8
Case Study 1: Meat Slaughtering and Processing Practices

THE DANISH APPROACH TO FOOD SAFETY ISSUES RELATED TO PORK PRODUCTS

BENT NIELSEN

Section for Zoonotic Diseases, Veterinary and Food Advisory Service, Federation of Danish Pig Producers and Slaughterhouses, Copenhagen, Denmark

DANISH CONSUMERS' PERSPECTIVES ON FOOD SAFETY

Danish consumers focus increasingly on food safety and the welfare of all types of livestock. The consumers' attitude to food safety and animal welfare is based on both correct and factual information, and also to a very large extent on beliefs and old wives' tales. Both the media and Danish politicians have long since found out that food safety and animal welfare are issues that sell. Hardly a month goes by without a newspaper publishing a critical story about the poor quality of food products, the use of antibiotics or the minimal space allocated to livestock in modern livestock buildings.

Over the past 20 years, Danes have become increasingly distanced from livestock production in Denmark, and the rural population now accounts for less than 5 percent of the Danish population. With almost no direct experience of livestock production, most consumers are at the mercy of the information or misinformation provided by the media and the politicians. Below follows an



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Incorporating Science, Economics, and Sociology in Developing Sanitary and Phytosanitary Standards in International Trade: Proceedings of a Conference 8 Case Study 1: Meat Slaughtering and Processing Practices THE DANISH APPROACH TO FOOD SAFETY ISSUES RELATED TO PORK PRODUCTS BENT NIELSEN Section for Zoonotic Diseases, Veterinary and Food Advisory Service, Federation of Danish Pig Producers and Slaughterhouses, Copenhagen, Denmark DANISH CONSUMERS' PERSPECTIVES ON FOOD SAFETY Danish consumers focus increasingly on food safety and the welfare of all types of livestock. The consumers' attitude to food safety and animal welfare is based on both correct and factual information, and also to a very large extent on beliefs and old wives' tales. Both the media and Danish politicians have long since found out that food safety and animal welfare are issues that sell. Hardly a month goes by without a newspaper publishing a critical story about the poor quality of food products, the use of antibiotics or the minimal space allocated to livestock in modern livestock buildings. Over the past 20 years, Danes have become increasingly distanced from livestock production in Denmark, and the rural population now accounts for less than 5 percent of the Danish population. With almost no direct experience of livestock production, most consumers are at the mercy of the information or misinformation provided by the media and the politicians. Below follows an

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Incorporating Science, Economics, and Sociology in Developing Sanitary and Phytosanitary Standards in International Trade: Proceedings of a Conference outline of the most important factors affecting Danish consumers' perception of food safety. Comparison with Sweden Denmark is a neighbor of Sweden. Danish politicians and the Danish media often compare Danish and Swedish conditions because both countries are very similar in a number of respects. It is, therefore, natural for Danish consumers and their professional and industrial bodies to look at food safety conditions in Sweden and to make comparisons with conditions in Denmark. Over the past 30 years, Sweden has fought a very active battle against Salmonella in its livestock production. The occurrence of Salmonella in Swedish livestock production is close to nil, and, in reality, Swedish food products are considered to be Salmonella free. The use of antibiotic growth promoters has been banned since 1986, and the use of antibiotics for therapeutic purposes is heavily restricted. Finally, a number of special welfare requirements have been introduced in respect to livestock production in recent years, such as a minimum floor area per animal, which is approximately 30 percent larger than the Danish equivalent. CONSUMER REQUIREMENTS OF DANISH MEAT Danish consumers make certain requirements and have certain expectations of the meat they buy. The most important requirements are the following (as in Sweden): an absence of zoonotic agents such as Salmonella; an absence of chemical residues such as antibiotics, hormones, pesticides, etc.; and a wish for good animal welfare throughout the life of the pig, including slaughtering. Zoonotic Agents Diseases that can be transmitted from animals to humans and vice versa are called zoonoses. Danes are very sensitive to the occurrence of zoonoses both in meat produced in Denmark and in imported meat. It is the general attitude among consumers that zoonotic agents must not be found in Danish food products. All Danish consumers know of Salmonella, and they know that the bacteria do occur in meat from time to time. In the past year, there has been considerable focus on the difference between the levels of Salmonella in Danish and imported meat. Danish meat has a very low prevalence of Salmonella in comparison with other countries, with the exception of the other Scandinavian countries. This has resulted in a demand for the testing of imported meat. This trend was reinforced considerably in 1998, following increased focus on the multiresistant Salmonella typhimurium DT-104. DT-104 is typically

