Infernal contradictions

Synopsis : The manufacturer’s instructions for miticide use are often poorly worded, confusing or contradictory. Many beekeepers already struggle to control Varroa and this makes things worse.

Introduction

How many beekeepers read the documentation that accompanies the miticides they use for Varroa control? How many understand what all the terms – including the pharmacological ones – mean?

Posology anyone?

What about the phrase “Withdrawal period”? 

Can all miticides containing the same active ingredient be used in the same way? If not, why not?

What about repeat usage? Can you repeat a treatment (if needed) if the instructions do not explicitly state that repeat treatments are not allowed? 1 Or can you only administer a second application if the instructions explicitly state that it is allowed?

And if a you are allowed to apply a second treatment, can you administer a third? What about treating in November and the following January? Two different calendar years, but well under one year apart.

Don’t expect any answers to these or related questions in this post 😉 .

Out, damn'd mite ...

Out, damn’d mite …

The intention here is to highlight the slightly shambolic nature of the documentation that accompanies (and sometimes does not accompany, but which you are probably expected to read!) the miticides approved for use in the UK. I don’t have time to cover all the miticides in a single post so will restrict this post 2 to two containing formic acid and one that contains oxalic acid.

And … while we’re at it … which are the legally binding instructions? Those in teensy-weensy lettering on the purchased product or the ones listed in the Veterinary Medicines Directorate (VMD) database?

MAQS and FormicPro

MAQS (Mite Away Quick Strips) and FormicPro are very similar products.

Actually, they are so similar that it’s rather difficult to tell them apart.

MAQS

The packaging is similar – a cardboard box or plastic tub filled with sachets, each containing two strips impregnated with formic acid (and some other stuff – but what isn’t specified). Even the price is similar; two doses (by which they mean sufficient to treat two hives, or one hive twice, cost an eye-watering 3 £16.50. I’ve not checked other suppliers, but Thorne’s list the 2, 10 and 30 dose boxes of MAQS and FormicPro at identical price points 4.

FormicPro

If you bother to read the online documentation (which you should) you will see that both are marketed by NOD Apiary Ireland Limited, and that each strip contains 68.2 g of formic acid. Even the description of the individual gel strips is very similar:

Brown, semi-rigid to soft gel strip covered in a biodegradable laminated paper, which maintains form (FormicPro).

Each strip is an off-white to caramel coloured gel wrapped in white laminated biodegradable paper (MAQS).

So, we have the same active ingredient, formulated in the same way, packaged in a similar manner, with identical diagrams for how to apply two strips to the brood box. The temperature range recommended for use is identical and both have similar warnings about queen damage.

The same but different

But, although MAQS and FormicPro appear to be essentially the same, from a practical beekeeping standpoint they are very different.

MAQS can be used with honey supers on the hive but FormicPro cannot.

Of course, pedantically, that’s not exactly true.

You could use them ’any-damned-way’ you please, but you would probably be breaking the rules.

You are allowed to use MAQS when there are honey supers present, but you are not allowed to use FormicPro – in all other regards an identical product – when there are honey supers on the hive. 

Here are the relevant words from the online SPC’s (Summary of Product Characteristics) 5:

Supers with honey must be removed from the hive prior to product application. See Section 4.5. Honey stored in super(s) put on for the treatment period must be removed and not used for human consumption. Spent strips must be removed before supers intended for harvest are placed on the hive (FormicPro – section 4.11 ‘Withdrawal period’).

The strips may be applied during honey flow; put on honey supers if honey flow is anticipated, to allow adequate space for colony expansion (MAQS – section 4.5 ‘Special precautions for use’).

There is one other difference as well … you can buy FormicPro whereas MAQS appears to be out of stock from all the suppliers I’ve checked.

Perhaps it has been withdrawn already by the manufacturer … ?

This is going to confuse a lot of beekeepers who have come to value MAQS as a short-term and effective treatment for Varroa management during the season.

Many will continue to use FormicPro in the same way that they used MAQS … which could be problematic if they are visited by a Seasonal Bee Inspector.

Summary of Product Characteristics (SPC)

Any miticides you purchase should be accompanied by a set of instructions – on the outside of the box, or the foil packet or wherever. These are often like ’ant tracks’ – illegibly small printing, almost impossible to read without the use of a binocular microscope 6.

Api-Bioxal … where’s my microscope?

Importantly, the packet will also carry a lot number and a use by date – you need to keep records of the former for several years 7 after use. I almost always forget to write this into my notes, but I always photograph the packet so have a dated copy on my ‘phone.

Use the VMD search facility to avoid the budgie treatments

If you want to review the official documentation for the miticide you need to visit the Veterinary Medicines Directorate Product Information Database. With a bit of rummaging around (Hint .. the search facility is your friend 8 ) you can usually find at least two official documents for each authorised product:

A document prefixed SPC (the Summary of Product Characteristics).

A document prefixed QRD (for Quality Review of Documents), which is the Product Literature; essentially the labelling and text that is supplied when you purchase the product.

If you read these you will find a large amount of duplication. These documents are periodically revised – the MAQS and FormicPro paperwork is all dated June 2022, with MAQS being first authorised in 2013 and FormicPro in 2021.

Discrepancies and confusion

Aside from the ‘biggy’ (not being allowed to use FormicPro when there are supers on the hive) there are other discrepancies or confusing text in these documents.

