Food Safety in the U.S.

As food recalls over the past year have flourished, the public, the media, the government, industry, farms, and organic gardeners have acknowledged the need for effective and enforceable measures of food safety in the United States. Just to focus on a few problems, the Los Angeles Times reported that as of April 8, 2009, a voluntary recall had been issued for 3,900 peanut products in connection with an outbreak of Salmonella that led to at least nine deaths in the past months. Jalapeno peppers turned out to be the culprits causing foodborne illnesses that the FDA attempted to address last year.

Manufacturer Response

Responsible companies in the food industry have taken this issue seriously. For example, the Grocery Manufacturers Association (GMA) conducted a forum recently, bringing together scientists to “develop a comprehensive plan for preventing food-related health outbreaks,” according to its Web site, www.gmabrands.com. In February and March of this year, a paper was produced by a task force of industry experts, formed by GMA, to address the difficulties and best practices for eradicating Salmonella in low-moisture foods. Similarly, Chiquita and the Dole Food Company cosponsored a global conference on produce food safety standards with break-out session tracks on both pre-farm and post-farm gate audits.

Moreover, we can already see that the Obama administration and the FDA are acting boldly to increase government oversight of food safety. Although there were no confirmed illnesses, on April 6, 2009, a large pistachio processor agreed to recall its entire 2008 crop. In conjunction with this recall, the FDA told consumers to avoid eating pistachios. The New York Times reported that this was the first time the FDA had issued such a warning with no reports that anyone had been ill as a result of the product. Apparently, with the pistachio recall, the FDA sought to improve upon its more cautious and slower actions during the recent peanut recalls.

The purpose of this article is to update risk managers and attorneys who represent manufacturers on the progress made by Congress, various agencies, and policymakers in the area of food safety.

Range of Proposals

As Congress, The Centers for Disease Control (“CDC”), The Food and Drug Administration (“FDA”), the food industry, and state and local government health agencies attempt to improve food safety, proposals range from more strict enforcement of existing laws, better means of identification and communication concerning outbreaks of foodborne illness, broader recalls of entire product lines, and more effective auditing of compliance with food safety standards. Yet, as we have seen in the past few years, when food products are a compilation of many small parts, whether shreds of lettuce or pieces of ground beef, traditional sampling processes may be insufficient to identify inadvertent contaminants, much less intentional contamination of products.

As medical professor and epidemiologist Dennis G. Maki, M.D. recently wrote in an article published in the New England Journal of Medicine, “[w]e must ask ourselves how foodborne disease can develop in 76 million residents of one of the world's most technically advanced countries each year, causing 350,000 hospitalizations and 5,000 deaths and adding $7 billion to our health care costs despite intensive regulation of food production and distribution.” Dennis G. Maki, M.D., Coming to Grips with Foodborne Infection ' Peanut Butter, Peppers, and Nationwide Salmonella Outbreaks, 360 New Eng. J. Med., Mar. 2009, at 949. Maki's article provides information about existing food safety measures, proposed new food safety legislation, and a variety of policy recommendations, all intended to protect the public from foodborne illness. Evaluation of these measures, which may be implemented over time, leads to the unavoidable conclusion that we can be much safer by eliminating from food contaminants that lead to food borne illness than by attempting to find them, trace them, and treat them.

The Problem

The CDC's Morbidity and Mortality Weekly Report (“MMWR”) of April 10, 2009 announced that “Foodborne diseases remain an important public health problem in the United States.” The CDC utilizes a surveillance network called FoodNet to collect data from 10 states: Connecticut, Georgia, Maryland, Minnesota, New Mexico, Oregon, Tennessee, California, Colorado and New York. Sadly, the incidence of most foodborne infections, according to the CDC, is highest in the young, children less than four years old, and in people over 50 years old. While children have the highest incidence of infection, the fatality rate is higher in the over-50 population. Goals set for reduction of foodborne pathogens were not reached in 2008, according to the CDC, because of “gaps in the current food safety system and the need to continue to develop and evaluate food safety practices as food moves from the farm to the table.” In 2008, the occurrence of a variety of infections from E coli to Listeria did not change significantly in comparison to the incidence of infections in 2005, 2006, and 2007. Reportedly, Salmonella fell the farthest from its target, as 7.4% of outbreak-associated infections in 2008 were Salmonella cases. The CDC noted that “enhanced and food-specific measures are needed to: 1) control or eliminate pathogens in domestic and imported foods; 2) reduce or prevent contamination during growing, harvesting and processing; and 3) continue the education of restaurant workers and consumers about risks and prevention measures.