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Incorporating Science, Economics, and Sociology in Developing Sanitary and Phytosanitary Standards in International Trade: Proceedings of a Conference resistant to ampicillin, chloramphenicol, streptomycin, sulfonamides and tetracycline, but has a high ability to develop further resistance to quinolones and trimethoprim (Danish Zoonosis Centre, 1999). It can, therefore, be more difficult to treat humans who develop DT-104 salmonellosis with antibiotics. In Europe, the typical first-choice drug used to treat serious salmonellosis in humans is a quinolon, ciprofloxacin. In cases when the salmonellosis has been caused by a quinolon-resistant DT-104 strain, there is a risk of treatment failure, which may be extremely critical for the patient. The multiresistant DT-104 is frequently found in most European countries (with the exception of Scandinavia) the Far East, and increasingly also the United States. DT-104 is extremely rare in Danish livestock production. Between 1991 and October 1998 only 25 swine herds had been affected in all of Denmark, and the occurrence of DT-104 in pork is correspondingly low, approximately 1 out of 35,000 meat samples examined. The demand from Danish politicians and thereby also Danish consumers is for the complete absence of multiresistant DT-104 bacteria in all meat, Danish as well as imported. Some Danish pig herds are being stamped out in order to eradicate DT-104 on the farms. All meat from a DT-104 herd must be subjected to heat treatment to prevent exposure of consumers to DT-104 contamination. This represents a dramatic sharpening of the population's view on Salmonella. The general attitude to the presence of other Salmonella bacteria in food products has been sharpened similarly in the course of 1998. The level of Salmonella in Danish pork is very low. Over the past four years, Salmonella has only been found in approximately 1 percent of the 28,000 samples examined annually by the Danish slaughterhouses. However, Danish consumers still believe that this is too high, although most other industrialized countries have Salmonella in 5–30 percent of their pork. Danish consumers have also heard of the Campylobacter bacteria. However, this zoonosis is primarily linked with poultry, not pork. Very few consumers know of other zoonoses in food products. When discussing the issue of zoonotic diseases, it is worth mentioning that Denmark demands a non-discriminating testing of imported meat. Five percent of pork and beef batches, and 10 percent of poultry batches are tested for the presence of bacteria using cultural methods. Testing of imported meat is performed on the same level as testing of domestic meat which, consequently, is designated as a non-discriminating testing. Test results for both domestic and imported meat are published on the homepage of the Danish Department of Agriculture. Residues of Antibiotics, Hormones, Pesticides, Heavy Metals, and Others During the past three years there has been considerable focus on the use of antibiotics in livestock in Denmark, especially antibiotic growth promoters. Consumers are concerned about two aspects: the risk of residues and the development of antibiotic-resistant bacteria transmissible to humans.

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Incorporating Science, Economics, and Sociology in Developing Sanitary and Phytosanitary Standards in International Trade: Proceedings of a Conference Many consumers share the misunderstanding that the use of antibiotic growth promoters leads to residues in meat. The Danish Veterinary Services examine approximately 20,000 carcasses of swine annually for a large number of residues of antibiotics. Only 3–5 carcasses are found to be positive. Thus, antibiotic residues in Danish pork are not a real problem. There has been an increasing fear among Danish and Swedish microbiologists that the long-term use of antibiotic growth promoters can promote the development of antibiotic-resistant bacteria transmissible to humans. Researchers fear that, in the long term, this may reduce the possibilities for treating infections in humans (Bager and Emborg, 1999). Consequently, use of the antibiotic growth promoter avoparcin has been banned since 1996. Since March 1, 1998, Danish pig producers have introduced a voluntary ban on the use of growth promoters in pigs weighing more than 35 kg. At the same time, Danish cattle and poultry producers introduced a complete ban on the use of growth promoters. The Danish government wishes to stop the use of growth promoters as soon as possible and on September 1, 1998, introduced a special tax on antibiotic growth promoters. This means that it no longer makes sense economically to use them. In September 1998, the European Union (EU) conference ''The Microbiological Threat" was held in Copenhagen. The object of the conference, which received much attention in the media, was to harmonize the policies of the EU countries in the area of antibiotics. As a result of the conference, Danish pig producers decided to stop the use of antibiotic growth promoters completely within the next year. At the moment, there has already been a considerable decrease in the number of farms using antibiotic growth promoters for piglets. This is considered a big step in the right direction by consumers, even though there is no conclusive documentation on the risk of continued use of antibiotic growth promoters for swine. As in the case of the zoonotic agents, the consumers' attitude is that consumers should be given the benefit of the doubt. Consumers are not particularly concerned with residues of hormones, pesticides, and heavy metals as pork has not been linked with these issues by the Danish media. The Danish Veterinary Services regularly examine carcasses of swine for these residues, but so far there have been no positive findings. WELFARE For Danish consumers, animal welfare and food safety are closely related. The demand for organic vegetables, grain products, eggs, milk, cheese, and meat has increased dramatically. An increasing proportion of Danish consumers is convinced that a high level of animal welfare equates to an absence of zoonotic agents, antibiotic residues, etc. There is no doubt that increased animal welfare can leave consumers with a better moral taste in their mouths. However, there is no link between a high level of animal welfare and the absence of zoonotic agents. So far, studies in Denmark have shown that the levels of Salmonella in conventional pigs and special welfare pigs are the same. This is a message that consumers find hard to accept.

