Disease outbreaks that originate from consumption of food attract great media attention, and create concerns for many in society…for good reason. The recent outbreak of Escherichia coli (E. coli) in Europe is a good example of this and the societal problems that ensue.  As of July 26, 2011, the European Centre for Disease Prevention and Control had reported 3900 confirmed or probable E. coli cases including 46 deaths from the recent E.coli outbreak in Europe.  The media attention that a disease outbreak like this causes is staggering!

How staggering?

A Google search of the word sequence “E coli Europe 2011″ on July 26 resulted in 10,600,000 results!  Media scrutiny like this can create the image for many in society that food safety issues abound.  The fact is, however, that individuals living in developed countries have the safest food supply in recorded history.  the challenge is how to communicate this effectively to the public.

The story of how agriculture research and contemporary food production practices allow the United States to produce the world’s safest food supply is one that tends to get “lost” in the media frenzy that explodes after a disease outbreak that is linked to food.  When one looks at the record of food-borne diseases throughout recorded history, it is evident that today we have an armada of scientific and public health resources that are remarkably effective in reducing risk of contracting disease from food.  In addition, the public health and diagnostic infrastructure that is in place is phenomenal at determining the cause of the disease outbreak, and delivering appropriate, high-level health care.  I do not talk with many individuals who would like to live life using the biomedical and public health resources that were available in 1850.

To illustrate the power of science, consider the E. coli outbreak that began in Germany in May, 2011…by June 29, 2011, a paper [Brzuszhiewicz et al. Genome sequence analyses of two isolates from the recent Escherichia coli outbreak in Germany reveal the emergence of a new pathotype:  Entero-Aggregative-Haemorrhagic Escherichia coli (EAHEC)] had been published online in the science journal “Archives of Microbiology” that presented the complete genome (DNA) sequence analyses of two isolates from the outbreak!  This would have been impossible 10 years ago!

In the face of a disease outbreak like the one in Europe, we should not lose sight of the fact that advances in science and medicine have had a dramatic and beneficial impact on reducing risk of contracting food-borne disease. Advances in numerous technologies have made this possible.  These include:  canning; autoclaving; refrigeration; microbiology; assay technology (including rapid pathogen assays); meat science; packaging; use of biotechnology; shipping; epidemiology; disease outbreak tracking; and public health monitoring and intervention!

To the point of food safety…then versus now…we should be appreciative of the marvelous food safety systems that are in place, and extol the benefits of the scientific and technological advances that have made all of these possible.  The food-borne outbreaks that occur are identified and dealt with quickly (especially versus prior decades) because of enhanced vigilance, application of science and public health monitoring.

Did you ever wonder where your milk comes from?  And, no, I am not referring to cows.  My question pertains to the geographic regions of the United States that contribute most to milk production.

As you will see, the results are revealing.

Based on information released by the Market Administrator for the Central Federal Order No. 32, 59 counties accounted for 50% of the U.S. milk production (see Figure 1).

When you look at the map, it is evident that milk production is concentrated in a few geographic regions of the United States.  The 11 counties (in red) that account for 25% of all milk produced in the United States are perhaps a more telling illustration of this.  To put the 25% of milk in context, total milk production in the United States in 2010 was about 193 billion pounds!

You might ask: what does this mean?

One, a lot of milk/dairy products gets transported significant distances to get to consumers. Advances in technology have enabled this.  Two, the greatest concentration of milk production is in California.  And, three, the concentration of dairy production has important biosecurity implications.  For example, if a dairy disease outbreak occurs in relatively few regions in the country, this would have a huge impact on milk production and availability to consumers throughout the country.

I have thought a lot about a “targeted strike” on the U.S. food system.  One example of a targeted strike is the intentional release of an animal pathogen (such as the virus that causes food and mouth disease) with the intended consequence of causing economic and social upheaval. With respect to the dairy industry, the concentration of a lot of cows in few counties in the United States would greatly facilitate causing a “big time” problem.  This concentration of food production is not unique to the dairy industry…it is common for other animal and plant commodities, as well.

