OIE Collaborating Centre Reports
Activities in 2013
Title of Collaborating Centre:
Address of Collaborating Centre:
Veterinary Drug Regulatory
Programmes
Center for Veterinary Medicine (CVM), Food and Drug
Administration, Department of Health and Human
Services, United States of America, 7519 Standish Place,
HFV-1, Room 177, Rockville, Maryland, 20855, USA
Tel.:
240-276-9300
Fax:
240-276-9030
e-mail address:
website:
CVMIPT@FDA.HHS.GOV
http:www.fda.gov/AnimalVeterinary/default.htm
Name of Director of Institute
Dr Bernadette M. Dunham
(Responsible Official): Director, Center for Veterinary Medicine,
U.S. Food and Drug Administration
Name (including Title and
Position) of Head of the
Collaborating Centre (formally
OIE Contact Point):
Name (including Title and
Position) of writer of this report
(if different from above)
Annual reports of OIE Reference Centres, 2013
Dr Merton V. Smith
Director, International Programs and
Product Standards
Office of the Director, Center for
Veterinary Medicine
Jon F. Scheid
International Communications Manager
1
Veterinary Drug Regulatory Programmes
Summary of activities specifically related to the mandate of
OIE Collaborating Centres
ToR:
To provide services to the OIE, in particular within the region, in the designated
specialty, in support of the implementation of OIE policies and, where required, seek for
collaboration with OIE Reference Laboratories
ToR:
To identify and maintain existing expertise, in particular within its region
1.
Activities as a centre of research, expertise, standardisation and dissemination of
techniques within the remit of the mandate given by the OIE
Disease control
Epidemiology, surveillance, risk assessment, modelling
Training, capacity building
Zoonoses
Wildlife
Avian diseases
Aquatic animal diseases
Animal welfare
Diagnosis, biotechnology and laboratory
Veterinary medicinal products
Vaccines
Food safety
Feed safety
Other (Name the category: Veterinary Drug Regulatory programmes)
ToR:
To propose or develop methods and procedures that facilitate harmonisation of
international standards and guidelines applicable to the designated specialty
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
2
Proposal title
Scope/Content
Applicable area
Implementing programs
as part of the WHO
Advisory Group on
Integrated Surveillance of
Antimicrobial Resistance
(AGISAR) and WHO Global
Foodborne Infections
Network (GFN)
The 5th AGISAR meeting of the WHO
was held jointly with a meeting of the
WHO GFN. The meetings covered issues
related to building laboratory capacity
for monitoring antimicrobial resistance
and to finalizing WHO guidance
documents on integrated surveillance.
Surveillance and control of animal
diseases
28th VICH Steering
Committee meeting
Dr Bernadette Dunham, Director of the
Center for Veterinary Medicine, served
as Chair of the meeting. The goal of
participating in the VICH is to harmonize
standards and protocols for the safety,
quality, and efficacy studies required to
license or approve veterinary medicines;
protect human and animal health by
ensuring the safety and efficacy of
animal drugs, including drugs intended
for food producing animals; exchange
scientific/regulatory information
Surveillance and control of animal
diseases
Food safety
Animal welfare
Food safety
Animal welfare
Annual reports of OIE Reference Centres, 2013
Veterinary Drug Regulatory Programmes
Proposal title
Scope/Content
Applicable area
between CVM and its regulatory
counterparts, international standardsetting organizations, and industry; and
develop and maintain working
relationships with regulators, scientists,
and industry personnel in foreign
countries.
29th VICH Steering
Committee meeting and
3rd VICH Global Outreach
Forum
This meeting of the VICH Steering
Committee was held in conjunction with
the third meeting of the VICH Outreach
Forum. The Steering Committee, OIE,
and the Forum participants discussed
means to improve the understanding of
the implementation of VICH Guidelines
in Outreach Forum member countries
and regions. And the Committee
discussed means to enhance the
participation of Outreach Forum
members in VICH technical activities
Surveillance and control of animal
diseases
Food safety
Animal welfare
ToR:
To establish and maintain a network with other OIE Collaborating Centres designated
for the same specialty, and should the need arise, with Collaborating Centres in other
disciplines
ToR:
To carry out and/or coordinate scientific and technical studies in collaboration with
other centres, laboratories or organisations
3.
