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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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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.

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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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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.

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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.

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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.

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According to the USDA, National Steak and Poultry announced a voluntary a precautionary recall of approximately 248,000 pounds of beef products.

Based upon preliminary epidemiological data, the CDC and FSIS believed there was a possible association between limited numbers of E. coli O157:H7 illnesses and the consumption of certain steak products. Many illnesses, however, showed no connection to National Steak or the beef products it processed.

Nevertheless, in an abundance of caution, the company announced a precautionary recall of certain products. Click on the following link to view a copy of the FSIS Recall Release. The investigation is continuing, and the original source of the contamination has yet to be determined.

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

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On November 17, 2009, Fairbury Steaks issued a voluntary and precautionary recall of fresh ground beef. The recall followed an announcement by FSIS that routine regulatory samples collected from the processor had tested positive for E. coli O157:H7. But, did FSIS make a mistake? And, was Fairbury wrongfully accused?

The sample collected by FSIS was taken from a 90 pound batch of finished product. The finished product was processed by Fairbury using frozen beef from another supplier. The frozen beef was sold to Fairbury with a certificate of analysis, documenting that it had been tested for E. coli, and that all tests were negative. In turn, all 90 pounds, once ground, were destined for a single Nebraska restaurant.

According to Dennis Brown, Fairbury’s owner, the ground beef collected for the routine FSIS sampling was collected from a single bag. The contents of the bag were then split in half – one half for FSIS and one half for Midwest Laboratories of Omaha (Fairbury’s own, third-party lab). According to Brown, Fairbury learned on November 14, 2009 that its sample was negative. Three days later, however, the USDA reported that its sample was positive.

What to do? Well, based solely upon its own testing, FSIS urged Fairbury to recall all 90 pounds of ground beef shipped to the Nebraska restaurant. Click on the following link to view the FSIS Recall Release.  And, although the company followed FSIS’ recommendation, Fairbury was not convinced that its meat was contaminated with E. coli.

To satisfy its own concerns, Fairbury recovered all 90 pounds of ground beef it had shipped to the Nebraska restaurant. The company then took samples from each of the nine packages that were returned, and had all nine samples tested by Midwest.

To assure the integrity of sampling, two FSIS representatives watched Brown cut open the nine packages of recalled beef, collect the nine samples, and then ship the samples to Midwest. In turn, all the samples from all the packages, plus a sample from a replacement shipment to the customer (which was included in the collection), tested negative for E. coli.

Although a negative result does not necessarily prove the absence of the pathogen, the numerous and multiple negative test results from the recalled product raise significant questions about the reliability and limits of regulatory testing, the potential for mistakes in governmental laboratories, and the amount of safe product companies are, in some instances, being asked to destroy. Although this recall involved only 90 pounds, the next may involve 900,000.

When asked about the contradictory test results, Brown admitted he's a bit confused. Given the number of negative samples from the recalled product, Brown believes that FSIS either had a false positive or there was cross-contamination in the government's lab.

Unfortunately, Neil Gaffney, a spokesman for FSIS, declined to comment on either possibility – including the history or extent of FSIS false positives.

Thus, in the absence of any response, it appears that the real answer in this case, like the ground beef that was recalled, could potentially have been a bit too much (for at least some) to swallow...

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Food safety, of course, is a top priority for our nation’s food processors.

In addition to numerous other interventions, poultry processors also train employees to visually inspect carcasses for potential defects prior to final USDA approval.

This system of visual screening, however, is only as good as the human eye. Thus, in a continuing effort to push the food safety envelop even further, researchers have now proven that computer imaging can lend a helping hand.

The US Agricultural Research Service (“ARS”) has announced the development of an automated hyperspectral imaging system that can accurately detect food safety and quality defects (including small amounts of fecal contamination) on poultry carcasses. Hyperspectral imaging is a technique that combines digital imaging with spectroscopy, creating individual wavelengths of light that pinpoint contaminants.

The new system was developed, in conjunction with Stork Food Systems, by ARS scientists at the Quality and Safety Assessment Research Unit in Athens, Georgia. Notably, a prototype was recently tested in a poultry plant to evaluate its performance under commercial conditions. In the trial, carcasses were imaged after evisceration (but prior to washing) at a rate of 150 birds per minute. According to reports, the system ran successfully for several days. Nevertheless, while the initial trials showed great promise, researchers are still working to refine the system to better avoid false-positives.

