Food Liability Law Blog

The Best Thing. Ever.

Richard Goldfarb — Wed, 16 May 2012 17:00:00 -0800

In the conclusion to Aaron Bobrow-Strain’s White Bread: A Social History of the Store-Bought Loaf, he describes how he, a home bread baker, captures the microbes for his homemade sourdough. It’s not what we’d call hygienic, but it also apparently makes a delicious bread. Bobrow-Strain’s own behavior is really what tells you his conclusion: where bread is concerned, everything you’ve been told is wrong. Within limits.

Notwithstanding that its very title is a synonym for blandness, White Bread tells a compelling story in an accessible way. Over and over, we see how industry, government, science and the media gang up on their nemeses—home bakers and small-scale bakeries. Muckrakers warned of “disease-breeding bread” and a newspaper claimed, “Dough kneaded with the hands always runs the risk of contagion.” The result was the rise of industrially-baked bread, nearly all white bread.

Bobrow-Strain also tells the story of food evangelists like Sylvester Graham (namesake but probably not the inventor of the eponymous cracker) and how fortifying bread with vitamins was a factor in winning World War II. He reveals that much of America’s current industrial bread is actually owned by Grupo Bimbo, the Mexican baking conglomerate, which owns such iconic brands as Sara Lee, Arnold, Orowheat and Roman-Meal. He describes the counterculture’s push for whole wheat bread and how it has, with help from large-scale bakeries, overtaken white bread in the past few years for the first time.

The food liability takeaway here is nothing new, but a good reminder in a nice package: there is always a way to question conclusions from government or academia for their potential bias. If you are challenging a government mandate, find the bias and attack it. If you are on the side of the mandate, be ready for a challenge from the other side. The kind of research Bobrow-Strain has undertaken here is available on almost any government food mandate. Ignore it at your peril.

What I really enjoyed, though, were his explanations for two longstanding clichés. First, one that has become a punch line by now but was taken seriously when I was a kid, “Eat your vegetables, children are starving in Europe.” Bobrow-Strain describes the drought in the summer of 1946 in Europe, which did in fact starve Western Europe just as it was recovering from the ravages of war. The next year’s harvest was no better. Britain had less wheat flour available for civilians than it did during the war. France was basically starving. And a war-weary America responded by limiting its own bread consumption (perhaps by adding garden vegetables to the plate instead) and exporting flour to make billions of loaves of bread to Europe. This may have had a meaningful impact on how Western Europe thwarted Communism.

The other one really describes the one story in the book where government had nothing to do with it: the advent of sliced bread. July 6, 1928 (a couple days after my dad turned two and three weeks before my mom was born) was the date the Chillicothe Baking Company in Missouri produced the world’s first pre-sliced bread, invented by Otto Rohwedder. And, amazingly, it was indeed the best thing, the thing that legitimately can be compared favorably to any invention—television, the Walkman®, the VCR, the personal computer, the cell phone. Within weeks, sales of sliced bread soared 2000%. By 1929, it had pretty much swept the country. A bakery in Florida was struggling because it bucked the trend; when it gave in, its sales increased 600% immediately. By 1936, 90% of commercially bought bread in the United States was sliced.

Bobrow-Strain asks a legitimate question: why did this innovation so completely sweep the country? Though I bake my own bread and slice it by hand, I think I have the answer. In those days, households often had far more people in them than they do today. Families had more children, and several generations of a family could live in one house (my great-grandparents and a great-uncle and great-aunt lived under the same roof as my grandparents when my mother was born). And people didn’t buy lunch at school or at work; they made it, and it was nearly always sandwiches. So imagine a family of six kids and four adults, all the kids school-age and three of the adults working out of the house. Two slices of toast at breakfast and two sandwiches apiece, that’s about sixty slices of bread a day to prepare in time for people to leave the house in the morning. Sliced bread would be a pretty legitimate labor-savings, and at essentially no cost. Best thing indeed.

FSIS Proposes New Procedures to Improve Traceability

Claire Mitchell — Tue, 15 May 2012 16:38:45 -0800

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.

Accident in Search of a Cause of Action: the Alaska Supreme Court Strikes Out

Richard Goldfarb — Fri, 11 May 2012 17:00:00 -0800

The 20th century dramatist George S. Kaufman told the story, presumably apocryphal, of receiving a bill from his lawyer with the entry “For crossing the street to speak to you and discovering it was not you.” A recent Alaska Supreme Court case, Estate of Mickelsen v. North-Wend Foods, Inc., indicates that Kaufman may have been an optimist.

The case involves facts that wouldn't seem to implicate any issues we discuss on this blog. Simply put, a motorist made an illegal left turn across traffic mid-block in Anchorage and killed a motorcyclist heading in the opposite direction. The motorcyclist crashed into the car, so presumably he didn’t have enough time to swerve or stop. The unstated but obvious subtext, of course, is that the motorist did not have the resources to fulfill the damages caused.

