October 25, 2012 NAHLN Concept Paper Page 1 of 6

United States Department of Agriculture

Animal and Plant Health Inspection Service

and

National Institute of Food and Agriculture

A Proposal for a Revised Structure of the

National Animal Health Laboratory Network

(NAHLN)

October 2012
October 25, 2012 NAHLN Concept Paper Page 2 of 6

Executive Summary

The National Animal Health Laboratory

Network (NAHLN) is a nationally

coordinated network and partnership of 

Federal, State, and university-associated

animal health laboratories. NAHLN

laboratories provide animal health

diagnostic testing to detect biological threats 

to the nation’s food animals, thus protecting 

animal health, public health, and the nation's 

food supply.

This paper:

1. Defines the NAHLN laboratory

membership structure;

2. Recognizes NAHLN oversight by the U.

S. Department of Agriculture (USDA);

3. Identifies the role of the NAHLN 

Coordinating Council;

4. Identifies the National Veterinary Service 

Laboratories (NVSL) as the reference 

laboratories for the NAHLN; and,

5. Affirms the opportunity for each State to 

have a NAHLN laboratory as long as 

State laboratories meet defined minimum 

criteria.

These actions will allow the NAHLN to 

achieve its original surveillance and 

response goals and expand its capability and 

capacity for detecting emerging and 

zoonotic disease to protect animal health, 

public health, and the nation’s food supply. 

Moreover, codification of USDA oversight

of the NAHLN, the existence of a NAHLN 

charter, and the outline of the network 

structure will give the NAHLN the 

flexibility to respond to future national 

animal health testing needs. The NAHLN 

will gain this flexibility through clearer 

designation of network members’ roles and 

responsibilities, and through the ability to 

more easily expand or contract NAHLN 

testing capabilities and capacities. Other 

elements, such as the actual NAHLN charter 

and the specific requirements for each level 

of laboratory participation, will be 

referenced in program standards and will 

allow the NAHLN to respond to the 

changing needs of animal agriculture.

Introduction

The NAHLN is the result of mutual 

recognition by members of the American 

Association of Veterinary Laboratory

Diagnosticians (AAVLD) and Federal 

officials that a nationally coordinated 

network of animal health diagnostic 

laboratories is essential to protecting animal 

health, public health, and the nation's food 

supply from foreign animal and emerging 

diseases. In 2002, the USDA established a 

partnership with State and universityassociated animal health diagnostic 

laboratories, with funding derived from 

appropriations authorized under Public Law 

107-38 (Emergency Supplemental 

Appropriations Act for Recovery from and 

Response to Terrorist Attacks on the United 

States, codified at 50 U.S.C 414) to leverage 

and unite existing Federal and State animal 

health diagnostic resources. Funding 

continues through congressional 

appropriations to the USDA, and substantial 

support from State governments.

Originally composed of 12 laboratories, the 

NAHLN has grown to include 12 Core, 28 

Member, and 9 Contract laboratories. Core 

laboratories are regionally distributed and 

capable of testing large numbers of samples 

that originate from food animal species. 

Member laboratories are more widely 

disseminated than Core laboratories, and 

facilitate greater geographic coverage.

Contract laboratories provide diagnostic 

testing for specific disease agents. In 

addition, a small number of adjunct 

laboratories, such as Food Safety and 

Inspection Service (FSIS) laboratories, 
October 25, 2012 NAHLN Concept Paper Page 3 of 6

contribute to NAHLN efforts by providing a 

specific but needed diagnostic capability. 

The NAHLN is overseen and administered 

by the USDA, with operational oversight 

provided through the Animal and Plant 

Health Inspection Service (APHIS). 

Initially, a steering committee composed of 

staff from State and university-associated 

animal health laboratories, additional 

representatives from the AAVLD, a State 

veterinarian, and USDA staff was formed to 

provide input to NAHLN leadership. The 

steering committee was discontinued in 

2009, and a NAHLN Coordinating Council 

was established to represent State regulatory

and laboratory partners rather than 

professional or other organizations.

The Coordinating Council is composed of 

USDA representatives, State animal health 

officials, and State employee representatives 

of NAHLN laboratories. USDA established 

and approved a charter for the NAHLN 

Coordinating Council. This charter defines 

Federal oversight of the NAHLN and the 

roles and responsibilities of USDA agencies, 

the NAHLN Executive Committee, and the 

NAHLN Coordinating Council. The

structure of the network was not changed.

Proposed Changes

Recent feedback from a wide variety of 

stakeholders indicates that the NAHLN 

structure needs to change to fully meet 

original surveillance and response goals, and 

to expand detection of emerging and 

zoonotic diseases. While the current 

NAHLN structure of Core, Member, and 

Contract laboratories has served the 

stakeholders well, the changes proposed in 

this paper ensure that the NAHLN continues 

to meet current and future needs.

