It is generally accepted that the origin of COVID should be clearly understood and should be supported with factual and scientific documentation. The international public health community should be able to analyze the factors leading to the emergence of the infection that emerged in Wuhan, China during late 2019 and the subsequent worldwide spread.  This information is critical in planning surveillance programs and to develop an appropriate response to an inevitable future pandemic.

The Director-General of the WHO, Dr. Tedros Ghebreyesus stated that, “For the sake of the millions of people who died and those who are living with long COVID, we must understand the origin of COVID-19 by exploring all hypotheses.” The WHO considers an investigation of the origin of the pandemic as a “scientific and moral imperative to help prevent future outbreaks”.

The WHO in Geneva approached the origin of COVID from a scientific perspective. From the outset China was evasive and non-cooperative with the WHO as to the extent and severity of infection. The Agency belatedly sent an impartial panel of scientists to Wuhan to investigate the origins of the pandemic. This stage-managed tour deprived WHO-nominated virologists and epidemiologists of the opportunity to review source data and to interview scientists and clinicians associated with the outbreak. In the absence of transparency the origin of the infection has become politicized in both the U. S. and China with evident finger pointing and some outlandish and unsupported theories of origin. 

The U.S. House and Senate have voted unanimously to declassify all U. S. intelligence information on the origin of the pandemic.  This will facilitate Congressional enquiries into the origin of the disease. It remains for the President to now enact the legislation that requires release of  “any and all information relating to potential links between the Wuhan Institute of Virology and the origin of coronavirus disease”.  It is questioned whether the President will sign the Bill, although with overwhelming passage in both houses, a veto by the President would be subject to an instant override.

According to Reuters, eight federal agencies have investigated the origin of COVID without attaining unanimity as to the source, whether a natural emergence in wild animals or an accidental laboratory release. This is attributed to the lack of human intelligence in the form of credible whistleblowers or published studies other than those emanating from China that may be presumed to be subject to Government censorship.

To dispel one theory in circulation, it is highly unlikely that SARS-CoV-2 virus responsible for COVID-19 was created as a bioweapon. A human coronavirus developed from bats would be lower than a 10^th choice among available pathogens. Intending perpetrators of a bioweapon intended for deployment should have a stockpile of effective vaccines or therapeutic agents to protect their forces in advance of an attack. The absence of a specific vaccine and known instability of the virus mitigate against a deliberate attempt at weaponization.

There are two leading theories of the origin of COVID. The first is a spontaneous mutation of a coronavirus in a free-living animal reservoir with the pathogen that crossed over into susceptible human contacts. The fact that the population of China has a predilection for consuming a variety of reptilian and mammalian exotics purchased in both rural and urban wet markets creates the potential for emergence of an infection carried by animals. It is evident that SARS, the progenitor of COVID, that emerged in Foshan with a 7 million population in November 2002 was associated with patients having contact with urban wet markets as opposed to patients in rural areas. Apparent concentration of early cases residing in the vicinity of the Wuhan Huanan Seafood Market was presented as evidence of the animal to human route. This was reinforced by recovery of SARS-CoV-2 virus from animal stalls and locations in the market subsequent to closure. These lines of investigation provide circumstantial evidence but do not confirm that the market was the source of infection.   In a characteristic response, authorities in China initially suppressed information concerning the outbreak and failed to cooperate with international health agencies to control the spread of the disease. More recently in the face of criticism scientists in China have implicated Asian raccoon dogs (Nyctereutes procyonoides) as a carrier of SARS-CoV-2 virus.

The second prevailing theory of the emergence of COVID relates to inappropriate gain of function experiments on bat coronaviruses conducted by the Wuhan Institute of Virology. It is possible that with defective BSL-3 protocols, dissemination of a modified virus pathogenic to humans occurred. This could have been achieved either by spread from infected laboratory personnel or by release of the virus by the aerogenous route. The implicated wet market is three miles distant from the Institute, on the West bank of the Yangtze River that separates the urban area of the City. If China wishes to disprove the lab-leak theory, relevant serologic data and health records should be made available to investigators together with gene sequences of early cases. This data requested by the WHO panel was not released.

This commentator has taken a proverbial 30,000-foot view of the emergence of COVID as we know it, and applied logic in the absence of analyzable data. It would appear to this commentator that the emergence of COVID in the city of Wuhan with a population of 12 million and the home of an Institute working with bat coronaviruses, represents a coincidence of overwhelming proportions. This is in recognition of twenty other metropolitan areas in China each with more than five million inhabitants and presumably without ongoing bat coronavirus research.

China did not do itself any favors by initial denial of the existence of the outbreak and then failing to acknowledge contagious transmission. Refusal to admit impartial and qualified epidemiologists offered by the WHO in the early stages of the outbreak and delays in allowing visits by WHO consultants and then obstructing the WHO mission to investigate the source of the disease represent a presumption of guilt, inconsistent with the actions of a responsible nation. Consistent stonewalling, muzzling of scientists, removal of gee sequences from websites and refusal to provide data, although established standard operating procedures for China, creates the impression that Government has a lot to hide. This Nation has effectively rendered the entire World a disservice and brought upon itself the suffering from the economic impact of lockdowns and high mortality.

The U. S. Food and Drug Administration (FDA) has submitted requests for enhancements and activities that will add $7.2 billion to the Fiscal Year 2024 budget. In supporting the request, the Commissioner, Dr. Robert M. Califf, stated that the funding is required for vital oversight of tobacco products, to strengthen medical product safety and to ensure that programs have the highest success for the good of public health.

The FDA release notes, “Building on lessons learned from the infinite supply chain response, the budget includes funding to modernize infant formula oversight and to respond to shortages of critical foods and to reduce exposure to toxic chemicals in food.”  It is evident that the FDA intends to expand oversight of the animal feed industry including ingredients that are combined, packaged and sold as animal food.  It is however unclear whether the FDA is referring to animal feed or food derived from animals in their request for funding since the USDA-FSIS is responsible for red meat and poultry.

Among the components of the budget, FDA has requested: -

• $130 million for food safety and nutrition modernization.  This activity would include food labeling and the oversight of animal feed.  It is evident that the request relates to the widely criticized reorganization implementing a matrix structure.
• $10 million is requested for improvements in information technology including emerging threats, and allowing real-time continuously access, analysis and aggregation of information.
• $16 million is requested for “mission support functions within the Office of the Commissioner”.  This is intended to provide strategic direction, policy coordination and business services to enhance the efficiency of FDA programs.

The FDA intends to require animal drug sponsors to make post-approval safety-related label changes based on information that becomes available after approval.  FDA will request the authority to exclude products or classes of products that either the FDA or the Environmental  Protection Agency consider deleterious.  The FDA intends to assume regulatory authority for animal-use pesticides to be regulated as animal drugs.

The FDA intends requiring industry to test food products to be consumed by infants and children for the presence of toxic elements and make available the results of assays.  This requirement relates to the revelation that juices marketed for children were and are contaminated with heavy metals.

