Bovaer to be added to cattle feed

[CliffH]

@everydayupsanddowns. Quite agree with you, especially on your earlier point about polarised times. @Wendal and myself both think that there is a middle ground and the best way to find it is not to polarise things further by making comments suggesting we support one extreme or the other when we have no clear knowledge of the subject under discussion.

I will not take offence at the "jeering and thumbing your nose" jibe. I have had far worse things said about me.

... which makes me think that an entertaining 'sub-thread' could be, "The worst thing that's ever been said about me is ...".

 

[Docb]

... which makes me think that an entertaining 'sub-thread' could be, "The worst thing that's ever been said about me is ...".

You start🙂

 

[CliffH]

You start🙂

"You're sick, you are!" (from the mother of an ex-fiancee) 🙄

 

[JITR]

Starting with cows (what next?) bovaer has been declared a "safe" additive by both European and UK regulators as "it doesn't transfer into milk".

ALL English cows to be given controversial Bovaer feed by 2030

A document mentioning a Department for Environment Food and Rural Affairs plan to mandate the use of 'methane-suppressing feed products' English cattle is circulating on social media.

www.dailymail.co.uk

Tom Whipple, Science Editor, responded in The Times: It's not a conspiracy if you haven't bothered to check

Of course, if you have serious doubts, you should apply the precautionary principle. Stop consuming milk and dairy products, unless you are certain of their provenance.

 

[beating_my_betes]

My reading was that @Docb was simply, and quite rightly, encouraging us to remember that the conversation is outside our fields of knowledge and experience, and that we should hold it lightly, recognising that in the end whatever we think on the matter is unlikely to have any consequence, and certainly isn’t worth disagreeing about. 🙂

You've clearly misunderstood my position. It's all good, though.

 

[Docb]

"You're sick, you are!" (from the mother of an ex-fiancee) 🙄

I was part of a group at one time, all of whom were well over 6ft - the tallest was all but 7ft. Me at a mere 5ft 6" was frequently referred to as the poison dwarf.

 

[Amity Island]

As somebody who spent much of their life in an industry where safety was at the forefront of almost all decision making, I find the conversations in threads of this sort rather like listening in on a pub conversation about diabetes.

Best to keep out of it.

Hi DocB,

My point is much simpler though. It doesn't rely upon any expertise, any knowledge, any intellect or discussion.

Words have meaning. Without meaning, words are meaningless.

Definition is the starting point no matter what field, context or industry and I don't think it unreasonable to want to know what is meant by the word "safe" in the context it's being used/sold. E.g additives to animal feed.

I know that in the pharmaceutical industry "safe" is defined as the "benefits outweigh the risks". To me, this definition has nothing to do with safety. Whereas, in other industries, "safe" is something that is measured. With each event being logged and that at some point, it would be declared unsafe. In the pharmaceutical industry, post release, these events will just get added to the safety sheet, not necessarily declared unsafe.

 

[Wendal]

which entrenched position? and which scientific

Hi DocB,

My point is much simpler though. It doesn't rely upon any expertise, any knowledge, any intellect or discussion.

Words have meaning. Without meaning, words are meaningless.

Definition is the starting point no matter what field, context or industry and I don't think it unreasonable to want to know what is meant by the word "safe" in the context it's being used/sold. E.g additives to animal feed.

I know that in the pharmaceutical industry "safe" is defined as the "benefits outweigh the risks". To me, this definition has nothing to do with safety. Whereas, in other industries, "safe" is something that is measured. With each event being logged and that at some point, it would be declared unsafe. In the pharmaceutical industry, post release, these events will just get added to the safety sheet, not necessarily declared unsafe.

Evening Amity,
The feed additive industry is no different to the pharmaceutical industry in that all products need to be licensed and classified accordingly.
Even if Bovaer if my understanding is correct is classified as non medicinal as most feed additives are.
So all products have a data sheet which lists its details and any contradictions etc so in the case of a food producing animal like cow then would be meat or milk withdrawal.
So any definition of safety is made by likes of EMA/ MHRA/FDA etc and their regulatory system in terms of whether they Apprivevthe product or not and what classification they allocate and restrictions they decide on.
Each product will go through a separate regulatory pathway so phase 1,2 and pivotal phase 3 in case of Vaccines and drugs and then be subject to close monitoring even after Approval.
So I accept the decision of the regulators in deciding on my behalf what is safe or not safe based on their expertise and them knowing the full facts.
I accept others may not share the same level of confidence but that is the system we have and in balance I am happy with it.
ATB

 

[everydayupsanddowns]

I know that in the pharmaceutical industry "safe" is defined as the "benefits outweigh the risks". To me, this definition has nothing to do with safety. Whereas, in other industries, "safe" is something that is measured. With each event being logged and that at some point, it would be declared unsafe. In the pharmaceutical industry, post release, these events will just get added to the safety sheet, not necessarily declared unsafe.

