By any measure, the attempts by USDA-APHIS to eradicate Highly Pathogenic Avian Influenza have been an abject failure.  In any event, it is an epidemiologic reality that it is impossible to eradicate an endemic disease with wild avian and mammalian reservoirs.  Rapid diagnosis, depopulation, disposal and decontamination are effective and appropriate approaches to an introduction of an isolated exotic disease. Since 2020 and possibly prior to this time, the current approach relying on variable levels of biosecurity cannot protect flocks.  With the emergence of bovine influenza-H5N1, the situation has become more complicated.  It is now evident that close to 170 diagnosed herds affected by H5N1 in 13 states represents the potential for transmission to large egg-production complexes.

Last week, the USAPEEC, the National Chicken Council, the National Turkey Federation, United Egg Producers and USPOULTRY submitted a joint letter to the Secretary of Agriculture expressing concern over HPAI and seeking “novel methods to prevent, detect and respond to this virus.” At this time, a logical and appropriate but belated initiative.  The letter included the phrase “novel methods to prevent” HPAI. Given that the approach by USDA is entirely reactive  something “novel” beyond biosecurtity is required. But then we come to the “V’ word that shall not be uttered! The letter expressed the need to “preserve all U.S. export markets for poultry products” evidently a manifestation of the inherent conflict among the associations concerning vaccination. The communication did however refer to “conducting important research, particularly as it pertains to vaccines”. As far as assessing combinations of biosecurity with vaccination, “important research” especially in the laboratory is a delaying tactic since there is adequate field evidence of efficacy. What is needed is a USDA supervised field evaluation following the successful implementation for the  foie gras industry in France. A suitable U.S. candidate would be Weld County CO. USDA has recorded seven cases among four complexes in 30 months with one farm affected three times and a second twice, suggesting epidemiologic factors contributing to regional endemnicity..

The problem is that the U.S. producers and specifically the broiler segment are justifiably concerned over potential loss of export markets as a result of introducing a controlled vaccination program.  This restraint should be critically reviewed.  The bulk of our low-price leg quarters are destined to nations that either have endemic HPAI or are probably willing to accept an APHIS certification program based on PCR assay. This innovation would certify that flocks of origin destined for export are free of infection prior to slaughter and shipment.  Nations that are unwilling to accept appropriate documentation and that persist in imposing unrealistic, anachronous and unjustified embargos against the U.S. to protect their domestic industries are probably not prospects for export.

While the export impasse prevails, egg production and turkey producers are experiencing losses beyond the previously limited fall and spring migration periods. This is especially the case in regions with a high concentration of production involving these two segments of U.S. production.

It is not necessary to conduct ‘research’, there is adequate published information available as to the effectiveness of commercially available vaccines in reducing the incidence of outbreaks and facilitating control of the disease. 

The zoonotic implications of H5N1 is evidenced by workers involved in depopulation of an infected egg complex in Colorado with a prevalence rate yet to be determinedwhen investigations have been completed. Affected individuals displayed not only conjunctivitis but also respiratory symptoms and malaise. This is consistent with the acquisition by the avian H5N1 virus of a mammalian adaptation marker E627K indicating that the original avian virus isolated from dairy cows and human contacts is now more infectious and pathogenic for humans.  Introduction of H5N1 virus onto egg production complexes with upwards of two million susceptible hens creates the potential for mutations, some of which may result in emergence of a zoonotic strain that may even become contagious.

The letter addressed to APHIS presents a ‘chicken or an egg’ dilemma.  The emphasis was placed on USDA to engage with trading partners to obtain commitments to accept U.S. exports in the event of introducing a controlled vaccination program. If we wait for assurances from a number of trading partners, as a pre-requirement for vaccination, we will continue to depopulate egg production and turkey farms ad infitinum.

Vaccination is now accepted by the World Association of Animal Health as a component of a broader strategy including biosecurity to suppress avian influenza. The question of vaccination may well pass beyond the purview of USDA if a zoonotic strain emerges or if a recombinant event results in the emergence of a pandemic strain of influenza incorporating avian genes.

During the 1970s, the world’s poultry industries were faced with velogenic viscerotropic Newcastle disease.  The infection was effectively controlled by vaccination.  Avian influenza is ‘the Newcastle disease of the 2020s’ and should be approached with a similar mindset that existed half a century ago.

The letter from the poultry organizations is a first step and clearly indicates a willingness to consider vaccination to preserve flocks and herds and to avert a possible U.S. epidemic or a worldwide pandemic of H5N1v influenza among susceptible human populations.

The Farm Bill that should have been enacted in 2023 is no further in resolution despite the extension which expires at the end of September 2024.  The House Committee on Agriculture passed H.R.8467, the Farm, Food and National Security Act of 2024 on a bipartisan 33-21 vote.  This Bill has yet to be considered by the House as the Committee Chair, Glenn Thompson (R-PA) has insufficient votes for passage.  A further complication is that the Congressional Budget Office has yet to provide a projection of cost that is necessary for members to vote on this necessary legislation.  The House Freedom Caucus regards the House Bill as too high especially with regard to SNAP benefits.

The Senate Agriculture Nutrition and Forestry Committee has yet to mark up their bill. Chairperson, Debbie Stabenow (D-MI), is steadfast in retaining SNAP benefits, threatening to pass the responsibility for the Farm Bill to the 119^th Congress.

