USDA Approves Non-GMO Label Claim for Meat and Egg Products

Coauthored by Andrea Canfield and Claire Mitchell:

The Food Safety and Inspection Service (FSIS),  the division of the U.S. Department of Agriculture (USDA) charged with regulating the safety and proper labeling of meat, poultry, and egg products, recently approved the Non-GMO Project Verified label claim for meat and liquid egg products. The label, certified by the Non-GMO Project, is intended to inform consumers that the animal was not raised on a diet that consists of genetically engineered ingredients, like corn, soy and alfalfa.

In October 2012, representatives from the Non-GMO Project, a third-party certifying organization, approached FSIS about potentially indicating on product labels under FSIS jurisdiction that the animals were fed diets without genetically engineered ingredients. USDA spokeswoman Cathy Cochran noted that FSIS “worked with the Non-GMO Project, three food companies, the Food and Drug Administration, and the Agricultural Marketing Service to be sure that the potential [non-GMO] label claims are truthful and not misleading to consumers.” According to Cochran, the agency took great care in vetting the Non-GMO Project’s standards, requirements and auditing processes before giving its approval.

Importantly, the approval of the Non-GMO Project Verified label does not necessarily signal a USDA policy shift with regard to non-GMO products. Cochran explained that FSIS allows companies to, “demonstrate on their labels that they meet a third-party certifying organization’s standards, provided that the third-party organization and the company can show that the claims are truthful, accurate and not misleading.” Cochran added that “[t]he agency…is not certifying that the labeled products are free of genetic engineering or genetic modifications.” Instead, the labels simply indicate that the products meet the standards of a third-party certifier regarding the use of non-GMO feed.

In order for a product to bear the Non-GMO Project’s verification seal, the product must have been produced according to consensus-based best practices for GMO avoidance. As described in the Non-GMO Project’s Standard, those practices require farmers, processors, and manufacturers to:

  • Perform ongoing testing of all at-risk ingredients.
  • Ensure that the product contains less than 0.9% GMO ingredients.
  • Abide by rigorous traceability and segregation practices to be followed in order to ensure ingredient integrity through to the finished product.
  • Verify compliance through an annual audit.
  • Allow for onsite inspections for high-risk products.

Representatives at the Non-GMO Project emphasize the fact that the non-GMO verification seal is not duplicative of the USDA certified organic label. Though genetic modification is an excluded method by the National Organic Program, GMOs are not prohibited substances and no GMO testing is required of organic products. This means that GMO ingredients can still be found in certified organic products as a result of accidental contamination. The Non-GMO Project requires product testing as a component of its Standard to ensure the level of GMO ingredients in a product falls below the action threshold. Yet even with the Non-GMO Project’s rigorous testing requirements, the high risk of contamination to seeds, crops, ingredients and products makes a claim that a product is entirely “GMO free” legally and scientifically indefensible.

Currently, there is no federal labeling requirement to indicate whether a food product was, or was not, developed using genetic engineering and only two states have passed GMO labeling laws; however, according to the Non-GMO Project’s Executive Director, Megan Westgate, “non-GMO” is the fastest growing label claim in the industry appearing on over 800 brands and 10,000 products. For those interested in learning more about the Non-GMO Project Verified mark, contact the Non-GMO Project’s Product Verification Program team at 877-358-9420 x102.

FSIS Tells Ground Poultry Producers to Reassess Their Food Safety Plans

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) issued a press release on Wednesday, December 5, 2012, announcing that companies producing raw ground chicken and turkey and similar products will be required to reassess their sanitation procedures and pathogen control plans over the next few months. Specifically, over the next 90 days, producers of raw ground chicken and turkey must conduct a thorough examination of its current Hazard Analysis and Critical Control Points (HACCP) to confirm its ability to identify hazards and better prevent foodborne illness. After the 90 day period, FSIS inspection program personnel will begin verifying that establishments that manufacture raw ground turkey or chicken products have indeed reassessed their HACCP plans.

FSIS will be documenting whether establishments made any changes to their HACCP plans in response to the required reassessment and will later evaluate those changes. Later, the agency intends to publish guidance materials for the industry on best practices to reduce Salmonella in ground and comminuted (further processed by mechanical separation or deboning and chopped, flaked, minced or broken down) poultry.

In making this announcement, officials at FSIS are hoping to lower the prevalence of Salmonella contamination within these types of products. This attention to the ground poultry product industry with a focus on Salmonella comes as a response to recent outbreaks that have sickened hundreds across the country in the past few years. Just in the last two years there have been two major Salmonella outbreaks associated with ground poultry products that affected consumers nationwide.

