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The Elephant and the EPA


The Elephant and the EPA

Randy Oliver

ScientificBeekeeping.com

First published in ABJ April 2024

 

A related pair of issues are coming to a head: (1) The “elephant in the room” that nobody wants to talk about –– that the EPA is feeling increasing pressure to ramp up enforcement against beekeeper use of unapproved treatments, and (2) the increasing development by varroa of resistance to the miticide amitraz. These issues are not going to “go away,” and ignoring an issue can turn it into a problem. So what’s our Plan B?

Our Situation is Hardly Unique or Unexpected

Most beekeepers in the world have varroa in their hives, and in countries that have relied on neurotoxic synthetic miticides to control the pest, they’ve found that these silver bullets “work great, until they don’t” [[1], [2]]. In tropical and Mediterranean countries, where mites enjoy more reproductive cycles per year, beekeepers are complaining that the synthetic miticides are no longer efficacious. Their reports provide a crystal ball for beekeepers in North America — unless a new silver bullet hits the market soon, we’re gonna need to adopt different methods for dealing with the mite. Our most promising fallbacks are the adoption of resistant stocks, and a shift to biopesticides –– notably oxalic and formic acids, thymol, and perhaps other plant essential oils (two things that I have been focusing on for some years).

How Did We Get to Where We Are?

Americans in general, and beekeepers in particular, have always been “do-it-yourselfers.” At a convention, when a researcher names a promising new active ingredient against varroa, I see beekeepers in the audience pulling out their pens. They’ll likely be experimenting with that active ingredient well before someone goes through the EPA’s costly and time-consuming registration process.

Practical result: Beekeepers are an “orphan industry,” without enough buyer demand to make it cost-effective for developers of formulated varroa-control products to go through EPA’s expensive registration process. This has resulted in there being a paucity of registered varroa treatments, all of which are unduly expensive. The EPA is aware of this, and is now fast-tracking registration of biopesticides, as well as a new amitraz product (Figure 1).

Fig. 1 The EPA has recently fast-tracked registration of new formulations of two existing active ingredients. This sort of product competition is good for us, both option-wise and price-wise.

In 1988, shortly after varroa hit our shores, this very journal published an article from Israel [[3]] stating that: “Colonies in Israel infested with V. jacobsoni were treated with Mavrik (a.i. fluvalinate). A small piece of plywood which had been soaked in 20% Mavrik emulsion and then dried was hung between the combs in the centre of the brood nest. … It is concluded that four Mavrik treatments per colony per year can keep V. jacobsoni populations to levels below the economic damage threshold.”

This was a watershed moment for the pesticide-averse beekeeping industry –– for the first time, we became the main source of pesticide contamination of our combs (setting a new baseline for exposure of our bees to pesticides). The “off-label” use (using it for a different pest than those specified on the label) of Mavrik was already well established before Apistan got registered by the EPA in 1990. Since the registered product was far more expensive, and tougher to apply and remove than homemade towels, most large-scale beekeepers stuck with their homebrews.

Anyway, the result of widespread and continual use of fluvalinate in the U.S. followed the same trajectory that occurred in Mediterranean Europe, with mites soon developing widespread resistance to the chemical. By the late 1990s, commercial beekeepers were desperate for something else. The EPA, which was actively phasing out dangerous organophosphate insecticides, registered coumaphos in safe-to-apply Checkmite+ strips in 1999. By this time, commercial beekeepers had earned the moniker of being “pesticide scofflaws,” and since Checkmite+ was more expensive than powdered Co-Ral cattle dip, some started dusting their hives with it –– a foolishly risky thing for an applicator to do! Anyway, within three years mites developed resistance to that silver bullet, and a number of those who had used it off-label had so seriously contaminated their combs that they had to burn them all!

In 2004, ARS researcher Patti Elzen wrote [[4]]: “Given the serious situation of [mite] resistance to both registered compounds [fluvalinate and coumaphos], there is a critical need to develop alternative control strategies.”

By this time thymol had been registered as Apiguard and Apilife VAR, and formic acid in Mite Away pads. After using Apistan for several years, and Checkmite+ once, I decided to step off the synthetic miticide treadmill of watching mites develop resistance to one silver bullet after another, and went through a long learning curve experimenting with formic acid, drone brood removal, thymol, sugar dusting, and oxalic acid to figure out which ones were efficacious (working under a Pesticide Research Authorization when required).

