Cancéropôle Lyon Rhône-Alpes

Background:

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 overwhelmedthis 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.

Permalink

Comments are closed.

Harvey Glick
The Economic Times (India)
Published June 19, 2007

In the 1960s, India produced only about 10 million metric tonnes of wheat annually, and crop failures created massive food shortages that required emergency shipments of grain to prevent widespread famine. Today, India produces over 70 million metric tonnes of wheat. This is due in large part to the success of the Green Revolution, based on new genetic improvements of crops combined with efficient use of crop production inputs.

However, food security remains a global challenge today and famine still threatens several parts of the globe. There remains a critical need to develop new agricultural technologies that will increase yields and eliminate crop failures and famines. Many scientists believe that new plants developed using modern biotechnology will play an important role in increasing our ability to produce enough food. Often called the Gene Revolution, advances in biotechnology are having dramatic impacts on global agricultural production.

Biotech crops were planted on over 100 million hectares last year by 10 million farmers in 22 countries and the results have been well documented. In all countries where farmers have access to biotech crops, yields are higher and production costs are lower, making farmers more efficient than ever before. Since 2003, when biotech Bt cotton was introduced, India’s cotton output has almost doubled to 27 million bales weighing 170 kilograms each, and average yields are up around two-thirds, largely because of lower rates of pest infestation in the hardier Bt-cotton varieties.

One of the most significant contributions from biotech crops has been their impact on the environment, although this has largely gone unnoticed. Unlike the original Green Revolution, which saw large increases in use of pesticides and fuel, the new biotech crops of the Gene Revolution help reduce the use of inputs like pesticides, fuel and water. EU economists reported that biotech crops have been responsible for a decrease in pesticide use of over 200 million kg, which has reduced the environmental impact by more than 15%. Fewer pesticide applications mean less use of fuel and water on the farm. In India, pesticide use in Bt cotton has been reduced by half and this has reduced the use of fuel and water as well as reducing farmer exposure.

Greenhouse gases are a much discussed topic today, but agriculture is often overlooked in this discussion. In fact,agriculture is a contributor of greenhouse gases and studies have shown that biotech crops help decrease these emissions. Scientists estimate that biotech crops planted in 2005 decreased global emission of carbon dioxide by 20 billion pounds. This is the equivalent of removing 4 million cars from the road for a whole year.

Indian farmers have always been in the forefront of innovation and have rapidly adopted these new biotech cotton varieties. Last year over 2 million small farmers planted an average 1.6 hectares of biotech cotton and Indian cotton yields have greatly increased. More importantly, these new crops are grown in a more sustainable manner, with less use of pesticides, fuel and water and less impact on the environment. Biotech cotton has been an overwhelming success story in India but production in many other crops has been stagnant and there are increasing calls to introduce these new biotechnology improvements to other crops to help Indian farmers become more efficient and more competitive.

As we look forward, the challenges become even greater. Every year, India loses valuable farmland to development and access to water becomes more challenging. There are greater demands to grow more food on less land, and in a more sustainable fashion with less environmental impact. All this must be done while dealing with climate change and the uncertain impacts on agriculture.

Improvements in agricultural technology are a critical component of meeting this challenge and biotech crops are already making a contribution. Insect protected crops and herbicide tolerant crops allow farmers to achieve high yields even while using fewer pesticides.

New drought tolerant crops, which will grow and survive even when rainfall is not optimal, are being developed through biotechnology. Imagine how this can help farmers who wonder each year as they plant their crop if they will receive enough rainfall to produce a good crop. The development of crops that can be used as biofuels is another important development. These biofuels, which are a renewable energy source that is clean burning, provide an important alternative to traditional fuels that also can contribute to a reduction in carbon emissions.

From the first Green Revolution to the current Gene Revolution, innovative new technologies have significantly improved our ability to feed our planet. Farmers in India and around the world, who have pioneered the use of Bt and RR crops developed from modern biotechnology, have seen their innovation rewarded in terms of higher production and lower environmental impacts. Future innovations like biofuels and drought-tolerant crops will further contribute to sustainable production efficiencies.

