.

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According to the FDA, Johnny's Fine Foods (of Tacoma, Washington) has announced a precautionary and voluntary recall of various French Dip Powdered Au Jus Products distributed to retail outlets nationwide.

The products subject to the recall include: (1) French Dip Powdered Au Jus in 6oz bottles; and (2) French Dip Powdered Au Jus in 1.1oz foil packets.

The Johnny's French Dip Powdered Au Jus 6oz is packaged in a clear plastic bottle with a red, white and blue label. The expiration date for this product is 0332. The Johnny's French Dip Powdered Au Jus 1.1oz is packaged in a red, white and blue foil packet. The expiration date for this product is 02212. Both of these products had been distributed nationwide and are sold in retail stores. Click on the following link to view a copy of the FDA Recall Release.

The recalled products were made using hydrolyzed vegetable protein manufactured by Basic Food Flavors (located in Las Vegas, Nevada). Basic Food Flavors initiated a recall of the hydrolyzed vegetable protein following discovery of Salmonella contamination during testing. It is also important to note, despite the issuance of a precautionary recall, that to date there have been no reported illnesses associated with the consumption of these products.

According to the company, the recalled products should be discarded. Additionally, consumers with any questions may contact Johnny's Fine Foods at 1-800-962-1462, Monday through Friday (8am to 3pm Pacific Standard Time).

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According to the FDA, Wholesome Spice (of New York) has announced a recall of crushed red pepper because of a potential link to illnesses associated with an ongoing nationwide Salmonella Montevideo Outbreak. As of February 24, there had been as many as 238 individuals from 44 states infected with the outbreak strain.  Click on the following link to view a copy of the most recent CDC Outbreak Report.

Wholesome Spice manufactured and then distributed the crushed red pepper to Daniel International for use in the production of various sausage and salami products which had been previously recalled by Daniel. Click on the following link to view Previous Daniel Recall Updates.  According to reports, a broad investigation into the source of the contamination was ongoing, and FDA recently discovered that samples of Wholesome Spice crushed red pepper had tested positive for the outbreak strain. In response, Wholesome Spice immediately announced a recall of all potentially affected products.

The Wholproducts subject to the recall include all lots of 25 pound boxes of Crushed Red Pepper sold by Wholesome Spice between April 6, 2009 and January 20, 2010.

The Crushed Red Pepper was packaged in a clear plastic bag, which was then placed inside a cardboard box marked with an adhesive white label containing a blue border and blue and black lettering. The brand name on the product labels is WHOLESOME SPICES. The product name is listed as CRUSHED RED PEPPER. The 25 pound boxes of Crushed Red pepper were distributed throughout the Northeastern United States. The product was not sold at the retail level or directly to consumers. Click on the following link to view a copy of the FDA Wholesome Spice Recall Release.

In a separate news release posted on the Rhode Island Department of Health website, David R. Gifford, Rhode Island's health director, noted that the recall “confirms that the source of the Salmonella was from outside of Daniele's manufacturing plants." According to additional reports, Wholesome Spice is currently working closely with FDA to determine how the contamination occurred.

In any event, manufacturers who may have purchased any of the recalled products are being urged not to use the products, and to recall any other products which may have used red pepper as an ingredient. Manufacturers with questions may contact Wholesome Spice via telephone at (718) 388-1549, Monday to Friday between 8:30-4:30pm EST.

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Dr. Elisabeth Hagen has been selected to become the USDA’s newest Under Secretary for Food Safety. If confirmed, Hagen will serve with Agriculture Secretary Tom Vilsack.

"There is no more fundamental function of government than protecting consumers from harm, which is why food safety is one of USDA's top priorities," said Vilsack. " Dr. Hagen brings the background, skills, and vision to lead USDA's efforts to make sure that Americans have access to a safe and healthy food supply."

The Food Safety mission of USDA includes the Food Safety and Inspection Service (FSIS), which is the public health agency in the USDA responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged.

Dr. Elisabeth Hagen currently serves as the USDA's Chief Medical Officer, serving as an advisor to USDA mission areas on a wide range of human health issues. Prior to her current post, she was a senior executive at FSIS, where she played a key role in developing and executing the agency's scientific and public health agendas. She has been instrumental in building relationships and fostering coordination with food safety and public health partners at the federal, state, and local level.

Before joining the federal government in 2006, Hagen taught and practiced medicine in both the private and academic sectors, most recently in Washington, DC. She holds an M.D. from Harvard Medical School, and a B.S. from Saint Joseph's University. Dr. Hagen completed her specialty medical training at the University of Texas Southwestern and the University of Pennsylvania, and is board certified in infectious disease. She is married and lives with her husband and two young children in Northern Virginia.

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When I recently stood in for Mike Taylor as Keynote Speaker at the National Center for Food Safety and Technology annual meeting, I had no idea he would soon become the new Deputy Commissioner for Foods. The FDA created the new position, along with the Office of Foods, in August 2009.

As Deputy Commissioner for Foods, Taylor will help the FDA develop and implement a prevention-based strategy for food safety, plan implementation of new food safety legislation, and help ensure that food labels contain clear and accurate information on nutrition.

Taylor began his career as a staff attorney at FDA, holding various positions including deputy commissioner for policy. Taylor later served as administrator of the Food Safety and Inspection Service and acting under secretary for food safety at USDA. During his tenure, he initiated many reforms, including the development of comprehensive HACCP rules for meat and poultry processors and, through a policy statement, declaring E. coli O157:H7 an adulterant in ground beef.

Prior to becoming a senior FDA advisor in 2009, he served as a research professor at the School of Public Health and Health Services at George Washington University.

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According to the FDA, Bao Ding Seafood of New York has issued a voluntary and precautionary recall of Boiled Horse Mackerel products because they have the potential to be contaminated with clostridium botulinum.

The processed products subject to the recall include Boiled Horse Mackerel packaged in a vacuum packed plastic bag, net weight 450g. The products were sold throughout New York State, and consumers should not use the product even if it does not look or smell spoiled. Click on the following link to view the FDA Recall Release.

The potential problem was discovered during a routine inspection and subsequent analysis of product by food lab personnel, which confirmed that certian fish had not been properly eviscerated prior to processing. To date, no illnesses have been reported in connection with the consumption of these products. Nevertheless, consumers who may have bought the recalled products are being advised to return them to the place of purchase.

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According to the FDA, Willamette Shelling has announced a recall of 114,350 pounds of shelled hazelnuts. To date, additional companies affected by the recall include Willamette Filbert Growers, Kunze Farms, and numerous other distributors and grocers nationwide.

The Willamette Shelling hazelnuts subject to the recall were shelled at a facility (located in Newberg, Oregon) for distribution to numerous down-stream hazelnut processors. Specifically, shelled hazelnuts distributed by the company were sent to various Oregon processors, along with a Canadian processor, and then further distributed by those firms.

All products subject to the initial Willamette Shelling recall were packed in 25 and 50 pound corrugated boxes, and marked with lot code numbers 296091A, 299091A, 300091A, VH3696BO, and 310091A. The corrugated boxes were also marked with the following brand names: Kunze Farms, Evonuk Oregon Hazelnuts, Canadian Hazelnuts, and Firestone Farms. It is important to note, however, that Willamette Shelling unshelled hazelnuts are not affected by this recall. Click on the following link to view a copy of the FDA Recall Releas (Willamette Shelling).

Willamette Shelling announced the recall immediately after learning that routine, random sampling confirmed positive for Salmonella in one of its hazelnut production lots. In turn, in an abundance of caution, and to ensure consumer safety, the company elected to voluntarily recall all shelled hazelnuts processed at its facility between October 12, 2009 and November 25, 2009. Thus, any hazelnut processors who used potentially recalled product are urged to return the product directly to Willamette Shelling.

As noted, the additional following downstream companies affected by the recall included Willamette Filbert Growers (of Newberg, Oregon), Kunze Farms (of Dayton, Oregon), and additional distributors and grocers located in Colorado:

• Contemporaneous with the announcement of the original recall, Willamette Filbert Growers announced its own recall of 29,861 pounds of potentially affected Shelled Hazelnuts and Shelled Organic Hazelnuts. The Willamette Filbert products subject to the recall were packed in 25 pound corrugated boxes, labeled with “Willamette Filbert Growers” or “Meridian Organic Hazelnuts,” and lot code numbers 289091A and 311091A. The hazelnuts were distributed in Oregon and California through wholesale distributors and for direct delivery. Here too, unshelled hazelnuts are not subject to the recall. Click on the following link to view a copy of the FDA Recall Release (Willamette Filbert).

Any customers who may have purchased Willamette Filbert Shelled Hazelnuts or Meridian Organic Hazelnuts are being urged by the company to return the product to the place of purchase for a full refund. Consumers with questions may contact Ben Mitchell at (503) 538-9256.

• Following the original recall announcement by Willamette, Kunze Farms also announced its own recall of 32,950 pounds of potentially affected hazelnut kernels. The Kunze Farms product was packed in 25 pound cartons, under the product brand name of Kunze Farms, ‘Select Shelled Hazelnuts’ Dayton, Oregon, with the code numbers 289091A or 299091A. The hazelnut kernels were distributed to several different processors and wholesaler’s in the following areas: Dayton, Oregon; Milton-Freewater, Oregon; Hauppauge, New York; Mesa, Arizona; Cottonwood, Arizona; Seattle, Washington; Ogden, Utah; San Antonio, Texas.; and Parker, Colorado. Click on the following link to view a copy of the FDA Recall Release (Kunze Farms).

In turn, consumers who may have purchased Kunze hazelnuts affected by the recall are being urged by the company to return the products to the place of purchase for a full refund. Consumers with questions may contact Kurt Kunze at (503) 864-2102.

The Colorado Department of Public Health has also identified additional companies that have been affected by the recall. Click on the following link to view the CDPH Hazelnut Recall Notice.

In Colorado, the recalled hazelnuts were sold by Mountain Man Nuts and Fruits Co. via the Internet, to numerous stores and sales distributors. Additionally, the product was distributed in Colorado to a variety of retail firms for bulk sale, including Whole Food Markets, Ft. Collins Food Co-op, Mountain Mama Natural Foods in Colorado Springs, and Healthy Solutions, in Denver.

All firms receiving recalled product have reportedly been notified, and the product is being pulled from shelves. Currently, the following additional products and lot codes are being recalled:

• Filberts, 289091A, 299091A;

• Natural Mixed Nuts, 32009, 33809;

• Fancy Mixed Nuts, 8- and 16-oz. bags, 30909, 31309, 31709, 32009, 32309, 32909, 33509, 33709 34209, 34309, 34809, 34909 35009;

• Choice Mixed Nuts, 16-oz. bags, 31309, 32709, 33609, 34909;

• Dry Roast Mixed Nuts,16-oz. bags, 30909;

• Sweet Simplicity™ Trail Mix, 32909;

• Mountain Jubilee® Trail Mix, 8- and 16-oz. bags, 31309, 32409, 33709, 34909;

• Cinnamon Almond Appleanche™ Trail Mix, 31009;

• Fancy Mixed Nut Gift Packs, 1.75 lb., all product, except 35009; and

• Fancy Mixed Nut Gift Packs, 1 lb., all product, except 35009.

According to the CDPH, products with these lot codes may also have been used as a component in certian gift baskets, including the 12 Tastes Basket, Bounty Basket and Half-Pound Sample Baskets. Moreover, given the potentially wide distribution of recalled product, additional recalls will likely be announced.

DECEMBER 23, 2009 UPDATE:

In addition to the specific recalls identified above, additional downstream companies have announced or expanded recalls of potentially affected products.  These include the following:

• Evonuk Oregon Hazelnuts:  View the FDA Recall Release.

• Harry and David:  View the FDA Recall Release.

• Whole Foods Market®:  View the FDA Recall Release.

• Burnt Ridge Orchards: View the FDA Recall Release.

• Market of Choice:  View the FDA Recall Release.

• Mountain Man Nut & Fruit Co.®:  View the FDA Recall Release.

Finally, it is important to note that, to date, there have been no reports of illnesses associated with the consumption of these products. Nevertheless, Willamette has ceased production and is working closely with FDA to investigate the issue, and will resume production and shipment  when any potential concerns have been resolved.

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Today, more than 15 percent of the food consumed in the United States is imported from foreign shores.  In turn, more and more cosumers are begining to question what is, and what isn't, being done to ensure the safety of foreign food product imports. 

