TONI TARVER


Every year one in six Americans becomes sick from foodborne illnesses, resulting in 128,000 hospitalizations and 3,000 deaths, according to the U.S. Centers for Disease Control and Prevention. Despite the passing of new laws and regulations designed to ensure the quality of domestic and imported foods, minimize foodborne illness, and increase food safety, the frequency of foodborne illnesses causes many to question whether the quality of the nation’s food is increasing or merely plateauing. At IFT’s second Food Policy Impact Conference in Arlington, Va., Fred H. Degnan, Partner at King & Spalding, said that the acceptance of uncertainties and risks combined with scientific judgment and legal conclusion constitutes safety.

During the conference’s opening session, Degnan explained that the U.S. Food and Drug Administration (FDA) is “confronted with way more responsibilities and requirements than it can possibly hope to enforce.” As a consequence, despite the much lauded passing of the Food Safety Modernization Act (FSMA) in 2011, which would enact sweeping reforms to the U.S. food system, full implementation of the law has been delayed. Degnan identified the postponed enactment of the FSMA as one of the top food policy issues in 2012. Also at the top of his list was the defeat of Proposition 37, a mandate in California that would have required the labeling of genetically modified organisms (GMOs) and products containing GMOs. Degnan concluded that making decisions about food safety “is very messy,” but he expects the full implementation of the FSMA to be beneficial in this regard.

Carolyn DeWaal of the Center for Science in the Public Interest did not share his optimism. According to DeWaal, because several foodborne illness outbreaks have occurred since the passing of the FSMA, consumer confidence in the nation’s food system has waned. She pointed out that key provisions of the FSMA—biennial registration, preventive controls, performance standards, produce safety standards, and import oversight—have not been executed, and she doubted they would be anytime soon. The delayed implementation of the FSMA may be somewhat of a good tiding for food manufacturers. Leon Bruner of the Grocery Manufacturers Association said that the new law presents new regulatory hurdles that manufacturers will have to clear. Their main concerns are that the regulations are very prescriptive, costly, and unenforceable and that foreign supplier verification could create barriers to trade.

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To Label or Not to Label 

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On the issue of mandatory GMO disclosure, conference speakers were just as divided. Even though the labeling of GMOs is mandated in at least 60 countries, Melanie Fairchild-Dzanis, President of Regulatory Discretion, Inc., said that the FDA does not perceive genetically engineered products to be substantively different from conventional products. She characterized the defeat of Proposition 37 in California as marginal (53% to 47%) and set the stage for a feisty exchange between Jean Halloran, Director of Food Policy Initiatives at the Consumers Union, which publishes Consumer Reports, and Gregory Conko, Executive Director and Senior Fellow at the Competitive Enterprise Institute.

Because soy, corn, and canola are the predominant genetically engineered ingredients, processed foods contain the most GMOs. Halloran said that consumers receive almost no benefits from GMOs or the products made from them. She expressed her concern that genetic engineering of foods could introduce allergens that are not normally present in common foods; these allergens are not likely to be among customary allergy declarations (e.g., peanuts, tree nuts, shellfish, etc.). Consumers who are allergic to uncommon allergens could eat an unlabeled GMO, experience an allergic reaction, and not realize what triggered it. Moreover, countries that require mandatory labeling—all European Union countries, Australia, Brazil, and others—have a mandatory safety assessment procedure for genetically engineered ingredients while the United States does not. Halloran warned that an ethical issue exists with respect to genetic engineering, speculating that scientists may want to put human genes in cows or fish genes in strawberries. “We’ve been doing plant breeding for years, and we’ve even been doing wide crosses. [Genetic engineering] is a very different technique; it’s quite an advance in science. Genetically engineered food is basically different from anything people have ever eaten before. People ought to be able to know [whether] the food they’re eating is genetically engineered,” she said.

Conko countered Halloran’s position with credible arguments. He explained that civilization has long relied on the ability to modify plants to make them more suitable as food; these modifications are genetic. “Every legitimate risk, including the ones that [Halloran] talked about, that has been raised about biotechnology and [GMOs] also exists with nonengineered breeding [and] often at a greater level,” he said. For example, common criticisms of genetic engineering of plants are that gene-swapping between species is not a natural occurrence and that interspecific genetic combinations could be hazardous to consumer health. To the contrary, Conko emphasized, genes are constantly rearranged, trans-located, and spliced in nature. Conventional breeding introduces thousands of genes across plant species. Moreover, every plant consumed—including organically grown produce—has common plant toxins, anti-nutrients, and potential allergens. Conko stressed that unassisted plant mutations have been occurring for decades and can generate the same kinds of traits as those produced by food biotechnology. From the scientific point of view, the standard assessment of conventionally grown food crops is sufficient to demonstrate safety of GMOs, he said.