The FDA will apply funding to effect mandatory recall covering all human and animal drugs medical devices, tobacco products, cosmetics and foods that are currently under the jurisdiction of the FDA and are subject to recall.

While it is recognized that a government agency should be responsible for maintaining the safety and efficacy of drugs and medical devices, the question of divided jurisdiction among the FDA, USDA-FSIS and EPA among other Federal agencies raises the issue, now openly discussed,  whether the U. S. public would be better served by an independent Food Safety Agency.

Dr. Califf is asking for a lot of money to achieve what is necessary but should have been incorporated in the mission of the agency.  Dr. Califf is attempting to pour money into an agency with an inappropriate organizational structure and a culture indifferent to food safety. Recent history confirms that the FDA has underperformed with respect to food safety, resulting in a number of significant outbreaks of foodborne disease, potential toxicities and obvious failures in oversight of the mission to protect consumers.

The FDA press release on March 9^th is replete with jargon and lofty promises. Implicit in the release will be the imposition of inappropriate restraints and regulations with respect to animal production and on the compounds required to maintain profitability in the agricultural and livestock sectors.

Without demonstrating that he can run the FDA to accomplish the basic missions of the Agency, Dr. Califf appears intent on mission creep and acquiring jurisdiction over aspects of animal production for which the FDA is ill-suited.

EGG-NEWS supports the reasoned recommendations of prominent experts including attorney William Marler to create a separate food agency split from the FDA. Egg-News goes a step further in suggesting that any new agency should incorporate the functions of the USDA-FSIS. Pathogens are unresponsive to Washington turf bureaucracy. Oversight of food safety should be a seamless activity devoid of jurisdictional disputes such as the responsibility for pizzas with either cheese or pepperoni toppings.

Europe is leading the way in developing, investigating and evaluating deployment of vaccines to control avian influenza.  France will initiate a program mid-year as a response to unsuccessful eradication activities conducted almost annually. Expenditure in France was close to $1.5 billion for compensation and control in 2022.

Field evaluation of vaccines is in progress in the Netherlands, Italy, and Hungary involving the major segments of poultry production.

The European Union has accepted the principle of vaccination that will apply to 27 member nations.  In accordance with recent decisions, vaccinated poultry, their products and day-old chicks can move freely within the EU effective March 2023. The Russian Union of Poultry Producers has evolved a strategy to administer vaccines against HPAI as an additional measure to control and prevent infections. Their decision was based on the need to maintain food security in the face of sanctions. But also in the realization that biosecurity alone was unable to interdict aerogenous spread of virus

A variety of vaccines are now available with technology superseding the previously deployed hemagglutinin-specific, inactivated oil-emulsion vaccines. Biopharmaceutical manufacturers are now applying rHVT vector and mRNA technology for a new generation of vaccines. Commercially available rHVT vectored vaccines have been used successfully for a number of years in some countries in Asia, the Middle-East and in Mexico. They will be deployed in some South American nations including Bolivia, Peru and Ecuador currently experiencing outbreaks of HPAI.

Opposition to vaccination against avian influenza is waning as nations realize that the H5N1 panornitic is not abating and that both migratory and domestic wild birds are both susceptible and are disseminating virus. The decision to implement vaccination as a component of a national control program follows the recognition that H5N1 HPAI is endemic in a nation or region.  The fact that the virus has been identified in 47 states of the U.S., has required the depopulation of 57 million commercial birds including 10 million turkeys and 44 million laying hens and that sporadic outbreaks have persisted for over a year suggests that the infection can no longer be regarded as exotic and is de facto seasonally and regionally endemic.

A major objection to vaccination is that immunized flocks may excrete virus if infected without an apparent clinical response.  This is an obvious but surmountable obstacle. Shedding of virus is limited to about two weeks during which flocks can be quarantined.  The complaint that vaccination will create a problem through differentiating vaccinated flocks from those that are infected is now spurious.  Apart from the application of DIVA vaccines, the status of any flock can be established rapidly using PCR antigen detection.  It is possible to certify that any flock or complex producing eggs or poultry meat is HPAI-negative based on PCR assay on the day before processing or packing. Export of poultry products will in future be based on acceptance of WOAH principles relating to regionalization for commercial shipments in addition to compartmentalization for eggs and day-old chicks.

It is ironic that nations including China and South Africa that have placed HPAI-related barriers against importation from entire states in the U.S. have infected flocks in their own countries.  This is contrary to the trade regulations of the World Organization for Animal Health.

It is axiomatic that it is almost impossible and ultimately extremely expensive to eradicate an endemic disease, especially when the pathogen is constantly introduced by migratory birds. It should be accepted that avian influenza is in effect “the Newcastle disease of the 2020’s”.  This catastrophic infection was effectively controlled and is no longer a restraint to commercial production as a result of extensive and effective immunization, despite the absence of durable biosecurity in many nations.

The problem of implementing a vaccination program against avian influenza in the U.S. is not the availability of effective vaccines.  The restraint lies in intransigence among veterinary service administrators who are following a playbook antedating the 1984 outbreaks in Pennsylvania. Collectively they have failed to recognize the differences in the epidemiology of the current epornitic of H5N1 avian influenza and the growth of the industry since the outbreaks of H5N2 HPAI, four decades ago.  Obstructing vaccination by delaying approval of vaccines that are used effectively in other nations, adherence to the export bogy and inappropriate interpretation of science to maintain a business-as-usual approach will not ultimately prevent vaccination.

Based on the cost to the public and private sectors and to consumers, the U.S., Congress will likely turn off the compensation spigot and force adoption of vaccination. 

Public health authorities will react aggressively if and when transmission to human contacts of infected poultry occurs. This is predicated on the wide range of terrestrial and aquatic mammals that are apparently susceptible to and die following exposure to H5N1 AIV. Infection is acquired from predation or from the environment and then spread intra- and inter-species.

Opposition to mass depopulation is gathering force and is generating opposition among average consumers. As we move into Spring with the prospect of an upsurge in avian cases it must be recognized that the HPAI situation has expanded from a veterinary problem to encompass the economy and public health considerations. Vaccination cannot continue to be ignored as a component of control and suppression of HPAI in the World and the U.S.