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Incorporating Science, Economics, and Sociology in Developing Sanitary and Phytosanitary Standards in International Trade: Proceedings of a Conference CONCLUSIONS Danish and other Scandinavian consumers' demands for food safety are increasing. The ideal situation would be an absence of zoonotic agents and all types of chemical residues. At the same time, the animal must have been reared under optimum welfare conditions. In this way, it should be possible to ensure that the food products bought by consumers are very safe and also that consumers can eat the meat from the animal with a clear conscience. For the most part, Danish pig producers have been able to comply with the wishes of Danish consumers. Seen in an international perspective, the level of zoonotic agents is very low, chemical residues are virtually nonexistent, and pig producers are in the process of adopting more welfare-friendly systems for their livestock buildings. AN UPDATE ON THE DANISH SALMONELLA REDUCTION PROGRAM In 1993 a preliminary Salmonella surveillance program of slaughter pig herds was initiated with a permanent program being established in January 1995. In 1998, the program was revised and new initiatives have been implemented. The aim of the compulsory program is to reduce the prevalence of Salmonella in slaughter pig herds and pork. Here I describe the monitoring program of slaughter pig herds, the regulations that the herd owners are required to follow, and the results achieved so far. An update of the system has been presented recently at the International Pig Veterinary Society (IPVS) Conference, Birmingham, United Kingdom (Emborg et al., 1998). Materials and Methods The Salmonella reduction program consists of the following parts: Serological monitoring of all herds producing more than 100 slaughter pigs per year. Assignment of herds into one of three levels (1, 2, or 3) based on the prevalence of seroreactors. Mandatory advising and elaboration of a Salmonella intervention plan for all herds in levels 2 and 3. Furthermore, the program includes monitoring of Salmonella in animal feed, breeding and multiplying herds, and the prevalence in pork products. Finally, pigs from level 3 herds are slaughtered under special hygiene precautions (none of these parts of the program are described in this paper). The above-mentioned parts of the program are performed as follows:

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Incorporating Science, Economics, and Sociology in Developing Sanitary and Phytosanitary Standards in International Trade: Proceedings of a Conference The herd-monitoring scheme makes use of an indirect enzyme-linked immunosorbent assay (ELISA) based on a combination of the lipopolysaccharide (LPS) antigens O:1, 4, 5, 6, 7, and 12 (the so-called mix-ELISA). The assay was developed by the Danish Veterinary Laboratory for the use on serum, but has been modified to be used also on meat juice (Nielsen et al., 1995). Meat juice is obtained when frozen meat samples from slaughter pigs are thawed. The slaughterhouses collect meat samples continuously from about 16,000 herds with samples being taken at random from each herd. Each quarter, between 8 and 60 meat samples are collected from each herd, with the number of samples determined by the number of pigs delivered for slaughter. Around 800,000 meat juice samples are examined annually for Salmonella antibodies at the laboratory (Mousing et al., 1997). The result of the examination of the meat juice samples is summarized monthly for the individual herd. Based on the proportions of seroreactors during the previous three months, the herds are assigned to one of three levels. Level 1 herds have no or very few seroreactors, level 2 herds have a relatively high proportion of seroreactors, whereas level 3 herds have an unacceptably high proportion of seroreactors (Mousing et al., 1997). Both the herd owners and the slaughterhouses are informed monthly about the Salmonella level of the herds. When a herd is placed in levels 2 or 3, the herd owner must initiate a Salmonella intervention plan (Mousing et al., 1997). Since January 1995, owners of the herds assigned to levels 2 and 3 are requested by the slaughterhouse to seek advice on how to reduce the prevalence of Salmonella in the herds. The herd owner, a veterinary surgeon, and a pig consultant must elaborate a herd-specific intervention plan, otherwise the slaughterhouse will collect a penalty per slaughtered pig delivered until the plan has been elaborated and received by the slaughterhouse. Three months after the assignment to levels 2 and 3, the veterinary surgeon and the pig consultant must certify that the program agreed upon is being followed. If not, the slaughterhouse will again collect a penalty per slaughtered pig (4 percent of the value of each finisher slaughtered). If the herd remains in levels 2 or 3, or the herd is reassigned to levels 2 or 3 six months after the first assignment, it is required that the owner again seek advice on how to reduce the Salmonella prevalence in the herd as described above. From August 1996, the requirements of the intervention in the levels 2 and 3 herds were increased. Ordered by the Danish Veterinary Services, these requirements include that a sufficient number of pen fecal samples must be collected and analyzed in order to clarify the distribution of Salmonella in the herd. Based on these results, an appropriate intervention plan must be prepared (Emborg et al., 1997). In addition, the slaughterhouses announced in July 1996 that from January 1997, a slaughtering fee would be charged on all herds assigned constantly to level 3 for more than six months. The fee will be collected until the herd is assigned to levels 1 or 2 (Emborg et al., 1997).

