Editorial


Hygiene and Food Safety at Farmers Markets Questioned

11/07/2018

Pennsylvania State University College of Agricultural Sciences recently conducted a survey of food safety practices at farmers markets. The study disclosed that vendors have minimal training in food safety including storage and handling. A notable conclusion from the study was that there was a wide discrepancy between evaluation of standards by professional observers and the self-reported assessment by vendors. Almost half of farmers’ markets offer prepared foods and two thirds sell meat and poultry.

It is calculated that there are more than 8,000 farmers’ markets in operation in the U.S. A large increase occurred during the Obama Administration which promoted the direct farmer-to- consumer chain as a means of “saving” family farms.

Some of the discrepancies noted by the Pennsylvania State researchers included:

  • Failure to maintain raw and temperature-sensitive foods under refrigeration
  • Failure to implement food safety including the use of gloves when handling food
  • Concurrent handling of money and unpackaged foods
  • Allowing contact between ready-to-eat foods and high-risk foods including meat and seafood.

German "Bauermarkt Display"

The principal researcher noted that indirect and surreptitious observation disclosed deviations from acceptable practice since the traditional clipboard approach generally provides a distorted assessment of practices as store holders are alerted to the need for compliance.

The study involved assays for bacterial pathogens. E.coli was present in 40 percent of beef samples, 18 percent of pork, 15 percent of kale and 29 percent of lettuce. Of greater significance was the presence of Listeria on 8 percent of beef sampled, 2 percent on kale, 4 percent on lettuce and 7 percent on spinach. There were no studies correlating observations made by the researchers in Pennsylvania into possible outbreaks of foodborne infection.

The research team included Dr. Rama Radhakrishna, Professor of Agricultural and Extension Education, Dr. Jonathan Campbell of the Department of Animal Science and Dr. Cathy Cutter, Professor of Food Science all of Pennsylvania State College of Agriculture. They all emphasized the need for training with emphasis on food safety.

The rapid expansion of farmers markets in the U.S. during the 2010s was not accompanied by appropriate investment in facilities. The situation in the U.S. with makeshift tables and stalls in parking lots can be contrasted with traditional farmers markets in Western European nations including France and Germany. Vendors use custom trailers with refrigeration and display cases. The standard of hygiene matches that of supermarkets. Even the stalls selling vegetables and non-perishable foods conform to acceptable standards of presentation and hygiene.

USDA funding was extended to farmers markets during the tenure of Tom Vilsack the former Secretary of Agriculture, but there was a disproportionate concern for public health. The situation nationwide should be rectified with involvement of the extension departments of Land-Grant colleges.

 


 

Influence of E.U. Welfare Policy on Aviary Systems in the U.S.

10/28/2018

It is axiomatic that trends in flock welfare in the E.U. have a direct, albeit delayed, effect on housing systems in the U.S. This is due to the close association among welfare organizations on either side of the Atlantic. Going back two decades, the initial standards established for U.S. broiler production were strongly influenced by the U.K. Royal Society of Prevention of Cruelty to Animals (RSPCA). The two U.S. certifying agencies closely adapted housing and operational practices as required by the RSPCA and these were also incorporated in the original standards adopted by the National Chicken Council. We have observed the influence of E.U. practices on introduction of “slow growing” strains of broilers, controlled atmosphere stunning, mechanical harvesting and sub-therapeutic administration of antibiotics.

A second consideration is that food service companies and retail chains are either multinational in ownership or their policies are heavily influenced by perceptions of consumer attitudes regarding welfare in the industrialized economies of Western Europe. Design of housing, selection of equipment and management of flocks is obviously predicated by a response to consumers and an escalation in regulatory standards. This is especially the case with respect to housing of laying flocks. The E.U. initiated a departure from the use of conventional cages in Union Council Directive 1999/74/EU designating a ban on conventional cages effective January 1st 2012, allowing a 13-year transition period to alternative systems. Initially there was a move to enriched colony modules and then with additional restrictions and consumer demands, to aviaries and floor systems. This trend was evident in the U.S. approximately a decade later. Initially California Proposition #2 and subsequent rules placed restraints on confined housing. This was followed by the successive announcements by QSRs and retailers in 2016 disallowing conventional cages and will extend forward with the presumed passage of California Proposition #12 of 2018.

