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Appendix C Summary Reports of Field Visits The field visits were designed to give members of the committee an oppor- tunity to observe conditions in a few developing countries, representing diverse income levels, economic structure, and scientific and medical capacity. (See Tables 3-1 and 3-2 on pages 63 and 64, which provide data characterizing each of the countries visited as well as several other countries within and outside the former Soviet Union, for purposes of comparison.) There was no expectation that these trips would result in comprehensive assessments of the biosecurity and biosafety situations in individual countries or provide the basis for sub- sequent programmatic activities by the Department of Defense or other U.S. government agencies. The brief reports included in this section reflect the views of the travelers based on the limited number of institutions and experts they were able to visit and meet. More detailed oral reports were provided to the full committee. SUMMARY OBSERVATIONS FROM FIELD VISIT TO THE DEMOCRATIC REPUBLIC OF THE CONGO Trip Participant: Claire A. Cornelius, D.V.M., U.S. Army, currently Ph.D. can- didate, University of Chicago, committee member Visit Dates: October 25-31, 2008 (1) Biosecurity awareness; pathogens and vulnerabilities of concern; and governmental legislation, regulations, and policies to address vulnerabilities A major legislative transition occurred in the Democratic Republic of the Congo (DRC) during the visit, precluding any formal meetings with ministry 

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 APPENDIX C leaders in the sectors of health, agriculture, national education, scientific and technological research, trade, and environment. However, in discussions with other public health leaders, it was clear that the DRC is both aware of and committed to strengthening its biosafety and biosecurity framework. The DRC is party to the Convention on Biological Diversity and the Cartagena Protocol on Biosafety (ratified on February 8, 2005) and, in partnership with the Global Environment Facility administered by the United Nations Environment Pro- gram, has begun to establish a national biosafety framework in order to address potential risks associated with the use of modern biotechnology. Although there are several highly dangerous pathogens endemic to the country, research on these pathogens appears to occur primarily in partnership with other countries that have dedicated biosafety level 3 or 4 (BSL-3 or -4) lab- oratories and expertise outside Africa. Congolese scientists would like to greatly improve both their capacity and their capability to conduct comprehensive diagnostics and characterization of strains isolated within their borders as well as to have a reference or training laboratory for other institutions in Africa. In the human health sector, Ebola and other hemorrhagic viruses, avian influenza, poliomyelitis, tuberculosis, HIV, anthrax, plague, monkeypox, African sleep- ing sickness, rabies, diarrheal diseases, malaria, and Buruli ulcers are of high diagnostic priority. From both the veterinary and the conservation perspectives, Ebola (especially in endangered primates), rabies, brucellosis, plague, blackleg, anthrax, foot-and-mouth disease, diarrheal and chronic wasting diseases in hoof stock, and a variety of parasitic maladies represent illnesses of major clinical interest. Although there is a basic disease surveillance system in place, data collection, analyses, alerting systems, and rapid response in remote regions of the country still remain largely inefficient and uncoordinated. (2) Budget, personnel, and other challenges in upgrading biosecurity Budgets for biosafety, biosecurity, biomedical education, advanced labora- tory equipment, and even basic research at key public health institutes and universities (for example, the University of Kinshasa, the University of Lubum- bashi, and the University of Kisangani) are insufficient. More training and career placement are required to develop specialists in biosafety, biotechnology (especially microbiology, molecular biology, and immunology), international law, medicine (human and veterinary), information technology, and public education, especially with regard to the tenets of the Cartagena Protocol. (3) Interests and programs of foreign organizations and interests of local government in international engagement on biosecurity issues Ministry officials and researchers strongly support cooperative capacity- building programs with the European Union, the United States, and other

