Defending Food Safety

When Are Food Companies Required To Report Potentially Dangerous Foods Under The FDA Reportable Food Registry?

Shawn Stevens — Sun, 07 Mar 2010 18:23:53 -0600

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.

Nationwide Recall of Hydrolyzed Vegetable Protein Triggered By Salmonella Concerns

Shawn Stevens — Thu, 04 Mar 2010 17:46:13 -0600

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.

Food Companies Now Have Obligation To Report Potentially Dangerous Foods Under FDA Reportable Food Registry

Shawn Stevens — Mon, 01 Mar 2010 18:23:53 -0600

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.

Salmonella Concerns Prompt Recall Of French Dip Powdered Au Jus Products

Shawn Stevens — Sat, 27 Feb 2010 12:57:33 -0600

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).

Salmonella Outbreak Traced To Red Pepper

Shawn Stevens — Thu, 25 Feb 2010 13:50:10 -0600

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.

FSIS Responds To Petition By Plaintiffs' Attorney To Declare Non-O157 STECs Adulterants In Beef

Shawn Stevens — Mon, 22 Feb 2010 00:30:00 -0600

Shortly after the 1993 Jack in the Box outbreak, the Food Safety Inspection Service (“FSIS”) issued a policy statement declaring E. coli O157:H7 to be an adulterant in ground beef. Since this announcement, and as things currently stand, no other non-O157 Shiga toxin producing E. coli (“non-O157 STECs”) are considered adulterants in whole-intact and non-intact beef products.

In October 2009, however, Bill Marler (a national plaintiffs’ food lawyer) petitioned FSIS to issue an interpretive rule declaring all enterohemorrhagic (EHEC) Shiga toxin-producing serotypes of E. coli, including all non-O157 serotypes, to be adulterants in ground beef within the meaning of the Federal Meat Inspection Act. Click on the following link to view a copy of the Marler Clark Non-O157 STEC Petition.

According to Marler, there have been numerous food-borne illness outbreaks involving non-O157 STECs over the last 20 years which, in his view, justify a change in current FSIS policy. Despite the underlying implication that non-O157 STECs are and will continue to be a growing national problem, however, very few reported outbreaks have been associated with these pathogens in the United States.

Even FSIS agrees that outbreaks may be rare. At its 2007 non-O157 STEC Policy Meeting, FSIS noted that there have been only 13 outbreaks since 1990 associated with non-O157 STECs in the United States. Notably, of the 13 outbreaks that were reported, many were attributable to fresh produce, and none were associated with ground beef. Additionally, in 2005, CDC reported that there had been only 501 confirmed cases nationwide. While these low numbers may ultimately be explained in part by limited testing, it may also be premature to conclude outright that non-O157 STECs are so predominant as to justify an overhaul of the current FSIS approach to pathogen testing and regulation.

FSIS agrees that available data is sparse and may not support a change at this point in FSIS policy. In its recent response to the pending petition, FSIS confirmed that “the agency cannot reach a decision about the substance of the petition until it has developed additional laboratory capacity to detect and isolate various non-O157 STEC groups.” Click on the following link to view the FSIS Response to Marler Clark Petition.

Although FSIS plans to conduct additional research in this area, the agency concedes that, given the current limits of available data, it cannot effectively identify or even address the potential issues with these organisms. And, although additional research will eventually be completed, it remains to be seen whether the resulting findings will ultimately support the conclusion that non-O157 STECs are and should be treated as a significant and wide-spread public health concern in the United States.

In any event, based upon FSIS’ response, it does not appear that the agency will be taking any action on the petition soon. Thus, at least in the short-term, we will likely be left watching - with interest - as numerous scientists and public health officials continue to chew on this issue.

Mande Calls For More Rapid, Robust And Reaching Pathogen Testing

Shawn Stevens — Tue, 16 Feb 2010 18:54:25 -0600

In a recent speech, USDA Deputy Under Secretary for Food Safety Jerold Mande outlined various areas of research he believes will help improve food safety.

During his remarks, Mande noted that he would like to push for more rapid and effective testing. "We need better sampling methods, along with tests that more rapidly detect a broader range of harmful pathogens," he said. "We also need stronger assurance that laboratories used by companies have the expertise and experience to do effective food safety testing."