Did your Collaborating Centre maintain a network with other OIE Collaborating Centres
(CC), Reference Laboratories (RL), or organisations designated for the same specialty, to
coordinate scientific and technical studies?
Yes
Name of OIE CC/RL/other
organisation(s)
No
Location
Region of
networking Centre
Purpose
National Veterinary Assay
Laboratory, Japan Ministry of
Agriculture, Forestry, and
Fisheries
Tokyo
Africa
Americas
Asia and Pacific
Europe
Middle East
CVM made extensive preparations for a
long-term (2-month) visit by a scientist of
Japan’s NVAL to exchange information on
policies that address safe use of animal
drugs. The preparations included
identifying key subject areas and
recruiting subject matter experts to
discuss those areas with the visitor.
European Medicines Agency
London
Africa
Americas
Asia and Pacific
Europe
Middle East
To strengthen collaborative efforts for
GMP inspectional report exchanges.
Institute of Veterinary Drug
Control
Beijing
Africa
Americas
Asia and Pacific
Europe
Middle East
To discuss GMP requirements and learn
about antimicrobial drugs requirements.
Annual reports of OIE Reference Centres, 2013
3
Veterinary Drug Regulatory Programmes
Name of OIE CC/RL/other
organisation(s)
4
Location
Region of
networking Centre
Purpose
China General Administration
of Quality Supervision,
Inspection and Quarantine
Beijing
Africa
Americas
Asia and Pacific
Europe
Middle East
Training about safe animal feed, including
drugs used in feed.
China Academy of
Agricultural Sciences, Ministry
of Agriculture
Beijing
Africa
Americas
Asia and Pacific
Europe
Middle East
Discuss possible collaboration with
Institute of Standards and Testing
Technology for Agri-Products.
Tripartite meeting of
European Medicines
Agency, Canadian Drugs
Directorate, and CVM
Teleconference
Africa
Americas
Asia and Pacific
Europe
Middle East
Discuss joint issues about animal drug
review and approval.
China Academy of
Agricultural Sciences
Beijing
Africa
Americas
Asia and Pacific
Europe
Middle East
Discuss CVM’s drug regulatory
responsibilities and how they related to
the work of the Academy; developed
plans for CVM visit to the Academy later
in the year.
German Federal Office of
Consumer Protection and
Food Safety
Braunsch
weig,
Germany
Africa
Americas
Asia and Pacific
Europe
Middle East
Discuss VICH Pharmacovigilance Expert
Working Group; and discuss ways to
share Adverse Drug Events more quickly.
Members of European
Parliament’s Environment,
Public Health and Food Safety
Committee
London
Africa
Americas
Asia and Pacific
Europe
Middle East
Discuss issues of mutual interest,
including veterinary drugs.
UK’s Department for
Environment, Food, and Rural
Affairs
London
Africa
Americas
Asia and Pacific
Europe
Middle East
Discussions of National Antimicrobial
Resistance Monitoring System.
China Ministry of Agriculture
Shandong
Africa
Americas
Asia and Pacific
Europe
Middle East
Discuss future collaboration in areas of
animal drug regulation and antimicrobial
resistance.
Agence Nationale de Securite
Sanitaire de L’alimentation,
de L’environnement et du
Travail
MaisonsAlfort,
France
Africa
Americas
Asia and Pacific
Europe
Middle East
Exchange of information about the
functions of the ANSES and CVM,
including the appropriate regulation of
animal drugs.
China General Administration
of Quality Supervision,
Inspection and Quarantine
Beijing
Africa
Americas
Asia and Pacific
Europe
Middle East
Discussion of feed import requirements
and safety of pet treats, including animal
drug residue issues.
Canadian Veterinary Drugs
Directorate
Ottawa
Africa
Americas
Asia and Pacific
Europe
Discuss joint issues of animal drug review.
