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3 Critical Issues From March to September 2011, the committee heard from various stakeholders in the United States and abroad. In the foreign workshops the travel delegations met government regulators from a dozen different low- and middle-income countries (see Appendix E). It also met with rep- resentatives of multinational and national food and medical companies, nongovernmental organizations (NGOs), regional economic organizations, donor organizations, and universities (see Appendix E). In its deliberations the committee synthesized what it learned in these workshops, identifying nine common problems that cut across countries and industries. These are the nine main problems on which the committee focused its discussions. This input and background research informed its analysis of the main issues developing country regulators face. The committee found that regulators abroad face problems with: adher- ing to international standards, controlling supply chains, infrastructure, their laws, their workforce, institutional fragmentation, surveillance, communica- tion, and political will. A detailed analysis of each of these gaps follows. ADHERENCE TO INTERNATIONAL STANDARDS One of the main responsibilities of a regulator is to ensure the food and medical product supply meets agreed upon standards for safety and quality. National regulatory authorities are entitled to set their own standards, but established international norms are expedient to use; they also facilitate trade. Some standards are set into a country’s legal code, others are set by private organizations or corporations (Giovannucci and Purcell, 2008). 79

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80 ENSURING SAFE FOODS AND MEDICAL PRODUCTS Standard setting is one of the regulatory authority’s main responsibilities, separate from its responsibilities to enforce standards. For the purposes of this section, standards means “established norms or codified requirements for a product, such as material specifications or technical standards for performance. Standards may be developed by regulatory agencies, public organizations, or industry associations” (Marucheck et al., 2011, p. 714). Tables 3-1 and 3-2 list some important organizations and describe their work in standard setting. Proponents of standards maintain that their use helps traceability through the supply chain, eliminates redundant audits, and when, harmo- nized across markets, decreases bureaucracy. Others see standards as little more than fines on poor countries because of the high costs of compliance (Marucheck et al., 2011). A debate on this topic is outside the scope of this report. Regardless of the reasons these standards exist, quality assurance and adherence to international norms are essential as developing countries introduce regulated goods into the global marketplace. Adherence to Food Standards Adherence to international standards is a problem in the agri-food in- dustry in many low- and middle-income countries. In these countries there is a large domestic market for products that stringent regulatory authori- ties would reject. People in developing countries often do not demand, for example, process certification or assurance of minimal pesticide residues. This may be because they are often not aware of the public health risks international standards aim to protect against. They may also assume, sometimes incorrectly, that it is possible to assess the producer’s quality practices at point of purchase when the market has few middle men. More importantly, these countries still struggle to feed their citizens; concerns about trace pesticide residues seem frivolous in comparison to hunger. The threat of death from starvation in the next month will dwarf theoretical cancer risks in 50 years. In China, for example, food safety has only been an official priority for the past 12 years (Gale and Buzby, 2009). It is especially difficult in such a large country to keep the estimated 200 million farmers working plots of 2 acres or less abreast of good agricultural practices (Gale and Buzby, 2009). China’s roughly 400,000 cottage industry food processers face similar chal- lenges (Gale and Buzby, 2009). The involvement of the least developed countries and their in- stitutions in international standard setting organizations such as Codex is often nominal. The Codex Trust Fund aims to correct this by supporting scientists from the least developed countries and small island nations to participate better at Codex (WHO, 2011a).

