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.
Yesterday, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a news release (PDF) announcing that a genetically engineered (GE) variety of wheat was found growing on an Oregon farm. APHIS was first notified of the issue by an Oregon State University (OSU) scientist who reported that initial tests of wheat samples from an Oregon farm indicated the possible presence of GE glyphosate-resistant wheat plants.
Here’s what you need to know:
Earlier in April 2013, an Oregon farmer noticed wheat plants that had germinated and developed in a place where they had not been intentionally planted, so-called “volunteer” plants. The farmer also found that these wheat plants were resistant to glyphosate, a systemic herbicide used to kill weeds known to compete with commercial crops. The farmer then sent the samples to OSU for analysis, which later tested positive for the glyphosate trait.
The OSU scientist contacted APHIS on May 3, 2013 to inform the agency of her findings. After immediately launching an investigation and conducting further sampling and testing, APHIS officials announced that the samples taken showed the presence of the same GE glyphosate-resistant wheat variety that Monsanto was authorized to field test in 16 states from 1998 to 2005. Specifically, over this seven year period, APHIS authorized over 100 field tests with this specific glyphosate-resistant wheat variety in Arizona, California, Colorado, Florida, Hawaii, Idaho, Illinois, Kansas, Minnesota, Montana, Nebraska, North Dakota, Oregon, South Dakota, Washington, and Wyoming.
This news has come as a surprise to many since there are no GE wheat varieties for sale or in commercial production in the U.S. The reason being that, unlike some other commercial crops such as GE sugar beets and corn that have been deregulated by APHIS, there are currently no GE wheat varieties that have obtained deregulated status from APHIS. In addition, to date, GE wheat varieties are not authorized for commercial sale or planting in any country.
However, despite the fact that GE wheat is not approved for planting in the U.S., government officials have confirmed that detection of this wheat variety does not pose a food safety concern. According to an investigation report (PDF) issued by APHIS in connection with the GE glyphosate-resistant wheat found in Oregon, the Food and Drug Administration (FDA) completed a voluntary consultation on the safety of food and feed derived from this GE glyphosate-resistant wheat variety in 2004. FDA ultimately determined that the GE glyphosate-resistant wheat variety is as safe as non-GE wheat currently on the market. FDA’s consultation summary, which includes the developer’s conclusion that “this wheat variety is not materially different in composition, safety, or any other relevant parameter from wheat now grown, marketed, and consumed,” can be found here.
Michael Firko, Acting Deputy Administrator for APHIS’ Biotechnology Regulatory Services, explained that the agency is taking the situation and the continuing investigation very seriously. APHIS is collaborating with state, industry, and trading partners to understand how the situation might have arisen and whether there are any more affected areas.
What is yet to be seen is how this event may influence Washington state voters come November. Initiative 522, also known as the “Mandatory Labeling of Genetically Engineered Food Measure,” is an initiative to the legislature on the ballot in Washington that will be decided in the general election on November 5, 2013. Similar to California’s Proposition 37 that failed with voters last year, Initiative 522 would require GMO labeling on raw or processed food offered for sale to consumers if the food is made from plants or animals produced through genetic engineering.
If Initiative 522 passes in November, this particular event would likely not trigger in liability for a producer or retailer’s failure to label the GE wheat. Initiative 522 specifically exempts from labeling any “raw agricultural commodity or food that has been grown, raised, produced, or derived without the knowing and intentional use of genetically engineered seed or food.” (emphasis added). However, there could be other legal ramifications if officials determine that the cause of the incident amounts to a violation of the Plant Protection Act (PPA). Under the PPA, if a violation is found, APHIS has the authority to seek penalties for such a violation including civil penalties up to $1,000,000 and potential criminal prosecution.
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.
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.
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.
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.
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.
A 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.
If you're in the Seattle area March 22, please join me at Parker, Smith & Feek's offices in Bellevue for a discussion of the new Food Safety Modernization Act, the Reportable Food Registry, and how to survive a food product recall. Here is the full announcement of the event, including a link to registration (no charge). Hope to see you there.
The FDA recently took the relatively unusual step of obtaining a court-issued warrant to seize all cheese products at Estrella Family Creamery, a small, family-owned artisan cheese maker in Washington State. According to the United States Attorney's Office for the Western District of Washington, "the FDA asked Estrella to recall all cheese products. The company refused." The FDA requested the recall after both products and the manufacturing environment at Estrella tested positive for Listeria. A copy of the FDA form 483 report immediately pre-dating the recall request is here.
As the Estrella situation illustrates, the FDA is not just focused on large-scale manufacturing. As the FDA and USDA move to more risk-based allocation of resources, they are increasingly concerned about smaller operations and retail. Below are issues any food manufacturer must tackle when it comes to Listeria (much of this also applies to other food-borne pathogens).
What is Listeria?
Listeria monocytogenes is a bacterium that causes listeriosis, which primarily affects persons of advanced age, pregnant women, newborns, and adults with weakened immune systems. Though it affects only a small portion of the population, Listeria is the most deadly food-borne pathogen in the United States, killing 20-30% of all those who become seriously ill.
