Summary of risk mitigation proposal submissions related to the risk assessment on the importation of honey bee packages from the United-States

The purpose of this document is to summarize and assess risk mitigation proposal submissions that the Canadian Food Inspection Agency (CFIA) received from stakeholders during the open to public period that spanned from November 7, 2024 to January 31, 2025, for consideration as part of the risk analysis.

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Glossary

List of acronyms:

AHB:
Africanized honey bees
AFB:
American foulbrood
CFIA:
Canadian Food Inspection Agency
EFB:
European foulbrood
SHB:
Small hive beetle
U.S.:
United States
USDA – APHIS:
United States Department of Agriculture – Animal and Plant Health Inspection Service
WOAH:
World Organization for Animal Health
WTO:
World Trade Organization

The following definitions are taken from the Terrestrial Code of WOAH.

Hazard identification:
involves identifying the pathogenic agents which could potentially produce adverse consequences associated with the importation of a commodity.
Risk analysis:
the process comprised of hazard identification, risk assessment, risk management and risk communication.
Risk assessment:
the evaluation of the likelihood and the biological and economic consequences of entry, establishment and spread of a hazard.
Risk management:
the process of identifying, selecting and implementing measures that can be applied to reduce the level of risk.
Veterinary Authority (VA):
means the Governmental Authority of a Member Country having the primary responsibility in the whole territory for coordinating the implementation of the standards of the Terrestrial Code.

Summary of stakeholder risk mitigation proposal submissions

  • Propose a limited regional trade strategy
  • Evaluate the Impact on Inter Provincial Movement
  • Propose import inspection procedures and national surveillance
  • Propose a pilot project to import from Northern California
  • Risk mitigation for all identified hazards
  • Transport inspections upon entering Canada
  • Propose using current import conditions of queens for the importation of packages and best management practices post importation

CFIA's response to the proposed measure

The open to public proposal period was the opportunity for stakeholders to provide risk mitigation proposals (in other words: to submit risk mitigation measures) that could demonstrate clearly and scientifically how the implementation of measures could reduce the level of risk to negligible level as outlined in the risk management framework document. The expectations of the risk management framework document clearly defined the mandatory requirements for consideration of potential risk mitigation measures which includes the requirement for addressing all risk pre-exportation. For the purpose of this process, the proposal did not provide any scientific risk mitigations measures and did not meet the criteria of the expectation of risk management.

The CFIA is not involved in post-import oversight relating to honey bees, as such all matters relating to regional trade strategies and interaction implications between provincial jurisdictions (in other words: interprovincial movement, provincial policies and legislation) are not under the regulatory mandate of CFIA and are out of scope of the expectations of Risk Management.

Although provincial surveillance programs (already in place in most provinces through Provincial Agriculture Departments and/or Tech Transfer Programs) provide monitoring of domestic stock health status, the enhancement of a national surveillance strategy of domestic stock does not mitigate the hazard risks at the source and does not meet the criteria of expectations for risk management.

The notion of a regional trade strategy implies a zone determination (that is clear differentiation of health status of sub population of a species) in the exporting country which no zoning proposal by USDA-APHIS has been provided to CFIA.

The procedure for determining the specific animal health status of a zone depends on the epidemiology of the disease, including the presence and role of vectors, susceptible wildlife and environmental factors, the animal production systems and the application of biosecurity and sanitary measures, including movement controls. Biosecurity and surveillance are essential components of the zoning determination and need to be developed through active cooperation between industry and the Veterinary Authority of exporting country.

The final authority over the zone, for the purposes of domestic and international trade, lies with the Veterinary Authority. Zoning submissions should follow the standards recommended in Chapter 4.4 of the Terrestrial Code. The exporting country must be able to demonstrate, through detailed documentation provided to the importing country, that it has implemented the recommendations in the Terrestrial Code for establishing and maintaining a zone.

An experimental essay (Hypothesis/Pilot testing) to explore importation without addressing the multiple identified hazards with risks above CFIA's negligible risk level is not a risk mitigation measure and does not meet the criteria outlined in the expectations for risk management. Experimental essays involve a high level of uncertainty with unexpected/unanticipated outcome, and exceeds CFIA's acceptable level of risk.