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 APPENDIX C African nations on biosecurity and infectious disease research and welcome new partnerships. Staff members from the Central Veterinary Laboratory have received training from the International Atomic Energy Agency and collab- orated with investigators from the University of London, Royal Veterinary College; the Institute of Tropical Medicine (ITM)-Antwerp; the Onderspoort Veterinary Institute in South Africa; and the Centers for Disease Control and Prevention (CDC) in Atlanta. Similarly, the National Institute of Biomedical Research of the DRC Ministry of Public Health has ongoing projects with several countries in Africa (particularly for trypanosomiasis research), ITM- Antwerp, the U.S. Army Medical Research Institute for Infectious Diseases, CDC, and the Pasteur Institute; and it serves as a World Health Organization reference laboratory for poliomyelitis. List of Institutions Visited • National Institute of Biomedical Research, DRC Ministry of Public Health, Kinshasa, Kole • Central Veterinary Laboratory, Kinshasa • CDC Global Aids Program office, Kinshasa • Central African Regional Program for the Environment of the U.S. Agency for International Development, Kinshasa • U.S. Embassy, Kinshasa SUMMARY OBSERVATIONS FROM FIELD VISIT TO MEXICO Trip Participants: Joseph Silva, former dean of medicine, University of Califor- nia, Davis; and Michael Clegg, Donald Bren Professor of Biological Sciences, Department of Ecology and Evolution, University of California, Irvine, and foreign secretary, National Academy of Sciences (NAS) Visit dates: October 6-10, 2008 (1) Biosecurity awareness; pathogens and vulnerabilities of concern; and gov- ernment legislation, regulations, and policies to address vulnerabilities Biosecurity awareness is high across Mexican institutes, agencies, and uni- versities. Planning and implementation of effective programs are under way. While we could not visit all the laboratories in Mexico, we learned that salmo- nella, anthrax, clostridia, tuberculosis, hantaviruses, multidrug-resistant enteric organisms, dengue, and plasmodium (malaria) are of most concern. In addition, the United States has experienced serious outbreaks originating from Mexican agricultural produce contaminated with Cryptosporidia and Escherichia coli.

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 APPENDIX C Mexico has more daily interactions with the United States than any other country, including Canada. Specialists are fully aware of problems (especially infectious diseases) related to border control. Mexico is an important hub for distributing or transmitting infections to the United States. The cross-border commercial and tourist traffic is sizeable. Mexico City and Mexico’s ocean shoreline cities attract many international travelers by air or cruise ships. Many of these travelers also visit the United States. Several major outbreaks of food- borne diarrhea related to the ready and relatively cheap supply of vegetables and fruit exported by Mexico occur in the United States almost annually. Thus, it is in the interest of the United States to sponsor the development of a rapid surveillance system with accurate and rapid and high-quality diagnostic capabil- ities in this neighboring developing country. Most of those contacted expressed the view that they have enough laws to control infections, except for the author- ity to institute total isolation of individual citizens (that is, home or institutional confinement with all its aspects, including body location monitors). (2) Budget, personnel, and other challenges in upgrading biosecurity Mexico is a large country facing significant economic challenges, and this may explain in part why federal funding of science and technology is less than 0.4 percent of the country’s gross national product (compared to approximately 1 percent for Brazil, the most populous country of Latin America). Despite this low level of investment, Mexico has established good research capabilities; and governmental surveillance for infection is improving, as is the establish- ment of modern laboratories with well-trained investigators. More funding would accelerate their growth. An occurrence of a natural outbreak with an especially dangerous pathogen (EDP) or international release of an EDP could pose a large threat to the United States because of our border porosity and its migrant crossings. Protection on the Mexican side is provided by 12 national institutes within a system equivalent to the U.S. National Institutes of Health (NIH) system. Of these 12 institutes, 10 also have education in their missions besides research. Owing to the volume of human movement and to the diffuse geographic interconnections between the United States and Mexico, U.S. health security is strongly intertwined with that of Mexico. Thus, it is important to augment current Mexican programs to reduce biological threats in this territori- ally large and populous country. We visited a few laboratories in a short period. Thus, any attempt to make estimates of the resources needed to improve biosafety and biosecurity would be superficial. Suffice it to state that all laboratories visited expressed keen interests in upgrading their security systems (new equipment and technolo- gies and especially training). We believe the costs will be modest because of well-developed extant programs. All welcome more one-on-one training for

