Shane Commentary


Moderna to Receive Grant from BARDA for Human AI Vaccine

07/08/2024

The Biomedical Advanced Research and Development Authority (BARDA) has awarded Moderna $176 million to develop a pandemic influenza vaccine for humans.  The Agency focuses on preparation for potential pandemics and is responding to general concern by virologists and epidemiologists over the wide range of marine and terrestrial mammals susceptible to H5N1 clade 2.3.4.4b.  The perceived need for a vaccine has been stimulated by the emergence of bovine influenza-H5N1 that has been confirmed in more than 140 herds in twelve states in the U.S.

 

Moderna developed mRNA vaccine technology used to produce a successful vaccine against SARS-CoV-19 (COVID).  An mRNA vaccine against H5 and H7 influenza strains previously developed by Moderna is currently undergoing evaluation in human volunteers. Results of the Moderna mRNA-1018 evaluation to provide protection against both H5 and H7 subtypes will be available by the end of the current year

 

It is fortunate that mRNA vaccines are prepared without the use of time-consuming egg propagation and can be modified quickly to respond to changes in field viruses to optimize protection. Stephanie Bacel CEO of Moderna stated, “mRNA vaccine technology offers advantages in efficiency, speed of development and production, scalability and reliability in addressing infectious disease outbreaks as demonstrated during the COVID-19 pandemic.”

 

To date only four cases of mild H5N1 avian influenza have been confirmed among a large number of susceptible dairy herd workers, despite close contact with cows and raw milk. Notwithstanding the low risk of an emerging U.S. epidemic public health agencies consider it prudent to make provision for the emergence a zoonotic strain that may become capable of human-to-human transmission.

 

In related action, cell-derived vaccine manufactured by CSL Seqirus will be dispensed into ready-to-administer doses to protect farm workers, veterinarians, health-care providers and first responders.  Approximately 4.8 million doses will be available with the E.U. purchasing a large quantity.  Finland has announced that it will embark on a program of preventive vaccination of at-risk personnel although as yet, bovine influenza-H5N1 has not emerged in Europe.  Finland has a special concern over workers on fur farms since mink and foxes are susceptible to H5N1 infection with a number of farms having been depopulated as a result of exposure during 2023.

 

U.S. public health authorities and the WHO confirm that the risk of a zoonotic and pandemic strain of H5N1 emerging is low but the consequences could be catastrophic and accordingly appropriate preemptive action has been initiated both in the E.U. and the U.S.


 

Ephemeral Streams Contribute Potential Pollution to River Water

07/03/2024

During 2003 a U.S. Supreme Court (SCOTUS) ruling on Sackett v Environmental Protection Agency determined that ephemeral streams are not protected under the Clean Water Act leading to a revision of the WOTUS Rule.  By definition, ephemeral streams contain water only following rainfall and may be dry for extended periods.  Following this decision, a June 2024 reversal of the Chevron Defense in Loper Bright Enterprises v Raimondo has deprived scientists, economists and specialists within federal agencies of the right to interpret ambiguous legislation following a “reasonable and rational” consideration of issues.  Chief Justice John Roberts in the majority opinion noted “The implicit delegation of authority to Agencies was ‘misguided’ because Agencies have no special competence in resolving statutory ambiguities”. Accordingly, jurors will now become hydrologists in addition to their acquired expertise as gynecologists, pharmacologists and epidemiologists.

 

The Sackett decision is now clearly unfounded based on recent research conducted at the University of Massachusetts, Amherst.  Dr. Craig Brinkerhoff and colleagues mentored by Dr. Colin Gleason, Professor of Civil And Environmental Engineering clearly demonstrated the contribution of ephemeral streams to water flow in rivers.  These bodies of water may contribute as much as 55 percent of water that reaches the mouth of river systems across the U.S east of the Rockies.  In some areas, ephemeral streams in mountainous areas of Nevada and California may contribute 90 percent or more of water reaching the termination of western river systems.

 

Research leading to the recognition of the importance of ephemeral streams included application of hydrologic models based on field data.  This approach was used to determine the proportion of the river flow derived from ephemeral streams.

 

Dr. Brinkerhoff concluded that the study provided evidence that the contribution of ephemeral streams is significant to major waterways.  Accordingly, pollution in ephemeral streams that are now excluded from EPA jurisdiction will become greater sources of pollution unless appropriate state and local control is applied.  The implications of the research conducted at the University of Massachusetts is exemplified by Dr. Brinkerhoff in “all things are connected; we cannot regulate water bodies ad hoc”.


 

U.S. Farmers’ Associations Recognize Vulnerability of Exports to China

06/18/2024

U.S. farmers’ associations have asked policymakers not to involve food in a trade war with China.  This is a forlorn hope. Stan Born, Chair of Trade Policy and International Affairs Advocacy for the American Soybean Association, noted, “I have gone to Washington, D.C. and I talked to senators and representatives. I always emphasize the business of our food.  This is one area that we should keep separate and keep it clean and not use it as a hammer.”  His comments reflect growing concern over volumes of agricultural exports to China, a significant buyer of corn and soybeans.

 

The American Soybean Association cannot hope to continue exporting to China against existing punitive tariffs and the threats of escalation with a different Administration.  Even with a level playing field, Brazil can produce and ship to China cheaper than the U.S.  Corn, soybean and sorghum farmers should recognize the realities of extreme competition and trade barriers and plan accordingly.  For consecutive calendar years 2017 through 2019, the U.S. supplied 34 percent of soybean requirements for China amounting to 95.5 million metric tons.  This was followed by a decline to 17 percent of 88.5 million metric tons in 2018 and 16 percent of 88 million metric tons in 2019.  Subsequent to establishing the Phase 1 Trade Agreement, it was anticipated that China would import 95.0 million metric tons during the 2020/ 2021 market year but in reality only 16 million tons was shipped through August 2021.  For the current market year to date, cumulative exports of 40 million metric tons of soybeans to all recipients with China as the major importer, are 17 percent lower compared to the equivalent week of the previous market year.  In contrast, corn exports have attained 40 million metric tons, 24 percent higher compared to the equivalent week of the 2022-2023 market year.