With the imperative imposed by retailers, QSRs and food service companies to transition from cages by the early to mid-2020s, aviaries provide a practical and cost-effective alternative for U.S. producers operating in-line complexes. The question arises as to the “acceptability” of different configurations with an emphasis on access from the modules to litter. Early versions of aviaries could be regarded as enriched colonies with release of flocks at the discretion of the manager. Confinement of hens by lockable doors on the front of modules are no longer acceptable in Germany. A prominent U.S. retail chain has expressed disapproval of systems which do not allow unrestricted access to the litter area between and beneath rows of modules.

The Verein fur Kontrollierte Alternative Tierhaltungsformen, eV (KAT) of Germany, functioning as the principal accreditation and certification agency has ruled on configuration of aviary modules. The Agency will no longer certify systems with movable front grids (doors) either manual or mechanized, which could confine laying flocks to the tiers of aviaries. Lockable front doors (grids) must be sealed open after the early post-transfer acclimation (training) period, with no ability for mechanical closure to confine flocks. KAT specifically disqualifies combination systems which could be operated as either an enriched colony with confinement or as an aviary, to allow access to litter by opening doors. The KAT objection to combination systems extends beyond basic operation with respect to doors and the potential for confinement. Their philosophy incorporates the perception of “openness” and freedom of hens to move freely in horizontal and vertical planes using the cube volume of their house. Farms or complexes with houses equipped with both unapproved and approved aviaries in adjacent houses at the same location will not be certified under the KAT program.

The implication for U.S. producers is self-evident. Unlike Las Vegas what happens in the E.U. with respect to welfare does not necessarily stay there.  Installation of an aviary system allowing for other than complete and unrestricted access will in all probability be unacceptable to major chains and QSRs and the certifying agencies following the precedents established in the E.U. Future compliance and market acceptability are especially important considerations going forward as the industry resumes the transition from housing in conventional cages to aviary systems. Selection from among available alternative aviary designs will obviously determine future positioning of eggs and products in the marketplace and will influence the return on capital invested in either conversions or new complexes. 


 

Questionable Significance of a Study Purporting to Demonstrate that a Yeast Product can Suppress Salmonella Braenderup

10/25/2018

A supplier of a widely used yeast supplement recently circulated a promotional circular demonstrating the apparent ability of feces from hens fed the product to suppress Salmonella Branderup in vitro. The obvious motivation for the in vitro study conducted by the company was to demonstrate apparent bactericidal or bacteristatic action of the supplement on Salmonella Braenderup as previously claimed for Salmonella Enteritidis.

EGG-NEWS consistently supports scientific advances and comments on research which may have practical implications for sustainability, flock health or safety. On the distaff side, EGG-NEWS will always question promotional claims which lack scientific substance or are based on supposition or speculation especially when appealing to the cupidity of those who are unable to evaluate data or are subject to coercive marketing.

The promotional release describes the evaluation as an “intestinal activity modifier model”. Basically hens were fed the yeast product and excreta was assayed for volatile fatty acid content. In addition, the effect of feces from treated hens compared to controls was evaluated for the ability to suppress Salmonella Braenderup in vitro.

The release demonstrated a statistically significant increase in volatile fatty acids, which is biologically plausible and consistent with administration of a prebiotic to hens. The significance of the increase in volatile fatty acids in relation to the probability of infection of a flock with Salmonella Branderup was not addressed. The ability of the increased volatile fatty acids content of the terminal intestinal tract to actually reduce the level of shell contamination with Salmonella Braenderup was beyond the scope of the study but obviously relevant to the real-world situation..

The second aspect of the in vitro evaluation was the claim that supplementing diets with the yeast product suppressed Salmonella Braenderup. There was no description of the procedure used but data demonstrated that the level of Salmonella Braenderup was reduced from 6.86 log to 5.92 log per gram of feces representing a 0.94 log reduction. Again, the practical or epidemiologic significance is questioned of a ten-fold reduction in the quantum of Salmonella Braenderup as a result of supplementing diets with the yeast product.

It is generally accepted in the U.S. egg industry that the problem of Salmonella Braenderup attributed to the farm in question was due to environmental and operational factors specific to the complex, leading to the limited outbreak among consumers. There is no evidence that Salmonella Braenderup is widely distributed in the U.S. egg industry as evidenced by the fact that only one egg-attributed outbreak has occurred over many decades of public health surveillance of Salmonella.