The CFIA's comprehensive import risk analysis, encompassing the hazard identification, the risk assessment and the risk management framework, has identified hazard risks, and clearly demonstrated scientifically that the final risk estimate under the expected volume of importation, taking into account the probability of entry, exposure and establishment of each identified hazards on at least one recipient hive in Canada would be 100% and that the overall national-scale impact for each of these hazards would be moderate, which is above CFIA acceptable level of risk and as such mitigation measures are required. While some of the proposed mitigation measures partially addressed certain hazards, the feasibility and practicality of implementing these measures on a commercial scale is inconclusive with regard to their effectiveness in achieving the CFIA's acceptable level of risk, particularly given the estimated import volume of approximately 50,000 packages. Furthermore, no single proposal could mitigate all 4 pathogens when considered in isolation or in combination with the others (with SHB being the weak link).

The assessment also clearly determined that honey bee packages present a higher risk of importing identified hazards than caged queens, and that current import conditions for queens were insufficient to mitigation hazard risk for packages which was also corroborated in the 2014 risk analysis.

No additional risk mitigation measure was provided to CFIA that scientifically demonstrates how the proposed measures could reduce risk levels of identified hazards to negligible level as outlined in the expectation of risk mitigation in the risk management framework document.

"Simple Best Management Practices (BMP)" as a mitigation proposal fails to provide any comprehensive construct of a risk mitigation measure that scientifically demonstrate how BMP could reduce risk level of identified hazards to negligible level prior to entering Canada (in the country of origin), nor does it meet the expectations of risk management outlined in the risk management framework document.

Although best management practices are strategies that should strongly be advocated to safeguard the Canadian bee population, the issue relates to post importation strategies which falls under oversight of individual provincial jurisdictions and out of scope of expectation of risk management outlined in the risk management framework document.

The economics for Canadian beekeepers is challenging. They must have access to reasonably priced healthy honey bee packages in order to be competitive in world honey markets and to ensure crop pollination.

CFIA's response to comment

The CFIA does not have a duty of care to protect the economic interests of stakeholders. The CFIA's regulatory mandate under the Health of Animals Act and regulations is to help protect Canadian animal health, which includes the health of the Canadian honey bee population.

Africanized Honey Bees (AHB)

Propose for packages current importation regulations for queen honey bees from California that require:

  • Africanized honeybees have not, within the past year, been detected within 30 miles of the apiaries from which the queens originate, and that
  • Mitochondrial Polymerase Chain Reaction-DNA (PCR_DNA) test results must not show signs of A. m. scutellata in the progeny of the breeding queens

CFIA's response to the proposed measure

These are the current import conditions for the importation of honey bee queens. The hazard identification and risk assessment determined that honey bee packages presented a higher risk of importing identified hazards than queens because they cannot be thoroughly inspected for presence of hazards, which was also concluded in the 2014 risk analysis, therefore the status quo of import conditions for queens is not a valid mitigation option to mitigate the hazard risks for the importation of honey bee packages.

There is the potential for importing Africanized Drones in packages and PCR test has limitations and fails to determine biparental genetic markers. In combination, the import conditions work for queens but not for a package containing roughly 10 000 bees.

No additional supporting scientific and comprehensive risk mitigation measure was provided to CFIA in this proposal.

Propose CFIA to recognize a modern, genetic SNP-based test

CFIA's response to the proposed measure

Although the SNP test appears promising as a measure for the importation of queens and bee semen, this new substitute test for detecting scutellata genetics has not been documented in relation to the production of packages. It is unclear how the test could be applied to worker bees and drones given that packages are produced using bees from multiple colonies. Therefore, the current import condition for honey bee queens requiring that "Africanized honeybees have not, within the past year, been detected within 30 miles of the apiaries from which the queens originate" would remain a necessary condition of import.

The packing process of packaged bees - Continuation of ongoing Best Management practices and education on queen excluders and hive inspection /beekeepers to evaluate colony behavior to determine Africanized genetics.