Even if all things were equal and there were no punitive tariffs or commercial conflict, China would favor Brazil and other South American nations for supplies of corn and soybeans.  The situation becomes even more difficult with an ongoing trade war and extreme competition and attempts at political and military one-upmanship.

 

This situation is completely beyond the influence of commodity producers’ associations, and this reality should be taken into account with respect to planting for the 2025 season.

 

Should exports fall further from current production levels, there will be a reduction in the price of soybeans even with diversion to biodiesel.  Ultimately, this will benefit all segments of livestock production.  A similar situation pertains to corn, the price of which is artificially supported by production of ethanol that represents a tax on all who eat and drive.


 

Contentious Additive Bill Passed by California Assembly

06/03/2024

The California Assembly has passed AB2316 by a 59 to 0 vote with 21 abstentions.  The bill will ban six commonly used coloring agents and titanium dioxide additives in meals destined for school lunch programs supported by the state.  The bill was supported by Consumer Reports and the Environmental Working Group.  The sponsor, Assemblyman Jesse Gabriel (D-Encina) has opposed dye additives and was responsible for the California Food Safety Act enacted last year banning four additives for food manufactured, delivered and sold in California.  This action stimulated initiatives in Illinois and New York that intend to ban red dye #3 and potassium bromate.

 

There is considerable opposition to AB2316, principally from the California Brands Association that, stated “The measure usurps the comprehensive food safety and approval system and will limit the availability of foods.” Opponents of AB2316 correctly point to the established system applied by the federal government to register or ban additives including coloring agents.  Federal and state systems review additives and make decisions based on scientific data.

 

With respect to the sponsor of AB2316, Assemblyman Gabriel states, “As a lawmaker, a parent and someone who struggled with ADHD, I find it unacceptable that we allow schools to serve foods with additives that are linked to cancer, hyperactivity and neurobehavioral harms.”  It is an unfortunate state of affairs that elected legislators have suddenly become experts on food safety and toxicology, in the same way that members of House, Senate and the judiciary are now gynecologists.  While there is need to ensure that additives do not detract from the wholesomeness of foods, imposing bans on a statewide basis without adequate scientific review creates problems for industry and consumers.

 

It is a matter of fact that the U.S. Food and Drug Administration, the European Food Safety Authority and the WHO Joint Expert Committee on Food Additives have rejected any causal association between currently used food coloring agents and any adverse neuro-behavioral effect in children. The California Assembly is embarking on a potentially harmful and unnecessary program of banning innocuous additives based on the presumptions and predilections of an assemblyman with an unfortunate disability.  We have seen this movie before relating a discredited and spurious relationship between childhood vaccination and autism.  Legislation should be based on scientific reality not on personal convictions and prejudices however well motivated.


 

Food Inflation Emerging as a Political Issue

05/27/2024

Senator Elizabeth Warren (D-MA) and Representative Jim McGovern (D-MA) addressed a letter to the President calling for a joint task force to investigate pricing of food through the entire supply chain. Measures the legislators have called for include: -

 

  • Establishing a joint task force within the Commodities Futures Trading Commission and the Federal Trade Commission to investigate possible manipulation of food prices.
  • Urging the Department of Justice and the Federal Trade Commission to block mergers and acquisitions in the food industry that may result in an increase in food prices for consumers.
  • Encouraging the Department of Justice to prosecute companies that engage in price fixing or anticompetitive activities.
  • Enforcing federal legislation prohibiting price gouging including the Robinson Patman Act.
  • Initiating prosecution of companies that engage in price manipulation.

 

Food inflation was evident during the COVID years but over the past two years there has been a steady decrease in the rate of inflation for food at home. The Bureau of Economic Analysis release on April 26th of the Personal Consumption and Expenditure Price Index showed a 12-month increase in food of 1.5 percent. The May 15th release of the April 2024 Consumer Price Index showed a 1.0 percent decrease in the category “Meat, Fish and Poultry” from March. On an annual basis all food was up 2.2 percent with food-away-from home up 4.1 percent. The April Price Index for Final Demand  (PPI) released on May 14th showed a 0.7 percent decline in the food category from March

 

Contrary to the allegations raised by Senator Warren, quarterly reports of the major food retailers do not denote high profitability with reported low gross and profit margins.

 

Food inflation is regarded as a worldwide problem.  For three years, the Government of France has pressured manufacturers and retail chains on margins in their annual negotiations.  There are calls for restraints on grocery margins in the U.K.  Australia recently concluded a Commission of Inquiry into the negative consumer effects of the oligopolistic situation in grocery retail.  Canada has introduced a Grocery Code of Conduct to which all retailers with the exception of Walmart have subscribed.

 

Weekly and monthly reports in EGG-NEWS document egg production costs and wholesale prices over a number of years. Producers have experienced marked fluctuation reflected in quarterly bottom line results. Egg producers were selling below cost over approximately eight months in 2023 given prices for feed and labor and other inputs including energy and packaging.

 

If any aspect of egg production should be reviewed, it is suggested that the widely used benchmark price discovery system requires evaluation as it amplifies upward and downward movements in price, benefitting chains to the possible detriment of consumers.

 

The contentions by Sen. Warren and Rep. McGovern are unfounded based on recent economic data although some suggestions in the letter to the President have validity.


 

USDA Support of Land-Grant HBUCs

05/21/2024

Deputy Secretary of Agriculture Xochitl Torres Small confirmed that USDA will support scientific research and extension at Historically Black 1890 Land-Grant Universities.  The announcement followed a tour of 14 institutions.

 

Funding will be used to support 68 projects that are intended to extend diversity in higher education and equip the 1890 Land-Grant Universities with additional resources.  Projects funded will include curriculum design, faculty development, student recruitment and retention and basic and applied research.