The epidemiologic significance of the in vitro study is obviously in question and a cynical approach would be to conclude that the manufacturer was stretching microbiology to promote a product of questionable value with respect to suppressing potential salmonellosis among consumers. 

It would have been more acceptable if the company in question had demonstrated that hens fed the supplement were refractory to intestinal colonization following challenge or that meaningful suppression of Salmonella Branderup could be achieved by dietary supplementation. The approach taken by the company would be more credible had the study been published in a peer reviewed journal.

Research conducted by Land-grant universities, institutes and the R & D departments of biopharmaceutical companies is intended to confirm safety and efficacy of products to suppress flock infection leading to foodborne diseases. Positive results, subject to peer review or FDA scrutiny allow compounds to be registered for a specific use. Commercial acceptability depends on demonstrated efficacy and cost-benefit. Performing studies of dubious scientific merit to   promote a product is sophistry and the principle is even more egregious when based on concern and fear arising from severe financial loss due to a pathogen of limited significance.

The draft of this editorial was submitted to a technical service veterinarian of the company concerned with an offer to post a rebuttal of the points raised. No response was obtained within two weeks-Editor.


 

Evolution of H7N9 Virus in China

10/20/2018

H7N9 emerged as a zoonotic infection in Guangdong Province during early 2016.  A recent article* reported on molecular analysis of 16 strains of H7N9 virus sequenced during 2015-2017.  It was determined that the isolates could be segregated into three antigenic clusters denoting different lineages.  The difference among strains involved mutations determining the structure of hemagglutinin sites involved in antigenicity.

 

There is concern that recombinants could arise between H7N9 and other widely distributed avian influenza viruses including H9N2.  This serotype is frequently isolated from live poultry in wet markets especially during seasonal outbreaks of influenza.

 

Highly pathogenic H7N9 virus has become more pathogenic in mice and demonstrates a higher level of thermal stability compared to low-pathogenicity strains.  Serologic surveys applying hemagglutination inhibition demonstrated that highly pathogenic H7N9 viruses now occur in several provinces in China and are responsible for clinical outbreaks and extensive losses in poultry flocks.

 

The authors warned of the possibility of widespread dissemination of H7N9 virus through migration of free-living birds similar to the situation following the emergence of H5N1 virus in the early 2000’s. Despite extensive use of vaccine in China, adaptation of the virus is occurring through mutation justifying intensified surveillance applying molecular epidemiology.

 

It is possible that an H7N9 reassortant may represent the next challenge to poultry industries in North America and the E.U. This presumes maintaining high levels of biosecurity at both the structural and operational levels. Erecting and managing complexes with 1 million or more hens without shower-on/shower-off installations, effective vehicle decontamination, bird-proofing and procedures to limit introduction of pathogens is playing “influenza roulette” especially if farms are situated on a migratory flyway and near an expanse of water.

 

*Lu, J. et al Molecular Evolution, Diversity, and Adaptation of Influenza A (H7N9) Viruses in China.  Emerging Infectious Diseases 24: 1795-1805

 


 

Move to Recyclable and Sustainable Packaging

10/16/2018

Mondelez International is the latest in a series of manufacturers to announce programs to reduce waste generated from packaging. It is planned to convert all packaging to recyclable status and to provide consumers with relevant information by 2025. This is a worldwide initiative and is part of the company’s long-term vision for zero-net waste in packaging. A number of initiatives will be implemented including:

  • Use of recyclable material for all packaging by 2025. Paper-based packaging will be sustainably sourced by 2020.
  • Comprehensive recycling information will be provided to consumers by 2020.
  • Mondelez will support industry coalitions and public-private partnerships to develop vital waste-management infrastructure.

It is calculated that 150 million pounds of packaging material worldwide will be eliminated by 2020. Since 2013, Mondelez International has eliminated 100 million pounds of packaging material. This has been achieved through redesign of tubs used in the U.K. using less plastic, reduction in use of corrugated paper and diminishing the thickness of packaging films.

Sustainability in packaging is an irreversible trend and will have implications for food producers in their relationship with customers and through public perception.