I’ve already listed one example …

The MAQS SPC indicates the ability to use the product when supers are present under section 4.5 ’Special precautions for use’.

In contrast, the FormicPro SPC indicates that the product cannot be used when honey supers are present under section 4.11 ’Withdrawal period’, though they do refer to section 4.5 (where, perplexingly, only empty honey supers are mentioned).

Section 4.5 seems to me to be the logical place to mention the ever-so-slightly-critical matter of not being allowed to use FormicPro when there are honey supers present.

Does anyone proof read or sanity check these documents?

If so, why don’t they ever define the term withdrawal period?

If you do a search online for ’withdrawal period’ there are all sorts of things about hormonal birth control and legal contract cancellations, but you need to scroll down to the penultimate item on the first page to get the relevant meaning:

The time that must elapse between the last administration of a veterinary medicine and the slaughter or production of food from that animal, to ensure that the food does not contain levels of the medicine that exceed the maximum residue limit.

And that’s from the European Medicines Agency; it wasn’t until somewhere on the third page of results I could find anything from the VMD 9.

Helpful? Not 🙁 .

Of course, there’s an argument that if you’re applying the ‘medicine’ then you should understand all the paperwork and seek further advice if needed.

But I suspect many do not.

More vagueness

Whilst very specific in places e.g. duration of treatment, maximum temperature for use 29.5°C (Really? Does that 0.5°C make a difference? How many domestic thermometers are that accurate?), the documentation also carries other contradictory or vague instructions.

Both MAQS and FormicPro contain the following words under Section 4.4 (‘Special warnings for each target species ‘) of the SPC

Use according to local treatment recommendations, if available.

Who makes these local treatment recommendations? Are they legally binding? Can you just invent them? What can they cover or not cover? Could the local treatment recommendations state “Use five strips for a month”?

And what about disposal of the used, unused and waste products? Here you will find instructions in two separate places in the SPC.

When removed, dispose of by composting (FormicPro, Section 4.9 “Administration”).

The strips do not need to be removed from the hive after the application period of 7 days as the honey bees dispose of the spent strips. If they are removed, dispose of by composting (MAQS, Section 4.9 “Administration”).

And, confusingly …

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements (MAQS and FormicPro Section 6.6 ‘Special precautions for disposal’)

So can they be composted, or do ‘local requirements’ take precedence?

I can’t even be bothered to comment on section 4.6 ‘Adverse reactions’ which helpfully define very common, common, uncommon, rare etc events, but then only apply them to one adverse reaction, despite listing many others.

Grrrrr.

I’ve spent a career trying to make sense of badly worded, confusing, verbose, self-contradictory documents (until the arrival of ChatGPT this was the norm for both student essays and University administrative paperwork) but some of these instructions still baffle me.

Api-Bioxal

The active ingredient in Api-Bioxal is oxalic acid (OA). I’ve discussed this extensively in previous posts. There are several other miticides listed on the VMD database that have OA as the active ingredient; Oxuvar, VarroMed (which also contains formic acid), Dany’s BienenWohl powder/solution and Oxybee. Of these, the last two may not be routinely available in the UK.

I’m going to restrict my (brief) discussion to Api-Bioxal as it’s the only one I’m familiar with and because it highlights a different form of internal infernal contradiction in the official instructions and paperwork.

The Api-Bioxal SPC and instructions clearly state (in section 4.5 ’Special precautions for use’ … or ‘the logical place’ as it should be known) that it should be administered when supers are not present on the hive.

In addition, it also clearly states that the withdrawal period is ‘Zero days’ 10.

Sublimox vaporiser

Sublimox vaporiser … phoretic mites don’t stand a chance

The duration of application for MAQS and FormicPro is seven days and the formic acid permeates the cappings and kills mites in capped cells. In contrast, Api-Bioxal is a single shot treatment … it may (or may not) remain active in the hive for some time after administration, but you essentially apply it and walk away.

Job done 🙂 .

Oxalic acid does not penetrate capped cells and so is only effective if the colony is broodless. The instructions are clear on this point (to their credit).

A single shot used once … or twice?

The instructions describe two approved methods of administering Api-Bioxal. Trickling a 4.2% (w/v) solution made up in 1:1 (‘thin’) syrup onto the visible seams of bees, or vaporising a hive with up to 2.3 g of Api-Bioxal.

Administration by trickling … Up to two treatments per year (winter and/or spring-summer season in brood-free colonies). The treatment should be made in a single administration.

Administration by vaporisation … Maximal dose 2.3g per hive as a single administration. One treatment per year.

I think the ‘single administration’ means that you cannot split a treatment into two e.g. vaporise 1.15 g twice, or trickle 2.5 ml per seam and then repeat it the following day.

What’s odd is that trickling can be conducted twice per year, whereas vaporisation cannot. What about vaporising in December and January? i.e. once in each of two successive years … which could even be on successive days (31/12 and 1/1).

This is odd for two reasons – firstly it seems strange that the same compound can be administered a different number of times depending upon the route of administration.

Well, OK, perhaps it’s really bad for the colony to be vaporised? In that case it would be understandable, though some explanation of the point would help.