Rachel Lattimore, Partner at Arent Fox LLP, reinforced Conko’s perspective by pointing out that all biotechnology products are subject to science-based regulation under existing, product-based statutes. Lattimore indicated that no new biotechnology legislation is necessary because GMOs are already covered by existing laws. Biotechnology crops must be as safe to grow and as safe to eat as conventional crops. Moreover, there is no mandatory premarket testing for conventional plants even though many food plants contain low levels of toxins that can increase with natural/normal plant breeding practices. Lattimore ended her discussion by referring to the FDA’s policy on foods derived from new plant varieties: Substances introduced into food are either new food additives that require premarket approval or generally accepted as safe (GRAS) and thus exempt from premarket review.

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Tricks of the Trade

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An examination of the FDA’s policy on what constitutes a food, food additive, or a GRAS exemption was a judicious prologue to a lively discussion on the importing and exporting of food products. Sarah Roller, Partner at Kelley Drye & Warren LLP, identified which agencies are involved in regulating food while acknowledging that the FDA is just not equipped with the resources to monitor all imported foods. Besides adhering to the rules of domestic agencies such as the FDA, the U.S. Dept. of Agriculture, and the U.S. Customs and Border Protection, U.S. exports and imports also fall under the purview of the World Trade Organization, which relies on the General Agreement on Tariffs and Trade, technical barriers to trade, and the Sanitary and Phytosanitary Measures Agreement.

U.S. food products constitute 22% of global traded products, but the amount of exports from developing countries is increasing at a faster rate than that of developed countries. Karen Hulebak, Principal at Resolution Strategy, explained why this creates tension in both developed and developing countries. When a dispute arises between two countries over a trade issue, the World Trade Organization’s dispute resolution board relies on the Codex Alimentarius Commission to resolve the disagreement. However, adherence to Codex standards is not mandatory; each member country can develop its own food standards. Hulebak said that the private standards established by the Global Food Safety Initiative (GFSI) are creating a level of frustration because they are usually not congruent to Codex standards. “Private standards, which are in essence contractual arrangements between companies … are misunderstood largely because they use the word ‘standard,’ which normally refers to something established by a government,” Hulebak said. GFSI standards are stricter and much more difficult for developing countries to achieve. As a consequence, developing countries are being disenfranchised from the global trading arena.

Hulebak revealed that private standards such as those issued by GFSI are typically not based on documented risk assessments: “The private standards are developed in a nonopen, nontransparent way, oftentimes not justified by risk assessment—virtually always not justified by risk assessment—and poor countries feel that they will never be able to reach those marks.” In her opinion, this is tantamount to fraud and prevents developing countries, which usually have only one product (i.e., food) to trade, from participating in the global market. Private standards are so lofty that developing countries could never meet them as neither the exporters nor the countries have the fiscal resources to do so. When asked whether she believed that the standards were deliberately established to maintain the status quo of the food trade market, which is dominated by 10 developed countries, Hulebak replied, “Certainly, no one would ever admit that, [but] it is possible that some companies found that they didn’t like the lower prices of some types of produce that were available from some small producers [in developing countries]. I don’t know if it’s any more or less admirable than competing on the grounds of safety and saying, ‘My product is safer than yours.’ I think we need to get past all of that and on to a fair, more open trade policy and trade rules that let everybody trade and make sure that the consumer is kept safe with honest standards. ”

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Great Expectations 
The conference closed with a panel of experts giving their opinions on which food policy issues would be prominent in 2013. Marianne Smith Edge, Senior Vice President, Nutrition & Food Safety, International Food Information Council, stressed that overweight and obesity will continue to be major concerns in 2013, highlighting the fact that the 2010 Dietary Guidelines for Americans were written to address an obese population. (Previous iterations of the guidelines were written for a healthy-weight population.) Sixty percent of consumers have their own personal trustworthy sources—many of which originate from the Internet and personal anecdotes. Edge thus concluded that most consumers have a dearth of knowledge and comprehension with respect to science. She expressed the same concern about policymakers: Despite the 2010 Dietary Guidelines’ emphasis on sodium, there has been no increase in sodium intake over the past 50 years. She conveyed her hope for a bigger dialogue on the integrity of science in 2013 and beyond to prevent the implementation of food policies that have no scientific basis.

David Acheson, Partner at Leavitt Partners, and Hilary Thesmar, Vice President of Food Safety Programs at Food Marketing Institute, focused on contaminated foods and product recalls. Acheson predicted improvements in the recalling of contaminated foods, and Thesmar explained why his prediction could materialize. Retailers have a vested interest in keeping food safe, she said. If a customer becomes ill from a product, then the customer is unlikely to purchase the product again and may not return to the retail outlet that sold the product. Thesmar revealed that food recalls occur virtually every day and retailers have a hard time keeping up. Retailers would like to see stricter enforcement of regulations and guidelines for the safe transporting of food on trucks, thereby catching foodborne contaminations before products arrive at retail outlets. 

 

Toni Tarver is Senior Writer/Editor for Food Technology magazine
([email protected]).