The Ministry of Health of Cambodia reported an apparent cluster comprising one fatality due to H5N1 avian influenza with 1 additional confirmed case.  Dr. Youk Sambath, the Secretary of State in the Ministry of Health, dispatched a team to investigate the apparent outbreak.  Samples were obtained from residents of villages in the commune of Romlech in Prey Veng Province.   Specimens were examined by the Pasteur Institute a reference laboratory in Phnom Penh, the Nation’s capital.  Four of  eleven suspect cases were symptomatic but all of these cases  proved to be AI-negative. Sequencing  of virus from the two confirmed cases (deceased daughter and recovered father) identified the H5N1 virus as clade 2.3.2.1c that has circulated in chickens in Cambodia for a number of years. The current panornitic strain present in five continents is classified as clade 2.3.4.4b

During recent weeks, reports of H5N1 clade 2.3.4.4b causing deaths in free-living animals have been submitted to the World Organization for Animal Health.  The diversity among terrestrial mammals in 2022 includes free-living foxes, skunks, raccoons, bears and cougars in addition to animals in zoo collections.  During 2022, cases of marine mammals were identified with seals dying along the coast of Maine, a walrus in Norway and more recently, up to 700 sea lions along the coast of Peru.  During late 2022, a mink farm in Spain with 50,000 animals reported H5N1 strain avian influenza, presumably acquired from consuming raw poultry or from contact with free-living birds.  Rapid spread within the farm suggested mink-to-mink transmission.  The World Health Organization has not released information on the sequencing of the virus from mink to determine whether mutations  occurred, facilitating intra-herd transmission.   WHO virologists will be evaluating whether mutations in the virus were responsible for any emerging clusters in Asia.

To date, there has only been one case of transmission of H5N1 fin the U.S. from  dead birds or from entrained dust and dander, affecting a worker employed in depopulating a large egg-production complex in the Midwest. Despite many thousands of man-days of exposure among workers during the 2022 epornitic the single asymptomatic and confined case mitigates against direct transmission from infected flocks to humans at this time. Mutations occurring in the current H5N1 virus in Asia could change the present health situation.  

Implications arising from a strain capable of infecting humans even without human-to-human transmission would be of extreme significance to public health authorities worldwide and to the financial viability of the world’s poultry industries.

Pandemics of zoonotic origin have previously emerged in rural areas in Asia as isolated clusters.  Villagers who are infected may carry a virus to cities with wet markets serving to amplify and disseminate the pathogen. International air transport has been shown to distribute infection worldwide within a short period.  This was evidenced by the spread of SARS and COVID and previous influenza pandemics.

Human-to-human transmission would undoubtedly accelerate the acceptance and deployment of avian influenza vaccine for flocks worldwide. Creating immune populations will be necessary to prevent the emergence of a novel and potentially infectious HPAI strain transmissible to humans.  The longer the duration of the current panornitic and the higher the concentration of susceptible birds in large flocks or regions, the greater will be the probability of mutations occurring that may  affect humans. The emergence of an H5N1 strain in Asia expressing genes capable of infecting humans is a presumed mechanism by which a pandemic could emerge. China has addressed the problem of H7N9 transmission of HPAI from chickens to consumers patronizing wet markets by vaccinating supply flocks

EGG-NEWS has consistently advocated routine annual influenza vaccination of all employees coming into contact with live poultry.  This would reduce the rare probability of a recombination event between human and avian strains, resulting in a potentially pathogenic strain capable of human-to-human transmission. 

The quicker that the U.S. adopts a program of strategic vaccination concentrating on large egg-production complexes in high-risk areas, in addition to broiler breeders and turkeys, the greater will be our level of security.  Vaccination will not supplant biosecurity but should reduce the risk of emerging mutants. Obviously there will still be the need to deplete infected flocks showing mortality as a result of infection.

The USDA-APHIS, our industry associations and health administrators must discard the fallacy that H5N1 strain HPAI is exotic to the U.S. or for that matter, North America.  Any disease that requires the depopulation of 55 million commercial poultry, persists for over a year and emerged in 47 states with extension to free-living domestic birds and mammals cannot be regarded as exotic.  At the best, H5N1 HPAI is regionally and seasonally endemic.

It is axiomatic that avian influenza is the “Newcastle disease of the 2020s”.  This catastrophic disease was successfully contained during the 1960s and suppressed with appropriate vaccination. Until 2020, avian influenza was regarded as an exotic disease that could be eradicated.  The extent of the infection over five continents suggests a more realistic approach to control and prevention.  The possibility of human infection has created a higher level of concern and the need for rapid action.  For years, the USDA-APHIS has been subscribing to the principle of “One-health.” Given the potential of an H5N1 pandemic in addition to the panornitic in progress, now is the time to deploy whatever vaccines are available as an adjunct to traditional control measures.

During the past week, the Congressional Budget Office projected that the ten-year cost of the 2023 Farm Bill would attain $1.5 trillion, about 57 percent higher than the 2018 Farm Bill.  It is emphasized that estimates are provisional and are essentially projections based on broad assumptions relating to initial costs and inflation that will occur over a decade.  The Thrifty Food Plan is the major contributor to the increase and takes into account the Congressional Budget Office estimate for SNAP expenditure at $93 billion for the 2023-2032 period.

Members of the Senate Agricultural, Forestry and Food Committee consider the projected expenditure on the Thrifty Food Plan to be “unacceptable.” Senator John Boozman (R-AR) highlighted the extent of the $250 billion cost of the program from July 2021 to May 2022 coinciding with additional COVID expenditures that formed the baseline on which the projection was calculated.

If extra funding is assigned to SNAP, other programs will have to be shaved, including commodity support and conservation. It is apparent that negotiations to produce an acceptable farm bill will be contentious. The respective House and Senate chairs will have to demonstrate diplomacy and tact in achieving a bipartisan consensus in their respective committees. Compromise rather than brinkmanship will be required to draft a Farm bill that can be enacted and that satisfies the needs of diverse stakeholders and political ideologies.

On January 19^th Farm Action a self-described “Advocacy organization that works for everyone, not just a handful of powerful corporations” addressed a letter to Lina Khan, Chair of the Federal Trade Commission, accusing the egg industry of collusion to raise prices.  The letter cites USDA data on egg prices and flock depopulation following highly pathogenic avian influenza (HPAI) in 2022.  It is a matter of record that close to 44 million hens were depleted from February through mid-December 2022 covering 41 farms in 11 states including 22 large complexes holding from 500,000 to 6 million birds. The average size of the U.S. flock in production during 2022 was reduced by approximately 20 million hens from the pre-HPAI level of 325 million.  The data presented by Farm Action is disputed since assertions are taken out of context and the accusations of collusion are vigorously rejected.  In the absence of proof of either direct or indirect consultation on prices, the emotional and accusatory tone of the letter suggests a malicious bias inconsistent with fact.  Reference to previous lawsuits settled during 2018 are totally irrelevant to the present situation caused by HPAI.

Removal of 20 million hens or 6.2 percent of the producing flock reduced supply.  The price of eggs is determined by the relationship between supply and demand. Price as we learned in Econ. 101 will be influenced by the relationship of the two variables.  The amplitude of the price increase was influenced by the prevailing benchmark price discovery system compiled and disseminated by a commercial firm serving both the industry but more specifically buyers for retailers.  The benchmark is based on Midwest Large but also includes other sizes and regions and is intended to establish the basis of price negotiations between retail chains and producers.  Admittedly, a CME quotation, based on Midwest large, would be a more equitable determinant of price compared to the current benchmark but that is only an aspirational consideration.

