Wednesday, May 20, 2015

The Wild Problems of Agriculture

The United States (and World) has a long history of intertwined resources and animals. We sow, harvest, and consume food from a variety of agriculture practices to fuel our need for human energy. Agriculture and wild animals are both historical in our existence as humans.

A recent article published in the Food Safety News ( described a scenario that highlights the relationship between some farmers in the nation and wild animals. Some farmers experience crop loss due to wild animals; however, crop loss is just one problem. Another is crop contamination due to food pathogens scattered among crops as a result of animal dwelling.

Crop damage from wild animals is an increasing problem throughout the nation. Take Indiana for example, a state known for contributing agricultural products in corn and soybeans. According to the USDA National Agricultural Statistics Service of 2002, over 65 percent of the state is farmland. Also, the state rakes in $1.5 billion annually from wildlife-related activities. [1] Because of the mix of healthy wild animal populations and farmland, crop damage is a problem for Indiana farmers. In fact, farmers around the nation are effected. An estimated crop damage and loss from ranchers and farmers exceed 4.5 billion annually. [2] Crop damage is caused from a multitude of species including but not limited to deer, raccoons, bears, bird species, and rabbits.

In addition to crop damage, wild animals can contaminate crops with pathogens. These pose health risks. One realm of agricultural products that are great affected by wild animal pathogens is fresh fruits, nuts, and vegetables. These products are minimally processed and often not treated with a kill step, heat or chemical treatment. The risk occurs when wild animals rummage through crops. Outbreaks are related to fecal contaminations or surrounding watersheds after wild/ feral animals come into the area. [3] The Centers for Disease Control and Prevention (CDC) roughly estimates that plant commodities caused approximately 46% of domestically acquired food-borne illnesses from 1998 to 2008. [4] An example is the outbreak in 2006 of Escherichia coli 0157:H7. [5] The outbreak was traced back to a spinach crop in California contaminated from cattle and feral swine fecal matter. [6]

Wild animals present risks for crop damage and health.  While many other risks are present, such as ground water contamination, these two risks directly correlate to wild animals on the farmland. In realizing that farmers struggle with crop damage, states allow depredation permits to allow farmers to cull wild animals to prevent crop loss. Permitting often includes shooting, trapping, and relocating. The various methods often depend on the state. Some states require counseling and more detailed systems than others.

Iowa’s depredation system is comprehensive in giving farmers the option for advice, alternative plantings, counseling, and depredation permits. Indiana maintains a diverse system with multiple options including permits for harvesting, pesticides, relocating, and euthanizing. Ohio allows permitting for crop damage and nuisance wild life; online manuals and instructions are available. A system also exists for federally protected species that become a hindrance. For example, the United States Fish andWildlife Service offer permitting for migratory birds. Of course many of these concerns mentioned revolve around crop damage from wild animals and not health risks.

Depredation systems are reasonable; farmers can be greatly affected by crop damage. However, some states should focus more on proactive efforts rather than reactionary efforts. Examples of proactive efforts can be wildlife studies before plantings, barriers, fencing, and crop choice. This may require counseling and more interaction with the farmers, the land, and the animals. The proactive approach can be beneficial to decrease depredation conduct.

In today’s increasing concern for food safety, more attention can be paid to wild animal health risks in these state systems. As more light is shed on crop health risks, law may require more attention in the future. Just as counseling and proactive conduct can ease crop damage, health risks from cropland wild animals can be decreased as well. The consumer, the wildlife, and the farm can potentially benefit from such approaches in the future. 

[1] Brian J. MacGowan, Lee A. Humberg, James C. Beasley, Travis L. DeVault, Monica I. Retamoa, and Olin E. Rhodes, Jr., Corn and Soybean Crop Depredation by Wildlife, Perdue University Extension Service, Department of Forestry and Natural Resources. Page 2.
[2] Brian J. McGowan, Lee A. Humberg, James C. Beasley, Travis L. DeVault, Monica I. Retamosa and Olin E. Rhodes, Jr., Corn and Soybean Crop Depredation by Wild Animals, Department of Forestry and Natural Resources, Purdue University, Extension Service, Page 2.
[3] Michele T. Jay-Russell, What is the Risk from Wild Animals in Food-borne Pathogen Contamination of Plants?, Address: Western Center for Food Safety, University of California, Online Version of the article found at:, Page 1.
[4] Painter JA, Hoekstra, Ayers T, Tauxe RV, Braden CR, Angulo FJ, et al. Attribution of foodborne illnesses, hospitalizations, and deaths to food commodities by using outbreak data, United States, 1998-2008. Emerging Infectious Diseases 2013;19:407-13.
[5] Infra fn. 2 at page 2.
[6] Id.