In response, the Department of Homeland Security ("DHS") recently announced the creation of a new group, called the Import Safety Commercial Targeting and Analysis Center ("CTAC"), designed to enhance federal efforts to ensure the safety of imported foods.

Recommended by President Obama’s Food Safety Working Group, the new center will be staffed with about 30 members, will operate under the direction of Customs and Border Protection ("CBP"), and will receive direct assistance from numerous additional governmental agencies, including the FDA, EPA and CPSC. As one of CBP's six commercial targeting centers in the United States, the CTAC will target shipments of imported cargo, including food, for potential safety violations.

"In addition to guarding against terrorism and crime, securing our borders and facilitating legitimate trade involve ensuring the safety of imported [food] products," said DHS Secretary Napolitano. "This new targeting center will enhance the inspection of goods entering our country by centralizing and strengthening federal efforts to protect U.S. consumers."

Agriculture Secretary Tom Vilsack and HHS Secretary Kathleen Sebelius also backed the initiative. “With so much food coming from abroad, we must do all we can to ensure that it conforms to the same safety standards as our own food safety systems,” said Sebelius. “The new CTAC announced today is an important step toward the type of collaboration necessary to ensure that Americans have access to a safe and healthy food supply,” added Vilsack.

As part of its collaboration with CBP, FSIS will also extend its enforcement efforts to target ineligible imports, and investigate suspicious shipments based on manifest information filed prior to the arrival of goods at U.S. ports.

Ultimately, the new facility, which will be located adjacent to CBP's Office of International Trade in Washington, will strive to enhance the safety of foreign food product imports by promoting the three core principles announced by the Food Safety Working Group: Prevention, Surveillance and Response.

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According to the FDA, Unilever has announced a precautionary and voluntary nationwide recall of all Slim-Fast® ready-to-drink (RTD) products in cans.

The products affected by the recall are packaged in paperboard cartons containing four, six or 12 steel cans that are 11 FL OZ (325 mL) each. Individual cans are also sold in certain retail outlets. The recall involves all Slim-Fast® RTD products in cans, regardless of flavor, Best-By date, lot code or UPC number. Click on the following link to view a List of Recalled Products.

No other Slim-Fast® products, including Slim-Fast® powdered shakes, meal bars or snack bars, have been affected by the recall.

The recall was initiated after the company conducted quality testing on Slim-Fast® RTD products in cans. Because possible issues involving Bacillus cereus, the company announced, in an abundance of caution, a precautionary recall of all RTD products in cans that are currently in distribution centers, on-shelf or in back rooms in retail outlets or in consumers’ homes. Click on the following link to view a copy of the FDA Recall Release.

It is also important to note that, to date, there have been no reports of any illnesses associated with the consumption of these products. And, although Bacillus cereus in some instances can cause diarrhea and nausea, the possibility of serious illness or other significant health consequences is remote. Nevertheless, the company working to identify and correct any potential processing issues, and plans to resume production once they have been fully addressed and corrected.

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According to the FDA, Timco Worldwide Inc. (based in Davis, California) has announced a voluntary recall of a limited number of Large Seedless Watermelons.

The Large Seedless Watermelons affected by the precautionary recall contain the “MelonUp!” sticker label, with a PLU (Price Look Up) # 4032 and UPC # 0 33383 40240 6. The watermelons were distributed to select grocers, wholesalers and processors in California and Texas. Click on the following link to view a copy of the FDA Recall Release.

Timco announced the recall immediately after learning that routine, random sampling by a distribution company confirmed positive for Salmonella. In turn, the company announced, in an abundance of caution, a recall of all potentially affected products.

It is also important to note that, to date, there are no reports of illnesses associated with the consumption of these products. Nevertheless, consumers who may have purchased watermelons in the markets noted above (with the MelonUp! label) are being urged by the company to return them to the place of purchase for a refund. In turn, consumers with questions, or who need additional information, are invited to contact the company at 1-530-757-1000 (press “4” for Food Safety).

As with all fresh fruits and vegetables, Timco also recommends that fresh melons be thoroughly washed and rinsed before cutting and/or consuming them.

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According to the FDA, Five Crowns Marketing (based in Brawley, California) has announced a voluntary and precautionary recall of select cantaloupes packed under the Majesty label.

The cantaloupes affected by the precautionary recall were packed in various sizes with and without individual “Majesty” stickers. All cartons carry the label "Majesty," and are further identified with lot numbers 198 2 or 198 3, and pack dates of Nov 4, Nov 6, and Nov 10. Additionally, the cantaloupes in the identified lots were harvested and shipped to wholesalers, retailers, and food service operators in the states of Alabama, California, Illinois, Michigan, Minnesota, New York, Ohio, Oregon, Pennsylvania, and Tennessee. Click on the following link to view the FDA Recall Release.

Five Crowns Marketing announced the recall immediately after learning that routine testing on a lot of cantaloupes packed on November 4, 2009 confirmed positive for Salmonella. In turn, the company announced, in an abundance of caution, a recall of all cantaloupe from the same lot.

It is also important to note that, to date, there have been no reports of illness associated with the consumption of these products. According to the company, most of the cantaloupes have likely already passed through the distribution chain. Nevertheless, the company continues to work with its customers to ensure that all of the potentially affected cantaloupes have been accounted for.

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An outstanding group of international food safety regulators, academics, industry leaders and top food safety lawyers are gathering in Beijing this week for a 2 day conference on food safety.

The Third Annual China International Food Safety and Quality Conference is designed to provide expert perspective on emerging industry trends impacting foreign food product imports, production and safety.

Speakers include Ge Zhirong, President, China Entry-Exit Inspection and Quarantine Association; Wang Yong, Minister, General Administration for Quality Supervision Inspection & Quarantine; David Tharp, International Association for Food Protection; Michael Pulch, European Commission to China, Bernard Kuhnle, German Federal Ministry of Food, Agriculture and Consumer Protection; Murray Lumpkin, FDA; Robert Charlebois, Canadian Food Inspection Agency; Art Liang, CDC and many, many more.

In turn, I will be speaking this year about the impact of food safety litigation in the United States on foreign food product production, imports and safety. Fellow food safety attorneys Bill Marler and David Ernst will offer additional perspective on food safety litigation at home and abroad.

More, of course, to follow.

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Following recent media coverage involving the regulation of our food supply, Agriculture Secretary Tom Vilsack issued a statement highlighting the continuing efforts of USDA to ensure that our food remains as safe as it can be. Click on the following link to view the USDA Statement.

“Over the last eight months since President Obama took office,” said Vilsack, “the USDA has been aggressive in its efforts to improve food safety, and has been an active partner in establishing and contributing to President Obama's Food Safety Working Group.”

"Protecting public health is the sole mission of the USDA Food Safety and Inspection Service. FSIS has continued to make improvements to reduce the presence of E. coli O157:H7 and the agency is committed to working to reduce the incidence of food-borne illnesses caused by this pathogen.

"Shortly after coming into office, the Administration created a high-level Food Safety Working Group to coordinate food safety policies, focus greater resources on prevention, and improve response to outbreaks. Since doing so, we have taken the following actions:

• Launched an initiative to cut down E. Coli contamination (including in particular contamination from E. Coli O157:H7) and as part of that initiative, stepped-up meat facility inspections involving greater use of sampling to monitor the products going into ground beef;

• Appointed a chief medical officer within USDA's Food Safety Inspection Service to reaffirm its role as a public health agency;

• Issued draft guidelines for industry to further reduce the risk of O157 contamination;

• Started testing additional components of ground beef, including bench trim, and issuing new instructions to our employees asking that they verify that plants follow sanitary practices in processing beef carcasses; and

• Designed the Public Health Information System (PHIS) in response to lessons learned in past outbreaks.

According to Vilsack, "the USDA is also looking at ways to enhance trace back methods and will initiate a rulemaking in the near future to require all grinders, including establishments and retail stores, to keep accurate records of the sources of each lot of ground beef."

"No priority is greater to me than food safety," said Vilsack, "and I am firmly committed to taking the steps necessary to reduce the incidence of food-borne illness and protect the American people from preventable illnesses. We will continue to make improvements to reduce the presence of E. coli 0157:H7."

Because there is no technology (with the exception of irradiation or cooking), however, to ensure that raw animal products can be made sterile, FSIS continues to remind consumers that thoroughly cooking raw animal 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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It's not www.defendingfoodsafety.com.  But, it may be a close second.

Numerous food safety improvement measures have been initiated in the United States this year. One of the latest, unveiled by the FDA, USDA and Department of Health and Human Services, is a food safety website. The website, www.foodsafety.gov will provide a broad variety of information relating to food safety, including recall information and food handling tips. It will include news and information from each of the governmental agencies including FDA, USDA and CDC responsible for overseeing food safety in the United States.

The site, which is described as a gateway to federal food safety information, provides a wide array of information and resources for consumers to utilize. Among the numerous tools available on the site, are food safety educational materials for download, information about pathogens, podcasts and also an “ask a question” link whereby a consumer can receive an answer to a specific question.. The food safety information is broken down by food groups. It is both easily navigable and readily accessible.

According to the Food Safety Working Group, the federal government will continue “to enhance www.foodsafety.gov to better communicate information to the public and include an improved individual alert system allowing consumers to receive food safety information, such as notification of recalls. Agencies will also use social media to expand public communications.”

Future plans include expanding the website to have mobile access and text alerts.

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According to the FDA, Muranaka Farms has announced a voluntary recall of 1005 cases of 60 count bunched Parsley because it has the potential to be contaminated with Salmonella.

The recall was trigged as a result of a voluntary sampling program conducted by the California company in cooperation with the FDA, which revealed that certain finished products could potentially contain the bacteria. Click on the following link to view the FDA Recall Release.

The specific products affected by the recall include 60 count fresh bunched parsley Lot Code 0023909. The products were shipped in a brown wax carton under the Muranaka Label with a parsley silhouette on the side. In turn, individual parsley bunches were banded using a red rubber band. The lot code 0023909 is on a sticker on the outside of the carton.

The affected products were distributed in the following 10 states: Arizona (30 cases), California (574 cases), Colorado (35 cases), Florida (60 Cases), Iowa (3 cases), Illinois (1 case), Missouri (7 cases), Tennessee (5 cases), Texas (278 cases) and Wisconsin (12 cases). These cases were distributed within both retail and foodservice outlets.

Because of Muranaka Farm's trace recall program the company was able to immediately determine which customers purchased the product in question. Muranaka's food safety protocols also ensure the company was able to determine the amount of cases harvested, the crew harvesting the product, and the field on which the parsley was grown and harvested. The company is continuing to work with the FDA to determine a potential cause.

It is also important to note that, to date, there have been no reported illnesses associated with the consumption of these products. Moreover, although the product is over two weeks old, and likely past its useable shelf-life, the company is nevertheless working diligently with customers to ensure that the products are fully accounted for and out of the supply chain.

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The FDA has announced a new tool it believes will help prevent future cases of food-borne illness – the Reportable Food Registry.

In 2007, former President Bush signed into law the Food and Drug Administration Amendments Act (Public Law 110-85). The Act, which amended the Federal Food, Drug and Cosmetic Act by creating a new section 417 (21 U.S.C. 350f), required the Secretary of Health and Human Services to establish a mandatory reporting registry for potentially dangerous foods. The stated purpose of the amendment was to provide FDA with “a reliable mechanism to track patterns of adulteration in food.” Implementation of the new law, however, was delayed while the FDA worked on developing an effective electronic reporting system.

Now that the Reportable Food Registry (“RFR”) is up and running, the mandatory reporting requirements have gone into effect. The new FDA rules apply to any company that is required to submit registration information to the FDA for a food facility “that manufactures, processes, packs, or holds food for human or animal consumption in the United States.” In turn, the rules extend to any food or animal feed regulated by the FDA, except for infant formula and dietary supplements which are covered by other regulatory requirements.

Under the new FDA rules, a food company is now required to alert the FDA – through the RFR Portal – within 24 hours of becoming aware it has sold and shipped a "reportable food." According to the FDA, a reportable food is defined as any food product that has a “reasonable probability” of causing health problems or death in humans or animals.