But by that time, most commercial beekeepers had already become thoroughly accustomed to using off-label Taktic (amitraz), which still remained efficacious and simple to apply, so my articles on shifting to biopesticides fell largely upon deaf ears.

Then in 2013 I was approached by the manufacturer of amitraz, who asked me for my opinion on whether it would be worth his while to spend nearly a million dollars for his company to register amitraz in a plastic strip for varroa control. To do so, since EPA had determined that due to amitraz having been recently registered for use in tick collars for dogs, that it had filled its “risk cup” — and to register an additional product, another product would need to be withdrawn from the market — the manufacturer decided to let go of Taktic, and I was given a heads-up that it would be pulled from the market within a year, but that I couldn’t disclose that information.

Have You Got a Plan B?

I feared that my commercial compatriots would be caught off guard, having not yet learned how to use alternative treatments. So at national conventions, I tried to sneak in a heads-up (Figure 2).

Fig. 2 In order not to disclose confidential information, I purchased a can of Taktic (still unused to this day) and had my son Eric pose for the photos, suggesting that the chemical might soon lose efficacy. Once Apivar was brought to market, I warned that “It would be wise for beekeepers to rotate Apivar treatments with other active ingredients to delay the inevitable development of resistance to this product by varroa.” [[5]]

We all knew that it would eventually happen: Repeated applications of a single active ingredient, without rotation with chemicals having different modes of action, engaged our industry in a (successful) selective breeding program for mites resistant to amitraz. It’s just taking a lot longer with amitraz than it did with the previous silver bullets. Amitraz is now requiring so many treatments per year that many commercial beekeepers are finally rotating in other treatments, or completely giving up on the chemical.

The bottom line: Amitraz has been a lifesaver for commercial beekeepers, but it appears that the joyride with this miticide may be nearing an end — not only due to its loss of efficacy, but because of concerns about maintaining the image of “pure” honey, resentment from other beekeepers who are dealing with the greater cost of using registered products, but perhaps most importantly, complaints to the EPA from apiary inspectors who don’t feel right about turning a blind eye toward beekeepers’ scofflaw attitude toward pesticide use. By all means, read the letter sent to the EPA in 2021 by the Association of American Pesticide Control Officials –– which demanded immediate enforcement action to be taken against the use of illegal pesticides by beekeepers [[6]]. This brings us to:

Beekeepers and their Regulators

In some countries (such as in the EU), miticides are regulated by strict veterinary agencies, and beekeepers tend to be compliant with the law. In the U.S., miticides are currently regulated by the EPA as pesticides, but read Charlie Linder’s articles regarding how the FDA is considering taking responsibility (which could have dire consequences for beekeepers).

Worldwide, the synthetic miticides fluvalinate, bifenthrin, coumaphos, and amitraz are widely registered, but there may be fewer or additional options available in any country. Ditto for oxalic, lactic, hops beta, and formic acids, as well as thymol and other essential oils. And approved application methods vary — some agencies feel that beekeepers can’t safely handle liquid formic acid, whereas others allow the burning of paper ribbons of amitraz.

I recently returned from Azerbaijan (Figure 3), where it is the Wild West as far as use of unregulated varroa treatments, with a wide array of formulated products and mixtures of active ingredients being shipped in from surrounding countries.

Fig. 3 A queen production yard in Azerbaijan. The hive bodies are huge and heavy –– containing eleven Dadant deep (12”) frames, with the boxes made of 1½”-thick wood. The beekeepers there are justifiably worried about Tropilaelaps which is already causing havoc in neighboring Russia.

The risk to employees: EPA is not only concerned about amitraz residues in honey and beeswax, but also that beekeepers (and their employees) who mix it up and apply it are at risk of reproductive, developmental, and neurological harm, especially when the emulsifiable concentrate is used.

Heads up: Now that the EPA fast-tracked the registration of a quick-release amitraz treatment (Amiflex) and two oxalic products (Varroxsan and EZ-OX), they may well be gearing up for serious enforcement action. So I’ve been working hard to see whether we can convince the EPA and our state agencies to allow us to use generic oxalic, formic, and thymol.

