The Status of Our Industry Regarding Varroa Management and What Can We Do About It?

The Status of Our Industry Regarding Varroa Management

and

What Can We Do About It?

Part 2

First Published in ABJ August 2023

Randy Oliver

ScientificBeekeeping.com

CATCH UP

Last month I wrote about the options (legal or unapproved) that beekeepers are taking to deal with varroa as it evolves resistance to amitraz. In this installment, I’ll review proposed options for the beekeeping industry could take at the legislative level, specifically what we could lobby for in the upcoming Farm Bill. I’ve spent some time reviewing each proposal, and suggest that we don’t waste our time on those with little chance of success — such as the 2(ee) exemptions for extended-release oxalic acid passed by a few states, and then later denied by EPA.

THE SHIFT FROM XENOBIOTICS TO “NATURAL” BIOCHEMICALS

Some of the earliest pesticides used in agriculture, such as copper, arsenic, mercury, creosote, naphthalene and nicotine, were not in any way ecologically “friendly.” Since the Second World War, those nasty pesticides have largely been supplanted by synthetic manmade chemicals (xenobiotics not found in nature), such as organochlorides, organophosphates, carbamates, and neonicotinoids ― to which biological systems had never been exposed. Due to the persistence of some of these xenobiotics, their negative effects upon off-target species and the environment, and their unknown long-term effects upon our health, there is a push to instead use biochemicals naturally produced by plants or animals, which quickly biodegrade, and to which our bodily detoxification mechanisms have adapted over the course of evolution.

The EPA and USDA are very much in favor of this shift, making a special case for naturally-occurring “minimal risk” pesticides and “biopesticides” (naturally occurring substances that control pests by non-toxic mechanisms). Unfortunately, fine distinctions and arbitrary decisions have led to including varroa-toxic formic acid, menthol, and sucrose octanoate in EPA’s list of biopesticides [[1]], while excluding oxalic acid and thymol from both that list and the Minimal Risk list [[2]] (Table 1).

OUR PROBLEM WITH CURRENTLY-REGISTERED PRODUCTS: VARROA CONTROL WHILE COLONIES ARE PRODUCING HONEY

In many regions, due to climate or the timing of the nectar flows, there are no practical and efficacious registered treatments for controlling varroa while honey supers are on the hive. This is a problem, since during this period mites continue to reproduce at an exponentially-increasing rate — leading to serious, but preventable, colony losses later in the season.

There are three main issues involved:

• Due to the need to avoid contamination, some products are not allowed to be applied during the production of honey for human consumption.
• Label restrictions unreasonably limit application methods of registered products, even though they have tolerance exemptions in honey.
• Time-consuming labor or applicator safety issues are involved with the three natural treatments that are approved for use during the nectar flow (detailed below).

There is no need for beekeepers to fight the EPA, but rather we should ask EPA, and perhaps our legislators, to help us, as a minor industry, to be able to legally use expanded application methods for the safe and non-contaminating natural treatments, notably oxalic and formic acids, and thymol. Unfortunately, the few registered products on the market may be unreasonably expensive, and their labeling too restrictive for the needs of beekeepers in different climates and operations.

THE RISK TO APPLICATORS

The EPA must take into account the risk to the applicator involved with the application of any pesticide. But unlike a farmer who can spray a product onto their crop from the safety of the cab of an air-conditioned tractor, the beekeeper must apply varroa treatments — working in the full sun on hot days — to the brood chamber of each individual hive.

The application methods for the currently-registered miticides approved for application during the nectar flow are not only unreasonably time consuming, but also involve unacceptable risks to any beekeeper having more than a few hives. There are three main risks involved are:

• The physical exhaustion and chance of bodily injury involved in the removal and restacking of hundreds or thousands of heavy honey supers in order to apply the product to the brood chambers beneath them (especially when repeated applications are required).
• The heat stress involved with the above labor during the typical high temperatures that occur during the nectar flow, especially with the required Personal Protective Equipment (thick vinyl gloves, heavy clothing, or masks) called for by the label. The removal and restacking of honey supers is hard physical work, which in hot weather can easily lead to heat stroke.
• The exposure risk to the applicator involved with the unavoidable fumes of formic acid and heat-vaporized oxalic acid, especially when involved when treating thousands of individual hives during hot weather. The hard physical work and heat stress greatly increase the chance for accidents leading to acid vapor exposure.