As explained by the FDA, some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

In turn, once a food company discovers a problem with a product it has shipped, and submits a report through the RFR, it will be required to cooperate with the FDA to help determine the cause and prevent potential health problems. Companies will also be required to notify relevant suppliers and distributors of any potential safety issues, be ready to submit further data and tests to the FDA, and initiate their own investigation if the problem is thought to have originated internally.

Notably, however, the new reporting requirements apply only to products that have been shipped into commerce. For this reason, a food company is not required to report a problem to the FDA if it discovered the problem before a food product was shipped, and then corrected the problem or destroyed the food.

Although Michael Taylor (senior advisor to the FDA commissioner) stated that industry should be able to easily judge when a food product is “reportable” under the new guidelines, the Grocery Manufacturers Association quickly responded raising concerns over what it called “questions and ambiguities” in the registry. In turn, the GMA urged the FDA to remain flexible, and to help work through potential ambiguities, as the new regulations go into effect.

For additional information on the registry and reporting requirements, please visit www.fda.gov/ReportableFoodRegistry

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According to the FDA, Melon Acres has announced a voluntary and precautionary recall of cantaloupes because they may have the potential to be contaminated with Salmonella.

The cantaloupes affected by the voluntary recall were distributed through Farm-Wey Produce (of Lakeland, Florida) between August 13 and 14, 2009. The cantaloupes, identified as 41 MG 10, Bin Numbers 4753-4980, were shipped to Aldi's in Greenwood, Indiana and to Meijer in Lansing, Michigan, Newport, Michigan, and Tipp City, Ohio. Click on the following link to view the FDA Recall Release.

The recall was issued following routine testing by the FDA on Tuesday, August 11, 2009, which revealed that a single sample (from twenty cantaloupes taken by the Agency) tested positive for Salmonella. The FDA reported the positive test to Melon Acres on Friday, August 21, 2009.

In turn, the FDA and Melon Acres worked together to identify the field in which the positive sample was grown. According to the company, no further shipments will be made from the source field. Additionally, on August 7, 2009, Primus Labs, a third party food safety auditing firm specializing in produce, inspected Melon Acres' fields and facilities regarding its food safety practices. Melon Acres received grades of excellent/good respectively, in this audit.

It is also important to note that, to date, there have been no reported of illnesses associated with the consumption of these products. Further, the company wishes to assure the public that stringent Food Safety Programs are in place at its shipping locations and fields, and is working closely with the FDA to identify the potential source of contamination.

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According to the FDA, Quesos Mi Pueblito has announced a voluntary recall of certian cheese products because they may have the potential to be contaminated with Listeria monocytogenes. Click on the following link to view the FDA Recall Reslease.

The specific products affected by the recall, with "sell by dates" from February 2, 2009 to the present, are as follows:

• LA FE OAXACA STRING CHEESE: [USP: 0 23545 40115 6] 14 oz. pack (plastic package);

• EL VIEJITO OAXACA CHEESE: [USP: 7 18122 18071 4] 14 oz. pack, 10 lb. ball (plastic package);

• MI PUEBLITO COTIJA/AñEJO: [USP: 0 24077 10221 4] vacuum packed in plastic wrap by specific weight (plastic wrapped);

• MI PUEBLITO CUAJADA FRESCA: [USP: 0 24077 10216 0] 14 oz. pack (plastic wrapped);

• MI PUEBLITO QUESO COLOMBIANO DE ARRIERO: [USP: 0 24077 10219] 1 / 8 oz. pack (plastic package);

• MI PUEBLITO QUESO MOLIDO: [USP: 0 24077 10211 5] 14 oz. pack (plastic package);

• MI PUEBLITO QUESO COTIJA TRIANGULO: [USP: 0 24077 10220 7] 14 oz. pack (plastic package);

• MI PUEBLITO QUESO FRESCO: [USP: 0 24077 100258] 14 oz. pack, 10 lb. ball (plastic package);

• MI PUEBLITO QUESO FRESCO DE RANCHO: [USP: 0 24077 10215 3] 14 oz. pack (plastic clam shell container, plastic wrap);

• MI PUEBLITO QUESO CASERO: [USP: 0 24077 10222 1] 14 oz. pack (plastic clam shell container, plastic wrap);

• MI PUEBLITO QUESO OAXACA: [USP: 0 24077 10224 5] 14 oz. pack (plastic package);

• MI PUEBLITO REQUESON: [USP: 0 24077 10200 9] 15 oz. pack (plastic package); and

• MI PUEBLITO SERRANO: [USP: 0 24007 10200 0] 16 oz. pack (plastic package).

The recalled products (produced by the company in Passaic, New Jersey) were distributed through Puebla Foods, Inc. to retail stores and wholesalers in New Jersey, New York, Maryland, Delaware, and Virginia. Click on the following link to view the affected Product Labels. The potential problem was discovered through routine sampling and analyses conducted by the New Jersey Department of Health.

It is also important to note that, to date, no illnesses have been associated with the consumption of these products. Nevertheless, consumers who have purchased these products are urged to return them to the place of purchase for a full refund.

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According to the FDA, SUPERVALU has announced a voluntarily recall of frozen Culinary Circle Gourmet Macaroni and Cheese products because they may have the potential to be contaminated with listeria monocytogenes.

The products affected by the recall include Culinary Circle Gourmet Macaroni and Cheese (a frozen product) sold in 38 oz. packages with a UPC# of 41130 38704. The products were sold at numerous SUPERVALU-owned stores including Acme, Albertsons, biggs, Cub Foods, Farm Fresh, Hornbacher’s, Jewel-Osco, Lucky, Shaw’s/Star Market, Shop ‘n Save, and Shoppers Food & Pharmacy. Click on the link to view the FDA Recall Release.

It is important to note that there have been no reported illnesses associated with the consumption of these products. Rather, the possibility for contamination was identified through routine microbiological sampling at the manufacturing facility.

In turn, because the safety of its customers is a top priority of the company, SUPERVALUE has elected, in an abundance of caution, to issue a precautionary and voluntary recall of these products.  Health officials also remind consumers that thoroughly cooking all raw foods will typically destroy any pathogens that may be present, and render such products safe

Customers who have purchased the affected product can bring it back to their SUPERVALU-owned store for a full refund or exchange.

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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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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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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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Defending food-borne illness cases throughout the country, we understand better than anyone the uncertianty surrounding recent reports that raw Nestle cookie dough may be the source of an ongoing nationwide E. coli O157:H7 outbreak. Although, historically, E. coli has been linked to outbreaks involving water, spinach, lettuce, alfalfa sprouts, fruit juices, salami, cheese, and raw (or, undercooked) meat, cookie dough has never been implicated.

Nevertheless, since March 2009, federal and state investigators have been attempting to identify the likely source of a nationwide E. coli outbreak which has affected about 66 people in 28 states. To date, about 25 individuals have been hospitalized.

Although the true source of the ongoing outbreak remains uncertain, health officials recently announced that a number of cases associated with the outbreak reportedly consumed raw Nestle Toll House cookie dough prior to the onset of their illnesses.

In Colorado, for example, of five cases recently linked to the nationwide outbreak, four reported eating raw cookie dough. Nevertheless, although such reports may suggest an association with a particular food, epidemiology alone (without the added benefit of microbiological confirmation in an implicated product) is often insufficient to determine the cause of an outbreak. For this reason, Alicia Cronquist, an epidemiologist with the Colorado Department of Health (“CDH”), stated further that, although we want consumers to be aware, "[w]e can't be certain that raw cookie dough is the source of these infections." Click on the following link to view the CDH Press Release.

Despite lingering uncertainty, these reports prompted an immediate response from Nestle. Noting that the safety of consumers is paramount, and although E. coli has not been isolated from any of its products, the company elected, in an abundance of caution, to issue an immediate, voluntary and precautionary nationwide recall of refrigerated Nestlé Toll House cookie dough products. In turn, Nestle spokeswoman Roz O'Hearn confirmed that "this has been a very quickly moving situation." O'Hearn highlighted further that, after learning of a potential problem, "the company took action in less than 24 hours." Click on the following link to view the Nestle Press Release.

Thus, as the investigation continues, both Nestle and health officials have asked consumers not to eat prepackaged refrigerated cookie dough. The precautionary recall includes refrigerated cookie bar dough, cookie dough tub, cookie dough tubes, limited edition cookie dough items, seasonal cookie dough and Ultimates cookie bar dough. It does not, however, affect any other Toll House products. Click on the following link to view the FDA Recall Release (and list of affected products).

While Nestle is working closely with the FDA to determine whether any of its products are indeed implicated, the Minnesota Department of Health (“MDH”) is testing products collected from retail stores and from ill consumers' homes. Currently, the MDH is investigating six cases with onset dates between May 3 and June 11. Click on the following link to view the MDH News Release.

Finally, it should be noted that, regardless of the ultimate source of the outbreak, consumers should never eat raw cookie dough. According to Carlota Medus, an epidemiologist with the MDH, “cookie dough, whether purchased in a tub from the store, or made at home from scratch, should not be eaten raw.”  This, of course, is because many raw products can potentially carry pathogens that might cause illness if improperly handled and prepared.  This is also why the labels on raw cookie dough clearly state that the products should always be baked before consumption.  When properly handled and prepared (and cooked to an internal temperature of at least 165 degrees), cookies make from raw dough are perfectly safe for consumption.

In any event, the safety and quality of its products, says Nestle, is a non-negotiable priority. For this reason, the company has apologized for any inconvenience caused by the precautionary recall.

And, until a source is conclusively determined, we of course will continue to provide updates on the continuing investigation.

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Following recent increases in public and media attention focused on food-borne illness, outbreaks and recalls, the House Energy and Commerce Committee has approved the Food Safety Enhancement Act of 2009. The proposed legislation is designed to enhance FDA food safety-related authority. 

The bill, H.R. 2749, passed the committee unanimously with an amendment that would exempt food production facilities and products regulated exclusively by the Federal Meat Inspection Act, the Poultry Products Inspection Act or the Egg Products Inspection Act.  The bipartisan bill, spearheaded by Chairman Henry Waxman (D-CA) and Chairman Emeritus John Dingell (D-MI), has received support from a broad coalition of consumer and public health organizations.

According to reports, the full House is expected to vote on the bill prior to the July 4 recess. Click on the following link to view a copy of the proposed legislation, as amended. If enacted, the bill would give the FDA new authority to create robust food safety standards, to establish rules for enhancing traceability, to increase inspections at high-risk facilities, to mandate food product recalls, and to enforce new penalties for violations of federal food safety requirements.

The legislation would also increase FDA funding to facilitate these efforts by requiring food companies to pay new annual registration fees of $500.

Although proposed food safety initiatives are also planned for debate in the U.S. Senate, these efforts, reportedly, may be stalled as a result of ongoing legislative efforts associated with proposed health care reform.

In any event, we’ll continue to report as the debate continues.

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Chang Farm, a Massachusetts company, has issued a voluntary recall of various bean and soy sprouts because of possible Listeria monocytogenes contamination. The sprouts were distributed to restaurants and retail stores throughout Connecticut, Massachusetts, New York, and New Jersey. Click on the following link to view the FDA Recall Notice.

According to the FDA, the contamination was discovered after a product sample (obtained from a retail store in New York) tested positive for Listeria. To date, no illnesses have been associated with the recalled sprouts.

The affected products, labeled as Chang Farm Brand soy sprouts and bean sprouts, are packaged in 10-pound bags (bulk) and 12-ounce plastic bags (retail). The soy sprouts have a “Sell By” date of May 23, 2009 or May 24, 2009, and the bean sprouts have a “Use By” date of May 23, 2009 or May 24, 2009.

All grocery stores, food services, and other retailers in Massachusetts, Connecticut, New York, and New Jersey are being advised to remove the recalled products from their shelves. In turn, consumers should either discard the products, or return them to the place of purchase.

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The House Energy and Commerce Committee has released a discussion draft of the Food Safety Enhancement Act of 2009 which, if passed, would require food manufacturers to pay an annual fee of $1,000 to fund increased inspections by the FDA.

Under the draft bill, high-risk food production facilities would be inspected by the FDA every 6 to 18 months, while low-risk facilities would be inspected every 18 months to three years. In addition to the annual inspection fee, the legislation would also require food manufacturers to pay for costs associated with any additional inspections triggered by food product recalls.  Click on the following link to view a Summary of the Food Safety Enhancement Act of 2009.

