The Elephant and the EPA

Table of Contents

The Elephant and the EPA

Randy Oliver

ScientificBeekeeping.com

First printed in ABJ April 2024

A comparable pair of problems are coming to a head: (1) The “elephant within the room” that no person desires to discuss –– that the EPA is feeling expanding power to ramp up enforcement towards beekeeper use of unapproved remedies, and (2) the expanding construction through varroa of resistance to the miticide amitraz. Those problems aren’t going to “move away,” and ignoring a subject can flip it right into a drawback. So what’s our Plan B?

Our State of affairs is Rarely Distinctive or Sudden

Maximum beekeepers on the planet have varroa of their hives, and in international locations that experience trusted neurotoxic artificial miticides to management the pest, they’ve discovered that those silver bullets “paintings nice, till they don’t” [[1]^{, [2]}]. In tropical and Mediterranean international locations, the place mites experience extra reproductive cycles in line with 12 months, beekeepers are complaining that the bogus miticides are not efficacious. Their experiences supply a crystal ball for beekeepers in North The usa — except a brand new silver bullet hits the marketplace quickly, we’re gonna wish to undertake other strategies for coping with the mite. Our maximum promising fallbacks are the adoption of resistant shares, and a shift to biopesticides –– significantly oxalic and formic acids, thymol, and most likely different plant very important oils (two issues that I’ve been that specialize in for some years).

How Did We Get to The place We Are?

American citizens normally, and beekeepers particularly, have at all times been “do-it-yourselfers.” At a tradition, when a researcher names a promising new energetic factor towards varroa, I see beekeepers within the target market pulling out their pens. They’ll most probably be experimenting with that energetic factor smartly earlier than anyone is going during the EPA’s pricey and time-consuming registration procedure.

Sensible consequence: Beekeepers are an “orphan trade,” with out sufficient purchaser call for to make it cost-effective for builders of formulated varroa-control merchandise to move via EPA’s dear registration procedure. This has led to there being a paucity of registered varroa remedies, all of that are unduly dear. The EPA is acutely aware of this, and is now fast-tracking registration of biopesticides, in addition to a brand new amitraz product (Determine 1).

The Elephant and the EPA

Fig. 1 The EPA has not too long ago fast-tracked registration of recent formulations of 2 current energetic substances. This type of product festival is excellent for us, each option-wise and price-wise.

In 1988, in a while after varroa hit our shores, this very magazine printed a piece of writing from Israel [[3]] pointing out that: “Colonies in Israel infested with V. jacobsoni have been handled with Mavrik (a.i. fluvalinate). A small piece of plywood which were soaked in 20% Mavrik emulsion after which dried used to be hung between the combs within the centre of the brood nest. … It’s concluded that 4 Mavrik remedies in line with colony in line with 12 months can stay V. jacobsoni populations to ranges beneath the industrial harm threshold.”

This used to be a watershed second for the pesticide-averse beekeeping trade –– for the primary time, we changed into the principle supply of pesticide contamination of our combs (environment a brand new baseline for publicity of our bees to insecticides). The “off-label” use (the use of it for a distinct pest than the ones specified at the label) of Mavrik used to be already smartly established earlier than Apistan were given registered through the EPA in 1990. For the reason that registered product used to be way more dear, and more difficult to use and take away than home made towels, maximum large-scale beekeepers caught with their homebrews.

Anyway, the results of popular and chronic use of fluvalinate within the U.S. adopted the similar trajectory that happened in Mediterranean Europe, with mites quickly creating popular resistance to the chemical. Through the overdue Nineteen Nineties, business beekeepers have been determined for one thing else. The EPA, which used to be actively phasing out unhealthy organophosphate pesticides, registered coumaphos in safe-to-apply Checkmite+ strips in 1999. Through this time, business beekeepers had earned the moniker of being “pesticide scofflaws,” and because Checkmite+ used to be dearer than powdered Co-Ral livestock dip, some began dusting their hives with it –– a foolishly dangerous factor for an applicator to do! Anyway, inside 3 years mites advanced resistance to that silver bullet, and various those that had used it off-label had so severely infected their combs that they needed to burn all of them!