In conducting these reassessments, FSIS is advising companies to look at, among other things, the following:

[E]stablishments should evaluate the adequacy of their sanitation procedures for processing equipment, including grinders, blenders, pipes, and other components and surfaces in contact with the product. Thus, Sanitation SOPs, other prerequisite programs, or HACCP plans should address procedures that ensure that all slaughter and further processing equipment, employee hands, tools, and clothing, and food contact surfaces are maintained in a sanitary manner to minimize the potential for cross contamination within and among lots of production. In addition, FSIS expects establishments to ensure that slaughter and dressing procedures are designed to prevent contamination to the maximum extent possible. Such procedures should, at a minimum, be designed to limit the exterior contamination of birds before exsanguination, as well as minimize digestive tract content spillage during dressing process.

Other FSIS recommendations include validating cooking instructions, examining lotting practices that minimize contact between lots, and requiring suppliers to show that they have used a Salmonella intervention step.

In FSIS’s notice, the agency also announced that it will be expanding the Salmonella verification sampling program to include other raw comminuted poultry products, in addition to ground product; it will be increasing the sample size for laboratory analysis from 25 grams to 325 grams to provide consistency as the Agency moves toward analyzing samples for Salmonella and Campylobacter; and it will be conducting sampling to determine the prevalence of Salmonella in raw comminuted poultry products.

Although these new procedures are intended for producers of ground or comminuted chicken and turkey products, FSIS is recommending that manufacturers of comminuted products derived from cattle, hogs, and sheep or comminuted poultry products derived from poultry other than chicken or turkeys also consider assessing whether their food safety systems present food safety vulnerabilities.

Egg Safety Rule Now Effective for Midsized Facilities

Egg-associated illness caused by Salmonella has long been recognized as a serious public health problem. Specifically, Salmonella Enteritidis, a bacterium commonly found inside shell eggs that appear normal, continues to be one of the leading bacterial causes of foodborne illness in the United States. These eggs primarily become contaminated on the farm because of infection in the laying hens.

During the 1990s, the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture implemented a series of post-egg production safety efforts such as refrigeration requirements designed to inhibit the growth of bacteria that may be in an egg. Those efforts, as well as egg quality assurance programs (EQAPs) and consumer and retailer education, contributed to a decrease in Salmonella Enteritidis illness during the mid-1990s. However, while these steps limited the growth of bacteria, they did not prevent the initial contamination from occurring. FDA and USDA officials became aware that further reductions in Salmonella Enteritidis illness could not be accomplished without additional federal measures addressing the contamination of shell eggs.

Just over three years ago, in July 2009, the FDA, in collaboration with the USDA’s  Food Safety and Inspection Service (FSIS), announced a new food safety regulation that it expected would prevent approximately 79,000 cases of foodborne illness and 30 deaths caused by consumption of eggs contaminated with the bacterium Salmonella Enteritidis each year.

In July 2010, the rule become effective for egg producers having 50,000 or more laying hens. Most recently, as of this past Monday, July 9, 2012, egg producers with fewer than 50,000 but at least 3,000 laying hens whose shell eggs are not processed with a treatment, such as pasteurization, are required to comply with the egg safety regulation as well.

Some of the highlights under the rule include that egg producers whose shell eggs are not processed with a treatment, such as pasteurization 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 eight-week time period (four tests at two-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
  • Refrigerate eggs at 45 degrees F during storage and transportation no later than 36 hours after the eggs are laid (this requirement also applies to egg producers whose eggs receive a treatment, such as pasteurization).

To ensure compliance, egg producers must also maintain a written Salmonella Enteritidis prevention plan along with records documenting their compliance. Egg producers covered by this rule must also register with the FDA. The FDA will develop guidance and enforcement plans to help egg producers comply with the rule and will also begin inspecting medium-sized facilities with fewer than 50,000 but at least 3,000 laying hens in the final quarter of this year.       

New FSIS Policy on the "Big Six" Takes Effect Today

Between November 1992 and February 1993, the United States experienced one of the nation’s worst foodborne illness outbreaks in recent history. State health agencies, in collaboration with the Centers for Disease Control and Prevention (CDC), ultimately confirmed that more than 500 infections and 4 deaths were caused by consuming hamburgers tainted with E. coli O157:H7. This outbreak signaled the need for greater controls based on science to prevent foodborne illness and protect consumers.