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TABLE 3-1 International Standard Setting Organizations for Food Year Organization Established What they do What they set standards in United States 1820 “USP establishes documentary and reference standards • Purity and identity of food ingredients Pharmacopeial to ensure the quality and consistency of medicines, (USP, 2011a) Convention (USP) dietary supplements, and food ingredients” (USP, 2008). AOAC International 1884 AOAC International provides science-based expertise to de- • Single laboratory validation for botanicals velop voluntary consensus standards or technical standards • Study validation through stakeholder consensus and working groups (AOAC, • Food microbiology 2011). • Characterization of antibodies used in immunochemical methods of analysis for mycotoxins and phycotoxins (AOAC, 2009) 1947 • Food Products International A network of national standards institutes from 162 coun- Organization for tries (ISO, 2011a) that sets trade standards and fosters • Good Management Practices Standardization (ISO) standardization activities (Giovannucci and Purcell, 2008b). • Management systems for food safety 1952 • Procedures and references International “The IPPC provides an international framework for Plant Protection plant protection that includes developing international • Pest surveillance, survey, and monitoring Convention (IPPC) standards for phytosanitary measures for safeguarding • Import regulations and pest risk analysis plant resources” (IPPC, 2011). • Compliance procedures and phytosanitary inspection methodologies • Pest management • Post entry quarantine • Exotic pest emergency response, control, and eradication • Export certification (IPPC, 2011) International 1962 ICMSF provides science-based guidance to both • Microbiological limits and criteria in food Commission on government and industry on evaluating and controlling (ICMSF, 2011) Microbiological the microbiological safety of foods (ICMSF, 2011). ICMF Specifications for is not a standard setting organization. It is included here Food (ICMSF) because of its valuable advisory role. 81 continued

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TABLE 3-1 Continued 82 Year Organization Established What they do What they set standards in • Food quality and safety Codex Alimentarius 1963 Codex is responsible for developing “food standards, Commission guidelines and related texts such as codes of practice • Codes of hygienic or technological practice under the Joint FAO/WHO Food Standards Program” • Pesticide and food additive evaluation (CAC, 2011). “The purpose of the program is to protect • Limits for pesticide residue the health of consumers, ensure fair trade practices • Guidelines for contaminants (Henson and in food trade, and promote the coordination of all food Humphrey, 2009) standards work undertaken by international governmental and non-governmental organizations” (CAC, 2011).

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TABLE 3-2 International Standard Setting Organizations for Medical Products Year Organization Established What they do What they set standards in • Identification testing United States 1820 “USP establishes documentary and reference standards Pharmacopeial to ensure the quality and consistency of medicines, • Limit testing for impurities or related Convention (USP) dietary supplements, and food ingredients” (USP, 2008). compounds • Assays for drug substances and formulations • System suitability testing (USP, 2011c) • Product quality verification services for drug substances and excipients used to make over-the-counter and prescription pharmaceuticals (USP, 2011d) International 1947 A network of national standards institutes from 162 coun- • Requirements and testing methods for medical devices (ISO, 2011b) Organization for tries (ISO, 2011a) that sets trade standards and fosters stan- Standardization (ISO) dardization activities (Giovannucci and Purcell, 2008b). International 1990 The ICH “makes recommendations toward achieving • Good Clinical Practices Conference on greater harmonization in the interpretation and application • Good Manufacturing Practices of medicines, Harmonization (ICH) of technical guidelines and requirements for pharmaceutical biologics, and vaccines product registration” (ICH, 2011). • Standards for the transfer of regulatory information • Medical device safety, e ectiveness, The Global 1992 The GHTF encourages the harmonization of regulatory prac- performance, and quality (GHTF, 2007) Harmonization tices related to ensuring the safety, e ectiveness, perfor- Task Force (GHTF) mance, and quality of medical devices, promoting advance- ments in technology, and assisting international trade. This is accomplished through the publication and dissemination of harmonized guidance documents on basic regulatory practices (GHTF, 2007). European Directorate 1996 The EDQM “protects public health by enabling the • Quality and safety of medical products (EDQM, 2011) for the Quality development, supporting the implementation, and of Medicines and monitoring the application of quality standards for safe Healthcare (EDQM) medicines and their safe use (EDQM, 2011).” 83