In 2004, ARS researcher Patti Elzen wrote [[4]]: “Given the intense scenario of [mite] resistance to each registered compounds [fluvalinate and coumaphos], there’s a vital wish to expand choice management methods.”

Through this time thymol were registered as Apiguard and Apilife VAR, and formic acid in Mite Away pads. After the use of Apistan for a number of years, and Checkmite+ as soon as, I made up our minds to step off the bogus miticide treadmill of observing mites expand resistance to 1 silver bullet after some other, and went via a protracted studying curve experimenting with formic acid, drone brood removing, thymol, sugar dusting, and oxalic acid to determine which of them have been efficacious (operating below a Pesticide Analysis Authorization when required).

However through that point, maximum business beekeepers had already turn out to be completely acquainted with the use of off-label Taktic (amitraz), which nonetheless remained efficacious and easy to use, so my articles on moving to biopesticides fell in large part upon deaf ears.

Then in 2013 I used to be approached through the producer of amitraz, who requested me for my opinion on whether or not it could be value his whilst to spend just about 1,000,000 bucks for his corporate to sign up amitraz in a plastic strip for varroa management. To take action, since EPA had decided that because of amitraz having been not too long ago registered to be used in tick collars for canines, that it had crammed its “possibility cup” — and to sign up an extra product, some other product would wish to be withdrawn from the marketplace — the producer made up our minds to let move of Taktic, and I used to be given a heads-up that it could be pulled from the marketplace inside a 12 months, however that I couldn’t divulge that knowledge.

Have You Were given a Plan B?

I feared that my business compatriots could be stuck off guard, having no longer but discovered methods to use choice remedies. So at nationwide conventions, I attempted to sneak in a heads-up (Determine 2).

Beekeepers and their Regulators

In some international locations (comparable to within the EU), miticides are regulated through strict veterinary businesses, and beekeepers have a tendency to be compliant with the regulation. Within the U.S., miticides are at present regulated through the EPA as insecticides, however learn Charlie Linder’s articles referring to how the FDA is thinking about taking duty (which will have dire penalties for beekeepers).

International, the bogus miticides fluvalinate, bifenthrin, coumaphos, and amitraz are broadly registered, however there is also fewer or further choices to be had in any nation. Ditto for oxalic, lactic, hops beta, and formic acids, in addition to thymol and different very important oils. And authorized software strategies range — some businesses really feel that beekeepers can’t safely deal with liquid formic acid, while others permit the burning of paper ribbons of amitraz.

I lately returned from Azerbaijan (Determine 3), the place it’s the Wild West so far as use of unregulated varroa remedies, with a wide selection of formulated merchandise and combinations of energetic substances being shipped in from surrounding international locations.

Fig. 3 A queen manufacturing backyard in Azerbaijan. The hive our bodies are massive and heavy –– containing 11 Dadant deep (12”) frames, with the bins manufactured from 1½”-thick wooden. The beekeepers there are justifiably fearful about Tropilaelaps which is already inflicting havoc in neighboring Russia.

The danger to staff: EPA is not just interested in amitraz residues in honey and beeswax, but additionally that beekeepers (and their staff) who combine it up and follow it are prone to reproductive, developmental, and neurological hurt, particularly when the emulsifiable listen is used.

Heads up: Now that the EPA fast-tracked the registration of a quick-release amitraz remedy (Amiflex) and two oxalic merchandise (Varroxsan and EZ-OX), they might be gearing up for critical enforcement motion. So I’ve been operating exhausting to look whether or not we will be able to persuade the EPA and our state businesses to permit us to make use of generic oxalic, formic, and thymol.

