Bovaer is a feed additive designed to reduce methane emissions from cattle, but its introduction has ignited a flurry of consumer questions and concerns. Some critics question the rigorousness of testing procedures, particularly regarding human consumption of milk from Bovaer-fed cows.
Concerns also centre on the potential for adverse effects, highlighted by reports of tumours in rats exposed to high doses of 3-NOP, the main ingredient in Bovaer, and what effect it will have on our meat, milk, butter, cheese and dairy products, but furthermore, it is not clear whether crops grown in ground where manure has been used as a fertiliser will be affected.
I’m no scientist, but I’m a concerned consumer, and I believe we deserve transparency and thorough research before new products like this are introduced into our food chain, let alone potentially mandated. So, let’s deep dive into what we know about Bovaer, its FDA approval process, and the potential risks it poses.
In this article
What is Bovaer, and how does it work?
Bovaer is a feed additive developed by the Dutch company DSM-Firmenich that’s claimed to reduce methane emissions from cattle, specifically enteric methane produced during their digestion. It contains 3-nitrooxypropanol (3-NOP) as its active ingredient, along with silicon dioxide and propylene glycol. A tiny amount, just a quarter teaspoon per cow per day, is supposed to reduce methane emissions by an average of 27%.
While reducing methane emissions is a positive step towards tackling climate change, questions linger about the potential health and environmental impacts of this synthetic additive.
FDA Approval: Is Bovaer a Drug or a Feed Additive?
It seems even the FDA isn’t entirely sure what to make of Bovaer. The U.S. Food and Drug Administration (FDA) classifies it as a drug because it affects the animal’s bodily functions. However, they’ve decided not to enforce standard drug regulations for Bovaer, including new animal drug approval, pharmaceutical current Good Manufacturing Practice, adverse event reporting, labeling, drug establishment registration, and drug product listing, believing it poses a “low risk to humans and animals”.
This decision to exercise “enforcement discretion” raises concerns about the lack of rigorous safety monitoring procedures. After all, if it’s powerful enough to change a cow’s biological processes, shouldn’t we be absolutely certain it’s safe for the animal and anyone consuming its milk?
To me, it feels like a bit of a loophole – calling it a drug, yet choosing not to regulate it as one. This lack of clarity and potential for relaxed oversight is definitely a red flag for me.
What Do Studies Say About Bovaer’s Safety?
The lack of transparency about the FDA’s decision-making process is just the tip of the iceberg. When you look into the actual research and safety assessments, you find more reasons to be concerned.
The available research on Bovaer raises questions about its safety for animals, particularly at higher doses. For instance, in one tolerance study, cows given the highest doses of 3-NOP displayed reduced feed intake and reduced heart weight. While no pathological signs were observed, the small sample size of this study (only four cows per group) makes it difficult to draw definitive conclusions. Another study reported a decrease in ovary size and reduced enzyme activity in cows receiving high doses of 3-NOP. Again, these findings, while not deemed adverse effects by the assessing group, warrant further investigation to understand the long-term consequences.
The UK’s Advisory Committee on Animal Feedingstuffs (ACAF) also acknowledged that, based on tests conducted using the active substance 3-NOP, Bovaer should be considered corrosive to the eyes, a skin irritant, and potentially harmful by inhalation. This poses potential risks not only to the animals but also to the farmworkers handling the additive.
Early in the assessment process, concerns were raised regarding the absence of analysis for dioxins and heavy metals in the final Bovaer product. The applicant subsequently addressed some of these concerns, but it highlights the importance of rigorous testing and transparency throughout the approval process.
Toxic Chemicals in Bovaer:
H315 – Causes skin irritation
H318 – Causes serious eye damage
H361f – Suspected of damaging fertility
Perhaps the most alarming fact is that the long-term effects of consuming milk from cows fed Bovaer haven’t been studied in humans. This means we are essentially part of a giant, uncontrolled experiment. The fact that a 2021 study discovered deposits of 3-NOP in the liver, adrenal glands, kidney, fat, muscles, and brain of rats adds another layer of concern. If the active ingredient can end up in the organs of rats, what’s to say it can’t happen in humans?