The ARS researchers are also collaborating with the Environmental Microbial and Food Safety Laboratory in Maryland, which has developed a similar on-line system designed to differentiate diseased poultry carcasses from those that are wholesome. The system relies upon the same imaging technology, but uses different wavelengths.

In any event, the two groups are now attempting to merge the systems into a single unit, which will include an imaging camera and detection software. According to reports, the team plans to have a prototype of the joint system ready for further trials later this year.

Congrats to all.

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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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The USDA has published new rules for a proposed program, under which select State-inspected establishments (with 25 or fewer employees) will be eligible to ship meat and poultry products in interstate commerce. Click on the following link to view the Proposed Rule.

The new program was created as part of the 2008 Farm Bill to supplement the existing Federal-State cooperative inspection program to allow State-inspected plants with 25 or fewer employees to ship products across State lines. This announcement is part of the USDA's new Know Your Farmer, Know Your Food Initiative, which seeks to better connect consumers with local producers to help develop local and regional food systems to spur economic opportunity.

"This new cooperative interstate shipment program will provide new economic opportunities for many small and very small meat and poultry establishments, whose markets are currently limited," said USDA Deputy Under Secretary for Food Safety Jerold Mande. "We can provide new markets for these establishments, while maintaining the integrity of the Federal mark of inspection."

Currently, 27 states operate State Inspection Programs for meat and poultry, and FSIS verifies that the State programs are implementing requirements that are "at least equal to" those imposed under the Federal meat and poultry products inspection acts. Click on the following link to view the Current List of Qualifying States. For these programs, FSIS provides up to 50 percent of the State's operating funds and provides oversight and enforcement of the program.

Under the proposed rule, selected establishments will receive inspection services from federally trained and/or supervised State inspection personnel who will verify that the establishments meet all Federal food safety requirements. Meat and poultry products produced under the voluntary cooperative program will bear an official USDA mark of inspection, thereby enabling interstate shipment of the products.

State-inspected establishments that are not selected for the voluntary cooperative program, including state-inspected establishments with more than 25 employees, are only eligible to sell and ship their products within their State.

Comments must be received on or before Monday, November 16, 2009, through the Federal eRulemaking Portal at www.regulations.gov, by mail to: FSIS Docket Room, USDA, FSIS, OPPD, Docket Clearance Unit, 5601 Sunnyside Avenue, Stop 5272, Beltsville, MD 20705.

All comments must identify FSIS and the docket number FSIS-2008-0039. Once received and published, interested parties will be able to View All Comments Online.

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At a recent conference focused on the prevention of E. coli, the USDA came prepared to comment on its current thinking relating to new and emerging policy initiatives. In turn, Dan Engeljohn (Deputy Assistant Administrator of the FSIS Office of Policy and Program Development) offered a number of pointed observations.

In cases involving a further processor which commingles raw materials from multiple suppliers, it can sometimes be difficult to trace the source of a subsequent outbreak to a single supplier. As a result, Engeljohn explained that the USDA is currently analyzing the merits of using the internal microbiological testing data generated by a further processor of product testing positive for pathogens to help the agency trace the pathogen back to the originating slaughter facility.

With respect to slaughter facilities themselves, Engeljohn also announced that the USDA may issue criteria for assessing prudent "high event day determinations.” Although the USDA concedes that 100 percent testing at any large slaughter operation would likely produce at least some positives during any given day of production, Engeljohn noted further that a large number of positives in a short period of time could potentially be a red flag.

Engeljohn also confirmed that the USDA is continuing its work on validating the methodology for testing and identifying non-O157 Shiga Toxin-Producing E. coli (STECS), from six serogroups (O26, O103, O111, O121, O45 and O145), in FSIS samples. Once sufficient baseline data can be collected and assessed, the agency will likely make a determination whether to classify any of these pathogens as adulterants in raw ground product. In addition, although whole-intact cuts of beef containing E. coli O157:H7 are not considered adulterated under current law, Engeljohn suggested that USDA is continuing to consider whether it may someday modify this standard.

Moving forward, we will, of course, continue to report on new and emerging developments.

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Health officials throughout the country are investigating a new Salmonella outbreak which has potentially sickened dozens nationwide.

According to the Colorado Department      of Public Health and Environment ("CDPHE"), the outbreak involves an antibiotic-resistant strain of Salmonella Newport. In Colorado, at least 21 people have been sickened in 10 counties, and four of the victims have been hospitalized. Although no conclusions have been issued regarding the source of the outbreak, preliminary indications suggest that the outbreak could potentially be associated with the consumption of undercooked ground beef. Click on the following link to view a copy of the CDPHE News Release.