Founding principles that guided NAHLN 

development in preceding years remain 

intact. For each participating laboratory,

these are:

a. Operate within a quality management 

system that meets AAVLD, ISO 17025,

or equivalent requirements;

b. Establish and maintain competency of 

laboratory personnel;

c. Use standardized protocols, reference 

materials, and equipment;

d. Participate in communications and 

reporting systems established by the 

NAHLN;

e. Use facilities with biosafety/biosecurity

levels requisite for testing performed; 

and

f. Evaluate preparedness (identify and 

prioritize gaps) through scenario testing.

The NAHLN structure described below is 

intended to ensure continuation of the 

founding principles while addressing 

changes necessary to allow for needed 

flexibility and added capacity to more 

completely address the current gaps in the 

nation’s surveillance, detection, and 

response capability.

Proposed NAHLN Structure

Governance: The proposed NAHLN 

structure preserves its current oversight, 

leadership, administrative structure, and 

roles and responsibilities as outlined in the 

USDA-approved NAHLN charter

(appended). Specifically, the USDA will 

provide Federal oversight with APHIS being 

responsible for operational aspects of the

NAHLN. An Executive Committee

composed of USDA staff will continue to

review and implement the NAHLN strategic 

and operational plans. The Coordinating 

Council, composed of USDA staff, State 

employee representatives of NAHLN

laboratories, and State animal health 
October 25, 2012 NAHLN Concept Paper Page 4 of 6

officials, will continue to provide a forum to 

discuss the NAHLN’s current and future 

needs.

Participation: Under the proposed 

structure, each State can sponsor a publiclyfunded NAHLN laboratory. However,

participating laboratories must have

sufficient laboratory-generated income,

State resources, or other public funds to 

qualify for their level of participation (see 

below). Having State-based NAHLN 

laboratories allows for proximity to and 

linkages with producers and veterinarians 

critical to early detection of foreign animal 

and emerging diseases. Qualifying 

requirements are tiered, and based on

current understandings of the needs of the 

overall network (see below). To maintain a 

NAHLN designation, qualifying laboratories 

will undergo annual reviews to demonstrate 

adherence to established NAHLN policies 

and procedures.

Laboratory designations: Participating

laboratories will be designated as Levels 1, 

2, 3, Affiliate, or Specialty laboratories. 

Level 1, 2, and 3 laboratories are publiclyfunded State and university-associated

animal health diagnostic laboratories. 

Affiliated laboratories are publicly-funded

laboratories that may occasionally perform 

NAHLN-related testing, and currently

include the FSIS, the National Wildlife 

Health Center (NWHC), and the Department 

of Defense, Fort Sam Houston laboratories. 

Specialty laboratories are private or 

commercial enterprises that provide 

diagnostic capabilities that do not exist at 

needed capacities within the NAHLN.

To participate in the NAHLN, specialty 

laboratories must have a written, USDAapproved plan that demonstrates the ability

to avoid conflicts of interest in the testing 

they perform. USDA will have 

responsibility for decisions regarding 

laboratory membership and tier designations 

in the NAHLN, with input on criteria from 

the NAHLN Coordinating Council and other 

NAHLN stakeholders. All NAHLN 

laboratories are subject to an annual 

accountability review with the designation 

of Level 1 laboratories reassessed at least 

every 5 years.

The principal difference between Level 1 

and Level 2 laboratories is that Level 1 

laboratories must meet each defined 

criterion, whereas Level 2 laboratories must 

only meet a subset of Level 1 criteria and 

have the option of meeting others as 

resources permit. Level 3, Affiliate, and 

Specialty laboratories need not be 

accredited, but will be required to have a 

USDA-approved quality management 

system. Affiliate and Specialty laboratories 

must also establish operational relationships 

with a designated NAHLN laboratory and 

with the State animal health official for the 

State in which the laboratory is located.

Level 1 Laboratories: Similar to current 

Core laboratories, Level 1 laboratories will 

have the capacity to perform tests on large 

numbers of samples that originate from U.Sfarmed food animals. Unlike the current 

Core laboratories, the number and identity

of Level 1 laboratories may change by

adding or removing laboratories depending 

on national need and available funding.