When the Going Gets Worse… Understanding the FDA Recall

The food business is broad and layered consisting of several consumers and business models. It consists of manufacturers, packers, distributers, and retailers, many small and large. There are several different supply chains consisting of farm to fork operations, retail chains for affordable options, and local regional markets.

The FDA plays a significant role in our society by providing regulatory efforts on various foods, drugs, biologics, medical devices, radiating products, cosmetics, veterinary products, and tobacco products. Regarding food, there are real health concerns regarding food pathogens and sickness that can affect consumers. The question begs, when and how can FDA initiate and recall food products that pose risk?

This question became of utmost importance to my family in midst of the recent Blue Bell Creameries listeria outbreak. My family owns and operates a small Ice Cream Shop in Western North Carolina where we previously sold Blue Bell products. So we asked ourselves, what exactly is a FDA recall?

Recall is a mechanism enforced and policed by the FDA to pull many products (often food products) from the market in order to protect the public from exposure or injury. The food policy “recall regulations are found at 21 CFR Part 7. It is an effective method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration. 21 C.F.R. Part 7.40.  A “recall” is defined in 21 C.F.R. 7. 3(g) as a firm’s removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers, and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.

The recall can be voluntary; manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk or injury. 21 C.F.R. 7.40(a). The recall is an alternative to the other approaches the FDA rarely pursues. Recall alternatives are FDA-initiated court actions for removing products from the consumer market place. 21 C.F.R. 7.40(a). The recall function was created to provide assurance and to increase safety; FDA recall procedures, monitoring, and analysis achieve these goals. 21 C.F.R. 7.40(a).

The FDA can request a recall when a company does not voluntarily recall a product itself. These recalls however are reserved for urgent situations. 7 C.F.R.7.40(b). The recall is a policy-based procedure to provide more protection in more reasonable manners as opposed to other procedures. In addition to court-initiated actions, the FDA can order a seizure. Court-initiated remedies and seizures are often problematic when products are consumed and already available to consumers. However, they are needed in several situations. They are helpful when an entity refuses to follow an FDA request, a recall would not be effective, or further violations are discovered. 21 C.F.R. 7.40(c).

Health hazard evaluations and recall classifications are found at 21 C.F.R. 7.41. These regulations detail how health hazards will be evaluated by the FDA in accordance to the list of factors to be considered.  The factors considered will then enable the FDA to classify the health hazard and declare the recall as one of three different classifications. 21 C.F.R. 7.41(6)(b). If a recall is requested, the FDA has the option of detailing a recall strategy for the company.  A recall request from the FDA can only be made when the FDA has made several prerequisite determinations. These determinations can be found at 21 C.F.R. 7.45(a).

The FDA is striving to improve the recall function. Most recently, the FDA is implementing a FDA mandatory recall function. The mandatory recall authority is authorized from Section 206 of the Food Safety Modernization Act that compliments the Federal Food, Drug, and Cosmetic Act. This is highlighted in the recent draft guidance published by the FDA in finalizing their mandatory recall procedures. The draft is available for public comment for 60 days starting May 7th, 2015 in which the FDA will consider all comments before drafting the final version.

Consumers interact daily with many products and food fibers that present risks to our health. Many of these products are regulated by the FDA and fall under the FDA’s regulatory power. Knowing the framework of the FDA “recall” can help consumers better understand our food industry and food safety. 

Tuesday, May 12, 2015

Final Rule on "Gluten-Free" Labeling Is Now In Effect

After a year of phasing in compliance, the Food and Drug Administration now requires any food labeled “gluten-free,” to contain no more than 20-parts per million of gluten, which is the lowest level detectable in food and one that would generally be acceptable even for those who suffer extreme gluten-intolerance health problems. The final rule also holds foods labeled “without gluten,” “free of gluten,” and “no gluten” to the same standard. The rule also brings the United States in line with international labeling standards that are employed across Europe and other parts of the world.

