OIE Collaborating Centre Reports
Activities in 2012
Title of Collaborating Centre:
Address of Collaborating Centre:
Diagnosis of Animal Diseases and
Vaccine Evaluation for the Americas
National Veterinary Services Laboratories and
Center for Veterinary Biologics
PO Box 844
1920 Dayton Ave.
Ames, IA 50010
Tel.:
515-337-7266; 515-337-6100
Fax:
515-337-7397
e-mail address:
website:
elizabeth.a.lautner@aphis.usda.gov;
rick.e.hill@aphis.usda.gov
http://www.aphis.usda.gov/animal_health/lab_info_services/
http://www.aphis.usda.gov/animal_health/vet_biologics/
Name of Director of Institute
(Responsible Official):
Dr. E.A. Lautner
National Veterinary Services Laboratories, VS, APHIS,
USDA
Dr. R.E. Hill, Jr.
Center for Veterinary Biologics, VS, APHIS, USDA
Name (including Title and
Position) of Head of the
Collaborating Centre (formally
OIE Contact Point):
Dr. E.A. Lautner
National Veterinary Services Laboratories, VS, APHIS,
USDA
Dr. R.E. Hill, Jr.
Center for Veterinary Biologics, VS, APHIS, USDA
Name (including Title and
Position) of writer of this report
(if different from above)
Ms. M. L. Sprecher
National Veterinary Services Laboratories, VS, APHIS,
USDA
megan.l.sprecher@aphis.usda.gov
Ms. C.J. Bare
Center for Veterinary Biologics, VS, APHIS, USDA
chelsea.j.bare@aphis.usda.gov
Annual reports of OIE Reference Centres, 2012
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Diagnosis of Animal Diseases and Vaccine Evaluation in the Americas
Summary of activities specifically related to the mandate of
OIE Collaborating Centres
1.
Activities as a centre of research, expertise, standardisation and dissemination of
techniques within the remit of the mandate given by the OIE
 Received official notification from the OIE that the Foreign Animal Disease Diagnostic Laboratory
(FADDL) was approved as an OIE Reference Laboratory for FMD.
 Served on the tripartite (U.S.-Canada-Mexico) North American Foot-and-Mouth Disease (FMD) Vaccine
Bank Technical Committee (NAFMDVB TC). The NAFMDVB TC meets face-to-face twice a year to
address preparedness issues related to vaccine availability and use in the event of an outbreak of FMD in
Canada, Mexico, or the United States.
o Participated in the face-to-face meeting of the Technical committee in Winnipeg, Canada.
o The meeting of the Technical committee in Greensboro, North Carolina, included briefings of the
Commissioners of the North American Vaccine Bank.
 Participated in the National Veterinary Stockpile tabletop exercise addressing steps required to mobilize
the NAFMDVB repository material to appropriate recipients for the preparation of vaccine in the event on
a FMD outbreak in the U.S.
 Provided PCR testing protocols and reagents for Swine Influenza Virus (SIV) to the Centre de
Coopération Internationale en Recherche Agronomique pour le Développement (CIRAD) in Guadeloupe,
French West Indies.
 Recovered a strain of virulent Newcastle Disease virus (vNDV) in three vials of vaccine confiscated.
Characterization of the isolated virus by sequence analysis identified a low virulent Newcastle Disease. A
second diagnostic technique, chicken pathogenicity testing, identified a highly pathogenic virus consistent
with vNDV. The vNDV was also re-isolated from the dead chicks.
 Responded to an inquiry from the Servicio Agrícola y Ganadero (SAG), Departamento de Laboratorios y
Estaciones Cuarentenarias Agrícola y Pecuaria, Pudahuel, Chile regarding sub-typing and sequencing of
SIV field strains.
 Attended the Global FMD Research Alliance Workshop in South Africa. This was hosted by the
Agricultural Research Council-Onderstepoort Veterinary Institute of South Africa.
 Received swine serum samples from the Animal Health Bureau of Panama for testing for Porcine
Reproductive and Respiratory Syndrome (PRRS) virus. NVSL was asked to perform testing to
differentiate between U.S., European and Asian strains of PRRS.