The chairman of the House committee, Rep. Henry Waxman (D-Cal.), stated that the proposed legislation is aimed at protecting the nation's food supply. According to Waxman, the new bill “recognizes that the hallmark of strong food safety legislation must be a shared responsibility for food safety oversight between FDA and industry.”

Although food manufacturers are not currently required to pay FDA inspection fees, current budget requests for the FDA include $260 million in new food safety initiatives, with about 35% of that anticipated to come from fees paid for directly by the food industry. While food industry groups strongly support the broad goals of the new proposed food safety measures, questions have been raised about the timing of new fees. According to industry representatives, new inspection fees are being proposed at a particularly bad time, given the slowing economy, for both food companies and consumers alike.

Among other things, the proposed legislation would also require food manufacturers to better trace the food they manufacture abd sell, and would give the FDA authority to issue mandatory recalls. The bill, if passed, would also strengthen criminal and civil penalties for any food companies that fail to comply with federal regulations.

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The U.S. Senate has officially confirmed Dr. Margaret Hamburg to lead the Food and Drug Administration (“FDA”). Hamburg, a bioterrorism expert, will be sworn in as the 21st commissioner of the FDA, and only the second woman to hold the post in 100 years of agency history. She was confirmed unanimously.

Hamburg’s first priority will be to help direct the development of a vaccine for the H1N1 flu. Notably, Hamburg has, in turn, promised to place greater emphasis on food safety. In the midst of numerous high-profile food-borne illness outbreaks, Hamburg stated she intends to shift the agency’s focus from chasing outbreaks once they occur to preventing them in the first instance. To accomplish this goal, Hamburg would also like to take advantage of the recent spike in food safety awareness by media, consumers and industry. As she puts it, “the growing consensus among experts and industry is that now is the time to shift to a food safety system that puts prevention first.”

We, of course, wish her the best as we all work, collectively, to enhance food safety.

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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 to help modernize our food safety system. The group intends to foster “collaborative partnerships with consumers, industry and regulatory partners” and, through a transparent process, “build a food safety system to meet the challenges posed by a global food supply in the 21st century.” Click on the following link to visit the President’s Food Safety Working Group Website.

Last week, the Food Safety Working Group held its first “Listening Session” at the White House. Participants included numerous stakeholders representing a diverse range of organizations. Secretary of Agriculture Vilsack, who delivered the opening remarks, told participants that food Safety is of the highest concern for all of us. Although Vilsack noted that “Americans enjoy one of the safest food supplies in the world,” he also stated that more can should be done to improve food safety at all levels. Vilsack’s remarks are included below:

Welcome. Thank you for taking time to join us this morning.

Food Safety is of the highest concern for all of us here today. While Americans enjoy one of the safest food supplies in the world, we have witnessed too many outbreaks that make us worry that the food on our dinner plate or in our child’s lunch box will harm instead of nourish. This is not acceptable.

Today is the beginning of a significant and critical process that will fully review the safety of our nation’s food supply.

President Obama has pledged his full support in this matter and has charged the Food Safety Working Group with examining all aspects of food safety, be it meat or produce, fresh or frozen, whether it is imported, or produced domestically.

This issue will be one of USDA’s highest priorities. We are in the midst of reviewing all of our statutory authorities, as well as administrative and regulatory steps we can take, to ensure that our actions support public health and consumer safety to the fullest extent.

We have reviewed the Federal Meat Inspection Act, looked over our existing Hazard Analysis and Critical Control Point regulations, reviewed our enforcement authorities, and looked at how we collect data. While we are doing a good job, we at USDA can always do better.

I’d like to outline several specific challenges we need your input on:

•  Prevention. The key to a functioning food safety system is preventing foodborne illness. That means robust standards and sufficient authorities to prevent illnesses from occurring. Both FDA and USDA have embraced this principle and we must have a consistent approach.

•  Surveillance and Response. Our regulatory agencies must actively watch for disease outbreaks and take rapid action to ensure that we have effective and targeted recalls. Such recalls are in the interests of public health and the strength of industry sectors that might otherwise be tarnished by massive recalls.

•  As many people know first hand, in this economy we do not have unlimited resources. Nor can we simply pass higher food production costs onto struggling consumers. We must ensure that we are allocating our food safety resources effectively and efficiently. That means focusing the most attention on the products that have the most potential to cause harm.

•  The safety of a product should not be determined by where it originated. We live in a global community and by working more closely with our partners around the world we can make sure that the food the US is importing is as safe as the food we are exporting.

 •  All parts of the food safety system need to coordinate and work together in a seamless fashion. The FDA and USDA must do a better job of coordinating and I know that Secretary Sebelius and I will drive our agencies to improve coordination.

•  Industry, government, and consumer: each of us brings a piece of the puzzle. We can only solve this if all pieces are represented. It is time for us to set aside past frustrations, collaborate, and move forward together.

Finally, we need to develop a way to measure our success. I am confident that by working together, we will make improvements to the safety of our food supply. But we need a way to track our progress both in the short and long term, so that we do not settle for merely okay, but continually strive for improvement. Lives are at stake and good is simply not good enough.

Thank you again for joining us today.

The Secretary also thanked the participants’ mutual commitment to food safety, highlighted the Administration’s broad support for the modernization of food safety initiatives, and pointed to new and enhanced coordination between HHS and USDA to support this goal.

ViIsack also challenged government, industry and consumers to work more closely to improve food safety. This is good advice.

In the end, we all shoulder responsibility (whether producing or preparing food) to ensure that the meals we serve to our families are, indeed, as safe as they can possibly be.

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The Grocery Manufacturers Association ("GMA") has announced new, wide-ranging industry initiatives designed to improve the safety and security of our nation’s food supply. The initiatives, geared toward better food-borne illness prevention and response, are outlined in Prevention, Partnership and Planning: Supply Chain Initiatives to Improve Food Safety. The new initiatives include:

• Product Recall Modernization: 

Enhanced communication is the best way to ensure that food products, when recalls are announced, can be identified and removed from the marketplace as quickly as possible. Thus, the Food Marketing Institute ("FMI") and GS1-US, with the support of GMA, have developed and launched a new, electronic, Web-based product recall portal designed to facilitate the rapid and accurate flow of information between manufacturers and retailers during product recalls. GMA plans to participate closely with FMI and GS1-US to expand the use and capability of this recall communication tool.

• Accredited Third Party Food Safety Audit Certification:

Third party audits are an important part of America’s food safety net. To ensure rigor and integrity in third party certification, policymakers and industry leaders will be encouraged to engage auditors employed by certification bodies accredited to international standards by recognized organizations such as the American National Standards Institute ("ANSI"). ANSI is widely respected as the recognized accrediting body for conformity assessment systems in the U.S., and is recognized by the federal government as well as internationally.

In addition, GMA plans to work with its public and private partners, including FMI, to facilitate the implementation and recognition of certification systems. By increasing the number of well-qualified auditors, and developing universal food safety auditing criteria, industry leaders and policymakers will likely be better able to ensure that auditors are competent to review a particular facility. This should also discourage duplicative audits, reduce auditing costs, and encourage wider use of third party certification/audits throughout the food industry. Ultimately, it is anticipated that wider use of third party certification/audits can and will reduce the risk of food-borne illnesses.

• Modernization and Implementation of Good Manufacturing Practices (GMPs) for Food:

The FDA is currently working on updating and issuing Good Manufacturing Practices (GMP) regulations for food, which can be a critical component of any food safety system. Once the FDA regulations are updated and issued, GMA plans to provide industry-wide training and education to ensure rapid and wide-spread adoption of the new and updated GMPs.

According to Pamela G. Bailey, GMA president and CEO, “[w]e want consumers and policymakers to know that we are vigilant when it comes to product safety and consumer protection. We are stepping up to the plate, taking responsibility and developing innovative reforms to improve the safety of our products.” Bailey hopes the initiatives, coupled with proposed FDA food safety reforms, “will significantly reduce the number and type of food recalls, and strengthen our overall food safety system.”

In addition, explains Bailey, “we are developing enhanced food safety education and training for member and non-member companies, assessing and enhancing our crisis management capability, and expanding our ability to communicate during product recalls to ensure we are doing our part to protect consumers.”

Thus, once again, GMA has demonstrated its commitment as a food safety leader, working closely with stakeholders from the entire supply chain to develop comprehensive food safety solutions that will not only improve the safety of our food, but will also enhance the confidence of our consumers.

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As the FDA works to protect and promote the public health, it is requesting $3.2 billion as part of it's fiscal year (FY) 2010 budget. The request represents a 19% increase over the current FDA budget. Click on the following link to view a summary of the FDA Proposed Budget.

Notably, the FDA has asked for an additional $259.3 million to fund a new food safety initiative. The goal of the new initiative, “Protecting America’s Food Supply,” is to better prevent intentional and unintentional contamination of foods through risk-based prevention and verification. The initiative, as proposed, would focus on foreign and domestic sources of ingredients, components, and finished products at all points in the supply chain.

In addition, the FDA also proposes to collect a total of $94.4 million in new user fees from the registration of food facilities. It is anticipated that the additional fees will enable the FDA increase routine inspections, while at the same time conducting additional inspection for those facilities that fail to meet the FDA’s safety standards.

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The source of the multi-state Salmonella Outbreak linked to fresh alfalfa sprouts has likely been determined.

According to reports, the Salmonella strain implicated in the outbreak likely originated from seeds sold by the Caudill Seed Company of Louisville, Kentucky. In turn, Lyle Orwig, a company spokesman, stated that the offending seeds were imported by Caudill from Italy. As reported previously, Caudill has withdrawn all seed batches with six-digit lot numbers starting with “032”; the recalled seeds are packaged in 50-pound white bags marked with a white or yellow label.

Although testing did not reveal any Salmonella at Caudill’s facilities, Orwig reports that, “what [the FDA] has said to us, is the cases all led to sprouts, from multiple growers, and the common link is seeds.”  Seeds, anyway, from Italy...
 

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Working closely with the FDA, KLEEN-PAK FOODS refined its spinach recall, originally announced yesterday, to include spinach products distributed to Minnesota. The precautionary recall was announced following the discovery of Salmonella in limited product samples during routine testing.

The precautionary recall involves 10 ounce and 1 pound packages of fresh spinach distributed in retail stores and food wholesalers in Wisconsin, the Chicago area, and Minnesota. The products are marked with a use by date of 4/29, 4/30, and 5/01.

No illnesses have been reported, and KLEEN-PAK is continuing to work closely with the FDA to determine the original source of the potential contamination.

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As pistachio recalls continue to expand, Setton Pistachio of Terra Bella, Inc. (“Setton”) has issued a clarification to wholesale customers regarding the identification codes for wholesale bulk pistachio products originally recalled on April 6, 2009. The clarification does not concern product codes on retail products sold to consumers (search for recalled products using the FDA Pistachio Recall database found on the left-hand side of our blog).

The April 6 voluntary recall included all roasted shelled pistachios and roasted in-shell pistachios from the 2008 crop (and a small amount from the 2007 crop that was packaged alongside the 2008 crop) due to potential contamination with Salmonella. The recall also included raw shelled pistachios from the 2008 crop (and a small amount from the 2007 crop that was packaged alongside the 2008 crop) that were not subsequently roasted prior to retail sale. Setton’s raw in-shell pistachio shipments were NOT affected by the recall.

For bulk packages received by wholesale customers, products with either "7" or "8" as the 4th digit of the FMO number, and packaged between Julian dates 245 through 366 and 001 through 084 and shipped after September 1, 2008, are included in the recall. Thus, wholesale customers should check their stocks to determine if they have any of the affected products on hand.

If wholesale customers do have products covered by the April 6 recall, they should discontinue distributing them and contact the Company at (559) 535-6050 to make arrangements for the return or appropriate destruction of the affected products. If recalled products were distributed to other firms that further mixed, repackaged or distributed the bulk products, those customers should be informed of the recall, and should be directed to contact the FDA.

A list of pistachio products NOT affected by the ongoing recalls can be found at www.pistachiorecall.org.

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The answer, I suppose, depends upon who you ask.

With increased population, improved governmental outbreak surveillance, expanding media coverage, more public awareness, better attentiveness by healthcare professionals and increased frequency (along with substantial improvements) in testing, we might be justified to expect that the numbers of confirmed food-borne illnesses would be climbing like an uncontrolled fever. Nevertheless, according to a recent report issued by the CDC, the incidence of food-borne illnesses over the last three years has actually hit a “plateau.”