Products must not contain any wheat, barley or hybrids, or be derived from a gluten-containing grain that has not been processed to remove gluten. However, some products that are labeled "gluten-free" that have levels above the defined levels of acceptability for gluten-free products are permitted to remain on shelves as the ban isn't retroactive. "Gluten-free" products with long shelf-lives, like pasta, may remain on shelves even after the the implementation of the final rule (see FDA's Q&A on compliance).

As mentioned in the final rule, the FDA will engage in additional rulemaking to establish how it will determine compliance for hydrolyzed and fermented foods (e.g., yogurt, sauerkraut, hydrolyzed protein) because the current methods cannot quantify gluten in these foods. In the meantime, hydrolyzed and fermented foods that meet the definition of "gluten-free" may bear a gluten free claim. The FDA will exercise enforcement discretion to beer that currently makes a “gluten-free” claim and that are (a) made from a non-gluten-containing grain or (b) made from a gluten-containing grain, where the beer has been subject to processing that the manufacturer has determined will remove gluten. This enforcement discretion pertains only to beers subject to FDA’s jurisdiction and that were making a "gluten-free" claim as of August 5, 2013. Please note that the FDA regulates non-malt beers (beers made without malted barley or hops).

The effective compliance date of the rule is August 5, 2014. Products labeled prior to the compliance date that bear the claim “gluten-free” will not be subject to regulatory action by FDA. However, any product labeled by the manufacturer on or after August 5, 2014, bearing a “gluten-free” labeling claim that does not comply with the definition will be subject to regulatory action. The "gluten-free" final rule applies only to packaged foods, the FDA expects restaurants that use “gluten-free” on their menus are consistent with the federal definition; however, the final rule does obligate restaurants to be in compliance.

Monday, May 11, 2015

Antioxidant Labeling Claims Continue to Keep Plaintiffs Lawyers Busy

In a recent suit filed in California, Millennium Products, Inc., the maker of GT’s Kombucha and Synergy drinks, was challenged on claims that its drinks contain "powerful antioxidants", which plaintiffs claim is in violation of the Food, Drug and Cosmetics Act because the antioxidant statements it makes are misleading and unauthorized nutrient content claims as proscribed by the FDA.

Pursuant to federal regulations, a nutrient content claim is a claim on a food product that directly or by implication characterizes the level of a nutrient in the food (e.g., "low fat," "high in oat bran," or "contains 100 calories"). Only those claims that are specifically defined in the regulations may be used, all other claims are prohibited. Previously approved nutrient content claims characterize the level of a particular nutrient (e.g., ‘low sodium’), whereas a term such as ‘high in antioxidants’ ties a claim (i.e., ‘high’) to a class of nutrients that share a specific characteristic (i.e., they are antioxidants).

GT’s label use lists “EGCG 100mg" (a polyphenol found in tea with recognized antioxidant properties) in order to substantiate their antioxidant claim. However, for claims characterizing the level of antioxidant nutrients in a food, a reference daily intake (RDI) must be established for each of the nutrients that are the subject of the claim, but in this case there is no established RDI for EGCG (see FDA Warning Letter). Moreover, since GT's product is a type of tea, and the FDA considers tea a food with no nutritional significance, the plaintiffs claim the drinks do not contain “even a single antioxidant nutrient with an established RDI."

It is important to note that Millennium Products, Inc. isn't the only company to face legal action in recent years from consumers making false labeling claims. Recently, Twinings North America, Inc. was sued for allegedly deceiving consumers by mislabeling its teas as a "natural source of antioxidants", however, in this case the judge dismissed the lawsuit stating that a "natural source of antioxidants" is not a nutrient content claim because it did not state or imply the level of antioxidants. However, in a warning letter sent in 2012, the FDA noted that the statement "very powerful antioxidant" is an unauthorized nutrient content claim because "very powerful" characterize the level of antioxidants in the product. Other tea producers were also sent warning letters by the FDA over their green teas because they were improperly labeled with the term “antioxidant” (see Unilever, Inc., maker of Lipton Tea, and Dr. Pepper Snapple Group).