So whom did the estate sue? The franchisee and owner of the land on which a fast food restaurant sits. Their alleged mistake: not taking sufficient steps to warn the motorist not to make an illegal left turn into the exit to their drive-through.

Understand, the case had been dismissed on a Rule 12(b)(6) motion, which presents a pretty high standard, "failure to state a claim on which relief can be granted." But it's hard to see where the claim is here.

Mickelsen’s complaint alleges that [defendants] created an entry and exit system that had the effect of enticing . . . patrons to enter the premises by making an illegal turn across two lanes of traffic, that . . . customers in fact regularly used the short-cut, that [defendants] w[ere] or should have been aware of such use, and that this dangerous condition led to the fatal accident.

This is notwithstanding that the left turn involved illegally turning across a double yellow line and that there are, not surprisingly, traffic laws that impose on a driver making any kind of left turn the duty to do so only when no oncoming driver might smash into your car. Neither of those traffic laws relate to whether there is a driveway the illegal and negligent driver is turning into or the identity of the business that driver may be trying to patronize. And just to make it clear, “[b]ecause the width of the curb-cut accommodates only one vehicle at a time, drivers must often roll one tire over the raised curb in completing the short-cut maneuver.” So drivers would need to violate two important traffic laws and roll over a raised curb to undertake this “short-cut.” This, in Alaska, is “enticement” that is sufficient to create a cause of action that must be defended at great cost. (more after the jump)

So how did the Alaska Supreme Court reach this decision? It claimed it was bound by a prior precedent, Webb v. City and Borough of Sitka, 561 P.2d 731 (Alaska 1977).”

Webb established that “[a] landowner or owner of other property must act as a reasonable person in maintaining his property in a reasonably safe condition in view of all of the circumstances, including the likelihood of injury to others, the seriousness of the injury, and the burden on the respective parties of avoiding the risk.”

Here’s the difference: Webb involved a landowner, in this case the City and Borough of Sitka, which had put out a sidewalk on which the plaintiff had tripped and fallen. There was simply no issue in Webb as to the relation between the plaintiff and the defendant; the defendant was on the plaintiff’s sidewalk when she tripped and broke her hip. The Alaska Supreme Court declared this “controlling precedent” establishing the restaurant’s duty to the motorcyclist who was passing by when the motorist had made its doubly illegal left-hand turn. It is pretty close to impossible to see why.

There was a dissent in Mickelsen and it will not surprise you that it has the better of the argument, by far.

I do not believe that [defendants’] duty extends to [plaintiff], an innocent person with no connection to [defendants] (that is, he was not a customer of [the restaurant] but merely an innocent person driving past the restaurant on a public highway when another person made an illegal turn in front of him, causing the collision and his death). I also think that [defendants] have no duty to prevent a person from making an illegal turn in his wrongful attempt to shortcut into [defendants’] parking lot. To extend a business’s duty to the circumstances of this case will vastly expand the potential liability and attendant costs to businesses all over Alaska. This places an intolerable burden not only on those businesses, but on society at large, because the costs of this greatly expanded liability will surely be passed down to the people in the form of higher costs for goods and services, higher insurance costs, and increased litigation.

The dissenting justice, Justice Craig Stowers, added that the plaintiff was asking the court to

impose liability on anyone who is aware of another’s self-destructive behavior, has any ability to prevent that behavior, and fails to save the injured party from his or her own conduct. Such a holding would transform the law of negligence from a means whereby a person may recover for losses caused by the danger which another’s unreasonable behavior created, to a mechanism permitting persons injured by their own conduct to compel any who failed to prevent that conduct to share in the burden of their negligence.

But that language, Justice Stowers pointed out, came out of another Alaska Supreme Court case, one that the majority had distinguished because the “self-destructive behavior” was that of the plaintiff (who was injured while sledding on a defendant’s street). But the principle it represents, that we do not impose tort liability on people without there being a clear duty to protect other people from foreseeable harm, is far more germane to the case than Webb decision, which did not have to consider those issues at all.

To return to Mr. Kaufman, imagine that his lawyer had been killed while jaywalking to greet someone who turned out not to be him. In Alaska, his heirs might well have been able to get past as 12(b)(6) motion to sue Mr. Kaufman for his audacity in permitting another person to look like him.

Sale Procedures Approved in AFA Bankruptcy

Brandy Sargent — Thu, 10 May 2012 14:21:34 -0800

The Delaware Bankruptcy Court has approved procedures for a sale of AFA Investment, Inc. and its affiliates’ assets. As approved, the procedures are largely as reported here on April 20, 2012, with some changes:

· AFA has until June 11, 2012 to identify a stalking horse bidder. If one isn’t identified, AFA must file its own proposed form of asset purchase agreement on that date.

· Qualifying bids are due by June 19, 2012 at 4:00 p.m.

· If an auction is held, it will be on June 21, 2012 at 10:00 a.m.