CFIA's response to the proposed measure

The practice of using queen excluders does not provide assurance that Africanized drones would be completely excluded from the produced package. Drawbacks exist in practicality, feasibility and effectiveness of implementation. Their use is also ineffective for SHB as the pest can easily pass through excluders.

Visually assessing a colony's aggressivity level is a subjective perception which has no scientific diagnostic validity to confirm AHB genetics. This is not a risk management option since it does not provide any construct of a risk mitigation measure that scientifically demonstrates how it could reduce risk levels of identified hazards to negligible level prior to entering Canada. It does not address hazard risks identified within the risk assessment nor meets the expectations outlined in the risk management framework document.

Propose to avoid honeybees with the most 'Africanized' genetics, a sample should have less than 40% scutellata genetics. Based on all current knowledge bees with more than 40% scutellata genetics cannot live feral in Canada.

CFIA's response to the proposed measure

Statement claiming determination of a threshold of less than 40% scutellata genetics is not scientifically substantiated. The mitigation proposed fails to provide any comprehensive construct of a risk mitigation measure that scientifically demonstrates how it could reduce risk levels of identified hazards to negligible level prior to entering Canada (in the country of origin), nor does it adhere to the expectation outlined in the risk management framework document.

Propose that current import conditions for related to certification free from Africanized genetics should not be included on the APHIS export health certificate.

CFIA's response to the proposed measure

The hazard identification, the risk assessment and the risk management framework, have identified AHB as a hazard risk, and clearly demonstrated scientifically that the final risk estimate under the expected volume of importation, taking into account the probability of entry, exposure and establishment on at least one recipient hive in Canada would be 100% and that the overall national-scale impact would be moderate, which is above CFIA acceptable level of risk and as such mitigation measures are required for AHB.

The assessment also clearly determined that honey bee packages present a higher risk of importing identified hazards than caged queens, as also corroborated in the 2014 risk analysis and concluded that current import conditions for queens were insufficient to mitigation hazard risk for packages.

In 2004, import conditions were implemented to allow hand picked queens under the following mandatory requirements:

  • PCR-DNA Testing for AHB; and
  • Africanized honeybees have not, within the past year, been detected within 30 miles of the apiaries from which the queens originate; and
  • A certificate endorsed by the competent authority of the State Department of Agriculture (USDA-APHIS) must accompany the shipment

CFIA maintains its position on current import condition requirements relative to AHB for the importation of queens from the US.

No supporting scientific and comprehensive risk mitigation measure was provided to CFIA.

Small Hive Beetle (SHB)

  • Climatic barriers / Regular hive inspections / SHB traps
  • Propose continuation of ongoing practice and education
  • Proposes that package exporting operations in the U.S. are certified as being small hive beetle-free and that small hive beetle traps containing an active pesticide (that is fipronil or coumaphos) are placed within the package containers to trap and kill any small hive beetles
  • 6 northern California counties have a formal agreement in place for SHB quarantine, and based on this agreement, all colonies that move into these counties would be subject to inspection for SHB
  • In California counties that currently have SHB quarantine efforts in place, we propose mitigations identical to the current protocol for export of honey bee queens from the United States to Canada

CFIA's response to the proposed measure

SHB are small but can be seen easily with the naked eye. SHB adults move rapidly to dark corners and crevices when hives are opened therefore unlikely to be inadvertently included in shipments containing hand-picked queens and attendants. Hand picking allows for honeybees intended for export/import to be inspected. Queen, along with 4 attendant workers, all of whom are hand picked, are individually placed in the cage. Thus, SHB could be seen in a queen cage, while this would be virtually impossible in a package of roughly 10 000 bees.

Considerably higher rates of SHB importation can be expected with packaged bees, since living organisms in a colony (such as SHB) or on the bees themselves are much more likely to be shaken into a shaker box or package and could evade detection. Inspections for SHB upon entry into Canada would not be feasible because, in a package, the worker bees will cluster around the queen, and an inspector would see the outer layer of bees, but not the vast majority of bees on the inside. Further, packages have nooks and crannies that SHB could insert themselves into to avoid detection. It would not be practical to inspect every package and somehow look through all the bees and inspect all the nooks and crannies. Even a subsample would be difficult to certify and verify because the beetles are small, and they might be difficult to see in packages.