The decision to modify the number or

location of Level 1 laboratories will be 

based on (1) overall national need, (2) 

population density of the food animals of 

interest, (3) geographic location, (4) testing 

capabilities, (5) personnel expertise, (6) 

facilities and other infrastructure, and (7) 

level of State support.
October 25, 2012 NAHLN Concept Paper Page 5 of 6

To be classified as a Level 1 NAHLN 

laboratory, a laboratory must:

a. Maintain capacity to provide surge 

testing for disease agents of interest;

b. As requested by the USDA, participate 

in surveillance testing;

c. Be fully accredited by AAVLD, ISO 

17025, or by another accrediting body

with equivalent standards;

d. Perform all work within a quality

management system under the direction 

of a quality manager;

e. Have staff members trained and 

proficiency tested in diseases of interest;

f. Possess a functional laboratory

information management system 

(LIMS);

g. Have the capability to electronically 

send diagnostic test results to APHIS 

databases;

h. Report test results within timeframes 

indicated in NAHLN standard operating 

procedures;

i. Help further develop the NAHLN IT 

system;

j. As requested by the USDA, help other 

laboratories develop and implement IT 

capabilities to permit them to 

communicate testing results with 

NAHLN;

k. Provide and maintain biosafety level 3 

laboratory space adequate for work 

performed;

l. Possess ongoing State funding adequate 

to maintain equipment and laboratory

space used for NAHLN purposes;

m. As requested by the USDA, send staff 

members to other laboratories or field 

operation centers during emergency 

situations;

n. As requested by the USDA, provide

training for NAHLN test procedures;

o. Accept samples that originate from other 

States affected by disease outbreaks, 

especially those from Level 2 

laboratories;

p. Assist with NAHLN test development 

and validation;

q. Participate in NAHLN-related activities 

(e.g. subcommittee and working group 

activities, development of training 

programs, scenario testing exercises, 

AAVLD/USAHA NAHLN Joint 

Committee, etc.);

r. As requested by the USDA, participate 

in auditing NAHLN or prospective 

NAHLN laboratories;

s. Have an acceptable periodic review 

conducted under the oversight of USDA.

Level 2 Laboratories: Similar to current 

Member laboratories, Level 2 laboratories 

provide greater geographic coverage and 

consequently more rapid disease detection. 

To be classified as a Level 2 NAHLN 

Laboratory, a laboratory must meet most of 

the requirements outlined above for Level 1 

Laboratories, except that Level 2 

Laboratories:

a. Are not required to maintain capacity to 

provide for surge testing;

b. May be provisionally accredited by

AAVLD or by another accrediting body 

to World Organization for Animal health 

(OIE) standards, ISO 17025, or 

equivalent standards;

c. Perform all work within a quality

management system under the direction 

of a quality manager;

Have no requirement for biosafety level 3 

laboratory space; and

d. In reference to items i – q (except k – the 

biosafety requirement), participate as 

resources allow.

Level 3 Laboratories: These laboratories 

participate primarily in surveillance 
October 25, 2012 NAHLN Concept Paper Page 6 of 6

activities. To be classified as a Level 3 

NAHLN laboratory, a laboratory must:

a. As requested by the USDA, participate 

in surveillance testing;

b. Work under a NAHLN-approved quality

management system overseen by a 

quality manager;

c. Have staff members trained and 

proficiency tested in diseases of interest;

d. Have a functional LIMS;

e. Report test results within timeframes 

indicated in NAHLN standard operating 

procedures.

Affiliate Laboratories: These are publiclyfunded laboratories that may occasionally 

perform NAHLN-related testing. To be 

classified as a NAHLN Affiliate laboratory, 

a laboratory must meet the requirements of a 

Level 3 laboratory, plus:

a. Establish a memorandum of 

understanding with the USDA that 

defines the role and relationship of the 

laboratory within the NAHLN; and

b. Establish operational relationships with a 

designated NAHLN laboratory and with 

the State animal health official of the 

State in which the laboratory is located.

Specialty Laboratories: These are private 

laboratories that have a specific, but needed,

capability as determined by the USDA with

input from the Coordinating Council. To be 

classified as a NAHLN Specialty laboratory, 

a laboratory must meet the requirements of a 

Level 3 laboratory, plus:

a. Establish operational relationships with a 

designated NAHLN laboratory and with

the State animal health official of the 

State in which the laboratory is located; 

and

b. Have a written, USDA-approved plan 

that demonstrates the ability to avoid 

conflicts of interest in the testing they

perform.

Reference Laboratories: The NAHLN 

Reference laboratories are the NVSL. In 

fulfilling this role, NVSL personnel provide:

(1) oversight on testing and reporting 

procedures; (2) assay development, 

validation, and deployment; (3) proficiency

tests; (4) reference materials; and (5) 

procedure training.

Summary

The proposed revisions to the structure of 

the NAHLN and codification of USDA 

oversight, the existence of a NAHLN 

charter, and the outline of the network 

structure will give the NAHLN flexibility to 

respond to future national animal health 

testing needs. The proposed changes clarify

the roles and responsibilities of network 

members and provide the ability to more 

easily expand or contract NAHLN testing 

capabilities and capacities. Having the actual 

NAHLN charter and the specific 

requirements for each level of participation

referenced in program standards but not 

codified allows the NAHLN to respond 

readily to the changing needs of animal 

agriculture.

The proposed changes will allow the 

NAHLN to achieve its original surveillance 

and response goals and to expand detection 

of emerging and zoonotic diseases to protect 

animal and public health as well as the 

nation's food supply.