If you wondering what the impact of an “intended” animal disease outbreak might be in the United States, consider the consequences of the foot and mouth disease outbreak in the United Kingdom in 2001…it had an economic impact of about $10 billion (see:  Impact of Bioterrorism on Agriculture in the U.S.).  If this occurred in the United States, the economic impact likely would be far greater!  And, how the public would respond is likely to be closer to chaos than calmness.

The International Service for the Acquisition of Agri-biotech Applications (ISAAA) has released their annual report Global Status of Commercialized Biotech/GM Crops: 2010.  The report presents interesting and compelling information about the rapid global adoption of genetically modified (GM) crops.

2010 marks the fifteenth anniversary of the commercialization of biotech crops. As a result of the consistent and substantial economic, environmental and welfare benefits offered by biotech crops, millions of large, small and resource-poor farmers around the world continued to plant significantly more acres of biotech crops in 2010.

The ISAAA Report notes that progress was made on several major fronts: accumulated acreage planted from 1996 to 2010 reached an historic global milestone; a significant double-digit year-over-year increase in biotech crop acreage was observed as well as a record number of biotech crop countries; the number of farmers planting biotech crops globally increased substantially; across-the-globe growth, reflected increased stability of adoption and that biotech crops are here to stay.

These are very important developments given that biotech crops already contribute to some of the major challenges facing global society, including: food security and self-sufficiency, sustainability, alleviation of poverty and hunger, help in mitigating some of the challenges associated with climate change and global warming.  The potential of biotech crops for the future is enormous.

It is impressive that in 2010 the accumulated acreage planted during the 15 years, 1996 to 2010, exceeded for the first time, 1 billion hectares, which is equivalent to more than 10% of the total land area of the USA (937 million hectares) or China (956 million hectares). It took 10 years to reach the first 500 million hectares in 2005, but only half that time, 5 years, to plant the second 500 million hectares to reach a total of 1 billion hectares in 2010.

A record 87-fold increase in acreage planted to GM crops occurred between 1996 and 2010, making biotech crops the fastest adopted crop technology in the history of modern agriculture.

To read more about this informative report that clearly presents the need for, and value of biotechnology, click here.

A great article has just been published in the May 12 issue of the  Journal of the American Medical Association (JAMA).  The article Bring Back Home Economics Education was written by Drs. Alice Lichtenstein and David Ludwig of Tufts University and Children’s Hospital in Boston, MA.  The article advocates the need to “bring back” Home Economics education and the role this could play in prevention of adolescent overweight and obesity.

Home Economics, otherwise known as domestic education, was a fixture in secondary schools through the 1960s, at least for girls. The underlying concept was that future homemakers should be educated in the care and feeding of their families. This idea now seems quaint, but in the midst of a pediatric obesity epidemic and concerns about the poor diet quality of adolescents in the United States, instruction in basic food preparation and meal planning skills needs to be part of any long-term solution.

About 35% of adolescents are overweight or obese, a prevalence that approaches 50% in minority populations. Excessive weight among youth affects virtually every organ system and, according to a recent study, increases the risk of premature death. In addition, obesity adversely affects self-esteem, academic accomplishment, and future earning potential of children.

My encouragement is that you read the article and appreciate the pressing need to implement programs that effectively reduce the incidence of adolescent overweight and obesity.

A GAO report issued on May 22, 2008 (GAO-08-821T, HIGH-CONTAINMENT BIOSAFETY LABORATORIES, DHS Lacks Evidence to Conclude that Foot-and-Mouth Disease Research Can be Done Safely on the U.S. Mainland reviews the background of foot and mouth disease (FMD) research in the U.S. and elsewhere. This report questions the basis for the Department of Homeland Security (DHS) support for the movement of FMD virus and research from the current location at Plum Island Animal Disease Research Center (PIADC) to the newly announced National Bio and Agro-Defense Facility (NBAF) site managed by Kansas State University. In the GAO report, concern was raised regarding a study where DHS relied on a secondary study that the United States of Agriculture (USDA) commissioned and that a contractor conducted in May 2002. This study examined the question of whether it is technically feasible to conduct exotic disease research and diagnostics, including FMD and rinderpest, on the U.S. mainland with adequate biosafety and biosecurity to protect U.S. agriculture? Some significant problems existed in the conduct of this study. Nonetheless, DHS continues to cite to this study as supporting the closing of PIADC, and being the basis of support for the $450 million facility funded to Kansas State University. Various concerns are raised by GAO regarding this USDA study and the readership of this blog is encouraged to read the report in detail and the GAO criticisms.