Although regular hive inspections and the use of SHB traps have been advocated as part of best management practices strategies to curtail impacts of beetles to honey bee colonies, these practices do not provide any guaranteed assurance nor scientifically demonstrates how it could reduce risk levels of identified hazards to negligible level prior to entering Canada. Furthermore, inspections upon entering does not mitigate the hazard risk at the source.

The effect of climate change has been accounted for in the uncertainties of the risk assessment. A probabilistic extrapolation can be made to correlate an anticipated expansion in the distribution range of the identified hazard risk. Consequently, this reinforces the need for mitigating measures to reduce the hazard risk to negligible level prior to entry of the hazard entering Canada.

SHB-Free zone requires USDA-APHIS determination involving strategic Veterinary oversight/surveillance program/movement protocols. Furthermore, concerns regarding off label use of pesticides (coumaphos is toxic, has prolonged residual effects – accumulates in hive products) and potential collateral/secondary development of varroa mite resistance.

No mitigation measure of SHB-freedom zone plan has been provided to CFIA.

The use of a pesticide within packages fails to scientifically demonstrate how it could reduce risk levels of identified hazards to negligible level nor meets the expectations outlined in the risk management framework document.

In 2024, a shipment of caged queens originating from within the California counties contained 15 SHB larvae within the shipment, which was discovered at port of entry into Canada, shedding doubt on SHB quarantine effort proclamation status of these counties and concerns regarding the actual rigorousness of the State's inspection protocols.

No risk mitigation measure was provided to CFIA that scientifically demonstrates how it could reduce risk levels of SHB to negligible level for packages prior to entering Canada in this proposal.

U.S. packages are produced and exported in the spring, this will greatly limit the probability of SHB importation into Canada in comparison to countries exporting packages to Canada in the exporting country's late summer/fall when there are high SHB populations in parent colonies.

CFIA's response to the proposed measure

The statement is unsubstantiated, and the action proposed does not represent a mitigating measure nor does it scientifically demonstrate how it could reduce risk levels of identified hazards to negligible level nor adheres to the expectation outlined in the risk management framework document.

Seasonality of producing packages is not the issue but rather the requirement of SHB zone freedom which other countries that export to Canada have complied as defined by the WOAH.

Furthermore, SHB is widespread in most states therefore remaining a substantial risk regardless of seasonality. In fact, well-established populations of SHB are now considered to be present in all of the mainland US (Neumann, et al., 2016).

No zoning component was provided to CFIA in the USDA-APHIS's risk management proposal.

The risk level assigned to the United States by CFIA as a result of this risk assessment also does not seem to be in agreement with the approach taken for other countries based on APHIS' understanding of Canada's current import allowances which permit importation of packages originating from countries where packages are being produced in late summer-fall season, when SHB populations are at their highest.

CFIA's response to the proposed measure

This is not a risk mitigation proposal but a statement of an opinion.

The risk level assigned to the US is effectively different than for other countries as determined by the process of risk analysis. The hazard identification, the risk assessment and the risk management framework, which comprehensively demonstrated scientifically that the final risk estimate under the expected volume of importation, taking into account the probability of entry, exposure and establishment of each identified hazards on at least one recipient hive in Canada would be 100% and that the overall national-scale impact for each of these hazards would be moderate, which is above CFIA acceptable level of risk and as such mitigation measures are required for SHB.

Canada allows importation from other countries with comprehensively defined SHB free-zones as per WOAH code. This differs from the US as no SHB-free zone has been proposed nor certified from USDA-APHIS. In fact, well-established populations of SHB are now considered to be present in all of the mainland US (Neumann, et al., 2016).

No additional risk mitigation measure was provided to CFIA in this proposal that scientifically demonstrates how measure could reduce risk levels of identified hazards to negligible level nor adheres to the expectation outlined in the risk management framework document.