What should you do if your product tests positive for Listeria?
Assemble your well-rehearsed crisis management team immediately if a product tests positive (or if a regulator believes that your product may be contaminated). Members of the crisis management team; food safety personnel; company executives; and representatives from accounting, legal, supply chain, sales and customer service all are essential in the decision making process below.
Can you trace back and isolate contamination?
Quality assurance and food safety personnel need to answer trace-back issues as soon as possible. Can you determine the source of the contamination? Is it limited to one lot or a single day of production? How often are production facilities sanitized? How often are production surfaces swabbed for Listeria? Does the production facility re-use contaminated product from shift to shift?
Will you have to issue a recall?
Both the FDA and USDA lack mandatory recall authority. Though, as Estrella learned, the agencies do have the bully pulpit and the ability to get a court order to seize products. Because of the high mortality rate, regulators (federal and state) take any positive Listeria test result in food products extremely seriously.
If the food is considered a ready-to-eat product (RTE), a positive Listeria test will almost invariably lead to the FDA or USDA requesting a class I recall.
Even for a non-RTE food, a positive Listeria test will lead to a requested recall. If the agencies believe that the cooking instructions are clear, are easily followed by consumers and, if followed, will kill the bacterium, then the recall may be considered class II.
A primary difference between class I and II is that the class I recall will result in much greater publicity. For FDA-regulated facilities, a class I recall also triggers reporting and notification requirements under the Reportable Food Registry (RFR).
What does the Reportable Food Registry require?
RFR requires FDA-registered facilities to report to the FDA portal within 24 hours when there is a "reasonable probability that an article of food will cause serious adverse health consequences." As part of the report, information must be submitted "one step back and one step forward" in the supply chain. Once a report is submitted, the FDA will promptly alert your customers of the "reasonable probability" that your product will result in "adverse health consequences or death." If suppliers and customers are also FDA facilities, the FDA will also pressure those companies to report to the portal.
The ticking of the RFR's 24-hour reporting deadline forces a company to make snap decisions that might affect its entire business. While RFR reports can be amended or withdrawn based on new information, in the world of food products, the bell can almost never be unrung. A more lengthy discussion of the RFR can be found here.
How do you marshal your case with the regulators?
Assuming that you have information showing that contamination is limited (or non-existent), how do you convince the regulators? The FDA and USDA’s concern is public health (and politics). The regulators’ concern is not for your business.
Providing information to the regulators in a manner they perceive as credible, prompt and transparent is critical. Once the regulators lose confidence in your company's credibility and competence, the game may be over. In most cases, the most effective way to marshal your evidence is a well-prepared and credentialed crisis management team (e.g., food safety, quality assurance, supply chain, accounting, sales, legal, media, etc.).
As we reported some time ago, a class action suit was pending in the Eastern District of Missouri against Aurora Dairy, its organic certifier and certain retailers for violation of state consumer protection laws. The district court had dismissed the case on the grounds that all claims were preempted by the Organic Foods Production Act of 1990 (OFPA), and the plaintiffs appealed to the court of appeals for the Eighth Circuit. On September 15, the Eighth Circuit affirmed the dismissal of some of the claims and remanded the remaining claims to the district court.
Nineteen class action suits across the nation had been consolidated into a single action in the Eastern District of Missouri. In a consolidated class action, the plaintiffs made claims against Aurora Dairy Corporation, a certified organic dairy located in Boulder, Colorado, QAI, Inc., a certifying agent under the National Organic Program administered by the USDA, which had certified Aurora’s milk as organic, and certain retailers who had sold Aurora’s milk under Aurora’s brand as well as under their own store brands. A total of 57 counts were brought against the several defendants, on theories ranging from violation of state consumer protection laws to violation of implied warranties under the Uniform Commercial Code to unjust enrichment and negligence per se. The district court dismissed all the claims on the grounds of so-called “conflict preemption”, where allowing states to regulate an area would conflict with Congress’s regulation scheme.
The Eighth Circuit agreed with the conflict preemption analysis as it related to QAI, the certifying agent, which was dismissed from the case in full, and as it related to the labeling of the products as “organic” based on the certification by QAI.
To the extent the class plaintiffs, relying on state consumer protection or tort law, seek to set aside Aurora’s certification, or seek damages from any party for Aurora’s milk being labeled as organic in accordance with the certification, we hold that state law conflicts with federal law and should be preempted.
The court of appeals disagreed, however, with the district court on other claims, stating,
Preempting state law claims unrelated to the decision to certify, and certification compliance, does not advance the purpose of establishing national standards for organic foods. Nor does preemption of the facts underlying certification advance the goals of assuring consumers that organics meet a consistent standard, or in facilitating interstate commerce in organics.
The court remanded the case to the district court to determine, based on the standards in its decision, which claims would survive against Aurora and the retailers. This was due in part to the district court having not decided, on the grounds that it was moot, motions by the defendants to strike the consolidated complaint and by the plaintiffs’ motion to the amend it. Thus, the district court’s first task would be to decide those motions before it can determine what claims, if any survive.