Talking point for our legislators: What our industry needs are additional methods for controlling varroa while honey supers are on the hive, notably inexpensive natural treatments or application methods that pose less risk to the applicator.

UNDERSTANDING THE EPA

For us beekeepers to ask for any legislative action, we gotta understand the mandate that EPA works under.

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was signed into law by President Harry S. Truman in 1947 to regulate the distribution, sale, and use of pesticides. In 1972 power was transferred the Environmental Protection Agency (EPA) (which had been established by President Richard Nixon in 1970). The first iterations of the law focused on labeling and ensuring that chemicals were not adulterated, but did not focus on the environmental and public health effects of pesticide use; this did not come until 1972. Congress has passed amendments to FIFRA numerous times since then.

FIFRA now contains 284,623 words [[3]] and is enforced by the Office of Pesticide Programs (OPP).  Unless specifically exempted, all pesticides distributed, sold, or used in the United States must be registered by the EPA and regulated by the Office of Pesticide Programs (OPP). In order to gain registration, a manufacturer must show that the pesticide will generally cause no unreasonable risk to man or the environment, while taking into consideration the economic, social, and environmental costs and benefits of use of the pesticide, dietary risk from residues, as well as not endangering agricultural workers during their application.

Practical consideration: It may be easier to get Congress to pass an amendment to FIFRA than to ask the OPP to approve a requested exemption.

USE, REGISTRATION, OR LEGISLATIVE OPTIONS ON THE TABLE

Below are the short versions of my assessments of each option (you can contact me for more detailed versions).

Potential Action Item #1: Applying for FIFRA Section 24(c) Special Local Need Registrations

Individual states are allowed to register a new end-use product or an additional use of a federally registered pesticide product to address an existing or imminent pest situation. The pest situation must be a special local need within the state that cannot be mitigated by a currently registered product [[4]].

We could argue that varroa’s development of resistance to amitraz is certainly an imminent problem, and that the very limited label directions for the currently-approved varroacides that can be applied during a nectar flow are too restrictive and unduly risky to the applicator.

Pro: Might work.

Cons: It would be a long shot. An SLN designation requires the consent of the Registrant of the active ingredient, which Chemicals Laif (Veto Pharma) is not interested in giving, so as far as any SLN registration of different application methods for oxalic acid, this option is Dead on Arrival.

My assessment: Since at best this would only apply to the use of Api-Bioxal, it’s doubtful that it would be worth the effort, especially since EPA may reject the applications. Chance of success is low.

Potential Action Item #2: Utilize USDA’s Office of Pest Management Policy (OPMP) to Help Us.

USDA, under §7653, with regard to the specific purpose of collaborating with the EPA and agricultural stakeholders in the availability, and use of economically and environmentally sound pest management tools, practices, and policies, established the Office of Pest Management Policy (OPMP), with the mandate to provide leadership to ensure coordination of interagency activities with the Environmental Protection Agency, the Food and Drug Administration, and other Federal and State agencies.

“The Office of Pest Management Policy shall consult with agricultural producers that may be affected by pest management or pesticide-related activities or actions of the Department or other agencies as necessary in carrying out the Office’s responsibilities under this section.” [[5]]

Limitation: The OPMP can only advocate, not regulate or approve varroacides.

My assessment: The OPMP is already helping us, but they don’t set actual pesticide policy.

Suggested action: Our industry needs to engage in consultation with OPMP and suggest how they might advocate on our behalf.