In addition, Mande stated that FSIS inspectors should be given more sensitive and effective ways to detect food-borne hazards. Here too, Mande opined that the agency “needs to do a better job equipping our inspectors with the means to not let harmful pathogens slip by as we stand watch."

Next, Mande called for additional research to better identify what he referred to as “those unidentified pathogens” which could potentially be responsible for a majority of food-borne illnesses in the United States. According to the CDC, as many as 80 percent of illnesses, 70 percent of hospitalizations and 65 percent of deaths could be caused by agents other than the 30 pathogens CDC currently tracks.

Finally, Mande also suggested, and rightfully so, that additional research was needed to give farmers and ranchers better tools in order to fight food-borne pathogens. "To take the next big step forward on food safety we need to do more to have fewer pathogens on food animals when they arrive at the slaughterhouse gate," he concluded.

Despite Safety Benefits, FSIS Delays Approval Of New Food Safety Technology

Shawn Stevens — Mon, 08 Feb 2010 00:30:00 -0600

Although most people believe that the decision to develop and utilize ground-breaking food safety technology rests exclusively in the hands of industry, this view is often mistaken.

Rather, the use of most new interventions that could immediately increase the safety of our food depends, not upon industry, but upon the approval of the federal government. And, when federal officials refuse or fail to act, both industry and consumers can suffer.

In 2004, the American Meat Institute (AMI) submitted a petition to FSIS to approve the use of carcass e-beam irradiation technology in meat plants. AMI requested that the petition be granted so that low levels of irradiation could be applied to the surface of chilled beef carcasses as a food safety processing aid. The use of such technology has proven to be an effective measure in reducing the presence of pathogens in raw meat products.

And yet, despite the obvious food safety advantages, the agency has for five years refused to approve use of the technology. To the surprise of many, agency officials announced in a recent meeting with the North American Meat Processors Association (NAMP) that no decision would be forthcoming soon.

Presumably, the reason carcass irradiation is an issue with FSIS is because AMI requested that it be approved as a “processing aid.” If the request was granted, processors would be allowed to use the technology without having to place special labels on meat processed with the intervention. Without specifying what, exactly, it was referring to, however, the FSIS stated simply that, “because of other recent events, processing aids in general are under greater scrutiny right now."

Although all of this may be true, with an increasing ability to detect food-borne illnesses and outbreaks nationally, the overall safety of food is under greater scrutiny as well.

In any event, carcass irradiation has often been cited by the meat industry as viable way forward in the fight against E. coli O157:H7 in ground beef. Keeping the word "irradiation" off labels, or even changing its description to something like "pasteurization," have been suggested as ways to increase public acceptance. This is because, previously, the use of low levels of irradiation to treat finished ground beef products fell flat, in large part, because the USDA required the use of a radura symbol on ground beef labels which simply scared the public away.

Frustrated by the lack of progress on its long-standing request, the AMI recently sent a letter to FSIS officials urging them to take action on the outstanding petition. FSIS then responded by saying the issue was being held up because it was waiting for the AMI to answer some of its queries on the petition. AMI, however, reported that it had never received any questions or concerns from the agency.

The controversy intensified last week when, as noted, FSIS informed NAMP of its intent not to grant the petition. When FSIS was asked to provide additional details regarding the continuing delay, it again stated that “AMI [still] needs to provide answers to [FSIS’] questions in order for FSIS to be able to act further on the petition.” Once again, however, the meat association denied being contacted by the FSIS, stating it had “received no formal response to [the] petition, including any questions or concerns that FSIS may have”.

AMI executive vice president James Hodges stated further that there was no reason to continue delaying evaluation of the matter. “AMI has submitted all information needed for FSIS to . . . publish a proposed rule regarding treating carcass surface irradiation as a processing aid”, he said. “Questions or issues about the technology [can be] best addressed through the rulemaking process that will be required to establish the parameters regarding applying this proven food safety technology. We look forward to a favourable response from FSIS.”

Having defended well-intentioned food companies for nearly ten years, and having witnessed the onslaught industry has received recently from media and congress for “failing to do more,” I am perplexed at the lack of urgency displayed by the agency. Perhaps this is yet another example of how government, rather than solving our problems, can often make them worse.

