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Climate alarmists score an own goal: Bovaer’s major route of excretion is CO2

Climate alarmists score an own goal: Bovaer’s major route of excretion is CO2

The drug Bovaer which is described as a feed additive for dairy cows to “reduce emissions” has been disclosed as consisting of three ingredients: silicon dioxide, propylene glycol and 3-nitrooxypropanol (“3-NOP”).

Writing for UK Column, Dr. Mike Williams takes a brief look at the studies done on 3-NOP to establish if it is “safe and effective.”

The European Food Safety Authority’s (“EFSA’s”) Panel on Additives and Products or Substances used in Animal Feed (“FEEDAP”) concludes that the genotoxicity potential of 3-NOP cannot be ruled out, indicating a potential to cause cancer, he writes.  3-NOP’s impact on humans is unknown as it remains untested.

3-NOP was found to induce chromosome damage and gene mutations and an increase in benign gastrointestinal mesenchymal tumours in studies on female rats.  Adverse effects on fertility and reproduction were also seen in rats, including severe reduction of spermatogenesis in males and failure to become pregnant in females at high doses.

Although studies show that 3-NOP does not transmit in dosed animals’ milk, the breakdown product of 3-NOP, 3-nitrooxypropionic acid (“NOPA”), was detected in cow’s plasma and milk, and is assumed to be responsible for testicular toxicity.

In a twist which shows climate alarmists’ plans to be self-defeating, the use of 3-NOP in cows also results in increased hydrogen emissions and the major route of excretion is as carbon dioxide (CO2).

Is Bovaer Safe and Effective?

By Dr. Mike Williams, a medical consultant operating in private practice, as published by UK Column on 5 December 2024.

We live in a time when people perceive many threats; not least the ongoing attacks on farming: meat and dairy production. And the latest, in the form of feed for dairy cows, by a product called Bovaer.

Food, of course, is vital, and it is no surprise therefore when people perceive a threat to their food, they get angry, and boycotts start.

Bovaer is added to cow’s feed in order to reduce methane production and protect against “Climate Change.”

Notwithstanding the lack of credible evidence beyond modelling and failed predictions a la “Climate Change,”even if one were to believe in it, does this product make sense, and is it safe to add to our food supply?

First of All, What is Bovaer?

Bovaer is a product added to cow’s feed consisting of silicon dioxide, propylene glycol and organic compound 3-nitrooxypropanol (known as 3-NOP). In the EU it’s deemed a feed additive, but in the US, it’s classed as a drug:

“Based on the information provided in your letter, Bovaer® 10 is an article (other than food) intended to affect the structure or any function of the body of an animal, and therefore it is a drug.”—FDA.

However, the FDA feels that the normal requirements and testing for a drug need not apply:

“Although Bovaer® 10 is an unapproved drug, at this time we do not intend to initiate enforcement action with respect to the drug requirements listed above for Elanco’s marketing Bovaer® 10 or use provided FDA continues to have no questions or public health concerns about Bovaer® 10.”—FDA.

But they do add:

“Report electronically through the Safety Reporting Portal4 within 24 hours after you determine that, due to an issue or problem with Bovaer® 10, there is a reasonable probability that the use of, or exposure to, Bovaer® 10 or product containing Bovaer® 10 will cause serious adverse health consequences or death to humans or animals.”—FDA.

How reassuring.

They also offer this warning:

In rat studies, 3-NOP was found widely distributed:

In tissues, the highest concentrations were found in the liver (184.5 μg 3-NOP-eq/g), adrenal glands (159.3 μg 3-NOP-eq/g) and kidney (118.4 μg 3-NOP-eq/g). Low concentrations were found in fat (58.9 μg 3-NOP.