Bovaer and the Connection to Bill Gates
While there is no direct involvement of Bill Gates in the development or production of Bovaer, Bill Gates’ investment firm, Breakthrough Energy Ventures (BEV), invested $12 million in Rumin8, an Australian start-up developing feed supplements to reduce methane emissions from livestock. This investment occurred in January 2023.
Rumin8 is a competitor to Bovaer, which is owned by the Dutch-Swiss company DSM-Firmenich. BlackRock holds approximately 3.19% of the shares in DSM-Firmenich, which translates to about 8,450,181 shares.
DSM-Firmenich received £10 million to open a plant in Ayrshire to significantly increase the production of Bovaer.
BlackRock does not own BEV. However, BlackRock has engaged in partnerships and made significant philanthropic contributions to initiatives associated with Breakthrough Energy.
Notably, the BlackRock Foundation granted $100 million to Breakthrough Energy’s Catalyst Program, aimed at accelerating clean energy technologies necessary for achieving net-zero emissions by 2050.
Bill Gate’s Breakthrough Energy Ventures invests ‘in companies focused on ‘cultivated’ meat (aka fake meat), including those producing cultivated or lab-grown meat.
Notably, BEV has made significant investments in various startups within this sector, including Impossible Foods and Memphis Meats (now known as Upside Foods) which are prominent players in the development of synthetic meat products.
Furthermore, BEV has been involved in funding initiatives aimed at improving the sustainability and efficiency of alternative protein production, recognizing the growing market and technological advancements in this field
DSM-Firmenich has invested in fake meat company Meatable. Recently, Meatable secured $35 million in funding during its Series B round, with DSM-Firmenich being one of the key investors.
DSM-Firmenich’s involvement is part of a strategic initiative to support the development of alternative proteins, including cultivated meat, as they believe this technology is crucial for the future of sustainable protein sources. The partnership also includes a joint development agreement that allows DSM to lend expertise in areas such as fermentation and cell analysis to enhance Meatable’s production capabilities
Public Concerns and the Push for Transparency
The news of Arla’s Bovaer trial in the UK sparked a fierce backlash on social media, with many consumers expressing concerns and calling for a boycott of Arla products. The lack of long-term safety data for human consumption and the potential for unknown risks are driving this public outcry. People are right to demand transparency about what they’re consuming and question the potential consequences of these novel feed additives.
Some commentators have attempted to dismiss these concerns, labeling them as “misinformation”. However, the limited research, unanswered questions, and the FDA’s own classification of Bovaer as a drug, albeit with relaxed enforcement, lend legitimacy to the public’s anxieties.
Here are all the brands and partnerships with Arla (they supply all supermarket own label dairy products!)
| Product Category/Brand | Seller/Supplier | Feed Additive Status |
|---|---|---|
| All own-brand dairy products | Aldi | Involved in Arla’s Bovaer trial |
| Lurpak butter, Anchor butter, Cravendale milk, Castello cheese | Arla Foods UK | Conducting Bovaer trials |
| All own-brand products | Asda | Potential Bovaer use, based on social media speculation |
| All chocolate products | Cadbury | Potential Bovaer use, based on social media speculation |
| Own-brand products | Co-op | Potential Bovaer use, based on social media statements |
| Own-brand milk, butter, cheese | Farmfoods | Potential Bovaer use, based on social media speculation |
| Milk, Butter, Cream, Cheese, Yoghurt, Ice Cream | Grahams | Potential Bovaer use, based on social media statements |
| All own-brand products | Marks and Spencer | Involved in Arla’s Bovaer trial |
| All products containing dairy | Mars | Potential Bovaer use due to sustainability goals, but not confirmed |
| Milk, Other dairy and non-dairy | Milk & More | Potential Bovaer use, based on social media statements |
| All own-brand products | Morrisons | Involved in Arla’s Bovaer trial |
| Own-brand products | Sainsbury’s | Potential Bovaer use, based on social media speculation |
| All own-brand products | Tesco | Involved in Arla’s Bovaer trial |
Financial Incentives and Pressure on Farmers
Adding to the complexity of this situation is the significant financial incentive being offered to farmers to adopt Bovaer. Pharmaceutical company Elanco, which has an agreement with DSM to market Bovaer, is offering farmers cash through carbon credit systems. This financial incentive, while understandable from a climate change mitigation perspective, might lead to premature and widespread adoption of the additive before its long-term effects are fully understood.