The good old days … trickle treating colonies before Api-Bioxal

Trickling and vaporising do cause differential damage to colonies, but it is trickling that does more damage. Trickled OA damages open brood and studies from the LASI group in Sussex showed that colonies trickle-treated when brood was present were subsequently weaker than those that were vaporised (Al Toufailia et al., 2015).

Conversely, several studies of repeated vaporisation have shown that it is well tolerated by the colony.

So, in this instance the instructions are at odds with my understanding 11 of the current science.

Zero days

If the withdrawal period for Api-Bioxal is zero days (it is), can you add a stack of supers to the colony the day after vaporising or trickle treating a colony?

I think you can 12.

Which is a little odd as the oxalic acid remains active in the colony for several days after it is added. If you apply Api-Bioxal and then monitor mite drop on a daily basis over about a week it often peaks a day or two after it is administered, but goes on at a reducing rate for ~5-6 days. Whilst it could just be taking its time killing the mites 13, I think it is more likely that residual activity remains for several days.

Perhaps the wording in the instructions on ‘honey flow’ precludes this, but you can certainly add supers before a honey flow and I’d argue that the wording isn’t completely clear cut.

Licensing

I know almost nothing about the licensing of veterinary medicines. My understanding is that a license is applied for, supported by evidence of efficacy, toxicity etc. and that it is restricted in terms of the range of methods used to apply the miticide.

Therefore, if the manufacturer only applies for a license for trickling or vaporisation, then that’s what they get (if approved). Varromed (an OA solution) can be administered by trickling and spraying. When made up for spraying the OA solution has a long shelf life as there is no sugar present.

But that’s not an option for Api-Bioxal 🙁 .

Beekeepers are restricted in what they can (legally) do by what the manufacturer sought a licence for, even if there are better ways of administering the active compound, or even if the scientific evidence (sometimes preceding licensing, and certainly preceding updates of the documentation) indicates that – for example – repeat administration is both safe and effective.

Trying to make sense of it all

In Scotland a Working Group has been established to try and resolve some of these discrepancies and provide better advice to beekeepers on the use of the currently licensed miticides.

The Working Group involves representatives from a variety of interested parties including an acronym salad comprising SASA, VMD, BFA, FSS, SBA, SRUC, SEPA, APHA, DEFRA, DAERA, NBU and some academics and ex-academics with a particular interest in honey bee health.

I have written a lot about Varroa control on this site. In my view it is relatively straightforward to control mite numbers using the currently licensed miticides appropriately. In my experience it is easier to do this in Scotland, where we have lower winter temperatures and a greater chance of an extended broodless period.

However, Scotland – unlike the Midlands where I have also kept bees – offers some additional complications where Varroa control is concerned. Our most important (by £££) nectar source is heather which yields late in the year, too late in some years to subsequently protect the winter bees from mites and viruses.

Balancing the needs of the bees (low mites and viruses to overwinter successfully) with those of the beekeeper (hundreds of kilograms of heather honey) requires a careful balancing act and a good understanding of the benefits and limitations of the miticides available.

In turn, this needs good documentation and better advice that is both easily accessible and understandable by beekeepers.

And … to my surprise – and I look forward to it being confirmed or refuted – I’m told that the SPC is the legally binding document with regard to the use or misuse of licensed miticides.

I’ve (had to) read them all now … have you?


References

Al Toufailia, H., Scandian, L., and Ratnieks, F.L.W. (2015) Towards integrated control of varroa: 2) comparing application methods and doses of oxalic acid on the mortality of phoretic Varroa destructor mites and their honey bee hosts. Journal of Apicultural Research 54: 108–120 https://doi.org/10.1080/00218839.2015.1106777

Footnotes

  1. Too many double negatives there, sorry.
  2. The first in a series of 41.
  3. That’s a pun based upon the chemical content … whilst expensive for a small amount of formic acid, this is insignificant when compared with the financial hit if you lose the colony.
  4. £58 and £155 for 10 and 30 doses respectively, a compelling reason to buy with fellow beekeepers if you only have a few hives.
  5. More on these documents shortly.
  6. Or perhaps I just need even stronger glasses?
  7. Five? I can’t remember off the top of my head.
  8. Limit your search to ‘species = bees’ to avoid the horse tranquillisers, dog worming tablets and treatments for scaly face in budgerigars.
  9. And that was a withdrawn document.
  10. Of course, there’s no explanation what this means.
  11. And I’m not the only one.
  12. And, as it’s zero, what about immediately?
  13. Serves them right!

50 thoughts on “Infernal contradictions

  1. Larry Krengel

    Dealing with varroa is often like getting lost in a house of mirrors. Counting mites is difficult and lacking in reliability. Dosing is difficult to control. Side effects are ill-defined. Timing, temperature and repeat intervals often intertwine to make the beekeeper life complicate. David, I agree with you. Yet, if one wishes to keep bees and have them survive, one needs to make the best of a convoluted situation. Being from the US, I know things may be a bit different, but I have two resources that work well for me. The first is from the Honey Bee Health Collition – https://honeybeehealthcoalition.org/resources/varroa-management/… and a short guide frem the Wisconsin Department of Agriculture – https://datcp.wi.gov/Documents/TreatmentOptions.pdf.

    Reply
    1. David Post author

      Hi Larry

      Thanks for those links. I’ve not yet had a chance to read the information, but it’s clear that there are different rules that apply in different parts of the world – and presumably some parts that have no rules! The principles of Varroa control are the same though … understand those (and I’ve written quite a bit on the topic here) and then apply the miticide that best achieves the goals that is allowed in your location.