(The author is Director, Scientific Affairs, Monsanto)

Permalink

Comments are closed.

More than 500 interested parties join Monsanto to ask FDA and FTC to focus on companies that use deceptive milk labels and ads

ST LOUIS (April 3, 2007) – Monsanto Company announced today that letters from more than 500 concerned individuals and Monsanto have been submitted to the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) requesting action to stop deceptive milk labeling and advertising. The two letters outline how certain milk labels and promotions that differentiate milk based on farmer use of POSILAC bovine somatotropin (bST) are misleading to consumers and do not meet the standards set by laws and regulations for either the Federal Trade Commission or the Food and Drug Administration.

“The people who signed these letters are dairy producers, industry professionals and consumers from across the country who have expressed concerns about specific labels they find to be false or misleading,” said Kevin Holloway, president of Monsanto Dairy Business. “In many cases, they came to Monsanto to find out what could be done about milk marketing tactics that disparage milk and deny farmers a choice in using approved technologies. We believe FDA and FTC are the correct agencies to address the matter with the companies who employ misleading labels or promotions.”

The letter to the FDA highlights deceptive milk labels and calls for clear guidance and enforcement by FDA to address labeling that disparages milk from cows supplemented with POSILAC. The letter to the FTC outlines deceptive advertising and milk promotions that mislead consumers and requests FTC begin an investigation into the challenged practices. Specific examples of misleading labels and ads are cited and attached to the letters. Letters and attachments are available at www.monsanto.com/posilac/letters.

Monsanto submitted the first set of signed letters on behalf of all who signed them in February and continues to compile additional letters as dairy producers and others sign them.

“This is of great concern to dairy producers, “said Dennis Areias, a Los Banos, Calif., dairy producer who signed the letters. “Deceptive labels suggest to consumers that there is something wrong with the milk they have been drinking for the past 13 years. Even though the companies that print these labels know this is not true, they choose to mislead consumers in an effort to charge more money for the same milk.”

FDA conducted a thorough review of POSILAC before approving the product in 1993 and determined milk from supplemented cows to be the same as milk from non-supplemented cows.

In a recent study, lab analysis of 95 different brands of retail milk purchased in 48 states confirmed all milk naturally contains the same hormones. There was no difference in hormone content of retail milk based on label claims regarding the use of POSILAC. The findings of the study, conducted by Monsanto with third-party testing facilities and an independent auditing firm, reinforce that milk marketing claims differentiating milk based on the use of POSILAC are meaningless.

“Deceptive labels and ads are not only damaging to dairy producers who are forced to give up technology that helps them make a living, they hurt consumers” said John Vrieze, an Emerald, Wisc., dairy producer who also signed the letters to the FDA and FTC. “The misleading language clearly aims to scare people into paying more for the same milk. These ill-gotten gains are not shared with farmers and shame on us if we would seek to profit by disparaging the image of milk that we have invested heavily in promoting as a safe, healthy product.”

********

Terry Etherton’s perspectives about misleading labels.

The filing of the Petitions with FDA and FTC is an important stop to pursue in the context of promoting “truth-in-labeling”. As the release conveys (and has been covered in my Blog), many milk marketers have gone down the path of seeking forgiveness rather than regulatory approval for using the countless (and shameless) labels that different milk and dairy products by the use of “absence claims”. They have gotten away this - FDA and FTC need to step in and FIX the problem.

These absence claims have one objective: to scare consumers. The idea that rbST-free milk and organic milk should be differentiated from conventional milk on the basis of labels that communicate “no antibiotics, artificial hormones, or dangerous pesticides” is a prime example of the smoke and mirrors milk marketing campaigns that are ongoing. The fact is that ALL milk is the same relative to composition, safety and wholesomeness.