Thus, we too urge FSIS to take action on AMI’s proposal. If we truly want to advance food safety, we should start by convincing our government to advance those technologies that make it possible.

Defending High-Profile Food-Borne Illness Outbreaks And Claims

Shawn Stevens — Tue, 02 Feb 2010 13:45:03 -0600

Given recent improvements in national food-borne illness outbreak surveillance, more food-borne illnesses are being identified, and more outbreaks are being reported.

By extension, many of these outbreaks are being associated with an increasing number of foods, and more companies are – either directly or indirectly – being affected.

For nearly a decade, we have been defending food companies across the country in high-profile outbreak litigation (involving meritorious and non-meritorious allegations). During this period, we have also learned first-hand that when outbreaks do occur, not all investigations are performed properly, and not all resulting claims have merit.

Because of limited resources and other reasons, many outbreak investigations are still unable to identify the real culprit, and some continue to identify the wrong source. Unfortunately, in these and other cases, many claimants (and their attorneys) continue to sue the wrong party.

Thus, when a food company is faced with an outbreak, it is critical to obtain experienced counsel counsel: (1) who understand how food-borne illnesses are tracked, investigated and confirmed; (2) who can help challenge developing assumptions and conclusions regarding potential source; (3) who can effectively respond to regulators and media during an outbreak and recall; and (4) who know how to properly defend food-borne illness claims and lawsuits when they do, indeed, occur. Over the last 10 years, our firm has written the doctrine on Defending Food-Borne Illness Outbreaks And Claims.

Although we enjoy one of the most plentiful, affordable and safest food supplies in the world, we also live in one of the most litigious societies. Thus, despite the fact that food-borne pathogens are (and likely always will be) an inherent part of our food supply, and despite the fact that individual risk can be greatly reduced through responsible consumer behavior, many individuals will continue to be affected by food-borne illness and, unfortunately, regardless of source or cause, many will continue to sue.

In recognition of your incredible efforts to provide safe and plentiful food to our families, we are proud, when lawsuits are threatened, to protect and defend yours.

Elisabeth Hagen Selected To Become Under Secretary For Food Safety

Shawn Stevens — Tue, 26 Jan 2010 17:48:08 -0600

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.

Nationwide Salmonella Concerns Trigger Precautionary Sausage Recall

Shawn Stevens — Sat, 23 Jan 2010 15:06:16 -0600

According to the USDA, Daniele International (with operations in Pascoag and Mapleville, Rhode Island) has announced a voluntary and precautionary recall of approximately 1,200,000 pounds of sausage products which had been distributed nationwide.

The recall was announced as a precautionary matter, during the course of an ongoing CDC investigation into the source of a Salmonella Montevideo outbreak which has sickened hundreds in over 40 states.

Based upon analysis of preliminary epidemiological data, the CDC and FSIS believed there was a possible association between limited numbers of these illnesses and the consumption of certain sausage products. Some illnesses, however, showed no connection to Daniels or the products it processed. Nevertheless, although the investigation is ongoing, the CDC has posted information about the multi-state outbreak on its website. Click on the following link to view the most recent CDC Outbreak Report.

Because of speculation that the potential source of the salmonella in sausage products may be linked to contaminated pepper, the company elected to recall all products which may be potentially affected. Click on the following link to view the FSIS Recall Release. As the investigation continues, Daniels is working closely with state and federal agencies to help determine the most likely source.

JANUARY 31, 2010 UPDATE:

As the investigation continues into the source of the national Salmonella Montevideo outbreak, Daniels has announced an expansion of its original January 23, 2010 recall. The expanded recall, involving approximately an additional 17,000 pounds of sausage products, was announced after the finding of Salmonella in certain samples of sausage not included in the original recall. Click on the following link to view the January 31, 2010 FSIS Recall Release.

FEBRUARY 4, 2010 UPDATE:

As the investigation continues into the source of the national Salmonella Montevideo outbreak, Daniels announced a second expansion of its ongoing recall. The expanded recall, involving approximately an additional 23,000 pounds of sausage products. Click on the following link to view the February 4, 2010 FSIS Recall Update. FSIS has also published a list of all the retail locations to which these products were distributed and sold. Click on the following link to view the FSIS Retail List.