Anticipating a Problem, and Being Proactive

The above problems have been a long time coming, with many in our industry hiding their heads in the sand, hoping that they’d never have to face them. In my humble opinion, the smart thing to do would be to anticipate that change was imminent, and be ready with a workable solution.

So I myself, along with a few others, proactively first asked the EPA to grant us an exemption (similar to New Zealand’s [[7]]), for our use of the generic, off-the-shelf “natural” chemicals oxalic acid, formic acid, thymol, and food-grade plant essential oils (hereafter referred to as the “Natural Treatments”) for miticidal purposes. When that request was denied, impressed by the diligence of lawyers I’d seen on TV, I dove into FIFRA (the mandate that gives the EPA its authority to regulate pesticides) to look for a Plan B.

Freedom vs. Regulation

Lo and behold, I found a loophole in 7 U.S.C. § 136a(a) of FIFRA: To the extent necessary to prevent unreasonable adverse effects on the environment, the Administrator may by regulation limit the distribution, sale, or use in any State of any pesticide that is not registered.”

The way that I interpreted that sentence was that that FIFRA gives the EPA the mandate to regulate the production, distribution, sale, and use of any pesticide that poses unreasonable risk to the environment, but not a mandate to restrict the use of those that do not pose such risk.

So I wrote a letter to the Office of Pesticide Programs requesting clarification [[8]]. When I didn’t get a reply, I asked the ABF and AHPA to send it again as cosigners (to which the Agency finally replied). In subsequent virtual meetings, EPA employees confirmed that my interpretation was correct, and that they would work with us to clarify how we could apply the unregistered natural treatments.

To our surprise, what their lawyers instead did was to wrap our request for clarification into their response to the apiary inspectors in their “Advisory on the Applicability FIFRA and FFDCA for Substances used to Control Varroa Mites in Beehives.” [[9]]. The EPA’s lawyers apparently get paid by the word, so they swallowed a dose of Lesfuquithum and produced a nearly 3000-word document. Unfortunately, many beekeepers found it to be unclear in critical specifics.

What Did the Advisory Say?

Nothing much that we didn’t already know –– that there are registered varroacides available for purchase, and that the label is the law. But hidden deep in the Advisory was the answer to our question:

“EPA considers any application of an unregistered pesticide for other than personal use (e.g., application of an unregistered pesticide to another person’s property) to be distribution of an unregistered pesticide and a violation of FIFRA” (emphasis mine).

Practical application: This was a roundabout way of saying that since use of the Natural Treatments poses no unreasonable risk to the environment, that FIFRA does not grant EPA authority to regulate our use (as opposed to the sale or distribution) of them. Their Advisory left a number of questions unclearly answered (Figure 4).

Fig. 4 I consider the Agency’s publication of the convoluted sentence above to be a weak “win,” but it appears that the EPA doesn’t want to give us a straight answer. So I went back through FIFRA, and found that “Under FIRA, the EPA is bound by law to inform and educate pesticide users about accepted uses and other regulations” [[10]].

Letter #2, and My Legal Points

Continuing to play lawyer, I’ve now written a draft for a second letter to send to the EPA, stating, “In this letter we are not in any way challenging the EPA nor the Advisory, but only asking for clarification of details,” reminding them of their duty to inform and educate us regarding “accepted uses.”

I point out that the EPA encourages the use of biopesticides, and that beekeeper adoption of biopesticides would reduce our use of currently-registered “conventional” miticides that unfortunately contaminate our combs and honey, and exhibit greater risk to man and the environment.

Also, as acknowledged in the Advisory, FIFRA does not differentiate between “own use” and “personal use.” This is a key point for which we are asking for more clarification, especially since the Advisory later uses the undefined term “personal” in the statement: “Personal use would not likely include activities that involve any operation in commerce such as selling or distribution of bees/colonies, pollination services, or honey.”

The above argument appears to be created out of whole cloth. FIFRA does not differentiate between “hobbyists” and migratory beekeepers as end users, so we beekeepers are unclear about why the Advisory does so. Nor does the Advisory’s newly-created term “own personal use,” appear in FIFRA, nor has EPA developed any special exceptions to FIFRA regulation for what might be considered “own personal use.” And what’s with their using the word “likely” in the sentence “Personal use would not likely include activities that involve any operation in commerce such as selling or distribution of bees/colonies, pollination services, or honey”?