Disruption in the supply chain during 2022 was evidenced by fluctuation in and a progressive reduction of the weekly stock levels as reported by the USDA-Economic Research Service.  Shell egg inventory at the beginning of January 2022 attained 2.04 million cases.  In January 2023, inventory had fallen 23.2 percent to 1.56 million cases.  This was mainly due to depopulation of flocks, reducing supply.  Concurrently, demand increased associated with inflation in the price of alternative proteins with eggs representing an outstanding value proposition for consumers.

Retailers have traditionally used the benchmark price to negotiate wholesale prices and developed strategies to play the market by anticipating future declines or rises in the benchmark price. Fluctuation in stock levels in a rising market created uncertainty among buyers with a reluctance to lock in large purchases and to maintain adequate inventory in distribution centers and stores.  In many cases, retail chains with ineffective logistics were unable to stock shelves, creating a higher demand for shell eggs that in turn fueled retail price increases.

The Farm Action letter to the FTC claims price gouging by the largest producer in the U. S.  It is a matter of record that profits generated by Cal-Maine Foods, Inc. during Fiscal 2022 attained a profit margin of 7.5 percent calculated as the net income expressed as a percentage of revenue.  For the six Fiscal Years 2017 through 2022, the company recorded a profit margin of 1.9 percent due to low prevailing prices and high production costs in many years preceding the outbreak of HPAI.  By selecting Fiscal 2022 as the measure of profitability, Farm Action effectively “cherry picked” a single year to establish a high profit margin for the Company.  For the 17-year sequence commencing in Fiscal 2006, Cal-Maine Foods, Inc. generated a profit margin of 5.1 percent which certainly does not indicate manipulation of the egg market to their advantage.

If there has been any unethical inflation of margins the FTC should look to the major retail chains. During the past week Large eggs were priced at $3.99 retail as determined by the USDA. This compares to the Midwest wholesale price of $2.65 per dozen as delivered to warehouses. The difference represents a retail margin of $1.34 per dozen or 50.5 percent above the wholesale price. Although the benchmark price has declined by at least 40 percent over seven weeks consumers have yet to benefit from the reduction borne by producers.

The claims by Farm Action that a vast conspiracy was engineered to raise the price of eggs is without any substantiation. The extreme rise in price can be attributed to imbalance between supply and demand occasioned by depletion of a noteworthy proportion of the producing flock.  This contention is supported by the recent decline in the price of eggs as demand has fallen and supply has stabilized.  It is a matter of record that the average combined regional large benchmark egg price during the last week of December attained $5.40 per dozen.  By the first week in February 2023, price had fallen 40.7 percent to $3.20 per dozen. The decline in price over seven consecutive weeks was accentuated by the precipitous downward movement in the benchmark price.  It is self-evident that if egg producers were colluding, steps would have been taken to avoid the precipitous drop in price.

Despite the unsubstantiated accusations of Farm Action, the price of eggs over the period January 2022 to through February 2023 was the result of a disequilibrium in supply and demand with the amplitude of price fluctuations accentuated by the benchmark pricing system.  If Farm Action claims collusion, then they are obliged to present evidence.  Most certainly their letter to the FTC was more for the consumption of the membership of their organization than to convince Federal regulators. The U.S. egg industry should welcome a review of egg prices.  If conducted in a responsible manner by competent agricultural economists, the fallacies in the assertions made by Farm Action will become evident.

The FDA has experienced a series of food-related crises, adverse press reports, the resignation of Frank Yiannas and Congressional pressure. Following an external review the FDA Commissioner, Robert Califf, has provided what he characterizes as a “rough draft of a plan” to reorganize food-related responsibilities of the Food and Drug Administration.  His intent is to restore the position of Deputy Commissioner of Foods, injudiciously eliminated by the previous short-term Commissioner, Dr. Scott Gottlieb, appointed by the previous Administration.

The proposed changes are intended to consolidate oversight of food within the FDA and restore some of the organizational improvements introduced by a previous Commissioner, Dr. Margaret Hamburg during her tenure from 2009 to 2015.

Under the Califf proposal, a Deputy Commissioner for Human Foods would report to the Commissioner and would administer the Human Foods Program.  The FDA announcement indicated that there would be a nationwide search to recruit this incumbent.  Considerable time and money could be saved if Frank Yiannas previously the FDA Deputy Commissioner for Food, Policy and Response could be persuaded to take the position, given his experience in industry and his knowledge of the Agency.  In his more than gracious January 25^th letter of resignation he cataloged achievements in improving aspects of regulation of the food supply. He urged consolidation of various entities within the FDA with the need to empower the Deputy Commissioner for Foods with line authority commensurate with the responsibility to protect the Nation’s food supply.

Dr. Califf may be an excellent research scientist and hospital administrator but he appears reticent to apply sound principles of organization.  His “draft plan” is, at best, fuzzy and deviates from Congressional intent and knowledgeable advice. The rough draft does not have clear lines of authority and responsibility.  Califf is rearranging the deck chairs of the Titanic and avoiding radical change to organization and culture.  Unless he establishes a clearly defined, integrated and comprehensive human foods program encompassing research and regulation, the FDA will continue to respond reactively to crises.

The plan calls for a Center for Excellence in Nutrition to serve as an informational entity advising consumers on food choices.  An Office of Critical Foods mandated by the 2023 Consolidated Appropriations Act will function within this Center.  The Office of Integrated Food Safety Systems Partnerships will attempt to coordinate response activities with state and local regulatory agencies.  The FDA will establish a Human Foods Advisory Committee to consider emerging issues and innovation.

Following the recommendations of the Reagan-Udall report, FDA will introduce advanced information technology and analytical modalities.  The Office of Regulatory Affairs will support the human foods program and will concentrate on inspections, laboratory assays, investigations and imports.

In the short term Dr. Califf intends for the Centers for Food Safety and Applied Nutrition, the Office of Regulatory Affairs and the Office of Food Policy and Response to report directly to him.  This extends his management span beyond what would be regarded as optimal and will be a recipe for infighting and incoordination.

At the end of the day, the most logical reorganization would be to separate food from the existing FDA with the Agency then concentrating on drugs and medical devices.  A new Food Safety Agency would, however, only operate efficiently if it incorporated the current responsibilities of the Food, Safety and Inspection Service of the USDA.  Radical interdepartmental reorganization would allow a dedicated team of scientists, administrators and regulators to concentrate on all aspects of food, both domestic and imported.  The proposed Food Safety Agency would operate in the same way as the EPA and would require Congressional involvement through enabling legislation and funding.  The current situation with two major departments and many agencies having some involvement in food policy and regulation is inefficient.  A pizza may fall under the jurisdiction of the FDA but if it has a meat topping, the FSIS is involved.  We cannot afford a pizza mentality where disparate agencies fight for turf, funding, head counts and status.

