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Bovaer to be added to cattle feed

everydayupsanddowns said:
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 And depending on the severity of reactions drugs can be withdrawn.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).
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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.
 
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Wendal said:
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
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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.
 
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Amity Island said:
My point is that I'd like to be informed of what their definition of "safe" is.
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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.​
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It does not cause cancer (it is not carcinogenic or genotoxic) and poses no safety concerns to consumers, animals or the environment.​
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More than 58 studies on potential risks were evaluated and it was concluded that the additive is safe at twice the recommended dose.​
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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.
 
Bruce Stephens said:
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.
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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.
 
@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.
 
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JITR said:
However, I suppose it any additive may have unforeseen consequences.
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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.
 
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 www.soilassociation.org
 
@CliffH @Wendal - my background is in the nuclear industry and empathise with the points you make. There is an additional point in that industry that most tend not to appreciate. If you get a safety decision hopelessly wrong then it would be you and the rest of the workforce who would bear the brunt and that concentrates the mind wonderfully.
 
Seems it is actually quite difficult to determine which dairy products (from labels etc) are from bovaer fed cattle. Organic is also not guaranteed unless it is also soil association certified. Another way to be certain if a product is bovaer free is to buy direct from local farms who can confirm if bovaer is not being added to the feed.
 
Amity Island said:
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".

Bovaer is a compound made of silicon dioxide, propylene glycol and organic compound 3-nitrooxypropanol which is shortened to 3-NOP.

Bovaer is a dietary supplement for cattle that, when added to their food, helps reduce the amount of methane they produce in digestion, a gas that contributes to climate change.

www.dailymail.co.uk

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 www.dailymail.co.uk
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Basically sand, anti-freeze and something out of a chemistry set, sounds delicious.
 
SilverShaded said:
Basically sand, anti-freeze and something out of a chemistry set, sounds delicious.
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One certainly wouldn't consider 3nop as feed/food.

Even if 3nop was actually safe, what benefit is it to the cow? What possible benefits are there to the cow against any potential risks to the cow?
 
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Many farmers are refusing to add this to their cattle feed.
Some have no choice as they are in mid contract with Arler(?) Check where your milk is from..
We are lucky to be able to buy our milk, from our local farm shop and a herd that isn't feed Bovaer.
 
Docb said:
@CliffH @Wendal - my background is in the nuclear industry and empathise with the points you make. There is an additional point in that industry that most tend not to appreciate. If you get a safety decision hopelessly wrong then it would be you and the rest of the workforce who would bear the brunt and that concentrates the mind wonderfully.
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I did some work with BNFL years ago as a management consultant: I was struck by the 'safety culture' that seemed to permeate every aspect of their work, because of the catastrophic potential consequences of error!
 
CliffH said:
I did some work with BNFL years ago as a management consultant: I was struck by the 'safety culture' that seemed to permeate every aspect of their work, because of the catastrophic potential consequences of error!
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One thing that comes with that comes with that culture is an appreciation that safety is relative, not absolute. Nothing is absolutely safe, it is just that one thing is safer than other. It also makes you think about risk and quantifying that risk. You can then set standards whereby a risk is considered to be of no consequence. That standard would be related to consequences but it allows decisions to be made on a rational rather than an emotional basis.

What I find interesting in the discussion in threads of this sort is the way concern about the infinitesimally low risks associated with a food additive for cattle is expressed by people who no doubt quite happily travel in motor cars, a form of transport that kills and maims people daily. Much higher risks become acceptable in when a situation is familiar.
 
Docb said:
One thing that comes with that comes with that culture is an appreciation that safety is relative, not absolute. Nothing is absolutely safe, it is just that one thing is safer than other. It also makes you think about risk and quantifying that risk. You can then set standards whereby a risk is considered to be of no consequence. That standard would be related to consequences but it allows decisions to be made on a rational rather than an emotional basis.

What I find interesting in the discussion in threads of this sort is the way concern about the infinitesimally low risks associated with a food additive for cattle is expressed by people who no doubt quite happily travel in motor cars, a form of transport that kills and maims people daily. Much higher risks become acceptable in when a situation is familiar.
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Yes: I remember when I was walking down a staircase in a BNFL building once, someone passing on the other side told me to use the handrail, which I wasn't - and pointed out how many accidents are caused by people tripping on stairs! Apparently BNFL embedded 'safety behaviour' into every aspect of their work - not just in terms of handling nuclear material. Whenever I was on site I was more concerned about somehow becoming radioactive, rather than the much greater risk of falling down stairs!
 
CliffH said:
Yes: I remember when I was walking down a staircase in a BNFL building once, someone passing on the other side told me to use the handrail, which I wasn't - and pointed out how many accidents are caused by people tripping on stairs! Apparently BNFL embedded 'safety behaviour' into every aspect of their work - not just in terms of handling nuclear material. Whenever I was on site I was more concerned about somehow becoming radioactive, rather than the much greater risk of falling down stairs!
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At one point (forget exactly when) an analysis of accidents within BNFL showed quite clearly that when it came to nuclear matters, the company safety record was impeccable but when it came to straightforward industrial safety, performance was distinctly average. There was a big internal campaign to improve this based on the idea that mitigating risks associated with everyday things would set standards which would reflect on less everyday things. Holding hand rails on stairs was one of those simple things.
 
Docb said:
At one point (forget exactly when) an analysis of accidents within BNFL showed quite clearly that when it came to nuclear matters, the company safety record was impeccable but when it came to straightforward industrial safety, performance was distinctly average. There was a big internal campaign to improve this based on the idea that mitigating risks associated with everyday things would set standards which would reflect on less everyday things. Holding hand rails on stairs was one of those simple things.
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I worked with BNFL between 1998 and (I think) 2000: what you say sounds familiar, so I'm guessing that the initiative that you mention would have been around that time.
 
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