Recent efforts to reduce food contamination have resulted in some success. For example, an initiative implemented by the United States Department of Agriculture Food Safety and Inspection Service resulted in a decrease of Salmonella in raw chicken. Unfortunately, the percentage of ground beef samples found to be contaminated increased in 2008. From a positive perspective, perhaps the increase occurred as a result of increased sampling in higher risk facilities and improved laboratory detection; however, the increase may indicate the presence of contaminants was actually higher.

According to the MMWR, Listeria occurred at an overall rate in 2008 of 0.29 per 100,000 people. Salmonella incidence was much higher, at 16.20 per 100,000 population.

How Can Consumers Stay Safe?

The CDC has made several food handling and preparation recommendations that consumers can use to reduce their risk of foodborne illness. These include avoiding consumption of unpasteurized milk, raw or undercooked oysters, or other raw or undercooked foods from animals, such as eggs, ground beef, and poultry. The CDC recommends that consumers should choose pasteurized eggs, high'pressure-treated oysters, and irradiated produce. They also suggest that we should all wash our hands before and after contact with raw meat, raw foods derived from animal products, and animals in their environments. Detailed information on food safety practices from the CDC is available at http://www.foodsafety.gov and http://www.fightbac.org.

What Is Congress Doing?

Congress currently has in committee (before the House Committee on Energy and Commerce and the House Committee on Agriculture) H.R. 875, Food Safety Modernization Act of 2009, which establishes a new Food Safety Administration (FSA) in the federal Department of Health and Human Services. This government agency would take control of all functions of federal agencies that relate to the administration or enforcement of food safety laws. The new FSA would enforce performance standards for food safety, establish a food inspection program, expand existing food borne illness surveillance systems, hold imported food to the same standards as domestic food, and establish a traceability system for food. According to the Congressional Research Service Summary, the legislation requires the administrator of the new FSA to: “1) identify priorities for food safety research and data collection; 2) maintain a DNA matching system and epidemiological system for foodborne illness identification, outbreaks and containment; 3) establish guidelines for a sampling system; 4) establish a national public education program on food safety; 5) conduct research on food safety; and 6) establish a working group on surveillance.” Summary available at http:www.govtrack.us/congress/bill.xpd?bill=h111-875&tab=summary. It requires the Secretary to act through the director of the CDC to develop a federal health registry. The version introduced in the House includes significant enforcement authority. Section 405 of the draft legislation imposes a civil penalty that may be assessed by the Administrator of the FSA up to $1 million for each act violating the food safety law and each day during which that act continues ' which is considered by the legislation to be a separate offense. Criminal sanctions are reserved for offenses that result in serious illness or death. A person violating food safety laws who causes a serious illness shall be imprisoned for not more than five years, and/or fined according to the legislation. In the case of offenses resulting in death, the perpetrator is to be imprisoned for not more than 10 years and/or fined. The legislation also includes whistleblower protection. Importantly, the legislation establishes a national traceability system so that the FSA would retrieve “the history, use, and location of an article of food through all stages of its production, processing and distribution.” H.R. 875, ' 210(a).

What Are Best Practices Recommendations?

Dr. Maki's New England Journal of Medicine article includes sound, achieveable, practical, and probably effective measures intended to build upon food safety measures taken back in 1996. Maki, supra, p. 2. These existing measures include the USDA's Pathogen Reduction, Hazard Analysis, and Critical Control Point (“HACCP”) Program, the surveillance program now covering ten states called FoodNet, and PulseNet. PulseNet is a system that uses pulsed field gel electrophoresis DNA to subtype pathogens that have been identified in laboratories. Using these systems, the CDC currently has the ability to essentially fingerprint a bacterium and identify its presence both at the source or supplier and in the patient. Although many people believe we should return to eating foods produced on small farms that are organic or more natural, Maki believes that it would not be possible to use these methods of farming to feed “300 million Americans, let alone the rest of
the world.” Id. at 951-52. He writes, “Efficient, industrialized production of huge quantities of food is an escapable necessity to avoid food shortages and global famine. The challenge is to enhance the quality and safety of industrially produced food.” Id. at 952. If that challenge is met, nothing prevents any of us from planting our own organic garden or buying from local farms we know and trust. Some good, specific recommendations Maki makes include the following:

• Expand FoodNet;
• Monitor more efficiently;
• Research;
• Require traceability;
• Address antibiotics;
• Focus on food preparation facilities; and
• Food irradiation.