According to the CDPHE, eight other states have reported cases that are related to the ongoing outbreak. The USDA, CDC and numerous state health agencies are cooperating in the ongoing investigation.

Although the Colorado news release did not specifically identify the other states involved in the investigation, one of them, reportedly, could be Maine.  On July 31st, the Maine Center for Disease Control and Prevention alerted health care providers and lab directors throughout the state to an outbreak of salmonellosis due to "an unusual type of Salmonella." Six cases have been confirmed in three counties. At least two of the isolates recovered from patients in this outbreak are resistant to the antibiotic ampicillin. Click on the following link to view a copy of the Maine News Release.

All of the Colorado and Maine outbreak cases developed in late June and early July.

The CDPHE, of course, is reminding consumers and food handlers to handle ground beef properly to avoid cross contamination, and to cook ground beef thoroughly. The FSIS likewise reminds consumers that thoroughly cooking raw beef products to an internal temperature of 165 degrees will destroy any pathogens that may be present, and will render the products safe.

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Agriculture Secretary Tom Vilsack and Health and Human Services Secretary Kathleen Sebelius have announced that “prevention and partnership” will guide their departments' efforts to safeguard our food supply. These announcements are based on the public health principles embraced by the White House Food Safety Working Group led by Sebelius and Vilsack.

According to Vilsack, "making prevention a priority is critical to reducing food-borne illness and one of the three food safety principles of President Obama's Food Safety Working Group.” In turn, Vilsack and Sebelius announced the following new initiatives designed to accomplish these goals.

Beef Safety - E. Coli Testing Of Bench Trimmings

For starters, the USDA's Food Safety Inspection Service (FSIS) is issuing guidance for inspectors to begin conducting routine sampling of bench trim for E. coli. In the past, the FSIS had not routinely tested bench trim. Rather, FSIS started E. coli O157:H7 testing with ground beef, and expanded testing to other beef components used in ground beef. Bench trim, which will now be tested as well, includes pieces left over from steaks and other cuts that are then used to make ground beef. FSIS is also issuing streamlined, consolidated instructions to its personnel for inspection, sampling and other actions to help reduce E. coli O157:H7 in beef. Click on the following link to view a copy of the FSIS Sampling Notice.

Produce Safety – New Draft Guidance

Secretary Sebelius also praised new draft guidances prepared by the FDA, an agency within HHS, aimed at minimizing contamination in leafy greens, tomatoes, and melons. According to Sebelius, "the proposed controls provide a guide for growers and processors to follow so they may better protect their produce from becoming contaminated." The draft guidances also represent a shift in strategy for the FDA, from a food safety system that often has been reactive to one that is based on preventing food-borne hazards. Click on the following link for information on the Draft FDA Guidances.

Although the new controls are aimed at preventing contamination in the first instance, Secretary Sebelius also confirmed that consumers play a vital role in ensuring the safety of the fresh produce they eat. In turn, she offered the following tips from the CDC:

• Buy wisely. Don't buy produce that is bruised or damaged. When buying fresh cut produce, choose only items that are refrigerated or surrounded by ice.

• Refrigerate promptly. Certain perishable fresh fruits and vegetables (e.g., strawberries, lettuce, herbs, and mushrooms) should be stored in a clean refrigerator at a temperature of 40ºF or below. If you aren't sure whether an item should be refrigerated, ask your grocer. Produce that is purchased pre-cut or peeled should be refrigerated within two hours.

• Prepare produce with clean hands. Wash hands for 20 seconds with warm water and soap before and after preparing fresh produce.

• Wash produce thoroughly. Rinse fruits and vegetables under running water. Scrub firm produce such as melons and cucumbers with a clean produce brush. All unpackaged fruits and vegetables, as well as those packaged and not marked pre-washed, should be thoroughly rinsed before eating. This includes produce grown conventionally or organically at home, or produce from a grocery store or farmer's market.

• Do not cross contaminate. Don't give bacteria the opportunity to spread from one food to another. Consider using one cutting board only for foods that will be cooked such as raw meat, and another one for ready-to-eat foods such as raw fruits and vegetables.

According to FDA Commissioner Margaret A. Hamburg, the new draft guidances embody the Administration’s and FDA’s prevention-oriented food safety strategy.” She also confirmed that, while the proposals are still in draft form, “they will be made final as soon as possible after public comment, and will be followed within two years by enforceable standards for fresh produce.”