 

Technology For the Sake of Technology Will Not Add to Profit

10/01/2018

The September 1st edition of The Economist outlines the contribution of space technology to intensive agriculture. Thrive MV is one of seven companies supported by the European Space Agency in a business incubation center outside Harwell in Oxfordshire. The objective of the collaborative is to find applications for space technology in industry and agriculture. Admittedly some projects such as remote sensing using drones to assess the health of crops is justified. Some of the projects however which are under development appear to be make-work and Rube Goldberg in concept.

Thrive Multi Visual is devising a chicken robot based on a NASA Mars Explorer. The tracked vehicle will move around the house and determine the weight of chickens based on visual images. Have these guys not heard of automatic hop-on-hop-off weighing scales?

Other technology is being applied to develop environmental control systems which at present can be bought off-the-shelf and which contribute to acceptable growth and livability parameters close to genetic potential.

The Economist writer blames farmers for not adopting advanced technology. Claire Lewis, CEO of Thrive MV believes that agriculture is “no way near as tech-enabled as it should be”. On the one hand, Ms. Lewis probably does not know enough about intensive agriculture to be able to make the assertion, since computerized ventilation systems are extremely sophisticated. Another reason for the reluctance of farmers to purchase sophisticated technology is that farming is at best a marginal business and beneficial return to cost ratios are a significant consideration in capital investment.

During the past decade, the public sector has extended seed financing and has housed start-ups in incubators to exploit technology and to develop saleable products. Very few of the “seeds” actually germinate and become commercially viable companies.

Farmers are extremely willing to adopt proven technology which offers a return on investment. This is evident in walking the aisles at the IPPE and the Midwest Poultry Federation Conference Exhibition. Each year, new products and concepts are offered, but unless these companies are back the next year, there is obviously little or no commercial adoption. Some of the concepts are well-meaning, but impractical. Others, such as contact lenses for hens to prevent cannibalism were outright scams.

Funding for agricultural and livestock research is critical to feeding our existing population of whom at least 25 percent are food insecure. Advances in productivity and yields will be required to feed the next generation and the projected nine billion on Planet Earth by 2050. Technology may be beneficial but it has to be practical and financially attractive.


 

Business Sectors Evaluating Effect of Tariff War

09/27/2018

Both the high-tech manufacturing sector and retail are assessing the potential impact of the succession of announcements placing tariffs on imports from China.

The latest to sound an alarm is Walmart, the world’s largest retailer. In a letter addressed to U.S. Trade Representative Robert Lighthizer, Walmart confirmed that the most recently announced tariffs will raise prices to consumers representing an indirect tax.

The letter stated “As the largest retailer in the United States and a major buyer of U.S. manufactured goods (this is somewhat cynical as the company has always relied heavily on China, despite “Buy America” campaigns and in store images), we are very concerned about the impacts these tariffs would have on our business, our customers, our suppliers and the U.S. economy as a whole.”

The fact that the letter was addressed to Lighthizer over two weeks ago and in the interim the Administration has announced increased tariffs suggests that political considerations are outweighing prudence and judgement.

In the conflict with China, the Administration has apparently not taken into account the implacability of our trade adversary and the damage to our economy.

Walmart is not simply a commercial entity in Arkansas running a chain of big-box stores. Virtually every U.S. worker has either a direct or an indirect investment through 401k programs, pension funds and ownership of shares. Engaging in an escalating war with the World’s second largest economy and subject to strong central-government control, is subject to the Law of Unintended Consequences”.


 

Potential for Biomarker Gender Selection

09/20/2018

A number of companies and research institutes have claimed to have developed technology to differentiate between eggs containing male or female embryos at an early stage of incubation.

The most biologically plausible system to date has been developed by an Israeli company using technology developed by Professor Danny Offen at the Medical School of Tel Aviv University.

 

The company eggXYt has approached the problem of early differentiation by genetic manipulation.  The system apparently involves adding a detectable marker to the male sex- determining chromosome to allow differentiation using the branded seXYt system. If effective the procedure could resolve the problem of destruction of male egg-strain chicks at the commercial level. 

As yet there have not been any peer reviewed articles on the system or projections of cost. Presentations made by the entrepreneurial founder and the company website are long on the obvious advantages but short on scientific details. The concept has received seed funding from agencies in Europe and was a 2018 recipient of a Pearse Lyons Accelerator Program which supports start-ups with the potential to enhance food production by providing seed funding.