The 1993 E. coli outbreak that affected hundreds of people in 4 states became the catalyst for the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service’s (FSIS) decision to declare E. coli O157:H7, a harmful and potentially lethal strain of the bacteria, an adulterant in October 1994. Thus, under to the Federal Meat Inspection Act (FMIA), any raw ground meat that tests positive for O157 is declared adulterated and cannot be sold for human consumption.

FSIS subsequently began a sampling program to test for the pathogen in federally inspected establishments and retail stores. According to the CDC, the rate of E. coli O157 illnesses has been reduced by nearly 50 percent since 1997.

Despite these successes, food safety and public health advocates as well as lawmakers have been pressing FSIS to regulate six other strains of Shiga toxin-producing E. coli (STEC) the same way they do the well-known E. coli O157:H7 for years. Specifically, groups have urged FSIS to also declare the O26, O45, O103, O111, O121 and O145 serotypes, often referred to as the “Big Six,” as adulterants in beef. Those strains can cause severe illness and even death, especially among the most vulnerable members of the population such as young children and the elderly.

In September 2011, FSIS caused a stir in the meat industry when it announced its plan to institute  a zero-tolerance policy for the “Big Six” strains of E. coli that are responsible for human illness. The agency issued a Federal Register notice on September 20, 2011 indicating that raw, non-intact beef products that are intended for use in raw non-intact product, that are contaminated with STEC O26, O45, O103, O111, O121 and O145 will be adulterated within the meaning of 21 U.S.C. 601(m)(1) because they contain a poisonous or deleterious substance which may render them injurious to health.

When FSIS first made this announcement, it indicated that implementation of the testing program for these six additional strains would begin on March 5, 2012. However, FSIS delayed the start date for the program to June 4, 2012 in order to “allow industry time to implement any appropriate changes in food safety systems, including control procedures in their processes.”

As of today, FSIS’ new policy on six additional non-O157 STEC strains will be in effect. FSIS will now begin routinely testing raw beef manufacturing trim, a major component of ground beef, for the “Big Six.” As with E. coli O157:H7, products found to be contaminated with any of the six additional strains will be adulterated and, as a result, will not be allowed into commerce.

USDA Launches New Online Tool for Faster Label Review

The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) is the primary agency charged with regulating the nation’s supply of meat, poultry, and egg products. Besides ensuring the safety and wholesomeness of those products, FSIS is also charged with the important function of reviewing the accuracy of all meat, poultry, and egg product labels.

Specifically, the Labeling and Program Delivery Division (LPDD) serves as the agency’s expert group on label review. The LPDD Staff examines all labels and labeling, including all forms of product identification, claims, net weight, species identification and nutrition related to meat, poultry, and egg products.

Typically, companies mail or hand deliver label applications to FSIS, which are then edited before being returned in hard copy. The agency often receives approximately 150 to 200 of these label submissions daily. As a result, the label review process can take weeks.

Yesterday, however, FSIS launched a new, web-based label approval system, called the Label Submission Approval System (LSAS), that aims to make the product label review process faster, cheaper, and more accurate. According to FSIS’ press release, “[LSAS] will make it possible for food manufacturers to submit label applications electronically, will flag application submission errors that could delay the approval process, and will allow users to track the progress of their submission.”

Under Secretary for Food Safety Dr. Elisabeth Hagen is hopeful that LSAS will be a vast improvement from the label review process currently in place. Hagen stated, “This new system will expedite and simplify the review process for meat, poultry and egg product labels. Reducing the review times for labels will enhance the agency’s ability to ensure that accurate information is applied to product labels and reaches consumers quickly.”

Meat, poultry and egg product establishments should consider using this new tool as it will save time and money for both the industry and the agency. However, FSIS is strongly encouraging those companies to first review the LSAS User’s Guide before attempting to submit their first label(s) through the new system. In addition, the agency plans to host webinars over the next few weeks to provide more information.

FSIS Proposes New Procedures to Improve Traceability

Recently, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) issued a notice announcing new procedures that it intends to implement when FSIS or other Federal or State agencies find a presumptive positive for Escherichia coli (E. coli) O157:H7 in raw ground beef. The impetus behind these new procedures was to improve the agency’s ability to trace contaminated food products in the supply chain, to act against contaminated foods sooner, and to better protect consumers from foodborne illness in meat and poultry products.

FSIS is proposing to launch traceback investigations sooner and pinpoint additional potentially contaminated product when the agency finds E. coli O157:H7 through its routine sampling program.