Potential Action Item #3: Ask IR-4 for Help

The IR-4 (Inter-Regional Research) Project (aka the Minor Crop Pest Management Program) develops data necessary for the registration of safe pesticides with EPA. IR-4’s mission is to facilitate registration of sustainable pest management technology for fruits, vegetables, ornamental plants, and other “minor” crops. IR-4 works in coordination with the Environmental Protection Agency to assist in the collection of residue and efficacy data in support of the registration or reregistration of minor use pesticides and the determination of tolerances for residues of minor use chemicals in or on raw agricultural commodities. Since its founding, IR-4 has facilitated the approval of thousands of pesticide registrations through EPA, many of which provide growers with innovative pesticide products (including varroacides) that minimize health and environmental risks.

There are synthetic miticides already registered for uses other than varroa control [[6]]. If a Registrant wanted to expand its use for beehives, it would require only a label amendment. IR-4 could help to collect required data, such as that required for a residue tolerance in honey. But our industry has already shown the chemical companies that if an already-registered plant-protection product (such as Mavrik or Taktic) is cheaper than a formulated product specifically for beehives (respectively Apistan or Apivar), that commercial beekeepers will likely buy it instead, so might not justify the cost involved in pursuing an additional registration.

However, as we discover other ingredients on the Biopesticide list, new modes of action against varroa (such as RNAi, odorants, or behavioral disruptors), IR-4 might help get them through the regulatory process.

Pro: IR-4 is willing to help us, although we would likely need to pay them for the necessary data collection.

Cons: IR-4 is mainly interested in the testing of novel active ingredients and formulations.

My assessment: IR-4 is mostly interested in helping to register biopesticides, but doesn’t set pesticide policy. The process of registering new products or application methods could take some time.

Potential Action Item #4: Shift regulation of Varroacides to the FDA

Currently, EPA and FDA determine regulatory oversight of pesticides and new animal drugs based on the rationale described in a Memorandum of Understanding (MOU) between the agencies signed in 1971 and revised in 1973. Parasite treatment products applied topically to animals (including pets) generally are regulated by EPA if they remain on the skin to control only external parasites, and by FDA if they are ingested and absorbed systemically into the bloodstream. Although this idea has been floated that varroacides might better be regulated by the FDA, either as over-the-counter products, or by veterinary prescription,

• The registration requirements by FDA for parasite treatments may be tougher than those by the EPA for pesticides.
• Vets have severe limitations for prescribing extra-label usage, and it’s doubtful that FDA would look more leniently upon alternate routes and dosages than the EPA.
• Since Api-Bioxal is already registered, FDA would not allow generic OA usage.
• FDA might revisit the residue concerns for honey.

Pros: Not clear.

Cons: Of questionable benefit to our industry. Most stakeholders are opposed.

My assessment: This option appears to be a non-starter.

Potential Action Item #5: Petition the EPA to Add Honey Bees to the Minor Use Crop List

Designation of a pesticide for minor use is intended to identify situations where registrants of potentially useful pesticide products (in our case, varroacides) may not need to apply for registration because the potential returns are low (This lack of economic incentive is a huge issue for us, greatly limiting the number of registered products available for our use). Crops (in our case beehives) qualify if there are fewer than 300,000 acres in production in the United States.

It takes 19,300 beehives to cover an acre. Thus the 3 million hives in the U.S. would cover 155 acres. So we should definitely qualify for Minor Use registration.

Minor uses also include pesticides applied for control of disease vectors such as mosquitoes, ticks, cockroaches, rodents and disease-causing organisms (varroa is the vector for DWV).

In 2018, the EPA released a Pesticide Registration Notice [[7]] to clarify and revise the EPA’s interpretation of “minor use” under FIFRA section 2(ll) as it applies to the registration of pesticides. Although there were several comments submitted to EPA, not one came from our industry representatives.

Suggestion: We beekeepers should make sure that our national organizations submit comments when EPA asks for input on decisions that may be of benefit to our industry!

Pro: If we were successful with this petition, it might decrease the costs for registering products intended for varroa control. So perhaps worth pursuing.