Interestingly, Maki closes with the ultimate food safety recommendation, that is already implemented by meat producers and approved for certain produce ' irradiation of food. This is thought to be safe because the low dose of ionized radiation needed to eliminate pathogens is too low to make the food radioactive or dangerous to human consumption. Maki notes, “Research has shown that irradiation kills pathogens or markedly reduces pathogen counts without impairing the nutritional value of food or making it toxic, carcinogenic, or radioactive.” Id. at 953. See also Michael T. Osterholm, Ph.D., M.P.H. and Andrew P. Norgan, The Role of Irradiation in Food Safety, 350 New Eng. J. Med., Apr. 2004, at 1898.

Agencies that have endorsed the radiation of food include the FDA, the CDC, the USDA, the American Medical Association, the World Health Organization and the European Commission's Scientific Committee on Food. Irradiation of fresh meat has been allowed in the United States since 1997, and in 2008, the FDA approved irradiation of iceberg lettuce and spinach. Maki writes that “The CDC has estimated that irradiation of high-risk foods could prevent up to a million cases of bacterial food borne disease each year in North America.” Id.

Conclusion

As Congress and the Obama administration attempt to toughen up food safety measures in the United States, policymakers will be well served to be attentive to Dr. Maki's recommendations and include within the program a public relations campaign to help the public accept the concept of irradiation of high-risk foods. The proposed legislation, coupled with Maki's suggestions, has the potential to make peanuts, peppers, pistachios, and all high-risk foods safer to eat.

Laura Owens focuses her practice on complex litigation, including product liability, mass torts, and class actions. She has extensive experience in e-discovery, advises companies about the laws and regulations governing consumer products, including the Consumer Product Safety Improvement Act of 2008, and maintains an active practice before the Consumer Products Safety Commission (CPSC). She is the former leader of Alston & Bird's Product Liability Group.

As food recalls over the past year have flourished, the public, the media, the government, industry, farms, and organic gardeners have acknowledged the need for effective and enforceable measures of food safety in the United States. Just to focus on a few problems, the Los Angeles Times reported that as of April 8, 2009, a voluntary recall had been issued for 3,900 peanut products in connection with an outbreak of Salmonella that led to at least nine deaths in the past months. Jalapeno peppers turned out to be the culprits causing foodborne illnesses that the FDA attempted to address last year.

Manufacturer Response

Responsible companies in the food industry have taken this issue seriously. For example, the Grocery Manufacturers Association (GMA) conducted a forum recently, bringing together scientists to “develop a comprehensive plan for preventing food-related health outbreaks,” according to its Web site, www.gmabrands.com. In February and March of this year, a paper was produced by a task force of industry experts, formed by GMA, to address the difficulties and best practices for eradicating Salmonella in low-moisture foods. Similarly, Chiquita and the Dole Food Company cosponsored a global conference on produce food safety standards with break-out session tracks on both pre-farm and post-farm gate audits.

Moreover, we can already see that the Obama administration and the FDA are acting boldly to increase government oversight of food safety. Although there were no confirmed illnesses, on April 6, 2009, a large pistachio processor agreed to recall its entire 2008 crop. In conjunction with this recall, the FDA told consumers to avoid eating pistachios. The New York Times reported that this was the first time the FDA had issued such a warning with no reports that anyone had been ill as a result of the product. Apparently, with the pistachio recall, the FDA sought to improve upon its more cautious and slower actions during the recent peanut recalls.

The purpose of this article is to update risk managers and attorneys who represent manufacturers on the progress made by Congress, various agencies, and policymakers in the area of food safety.

Range of Proposals

As Congress, The Centers for Disease Control (“CDC”), The Food and Drug Administration (“FDA”), the food industry, and state and local government health agencies attempt to improve food safety, proposals range from more strict enforcement of existing laws, better means of identification and communication concerning outbreaks of foodborne illness, broader recalls of entire product lines, and more effective auditing of compliance with food safety standards. Yet, as we have seen in the past few years, when food products are a compilation of many small parts, whether shreds of lettuce or pieces of ground beef, traditional sampling processes may be insufficient to identify inadvertent contaminants, much less intentional contamination of products.