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

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

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

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

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

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According to the FDA, the Plainview Milk Products Cooperative has announced a voluntary recall of various milk products following the discovery of potential Salmonella contamination. The recall includes all instant nonfat dried milk, whey protein, fruit stabilizers, and gums (thickening agents) produced by the company during the past two years at its facility in Plainview, Minnesota. Click on the following link to view a copy of the FDA News Release.

The investigation which led to the recall is an interesting example of the ways in which the governmental agencies, which oversee the food industry, can and do work together to identify any potential problems which may arise. The investigation began when the USDA found Salmonella in 100-gram pouches of Dairyshake powder that were not for retail sale. The USDA then alerted the FDA, who later discovered salmonella on some of the processing equipment used in the Plainview plant. The FDA conducted the investigation in collaboration with USDA, CDC, the Minnesota Department of Agriculture, and various state and local health departments.

The products which were voluntarily recalled have not been linked to any illnesses, nor did they reach consumers directly. Rather, they were sold to other downstream companies, which then used the ingredients to process other foods.

We will, of course, continue to report on continuing developments.

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Nearly five months after the new administration took office, there is still no indication when an undersecretary for food safety will be named. Secretary of Agriculture Tom Vilsack recently confirmed that the delay is due at least in part to the administration's commitment to avoid hiring former lobbyists.

According to Vilsack, those restrictions, coupled with continuing efforts to thoroughly evaluate all potential candidates, has taken significant time. Additionally, some leading candidates formerly under consideration have declined the position. Dr. Mike Doyle, director of the Center for Food Safety at the University of Georgia, for instance, reportedly passed on the invitation, stating he would prefer to continue his role at the University of Georgia.

When named, the new undersecretary will be forced to quickly address numerous emerging food safety initiatives. Although lobbyists claim it is hard for the FSIS to participate fully in the consideration of new initiatives without a sitting undersecretary, Congress nevertheless continues to debate new legislation, and the President's Food Safety Working Group continues to work toward framing new policy.

Thus, we look forward to a formal decision soon, such that all stakeholders can effectively participate in our continuing and collective efforts to strengthen food safety.

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The Ohio Department of Health is currently investigating a potential E. coli O157:H7 outbreak involving numerous cases in Ohio, Pennsylvania, and Illinois.

In turn, Valley Meats LLC (a Coal Valley, Illinois, company) announced a precautionary and voluntarily recall of certain ground beef products after learning the products could potentially be associated with reported illnesses. This possible association was announced by the Ohio Department of Health as part of its ongoing epidemiological investigation.

Approximately 95,898 pounds of ground beef were affected by this voluntary and precautionary recall. The products at issue were produced on March 10, 2009, bear establishment number “EST. 5712,” and were sold nationwide to numerous distributors. Several Valley Meats brands were included in the recall, including 3S, Grillmaster, J & B, Klub, Thick 'N Savory and Ultimate. Click on the following link to view a complete list of products affected by the recall.

Because all raw ground beef products can potentially carry harmful bacteria, the USDA instructs consumers to only eat ground beef patties that have been thoroughly cooked to an internal temperature of 160°. Thoroughly cooking raw beef will destroy any pathogens that might be present, and render the products perfectly safe.

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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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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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The USDA has granted a conditional license for the nation's first E. coli O157:H7 cattle vaccine. The vaccine is designed to reduce the level of E. coli O157:H7 in the intestines of host cattle, and to prevent the bacteria from spreading in feed lots.

Although additional efficacy tests still need to be conducted, the conditional license granted by the USDA will allow Epitopix LLC, the manufacturer of the vaccine, to begin offering the product for sale. The company developed the vaccine along with researchers from Kansas State University and West Texas A&M University.

During testing, researchers conducted a challenge study, a natural infection trial, and two large-pen field studies of the vaccine at commercial feedlots. According to reports, the vaccine reduced the number of cattle testing positive for the O157:H7 bacteria by 85 percent. Of the animals that did test positive for the pathogen, the vaccine reportedly eliminated 98 percent of the bacteria. "Those are impressive numbers," said Dr. Michael Doyle, director of the University of Georgia's Center for Food Safety. In turn, Jim Sandstrom, of Epitopix, confirmed that the vaccine “represents a significant breakthrough in the beef industry's ongoing effort to reduce E. coli O157:H7."

Following additional studies, Epitopix will likely gain full approval for the vaccine. The company estimates that, eventually, the vaccine will protect as many as 10 million cattle every year (about 1/4 of the country's annual cattle supply), and will likely cost less than $10 per head. One of the country's largest beef producers has already expressed interest in purchasing the vaccine.