Furthermore, government bodies are also pushing for the adoption of Bovaer. The US Department of Agriculture and the UK’s DEFRA are providing financial support to farms implementing products like Bovaer. DEFRA has even stated its intention to eventually “mandate” the use of Bovaer in cattle systems across England. This raises concerns about the potential for regulatory capture and the prioritization of industry interests over public health and thorough scientific investigation.
While Bovaer might seem like a promising solution to reduce methane emissions from cattle, and therefore potentially help combat climate change, we can’t ignore the red flags. The lack of transparency in the FDA approval process, combined with the limited safety data, conflicting information, and the potential for long-term health impacts, demands a more cautious and research-driven approach.
Consumers have a right to know what’s in their food and to demand products that are both sustainable and safe. Until we have more definitive answers about the long-term consequences of Bovaer, I’ll be sticking to organic milk and supporting farmers who prioritize animal welfare and environmental stewardship without resorting to potentially risky quick fixes.
More Reasons to Question Bovaer
The safety concerns surrounding Bovaer extend beyond the limited animal studies and the lack of human trials. There are also concerns about the genotoxicity of 3-NOP, the active ingredient in Bovaer. Genotoxicity refers to the ability of a substance to damage DNA, which can lead to mutations and potentially cancer.
There are several legitimate concerns about the genotoxicity of 3-NOP and the potential long-term consequences for both animals and humans.
One of the most worrying findings is from a 2-year carcinogenicity study in rats. In this study, benign mesenchymal cell tumours were found in a statistically significant number of female rats given the highest dose of 3-NOP. While the study’s initial report concluded there was evidence of carcinogenicity, a subsequent reanalysis by an independent group of pathologists found a lower number of tumours, suggesting that the evidence might be inconclusive. However, the presence of these tumours, even at a lower rate, raises concerns and highlights the need for further research to fully understand the potential carcinogenic effects of 3-NOP.
According to this FDA document, 3-Nitrooxypropanol, the active ingredient in Bovaer® 10, which is now being used as a feed additive for cows—ostensibly to “reduce methane emissions”—”may damage male fertility and reproductive organs”.
Adding to the concern is the fact that the same study also observed mesenchymal cell hyperplasia, a precancerous condition, in both male and female rats at high doses. The presence of hyperplasia, even in the absence of malignant tumours, suggests that 3-NOP has the potential to disrupt cell growth and development, which could lead to cancer in the long term.
There are conflicting results from genotoxicity studies. Some in vitro micronucleus assays showed positive results, indicating that 3-NOP could damage DNA in cells. However, two in vivo micronucleus studies produced negative results. The Advisory Committee on Animal Feedingstuffs (ACAF) acknowledged these conflicting findings but ultimately concluded that 3-NOP is not genotoxic in vivo, meaning it doesn’t damage DNA in living organisms. This conclusion is based on the negative results of the in vivo studies and the assumption that bone marrow would have been exposed to 3-NOP in those studies.
However, the fact that there were positive results in some in vitro studies should not be ignored. It suggests that 3-NOP does have the potential to damage DNA under certain conditions. More research is needed to understand why these discrepancies exist and to fully assess the potential genotoxicity of 3-NOP.
The Oxetane Question: A Potentially Toxic Metabolite
Another concern highlighted in the sources is the presence of oxetane, a potential alkylating agent, as a metabolite of 3-NOP. Alkylating agents are substances that can add alkyl groups to DNA, which can lead to mutations and cancer. The sources note that oxetane was identified as a metabolite in an in vitro study using rumen fluids, but it was not found in in vivo studies. The ACAF suggested that oxetane might be an artefact of the in vitro study and is unlikely to persist in the rumen because it would be rapidly metabolised.