Annual reports of OIE Reference Centres, 2013
Veterinary Drug Regulatory Programmes
Name of OIE CC/RL/other
organisation(s)
Location
Region of
networking Centre
Purpose
Middle East
Korean Food and Drug
Administration
Seoul
Africa
Americas
Asia and Pacific
Europe
Middle East
Discuss animal drug review standards.
Centre for Food Safety Risk
Assessment
Beijing
Africa
Americas
Asia and Pacific
Europe
Middle East
Safety of food from animals, including the
prevention of unsafe residues of animal
drugs.
Swedish National Veterinary
Institute
Oslo
Africa
Americas
Asia and Pacific
Europe
Middle East
Safety of animal drug residues.
World Health Organization,
Department of Food Safety
and Zoonosis
Geneva
Africa
Americas
Asia and Pacific
Europe
Middle East
Activities related the Joint Expert
Committee on Food Additives, including
the issue of unapproved animal drugs.
Japan Ministry of Agriculture,
Forestry, and Fisheries
Tokyo
Africa
Americas
Asia and Pacific
Europe
Middle East
Discuss animal drug review issues.
European Medicines Agency
London
Africa
Americas
Asia and Pacific
Europe
Middle East
Discuss animal drug safety.
Chile Government and
ASPROCER (Pork producers
Trade Association of Chile)
Santiago
Africa
Americas
Asia and Pacific
Europe
Middle East
Discuss animal drug approval process.
4.
Did your Collaborating Centre maintain a network with other OIE Collaborating Centres,
Reference laboratories, or organisations in other disciplines, to coordinate scientific and
technical studies?
Yes
Name of OIE CC/RL/other
organisation(s)
Centre for Veterinary
Biologics, U.S. Department
of Agriculture, Animal and
Plant Health Inspection
Service
No
Location
Ames,
Iowa,
USA
Annual reports of OIE Reference Centres, 2013
Region of
networking Centre
Africa
Americas
Asia and Pacific
Europe
Middle East
Purpose
Coordinate issues involving the
regulation of veterinary medicines.
5
Veterinary Drug Regulatory Programmes
ToR:
To place expert consultants at the disposal of the OIE.
5.
Did your Collaborating Centre place expert consultants at the disposal of the OIE?
Yes
6
No
Name of expert
Kind of consultancy
Subject
Dr David White
Participation in OIE Ad Hoc
Group on Antimicrobial
resistance.
Provided expert advice on antimicrobial
resistance issues.
Dr Bettye Walters
Participation in OIE General
Assembly meeting
Discussed OIE/FDA International Cooperative
Agreement and other work under OIE Global
Fund for Animal Health and Welfare.
Dr Don Prater
Participated on the Indicators
Task Force
Dr Don Prater
Advisory Committee of the OIE
World Animal Health and
Welfare Fund
The main discussion points included
previously established macro-program
indicators and their usage, specific categories
of activities and programs of the OIE World
Fund, their outcomes and possible indicators
to measure compliance with the OIE
standards, and the development of countryspecific indicators to measure and evaluate
progress from compliance missions. FDA,
along with other U.S. Government Agencies,
had requested formation of the Task Force in
2011.
Dr Prater presented the work of the OIE Task
Force on Performance Indicators.
Dr Don Prater, Dr Steve
Vaughn, and Dr Bill
Flynn
OIE Global Conference on the
Responsible and Prudent Use
of Antimicrobial Agents for
Animals
Implications for Registration and Approval of
Innovative Technologies. The search for
appropriate therapeutic interventions extends
well beyond simply finding new antibiotics.
The future solutions will depend on new
innovative technologies. The development
and commercialization of these novel
technologies are inherently more difficult and
risky for the animal health industry to pursue.
Some of this risk lies in the regulatory
environment in which these new technologies
will be evaluated. CVM has developed a new
approach to the development and evaluation
of novel technologies intended for use as
animal drugs. This presentation discussed the
efforts underway by CVM to meet the
challenges presented with these novel
technologies.
Dr Pat McDermott and
Dr Don Prater
OIE Global Conference on the
Responsible and Prudent Use
of Antimicrobial Agents for
Animals
FDA perspectives on the use of antibiotics in
veterinary medicine.