The findings are from 2008 data reported by FoodNet, a collaborative project of CDC, FSIS, the FDA and 10 separate states. Click on the following link for a copy of the CDC Report. According to CDC findings, incidence rates in 2008 for Campylobacter, Listeria, E. coli O157:H7, Salmonella, Shigella and other pathogens did not change significantly when compared to the previous three years (2005-2007). Moreover, significant declines since 1996 were reported in the incidence rates involving numerous, other food-borne infections.

Despite these findings, Robert Tauxe, deputy director of CDC's Division of Food-borne, Bacterial and Mycotic Diseases, suggested that we may have “reached a plateau in the prevention of food-borne disease.” In turn, David Goldman, assistant administrator of FSIS, indicated he was “concerned about the lack of progress in reducing the incidence of food-borne illness."  Click on the following link to learn how food-borne illnesses are tracked.

Has prevention really hit a plateau? Or, could the total number of illnesses be falling? Despite dozens of feverish outbreaks (and thousands of reported illnesses) recently associated with a long list of previously never-mentioned foods (such as produce, pot pies and peanut butter), the numbers of most food-borne illnesses (according to the CDC) have been holding firm. Although it might be easy to interpret such studies at face value, the real answer (lurking somewhere in the report’s constituent ingredients) might be far more complex.

Many will admit that, in years past, given considerable limitations in surveillance, testing and reporting, a large percentage of total illnesses simply went unreported. Given better public awareness and recent strides in our ability to detect and identify a greater number of food-borne illnesses and outbreaks, the lack of any perceivable increase in the CDC numbers could actually – in my humble view – represent a decline in total cases.

So, are food-borne illnesses declining, increasing or holding firm? While I doubt (and, there is no evidence) that the incidence rates for food-borne illness are on the rise, there are plenty of reasons to believe that we may have started – at the very least – to get this fever under control.

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Nuts. Following one of the largest food recalls in history (involving peanut products distributed by PCA), the pattern may be repeating. Setton Pistachio of Terra Bella, Inc. (in California), is expanding its earlier recall of 2,000,000 pounds of pistachios to include ALL pistachios produced in 2008.

That’s a lot of pistachios. Setton, reportedly, is the second largest pistachio distributor in the nation.

As the FDA and the California Department of Public Health continue to investigate Salmonella contamination in pistachios, Setton voluntarily expanded its March 30, 2008 recall to include all lots of roasted in-shell pistachios and roasted shelled pistachios produced from nuts harvested in 2008. The Company is also recalling all raw shelled pistachios from the 2008 crop that are not subsequently roasted prior to retail sale.

Because the pistachios were sold to numerous downstream customers, and used as ingredients in a wide variety of foods, the expanded recall will likely affect many additional products, and is expected to result in numerous additional recalls. Click on the following link for a searchable database of recalled products. This database is updated continuously by the FDA, and will likely grow as potentially affected products are identified and new recalls are announced.

In the meantime, the FDA is advising wholesalers, retailers, restaurants and food service establishments not to sell or serve any pistachios (or pistachio-containing products) until the original source of the pistachios can be determined. Companies should check with their suppliers to determine whether the source of the pistachios is Setton. Additionally, consumers should not eat pistachios or food products containing them (such as pistachio bakery goods and pistachio ice cream) until they determine that the products are not affected by the recall. Visit the following link for a list of those products NOT believed to be affected by the current recalls.

As noted, the recalls triggered earlier this year by investigations into PCA were some of the largest in history. Thousands of products and hundreds of companies were affected. In turn, as the current pistachio investigation continues, we will wait patiently to see whether, and to what extent, pistachios can distinguish (or, at the very least, unstick) themselves from peanut butter . . . 

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Food safety has long been a battle fought on multiple fronts. Once again, the principle proves true. As we continue to report on the absence of effective food safety laws abroad, our colleagues here at home are working feverishly to improve the effectiveness and efficiency of our own food safety system.

Is it possible, some ask, that all federal food safety responsibilities might be integrated into a single food safety agency? Although not likely in the very short-term, it would seem, at the very least, that the table is being set. As the search continues for new solutions to new food safety challenges, Trust for America's Health, along with the Robert Wood Johnson Foundation, released a report advocating significant changes to our national food safety system. The report, Keeping America's Food Safe: A Blueprint for Fixing the Food Safety System at the U.S. Department of Health and Human Services, outlines various weaknesses in the current system, and proposes, among other things, numerous improvements to the food safety functions of the  Department of Health and Human Services (“HHS”). In essence, the report advocates (as a first step) the creation of a new, stand-alone food agency within HHS.

Currently, the Food and Drug Administration (“FDA”), an agency within HHS, has responsibility for regulating the safety of drugs, medical devices and many foods. Although the United States Department of Agriculture, through its Food Safety and Inspection Service (“FSIS”), is responsibile for all meat, poultry and egg products sold in interstate commerce, the FDA regulates the safety of virtually all other foods (Learn how our food is currently regulated). To view the current, rather confusing, organizational structure of the FDA, click on the following link :

To increase efficiency (and decrease confusion), the new report urges Congress to quickly create a stand-alone Food Safety Administration (“FSA”) within HHS. Conceptually, the proposal would effectively split the FDA into two seperate agencies, each operating on the same plane - one devoted to food and the other devoted to drugs and medical devices. While the FSA would be responsible for regulating food safety, the drug and device sections of the FDA would become a separate agency called the “Federal Drug and Device Administration.” According to the report, a stand-alone food agency would fix the following key weaknesses under the current  structure:

• Inadequate leadership, prioritization, and coordination within FDA: No FDA official whose full-time job is food safety has line authority over all food safety functions. FDA's three major food safety components are managed separately, hampering efforts to effectively prevent disease outbreaks.

• Inadequate technologies and inspection practices: Current laws and practices are antiquated. Existing laws date back to 1906 and 1938, and policies are disproportionately focused on monitoring food after it has been produced, instead of trying to prevent and detect problems throughout the entire production process. And, there is no system in place to keep inspection practices up-to-date with the constantly modernizing food production technologies and practices.

• Inadequate staffing and resources: The FDA's Science Board found the agency is chronically underfunded. While the U.S. Government Accountability Office reports the turnover rate in FDA science staff in key areas, including food safety, is twice that of other government agencies.

• Inadequate inspection of imports (my favorite): Only one percent of imported foods are currently inspected, even though approximately 60 percent of fresh fruits and vegetables and 75 percent of seafood Americans consume is imported.

A stand-alone food safety agency such as the FSA would also, according to the report's authors, result in integrated and accountable senior leadership, integrated public health and science functions, and integrated compliance and enforcement programs. Click here (or on the picture to the right) to view the proposed organizational structure of a new FSA.  Ultimately, according to Risa Lavizzo-Mourey, president and CEO of RWJF, the proposal contained within the report is needed to ensure that "food safety [becomes] a priority on the prevention menu." 

Notably, in addition to the significant proposed changes to the fundamental structure of FDA, the report advocates (as a second step) potential future changes to FSIS and other agencies as well. Although FSIS in the short-term would likey continue to operate within the USDA as a separate agency, the report ultimately recommends that all current federal food safety functions (including FSIS responsibilities) should eventually be integrated into a single food safety agency. Thus, although the proposed immediate changes to the FDA will likely garner the most attention as the report is studied and considered, pointed advocacy for a single food safety administration (for all federal food regulatory functions) will likely follow.

In any event, as part of its vision, the report also recommends that a spot at the table be cleared (assuming a new food safety agency is created) for a single Food Safety Czar. We, of course, will wait for a response from Congress and the Obama Administration before we offer our comments on potential candidates . . .

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As industry continues to announce recalls of peanut butter products affected by the ongoing Salmonella Typhimurium outbreak, Congressman Waxman held hearings focused on shortcomings in the third-party food safety audits perfomed on behalf of the Peanut Corporation of America (“PCA”). The hearings were triggered after the American Institute of Baking (“AIB”), a private auditing company hired by PCA, was accused of failing to identify various sanitary problems during food safety audits of PCA's facility. Click on the link to view a copy of Congressman Waxman's Opening Remarks.

On March 5, 2009, Michael Moss and Andrew Martin of the New York Times were the first to critique the AIB audits in their article, “Food Safety Problems Slip Past Private Inspectors.” We similarly reported about various inconsistencies found in AIB's reports involving PCA’s plants. On March 27, 2008, for instance, an AIB Food Safety Audit gave PCA credit for developing and implementing a HACCP program “for all processes and product lines.” On April 29, 2008, however, a NSF Cook & Thurber Audit found “[no] documented . . . Hazard Analysis for each of the process steps.”

During the hearings, held by the House Energy and Commerce Subcommittee on Oversight and Investigations, it was also revealed that at least one food company, Nestle USA, used its own inspectors to audit PCA’s facilities. Following a 2002 Nestle Audit, the company concluded that PCA failed to meet its minimum requirements for suppliers. In turn, Nestle elected not to purchase peanut butter products from PCA. In a separate 2006 Nestle Audit of PCA’s Plainview, Texas facility, the company once again concluded that PCA failed to satisfy its food safety standards. While Nestle’s own audits identified numerous key food safety and sanitary issues in this facility, AIB in 2008 awarded PCA a certificate for "superior quality” following its own audit of the plant:

As we reported previously, PCA voluntarily closed its Plainview facility in February 2009 (only months after this certificate was issued), after governmental investigators discovered numerous sanitary issues existing in the plant. As a result of its own, continuing investigation, Texas health officials eventually ordered a recall of all products ever produced at the facility since it opened in March 2005.  Click on the link to view photos of the insanitary conditions of PCA's facilities.

Many companies that purchased peanut butter from PCA, of course, relied upon the inspections and conclusions of auditors like AIB. Kellogg, one of the companies which relied upon such third-party reports, lost $70 million after having to recall millions of packages of peanut butter crackers manufactured using PCA raw materials. In turn, David Mackay, Kellogg’s chief executive officer, recently joined the growing ranks of responsible food companies seeking tighter food safety laws.  Click on the link to view a copy of Mackay's Statement.  Also providing statements were Martin Kanan (President and CEO of Kanan Enterprises, Inc. d/b/a King Nut), and Heather Isely (Vice President of Vitamin Cottage Natural Foods).  On January 6, 2009, Salmonella was isolated from King Nut peanut butter manufactured using raw materials from PCA's Blakely, Georgia facility.  As recalls of King Nut peanut butter were announced, the source of the pathogen was quickly traced to PCA.  In turn, Vitamin Cottage peanut butter products, made from raw materials from PCA's Plainview, Texas facility, were also found to contain Salmonella.

During testimony today, the committee also released numerous emails exchange before and during the ongoing recalls. In one email, written before the source of the outbreak was identified, Pete Hatfield (an AIB Auditor) tells Sammy Lightsey (a PCA plant manager) that he’s “lucky” Hatfield is performing his annual food safety audit. Click on the link to view the Lightsey email.

In a second email, written as the source of the emerging outbreak was discovered, Stewart Parnell (the President of PCA) tells Joe Valenza (the Vice President of King Nut) that he “[was] sure it's something we did." Recognizing that recalls could not be avoided, Parnell concludes: "now my heart is really in my throat.  I think I'm going to church tonight." Click on the link to view the Parnell email.

In the third email, written as hundreds of recalls had already been announced, NSF representatives discuss the concerns raised by the AIB audits, the lack of micro data made available by PCA to auditors, and the potential implications for third-party auditing firms. Click on the link to view the NSF / Slawinski email.

Debate has begun and will surely continue regarding the quality of third-party food safety audits. Although most audits are valuable, and play an important role in our food safety system, we trust that, moving forward, all auditors, and the companies that rely upon their conclusions, will not repeat the mistakes of a select few.

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Over the last decade, there have been numerous attempts to reform our food safety laws. As our ability to identify food-borne illnesses and outbreaks continues to improve (special thanks to the CDC, PulseNet and OutbreakNet), at least some weaknesses that were rarely, if ever, considered are now being found. Thus, although most meals consumed in this country remain perfectly safe, the recent peanut butter recalls have those advocating the need for additional checks and balances, at least for certain segments of industry, finding growing support.