At issue in both polarized committees is the allocation of funds to supplemental nutrition and conservation on the one hand as opposed to crop support payments.  A further complication is the multitude of bipartisan agricultural related special interest bills to be included in the 2024 version. Most are contentious including the so-called EATS Act relating to restrictions imposed by the California Proposition #12, ruled by SCOTUS as constitutional.  The ranking member of the Senate Committee, John Boozman (R-AR), has proposed a version that closely follows the House Bill that has no chance of passage.

At the present time, Congress has six working weeks to resolve outstanding issues to allow both chambers to pass their respective versions and then engage in bipartisan reconciliation.

The need for an equitable Farm Bill is indicated by projections of lower prices for agricultural commodities based on availability of corn and soybeans and lower demand and world trade.  Normally the Farm Bill is the least contentious of major legislation but a highly polarized Congress, especially in an election year, is impeding the normal bipartisan approach to resolution.

Ranking member of the House Agricultural Committee, David Scott (D-GA), characterized the situation as “This delay hurts the American people especially in our rural communities where our farms are.  It injects uncertainty into our Nation’s economies both rural and urban.  The willingness to delay the Bill to play election-year politics is selfish and disrespectful to our farmers.” 

Failure to enact a 2024 Farm, Food and National Security Act will have far reaching consequences for both farmers and exporters.  Costs of production are rising, interest rates remain high, commodity prices are falling and margins for commodities are shrinking.  The agricultural community deserves better than bipartisan bickering and intransigence over social issues and entrenched political principles.

In a June 25^th webinar organized by the National Academies of Science, Engineering and Medicine, Dr. Rosemary Sifford, Chief Veterinary Officer for the USDA expressed an optimistic Departmental message stating, “We believe if we can stop the movement of infected cattle, improve biosecurity and help producers we can eliminate H5N1 virus in dairy herds. The operative word in this simplistic statement is ”IF”. We are reminded of the old Texas adage, If a frog had wings it would not bump it’s butt on the ground.

In contrast veterinarians and epidemiologists with both field and laboratory experience are critical of the lackluster and uncoordinated response by Federal agencies It is now three months since the infection was diagnosed in a herd in Texas and presumably six months after H5N1 virus transitioned from avian species to dairy cows. Dr. Michelle Kromm an experienced avian veterinarian believes that if not currently endemic, the infection will become a permanent reality in the dairy industry.

A major obstacle to an understanding of the distribution of the virus and the method of spread relates to a combination of indifference and denial within the dairy industry based on the reality that the virus can be inactivated by pasteurization.  Overt obstruction by some state officials and resistance to cooperation with more responsive state departments of agriculture and public health agencies has impeded progress in understanding the epidemiology of bovine influenza-H5N1. 

Currently indirect methods are applied to determine the presence of infection in areas.  This includes sampling of milk at the supermarket level as conducted by Dr. David O’Connor at the University of Wisconsin, Madison, or wastewater assays performed by Wastewater SCAN a project devised and implemented by Dr. Alexandria Boehm of Standford University and Dr. Marlene Wolfe of Emory University. Wastewater sampled from Amarillo, TX. demonstrated the presence of H5N1 virus approximately three weeks before the first clinical case emerged in a dairy herd in the area.

In contrast to the relative inactivity of U.S. agencies, the German Federal Friedrich Loeffler Institute embarked on an intensive program for evaluation of the U.S. isolate and viruses derived from wild birds.  Their program headed by Dr. Martin Beer has demonstrated the propagation of H5N1 virus in mammary tissue and the ability to infect cows by introduction of virus into the teat canal. The Institute can now propagate H5N1 virus on bovine respiratory cells as an in vitro research modality.

With approximately 140 confirmed H5N1-infected herds in 12 states, Dr. Beer believes that the virus could be eradicated but this would involve intense surveillance and quarantine of affected herds with limitation on movement of cattle. This approach would mirror the previous successful suppression and then longer-term eradication of bovine tuberculosis and brucellosis in commercial herds.

Allowing interstate movement of cattle from herds demonstrating negative milk assays is probably inadequate.  Relying on “best practices” and the use of PPE and biosecurity may be self-comforting in USDA offices and conference rooms but is unrealistic in relation to the practical situation in dairy herds that may hold in excess of 5,000 animals with dozens of workers, many with limited literacy or English comprehension.

Vaccination is not considered a viable control measure given the unknowns concerning protection against systemic and mammary gland infection.  Introduction of a vaccination program would have implications for international trade of milk and dairy products notwithstanding the elimination of virus by pasteurization.

There is a deep bench of avian practitioners and veterinary epidemiologists who can advise the dairy industry as to short-term preventive measures. This repository of knowledge is negated by an evident lack of cooperation from herd owners and state regulators with the exception of Michigan and now Colorado.

The 600-pound gorilla in the room is the risk of subsequent mutations occurring in H5N1 influenza virus now adapted to mammals that may result in the emergence of a zoonotic strain capable of not only infecting human contacts but facilitating person-to-person transmission.

On June 27^th the U.S. Department of Agriculture announced that compensation would be extended to eligible dairy farmers with herds infected by bovine influenza-H5N1.  Funds will be available from the Emergency Assistance for Livestock, Honeybees and Farm-Raised Fish Program (ELAPE).  This concession was made possible by an alteration in the Rule relating to ELAPE.

Eligibility will be based on a confirmed diagnosis made by the APHIS National Veterinary Services Laboratory. Additional requirements will comprise:

• Losses from milk production extending from 14 days prior to sample collection with a positive result for 120 subsequent days.