Cons: It’s unlikely that EPA would even consider granting exemptions for Minor Use Registrations of thymol, formic, or oxalic in generic form. EPA would likely only allow use of registered active ingredients from approved suppliers, new labels, etc.

My assessment: This may be worth a try, but we should check with EPA before pursuing. Again, the gears of EPA turn slowly, so this would not help us in the short term.

Potential Action Item #6: We Petition the EPA to Include Additional Active Ingredients to the “Minimal Risk” List

Specifically: Our industry could petition the EPA to add certain additional generic natural substances to their Minimal Risk list (limited specifically to application to beehives).

In 2021 EPA solicited public comments and suggestions about the petition process for exemptions regarding pesticides from registration and other requirements under FIFRA, where the pesticides are determined to be of a character unnecessary to be subject to regulation under FIFRA. The Agency was considering streamlining the petition process and revisions to how the Agency evaluates the potential minimum risk active and inert substances, factors used in classes of exemptions, state implementation of the minimum risk program and the need for any future exemptions or modifications to current exemptions.

Some 39 comments were submitted, but not one came from the beekeeping industry. We missed our chance to have thymol and formic and oxalic acids added to the Minimal Risk list.

Suggestion: We beekeepers should make sure that our national organizations submit comments when EPA asks for input on decisions that could be of benefit to our industry!

One public comment made the point that:

One of the processes that needs the most improvement is the cost and time burden on the implementation of decisions. Today, the current cost to introduce a new substance [can be] over $900,000 dollars … This is a burden that many businesses simply cannot afford. Second, the complexity of registering pesticidal products is too much for a small business to handle without outside guidance. Overall, [our] suggested action is to streamline the process … if the substance is widely used in the public.

Formic, oxalic, and thymol are all natural components of our food, and in “chemical form” are widely and safely used by the public (especially by beekeepers). Although the EPA “promotes the use of safer pesticides, including biopesticides, as components of IPM programs,” it hasn’t moved very quickly to add additional presumably safe ingredients to its Minimal Risk list; in fact they’ve added only one ingredient (chitosan) since publication of the original list in 1996 (for the mathematically disinclined, that was 27 years ago!).

Similar to how EPA responded to a petition to add chitosan to the Minimal Risk list, our industry could petition EPA to add more active ingredients already in their registry to the Minimal Risk list, including thymol, formic and oxalic acids, and a large number of aromatic plant oils which exhibit varroacidal action. Due to the relatively tiny amounts used by the beekeeping industry, the application of any of the above active ingredients to beehives would not cause any unreasonable risk to man or the environment. Beekeepers in New Zealand have set an example of how it works to allow them the freedom to apply these generic natural chemicals.

Pros: Since varroa is evolving more quickly than new miticidal products are being registered, it would be of great benefit to the United States beekeeping industry for EPA to expand their Minimum Risk Exemption to include formic, oxalic, and lactic acids, thymol, and additional plant oils that have shown promise.

If more ingredients were added to the Minimal Risk list, we could immediately begin experimenting with them, and likely quickly develop new varroa-control methods and formulations. And since beekeepers are already familiar with registered thymol and organic acid products, it would be a huge step forward to allow us to use the off-the-shelf generic ingredients in addition to registered formulations and products.

Pros: The addition of generic thymol, and oxalic and formic acids to the Minimal Risk list would help our industry immensely, since beekeepers could customize application methods for their specific conditions, and lead to the development and marketing of new formulated products.

Cons: It will take the submission of a petition and follow-up. We may need to file toxicology reports relevant to application to beehives. The current Registrants of formulated products may object to their active ingredients being given a “free pass” after spending large sums to get their products registered by EPA. Each state has its own statutes and regulations concerning pesticide registration and regulation, and the states are not required to permit the sale of an exempted product simply because it meets the 40 CFR 152.25(g) conditions for minimum risk exemption. But the biggest drawback would be that it would likely take a long time for EPA to go through the process.