You have probably heard about the great egg recall of 2010, which has required Wright County Eggs of Galt, Iowa to recall an ever-growing number of shell eggs because of fears of salmonella enteriditis.
An interesting issue here is the non-overlapping jurisdiction of USDA and FDA over eggs in the shell. According to the FDA:
Generally, USDA is responsible for egg safety at what are called breaker plants or egg products processing facilities. In these facilities eggs are broken and pasteurized. FDA is responsible for shell egg safety and egg products once they leave the breaking facility.
The FoodSafety.gov page about safely handling and dealing with eggs is a good place to start for consumers worried about their own eggs.
We also repeat the advice we have collected from previous outbreaks:
- Have a crisis management plan in place.
- Know what you will do when the investigators knock.
- Double check the language in your insurance policy to ensure that it covers the particular facts of a recall. In 2008, Ken blogged about this issue after the tomato outbreak and in 2009 after the peanut recall.
- If you know your products are not affected by the outbreak, publicize this appropriately and ask your trade organization to help with that as well.
- If your products are involved, consider getting criminal law advice as well as advice about civil law responsibilities.
- Reconsider how you choose your suppliers, and what you do to qualify them.
- Publicize whatever is happening on your web page; consumers who hear about your product being recalled may check your web page and don't want to see a sales pitch for the very product subject to recall.
- Review your supply contracts to ensure that you have recourse against someone selling you tainted product, but remember that such entities are unlikely to have adequate resources to make you whole; that is what insurance is for, and also what prevention is for.
- Consider how to publicize the situation to consumers who use different languages.
American Conference Institute (“ACI”) will hold its 4th National Conference on Food-Borne Illness Claims in Chicago, October 27 to 28. Highlights of this year's conference will include:
• Appearances by a number of current and former high-level regulators such as Dr. Arthur Liang from CDC, Dr. David Goldman from USDA, Dr. David Acheson formerly of FDA, Dr. Bob Brackett formerly of CFSAN, Jack Guzewich from FDA, Dr. Bill Keene from Oregon Public Health Division and Benjamin Miller from Minnesota Department of Agriculture
• Mock witness examination of a testifying epidemiologist
• Insights from of the nation's top in-house and outside food-borne illness counsel
The complete conference brochure can be linked here.
Unfortunately, my schedule won't allow me to join the conference this year (I've spoken at the first three ACI national conferences on food-borne illness). But I can arrange for a conference discount. Just give me a call (206-386-7595) or send me an email.
The Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture is finally revising its standards for olive oil, promulgated way back in 1948, to bring them in line with the International Olive Council (IOC), an organization established under United Nations auspices that represents 98% of the world’s olive oil production, nearly all in the Mediterranean basin (the U.S. is not a member). It is doing so at the behest of the California Olive Oil Council (COOC), which is the trade association of U.S. olive oil producers, essentially all of whom are in California.
The new regulations, which are effective on October 25, can be found here, and here is a release the AMS put out describing them. Pretty clearly, terms like "U.S. Fancy" are quaint and obsolete with respect to how olive oil is marketed, and standards for what the terms "Extra Virgin" and "Virgin" olive oil mean are important for olive oil producers, distributors, retailers and consumers.
COOC was also a funder of a study, which has received much press attention, about the accuracy of olive oils labeled as “extra virgin” in advance of the effectiveness of the new AMS regulations. The study has resulted in headlines like, “Olive Oil Study Questions ‘Extra Virgin’ Claims” and the even more provocative, “Olive Oil Study Questions Claims of Virginity.”
The study showed, among olive oils purchased by the researchers in three parts of California (the Bay Area, Sacramento and Los Angeles County) a difference in the accuracy of “extra virgin” labeling between domestic and imported olive oils. Using tests that are used by IOC and in the AMS regulations, as well as other tests used by the German Fat and Oil Society and Australian Olive Association (neither Germany nor Australia being IOC members), there was a distinct difference in the quality of the oils tested, with the domestic olive oil coming off better.
The study makes no claim to any statistical significance for its findings, which is not surprising considering they only examined 14 imported and five domestic brands, buying one of each imported brand in three different places in California and one of each domestic brand in two. Equally unsurprisingly, the North American Olive Oil Association (NAOOA), which represents olive oil importers, has questioned the study's conclusions, which they say are not in line with the results of their own periodic tests of their members' products. Both groups appear to be supportive, however, of the AMS regulatory action.
One thing in the NAOOA press release about the new regulations struck me, however.
But the practice of labeling lower-quality olive oil as top-end — and charging a premium for it — is technically legal in the U.S.
The reason is simple: There are no federal rules that define what is — or is not — "virgin" or "extra virgin" olive oil, said Vito S. Polito, professor of plant sciences at UC Davis and co-chairman of the school's Olive Center, a research group.