While the ACAF downplays the significance of oxetane, its presence as a potential metabolite, even if transient, is a cause for concern. The fact that it’s a potential alkylating agent warrants further investigation to determine if it poses any risk to animal or human health. The absence of oxetane in in vivo studies doesn’t necessarily rule out the possibility that it could be formed in the rumen under certain conditions or that it might have other, as yet unknown, effects.
“If you have to wear gloves to handle it, how is it safe for cows to eat ? What will it do the delicate lining of their stomach?”
Propanediol: Another Metabolite Worth Investigating
The primary metabolite of 3-NOP in the rumen is 1,3-propanediol, a substance that’s generally considered safe. The ACAF concluded that propanediol doesn’t accumulate in the rumen and is not a cause for concern. However, it’s worth noting that propanediol is used in a variety of industrial applications, including as a solvent and antifreeze agent. While it’s considered safe at low levels, the long-term effects of consuming propanediol from milk produced by cows fed Bovaer have not been studied. Further research is needed to confirm that the levels of propanediol in milk from Bovaer-fed cows are indeed safe for human consumption.
NOPA Residues in Milk
Sources also address the presence of 3-nitrooxypropionic acid (NOPA), a primary metabolite of 3-NOP, in milk. The ACAF concluded that the levels of NOPA residues in milk are low enough not to be a cause for concern based on their exposure assessment. This assessment relied on the lower limit of quantification (LLOQ) level of 5 µg/kg used in the studies.
However, it’s crucial to acknowledge that this conclusion is based on a conservative estimate using the LLOQ. It doesn’t necessarily account for the possibility that NOPA levels could be higher in milk from cows given higher doses of Bovaer or under different dietary conditions. Further research is necessary to determine the actual range of NOPA concentrations in milk from Bovaer-fed cows and to confirm that these levels are consistently safe for human consumption over the long term.
More Questions Than Answers
The evidence surrounding Bovaer’s safety remains incomplete and raises concerns that require further investigation. The limited animal studies, the lack of human trials, the conflicting genotoxicity findings, the presence of potentially toxic metabolites, and the uncertainty surrounding NOPA residues in milk all highlight the need for a more cautious approach. While reducing methane emissions from cattle is a worthy goal, it shouldn’t come at the expense of human or animal health.
What about Bovaer, the methane inhibitors they are feeding to cows to fight climate change? Are you a fan of this? My thoughts below! pic.twitter.com/muj9DOWJdW
— Dr Shawn Baker 🥩 (@SBakerMD) December 5, 2024
Before Bovaer is widely adopted and potentially mandated, as is being suggested in the UK, we need more comprehensive research to address the unanswered questions and ensure that this “solution” doesn’t create more problems than it solves. Transparency, rigorous scientific investigation, and a precautionary approach should guide decisions about introducing new technologies into our food chain, especially those with the potential for widespread and long-lasting impacts.
Bovaer and the Dairy Industry
Research reveals a complex landscape surrounding the introduction of Bovaer, a methane-reducing feed additive for cattle, into the UK dairy industry. While the potential for reducing greenhouse gas emissions is a significant driver, concerns about safety, transparency, and potential long-term consequences are fueling debate and prompting calls for caution.
“The biggest lie in the world right now is that cows are killing the planet. At the core of that lie is how methane is calculated.”
— James Melville 🚜 (@JamesMelville) November 28, 2024
He’s right. After 10-12 years, methane is broken down into CO2, entering a natural carbon capture cycle absorbed by plants via photosynthesis,… pic.twitter.com/8yXtBIydEa
The Allure of Methane Reduction and the Push for Adoption
The dairy industry is under increasing pressure to address its environmental impact, particularly its contribution to greenhouse gas emissions. Arla, Europe’s largest dairy company, aims is to gather evidence on the effectiveness of the additive in real-world farm settings and potentially pave the way for wider adoption. The trials are being presented as a way to “test out where we can drive change at scale to bring down emissions.”
DSM-Firmenich claims that the additive can reduce methane emissions from dairy cows by an average of 30%. They also estimate that Bovaer could lower the scope 3 emissions of dairy products by 10-15% CO2 equivalents per litre of milk.