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 APPENDIX C their personnel in these areas. CDC and NIH are important for the training to date. (3) Interests and programs of foreign organizations and interests of local government in international engagement on biosecurity issues Currently, Mexico receives assistance from various U.S. universities, as well as those from Canada, the United Kingdom, and Germany. Local organizations are interested in receiving assistance for biosecurity upgrades and training in biosafety and biosecurity and for construction of additional BSL-3 laborato- ries with sustained support for personnel, supplies, and equipment. There is also interest in expanding research collaborations with U.S. investigators. U.S. agencies concerned with epidemiology and surveillance responsibilities should review how to better provide more timely information on infectious outbreaks affecting humans, animals, and plants. Some consideration should be given to periodically and regularly incorporating Mexican institutions into a better information network with U.S. agencies. List of Institutions Visited • National Center of Epidemiological Surveillance and Disease Control, Mexico City • Institute of Diagnostic and Reference Epidemiology, Mexico City • Institute for Biotechnology, Cuernavaca • National Autonomous University of Mexico, Cuernavaca • U.S. Embassy, Mexico City • National Institute of Genomic Medicine, Mexico City • Ministry of Foreign Affairs, Mexico City • Center for Research and Advanced Studies of the National Polytechnic Institute, Irapuato • University of Monterrey, Monterrey • U.S.-Mexico Foundation for Science, Mexico City SUMMARY OBSERVATIONS FROM FIELD VISIT TO MALAYSIA Trip participants: Timothy P. Endy, State University of New York, Upstate Medical University, Department of Medicine, committee member; and Alice Chu, U.S. Embassy, environmental, science, technology, and health officer and control officer Visit Dates: October 17-21, 2008

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 APPENDIX C (1) Biosecurity awareness; pathogens and vulnerabilities of concern; and gov- ernment legislation, regulations, and policies to address vulnerabilities Malaysia is a developing country with an emerging biotechnology base in Southeast Asia. It is a member of the Organization of the Islamic Conference and strongly emphasizes its Islamic roots. Malaysia has several emerging patho- gens of interest to this committee. It was the site of a large Nipah virus outbreak in the late 1990s that resulted in hundreds of deaths, the culling of the entire pig population, and economic loss from the pig industry. This outbreak illustrated some of the current issues in Malaysia. The Nipah outbreak resulted in racial tensions in Malaysia, specifically in the form of discrimination against Chinese Malaysians, who, as non-Muslims, are the only ethnic group that raises pigs. There were also initial accusations that the Nipah outbreak occurred as a result of U.S. bioweapons experiments. In addition, Malaysia was one of the countries that experienced cases of severe acute respiratory syndrome in 2001, and it also has current concerns over avian influenza. Select agents that are endemic in Malaysia include Japanese encephalitis, Nipah virus, and melioidosis. The racial tensions in Malaysia are significant. The U.S. Department of State’s Biosecurity Engagement Program spon- sored a conference entitled “Biosafety, Biosecurity Asia: Concept, Issues and Challenges” in Kuala Lumpur, Malaysia, on May 21-22, 2007. This was cospon- sored by the Malaysian Ministry of Defense and chaired by the Malaysian Science and Technology Research Institute for Defense (STRIDE). The confer- ence’s stated objectives were (1) to establish a mechanism for creating biosafety and biosecurity awareness and education, (2) to create a platform to explore issues pertaining to national acts on biosafety and biosecurity worldwide, and (3) to become a catalyst for regional and international cooperation on biosafety and biosecurity issues. The minister of the interior delivered a speech on behalf of the prime minister of Malaysia, stressing that this conference addressed three critical issues for Malaysia: (1) national security, (2) public health, and (3) biotechnology. There were 11 governmental organizations participating in this conference, with STRIDE in the lead. Malaysia is a signatory to the Biologi- cal Weapons Convention, has passed its own Prevention of Infectious Disease Act, and has passed and currently is revising a Biosafety Act, including a select agent list. (2) Budget, personnel, and other challenges to upgrading biosecurity Malaysia has invested heavily in the creation of modern laboratories, BSL-3 facilities, and applied research. Malaysia funds approximately 400 Ph.D. stu- dents per year to receive scientific training outside Malaysia and has an active grants program to attract them back to Malaysia. All institutes visited consid-

