In the July issue of this Journal, I wrote about the options (legally allowed or unapproved) available to U.S. beekeepers for varroa management, especially with regard to use of the “natural miticides” [[1]]. However, after having the Chief of the Biochemical Pesticides Branch summarily reject my request for EPA to consider granting beekeepers an Own Use Exemption for the organic acids and thymol, I went back and reread the text of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) more deeply.

Allow me to again state that I am by no means a lawyer, but I just wanted to make sure that I wasn’t missing anything. So I searched the text of FIFRA for terms such as “use,” “regulation,” “unlawful,” and “exemptions.” I read a lot of paragraphs and sections, but didn’t find anything of particular applicability to us, until I searched for the word “unregistered.” And bingo — it looked as though I might have found a loophole!

A LOOPHOLE?

Definition of terms: Section 2 of FIFRA states: “The term ‘‘pesticide’’ means (1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.”

Practical application: This means that off-the-shelf oxalic or formic acids or thymol are magically turned into “unregistered pesticides” the moment that they are used with the intent to control varroa — so watch your thought bubble!

To my surprise, regarding the use of unregistered pesticides, (such as generic oxalic, formic, or thymol) I discovered that FIFRA does not mandate that the EPA regulate their use, but only that the Agency has an option to do so, based upon its determination that regulation would be necessary to prevent unreasonable risk. Aha, could this be an avenue worthy of pursuit?

So I decided to try my luck again, and carefully wrote a letter to the Chief, requesting clarification. By “carefully,” I mean that I refined draft after draft, since I figured that I’d only get one chance at getting a favorable answer.

“THE LETTER”

Here’s a copy of the letter:

Sent: Sunday, July 23, 2023 9:03 AM

Dear [Intentionally Withheld],

In a previous meeting, we beekeepers asked you about EPA granting beekeepers an own use exemption (similar to that in New Zealand’s [^a]) for application of generic substances such as formic and oxalic acids to their beehives. I now realize that we had asked you the wrong question — it is not up to the EPA to grant exemptions; according to Section 136a of FIFRA, such use is exempt by default.

Authority to Regulate

Section 136a states that “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 …” [boldface mine].

Note that Section 136a does not state that the Administrator shall regulate the use of any unregistered pesticide, but only that it may. As far as beekeepers are concerned, our interpretation is that FIFRA does not confer blanket authorization for the EPA to regulate or restrict the use of every off-the-shelf “natural” substance used for pesticidal purposes within beehives, but may limit the use only of those that it has determined would cause unreasonable adverse effects on the environment.

Such a decision to limit the use of a specific pesticide would need to be based upon a determination from a formal risk assessment by The Environmental Fate and Effects Division that such regulation is necessary to prevent unreasonable adverse effects on the environment.

So the questions that we beekeepers should have asked you are:

Whether the OPP has formally determined that it is necessary for the EPA to limit the use by beekeepers of unregistered, generic, off-the-shelf oxalic acid, formic acid, thymol, or food-grade plant oils for varroacidal purposes in their own hives, in order to prevent unreasonable adverse effects on the environment.
If so, has the EPA published their risk assessment to justify that decision and, where can we find that risk assessment to read?
And has the EPA decided to enforce action against such own use?

Unreasonable Adverse Effects on the Environment

The term “unreasonable adverse effects on the environment” means (1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or (2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under Section 346a of Title 21.

Regarding the use (as opposed to the advertisement or sale) of the generic off-the-shelf substances oxalic acid, formic acid, thymol, and food-grade plant oils by beekeepers for pesticidal purposes in their own beehives, we cannot imagine how EPA could have determined that own use of these substances would result in “unreasonable risk” to either man or the environment.

Unreasonable risk to man (the applicator)

Similar to wood bleach, oven and toilet cleaners, and any number of off-the-shelf solvents, the above substances are commonly used by the public without unreasonable risk to the user. The minimal amount of injuries to beekeepers from using these substances in the U.S. and New Zealand (where such unregulated use is permitted) suggest that there is no unreasonable risk to the applicator.