FEBRUARY 16, 2010 UPDATE:

The FSIS has announced another expansion of the recall originally issued on January 23, 2010. The expanded recall was triggered after a finding by FSIS of salmonella in an unopened salami product, and involves an additional 115,000 pounds of products. Click on the following link to view a copy of the FSIS Expanded Recall Release.

According to the CDC, the outbreak currently involves over 230 people from 44 states. Ove these, approximately 44 people have been hospitalized, and no deaths have been reported. As noted above, however, some individuals have reported no exposure to Daniels or any of its products. For this reason, the CDC, FSIS, countless state and local health officials, as well as Daniels representatives, are continuing to work tirelessly to determine the most likely original source of the contamination. Click on the following link to view the most recent CDC Outbreak Report.

We, of course, wish them luck in their continuing endeavors.

Mike Taylor Appointed To New Food Safety Post

Shawn Stevens — Tue, 19 Jan 2010 17:16:33 -0600

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.

E. Coli Concerns Prompt Ground Beef Recall

Shawn Stevens — Sun, 17 Jan 2010 21:47:46 -0600

According to the USDA, Huntington Meat Packing (of Montebello, California) has announced a voluntary and precautionary recall of approximately 864,000 pounds of ground beef products.

The following products, produced between February 19, 2008 and May 15, 2008, and January 5, 2010 and January 15, 2010, are subject to the recall:

40 lb. boxes of "Huntington Meats Ground Beef"
40 lb. boxes of "HUNTINGTON MEAT PKG. INC. BEEF GROUND FOR FURTHER PROCESSING"
40 lb. boxes of "BEEF BURRITO FILLING MIX"
10 lb. boxes of "IMPERIAL MEAT CO. GROUND BEEF PATTY"
20 lb. boxes of "IMPERIAL MEAT CO. GROUND BEEF PATTY"
10 lb. boxes of "El Rancho MEAT & PROVISION ALL BEEF PATTIES"

Each box bears the establishment number "EST. 17967" inside the USDA mark of inspection on the label. The products were shipped to distribution centers, restaurants, and hotels within the State of California. Click on the following link to view the FSIS Recall Release.

The problem was discovered during a Food Safety Assessment (FSA) by FSIS personnel. During a review of the establishment's records, FSIS determined that these products could potentially be contaminated with E. coli O157:H7. While these products are normally used fresh, the establishment announced a broader recall because of the possibility that some products could still be frozen and in commerce. Media and consumer questions regarding the recall should be directed to the company owner, Robert Glenn, at (888) 894-8242.

To date, there have been no reported illnesses associated with the consumption of these products. FSIS also reminds consumers that thoroughly cooking raw beef products to an internal temperature of 160 degrees will destroy any pathogens that may be present, and will render the products safe.

FEBRUARY 12, 2010 UPDATE:

Based upon the results of an ongoing FSIS Food Safety Investigation, the agency has announced that the recall originally announced on January 18, 2010 has been expanded to include approximately 4.9 millions pounds of beef and veal products produced at the plant between January 22, 2009 and January 4, 2010. Click on the following link to view the FSIS Expanded Recall Release.

Listeria Concerns Prompt Recall Of Numerous Peanut Butter, Cheese, Salsa And Other Products

Shawn Stevens — Fri, 15 Jan 2010 21:24:53 -0600

According to the FDA, Parkers Farm, Inc. (of Coon Rapids, Minnesota) has announced an expanded recall of various peanut butter, cheese and salsa and other products, to include all date codes, because they have the potential to be contaminated with listeria monocytogenes.

The recall, originally announced January 8, 2010, affected product with sell by dates of specific ranges. The expanded recall now includes all products and all sell by dates.

The recalled products were distributed nationwide in the following retail stores: Hy-Vee, Cub, Rainbow, Byerlys, Lunds, Target, Whole Foods, Jewel, Dominicks, Marsh, Price Chopper, Shop Rite, Nash Finch, Sams Club, Costco, Safeway, Kroger, Wal-Mart, Aldi. Click on the following link to view the FDA Recall Release and list of affected products.

The recall was a result of a sampling done by the state of Wisconsin and the state of Minnesota which revealed that some finished products contained the bacteria. The state of Minnesota, FDA, and the company continue their investigation into what, exactly, caused this potential problem.