As lawsuits are increasingly targeting food and beverage makers challenging their labeling claims, it is more important than ever to make sure your labels are thoroughly reviewed prior to introducing the products into the marketplace.  We will continue to monitor labeling claim lawsuits, so please check back for updates.

Friday, May 8, 2015

A Role for States in Antibiotic Regulation?

On April 13, 2012, the U.S. Food and Drug Administration (FDA) issued a guidance for industry, titled "The Judicious Use of Medically Important Antimicrobial Drugs in Food Producing Animals." Under this non-binding "Judicious Use" framework, the appropriate use of medically important antibiotics in food-producing animals is limited to those instances that are: (1) "considered necessary for assuring animal health;" and (2) "include veterinary oversight or consultation." However, some may find it troubling to learn that FDA lacks even basic data on antibiotic use in animal agriculture, making a determination of whether the industry is complying with the judicious use standard nearly impossible to obtain.

For more than three decades, scientists from various disciplines have been sounding the alarm over the use of antibiotics in animal agriculture, to no avail. While there is data to indicate a correlation between antibiotic use in livestock operations and antibiotic-resistant infections in humans, many in the industry are quick to point out that a causal link has never been established. Though not explicitly stated, the implication is that no causal link has been established because none exists. However, an absence of evidence is not evidence of absence. In order for scientists to determine whether a direct causal link exists, they need access to information about how, when, why, and to what extent antibiotics are being used. As stated above, FDA lacks this information. And, if the past is any indication, Congressional interference with FDA regulatory activities makes it unlikely that FDA will be able to gather this information in the near future.

One solution to this entrenched and rather contentious issue is for States to implement reporting requirements for antibiotic use in animal agriculture. Unlike the Federal Government, the States wield the police power, allowing them to regulate to protect the public health and safety. The States could simply require all animal agricultural operations to report their antibiotic use, and then share that information with FDA. This information would then help FDA determine whether additional regulatory action needs to be taken, including mandatory guidelines for use, or withdrawal of approval for antibiotics that pose a risk to human health. However, it’s no secret that the political process that takes place in State capitals is not so very different from what takes place on Capitol Hill. Whether the States would be willing to take on the role of regulator in this instance remains unclear.

Whatever happened to all those GMO labeling bills?

So, what is the status of all of those GMO labeling bills and other initiatives that you may have heard about over the last year or so?

Two states – Oregon and Colorado – had mandatory labeling initiatives in the recent November, 2014 elections.  Voters turned them down in both states:  by a wide 65% -- 35% margin in Colorado and by a close 50.03% -- 49.97% in Oregon (this follows a prior defeat in the state in 2002).
In 2013, voters in Washington State rejected a GMO-labeling bill, by a vote of 51% to 49%.  And, in 2013, California voters defeated a GMO label law by 51.4% to 48.6%.  

Therefore, no state-wide ballot initiative has yet succeeded.

State legislatures have, in some cases, stepped in to the void.  In May, 2014, the Governor of Vermont signed the first law requiring the labelling of genetically-modified foods.  The Vermont law requires that any food shall be labeled as produced entirely or in part with genetic engineering if it so produced and if it is offered for sale in Vermont after July 1, 2016.  (Read the law here:  The law includes a de minimis exception where genetically-engineered materials make up no more than 0.9 percent of the total weight of the processed food, and an exception for restaurants and similar food establishments.  As its state legislators predicted, a challenge to the law is pending in federal court.  On April 27, 2015, the judge in the case dismissed the Grocery Manufacturers Association’s motion (GMA was joined by other food associations as plaintiffs) for a preliminary injunction to prevent the law from going into effect while litigation is pending.  The judge did not, however, grant Vermont’s motion to dismiss the case, which means that it will probably proceed to trial.  The plaintiffs have not yet filed an appeal.  