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Incorporating Science, Economics, and Sociology in Developing Sanitary and Phytosanitary Standards in International Trade: Proceedings of a Conference Results and Discussion The results of the Danish Salmonella surveillance program comprising approximately 16,000 slaughtered pig herds from June 1995 to August 1998 are presented below. Seropositive Meat Juice Samples The number of seropositive meat juice samples varied between 4 and 7 percent in the period 1995 to the end of 1997, while a significant decrease was observed from October 1997 to June 1998, reaching a minimum at 2.3 percent (which is considered a very low prevalence). Since June 1998, the number of seropositive meat juice samples has remained below 3 percent. It is assumed that the observed decrease in seropositive meat juice samples is a consequence of more effective Salmonella reduction strategies at the farm level. Level 2 and 3 Herds Throughout the surveillance period the percentages of levels 2 and 3 herds ranged from 2.4 to 4.3 percent and 1.1 to 2.3 percent, respectively. Although the percentages of herds assigned to level 2 varied, the percentage did not decrease significantly before the spring of 1998, as a result of the decreasing number of seropositive meat juice samples. The number of level 2 herds has remained below 3 percent in the period February to September 1998. From August 1996 to March 1997, a significant decrease was found in the proportion of level 3 herds (β = –0.032, P = 0.011) (Emborg et al., 1997). However, since March 1997 no further decrease occurred, with the proportion of level 3 herds remaining between 1.2 and 1.8 percent. Surprisingly, the significant decrease in meat juice samples in 1998 did not decrease the number of level 3 herds. The decrease in the proportion of level 3 herds from August 1996 to March 1997 may be associated with the obligatory requirements to collect and analyze pen fecal samples for Salmonella, which were introduced in August 1996, and the announcement in July 1996 that a slaughtering fee would be effective starting in January 1997. It appears that a further decrease in the proportion of level 3 herds and an additional decrease in the proportion of level 2 herds are possible only if the number of chronically infected herds is reduced. During the surveillance period, owners of 3,955 herds (about 25 percent of the 16,000 herds) have been requested to seek advice on how to reduce the Salmonella prevalence in the herds (Table 8-1). In 1,747 (44 percent) of the herds, the high prevalence of Salmonella did last more than six months and the consequences were two or more requirements to seek advice. In 233 (5.9 percent) herds the problems with Salmonella have been so persistent that 5 to 7 requirements to seek advice have been necessary.

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Incorporating Science, Economics, and Sociology in Developing Sanitary and Phytosanitary Standards in International Trade: Proceedings of a Conference Table 8-1. Monitoring Results of the Salmonella Reduction Program No. of Times a Herd Owner was Required to Seek Advice on Reducing the Salmonella Prevalence in the Slaughter Pig Herds No. of Slaughter Pig Herds Percent of Total No. of Slaughter Pig Herds 1 2,208 55.8 2 823 20.8 3 436 11.0 4 255 6.4 5 141 3.6 6 85 2.1 7 7 0.2 Total 3,955 100 New Initiatives The number of herds with more than five requirements is clearly unsatisfactory. Too many of the chronically infected herds stay too long in level 3, and the finishers (pigs that reached the slaughter weight) consequently have to be slaughtered under increased hygiene precautions. In spring 1998, the Federation of Danish Pig Producers and Slaughterhouses decided to increase the pressure on the chronically infected herds and level 3 herds in general to reduce the number of finishers for special hygiene slaughter. Two new initiatives were introduced by September 1, 1998: second-opinion advisers and a level 3 slaughter fee. Second-Opinion Team If the fifth requirement is given within 36 months, two second-opinion advisers must participate in the preparation of the intervention plan. The second-opinion advisers consist of a team of five veterinarians and five swine consultants who are specialists on Salmonella. The cost of a veterinary advice amounts to approximately $200–300 (U.S.). Level 3 Slaughter Fee In addition, the slaughterhouse will collect a fee per level 3 finisher slaughtered under special hygiene conditions. The reason for collecting the slaughter fee is the extra spending due to slaughter under special hygiene precautions. The estimated cost per finisher for a special slaughter is $25. From September 1998, the slaughter fee will be calculated as presented in Table 8-2.

