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Suggested wording and pitch for an Own Use Exemption




DRAFT IN PROGRESS updated 24 June 2023

Suggested Text for an Amendment to FIFRA

I have zero legal background, but suggest that we pitch a short and sweet amendment to be placed in the Farm Bill.  There is already a section in FIFRA 40 CFR 152.25 regarding exemptions.

§ 152.25 Exemptions for pesticides of a character not requiring FIFRA regulation.

Congress could simply add after exemption (f) Minimum risk pesticides, a brief exemption (g)  to exempt the own use of generic natural products by beekeepers.  Suggested text:

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A BILL

To amend the Federal Insecticide, Fungicide, and Rodenticide Act to provide an exemption for pesticidal use of specified generic natural substances by beekeepers, limited to application to their own hives.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress

SECTION 1. SHORT TITLE. This Act may be cited as the ‘‘Beekeeper Own Use Exemption of 2023’’.

SEC. 2. EXCLUSION FROM REGULATION UNDER FIFRA.  

IN GENERAL.  The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) is amended by inserting after section 152.25 Exemptions for pesticides of a character not requiring FIFRA regulation.

 ‘‘(g) EXEMPTION FOR OWN USE BY BEEKEEPERS OF GENERIC NATURAL SUBSTANCES

‘‘Since the use of generic oxalic acid, formic acid, thymol, or food-grade plant oils applied to bee hives poses no unreasonable risk to man or the environment, the use of these substances for parasite control in one’s own bee hives shall not be subject to regulation under this Act.  This exemption is limited to the preparation and application of these generic products by a person for their own use, and does not affect the requirement for registration of products to be advertised or sold for pesticidal purposes.”

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Suggested Pitch to Legislators

This is a case of unreasonable regulation, rather than a question of “unreasonable risk.”  The use of commonly-available natural plant products by beekeepers to control the varroa mite should be exempt from regulation by the Administrator of FIFRA.

What our regulators should keep in mind is that people only respect laws that they feel are reasonable. Unreasonable laws tend to be ignored and not enforced.  The unfortunate fact is that the entire beekeeping industry  has rationalized using unapproved methods to control varroa.  This amendment would  help to bring beekeepers into compliance with the law, and clarify the law for those responsible for enforcement.

FIFRA’s mandate is that the application of any pesticide should result in “no unreasonable risk to man or the environment.” It’s obvious to any beekeeper that using oxalic acid, formic acid, or thymol in their hive would in no way create either of those risks. Our regulators need to understand that for us to respect them, EPA’s regulations must make “common sense.”

The advantages of this Amendment are:

  • This would be a minor amendment to FIFRA included in the Farm Bill, simply adding an additional paragraph to the list of existing exemptions.
  • It would apply solely to natural, off-the-shelf biodegradable substances, not to synthetic chemicals.
  • Beekeepers would be exempted from regulation soley for the use of (as opposed to the sale of) these specific natural substances.
  • It would be limited solely to applications to bee hives by the beekeepers themselves.
  • Any preparations of the generic substances could only be made by the beekeeper for their own use.
  • EPA would continue to regulate the sale of any products sold for their pesticidal effects against varroa.
  • No prepared products could be advertised or sold for pesticidal purposes unless they were registered with the EPA.
  • 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.

This amendment is along the line of the exemptions for Minimal Risk pesticides and Minor Use Crops (bee hives), and simply bypasses the slow-movng  EPA (which focuses on registration and sale of pesticides) by instead adding a tiny amendment to FIFRA (as to the own use of these natural substances by beekeepers) in the upcoming Farm Bill.  As far as use in bee hives, these natural substances should all be on EPA’s Minimal Risk list (as far as use in bee hives) anyway, but EPA moves at glacial pace, and has only added a single substance to the list since its writing in 1996.

The EPA’s strict adherence to the letter of the law regarding FIFRA, and to protect themselves from liability or lawsuits, may put them at odds with common sense and beekeeper practical experience. The active ingredients of the organic acids oxalic or formic, or the plant extract thymol, due to their rapid biodegradation, when applied to beehives pose absolutely no unreasonable risk to the environment, and since they all have tolerance exemptions in honey, no risk to the consumer, and with reasonable precaution, no more risk to the applicator than do commonly-used oven or toilet cleaners, bleaches, swimming pool treatments, etc.