• Losses from cows maintained for commercial milk production.

• Eligible cows should have been in lactation prior to the positive diagnosis.

In commenting on the compensation program Secretary of Agriculture Tom Vilsack stated, “When something unexpected like H5N1 threatens the economic viability of producers we are committed to finding ways where we have the authority to do so, to revisit existing program polices and provide the financial support needed to help producers recover and sustain production.”

To date close to 130 herds in twelve states have been diagnosed with bovine influenza-H5N1.  The introduction of the ELAPE compensation program will most certainly reveal additional cases since there is now an incentive for farmers to undertake diagnostic procedures.

The question arises as to why ELAPE funding is extended to dairy farmers impacted by bovine influenza-H5N1 although previously there was no direct support for egg producers confronted with coryza in 2023 or hog famers suffering losses from PRRS. It is also questioned whether USDA has established a precedent to compensate for exposure to a pathogen in the absence of accepted principles of biosecurity? USDA should clearly define and articulate their policy on compensation in the event of emergence of an erosive disease in a given livestock segment. The USDA also owes stakeholders including taxpayers the justification for payments under ELAPE and possible limits on duration of compensation especially if the infection becomes  (or is already) endemic.

This commentator does not begrudge the compensation paid to owners of affected dairy herds but a clear statement of policy and future action on disease-related compensation should be forthcoming. This will dispel any hint of partiality by the USDA or the Secretary given his tenure as president of the U.S. Dairy Export Council during 2017 through 2021, that could be interpreted as favoring a specific sector of livestock production

According to a release by the Michigan Department of Agriculture and Rural Development the State will offer eligible dairy farmers up to $28,000 to participate in field epidemiologic studies on bovine influenza-H5N1.  The State in collaboration with USDA-APHIS will obtain environmental samples and swabs from workers and herds.  The objective will be to determine how the virus was introduced onto farms and factors contributing to intra-herd spread. To date eleven farms have enrolled in the program and will participate in conducting regular tests on milk and herds.

As reported previously in EGG-NEWS scientists at the German Federal Veterinary Research Institute have initiated studies using available BL-3 level isolators to determine routes of infection. A similar program is presumed to be in progress at the National Bio and Agri Defense Facility in Kansas.

The approach to diagnosis and investigation of bovine influenza-H5N1 in Michigan contrasts with the negative response advocated by the Commissioner of Agriculture of Texas who considered that obtaining samples from herds and workers by the CDC for assay was an “overreach”.

It is evident that  H5N1 virus is inactivated in milk by pasteurization and in meat by cooking there is limited concern over risk to consumers. Virologists are monitoring field isolates for potential genetic changes that could predict the virus from becoming zoonotic.  The greater the number of herds and flocks infected, the greater possibility of mutations occurring. It is apparent that practical structural and operational biosecurity is inadequate to absolutely prevent infection of poultry farms and probably less so for dairy herds. This is due to dissemination by free-living birds with the possibility of airborne infection.

The world population has no antibody protection against the H5 strain of avian influenza emphasizing the need for proactive planning for local epidemics or multinational pandemics. This includes stockpiling of vaccine and immunization of farm and plant workers, their families and health care providers. Mutation of the current circulating H5N1 virus to become infectious for humans will create problems for food supply and the economy. In a worst-case situation emergence of human-to-human transition would revisit past influenza pandemics and our recent experience with COVID.

USDA-APHIS has responded aggressively with a detailed, preliminary epidemiologic investigation of the expanding incidence rate of bovine influenza-H5N1 outbreaks among dairy cattle in Michigan with spillover to egg production complexes.  At the outset, the Agency is to be complemented by deploying highly qualified personnel from the Strategy and Policy and the Field Operations units to Michigan together with participation and support by the National Veterinary Services Laboratories. The team of seven APHIS veterinarians with collectively ten post graduate degrees or board certifications was assisted by a colleague at the Colorado State University College of Veterinary Medicine and with resources and support from the Michigan State Veterinarian.

Bovine influenza-H5N1 virus characterized as genotype B3.13 was diagnosed during late March in a dairy herd in Texas.  Subsequent genomic assay suggests that the infection was circulating in dairy herds since late December 2023. Clinically the disease in cows presents as an acute decline in milk production, anorexia and depression in habitus. 

Cattle shipped from the index farm were received by a herd in Michigan on March 8^th.    Clinical signs were detected on March 20^th. This was followed by an episode of high mortality in an in-line egg production complex near Saranac, MI. confirmed as HPAI on April 2^nd.  Whole genome sequencing of virus isolates from the Michigan dairy and poultry operations were identified as Eurasian lineage goose/Guangdong, clade 2.3.4.4b, genotype B3.13 with homology among isolates from both the dairy herd and layer complexes.

The USDA team published their preliminary findings on June 9^th and circulated the manuscript in the form of a report that encapsulated epidemiologic findings including recommendations for prevention*.  The report comprised observations made on 15 dairy herds and 8 poultry flocks covering the period March 29^th through May 16^th.

The principal epidemiologic findings included: -

• Almost a third of dairies employed workers who owned livestock or poultry at their personal residences.
• There was extensive commonality of employment among dairy herd workers.  Twenty percent of those employed and 7 percent of their family members worked with dairy herds other than their principal location.
• Of considerable significance to interspecies transmission, seven percent of workers on the affected dairies also worked on poultry farms and 13 percent of workers on affected dairy farms had family members working on poultry complexes.
• With respect to the dairy operations, 62 percent used shared vehicles to transport live cattle but only 12 percent of responders recorded decontamination after delivery.
•  All dairy farms had regular visits by veterinarians, consultants and contract haulers with evident direct contact among herds.  Almost half of the dairy herds used a contractor to dispose of dead animals with a history of removal within 30 days of the emergence of clinical signs in 40 percent of the affected herds.
• As with all dairy operations, milk haulers visited operations at least daily.