At the heart of the debate is the question as to what existing laws and statutes govern the site for FMD research in the United States? DHS assumed control of PIADC on June 1, 2003 based on authority granted by the Homeland Security Act of 2002. On January 30, 2004 DHS was instructed by Homeland Security Presidential Directive / HSPD-9 (Defense of United States Agriculture and Food) to undertake several actions to protect United States agriculture and food systems, and improve infrastructure to both natural and intentional acts which would erode U.S. agriculture. DHS has identified PIADC as “reaching the end of its life cycle”, and as lacking critical capabilities to continue as the primary facility for such work. DHS initiated actions to replace PIADC which was judged as antiquated using the following authority, specifically clause (24), cited from HSPD-9.

Research and Development (numbers in parenthesis are paragraph markings as appearing in HSPD-9)

(23) The Secretaries of Homeland Security, Agriculture, and Health and Human Services, the Administrator of the Environmental Protection Agency, and the heads of other appropriate Federal departments and agencies, in consultation with the Director of the Office of Science and Technology Policy, will accelerate and expand development of current and new countermeasures against the intentional introduction or natural occurrence of catastrophic animal, plant, and zoonotic diseases. The Secretary of Homeland Security will coordinate these activities. This effort will include countermeasure research and development of new methods for detection, prevention technologies, agent characterization, and dose response relationships for high-consequence agents in the food and the water supply.

(24) The Secretaries of Agriculture and Homeland Security will develop a plan to provide safe, secure, and state-of-the-art agriculture biocontainment laboratories that research and develop diagnostic capabilities for foreign animal and zoonotic diseases.

(25) The Secretary of Homeland Security, in consultation with the Secretaries of Agriculture and Health and Human Services, shall establish university-based centers of excellence in agriculture and food security.

The above citation is very important at several levels. Nowhere in HSPD-9 is FMD mentioned directly. However, DHS states authoritatively that FMD virus and research will be housed at the NBAF. The Secretary of Agriculture is directed to assist DHS in plans to upgrade biocontainment and diagnostic capabilities without reference to other legal obligations. Most importantly, nowhere in HSPD-9 is it mentioned that PIADC should be closed and research relocated. This brings us to the point of asking: what exactly is the authority conveyed through a Presidential Directive? These documents are referred to in different ways in Presidential Directives depending on the administration occupying the Executive Office. From the White House briefing room we cite: “PRESIDENTIAL ACTIONS In this section you will find official actions by the President that have a significant impact on how the federal government functions but do not require legislation or Congressional approval . . . ”

Herein is the problem and this problem was referenced, but not detailed, by the GAO study. FAD research and the legal justification to establish and maintain PIADC is well documented in 21 USC 113a. United States Code (U.S.C.) is a compilation and codification of the general and permanent federal law of the United States. Specifically 21 USC 113a states:

“The Secretary of Agriculture is authorized to establish research laboratories, including the acquisition of necessary land, buildings, or facilities, and also the making of research contracts under the authority contained in section 427i(a) of title 7, for research and study, in the United States or elsewhere, of foot-and-mouth disease and other animal diseases which in the opinion of the Secretary constitute a threat to the livestock industry of the United States: Provided, that no live virus of foot-and-mouth disease may be introduced for any purpose into any part of the mainland of the United States (except coastal islands separated therefrom by water navigable for deep-water navigation and which shall not be connected with the mainland by any tunnel) unless the Secretary determines that it is necessary and in the public interest for the conduct of research and study in the United States (except at Brookhaven National Laboratory in Upton, New York) and issues a permit under such rules as the Secretary shall promulgate to protect animal health, except that the Secretary of Agriculture may transport said virus in the original package across the mainland under adequate safeguards, and except further, that in the event of outbreak of foot-and-mouth disease in this country, the Secretary of Agriculture may, at his discretion, permit said virus to be brought into the United States under adequate safeguards.”