If you are interested in participating in the sale process or would like a full copy of the bidding procedures, please contact Brandy Sargent at (503) 294-9888 or David Levant at (206) 386-7601.

Food Processors Prop 65 Chemicals of Interest

Lee Smith — Tue, 08 May 2012 13:06:41 -0800

We recently posted a blog concerning food products and Proposition 65. There have been several chemicals in the news lately that may concern food processors, including methanol, pulegone, beta-myrcene, and PCBs.

Methanol, also known as wood alcohol, can be produced by natural fermentation of fruits and vegetables, and additionally when fruit cell membranes are broken during processing. When the legal levels were proposed, the California Office of Environmental Health Hazard Assessment (“OEHHA”) also issued an Interpretive Guideline, indicating that naturally occurring methanol resulting from pectin was excluded. Although the proposed Maximum Allowable Dose Levels (“MADLs”) would exempt naturally occurring pectin, they might not apply to pectin made as a result of human activity or pectin used as an additive. Pectins are used as gelling agents, colloids, and stabilizers in various food and beverage products. One manufacturer of pectin requested a public meeting concerning the methanol MADLs. That meeting was scheduled for May 7, 2012, and the public comment period was extended to May 21.

In addition several food additives have been proposed for listing: Pulegone is a mint flavoring used in drinks, peppermint, dental products, and herbal medicines, and as a fragrance. Beta-myrcene is a component of essential oils such as hop, bay verbena, and lemongrass. It is also used for adding aroma to products and to flavor chemicals, concentrates, soaps, and detergents.
Several trade organizations have submitted comments that argue that the listings of these chemicals are based on faulty science and are premature. These chemicals are being listed under the Labor Code Mechanism, which was unsuccessfully challenged by producers last year. The trade organizations also indicated that the listing was premature because the actual monograph has not yet been issued. Industry commentators believe that the monograph will address the faulty data, and that the determination of listing should pass to the Carcinogen Identification Committee (“CIC”). The CIC requires more intense scrutiny than is required under the Labor Code Mechanism.

PCB NSRLs Reset

OEHHA recently proposed updated exposure limits for PCBs (polychlorinated biphenyls) in food; a No Significant Risk Level (“NSRL”) based on an EPA risk study. The agency proposed a NSRL of .35 micrograms per day for exposure as oppossed to the current level of .09 micrograms. OEHHA also proposed a MADL for PCBs of 2.3 micrograms for exposures causing reproduction toxicity that was based on a 1995 study. The proposed NSRL applies only to environmental mixtures of PCBs that are in food products, such as those found in certain meats, fish, shellfish, eggs, and dairy products. They do not apply to mixtures of water-soluble PCBs in aqueous solutions.

A recent settlement agreement should be of interest to other producers.

Muscle Milk Pays 2.6 Million

Muscle Milk brand products (Cytosport) is in the process of settling a class action lawsuit that alleged that its products contained elevated levels of arsenic, cadmium, and lead, which posed a health threat. The settlement, initially $2.6 million, contains a mechanism for Cytosport to identify naturally occurring levels of these chemicals on which to base a safe dosage level that also takes into account the naturally occurring levels. These levels relate to the Proposition 65 exemption for chemicals that contain naturally occurring levels, which may in some instances be subtracted from the total concentration before comparing them to the thresholds. Manufacturers must also show that they attempted to lower the levels and that no additional measures are feasible.

Prop 65: What Food and Beverage Manufacturers Need to Know

Melissa A. Jones — Tue, 24 Apr 2012 13:41:25 -0800

Recently I drafted an article on California's Proposition 65, which was published on FoodProcessing.com on April 9, 2012. More information about the article, with a link to the article on Proposition 65 can be found here: www.stoel.com/showarticle.aspx

FSIS' New Rule on Poultry Inspection Remains Open for Comment

Claire Mitchell — Tue, 24 Apr 2012 13:06:41 -0800

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.

Nationwide Beef Processor, AFA, to Sell All Assets in Bankruptcy

Brandy Sargent — Fri, 20 Apr 2012 10:38:38 -0800

AFA Investment Inc., and its affiliates, including AFA Foods, American Foodservice Corporation, United Food Group, LLC, and American Fresh Foods (together “AFA”) have requested that the Bankruptcy Court overseeing their Chapter 11 cases approve procedures for a sale of all of their assets. The sale process was a condition required by AFA’s lenders to continue financing the companies in bankruptcy.

AFA reports that 98 potential buyers have surfaced so far and that 36 have executed nondisclosure agreements. However, none have yet been chosen by AFA as a “stalking horse” bidder, so the sale process is being conducted, at least for now, as an open or “naked” auction.

A hearing on the requested procedures is set for May 8, 2012. AFA’s proposed procedures include:

· AFA will have until May 29, 2012 to obtain one or more letters of intent.

· Potential bidders would have until noon on June 11, 2012 to submit “qualified bids.”

· If more than one qualified bid is received, an auction will be held at 10:00 a.m. on June 12, 2012, at the office of AFA’s counsel in Delaware.