The epidemiologic evaluation based on a questionnaire requiring participation of up to two hours by a responsible reporter and follow-up investigations and an environmental sampling form the basis of the publication.

The major conclusions of relevance to the outbreak included: -

• Introduction of the virus into Michigan herds by infected but apparently asymptomatic cattle originating in Texas.
• Evident inter-herd and inter-flock dissemination of H5N1 by movement of personnel, lactating cows and vehicles, without appropriate operational biosecurity.
• HPAI H5N1 genotype B3.13 was detected in pigeons, a starling, cats, raccoons, opossums and foxes at five of the dairy farms surveyed and on one participating poultry farm.  The question arises as to whether the free-living resident passerine birds introduced the infection by viral shedding or whether they became infected by contact with a contaminated environment.  Cats are highly susceptible to infection and demonstrate clinical signs and death. They may be involved as a ptential link between wild birds and cattle.  Cats could also have become infected by consuming discarded raw milk from infected cows.
• Movement of personnel and their families among dairy and poultry farms was considered to be significant in the context of the extension from the initial cases in dairy herds to the catastrophic loss involving 4.8 million hens among six farms under common ownership.  It is understood that workers were not required to disrobe and shower before donning company-provided outer clothing.  The investigation confirmed that at least 20 employees of three poultry flocks worked weekend shifts at two dairy farms.  The report also confirmed that shared housing could have contributed to dissemination of infection in the case of three poultry farms and two dairy herds.

Recommendations to prevent infection included: -

• Maintaining closed herds although 9 out of 15 farms that were evaluated did not receive animals within 30 days of their respective outbreaks.
• Surveillance of both individual animals by PCR assay of respiratory swabs and pooled samples of milk is now mandated before interstate movement of lactating cows.  Clearly, this is inadequate since heifers could transmit infection and individual states should be required to impose a similar restriction on intra-state movement.  Recommendations in the Secure Milk Supply Enhanced Biosecurity Plan should be followed. 
• The Michigan Department of Agriculture and Rural Development issued a Determination of Extraordinary Emergency-HPAI Risk Reduction Response Order on May 1^st requiring adherence to acceptable operational biosecurity.  It is noted that procedures to limit transmission of infection require structural biosecurity including facilities to decontaminate personnel vehicles and equipment which, if absent, invalidates operational biosecurity.
• It is a longstanding practice within the poultry industry to require personnel to avoid visiting other poultry farms or maintaining poultry at their homes.  The industry has, however, not considered swine or dairy operations as a possible source of infection.  Even in the absence of a prohibition of contact with other farms, introduction onto egg production complexes may have been avoided by decontamination of personnel using available showers.
• Since the early April outbreak in the Michigan egg production complex, virtually all poultry producers have amended their personnel requirements to include a ban on working on any other livestock operation with some companies extending this restriction to family members.  Since declarations are voluntary and impossible to verify, disrobing, showering and donning company-provided outer clothing and PPE is considered to be an essential preventive measure.

The report prepared and published by USDA-APHIS illustrates how a field investigation with appropriate laboratory support can be implemented within a short period, given resources but more important with motivation and direction by senior administrators. Since the onset of the current epornitic in 2022, APHIS has functioned to diagnose outbreaks of avian influenza and to depopulate flocks. The APHIS concentration has been an attempt to eradicate a seasonally and regionally endemic infection introduced and disseminated by migratory waterfowl that constitute reservoirs and shedders. The Agency has neglected epidemiologic studies that could have contributed to recommendations for prevention. Only two superficial and flawed reports were belatedly published, based on telephone-administered surveys one year after the 2022 outbreaks in diverse egg production and turkey grow-out farms respectively. Information including the critical determination of whether HPAI can be transmitted, albeit it over short distances, by the aerogenous route would have been helpful along with other recommendations based on logical assumptions and more structured and focused investigations. 

The rapid response by APHIS, with real-time recommendations relating to H5N1 outbreaks in Michigan demonstrate that the Agency is capable of responding to a disease emergency.  Why was a similar approach not adopted in 2022 following the emergence of HPAI collectively responsible for subsequent depopulation of close to 90 million commercial poultry? Does APHIS operate according to the Animal Farm ethos of “Four legs good-two legs bad”? There is a lot that the poultry industry needed to know 50 million or so birds ago!

*Nguyen, T-Q., et al.  2024 Highly Pathogenic Avian Influenza (H5N1)-Michigan Dairy Herd and Poultry Flock Summary BioRxlv.org.doi.org/10.1101/2024.05.01.591751.

With the emergence of bovine influenza-H5N1 in dairy herds and ongoing outbreaks of HPAI in poultry flocks, legal experts are examining the implications of workers contracting the infection. This is notwithstanding the paucity of cases and mild symptoms to date. In a review authored by Charles Palmer of the law firm Michael Best and Freidrich, obligations of employers are considered with respect to the possible emergence of a zoonotic infection.