Prompted by the recent recalls, lawmakers have proposed revised food safety legislation – the new FDA Food Safety Modernization Act -- which would give the FDA additional resources to more closely regulate food safety. The bipartisan bill was sponsored by Senators Dick Durbin (D-Ill.), Judd Gregg (R-N.H.), Ted Kennedy (D-Mass.) and Richard Burr (R-N.C.). A parallel bill, the Safe Food Enforcement, Assessment, Standards and Targeting Act of 2009, was also introduced in the House. The new legislation proposes to increase the frequency of inspections at food facilities, give the FDA expanded access to company records and testing results, and allow the FDA to mandate recalls if a food company fails to follow the agency's recommendations. As reported and summarized by Janie Gabbett, from Meatingplace.com, the new bill will specifically:

• Require all food production facilities to implement preventive plans to address hazards and prevent adulteration, and give the FDA access to the plans and relevant documentation;

• Expand the FDA’s access to records in a food emergency;

• Allow the FDA to recognize laboratory accreditation bodies to ensure food testing labs meet high quality standards, and to require test results to be reported to the FDA;

• Allow the FDA to enable qualified third-parties to certify that foreign food facilities comply with U.S. food safety standards;

• Require importers to verify the safety of foreign suppliers and imported food;

• Allow the FDA to require certification for high-risk foods, and to deny entry to any food that lacks certification;

• Increase FDA inspections at all food facilities, including annual inspections of high-risk facilities, and inspections of other facilities at least once every four years;

• Enhance food-borne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on food-borne illnesses;

• Require the Secretary of HHS to establish a pilot project to test and evaluate new methods for rapidly and effectively tracking/tracing fruits and vegetables in the event of a food-borne illness outbreak;

• Give the FDA the authority to order a mandatory recall of a food product when a company fails to voluntarily recall the product upon the FDA's request;

• Empower the FDA to suspend a food facility's registration if there is a reasonable probability that food from the facility could cause serious adverse health consequences or death;

• Direct the FDA to help food companies protect their products from intentional contamination, and rapidly respond to food emergencies;

• Increase funding for the FDA's food safety activities through increased appropriations and fees for domestic and foreign facilities.

In addition to receiving bipartisan support, many food companies and industry organizations have voiced support for the bill as well. Vocal supporters include General Mills, Kraft Foods and Kellogg's, along with the Grocery Manufacturers Association, the National Restaurant Association and the Produce Marketing Association. As reported by FoodNavigator-USA.com, Kirstie Foster, spokesperson for General Mills, stated:

“We are strong advocates for food safety system modernization and reform. Ensuring food safety is the highest priority of our industry. We support reform that includes both greater authority and greater resources to strengthen our ability to prevent and respond to food safety issues.”

In turn, Kraft spokesperson Susan Davison agreed, indicating that “the proposed legislation will make significant improvements . . .” Such comments were also echoed by the GMA, in a statement issued by president and CEO Pamela Bailey:

“Ensuring the safety of our products is the food industry’s most important priority... In particular, GMA supports proposals requiring all food companies to have a comprehensive food safety plan in place. It is absolutely critical that manufacturers take a preventative approach in identifying and evaluating potential hazards, and building food safety into the manufacturing process from the very beginning.”

Finally, according to Supermarketnews.com, Tom O’Brien, a representative for the PMA, also expressed support:

“I think the bills, if they get enacted, will restore consumer confidence in FDA, which in turn restores confidence in the food supply. They modernize FDA’s authorities, and they tell it that they should regulate based on the risk of any particular commodity. Those are very important things that we look for in legislation.”

Although the proposed legislation, if passed, would likely strengthen what already is a robust food safety system, there is unfortunately no solution that can completely eradicate food-borne illness. Like the common cold, flu and other ailments, illness occurs because microscopic pathogens exist in our world and can very easily contaminate our environment, our bodies and our food. Even if present in only small amounts that avoid detection, these organisms can eventually grow and multiply to levels that cause illness (whether introduced at a production facility or anywhere in the distribution chain). Moreover, despite continued best efforts to test for and find these pathogens, nature will continue to do its best to avoid being caught. Thus, although the proposed legislation will not eradicate illness, we are hopeful the new initiatives will, at the very least, help us more proactively identify and solve potential problems before they occur. 

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As fallout continues from the peanut butter recalls originally announced in early January 2009 by the Peanut Corporation of America ("PCA"), some have wondered why the original Salmonella outbreak investigation took so long, and why recalls are still continuing. Unfortunately, most food-borne outbreaks take weeks (and, sometimes months) to identify because of the complexity of the issues involved. Incubation periods (the delay between food consumption and symptom onset) can range from hours to many weeks depending upon the pathogen at issue (Learn about common pathogen incubation periods). Once a pathogen has been isolated from a patient, additional time is needed to perform genetic testing on the samples to determine whether other cases are potentially linked. In turn, if numerous cases are identified and a food-borne illness investigation is initiated, additional days or weeks can be added as state and local health officials attempt to identify a single food (or other) source that is common to all the cases (Learn how food-borne illnesses and outbreaks are investigated and tracked).

This process, of course, becomes exceeding difficult in outbreaks involving common foods – or, as demonstrated in the Salmonella peanut butter outbreak, foods that used the same raw materials but do not appear on their face to have any link (i.e., ice cream, candies, granola bars and even dog biscuits). Thus, although the ongoing salmonella outbreak took significant time to identify, hats off to the CDC and FDA for being able to conclusively establish a common source. Click on the following link to download a PDF of the FDA’s Salmonella outbreak investigation timeline:

After illnesses are reported and confirmed, a common source is found, and recalls are initiated, investigators and industry must then work to remove all potentially implicated product from distribution. Here too, this process becomes extremely difficult when a recalled product is used as a raw material in countless common foods. In this outbreak, the process was confounded further because what began as a recall from a single facility (and involving product produced during a relatively limited period of time) quickly morphed into a recall involving years of production from multiple plants. Following the expended recall at PCA’s Blakely, Georgia production facility (involving all products produced at the plant since January 1, 2007) and the subsequent recall from PCA’s Plainview, Texas facility (involving all products produced at the facility since it opened in March 2005), FDA and industry alike quickly found themselves overwhelmed with the task of determining what downstream food products might potentially be implicated. Click on the link below to download a PDF of the FDA’s “simplified” PCA peanut product distribution flowchart:

As demonstrated by the FDA timeline and distribution chart, investigating the outbreak, and coordinating what will likely be remembered as one of the largest recalls in history, proved extremely complex. To date, more than 2,700 consumer products have been affected, and the recalls are continuing (search for affected food products using the FDA Recall Interface located on the left-hand column of our blog).  Thus, despite the overwhelming frustration experienced by FDA, industry and consumers as a result of the ongoing outbreak, investigation and recalls, we once again express our gratitude to all of those working tirelessly to bring this matter to its closure.

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As recalls continue following the discovery in early January 2009 of Salmonella Typhimurium in peanut butter produced by the Peanut Corporation of America (“PCA”) in Blakely, Georgia, the Texas Department of State Health Services (“TDSHS”) has now confirmed that Salmonella was also isolated from peanut meal produced at PCA’s Plainview, Texas facility. Doug McBride, a spokesman for the TDSHS, also confirmed that the sample was the same strain as the ongoing nationwide outbreak.

PCA voluntarily closed its Plainview facility weeks ago, after a private lab sample showed likely Salmonella contamination. Soon thereafter, Texas health officials ordered a recall of all products ever produced at the facility since its opening in March, 2005.

As we reported earlier, the Colorado Department of Public Health and Environment had previously linked as many as six illnesses (that were associated with the national outbreak) to products distributed from PCA's Plainview facility. Additionally, an open container of Vitamin Cottage fresh ground peanut butter, made from raw materials produced at the Texas plant, had previously tested positive for the outbreak strain as well.

PCA also recently announced, in its latest Press Release, that because of continuing bankruptcy proceedings, it is no longer able to communicate with customers of recalled products. As a result, PCA customers should contact FDA Recall Coordinators regarding the proper disposition of any recalled products.

To date, over 2,600 consumer products have been affected by the continuing recalls. The national outbreak is believed to have sickened over 650 people in 45 states, and is suspected of contributing to as many as nine deaths. For the latest information, visit the FDA Peanut Butter Recall Website.  We, of course, will continue to report additional developments as well.

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As the CDC outbreak investigation continues, and thousands of products are recalled, reported cases are on the decline. 

In early January 2009, the CDC and public health officials determined that peanut butter products were the likely source of the ongoing national Salmonella Typhimurium outbreak. Product testing eventually prompted recalls of various peanut butter products produced by the Peanut Corporation of America (“PCA”). Crisis management efforts, at all levels, then began in earnest.  On January 28, 2009, PCA recalled all peanuts, peanut meal, peanut paste and peanut butter, distributed from its Blakely, Georgia facility since January 1, 2007. Following additional governmental investigations, PCA also recalled all products, including peanut meal, granulated peanuts and dry roasted peanuts, produced and distributed from its Plainview, Texas facility since the plant opened in March 2005.

PRODUCTS AFFECTED:

Although the majority of products produced by PCA were not distributed for direct consumer sale, most products were distributed to downstream manufacturers for use as ingredients in many other products. As a result, the PCA recalls prompted hundreds of these manufacturers to recall their own products as well. Given the expansive scope of the recalls, and diverse use of PCA’s products as raw materials in many consumer foods, the FDA and industry are continuing their efforts - even to this day - to determine what additional products might potentially be affected. So far, more than 2,000 consumer products have been recalled. To find products affected, use the searchable FDA Recall Interface on our blog (just scroll down the left-hand column).

PRODUCTS NOT AFFECTED:

According to the CDC, major national brands of jarred peanut butter found in grocery stores are NOT affected by the recall. As we reported previously, Girl Scout Cookies are also Not affected. For a list of additional products not affected by the ongoing recalls, please visit the American Peanut Council Website.

CDC INVESTIGATIVE UPDATES:

The following are highlights from the CDC’s most recent investigation update:

• Case count is 642 in 44 states with latest confirmed, most recent reported illness beginning on January 28, 2009;

• Although the outbreak is continuing, the numbers of new cases have declined modestly since December. Many recently ill persons report eating peanut butter and other recalled peanut-containing products; and

• Consumers should continue to check at home for recalled peanut butter containing products, and discard them.

As noted, as of February 15, 2009, 642 persons believed to be infected with the outbreak strain have been reported from 44 states. The number of ill persons identified in each state is as follows: Alabama (2), Arizona (13), Arkansas (6), California (76), Colorado (15), Connecticut (10), Florida (1), Georgia (6), Hawaii (4), Idaho (16), Illinois (9), Indiana (9), Iowa (3), Kansas (2), Kentucky (3), Maine (5), Maryland (8), Massachusetts (48), Michigan (35), Minnesota (39), Missouri (14), Mississippi (7), Nebraska (1), New Hampshire (13), New Jersey (23), New York (28), Nevada (6), North Carolina (6), North Dakota (17), Ohio (94), Oklahoma (4), Oregon (12), Pennsylvania (19), Rhode Island (4), South Dakota (4), Tennessee (13), Texas (9), Utah (6), Vermont (4), Virginia (21), Washington (18), West Virginia (2), Wisconsin (5), and Wyoming (2). Additionally, one ill person was reported from Canada (learn how food-borne illness outbreaks are tracked).

Oregon public health officials also recently confirmed, in a press release, that the ongoing outbreak may have also affected some pets. One laboratory-confirmed case of Salmonella in a dog from an Oregon household was reported, and further characterization of this Salmonella isolate is pending. Salmonella resembling the outbreak strain was also reportedly isolated by a private laboratory from recalled Happy Tails dog biscuits from the dog’s household. 

We, of course, will continue to report new developments.

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Agriculture Secretary Tom Vilsack recently announced that, despite previous opposition, he now favors combining the food safety functions of the United States Department of Agriculture (“USDA”) and Food and Drug Administration (“FDA”) into a single food safety agency. Currently, the USDA through it’s Food Safety and Inspection Service (“FSIS”) is responsible for regulating the safety of meat, poultry and egg products. In turn, the FDA has responsibility for most other foods. In his recent comments, Vilsack also stated that he has not yet decided whether a single agency would be best located within the FSIS, the FDA or an independent agency.