· AFA would have until 24 hours before the auction to choose a stalking horse against which other bidders would compete at the auction. If a stalking horse is chosen, a copy of the proposed asset purchase agreement will be filed with the Bankruptcy Court. A stalking horse may be provided with certain “bid protections” if approved by the Bankruptcy Court, including topping fees, asset mix requirements (to deter piecemeal purchases), and minimum overbids.

· Qualified bids must include, among other things: (a) a list of assets to be purchased, (b) the purchase terms, (c) a form of asset purchase agreement (or a redline against any stalking horse agreement), (d) a waiver of financing and due diligence contingencies, (e) an irrevocable offer until the earlier of July 25, 2012 or two business days following a sale; (f) a commitment to close by June 22, 2012; (g) a commitment to prepare evidence necessary to prove good faith under the Bankruptcy Code; (h) evidence of the buyer’s ability to provide adequate assurance of performance of any contracts to be assumed as part of the sale; and (i) a deposit of 10% of the proposed purchase price.

· Due diligence is available upon execution of an acceptable nondisclosure agreement and proof of financial ability to close.

Parties have until April 30, 2012 to file any objections to the procedures.

If you are interested in participating in the sale process or would like a full copy of the proposed bidding procedures, please contact Brandy Sargent at (503) 294-9888 or David Levant at (206) 386-7601.

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

Claire Mitchell — Fri, 06 Apr 2012 15:08:37 -0800

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.

FDA Will Continue to Study the Safety of BPA

Claire Mitchell — Tue, 03 Apr 2012 14:42:48 -0800

In following up from a previous Food Liability Law blog post that was recently published on Law360, the U.S. Food and Drug Administration (FDA) announced on Friday, March 30, 2012, that is was denying a petition by the Natural Resources Defense Council (NRDC) to ban the use of Bisphenol A (BPA) in food and beverage packaging materials.

The NRDC had filed a petition with the FDA in October 2008. The petition challenged the FDA’s position that exposure to BPA in low levels is safe, and accordingly, requested that the FDA ban the use of BPA as a food additive or in any substance that may become a component of a food product, as defined by the Federal Food, Drug and Cosmetic Act (FFDCA). Pursuant to a court order issued in December 2011, the FDA had until Saturday March 31, 2012 to issue a response to the NRDC’s petition.

The FDA explained in its denial letter that it appreciates the NRDC’s concern for consumer safety, and it will continue to broadly and comprehensively review scientific data regarding the effects of BPA on human health. In addition, the FDA plans to complete studies already in progress at the agency’s National Center for Toxicological Research (NCTR). The letter concluded:

FDA has determined, as a matter of science and regulatory policy, that the best course of action at this time is to continue our review and study of emerging data on BPA. . . . FDA is performing, monitoring, and reviewing new studies and data as they become available, and depending on the results, any of these studies or data could influence FDA's assessment and future regulatory decisions about BPA.

Douglas Karas, a spokesman for the FDA, stated, “I cannot stress enough that this is not a final safety determination on BPA.” He added, “This is a decision on the NRDC petition. The FDA denied the NRDC petition because it did not have the scientific data needed for the FDA to change current regulations, which allows the use of BPA in food packaging.”

Yet, despite the FDA’s decision to deny the NRDC’s petition, many major food companies have already begun using alternative packaging methods thereby eliminating BPA in order to quell public concern over the potential risks associated with the chemical.

Members of Congress Send Letter to FDA in Support of GMO Labeling

Claire Mitchell — Mon, 02 Apr 2012 13:26:23 -0800

Recently, on March 12, 2012, 55 Members of Congress sent a letter to the U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg calling on the agency to require the labeling of genetically engineered (GE) foods.

According to a press release from the nonprofit organization Center for Food Safety:

The bicameral, bipartisan letter led by Senator Barbara Boxer (D-CA) and Congressman Peter DeFazio (D-OR) was written in support of a legal petition filed by the Center for Food Safety (CFS) on behalf of the Just Label It campaign and its nearly 400 partner organizations and businesses; many health, consumer, environmental, and farming organizations, as well as food companies, are also signatories. Since CFS filed the labeling petition in October 2011, the public has submitted over 850,000 comments in support of labeling.

The letter comes as the most recent move in the longstanding and familiar debate over whether the U.S. should require labeling of GE foods. For years, proponents of labeling have emphasized that consumers have a right to know what is in their food and have expressed concern over the potential unintended consequences of consuming GE food products. On the other hand, opponents have maintained that the expense and difficulty of labeling GE food products would be prohibitive.

As background information, GE or genetically modified (GM) foods are those whose genetic makeup has been altered using laboratory techniques in order to achieve certain desirable traits such as pesticide resistance, drought tolerance, or improved nutrient content. This process involves the introduction of foreign or synthetic DNA material into the organism’s cells. The technology used to produce genetically modified organisms (GMOs) is fairly new, having only been developed in the early 1970s. However, today, the use of that technology in commercial food production is widespread.