 

Funding will be made available from the National Institute of Food and Agriculture, 1890 Institution Teaching, Research and Extension Capacity Building Grants Program.

 

As with all funding programs initiated and administered by the current USDA, it is hoped that there will be accountability and that quantifiable benefits will be derived from the funds applied.  While not begrudging funding for the 1890 Land-Grant universities, it is questioned whether a higher level of diversity, training and productivity could not be achieved by funding scholarships and programs at the various large state land-grant universities?


 

House Version of Farm Bill Includes EATS Provision

05/20/2024

The inclusion of EATS Act provisions represents a significant difference between the House and Senate versions of the 2023, delayed Farm Bill. EATS was included by the House Committee on Agriculture but was not incorporated in the Senate Committee draft.  The EATS Act is essentially a provision that would limit or prevent individual states to enact legislation that would determine production methods to produce food shipped to and sold in a state.  The Act was indirectly suggested by the 2023 Supreme Court decision that upheld the constitutionality of California Proposition #12 and Massachusetts Question #3.  At issue is the ban on gestation crates for sows producing piglets that are grown and processed for pork sold in California and Massachusetts.

 

The EATS Act is essentially moot since there is adequate non-confined housing for sows in the U.S. to satisfy California and New England state requirements. Conversion from gestation crates to group housing has progressed over successive years.  Even if the EATS Act is incorporated into the eventual Farm Bill, it will have no effect on the decision of retailers and restaurant chains to source pork derived from sows held under group housing.  Inclusion of the EATS provisions in the final Farm Bill is considered to be questionable given the extensive bipartisan opposition to the practice of confining sows to gestation crates.


 

Extremist Animal Rights Advocates File Oregon Initiative 28

05/12/2024

People for the Elimination of Animal Cruelty Exemptions have filed for Initiative Petition 28 to be decided by the voters of Oregon during the 2026 general election.  The ballot initiative would remove certain exemptions from animal cruelty laws prohibiting any activity other than self-defense or veterinary practice that intentionally injures or kills animals. Adoption of Oregon IP28 would effectively invalidate all livestock operations.

 

The intent as stated would be to “be protective of the needs of animals and to codify their right to life and bodily autonomy.” IP28 would also establish a “Humane Transition Fund” to provide grants to replace lost income, compensate farmers, to subsidize job retaining and permit conservation and re-wilding of livestock.

 

This extreme and unworkable proposition representing the most radical ideology should not pass.  It will however generate awareness of the negative aspects of livestock production and raise funds for the organizers.

 

Ballot initiatives were regarded as necessary as territories became states, but they are now anachronistic and run counter to the regular legislative process with inherent checks and balances.  It is far easier to bamboozle voters with complex and deceptively worded propositions that appear at face value to be elementary but have serious unintended consequences.  Did the voters agreeing with California Propositions #2 and #12 realize they were effectively voting for a $0.50 to $1.00 per dozen increase in the price of eggs when they were coerced into empathizing with cage-housed chickens?  The so-called “Pacelle-Tax” is an unintended consequence of passage of the two California propositions. The outcome was only possible through the system of ballot initiatives that has effectively distorted the government of our Nation’s most populus state with a population of 39 million and an economy ranking as the 5th largest in the world.

 

 It is now time to eliminate legislation by voter initiative through constitutional amendments. Unfortunately there are too many vested interests benefiting financially from the status quo to expect meaningful change. A starting point would be to increase the number of valid signatures required to allow a petition to be placed on the ballot and to allow legislatures or Governors the power to deny petitions.


 

FDA Issues Guidance on GM Animals

05/07/2024

The U.S. Food and Drug Administration has issued Guidance for Industry (GFI) #187A Heritable Intentional Genomic Alterations in Animals:  Risk-Based Approach and a revised draft GFI #187B Heritable Intentional Genomic Alteration in Animals:  The Approval Process.

 

In addition, the FDA has entered into a Memorandum of Understanding with the U.S. Department of Agriculture to clarify their respective roles and responsibilities in regulation of intentional genomic alteration.

 

At the outset, the FDA jurisdiction over regulation of genetic modification should be limited to a judicial minimum.  The Agency does not have the staff or expertise to understand the realities of genetic modification, whether by insertion or deletion of genes in livestock.  There is obviously a justification for the FDA to be involved in genetic modification where the end product is a biopharmaceutical produced in eggs or milk. 

 

Genetic modification of animals intended for food is a separate issue to biopharmaceuticals and is beyond the competence of the FDA.  This is denoted by the almost two-decade process of approval of Aquabounty® salmon.  Inability of the FDA to make considered decisions regarding approval within a reasonable time has placed the U.S. at a disadvantage with respect to the E.U. and China.  The practical application of CRISPR offers advantages to breeders in developing livestock with resistance to disease, adaptability to heat and benefits yet to be determined.

 

The April 2024 Memorandum of Agreement between the FDA and the USDA is intended to establish policies and procedures to enhance the exchange of information with the objective of enabling an efficient, seamless regulatory process.

 

The FDA is encouraging developers of intentional genomic alteration to approach the Agency early in their research and development or to discuss the specific risk profile of the proposed product and the appropriate pathway for commercialization.  This is a clear admission of technological ignorance, and that the FDA intends to continue using the established playbook of delay in making a decision.

 

The FDA underperforms in the areas over which it has direct mandates including regulation of imported foods, inspection of foreign and domestic pharmaceutical plants. The FDA has a rap sheet of failures including the baby formula debacle, lead contamination of infant foods and failure to suppress bacterial foodborne infections associated with produce.

 

EGG-NEWS has long campaigned for a separate food safety agency independent of both the USDA and the FDA.  Advances in genomic alteration of livestock justify extreme changes in the structure and implementation of food safety regulation.


 

Department of Energy CO2 Sequestration Project a Failure

05/01/2024

The National Energy Technology Laboratory of the Department of Energy, has funded a $281 million demonstration project at an ADM plant in Decatur, IL. over a number of years. The program represents the collaboration between ADM, Schlumberger Inc. and the Illinois State Geological Survey. The project effectively captured only 10 to 12 percent of CO2 produced in ethanol production with the remainder vented to the atmosphere. The Department of Energy claims that 2.8 million metric tons of CO2 have been stored in contrast to the EPA value of 3.94 million metric tons.