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84 ENSURING SAFE FOODS AND MEDICAL PRODUCTS Still, the poorest countries do not have representatives with sufficient expertise to participate meaningfully in standard setting meetings (Afri- can Union Interafrican Bureau for Animal Resources, 2011). Sometimes logistical constraints complicate participation in these meetings. Inter- national travel is too expensive for regulatory agencies to fund (World Bank, 2008). There is also evidence that, especially in Sub-Saharan Africa, the food producers have no way to give input into standard development (World Bank, 2003). This means that small- and medium-size enterprises, and even some larger firms, rely on their importing agents or their national regulatory authority to make information available. There are also too few scientists qualified to analyze the standards. Without advocates these countries become “standards-takers” rather than active participants in the dialogue (World Bank, 2003). It is expensive to adhere to international standards. At the very least it requires a supplier to be able to trace products through the supply chain and show proof of adherence to best practices at all stages of production. This proof usually takes the form of a certificate of inspection, audit, or accredita- tion. Producers pay for inspections and certification, and for small producers these costs are prohibitively high (Giovannucci and Purcell, 2008). Some agri-food standards, those on pesticide residues for example, rely on tech- nical skills and laboratory equipment that are essentially missing in many developing countries (Jaffee and Henson, 2004; World Bank, 2003). For all these reasons, the World Trade Organization (WTO) called for donor aid to improve developing countries adherence to standards in their Sanitary and Phytosanitary (SPS) agreement. Bilateral and multilateral agencies spent between $65-$75 million a year in the years after the agreement on building capacity for agri-food health management (Jaffee and Henson, 2004). The full benefit of these investments is yet hard to measure. There is a learning curve when new technology is introduced to a sector, as well as a time lag when new staff are trained to use it (World Bank, 2003). In the meantime, the inability to adhere to standards deepens inequali- ties in market access between counties (Belton et al., 2010). Only eight countries, most of them in Latin American, account for two-thirds of all fruit and vegetable exports from emerging economies (Stcichele et al., 2006). Even these Latin American countries, with relatively advanced sys- tems for maintaining standards, can be subject to border rejections, and rejections cost middle-income countries about $1.8 billion in 2001 (Jaffee and Henson, 2004). Border rejections are only a fraction of the income lost. Econometric analysis indicates that China alone lost an estimated $8 billion in export income in 2002 because of failure to meet standards (Lu, 2005). The individual financial losses are also heavy. Vietnamese farmers who can

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85 CRITICAL ISSUES comply with supermarket standards earn about 400 percent higher profits than those who cannot (M4P, 2006). Access to export markets could improve the economies in some of the least developed countries, and the health and social benefits of adhering to standards cannot be understated. Aflatoxin, a food contaminant, accounts for an estimated 25,200-155,000 cases of liver cancer a year, overwhelm- ingly in countries without strict food standards (Liu and Wu, 2010). Even in the United States roughly 3,000 people die every year from foodborne ill- ness (CDC, 2011). The Centers for Disease Control and Prevention (CDC) estimates that food imported to the United States caused 2,348 illnesses between 2005 and 2010 (CDC, 2012). Half of these outbreaks happened in 2009 or 2010, and about 45 percent of them have a probable source in Asia (CDC, 2012). Globally, there are an estimated 155,000 deaths each year from food- borne Salmonella infections alone (Majowicz et al., 2010). Adherence to manufacturing and agriculture standards would improve working condi- tions and protect the environment in many countries. Farming in accor- dance with good agricultural practices, for example, improves soil quality and prevents erosion (Poisot et al., 2004). Adherence to Medical Product Standards In many ways, problems in adhering to international standards in the medical products industry are similar to those in agriculture and food. Regulators in low- and middle-income countries depend on standards devel- oped abroad; they often have minimal input into the standard setting process. Even more so than with agri-food standards, adhering to drug, biologics, and device standards demands sophisticated testing laboratories and control of complicated supply chains. The International Conference on Harmonization of Technical Require- ments for Registration of Pharmaceuticals for Human Use (ICH) is a stan- dard setting organization for drugs; it has membership from European, Japanese, and U.S. pharmaceutical industry associations, and the drug regulatory agencies of 17 countries (Abraham, 2002; ICH, 2011a). ICH activities generally focus on its member countries, but it is increasingly working to improve good manufacturing practices around the world. It held a training on the same for southern African regulators in Tanzania in June of 2011, for example (ICH, 2011b). As in the agri-food sector, developing countries are standard-takers rather than standard-makers. This can cause problems. Until recently the ICH guidelines on medicine shelf life, for example, failed to account for stability in hot, humid climates (Kopp, 2006). A working group of South- east Asian nations remedied this and brought attention to the problems of