 Conducted inspections of various veterinary biologics manufacturing facilities in Australia, Canada, Czech
Republic, Germany, Mexico, South Korea, and New Zealand that produce biologics imported into the
United States.
 Collaboration with the Haitian government, OIE, FAO, and a commercial laboratory to develop a porcine
teschovirus (PTV) vaccine for use in Haiti.
 Attended the U.S. Antibiotic Resistance: USDA Planning Workshop, May 15-17, in Beltsville, Maryland.
This forum was organized by the USDA Agricultural Research Service, Animal and Plant Health
Inspection Service, and the Food Safety Inspection Service to assist in developing an action plan regarding
antibiotic resistance.
 Provided rabbit and guinea pig antisera to LADIVES Panama. The antisera are OIE standard diagnostic
reagents to be used for vesicular disease AgELISA.
 Administered proficiency tests for 40 State Veterinary Diagnostic Laboratories in the NAHLN regarding
molecular diagnostics for FMD.
2.
Proposal or development of any procedure that will facilitate harmonisation of international
regulations applicable to the surveillance and control of animal diseases, food safety or
animal welfare
 Served on the International Cooperation on Harmonization of Technical Requirements for the Registration
of Veterinary Medicinal Products (VICH) Steering Committee as the U.S. representative for veterinary
biological products. The primary "products" of the VICH are harmonized Guidelines which represent
scientific consensus regarding regulatory requirements for the three regions. VICH is a unique project that
brings together the regulatory authorities of the European Union, Japan, and the United States,
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Annual reports of OIE Reference Centres, 2012
Diagnosis of Animal Diseases and Vaccine Evaluation in the Americas
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3.
representatives from the animal health industry in the three regions, as well as Canada and Australia/New
Zealand as official observers, to harmonize technical requirements for the registration of veterinary
products (both drugs and biologics).
Attended the 27th VICH Steering Committee Meeting held in Brussels, Belgium.
Provided personnel to VICH Expert Working Groups created to draft and recommend the harmonized
biologics guidelines for Quality Monitoring, Pharmacovigilance, and Target Animal Safety.
Co-hosted the OIE/ Institute for International Cooperation in Animal Biologics 2012 Veterinary Biologics
Training Program. The program consisted of three blocks focusing on immunology, manufacturing and
regulatory requirements, and laboratory testing. Participants included 52 international attendees,
representing 27 different countries.
Represented USDA at a workshop for OIE National Focal Points for Veterinary Laboratories in Tecámac,
Mexico. The focus of these meetings was to discuss a global program of capacity building that provides
good governance concepts to member countries, and to explain roles and responsibilities of member
countries to the OIE.
Provided training and represented the U.S. at the Regional Training Seminar for OIE National Focal Points
on Veterinary Products in Sao Paulo, Brazil. The aim of the program was to provide good governance
concepts, and to explain roles and responsibilities of the OIE for member countries. The training included
presentations, through practical exercises, of the structure, organization, and the elaboration of a guideline
and global outreach regarding VICH.
Represented the United States at the OIE Seminar on Harmonization and Control of Veterinary Medicines,
and the Committee of Veterinary Medicines for the Americas (CAMEVET) in Sao Paulo, Brazil. The
objectives of these meetings included information sharing, trade facilitation, and harmonization of the
registration of veterinary medicine products.
Provided training, facilitated, and represented the United States at the Regional meeting for the OIE Focal
Points for Veterinary Medicinal Products in Mombasa, Kenya. The aim of the program was to provide
good governance concepts, and to explain roles and responsibilities of the OIE for member countries. The
training included presentations, through practical exercises, of the structure, organization, and the
elaboration of a guideline and global outreach regarding VICH.
Networking
a)
Maintenance of a network with other OIE Collaborating Centres designated for the same
specialty, and
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b)
Should the need arise, maintenance of a network with Collaborating Centres in other
disciplines
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4.
Participated, as a member of the scientific review panel, in the scientific review of the Rabies
Program, Poxvirus and Rabies Branch, Division of High-Consequence Pathogens and pathology,
National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and
Prevention. The Rabies Program conducts laboratory and field studies, surveillance, health
education, and epidemiologic investigations of rabies and related lyssaviruses. Additional attendees
included representatives from Pan American Foot and Mouth Disease Center (PANAFTOSA), Pan
American Health Organization, and OIE Reference Laboratories.