In the short term, Dr. Califf should implement what has been advised, consolidate and facilitate an eventual transition to a Federal Food Safety Agency. As a signal that the FDA will not tolerate dereliction of duty and incompetence he should consider firing those individuals who sat on the Abbott whistle blower’s report for months and did nothing to avert the infant formula crisis.  Those who received the report by registered mail apparently kept it from Frank Yiannas who would have reacted more forcefully but the structure imposed on the FDA and those who subscribed to a culture of indifference contrived to sequester him in a bubble.

We hope for changes but it unfortunately takes a catastrophic event such as the 9/11 attacks to result in a Department of Homeland Security consolidating disparate agencies that collectively failed to develop a proactive approach to national security. Until the changes suggested by the Reagan-Udall Commission are implemented and functional our food supply is at risk. Congress should revisit the concept of a Food Safety Agency since Dr. Califf is applying a band aid to a lesion that requires radical surgery.

The fault lines dividing protagonists of vaccination against highly pathogenic avian influenza (HPAI) and those against this modality were evident at the UEP Committee briefing on January 24^th and in hallways and show booths during the IPPE. The overwhelming sentiment within the egg production and turkey segments of the U. S. poultry industry is in favor of some application of vaccination as a supplement to existing control measures.  The broiler industry is opposed to vaccination based on the perceived impact on trade, since close to sixteen percent of RTC voume produced in 2013 will be exported.

The epornitic of 2022/3 is not a repetition of 2015.  The realities are:-

• The H5N1 strain with Eurasian genes is now a panornitic strain present in the E.U., Asia, and the Americas with Brazil, thus far, the only major poultry producing nation unaffected. Both Australia and New Zealand are at this time, free of infection due to remoteness from migratory flyways.
•  Highly Pathogenic Avian Influenza strain H5N1 is considered by many poultry health professionals to be de facto endemic in the U. S.  This opinion is based on the infection having been diagnosed on commercial farms in more than 35 states, has required the depopulation of 56 million birds to date, is affecting both commercial and backyard flocks and has continued for twelve months. This scorecard is inconsistent with an exotic infection.  Currently, many species of both migratory waterfowl and domestic birds show clinical signs and high mortality unlike previous H5 and H7 strains affecting only domestic poultry. 
• The infection is regularly isolated from free-living mammals, including foxes, skunks, mink, bears, seals and a walrus.  The limited surveillance of wildlife has provided inadequate confirmation of the extent of infection and the range of species involved.
• There is adequate anecdotal evidence to suggest that the disease can be transmitted over relatively short distances by the aerogenous route, thereby reducing the ability of commercial poultry producers to prevent infection through conventional biosecurity procedures.

It is an axiom that Highly Pathogenic Avian Influenza is the Newcastle disease of the 2020s.  During the 1960s and 1970s, velogenic viscerotropic Newcastle disease (vvND) was a catastrophic infection limiting production in intensive poultry industries in the E.U., Asia and Africa.  This commentator observed the futile attempts of the Department of Agriculture to stamp-out what was evidently an endemic disease in the Republic of South Africa.  When the Government ran out of money, resources and patience, and allowed vaccination, the industry responded by effectively suppressing the infection and restoring both production and profitability.

From comments provided by Julian Madeley, CEO of International Egg Commission, it is obvious that E.U. nations have recognized that HPAI H5N1 is endemic and are moving forward with adoption of vaccination as a component of their control programs.  Stamping-out has proven to be ineffective, especially with free-range flocks as in France.  Cynically it can be stated that this nation has successfully eradicated HPAI but on a successive annual basis over a number of years.

Dr. David Swayne recently organized an international conference on the application of HPAI vaccine. He emphasized the advantages of vaccination as an additional “layer of protection”.  Establishing immunized populations in specific areas reduces the outbreak threshold for a given disease and reduces the financial impact when combined with traditional measures including depletion of affected flocks, quarantine and surveillance activities. Research conducted both at major universities and institutes worldwide and by the bio-pharmaceutics industry have provided a portfolio of vaccines that can be applied to specific types and ages of commercial poultry.

Dr. John Clifford, Veterinary Trade Policy Advisor to the USAPEEC and formerly Chief Veterinary Officer for the USDA, noted the difficulties associated with preventing infection applying current biosecurity practices.  He highlighted the administrative restraints to vaccination that are based on the false premise that HPAI H5N1 is exotic and therefore can be eradicated. It is obvious that USDA-APHIS is using a playbook based on the1984 Pennsylvania epornitic that was self-limiting.  In the absence of epidemiologic investigations that have been urged by state poultry associations and promoted by EGG-NEWS, APHIS continues to expend funds provided by their presumably bottomless piggybank, the Commodity Credit Corporation.

The contention expressed by a Senior Staff Veterinarian In The Poultry Health Strategy and Policy component of USDA-APHIS  that the cost of a surveillance program would be as expensive as the cost of depopulation is fallacious and intended to support business-as-usual. Not only have the private and the public sector experienced losses as a result of HPAI, consumers have had to pay considerably more for eggs and turkey meat. If as is inevitable, infection moves into the broiler segment, HPAI will represent an even greater liability to the economy.

The concerns expressed by the broiler industry regarding trade have current validity.   It would be possible, as Dr. Clifford noted, for changes to be effected in current U.S. policy to allow for limited and controlled vaccination.  Nations importing leg quarters from the U. S. have in large measure endemic HPAI in their own industries or subsistence flocks.  There is no specific ban on trade if a nation vaccinates according to World Organization for Animal Health regulations, providing that surveillance is maintained.  It would be possible for states to certify that a specific complexe or flocks are free of HPAI by applying PCR prior to export of a consignment.  The obstacles to introducing vaccination as an adjunct to limited depopulation are more institutional than scientific.  Administrators of the USDA-APHIS have pursued a policy of  “stamping out” a supposedly exotic disease without accepting the reality that HPAI is a panornitic infection and is de facto endemic in the U.S. After 50 million plus birds depopulated  over a year without achieving eradication, it is difficult for any government agency to admit that they were wrong and accept a change in the approach to control.

Once the attitudinal block is resolved, programs to introduce vaccination on the basis of priorities can proceed.  Breeder flocks and long-lived birds including egg-producing hens should be vaccinated.  Flocks raised in areas of high population density especially with a history of HPAI could then be considered for protection.  Some areas of the nation would remain susceptible based on a low probability of exposure.   At the end of the day, scientific fact and sound principles of epidemiology should prevail.  Effective vaccination will clearly reduce transmission between farms located in close proximity and will reduce replication of the virus both of which are, in fact, the justification for depopulation.

An unspoken component of the current debate over control of HPAI relates to the emergence of a strain of pandemic significance to human populations.  The fact that H5N1 appears to have adapted to mammals should serve as a warning.  Given enough susceptible birds or free-living mammals or for that matter, farmed mink in close association, over time, it is highly likely that a mutation may occur that not only results in infection of human contacts but may evolve to allow human-to-human transmission.  The quicker that HPAI can be suppressed, but not necessarily eradicated in the short term, the greater will be the benefits to the poultry industries of the world and humanity. Vaccination against HPAI must be adopted as a valid consideration in control programs otherwise we will stumble on destroying flocks at great expense with consequential losses to producers and consumers.