Expecting a Drawback, and Being Proactive

The above issues were a very long time coming, with many in our trade hiding their heads within the sand, hoping that they’d by no means have to stand them. In my humble opinion, the sensible factor to do could be to await that vary used to be drawing close, and be in a position with a workable resolution.

So I actually, in conjunction with a couple of others, proactively first requested the EPA to grant us an exemption (very similar to New Zealand’s [[7]]), for our use of the generic, off-the-shelf “herbal” chemical compounds oxalic acid, formic acid, thymol, and food-grade plant very important oils (hereafter known as the “Herbal Therapies”) for miticidal functions. When that request used to be denied, inspired through the diligence of legal professionals I’d observed on TV, I dove into FIFRA (the mandate that provides the EPA its authority to keep watch over insecticides) to search for a Plan B.

Freedom vs. Legislation

Lo and behold, I discovered a loophole in 7 U.S.C. § 136a(a) of FIFRA: “To the level important to stop unreasonable hostile results at the surroundings, the Administrator might through law prohibit the distribution, sale, or use in any State of any pesticide that isn’t registered.”

The way in which that I interpreted that sentence used to be that that FIFRA provides the EPA the mandate to keep watch over the manufacturing, distribution, sale, and use of any pesticide that poses unreasonable possibility to the surroundings, however no longer a mandate to limit the usage of the ones that don’t pose such possibility.

So I wrote a letter to the Place of work of Pesticide Techniques asking for rationalization [[8]]. After I didn’t get a answer, I requested the ABF and AHPA to ship it once more as cosigners (to which the Company after all answered). In next digital conferences, EPA staff showed that my interpretation used to be proper, and that they’d paintings with us to elucidate how lets follow the unregistered herbal remedies.

To our marvel, what their legal professionals as a substitute did used to be to wrap our request for rationalization into their reaction to the apiary inspectors of their “Advisory at the Applicability FIFRA and FFDCA for Ingredients used to Keep an eye on Varroa Mites in Beehives.” [[9]]. The EPA’s legal professionals it seems that receives a commission through the note, in order that they swallowed a dose of Lesfuquithum and produced a just about 3000-word report. Sadly, many beekeepers discovered it to be unclear in vital specifics.

What Did the Advisory Say?

Not anything a lot that we didn’t already know –– that there are registered varroacides that can be purchased, and that the label is the regulation. However hidden deep within the Advisory used to be the solution to our query:

“EPA considers any software of an unregistered pesticide for rather then non-public use (e.g., software of an unregistered pesticide to someone else’s assets) to be distribution of an unregistered pesticide and a contravention of FIFRA” (emphasis mine).

Sensible software: This used to be a roundabout manner of claiming that since use of the Herbal Therapies poses no unreasonable possibility to the surroundings, that FIFRA does no longer grant EPA authority to keep watch over our use (versus the sale or distribution) of them. Their Advisory left various questions unclearly responded (Determine 4).

Fig. 4 I imagine the Company’s e-newsletter of the convoluted sentence above to be a vulnerable “win,” however it seems that that the EPA doesn’t wish to give us a instantly solution. So I went again via FIFRA, and located that “Below FIRA, the EPA is certain through regulation to tell and teach pesticide customers about permitted makes use of and different laws” [[10]].

Letter #2, and My Felony Issues

Proceeding to play legal professional, I’ve now written a draft for a 2nd letter to ship to the EPA, pointing out, “On this letter we aren’t in any respect difficult the EPA nor the Advisory, however most effective inquiring for rationalization of main points,” reminding them in their responsibility to tell and teach us referring to “permitted makes use of.”

I indicate that the EPA encourages the usage of biopesticides, and that beekeeper adoption of biopesticides would cut back our use of currently-registered “standard” miticides that sadly contaminate our combs and honey, and showcase higher possibility to guy and the surroundings.