Attended the Workshop on Laboratory Diagnosis of African and Classical Swine Fever in Hannover,
Germany. This workshop was hosted by the European Union (EU) Reference Laboratory for African
Swine Fever (ASF) and the EU Reference Laboratory for Classical Swine Fever (CSF). Discussions
focused on laboratory diagnosis of ASF and CSF, including evaluation and discussion of 2011 ASF
and CSF inter-laboratory comparison tests and their results.
Placement of expert consultants at the disposal of the OIE
 Provided standard operating procedures on SIV isolation and PCR detection to an OFFLU Scientist with
the Emergency Prevention System Laboratory Unit, FAO.
 Attended the semi-annual OIE Biological Standards Commission meetings held at the OIE headquarters in
Paris, France. Dr. Schmitt, NVSL Diagnostic Virology Laboratory Director, was serving as the Vice
President of the Commission.
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Diagnosis of Animal Diseases and Vaccine Evaluation in the Americas
 Attended the “Engaging Intergovernmental Organizations 2012” course held at the OIE headquarters in
Paris, France and Food and Agriculture Organization of the United Nations headquarters in Rome, Italy.
 Attended a meeting in Rome, Italy to discuss Rinderpest eradication issues.
 Attended the 2nd Global Conference on FMD Control meetings in Bangkok, Thailand. These meetings
were sponsored by the OIE and FAO, and focused on new developments regarding vaccines, diagnostic
methods, and current research.
 Provided representation at the 5th Annual World Health Organization Working Group meeting on PCR for
the Detection of Subtype Influenza A Viruses in Geneva, Switzerland.
 Revised the following chapters in the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial
Animals:
o chapter 2.9.8 – Mange
o chapter 2.1.20 – West Nile Fever
o chapter 2.5.6 – Equine Infectious Anaemia
o chapter 2.1.3 – Bluetongue
o chapter 2.5.5 – Equine encephalomyelitis (Eastern and Western)
 Completed a review of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals chapter on
screwworms.
 Attended the 8th OIE/FAO FMD Reference Laboratory Network Annual Meetings in Jerez de la Fontera,
Spain.
 Participated in a review of Egypt’s vaccine production laboratory to assist in their production of new
vaccines for the control of FMD. The review was requested by the Egyptian Ministry of Agriculture and
Land Reclamation, General Organization for Veterinary Services.
5.
Provision of scientific and technical training, within the remit of the mandate given by the
OIE, to personnel from OIE Member Countries
 Provided PCR proficiency training on rRT-PCR for Newcastle Disease (ND) to veterinarians from the
Secretaria de Agricultura, Ganaderia, Dessarrolloy Rural Pesca y Alimentacion (SAGARPA) in Mexico
City, Mexico.
 Hosted three visitors from the Mexico-United States Commission for the Prevention of Foot and Mouth
Disease and Other Exotic Animal Diseases, and trained the visitors on preparing and evaluating
proficiency panels to carry out laboratory tests for exotic ND.
 Provided keynote lectures on “Eastern, Western and Venezuelan Equine Encephalitis and West Nile Virus
infections” and “Bluetongue and Epizootic Hemorrhagic Disease” at the Foreign Animal Disease
Recognition Course hosted by the Canada Food Inspection Agency in Winnipeg, Manitoba.
 Hosted a visitor from the Bovine Spongiform Encephalopathy Reference Laboratory at the Canadian Food
Inspection Agency in Lethbridge, Alberta.
 Provided training on vesicular stomatitis virus complement fixation diagnostic test methods.
 Attended the “Scientific Developments and Technical Challenges in the Progressive Control of FMD in
South Asia” meetings in New Delhi, India. This conference was organized by the FAO and the Indian
Council on Agriculture Research.
 Participated in a site visit evaluating Mexico’s Classical Swine Fever (CSF) and ND diagnostic
capabilities.