The above is literally the law of the land, and violations of this law are punishable through an assortment of penalties including Contempt of Congress. Returning to the topic, where exactly did DHS assume precedent to establish and award the NBAF contract? From the prior discussion the legal precedent is very clear – - only the Secretary of Agriculture or Congress can allow FMD virus to be moved from PIADC onto the mainland. This was established by law in 1949, and this law is still on the books and in effect. With reference to the Secretary of Agriculture, two questions arise. With the erosion of authority over FMD virus research, does USDA, or DHS, assume the obligations of indemnification should FMD escape biocontainment and damage U.S. agriculture? What is the consequence of actions by the current Secretary of Agriculture on binding commitments made by future Secretaries of Agriculture? Should plans for NBAF proceed and the existing PIADC be razed on the basis of “reaching the end of its life cycle”, and as lacking critical capabilities to continue as the primary facility for such work just to have a future Secretary of Agriculture reverse the decision, the ugly reality emerges of “what options exist”? In short, none! And, US agriculture will lack a FMD research program which could assist in vaccine development should this FAD occur at some time in the future.

This leaves open the question of: why has the U.S. Congress not been proactive in the award of the NBAF facility contract, and why is Congress not diligent in the enforcement of existing U.S. Code? Without bias, we assume that FMD research is suitably placed at PIADC consistent with existing law. Moreover, infrastructure upgrades could revitalize this facility, possibly at a fraction the cost of a site based on the mainland. NBAF is currently funded at an estimated cost of $450 million, which is considerable. However, an estimated loss of $1 billion could occur to the economy of the State of Kansas should FMD virus escape containment and impact the State. The latter figure was derived from a Kansas State University publication (Pendell et al., The Economic Impacts of a Foot-and-Mouth Disease Outbreak: A Regional Analysis. J. Agricultural and Applied Economics, 39:19-33. 2007).

In conclusion, a key question remains unanswered – - why is this blog the only source asking these questions?

On June 22, 2008, the Star Tribune newspaper (Minneapolis-St. Paul, Minnesota) published an article, “Is Labeling Milk as Free of Hormones a Bad Idea“, written by Lou Gelfand. The story is great example of the lousy and slanted journalism being practiced that focuses on agricultural biotechnology … in this case, rbST and milk labeling.

I have written about bad science journalism before. It continues to mystify me why some journalists fail to practice accurate and informative journalism. Must be easier to present a bias, distort the truth and mislead readers.

Enjoy the response that Ms. Bunting sent to the Star Tribune.

# # # #

As a 28-year veteran journalist, I find several inaccuracies in your article about milk labeling.

First, record high milk prices do not mean good income for dairy farmers. They are facing record high prices for all inputs — particularly feed, fuel, and fertilizer — surging farther and faster than milk prices (up 35-75% over year ago). The U.S. Department of Agriculture figures that dairy farms are profitable when the milk-feed ratio is 3.0 or above. Currently, it is 1.7!

Second, the dairy price support program does not “buoy” milk prices. This very low “floor” on the price of milk has not been triggered in years and it has not been adjusted for inflation. It is a non-factor.

Third, I am from Pennsylvania and our Sec of Agriculture did not “retreat.” A compromise was reached. Bottlers are prohibited from making “absence claims.” They are allowed to make production-related claims only, such as “produced from cows not treated with rbST.” They may not say “hormone free.” In addition, the FDA disclaimer stating no distinguishable difference in the milk must also appear on the label in a font size at least half the size of the claim.

Fourth, the countries mentioned do not ban products from cows treated with rbST (Posilac), they ban their farmers from using it because they market milk in a supply management or quota system. In Canada, for example, dairy farmers buy the right to sell a certain “quota” of milk. This keeps the supply tight and the price high to farmers. A production efficiency tool like rbST is certainly not going to be allowed by a nation that uses supply management.