The potential financial benefits for farmers are also significant. Elanco, a pharmaceutical company involved in the distribution of Bovaer, is offering farmers cash incentives through carbon credit systems. This means that by reducing their methane emissions with Bovaer, farmers can potentially earn money for their “environmental efforts,” making the adoption of the additive more financially attractive.
Growing Backlash and Concerns Over Transparency
Despite the enthusiasm surrounding Bovaer’s potential, a significant backlash has emerged, particularly on social media. Concerns about the use of additives in food products and the lack of long-term safety data are driving consumer apprehension. Some shoppers have expressed their intention to boycott supermarkets and brands involved in the trials, while others are demanding clear labelling of products that may contain milk from Bovaer-fed cows.
I also highlight concerns about the transparency of the approval process and the potential for conflict of interest. For example, the fact that an external consultant, contracted by DSM-Firmenich, was involved in attributing a cause for increased micronuclei in a genotoxicity study, rather than 3-NOP (the active ingredient in Bovaer), has raised alarm bells. This raises questions about the objectivity of the assessment and the influence of industry interests on the regulatory process.
The involvement of Blackrock, a multinational investment company heavily invested in the UK’s green energy transition, as the largest investor in DSM-Firmenich has also fueled skepticism. Some view this as evidence of a broader agenda to push for the adoption of technologies like Bovaer, potentially overlooking potential risks in the process.
Safety, Long-Term Effects, and Informed Choice
Citizens consistently emphasize the need for more research and a cautious approach to the adoption of Bovaer. The safety concerns raised, particularly regarding genotoxicity, potential carcinogenic effects, and the presence of potentially harmful metabolites, require further investigation. While some studies suggest that the levels of residues in milk from Bovaer-fed cows are within acceptable limits, the long-term effects of consuming these products remain unknown.
The lack of human trials is a significant gap in the current knowledge base. While animal studies provide valuable insights, they cannot fully predict the potential effects of Bovaer on human health. Long-term studies involving human participants are crucial to assess the safety of consuming milk and dairy products from Bovaer-fed cows over extended periods.
The National Farmers Union (NFU) has also acknowledged that “questions remain” over the impact of long-term Bovaer usage. They stress the need for a strong evidence base to give farmers confidence in using the product. The NFU’s stance underscores the importance of independent, rigorous research to address the concerns and provide clear guidance for farmers and consumers alike.
The push for mandatory adoption of Bovaer in England, as mentioned in some sources, is particularly concerning given the current knowledge gaps. Mandating the use of an additive without fully understanding its long-term consequences could have far-reaching implications for the dairy industry, consumer choice, and potentially, public health.
Moving forward, several key principles should guide decisions about Bovaer and other technologies aimed at addressing the environmental impact of livestock:
- Transparency: The approval process for Bovaer and the data supporting its safety and efficacy should be transparent and readily accessible to the public. This includes clear disclosure of any potential conflicts of interest.
- Comprehensive Research: Further research is needed to address the safety concerns raised, particularly regarding genotoxicity, potential carcinogenicity, and the long-term effects of consuming milk and dairy products from Bovaer-fed cows. This research should include long-term human trials.
- Consumer Choice: Consumers should have access to clear and accurate information about Bovaer and be able to make informed choices about the products they purchase. This includes clear labelling of products derived from Bovaer-fed cows.
- Precautionary Approach: A precautionary approach should be adopted, meaning that potential risks should be thoroughly assessed before Bovaer is widely adopted, especially through mandatory programs.
The dairy industry, regulators, and researchers have a responsibility to engage in open and honest dialogue about Bovaer, ensuring that decisions are based on sound science, public interest, and the principles of transparency and choice.
Ultimately, the goal should be to find sustainable solutions that balance environmental benefits with the well-being of animals and the health of consumers.
Calls for Caution
Despite the potential benefits, a vocal backlash against Bovaer has emerged, particularly on social media. Concerns center around the use of additives in food production and a perceived lack of transparency regarding Bovaer’s safety profile and long-term effects. Some consumers are calling for boycotts of supermarkets and brands involved in the trials, demanding clear labeling of products derived from Bovaer-fed cows.