As medical professor and epidemiologist Dennis G. Maki, M.D. recently wrote in an article published in the New England Journal of Medicine, “[w]e must ask ourselves how foodborne disease can develop in 76 million residents of one of the world's most technically advanced countries each year, causing 350,000 hospitalizations and 5,000 deaths and adding $7 billion to our health care costs despite intensive regulation of food production and distribution.” Dennis G. Maki, M.D., Coming to Grips with Foodborne Infection ' Peanut Butter, Peppers, and Nationwide Salmonella Outbreaks, 360 New Eng. J. Med., Mar. 2009, at 949. Maki's article provides information about existing food safety measures, proposed new food safety legislation, and a variety of policy recommendations, all intended to protect the public from foodborne illness. Evaluation of these measures, which may be implemented over time, leads to the unavoidable conclusion that we can be much safer by eliminating from food contaminants that lead to food borne illness than by attempting to find them, trace them, and treat them.

The Problem

The CDC's Morbidity and Mortality Weekly Report (“MMWR”) of April 10, 2009 announced that “Foodborne diseases remain an important public health problem in the United States.” The CDC utilizes a surveillance network called FoodNet to collect data from 10 states: Connecticut, Georgia, Maryland, Minnesota, New Mexico, Oregon, Tennessee, California, Colorado and New York. Sadly, the incidence of most foodborne infections, according to the CDC, is highest in the young, children less than four years old, and in people over 50 years old. While children have the highest incidence of infection, the fatality rate is higher in the over-50 population. Goals set for reduction of foodborne pathogens were not reached in 2008, according to the CDC, because of “gaps in the current food safety system and the need to continue to develop and evaluate food safety practices as food moves from the farm to the table.” In 2008, the occurrence of a variety of infections from E coli to Listeria did not change significantly in comparison to the incidence of infections in 2005, 2006, and 2007. Reportedly, Salmonella fell the farthest from its target, as 7.4% of outbreak-associated infections in 2008 were Salmonella cases. The CDC noted that “enhanced and food-specific measures are needed to: 1) control or eliminate pathogens in domestic and imported foods; 2) reduce or prevent contamination during growing, harvesting and processing; and 3) continue the education of restaurant workers and consumers about risks and prevention measures.

Recent efforts to reduce food contamination have resulted in some success. For example, an initiative implemented by the United States Department of Agriculture Food Safety and Inspection Service resulted in a decrease of Salmonella in raw chicken. Unfortunately, the percentage of ground beef samples found to be contaminated increased in 2008. From a positive perspective, perhaps the increase occurred as a result of increased sampling in higher risk facilities and improved laboratory detection; however, the increase may indicate the presence of contaminants was actually higher.

According to the MMWR, Listeria occurred at an overall rate in 2008 of 0.29 per 100,000 people. Salmonella incidence was much higher, at 16.20 per 100,000 population.

How Can Consumers Stay Safe?

The CDC has made several food handling and preparation recommendations that consumers can use to reduce their risk of foodborne illness. These include avoiding consumption of unpasteurized milk, raw or undercooked oysters, or other raw or undercooked foods from animals, such as eggs, ground beef, and poultry. The CDC recommends that consumers should choose pasteurized eggs, high'pressure-treated oysters, and irradiated produce. They also suggest that we should all wash our hands before and after contact with raw meat, raw foods derived from animal products, and animals in their environments. Detailed information on food safety practices from the CDC is available at http://www.foodsafety.gov and http://www.fightbac.org.

What Is Congress Doing?