Fifth, technologies that safely boost production efficiency are conserving our natural resources by producing more with less. In case you have not noticed, the U.S. and World population is expanding and our land base for producing food is shrinking. What could be more “green” than producing more milk with fewer cows, requiring less feed, less land to grow the feed, less manure waste nutrient to manage, etc. You get my drift.

Sixth, the only “sweet bonus” here is the one the retailers are collecting from consumers for “hormone-free” milk when actually all milk contains protein hormones as does nearly every food on the planet — plant or animal. There is no distinguishable difference between naturally occurring bovine somatotropin in the cow and the synthetic hormone used to supplement the cow. These cows actually benefit with greater longevity as they are producing milk at a profitable level for a longer period of time, so a farmer can afford to keep feeding and caring for a cow that does not breed back when she should for her next lactation. In those cases, if the milk production falls to a certain level and she is not with calf for another lactation, she would be sold for beef.

You see, rbST is not the “evil demon” activists and lately, journalists, seem to want to make it out to be. But of course, there are simply not enough journalists today with a solid background in science to discern the truth, and even fewer who truly understand agriculture and razor thin margins farmers operate on.

Sixty-six university dairy and veterinary scientists launched a broad attack Monday against milk processors and retail marketers who increasingly seek to advertise and label milk produced by cows not treated with Monsanto’s recombinant bovine somatotropin. A letter from professors at nearly every major land grant university asserted there was no difference between conventional and “rBST-free” or organic milk but that consumers were being misled by emotional advertising claims to pay higher prices.

“Organic and ‘rBST-free’ milk are routinely advertised as being somehow healthier, less risky, more environmentally friendly, and produced by ‘happier’ cows than conventional milk,” the scientists’ letter said. “Consumers are led to believe that organic milk is better, or that ‘rbST-free’ milk is safer. The truth is quite different, but behind these claims are very powerful corporate interests that know that they can sell the same product at a higher price if they can create doubt or spread fear about conventional milk.”

The letter was coordinated by dairy medicine Prof. John Fetrow of the University of Minnesota and Dairy and Animal Science Department Head Terry D. Etherton of Penn State and signed by leading academics including Dale Bauman of Cornell University in New York, one of the pioneers in studying rBST. They cited a recent study in which more than 200 different samples of conventional, “rBST-free” and organic milk from retail stores across the U.S. were tested by audited procedures and found to have the same nutrient content and identical levels of the estrogen, IGF-1, bST. None contained antibiotics.

“It is easy to scare people by using the word ‘hormone,’ but all milk contains hormones and always has,” the letter said. “The levels of these hormones are the same in whatever milk you drink, and their presence poses no health risk to humans. Vitamin D is a steroid hormone and is added to milk. Milk also contains protein hormones, such as bovine somatotropin (also called bST or bovine growth hormone, BGH) and IGF-1. Both are present in tiny quantities in milk, are digested just like any other protein you eat (steak or tofu), and have no effect in people when eaten.”

The anti-rBST campaign was “particularly deceptive,” it said. “The vague and unsupportable assertions about ‘cancer’ or ‘antibiotic resistance’ (bST is not an antibiotic) are simply not scientifically credible. Oft-repeated smear campaigns can, however, gradually shape the public’s perceptions, and major food corporations understand the power of fear in selling food.”

The scientists asserted that “corporate interests can increase their profits if people fear conventional milk. They can make more money selling ‘rbST-free’ milk at $4/gallon or organic milk at $6/gallon (or more) than by selling conventional milk at $3/gallon, and the majority of that profit differential stays in the corporation’s hands.” The letter singled out Dean Foods, the largest fluid milk marketer, and Whole Foods Markets, the largest organic grocery chain, for financing the Organic Center, which “spreads fear and disinformation about conventional milk and other products of conventional agriculture” and touts products from Dean-owned Horizon Organic and Whole Foods.