Additionally, as stated within the Advisory, FIFRA does no longer differentiate between “personal use” and “non-public use.” This can be a key level for which we’re inquiring for extra rationalization, particularly for the reason that Advisory later makes use of the undefined time period “non-public” within the remark: “Non-public use would probably not come with actions that contain any operation in trade comparable to promoting or distribution of bees/colonies, pollination products and services, or honey.”

The above argument seems to be created out of entire fabric. FIFRA does no longer differentiate between “hobbyists” and migratory beekeepers as finish customers, so we beekeepers are unclear about why the Advisory does so. Nor does the Advisory’s newly-created time period “personal non-public use,” seem in FIFRA, nor has EPA advanced any particular exceptions to FIFRA law for what could be thought to be “personal non-public use.” And what’s with their the use of the note “most probably” within the sentence “Non-public use would no longer most probably come with actions that contain any operation in trade comparable to promoting or distribution of bees/colonies, pollination products and services, or honey”?

An Instance to Believe

For example, corresponding to oxalic acid, the EPA does no longer imagine commonplace hand cleaning soap to offer unreasonable possibility to guy or the surroundings, and lists it at the least possibility inert exempt from tolerance, however does no longer record cleaning soap at the least possibility energetic factor. Subsequently, a rancher who makes use of hand cleaning soap with the intent to kill fleas on her goats could be “in my opinion the use of an unregistered pesticide.” In step with the Advisory, if she then rented her goats out for brush management, or offered them, or cheese constructed from their milk, she could be committing an “operation in trade” of distributing insecticides and matter to enforcement motion below FIFRA. It stretches credulity that the EPA would entertain such enforcement motion.

Now not most effective that, however the EPA obviously differentiates between “insecticides” and “handled articles” — the EPA does no longer prohibit the motion, condo, or sale of a beehive handled with registered merchandise, and thus has no justification to limit such “distribution” of beehives handled with unregistered oxalic, formic, thymol, or food-grade plant oils that pose no possibility to the surroundings. A fair more potent instance is the EPA’s determination to imagine seeds handled with concentrated quantities of neonicotinoids as “handled articles” exempt from law of sale or use.

We needless to say a beekeeper can not, below the definitions in FIFRA, distribute or promote an unregistered pesticide to someone else for pesticidal functions. However that definition applies most effective to the pesticide, to not the sale or delivery of a crop that has been handled with a pesticide. As within the aforementioned hypothetical case of the goat rancher, or the case of handled seed, FIFRA would imagine beehives handled with a pesticide to be “handled articles,” slightly than as insecticides themselves.

Likewise, would a beekeeper (whether or not “pastime” or “business”) who as an “finish consumer” carried out unregistered oxalic acid to their hive after which offered or rented that hive in some other state for pollination functions, be accountable of distribution of the ones insecticides? To my working out, there could be no restrictions at the transportation, condo, or promoting of hives that were up to now handled with purified oxalic acid, formic acid, thymol, or food-grade plant very important oils. We’d like a transparent solution to this query!

The EPA is justifiably interested in beekeepers inadvertently “adulterating” their honey through the use of impure energetic substances or unapproved excipients, adjuvants, or supply matrices (termed in FIFRA as “inerts”).

I indicate that to steer clear of adulterating honey meant on the market, beekeepers who use Herbal Therapies should use most effective the ones of top purity, and dilute them only with minimal possibility inerts (described as a frequently fed on meals commodity, animal feed merchandise, or fit to be eaten fats and oil as laid out in 40 CFR 180.950, or indexed as Inert Elements Eligible for FIFRA 25(b) Pesticide Merchandise). Such allowed inerts would come with water, isopropyl alcohol, glycerin, vegetable oils, mineral oil, cellulose, cardboard, paper, or frequently fed on meals commodities (all authorized to be used on meals plants) whilst colonies have been generating honey on the market. When no longer generating honey on the market, cotton or sawdust is also used. As well as, even supposing no longer of outrage as a well being possibility, thymol might impact the smell of honey, and will have to no longer be carried out whilst honey for harvest is at the hive.