 Provided an overview of modern methods of quality control and testing to Dr. Wazeera Al-Jak,
representative of the State Veterinary Company, Iraq Department of Biological and Medical Supervision,
Division of Vaccine Control. The purpose of the training was to provide the Department knowledge and
tools necessary to implement a transparent process of testing, identify appropriate testing methods, and
ensure that testing is completed according to international standards, within the Iraq veterinary biologics
program.
 Attended the European Partnership for Alternative Approaches to Animal Testing workshop on
implementation strategies of the consistency approach for veterinary inactivated rabies vaccines in
Brussels, Belgium. The goal of the workshop was to develop a clear vision and definition of the
requirements for applying consistency testing in lot release using in vitro antigenic quantification of
veterinary rabies vaccines.
 On-going OIE Twinning project for Avian Influenza and Newcastle Disease with the Official Livestock
and Agriculture Service Laboratory (SAG) in Chile.
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Annual reports of OIE Reference Centres, 2012
Diagnosis of Animal Diseases and Vaccine Evaluation in the Americas
 At the request of the OIE, resubmitted an application for OIE Twinning project for Equine Infectious
Anemia with the Servicio Nacional de Sanidad y Calidad Agroalimentaria (SENASA) in Argentina.
Approval is pending.
6.
Organisation of scientific meetings on behalf of the OIE
None.
7.
Coordination of scientific and technical studies in collaboration with other laboratories,
organisations or collaborating centres
 Met with Jeff Hammond, FMD expert from the World Reference laboratory for FMD, the Pirbright
Institute, United Kingdom, to discuss the USDA FMD project and associated challenges.
 Collaboration with the National Center for Foreign Animal and Zoonotic Diseases (FAZD) and Texas
Veterinary Medical Diagnostic Laboratory (TVMDL), Texas A&M University on the development of a
multiplex molecular test for detection of FMD, ASF, CSF, and endemic diseases from swine oral fluids.
 Collaboration with the FAZD on the development of a molecular penside test for FMD.
 Collaboration with a company. and the National Animal Health Laboratory Network on the deployment of
FMD NS serology for emergency preparedness to the NAHLN.
 Collaboration with the U.S. dairy industry, the NAHLN, the Pirbright Institute, and FAZD on development
of a test for screening bulk tank milk for FMD. Provided training and conducted an interlaboratory
comparison of a FMD diagnostic test for screening bulk tank milk to a subset of State Veterinary
Diagnostic Laboratories and the Pirbright Institute.
 Hosted a visitor from the Canadian Food Inspection Agency (CFIA) as part of a Canada/US twinning
initiative that is focused upon diagnostic research activities at the USDA. Discussion was held on mutual
diagnostic and research interests in the areas of anthrax, leptospirosis, and anaplasmosis.
 As part of a Canada/U.S. twinning initiative for Leveraging US-Canada Science and Technology
Knowledge for Animal Health Bio-Threats, NVSL hosted visitors from the CFIA to discuss mutual
diagnostic and research initiatives in the area of piroplasmosis reagent production and disease testing.
 Developed and implemented BEI inactivation and Ag purification methods of vesicular disease viruses for
producing the disease specific antisera on site.
 Participated in the interlaboratory comparison/proficiency test administered by the Pirbright Institute.
8.
Publication and dissemination of any information within the remit of the mandate given by
the OIE that may be useful to Member Countries of the OIE
 Provided an overview of USDA Swine Influenza surveillance efforts at the OFFLU meetings in Paris,
France.
 Provided training and represented the U.S. at the Regional Training Seminar for OIE National Focal Points
on Veterinary Porducts in Sao Paulo, Brazil.
 Provided training and presentation materials for the Foreign Animal Disease Diagnostician training course
held at NVSL facilities on Plum Island, New York, through USDA’s Professional Development Staff.
 Served as an invited speaker at a training course entitled “Quarantinable Diseases”, held in Piura, Peru.
This course, sponsored by the Servicio Nacional de Sanidad Agraria (SENASA) branch of the Peruvian
Ministry of Agriculture, provided training to Animal Quarantine workers for the government of Peru. An
expert from NVSL spoke on FMD, VSV, Swine Vesicular Disease, CSF and African Swine Fever.