The letter was released one week before an Ohio state review committee was to hold a hearing on a new regulation that would restrict “rBST-free” labeling and require a prominent label disclaimer that the milk is no different. It also would mandate record-keeping to verify the claim. The controversy has spread nationwide with Utah also contemplating label restrictions similar to Ohio’s and the legislatures of Missouri and Kansas considering bills to restrict “absence” claims. Pennsylvania proposed but withdrew a similar regulation. It also followed the announcement by Wal-Mart Stores, the leading U.S. food retailer, that it would sell own-label milk from rBST-free cows. Wal-Mart has not said whether it would put a claim on labels. A spokeswoman said only that the retailer was “considering our options on labels.”

Posted with permission.

I posted a press release on August 3, 2007 from the Department of Environment, Food and Rural Affairs (DEFRA) about a recent outbreak of Foot and Mouth Disease (FMD) in the United Kingdom.

On August, 8, 2007 the Health and Safety Executive (HSE) in the UK posted information that addresses potential breaches in biosecurity that may be linked to the outbreak. The HSE Report is presented below.

As discussed in the HSE Report, the FMD strain identified at the index farm was being worked on at the Institute for Animal Health (IAH) and Merial Animal Health Ltd. The farm is about 16 miles from these facilities. The HSE Report indicates that there is a strong probability that the strain involved in the farm outbreak originated from the IAH or the Merial sites. A question of great importance is whether this was an accidental or intended transfer of the virus from IAH or Merial. IF it is determined that the outbreak was the result of an intentional transfer from IAH or Merial, we will have witnessed a bioterrorism attack. However, in the absence of an admission, establishing this in a definitive way will be extraordinarily difficult, and I encourage readers to not jump to premature conclusions about the cause of the outbreak. However, readers must appreciate that the consequences of a bioterrorism attack(s) on animal agriculture are enormous (see Impact of Bioterrorism on Agriculture in the U.S.).

The Health and Safety Executive Report, August 8, 2007

• An outbreak of foot and mouth disease virus (FMDV) was confirmed at a farm in Surrey on 3 August 2007.
• Preliminary DEFRA investigations indicated that the virus may have originated from the Pirbright site at which two separate organizations are based: the IAH and Merial.
• A multidisciplinary cross-government team with representatives from HSE, DEFRA, the Veterinary Medicines Directorate (VMD) and the Environment Agency (EA) supported by others, conducted on-site investigations on 5, 6 and 7 August.
• This initial report outlines the investigation’s key lines of inquiry and the next steps planned as of 7 August 2007.

Purpose of the Investigation

The Health and Safety Executive was asked by the Government to lead a team to investigate any potential breaches of biosecurity at the IAH and Merial sites; whether such breaches may have led to a release of any specified animal pathogen and whether any such breaches had been rectified to prevent future incidents. A multidisciplinary team was assembled with expertise in a wide range of relevant areas, including in investigation; in working with highly infectious viruses; in engineering control systems relevant to containment; in veterinary medicine production; and in management systems for controlling risk and environmental protection issues.

The Legal Position

The primary legal requirement applying to the site is the Specified Animal Pathogens Order 1998, enforced by DEFRA, which requires licensing of work with FMDV. HSE’s primary remit is to regulate the health and safety of staff at IAH and the Merial sites and to regulate (jointly with DEFRA) human health and environmental risks from work involving genetically modified organisms (GMOs) at the IAH.

What We Did

• We concentrated on biosecurity issues associated with FMDV strain O1BFS67 as this was the strain associated with the outbreak.
• We concentrated on the time frame between 14 and 25 July 2007 as this was advised by DEFRA to be the most likely period of infection.
• We investigated whether or not this strain was in use at the IAH and Merial sites in that time frame and the precise nature of any activities undertaken.
• We investigated whether or not there had been any lapses in control measures which could have led to a breach in biosecurity and whether these could be linked to the outbreak.

To do this we carried out inspections of all facilities of both the IAH and Merial sites where the FMDV strain is handled. This involved checking key biosecurity measures including engineering controls, management systems, working practices and a review of the record logs. We reviewed documents, interviewed staff and visually inspected all the facilities.