 

Academics including Dr. William Burns, affiliated with Northwestern University, questioned the practicality of the project noting, “We have been providing these subsidies for a long time, billions and billions of taxpayer dollars and we still have very little to show for it.”

 

The ADM plant sequesters CO2 underground by injection into a sandstone formation.  According to reports, there are as many as 150 applications to drill and sequester CO2 applying modifications of injection technology that is used to release oil from low-yielding wells.

 

If the ADM Decatur plant is representative of the U.S., a considerable quantity of CO2 is vented to the atmosphere.  The subject plant produces 4.1 million metric tons of CO2 annually through fermentation of corn but captures approximately 10 percent of the quantity generated.  From 2011 through 2022, the plant emitted 53,168,273 metric tons of CO2 and on average stored 7.4 percent amounting to 3,941,344 metric tons.

 

Dr. Charles Harvey of MIT questioned the benefit of sequestering CO2 at an ethanol plant and maintains that ‘diluting’ gasoline with ethanol is more detrimental than using gasoline as a vehicle fuel.  This is based on the acreage needed to produce corn that is fermented with CO2 emissions and by combustion in vehicles.  Dr. Harvey notes, “If our interest is in using government resources to reduce CO2 emissions, that money would be much better spent not making ethanol.”  He added, “You’d really be better off just replacing those cornfields with solar panels.  You’d get a lot more reduction and you get cheaper electricity.”

 

According to Brendan Givens, Oil and Gas Watch reporter for the Environmental Integrity Project, the ADM facility in Decatur operates at a greater level of efficiency than other plants resulting in proportionately higher volumes of CO2 released than many facilities in operation.  

 

Despite the self-laudatory claims by the Renewable Fuel Association, ethanol does not contribute to energy independence and is demonstrably detrimental to the environment.  The entire ethanol industry owes its survival to government mandates and indirect supports. Despite science, logic and economics ethanol production persists at the expense of all who breathe, eat or ride only by virtue of the self-interest of corn-state legislators in Congress.


 

Disinclination to Compromise in Congress Inhibiting Passage of Legislation

04/16/2024

The 118th Congress has only passed 50 bills compared to an average of approximately 400 in a regular 2-year session.  This is due to polarization with extreme positions on both the left and right inhibiting compromise that is necessary for bipartisan progress.  Among delayed legislation is the 2013 Farm Bill that characterizes Congressional impotence.  In the Senate Agriculture Committee, Sen. Debbie Stabenow (D-MI) is advocating for liberal SNAP and WIC benefits and extension of funding for conservation using funds from the Inflation Reduction Act.  In contrast, Minority Ranking member, John Boozman (R-AR) is intent on increases in reference prices to support producers impacted by declining export prices and volumes. 

 

It is apparent that both the Senate and House are looking to the other chamber to pass a Farm Bill that may become a reality through subsequent compromise during reconciliation.  The House Agricultural Committee Chairman, Glen Thompson (R-PA), is committed to presenting a Farm Bill during the spring of this year.  As with the Senate, there is conflict regarding SNAP benefits and the overall cost of the Legislation.  Bringing a bill to the floor is also influenced by the narrow margin of the majority party with dissent evident despite a majority of only five votes.

 

The closer to the election, the more difficult it will be to enact legislation.  The 118th Congress has taken too many breaks and indulged in unproductive hearings and activities to the detriment of their responsibilities and the ultimate well-being of U.S. citizens.


 

OTA Value of the Certified Organic Seal Questioned

04/12/2024

In a self-adulatory release, the Organic Trade Association listed responses to a consumer survey on familiarity with the organic seal. Of those responding, 88 percent were either familiar or somewhat familiar with the term “organic”.  However, 86 percent were also aware of the “natural” designation, and 85 percent with “local” suggesting that the certified organic label is not necessarily unique or preeminent.  It is also noteworthy that “pesticide free”, “vegan”, “raised without antibiotics” and “grass fed” all scored at or above 80 percent in terms of familiarity.

 

The Organic Trade Association understandably claims that recognition of the Organic seal and the implied connotation justifies the differential in price from corresponding non-organic food items.  After decades of promotion and availability it is evident that twelve percent of consumers are still unfamiliar with the organic seal. This indicates the need for additional promotion of the claimed attributes of organic foods, requiring publicity and a justification of the price differential.

 

The survey also revealed that “fair trade” was relatively obscure with 58 percent of respondents either somewhat or very familiar with the term.  “Humanely raised” scored 72 percent but was  below the 76 percent for “hormone-free”.  The lowest score of 33 percent for consumer familiarity was accorded “regenerative”.

 

It is apparent that the “certified organic” designation is clearly the leader among numerous label claims, but it is questioned whether consumers really understand the structure of the National Organic Program and what it offers.  Foods accorded the certified organic seal are produced according to a set of regulations and standards that should eliminate the use of pesticides or additives that may be potentially deleterious.  The requirement that foods be either non-GMO in origin or in the case of livestock products, derived from herds or flocks fed non-GMO feed, has no scientific justification with respect to human metabolism and health. 

 

It is also noted that certification according to the National Organic Program is based on a review of documentation and is not supported by any structured program of laboratory assay to confirm freedom from GMO content, pesticides or additives. Annual FDA reports indicate low levels of detectable pesticide residues, not materially different from their organic equivalents. Pesticide assays conducted by the FDA yield levels below established non-effect values indicating the acceptability of conventional domestic fruit and produce. The USDA certified Organic Seal does not address food safety with respect to the potential presence of bacterial pathogens.

 

The Organic Trade Association clearly describes additional costs including production, processing, certification, and other fees to justify the higher cost of certified organic foods.  The question arises as to whether consumers derive a commensurate benefit given the price differential between conventional and certified Organic products.