Within the draft, I requested a sequence of explicit questions, following this be aware:

Our questions beneath relate only to software through beekeepers of unregistered, generic, purified oxalic acid, formic acid, thymol, or food-grade plant very important oils (hereafter known as “the above biopesticides”).
Our questions relate only to a beekeeper appearing as an finish consumer, no longer as a manufacturer or distributor — particularly referring to interstate delivery.
As finish customers, we might simply be diluting the above biopesticides for software only to our personal hives.
Since our questions are about criminal compliance with FIFRA, and because we might provide the solutions from EPA to our State Lead Companies, we’re inquiring for transparent sure/no solutions.

I finished the draft with “We thanks for operating cooperatively with us beekeepers and our State Lead Companies, and hope for an expeditious answer clarifying main points for complying with FIFRA and state laws.”

An Instance of Our State of affairs

For example of ways ridiculous our present scenario is, as I sort those phrases (in February), nearly all of our nation’s beehives are at present in my house state (pollinating almonds), the place because of oxalic acid no longer but being registered in California, it’s a criminal offense for any beekeeper right here to use a unmarried drop of oxalic acid to any of the ones two million hives with the intent to management varroa, and in keeping with the Advisory, in the event that they did, once they took their hives again house, they may well be charged with distributing an unregistered pesticide! (Determine 5).

Fig. 5 At the present time of this writing, for more or less 80% of the beehives in The usa, it could be unlawful to dribble oxalic acid (whether or not generic or registered Api-Bioxal) with the intent of controlling varroa, even supposing it could be completely criminal to make use of it to bleach your best bars! What a daft scenario we’re in!

Postscript

I simply had a joint assembly with the leaders of the American Beekeeping Federation and the American Honey Manufacturers Affiliation. Even though their blended memberships it seems that encompass fewer than 1000 beekeepers, they do constitute the ones beekeepers who’re keen to pay the fee to offer our trade a presence in Washington. I’m a member of each organizations, and strongly appreciate and toughen their critiques.

I requested their leaders whether or not they needed to publish my request for additional rationalization to the EPA. They have been reluctant to take action, feeling that we’ve already gotten the entire solutions from the EPA that we’re more likely to get, and that they didn’t wish to waste their political capital to push additional. As chances are you’ll believe, this used to be disappointing to me.

On the other hand, I’ve since spoken with others who really feel that we will have to be extra proactive, and no longer have our movements held again because of worry of the EPA, since our trade as a complete will have to attempt to return into compliance with FIFRA. There are many business beekeepers operating to get into compliance, and who really feel that we’d like transparent solutions referring to EPA’s coverage referring to our “personal use” of the unregistered Herbal Therapies, in order that we will be able to then way our personal State Lead Companies and request that they practice the EPA’s lead.

Sensible software: Beekeepers are most probably going to wish to personally petition every of their very own State Lead Companies with a view to freely use the generic Herbal Therapies. It could be a lot more uncomplicated for them to take action if the EPA higher clarified its place on the main points of ways we will be able to use them with out developing unreasonable possibility to the surroundings.

A Request for Assist

I would not have the hubris to assume that I will have to be the only to constitute our trade, nor that I’m certified to spar with EPA’s legal professionals. I’m only a unmarried beekeeper, asking a big govt company to provide an explanation for their interpretation of the regulation –– one thing generally reserved for the courts.

After I acted by myself, the EPA neglected me till I were given our nationwide organizations to signal on. And even if they did solution, their legal professionals intentionally have shyed away from without delay answering my query, and the Company made no effort to “tell and teach” us referring to permitted makes use of. So excellent success petitioning your personal SLA with out transparent solutions from the EPA!