Section 5 (a) 1, the General Duty Clause of the Occupational Safety and Health Act places an onus on employers to respond to obvious hazards that may impact workers.  At the present time, it is not apparent that HPAI H5N1 in either poultry flocks or dairy herds is directly transmissible to workers despite three cases diagnosed and with one case associated with depopulation of a flock infected with HPAI.  All cases were mild and there was no evidence of person-to-person transmission.  In terms of the General Duty Clause, employers will be held to standards as issued by the Centers for Disease Control and Prevention.  Current recommendations include: -

• Avoiding direct physical contact with sick birds and animals.  This is obviously inappropriate where crews are used to depopulate flocks diagnosed with HPAI. The situation is unclear with respect to large herds in which there is a low prevalence of infection. Is it permissible to segregate affected cows and designate trained personnel to their care?

• Wearing appropriate personal protective equipment (PPE) that should be supplied by the employer.  This is an area where employers could be subject to criminal and civil  action in the event of failure to either supply PPE or train workers in their effective use.

The OSHA PPE standard (29CFR 1910.132) requires: -

• Disposable or non-disposable and fluid resistant coveralls and depending on circumstances, waterproof aprons and head gear.
• NIOSH approved particulate respirator with a minimum of N95 filtration.
• Properly fitted, unvented safety goggles or a face shield in the event of splashing of biologic fluids onto the respirator.
• Rubber footwear with sealed seams that can be sanitized.
• Disposable or non-disposable head covers.
• Disposable or non-disposable gloves.

Employees should be trained in donning and working with PPE.

CLS-Seqirus Vaccine Plant NC

OSHA sanitation standard (29CFR 1910.141) requires collection and appropriate disposal of both solid and liquid wastes in such a manner as to prevent direct contact with eyes and respiratory surfaces.  The sanitation standard requires bathrooms with hot and cold running water and soap and cloth or paper towels.  The requirement includes “air blowers”.  These units are potentially capable of disseminating virus particles entrained on dust and should be eliminated from the sanitation standard.

The poultry industry has gained sufficient and bitter experience in the possible location and timing of outbreaks and accordingly, structural and operational biosecurity is practiced and is  intensified under conditions of high risk.  The situation with respect to the dairy industry is less certain. More than 90 herds have been diagnosed with bovine influenza-H5N1 and the disease is now present in 12 states.  In the absence of a structured surveillance program, the actual extent of infection among dairy herds and possibly beef herds is unknown.

During the 2020 COVID outbreak, workers in red meat packing plants and poultry processing facilities were vulnerable to infection based on proximity of workstations and working in cold, high-moisture environments. With confusion over county and state officials to order plants closed and with plummeting hog and beef throughput on April 28^th 2020 a Presidential Executive Order was released in accordance with the Defense Procurement Act mandating plants to continue operation. This Order extended indemnity to employers against claims by sick workers provided that facilities were operated in accordance with CDC standards.  At the time, these were based on human influenza and involved masking, distancing and monitoring of health. 

In the absence of similar indemnification, employers will be vulnerable to both civil and criminal action in the event of exposure of workers to H5N1 in the absence of appropriate protective measures.

Cell-based vaccine production CSL-Seqirus

Should a zoonotic strain of H5N1 emerge, protective vaccination will be deployed from a bulk stock of 5 million doses currently being packed by CLS-Seqirus in North Carolina. The E.U has ordered vaccine from the Company with delivery scheduled over a four-year period. Finland intends offering vaccine to workers and farmers in contact with dairy herds, mink and poultry in addition to employees of packing plant, veterinarians, laboratory personnel and first responders.

As a simple precautionary measure, all workers in contact with poultry, dairy herds and other at- risk personnel and their families should receive the annual multivalent influenza vaccine when available in the fall. This will preclude an extremely rare but possible recombinant event between a human influenza strain and a poultry or livestock strain with the potential for emergence of a new virulent zoonotic virus.

The Centers for Control and Prevention (CDC) has demonstrated that implementation of food irradiation for eligible products over the period 2009 through 2020 would have potentially reduced the incidence of foodborne outbreaks caused by susceptible bacteria. In the retrospective CDC study, 482 foodborne outbreaks were examined with 155 attributed to a food product eligible for irradiation.  Chicken (34 percent of the eligible foods) and beef (20 percent) were the leading food products eligible for irradiation that were obviously contaminated at the time of purchase.  The CDC report noted, “ the illnesses, hospitalizations and deaths associated with outbreaks linked to irradiation-eligible food might have been prevented or reduced had those foods been irradiated.  Radiation treatment eliminates pathogenic microorganisms.”

During the 1980’s and 1990’s, food irradiation was promoted as a solution to foodborne infection caused by Salmonella, Campylobacter, E.coli (STEC) and Listeria.  Unfortunately, negative publicity and a reluctance to introduce the technology prevented adoption.  Isotopic irradiation using cobalt⁶⁰ is suitable to destroy foodborne bacteria in bulk-packed dense food products.  Cobalt⁶⁰ irradiation plants are expensive and depend on high utilization and throughput to offset fixed costs. With high demand and appropriate logistics, the cost of irradiation treatment is extremely low.  It is a matter of record that a high proportion of medical disposables are irradiated using cobalt⁶⁰ in dedicated free-standing plants. 

Recently electron beam pasteurization has become available as a more practical alternative to isotopic irradiation.  Similar to hospital x-ray installations, electron beam units can be installed in poultry production and food packaging plants without the restraints and costs associated with isotopic irradiation.  Electron beam units can be switched on and off to comply with plant operation and are ideal for small food items including IQF portions and small packages of fruit and vegetables.