 

Secretary Vilsack Criticized Over Use of CCC Funds by House Ag. Committee

03/25/2024

In testimony before the House Appropriations Subcommittee for Agriculture, Secretary Tom Vilsack was criticized for his allocation of funding under the Commodity Credit Corporation.  Rep. Andy Harris (R-ND), Chairman of the Subcommittee, characterized the Secretary’s use of CCC funding as a “slush fund”.  Republican members of the Committee have been critical of climate-related programs.  In addition, USDA is apparently spending money “outside the regular Farm Bill process”.

 

The CCC was established during the Great Depression to provide farmers with support in the face of falling prices for commodities. 

 

 

Extensive demands have been placed on funding by dairy, cotton, rice and peanut producers for support payments.  These allocations are a major point of dissention in negotiations to establish the much-delayed 2023 Farm Bill with Republicans pressing for higher farm payments and Democrats favoring SNAP and environmental expenditures.

 

The CCC provided funding for USDA-APHIS programs to control HPAI in previous epornitics including indemnity and reimbursement for decontamination.


 

Buzzwords or Substance?

03/22/2024

A recent posting by a representative of a major supplier of micronutrients to the feed industry recently promoted “blood biomarkers to detect potential performance and health challenges.”  The lack of substance and specifics in the article is a hallmark of flim-flammery especially when the current buzzwords  ‘artificial intelligence’ and ‘machine learning’ are invoked.  Obviously collection and interpretation of production data is critical to understanding and analyzing deviations from standard flock performance. These can be attributed to ingredient quality, climate, exposure to pathogens or deviations from acceptable management.

Blood values do not necessarily reflect the rate of metabolic processes or tissue composition.  This was the basic flaw of the concept on which Theranos was based. The Company non-technology claimed to be able to monitor dozens of parameters with a single drop of capillary blood. A dubious presumption at the outset but believed by ill-informed and avaricious venture capital and private investors

 

If the article claiming that nutritional status can be monitored by analysis of blood samples was specific with respect to individual values and supported by scientific substantiation, the premise would have been be more impressive.  Why select blood?  Because it’s easy to obtain and easy to ship to a laboratory?  For most metabolites, liver, muscle or bone tissue specimens would be more reflective of nutritional adequacy.

 

The article notes “blood biomarkers can predict when indicators of issues start to appear in a flock” as a breakthrough. We have been applying serology for decades to monitor antibody status including a determination of flock susceptibility and response to vaccination.

 

Consistently, companies generate “systems” claimed to monitor and predict performance without adequate scientific validation.  Their hallmark is a lack of specificity involving a clear relationship between the variable and outcome. By adding the superfluous "buzzword" claims for ‘artificial intelligence’ and ‘machine learning’, it is questioned whether the touted concept is not another iteration of an ongoing succession of “great new things” to promote existing or newly developed products.


 

Senators Pressing USTR and USDA to Increase Agricultural Exports

03/20/2024

On March 13th, almost all Republican members of the Senate signed a letter addressed to Katherine Tai, U.S. Trade Representative and Secretary of Agriculture Tom Vilsack expressing discontent with the decline in agricultural exports.  Specifically, the Senators requested information on specific actions the current Administration intends to implement to increase agricultural exports in 2024 and whether new or improved free-trade agreements will be entered into in the current year.

 

The Administration has urged Congress to fund market development programs that have some impact especially in new markets and for new products.  The U.S. exports mostly undifferentiated commodities as cotton, soybeans, corn, and rice.  These products are purchased by importers based on availability and landed price including ocean freight and duties. 

 

The letter from the senators takes issue with the Administration for pursuing an unambitious U.S. trade strategy that is “failing to meaningfully expand market access or reduce tariff and non-tariff barriers to trade.”  The Senators should remember that the previous Administration withdrew from the Trans-Pacific Partnership that was subsequently reconstituted to include eleven nations bordering the Pacific including Canada and Mexico and it eliminated a wide range of taxes and duties to the disadvantage of the U.S. Some bilateral trade agreements have been negotiated such as with Japan that was let down by the precipitous withdrawal by the U.S. in 2017.  The previous Administration imposed punitive duties on the People’s Republic of China that have been retained by the present Administration.

 

For consecutive years 2017 through 2019 the U.S. supplied 34 percent of soybeans requirements for China amounting to 96 million metric tons.  This was followed by decline to 17 percent of the requirements in 2018, followed by a lower proportion in 2019.  Despite negotiation of Phase I of a trade agreement, China did not follow through with imports of soybeans as negotiated. Demand by our major customer declined sharply during the current market year based on a reduction in pork production and Government restrictions on inclusion of soybean meal in diets for livestock.  Total exports of soybeans for the current year are 18.9 percent lower than for the corresponding week in the 2022-2023 market year.  In contrast, China continues to import corn with total exports for the current market year 31.5 percent higher than for the corresponding week during the previous market year.

 

 The Senators representing their agricultural constituencies fail to recognize the formidable expansion in production of soybeans and corn by Brazil and Argentine among other nations.  Russia has become a major exporter of wheat and despite lower harvest; Ukraine is still a major supplier. 

 

As we enter the second quarter of 2024, the demands for new free-trade agreements appear cynical in an expectation that the Administration is somehow required to pull reluctant rabbits out of a very large hat.  Due to no fault of the current Administration and based on the overhang of COVID on the World economy, competition at lower cost and domestic protectionism over at least two Administrations, there is an inevitability over declining exports.  Had the world entered into a depression following the COVID years, the situation would have been far worse?

 

The situation is somewhat reminiscent of Michael Dukakis campaigning for the Democratic candidacy in Iowa who opined that farmers were growing too much corn. He was asked by a farmer what he should grow other than corn at a time when the price was depressed.  The Candidate based on his elitist’s leanings suggests that “Belgian endives” were a suitable replacement, effectively scuttling support in the Midwest. Corn growers have the Renewable Fuel Standard that accounts for a third of the crop being converted to ethanol and with biodiesel absorbing 40 percent of soy oil. Both fuels benefit farmers at the expense of livestock producers and consumers and the respective industries would be non-viable without Federal mandates.

