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height="0.8958333333333334in"}Telephone: 530-754-9719

Fax: 530-752-5680

Office of the Secretary-Treasurer

American Association of Veterinary Laboratory Diagnosticians, Inc.

PO Box 1770

Davis, CA 95617-1770

November 13, 2023

**Proposed Rule to Allow Real-Time PCR Testing for**

**Avian Influenza Virus by**

**Industry-Owned NPIP Laboratories**

The American Association of Veterinary Laboratory Diagnosticians (AAVLD)
representing the majority of the state components of the National Animal
Health Laboratory Network (NAHLN) and over 1500 members oppose the
proposed rule to allow non-NAHLN industry-owned National Poultry
Improvement Plan (NPIP) laboratories to perform rRT-PCR matrix testing
for avian influenza (AI) virus for the following reasons.

-   **This represents a conflict of interest.**

It is not in the interest of the industry to report positive results.
Failure or delays in reporting due to marketing concerns can hinder a
rapid response. This type of AI surveillance is the mechanism for
detecting highly pathogenic H5N1, a foreign animal disease agent.
Because unreported foreign animal disease threatens agriculture core
infrastructure and because many of these disease agents are highly
pathogenic, zoonotic and affect multiple animal species, industry
currently is not allowed to perform surveillance for foot and mouth
disease or other foreign animal diseases. Currently, USDA is opposing
lawsuits to allow private industry testing for bovine spongiform
encephalopathy. AI surveillance by real-time reverse-transcriptase
polymerase chain reaction (rRT-PCR) is no different. In addition,
diagnosis of highly pathogenic AI is a more sensitive issue because of
the zoonotic potential of these viruses. The credibility and structural
integrity of the US National Animal Health Surveillance System is placed
at risk by allowing testing by industry.

-   **Loss of data or delays in reporting to the state animal health
    officials.**

State-based local authorities, State Veterinarians, have a vital role to
respond to reported animal disease incidents. Samples for AI testing
will be sent across state lines to a central industry-held laboratory.
This creates multiple difficulties and potential delays in reporting
results or loss of data to the state veterinarians. There may be delays
in shipping samples to a central industry laboratory. Sample tracking to
identify state of origin could be compromised if there are insufficient
laboratory information management systems for sample tracking, resulting
in loss of data to the state of origin. Delays in testing, delay in
reporting or failures to report, or delays forwarding samples for
confirmatory testing to NVSL all compromise the ability of a state to
rapidly respond to a low pathogenicity or high pathogenicity AI
outbreak. National coordination of multi-state responses depends on
access to complete, correct and accurate information in a timely manner.
Millions of dollars of public funds have been spent monitoring wild bird
populations, commercial poultry, backyard flocks and live bird markets.
Data, including negative test data, is necessary for analysis and
characterization of disease presence by sector populations. The
credibility and structural integrity of the US National Animal Health
Surveillance System is placed at risk by allowing testing by industry.

-   **Lack of accreditation/quality system for NPIP laboratories**

There are no specific listed requirements in the NPIP provisions for
NPIP authorized laboratories and no quality assurance regulations,
making it difficult to determine the quality of the laboratory or
laboratory results. NAHLN laboratories are accredited by the American
Association of Veterinary Laboratory Diagnosticians or audited by NVSL.
External auditors are trained and audited laboratories must comply with
requirements based on OIE standards, including maintenance of a quality
system, employment of a quality manager, record keeping, acceptable
laboratory physical and environmental conditions, and documentation and
validation of all procedures and practices. In addition, most NAHLN
laboratories require compliance with national biosafety regulations and
practices, as well as OSHA requirements. NPIP authorized laboratories
are subject to inspection by Service and **[not]{.underline}** NVSL, so
there is no standardization of quality with NVSL or the NAHLN. Many NPIP
authorized laboratories have never been inspected by the Service, even
though they are listed as authorized laboratories. While the Official
State Agency does have the ability to inspect authorized laboratories;
Contact Representatives may not have the skills or knowledge required to
ensure that an authorized laboratory is performing quality diagnostic
testing by qualified staff members.

-   **Limited federal/NVSL resources.**

Resources for auditing laboratories by NVSL are limited. NVSL would have
to ensure that laboratories meet OIE or ISO17025 standards, which
requires detailed auditing. Resources at NVSL for training and
proficiency testing are already a limiting factor for adding trained
personnel to NAHLN laboratories. Confirmatory testing of all
matrix-positive samples creates additional limits on NVSL resources.
Despite justifications of increased surge capacity, there has been no
scientific modeling that would indicate that the current NAHLN
laboratory capacity is insufficient to handle the current need for
surveillance or response to an outbreak.

-   **Potential for false-positive results or premature reporting.**

Performing the matrix testing can result in false positives if there is
insufficient physical separation of PCR testing areas or reagents,
contamination of samples, inappropriate equipment maintenance and
calibration, insufficient technical training, etc. The non-NAHLN NPIP
laboratories will only do matrix testing and not perform further testing
to determine if the AI positive sample is an H5 or H7 virus. This may
result in a substantial number of matrix-positive samples that will need
to be forwarded to NVSL for further testing for H5 or H7 viruses. This
situation creates a concern for premature reporting of positive results
or delay in confirming negative results, which could have immediate and
long-term adverse market and trade effects.

-   **Biosafety and public health concerns.**

If a true positive H5N1 sample is handled at an industry laboratory,
there is a concern for transmission to humans exposed in the laboratory
that must be addressed. This includes laboratory worker exposure risk
and safety, sample handling and subsequent disposition and
decontamination of the facilities. In public health laboratory systems
(the Laboratory Response Network), only approved state or federal (not
private or industry) laboratories are allowed to perform this type of
testing due to public health concerns, as well as need for timely
reporting to state public health officials and the need to maintain the
integrity of reporting systems that provide data for analysis.
Industry-owned and operated laboratories have no legal requirement to
report to public health authorities.

Respectfully,

AAVLD Executive Committee

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Dr. Grant Maxie, President Dr. Gary Anderson, Vice President
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Dr. Barbara Powers, Immediate Dr. Sharon Hietala, Secretary-Treasurer

Past President