      I’ve got an email reply half-written to you as well … later this w/e (I hope) 😉

      Cheers
      David

      Reply
  2. Paul Lindstrom

    Yes, it doesn’t make sense that you can trickle Api-Bioxal twice, but not vaporise it twice. And with mild winters (no full brood brake) we need to sublimate OA three times to have full effect. It’s not easy to be a good beekeeper and follow the legal demands it seems.

    Reply
    1. David Post author

      Hi Paul

      I’d be interested in any data that shows that three sublimations are fully effective (or at least as effective as treating when broodless). The only proper study I’ve seen of this is the one in the US where the dose was too low (!) … I discussed it recently in Repeated OA vaporisation.

      Specifically I’d like to see alcohol washes before to show infestation levels, and something long-lasting like Apivar afterwards to show residual infestation. I’ve got some scruffy calculation and half-baked observations that suggest it might be less good than some people think.

      Cheers
      David

      Reply
  3. Stephen tompsett

    Thanks David. I thought you’d moved your hives to an area where there was no varroa. Do you still treat them anyway?

    Reply
    1. David Post author

      Hello Stephen

      This isn’t about my bees … it’s about your bees 😉 I have bees in both Varroa-free and -present locations and I certainly wouldn’t move the bees between them. You can lose Varroa-free status in the blink of an eye and it is probably never recoverable.

      I don’t treat my Varroa-free bees.

      Cheers
      David

      Reply
  4. David Libchaber

    I am very surprised to read your information about Formic Pro. Could the same product fall under two different uses in two different continents? I have linked the page that details how to use Formic Pro for north America. On that video, starting at 3:20, you will hear clearly stated that you can use Formic Pro with honey supers on….Very odd.

    https://nodglobal.com/formic-pro-application/

    Reply
    1. David Post author

      Hello David

      Many thanks for that. It’s clear that there are different geographic ‘rules’ depending on where/how/what the product was licensed for. Of course, it just makes our task as internet-connected beekeepers that much harder … some over here might read the US ‘rules’ and think they apply universally.

      What a mess!

      Cheers
      David

      Reply
  5. Archie McLellan

    Hello David

    Thank you for such a clear account of the mess that is the VMD’s management of some miticide instructions (labels). Whenever I read an article like this, I ask myself if it’s going to be seen by those responsible for the mess, so that they might realise they’ve got some explaining – or more – to do.

    I see that the ‘acronym salad’ includes the VMD. Should that fill me with hope? Perhaps they’ve heard much of this before. Maybe they’re very under-staffed. And bee meds are a very small part of the work they do.

    Like many beekeepers, I want to do the right thing by finding the best information available. That is not restricted to the instructions on a product label and those who claim that the label contains all we need to know do more harm than good. We live in an imperfect world. One manifestation of this is that some of our laws might need reviewing, and it takes a while for that to happen. In the meantime, in this case, individual beekeepers may well decide for themselves what course of action is in their bees’ best interests.

    Reply
    1. David Post author

      Hi Archie

      Don’t hold your breath for any ‘explaining’. I know nothing about other veterinary medicines, perhaps even the horse tranquillisers, dog worming tablets and ‘Polly’s Patented Elixir for Scaly Faced Budgies’ are similarly opaque. I can’t be bothered to look and am even less qualified to judge.

      I don’t even know if there’s a mechanism to get the official paperwork improved via VMD, or whether all this type of exercise is likely to do is add another layer of stuff that beekeepers are expected to (but often won’t) read 🙁

      And with that depressing thought I’ll sneak out before the rain starts to add some pollen patties to a few colonies.

      Cheers
      David

      Reply
        1. David Post author

          The Apiarist’s patented reminder service will soon be rolled out commercially, carefully tailored to your latitude, the prevailing temperature, local phenological observations from Nature’s Calendar and (a stroke of genius this last bit) your forgetfulness as a beekeeper.

          Watch this space
          David

          Reply
  6. Kevin Dolan

    We can use formic pro when honey supers are on In Canada, must be a different registration but not sure why the regional regs?

    Reply
    1. David Post author

      Hi Kevin

      Yes, there are geographic differences in what’s allowed or not allowed. For beginners particularly this must be confusing. I suppose it (again) emphasises the ‘local’ nature of beekeeping. Why they’re different is another question, and one I don’t know the answer to. It must be something to do with how the licensing systems work, what’s already approved, the extant practices and goodness knows what else.

      Cheers
      David

      Reply
  7. Simon

    Thanks for this article. I thought it was just me! I am a new beekeeper and I have been reading up on varroa and its treatment before I start. I have found the instructions “sketchy at best”. My background is in hospital paediatrics, so i am very familiar with different manufacturors of the same drug giving different advice, but for veteneary medications it is next level. The appears to be a lack of regular structure of information provided. One thing I am used to however, is dosing based on formulation and route of administration – pharmacokinetics and pharmacodynamics can get super interesting at times. A favourite example of this is the dosage (mg/kg) of the antibiotic gentamicin when given intavenously – a neonate has the highest dose, and adult the lower, and an elderly patient has a higer dose. – all related to fat levels/type/distribution which change with age. I can see why an oxalic dribble would cause more damage – i would assume this would be due to a lack of uniform distribution causing areas of high and low concentration, with high concentration areas having more side effect / toxicity related issues. Hmm this was meant to be a quick reply and i’m rambling… needless to say the article stimulated my grey cells a little. Time for the vmd to get a grip on medication documentation… Thank you Sir!