In the event that FSIS detects a presumptive positive test result for E. coli, the agency will identify the supplier of the product and any processors who received contaminated product from the supplier, once confirmation is received. According to FSIS representatives, this proposed change in policy gives FSIS the opportunity to better prevent contaminated product from reaching consumers.

Under FSIS’s current traceback policy, the agency does not begin conducting any investigations or follow up activities until positive results based on FSIS testing are identified or until outbreaks occur.

According to USDA Under Secretary for Food Safety Dr. Elisabeth Hagen:

The additional safeguards we are announcing today will improve our ability to prevent foodborne illness by strengthening our food safety infrastructure. Together, these measures will provide us with more tools to protect our food supply, resulting in stronger public health protections for consumers.

She added, “We will be acting at the presumptive stage,” The new procedures are expected to expedite the investigation of E. coli contamination by a day or two. “When we’re talking about traceback, every minute counts,” said Hagen.

The agency is inviting any interested person to submit comments on this notice by mail or electronically at http://www.regulations.gov. FSIS is requesting that comments on the proposed policies and procedures be submitted by July 6, 2012.

FSIS' New Rule on Poultry Inspection Remains Open for Comment

Earlier this year, the U.S. Department of Agriculture (USDA) issued a press release indicating that the agency’s Food Safety and Inspection Service (FSIS) was proposing a new rule to modernize young chicken and turkey slaughter inspection.

Specifically, the rule intends to expand the use of the flexible, more efficient, fully integrated meat and poultry inspection system originally developed by FSIS in the late 1990s known as the HACCP Based Inspection Models Project, or HIMP. According to Alfred Almanza, Administrator of USDA’s FSIS, there have been 20 broiler plants under a HIMP pilot program since 1999. He explained that this 13-year-old study was undertaken to determine how best to modernize poultry inspection on a large scale. By expanding HIMP, FSIS aims to focus its inspection resources on the areas of the poultry production system that pose the greatest risk to food safety: the unseen threat of Salmonella and Campylobacter.

Some of the key elements of that new system include:

(1) Requiring establishment personnel to conduct carcass sorting activities before FSIS conducts online carcass inspection so that only carcasses that the establishment deems likely to pass inspection are presented to the carcass inspector; (2) reducing the number of online FSIS carcass inspectors to one per line; and (3) permitting faster line speeds than are permitted under the current inspection systems it replaces.

In the USDA’s January news release, Secretary of Agriculture Tom Vilsack supported implementation of the new rule by stating that “[t]he modernization plan will protect public health, improve the efficiency of poultry inspections in the U.S., and reduce spending.” He added, “The new inspection system will reduce the risk of foodborne illness by focusing FSIS inspection activities on those tasks that advance our core mission of food safety. By revising current procedures and removing outdated regulatory requirements that do not help combat foodborne illness, the result will be a more efficient and effective use of taxpayer dollars.” Significantly, FSIS representatives pointed out that the new rule would prevent 5,200 foodborne illnesses annually, would save taxpayers approximately $90 million over three years, and save the poultry industry more than $250 million annually.

Yet, despite noting the positive impact that the proposed expansion of the HIMP poultry inspection system would have on both food safety and taxpayers’ wallets, the USDA received a great deal of criticism from consumers, food safety advocacy groups, the media, and FSIS inspectors themselves.

In particular, critics argued that the HIMP model relinquishes most of the physical poultry inspection duties to the companies that produce the birds for ultimate retail sale. Company employees, rather than FSIS inspectors, will be tasked with sorting defective chickens and examining other quality assurance issues. Inspectors will be responsible for reviewing each bird for fecal contamination. Inevitably, the reduced role of the FSIS inspector will eventually result in the elimination of between 800 and 1,000 FSIS inspectors jobs.

In addition, many are concerned that, under the new rule, poultry plants will be allowed to speed up their lines from an inspection rate of 140 birds per minute to 175 birds per minute. Some inspectors urge that raising the line speed would result in an increased number of unsafe and unwholesome poultry products winding up on the consumer’s dinner table.