Proposed mitigation measures for all other areas/states

  • No clinical signs/visual inspection
  • In the case that clinical signs are detected in an apiary, fall traps must be placed in all colonies to reduce SHB populations in the coming spring
  • SHB spring monitoring utilizing Schäfer strips
    1. The monitoring protocol presented in Schäfer et al. (2008), that are, Schäfer strips, will be utilized for detecting the presence of SHB in parent colonies from which a package is to be made
    2. Schäfer strips will be placed in all parent colonies within 1 week of package preparation and will remain in place for at least 48 hours
    3. If an SHB is detected in a colony, a registered pesticide for SHB will be applied to that colony prior to the production of packages in accordance with label recommendations. The action threshold will be set at 1 beetle per trap

CFIA's response to the proposed measure

An assumption in the risk assessment, which captured best management practices, is that if the presence of SHB is known in a colony by the bee producer, bees from this colony will not be included in a package destined to export to Canada. However, the consideration for import would still require SHB zone freedom designation.

Although best management practices (use of Schäfer strips/traps) are strategies advocated to safeguard honey bee health and curtail threats to colonies, the proposal fails to provide any comprehensive construct of a risk mitigation measure that scientifically demonstrates how it could reduce risk levels of identified hazards to negligible level prior to entering Canada (in the country of origin).

Furthermore, WOAH provides SHB-free zone provisions for mitigating the importation of SHB (WOAH International Standards – Chapter 9.4. – Infestation with Aethina tumida (Small Hive Beetle)).

For the purpose of this process, the proposal did not define or provide a SHB-free zoning proposal supported by the Competent Veterinary Authority of the exporting country. No thoroughly detailed documentation of surveillance, control programs and biosecurity plans that scientifically differentiate the health status of the sub-population within the exporting country has been provided within the proposal submission.

No additional risk mitigation measure was provided to CFIA that scientifically demonstrates how measure could reduce risk levels of identified hazards to negligible level nor adheres to the expectation outlined in the risk management framework document.

American Foulbrood resistant to Tetracycline (rAFBotc)

"Use of Antibiotics – Tylosin has been highly effective, and AFB is rare in Northern California hives. Northern California producers will continue the prudent use of antimicrobials under advisement from their Veterinary Authority.

Certification of exporting apiaries not only for the presence of clinical symptoms AFB, but for AFB spore loads. If an aggregate sample of bees from the apiary was above 100 CFU's per bee, in the absence of clinical symptoms, it should also be considered non-sanitary for export.

Culturing the AFB strain isolated from spores (above) for resistance. If positive for tylosin or lincomycin resistance, then the exporting apiary would fail

CFIA's response to the proposed measure

This is of concern since Tylosin is a second level antibiotic option usually only prescribed when Tetracyclines are ineffective (development of Oxytetracycline resistance) which is the component of the AFB risk highlighted in the risk assessment. Furthermore, relying on the simple benevolence of producers using antimicrobials prudently under the guidance of their veterinary authority does not provide scientific validation that proper label use of antibiotics is being exercised, nor does it provide assurance of freedom from AFB disease and resistant strains. The broad use of Tylosin provides an additional risk for increased and rapid development of antimicrobial resistance.

Regardless of rarity of AFB claim in Northern California, the magnitude of hive migration for California almond pollination cannot be dismissed as disbursement vector for AFB and resistant strains. Widespread use of tetracyclines (1st line antibiotics) not only favors the natural selection of resistant bacterial strain, but also diminishes the life expectancy of honey bees, causes disequilibria in the normal microbiota of the beehive and generates risk of honey contamination. Tetracyclines and Tylosin supress clinical signs of disease by controlling only the vegetative cell bacteria but have no effect on bacterial spores which continue to accumulate in the hive and remain infective for decades.

Furthermore, bypassing 1st line antibiotics(tetracycline) in favor of standardized use of alternative 2nd line antibiotics (Tylosin) seeds concern that the identified hazard of rAFBotc potentially has been achieved in northern California colonies. Jumping straight to 2nd line antibiotics will only further the development of additional resistance.

It is also important to point out, that many countries have prohibited the use of alternative antibiotics to curtail disease resistance and residue in food.

In Canada, Tylosin can only be used by prescription from a veterinarian in bee colonies with an active infection of American Foul Brood (AFB).