Permalink

Comments are closed.

Background:

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 August2007.

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.

Permalink

Comments are closed.

Harvey Glick
The Economic Times (India)
Published June 19, 2007

In the 1960s, India produced only about 10 million metric tonnes of wheat annually, and crop failures created massive food shortages that required emergency shipments of grain to prevent widespread famine. Today, India produces over 70 million metric tonnes of wheat. This is due in large part to the success of the Green Revolution, based on new genetic improvements of crops combined with efficient use of crop production inputs.

However, food security remains a global challenge today and famine still threatens several parts of the globe. There remains a critical need to develop new agricultural technologies that will increase yields and eliminate crop failures and famines. Many scientists believe that new plants developed using modern biotechnology will play an important role in increasing our ability to produce enough food. Often called the Gene Revolution, advances in biotechnology are having dramatic impacts on global agricultural production.

Biotech crops were planted on over 100 million hectares last year by 10 million farmers in 22 countries and the results have been well documented. In all countries where farmers have access to biotech crops, yields are higher and production costs are lower, making farmers more efficient than ever before. Since 2003, when biotech Bt cotton was introduced, India’s cotton output has almost doubled to 27 million bales weighing 170 kilograms each, and average yields are up around two-thirds, largely because of lower rates of pest infestation in the hardier Bt-cotton varieties.

One of the most significant contributions from biotech crops has been their impact on the environment, although this has largely gone unnoticed. Unlike the original Green Revolution, which saw large increases in use of pesticides and fuel, the new biotech crops of the Gene Revolution help reduce the use of inputs like pesticides, fuel and water. EU economists reported that biotech crops have been responsible for a decrease in pesticide use of over 200 million kg, which has reduced the environmental impact by more than 15%. Fewer pesticide applications mean less use of fuel and water on the farm. In India, pesticide use in Bt cotton has been reduced by half and this has reduced the use of fuel and water as well as reducing farmer exposure.

Greenhouse gases are a much discussed topic today, but agriculture is often overlooked in this discussion. In fact,agriculture is a contributor of greenhouse gases and studies have shown that biotech crops help decrease these emissions. Scientists estimate that biotech crops planted in 2005 decreased global emission of carbon dioxide by 20 billion pounds. This is the equivalent of removing 4 million cars from the road for a whole year.

Indian farmers have always been in the forefront of innovation and have rapidly adopted these new biotech cotton varieties. Last year over 2 million small farmers planted an average 1.6 hectares of biotech cotton and Indian cotton yields have greatly increased. More importantly, these new crops are grown in a more sustainable manner, with less use of pesticides, fuel and water and less impact on the environment. Biotech cotton has been an overwhelming success story in India but production in many other crops has been stagnant and there are increasing calls to introduce these new biotechnology improvements to other crops to help Indian farmers become more efficient and more competitive.

As we look forward, the challenges become even greater. Every year, India loses valuable farmland to development and access to water becomes more challenging. There are greater demands to grow more food on less land, and in a more sustainable fashion with less environmental impact. All this must be done while dealing with climate change and the uncertain impacts on agriculture.

Improvements in agricultural technology are a critical component of meeting this challenge and biotech crops are already making a contribution. Insect protected crops and herbicide tolerant crops allow farmers to achieve high yields even while using fewer pesticides.

New drought tolerant crops, which will grow and survive even when rainfall is not optimal, are being developed through biotechnology. Imagine how this can help farmers who wonder each year as they plant their crop if they will receive enough rainfall to produce a good crop. The development of crops that can be used as biofuels is another important development. These biofuels, which are a renewable energy source that is clean burning, provide an important alternative to traditional fuels that also can contribute to a reduction in carbon emissions.

From the first Green Revolution to the current Gene Revolution, innovative new technologies have significantly improved our ability to feed our planet. Farmers in India and around the world, who have pioneered the use of Bt and RR crops developed from modern biotechnology, have seen their innovation rewarded in terms of higher production and lower environmental impacts. Future innovations like biofuels and drought-tolerant crops will further contribute to sustainable production efficiencies.