 

Even if the technology proves both technically and financially feasible, the major problem facing the developers is that it is based on genetic manipulation. The demographic opposed to intensive livestock agriculture in general and egg production specifically, as a result of destruction of male chicks will also be opposed to what they would regard as GM technology and in some cases philosophical objections on the grounds of “gender discrimination” The Company will have to enter into JV agreements with the major breeding companies for the system to achieve commercial adoption. All primary breeders have adopted a no-GMO policy which would appear to be a hurdle for eggXYt.

Yehuda Elram, CEO (left) and Prof. Daniel Offen

co-founders of eggXYt.

 

From publicity eggXYt is claiming to apply CRISPR technology which involves deletion of genes. However the concept must involve addition of a marker to a chromosome.  While EGG-NEWS strongly supports what may be regarded as a beneficial process, those biased against GM technology will most certainly oppose the procedure.

 

The co-founder and CEO of the company Yehuda Elram is welcome to prepare a posting providing more details of the process and to provide results of trials to demonstrate proof of principle and a projection of cost using their selected business model.


 

The Wall Street Journal Poses the Question Are Eggs Bad for You?

09/19/2018

It was with extreme surprise and a sense of disappointment that The Wall Street Journal resuscitated the debate over egg cholesterol in the September 17th edition.

Dr. William Roberts, Executive Director of the Baylor Scott and White, Heart and Vascular Institute at Baylor University and Medical Center dredged up the usual canards concerning egg cholesterol. It is surprising that a scientist in his position still believes that a large egg contains 215 to 275 mg of cholesterol. It is now generally accepted that the content of large eggs is in the range of 175 to 200 mg.

The major points advanced by Roberts concerning the potential deleterious effect of eggs relates to studies involving herbivores in which plaque develops in the intima of arteries after feeding diets with exceptionally high cholesterol content, inconsistent with a human diet containing one egg per day. Roberts also criticizes research published in peer-review journals showing no demonstrable effect from moderate consumption of eggs as being biased due to support from the Egg Nutrition Center, a component of the American Egg Board.

In contrast, Dr. Maria Fernandez, professor in the Department of Nutritional Sciences at the University of Connecticut maintains that there is no evidence to suggest that consuming an egg each day elevates the risk of cardiovascular disease. She notes that dietary guidelines released by the U.S. Department of Agriculture in 2016 no longer place an upper limit on dietary cholesterol intake.

Consistently, studies conducted by independent researchers have shown that there is no adverse effect from moderate consumption of eggs and biomarkers of heart disease are not elevated by an intake of one egg per day. Dr. Fernandez also pointed to the beneficial nutrient content of eggs, a fact which is grudgingly conceded by Dr. Roberts.

Egg cholesterol as a factor in inducing cardio-vascular disease is a dead issue. Why The Wall Street Journal should dredge up outdated concerns given the host of other public health problems is questioned. Perhaps the WSJ should concentrate on the 72,000 drug overdose deaths in 2017 as an issue of significance. Given their emphasis on business and economics, the WSJ could also consider the cost of both prescription and generic drugs and healthcare in general.


 

The Employment Enigma

09/03/2018

As Congress faces reconciliation of the 2018 Farm Bill, it is appropriate to consider the problem of acquiring and retaining labor on U.S. farms. To be frank, we are reliant on workers from nations south of our border to work in produce fields, dairies, poultry farms and processing plants. The House version of the Farm Bill incorporates a mandatory work requirement for recipients of SNAP benefits, the Senate is opposed to this requirement although it is hoped that a compromise will be reached to enable passage of the bill. It is now obvious that an extension will be required, since existing legislation will expire in September.

In 1996, the Welfare Update mandated 80 hours of work or training for able-bodied adults 18-50. Non-compliant recipients were limited to three months of benefits. This provision was honored more in the breach than reality since states were allowed to exercise waivers.

The inner city areas have disproportionate unemployment rates and are heavily dependent on federal handouts. If those dependent on government programs to survive were to move to areas where there is a demand for labor, there would be a marked reduction in expenditure for SNAP and similar support programs.

Traditionally workers have moved to areas of opportunity. During the Great Depression, dispossessed farmers from the Dust Bowl relocated to California. More recently oil field workers displaced form the Gulf obtained work in new fields in North Dakota.