This is not about the registration or sale of these substances as pesticides, but is only with regard to the own use of off-the-shelf generic natural substances by beekeepers.  Beekeepers already commonly use generic oxalic and formic acids, thymol, or food-grade plant oils in their hives to control varroa mites — this amendment would simply bring them into compliance with the law.

The restriction against selling is a key point that differentiates this bill from a Minimal Risk Exemption, since (1) EPA would continue to regulate these substances in formulated products for sale and (2) current registrants of formulated oxalic, formic, or thymol products would not have wasted money in getting their products registered (so there may be less pushback by them against this, since it still leaves the door open for companies to develop, register, and sell formulated products for beekeepers who would rather purchase tested ready-to-use treatments).  It would also promote experimentation and development of new application methods that could then be submitted for regulatory approval).

Beekeepers themselves are in the best position to balance the chemical risks to the applicator involved in using oxalic or formic acids or thymol, versus the EPA requirement to wear bulky, heat-trapping protective gear in hot weather, and the dangerous labor involved in unstacking and restacking honey supers to apply a treatment ― based upon our practical field experience, EPA’s label requirements are ridiculously excessive.  Unlike as with the application of neurotoxic synthetics, so long as an applicator wears safely glasses when handling acids, there is little risk of long-term health issues involved in the handling of these active ingredients.  Yes, some are acids, but even in risk-averse Europe beekeepers are allowed to handle liquid formic acid (not to mention that in this country aerosol cans of concentrated lye oven cleaner and acid toilet bowl cleaners are routinely used in households ).

There is no need to mention preparation methods — this exemption has nothing to do with how a beekeeper applies a substance.

Here’s the problem: it is perfectly 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, they would be breaking the law.   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 bee hives posed no risk to man or the environment, wisely granted beekeepers an Own Use Exemption [[i]] 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. 

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

7 U.S. Code § 136a – 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.

I boldfaced the key words ― the Administrator may limit the use of a pesticide only if it causes unreasonable adverse effects.  Since application of the generic forms of these natural generic substances within the confines of bee hives 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 a specific exemption amendment to section 136a.

Additional Material

Pesticide sale or use under FIFRA

7 U.S. Code § 136a – 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.

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. 

The applicable sections of FIFRA are where it defines a “pesticide” as “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest” (§ 152.3 Definitions).   However, FIFRA does allow for certain products to be exempted from registration under 40 CFR §§ 152.25.  And FIFRA does recognize beekeepers applying products within their hives as a special case in 40 CFR 152.8(b) A product intended to force bees from hives for the collection of honey crops.

FIFRA also exempts from registration Minimum Risk Pesticides, including thyme oil and a number of acids.  Unfortunately, EPA has not yet added generic thymol, or formic or oxalic acids to the List, despite them all being naturally-occurring chemicals commonly produced by plants or animals, all having tolerance exemptions in honey, and exhibiting absolutely minimal risk to man or the environment.  It’s pretty obvious that applying these chemicals to bee hives at a dose that does not kill the bees is not going to result in harm to the environment.

Rather than petitioning the EPA to go through the tedious process of adding them to the Minimal Risk list (which would allow pesticidal use of these ingredients by anyone), it would be more straightforward to add a specific §152.25 exemption limited to application of these generic ingredients to within the confines of bee hives, limiting them to a beekeeper’s own use alone, and not allowing sale of any prepared products unless registered by the EPA, or eventually added to the Minimal Risk List.

The example of New Zealand

New Zealand’s Ministry for Primary Industries realized that their beekeepers were already using generic thymol, or formic or oxalic acid in their hives.  Since such use obviously constituted no risk to the public or the environment, and having no desire for all beekeepers to be pesticide scofflaws, granted them an exemption when a beekeeper prepares and applies preparations containing generic natural substances, such as thymol, oxalic acid or formic acid, to their own hives for control of varroa mites.

The exemption applies to a substance or compound made from these chemicals, prepared by the beekeeper for use only in hives that they own.  The exemption does not apply to registered varroa-control products, nor does it allow the sale of formulated unregistered products made from these generic ingredients.

The beauty of New Zealand’s solution is that Registrants are still free to develop, register, advertise, and market varroa control formulated products for sale (there are several already registered and sold in the country).  This exemption places full responsibility for safe preparation and application of these generic products upon the beekeeper themselves, releasing the Ministry from liability.

New Zealand’s own use exemption

 

Citations

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

 

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