 Participated and provided presentations at the Vaccines and Diagnostics for Trans-boundary Animal
Disease workshop, held in Ames, Iowa. The workshop focused on state of the art measures related to
vaccine and diagnostic tool development for significant trans-boundary animal diseases. The meeting was
sponsored by the U.S. Department of Homeland Security, Science and Technology Directorate; Center for
Excellence for Emerging and Zoonotic Animal Diseases; Iowa State University Center for Food Security
and Public Health Institute for International Cooperation in Animal Biologics; and the International
Association for Biologicals.
 Hosted the International Workshop on Alternative Methods for Leptospira Vaccine Potency Testing: State
of the Science and the Way Forward in Ames, Iowa. The workshop was sponsored by the National
Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, and the
Interagency Coordinating Committee on the Validation of Alternative Methods. The focus was scientific
Annual reports of OIE Reference Centres, 2012
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Diagnosis of Animal Diseases and Vaccine Evaluation in the Americas
review of the currently available potency tests, national and international regulatory requirements for such
tests, and possible development of in vitro tests for Leptospira vaccines.
 Provided presentations at the International Symposium, “Alternatives to Antibiotics: Challenges and
Solutions in Animal Production” in Paris, France. The presentation discussion of potential impacts,
implementation or policies around the potential of biological products as a unique solution to preserving
the effectiveness of pharmaceutical/antimicrobial products.
Publications:
Maan NS, Maan S, Belaganahalli MN, Ostlund EN, Johnson DJ, Nomikou K, Mertens PP (2012). Identification
and differentiation of the twenty six bluetongue virus serotypes by Rt-PCR amplification of the serotype-specific
genome segment 2. Plos One. 7(2):e32601.
Hines NL, Killian ML, Pedersen JC, Reising MM, Mosos NA, Mathieu-Benson C, Miller CL. (2012). An rRTPCR assay to detect the matrix gene of a broad range of avian paramyxovirus serotype-1 strains. Avian Dis.
Jun;56(2):387-95.
Kitikoon P, Vincent AL, Gauger PC, Schlink SN, Bayles DO, Gramer MR, Darnell D, Webby RJ, Lager KM,
Swenson SL, Klimov A. (2012). Pathogenicity and transmission in pigs of the novel A(H3N2)v influenza virus
isolated from humans and characterization of swine H3N2 viruses isolated in 2010-2011. J Virol. Apr 4.
Killian ML, Swenson SL, Vincent AL, Landgraf JG, Shu B, Lindstrom S, Xu X, Klimov A, Zhang Y, Bowman
AS (2012). Simultaneous Infection of Pigs and People with Triple-Reassortant Swine Influenza Virus H1N1 at a
U.S. County Fair. Zoonoses and Public Health. doi: 10.1111/j.1863-2378.2012.01508.x.
Clavijo A, Nikooienejad A, Esfahani MS, Metz RP, Schwartz S, Atashpaz-Gargari E, Deliberto TJ, Lutman MW,
Pedersen K, Bazan LR, Koster LG, Jenkins-Moore M, Swenson SL, Zhang M, Beckham T, Johnson CD,
Bounpheng M. (2012). Identification and Analysis of the First 2009 Pandemic H1N1 Influenza Virus from U.S.
Feral Swine. Zoonoses Public Health. 2012 Sep 17. doi: 10.1111/zph.12006.
Bowman AS, Sreevatsan S, Killian ML, Page SL, Nelson SW, Nolting JM, Cardona C, Slemons RD. Molecular
evidence for interspecies transmission for H3N2pM/H3N2v influenza A viruses at an Ohio agricultural fair, July
2012. Emerging Microbes and Infections. 2012; 1(33).
Courtney SC, Susta L, Gomez D, Hines NL, Pedersen JC, Brown CC, Miller PJ, Afonso CL. Highly Divergent
Virulent Isolates of Newcastle Disease Virus from the Dominican Republic are Members of a New Genotype that
May have Evolved Unnoticed for Over Two Decades. J Clin Microbiol. 2012 Nov 28.
Courtney SC, Gomez D, Susta L, Hines NL, Pedersen JC, Miller PJ, Afonso CL. (2012). Complete genome
sequencing of a novel newcastle disease virus isolate circulating in layer chickens in the Dominican Republic. J
Virol. Sep;86(17):9550.