My assessment: It’s a long shot, but perhaps EPA might add these generic substances to the List, perhaps limiting their use to varroa control in beehives. It’s worth formally petitioning them. But it would likely take a long time for them to go through the process, even if they decided to do so.

Potential Action Item #7: Ask our Legislators to Pass an Own Use Exemption Amendment to FIFRA

I’ve saved what I feel is our best option for last — it’s kinda a combination of Actions #5 & #6, but it would bypass the EPA by instead asking Congress to add a tiny amendment to FIFRA in the upcoming Farm Bill.

Here’s the problem: It is completely legal for a beekeeper to put generic oxalic or formic acid, thymol, or plant oils into their hives for the purpose of colony health, bee repellency, or the cleaning of frames or combs. Neither the EPA or FDA are concerned about risk to the environment nor to the honey consumer. But if in their mind the beekeeper is using them for pesticidal purposes, it would be against the law. I underlined the two key words —generic and use. This is not about the sale of pesticides, only with regard to use of off-the-shelf generic natural substances. Our predicament is that this creates a cloudy situation for beekeepers and those responsible for the enforcement of FIFRA.

New Zealand’s Ministry for Primary Industries, understanding this predicament, and realizing that (1) beekeepers needed help (and would likely help themselves anyway), and (2) that these generic natural substances applied to beehives posed no risk to man or the environment, wisely granted beekeepers an Own Use Exemption [[8]] for “compounding of substances for their own use.” To wit: “(1) The exemption applies to a substance or compound prepared by a person for use on animals or plants that they own, or on any land, place or water that they own or occupy. (2) In a beekeeping context, the ‘own use’ exemption is commonly used when a beekeeper prepares and applies preparations containing generic substances, such as oxalic acid or formic acid, to their own hives for control of Varroa mites.” The preparations can only be made by the beekeeper for their own use, and cannot be advertised or sold.

Pesticide regulation is different in the U.S. than in New Zealand, so (in my opinion) our best course of action is to combine the elements of the “Minor Use” and “Minimal Risk” components of FIFRA, and ask our legislators to place an amendment to FIFRA in the upcoming Farm Bill, granting an exemption to regulation for beekeepers applying generic thymol, oxalic, formic, or lactic acids, or food-grade aromatic plant oils to their own hives.

The logic for an exemption comes from the text of FIFRA itself:

7 U.S. Code § 136 – Registration of pesticides (a) Requirement of registration

“Except as provided by this subchapter, no person in any State may distribute or sell to any person any pesticide that is not registered under this subchapter. 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 under this subchapter and that is not the subject of an experimental use permit under section 136c of this title or an emergency exemption under section 136p of this title” [highlighting mine].

I boldfaced the key words ― the Administrator may limit the use of a pesticide only if it causes unreasonable adverse effects. Since use of the generic forms of these natural generic substances within the confines of beehives would clearly not result in any unreasonable effects on the environment, it is not necessary for the Administrator to regulate their use (as opposed to registration or sale of formulated products), and such use should be exempt from regulation under FIFRA. We’d simply be asking for our legislators to codify that fact, not with an emergency exemption, but rather with a specific exemption amendment to section 136a.

Our fallback plan:  If we can’t get Congress to pass an exemption, we could instead take the EPA to court to see whether we could convince a judge to agree that since the use of these substances by beekeepers poses no risk to the environment, that such use should be exempted by regulation under FIFRA.

As an example, groups supporting the development of plant biostimulants feel that the Farm Bill is “the most logical place for inclusion” of an amendment to FIFRA [[9]].

The advantages of this option are:

• This could be a minor amendment to FIFRA included in the Farm Bill, by simply adding an additional exemption.
• EPA would continue to regulate the sale of any products sold for their pesticidal effects against varroa.
• But beekeepers would be exempted from regulation for the use of (as opposed to the sale of) these specific natural substances.
• It would be limited solely to applications to beehives by the beekeepers themselves.
• Any preparations of the generic substances could only be made by the beekeeper for their own use.
• It would be up to the beekeeper to decide how to choose and use each substance or product (in rotation), following guidance by USDA’s Office of Pest Management Policy or by state agricultural extension.
• No prepared products could be advertised or sold for pesticidal purposes unless they were registered with the EPA.

