Comment from Timothy Baszler

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 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.