I suppose we can all have our own definition of "technically legal." Something could be thought of as technically legal if doing it does not result in criminal sanctions, or result in the product being forcibly recalled from store shelves. In those senses, I suppose selling something as "extra virgin" olive oil would be, until the AMS regulations come into effect in October, "technically legal." But if one took it to mean there are no adverse legal consequences, may I beg to differ? Readers of this blog will remember the implied warranty of merchantability contained in Section 2-314 of the Uniform Commercial Code. One key provision of that warranty is that the goods "conform to the promise or affirmations of fact made on the container or label if any." It doesn't require federal standards to say what extra virgin olive oil is; any form of evidence of a standard, such as, say, the IOC standards, would presumably be admissible into evidence to show what the common understanding of the term is. If the goods sold do not conform to the standard found by the court or jury, then damages under Article 2 will be available.
For consumers, it should be even easier. If you buy something labeled extra virgin olive oil and the bottle, when opened, smells rancid, take it back to your retailer. If it smells delicious, enjoy one of nature's true wonders.
Click on the image below to view the slide-deck from the presentation that I recently gave with Scott Rickman from Del Monte at ACI’s summit on Food Safety and Regulatory Compliance in Chicago. The ACI summit was a nice introduction to food regulation byFDA, USDA, FTC, EPA and DHS. Our presentation was intended to start from the premise that the job of a food lawyer (whether inside or outside counsel) does not end at ensuring regulatory compliance. Products that are regulatory-compliant may still be subject to putative class claims.
In 2008, the DOJ and 16 states challenged the merger of JBS and the National Beef Packing Company, leading the parties to abandon the deal. In its amended complaint filed against the transaction, the DOJ opposed the merger, claiming that it would have combined two of the four largest beef packing companies in the U.S. (“Post merger, over 80% of the nation’s fed cattle packing capacity would be controlled by a three-firm oligopoly. . . .”).
The DOJ’s concern about concentration in the meat packing industry apparently continues. As is often the case, a merger investigation educates regulators, and after the investigation concludes, the government’s lawyers maintain an interest in the industry. In March, the DOJ Assistant Attorney General for the Antitrust Division, Christine Varney, declared that in the near future we will see “unprecedented cooperation and collaboration between [the DOJ] and the USDA,” in her remarks at the first DOJ/USDA competition workshop, held in Ankeny Iowa. Varney noted that collaboration will include “taking full advantage of the authority that’s delegated to us in the Packer[s] and Stockyard[s] Act,” a 1921 statute that specifically addresses competition in the meat packing industry.
Earlier this month, the Associated Press reported that officials from the USDA’s Grain Inspection, Packers and Stockyards Administration (”GIPSA”) are speaking to cattle ranchers about competition and pricing in the meat packing industry. CEO of the Ranchers-Cattlemen Action Legal Fund (“R-CALF”), Bill Bullard, is quoted in the article, noting that ranchers in his organization have been frequently meeting with USDA officials in recent months. Ranchers argue that the country’s four biggest meat packing companies (Tyson Foods, JBS, Cargill, and National Beef) benefit from “buyer power.” They claim that buyer power drives down prices for the cattle that they raise. Economists would argue that such buyer power ultimately benefits customers.
In any event, does all this talk mean that aggressive enforcement of the Packers and Stockyards Act (to the benefit of ranchers) is on the horizon? A USDA official quoted in the Associated Press article suggests that may be true, corroborating the Assistant Attorney General’s comments above (“[W]hat we’re doing at GIPSA now is trying to . . . enforce the Packers and Stockyards Act . . . .”).
The DOJ and USDA are spending this entire year evaluating antitrust and competition policy in the agriculture industry, starting with a series of public workshops. There will be a workshop on the poultry industry on May 21, in Normal, Alabama. On August 27, the agencies will host a workshop in Fort Collins, Colorado, addressing “concentration in livestock markets, buyer power and enforcement of the Packers and Stockyards Act.”
Cleaning Up the Docket - Northern District of California Dismisses Lanham Act Claim Alleging Mislabeling of Personal Care Products
As we have blogged about, litigation regarding product labeling has been a hot topic within the food and beverage industry. A recent decision from the Northern District of California could hold interesting implications for Lanham Act claims centering on the labeling of products as “organic.” While the case, One God Faith, Inc. v. Hain Celestial Group, Inc., involved personal care products rather than agricultural products, the rationale used by the court in reaching its decision to dismiss the claims of the plaintiff is illustrative for the general category of “organic”-labeled products.
In One God Faith, plaintiff, a manufacturer of personal care and cosmetic products, including soap labeled as United States Department of Agriculture (“USDA”) certified “organic” or “Made with Organic” oils in compliance with USDA National Organic Program (“NOP”) standards, sued multiple defendants under § 43(a) of the Lanham Act alleging defendants falsely, misleadingly, and confusingly labeled and advertised similar products as “organic” even though they did not meet NOP standards for the designation, resulting in a loss of sales for plaintiff.