Congress currently has in committee (before the House Committee on Energy and Commerce and the House Committee on Agriculture) H.R. 875, Food Safety Modernization Act of 2009, which establishes a new Food Safety Administration (FSA) in the federal Department of Health and Human Services. This government agency would take control of all functions of federal agencies that relate to the administration or enforcement of food safety laws. The new FSA would enforce performance standards for food safety, establish a food inspection program, expand existing food borne illness surveillance systems, hold imported food to the same standards as domestic food, and establish a traceability system for food. According to the Congressional Research Service Summary, the legislation requires the administrator of the new FSA to: “1) identify priorities for food safety research and data collection; 2) maintain a DNA matching system and epidemiological system for foodborne illness identification, outbreaks and containment; 3) establish guidelines for a sampling system; 4) establish a national public education program on food safety; 5) conduct research on food safety; and 6) establish a working group on surveillance.” Summary available at http:www.govtrack.us/congress/bill.xpd?bill=h111-875&tab=summary. It requires the Secretary to act through the director of the CDC to develop a federal health registry. The version introduced in the House includes significant enforcement authority. Section 405 of the draft legislation imposes a civil penalty that may be assessed by the Administrator of the FSA up to $1 million for each act violating the food safety law and each day during which that act continues ' which is considered by the legislation to be a separate offense. Criminal sanctions are reserved for offenses that result in serious illness or death. A person violating food safety laws who causes a serious illness shall be imprisoned for not more than five years, and/or fined according to the legislation. In the case of offenses resulting in death, the perpetrator is to be imprisoned for not more than 10 years and/or fined. The legislation also includes whistleblower protection. Importantly, the legislation establishes a national traceability system so that the FSA would retrieve “the history, use, and location of an article of food through all stages of its production, processing and distribution.” H.R. 875, ' 210(a).

What Are Best Practices Recommendations?

Dr. Maki's New England Journal of Medicine article includes sound, achieveable, practical, and probably effective measures intended to build upon food safety measures taken back in 1996. Maki, supra, p. 2. These existing measures include the USDA's Pathogen Reduction, Hazard Analysis, and Critical Control Point (“HACCP”) Program, the surveillance program now covering ten states called FoodNet, and PulseNet. PulseNet is a system that uses pulsed field gel electrophoresis DNA to subtype pathogens that have been identified in laboratories. Using these systems, the CDC currently has the ability to essentially fingerprint a bacterium and identify its presence both at the source or supplier and in the patient. Although many people believe we should return to eating foods produced on small farms that are organic or more natural, Maki believes that it would not be possible to use these methods of farming to feed “300 million Americans, let alone the rest of
the world.” Id. at 951-52. He writes, “Efficient, industrialized production of huge quantities of food is an escapable necessity to avoid food shortages and global famine. The challenge is to enhance the quality and safety of industrially produced food.” Id. at 952. If that challenge is met, nothing prevents any of us from planting our own organic garden or buying from local farms we know and trust. Some good, specific recommendations Maki makes include the following:

• Expand FoodNet;
• Monitor more efficiently;
• Research;
• Require traceability;
• Address antibiotics;
• Focus on food preparation facilities; and
• Food irradiation.

Interestingly, Maki closes with the ultimate food safety recommendation, that is already implemented by meat producers and approved for certain produce ' irradiation of food. This is thought to be safe because the low dose of ionized radiation needed to eliminate pathogens is too low to make the food radioactive or dangerous to human consumption. Maki notes, “Research has shown that irradiation kills pathogens or markedly reduces pathogen counts without impairing the nutritional value of food or making it toxic, carcinogenic, or radioactive.” Id. at 953. See also Michael T. Osterholm, Ph.D., M.P.H. and Andrew P. Norgan, The Role of Irradiation in Food Safety, 350 New Eng. J. Med., Apr. 2004, at 1898.

Agencies that have endorsed the radiation of food include the FDA, the CDC, the USDA, the American Medical Association, the World Health Organization and the European Commission's Scientific Committee on Food. Irradiation of fresh meat has been allowed in the United States since 1997, and in 2008, the FDA approved irradiation of iceberg lettuce and spinach. Maki writes that “The CDC has estimated that irradiation of high-risk foods could prevent up to a million cases of bacterial food borne disease each year in North America.” Id.

Conclusion

As Congress and the Obama administration attempt to toughen up food safety measures in the United States, policymakers will be well served to be attentive to Dr. Maki's recommendations and include within the program a public relations campaign to help the public accept the concept of irradiation of high-risk foods. The proposed legislation, coupled with Maki's suggestions, has the potential to make peanuts, peppers, pistachios, and all high-risk foods safer to eat.

Laura Owens focuses her practice on complex litigation, including product liability, mass torts, and class actions. She has extensive experience in e-discovery, advises companies about the laws and regulations governing consumer products, including the Consumer Product Safety Improvement Act of 2008, and maintains an active practice before the Consumer Products Safety Commission (CPSC). She is the former leader of Alston & Bird's Product Liability Group.