The ProEgg cooperative established less than two months ago represents a new model for the industry.  This entity is constituted under the Capper-Volstead Cooperative Marketing Association Act. Enacted in 1922 this legislation allows bona fide farmers to form an association for their mutual benefit to market their products.  The Capper-Volstead Act provides limited antitrust protection and is regarded as the “Magna Carta” for agricultural cooperatives.

According to Ric Herrera, CEO of the ProEgg cooperative, the enterprise came into being in response to supply chain disruption associated with state hen housing legislation and more recently, the extensive HPAI epidemic. Combining expertise and resources, while creating a stable, consistent volume through the “pooling” of eggs from cooperative members.

The initial eight members of the Cooperative include Cal-Maine Foods, Central Valley Eggs, Colorado Eggs, Hickman’s Egg Ranch, Oakdell Egg Farm, Opal Foods LLC, Ritewood Egg Farm and Willamette Egg Farms.

The Cooperative should represent a win-win for all participants, through rationalization of the supply chain and obvious contribution to sustainability. Customers will benefit from more extensive availability associated with a potential large supply flock with centralized marketing and distribution.  Producers will be able to have consignments consolidated, reducing transport and delivery costs. 

It is anticipated that additional producers will join the Cooperative and will attain the same benefits as the founding members of the Cooperative.

According to the Capper-Volstead Cooperative Act, there are restraints on the mode of operation.  A Cooperative must function for the benefit of producer members with no outside entities involved.  The Act specifically prohibits predatory pricing practices, pricing discrimination, attempts to raise prices by restricting output or collusion among members to the detriment of trade.  The Act was passed in 1922 as an exemption from existing antitrust legislation but was, vetoed by President Wilson.  The House overrode the veto in 1921 and the Senate in the following year.

It is evident that the management of ProEgg will have to tread a very narrow path since customer groups will complain to the Department of Justice as a result of any practice that deviates from the Act and established case law.  The Secretary of Agriculture has the right to intervene in the event of any questionable or overt practice that is either explicitly disallowed or is considered inappropriate.

Given the experience of the CEO and the composition of the membership, illegal practices are considered unlikely but the retail chains comprising the customers will be monitoring the operation of the Cooperative.

It would be beneficial for ProEgg to promote the Cooperative in social media and to generate a positive image among consumers.  It is understood that the Cooperative will emphasize benefits and will demonstrate the advantages of a rational and efficient supply chain.

The power and marketing leverage represented by the prevailing industry benchmark cost system will be minimized, given the spread of ProEgg across eleven western states, the population of consumers served and the availability of eggs from the flocks operated by membership. If the ProEgg model gives rise to similar cooperatives that are in turn successful in the Northeast and even the Midwest, it may be possible to develop a CME Midwest Large quotation that could serve as a more effective benchmark, avoiding the extreme fluctuations that are evident following any disruption in the supply chain.

EGG-NEWS welcomes the emergence of ProEgg as an innovative advance in rationalization of marketing eggs under the umbrella of the Capper-Volstead Cooperative Marketing Association Act.

Both international public health authorities and economists are closely observing the response to the abrupt change in official policy regarding control of COVID in China.  Official statistics, always questionable, now admit to over 100,000 fatalities since late December.  Social media in China characterize the escalating incidence rate as a haixiao or tsunami.  International epidemiologists suggest that as many as 40 million new cases are occurring daily. In high-density mega-cities, such as Beijing and Shanghai, as many as 70 percent of the population may already have been exposed.

The Government of China describes the abrupt change in policy from zero COVID to laissez faire (or “let it rip”) as “optimization of prevention and control measures”.  It is evident that China wasted three years in an attempt at containment requiring shutdowns. The Government failed to prepare for eventual restoration to pre-COVID social and economic activity by immunizing the population and preparing for an upsurge in hospitalization and ICU admissions.

Airfinity, a research company based in London, forecast fatalities at 10,000 per day, peaking at 25,000 after the Lunar New Year on January 22^nd.  The Economist predicted that as many as 1.5 million may die from COVID in coming months.  The real effect of allowing free movement among a population that is inadequately immunized will only become apparent after return of urban residents to their traditional homes in far-flung provinces following the annual three-week migration.

The burden of COVID will fall disproportionately on the elderly who, unlike their counterparts in Europe and North America, have resisted vaccination even using the imperfect, inactivated domestic vaccines. These are based on obsolete technology and include antigen from the Wuhan 2019 strain. The vaccines manufactured in China require three doses and offer limited immunity against current sub-variants of Omicron strain of SARS-CoV-2 in circulation.  Irrespective of Government statistics that are manipulated, the incidence rate of COVID may be judged from demands for cremation that far exceed capacity and a concurrent black market for Paxlovid.

The justification for the Government decision to lift all COVID precautions without an appropriate transition period, is questioned.  In the first instance President Xi Jinpeng considered it necessary to keep the lid on the pot until he was confirmed for a third term at the 20th National Congress (Ershi Da) during October 2022. Unprecedented street demonstrations coupled with an obvious decline in exports and plummeting GDP were important factors leading to the decision. 

Despite abandoning restrictions, daily activities and hence, the economy have not returned to pre-COVID activity.  The surge in cases has sharply restricted the availability of workers in some provinces with Guangdong, Shandong, and Jiansgu impacted by absenteeism that ranges from 25 to 50 percent of workers at present.  Despite accumulated savings during the 3-year shutdown, consumers are reticent to venture into shopping areas and restaurants, although the young have returned to bars and night-life and entertainment.

It is understood that Foxcon, a major assembler of electronics and source of export volume, warned the Government that lockdowns were seriously impacting the credibility of China as a reliable supplier.  This is evidenced by importers and companies in North America and Europe shifting production from China to plants in Viet Nam and India especially since the onset of COVID. 

During the past five years and with intensification during COVID, President Xi has waged war on the private sector.  Charges of corruption and fraud whether justified or not have been levied against property developers and entrepreneurs representing the new billionaires in a nation only recently freed from the shackles of doctrinaire communism and the inflexibility of Chairman Mao.  Lingling Wei, correspondent for the Washington Post, based in Beijing, recently described the apparent changes in policy with regard to the private sector. Speaking with Fareed Zakaria on the CNN program GPS on Sunday, January 15^th, she stated that the Government now recognizes that growth in the economy will only be achieved through the private sector.  The traditional playbook of government spending on infrastructure projects to boost the economy will probably not be effective in restoring GDP and entrepreneurs including Jack Ma are now undergoing rehabilitation.