From a legislative standpoint, this option is not theoretical ― it’s already being successfully used in New Zealand, and could simply be copied! The simple fact is that the use of these generic products in beehives should be exempt from regulation by FIFRA, since oxalic, formic, and thymol pose no unreasonable risk to man or the environment when limited to application to beehives, and all already have exemptions from tolerance in honey.And there is already a place for exemptions in FIFRA.

An Own Use Exemption would, similar to as in New Zealand, allow beekeeping suppliers to stock generic organic acids and thymol, but they could not make any pesticidal claims for them. The suppliers would continue to stock registered products for beekeepers wishing to use conveniently-packaged, tested formulations (such as the currently-registered plastic strips, formic pads, and thymol gel).

Pros: This would be the simplest and most straightforward solution, and allow beekeepers to avoid being pesticide scofflaws. This option would solve our predicament immediately, and allow us to use these generic natural substances without needing to wait for EPA to decide whether to add them to the Minimal Risk list. Adding a simple amendment to FIFRA to the farm bill should be apolitical, and strongly supported since we beekeepers are a very minor industry, but have some political clout due to our importance in crop pollination, plus the honey bee being a poster child for the environment.

Cons: Our legislators would likely ask EPA for their opinion, and if EPA objects strongly, they might be hesitant to pursue it. Thus beekeepers would need to request it even more strongly.

ACTIONS TO TAKE

At the state level

A number of beekeepers have asked me about actions to take at the state level. Unfortunately, states are allowed to impose pesticide regulations more restrictive than the EPA’s, but not less restrictive, so it may be a waste of time to pass pesticide exemptions at the state level, since (as with the case of the 2(ee) exemptions) EPA will likely overrule them.

However, in general, states (through their State Lead Agency) have primary authority for compliance monitoring and enforcement against illegal pesticide use. States can issue bulletins to their inspectors regarding guidance for discretion of enforcement.

At the federal level

Our best course of action would be at the federal level, but we’ll need state legislators to support an amendment to FIFRA in the Farm Bill. Should beekeepers in any state be able to catch the ear of a supportive legislator, they could ask them to contact the agricultural committee staffs of the chairpersons of the House and Senate Agriculture Committees.

A SUGGESTED AMENDMENT

I’ve posted suggested text for an amendment to FIFRA, plus suggested wording for pitching it to our legislators at [[10]].

CITATIONS AND NOTES

[1] https://www.epa.gov/ingredients-used-pesticide-products/biopesticide-active-ingredients

[2] https://www.epa.gov/sites/default/files/2018-01/documents/minrisk-active-ingredients-tolerances-jan-2018.pdf

[3] I haven’t yet read every word, but it would be something to do if you were ever spending a few years in prison due to an enforcement action.

[4] https://www.cdpr.ca.gov/docs/registration/manual/guidance.pdf

[5] https://uscode.house.gov/view.xhtml?req=granuleid:USC-2000-title7-section7653&num=0&edition=2000

[6] Bahreini, R, et al (2020). Evaluation of potential miticide toxicity to Varroa destructor and honey bees, Apis mellifera, under laboratory conditions. Scientific Reports 10(1) 21529.

[7] https://downloads.regulations.gov/EPA-HQ-OPP-2015-0814-0016/content.pdf

[8] https://www.mpi.govt.nz/dmsdocument/37901-Advertising-and-own-use-guidance-for-compounds-for-management-of-disease-in-beehives-Guidance

[9] Farm bill could include FIFRA exemption effort for plant biostimulants

The text of their bill is available at To amend the Federal Insecticide, Fungicide, and Rodenticide Act to provide for a consistent definition for plant biostimulants.

[10] https://scientificbeekeeping.com/suggested-wording-and-pitch-for-an-own-use-exemption/