An Example to Consider

As an example,  akin to oxalic acid, the EPA does not consider common hand soap to present unreasonable risk to man or the environment, and lists it as a minimum risk inert exempt from tolerance, but does not list soap as a minimum risk active ingredient. Therefore, a rancher who uses hand soap with the intent to kill fleas on her goats would be “personally using an unregistered pesticide.” According to the Advisory, if she then rented her goats out for brush control, or sold them, or cheese made from their milk, she would be committing an “operation in commerce” of distributing pesticides and subject to enforcement action under FIFRA. It stretches credulity that the EPA would entertain such enforcement action.

Not only that, but the EPA clearly differentiates between “pesticides” and “treated articles” — the EPA does not restrict the movement, rental, or sale of a beehive treated with registered products, and thus has no justification to restrict such “distribution” of beehives treated with unregistered oxalic, formic, thymol, or food-grade plant oils that pose no risk to the environment. An even stronger example is the EPA’s decision to consider seeds treated with concentrated amounts of neonicotinoids as “treated articles” exempt from regulation of sale or use.

We understand that a beekeeper cannot, under the definitions in FIFRA, distribute or sell an unregistered pesticide to another person for pesticidal purposes. But that definition applies only to the pesticide, not to the sale or transport of a crop that has been treated with a pesticide. As in the aforementioned hypothetical case of the goat rancher, or the case of treated seed, FIFRA would consider beehives treated with a pesticide to be “treated articles,” rather than as pesticides themselves.

Likewise, would a beekeeper (whether “hobby” or “commercial”) who as an “end user” applied unregistered oxalic acid to their hive and then sold or rented that hive in another state for pollination purposes, be guilty of distribution of those pesticides? To my understanding, there would be no restrictions on the transportation, rental, or selling of hives that had been previously treated with purified oxalic acid, formic acid, thymol, or food-grade plant essential oils. We need a clear answer to this question!

 

The EPA is justifiably concerned about beekeepers inadvertently “adulterating” their honey by using impure active ingredients or unapproved excipients, adjuvants, or delivery matrices (termed in FIFRA as “inerts”).

I point out that to avoid adulterating honey intended for sale, beekeepers who use Natural Treatments must use only those of high purity, and dilute them solely with minimum risk inerts (described as a commonly consumed food commodity, animal feed item, or edible fat and oil as specified in 40 CFR 180.950, or listed as Inert Ingredients Eligible for FIFRA 25(b) Pesticide Products). Such allowed inerts would include water, isopropyl alcohol, glycerin, vegetable oils, mineral oil, cellulose, cardboard, paper, or commonly consumed food commodities (all approved for use on food crops) while colonies were producing honey for sale. When not producing honey for sale, cotton or sawdust could also be used. In addition, although not of concern as a health risk, thymol may affect the odor of honey, and should not be applied while honey for harvest is on the hive.

In the draft, I asked a series of specific questions, following this note:

  1. Our questions below relate solely to application by beekeepers of unregistered, generic, purified oxalic acid, formic acid, thymol, or food-grade plant essential oils (hereafter referred to as “the above biopesticides”).
  2. Our questions relate solely to a beekeeper acting as an end user, not as a producer or distributor — specifically regarding interstate transport.
  3. As end users, we would merely be diluting the above biopesticides for application solely to our own hives.
  4. Since our questions are about legal compliance with FIFRA, and since we may present the answers from EPA to our State Lead Agencies, we are asking for clear yes/no answers.

I ended the draft with “We thank you for working cooperatively with us beekeepers and our State Lead Agencies, and hope for an expeditious reply clarifying details for complying with FIFRA and state regulations.”

An Example of Our Situation

As an example of how ridiculous our current situation is, as I type these words (in February), the vast majority of our country’s beehives are currently in my home state (pollinating almonds), where due to oxalic acid not yet being registered in California, it is against the law for any beekeeper here to apply a single drop of oxalic acid to any of those two million hives with the intent to control varroa, and according to the Advisory, if they did, when they took their hives back home, they could be charged with distributing an unregistered pesticide! (Figure 5).

Fig. 5 At the moment of this writing, for roughly 80% of the beehives in America, it would be illegal to dribble oxalic acid (whether generic or registered Api-Bioxal) with the intent of controlling varroa, although it would be perfectly legal to use it to bleach your top bars! What a ridiculous situation we are in!