The U.S. Food and Drug Administration has approved a range of foods for irradiation including meat, poultry, shell eggs and spices, Unfortunately due to concerns over consumer resistance there has been minimal application other than for approximately one-third of imported spices.

For food irradiation to be accepted, an intensive program of consumer education will be required.  The major points to be conveyed are that nutritional content is not affected by the treatment, there is no residual radioactivity in the product, non-spore forming bacterial pathogens are inactivated if the process is carried out in conformity with FDA standards.

Attempts are being made to declare a wide range of Salmonella as adulterants in chicken and turkey products.  Given current pre-harvest and processing technology, it is impossible to reduce the probability of contamination to levels that would support existing production with standards approximating near-zero tolerance without an effective kill step.  Application of irradiation applying electron beam treatment of tray-pack or IQF products could be achieved at costs at or below one cent per lb.

If electron beam treatment is introduced, there will have to be complete transparency in labeling accompanied by promotion by federal agencies with assurances of safety and efficacy and above all endorsement by public health agencies and consumer groups.

Given that we are still contending with opposition against pasteurization of milk introduced over 150 years ago, obtaining acceptance of food irradiation, even applying electron beam treatment, analogous to x-rays will require a coordinated informational program.

The USDA will assign $22.2 million to the Animal and Health Inspection Service to implement 81 projects in 48 states.  Activities will be conducted by universities, industry organizations and state veterinary diagnostic laboratories. Funds will be assigned from the National Animal Disease Preparedness and Response Program funded in 2018.

Jenny L. Moffitt Under Secretary for USDA Marketing and Regulatory Programs noted, “Bolstering animal disease preparedness is critical because these diseases devastate livestock and hardworking farmers whose animals are affected and threaten America’s access to safe, healthy, affordable food.”

It is hoped that APHIS will assign resources to an epidemiologic investigation of avian influenza.  Since 2022, over 80 million commercial birds have been depopulated with only lip service to epidemiologic studies that could provide meaningful improvements in prevention and control.  The Agency continually and justifiably promotes “biosecurity” as a principle but without considering specifics relating to structural and operational biosecurity. APHIS fails to relate the probability of exposure with various types of commercial farms and to consider the structure and organization of the various industry segments.  From direct personal contact with middle-level federal Veterinarians, it is evident that epidemiologic studies leading to prevention have been largely downplayed with a concentration on the reactive cycle of detection, depopulation, quarantine and decontamination.

APHIS continues with a policy of attempting to eradicate a disease that is both regionally and seasonally endemic.  This King Canute approach draws heavily on Commodity Credit Corporation funding. This is costly to public agencies, producers and ultimately consumers.

Projects that should be considered include:

• Confirmation of aerogenous transmission of avian influenza virus.

• Determining the duration of shedding of virus by migratory waterfowl and domestic birds following infection.

• Persistence of virus in soil and water over a range of conditions as influenced by temperature, humidity and intensity of exposure to sunlight on soil and impervious surfaces.

• Establishing risk factors for introduction of infection onto large egg production complexes in addition to contractor broiler, turkey, and breeder farms using real time field and molecular epidemiology.

• Expedite the evaluation of available commercial avian influenza vaccines and formulate a policy for their deployment.

A number of legislators including Senator Chuck Grassley (R-IA) have developed a sudden interest in H5N1 now that it has emerged in the dairy industry.  Senator Grassley is correct in encouraging communication among federal agencies involving specialists in virology, epidemiology, wildlife biology and other disciplines necessary to develop integrated programs to control catastrophic diseases.

Parochial concerns as expressed by the Commissioner of Agriculture of the state of Texas dissuading cooperation into investigations into the source and prevalence of bovine influenza-H5N1 are unconstructive. Resistance to cooperation with federal agencies may delay prevention and spread and contribute to the remote possibility of emergence of a strain of H5N1 pathogenic to humans and capable of person-to-person spread. In the unlikely event of emergence of a zoonotic form of H5N1 he and those who oppose scientific investigation and reality will have a lot to answer for. The Commissioner will be removing his ostentatiously large and pristinely white trademark Stetson at numerous funerals—but let us work together to obviate this eventuality. We are not China.  We face reality. We do not suppress science. We work to achieve the best possible outcome when faced with challenges of disease and climate. Or do we? Naah!

The recent emergence of bovine influenza-H5N1 now diagnosed in 54 herds in 9 states, creates a risk of infection from consuming non-pasteurized milk.  Heat treatment during pasteurization effectively destroys most viruses and non-spore forming bacterial pathogens. To date there is no indication that either consumers of fluid milk or eggs have been impacted by bovine influenza-H5N1 or the avian counterpart. The fact that eggs have not been subject to consumer resistance following outbreaks of HPAI is attributed to prompt cessation of distribution from affected complexes and that eggs are cooked in home and institutional kitchens providing a justified sense of security. 

Predictably, CDC has warned against drinking raw milk.  From 1998 to 2018, the CDC documented 200 outbreaks directly attributed to raw milk, resulting in 2,600 cases and 225 hospitalizations.  Prior to mandatory pasteurization for milk shipped interstate, 25 percent of all cases of foodborne infection could be traced to milk and dairy products.  Currently, milk and dairy are responsible for slightly less than one percent of foodborne infections.  It is calculated that one percent of the population regularly consume non-pasteurized milk representing 0.006 percent of all fluid milk consumed. This minute quantity is responsible for a disproportionate number of milk-borne infections.