There will be little if any increase in demand by China for U. S. agricultural products over the remainder of the current marketing year ending in September. Corn exports, predominantly to China, are down by half over the corresponding period in the 2021-2022 year.  Soybean exports are proceeding at a more favorable rate, down six percent for market year 2022-2023.  Recent weekly orders for commodities by China have been, at best, lackluster.  Exports of broiler products to China our best customer by value will, in all probability, continue at existing levels.  For the first eleven months of 2022, exports of all broiler products to China amounted to 583,425 metric tons valued at $1,024 million, 33 percent higher than in 2021.  Of the volume shipped during the first ten months of 2022, feet accounted for 79 percent of volume with only 16 percent represented by legs and leg quarters, the principal export commodity by the U.S. broiler industry. 

In the intermediate term, China will achieve a measure of control over COVID with factory production restored and supply chains strengthened.  It is possible that during late 2023, congestion may reoccur in U. S. West Coast ports, although Gulf and East Coast ports have been expanded and equipped to accommodate imports from China and other Asian nations.

 From a public health perspective, infection of a large, susceptible population with current strains of COVID has the potential to produce new variants that may demonstrate either higher infectivity, pathogenicity or both.  This has implications for the entire world population. Attempting to confine variants to China by imposing travel restrictions is essentially shutting the stable door after the horse has bolted.  We can only hope that WHO has sufficient leverage with more receptive elements within the public health system of China to release reliable statistics and above all the molecular characterization of variants.  In the interim, genetic sequencing of isolates derived from aircraft wastewater can provide some indication of variants circulating in Asia and other continents. 

We can but hope that China can control COVID, applying effective mRNA vaccines that can be modified in the short term in response to emerging variants.  Increasing purchasing power among consumers will maintain demand for broiler feet, soybeans and corn, although the U. S. will compete with Brazil and Argentina for many commodities.

A report analyzing the structure and effectiveness of the Food and Drug Administration requested by Commissioner by Dr. Robert Califf in July was released in November. The FDA is responsible for oversight of the U. S. food industry with sales of $1.5 trillion and is also charged with ensuring the wholesomeness of imported foods. 

Under extreme pressure from media and Congress Dr. Califf had no option other than to go outside his Agency to obtain an impartial and objective evaluation of operations relating to the food-related activities of the FDA. Questions concerning the effectiveness of the Agency have received recent attention and especially a publication by Helena Bottemiller Evich, an experienced investigative journalist. Public and institutional concern has followed revelations of inactivity over heavy metal contamination of juices, Cronobacter in infant formula and ongoing foodborne disease outbreaks.

The expert panel that reviewed the FDA was headed by Dr. Jane Henney, a former Commissioner of Food and Drugs and included five research specialists and past regulators.  The panel reviewed the structure and leadership of the FDA, available resources and the authority vested in the Agency. Dr. Henney characterized the report as “providing constructive recommendations that will take time to work through and implement but will benefit the health and safety of the American public”.

The panel through interviews and evaluation of organizational charts demonstrated that food is a stepchild of the FDA compared to drugs and medical devices.  The report noted that the Human Foods Program has “contributed to a culture of indecisiveness and inaction and created disincentives for collaboration”.  In 2019, the FDA organizational structure was modified resulting in the elimination of the position of the Deputy Commissioner for Foods and Veterinary Medicine. The respective heads of the Center for Food Safety and Applied Science, the Office of Food Policy and Response and the Office of Regulatory Affairs all were reassigned to report directly to the Commissioner of the FDA in addition to other functions relating to drugs.  This diluted the effectiveness of the Human Foods Program.  In the absence of a clear chain of command, functions within the FDA operated without consultation, resulting in duplication and omissions.  The report specifically cited the infant formula crisis that emerged in 2021 as an example of structural and organizational deficiency.  The report recommended the restoration of a Deputy Commissioner for food-related matters, reporting directly to the Commissioner and coordinating relevant working groups.

Neglect of food-related responsibilities is evidence by the 240 vacancies in the Human Foods Program and the fact that the Center for Food Safety and Applied Nutrition currently has the same number of full-time employees as were employed in 1978.  Deficiencies in the organizational structure were obviously exacerbated by interpersonal factors as detailed in a 2022 investigative report on the FDA and its activities with respect to food.

The Reagan-Udall Foundation report recommended that funding should be increased to hire suitably qualified, trained and able scientists and administrators who command salaries in industry and academia beyond the scale offered by the FDA. The report also recommended that the FDA has been reticent to exercise its recall authority, leading to delays in removing potentially harmful products from supply chains.

Response to the report has been generally favorable, especially with regard to Commissioner Califf who initiated the process.  Brian Ronholm, Director for Food Policy at Consumer Reports, noted, “We cannot afford to tolerate the status quo and let this moment go by without adopting fundamental changes to improve the ability of FDA to protect the public and ensure our food is safe.”  Outgoing House Appropriations Chair, Rosa DeLauro (D-CT) urged a positive response by Commissioner Califf noting, “FDA needs a change, and the Reagan-Udall Report is a formal acknowledgement of the issues plaguing the food program that begins to chart that path forward.”

 In response to the report, Commissioner Califf stated, “The Agency is committed to providing a public update on the new vision at the end of January 2023.”  He added, “I will closely oversee the Human Foods Program until a determination is made on how we will strengthen and modernize the Program.”  He concluded by stating, “I am fully committed to building a world-class Human Foods Program that works best for the public, our stakeholders and our employees and that will allow us to effectively deliver on our mission. 

One of the options offered in the report comprised separation of the food responsibilities from the FDA and assigning responsibility to a dedicated food safety agency as in the EU.  It is this commentator’s belief that ultimately this radical departure will occur, especially if the recommended changes in structure and additional funding do not result in a more proactive and effective outcome. Any serious crisis to emerge relating to either domestic or imported food may energize Congress and generate a groundswell for a radical but ultimately effective transition

It is hoped that real progress will follow the Reagan-Udall Foundation report and that subsequent action will rise to a level higher than moving the deck chairs on the Titanic.”

COVID is now regarded as out of control in the People’s Republic of China. Following the precipitous ending of an intended “Zero COVID” policy

imposed by the communist government of China all pretense of suppression was abandoned following the 20^th Congress and the subsequent street demonstrations.  Based on hubris and contrary to basic epidemiologic principles, the central government attempted to eliminate COVID infection by a process of mass screening with localized and, in some cases, metropolitan shut-ins and quarantines.  This approach, coupled with an obviously ineffective vaccine has resulted in a high proportion of the population being susceptible to COVID. The government of China squandered two years during which they could have deployed an mRNA vaccine, expanded hospital facilities and established an inventory of effective anti-viral drugs It is estimated from a variety of models that half of the population of China will be exposed to COVID within the first quarter of 2023 and that fatalities may exceed 1.5 million inn three months with the elderly most affected.