    Reply
    1. David Post author

      Hi Simon

      You almost lost me at “pharmacokinetics and pharmacodynamics can get super interesting at times” 😉 …

      I think OA dribble is toxic to open brood because of the acidity of the solution to the larvae, which are presumably much more sensitive than adults and not protected like pupae. It may not be a lack of uniform distribution. Even gross overdosing by vaporisation is pretty well tolerated.

      I think your comment about the lack of a regular structure to the information is a really important one. I was just comparing a couple of the documents and they’re all over the place. The frequency of side-effects are particularly poorly documented (I wonder why??).

      For example, loss of queens upon formic acid treatment is well known and I’m pretty sure it is also quantified (I’ve read at least one paper on this and will try and dig it out). If the manufacturers had to state 25% of queens will be lost within a week would we be so keen to purchase it? Instead they talk in rather generic terms about supersedure and checking the colony a month later.

      Cheers
      David

      Reply
  8. Maccon Keane

    Dear David
    I expect this May be the least commented on post this year and you frustration shines through in the text. As you rightly say in veterinary or human medicine licensing is sought by producers for a specific dose, compounding, administration method and duration. If approved by the regulatory authority the UK /EU license is granted for that indication only.However it is very common in human medicine that the standard use of that drug is not for that indication indeed not even that disease however companies commonly do not seek a license for the new use as the process is torturous and very expensive. Essentially if the product is commercially available through the original license they assume users ( doctors / vets / beekeepers) will use the product according to the data as it emerges from trials / clinical practice. Technically this contravenes the license but there really isn’t an method to change this process easily. It is particularly relevant to medications that are ‘off patent’ which I expect applies to both formic acid and Oxalic acid as there is little / no profit in it for the company. PS I really admire you for reading SPC’s – truly the most boring literature in any language
    Kind regards
    Maccon

    Reply
    1. David Post author

      Hi Maccon

      It’s all a big mess. And, yes, it’s frustrating. Beekeeping is a refreshingly ‘broad church’ … all types of individuals and all levels of education. However, the documentation sometimes looks like it’s written for a classics-educated graduate who subsequently went to law school (after a first degree in veterinary science).

      I think the other problem is that the audience – commercial and amateur beekeepers – have very different expectations and needs from the treatments. Bee farmers often have a high volume/time limited approach, amateurs (like me) can be much more leisurely about things. Some of the midseason queen trapping methods look very promising but would be an unfeasible amount of work if you had a couple of hundred (let alone thousand) colonies.

      Oh well … onward and upward 🙂 … saw my first frogspawn here yesterday so spring must be out there somewhere …

      Cheers
      David

      Reply
    2. Archie McLellan

      ‘Essentially if the product is commercially available through the original license they assume users ( doctors / vets / beekeepers) will use the product according to the data as it emerges from trials / clinical practice. Technically this contravenes the license but there really isn’t an method to change this process easily. ‘

      I have a feeling this statement could be a game-changer. So, the manufacturers assume users will use the product according to the data as it emerges. Can ‘users’ assume that the regulatory authorities are aware that this happens and are happy to go along with it – perhaps when there is some degree of consensus?

      Reply
      1. David Post author

        A game-changer … or an inadequate defence when prosecuted for misuse ?! I suspect it might be a bit too vague and/or is subject to abuse … “Amitraz? Never did anyone any ‘arm! Show me someone that died from amitraz poisoning? You can’t? That’s why I’ve got 6 strips in the brood box all season (and 2 in each super). No mites at all. Luvverly honey.”

        I’m not sure common sense gets a look in with some of these types of paperwork or regulations 🙁

        Cheers
        David

        Reply
        1. Archie McLellan

          Point well made! And ignorance of the law, or worse, is no excuse.

          But (I was thinking while making up pollen sub patties), if what Maccon says is true, then his category of ‘users’ needs to be constrained a bit, and probably can’t include any old group of beekeepers!

          Reply
      2. Maccon

        Dear Archie and David
        I apologize for dragging this discussion out further than I had expected. However to clarify if an available medicine is used in a patient off-licence where clinical data exist for its benefit a doctor has the ability to discuss that with the patient prior to administering the drug and consent for same e.g. chemotherapy for a rare cancer. The regulatory authorities are fully aware of this practice and don’t play any role. It is based in clinical evidence. The issue rightly highlighted by David is that the analogous discussion can not be had with all consumers ( of honey) in the case of a beekeeper so our legal colleagues potentially could have a field day if there was a significant consequence to consumers. That said if there is good evidence for benefit ( to the bees) and no evidence of harm ( to the consumer) such as from a clinical trial I expect that would have the same standing legally as the human case and would potentially permit the change or use. However I am not a lawyer and this is just my opinion as someone who is involved in anti-cancer medicines regulation. As I stated before the licensing system is utterly inflexible and can not cope with typical changes in use of medicines animal or human that happen over time. Finally – general rule – if things go legal they never end well.