It is also important to note that, to date, no illnesses have been reported in connection with the consumption of these products. Nevertheless, the company is urging consumers who may have purchased these products to return them to the place of purchase. Consumers with questions can also contact the company at (800) 869-6685.

USDA Announces New E. coli O157:H7 Vaccines

Shawn Stevens — Mon, 11 Jan 2010 00:30:00 -0600

The USDA's Agricultural Research Service (“ARS”) has announced that its scientists have developed two vaccines that might reduce the spread of E. coli O157:H7 in cattle.

"Preventing E. coli O157:H7 from proliferating inside cattle helps limit contamination of meat at the packinghouse, and reduces shedding of the microbe," ARS said in a statement. "Manure-borne E. coli can sometimes be moved by rainfall into drinking water. What's more, in some instances, it can end up in irrigation water, and can potentially contaminate fruits, vegetables and other crops, increasing risk of an outbreak of food-borne illness."

The first form of the vaccine is comprised of cells of a strain of E. coli O157:H7 that lacks a gene called hha. A second form of the vaccine contains an E. coli strain that lacks both hha and a second gene, sepB. In each of the vaccines the E. coli strain produces immunogenic proteins, which trigger an immune system response that prevents E. coli O157:H7 from successfully colonizing in cattle intestines.

In preliminary tests, 3-month-old Holstein calves were immunized with a placebo or either form of the vaccine. Six weeks later, the animals received a dose of E. coli O157:H7 and for the next 18 days, their manure was tested for evidence of the microbe. Calves that received either vaccine had reduced or non-detectable levels of E. coli within only a few days after being inoculated with the bacteria.

Research microbiologists Vijay K. Sharma and Thomas A. Casey developed the vaccines in their laboratories at the agency's National Animal Disease Center in Ames, Iowa.

Volunteering For A Recall

Shawn Stevens — Fri, 08 Jan 2010 00:42:23 -0600

By Guest Blogger Cathy Crawford

The proposed regulations which are part of the Food Safety Modernization Act include provisions for mandatory recalls. While in rare cases, such provisions could potentially be helpful where a company is reluctant to conduct a recall, the vast majority of recalls are not only voluntary and effective, but often go above and beyond what may soon be defined as “requirements.”

Consider, for instance, the recent recall of various canned Slim-Fast products. Unilever should be commended for its voluntary and precautionary actions. In this regard, it is critical to note that there were no illnesses associated with the consumption of these products. Rather, a potential food safety issue was identified internally by the company and then immediately reported. Thus, this is not a case that demonstrates the importance of, or need for, additional government oversight. Rather, this was a responsible company which, on its own accord, accepted the need to react, and did react, proactively to address possible food safety concerns.

Next, and even more important, is the size of the recall. Large recalls sometimes lead the media and consumers to believe that our great American food supply is unsafe. This recall, however, demonstrates just the opposite. For Unilever, it was likely that the exact cause of the potential problem was not immediately understood. Nevertheless, all of the potentially affected products involved in the recall were simply assumed by the company to be possibly – not factually – contaminated. In truth, there may have been one contaminated container, none, or many. Because the company wanted to react quickly, however, it initiated a very expansive recall, hoping the public would respect its actions, rather than judging it for having produced a suspect product.

Often, the behind the scenes, certain data driving the scope and limits of a recall are not fully available to the public. In turn, what consumers see or believe is only that a company released a food product later subject to a recall, and then had to have it returned so it could be safely discarded. What is rarely explained is that most of the food involved in any recall is completely safe. Because it can’t quickly be "proven" to be either safe or unsafe, however, it is voluntarily recalled, in an abundance of caution, to remove all potential risk.

If, or more likely when, recalls become “mandatory,” most companies will of course strive to comply with those requirements imposed by the relevant federal agencies. In doing so, however, some companies may become dependent upon federal regulators to define the scope of a recall, and thus overlook the opportunity to do more than what is being strictly required. Thus, although we may see routine compliance, we may also witness a potential loss in some of the extraordinary efforts taken by companies when they themselves voluntarily define the scope of a recall and go the extra mile in the name of public confidence and food safety.