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Tom Vilsack, Secretary of the United States Department of Agriculture, announced that the final rule (74 FR 2658) for mandatory country-of-origin labeling (“COOL”) will become effective on March 16, 2009. Under the new rule, retailers will be required to notify customers of the country of origin of certain food products. Food products (or, “covered commodities”) included within the COOL program include whole muscle cuts, ground beef, lamb, chicken, goat and pork; wild and farm-raised fish and shellfish; perishable agricultural commodities (specifically fresh and frozen fruits and vegetables); and macadamia nuts, pecans, peanuts and ginseng. Additionally, for food such as fish and shellfish, the method of production, wild or farm-raised, must be specified.

Exempted from COOL, however, are various products (e.g., ingredients) used to manufacture “processed” food items. Processed foods are generally defined as: (1) any retail item derived from a covered commodity that has undergone specific processing resulting in a change in the character of the covered commodity; or (2) any retail item that has been combined with at least one other covered commodity or substantive food component. “Specific processing” that results in a change in the character of food includes cooking (e.g., frying, broiling, grilling, boiling, steaming, baking, roasting), curing (e.g., salt curing, sugar curing, drying), smoking (cold or hot), and restructuring (e.g., emulsifying and extruding). For this reason, Vilsack also expressed concerns, in an open letter to industry, that the definition of processed foods contained within the final rule "may be too broadly" drafted. Because Vilsack was also concerned about the labeling of products of mixed origins, and time allowances for labeling of certain ground meat products, he asked industry to voluntarily adhere to the following additional labeling practices:

• With respect to processed foods, Vilsack suggested that processors voluntarily use country-of-origin labeling for those products that "are subject to curing, smoking, broiling, grilling, or steaming."

• With respect to products derived from animals with multiple countries of origin, Vilsack asked processors to include labeling information identifying what production step -- born, raised and/or slaughtered -- occurred in each country.

• Finally, because final rule allows a label for a ground meat products to bear the name of a country when meat from that country was present in the processor's inventory within the last 60 days, Vilsack suggested that time allowance be reduced to 10 days.

American Meat Institute President J. Patrick Boyle stated that, despite Vilsack’s concerns, the organization was "gratified" that USDA is allowing the final rule to go into effect. Namely, this is because the new rule, in its current form, took nearly six-years (with assistance from industry) to develop. Boyle also noted that, once the rule is effective, nearly 95 percent of beef and pork products would likely be eligible to bear a "Product of the USA" label.

Nevertheless, Boyle also stated that it would ultimately be up to individual companies to decide whether to voluntarily comply with Vilsack’s recommendations. According to Boyle, "to the extent that companies are able and elect to go beyond [the] federal labeling requirements, as requested by Agriculture Secretary Vilsack, [that] is an individual company decision, which will have to be made in collaboration with a company's retail grocery customers . . .."

In any event, Vilsack confirmed that the USDA “will closely review industry compliance with the regulation and its performance in relation to these suggestions for voluntary action.” Depending upon such performance, the USDA “will [then] carefully consider whether modifications to the rule will be necessary to achieve the intent of Congress." The rule had also been under review on the orders of the new presidential administration. Ultimately, Vilsack stated that, allowing the rule to go into effect on March 16, 2009, and then monitoring implementation and compliance by industry, would likely be the most efficient way to evaluate the success of COOL, and also to determine whether additional rulemaking would be necessary.

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The State of California recently enacted a new criminal law, effective January 1, 2009, designed to prevent slaughterhouses from purchasing and processing non-ambulatory animals for human consumption. As enacted, Section 599f amended the California Penal Code to criminalize, without exception, the receipt and use of non-ambulatory animals by slaughter facilities.

In response, the National Meat Association (“NMA”) sought and obtained a preliminary injunction to prevent the State of California from enforcing the new law. NMA, et al. v. Brown et. al, Case No. CV-F-08-1963 (E.D. Cal. 2008). In its briefs, NMA argued that the treatment of non-ambulatory animals was already regulated extensively by the Federal Meat Inspection Act (“FMIA”), which expressly permits, subject to certain requirements, the receipt and use of non-ambulatory animals for slaughter. Under the FMIA (21 U.S.C. § 601, et seq.) and its implementing regulations, non-ambulatory animals may be processed for human consumption if the animals are first inspected for disease and then passed by a federal veterinarian inspector. Because the California law attempted to criminalize what the FMIA permits, NMA argued persuasively that the California initiative was preempted.