        Regards
        Maccon

        Reply
        1. David Post author

          Finally – general rule – if things go legal they never end well … unless you’re a lawyer on a fat hourly rate 🙁

          Many thanks for the additional clarification Maccon. Hopefully some more light will be shed on this topic c/o the Varroa Working Group. I fear that the inflexibility of the authorities and the lack of ‘clinical trials’ (and I bet peer-reviewed science would not count) would mean that the most likely outcome would benefit the lawyers and not the beekeepers or the bees 🙁

          Cheers
          David

          Reply
          1. Simon Minford

            Just to add some clarifications about a licenses and how they effect medication use. Drug licence’s are very expensive and difficult to get, and once one is granted that’s it – it’s very rare that more is done. it establishes that the drug is safe to use in the market place. However, drugs dosage and area of use can change over time based on research (This is what we are missing in beekeeping). An easy example of this is aspirin – it is a painkiller and was licensed as such, however, research showed that it had blood thinning properties,so it can be prescribed “off-label” for this condition(i.e. dosage and condition different from license). Ultimately as beekeepers I think we need to advocate for more research into bee health, which will in turn build a body of evidence that directs us to use the medications in a safer and more effective way. to end on a positive note, this is very achievable. A significant number of the medications given to children over the past 50 years have been unlicensed or “off label”. With continued effort over time and some changes to licensing laws this number is much reduced today.

          2. David Post author

            Hello Simon

            Many thanks for those helpful comments. It will be interesting to see what the VMD say about these types of revisions, but the absence of a secondary check (the prescription process for being used ‘off label’) might be an issue. I suspect the problem will always come down to money, or the lack of it. Would beekeepers pay for the research needed to justify a change of use – for example, to get generic OA approved for repeat vaporisation? The majority of the ‘bee health’ money, at least for primary research, comes from government and there’s not much of it. I doubt a grant application for this type of revision of use would be successful … which means funding would need to be from the manufacturers or perhaps bee-related charities. The former may think they’ve spent enough already, or have competing products in a different niche, and the latter tend to be rather small scale grants.

            What’s frustrating is that money is available for some fancy approaches e.g gene therapy, but not for simply improving wht already works reasonably well, but could work a damn sight better 🙁

            Cheers
            David

  9. Richard Hughes

    Hello David,

    In this particularly good year for honey, in addition to feeding fondant over winter, I have put one super under each brood box as stores for the colony. I treated with Apivar strips in each brood box in the autumn and trickled Apibioxal early in January. Am I able to safely use again the extruded foundation in the supers which were placed under each brood box but obviously not in direct contact with either miticide?

    Kind regards

    Reply
    1. David Post author

      Hello Richard

      Somewhere else on previous comments I’ve been asked that before. I don’t. I melt them out and get them redrawn. In a good flow bees will draw super comb in just a few days. However, whether you’re allowed to re-use is a different matter … you need to read the instructions (and the SPC’s) carefully and hope they make more sense to you than some of them do to me 😉 … or you can wait for a follow up article on amitraz-containing miticides which should follow (sometime).

      Finally, you might like to consider whether you want to even if you’re allowed to. I aim to produce the very best quality honey I possibly can, and that includes minimising the chances of any miticide residues.

      Cheers
      David

      Reply
  10. Jim Stuart

    David thank you – I have often thought my little grey cells were the problem.

    If only to abuse the words of Tom Lehrer “Vaporise, vaporise and let no vapour invade your eyes!”

    Have a good day,

    Jim

    Reply
    1. David Post author

      Hi Jim

      Don’t worry, it’s not just you. I’ve got a couple of degrees and have spent a career reading scientific papers and even the worst of those (like some of my own) are a doddle in comparison to some of the official SPC’s. Perhaps we need a peer review process?

      I think we need to find a rhyme for lungs as well because inhaling it is much worse …

      Cheers
      David

      Reply
  11. Liz Bates

    Looking at the VMD for Api-Bioxal (https://www.vmd.defra.gov.uk/productinformationdatabase/files/SPC_Documents/SPC_807534.PDF), it states: “When handling the powder (both during vaporisation and pre-treatment phases) wear a protective mask conforming to European standard EN149 (type FFP2), gloves and protective glasses. This mask appears to be one of the the ‘better’ ones used during Covid, to filter out 94% of particles. Despite mentioning that this applies to vaporisation (sublimation), no comment on the correct mask for the sublimation process, nor the fact that when wearing the correct mask one could be unaware of the vapour, which can burn the skin of the eyes. “Protective glasses” is a very loose term, and could well include those from hardware stores with airholes in the sides. I use swimming goggles as they have nowhere for the vapour to get in. Using the correct mask for sublimation exacerbates the risk as there is no warning….

    Reply
    1. David Post author

      Hello Liz

      The list of contradictions, anomalies and incomplete information is certainly not restricted to the things I listed.

      I didn’t specifically look at the safety things in a lot of detail and I’m in two minds whether they should be comprehensively covered in these sorts of documents or elsewhere. It’s certainly odd that they are so specific about precautions when weighing the powder, but not when generating cubic metres of vapour. I guess there’s a danger that page after page of safety ‘advice’ would be an even greater deterrent to people reading all of the information. On the other hand, vaporised OA is pretty unpleasant stuff and it is very important that users take appropriate safety precautions. At some point the user has to take responsibility for his/her actions e.g. I wouldn’t expect safety guidance on wearing big rubber wellies if using a 240 V sublimator on a wet day.