Thus, in my view, additional and pointed regulatory power in such circumstances may not be the best answer. Instead, a coordinated effort to increase and enhance industry education may be a better long term solution. Imagine, for instance, the difference of having careful drivers in a school zone where the community uses education and training to instill an authentic sense of care about driving near schools. Compare this to a place where the time allotted for drivers’ education courses has been reduced, but drivers are expected to travel at 25 mph only because it is mandatory. In the end, which environment is safer? In which case are drivers likely to push the limit farther, and drive a bit faster, when no one is looking?

I would rather see additional resources diverted to increased awarness and training than simply trying to legislate a quick solution to a perceived problem by empowering and then expecting regulators to both define and then require “mandatory recalls.” Remember the drivers’ educational videos that may have scared you and convinced you of the power in your hands when at the wheel? Perhaps something similar, along with increased annual Hazard Analysis and Critical Control Point (“HACCP”) and food safety training, would do more for our system than additional legislation.

The food safety systems in many companies include HACCP protocols as well as systems in compliance with globally accepted food safety standards such as the Safe Quality Foods (SQF) or the British Retail Consortium (BRC). There are times when these systems might fail to identify or prevent a hazard. In these cases, however, responsible companies most often act proactively and quickly to implement corrective actions. Those actions include protecting the public, finding the cause of the problem, eliminating that cause, and updating internal systems to ensure any changes are effective. These things don’t happen without training. No legislation can replace that.

Nevertheless, a mandatory recall provision will likely pass. Without robust and effective food safety training at all stages in the food chain, however, this by itself will not likely diminish the need for recalls, nor will future recalls become any more efficient or effective.

* Cathy Crawford serves as a consultant with the HACCP Consulting Group (HCG), based in Fairfax, VA, just outside of Washington, DC.

HCG provides food safety consulting services to the food industry. Founded in 1994, HCG offers food safety training and assistance to both the FSIS and FDA regulated food industry as well as in over 35 countries that export meat and/or poultry to the U.S. Five of HCG’s 10 partners are former FSIS officials with the others from the food industry and state inspection programs. We have basic and advanced HACCP training courses accredited by the International HACCP Alliance in College Station, TX. HCG also provides Serve Safe training to the restaurant industry and has provided food safety training at a well know Culinary Institute. For more information about HCG please visit HCG’s web site at www.haccpcg.com.

USDA Launches Toll-Free Help Line For Small Processors

Shawn Stevens — Thu, 07 Jan 2010 12:25:48 -0600

The USDA’s Food Safety and Inspection Service (“FSIS”) has announced the creation of a new help-desk, providing operators of small meat, poultry and egg processing establishments with access to knowledgeable specialists who can help them understand USDA directives, regulations and other information. The help-desk also will provide direct assistance to state and local food regulatory agencies.

"The FSIS is committed to providing assistance to businesses of all sizes that provide American consumers with access to a safe and healthy food supply," said Deputy Under Secretary for Food Safety Jerold R. Mande. "The small plant help-desk will help the development of small, local producers by offering a one-stop shop for questions about how to make sure their meat, poultry and processed egg products are safe, wholesome and properly labeled."

The new help-desk will support USDA's "Know Your Farmer, Know Your Food" initiative by helping small processors to reduce the time and expense of dealing with agency requirements. "Know Your Farmer, Know Your Food" is designed to continue the national conversation about developing local and regional food systems and finding ways to support small and mid-sized producers. It emphasizes the need for a fundamental and critical reconnection between producers and consumers, building on the 2008 Farm Bill, which provides additional flexibility for USDA programs to promote local foods. More information on the "Know Your Farmer, Know Your Food" initiative can be found at: www.usda.gov/knowyourfarmer.

The FSIS small plant help-desk will serve as a "one-stop shop" for plant owners and operators with questions. More than 90% of the 6,000 plants inspected by FSIS are small or very small. FSIS staff will assess callers' requests and provide information and guidance materials that best meet their needs. In situations where the answer is not readily available, the staff will research the issue and follow-up with the caller. As appropriate, the help-desk will provide a portal to other services, such as AskFSIS, FSIS' existing service offering agency responses to inquiries on agency policy.