(The author is Director, Scientific Affairs, Monsanto)

Permalink

Comments are closed.

More than 500 interested parties join Monsanto to ask FDA and FTC to focus on companies that use deceptive milk labels and ads

ST LOUIS (April 3, 2007) – Monsanto Company announced today that letters from more than 500 concerned individuals and Monsanto have been submitted to the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) requesting action to stop deceptive milk labeling and advertising. The two letters outline how certain milk labels and promotions that differentiate milk based on farmer use of POSILAC bovine somatotropin (bST) are misleading to consumers and do not meet the standards set by laws and regulations for either the Federal Trade Commission or the Food and Drug Administration.

“The people who signed these letters are dairy producers, industry professionals and consumers from across the country who have expressed concerns about specific labels they find to be false or misleading,” said Kevin Holloway, president of Monsanto Dairy Business. “In many cases, they came to Monsanto to find out what could be done about milk marketing tactics that disparage milk and deny farmers a choice in using approved technologies. We believe FDA and FTC are the correct agencies to address the matter with the companies who employ misleading labels or promotions.”

The letter to the FDA highlights deceptive milk labels and calls for clear guidance and enforcement by FDA to address labeling that disparages milk from cows supplemented with POSILAC. The letter to the FTC outlines deceptive advertising and milk promotions that mislead consumers and requests FTC begin an investigation into the challenged practices. Specific examples of misleading labels and ads are cited and attached to the letters. Letters and attachments are available at www.monsanto.com/posilac/letters.

Monsanto submitted the first set of signed letters on behalf of all who signed them in February and continues to compile additional letters as dairy producers and others sign them.

“This is of great concern to dairy producers, “said Dennis Areias, a Los Banos, Calif., dairy producer who signed the letters. “Deceptive labels suggest to consumers that there is something wrong with the milk they have been drinking for the past 13 years. Even though the companies that print these labels know this is not true, they choose to mislead consumers in an effort to charge more money for the same milk.”

FDA conducted a thorough review of POSILAC before approving the product in 1993 and determined milk from supplemented cows to be the same as milk from non-supplemented cows.

In a recent study, lab analysis of 95 different brands of retail milk purchased in 48 states confirmed all milk naturally contains the same hormones. There was no difference in hormone content of retail milk based on label claims regarding the use of POSILAC. The findings of the study, conducted by Monsanto with third-party testing facilities and an independent auditing firm, reinforce that milk marketing claims differentiating milk based on the use of POSILAC are meaningless.

“Deceptive labels and ads are not only damaging to dairy producers who are forced to give up technology that helps them make a living, they hurt consumers” said John Vrieze, an Emerald, Wisc., dairy producer who also signed the letters to the FDA and FTC. “The misleading language clearly aims to scare people into paying more for the same milk. These ill-gotten gains are not shared with farmers and shame on us if we would seek to profit by disparaging the image of milk that we have invested heavily in promoting as a safe, healthy product.”

********

Terry Etherton’s perspectives about misleading labels.

The filing of the Petitions with FDA and FTC is an important stop to pursue in the context of promoting “truth-in-labeling”. As the release conveys (and has been covered in my Blog), many milk marketers have gone down the path of seeking forgiveness rather than regulatory approval for using the countless (and shameless) labels that different milk and dairy products by the use of “absence claims”. They have gotten away this - FDA and FTC need to step in and FIX the problem.

These absence claims have one objective: to scare consumers. The idea that rbST-free milk and organic milk should be differentiated from conventional milk on the basis of labels that communicate “no antibiotics, artificial hormones, or dangerous pesticides” is a prime example of the smoke and mirrors milk marketing campaigns that are ongoing. The fact is that ALL milk is the same relative to composition, safety and wholesomeness.