What We Found
The following key lines of inquiry were investigated:

Identifying the virus strain

• We confirmed that the FMDV strain found at the outbreak farm was being worked on at both organizations at both the IAH and Merial sites during the period between 14 and 25 July 2007. This involved large scale production at the Merial site (10,000 liters) and a series of small scale experiments (less than 10 ml in each case) at the IAH site.
• We have initiated further studies intended to provide additional molecular information on the virus types in use at both organizations. This requires detailed technical analysis and the results are not available for inclusion in this report but are expected within a week.

Subject to the ongoing work detailed above, the indications are that there is a strong probability that the FMDV strain involved in the farm outbreak originated from the IAH or the Merial sites.

Potential for airborne release from the site

• We found no evidence of any working practices or incidents such as laboratory spillages or leakages from plant or equipment which could have led to a release of the FMDV strain within the contained working environment at either organization.
• We confirmed that all air being discharged to atmosphere from the contained working environments is first passed through a minimum of two high-efficiency particulate (HEPA) air filters.
• We confirmed that there is continuous monitoring of the pressures of the ventilation systems of the facility and that the HEPA filters are routinely integrity-tested in line with regulatory requirements.
• Examination of local wind conditions for the period indicates that there was only a very limited period during which the wind could have acted as a transmission link. This would have had to coincide with a release of virus through the ventilation system. We found no evidence of such a release.

We are further exploring the meteorological data, but at this stage, we consider there to be a negligible combined likelihood that there was an airborne release from the IAH or the Merial sites which was subsequently transferred to the first affected farm between the 14 and 25 July 2007.

Potential for waterborne release from the site

• We established that two separate effluent treatment systems exist on Pirbright site: one services the animal isolation unit at the IAH; the second services both the remainder of the IAH site together with the Merial site.
• We established that the effluent treatment system servicing the IAH animal isolation unit employs a thermal inactivation process. There was no evidence of it operating unsatisfactorily between the 14 and 25 July 2007.
• We established that the effluent treatment system servicing the remainder of the IAH site together with the Merial site employs a chemical inactivation process. Whilst control measures are in place at both premises to require chemical treatment of liquid effluent before it enters the system, a number of biosecurity issues have arisen which are subject to ongoing investigation. These include:
  • the integrity of the system and all associated pipework;
  • the potential for the FMD Virus to have entered this system during the specified time period;
  • whether heavy rain and flooding during the period may have overwhelmed this system;
  • whether any contaminated material could have been transferred between the IAH and Merial sites and the first affected farm.
• For virus to have escaped from the effluent pipe, this would have required a failure in the intermediate inactivation process either at the Merial or IAH site and this would have had to coincide with the flooding.

Waterborne release onto the site remains a possibility. But preliminary investigations into the possibility of whether surface water from flooding from the site could have reached and contaminated the affected farm have indicated that this was negligible due to the distance, topography and direction of flow. These issues are being investigated further.

Potential for Release from the Site by Human Movements

There are various potential routes for accidental or deliberate transfer of material from the site. We have investigated site management systems and records and spoken to a number of employees. As a result we are pursuing lines of inquiry.

Release by human movement must also be considered a real possibility. Further investigation of the above issues is required and is being urgently pursued.

The Next Steps

We will continue with our work and report further as necessary. This report also provides a basis for the independent review of biosecurity arrangements to be led by Professor Spratt of Imperial College. We are briefing Professor Spratt and his team and will also offer him continuing support.

Following an investigation of suspected vesicular disease by Animal Health on a holding near Guildford in Surrey, United Kingdom, laboratory results have this evening indicated that the Foot and Mouth Disease (FMD) virus is present in samples from cattle on the premises.

On the basis of the initial laboratory results Debby Reynolds, UK Chief Veterinary Officer has confirmed Foot and Mouth Disease. In accordance with the legislation and contingency planning arrangements all the cattle on the premises will be culled. A Protection Zone of three kilometers radius and a Surveillance Zone of 10 kilometers has been placed around the premises, and a national movement ban of all ruminants and pigs has been imposed.