However, both Almanza and Undersecretary for Food Safety at USDA Elisabeth Hagen maintain that the proposed rule is a step in the right direction for protecting public health. In response to the argument that the new rules places too much inspection authority in the hands of the poultry company, Almanza explained:  

Right now, we focus on visual inspections of birds, carcass by carcass, and we look for bumps and blemishes. Do these blemishes put Americans’ health at risk? No. But the unseen threats, salmonella and campylobacter, do. Today, we inspect poultry much the same way as we have since the Eisenhower administration, evaluating the quality of each carcass and doing industry's quality assurance work for them. Once upon a time, there was a good explanation for this: when FSIS first started inspecting poultry, quality assurance was thought to be the best way of keeping the public safe and holding industry accountable. But now that our scientific knowledge has advanced and helped us better identify true food safety threats, we cannot do the same thing we’ve been doing since the 1950s.

Further, Almanza said that the HIMP facilities have been permitted to use a line speed of 175 birds per minute since 1999. “In other words, we have more than a decade of experience slaughter running at 175 bpm, the proposed maximum line speed in the rule,” he added.

Hagen underscored that, even with those increased line speeds, when it comes to contamination, the HIMP pilot plants have performed far better than non-HIMP plants. Data collected from the HIMP plants over the last several years support FSIS’ proposition to expand the HIMP program to additional poultry slaughter facilities. 

Due to the negative response to the proposed rule, though, Undersecretary Hagen announced that the rule will remain open for public comment until April 26, 2012. Comments may be submitted electronically by visiting http://www.regulations.gov or by mailing them to Docket Clerk, U.S. Department of Agriculture (USDA), FSIS, Docket Clerk, Patriots Plaza 3, 355 E. Street SW., 8-163A, Mailstop 3782, Washington, DC 20250-3700.

FSIS Final Rule Imposes New Labeling Requirements for Meat and Poultry Products

Ground TurkeyA new U.S. Department of Agriculture Food Safety and Inspection (FSIS) rule, which was originally announced in a Federal Register notice published on December 29, 2010, will require nutrition labeling on the major cuts of single-ingredient, raw meat and poultry products and ground or chopped meat and poultry products unless one of several exemptions applies. This FSIS Final Rule recently went into effect in March 2012. Originally, the rule was to take effect on January 1 of this year; however, USDA officials delayed the effective date to allow the industry sufficient time to comply with the requirements.

The rule amends the Federal meat and poultry products inspection regulations, which previously required nutrition labels only on meat and poultry with added ingredients, such as marinade or stuffing. Under the new rule, packages of ground or chopped meat and poultry will be required to feature nutrition facts panels on their labels. In addition, whole, raw cuts of meat and poultry must now have nutrition facts panels either on their package labels or available for consumers at the point-of-purchase.

According to a press release from the FSIS:

The nutrition facts panels will include the number of calories and the grams of total fat and saturated fat a product contains. Additionally, any product that lists a lean percentage statement, such as “76% lean," on its label also will list its fat percentage, making it easier for consumers to understand the amounts of lean protein and fat in their purchase. The panels should provide consumers with sufficient information at the store to assess the nutrient content of the major cuts, enabling them to select meat and poultry products that fit into a healthy diet that meets their family’s or their individual needs.

Since the final rule was published, FSIS has posted the final point-of-purchase materials and examples of nutrition facts panels for ground or chopped products on its website. In addition, the Agency has conducted many other education and outreach activities to assist retailers and Federal establishments in complying with the requirements of the final rule, such as posting a PowerPoint presentation that gives an overview of the requirements of the final rule, presenting information at meetings, and responding to questions from industry stakeholders about the regulations through askFSIS at http://askfsis.custhelp.com/.

According to Undersecretary for Food Safety Dr. Elisabeth Hagen, the new FSIS requirements will allow consumers to make more informed choices about the food they purchase without having a significant effect on their wallets. It is estimated that implementation of these labeling requirements will add less than a half penny a pound to the cost of ground meat and poultry.

Some Take-Aways from ACI's 3rd National Forum on Food-Borne Illness Litigation

American Conference Institute (ACI) recently held its latest conference on food-borne illness litigation. The conference has been a fairly intimate gathering of the nation’s lawyers, insurers and experts involved with food-borne illness litigation.

This year, I had the privilege of moderating an in-house counsel “think tank.” The panel was composed of lawyers from a nice cross-section of food businesses: Yum Brands, Hormel, Fresh Express and SUPERVALU (though for each, food-borne illness litigation is a rare event)  A slide-deck from the panel can be found here.

Also among the presenters at this year’s conference were Center for Disease Control’s (CDC) Dr. Arthur Liang and USDA/FSIS representative Dr. Dan Engeljohn. Both presentations provided fascinating insight into changes afoot in food safety enforcement and policy at the federal level. Here are some of the take-aways:

“Outbreaks Waiting to Be Discovered” – Dr. Liang opined that, based on surveilled illnesses, most food-borne illness outbreaks are not presently discovered. He believes that recent data shows that there are perhaps 2-3 times more outbreaks nationally than what’s been uncovered over the last few years.