Congress has been slow to act on enabling legislation to provide H-    visa for foreign workers, especially those with both training and a desire to contribute to agricultural productivity.

In my work involving egg-production complexes, there is a dearth of available workers. Producers converting from conventional cages to aviaries recognize the need for additional labor, possibly in the region of two to three times that required for a flock of 150,000 to 250,000 caged hens. Standards for employment are steadily declining. Older workers with a strong work ethic are becoming more scarce. Substance abuse is a more important factor responsible for unreliability, carelessness and accidents.

Even if government policy allows more extensive use of foreign labor, it will be necessary to house immigrants. By the same token, acceptable housing will be required for labor moving from inner cities to rural areas. In addition to housing, it will be necessary to provide schooling and other services, altering the character of small towns which in any event are losing their traditional populations.

 

There are limits to mechanization and labor will always be required to produce food. The alternative to a rational immigration policy and encouraging relocation of U.S. citizens dependent on government support is self-evident. Agriculture is the nexus where immigration policy and welfare converge. Let us hope our legislators put aside ideology and address a growing problem which will restrict our ability to produce food.

It is evident that changes will be required in attitudes towards permanence of residency, acceptance of  “different” socio-economic groups and a redistribution of our population to address the need for agricultural labor.


 

PETA Video – Mahard Egg Farms

08/28/2018

Once again we are confronted with adverse publicity following the posting of a video by PETA allegedly depicting mishandling of hens on the Sulfur, OK Farm operated by Mahard Egg Farms.

 

Apparently during late July and early August, high temperatures resulted in episodes of mortality.  The video depicts the removal of mortality from cages with temporary storage in pits of high-rise houses. Dead hens were then elevated using a mechanized belt to a trailer for transport presumably to a landfill.  A few live hens were apparently present within the mass of dead birds.  The video depicts these hens being killed by slamming their heads against a bar on the trailer.  The worker involved in the task of distributing dead birds in the trailer did not appear to be supervised.

 

The video also showed hens presumably during routine depletion according to the PETA voice-over being placed into a kill cart with an open top which would not allow effective euthanasia using carbon dioxide.  This again resulted in conscious birds having to be killed by other than approved procedures.

 

Mahard Eggs is certified by the UEP welfare program. Obviously any deviation from acceptable practice especially when subject to a video posting on the social media degrades the value of the UEP program which in itself is an acceptable set of standards.  Obviously UEP auditors visit farms subscribing to the program at intervals and cannot be expected to ensure ongoing compliance on a 24/7 basis.  In this case however it is evident that workers involved in the process of disposing of heat mortality were not trained in appropriate methods of euthanasia including cervical dislocation.

 

Unfortunately with high acute mortality associated with excessive heat, some dead hens will not be removed from cages especially on the higher tiers where most mortality occurs.  The dead hens as depicted in the video show advanced decomposition (“pancakes”) denoting lack of diligence in removal of mortality. It is not possible to determine the number of dead birds in cages as intrusion and clandestine videos invariably concentrate on individual hens and cages.

 

It is understood that the local law enforcement authorities are investigating the case and as with other incidents in the past, low-level employees will probably be fined and life will go on.

 

As with many cases of alleged deviations from acceptable welfare, PETA made Kroger, a major customer of Mahard aware of the events and after review of the video the chain suspended purchasing from the producer.

 

Mahard Farms has a history of non-compliance with regulations.  The Environmental Protection Agency assessed a fine of $1.9 million for contamination of pasture with waste extending over the period 1997 to 2011.

 

The company was the subject of an FDA warning letter on April 26, 2017 confirming nonconformance with the Salmonella Prevention Rule which is strictly adhered to by all commercial producers.  The warning letter outlined major deviations from practices which are common to the industry and denotes a lack of concern for food safety and the potential to degrade the image of all producers.

 

The industry has progressed from the days when individual producers set their own standards and operated as they pleased. Now under regulations issued by the FDA, the EPA and the Department of Homeland Security, egg producers must conform to laws and regulations and bear the cost.  The UEP has established science-based standards for welfare to improve the image of our industry and provide customers with an assurance that flocks are treated humanely from hatch to depletion.