Nearly two decades ago, in May 1992, the FDA issued a Statement of Policy where it addressed the labeling of foods derived from new plant varieties, including plants developed by genetic engineering. The agency concluded that those GE foods do not differ from other foods in any meaningful or uniform way, and, as such, are not subject to special labeling requirements. This decision caused a stir among consumer advocacy groups who believed that GE foods should be labeled so that consumers can make fully informed choices. However, the FDA’s policy on GE food labeling has remained unchanged.

Congress’ letter from earlier this month urges the FDA to change that position. The letter notes that “[a]t issue is the fundamental right consumers have to make informed choices about the food they eat.” The Center for Food Safety has asked the FDA to respond to its petition within a “reasonable time.” It is unclear where the FDA will fall on this issue.

Yet despite the fact that there is currently no federal regulation mandating the labeling of GE foods, several states have begun to consider bills that would require labeling of GE foods or would prohibit them entirely. Among those states are California, Maryland, New York, North Carolina, Oregon, Tennessee, Vermont, and Washington. In addition, nearly 50 countries including the European Union member states, Japan and other important United States trading partners, have laws requiring companies to disclose the presence of GE ingredients on their food product labels.

It will be crucial for the food industry to pay careful attention to the changing state of the law surrounding GE food labeling to ensure that their product labels are in full compliance.

Nationwide Beef Processor Seeks Bankruptcy Protection Citing "Pink Slime" Furor

Brandy Sargent — Mon, 02 Apr 2012 12:15:26 -0800

AFA Investment Inc. and its affiliates, including AFA Foods, American Foodservice Corporation, United Food Group, LLC, and American Fresh Foods (together "AFA"), one of the largest ground beef processors in the United States, have filed for Chapter 11 bankruptcy protection.

AFA cited growing negative publicity over the use of boneless lean beef trimmings (identified as "lean finely textured beef" or "pink slime" in some articles) as well as lower retail demand for beef products, costly product testing programs, and a change of customer base from foodservice to retail customers as events causing the filing.

Ron Allen, AFA's Interim CEO, stated that the companies have hired an investment banker to market their assets and plan to idle their Los Angles, California processing facility this week. AFA reported consolidated booked asset value of $219 million against $197 million of liabilities. The companies currently have 850 full-time employees and operate facilities in Georgia, New York, Pennsylvania, and Texas, in addition to the California facility.

AFA requested approval of $60 million in "Debtor in Possession Financing" to be advanced by the companies' current first-priority lenders. One lending covenant would require AFA to file a motion to sell all of the companies' assets within the next 14 days. AFA also requested permission to continue to honor customer programs including rebates and returns, to pay certain "critical vendors" immediately, and to institute procedures for receiving and handling priority claims of vendors under the Bankruptcy Code.

The AFA bankruptcy follows news last week that other beef processors are reducing production in the wake of the furor and reported uncertainty in futures markets and auction prices.

Check back at the blog for additional information regarding the AFA bankruptcy as it becomes available.

Proposition 65: New Director of OEHHA

Melissa A. Jones — Thu, 22 Mar 2012 10:05:07 -0800

Yesteday, Governor Brown appointed George Alexeeff as the Director of the Office of Environmental Health Hazard Assessment (OEHHA) at the California EPA. Alexeeff has been the deputy director of OEHHA since 1998 and has worked at the department since 1988. He has a doctorate in pharmacology and toxicology from U.C. Davis.

Among other duties, OEHHA is responsible for maintaining the State's list of chemicals known to cause cancer or reproductive toxicity for purposes of Proposition 65. OEHHA also develops "safe harbor" numbers for some of the chemicals on the list (there are approximately 300 chemicals out of the 800+ Proposition 65 chemicals that have safe harbor numbers).

UCL Class Actions in California Expand Beyond "All Natural" Claims

Melissa A. Jones — Wed, 21 Mar 2012 14:17:53 -0800

The “All Natural” class action litigation in California has continued into 2012, as expected. The claims in California are being filed under California’s consumer-friendly unfair competition law (or UCL), which is codified in sections 17200 and 17500 of the California Business & Professions Code, and the Consumer Legal Remedies Act (CLRA).

Given the costs and risks associated with UCL and CLRA class actions, many companies are getting pro-active and are carefully analyzing their labels. The challenge for such companies, however, is that these lawsuits are not limited to labels that contain the words “All Natural.” They fall into several broad categories.

First, there has been litigation over products that are marketed as being healthy but contain allegedly unhealthy ingredients, such as trans fat, saturated fat, high-fructose corn syrup or sugar. Consumer protection class actions may also arise like a claim for a defective product-- where an otherwise healthy product experiences a manufacturing, packaging or storage deviation that takes its ingredients outside of the representations made on the label and subjects the manufacturer to litigation over “deceptive labeling” practices.