As debate continues about merging the food safety responsibilities of the USDA and FDA, Janie Gabbett (from Meatingplace.com) reported that the majority of industry participants in an online survey favored combining the food safety regulatory functions of the USDA and FDA, but only one in five believed that such a merger would result in improved food safety.

Of 289 readers who responded to the survey, 58 percent agreed the two agency functions should be combined, while 42 opposed a merger. When respondents were asked if they thought that a merger of the two agencies would improve food safety, 50 percent believed that food safety would remain unchanged, while 30 percent believed that the quality of food regulation could actually decline.

According to the survey, participants were more concerned with deficiencies in FDA regulation than in FSIS protocols. Namely, this is because, unlike the FDA, FSIS inspectors currently maintain a continuous, on-site presence in meat packing facilities, and also regularly test meat and poultry products for harmful pathogens. As a result, several respondents also concluded that if the agencies were to merge, the FDA would need to become more like FSIS, and not the other way around.

Other suggestions from survey participants included:

• Providing better technology and tools for inspectors;

• Increased laboratory testing;

• Imposing fines on plants with repeated serious violations;

• Requiring all food establishments to adopt and implement Hazard Analysis and Critical Control Point (“HACCP”) plans;

• Requiring all food establishments to adopt and implement sanitation standard operating procedures (“SSOPs”);

• Continuing to improve risk-based analysis of food safety systems in plants;

• Targeting high-risk foods (under FDA jurisdiction) and moving toward to the USDA model of inspection;

• Providing better training for inspectors; and

• Funding additional research to improve food safety.

According to Gabbett, many respondents also believed that, even with a single food safety agency, increasing the funding and number of federal inspectors would likely be needed to improve the effectiveness of regulations. According to one respondent, "simply merging two departments and changing their names . . . won't affect food safety." Rather, "there would need to be fundamental changes at the plant inspection level to actually make a difference."

Currently, the United States is the only industrial nation to have two separate federal food safety regulatory systems. Moving forward, we'll continue to post on emerging developments.

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As many as six cases associated with the ongoing Salmonella outbreak may have been traced to products produced at PCA's Plainview, Texas production facility. According to the Colorado Department of Public Health and Environment, these individuals reported exposure to peanut butter distributed by the Lakewood-based Vitamin Cottage. In turn, an open container of Vitamin Cottage fresh ground peanut butter, made from peanuts distributed from the Texas facility, tested positive for the outbreak strain of Salmonella. Because the container was opened, however, it is not yet known if the peanut butter was potentially contaminated at the Texas facility, or if the product was cross-contaminated with the outbreak strain after distribution (learn how food-borne illnesses and outbreaks are tracked). Vitamin Cottage, in a Recall Notice, announced last week that it was recalling these products.

It is estimated that, since opening in March 2005, PCA's Plainview, Texas facility produced and distributed about one-third of the volume of products that were distributed from the company's Blakely, Georgia plant.  Although Salmonella has not yet been isolated from any non-opened products distributed from the Plainview facility, it has been reported that truck loads of raw peanuts from PCA's Georgia facility were previously sent to the Texas plant.  Currently, the FDA is still waiting on lab confirmation from numerous product and environmental samples taken from the facility determine the extent, if any, of potential contamination. 

In addition to operating plants in Georgia and Texas, PCA also operated a facility in Virginia. The FDA has completed a comprehensive inspection of the Virginia plant, and has reported that all lab results were negative for Salmonella. Although PCA closed this facility following its bankruptcy announcement on February 13, 2009, the FDA has not taken any action against the Virginia plant or any of the products produced there.

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On Monday, February 9, 2009, the Plainview Peanut Co., a subsidiary of Peanut Corporation of America (“PCA”), voluntarily halted operations at its Plainview, Texas production facility pending the resolution of continuing governmental investigations.

On Thursday, February 12, 2009, the Texas Department of State Health Services announced, in a News Release, that it has ordered a recall of all products ever produced at the facility. The order followed the discovery of various sanitary issues identified in the plant.  The following day, on Friday, February 13, 2009, PCA formally declared bankruptcy.

The newest recall follows PCA's announcement, on January 28, 2009, that it was recalling all peanuts, peanut meal, peanut paste and peanut butter, distributed from it's Blakely, Georgia facility since January 2007.  PCA has now recalled all products, including peanut meal, granulated peanuts and dry roasted peanuts, produced and distributed from the Plainview, Texas facility since March 2005.   

Earlier, investigators reported that the Plainview facility had been operating for years without any inspections or licensure from the state. As the FBI continues its criminal probe into PCA's operations, we will continue to report new developments.  

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In the coming months, the FDA will likely begin requiring food manufacturers that obtain positive test results from product samples to report such findings to the agency. Although the new rules will likely have a significant impact on industry as adjustments are made to ensure compliance, the rules (once implemented) would likely add an additional layer of safety to our food regulatory system.

In 2007, former President Bush signed into law the Food and Drug Administration Amendments Act (Public Law 110-85). The Act, which amended the Federal Food, Drug and Cosmetic Act by creating a new section 417 (21 U.S.C. 350f), required the Secretary of Health and Human Services, no later than September 27, 2008, to establish a Reportable Food Registry. The stated purpose of the amendment was “to provide a reliable mechanism to track patterns of adulteration in food [which] would support efforts by the FDA to [better] target [its] limited inspection resources.” Implementation of the new law, along with its mandatory reporting requirements, however, has been delayed while the FDA continues to develop an effective electronic reporting system.

In its current form, the new food registry will apply to food manufacturers, and will define “reportable foods” as any article of food (other than infant formula) found to contain harmful pathogens, “for which there is a reasonable probability that the use of, or exposure to, such of food will cause serious adverse health consequences or death to humans or animals.” 21.U.S.C. 350f. If a food sample tests positive for any pathogen considered an adulterant for the particular food at issue, manufacturers would be required, within 24 hours, to submit an electronic report to the agency.

Currently, the FDA anticipates that the registry (and the associated reporting requirements) will likely go into effect sometime later this spring.  We, of course, will keep you posted.

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The salmonella peanut butter recall, which is still expanding, will likely be remembered as one of the largest in history.  On January 28, 2009, the Peanut Corporation of America ("PCA") announced a recall of all peanuts (dry and oil roasted), peanut meal, peanut paste and peanut butter that had been produced at its Blakely, Georgia facility since January 1, 2007.  Although none of the products involved in the expanded recall were distributed for direct consumer sale, the products were supplied to downstream manufacturers for use as ingredients in many other foods. To date, more than 1,500 consumer products have been recalled, and hundreds of companies (including manufacturers, distributors, grocers and retailers) have been directly impacted.  Find products affected by the ongoing recall using the searcheable FDA Recall Interface. (just scroll down the left-hand column of our blog). We will continue to keep the interface, which is updated coninuously, running until the outbreak has concluded and recalls have been closed. 

As you may recall, the salmonella outbreak was first identified by the CDC in late 2008.  On January 13, 2009, following the discovery of salmonella in its products, PCA announced the initial recall of peanut butter and peanut paste. On January 28, 2009, following an extensive governmental investigation into the manufacturing procedures utilized by the company, PCA expanded the recall to include all peanuts (dry and oil roasted), peanut meal, peanut paste and peanut butter produced at the facility since January 1, 2007. 

Given the expansive scope of the recall, and diverse use of PCA’s products as raw materials in many consumer foods, the FDA is continuing to work closely with industry to determine what additional products might potentially be affected. As continuing recalls are announced, the searchable interface will be updated automatically. 

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According to reports, Congress will likely hold public hearings on the ongoing salmonella outbreak and recalls.  Representative Henry Waxman (D-California) stated recently that the hearings, anticipated within the coming weeks, will likely focus on the Blakely, Georgia facility owned and operated by the Peanut Corporation of America (“PCA”).

As the FDA continues its investigation into the ongoing outbreak, early reports have suggested that salmonella was isolated, on various dates in 2007 and 2008 from certain PCA products, by private labs PCA employed for routine testing. These reports have also indicated, however, that subsequent testing resulted in negative findings.  Because the specific protocols followed by PCA and the labs in question (along with the specific circumstances surrounding the sampling and testing of such products) are not yet fully understood, all parties will need to wait for the investigation to be completed before any final conclusions can be made regarding the ultimate merits or implications of these reports.  Additional information may also be learned from the proposed hearings, during which it is anticipated that representatives of PCA and the laboratories in question may be called to testify.

On Wednesday, January 28, 2009, PCA expanded its initial recalls (announced on January 13, 2009 and January 18, 2009 respectively) to include additional products produced at the facility since January 1, 2007 (see our reports below).  For continuing updates regarding the growing list of products affected by the expanded recall, please visit the FDA Peanut Butter Recall Website.  The American Peanut Council has also published a list of products reportedly not affected by the ongoing recalls.

To date, more than 500 people may have become sick, and as many as eight people may have died, in connection with the ongoing outbreak.  Although most of these illnesses are presumed to be associated with peanut butter, not all cases may be directly linked.  Early reports have indicated that at least one person from Wyoming (who was carrying the outbreak strain) did not appear to have any known exposure to peanut butter products.

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The Peanut Corporation of America (PCA), in a press release, has announced an expanded recall of peanut butter products produced at its Blakely, Georgia facility. The expanded recall covers products produced at the facility since January 1, 2007 (the previous recalls only involved peanut butter and peanut paste products distributed from the facility since July 1, 2008).  In addition to peanut butter and peanut paste, the expanded recall includes all peanuts (dry roasted and oil roasted), granulated peanuts, peanut meal and similar products.

PCA reports that, although none of the products involved in the expanded recall were distributed for direct consumer sale, the products were distributed to downstream manufacturers for use as ingredients in many other products.  Amended lists of products potentially affected by the expanded recall have not yet been released, and will likely be announced in the coming days. 

For more information on recent developments associated with the ongoing recalls, please visit our Food Recall Tracker, or the FDA Peanut Butter Recall Website.

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As we continue to comment on food safety litigation avoidance and crisis management, several food industry groups on Friday, in letters to Congress, urged House and Senate leaders to quickly enact enhanced food safety reforms.  The letters announced that, although “Americans continue to enjoy the safest food supplies in the world, . . . new challenges require Congress and the Administration to modernize our food safety net.”  In turn, industry groups urged lawmakers to move forward on the following FDA proposals, originally announced in 2007, as part of the FDA’s Food Protection Plan:

• Require Domestic Food Safety Plans:  As proposed, the initiatives would require domestic food producers to affirmatively identify potential food safety risks associated with production methods and products, identify and implement enhanced production or other controls, and prepare formalized food safety plans (for FDA review) addressing such risks;

• Require Foreign Food Safety Plans:  Adoption of the pending initiatives would also empower the FDA to assist foreign governments seeking to adopt robust food safety regulations, and require foreign food product importers to better police foreign suppliers. The initiatives would also, in part, require domestic foreign food product importers to document food safety controls being implemented by foreign suppliers, and require such records to be available for FDA review; and

• Adopt A More Robust Risk-based Approach to Inspections:  As proposed, the initiatives would also enable the FDA to increase food safety inspections for those facilities and products (both foreign and domestic) that pose, based upon science and risk-based studies, the greatest risk of potential contamination.

In addition to encouraging a more robust food safety inspection system for domestic and foreign products, the letters also urged Congress to better enhance the safety of fruits and vegetables by establishing uniform standards for high-risk products.  In addition, the letters addressed the FDA’s continuing request for mandatory recall authority, which would be available to the agency in those rare circumstances where companies refused, following FDA recommendations, to initiate recalls voluntarily.

The letters were undersigned by numerous industry organizations, including the Grocery Manufacturers Association, the Food Marketing Institute, the American Frozen Food Institute, the International Bottled Water Association, the International Dairy Foods Association, the National Fisheries Institute, the National Restaurant Association, the Retail Industry Leaders Association, the Snack Food Association and the United Fresh Produce Association.  According to Pamela Bailey, President and CEO of the Grocery Manufacturers Association, improved food safety tools would ultimately enable us to better “maintain our position of global leadership and assure consumer confidence.”

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For nearly a decade, our food safety team has worked closely with food companies managing outbreaks and defending claims.  In most cases, outbreaks and recalls can be effectively managed by working closely with governmental agencies to gain a complete picture of an ongoing investigation, while at the same time encouraging investigators to freely and rapidly share developing information 

Unfortunately, however, accurate information regarding the potential sources or scope of an outbreak can sometimes be extremely difficult for companies to obtain.  This is because, once illnesses are identified, the CDC and FDA (along with state and local health departments) are the only entities who have real time access (via PulseNet and OutbreakNet) to the most current and important information regarding the developing outbreak. 