Certification of exporting apiaries on spore loads relative to threshold of 100 colony forming units (CFU) per bee has not been evaluated as a reference standard and is unsubstantiated scientifically. AFB spores are highly infectious, extremely resistant to desiccation and can remain viable for decades. Newly emerging larvae (12 to 36hrs after hatching) are the most vulnerable, with as few as 10 spores being sufficient to cause disease.

The CFIA agrees that all exporting apiaries testing positive for AFB spores for resistance to antibiotics (Tylosin, Lincomycin and including Oxytetracycline) should be failed. However, this mitigation measure alone does not provide protection against the pathogenesis of spore loads from sources colonies that have tested negative for resistance. Bacterial spores remain infective for years which can lead to AFB recurrence of the disease.

This is not a risk management option since it does not provide any construct of a risk mitigation measure that scientifically demonstrates how it could reduce risk levels of identified hazards to negligible level prior to entering Canada. It does not address hazard risks identified within the risk assessment nor meets the expectations outlined in the risk management framework document.

AFB - "Shaking packages: AFB is a brood disease, so when bees are shaken off of the comb, there is a significantly reduced risk of transferring AFB into the package. Part of process to produce package - inherent reduction in risk."

CFIA's response to the proposed measure

There is some validity that the level of bacteria and spores would be reduced when bees are shaken off the comb (in other words creating a shook swarm), and this reduction of infective components have been taken into account in the risk assessment (P4, page 43). However, the residual levels of infectious bacteria and spores remaining in the cohort of bees forming the package can still present a potentially high level of risk for disease transmission. As few as only ~ 10 AFB bacterial spores are sufficient to infect 0 to 3-day old larvae and cause disease. Spores proliferate rapidly in the larval mid gut which rapidly kills the larvae. From this, each dead larvae can contain 2500 million spores which become a tremendous and exponential source of disease propagation.

The risk assessment assumes that "if the presence of one of the hazards is known in a colony by the bee producer, bees from this colony will not be included in a package destined for export to Canada." The assessment also assumes regular and careful inspections of all brood frames in a hive. The wide variability in individual beekeeper perception, practice methods and knowledge would not provide assurance of conformity and compliance of sanitary practice which may cause some of the likelihoods to be underestimated.

The method does not provide any guaranteed assurance nor scientifically demonstrates how it could reduce risk levels of identified hazards to negligible level prior to entering Canada.

Transport methods: Queen should be shipped without honey in the feed to prevent the potential transmission of AFB and EFB.

All packages containing bees and queens will be made of new materials.

CFIA's response to the proposed measure

The industry practice is already reflected in the risk assessment which assumes that honey is not permitted as feed for the exportation of honey bee queens and that all containment vessels to export bees are required to be made of new material.

The proposal does not address the issues that honey bee packages present a higher risk of importing identified hazards than queens which was concluded in the hazard identification and risk assessment and also in the 2014 risk analyses as such risk mitigation measures are required to reduce risk level to negligible level of risk.

No scientific and comprehensive risk mitigation measure was provided to CFIA in this proposal.

Use of Dalan vaccine

CFIA's response to the proposed measure

The effectiveness of the vaccine is inconclusive. Although the vaccine provides hypothesis of concept, the only literature to date relates to isolated lab-controlled setting conducted by the manufacturer and the challenge with this technology is the lack of replicating proof of concept when testing in real / in the field settings. No unbiased third-party large-scale field studies have been conducted to support or discredit the company findings. Furthermore, there is no scientific evidence on the vaccine interaction in relation to different AFB strains and duration of immunity, as such, the vaccine does not scientifically demonstrate how it could reduce risk levels of identified hazards to negligible level prior to entering Canada nor its interaction efficacy regarding resistant AFB stains.

Propose evaluating the impacts of beekeeper practices on AFB transmission relative to queen breeding / producers actively selecting for hygienic behavior

CFIA's response to the proposed measure

What is being proposed is research/exploration of the transmission of AFB relative to beekeeper practices and not a risk mitigation measure. Therefore, studying producer practices in selecting for hygienic behavior in relation to AFB transmission is not a risk management option as it does not provide any construct of a risk mitigation measure that scientifically demonstrates how it could reduce risk levels of identified hazards to negligible level prior to entering Canada. It does not address the hazard risks identified (AFB and rAFBotc) within the risk assessment nor meets the expectations outlined in the risk management framework document.