Annual reports of OIE Reference Centres, 2013
Veterinary Drug Regulatory Programmes
ToR:
To provide, within the designated specialty, scientific and technical training to personnel
from OIE Member Countries
6.
Did your Collaborating Centre provide scientific and technical training, within the remit of
the mandate given by the OIE, to personnel from OIE Member Countries?
Yes
No
If the answer is yes, please provide the total number of trained persons for each of the following
categories:
a)
Technical visits: ................................................................ 6
b)
Seminars: ......................................................................... 5
c)
Hands-on training courses: .............................................. 1
d)
Internships (>1 month): ................................................... 0
Type of technical
training provided
(a, b, c or d)
a
Content
Country of origin of
the expert(s)
provided with
training
No. participants
from the
corresponding
country
More than 30 CVM specialists developed
detailed presentations about various
aspects of the way CVM reviews animal
drugs for a visiting scientist from the
National Veterinary Assay Laboratory of
Japan’s Ministry of Agriculture, Forestry,
and Fisheries. CVM made arrangements for
the visiting scientist to spend nearly two
months at CVM and to have access to many
of the programs the Center uses in its review
of animal drugs and in its monitoring of
Adverse Drug Experience Reports. The goal
of the presentations is greater exchange of
information between Japan and the U.S. on
regulatory issues.
Japan
1
b
Provided workshops on the safety and
efficacy of animal drugs, including drugs
intended for food producing animals;
exchanged scientific/ regulatory information
between CVM and its regulatory
counterparts, and gained insight into the
scientific and regulatory needs of CVM’s
international counterparts and industry.
People’s Republic of
China
50
b
Regional Training Seminar for OIE National
Focal Points for Veterinary Products.
Provided information about good
governance of veterinary products
(legislation, authorization, surveillance,
distribution, control); and provided
information about VICH General Principles
and an update on Outreach Forum
activities.
Sub-Saharan African
60
b
Provided training to CCAFRICA in Codex.
Nairobi
30
Annual reports of OIE Reference Centres, 2013
7
Veterinary Drug Regulatory Programmes
Type of technical
training provided
(a, b, c or d)
8
Content
Country of origin of
the expert(s)
provided with
training
No. participants
from the
corresponding
country
a
Visited by Chile Ministry of Agriculture,
Livestock and Agricultural Service;
ASPROCER - Pork Producers Trade
Association of Chile; and Elanco, to discuss
approval process (as it applies to
ractopamine), Codex reference standards
and perspective, and tolerance/standards
and FDA coordination for residue
prevention with the U.S. Department of
Agriculture.
Chile
7
a
Visited by representative of Sweden’s
National Veterinary Institute, to learn about
CVM’s process of tracking Adverse Drug
Experience reports, and to describe
Sweden’s Rapid Alert System for tracking
adverse drug events.
Sweden
1
c
Provided training on analytical methods to
determining nature of material and
additives in feed products.
China
2
a
Representatives of China’s IVDC visited CVM
to learn about CVM’s requirements for
veterinary product GMPs, and to learn
about CVM’s requirements for antimicrobial
drugs.
China
4
a
CVM presented a workshop with China’s
Institute of Veterinary Drug Control about
animal drug safety; from toxicology
assessments to setting tolerances/MRLs, in
Beijing.
China
85-90
b
CVM presented seminar on Safety of Animal
Drug Residues and Detections - exploring
bilateral collaboration, Jinan.
China
60
b
CVM presented seminar on U.S. Regulatory
Approaches to Safe and Effective Animal
Drugs: An Interactive Session with Faculty
and Graduate Students in in China Animal
Drug Testing and Research Center, Wuhan.
China
55
a
CVM participated in workshop on
antimicrobial resistance, to present
information on the National Antimicrobial
Resistance Monitoring System and the WHO
Advisory Group on Integrated Surveillance
of Antimicrobial Resistance. The workshop
was designed to aid the Brazilian
government in establishing a NARMS-like
program in-country to help ensure the
wholesomeness of products introduced into
international commerce, as well as aid
national health.