Nationally no animal movements are allowed except under license, controls are in place on movement of animal carcasses, animal gatherings, shearing and dipping are restricted, and all farms must increase levels of biosecurity. In both the Protection and Surveillance Zones, there will be requirements for increased levels of biosecurity on farms, movement controls, controls on transportation of dung/manure and treatment of animal products to ensure destruction of the FMD virus.

The farm itself has been under restrictions since late on Thursday evening when symptoms were reported to the local Animal Health office. A 1km temporary restriction zone was placed around the premises earlier today whilst investigations and testing were completed, in line with domestic and EU legislation.

According to an article published in FoodNaviator.com, Unilever, the parent company of Ben & Jerry’s, one of the most visible anti-biotechnology ice cream makers in the United States, has moved closer to gaining approval in Europe to use an ice-structuring protein (ISP) isolated from genetically modified yeast.

In their Summary, the Advisory Committee on Novel Foods and Processes of the United Kingdom Food Standards Committee stated they were satisfied by the evidence provided by Unilever that the range of uses for its ice structuring protein preparation is acceptable, subject to the applicant’s adherence to the proposed specification and the production parameters described above.

An interesting paradox isn’t it? Ben & Jerry’s attacks the use of rbST in the dairy industry, which is perfectly safe. Yet, their parent company, Unilever is seeking regulatory approval in Europe to use ISP isolated from yeast that have been genetically engineered to produce ISP.

My view – it is wonderful science. Wonder what the folks at Ben & Jerry’s think?

Read more about this in the Foodnavigator.com article below.

Unilever moves closer with GM ice cream protein

By Jess Halliday
Foodnavigator.com

4/10/2007 – Low fat ice cream made using a GM yeast moved closer to being approved for the European market, as the FSA published its draft opinion on Unilever technology under novel foods regulation.

The consumer goods firm applied to the UK’s Food Standards Agency (FSA) for novel foods approval to use ice-structuring proteins derived from a fermented genetically modified baker’s yeast last year.

The draft opinion that the ISP preparation is acceptable subject to proposed parameters, on which the FSA is currently eliciting comments,is a step towards Unilever gaining the go-ahead for Europe. However the agency opines that consumers should be made aware that products made using the ISP, even though the GM yeast cells are removed from the final product.

ISPs are naturally occurring proteins and peptides found in living organisms such as fish, which protect them from tissue damage in very cold conditions by modifying the size and shape of ice-crystals.

Unilever found that type III ISPs from the cold water fish ocean pout could be used in ice-cream products to make a large number of very small ice crystals, as opposed to the small number of large crystals produced by conventional freezing techniques.

This ice-structure enables different kinds of formulations, such as low-fat.

However since the it would be unsustainable to use proteins directly from the fish, Unilever developed a fermentation process using the GM yeast carrying the synthetic gene encoding for the ISP.

The European Commission stated in a recent report that ingredients produced by fermentation using GM micro-organisms not present in the final product do not fall under GM food legislation – and therefore do not need to be labelled as GM.

Although this applies to Unilever’s ISP, the FSA’s Advisory Committee on Novel Foods and Processes (ACNFP) said this was a special case, on the grounds of “the use of a synthetic gene sequence and the presence…of a significant proportion of cellular by-products from the fermentation process such as yeast proteins”.

Thus, it recommends that consumers should be provided with information indicating that the ingredient is made using a GM yeast – either through information provided on food packaging or “via other easily accessible routes”.

Given that European public opinion remains largely opposed to GMOs, such information could potentially turn some consumers off the
products.

Moreover, the novel foods application, required since the ISO was not commonly used in foods in the EU prior to 1997, has already caused considerable controversy with anti-GM campaigners.

Last July scientists working on behalf of pressure group the Independent Science Panel submitted their findings to the FSA that the health and safety risks that have not been taken into account.

Such concerns are likely to resurface during the consultation on the initial draft opinion.

The transgenic protein has already been authorised in Australia, New Zealand, Chile, Indonesia, Mexico, the Unites States and the Philippines.

In addition to the GM labelling, the agency also said that products made using the ISP preparation should carry labels indicating yeast derivation, for the benefit of allergy sufferers.