As we blogged about in our discussion of the POM v. Ocean Spray decision, pursuing a false advertising claim under the Lanham Act can be a difficult task for plaintiffs. When Congress enacted the Organic Food Products Act (“OFPA”) in 1990, the legislation that authorized the USDA to implement the NOP, it expressly declined to create a private right of action to enforce the statute or any of its implementing regulations. The plaintiff in One God Faith argued that the OFPA by its statutory language applies only to “agricultural products,” and the USDA has made clear that its comprehensive regulatory scheme governing the use of the term “organic” does not apply to personal care products, the category of products at issue in the case.
However, the court in One God Faith was not persuaded by this argument. While the court did find that it was undisputed that the USDA has declined expressly to impose the NOP standards on personal care products, this was not sufficient to justify the exercise of subject-matter jurisdiction by the Northern District. The court noted that the issue of amending existing regulations to include “organic” claims with respect to personal care products has generated significant recent discussion and that the USDA has asserted its authority over personal care products in other significant ways, including allowing producers and handlers of such products (including the plaintiff) to seek USDA certification under the NOP. As stated by the court, the mere fact that the USDA has not to date expressly imposed the NOP standards does not excuse plaintiff from exhausting available remedies under the USDA’s administrative appeal procedure. Consequently, the court held that granting the plaintiff its requested injunctive relief would negate the legislative bar on private actions and effectively enforce the NOP standards against defendants. As such, plaintiff’s complaint was dismissed for lack of subject-matter jurisdiction.
We’re in the “crystal-ball” season—time to look forward and assess what’s coming in 2010 and beyond. The most likely scenario: more of the same and landmark change.
More of the Same
The last few years have seen growth in both the number of food-borne illnesses detected and the variety of foods affected. This is because more resources are being put into detection (though the CDC recently reported an overall decline in epidemiological capacity by the states) and technology is continuing to advance (think Next Generation Sequencing). There’s little reason to believe these trends will abate in 2010. Expect more outbreaks. Expect to hear about recalls of products not previously implicated in food-borne illness.
Nobody doubts that we’re in the midst of the most significant legislative and regulatory changes in food safety in generations. Most believe that Congress will pass some form of food safety legislation (e.g., S 510 or HR 2749) in the new year. It will likely include the most comprehensive food safety reform in decades. Among other things, this legislation is likely to give FDA mandatory recall power and great authority for risk-based inspections, and require FDA to create a traceability program.
FDA and USDA are already pushing the boundaries of their current authority to become more aggressive on food safety and labeling enforcement. Examples include USDA moving toward classification of Salmonella as an adulterant, more aggressive rules on ground beef safety, and increased retail enforcement. FDA is already studying how traceability could work, being more aggressive in identifying products and retailers in the event of recalls, reexamining the effectiveness of current nutritional labeling requirements, and investigating whether front of pack nutrition labeling (FOP) practices need to be regulated.
And on the heels of legislative reform and increased regulatory enforcement come the lawyers. Action by the government creates new avenues for the plaintiffs’ bar. Food litigation will likely increase in prevalence both in product liability claims (i.e., food contamination) and in putative consumer fraud class claims into 2010 and beyond.
When Congress passes a statute and the Secretary of Agriculture issues a notice in the Federal Register interpreting the statute, it might seem self-evident that someone who believes that interpretation is wrong can appeal that interpretation in court and get a judgment on the merits. On November 18, the Ninth Circuit Court of Appeals said "not so fast."
The decision is a valuable reminder that just because you might allege a wrong, you will not necesarily be entitled to a remedy. The Ninth Circuit does a good job of making sure that the threshold question of standing must be answered satisfactorily before any other allegations in a complaint are reached. When, as here, it finds it not satisfied, the case is over.
The case was Levine v. Vilsack, and it involved what seemed at first a straightforward issue of statutory interpretation. The Humane Methods of Slaughter Act of 1958 ("HMSA of 1958") is the bedrock federal statute dealing with the means of slaughter of livestock. The key provision of the act, 7 U.S.C. Section 1902, provides as follows:
No method of slaughtering or handling in connection with slaughtering shall be deemed to comply with the public policy of the United States unless it is humane. Either of the following two methods of slaughtering and handling are hereby found to be humane:
(a) in the case of cattle, calves, horses, mules, sheep, swine, and other livestock, all animals are rendered insensible to pain by a single blow or gunshot or an electrical, chemical or other means that is rapid and effective, before being shackled, hoisted, thrown, cast, or cut; or
(b) by slaughtering in accordance with the ritual requirements of the Jewish faith or any other religious faith . . . .
The simple question presented in Levine was whether the phrase bolded above, "and other livestock", included fowl. Almost from the time the statute was first enacted, and most recently in 2005, the Secretary of Agriculture ruled that it did not. Levine along with a host of other plaintiffs, including The Humane Society of the United States, sued to overturn this interpretation.
The district court dismissed the case, treating it as a relatively straightforward case of statutory interpretation and agency discretion. The Ninth Circuit (perhaps wary of Justice Scalia's well-known dislike of legislative history) took a different tack.