• Food Safety Progress Being Undone by Retail Deli Operations – FSIS says there has been a “steady increase in risky behavior at the retail level.” According to Dr. Engeljohn, budget authority is being sought to intervene with retailers, particularly smaller supermarket deli operations.

Negative Tested Product Can Be Considered Adulterated - FSIS will be issuing a policy soon that for the first time will consider a “negative tested product to be determined adulterated” under circumstances where an associated product tested positive for pathogens.

Non-0157 STECs - FSIS will be finalizing methodology to detect non-0157 Shiga Toxin-Producing Escherichia coli (STEC).

2010 Food Safety Education Conference Announced

The U.S. Department of Agriculture’s Food Safety and Inspection Service has announced the 2010 Food Safety Education Conference. The conference will be held in Atlanta from March 23 through 26, 2010. Although the agenda is still a work in progress, you can expect sessions on foodborne illnesses, outreach to the medical community, food safety education initiatives, social marketing, and emerging industry trends and technologies.

The conference is accepting abstracts on food safety-related topics through August 16, 2009. More information on the conference and the abstract submission process is available through the links on the widget below.
 

USDA (FSIS) Becoming More Aggressive

At the recent Nebraska Governor’s Conference on Ensuring Food Safety, Dan Engeljohn from FSIS (USDA) announced a number of significant policy changes. FSIS’s changes in part are consistent with those previously announced under the last administration and in part represent the Obama administration’s new priorities. Those include (among other things):  

1. Supermarket Enforcement – FSIS has not emphasized retail (i.e., supermarket) surveillance and enforcement since the early 1990s. FSIS perceives an increase in beef processing (e.g., grinding) at the retail level. As discussed previously on this blog, FSIS also perceives a failure by many retailers to maintain proper production logs. Supermarkets should expect the following:  

A. Unannounced FSIS inspectors will be directed to pull samples on the spot if an inspector walks into a supermarket without good recordkeeping or with unsanitary conditions.

B. New regulations will be aimed specifically at retailers.

2. Non-O157 STECS to Become Adulterants – FSIS appears to be moving aggressively toward declaring at least certain non-E. coli O157 Shiga Toxin E. coli (STECs) as adulterants. FSIS is targeting strains known as E. coli O26, 103, 111, 121, 45, and 145. These strains account for 82% of non-O157 strains detected by PulseNet. Dr. Engeljohn explained that FSIS is looking carefully at these strains and is heading toward their regulation. But he commented that so far information collected about those infected with non-O157 STECs shows that these strains may be less virulent than O157.

3. Attention to Primal Cuts – At least two factors are driving FSIS to develop stricter regulation of primal cuts. First, FSIS learned in the last couple of years that needle-tenderizing injections of steaks are now commonplace in the industry. Second, FSIS is concerned about bench trim.

4. More Aggressive Release of Information to the Public – Dr. Engeljohn also indicated that FSIS will be more aggressive in releasing outbreak information sooner. No longer will FSIS await the kind of confirmation it previously required before requesting recalls or going public with outbreak information.

While the Obama administration has yet to announce an appointment for the FSIS’s Under Secretary of the Office of Food Safety, Dr. Engeljohn indicated that these initiatives are only the beginning. FSIS will be more aggressive on perceived issues of food safety.
 

 

Michigan Company Announces Frozen Pasta Recall

A Michigan maker of frozen pasta products has issued a recall for products that were distributed to seven states. Canton, Mich.-based Mucci Food Products is recalling an undetermined amount of frozen meat and poultry pasta products because the food was prepared without federal inspection.

The products were produced from May 1, 2008 to April 24, 2009 and distributed to California, Florida, Georgia, Illinois, Michigan, Missouri, and Ohio. The recalled products bear the establishment number “19177” or “P-19177” inside the USDA mark of inspection and the dates “1218” to “1149” located at the bottom of the product box.

The U.S. Department of Agriculture’s Food Safety and Inspection Service has complete details of the products subject to the recall, including images of the product labels. The USDA has not received any reports of illness as a result of consumption of the products.

Food-Borne Illness: Glass Half-Empty or Half-Full?