Demand for raw milk soared during the COVID period when it became a freedom issue as a counter to recommendations for masking and vaccination to control the emerging infection.  A raw-milk producer in California noted, “Anything that the FDA tells consumers to do, they do the opposite.” 

The demand for raw milk has surprised food safety experts.  Dr. Donald Schaffner of Rutgers University characterized that the demand for raw milk is “absolutely stunning” and Dr. Alex O’Brien, Coordinator for Safety and Quality at the Center for Dairy Research, stated, “I liken drinking raw milk to playing Russian roulette.  The more times people consume it, the greater the chance they will get sick.”  Notwithstanding reasons and scientific advice, social media is replete with false claims of nutritional superiority for raw milk and anecdotal reports of freedom from infection.  The very young are vulnerable to bacterial infections including STEC that is associated with hemolytic uremic syndrome.  Allowing pre-teens to consume raw milk is a form of abuse.

Dr. Matthew Motta of Boston University attributes the demand for raw milk as a manifestation of “partisanship, politic ideology, religion and cultural values” and not simply due to availability or ignorance. Dr. Motta recommends that federal health agencies should respond with appropriate advice and scientific fact on social media promoting the safety of pasteurized milk.  Unfortunately, in a polarized nation with web-disseminated misinformation and conspiracies, consumers have made up their minds and no amount of web postings will sway their convictions.

From a statement issued by Dr. Nirav Shah, Principal Deputy Director of the Center for Disease Control and Prevention (CDC), there is unanimity between his agency and USDA but state agricultural departments and individual dairy operations are obstructing investigations relating to the prevalence of infection in herds and workers.

With an emerging infection such as bovine influenza-H5N1 it is critical to determine as rapidly as possible the prevalence rate and geographic extent of the infection.  Both field and molecular data must be obtained and analyzed to ascertain the rate of spread and modes of infection in order to implement counter measures. Epidemiologic data can be used to predict the progress of the disease in cattle and genomic evaluation can assess the risk of extension to the human population.

The CDC, with their focus on human health, is obviously concerned over the possible incidence rate of H5N1 infection among workers and should be allowed to conduct surveys.  Texas Agriculture Commissioner Sid Miller stated, “They don’t need to do that, it’s overreach.”  With respect to Commissioner Miller, he is in no position to comment on the epidemiologic realities of emerging disease and apparently is oblivious to the potential of extension to humans, although only one diagnosed case has been documented.  Anecdotal reports by veterinarians visiting affected dairy herds suggest that individual workers demonstrated influenza-like symptoms including conjunctivitis.  Colorado with only one case is following 70 workers to establish infection and possible transmission to contacts.  Based on data from the CDC only 220 farm workers have been monitored for symptoms suggesting that only 150 workers have been evaluated among eight states where outbreaks have occurred.  Texas with the most cases among dairy farms reported has only tested 20 workers with clinical signs and the results of diagnostic procedures have not been released. PCR assay results are available within 24 hours!

It is now five weeks since the index case of bovine influenza was diagnosed. Preliminary studies on the sequencing of isolates of H5N1 belatedly released by USDA-APHIS suggest that the disease has been present in dairy herds since late December 2023.  To date there has been no structured evaluation of H5N1 prevalence among dairy herds on a national basis and the appropriate epidemiologic surveys on workers have not been conducted. This is despite the presence of RNA consistent with H5 influenza virus in both milk and wastewater especially in areas where outbreaks in dairy herds have occurred.

The World Health Organization has designated H5N1 avian influenza virus as a potential pandemic strain.  The Agency has urged surveillance including documentation of outbreaks in avian and now mammalian species and the WHO maintains a database of outbreaks and the library of genomic sequences. 

The parochial but understandable concern of state departments of agriculture as expressed in their desire to protect the milk industry is self-evident.  This standpoint obviously conflicts with the greater need to understand the epidemiology of bovine influenza-H5N1 and to develop a national program to limit infection.  Of greater concern is the possible extension of a mutant virus to workers and then to the general population.  The distribution of PPE is perhaps an initial step in preventing infection but will be difficult to implement given the underlying deficiencies in structural and operational biosecurity in comparison to egg-production complexes. Practical and cultural issues exist with the deployment and use of PPE that requires availability and acceptance.  We need to know the numbers of workers that may have been infected from an affected herd, the duration of the clinical phase and of viral shedding.  Surveillance based on molecular epidemiology including gene sequencing will be critical to timeously detect mutations that may contribute to infection of humans and person-to- person spread. It is understood that up to $98 million will be distributed by the USDA to provide 3,500 dairy farms with up to $28,000 to “contain the spread of the virus between animals and humans and for testing milk and animals for the virus” This commentator suggests that grants should be conditional on cooperation with federal agencies with respect to herd and worker surveillance.

We are not China.  We should not suppress necessary epidemiologic investigations or the data collected.  Bovine influenza-H5N1 and its avian counterpart will not simply go away, irrespective of the intensity of hope, denial and prayer. Fortunately it appears that the risk of contracting H5N1 from direct contact with cattle is minimal but this assumption is based on the current circulating virus and inadequate surveillance.  Pasteurization obviously destroys the virus that is secreted into milk from infected mammary tissue. A mutation in the viral genome could profoundly alter present circumstances and could result in widespread infection as with “swine flu”.  Dr. Shah notes, “We have all seen how a virus can spread around the globe before public health is even had a chance to gets shoes on, that’s a risk and one we have to be mindful of.” It is not what we know that has the potential to hurt the industry and population—but what we do not know.