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86 ENSURING SAFE FOODS AND MEDICAL PRODUCTS accepting ICH guidelines outside of ICH regions (Kopp, 2006). In other cases, the solutions for the standard-takers are not as clear. Far more rich countries than poor ones regulate diagnostics; of those that do only 68 per- cent require regulatory review of clinical trial data, and trial data with as few as 15 subjects are often acceptable (Peeling et al., 2010). When clini- cians in developing countries use diagnostics developed abroad they base their understanding of the tests’ predictive value on product inserts, values that are not accurate if the disease prevalence in the trial population differs from that in the population tested. Even when international standards are available to regulators and are appropriate, there are problems in adhering to quality standards if the med- ical regulatory authority has insufficient funding or trained staff or both. For example, one essential function of drug and biologic standards is to an- swer the questions, “Is this drug what is says it is, in the stated strength, and is it free of contaminants?” (Kenyon et al., 1994, p. 615). Quality-control laboratories answer these questions, but many countries cannot afford to set up and staff these laboratories (Leng and Matsoso, 2008). Outsourcing quality control is one way around this; private companies can do quality control for a national drug supply, as is the case in the United Kingdom. Leng and colleagues recounted hesitation to use private laboratories in both South Africa and Algeria though because of concerns about conflicts of interests given that the quality-control laboratories in question worked for both government and industry (Leng and Matsoso, 2008). Developing countries also face challenges in implementing good manu- facturing practices; the standards that ensure all manufacturing steps can be reproduced and result in the desired products. These are of critical im- portance in the production of vaccines and other biological products, given the inherent variability in testing a biologically active product (Milstien et al., 2009). The World Health Organization (WHO) Prequalification of Medicines and Vaccines Program facilitates access to quality medicines and vaccines for treating priority diseases. As Chapter 2 describes, this program evaluates product safety, quality, and efficacy and serves as the grounds for donor procurement. The vaccine and medicine companies that pass the evaluation must meet good manufacturing practices and be overseen by a competent national regulatory authority; it is the government regulator’s responsibility to enforce manufacturing standards (Brhlikova et al., 2007). In 2009 the WHO announced that it would withhold new prequalification evaluations from Indian companies barring improvements to their national regulatory authority (Milstien et al., 2009). In the same way, some consumers see WHO prequalification as an international vote of confidence in the national regulatory authority. On March 1, 2011, the WHO recognized the Chinese State Food and Drug Administration as compliant with international regulatory standards, a

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87 CRITICAL ISSUES decision that will allow for the eventual introduction of Chinese vaccines into international use (Jia and Carey, 2011). This may help restore public confidence in Chinese vaccine companies after a year of scandals. Sub- standard rabies and hepatitis B vaccines were rumored to have killed or sickened about 100 babies in Shanxi province in 2010; shortly afterward a company in Jiangsu province also produced substandard rabies vaccines (Jia and Carey, 2011). WHO prequalification drives compliance with international good man- ufacturing practices and gives incentive to improve government regulation. Economies of scale keep small countries out of the vaccine prequalification system. Similarly, WHO drug prequalification encourages adherence to international standards, at least in emerging economies large enough to support a manufacturing sector. Smaller countries depend on prequalifica- tion in their drug procurement. Pharmaceutical manufacture in most emerging economies was designed for generics, and their drug innovation system suffers. Some developing countries do not regulate human subjects’ protection in trials or require peer review of human subject protocols by institutional review boards, perhaps because governments see trials as a way for some of their citizens to get medical care (Kelleher, 2004). Still, the richest countries are home to 15 percent of the world’s population and 75 percent of drug trial par- ticipants (Herring, 2011). Consistent adherence to international research standards could change this and would give depth to the results of drug trials, increase understanding of drug development, benefit patients in the developing world, and improve the economies of least developed countries (Herring, 2011). CONTROLLING SUPPLY CHAINS Food and medical product supply chains are complex and far-reaching. In the United States, the 2002 Bioterrorism Act requires all parties in the food supply chain to identify the immediate previous source of their prod- ucts and the immediate recipient; known as one-up, one-back traceability (Gessner et al., 2007). When every actor is responsible for one-up, one-back reporting, it is possible to re-create the entire supply chain, even if no one party has a complete picture of it. Traceability requirements are less clear in medical products supply chains. During the 2008 heparin crisis neither the U.S. Food and Drug Administration (FDA) nor Baxter was able to re- create the heparin supply chain quickly; it took weeks to even get close to the source. The exact identification of the responsible actors was never possible (Pew Health Group, 2011). Multinational companies are exploring radio frequency identification tags and two dimensional bar codes to trace