Second, there has been litigation over products that claim to be “All Natural” or “100% Natural” that allegedly contain GMOs or other synthetic or artificial ingredients. The types of ingredients that have been challenged by plaintiffs include:

alkalized cocoa

ascorbic acid (vitamin C)

beta-carotene (vitamin A)

calcium pantothenate (vitamin B5)

cyanocobalamin

dutch cocoa

folic acid (a B vitamin)

glycerine

GMOs

inulin

niacinamide

potassium carbonate

pyridoxine hydrochloride

riboflavin

sodium benzoate

sodium citrate

soy proteins (from hexane)

xanthan gum

zinc oxide

Of course, many of these ingredients are used frequently in products and there is no evidence that they are harmful. But given the California Supreme Court’s recent finding that “labels matter” (as opposed to product quality), plaintiffs are seizing on the opportunity to claim that something that has been processed or contains any “artificial” ingredient cannot possibly be “All Natural.”

Third, there has been litigation over claims about the quality of ingredients, such as “100% Pure” claims on orange juice or coconut water labels.

Finally, there has been litigation over products that have unsubstantiated health benefit claims, such as “proven to reduce cholesterol,” “supports digestion, . . . metabolism, . . .[and] liver function,” “supports immunity,” “reduces risk of chronic diseases,” “promotes healthy joints,” or otherwise.

In the current environment (with the lack of guidance from FDA and various court rulings that have struck down motions to dismiss), companies cannot afford to ignore the risk of litigation. The important thing for companies to take away from the morphing UCL class action litigation in California is that a cursory review of product labels is no longer enough to help ensure loss prevention. The product, whether labeled “All Natural” or not, should be reviewed carefully as the litigation theories in California broaden. Indeed, as noted above, many of the class action lawsuits in California involve claims other than “All Natural.” Companies should conduct an intensive review of product ingredients (and consider testing) to ensure compliance with labeling regulations and to assess whether the ingredients and labeling claims are likely to result in unwanted attraction from the plaintiffs’ bar.

For more information on this topic, contact Melissa Jones and Tom Woods in the litigation department of the firm’s Sacramento office.

Methanol Listed on Prop 65 List, Methanol in Fruit and Vegetables Linked to Pectin

Lee Smith — Mon, 19 Mar 2012 14:28:25 -0800

As of March 16, 2012 Methanol was added to the Prop 65 list as a reproductive hazard. According to OEHHA ,Methanol occurs naturally in fruits and vegetables. Methanol is also formed when fruits and vegetables are physically prepared for consumption by slicing, chopping, pureeing and juicing. The production of free methanol in all these instances is the result of reactions in pectin, a principal component of plant cell walls and the middle lamella between them. Pectin is heteropolysaccharide contained in the primary cell walls of terrestrial plants. It is produced commercially as a white to light brown powder, mainly extracted from citrus fruits, and is used in food as a gelling agent particularly in jams and jellies. It is also used in fillings, medicines, sweets, as a stabilizer in fruit juices and milk drinks, and as a source of dietary fiber. Pectin will break down to methanol when the plant cell walls and middle lamellae are disrupted, as can happen through physical processes of food preparation. Methanol is also produced when pectin is digested after eating fruits and vegetables, but OEHHA does not believe that the pectin that is activated by chopping and slicing will increase over the amount that is produced during digestion.

In addition to the notice that methanol is now on the Prop 65 list, OEHHA released the Interpretive Guideline No 2012-01 that indicates that methanol resulting from Pectin in Fruits and Vegetables is considered to be Naturally Occurring under section 25501 of Prop 65 and thus not required to comply with the Prop 65 warning requirements. The interpretation leaves the door open as to whether pectin that is added to products is subject to Prop 65. The text of the exemption which excludes levels of these chemicals that occur naturally in food without addition by human activity, may be a hard standard to meet.

OEHHA has also proposed regulatory levels for the consumption of methanol both by ingestion and inhalation. The numbers although they appear to be high on their face, Maximum Allowable Dose Levels for methanol of 47,000 micrograms per day for inhalation and 23,000 micrograms per day for ingestion are not. Based on the numbers derived from the pectin interpretation, fresh orange juice may have methanol concentrations as high as 80 ppm. At that concentration the Prop 65 MADL level is arguably reached with just ten ounces of juice.

Comments may still be transmitted to OEHHA on these proposed MADLs until April 30, 2012.

FDA Issues Interim Regulation and Input on Document Inspection Requirements under FSMA

Lee Smith — Mon, 19 Mar 2012 09:53:55 -0800

Effective March 1, 2012, the FDA implemented an Interim Final Rule on the “Establishment, Maintenance, and Availability of Records” under the Food Safety Modernization Act, “FSMA”.