In thymus, renal fat, prostate, spleen, pancreas and lungs, the mean values ranged from 8.97 to 7.23 μg 3-NOP-eq/g for the low dose and about 7–10 times higher for the high dose. All other tissues had values close to or lower than plasma at 48 h after dosing, 7.03 μg 3-NOP-eq/mL and 51.92 μg 3-NOP-eq/mL, respectively, for the low and high doses. In females, a very similar distribution was found. Other organs like the ovaries, spleen, thymus, lungs, pancreas and uterus had mean values from 7.37 to 4.64 μg 3-NOP-eq/g for the low dose and about 7–10 times higher for the high dose. All other tissues had values close to or lower than plasma at this time, 4.22 μg 3-NOP-eq/mL and 34.47 μg 3-NOP-eq/mL, for the low- and high-dose levels. In carcass, radioactivity ranged from 3.1% to 4.4%, for both doses.

Is there any risk of harm?

Cancer?

3 NOP was also tested for its ability to induce chromosome damage in Hamster cells: “3-NOP can induce chromosome damage through a clastogenic mechanism of action.”

Other evidence:

The potential of NOPA to induce gene mutations was investigated … NOPA induced gene mutations by base pair substitutions in the genome of strains TA1535 and TA100 in the presence and absence of S9 mix.

The effect of NOPA on the mutant frequency of the cII gene was analysed in liver and duodenum of male and female transgenic Fischer 344 Big Blue® rats in compliance with OECD TG 488.45 … Neither mortality nor morbidity were observed, but clinical signs were reported in both male and female animals.

The authors stated that for 3-NOP: “Based on the above, the FEEDAP Panel concludes that the genotoxicity potential of 3-NOP cannot be ruled out.”

For those that aren’t aware, that means a potential to cause cancer.

What About Tumours?

[In rats] [t]reatment with the test substance resulted in an increase in the incidence of benign gastrointestinal mesenchymal tumours in the small intestines of females treated with 300 mg 3-NOP/kg bw per day. In addition to these mesenchymal tumours, hyperplasia of a similar type of mesenchymal cell was observed in the small intestine muscle layer of one female of both the 50 and 300 mg/kg bw per day group. No gastrointestinal mesenchymal tumours or hyperplastic mesenchymal cells were noted in the small intestines of males.

In females, the PWG noted three benign mesenchymal cell tumours in the 300 mg/kg bw per day group and one animal each in the 50 and 100 mg/kg bw per day group. In two additional females of the 300 mg/kg bw per day and two males of the 100 mg/kg bw per day group, mesenchymal cell hyperplasia was observed. The increased incidence of the benign mesenchymal tumours was not considered statistically significant

The FEEDAP Panel considered that, even if a statistical significance was not demonstrated, benign gastrointestinal mesenchymal tumours in the small intestines are rare findings and could not be considered as chance findings. Therefore, the NOAEL from this study is 100 mg 3-NOP/kg bw per day.

What About Fertility and Reproduction?

Study on female rats with 3-NOP:  “All females at 500 mg/kg bw [body weight] showed evidence of mating but none of the females became pregnant, and no corpora lutea or implantation sites were found in any of these females.”

For male rats:

Treatment with 500 mg 3-NOP/kg bw per day caused adverse effects in the testes and epididymides characterised by severe reduction of the spermatogenesis.

Slight to severe decrease in spermatogenesis was observed in the testes (characterised by tubular atrophy of germ cells, presence of multinucleated giant cells and tubular vacuolation) of most males of the 300 mg/kg bw per day group. Sperm motility was reduced in most of the males at 300 mg/kg bw per day accompanied by decreased total sperm counts in testes and epididymides. No evidence of recovery was observed after 13 weeks.

The FEEDAP Panel noted that the severe effects seen on testes and epididymides, affecting spermatogenesis, were observed in rats only. The FEEDAP Panel agreed on an overall NOAEL of 100 mg/kg bw per day for 3-NOP, derived from subchronic toxicity studies conducted in rats, mice and dogs.

Testicular toxicity was assumed to be due to the breakdown product of 3-NOP called NOPA because of how fast the metabolite is formed from 3-NOP.

But what of its effect on humans? We do not know – Untested.

Offspring?

Study on pups (offspring) from female rats treated with 3-NOP: ‘spleen weights of the F2-generation were statistically significantly lower in male pups at 25 mg/kg (absolute and relative to body weight), 50 mg/kg (absolute) and 100 mg/kg (absolute and relative to body weight) and in female pups at 50 mg/kg (absolute) and 100 mg/kg (absolute and relative to body weight).