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88 ENSURING SAFE FOODS AND MEDICAL PRODUCTS products through their supply chains (McMeekin et al., 2006). In develop- ing countries, controlling supply chains is even more of a problem. The Food Supply Chain Large multinational corporations such as Wal-Mart, Archer Daniels Midland, ConAgra, Nestle, Cargill, and Unilever control a great deal of the international food market. These companies have close relationships with their suppliers; they can trace their supply chains in developing countries, a considerable accomplishment considering that a granola bar contains ingredients from half a dozen different countries (Figure 3-1) (Carey, 2007). These companies monitor their supply chains using the principles of Hazard Analysis and Critical Control Points (HACCP), described in Chapter 2. There are five main links in the food supply chain: the farm, the packing house, the transportation, the market, and the consumer (UC Davis Depart- ment of Plant Sciences, 2011). Over the past decade there has been a rapid growth in production of high-value agriculture, premium products such as vegetables, fruits, and animal products. Much of Africa’s high-value exports are grown in coun- tries with high altitudes and year-round growing seasons and exported to Europe (Okello et al., 2007). There are usually separate supply chains feeding the export and domestic markets, with relatively little crossover. High-value agricultural products are highly perishable; logistics, in particu- lar the availability of airfreight space, play a significant role in their trade USA: high fructose corn syrup, sugar, wheat flour (produced & milled), whole China: vitamin & mineral supplements grain oats, sunflower oil, strawberry puree, cellulose, red dye #40 (B1, B2, iron, folic acid), honey Philippines: carrageenan Scotland: sodium alginate India: guar gum Italy: malic acid Denmark: Europe: citric acid lecithin (soy) FIGURE 3-1 Global sourcing of food ingredients. SOURCE: Roth et al., 2008.

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89 CRITICAL ISSUES (Okello et al., 2007). Orders from retailers come in late at night once the European markets are closed, but the crops are picked earlier in the day. When the export order does not match what the supplier packed, the order may end up in the local market, though usually the exporters cannot get the same price that they would have in the European market (Henson and Humphrey, 2009). With the notable exception of one participant from Uruguay, the guests at the various site visits for this study explained that there are two supply chains in their countries: one for export and one for local consumption. Standards are generally lower for the domestic market (Broughton and Walker, 2010; Llana, 2010). At the New Delhi meetings for this report, Indian participants mentioned that having two food safety standards does not trouble them; some stressed that Indians take care to avoid food spoilage at home by marketing daily and boiling their milk every hour. Others believe that Indians have higher innate immunity to foodborne disease than West- erners. Similar misconceptions are common in China (Roth et al., 2008). Spoilage is one of the main problems in the domestic supply chain of Workers in Honduras wash thousands of bananas a day, preparing them for evaluation. Bananas that are exactly the right weight, length, and color are packaged and shipped to the United States; those that are not acceptable are sold in Honduras. SOURCE: © 2007 Sarah Axelson, Courtesy of Photoshare.

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