The issue it confronted is in general known as standing. It derives from Article III of the Constitution, which grants the judiciary the power to decide "cases" and "controversies." The Ninth Circuit relied on a U.S. Supreme Court case called Lujan v. Defenders of Wildlife and its own decision in Salmon Spawning & Recovery Alliance v. Gutierrez to apply a three-part test to the standing issue in Levine.
(1) that plaintiffs had suffered an injury in fact that was concrete and particularized, and actual or imminent; (2) that the injury is fairly traceable to the challenged conduct; and (3) that the injury was likely to be redressed by a favorable court decision
It was on the third of these tests, whether the alleged injury was likely to be redressed by a favorable court decision, that plaintiffs' claims fell.
The problem lies in the statutory history of the HMSA of 1958 and a companion statute, the Federal Meat Inspection Act (the "FMIA"). Initially, the HMSA of 1958 had a enforcement provision in that the federal government was prohibited from buying meat that was not slaughtered in accordance with its terms. However, in 1978, Congress passed a new Humane Methods of Slaughter Act ("HMSA of 1978"), which repealed that provision of HMSA of 1958. As part of HMSA of 1978, Congress also amended the FMIA (initially passed in 1907 in reaction to Upton Sinclar's "The Jungle") to provide inspection requirements for slaughtering. Essentially, those inspection requirements became the replacement enforcement mechanism for the HMSA of 1958. But inspection requirements under the FMIA applied only to "cattle, sheep, swine, goats, horses, mules, and other equines." Without the "other livestock" language of HMSA of 1958, there was no argument that the FMIA inspection requirement could conceivably apply to poultry. However, in 2005, the FMIA was amended once again, deleting the specific list of animals and replacing it with the phrase "amenable species." As the court noted,
Amenable species was defined to include “those species subject to the provisions of this chapter on the day before November 10, 2005" as well as "any additional species of livestock that the Secretary considers appropriate."
Plaintiffs ultimate difficulty, the one they could not overcome, was that they sued for an interpretation under HMSA of 1958, and not to require or overturn agency action interpreting the phrase "amenable species" under the FMIA. As a result, regardless of the harms they claimed and regardless of the proper interpretation of "other livestock" under HMSA of 1958, there was no remedy the court could order for them based on the actual claims in their complaint.
The plaintiffs tried a lot of arguments to avoid this result. In a footnote (it's footnote 8 that continues over pages 15456-67 of the case), the court deals with the plaintiffs' argument that "if she prevailed, 'the number of chickens and other birds slaughtered inhumanely will be reduced, thus decreasing her risk of contracting food-borne illness . . . .'” The court points to other statutes that allow federal inspectors to reduce food-borne illness in poultry slaughterhouses. But it returns to the main point, which is that it has no power to order the Secretary to make a ruling under one statute when the complaint asks for relief under a different statute.
In federal court, standing is the gatekeeper of issues. Without standing under Article III, without being a party that has a real case or controversy in accordance with precedent, no case can proceed. In Levine, the plaintiffs tried unsuccessfully to straddle the gap between two statutes, as to one of which it claimed an incorrect agency interpretation, but under the other of which it would have had to look for relief. It was right of the Ninth Circuit not to give it a helping hand out of that gap.
Co-Authored By Guest Blogger Scott Hansen
According to its website, last Sunday’s New York Times article on E. coli and beef is among the most widely read pieces published by the newspaper this week. The article tells the story of a 22-year-old Minnesota dance instructor who was left paralyzed after being infected with a strain of E. coli in an “Angus Beef Pattie” she ate in fall of 2007. The article traces the story of her burger, points out the many limitations in the current system, and calls eating beef a “gamble.”
While the article is clearly targeted at meat producers and processors, food retailers selling beef products, such as grocery stores and restaurants, are also at risk. This piece is a reminder of the need for retailers to take steps to ensure proper systems and procedures for tracing food to its source (according to yesterday's statement by Secretary Vilsack, retail traceability of ground beef is soon to be a USDA requirement). The Times lauds Costco, which it says is one of the few big producers that tests trimmings for E. coli before grinding.
Retailers should also be mindful of the utility of supplier agreements sufficiently tailored to limit liability or to procure insurance coverage. The greater protections afforded by well-drafted supplier agreements and carefully placed insurance are the best way to mitigate exposure.
Some may choose strong indemnification provisions and additional insured provisions. Another route, not yet the prevailing trend in the industry but perhaps in the near future, involves wrap-up insurance covering the entire supply chain, accompanied by covenants of cooperation between members of the supply chain.
Wrap-up insurance/covenants of cooperation approach has the advantage of potentially avoiding expensive and reputation-damaging litigation between members of the supply chain. Wrap-up insurance is also more likely to result in sufficient coverage to protect the retailer or restaurant chain.
No matter the path chosen, thoughtful placement of insurance coverage and confidence in supply chain contracts can help a food company weather the storm of a food-borne illness outbreak.
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.