American foulbrood – AFB resistance to oxytetracycline is already documented through Alberta (Bee Health Insurance Program, 2023), and Saskatchewan (Oleskii, et al., 2023). It is documented in the USA as well as Italy (Alippi, López, Reynaldi, Grasso, & Aguilar, 2007). Rotating alternative treatments through the implementation of BMPs through proper IPM is critical to prevent the development of AFB resistance to any one specific mode of action by a particular antibiotic.

CFIA's response to the proposed measure

Although integrated pest management (IPM) and best management practices (BMP) are strategies that should strongly be advocated to safeguard the Canadian bee population, the proposed measure relates to post importation strategies which fails to provide any comprehensive construct of a risk mitigation measure that scientifically demonstrates how it could reduce risk levels of identified hazards to negligible level prior to entering Canada (in the country of origin). Furthermore, the measure does not address the hazard risk's resistance component (rAFBotc) identified within the risk assessment nor adheres to the expectation outlined in the risk management framework document.

No additional supporting scientific and comprehensive risk mitigation measure was provided to CFIA.

The risk of U.S. honey bee packages is mitigated by established honey bee inspection programs in the 2 states most likely to be involved in package exports, California and Georgia. Colony health checks of producers by veterinarians or state inspectors is a routine component of U.S. beekeeping.

CFIA's response to the proposed measure

If the health status related to AFB was different for the state of California and Georgia, a zoning determination by USDA-APHIS would be required.

For the purpose if this process, the proposal did not provide nor define a rAFBoxy-free zoning proposal supported by the Competent Veterinary Authority (USDA-APHIS) for the referenced states of California and Georgia. No thoroughly detailed documentation of surveillance, control programs and biosecurity plans that scientifically differentiate the health status of the sub-population of a species within the exporting country has been provided within the proposal submission. In the absence of supporting scientific documentation regarding the frequency of inspections and comparison of compliance between states, the impact of extensive interstate migration of colonies for pollination, prophylactic use of antimicrobials and diagnostic screening and surveillance for resistance as such, the proposed measure fails to scientifically demonstrate how it could reduce the risk to negligible levels prior to importation.

No additional risk mitigation measure was provided to CFIA that scientifically demonstrates how the measure could reduce risk levels of identified hazards to negligible level as outlined in the expectation of risk mitigation in the risk management framework document.

Varroa resistant to amitraz (rVARam)

Varroa - Queen breeding / Management practices - Ongoing performance and evaluation of the benefits of this practice / Ongoing efforts and evaluation to determine best practices for managing varroa mite and reducing selection for resistance are ongoing.

CFIA's response to the proposed measure

What is being proposed is research/exploration of varroa management relative to queen breeding practices and not a risk mitigation measure. Therefore, studying producers ongoing performance of queen breeding and varroa management practices is not a risk management option as it does not provide any construct of a risk mitigation measure that scientifically demonstrates how it could reduce risk levels of identified hazards to negligible level prior to entering Canada. It does not address the hazard identified (rVARam) within the risk assessment nor meets the expectations outlined in the risk management framework document.

Although there continues to be ongoing research efforts to better understand varroa, its biological evolution, pathogenic impact, and new treatment alternatives, no additional mitigation measures are proposed beyond existing import conditions for queens.

The hazard identification and risk assessment determined that honey bee packages presented a higher risk of importing identified hazards than queen because they cannot be thoroughly inspected for the presence of hazards, which was also concluded in the 2014 risk analysis, therefore risk mitigation measures are required.

The proposal does not meet the criteria for being a risk mitigation option as outlined in the expectation for risk management. No scientific and comprehensive risk mitigation measure was provided to CFIA in this proposal.

Certify exporting apiaries to ensure mite levels are below an acceptable threshold -- For queen exportation from California, this is currently a 1% phoretic level and I recommend this remain in place for if package bees were to be exported.