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 APPENDIX C ered bioterrorism a low risk and deemed the application of dual-use technology to be possible but also a low risk. They felt that biosafety and biosecurity were on the national agenda, as evidenced by investment in the development of safe laboratory practices and biosecurity. Malaysia is a developing nation with a high degree of biotechnological investment and potential for dual-use misdirection. They have select agents and endemic pathogens that could be used for bioterrorism. The minority population occupies the most educated parts of Malaysian society, including scientists and researchers. Malaysia has active trade and open borders with other Muslim countries (3) Interests and programs of foreign organizations and interests of local government in international engagement on the biosecurity issue Biosafety and biosecurity issues are clearly on the Malaysians national agenda. The Pacific Command, the Department of State, and Sandia National Laboratories have sponsored several workshops on biosafety and biosecurity in Malaysia. CDC is awaiting signature on a memorandum of understanding to place a CDC representative in Malaysia. All institute officials agreed on the need for better biosafety and biosecu- rity training, biosecurity collaboration, improved physical security of pathogen collections, and development of a personnel reliability program. When asked which organization is the best to deliver this type of training, they all acknowl- edged that the World Health Organization and Australian and Singaporean centers are acceptable. Some hesitated regarding CDC, citing mixed experi- ences with the center, and expressed doubts about the Department of Defense, but all had had good experiences with the Department of State. In conclusion, I would consider Malaysia a country of concern and a country that would benefit from the tools and training offered by the Biological Threat Reduction Program. List of Institutions Visited • National Public Health Laboratory, Sungai Buluh • Royal Malaysian Customs, Putrajaya • Science and Technology Research Institute for Defense, Taman Kajang Utama • Department of Chemistry; National Biotechnology Division, Putrajaya • Ministry of Science, Technology, and Innovation, Putrajaya • Infectious Diseases Research Center, Putrajaya • Institute for Medical Research, Putrajaya • Department of Veterinary Services, Putrajaya

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0 APPENDIX C SUMMARY OBSERVATIONS FROM FIELD VISIT TO MOROCCO Trip participants: Richard L. Witter, U.S. Department of Agriculture, commit- tee member, and NAS member; and Kelly Robbins, committee staff Visit Dates: October 12-18, 2008 (1) Biosecurity awareness; pathogens and vulnerabilities of concern; and governmental legislation, regulations, and policies to address vulnerabilities The country clearly is aware of biosafety and biosecurity issues and would like to develop self-sufficiency in this area, but the degree of concern varies among the different ministries and laboratories visited. A legislative framework has only recently been put in place, but implementation and enforcement need improvement. The Moroccan government is currently working to create a National Commission on Biosafety and Biosecurity. Few if any highly dangerous pathogens are being used in Morocco, and no collections of dangerous pathogens were identified. However, there is a desire among Moroccans to become players in this field, pending development of the needed facilities, training of staff, access to strains, and funds to support such programs. They would especially like to have the capability to diagnose such diseases with state-of-the-art technologies. Security and infrastructure at the two BSL-3 labs visited appeared very good, and the security of the central microorganism collection appeared ade- quate for the type of strains it contains. All the laboratories visited demon- strated awareness of biosafety, pointed out relevant equipment, and mentioned training for their researchers and students, although some commented that awareness and training could be improved. Less consideration has been given to the possibility of intentional releases, although the anthrax letter incidents of 2001 did raise awareness of Morocco’s insufficient response capabilities, even though suspicious letters received by the U.S. Embassy in Rabat and other Moroccan institutions ultimately turned out to be harmless. There may also have been an attempted bioterrorist incident in recent years, although full details were unavailable. Avian influenza, tuberculosis, HIV, anthrax, and hepatitis were most fre- quently cited as the most important pathogens for humans and peste des petits ruminants for animals. Rabies was also cited as a serious potential threat for both the human and the animal populations. Most persons characterized the information-technology-based Moroccan disease surveillance system as being very good, with a few respondents taking a somewhat more critical view. Despite the initial favorable assessments offered regarding the system, however, further discussion elicited acknowledgments that the system is not optimal. It was suggested that more training for first responders would be useful, and capacity building for epidemiologists who must analyze and use the data was