What Else Did They Notice As They Tried Out Different Dose Levels of 3-NOP With Mice:

A reduction of 6% in mean overall food consumption was observed at 700 mg/kg bw per day, when compared with the control group. Statistically significant dose-related decrease of triglycerides was reported in animals at 300 and 700 mg/kg bw per day. Significant dose related changes of serum phosphorus and potassium were noted at 300 and 700 mg/kg bw per day. A statistically significant decrease of absolute and relative thymus weights was observed in males at 700 mg/kg bw per day, of 22% and 23%, respectively, but with no clear dose response.

No sex differences in exposure were observed during the study for NOPA. Animals at 700 mg/kg bw per day showed partly closed eyes, piloerection, irregular or slow breathing, decreased activity and hunched gait, rare episodes of cold to touch. These signs appeared 1 h after dosing and some of them persisted at 3 h or the following morning after dosing. 

With dogs:

One female dog treated with 300 mg 3-NOP/kg bw per day was sacrificed after 3 weeks of dosing, following a sudden onset of severe clinical signs (including abnormal gait, lethargy, tremors and repetitive epileptic seizures). In this animal, NOPA plasma levels after dosing was high and very slowly decreased. The reason was unknown. According to the authors of the study, epilepsy is known to occur spontaneously in Beagle dogs.

Please note that they also detected breakdown products that they couldn’t identify in a rat study:  “[A] mixture of putative metabolites was present, being not possible to elucidate their structure due to the complexity of the matrix.”

Some Important Points About The Climate

Cows treated with 3-NOP produce higher hydrogen emissions:  “3-Nitrooxypropanol (3-NOP) is effective at reducing ruminal methane emissions in ruminants. But it also causes a drastic increase in hydrogen accumulation, resulting in feed energy waste.”

Also, the major route out of the body for 3-NOP is as CO2 (70%):  “An extensive metabolism of 3-NOP was consistently verified, mainly to 14CO2 (about 70% of the dose).”

Forgive me for stating the obvious, but for people worried about “Climate Change,” aren’t those supposed to be bad for the “Climate”?

Is 3-NOP Found In Milk and What About NOPA?

3-NOP was detected from one animal (cow) in the urine, and the 3-NOP breakdown product NOPA was detected in the cow’s plasma. And a milk study did reveal concentrations of NOPA in milk, at only 80% of the proposed use level of Bovaer.

Therefore, the statements that 3-NOP is not detected in milk is true (given their safety limits) but the metabolite NOPA is found in milk. And if you remember, testicular toxicity was assumed to be due to the breakdown product of 3-NOP called NOPA, because of how fast the metabolite is formed from 3-NOP.

One Other Concern

3-NOP breaks down mainly into NOPA, and NOPA is almost identical, bar one oxygen to 3-nitropropionic acid (“NPA”). NOPA is passed into cow’s milk. Please see below.

I’m not suggesting this is going to happen but what if NOPA, a metabolite of a drug 3-NOP, entered the milk supply and lost that oxygen, would that be a potential problem?

From a pioneer study on human 3-nitropropionic acid intoxication; contributions from metabolomics Skogvold et al:

The neurotoxin 3-nitropropionic acid (3-NPA) is an inhibitor of succinate dehydrogenase, an enzyme participating both in the citric acid cycle and the mitochondrial respiratory chain. In human intoxications, it produces symptoms such as vomiting and stomach ache in mild cases, and dystonia, coma, and sometimes death in severe cases.

In Conclusion

We may argue that some of the negative effects may not happen because they are dose-dependent but we simply don’t know what that effect will be in the long term on humans.

Even at doses approaching normal usage of Bovaer, animal studies demonstrated risk, including a potential to cause cancer with tumour formation. And let’s not forget the FDA’s warning of harm to fertility.

And if serious harm is caused down the line from this product, how will we know without long-term studies? How would someone know if the cancer they got came from some milk they drank?

I’ll end with a reply from one of the main UK food retailers:

Long-term, robust studies? Please. I think I’m getting Covid jab déjà vu.

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