 

The Senators are asking the Administration to push a piece of string on agricultural exports. Importing nations make purchase decisions on commodities based on actual need and landed price in a competitive market. Demands to increase exports engenders favorable constituent approval and generates political points in an election year.

 

 

 


 

The Need for Surveillance of Free-living Birds for HPAI

03/18/2024

A recent news item presented the views of Dr. Kyle Van Why, a wildlife biologist with USDA-APHIS Wildlife Services.  Dr. Van Why noted that his Agency is sampling dabbling ducks including mallards, teals and wood ducks that are known to be infected with various strains of avian influenza virus and specifically, the 2022-2024 H5N1 epornitic strain.

 

Dr. Van Why correctly noted that the mild winter encouraged ducks to congregate in mid-migration until the severe storm of mid-January that resulted in southward migration.  He stated, “We just didn’t have a full push until we had that one winter storm in January and then we had a big push of birds down and then they were gone.” 

 

Perhaps by concentrating on dabbling ducks, the USDA-APHIS is missing other non-clinically affected carrier species of HPAI.  If dabbling ducks are in their winter habitat along the Gulf, why did outbreaks occur in backyard flocks in diverse states including Massachusetts, Ohio, Texas and Minnesota during the week ending March 11th in addition to a case affecting commercial turkeys in South Dakota?  Logic would suggest that domestic resident free-living birds have become infected along with carnivorous scavenging mammals that may transmit the virus for, as yet, undetermined periods.  Backyard poultry housed with minimal biosecurity have little involvement with the infection of commercial flocks but serve as sentinels.

 

It would be of value for APHIS to sample a range of wild birds in the vicinity of confirmed outbreaks of HPAI both in backyard and commercial flocks.  It would also be of value to determine the duration and quantum of viral shedding in individual species.  There is considerable literature on the recovery of avian influenza viruses from orders other than Anseriformes and susceptibility of migratory and resident domestic bird species has been demonstrated by both surveys and through widespread mortality.

 

An additional aspect of research is assessing the persistence of avian influenza virus in water and soil although this has been investigated for strains of LPAI1.  Even more important will be to determine the distance over which avian influenza virus can be spread by the aerogenous route under a range of weather conditions.  There is adequate circumstantial and anecdotal evidence to suggest that the virus can be introduced into power- ventilated layer houses. Multitier units holding 200,000 hens may have a maximum exhaust displacement of 1.2 million ft3 per minute and even 400,000 ft3 per minute as a minimum rate during cold conditions.

 

If avian influenza is carried by a wide range of free-living bird species that are resident in the vicinity of poultry farms, the previous model of seasonal dissemination by migratory waterfowl is outdated2.  To concentrate on sampling hunter-killed dabbling ducks based on ease of attainment will provide prevalence rates in the species sampled but it will not advance our knowledge of the epidemiology of avian influenza and specifically H5N1.

 

It is questioned whether the administrators at APHIS are allocating sufficient resources to their field biologists and veterinarians to obtain an understanding of the changing epidemiology of avian influenza?  Are field projects and investigations constrained by past actions or prevailing policies?  Are we going to look back on the ongoing epornitic since 2022 in successive years and ask why we lacked imagination and flexibility in our approach to field evaluation that deprived us of an understand of the role of non-Anseriform avian reservoirs and disseminators of the disease?

 

1. Stallknecht, D. E., et al., Persistence of Avian Influenza Viruses in Water, Avian Diseases, 34:406-411 (1990)

2. Stallknecht, D. E. and Shane, S.M., Host Range of Avian Influenza Virus in Free-Living Birds, Veterinary Research Communications, 12:125-141 (1988)


 

FDA Requests $7.2 Billion Budget

03/12/2024

The Food and Drug Administration has requested $7.2 billion as a component of the proposed Federal FY 2025 budget.
 

According to the Commissioner, Dr. Robert M. Califf, “This new funding request will help us build on our accomplishments (?) and also modernize our Agency and operations as we plan for the future.”  Included in the request is an additional $15 million to promote a safe and nutritious U.S. food supply.  The newly created FDA Human Foods Initiative will allow the Agency to “prevent or mitigate foodborne illness outbreaks”.  The request also supports programs to reduce diet-related chronic diseases and attain the goals of the National Strategy for Hunger, Nutrition and Health.

 

The Agency is requesting $114 million to support recruitment and support of a public health workforce.  Does this represent a duplication of the activities of the Centers for Disease Control and Prevention? 

It is noted that the Agency will request $1 million to expand foreign offices and strengthen the quality of imported products.  Given that a high proportion of our pharmaceuticals are manufactured in China or India, this appears to be an inconsequential amount given the magnitude of the tasks facing the Agency. The FDA has the obligation to certify the quality, safety and purity of imported drugs available to U.S. consumers.

 

The FDA is also requesting new authorization relating to the safety of foods including infant formula through binding limits for contaminants, testing of final products, environmental monitoring for pathogens and mandatory reporting.

 

Each year the FDA requests a larger allocation of funds citing real challenges and problems that as an Agency they are unable to address and resolve.  Under the immediate-previous and current Commissioners, the U.S. public has been subjected to a number of food-related crises with evident negligence, inactivity and incompetence demonstrated by the Agency.

 

It is time for a new, independent food safety and nutrition agency independent of the FDA.


 

USDA-ARS Announces RF Pasteurization for Shell Eggs-Again

03/03/2024

The USDA-Agricultural Research Service, Eastern Region Research Center in Pennsylvania has adapted radio frequency heating technology for in-shell pasteurization of eggs. The principle of radio frequency heating is well established with numerous commercial applications. The ARS development team has successfully created a prototype installation that is effective in eliminating Salmonella within eggs without altering organoleptic properties.  An existing commercial scale process involving immersion in hot water is effective in pasteurizing eggs but does result in changes in albumen and is not an in-line process.