The FSMA statute among other new provisions, expanded the FDA’s authority to access and demand records from relating to the specific suspect article of food records, to include those relating to any other article of food that the FDA “reasonably believes is likely to be affected in a similar manner.” Although they are already in effect, the comment period for these rules is May 23, 2012. . These rules were not subject to the normal public review procedure because the FDA found that it was contrary to the public interest to delay them as the FSMA statute called for that access from its inception. The FDA has always indicated that” reasonable belief” determinations are made on a case by case basis because such decisions are fact-specific.

The expanded rule continues to reflect the requirement that records “must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request, from an officer or employee only designated by the Secretary of Health and Human services who presents appropriate credentials and a written notice.”

Also issued in February was a “Draft Guidance for Industry: FDA Records Access Directly Under Sections 414 and 704 of the Federal Food, Drug & Cosmetic Ad.”

The guidance makes clear that records request may:

Apply to either human and animal food;
Apply to both domestic and foreign persons;
The scope of records are those that are “needed to assist FDA in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to human or animals,” and they may access records needed to assist in determining whether there is a reasonable probably that the use of or exposure to the food will cause serious adverse health consequences or death to human or animals.

There is also a listing of what FDA believes are examples of the circumstances under which they would access documents for related food articles. They include:

Salmonella outbreaks with multiple foods implicated;
Multiple articles of food on an identical processing line;
Articles of food in shared use equipment;
Articles of food prepared, packed or held under similar conditions.

They also list examples of the type of records they could/would access:

Manufacturing records;
Raw materials (ingredients and packing) receipt records;
Product distribution records;
Product inventory records;
Test records;
Recall records;
Reportable food records;
Customer distribution lists;
Complaint and adverse event records.

The FDA also lists the types of records the FDA cannot access:

Records from farms;
Records from restaurants;
Recipes;
Financial data;
Pricing data;
Personnel data;
Research data;
Sales data other than shipment data researching sales.

In the document they also address actions they make take for refusal to provide records, including civil administration actions, suspension of registration, administrative detention, seizure of the food, issuance of a recall and injunction against the firm.

Finally, the FDA also issued a 52-page guidance for Industry, Edition 5, for Questions and Answers Regarding Establishment and Maintenance of Records by Persons who Maintain, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food. This document contains numerous scenarios to provide industry with a better understanding of how the rules play out in practice.

Coke and Pepsi to Change Formula to Avoid Prop 65 Labeling

Lee Smith — Fri, 16 Mar 2012 08:01:05 -0800

In follow up to previous articles, we note that a consumer group last week released a report that alleged that caramel colored sodas (Coke,Diet-Coke, Pepsi and Diet Pepsi) contain levels of 4-methylimidazole (4-MEI) that reached a level of 7 in a million cancer risk. The Center for Science in the Public Interest, claims that the carcinogen forms when ammonia or ammonia and sulfites are used to manufacture the caramel coloring that gives those sodas brown colors. In conjunction with their report the group requested that the Food and Drug Administration revoke its authorization for caramel colorings that contain 4-MEI, and in the interim to change the name of the additive to ammonia-sulfite process caramel coloring or chemically modified caramel coloring for labeling purposes.

Although according to industry experts the amount of soda that would trigger these effects is excessive, Coca Cola and Pepsi recently announced that they were changing their formulas, because of California's Prop 65 law that would require labeling if, as alleged, these products exceed the 1 in 100,000 risk that triggers labeling requirements.

As we noted earlier a sixty day notice has already been served on certain grocers with respect to similar products. The sixty day notice is the first step in the Prop 65 private enforcement process.

Upcoming Deadline for FDA to Decide Whether to Ban BPA

Claire Mitchell — Wed, 14 Mar 2012 16:30:39 -0800

Bisphenol A (BPA) is an industrial chemical that has been present since the 1960s in plastic used in consumer products, including reusable water bottles, sippy cups, and baby bottles, to prevent cracking. BPA is also used in the protective lining inside metal-based food and beverage cans to avoid corrosion. In recent years BPA has become the focus of a heated debate. Citing an increasing body of scientific evidence, consumer and health advocates argue that there is a link between disruptions in the endocrine system and the consumption of products packaged with materials that include BPA. Certain studies have identified BPA as a risk factor in breast and prostate cancer, early puberty, childhood obesity, autism, and hyperactivity. Accordingly, critics of BPA believe it is a substance unfit for human consumption and have urged a ban on its use in food and beverage containers.

The U.S. Food and Drug Administration (FDA) and the National Toxicology Program of the Department of Health and Human Services maintain that low level exposure to BPA does not pose a serious risk to human health based on studies employing standardized toxicity tests. However, both agencies have noted some concern about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children. The FDA has since undertaken to do further research into the potential health risks associated with BPA.

In attempt to put pressure on the FDA to clarify its stance on BPA, just over three years ago the National Resources Defense Council (NRDC) filed a petition with the FDA challenging its position that exposure to BPA in low levels is safe. The petition requested that the FDA ban the use of BPA as a food additive or in any substance that may become a component of a food product, as defined by the Federal Food, Drug and Cosmetic Act (FFDCA). For several months, the FDA delayed responding to the NRDC’s petition.