As a result, until developing outbreak information is actually shared by investigative agencies, food companies in the supply chain often have no idea what specific upstream companies, suppliers, product lines and/or lots might potentially be implicated in the ongoing investigation.  This is especially true when multiple companies are involved in the production of a product, and where lots are, in some instances, defined by hours or days.   In turn, most companies must wait for information to be shared by governmental investigators before even becoming aware that their products might potentially be involved - let alone to be in a position to determine whether to issue a precautionary recall of select foods.  This is also why, in our view, it is extremely important for consumers and industry alike to understand fully how food-borne illnesses and outbreaks are identified and tracked.

In the current salmonella outbreak investigation, these efforts, of course, are continuing.  Since our last update, an additional six companies have announced precautionary and voluntary recalls of select products manufactured with raw materials potentially associated with the current outbreak.  These companies include Landies Candies (select peanut butter filled chocolates), Lovin Oven (certain Peanut Crunch Chewy Granola Bars), Best Brands Corp. (peanut butter frozen cookie dough), Aspen Hills (certain cookie dough products), Nash Finch (select bakery products), and Chef Jay's Food Products (select peanut butter bars, cookies and brownies).  In turn, following the expanded recall by the South Bend Chocolate Company (which included various candies containing peanut butter), the Rain Creek Baking Corporation announced a voluntary and precautionary product withdrawal of select Peanut Butter Turtles, Baskets and Princesses. 

Although the CDC reports that it is still working to determine whether any additional food products might be affected, it confirms (as we reported previously) that these and other product manufacturers are working very closely with the agency to identify the existence and scope of any additional potentially affected foods.  We appreciate their joint and continuing efforts.  We also, of course, will continue to report as additional news develops.

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While the USDA and FSIS work hard to protect our meat and poultry supply, the FDA works to ensure that the remaining 78 percent of domestic and imported food remains safe.

Although the FSIS maintains a continuous presence in most meat and poultry plants, the FDA typically only visits food processing facilities once a year. Following a number of highly publicized recalls, however, some began suggesting that the FDA should follow the USDA model, requiring more regulation and a more visible federal presence within FDA-regulated food processing facilities. Thus, the question was called: Would the FDA become more like the USDA?

Maybe just a little. In November 2007, the FDA unveiled a new initiative, called the "Food Protection Plan." The plan avowed three “core elements” - prevention, intervention and response - to better ensure a safer quality of food for all Americans (FDA, “Food Protection Plan: One-Year Progress Summary”). While, as part of these efforts the FDA asked Congress for additional regulatory authority, including new mandatory recall powers, most agree it would be far too impractical, expensive and imprudent to demand or even require a significant increase in domestic inspection. In June, for instance, the Government Accountability Office actually condemned the plan for “failing to provide details on the costs or specific strategies.”

In any event, within the coming months, we will see where these efforts lead. Personally, I expect the FDA’s regulatory control to grow significantly in the coming years (resulting, for instance, in the implementation of a mandated HACCP-based system for many new categories of foods). Thus, although it remains unlikely in the near term that federal inspectors will be physically “moving in” to your food production facility (as occurs in slaughter establishments), you may nevertheless find them knocking on your door more often, at the very least, to critique your HACCP plan.

Stay tuned for new developments.

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• Return to Defending Claims.

Defending a food-borne illness claim requires a thorough understanding of how our food is regulated.  Because many governmental agencies (both state federal) play a role in the regulation of virtually all of the foods we eat, it is critical in every case to understand: (1) the role of each regulatory agency in the production of the food at issue; and (2) the specific laws, regulations and rules that apply to the particular product.  Although the history of federal oversight over our food supply is quite long and storied, the following discussion summarizes generally the progression and current status of the federal regulation governing the food we eat.

At the dawn of the last Century, our nation, through advances in science and technology, began to gradually understand the processes through which we could make food more accessible. Due to the emergence of rapid transnational shipping, improved preservation techniques and the ability of media to reach an increasing number of consumers, the food industry revolutionized. For the first time, food processors could viably ship perishable products anywhere in the nation.

As interstate shipment of food began to increase, however, food safety regulations were inadequate. In the absence of a federal approach (there had not yet been a need) America’s food laws were implemented primarily at the state and local level. As can be expected within a growing nation, industrial advances were quickly outpacing limited state and local regulations. In the meat industry, in particular, laws defining what constituted “adulteration” or “misbranding” were determined, if at all, by each individual state. Moreover, what was forbidden in one state was entirely lawful in another. This hodgepodge of inconsistent regulation soon inspired concerned citizens, consumer groups and social reformers to voice their concerns. Without a national approach to food safety (and a single set of rules), American citizens in the various States had no confidence in the origins or safety of the food they were eating.

During this period, technological advances outside of the food industry were also instrumental to inspiring incredible change. The emergence of inexpensive newspapers that reached across the nation gave individuals and consumer groups greater opportunity to voice their concerns. Social reformers, who otherwise would have remained unheard, could now reach a broad audience. The most famous example, of course, was Upton Sinclair. In his 1906 novel, The Jungle, Sinclair described the unsanitary conditions prevalent in large slaughter plants. The book described unwholesome carcasses being processed for use in food, processing taking place in unhealthy conditions, and meat and other food products coming into contact with contaminants present in the plants. Such conditions outraged the public, and the growing demand for change soon became too loud for Congress to ignore. Inspired by this national chorus, the federal government realized that a uniform food safety policy (i.e., a single set of rules) was essential to protect both the national economy and the health of American citizens.

The federal approach to food safety was, for all practical purposes, solidified in 1906, when the United States Congress passed the Wholesome Meat Act and the Pure Food and Drugs Act. These Acts (along with their successors) formed the framework for the national food safety policy that continues to exist to this day.

The 1906 Wholesome Meat Act (now known as the Federal Meat Inspection Act, 21 U.S.C. § 601, et seq.) was originally enacted in response to The Jungle. With the sweep of a pen, the federal legislation required continuous federal inspection within meat packing plants to ensure that all meat products sold in interstate commerce would be: (1) produced under sanitary conditions; (2) not adulterated; and (3) properly labeled. Today, the Federal Meat Inspection Act (“FMIA”) is enforced by the Food Safety Inspection Service (“FSIS”), an agency falling within the jurisdiction of the United States Department of Agriculture (“USDA”). In meat packing plants, the FMIA continues to require continuous, on-site inspection of the entire slaughter and processing process. In addition to its inspection responsibilities, the USDA also closely regulates product labeling. Over the decades, USDA’s authority has expanded to oversee poultry production under the Poultry Products Inspection Act (21 U.S.C. § 451, et seq.) and egg production under the Egg Products Inspection Act (21 U.S.C. § 1031, et seq).

Like the FMIA, the original Pure Food and Drug Act was also enacted in response to social pressure. While the Wholesome Meat Act was designed to oversee the production of meat, the Pure Food and Drug Act was created to increase confidence in many other foods. Here too, Congress was inspired to action following a number of well-publicized scandals involving the food industry, including one where American soldiers serving in the Spanish-American war were allegedly sickened by embalmed foods. Additionally, with advances in chemistry, it was becoming more common for business to use various additives to preserve foods. These activities, of course, also triggered additional debates involving the merits of substitute foods, such as margarine for butter, and the use of questionable “ingredients” such as coal tar, borax, and various food colors. In response, the 1906 Pure Food and Drugs Act, as originally enacted, forbade adulteration and misbranding of foods in interstate commerce. This Act was amended several times before being replaced in 1938 by the more stringent Federal Food, Drug and Cosmetic Act (“FDCA”). 21 U.S.C. § 301 et seq. Today, the FDCA is enforced by the Federal Food and Drug Administration (“FDA”), an agency falling under the jurisdiction of the Department of Health and Human Services (“DHHS”). Currently, the FDA has jurisdiction over approximately 78 percent of the domestic and imported foods sold in interstate commerce, and seeks to ensure that such products are safe, nutritious, wholesome, and adequately labeled. Although the FDA, unlike FSIS, does not provide continuous inspection in food processing facilities, it has jurisdiction (and conducts periodic inspections) where food is processed, packaged, stored and sold.

Although the USDA and the FDA share most of the regulatory responsibility for food safety in America, the following additional federal agencies are also responsible for food safety as part of their federal mandate:

• The Centers for Disease Control and Prevention (“CDC”), within the DHHS, gathers data on food-borne illnesses, investigates food-borne illness outbreaks, and monitors the effectiveness of numerous prevention and control initiatives. As part of these efforts, CDC also helps state and local epidemiologists (and state health laboratories) identify and prevent food-borne illness and other outbreaks. The CDC engages in these activities under the general authority of the Public Health Service Act. 42 U.S.C. § 201, et seq.

• The Environmental Protection Agency (“EPA”) protects the nation’s water supply by setting standards for drinking water under the Safe Drinking Water Act. 42 U.S.C. § 300g, et seq. The EPA also regulates pesticide products and establishes tolerances for residues on various food commodities and animal feed. The EPA operates under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”), 7 U.S.C. § 136, et seq., and the FDCA.

• The Animal and Plant Health Inspection Service (“APHIS”) is another agency which falls within the USDA umbrella. The APHIS is responsible for administering various federal laws and regulations to enhance the health and care of animals and plants. The APHIS assists with food safety on a national level by coordinating needed research and other efforts to protect the industry against pathogens or diseases that are a risk to humans.

• The Grain Inspection, Packers and Stockyards Administration (“GIPSA”) is another agency, within the USDA, which helps establish quality standards for food products. The GIPSA also coordinates a national inspection system for grain and related products (and reports its findings to the FDA) to ensure compliance with the FDCA, the United States Grain Standards Act, 7 U.S.C. § 71, et seq., and the Agricultural Marketing Act (“AMA”) 12 U.S.C. § 1141, et seq.

• The Agricultural Marketing Service (“AMS”), another agency within the USDA, is responsible for establishing quality and grading standards for various dairy, egg, fruit, meat, poultry, seafood and vegetable products. As part of the grading process, the AMS considers various safety factors, such as the cleanliness of the product. The AMS operates programs under a number of federal laws relating to food safety, including the AMA and the EPIA.

• National Marine Fisheries Service (“NMFS”), an agency within the United States Department of Commerce, administers voluntary seafood quality inspection programs. In addition to the inspection and certification of fish products for human consumption, the NMFS also provides inspection of animal feeds and pet foods derived from fish products. The NMFS operates under the AMA and the Federal Fish and Wildlife Act. 16 U.S.C. §742, et seq.

• The Federal Trade Commission (“FTC”) enforces the Federal Trade Commission Act, 15 U.S.C. § 41, et seq., which prohibits unfair or deceptive practices. The FTC’s food safety objective is to prevent the dissemination of false advertising which has the purpose of inducing the purchase of food.

Improving food safety is and always will be a scientific endeavor. As such, it will be important for our government to remain flexible as new technologies emerge and discoveries are made. The federal government understands this, and is constantly working to improve and enhance existing capabilities. The federal government expends vast resources in the fields of applied research and risk assessment as it relates to food safety. Research is conducted in a wide variety of disciplines, by a number of different entities. These include efforts by, among others, the National Institutes of Health, the National Institute for Food Safety Technology (MOFFET Center), the National Advisory Committee on Microbiological Criteria for Foods (“NACMCF”) and the USDA’s Agricultural Research Services.

In addition to extensive research, the federal approach to food safety has in recent years also focused on consumer and industry education. The federal government has developed food safety educational programs that span the entire farm-to-table continuum. This includes educating farmers, producers, distributors, food-handlers and consumers. An excellent example is the “FightBAC!” campaign, sponsored by the Partnership for Food Safety Education, which was created to help educate consumers about the potential food-borne illness hazards associated with improperly handling and cooking raw meat and poultry products.

Together, these agencies (and initiatives) promote food safety and attempt to reduce food-borne illness through inspections, surveillance, enforcement, research, risk assessment, pre-market approval, controls for safe processing, and education. The federal approach to food safety has evolved into a vast, multi-pronged food safety system managed by thousands of caring and dedicated Americans.

Copyright 2009 by Shawn K. Stevens

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