Permalink

Comments are closed.

Background:

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 August2007.

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.

Permalink

Comments are closed.

Harvey Glick
The Economic Times (India)
Published June 19, 2007

In the 1960s, India produced only about 10 million metric tonnes of wheat annually, and crop failures created massive food shortages that required emergency shipments of grain to prevent widespread famine. Today, India produces over 70 million metric tonnes of wheat. This is due in large part to the success of the Green Revolution, based on new genetic improvements of crops combined with efficient use of crop production inputs.

However, food security remains a global challenge today and famine still threatens several parts of the globe. There remains a critical need to develop new agricultural technologies that will increase yields and eliminate crop failures and famines. Many scientists believe that new plants developed using modern biotechnology will play an important role in increasing our ability to produce enough food. Often called the Gene Revolution, advances in biotechnology are having dramatic impacts on global agricultural production.

Biotech crops were planted on over 100 million hectares last year by 10 million farmers in 22 countries and the results have been well documented. In all countries where farmers have access to biotech crops, yields are higher and production costs are lower, making farmers more efficient than ever before. Since 2003, when biotech Bt cotton was introduced, India’s cotton output has almost doubled to 27 million bales weighing 170 kilograms each, and average yields are up around two-thirds, largely because of lower rates of pest infestation in the hardier Bt-cotton varieties.

One of the most significant contributions from biotech crops has been their impact on the environment, although this has largely gone unnoticed. Unlike the original Green Revolution, which saw large increases in use of pesticides and fuel, the new biotech crops of the Gene Revolution help reduce the use of inputs like pesticides, fuel and water. EU economists reported that biotech crops have been responsible for a decrease in pesticide use of over 200 million kg, which has reduced the environmental impact by more than 15%. Fewer pesticide applications mean less use of fuel and water on the farm. In India, pesticide use in Bt cotton has been reduced by half and this has reduced the use of fuel and water as well as reducing farmer exposure.

Greenhouse gases are a much discussed topic today, but agriculture is often overlooked in this discussion. In fact,agriculture is a contributor of greenhouse gases and studies have shown that biotech crops help decrease these emissions. Scientists estimate that biotech crops planted in 2005 decreased global emission of carbon dioxide by 20 billion pounds. This is the equivalent of removing 4 million cars from the road for a whole year.

Indian farmers have always been in the forefront of innovation and have rapidly adopted these new biotech cotton varieties. Last year over 2 million small farmers planted an average 1.6 hectares of biotech cotton and Indian cotton yields have greatly increased. More importantly, these new crops are grown in a more sustainable manner, with less use of pesticides, fuel and water and less impact on the environment. Biotech cotton has been an overwhelming success story in India but production in many other crops has been stagnant and there are increasing calls to introduce these new biotechnology improvements to other crops to help Indian farmers become more efficient and more competitive.

As we look forward, the challenges become even greater. Every year, India loses valuable farmland to development and access to water becomes more challenging. There are greater demands to grow more food on less land, and in a more sustainable fashion with less environmental impact. All this must be done while dealing with climate change and the uncertain impacts on agriculture.

Improvements in agricultural technology are a critical component of meeting this challenge and biotech crops are already making a contribution. Insect protected crops and herbicide tolerant crops allow farmers to achieve high yields even while using fewer pesticides.

New drought tolerant crops, which will grow and survive even when rainfall is not optimal, are being developed through biotechnology. Imagine how this can help farmers who wonder each year as they plant their crop if they will receive enough rainfall to produce a good crop. The development of crops that can be used as biofuels is another important development. These biofuels, which are a renewable energy source that is clean burning, provide an important alternative to traditional fuels that also can contribute to a reduction in carbon emissions.

From the first Green Revolution to the current Gene Revolution, innovative new technologies have significantly improved our ability to feed our planet. Farmers in India and around the world, who have pioneered the use of Bt and RR crops developed from modern biotechnology, have seen their innovation rewarded in terms of higher production and lower environmental impacts. Future innovations like biofuels and drought-tolerant crops will further contribute to sustainable production efficiencies.