Prompted by the FDA’s failure to respond, NRDC filed suit in 2010 seeking judicial intervention that would require the FDA to decide by a date certain whether the use of BPA, particularly in food packaging and any material likely to come in contact with food, should be banned. In a settlement agreement, the parties agreed FDA would make its decision about the use of BPA by March 31, 2012 - a date that is rapidly approaching. The FDA’s decision will come on the heels of France’s decision in early February 2012 to ban the use of BPA in all food packaging.

What impact would a ban of BPA have on industry if imposed? Almost certainly as companies adapted to the new ban, their costs would increase. The extent of those costs would likely differ based on the size of the company and the extent of required changes to production. The disruption may be dampened a bit because several food companies have anticipated the issue. A recent report issued by the U.S. Department of Agriculture indicates that several major U.S. companies have already begun using alternative packaging methods to comply with BPA bans on both state and international levels, and to meet increasing consumer demand for BPA-free products. Eden Foods, Muir Glen, Edward & Son, Trader Joe’s, Vital Choice, Wild Planet Foods, Oregon’s Choice Gourmet and Eco Fish already use BPA-free containers for some or all of their products. In addition, Heinz, Hain Celestial and ConAgra have begun taking steps toward eliminating the use of BPA in their packaging.

It will be interesting to see what decision the FDA will announce by the end of this month.

FSMA And Prop 65 At The GMA Conference

Lee Smith — Thu, 08 Mar 2012 15:32:13 -0800

Attorneys Lee N. Smith and Melissa A. Jones participated in the GMA 2012 Food Claims and Litigation Conference in Dana Point. Mr. Smith (his real name) spoke on the effect of the New Food Safety Modernization Act and its potential impact on litigation, and Ms. Jones (her real name) and Mr. Smith also presented an overview of Proposition 65 and recent developments with particular regard to food products.

How FSMA May effect Litigation

It was our premise that FSMA will affect litigation in two main areas. One related to the threshold standards under the statute, which have yet to be defined in detail by law or regulation and two, related to the potential increase in government actions under those standards and the commensurate increase in related plaintiff litigation.

The areas under FSMA that have similar thresholds are those that trigger recalls (Sec. 206) , reporting to the food registry (Sec. 211), deregistration (Sec 102), additional record review (Sec.101) and finally those that may trigger administrative detentions (Sec. 207). The first four sections are triggered by the reasonable probability standard, which is usually taken to be mean more than 50% or more probable than not; which is a low standard to trigger recalls or reporting. The other standard for detention is “A reason to believe” food is “adulterated or misbranded.” for administrative detentions." We believe that these standards will trigger litigation similar to the Del Monte Fresh litigation where industry challenged the FDA's lack of evidence available to require a detention and recall.

With respect to Prop 65 we discussed the Prop 65 listing process, and recent case law California Chamber of Commerce v. Schwarzenegger et al., 196 Cal. App 4th, 233 (2011) that supports listing that comes directly from listing made under the labor code.

We identified a recent preemption case that found that the regulation of poultry did not in fact pre-empt prop 65 (see Physicians Comm. for Responsible Med. v. McDonald’s Corp., 187 Cal. App. 4th 554 (2010) (federal Poultry Products Inspection Act did not preempt Prop 65 warnings) and discussed the naturally occurring defense under Prop 65 which is difficult and can costly to prove.

We also noted a recent sixty day notice for MEI; which was just listed last year. The chemical 4-MEI is a fermentation byproduct in certain food products including caramel coloring, soy sauce, Worcestershire sauce, wine and ammoniated molasses, as well as ammoniated livestock feed. The chemical is used in the manufacture of pharmaceuticals, photographic chemicals, dyes and pigments, cleaning and agricultural chemicals, and rubber. First Sixty Notice to grocers in Feb. 2012 as to carbonate soft drinks with caramel coloring.

We mentioned the recent listing of Sulphur Dioxide and the current dispute over safe levels. SO₂ is a colorless, nonflammable gas with a pungent odor. As a component of ambient air pollution, SO₂is found in combination with sulfuric acid, sulfur trioxide, ozone, nitrogen dioxide, and particulates, and its presence in ambient air occurs primarily as a result of fossil fuel consumption at power generation and other industrial facilities

• Used in many food products as a preservative including on Cherries and Raisins.

• Should have been listed as an inhalant hazard only.

Please contact us if you have any questions.

Proposition 65 case involving 4-MEI in soda

Melissa A. Jones — Tue, 14 Feb 2012 17:24:25 -0800

For news on the first alleged Proposition 65 violation concerning 4-Methylimidazole (4-MEI) in soda, see my blog posting in the environmental law blog. 4-MEI exists in some food and beverage products, including certain sodas, beers, soy sauces, breads, and coffees, among others.

http://www.californiaenvironmentallawblog.com/first-prop-65-notice-of-violation-issued-regarding-4-mei-in-soft-drinks/