The Centers for Disease Control has issued a study of the incidence of food-borne illness in ten states.  The study, by the Foodborne Diseases Active Surveillance Network, known as "FoodNet", in general concludes that food-borne illness has not significantly either increased or decreased in the United States since 2004, after substantial gains in food safety from 1996 to 2004. 

The Associated Press article on this, by Mike Stobbe, is entitled, "CDC: US food poisoning cases held steady in 2008."  This is an appropriately neutral headline.  What is interesting is how different media outlets have dealt with the story

Reuters, in an article by Julie Steenhuysen, uses the headline, "U.S. making little progress on food safety."  She emphasizes in the lede the use in the study of the word "plateaued."  Lyndsey Layton's Washington Post article is headed, "CDC Study Finds Some Food-Borne Illnesses Rising in U.S."  The article's lede actually says that the rate has "remained stagnant", and nowhere in the article is any mention made of any specific diseases whose rates have risen (the article instead clumps together some where rates have either risen or remained constant, without distinguishing which are which).  The UPI headline is "Little Progress in U.S. food safety", similar to the New York Times's "U.S. Food Safety No Longer Improving, Data Show". 

On the rosier side, the Wall Street Journal's Jacob Goldstein blogged with the headline, "Reality Check on Foodborne Illness Rate." Goldstein takes the position that the lack of an increase given the wide publicity to certain outbreaks is an indication that things are doing well.  It is not clear, however, whether Goldstein understood, as the Washington Post article reported,

The data did not include the ongoing national outbreak of salmonella illness linked to peanut products that began in late 2008 but peaked in the early months of 2009, with nearly 700 people sickened and nine killed.

So what does the report actually say?

 

Let's start with the report's own discussion of its own limitations.  To start with the title of the report is "Preliminary FoodNet Data on the Incidence of Infection with Pathogens Transmitted Commonly Through Food --- 10 States, 2008."  The word "Preliminary" is not featured in any of the above headlines.  Many of the articles do point out that the report is based on data from ten states, covering about 45 million people.  The report itself lists four important limitations to the validity of its data, none of which are discussed sufficiently in any of the media reports:

First, because FoodNet relies on laboratory diagnoses, changing laboratory practices might affect the reported incidence of some pathogens. For example, fewer laboratory-confirmed infections might be reported as a result of increased use of nonculture tests. Second, many foodborne illnesses (e.g., norovirus infection) are not reported to FoodNet because these pathogens are not identified routinely in clinical laboratories. Third, differences in health-care seeking behaviors between age groups might contribute to a much higher incidence of reported illness in certain age groups (e.g., young children and older persons) (10). Finally, although the FoodNet population is similar demographically to the U.S. population, the findings might not be generalizable.

That's a lot of noise.  In particular, the fourth issue, whether it is appropriate to generalize from the data in these ten states to the rest of the country, is critical.  FoodNet argues that its data are from states that, other than an underrepresentation of Hispanics, are not significantly different from U.S. census data for the entire country.  This misses, however, what I think is the more critical question, which is whether the participation of these ten states in FoodNet indicates something different about the public health organizations of those states compared to the remaining states.  It is possible that the other states are putting their funds into inspection and food safety education instead of statistics gathering, but it may be just as likely if not more that the states who participate are the ones whose public health organizations are the most modern and vigilant.  What this might mean for trends is quite problematic.  The ten states may have plateaued because they're doing all they can while there is progress elsewhere, or there may be worse conditions elsewhere that are not being reported.

The report covers ten enteric pathogens:

The report indicated only one increase, that for salmonella, which it stated was "not significant."  In addition, among salmonella serotypes, one (Saintpaul) increased significantly.  We previously reported that saintpaul was the main pathogen found in bad tomatoes in 2008.  Of the others, one increased some and one decreased some and the seven others didn't change. 

What is significant is not so much that the reports of these diseases among the ten states are increasing or decreasing (they appear to be doing neither) but that we are nearly at 2010, when the national health goals contained in the federal government's "Healthy People 2010" program are supposed to be met.  Salmonella incidence is supposed to be at 6.8 per 100,000 people by 2010 and it was at 16.2 in 2008, which is a long way away. 

The other critical lesson from the report is that the apparent plateauing has occurred despite a number of important public health measures that have been taken in the period studied.  These include the FSIS's salmonella initiative, the FDA's lettuce and spinach irradiation program, and the FDA's and Customs and Border Patrol's efforts relating to screening food imports

I imagine that the FDA and the CDC and the various state public health agencies are feeling more than a little like Hans Brinker right now.  However, I wonder if what is really going on, which the report doesn't talk about at all, is a combination of three things:  (1) the low-hanging fruit has been taken care of to a great extent; (2) some of the measures the reports touts were not completely implemented due to funding and other constraints (the importation program would be where I would start in studying this); and (3) pathogens evolve. 