True to form, the Government is no longer releasing statistics, but it is estimated that during December, as many 250 million of the Chinese population of 1.4 billion were exposed with fatalities running at over 10,000 per day.  The inactivated vaccine deployed in China in a two-dose sequence provides only short-term protection against severe clinical signs.  The vaccine is based on the 2020 Wuhan strain and is relatively ineffective against the predominant circulating viruses.  These include BA.5.2, a subvariant of the BA.5 Omicron sub-variant and strain BF7 also in circulation.  Both these viruses have emerged in Japan, although the level of protection afforded by mRNA vaccines and personal protective measures should reduce the impact of these variants. 

Both strains preceded the emergence of XBB.1.5 that has been identified in 29 nations. This Omicron variant was responsible for 41 percent of new cases in the U.S. and 70 percent in the Northeast during the last week in December 2022. This strain is highly efficient at binding human ACE receptor cells and is immune evasive. This virus is contributing to the rise in cases in the U.S. requiring hospitalization, averaging 6,500 per day for the week ending January 4^th 2023. The strain is responsible for most cases in India where it emerged, and has also extended to other Asian nations, including Singapore.

The situation in China has implications for the rest of the world.  The gross mishandling of COVID with resulting exponential explosion of new cases creates a situation favoring the emergence of new variants, some of which may be more pathogenic with potentially lower protection provided by current mRNA vaccines.

It is questioned whether the approach by the communist government of China was a cynical attempt to suppress infection prior to and during the 20^th National Conference that reappointed President Xi to an unprecedented third term and possibly life tenure.  Rapid transition from Draconian restrictions to lassiz faire will cost the nation dearly in lives, expenditure on health support and a loss in productivity.  Obviously, disruption in manufacturing output will depress GNP and may create a new wave of supply chain problems for the U.S and the E.U.

If the world and specifically, the WHO, were dealing with a rational government, appropriate control measures could be implemented on a global basis.  In the absence of epidemiologic data, disregard of transparency verging on obfuscation, international health authorities are operating in uncharted territory. Responding to the inevitability of dissemination of variant strains, many nations imposed restrictions on air travel from China. The simple expedient of demanding COVID Rapid Immunoassay tests before boarding international flights is ineffective. A few individuals on a long-haul journey will result in extremely high infection rates on landing as evidenced by a 40 percent positive test result from a planeload of tourists from China landing at Milan Airport, Italy.  Post-arrival testing is more effective, but quarantine facilities will be required to accommodate those positive and their contacts.  Outright bans on travel are ameliorative but those who are desperate will find ways to evade regulations.  Experience has shown that by the time travel restrictions are imposed, variant strains have already emerged in nations that establish programs of pre-departure testing.

Although we were looking forward to an end to COVID with required masking and other restrictions, it would appear that we are not by any measure out of the woods.  Common sense and basic preventive measures will have to be maintained for the current year.  Fortunately, our mRNA vaccines can be modified over the short term to produce more effective and specific protection provided as boosters. These are only effective on the personal and community levels if administered according to public health recommendations. 

We must have trust in our public health advisors, extend support to the Centers for Disease Control and Prevention and follow advice from medical specialists based on sound science.  Above all, we should reject speculation and politically tainted and anti-science misinformation circulating on the internet if we are going to come to terms with and coexist with this disease.

The European Food Safety Agency recently updated statistics relating to outbreaks of Highly Pathogenic Avian Influenza (HPAI) in Europe.   From October 2021 through September 2022, a total of 2,520 outbreaks have occurred in poultry with close to 4,000 detections in wild birds.  To date, 50 million birds have been depopulated in an attempt to eradicate the infection.  France recorded the highest number of outbreaks involving regions where pasture management of ducks, geese and chickens is followed.  Despite mandatory housing requirements, HPAI has continued with a surge in cases reported following the fall southward migration of free-living birds.  As with the U.S., there is evidence that domestic birds of diverse families are susceptible to HPAI strain H5N1, but it is unclear whether clinically unaffected birds can serve as disseminators of the virus and there is no reliable data on the duration of shedding.  Again, in common with the U.S. and Canada in 2022, there was no period of quiescence in summer in the E.U. with sporadic outbreaks reported, consistent with spread of the virus by domestic, non-migratory birds.

The European Commission has requested the European Food Safety Agency to determine the availability and efficacy of vaccines against Highly Pathogenic Avian Influenza for poultry and to develop control strategies incorporating vaccination. The Wageningen Institute in Holland has initiated a trial to determine the level and duration of protection against clinical signs and shedding in vaccinated chickens and ducks using commercially available and experimental vaccines.  Currently, vaccines are deployed in Egypt, and presumably other North African nations, and in Mexico.

Vaccination against HPAI was the subject of an international conference convened by the International Alliance for Biological Standardization held in Paris, France on October 25th and 26th.  This meeting considered a number of technical issues relating to vaccination but concentrated on trade and regulatory aspects that are advanced by opponents of vaccination.

Given the depopulation of over 50 million commercial poultry in the U.S. since the beginning of the 2022 epornitic, confirmation of the presence of H5N1 HPAI virus in 45 states and continuing recovery from free-living birds with sporadic outbreaks in commercial poultry, the classification of HPAI in the U.S. as an “exotic” disease must be questioned. A further complication is the growing realization based on circumstantial and anecdotal reports that HPAI may be transmitted over short to intermediate distances by the aerogenous route as has been demonstrated with Newcastle disease. This mode of infection would under practical conditions negate currently applied structural and operational biosecurity, suggesting alternatives, including vaccination to protect poultry.

It is impossible to eradicate a highly infectious endemic disease over the short or even intermediate term and accordingly, the USDA is faced with the options of either running out of money and resources or ultimately birds to depopulate.  The situation in Weld County, Colorado,  with five outbreaks among four large egg-production complexes in six months is a case in point. Essentially the USDA-APHIS is approaching the current epornitic with the same mindset as the 1994 outbreaks in Pennsylvania and is following a whack-a-mole strategy reliant on Commodity Credit Corporation funding.

The time has come to seriously consider strategic application of vaccination as a component of control. If we regard avian influenza as the “Newcastle disease of the 2020s” the approach to control and prevention is self-evident. We have universal vaccination against this previously catastrophic infection, trade continues and the disease is not a restraint to production except in some Scandinavian nations where vaccination is disallowed.

Adoption of vaccination to develop immune populations eligible for trade is feasible based on improved diagnostic capability to certify flocks as free of infection. Advances in vaccination technology will hopefully provide protection through automated or mass administration, raising regional or national flock immunity above the outbreak threshold. If vaccination is to be adopted as a co-strategy with existing control measures it will be necessary to modify outdated restrictions that ignore the realities of extensive worldwide endemic HPAI infection.

It is evident that opposition to vaccination incorporates irrelevant or spurious claims that are dated in the context of scientific advances and the reality of the ongoing World pandemic of H5N1 Avian Influenza. We need more field and molecular epidemiologic data on the mode of transmission of HPAI together with evidence that specific vaccines and their deployment will be effective in suppressing mortality and shedding. Above all we will require unanimity among segments of the U.S. poultry industry that effective vaccines will be commercially beneficial.