 

The question arises as to why the USDA-ARS is expending time and money to produce an RF pasteurizer.  There is no evident problem of salmonellosis associated with eggs.  Since the introduction of the FDA Final Rule on Salmonella in eggs in 2010 there have been no reported outbreaks of S.Enteritidis among consumers of eggs produced and packed under FDA rules.  There however may be a case for pasteurization of shell eggs destined for specific consumers including the immunosuppressed.  Serving egg dishes prepared from pasteurized liquids would provide a safe source of nutrition although eggs from regularly tested flocks would provide an acceptable level of risk.

 

Egg-NewsThe USDA press release was overtly deceptive in that the introductory paragraph cited 1.4 million cases of salmonellosis with 26,500 hospitalizations and 420 fatalities annually in the U.S.  Eggs produced in accordance with existing regulations and industry procedures are not contributing to salmonellosis among consumers. In actuality multiple serotypes and foods including produce, fruit and undercooked poultry meat are responsible for infection.

 

The fact that less than one percent of eggs marketed in the U.S. are pasteurized using the water immersion process, suggests a low demand for in-shell pasteurization and a lack of concern among both domestic and institutional users.

 

A number of alternative in-shell pasteurization systems have been developed including immersion in hot water, infrared and microwave heating in addition to RF pasteurization.  Over twenty years ago, the Government of South Korea developed a pasteurization process that failed to elicit interest. A developer in South Africa produced a microwave in-line system that was widely promoted without achieving commercial adoption.

It is regrettable that the USDA announcement implies an ongoing problem of salmonellosis attributable to eggs and that this prototype laboratory-scale RF pasteurizer would be a solution.  It is questioned why USDA funds are expended on a project with little prospect of commercial adoption or intended to alleviate a public health problem that has little to do with eggs. A far more useful project would be to develop a positive kill-step for leafy greens responsible for STEC, Salmonella and Listeria infection.

 


 

Collaborative Influenza Research Justified

02/25/2024

In a February 15th letter to the USDA, Senator Joni Ernst (R-IA)  requested information on funding collaborative experiments on avian influenza involving the U.S., the U.K. and a laboratory in China. The letter was stimulated by a misrepresentation circulated by White Coat Waste Project, an animal activist organization opposed to research using live animals.

 

The letter refers to Project 6040-32008-081-013-A, entitled U.S.-U.K.-China Collaboration: Predictive Phylogenetics for Evolutionary and Transmission Dynamics of Newly Emerging Avian Influenza Viruses.  The project was funded for the period beginning April 1, 2021 and is due to end at the end of February 2026.  The objective is to assess the pathogenicity of evolving avian influenza viruses of the H5NX clade 2.3.4.4b and for H7N9 and H9N2 lineages.  Evolution of these strains has been linked to the potential emergence of an influenza strain with pandemic zoonotic potential.  Experiments and analysis to be conducted over the course of the study period will determine how virus strains evolve and the response of hosts (quail, duck and chicken) to infection. Studies will include Japanese quail since this species has receptors for both avian and mammalian influenza viruses.  Challenge studies involving ducks and quail in addition to in vitro laboratory cell culture systems will be used to assess pathogenicity.

 

There is no indication from the description of the cooperative agreement that any form of gain-of-function studies will be conducted.  Most of the work will be completed in the U.S. with concurrent collaboration by scientists at the Roslin Institute in Scotland. Involvement by specialists in avian influenza in China was considered appropriate since they have access to endemic influenza strains circulating in poultry in that nation.

 

It can be accepted that the results of the studies, proposed and in-progress, will enhance our knowledge of the biology of avian influenza viruses of potential human health significance including aspects of immunology and molecular biology.  Results will be directly applicable to the development of improved diagnostic procedures and the development of human and avian vaccines.  Above all, knowledge obtained will improve our understanding of how avian influenza viruses may adapt to non-avian hosts.  It is a matter of record that the H5N1 panornitic strain has infected a wide range of both terrestrial and marine mammals. Fortunately to date there has been no evidence of human infection other than a limited numbers of cases and without confirming human-to-human transmission. 

 

It is regrettable that this project and aspects of research on respiratory pathogens have become politicized. Misleading statements have been made as to the purpose of the research with outlandish and unsupportable claims for risk. It is hoped that the response by the Office of the Secretary of Agriculture will reassure Senator Ernst and will moderate prevailing Sinophobia relating to medical research that emerged with COVID.


 

Iowa Egg Company Receives FDA Warning Letter

02/21/2024

A December 15th 2023, warning letter to the Iowa Egg Company located in Osage, IA. confirmed a wide range of deficiencies in conforming to the FDA Final Rule on Salmonella. Effectively product is technically “adulterated” under section 402 (a) (4) of the Federal Food Drug and Cosmetic Act Section 21 U.S.C. 342 (a) (4) as potentially injurious to health.

 

The warning letter followed issue of a FDA Form 483 following a June 2023 inspection of the complex by the Iowa Department of Agriculture, acting on behalf of the FDA.

 

The warning letter was issued since the company did not respond within the statutory period acknowledging deficiencies and providing an action program for remediation.

Defects noted by the Iowa Department of Agriculture included:

 

  • Failure to have available a written Salmonella Enteritidis Prevention Plan as required.

 

  • Failure to document that pullets were monitored for SE prior to transfer.

 

  • Failure to maintain an acceptable program to suppress rodents and flies and evident structural defects allowing entry of rodents.

 

  • Failure to document or implement appropriate holding temperatures for eggs.

 

  • Failure to comply with required ages for drag-swab screening of flocks for environmental SE contamination.

 

  • Failure to register a farm as required.

 

The delay between the FDA Form 483 in June 2023 and the warning letter in mid-December raises questions of timing in the response to obvious public health-related issues. Given the date of the original report documenting multiple defects relating to testing and other requirements, the FDA was negligent in waiting 21 weeks before issuing a warning letter.  Had flocks on the operation been infected with SE, product would have been released to the market with the potential for human infection. Any egg-borne outbreak of SE results in degradation of the image of the egg industry indirectly affecting all compliant farms.