My understanding is that the logging of reactions very much does affect whether a pharmaceutical is considered safe and affected after launch. And depending on the severity of reactions drugs can be withdrawn.

This can also happen (both positively and negatively) during the trial phases. If a sufficient proportion of individuals have a sufficiently negative reaction when human trials start, the trial is immediately stopped. Conversely, if the trial medication is astonishingly effective, and no one has a negative reaction, it can become unethical to continue with the comparator or placebo arm (which you know will have worse outcomes than the newly discovered wonder-drug).

I’m no pharma scientist or researcher, but I can only guess that the number of serious adverse reactions (as awful as they would have been for the individuals involved) were rare in comparison to the much larger number of people who had no adverse reaction and got the benefits of the vaccines (reduced severity, reduced transmission, faster recovery).

I can’t think of anything that is completely and absolutely safe with no documented risk. Even purified drinking water can cause major problems if you drink too much of it. At marathons it is apparently overhydration that is a bigger risk than dehydration, and can lead to collapse and serious harm. And yet if you don’t drink any water because of the potential risk of harm, you will surely die.

 

[CliffH]

Hi DocB,

My point is much simpler though. It doesn't rely upon any expertise, any knowledge, any intellect or discussion.

Words have meaning. Without meaning, words are meaningless.

Definition is the starting point no matter what field, context or industry and I don't think it unreasonable to want to know what is meant by the word "safe" in the context it's being used/sold. E.g additives to animal feed.

I know that in the pharmaceutical industry "safe" is defined as the "benefits outweigh the risks". To me, this definition has nothing to do with safety. Whereas, in other industries, "safe" is something that is measured. With each event being logged and that at some point, it would be declared unsafe. In the pharmaceutical industry, post release, these events will just get added to the safety sheet, not necessarily declared unsafe.

I think of it more as a continuum between 'safe' and 'unsafe', in any walk of life. That is, an earthquake would be very close to the extreme 'unsafe' end of the scale - but it's still just about possible to survive an earthquake. A kitten is very close to the extreme 'safe' end from an adult human's perspective - but a scratch from its claws might still cause blood poisoning. So, I'm not sure that there's much point trying to conceptualise things as completely either 'safe' or 'unsafe'.

Also, our perceptions of safety change over time, for cultural reasons and with the benefit of hindsight. When I was a child, the idea that talcum powder might be in any way unsafe would have seemed ridiculous - just as cigarettes were regarded as medically benign a hundred years ago.

Bringing it closer to home, drinking a can of Coke a day would be trivial for most people - but potentially an unsafe thing to do for those of us with Type 1.

 

[Wendal]

My understanding is that the logging of reactions very much does affect whether a pharmaceutical is considered safe and affected after launch. And depending on the severity of reactions drugs can be withdrawn.

This can also happen (both positively and negatively) during the trial phases. If a sufficient proportion of individuals have a sufficiently negative reaction when human trials start, the trial is immediately stopped. Conversely, if the trial medication is astonishingly effective, and no one has a negative reaction, it can become unethical to continue with the comparator or placebo arm (which you know will have worse outcomes than the newly discovered wonder-drug).

I’m no pharma scientist or researcher, but I can only guess that the number of serious adverse reactions (as awful as they would have been for the individuals involved) were rare in comparison to the much larger number of people who had no adverse reaction and got the benefits of the vaccines (reduced severity, reduced transmission, faster recovery).

I can’t think of anything that is completely and absolutely safe with no documented risk. Even purified drinking water can cause major problems if you drink too much of it. At marathons it is apparently overhydration that is a bigger risk than dehydration, and can lead to collapse and serious harm. And yet if you don’t drink any water because of the potential risk of harm, you will surely die.

Correct Mike the regulatory process increases in size to get statistical confidence in order to “ prove” the treatment is safe.There is no absolute guarantee of safety but that is life.
The whole process normally lasts about 10 years involving both pre clinical ( animal trials ) and then phase 1 which seeks to establish safety and dose level,phase 2 which tests efficacy as well as additional safety and then phase 3 which is the pivotal study normally involving 1000s of patients.
You highlight the issue that some trials have an interim analysis so normally after 75% of a phase 3 and it can be positive or negative so the trial gets stopped due to ethical considerations.
The Covid Vaccines were subject to an accelerated Approval process due to the urgency of the need for effective treatments but imo they still went through the normal regulatory process.
What made the process so rapid was the fact Oxford University already had ready candidates based on the Chimpanzee Adenovirus Vector which had been developed for other types of Covid so MERS and SARS etc and then the unprecedented cooperation between all parties to advance the process at an accelerated rate.