Brazil
65
Annual reports of OIE Reference Centres, 2013
Veterinary Drug Regulatory Programmes
ToR:
To organise and participate in scientific meetings and other activities on behalf of the
OIE
7.
Did your Collaborating Centre organise or participate in the organisation of scientific
meetings on behalf of the OIE?
Yes
National/
International
International
No
Title of event
Co-organiser
Date
(mm/yy)
Regional Training
Seminar for OIE National
Focal Points for
Veterinary Products.
Provide information
about good governance
of veterinary products
(legislation,
authorization,
surveillance, distribution,
control), and VICH
General Principles and
Update on Outreach
Forum activities.
OIE
12/13
Location
Mozambiq
ue
No.
Participants
40
ToR:
To collect, process, analyse, publish and disseminate data and information relevant to
the designated specialty
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
(Indicate in the appropriate box the number by category)
a)
Articles published in peer-reviewed journals: ................. 17
Smith M. (2013). The role of veterinary medicine regulatory agencies. Coordinating surveillance
policies in animal health and food safety ‘from farm to fork.’ 2013. Vol. 32 (2). 393-408.
Smith P., Alday-Sanz V., Matysczak J., Moulin G,. Lavilla-Pitogo C.R., & Prater D. (2013). Monitoring
and surveillance of antimicrobial resistance in microorganisms associated with aquatic animals.
Coordinating surveillance policies in animal health and food safety ‘from farm to fork.’ 2013. Vol.
32 (2). 583-593.
Sjolund-Karlsson M., Howie R.L., Blickenstaff K., Boerlin P., Ball T; Chalmers G., Duval B., Haro J.,
Rickert R., Zhao S., Fedorka-Cray P.J., & Whichard J.M. (2013) Occurrence of beta-lactamase genes
among non-Typhi Salmonella enterica isolated from humans, food animals, and retail meats in the
United States and Canada. Microbial Drug Resistance (Larchmont, N.Y.). Vol.19. Issue 3. 191-197.
De Alwis H.G., Girard L., Kijak P.J., & Rummel N. (2013). Determination of Erythromycin in
Medicated Salmonid Fish Feed by Liquid Chromatography and UV Spectroscopy. Journal of AOAC
International. Vol. 96. Issue 6. 1233-1238.
Glenn L.M., Lindsey R.L., Folster J.P., Pecic G., Boerlin P., Gilmour M.W., Harbottle H., Zhao S.,
McDermott P.F., Fedorka-Cray P.J., & Frye J.G. (2103). Antimicrobial resistance genes in multidrugresistant Salmonella enterica isolated from animals, retail meats, and humans in the United States
and Canada. Microbial Drug Resistance (Larchmont, N.Y.). Vol. 19. Issue 3. 175-184.
Son I., Zheng J., Keys C.E., Zhao S., Meng J., & Brown E.W. (2013). Analysis of pulsed field gel
electrophoresis profiles using multiple enzymes for predicting potential source reservoirs for
Annual reports of OIE Reference Centres, 2013
9
Veterinary Drug Regulatory Programmes
strains of Salmonella enteritidis and Salmonella. Infection, Genetics and Evolution: Journal of
Molecular Epidemiology and Evolutionary Genetics in Infectious Diseases. Vol. 16. 226-233.
Ju W., Shen J., Toro M., Zhao S., & Meng J. (2013). Distribution of pathogenicity islands OI-122, OI43/48, and OI-57 and a high-pathogenicity island in Shiga toxin-producing Escherichia coli. Applied
and Environmental Microbiology. Vol. 79. Issue 11. 3406-3412.
Toro M., Najjar M.B., Ju W., Brown E., Zhao S., & Meng J. (2013). Molecular serogrouping of Shiga
toxin-producing Escherichia coli using suspension array. Foodborne Pathogens and Disease.Vol.10.
Issue 5. 478-480.
Hoffmann M., Muruvanda T., Allard M.W., Korlach J., Roberts R.J., Timme R., Payne J., McDermott
P.F., Evans P., Meng J., Brown E.W., & Zhao S. (2013). Complete Genome Sequence of a MultidrugResistant Salmonella enterica Serovar Typhimurium var. 5- Strain Isolated from Chicken Breast.