      What’s odd is that they go to the trouble of detailing things for the powder and then and relatively cursory with the vaporised material … the implication being that it’s the powder that is more dangerous.

      Sort of related … I’m regularly asked about PPE for vaporising. I don’t provide details of what I use as I think it is the responsibility of the end user. Mine is (more than) appropriate for the way I use my machine, but it might not be for someone more reckless. If I said “use an XYZ mask” and someone still gassed themselves because it didn’t fit, or they’d not attached the filter or whatever (neither fundamental point being mentioned in my advice) then who is liable?

      In all my many years of laboratory and GM safety it was always the end user that had to assess the risk and define the appropriate precautions …

      Best Wishes
      David

      Reply
  12. Janey Bolton

    Hi David.
    Thanks for another very informative post. With regard MAQS and Formic Pro, it appears that in America and New Zealand it’s acceptable to use Formic Pro with honey supers in place. The implication being that it is issues around licensing that gives rise to the discrepancies. As licensing takes time and money (and time is money) one has to wonder whether the product has been pushed onto the UK market before the issue of honey supers was fully resolved. I suspect that at some point in the not too distant future Formic Pro will have the same rules as MAQS.

    Reply
    1. David Post author

      Hi Janey

      That’s a possibility, but it would need a change in the registration of FormicPro. Independently I’ve been told it might be production issues for MAQS and that it will be returning. In a way, the main purpose of my ranting was to point out the discrepancies with the paperwork (not make it a MAQS-specific issue) … they apply equally to some other products as I will discuss in a future post.

      Many beekeepers here were surprised that a seemingly identical product was not licensed for use with supers on the hive. I was one of them 😉

      Cheers
      David

      Reply
  13. Darrell Downey

    David,
    I am thankful that you have written on this problem. I have been keeping bees for 9 years in the state of Kentucky, U.S A. I have noticed and complained about the contradictions and confusion in the instructions of bee medications. The Api Guard thymol treatment for varroa instructions state to apply “1 50g dose for 2 weeks and then one more 50g dose for 2 weeks, at temperatures of 50F to 92F”. We have very hot and humid summers here, and the bees bearded too much when using Api Guard at that dose. I later discovered in the frequently asked questions (FAQ) from Vita Health website #14 question.” It is very hot where my hives are, Can I use Api Guard in these conditions?” answer: “In temperatures above 25C/ 77F it is possible (I think they changed it to “preferable)’ to use 25g one week apart instead of 50g 2 weeks apart and get a very good mite kill”.
    Vita Health now sells 25g sachets but are not available to us here in the USA. After discovering this “hidden” information a few years ago, I use a plastic spatula to equally split the 50g dose and carefully apply to another saved empty Apiguard tray (without disturbing the gel too much, of course). When I need to treat for varroa in hot conditions, I have been using 25g every week for 4 weeks and it has a very good mite kill, and it is much more tolerant to the bees.
    Why did they not state that in the directions for use in the first place?
    Also, the extra Apiguard trays are perfect to use when applying wax moth crystals for storage.
    Thanks for all.
    Darrell

    Reply
    1. David Post author

      Hi Darrell

      I’m also told that the MAQS/FormicPro 29.5°C upper limit (don’t forget that last 0.5°C !) is perhaps a bit of wishful thinking as well. I don’t use formic acids, but some people who do tell me they’ve had major issues with bearding and queen loss above 25°C. I’m sure the manufacturers want their products to be as widely used (sold) as possible, but if they are detrimental to the colonies at some of the extremes quoted then it’s disappointing.

      Apiguard has a lower limit of 15°C … lots of beekeepers report using it in Scotland in mid/late autumn. Not only is this too late to protect the winter bees, it’s also too cold for it to work effectively 🙁

      Apiguard used to sold here in 50 g trays and in large buckets. The latter were more economical and very practical. No longer … it’s just the trays now I think (but again, I don’t use it these days as it’s too cold here).

      Cheers
      David

      Reply
  14. Heidi Burgess

    I am so glad that it is not just me who is confused by the minefield that is verroa medication. At the end of last season, confused by instructions I emailed the Apilife Var team directly and received back more detailed and personalised instructions, which were different to the packaging. so maybe if we all started contacting the suppliers with our questions, then maybe they would realise that there instructions do not ‘cut the mustard ‘

    Reply
    1. David Post author

      Hi Heidi

      Just when I didn’t think it could get any worse … different instructions from manufacturers own instructions on the packaging, from the manufacturers (see also the comment from Darrell Downey). Whatever next? I’d hate to think the problems that could cause here.

      I’m reassured – but more than a little disappointed – that half the comments are about similar problems beekeepers have from areas other than the UK. Clearly this is a widespread issue. I’ve already discussed the ‘approval’ for ineffective repeat OA applications, another manifestation of the inadequacy of the whole thing.

      Cheers
      David

      Reply
  15. Roy Haynes

    Hello David
    A representative from NOD gave a short presentation at last year’s BBKA Spring Convention. I asked the question as to why FormicPro could not be used with supers present whereas MAQS could. His reply, in essence, was that the cost of obtaining a license for such usage was prohibitively expensive due to the extra testing involved and the limited market for the product. Their main selling point for FormicPro seems to be its longer shelf life. Personally, I would prefer the ability to use it with supers present.