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 APPENDIX C cited as a particularly urgent need. We also learned that medical waste disposal is a problem for many facilities, although commercial disposal services exist and their services could be expanded. (2) Budget, personnel, and other challenges in upgrading biosecurity Budgets for biosecurity at key research facilities are adequate, but are insufficient for many others. Several researchers cited an urgent need for a mechanism to allow researchers to obtain necessary reference strains from abroad, which would improve their capabilities for diagnosing disease out- breaks. More training for both researchers and first responders and enhanced border control capabilities were also frequent requests. A need for improved awareness of biosafety and biosecurity among students, researchers, officials, and the public was also noted. Some also cited a need for better legislative structures and the means to implement laws and policies. It appears that the Moroccan government is currently working on these issues and provid- ing at least some funds to carry out improvements in the infrastructure to support biosafety and biosecurity. Ensuring cooperation among the govern- ment ministries and other entities that will be involved will be a challenge. (3) Interests and programs of foreign organizations and interests of local government in international engagement on biosecurity issues Ministry officials and researchers alike strongly supported cooperative and capacity-building programs with the United States on biosecurity and infectious disease research. Although the number of highly skilled scientists in Morocco is not large, existing cooperative research efforts mainly involve Moroccan expatriates and could be expanded to a formal program that would engage more U.S. laboratories and researchers. Many suggested that Morocco is well positioned to serve as a regional center for collaboration and training. A few institutions have already exchanged visits with CDC for training purposes, and the Ministry of Higher Education and the National Institute of Hygiene worked with the Department of State (Biosecurity Engagement Program) to organize a training workshop in Rabat in November 2008. A few researchers also stated that their institutions had worked with Naval Medical Research Unit 3 (NAMRU-3) and were very appreciative of the training and consulta- tive services that had been provided. No one foresaw any problems in work- ing with the U.S. government, and in fact, many gave examples of successful collaboration with the United States in the past. That said, the present level of engagement with U.S. institutions lags far behind that of European institutions, especially France. Various nongovernmental organizations, such as the Verifica- tion Research, Training and Information Center, are also assisting Morocco with biosecurity issues. The European Union plans to assist Morocco with biosafety

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 APPENDIX C and biosecurity in 2008, although no details were yet available regarding their proposed activities. Coordination of any cooperative programs with the mul- tiple Moroccan agencies and U.S. and international partners will be crucial to ensure that resources are used most effectively. List of Institutions Visited • Directorate of Technology, Ministry of Higher Education, Training, and Scientific Research, Rabat • National Working Group (Pôle de Competance) for Soil Microbiology and Plant Biotechnology, Rabat • Department of Biotechnology, National Center for Energy and Nuclear Sciences and Technologies, Rabat • Pasteur Institute, Casablanca • Athisa Maroc, Casablanca • Directorate of Epidemiology and Disease Control, Ministry of Health, Rabat • World Health Organization Office in Morocco, Rabat • National Center for Scientific Research and Technology, Rabat • Laboratories of the Gendarmarie Royale, Rabat • Office of the Secretary General, Ministry of Higher Education, Training, and Scientific Research, Rabat • Moroccan Society of Biochemistry and Molecular Biology, Rabat • Unit of Microbiology, Immunology, and Contagious Diseases, Hassan II Institute of Agronomy and Veterinary Science, Rabat • National Institute of Hygiene, Ministry of Health, Rabat • Moroccan Network for Medicinal and Aromatic Plants, Rabat • U.S. Embassy, Economic Section, Rabat