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Incorporating Science, Economics, and Sociology in Developing Sanitary and Phytosanitary Standards in International Trade: Proceedings of a Conference Table 8-2. Special Slaughter Fees per Finisher Months in Level 3 Fee per Finisher ($) 0-3 0 4-6 3.30 7+ 6.30 To return to $0 per level 3 finisher, the herd must not be assigned to level 3 during the next 12 months. For example, if a herd stays five months in level 3, the farmer will be deducted $3.30 for every finisher in months 4 and 5. If the herd subsequently is assigned to level 1 for the next three months and then goes back to level 3 for an additional four months, the farmer will be deducted $3.30 per finisher for the sixth month (month 9 of the year) in level 3 and $6.60 per finisher for the seventh to ninth months (months 10-12 of the year) in level 3. Future goals for the Danish Salmonella reduction program is to reach a level of less than 0.5 percent of Salmonella in pork by the year 2001. This will be achieved by intensified control pre-harvest and increasing hygiene on slaughter plants. REFERENCES Bager, F. and Emborg, H.-D. 1999. Danish Integrated Antimicrobial Resistance Monitoring and Research Programme (DANMAP) 98 Report: Consumption of antimicrobial agents and occurrence of antimicrobial resistance in bacteria from food animals, food and humans in Denmark. Copenhagen, Denmark: Danish Zoonosis Centre. Danish Zoonosis Centre. 1999. Annual report on zoonosis in Denmark 1998. Hald, T., H.C. Wegener, and B.B. Jørgensen, eds. Copenhagen, Denmark: Danish Zoonosis Centre. Emborg H.-D., A. C. Nielsen, P. Thode Jensen, J. P. Nielsen, and J. Mousing. 1997. The Danish Salmonella Surveillance Programme of Slaughter pig herds. In the Proceedings of the 8th International Society of Veterinary Epidemiology and Economics (ISVEE), 07.14.1–3. Paris. Emborg, H.-D., V. Møgelmose, and B. Nielsen. 1998. Status of the Danish Salmonella Surveillance Programme of Slaughter Pig Herds. Birmingham, UK: International Pig Veterinary Society (IPVS). Mousing J., P. Thode Jensen, C. Halgaard, F. Bager, N. Feld, B. Nielsen, J.P. Nielsen, and S. Bech-Nielsen. 1997. Nation-wide Salmonella enterica surveillance and control in Danish slaughter swine herds. Preventive Veterinary Medicine 29:247–261. Nielsen B., D.L. Baggesen, F. Bager, J. Haugegaard, and P. Lind. 1995. The serological response to Salmonella serovars typhimurium and infantis in experimentally infected pigs. The time course followed with an indirect anti-LPS ELISA and bacteriological examinations. Veterinary Microbiology 47:05–218.

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Incorporating Science, Economics, and Sociology in Developing Sanitary and Phytosanitary Standards in International Trade: Proceedings of a Conference INTERNATIONAL HARMONIZATION UNDER THE SPS AGREEMENT BRUCE A. SILVERGLADE Center for Science in the Public Interest, Washington, D.C. I would like to thank the sponsors of today's conference for the opportunity to speak to you regarding how consumer organizations in the United States view the international harmonization of food safety regulations. The Center for Science in the Public Interest (CSPI) is a consumer advocacy organization based in Washington, D.C. The center is supported by almost one million subscribers to its magazine, Nutrition Action Health Letter, which reports on food safety and nutrition issues. CSPI was formed in 1971 and over the past two decades has campaigned for the elimination of hazardous food additives such as sulfiting agents, worked to improve meat and poultry inspection, and fought for mandatory nutrition labeling requirements. To further its role in international issues, CSPI became a recognized observer at the Codex Alimentarius Commission and formed a new organization called the International Association of Consumer Food Organizations (IACFO), which is an international coalition of consumer groups that work primarily on food safety and nutrition issues. Charter members include the Food Commission U.K., based in London, and the Japan Offspring Fund, based in Tokyo. IACFO has filed comments with various governments on the labeling of genetically engineered foods (IAFCO, 1998), issued a report on the regulation and marketing of functional foods (IAFCO, 1999), and has participated in Codex committee meetings. Today, I wish to present the consumer viewpoint on the process of international harmonization under the Sanitary and Phytosanitary (SPS) Agreement (see Appendix A). I will address whether we are harmonizing in an upward or a downward direction. To illustrate the concerns of consumers, I will review some of the recent activities of the Codex Alimentarius Commission, which is officially recognized under the SPS agreement as a source of international standards that can be used by the World Trade Organization (WTO) to resolve trade disputes. I will also examine how equivalency agreements developed pursuant to the SPS Agreement can affect the international harmonization process. Lastly, I will briefly discuss the role that science and other factors play in SPS decisions and draw some conclusions from CSPI's experience to date. It was actually after Congress passed mandatory nutrition labeling legislation in 1990 (Pub. L. No. 101-535) that CSPI began to open its eyes to international issues. After the nutrition labeling legislation took effect, the European Union (EU) began to complain that the new law was a trade barrier (European Commission, 1997). In response, CSPI began looking into