Inquiries can be made to the small plant help-desk by toll-free telephone or by email. The help-desk is open from 8:00 a.m. - 4:00 p.m. EST, Monday through Friday, excluding Federal holidays. To speak to a staff specialist during this time, call 1-877-FSISHelp (1-877-374-7435). You may also contact the help-desk by email at InfoSource@fsis.usda.gov.

Botulism Concerns Prompt Boiled Fish Recall

Shawn Stevens — Wed, 06 Jan 2010 16:27:17 -0600

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.

Beyond The Blog: A Preview of 2010

Shawn Stevens — Mon, 04 Jan 2010 00:30:00 -0600

2009 was a wonderful year for us at Defending Food Safety. From the launch of the blog only months ago, to speaking engagements in China, Mexico and coast to coast across the United States, we are lucky to have had the opportunity to meet and speak with so many about food-safety.

The coming year looks to see a lot of changes to the industry, both politically and regulatory. The outbreaks over the past year have thrust food-safety to the front of the national conscience and, with that attention, even the best, safest and most admirable companies will continue to be faced with new and emerging challenges.

The reality we face is that food is not sterile. We live, from a microbiological standpoint, in a dynamic world that is full of unseen and unforeseen dangers. The important thing is that we are prepared for contingencies and unfortunate events.

Having defended food companies for more than a decade—since the last century, in fact—we understand better than anyone the stress and hard work which goes into producing the food our families eat. That is why we are so proud to stand beside you in your times of need.

In addition to the broad range of litigation services we have historically offered, we are also now providing direct consulting to food companies across the nation who ask us to assess their food-safety protocols, to provide the tools and knowledge to improve them, and to minimize their exposure in the unlikely event of an outbreak.

We have also broadened our outbreak management capabilities to handle all aspects of crisis management. In the event of an outbreak, we will stand shoulder to shoulder with you, guiding you through the maze of your dealings with government regulators, the media, and the public. Our firm provides a wealth of expertise and experience that is unrivaled by any other in the nation. In your most difficult and trying times, we alone are suited to guide you smoothly and safely through the storms you may face.

We look forward to continuing our relationship with you over the course of the next year and beyond. We are also very grateful to those who have made 2009 a great year. We wish nothing but the very best to each of you and your families.

Again, as always, thank you for a job well done.

Home On The (Not So Free) Range

Shawn Stevens — Sat, 02 Jan 2010 00:30:00 -0600

In the past few years, the popularity of free-range poultry, pork and beef has increased dramatically.

It has been argued that, in addition to being a healthier and more humane way to raise animals, free-range food is better for consumers. And, although free-range foods tend to be significantly more expensive, consumers may not be getting what they bargained for.

One common justification for the increased cost is that free range food is healthier. A recent study published in the Journal of Foodborne Pathogens and Disease, however, found that levels of Salmonella, toxoplasma and even trichinosis were higher in free-range animals. This is likely because free-range animals are often exposed to a broader spectrum of environmental hazards than their counterparts, including a wider-variety of other animals, multiple water sources, diverse soils and even pathogens.

And, even setting health aside, many people insist that free-range animals taste better. Here too, however, studies have shown that in reality this might not be true. Research suggests that the increased price and altered perception of what is being consumed merely make people “think” that free-range necessarily equates to better quality (when, in many cases it does not). I am certain that, someday in the future, when we find ourselves eating meat produced in a test tube, there will undoubtedly be those who insist that meat coming from a living animal tastes far better, regardless of any actual differences. Food for thought, I guess.

In any event, the real issue at the “heart” of the matter may be the treatment of animals. Those who argue in favor of free-range farming do so, in most cases, because they believe the oft-publicized (and often incorrect) allegations of inhumane treatment of animals on large farms to be unacceptable. Although such arguments are noble, the fact remains that most animals for which we depend upon our survival are raised quite humanely, and free of pain and suffering.

In addition, few people know that there are currently no practical definitions or enforceable standards which dictate what it actually means to be “free-range.” In this regard, it is currently possible for an animal to characterized as “free-range” without ever having been outside. Simply allowing an animal access to the outdoors, even if for only five minutes a day, qualifies. Thus, the only way to really know how a particular producer raises its animals is to ask.

So, when you think about the health, taste and nobility of your next purchase, remember that, in many ways, free-range may not be so free.