One of Monty Python's most imitated sketches was "The Four Yorkshiremen." Even if you've never seen it, it will be instantly recognizable to you. It's the one where four men sit around talking about how tough they had it as kids, compared to how kids have it today. One starts by complaining about how small his house was, and another exclaims, "You had a house?" Eventually, the last one claims to have been roused from bed half an hour before he went to bed, worked 27 hours a day and paid for the privilege and then was murdered every night when he got home.
I was thinking about this sketch as I was contemplating how different from the last food recall about which I blogged, involving tuna in New England, was from the painfully slow recalls involving the salmonella finding that has led Plainview Milk Products Cooperative to recall the last two years of its products. As you might recall, the last recall involved fresh tuna steaks sold to three New England supermarket chains over four days before the problems were identified. By this time, most of the food subject to the recall had probably been consumed and the recall required only publicity in a limited area for those who might have frozen the steaks rather than eaten them fresh. Without denying the difficulties that North Coast Sea-Foods might have encountered in that recall, or the suffering of anyone who got scombroid poisoning, as a recall goes, they, in the words of Monty Python, had it easy.
The Plainview Milk Products Cooperative and everyone who bought from them, on the other hand, have it anything but easy, and the fact that almost every day new products are added to the recalled list demonstrates this.
It all started with a package of powdered milk shake mix. A USDA test showed there was salmonella in the powder. Plainview was the supplier of a main ingredient in the powder. Although tests of its products have uncovered no salmonella, there was salmonella found on some equipment in Plainview's plant. This triggered the recall. No persons have been found who have been made ill by any of Plainview's products.
Plainview does not sell products to consumers. However, as the recall has unfolded, the number and scope of products that are sold to consumers that incorporate Plainview's products has been shown to be huge. Included are:
- Instant non-fat dry milk
- Instant oatmeal
- Instant gravy
- Instant cocoa
- Sports drinks
- Instant milk shakes
Because the products are the kind that are shelf-stable, and the recall covers two full years, even after all the recalled foods have been identified, getting consumers to search pantries for them will be difficult. Indeed, a lot of these products were incorporated into emergency kits, the kinds of things you don't open until needed.
Another place where the powder can be found is in Meals-Ready-to-Eat, the famed MREs of the miltary. In other words, U.S. soldiers in Iraq and Afghanistan are having to toss out their vanilla, chocolate, strawberry and stawberry-banana milkshakes, according to Stars and Stripes. MREs are also used by FEMA and by campers.
As Ken noted recently, the two highest priorities on the Obama Administration's list for the FDA are Salmonella and a national traceback and response system. What the Plainview situation indicates is that, to be effective, the tracing system may need to go in both directions. It didn't take the FDA long to find that Plainview's products were incorporated into the milk shake mix, but it is taking a very long time to find all the products into which the same set of ingredients--including nonfat dry milk, fruit stabilizers, whey protein, and gum products--have also been incorporated.
The implications of such a system, however, are huge. Here are just a few:
- There is an identity between food safety information and confidential commercial information in terms of the relations between suppliers, manufacturers, distributors and retailers. How will this be kept confidential? Who will be trusted to keep it confidential?
- Who pays for the system, and who controls its expenses?
- What is the end point on the origination side? Does every farmer have to keep track of all the inputs into its produce?
- Manufacturers may use many sources of fungible goods; will they be required to trace these? Who pays the capital cost of changing from one big hopper to four small ones?
Finally, I would be remiss without mentioning the point made by Kimberly Lord Stewart, editorial director of Functional Ingredients Newsletter. As Ms. Stewart points out, there is no proof that the salmonella found in the milkshake powder came from the Plainview ingredients, and there are nine other ingredients in the powder made by others.
As Ms. Stewart says,
The Plainview situation has hints of the salsa recall, which initially implicated tomato growers, then salsa makers, only to find out the source of contamination was jalapeños. Traceability is a complicated and looming issue for processed foods. Looking for a needle in a haystack is easy compared to tracking down 9 lesser ingredients in DairyShake blends or multiple ingredients in salsa.
Or, as the late Graham Chapman would say, "Luxury."
USDA’s Be Food Safe Twitter Feed circulated its Fact Sheet titled “Beef . . . from Farm to Table.” First published a few years ago, this might be of interest to businesses involved in the sale, marketing, labeling, and/or packaging of beef. The article is a helpful primer on the history of beef, current industry practices, USDA’s role in inspection, consumer trends, cooking times, storage times, and food-borne illnesses associated with beef.
The Stoel Rives Agribusiness Group has sent out an alert reminding farmers and ranchers of the USDA's program that allows you to participate at the county level in discusssions relating to agricultural decisions in your community. The link to the website with materials needed to submit nominations (which opened on June 15) is here.
Ken, Bryan and I are all members of the Agricubusiness Group, along with lawyers experienced in all manner of topics related to agriculture. You can subscribe to its alerts here.
This week the Obama administration announced the launch of a new website for the recently formed food safety working group. Obama announced the formation of this group in March in the wake of the high-profile food safety issues surrounding PCA peanut products.