    Best wishes
    Roy Haynes

    Reply
    1. David Post author

      Hello Roy

      Many thanks for that update. I’ve also heard indirectly from NOD and it seems as though MAQS will be reappearing at some time in the future. I certainly hope so … not for me, but I know that a lot of beekeepers rely upon having a midseason treatment that’s compatible with honey supers being present. I also think that’s more important than shelf life. The VMD-available documentation does not indicate the differences in the shelf life.

      Cheers
      David

      Reply
  16. Darrell Downey

    We are allowed to apply Formic Pro in the USA with honey supers on. At the NOD website’s FAQ section, it states that ” Formic Pro can be applied with honey supers on in North America and New Zealand” and
    ‘All other countries do not have approval.” This does not make sense to me. It must be a regulatory issue.

    Reply
    1. David Post author

      Thanks Darrell

      Yes, frustrating … and when everyone turns to the internet for advice and you’ve no idea where (geographically) that advice originates, also confusing. We’ll see what happens here later this season as I’m hearing mixed explanations both for the differences and for the likely future arrangements.

      Cheers
      David

      Reply
  17. Roy Haynes

    Hello David

    Re the shelf life – Thorne’s website, on the page about Formic Pro, has a link entitled ‘Presentation on the differences between MAQS and FormicPro’ at the bottom of the description page. It takes you to a pdf from NOD which contains a table which shows the 24 month shelf life of FormicPro, as opposed to 12 months for MAQS.

    The storage temperatures given are rather intriguing too. MAQS must be kept below 25C, whilst FormicPro should be kept at ‘room temperature’ – whatever that is! However, both can be applied when the temperature is up to the magic 29.5C.

    https://www.thorne.co.uk/uploads/media/default/0001/23/d402b8ca92b4e79d7dcba1bb557ef6ac52f3c168.pdf

    Regards
    Roy

    Reply
    1. David Post author

      Many thanks Roy

      I wonder if there are real differences in ‘longevity’ upon storage, or if these just represent different people writing up the instructions and/or a lack of checking what’s been done before?

      The 29.5°C is just daft. I was expecting a tsunami of responses about people who used it at 25°C or 28.5°C and it slaughtered the queen … last year was so hot there must have been some places in the UK where it couldn’t be used because we’d reached 29.6°C …

      Cheers
      David

      Reply
  18. James

    Here’s another discrepancy for the list… The instructions on the batch of Apivar strips I have say that the treatment should be for a minimum of six weeks where no brood is present, up to ten weeks if brood is present. On the Veto Pharma(?) website however, it says six weeks and eight weeks respectively.

    James

    Reply
    1. David Post author

      Hi James

      Another one to add to the list. I’ll be dealing with Apivar in a future post. I think we need to be careful distinguishing between instructions supplied with a product and online information destined for a potentially global audience. I think the former are more important … despite the fact that many users are more likely to refer to the latter!!

      Cheers
      David

      Reply
  19. Dorothie Jones

    Hi David,
    A great article highlighting the complexities of varroa treatments in the UK!
    We get so many questions from our new beekeepers about this. We just have to parrot ‘follow the instructions’ but maybe we will discuss alternatives later on!

    In 2021 I spoke to someone from the VMD on a stand at the National Honey Show. She told me that the only legal requirement was to use only licensed products and you could technically be prosecuted for not doing so. However it was only an ‘expectation’ that you would follow the manufacturers instructions to the letter and as long as no harm was cause to the bees then it would be unlikely we would ‘get into trouble’ for what they know is common practice amongst beekeepers….Hmmm!

    Subsequently last year I managed to get replies from both the VMD and the manufacturers of Api-Bioxal explaining their stance on this matter.
    If you would like to see the full emails I am happy to forward them to you?

    The gist basically is that one dose only is sufficient for maximum effectiveness in controlling varroa and that there is no published evidence that further treatments are necessary (necessary not being the same as effective!) Both the manufacturers and the VMD are obliged to follow the European directive that for any pesticide/treatment the minimum dose necessary must always be the recommended one.
    Therefore until the manufacturers recognise scientific evidence that more the one treatment is actually ‘necessary’ the VMD will not change their stance.
    So looks like we’re stuck where we are for the foreseeable!
    Dorothie

    Reply
    1. David Post author

      Hello Dorothie

      I’d love to see the emails if you’re allowed to send them on … if that is the official line it fundamentally changes the way(s) we could manage Varroa. I think there is evidence – under certain circumstances – that more than one dose is necessary (though I acknowledge that there are some semantic arguments to be had as to what is effective and what is necessary!).

      My email contact is low down on the right margin somewhere.

      With thanks
      David

      Reply
  20. sean

    Hi David,
    Another interesting article.
    Have you any views on long lasting Oxalic Acid treatments which are left on the hive for a few months?
    Randy Oliver from Scientific Beekeeping mentions experimental work in the US and Argentina on long acting, high dose OA in glycerine.
    Looks like something quite promising

    Reply
    1. David Post author

      Hello Sean

      I’ve not tried it. It’s not approved over here and the EPA has just rescinded the authorisation for its use in the USA. I think it does look reasonably promising but don’t see an easy route by which it will get licensed here (or there).

      Sorry to be the bearer of bad news 🙁

      Cheers
      David

      Reply

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