Now let me let you in to what wasn't reported:  the report doesn't look too different from last year's.

Here is the critical paragraph from this year's report:

Despite numerous activities aimed at preventing foodborne human infections, including the initiation of new control measures after the identification of new vehicles of transmission (e.g., peanut butter--containing products), progress toward the national health objectives has plateaued, suggesting that fundamental problems with bacterial and parasitic contamination are not being resolved. Although significant declines in the incidence of certain pathogens have occurred since establishment of FoodNet, these all occurred before 2004. Of the four pathogens with current Healthy People 2010 targets, Salmonella, with an incidence rate of 16.2 cases per 100,000 in 2008, is farthest from its target for 2010 (6.8). The lack of recent progress toward the national health objective targets and the occurrence of large multistate outbreaks point to gaps in the current food safety system and the need to continue to develop and evaluate food safety practices as food moves from the farm to the table.

Here is the corresponding paragraph from last year's report:

Although significant declines in the incidence of certain foodborne pathogens have occurred since 1996, these declines all occurred before 2004. Comparing 2007 with 2004-2006, the estimated incidence of infections caused by Campylobacter, Listeria, Salmonella, Shigella, STEC O157, Vibrio, and Yersinia did not decline significantly, and the incidence of Cryptosporidium infections increased. The incidence of Salmonella infections in 2007 (14.92 cases per 100,000) was the furthest from the national target for 2010 (6.80 cases), and only infections caused by Salmonella serotypes Typhimurium and Heidelberg declined significantly.

There's really not a lot of news here, and if there is any, it's that the closeness of 2010 is making those goals seem harder to achieve.  When you actually look up the meaning of "plateau" in this context, Merriam-Webster's actually has two almost contradictory definitions.  Definition 2(b) is "a relatively stable level, period or condition."  Definition 3 is, "a level of attainment or achievement."  Neither one has a negative connotation.  In these times, even stability seems like a wonderful goal.  Attainment or achievement sound wonderful. 

 

 

2009 Priorities for USDA in Food Safety

I just returned from ACI’s Second National Forum on Food-Borne Illness, which included several interesting presentations and discussions. One was by Dan Engeljohn, Deputy Assistant Administrator of the Office of Policy and Program Development at the Food Safety and Inspection Service (“FSIS”). Mr. Engeljohn spoke about FSIS’s priorities for “2009 and beyond.” Takeaways from this presentation include:

Non-O157 STECs

FSIS is increasingly concerned with strains of E. coli other than O157:H7. Non-O157:H7 strains such as E.coli O121:H19 and O111 are growing more prevalent in the environment. FSIS is putting additional resources into developing methodology for detection of non-O157 STECs.

As FSIS, CDC, FDA and local health departments develop this methodology, the industry can expect more reported outbreaks and more liability exposure. Most experts believe that many non- O157:H7 outbreaks go undetected. Increased focus on detection of non-O157 E. coli strains is yet another reason to examine the sufficiency of your companies' insurance limits.

Frozen, Not Ready to Eat Meals


According to Mr. Engeljohn, because of recent salmonella scares, FSIS remains concerned about “frozen, not ready to eat” meals and specifically “frozen, not ready to eat” poultry meals. He explained that “evidence is mounting that these products cannot be safely prepared unless salmonella is controlled in the source materials.” In other words, FSIS now believes that no amount of package labeling or consumer education can prevent consumers from undercooking these meals.

FSIS jurisdiction over salmonella in poultry is limited. FSIS attempts restrict the sale of “frozen, not ready to eat” meals or impose more stringent standards against salmonella in poultry may be a reach for the agency. As discussed in Supreme Beef Processors v. USDA Salmonella, "is not an adulterant per se, meaning its presence does not require the USDA to refuse to stamp such meat 'inspected and passed.'" Absent statutory reform, FSIS action in this area may be challenged.

Listeria


Mr. Engeljohn stated that FSIS is “deeply concerned” about listeria. It believes that gains made in recent years at meatpacking plants may be undone by problems at supermarket deli counters. FSIS believes that little is being done to address critical control points at the retail level, such as proper cleaning and sanitizing of meat slicers. FSIS may be exploring ways to exercise more jurisdiction to regulate supermarket delis.