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Incorporating Science, Economics, and Sociology in Developing Sanitary and Phytosanitary Standards in International Trade: Proceedings of a Conference international trade issues to see if some of the biggest consumer victories in the United States could become the victim of trade disputes. My remarks today, however, should not be construed in any manner as an attack on free trade. Free trade promotes an efficient allocation of resources. It increases the variety of goods available to consumers and it lowers the prices of those goods. And free trade certainly encourages better world citizenship by facilitating peaceful cooperation and exchange. We are in a global economy to stay, and international harmonization of regulatory requirements is necessary. But are we harmonizing upward or downward? In what direction are we going? To the extent that international harmonization elevates health and safety regulations to a consistent level of excellence, consumers worldwide are well served. Under this scenario, international standards would incorporate the best features of national standards that consumer organizations believe provide the public with the highest levels of protection. However, if harmonization tends to reduce standards to some acceptable international norm, then consumer health and safety may be jeopardized regardless of the economic benefits brought about by free trade. President Clinton has recognized this, and in a 1998 speech last summer to the World Trade Organization he has called for a "leveling up," in his words, of consumer protection regulations and not a leveling down (Office of the President, 1998). But what is actually happening? We believe that international harmonization is leading to a leveling down of consumer standards. This is occurring for several reasons. First, under the SPS Agreement, international standards serve as a ceiling, not a floor. They are a maximum rather than a minimum. And there is nothing in the SPS Agreement that requires the setting of a minimum floor that countries can exceed; it is just the opposite. So there is implicit pressure for downward harmonization built into the SPS Agreement. Second, the SPS Agreement was adopted to facilitate trade, not to raise health and safety standards. The SPS is not a public health agreement, it is a business-oriented trade agreement that is supposed to reduce regulation and make it easier for companies to trade internationally. And, in fact, many of the processes involved with the SPS Agreement, particularly the proceedings of the Codex Alimentarius Commission, have become forums for deregulation. Third, public participation by consumer groups, environmental groups, and others in international proceedings is limited for obvious reasons related to resources and logistics. We hope that this will change, but at the present time, lack of consumer input is certainly one of the factors that we believe is leading to downward harmonization. I would now like to provide some illustrations of where downward harmonization is occurring. First, Codex has finalized a standard that does not require pasteurization of cheese (FAO/WTO, 1999). Pasteurization has been a hallmark of food safety in the United States. However, the Codex standard is based on practices common within the EU. This standard represents an example of where the U.S. has been forced to accept an international standard that fails to

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Incorporating Science, Economics, and Sociology in Developing Sanitary and Phytosanitary Standards in International Trade: Proceedings of a Conference provide the same level of public health protection afforded by domestic regulatory requirements. While U.S. government officials are quick to point out that nothing in the SPS Agreement requires us to adopt the Codex standard, they fail to note that other countries have a right of action to challenge current U.S. regulatory requirements in this area as a trade barrier, and that the U.S. would be hard pressed to provide a scientific justification for such requirements in light of the Codex standard. Second, as I mentioned, mandatory nutrition labeling in the United States has been attacked as a trade barrier. Proponents of this view frequently cite the Codex guidelines for nutrition labeling (FAO/WTO, 1993), which only require disclosures of such information if the manufacturer makes a nutrition claim. Because the U.S. requirement exceeds the Codex guidelines there have been proposals that the United States permit imports of foods that have some other, lesser form of nutrition information on the label as opposed to the full list of nutrients mandated by Congress. Label disclosures must be standardized to be effective. Public health and consumer organizations cannot teach people to use nutrition labels if they are not presented in a consistent format. Allowing imported products with some other country's nutrition label would jeopardize the objectives of the U.S. law and represent another example of downward harmonization. Third, Codex has adopted standards, opposed by the United States, for natural mineral water (FAO/WTC, 1997a) that allow greater levels of contaminants than permitted under U.S. Food and Drug Administration (FDA) regulations (21 CFR 165.110). The adoption of the Codex standard was quite a loss for the FDA, which fought for years to set stringent bottled water standards in the United States and now may be confronted with demands to permit the import of products that fall below those standards. Certainly there is a potential that international harmonization can raise standards. As David Vogel points out, we can trade up (Vogel, 1995); but whether this is what is happening is questionable. Two additional examples illustrate our concerns. The first is the WTO's decision in the growth hormones case (WTO, 1998) and the second is equivalency agreements developed by the U.S. Department of Agriculture (USDA) regarding meat and poultry inspection. The downward harmonization problem is illustrated by both of these matters. The hormone decision is obviously a very important decision under the SPS Agreement. CSPI has not campaigned against the use of hormones in the United States. We recognize that there is a significant percentage of Americans who want to buy organic or natural beef and dislike hormones as much as the Europeans, but in general, we have not made an issue about the use of hormones. For the sake of this discussion, I will assume that there is no human health risk posed by hormone use in the United States. Nevertheless, the EU does not want to buy U.S. beef, and this is not simply a protectionist issue. Certainly there is a degree of trade protectionism in the EU position, but that position is supported by the European public for other reasons. It would, in fact, be difficult for the EU to maintain such a protectionist stance if it was not the subject of popular support. Popular support for the hormone ban