(The author is Director, Scientific Affairs, Monsanto)

Permalink

Comments are closed.

More than 500 interested parties join Monsanto to ask FDA and FTC to focus on companies that use deceptive milk labels and ads

ST LOUIS (April 3, 2007) – Monsanto Company announced today that letters from more than 500 concerned individuals and Monsanto have been submitted to the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) requesting action to stop deceptive milk labeling and advertising. The two letters outline how certain milk labels and promotions that differentiate milk based on farmer use of POSILAC bovine somatotropin (bST) are misleading to consumers and do not meet the standards set by laws and regulations for either the Federal Trade Commission or the Food and Drug Administration.

“The people who signed these letters are dairy producers, industry professionals and consumers from across the country who have expressed concerns about specific labels they find to be false or misleading,” said Kevin Holloway, president of Monsanto Dairy Business. “In many cases, they came to Monsanto to find out what could be done about milk marketing tactics that disparage milk and deny farmers a choice in using approved technologies. We believe FDA and FTC are the correct agencies to address the matter with the companies who employ misleading labels or promotions.”

The letter to the FDA highlights deceptive milk labels and calls for clear guidance and enforcement by FDA to address labeling that disparages milk from cows supplemented with POSILAC. The letter to the FTC outlines deceptive advertising and milk promotions that mislead consumers and requests FTC begin an investigation into the challenged practices. Specific examples of misleading labels and ads are cited and attached to the letters. Letters and attachments are available at www.monsanto.com/posilac/letters.

Monsanto submitted the first set of signed letters on behalf of all who signed them in February and continues to compile additional letters as dairy producers and others sign them.

“This is of great concern to dairy producers, “said Dennis Areias, a Los Banos, Calif., dairy producer who signed the letters. “Deceptive labels suggest to consumers that there is something wrong with the milk they have been drinking for the past 13 years. Even thoughthe companies that print these labels know this is not true, they choose to mislead consumers in an effort to charge more money for the same milk.”

FDA conducted a thorough review of POSILAC before approving the product in 1993 and determined milk from supplemented cows to be the same as milk from non-supplemented cows.

In a recent study, lab analysis of 95 different brands of retail milk purchased in 48 states confirmed all milk naturally contains the same hormones. There was no difference in hormone content of retail milk based on label claims regarding the use of POSILAC. The findings of the study, conducted by Monsanto with third-party testing facilities and an independent auditing firm, reinforce that milk marketing claims differentiating milk based on the use of POSILAC are meaningless.

“Deceptive labels and ads are not only damaging to dairy producers who are forced to give up technology that helps them make a living, they hurt consumers” said John Vrieze, an Emerald, Wisc., dairy producer who also signed the letters to the FDA and FTC. “The misleading language clearly aims to scare people into paying more for the same milk. These ill-gotten gains are not shared with farmers and shame on us if we would seek to profit by disparaging the image of milk that we have invested heavily in promoting as a safe, healthy product.”

********

Terry Etherton’s perspectives about misleading labels.

The filing of the Petitions with FDA and FTC is an important stop to pursue in the context of promoting “truth-in-labeling”. As the release conveys (and has been covered in my Blog), many milk marketers have gone down the path of seeking forgiveness rather than regulatory approval for using the countless (and shameless) labels that different milk and dairy products by the use of “absence claims”. They have gotten away this - FDA and FTC need to step in and FIX the problem.

These absence claims have one objective: to scare consumers. The idea that rbST-free milk and organic milk should be differentiated from conventional milk on the basis of labels that communicate “no antibiotics, artificial hormones, or dangerous pesticides” is a prime example of the smoke and mirrors milk marketing campaigns that are ongoing. The fact is that ALL milk is the same relative to composition, safety and wholesomeness.

Permalink

Comments are closed.