 

If the FDA is sincerely interested in protecting the food supply then a 21-week delay in follow-up is unacceptable.  This situation appears to be a replay of the infant formula crisis but on a much smaller scale. Failure by the FDA to inspect major production facilities and a lack of response to evident problems of contamination led to a debacle characterized by a shortage of product with economic, political and social implications. It remains to be seen whether organizational changes at the FDA will improve concern within the Agency for food-related risks.


 

Opposition to the EATS Act

02/11/2024

The Ending Agricultural Trade Suppression (EATS) Act was drafted in response to the May 11th decision by SCOTUS upholding Proposition #12. It was the intent of the promoters of the Bill to incorporate the EATS Act into the 2023 Farm Bill that has been delayed to at the earliest, mid-2024.

 

The intent of the proposed legislation would be to prevent individual states from placing restrictions on systems used to rear and process livestock intended for sale in their states.

 

The U.S. egg industry has long since complied with Proposition #12 and Massachusetts question #3. There is an adequate supply of cage-free eggs to satisfy California and other states that have enacted legislation restricting the sale of eggs from conventional cages.

 

A number of companies involved in organic and premium meat production are opposed to the EATS Act and have addressed an open letter to Congress expressing their concerns. Signatories to the letter stated, “while some companies remain silent in the name of cheaper production cost we believe it is our responsibility to amplify the concerns of our customers and businesses partners through our platforms.”

 

Informed observers and jurists have opined on the direct and unintended consequences of the EATS Act over and above the welfare aspect.  The broadly framed act could invalidate a number of necessary state regulations and would be contrary to existing laws relating to methods of production, including suppression of livestock and poultry diseases.

 

The EATS Act was introduced to invalidate Proposition #12 that currently impacts a segment of the pork industry still using gestation crates for sows. The case is advanced by industry associations representing pork producers that the EATS Act would obviate the requirement for farmers to invest in group-housing for sows.  Economists at the University of California-Davis ascertained that there is adequate pork available from sows housed in compliance with California Proposition #12. The economists presented data to show that there would not be any restriction on states imposing sanctions against gestation crates and that no further investment is needed in the U.S. 

 

The problem facing the pork industry is that major retailers and food service operators are committed to source pork from piglets bred from sows maintained under group housing. As has been frequently stated in CHICK-NEWS, as far as the need for conversion is concerned the train left the station years ago.  Irrespective of legislation, public pressure and the policies of retailers will determine the extent of alternatives to gestation crates. Most major pork producers have recognized this reality and over the past decade have progressed in transitioning to alternative housing systems leaving those who would ignore the realities of the marketplace to rely on exports and low-price accessible markets.

 

It is ironic that lobbying by pork associations scuttled the “Egg Bill” that would have created a uniform Federal housing standard for hens. Now when their backs are against the wall a segment of pork producers are seeking Federal relief through legislation. 


 

South Dakota Senators Opine on AI Vaccination-Reason now Emerging

01/25/2024

Senators John Thune (R-SD) and Mike Rounds, (R-SD) have commented on control of HPAI that has severely affected turkey production in their state.  Noting that the USDA is “testing” vaccines, the legislators point to the more important aspect of trade.  In their letter to the Secretary of Agriculture, Senators Thune and Rounds state, “We recognize that without updated trade agreements, the use of HPAI vaccination can put our poultry and egg industry at a disadvantage.  So, now is the time to begin the tedious work of talking with our trading partners to solidify agreements that reflect the new reality.”

 

An obvious starting point is to rescind the ban on importation of poultry products from France based on the spurious justification of protecting the U.S. industry.  Limited use of HPAI vaccine on a seasonal and regional basis for specific segments of the industry at risk in France will have no deleterious effect on the U.S. This is based on the reality that HPAI is introduced seasonally and disseminated along four flyways by migratory waterfowl and marine birds.

 

An additional question relates to why the USDA is “testing” new vaccines given publications confirming relative efficacy of commercially available products as a practical control measure along with biosecurity.  It appears that the fall-winter phase of the 2023-2024 epornitic is waning and will cease as it did at the end of 2022.  The USDA has until spring to determine the efficacy and safety of both HVT-vectored vaccines for day old chicks and poults and inactivated oil emulsion vaccines for older birds.  Concurrently, as noted by the Senators, negotiations must be initiated with trading partners citing the World Organization of Animal Health endorsement of vaccination as an adjunct to biosecurity, quarantine and surveillance as control measures.

 

HPAI is the Newcastle disease of the 2020s. We learned to co-exist and maintain production despite persistence of the infection from the 1970s onwards by applying vaccination. So it should be with HPAI. This infection will never be eradicated and poses a threat of severe economic harm using current unsuccessful control measures.


 

Philippines Bans U.S. Imports from California and Ohio

01/21/2024

Based on diagnoses of highly pathogenic avian influenza in California and Ohio, the Ministry of Agriculture of the Philippines has banned importation of live poultry and products including meat and eggs effective January 15th or processed two weeks before diagnoses were made in the states concerned.

 

Importation by the 5th-ranked Philippines for first eleven months of 2023 amounted to 156,526 metric tons with a value of $163 million and at a unit price of $1,041 per metric ton, below the average value of $1,306 per metric tons for the period.    

 

This blanket ban of a U.S. state represents a 1980’s approach to prevention of highly pathogenic avian influenza.  Nations such as the Philippines should adhere to WOAH policies that recognize regionalization (zoning).  Banning of exports from entire states is not beneficial in terms of protecting flocks of the importing nation from a disease such as HPAI that is carried by migratory birds.  Importers should rely on certification of freedom from HPAI (avian influenza strains H5 and H7) as determined using PCR screening and zonal surveillance.

 

Unless the USDA-APHIS recognizes the realities of HPAI epidemiolog