Genome Announcements. Vol. 1. Issue 6. 491-508.
Ge B., Wang F., Sjolund-Karlsson M., & McDermott P.F. (2013). Antimicrobial resistance in
Campylobacter: susceptibility testing methods and resistance trends. Journal of Microbiological
Methods. Vol. 95. Issue 1. 867-870.
Lin A., Kase J.A., Moore M.M., Son I., Tran N., Clotilde L.M., Jarvis K., Jones K., Kasturi K., Nabe K.,
Nucci M., Wagley G.S., Wang F., Ge B., & Hammack T.S. (2013). Multilaboratory validation of a
luminex microbead-based suspension array for the identification of the 11 most clinically relevant
Shiga toxin-producing Escherichia coli O. Journal of Food Protection. Vol. 76. Issue 5. 218-230.
Martinez M.N., Antonovic L., Court M., Dacasto M., Fink-Gremmels J., Kukanich B., Locuson C.,
Mealey K., Myers M.J., & Trepanier L. (2013). Challenges in exploring the cytochrome P450 system
as a source of variation in canine drug pharmacokinetics. Drug Metabolism Reviews. Vol. 45. Issue
2. 5146.
Cao G., Meng J., Strain E., Stones R., Pettengill J., Zhao S., McDermott P., Brown E., & Allard M.
(2013). Phylogenetics and differentiation of Salmonella Newport lineages by whole genome
sequencing. PLoS One. Vol. 8. Issue 2.
Cao G., Ju W., Rump L., Zhao S., Zou L., Wang C., Strain E., Luo Y., Timme R., Allard M., Brown E., &
Meng J. (2013). Genome Sequences of Two Emerging Non-O157 Shiga Toxin-Producing Escherichia
coli Strains. Genome Announcements. Vol. 1. Issue 3.
Hoffmann M., Luo Y., Lafon P.C., Timme R., Allard M.W., McDermott P.F., Brown E.W., & Zhao S.
(2013). Genome Sequences of Salmonella enterica Serovar Heidelberg Isolates Isolated in the
United States from a Multistate Outbreak of Human Salmonella Infections. Genome
Announcements. Vol. 1. Issue 1. 5398-5405.
Chen Y., Mukherjee S., Hoffmann M., Kotewicz M.L., Young S., Abbott J., Luo Y., Davidson M.K.,
Allard M., McDermott P., & Zhao S. (2013). Whole-Genome Sequencing of Gentamicin-Resistant
Campylobacter coli Isolated from U.S. Retail Meats Reveals Novel Plasmid-Mediated
Aminoglycoside Resistance Genes. Antimicrobial Agents and Chemotherapy. Vol. 57. Issue 11. 144149.
Olumee-Shabon Z., Swain T., Smith E.A., Tall E., & Boehmer J.L. (2013). Proteomic analysis of
differentially expressed proteins in caprine milk during experimentally induced endotoxin mastitis.
Journal of Dairy Science. Vol. 96. Issue 5.
b)
International conference presentations: ......................... 6
Government of Brazil workshop on antimicrobial resistance; a presentation about the U.S.
experience with its National Antimicrobial Resistance Monitoring System.
China Ministry of Agriculture – several of its agencies; presentations about ensuring the safety and
efficacy of animal drugs, including drugs used for food-producing animals.
International Workshop on Feed Risk Assessment – Chemical Safety; presentation about assessing
risks for animal feed.
78th Joint FAO/WHO Expert Committee on Food Additive Residues in Veterinary Drugs in Food;
10
Annual reports of OIE Reference Centres, 2013
Veterinary Drug Regulatory Programmes
presentation about CCRVDF recommendations for priority review of animal drugs.
28th VICH Steering Committee; presentation as part of Steering Committee.
29th VICH Steering Committee, and 3rd VICH Global Outreach Forum; presentation as part of
Steering Committee.
c)
National conference presentations: ................................ None
d)
Other: ............................................................................... None
_______________
Annual reports of OIE Reference Centres, 2013
11