This website will assist in tracking the efforts of the working group. As discussed previously on this blog, this group is expected to make recommendations aimed at detection, awareness and government reorganization. Possible examples include increasing funding to states to monitor food-borne illness, combining FDA and USDA food safety efforts, reexamining mandatory recall authority, increasing retail enforcement and implementing more aggressive consumer warnings.
What is not clear is whether the working group will look beyond just detection, awareness and reorganization to bolder initiatives that may result in less consumer illness and less legal exposure for food sellers. Bolder initiatives could include funding for irradiation, consumer food safety education, and fast-track development and implementation of technology that can sample food products for whole colonies of microorganisms.
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.
Secretary of Agriculture Tom Vilsack issued a statement today emphasizing that U.S. pork products are safe and that there is no evidence that U.S. swine have been infected with the swine flu virus.
Calling trade restrictions on pork or pork products unnecessary, Vilsack said any such restrictions would be inconsistent with World Organization for Animal Health guidelines. “[I]t is not necessary to introduce specific measures for international trade in swine or their products, nor are consumers of pork products at risk of infection,” Vilsack said. The complete statement is available here.
A report in The New York Times notes that pork producers are questioning whether it is appropriate to call the virus “swine flu” given that there is no evidence of swine infection. The report states that officials in Thailand, one of the world’s largest meat exporters, have started calling the virus “Mexican flu.” An Israeli deputy health minister reportedly said Israel would follow suit to keep Jews from having to say the word “swine.”
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.
This week brought news of yet another nationwide Salmonella outbreak from a source not yet identified by government regulators. The last time we had a nationwide Salmonella outbreak for an extended period of time without identification of a definitive source the federal government initially singled out tomatoes imported from Mexico (a huge array of products). In that case, the government was wrong and wreaked financial havoc on many farmers and businesses.
So far, in the current outbreak, nothing more specific than “poultry, eggs and cheese” have been identified as possible sources. Last year’s outbreak involved Salmonella Saintpaul whereas the current outbreak is Salmonella Typhimurium, which is more commonly associated with poultry, eggs and cheese, but could come from almost anything.
That a source has yet to be identified to the media doesn’t mean that state and federal officials aren’t zeroing in on possible sources. Restaurant owners, retailers and food manufacturers should be ready for the regulators when they come knocking.
In the past, I’ve had clients who were worked over aggressively by regulators (especially federal officials) who were investigating a large, nationwide outbreak with an uncertain cause. These officials face enormous pressure from those in Washington and from the public. Federal officials can make demands that threaten an entire business. They can demand credit card receipts, contact information for customers, personal employee information, shutdown of the business and more. Noncompliance might mean the officials will go to the press and advertise that the business is a target of the investigation. Unlike local health officials, who are usually vested in the well-being of local food producers under their jurisdiction, federal officials may care only about the investigation and nothing else.
Any food business should implement its crisis response team the minute it suspects it could be targeted in an investigation like the one that is currently ongoing. Specialists in food safety and foodborne illness investigations, genetic microbiologists, public relations experts, accountants, quality assurance personnel, purchasing personnel and lawyers should be lined up and ready to go. Events may unfold quickly for your business (over the course of a day or even a morning). Everything needs to be done at that moment to assist a business in navigating what may appear to be an impossible crisis.
Dr. Bronner’s Magic Soaps (“Dr. Bronner’s”) received a favorable ruling recently in its suit against competitors that it believes are misleading consumers by labeling cosmetic products as “Organic”. Part of Dr. Bronner’s claim appears to be that “Organic” standards established by the U.S. Department of Agriculture (“USDA”) set the bar for consumer expectations of "Organic" cosmetic products. The USDA’s National Organic Program (“NOP”) standards, according to the USDA, do not apply to “cosmetics, body care, or personal care products”. Dr. Bronner’s argues in its complaint that “[p]ersonal care products labeled as in compliance with ‘Organic’ or ‘Made with Organic [up to three specified ingredients]’ under the NOP criteria reflect basic organic consumer expectations . . . .” (Brackets in original.)
Last week, a California Superior Court in San Francisco overruled the demurrer of Ecocert France (SAS) and Ecocert, Inc. A demurrer is essentially a request made to a court, asking it to dismiss a lawsuit on the grounds that no legal claim is asserted.
According to Dr. Bronner’s, the “Court turned aside the defendants’ arguments that Dr. Bronner’s, in its complaint filed with the Court, had not sufficiently spelled out how actual consumers, the company and competition in the organic personal care industry have been hurt by the defendants’ deceptive practices.” The court’s ruling does not necessarily mean that Dr. Bronner’s is likely to succeed, only that it has articulated colorable claims. The court did not rule on the merits of these claims.
This case should be watched closely by those in cosmetics and food industries. Dr. Bronner’s claims turn, at least in part, on its view of “consumer expectations.” Do consumers have expectations as to what “Organic” means? Does it mean something different for cosmetic products? These are just a few of the significant questions that may be addressed in the litigation.