Propose treating bees inside packages with an approved miticide. The treatment would need to be a miticide that would kill any potentially resistant mites, such as those resistant to amitraz, fluvalinate or coumaphos

Glycerol oxalic based pad or strip may be useful or a product containing active ingredients based on formic acid or thymol. Based on the volatility of these compounds, treatment for a short interval may be the only option available, with removal of the treatment device before shipping

CFIA's response to the proposed measure

The measure proposed is the existing import conditions for queens (requirement that varroa level must be below 1% within the colony). Queens are hand picked and can be inspected for presence of mites at caging time prior to shipping. Bees cannot be individually inspected in a package containing approximately 10 000 bees therefore the risk level of importing mites is far greater.

The suggested miticide treatment proposed (fipronil or coumaphos) would be an off-label use of a product in addition to being an in-transit treatment therefore not mitigating the hazard directly at the source prior to importation. Off-label treatments are usually prescribed by veterinarians on a case-by-case basis depending on professional diagnostics. Blanket standardization of off-label treatments would catalyze the development of resistance which is one of the risks identified in the RA. Furthermore, some of the suggested miticides (that is coumaphos) are toxic, have prolonged residual effects (that is residue accumulation) and have been proven to develop resistance rapidly with only a few treatments. As a result of the uncertainties surrounding off-label treatments, the measure fails to provide safeguards in preventing the development of resistance to miticides.

The suggested treatment proposed (glycerol oxalic base, formic acid or Thymol) would be an off-label use of a product. Off-label treatments are usually prescribed by Veterinarians on a case-by-case basis depending on professional diagnostics. Blanket standardization of off-label treatments would potentially promote the development of resistance which is one of the risks identified in the RA.

Although oxalic acid has demonstrated good efficacy for managing mites loads in honey bees, specific treatment recommendations are labeled accordingly to provide highest efficiency. Shortening treatment times, altering concentration levels of product, altering delivery mechanism of the treatment from what is recommended becomes an "experimental/trial" exercise.

As for Thymol, the label recommendation is for a 42-day treatment and requires specific prolonged ideal climate conditions (that is temperature dependent) for maximum efficacy. This has proved challenging as miticide treatment option and has resulted in significant variability in efficacy in many regions especially during fluctuation meteorological conditions.

As a result of the uncertainties surrounding off-label treatments, the measures fail to provide safeguards in preventing the development of resistance to miticides and do not scientifically demonstrate how they could reduce risk levels of identified hazards to negligible level nor meet the criteria of expectations risk mitigation the as outlined in the risk management framework document.

No additional risk mitigation measure was provided to CFIA that scientifically demonstrates how it could reduce risk levels of varroa to negligible level or address the issue surrounding rVARam prior to entering Canada.

Using amitraz resistance as a barrier to package importation is likely not justified. Also consider that varroa is regularly imported on attendant workers with queens from California.

Contends that varroa mites are in almost all areas from which packages are imported into Canada, and it is a well-established pest across Canada.

Amitraz resistance scenario status similar between Canada and US.

CFIA's response to the proposed measure

The statement that amitraz resistance is not a justifiable hazard by contending that varroa mites are regularly imported on attending workers with caged queens from California is unfounded.

The hazard identification and risk assessment clearly determined that honey bee packages (containing approx. 10 000 bees) present a higher risk of importing identified hazards than caged queens (1 queen with 2 to 6 attendants), as also corroborated in the 2014 risk analysis. As such, preventing the importation of a hazard that has been identified as being above the CFIA's acceptable risk level is not only justified, but also consistent with the CFIA's mandate under the Animal Health Act and regulations to protect animal health in Canada.

The CFIA acknowledges the referenced paper (Bahreini et al., 2025) published after the completion (fall 2024) of the hazard identification, risk assessment and risk management framework documents. However, the hazard identification document (p.76) did consider results related to the Y215H mutation associated with amitraz resistance in the US which has been found in Alberta on varroa mite samples collected from Alberta beekeeping operations during 2020 and 2022 (Bahreini, Personal communication, September 2023; CAPA, 2023 to 2024) . The recent findings of the referenced study (Bahreini et al., 2025), published after the completion of the risk assessment, are limited to isolated incidences in the province of Alberta and not widespread nationwide. Furthermore, the province of Newfoundland is currently free from varroa mites.

No actual risk mitigation measure is being proposed.