The dairy industry, state agriculture organizations, and federal agencies including USDA-APHIS and the CDC should cooperate according to a coordinated and agreed plan to determine the extent of bovine infection following “One Health” principles.  Currently the risk of mutation to a strain capable of infecting humans is very low based on accumulated knowledge. We are however in a situation of confronting a condition with a low probability of an adverse outcome for humans but with an extreme potential for morbidity and mortality and devastation of the Nation’s economy in a worst case scenario.  Let us learn from our unfortunate experience with COVID from 2019 onwards and not underrate the significance of the infection at a stage when practical control is still possible.

It is becoming increasingly evident that the U.S. poultry industry is divided on the desirability of preventive vaccination against Highly Pathogenic Avian Influenza. Given the duration and severity of the H5N1 epornitic that has persisted in seasonal waves of incidence since 2022, both turkey and egg production segments have been disproportionately affected.  In contrast there have been limited losses among broiler breeder and growing farms. The ongoing epornitic has resulted in depopulation of close to 90 million birds with 75 percent comprising commercial egg laying flocks or pullets, 16 percent turkeys and 7 percent broilers and broiler breeders.

At issue is the potential impact of even limited regional and sector vaccination on the export of broiler leg quarters.  The prevailing perception is that introducing any program of preventive vaccination would be an acknowledgement that the infection is endemic resulting in a number of importing nations imposing wide restrictions on importation.  The reality is that HPAI is effectively regionally and seasonally endemic in the U.S. given that both migratory birds that introduce infection and now many domestic species both serve as reservoirs and disseminators of the virus. Even the most extreme levels of biosecurity are ineffective in preventing introduction of infection based on anecdotal and scientific evidence that infection can be transmitted over short distances by the aerogenous route.  Since the 2022 epornitic, the USDA-APHIS has followed an outdated and anachronistic policy of eradication.  This is clearly a fallacious approach, inappropriate to a disease subject to seasonal introduction and with domestic wildlife reservoirs.

Adaptation of H5N1 to mammals with animal-to-animal transmission is evidenced by outbreaks in farmed mink and marine mammals during 2023.  The recognition that the infection is now present in the U.S. dairy industry raises concern for further changes in the H5N1 genome with the potential for the emergence of a zoonotic strain.

Given that highly pathogenic avian influenza caused by H5N1 is now a panornitic present on six continents, has changed attitudes towards preventive vaccination. The World Organization of Animal Health (WOAH) has accepted this modality as an adjunct to prevention along with biosecurity and quarantine.  The important question is whether limited vaccination in the U.S. would seriously impact export of leg quarters representing 97 percent of broiler exports.  Given the limited number of nations receiving U.S. exports, and the fact that many of these nations have endemic infection suggests that the restraints on exports may be overstated. It is clear that many nations have and will continue to use avian influenza as either a protective measure for domestic industries or for political purposes.  China applies vaccination against endemic HPAI but imposes prolonged restrictions on U.S. counties and states with diagnosed infections. This nation will act in their own interest irrespective of international agreements or scientific reality.  Many importing nations would be willing to limit restrictions to the county level.  Others might accept a certification program by which complexes or flocks of origin could be demonstrated to be free of virus by PCR assay prior to harvesting.

The NCC is justified in continuing to quantify the effect of trade restrictions although in reality vaccination would result in probably less disruption than is currently imposed.  The contention that vaccination would not eradicate HPAI is well recognized, but it must be accepted that the infection is now regionally and seasonally endemic.  The statement that vaccination “masks the presence of HPAI” is valid but flocks can be certified free of infection using PCR technology.

The NCC statement that “We currently support USDA and APHIS stamping out policy to eradicate the virus is essentially fallacious and self-serving since this is an unachievable objective and reflects the thinking of the 1990s.  The NCC encouragement of APHIS to “work with our trading partners to ensure that should a vaccination strategy be developed, we can continue to feed the world with poultry products” represents a departure from the ‘no-vaccination ever’ message.  The NCC is justified in its reservations over HPAI vaccination with respect to export and trade since this is of vital economic importance to the industry that must market 15 percent of RTC volume in the form of leg quarters, an undifferentiated relatively low-priced commodity.

The recent article by Mike Brown, President of the NCC, in a Delmarva publication indicates a more reasoned approach to vaccination that recognizes that the infection cannot be eradicated through ongoing depopulation of flocks.  Effective biosecurity (as opposed to the ‘make-belief’ version practiced) will not provide absolute protection against infection given the reality of aerogenous transmission.

Restriction on trade in poultry products as the result of vaccination may be influenced by future events including: -

• The unfortunate but likely possibility of introduction of HPAI into the U.S. broiler industry, resulting in significant losses.
• Recognition of HPAI among commercial flocks in Brazil.
• Extension of H5N1 or other strains to workers on U.S. livestock farms, processing and packing plants and their contacts.
• Availability of effective AI vaccines for mass application.

The “softening” of resistance by the broiler industry to preventive vaccination is encouraged and reflects an appreciation of the realities of the disease, the widespread distribution, financial impact and zoonotic potential. The NCC and USAPEEC should motivate the lifting of trade barriers against vaccination through representations to the WOAH, the International Poultry Council and the International Egg Commission to facilitate controlled and monitored immunization of egg-production and turkey flocks in U.S. areas of high risk.