A key concern is the potential for Bovaer to be harmful to both cows and consumers. Some studies have shown that 3-NOP, the active ingredient in Bovaer, can cause adverse effects in rats, including reduced heart weight, decreased ovary size, and the development of mesenchymal cell tumours. While the AFFAJEG, a group of experts evaluating the safety of feed additives, concluded that the additive is not carcinogenic at the recommended dose, they acknowledged its potential to cause mesenchymal cell hyperplasia and benign tumours at higher levels. Additionally, concerns have been raised about the presence of 3-NOP residues in milk and edible tissues, although the AFFAJEG concluded that the levels were not a cause for concern.
The limited scope of some safety studies is also a concern. For instance, a tolerance study using only four cows per group was deemed invalid by the AFFAJEG due to its small sample size and the premature euthanasia of two cows. The reliability of findings based on such limited data raises questions about the thoroughness of the safety assessment.
The lack of long-term human trials is another significant gap in the current knowledge base. While animal studies provide valuable insights, they cannot fully predict the potential long-term effects of consuming products from Bovaer-fed cows on human health.
Transparency issues have further fueled skepticism. The fact that an external consultant, hired by DSM-Firmenich, was involved in attributing an increase in micronuclei to the staining method rather than 3-NOP in a genotoxicity study has raised concerns about potential conflicts of interest. The involvement of Blackrock, a major investor in DSM-Firmenich, has also been viewed with suspicion, with some suggesting a financial motive behind the push for Bovaer adoption.
The potential for mandatory adoption of Bovaer in England is a particularly contentious issue. This prospect raises concerns about limiting consumer choice and potentially exposing the population to an additive whose long-term effects are not fully understood. The NFU, while acknowledging the potential of feed additives like Bovaer, has also stressed the need for a robust evidence base before widespread adoption.
Balancing Innovation with Precaution
The introduction of Bovaer presents a dilemma: balancing the urgent need to reduce greenhouse gas emissions with the potential risks associated with a novel technology. A nuanced approach is required, one that prioritizes scientific rigor, transparency, and consumer choice.
- Robust and Independent Research: Further research, particularly long-term human trials, is crucial to address the safety concerns surrounding Bovaer. This research should be conducted independently of industry influence to ensure objectivity and credibility.
- Transparent Communication: Regulators and the dairy industry must communicate clearly and openly about Bovaer’s potential benefits and risks. All relevant data and information should be readily accessible to the public. This transparency will build trust and enable informed decision-making.
- Consumer Choice: Consumers should have the right to choose whether or not they consume products from Bovaer-fed cows. This requires clear and accurate labeling of products, empowering consumers to make informed decisions aligned with their values and preferences.
- A Precautionary Approach: Given the uncertainties surrounding Bovaer’s long-term effects, a precautionary approach is warranted. This means erring on the side of caution and avoiding widespread adoption, particularly through mandatory programs, until a more comprehensive understanding of its safety profile is established.
The potential benefits of Bovaer in mitigating climate change are undeniable. However, rushing its adoption without addressing the legitimate concerns raised by consumers and experts could erode public trust and hinder the dairy industry’s efforts to achieve sustainability.
In my opinion, the focus should be on fostering a collaborative approach involving scientists, regulators, the dairy industry, and consumers. This will ensure that the pursuit of environmental goals does not come at the expense of human health, animal welfare, or the right to make informed choices about the food we consume.
A balanced and evidence-based approach is essential to navigate the complex landscape of Bovaer and ensure a sustainable and responsible future for the dairy industry.
References:
Safety and efficacy of a feed additive consisting of 3-nitrooxypropanol (Bovaer® 10) for ruminants for milk production and reproduction (DSM Nutritional Products Ltd), 19 November 2021
Arla trial sees 30 farmers use feed additive to cut emissions, FarmingUK, 26 November 2024
FDA Reply (PDF), May 24, 2024
Full Fart Milk
The Most Interesting Event in the Bovaer Saga Isn’t Necessarily the “Additive” Itself, The Stark Naked Brief, Dec 07, 2024
3-Nitrooxypropanol Compound Study, NIH
Elanco Bovaer 10 Safety Data Sheet (PDF)
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