In December, 2013, Connecticut's governor signed legislation that would require labeling on foods made with genetically-modified ingredients (read the law here:    

    While Connecticut was the first state to pass a labeling law, its rule does not take effect until at least four other Northeastern states, with a combined population of at least 20 million, pass similar laws.  Similarly, in January, 2014, the governor of Maine signed a GMO-labeling law, but the law won’t go into effect until 5 surrounding states pass a similar law. (   
Several attempts to pass laws failed in New York and in and Massachusetts in recent years, but efforts are ongoing there and in more than 20 other states. 
The specter of many differing state labeling laws, however, has led to concerns by food producers, who argue that different state requirements would be prohibitively expensive – in general, no manufacturer wants to have to do the same thing in one or more different ways – it only increases costs.  Manufacturers have therefore appealed to federal lawmakers, who have responded with two different approaches.

One, H.R. 4432 a bill reintroduced  on March 25, 2015 (it was first introduced in 2014) by Rep. Mike Pompeo (R-KA) and entitled the “Safe and Accurate Food Labeling Act of 2014,” which provides that no “bioengineered organism” shall be introduced into interstate commerce without premarket approval from the FDA.  (Read the text of the bill here:^Q1_424_a_1&nearest=H45FB103B5DF24181AEB5722668CB002C).  There is not yet a Senate version of the bill, however. The bill currently has 37 co-sponsors in the House (a list is here:{%22search%22:[%22HR+1599%22]}) and the American Farm Bureau Federation is fully backing the legislation.  However, the National Farmers Union opposes the bill.

The Act makes any sale without such premarket approval a “prohibited act” under the Federal Food, Drug, and Cosmetics Act.  The Act defines a “bioengineered organism” as a plant whose genetic makeup has been modified by recombinant DNA techniques to produce and the modification “could not otherwise be obtained using conventional breeding techniques.”  As with other FDA programs, the producer of the bioengineered organism used as food would submit its data to the FDA, demonstrating why the producer believes that its product “is as safe for use by humans or animals …  as one or more comparable marketed foods that are not produced from … such bioengineered organism[.]”  The FDA must approve or deny the application within 210 days of its submission.  Also, if approved, the FDA will make public the existence and content of a premarket application.  
       If, in approving the application, the FDA determines that there is a “material difference” between the food made with bioengineered organisms and comparable foods made without such organisms, the Secretary specify a label for the product that would adequately inform consumers of the material difference. The Act defines “material difference” as a difference that significantly alters the function or composition of the food, so that the usual name of the food no longer describes it; one that has significantly different nutritional properties than the comparable food; or one that contains an allergen that would not likely be present in the comparable food.       
Finally, the Safe and Accurate Food Labeling Act explicitly states that, in the regulations to be developed by the FDA to implement the Act, the FDA may not require food made with bioengineered organisms to be so labeled, although it may permit label descriptions of the way the food was modified to express characteristics different than the comparable food, and disclosure in advertisements (other than labels) that the food was developed with the use of bioengineering.
On the side of federal labeling legislation that would pre-empt a patchwork of state labels is the second recent federal foray into the debate:  the Genetically Engineered Food Right-to-Know Act, a bill recently reintroduced by Sens. Barbara Boxer (D-CA) and Richard Blumenthal (D-CT) and Rep. Peter DeFazio (D-OR).  The bill, H.R 1699 (, first introduced in 2013 with 67 co-sponsors, would amend the FDC Act to provide that a food is misbranded if it has been genetically engineered or contains one or more genetically-engineered ingredients and it has not been clearly labeled to indicate as much.  The bill would exempt food served in restaurants and similar eating establishments.  The bill also defines “genetically-engineered” foods as those produce with recombinant DNA techniques, as well as a “fusion of cells beyond the taxonomic family” that “overcome natural physiological reproductive or recombinant barriers” and that are “not techniques used in traditional breeding and selection.”  This bill currently has 40 co-sponsors in the House (H.R. 913:{%22search%22%3A[%22Genetically+Engineered+Food+Right-to-Know+Act%22]}) and 14 in the Senate (S. 511:{%22search%22%3A[%22Genetically+Engineered+Food+Right-to-Know+Act%22]}).  
The bill’s preamble states that Congress finds that “the process of genetically engineering food organisms results in material changes and the fact that foods are genetically engineered is of material importance to consumers[,]  and that “the cultivation of genetically engineered crops can have adverse effects on the environment in the form of cross-pollination of native plants, increased herbicide usage, and impacts on non-target and beneficial organisms, including the Monarch butterfly.” 
We don’t know when Congress will vote on either of these bills.  Stay tuned.