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Incorporating Science, Economics, and Sociology in Developing Sanitary and Phytosanitary Standards in International Trade: Proceedings of a Conference in Europe can be traced to various historical experiences and cultural values. There were problems in Italy with the use of hormones. The European consumer remembers that disaster, and distrusts government authorities even more in the wake of the mad cow disease fiasco (Echols, 1998). And in regard to cultural values, there is the view that America, through its agricultural exports, is trying to McDonaldize the EU food supply. Therefore, based on different historical experiences and cultural values, most European consumers have come to oppose the use of hormones in cattle. The point here is that the distaste for hormone-treated beef in the EU is real. Simply dismissing such attitudes as trade protectionism, as many U.S. officials do, is not useful because it does not address the views of European consumers. Moreover, simply trying to force the issue at the WTO is counterproductive and threatens to destabilize the entire world trading system. CSPI is concerned about the hormone decision from another standpoint. The decision could be interpreted as limiting the right of a nation to establish a zero-risk standard under certain circumstances. For example, the United States maintains the Delaney Clause to the Food, Drug and Cosmetic Act, which sets a zero-risk standard for cancer causing food and color additives (21 USC 348(c)(3)(A), 379e(b)(5)(B)). This regulatory approach embodies the philosophy that in some cases, the benefits from permitting a substance in our food supply (such as a artificial color additive that is used primarily in non-nutritious "junk" food) may be so minimal that no risk of cancer, even an extremely small one, can be justified. Consumer groups support the Delaney Clause, not because it is science based, but because it is based on this important principle and represents an insurance policy against weak regulation in times of budget crunches or competing priorities. It forces the FDA to make tough policy decisions when the agency might be pressured by industry to look the other way and ignore certain risks. But we would be hard pressed to argue before the WTO that it is science based. The WTO's decision in the hormone case could have a boomerang effect and come back to haunt the United States by jeopardizing consumer protection requirements like the Delaney Clause. The SPS Agreement was essentially written as a business document to increase agricultural exports, not to protect public health. Insufficient thought was put into it at the time it was drafted as to how it might hurt us in the United States in certain areas that we believe are important. Another example of where the principle of a downward harmonization seems to be at work involves equivalency agreements. The Codex Alimentarius Commission approved, over the objections of the U.S. government, equivalency guidelines for the establishment of import and export inspection and certification systems (FAO/WTO, 1997b) that do not require the use of government employees to inspect food products. The United States has long relied on government employees to inspect meat and poultry. The Codex guidelines approved in 1997 can be interpreted as sanctioning the use of company employees to inspect such products. It was pushed very heavily by

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Incorporating Science, Economics, and Sociology in Developing Sanitary and Phytosanitary Standards in International Trade: Proceedings of a Conference Australia, which has a conservative government in power, is deregulating quite actively, and favors the use of company employees as opposed to government employees to conduct inspections. CSPI feared that the Codex guidelines that were adopted would be used to pressure the United States to accept imports from countries that rely on company employees for inspection responsibilities. In fact, that is what has precisely happened. USDA, citing the Codex guidelines, has finalized equivalency agreements with numerous other countries that do not mandate the use of government paid inspectors. This action is inconsistent with domestic regulatory policy. For example, USDA's own regulations require Salmonella testing by government employees (7 CFR 381.94(b); 9 CFR 310.25(b)). The rules took effect in January 1998 for producers that have 500 or more employees. Fifteen countries that export meat to the United States have factories that employ 500 or more employees (House of Representatives, 1999). Under the equivalency agreements negotiated by USDA, these nations will agree to perform the Salmonella testing but, in many cases, will permit firms to use company employees to perform the necessary tests. In explaining their decision, USDA officials cited the Codex standard as a factor in their thinking and stated very plainly that, under the equivalency provisions of the SPS Agreement, they would not require other countries to use government employees to do the Salmonella testing. This decision establishes a double standard that not only consumer groups, but U.S. producers as well, should be concerned about. It does not have to be that way. Through equivalency agreements, we can certainly learn how to improve food safety requirements. The United States does not necessarily have the strongest requirements in every area. The U.S. food industry likes to say that it has the safest food supply in the world, but that is no longer true across the board. Therefore, we can certainly benefit from equivalency agreements if they are used to raise consumer protection standards. Unfortunately, they are currently being used to merely facilitate trade at the cost of lowering consumer protection requirements. It is an issue that concerns CSPI very much, and I can assure you that we will be working a great deal on it. Some will argue that harmonizing upward is too costly, especially for developing countries. The SPS agreement specifies that developing countries should receive technical assistance in order to comply with their SPS obligations. In reality, such technical assistance has rarely been provided. This must change. In order to maintain public support for international harmonization among consumers in developed countries, such nations must be required to provide technical assistance to developing countries so as to enable them to comply with world class standards. Finally, I will briefly address the role of science in policy making under the SPS Agreement. Obviously, science has to take a leading role, but science has its limits when it comes to risk management decisions and it is not value free. Risk assessments are based on assumptions and we have heard that these can be rooted in cultural values. Just the decision to do a risk assessment on a particular substance, but not on another substance, is a subjective judgment that may be based on cultural values. And although science has to play the leading role in informing policy decisions, other factors certainly enter into the equation. This