 

It is obvious that Mahard Eggs needs external independent advice to upgrade training and facilities and above all to create an acceptable culture of compliance with food safety, welfare and employment training.  If there are any other Mahards out there they need to engage in self-evaluation for their own benefit and as an obligation to the entire U.S. egg-production industry.

 


 

Is the FDA Competent to Conduct Epidemiologic and Farm Investigations?

08/22/2018

The recounting by Tony Wesner CEO of Rose Acre Farms of the “inspection” of the Hyde County N.C. complex by a team of FDA personnel raises serious questions as to the competence, training and experience of those involved in the investigation. Speaking at the Atlanta Regional Meeting organized by the UEP, Wesner described the procedures used by the team in sampling layer houses and the packing plant. His informative and completely transparent description is confirmed by the observations of a board-certified poultry veterinarian affiliated to the State of North Carolina. My colleague who was present at the time had profound doubts as to ability of the FDA team to effectively plan and implement a structured sampling program to determine whether the complex was the source of an outbreak of Salmonella Braenderup.

 

Only two of fifteen FDA inspectors assigned to the project had ever set foot on any commercial farm with livestock. It is evident that their experience was confined to pharmaceutical and food processing plants. This was evident in their assessment of the number of live mice observed in pits and the level of flies in houses resulting in an official FDA 483 Letter. While not excessive 25 live mice in 12 houses each 800’ in length was regarded as a serious infestation. A total of 25 “flying insects” were recorded over four days in an 80,000 square foot plant operating in-line with the laying houses. If mice and flies were regarded as being of epidemiologic significance in an alleged Salmonella outbreak why were no samples of these presumptive reservoirs obtained and assayed?

 

The FDA team spent an inordinate time sampling manure rows in pits. Wesner estimates that drag swabs in houses extended over 20 miles.  Approximately 200 swabs were taken in the plant apparently at random without an evident structured sampling plan consistent with other plants or investigations.

 

The FDA can be faulted on their epidemiologic investigation. From documents released after legal requests it is evident from a heavily redacted series of tables that interviews with patients were incomplete. In any event an outbreak limited to 50 diagnosed cases over six months could not be expected to elicit meaningful historic food data—who can remember eating eggs and their source whether in the home or at a restaurant weeks or months previously?

 

The FDA apparently applied Pulse Field Gel Electrophoresis (PFGE) assays in attempt to establish the molecular relationship among isolates. It is unclear from the limited responses by FDA whether more specific assays including whole genome sequencing regarded as the “gold standard” were subsequently applied to the investigation. The Company is still awaiting a final report from the FDA with microbiological results from the field investigation conducted during the week of March 26th.

 

The 2018 Salmonella Braenderup outbreak was in any event a speculative event. Hyde County produced close to 2.8 million eggs per day consumed by a population of 30 million in the area of distribution. T o produce only 50 cases in six months represents an infinitesimal risk of infection from the farm. If in fact eggs from Hyde County were the only source of infection an extended chain of unfortunate circumstances would have been necessary to produce even the flat and unconvincing epidemic curve recorded.  These factors would have included sequential shell penetration by the motile pathogen, defects in cleaning (no Salmonella were isolated from shell surfaces), thermal abuse subsequent to delivery, prolonged storage by retailers, restaurants or in households, undercooking and possibly immunosuppressed consumers.

 

The financial implications from the FDA “investigation” and subsequent voluntary recall are immense far exceeding the $30 million insurance payout. In the initial weeks 56,000 cases were consigned to landfills followed by transport to a non-company breaking plant.  Depopulation of the entire farm, decontamination, structural improvements and disruption of operations have added to the burden borne by the Company.

 

A dispassionate review of the situation reveals incompetence, lack of proportion in assessing epidemiologic and production-related factors and dereliction in responsibility regarding follow-through on reports and recommendations. This episode is justification for a separate Food Safety Agency independent of the FDA. It appears that the priorities of the Agency are distorted. They elicited concern over 50 cases of an apparent outbreak of salmonellosis but apparently are not involved to a proportional degree with 72,000 annual fatalities from opiod overdosing or gross violations of standards in pharmaceutical plants in China and India supplying 70 percent of generic drugs prescribed in the U.S.

 

People infected with the outbreak strain of Salmonella Braenderup, by date of illness onset*

*n=45 for whom information was reported as of June 13, 2018. Some illness onset dates have been estimated from other reported information.

 


 
















































































































































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