 

[Amity Island]

Evening Amity,
The feed additive industry is no different to the pharmaceutical industry in that all products need to be licensed and classified accordingly.
Even if Bovaer if my understanding is correct is classified as non medicinal as most feed additives are.
So all products have a data sheet which lists its details and any contradictions etc so in the case of a food producing animal like cow then would be meat or milk withdrawal.
So any definition of safety is made by likes of EMA/ MHRA/FDA etc and their regulatory system in terms of whether they Apprivevthe product or not and what classification they allocate and restrictions they decide on.
Each product will go through a separate regulatory pathway so phase 1,2 and pivotal phase 3 in case of Vaccines and drugs and then be subject to close monitoring even after Approval.
So I accept the decision of the regulators in deciding on my behalf what is safe or not safe based on their expertise and them knowing the full facts.
I accept others may not share the same level of confidence but that is the system we have and in balance I am happy with it.
ATB

Thanks @Wendal for getting the thread back on track.

My point is that I'd like to be informed of what their definition of "safe" is. That's all. From there I can make an informed decision about any product or service. Without a definition we are none the wiser.

Similarly with the effectiveness of the vaccines, we only got told one side of the story, with their 100% effective, without being informed that the actual absolute effectiveness was around just 1%.

As I started the comments, the world was told that the mRNA vaccines do not come through breast milk of vaccinated people. This was all "Fact" checked as was popular during the pandemic, however, it wasn't long until this was proven to be a false fact, the mRNA was proven to come through the milk.

 

[Bruce Stephens]

My point is that I'd like to be informed of what their definition of "safe" is.

https://food.blog.gov.uk/2024/12/05/bovaer-cow-feed-additive-explained/ says

The FSA safety assessment concluded there are no safety concerns when Bovaer is used at the approved dose.​

​

It does not cause cancer (it is not carcinogenic or genotoxic) and poses no safety concerns to consumers, animals or the environment.​

​

More than 58 studies on potential risks were evaluated and it was concluded that the additive is safe at twice the recommended dose.​

​

The additive is metabolised by the cows so does not pass into the milk. It was not found in milk in any of the trials presented to the FSA.​

I don't know whether they have a concrete definition of "safe", or whether that definition is (or could be, if there isn't one) useful.

 

[Amity Island]

https://food.blog.gov.uk/2024/12/05/bovaer-cow-feed-additive-explained/ says

The FSA safety assessment concluded there are no safety concerns when Bovaer is used at the approved dose.​

​

It does not cause cancer (it is not carcinogenic or genotoxic) and poses no safety concerns to consumers, animals or the environment.​

​

More than 58 studies on potential risks were evaluated and it was concluded that the additive is safe at twice the recommended dose.​

​

The additive is metabolised by the cows so does not pass into the milk. It was not found in milk in any of the trials presented to the FSA.​

I don't know whether they have a concrete definition of "safe", or whether that definition is (or could be, if there isn't one) useful.

Thanks. There must be a definition of safe though, otherwise what are they working to, what aims, standards, criteria etc

I will have a look into it.

 

[JITR]

@Amity Island
There has been a thorough investigation. You will have to trawl through the links below to work out what the safety criteria were. If you can't find a satisfactory definition, I'd suggest you contact the FSA.

However, I suppose any additive may have unforeseen consequences. If that's what you think avoid such foods.

See:
1. https://www.food.gov.uk/our-work/fsafss-opinions-on-twelve-applications-for-feed-additives-summary

Our safety assessment process​

Our risk assessors deliver the science behind our advice. They are responsible for identifying and characterising hazards and risks to health and assessing levels of exposure. Where the European Food Safety Authority (EFSA) had commenced an assessment of an application prior to the end of the transition period for the UK exiting the EU (applications in Annexes A to L), the FSA/FSS safety assessors will take the EFSA opinion into account as part of its safety assessment, where it has been published by EFSA. For applications in this consultation, the FSA/FSS have had access to all supporting documentation that was provided to EFSA for the purposes of forming its opinion as this information was provided to the FSA/FSS by the applicant. After safety assessment, the FSA/FSS have agreed with EFSA conclusions in its opinions.