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Incorporating Science, Economics, and Sociology in Developing Sanitary and Phytosanitary Standards in International Trade: Proceedings of a Conference happens every day at the Codex Alimentarius Commission, which plays a major role under the SPS Agreement. How else can one explain such close votes at Codex approving the use of growth hormones in cattle? If Codex were proceeding strictly on the basis of scientific consensus, such matters, by definition, would not be the subject of close votes. Voting would be unnecessary. But Codex decisions are not simply based on scientific consensus; factors other than science are most certainly entering into the decision-making process. One of these factors, so obvious that perhaps we do not see it, is trade concerns. We can debate the extent to which consumer and environmental concerns should be considered along with scientific factors, but trade concerns are already being taken into account in what are purportedly purely scientific decisions. If we are considering trade concerns at Codex, then we should certainly be considering consumer concerns, some of which are based on cultural differences, as well. Cultural differences play a very key role in explaining what some may think are just protectionist attitudes or what some may say is the misuse of science by the press or politicians. To many of the economists participating in today's conference, cross-cultural disputes simply look like trade protectionism. Every time an SPS dispute arises, they say, ''Well, it's just disguised protectionism." It is actually much more complicated. To many of the scientists participating in today's conference, these disputes may be attributed to consumer activists trying to generate publicity or politicians trying to garner votes. Those parties certainly play a key role, but SPS disputes cannot simply be chalked up to protectionist attempts to grab media attention, or to political pressures. Lawyers may say that SPS disputes are essentially legal disputes. The SPS Agreement is an international law, but SPS disputes do not only involve controversies over the meaning of legal terms. Cultural differences play a very, very large role. And there is no doubt that culture will continue to play a key role in what some may regard as purely scientific or economic issues. In conclusion, let me say that international harmonization can be a positive experience. It can lead to the adoption of international standards that embody the best consumer protection policies from around the world. The potential is there. As we proceed with the global economy, we really have only one option: to harmonize upward. Consumers will see any other course of action as untenable. The challenge is there and how we meet it will not only affect the future of food regulation, but whether public support for the world trading system will grow or diminish even further than it has already. REFERENCES Echols, M.A. 1998. Food Safety Regulation in the European Union and The United States: Different Cultures, Different Laws. Columbia Journal of European Law 4:525–543.

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Incorporating Science, Economics, and Sociology in Developing Sanitary and Phytosanitary Standards in International Trade: Proceedings of a Conference European Commission. 1997. Report on United States Barriers to Trade and Investment. Brussels, Belgium: European Commission. FAO/WHO (Food and Agriculture Organization of the United Nations/World Health Organization). 1993. Codex Alimentarius Commission: Codex Guidelines on Nutrition Labelling, CAC/GL 2-1985 (Rev. 1-1993). Joint FAO/WHO Food Standards Programme, Rome: FAO. FAO/WHO (Food and Agriculture Organization of the United Nations/World Health Organization). 1997a. Codex Standard for Natural Mineral Waters, ALINORM 97/20, Appendix II. Joint FAO/WHO Food Standards Programme. Rome: FAO. FAO/WHO (Food and Agriculture Organization of the United Nations/World Health Organization). 1997b. Guidelines for the Development of Equivalence Agreements Regarding Food Import and Export Inspection and Certification Systems, CAC/GL 34-1999. Joint FAO/WHO Food Standards Programme. Rome: FAO. FAO/WHO 1999. Codex Alimentarius Commission: Codex General Standard for Cheese, Codex Standard A-6-1978 (Rev. 1-1999). Joint FAO/WHO Food Standards Programme. Rome: FAO. IACFO (International Association of Consumer Food Organizations). 1998. Comments to Ministry of Agriculture, Forestry, and Fisheries, Japan. October 9. Washington, D.C.: IACFO. IACFO (International Association of Consumer Food Organizations). 1999. Functional Foods: Public Health Boon or 21st Century Quackery? Washington, D.C.: IACFO. The Office of the Federal Register, National Archives and Records Administration, (OFR/NARA), 1999. 7 CFR 381.94(b); 9 CFR 310.25(b); 21 CFR 165.110. Washington, D.C.: U.S. Government Printing Office. Office of the President. 1998. Speech: Remarks by the President at the Commemoration of the 50th Anniversary of the World Trade Organization. May 18. Washington, D.C.: The White House. U.S. House of Representatives. 1999. Hearings Before a Subcommittee of the Committee of Appropriations, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2000. Washington, D.C.: U.S. Government Printing Office. Vogel, D. 1995. Trading Up: Consumer and Environmental Regulation in a Global Economy. Cambridge, Mass.: Harvard University Press. WTO (World Trade Organization). 1997. WT/DS26/AB/R and WT/DS48/AB/R, EC Measures Concerning Meat and Meat Products (Hormones). Report of the Appellate Body, AB-1997-4. Geneva, Switzerland: WTO.