 

Postscript

I just had a joint meeting with the leaders of the American Beekeeping Federation and the American Honey Producers Association. Although their combined memberships apparently consist of fewer than a thousand beekeepers, they do represent those beekeepers who are willing to pay the price to give our industry a presence in Washington. I’m a member of both organizations, and strongly respect and support their opinions.

I asked their leaders whether they wished to submit my request for further clarification to the EPA. They were reluctant to do so, feeling that we’ve already gotten all the answers from the EPA that we’re likely to get, and that they didn’t want to waste their political capital to push further. As you might imagine, this was disappointing to me.

 

However, I’ve since spoken with others who feel that we should be more proactive, and not have our actions held back due to fear of the EPA, since our industry as a whole should strive to come into compliance with FIFRA. There are plenty of commercial beekeepers working to get into compliance, and who feel that we need clear answers regarding EPA’s policy regarding our “own use” of the unregistered Natural Treatments, so that we can then approach our own State Lead Agencies and request that they follow the EPA’s lead.

Practical application: Beekeepers are likely going to need to individually petition each of their own State Lead Agencies in order to freely use the generic Natural Treatments. It would be much easier for them to do so if the EPA better clarified its position on the details of how we can use them without creating unreasonable risk to the environment.

A Request for Help

I do not have the hubris to think that I should be the one to represent our industry, nor that I’m qualified to spar with EPA’s lawyers. I’m just a single beekeeper, asking a large government agency to explain their interpretation of the law –– something normally reserved for the courts.

When I acted on my own, the EPA ignored me until I got our national organizations to sign on. And even when they did answer, their lawyers deliberately avoided directly answering my question, and the Agency made no effort to “inform and educate” us regarding accepted uses. So good luck petitioning your own SLA without clear answers from the EPA!

I don’t know what to say to beekeepers who want to use unregistered oxalic or thymol. I don’t want to step on anyone’s toes, and feel that it’s important to address the EPA with a united voice. But unless the EPA’s roundabout confirmation that there is no federal restriction on one’s own use of unregistered Natural Treatments filters down to your SLA, it will likely remain illegal for you to use them.

Possible actions to take: So if there is indeed widespread beekeeper interest in pursuing getting our states to allow us to use unregistered Natural Treatments (again, New Zealand already does this), someone with political clout (a state or regulatory agency or beekeeper organization, or a friendly congressperson) will need to politely ask the EPA to answer our questions, or take them to court to force them to do so.

In addition, another proactive beekeeping friend of mine, Charlie Linder, is rallying our industry to ask Congress to pass an amendment to FIFRA in the upcoming Farm Bill –– adding oxalic and formic acids, thymol, and food-grade plant essential oils to EPA’s Minimum Risk Pesticides list (limited to application within beehives), which would open the door for inexpensive, off-the-shelf formulated products, as explained in this flow chart [[11]].

I’d be happy to help any state-level group or agency that wishes to move on this. You can read the draft of my letter at https://scientificbeekeeping.com/scibeeimages/2024-Response-to-EPA.docx and sign up for updates at https://scientificbeekeeping.com/scientific-beekeeping-newsletter/

Citations and Notes

[1] Credit to Dr. Frank Rinkevich.

[2] The Learning Curve: Part 4–The Synthetic Miticides. American Bee Journal, October 2009, and https://scientificbeekeeping.com/the-learning-curve-part-4-the-synthetic-miticides/

[3] Lubinevski, Y, et al (1988) Control of Varroa jacobsoni and Tropilaelaps clareae mites using Mavrik in A. mellifera colonies under subtropical and tropical climates. American Bee Journal 128: 48-52

[4] Elzen, P, et al (2004). Formic acid treatment for control of Varroa destructor (Mesostigmata: Varroidae) and safety to Apis mellifera (Hymenoptera: Apidae) under southern United States conditions. Journal of Economic Entomology 97(5): 1509-1512.

[5] Amitraz: Red Flags or Red Herrings? American Bee Journal, 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-Managed-Pollinator-Issue-Paper-August-4-2021.pdf

[7] Advertising and own use guidance for compounds for management of disease in beehives https://www.mpi.govt.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 services of the cooperative State extension services to inform and educate pesticide users about accepted uses and other regulations made under this Act.

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