Application for Annex M, RP1059 3-nitrooxypropanol (3-NOP) (Bovaer® 10), has undergone a full FSA/FSS safety assessment, including full review of the applicant dossier for ruminants (animals that chew the cud) for milk production and for reproduction. The views of the Animal Feed and Feed Additives Joint Expert Group (AFFAJEG) and the Advisory Committee on Animal Feedingstuffs (ACAF) have been taken into account in the FSA/FSS safety assessment for this application.

2. https://www.food.gov.uk/our-work/an...ants-for-milk-production-and-for-reproduction

FSA/FSS Safety Assessment:​

FSA/FSS has undertaken a safety assessment of application RP1059 for the use of 3-nitrooxypropanol (3-NOP) (Bovaer® 10) as a feed additive for ruminants (for example, cattle, sheep, goats) for milk production and for reproduction, from DSM Nutritional Products Ltd., Switzerland.

The application was evaluated by our independent Animal Feed and Feed Additives Joint Expert Group (AFFAJEG) and the Advisory Committee on Animal Feedingstuffs (ACAF). The FSA/FSS safety assessment was published on 31 March 2023 and can be found here. The assessment of 3-nitrooxypropanol shows that the conditions for authorisation in Article 5 (Opens in a new window)of the Regulation are satisfied.

The FSA/FSS opinion is that 3-nitrooxypropanol, as described in this application, is safe and is not liable to have an adverse effect on the target species, environmental safety and human health at the intended concentrations of use and under the proposed terms of authorisation. The proposed terms of authorisation are set out below.

 

[Bruce Stephens]

However, I suppose it any additive may have unforeseen consequences.

Which is why I'm sure there'll be surveillance to try to pick up such problems. It's not unheard of for things to be withdrawn after approval, after all, sometimes years after.

 

[Amity Island]

Which is why I'm sure there'll be surveillance to try to pick up such problems. It's not unheard of for things to be withdrawn after approval, after all, sometimes years after.

This article below is worth a read, I'm not convinced there will be the kind of safety surveillance one would expect.

According to this article the MHRA confirmed that they don't have the resources to monitor and investigate safety issues due to the shear volume of reported ADR. Instead, they will only be comparing (comparative) safety signals between other medicines not the safety of individual products. As they confirmed earlier, the MHRA are now changed into enablers for the pharmaceutical industry. Some issues only come to light 10 years after signals have been identified.

Patrick Vallance to health ministers in 2014 said that:

"In the future, medicines will come to market quicker with less data, with more research being conducted in the post-license phase.”

Why Medicine Safety Will Get Worse Not Better – The Daily Sceptic

Nick Hunt diagnoses the U.K. medicines regulator's shortcomings relative to other industries, and the prognosis looks bleak. Root and branch reform is needed, but he's not holding his breath.

dailysceptic.org

 

[JITR]

@Amity Island

About medication, sometimes we have a choice.

After diagnosing T2D my GP ordered me to start taking Metformin at once to get my blood glucose level down from a three figure HbAic. No discussion, no choice!

I looked into Metformin's potential ADRs. I did not like the sound of them, nor that no one knew how it worked. Professor Roy Taylor's VLCD looked a far a better bet: scientifically proven, quicker acting and more effective. Luckily I proved to be a 'responder', my FBG was down to normal in 7 days.

Up to us each of us to decide whether the pros and probabilities outweigh the cons in our case.

 

[Leadinglights]

@Amity Island

About medication, sometimes we have a choice.

After diagnosing T2D my GP ordered me to start taking Metformin at once to get my blood glucose level down from a three figure HbAic. No discussion, no choice!

I looked into Metformin's potential ADRs. I did not like the sound of them, nor that no one knew how it worked. Professor Roy Taylor's VLCD looked a far a better bet: scientifically proven, quicker acting and more effective. Luckily I proved to be a 'responder', my FBG was down to normal in 7 days.

Up to us each of us to decide whether the pros and probabilities outweigh the cons in our case.

Whether you take a medication is always your choice.

 

[Amity Island]

For those interested in organic products, this article was published by the soil association.

This has led us to receive a large number of questions about whether this feed additive would be permitted in organic. It would not.

Soil Association organic standards stipulate that all ingredients/components of a feed additive must be actively approved for use and be deemed safe and nutritionally useful for the animal. The main components that make up Bovaer® are not included in the list of approved products/compounds and as a result, Bovaer® would not be permitted under organic standards and for use in organic farming.

Arla buys milk from many different farms and they supply both organic and non-organic milk. Any organic milk they supply must meet organic regulation requirements and the production has to be completely separate from any non-organic milk. This must be demonstrated and independently audited every year.

Soil Association Bovaer Organic Arla Feed Additive

www.soilassociation.org