Lewis CE, Fry AM, Hermann JR, Siev D, Dusek DM, Gatewood DM. (2012). Potency testing of veterinary
rabies vaccines: replacement of challenge by in vitro testing: considerations for development of alternative assays.
Dev Biol (Basel).134:29-33.
Tong C. (2012). Euler’s contributions to mathematics useful in statistics. Am Stat. 66 (1):75.
Hermann J, Fry A, Reising M, Patterson P, Siev D, Gatewood D. (2012). Rabies vaccine standards: comparison
of the 5th and 6th WHO international reference standards to the USDA veterinary reference standard. Vaccine. Nov
6;30(48):6892-6. doi: 10.1016/j.vaccine.2012.09.002. Epub 2012 Sep 13.
Hermann J, Koski D, Taylor S, Gatewood D. (2012). Evaluation of the analytical sensitivity of a polymerase
chain reaction assay for the detection of chicken infectious anemia virus in avian vaccines. Biologicals.
Jul;40(4):266-9. doi: 10.1016/j.biologicals.2012.04.006. Epub 2012 May 15.
Stokes WS, Kulpa-Eddy J, Brown K, Srinivas G, McFarland R. (2012). Recent progress and future directions for
reduction, refinement, and replacement of animal use in veterinary vaccine potency and safety testing: a report from
the NICEATM-ICCVAM International Vaccine Workshop. Dev Biol (Basel). 134:9-21.
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Diagnosis of Animal Diseases and Vaccine Evaluation in the Americas
Stokes W, McFarland R, Kulpa-Eddy J, Gatewood D, Levis R, Halder M, Pulle G, Kojima H, Casey W,
Gaydamaka A, Miller T, Brown K, Lewis C, Chapsal JM, Bruckner L, Gairola S, Kamphuis E, Rupprecht CE,
Wunderli P, McElhinney L, De Mattia F, Gamoh K, Hill R, Reed D, Doelling V, Johnson N, Allen D, Rinckel L,
Jones B. (2012). Report on the international workshop on alternative methods for human and veterinary rabies
vaccine testing: state of the science and planning the way forward. Biologicals. Sep;40(5):369-81. doi:
10.1016/j.biologicals.2012.07.005. Epub 2012 Aug 11.
Nolting J, Fries AC, Slemons RD, Courtney C, Hines NL, Pedersen JC. (2012). Recovery of H14 influenza A
virus isolates from sea ducks in the Western Hemisphere. Version 2. PLoS Curr. 2012 Jan 26 [revised 2012 Feb
2];4:RRN1290.
Anthony SJ, St. Leger JA, Pugliares K, Ip HS, Chan JM, Carpenter ZW, Navarrete-Macias I, Sanchez-Leon M,
Saliki JT, Pedersen JC, Karesh W, Daszak P, Rabadan R, Rowles T, Lipkin WI. (2012). Emergence of Fatal Avian
Influenza in New England Harbor Seals. mBio. Jul-Aug; 3(4): e00166-12. doi: 10.1128/mBio.00166-12.
Borca MV, Pacheco JM, Holinka LG, Carrillo C, Hartwig E, Garriga D, Kramer E, Rodriguez L, Piccone ME.
(2012). Role of arginine-56 within the structural protein VP3 of foot-and-mouth disease virus (FMDV) O1 Campos
in virus virulence. Virology. 2012 Jan 5;422(1):37-45. doi: 10.1016/j.virol.2011.09.031.
Ehizibolo, D.O. et al.; Epidemiological Analysis, Serological Prevalence and Genotypic Analysis of Foot-andMouth Disease in Nigeria 2008–2009; Transboundary and Emerging Diseases (2012). In press.
Hines NL, Miller CL. (2012). Avian Paramyxovirus Serotype-1: A Review of Disease Distribution, Clinical
Symptoms and Laboratory Diagnostics. Vet. Med. Int., 2012:708216.
Hines NL. Molecular analysis of avian paramyxovirus serotype-1. Iowa State University, 2012, 118 pages;
ProQuest/UMI 12520.
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