Unreasonable risk to man (the public)

Since these natural products are already a part of the human diet and present in nature, and since all applications would be limited to the confines of wooden beehives, there is no unreasonable risk to the public. Not only that, but if beekeepers were to replace their current use of amitraz with these natural products, it would decrease the overall risk to the American public.

The economic benefit to the beekeeping industry

The few registered varroacides currently on the market are unreasonably expensive, often difficult to use, and with label directions that often do not reflect local climate and biological variations between individual honey bee colonies. The economic benefit to the beekeeping industry from being able to use these off-the-shelf natural products would be immense!

Unreasonable risk to the environment or off-target species

Since all these substances are naturally produced by plants or animals, are readily biodegradable, and applied only within the confines of bee hives, there is obviously no unreasonable risk to the environment. There would be no off-target species (other than the bees within that hive) exposed to the substance.

Unreasonable human dietary risk from residues

Since thymol, oxalic and formic acid already have exemptions from tolerance in honey, and since there is no restriction against adding food-grade aromatic plant oils to honey, application of these substances to beehives would not result in any unreasonable risk to the consumer.

Our Questions (again)

Has the OPP formally determined that it is necessary for the EPA to limit the use by beekeepers of unregistered, generic, off-the-shelf oxalic acid, formic acid, thymol, or food-grade plant oils for varroacidal purposes in their own hives, in order to prevent unreasonable adverse effects on the environment.
If so, has the EPA published their risk assessment to justify that decision and, where can we find that risk assessment to read?
And has the EPA decided to enforce action against such own use?

Our questions apply only to “own use” of the generic substances specified above. We understand that advertisement, distribution, or sale of these substances for pesticidal purposes requires registration and adherence to the instructions on the label.

Thank you for your time ― we look forward to your answers,

Randy Oliver

Footnote

[^a] (1) Schedule 2 of the ACVM (Exemptions and Prohibited Substances) Regulations 2011 provides for an exemption from registration under the ACVM Act referred to as the “own use” exemption. 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.

EPA’S RESPONSE

I received no response.

I brought this up with the leaders of our national organizations. We and our lobbyist had some Zooms, and both organizations decided to forward copies of my letter to EPA under their letterheads. In addition, we asked a couple of state legislators’ staffs to look into it.

To my great surprise, when I was at Apimondia in September, I got a call to join a Zoom with the Administrator of the EPA, along with the leaders of ABF and AHPA. My letter had apparently worked its way to the very top of the Agency. The meeting went very well, with the Administrator being very open to the situation that our industry is in with regard to options for varroa management. We were informed that the Agency had a team of its lawyers working on a response (and the next day I finally received an email formally acknowledging receipt of my letter).

WHERE WE NOW STAND

At the time of this writing (mid-October), we’ve still not received answers to the questions I asked in July.

Practical application: Of immediate applicability to beekeepers is that we’ve yet to receive an answer to the simple yes/no question “And has the EPA decided to enforce action against such own use?” The lack of an answer suggests that the EPA is still in the process of making a formal decision. That apparently means that we’d all been erroneously assuming that the EPA had determined (prior to my letter) that it was against the law for beekeepers to use unregistered oxalic, formic, or thymol in their hives with the intent to control mites.

So what can I say? The agricultural industry — of which we are part — is regulated by the EPA as to what we can use to manage pests and parasites. But at this point of time, we beekeepers have no idea as to whether EPA has determined that it is legal or not for us to use off-the-shelf generic “natural” products for the purpose of varroa control. Until we get clarification from the Agency, the answer remains up in the air …

Acknowledgements and Clarification

I’ve intentionally withheld some of the names of those involved in this discussion. I’ve got no beef with the EPA — every employee with whom I’ve been in contact appreciates our situation and has been very helpful — they are just doing their job in following the law as it is written. Ditto for those at the USDA who would rather remain anonymous. I do wish to credit the representatives of our industry who have helped me in this process — notably Charlie Linder, Dan Winter, Chris Hiatt, and our lobbyist Fran Boyd.

Citations and Notes

[1] https://scientificbeekeeping.com/the-status-of-our-industry-regarding-varroa-mgmt-and-what-can-we-do-about-it/

Category: Varroa Management