I don’t know what to mention to beekeepers who wish to use unregistered oxalic or thymol. I don’t wish to step on someone’s feet, and really feel that it’s necessary to deal with the EPA with a united voice. However except the EPA’s roundabout affirmation that there’s no federal restriction on one’s personal use of unregistered Herbal Therapies filters down for your SLA, it is going to most probably stay unlawful so that you can use them.

Imaginable movements to take: So if there may be certainly popular beekeeper hobby in pursuing getting our states to permit us to make use of unregistered Herbal Therapies (once more, New Zealand already does this), anyone with political clout (a state or regulatory company or beekeeper group, or a pleasant congressperson) will wish to with courtesy ask the EPA to respond to our questions, or take them to court docket to pressure them to take action.

As well as, some other proactive beekeeping good friend of mine, Charlie Linder, is rallying our trade to invite Congress to move an modification to FIFRA within the upcoming Farm Invoice –– including oxalic and formic acids, thymol, and food-grade plant very important oils to EPA’s Minimal Chance Insecticides record (restricted to software inside beehives), which might open the door for affordable, off-the-shelf formulated merchandise, as defined on this float chart [[11]].

I’d be at liberty to assist any state-level crew or company that desires to transport in this. You’ll learn the draft of my letter at https://scientificbeekeeping.com/scibeeimages/2024-Reaction-to-EPA.docx and join updates at https://scientificbeekeeping.com/scientific-beekeeping-newsletter/

Citations and Notes

[1] Credit score to Dr. Frank Rinkevich.

[2] The Studying Curve: Phase 4–The Artificial Miticides. American Bee Magazine, October 2009, and https://scientificbeekeeping.com/the-learning-curve-part-4-the-synthetic-miticides/

[3] Lubinevski, Y, et al (1988) Keep an eye on of Varroa jacobsoni and Tropilaelaps clareae mites the use of Mavrik in A. mellifera colonies below subtropical and tropical climates. American Bee Magazine 128: 48-52

[4] Elzen, P, et al (2004). Formic acid remedy for management of Varroa destructor (Mesostigmata: Varroidae) and protection to Apis mellifera (Hymenoptera: Apidae) below southern United States stipulations. Magazine of Financial Entomology 97(5): 1509-1512.

[5] Amitraz: Crimson Flags or Crimson Herrings? American Bee Magazine, October 2014, and https://scientificbeekeeping.com/amitraz-red-flags-or-red-herrings/

[6] https://aapco.org/wp-content/uploads/2021/08/SFIREG-Letter-to-EPA-for-Controlled-Pollinator-Factor-Paper-August-4-2021.pdf

[7] Promoting and personal use steering for compounds for control of illness in beehives https://www.mpi.government.nz/dmsdocument/37901/direct

[8] https://scientificbeekeeping.com/scibeeimages/Letter-to-Linda-Hollis.docx

[9] https://www.epa.gov/pollinator-protection/advisory-applicability-fifra-and-ffdca-substances-used-control-varroa-mites#violation-fifra-ffdca

[10] SEC. 23. [7 U.S.C. 136u] STATE COOPERATION, AID, AND TRAINING.

(c) INFORMATION AND EDUCATION. —The Administrator shall, in cooperation with the Secretary of Agriculture, use the products and services of the cooperative State extension products and services to tell and teach pesticide customers about permitted makes use of and different laws made below this Act.

[11] https://www.cdpr.ca.gov/medical doctors/registration/sec25/minimum_risk_flowchart.pdf

The Elephant and the EPA

Randy Oliver

ScientificBeekeeping.com

First printed in ABJ April 2024

Our State of affairs is Rarely Distinctive or Sudden

How Did We Get to The place We Are?

Have You Were given a Plan B?

Beekeepers and their Regulators

Expecting a Drawback, and Being Proactive

Freedom vs. Legislation

What Did the Advisory Say?

Letter #2, and My Felony Issues

An Instance to Believe

An Instance of Our State of affairs

Postscript

A Request for Assist

Citations and Notes

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