Indeed, the FMIA (a distant relative of the 1906 Wholesome Meat Act) regulates virtually every aspect of meat production. The Act requires continuous federal inspection in meat packing plants, often times by multiple inspectors. These federal inspectors are responsible for ensuring that all animals entering slaughter facilities are healthy and free from disease, and that all meat products subsequently produced from such animals are safe, wholesome and not adulterated. Currently, the federal statutory and regulatory scheme is enforced by the Food Safety Inspection Service (a sub-agency of the United States Department of Agriculture).

To ensure that the FMIA and its uniform national requirements are not usurped by the individual states, the FMIA contains an express preemption provision which prevents states from enacting or enforcing any laws that are “different” from the federal standards. 21 U.S.C. § 678. Thus, under the FMIA, any state laws which attempt to penalize a food producer for doing what federal law permits (whether the laws relate to production or product labeling) are strictly preempted.

In this case, the new California criminal law conflicted directly with the federal statutory and regulatory scheme. Because the FMIA permits the use of non-ambulatory animals for slaughter (assuming such animals have been declared to be free from disease by a federal FSIS veterinarian inspector), the Court granted NMA’s request for a preliminary injunction. In its February 19, 2009 Decision, the Court reasoned that the California Penal Code, Section 599f, was both expressly and implicitly preempted under the FMIA and its implementing regulations.

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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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Tom Vilsack, Secretary of Agriculture, promised today to quickly name a new head of the USDA's Food Safety Inspection Service (“FSIS”).

The FSIS, an agency falling within the jurisdiction of the USDA, enforces the Federal Meat Inspection Act, 21 U.S.C. § 601, et seq., by providing continuous on-site federal inspection within meat packing plants. On a daily basis, federal inspectors ensure that all meat products sold in interstate commerce are: (1) produced under sanitary conditions; (2) not adulterated; and (3) properly labeled. In addition to monitoring production, the FSIS also closely regulates meat product labeling. Over the decades, the agency’s policy making and inspection 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).

Leading candidates for the position currently include: (1) Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest; and (2) former FSIS administrator Barbara J. Masters. Ms. Masters currently serves as a senior policy adviser with the Washington law firm Olsson Frank Weeda Terman Bode Matz PC.

Other names that have been considered for the position include Dr. Michael Doyle, Director of the University of Georgia Center for Food Safety (see our post below, highlighting Dr. Doyle’s work on Globalization and Food Safety), Michael Taylor, a veteran of the Food and Drug Administration and George Washington University professor, and Bill Marler, a well-known Seattle-based food-borne illness attorney.

Good luck to all.

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I affectionately call him Buck Magnum.  You may know him by some other name.    Whatever his true identity, I would like to thank him for a job well-done.  

Buck’s story begins over one hundred years ago.  At the turn of the Century, we began shipping more and more food products between states.  Due to the emergence of rapid transportation, improved preservation techniques and the ability of media to reach additional consumers, food became more plentiful, affordable and accessible.  For the first time, food processors could viably ship perishable products anywhere in the nation.

While interstate shipments grew, however, food safety regulations became inadequate.  Industrial advances quickly outpaced limited state and local regulations.  In the meat industry, laws defining what constituted “adulteration” or “misbranding” were determined, if at all, by each individual state. Moreover, what was forbidden in one state was lawful in another.  This hodgepodge of inconsistent laws soon made it apparent that, without a national approach to food safety, a single set of rules, and a single agency to enforce them (enter Buck Magnum), American citizens could have no confidence in the origins or safety of their food. 

The federal approach to food safety was solidified in 1906, when 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 this day. The 1906 Wholesome Meat Act (now known as the Federal Meat Inspection Act, 21 U.S.C. § 601, et seq.) requires continuous federal inspection in meat packing plants, often times by multiple inspectors, to ensure that meat products are safe and wholesome, not adulterated and marked with the federal legend of inspection verifying the same.  

Today, the federal statutory and regulatory scheme is enforced by the Food Safety Inspection Service (a sub-agency of the USDA), via inspectors such as Buck.  In turn, I have watched quietly over the years as this picture has become, in some sense, legendary.  I have seen the photograph countless times on the internet, and have referenced it in publications, speeches and Powerpoints.  I even have a copy sitting next to the plant on my desk. 

Thus, if you know the true identity of this food safety icon, and can privately express our thanks, we'd be grateful.  Alternatively, if you could land me an autograph, you’d make my day.

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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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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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