Questions and Answers - Working Residue Levels in Honey
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Q1. What is the Issue?
Some beekeepers have been using veterinary drugs in an extra-label manner (using drug products for purposes other than indicated on the label) to control certain honey bee diseases for which either there is no approved veterinary drug or the approved drug was no longer effective. When residues of these drugs are found in honey, the honey may pose a potential risk to human health and is in violation of the Food and Drugs Act and Regulations (FDA and FDR).
Drug manufacturers are reluctant to invest in new drugs for minor species, such as honey bees, because there is little, if any return on their costs for research and development. The current Canadian regulatory framework for drug approvals requires that adequate and complete data be provided for all drug submissions. Since there are very few products available anywhere in the world to treat honey bee diseases, there is no available data to inform such a review.
In light of the lack of available drugs, HC and CFIA have identified the requirement for a mechanism to address the honey industry's need for healthy bees while ensuring that honey, a widely-used product by Canadians, does not pose an undue risk to human health.
Q2. What are Maximum Residue Limits (MRLs) and Administrative Maximum Residue Limits (AMRLs)?
MRLs and AMRLs are levels of veterinary drug residues that could safely remain in the tissue or food product derived from a food-producing animal that has been treated with a veterinary drug. This residue is considered to pose no adverse health effects if ingested daily by humans over a lifetime.
The "A" in AMRL stands for Administrative. An AMRL means that the scientific evaluation and decisions are complete and that regulatory process to publish this information is in progress. Once the regulatory process is complete the AMRL becomes an MRL.
Q3.What are Working Residue Levels (WRLs)?
There are no special provisions under the FDAR for drug submissions for minor species (i.e., there are no MRLs for honey). It is for this reason that Health Canada reached an agreement with the CFIA to develop a policy on WRLs for antimicrobials, as well as an associated list of antimicrobials.
WRLs are recommended levels for drug residues in honey below which there is considered to be no undue risk to human health. The WRLs for honey have been derived by extrapolating from AMRL/MRLs for antimicrobials that are approved for use in other food-producing animals such as chickens, swine and cattle. The WRLs are set conservatively and are not intended to represent AMRL/MRL values in honey. Since WRLs for these drugs are not promulgated into the FDAR, they do not represent approval for use in beekeeping and must not be interpreted as an encouragement of their use.
The WRLs provide guidance to honey producers on residue levels which are deemed not to pose undue risk to human health. The WRLs also provide guidance to CFIA inspectors for their monitoring and compliance activities.
Q4. Who was involved in the process of developing the WRLs?
Health Canada and the CFIA consulted with representatives from the Canadian Honey Council and the Canadian Honey Packers and Dealers Association before the WRL policy and the associated list of antimicrobials was finalized.
Q5. Why are there so many antimicrobial drugs on the list?
Health Canada and the CFIA became aware, through CFIA's National Chemical Residue Sampling Plan, that various antimicrobials are being used in Canada and other countries in the production of honey and had concerns that certain residues of these antimicrobials could lead to a potential risk to human health risk.
Q6. What about honey imported from other countries that use drugs that are banned in Canada?
WRLs are not provided for banned drugs such as chloramphenicol or nitrofurans, since the use of these drugs in Canada is strictly prohibited. Any honey containing residues of banned drugs will not be allowed to be sold in Canada.
Q7. Why is the CFIA allowing WRLs?
In the area of food safety, Health Canada and the CFIA share unique and complementary roles and responsibilities for the safety of Canada's food supply. Health Canada is responsible for establishing policies, standards and regulations for health products and food while the CFIA is responsible for all food inspection, compliance and enforcement activities.
It is important to note that the WRL policy is not a regulation. The public can be confident that this policy does not comprise the safety of the food supply because residue levels in compliance with the WRLs do not pose an undue risk to human health. The CFIA will use the WRLs as guidance in determining the appropriate level of enforcement action including whether any product action is necessary (e.g., product recalls, detentions and seizures).
Q8. How should antimicrobial drugs be used to control honey bee diseases?
If antimicrobial drugs are required to control the spread of disease, honey producers should work with their provincial apiarist/veterinarian to ensure safe and appropriate use of these drugs.
Q9. Are there alternatives to antimicrobial drugs for the control of microbial honey bee diseases?
There are several non-chemical ways of controlling microbial diseases. Honey producers should work with their provincial apiarist/veterinarian to ensure safe and effective use of these methods.
Practicing hygienic management in beekeeping may help to prevent disease and may decrease the need for antimicrobial drugs.
Q10. Are these WRLs permanent?
The WRLs will be reviewed periodically to reflect new scientific information. The WRLs are subject to modification or cancellation (with notice given).
Q11. Will the CFIA continue to monitor honey?
Yes, the CFIA operates a National Chemical Residue Monitoring Program for honey as part of its food safety enforcement and compliance responsibilities.
Q12. What happens to honey that has residues above the WRL?
Honey that has residues above the WRL will be subject to a Health Risk Assessment by Health Canada. Subsequent action by the CFIA will be based on this assessment and could include detention, recall, stop sale, disposal, prosecution and in the case of imported honey, return to the country of origin.
Q13. What happens to honey that has detectable residues within the WRL?
When honey contains drug residues within the WRL, the producer/owner of the honey will receive a letter from the CFIA informing them of the residues that have been detected but that there is no undue risk to human health. The notification will also state that when the use of a veterinary drug not approved for use in beekeeping is required, it should only be administered under the guidance of a professional apiculturist/veterinarian to minimize or eliminate the presence of drug residues in honey.
Q14. Do the WRLs apply also to imported honey?
Imported honey is subject to the same WRL policy and regulatory requirements as domestic honey. The CFIA carries out regular monitoring to verify the compliance of imported honey to Canadian regulations. Importers are strongly encouraged to implement Good Importing Practices to ensure that imported honey is in compliance with Canadian regulations. Honey originating from countries with a known history of non-compliance is sampled by the CFIA more frequently than honey from other countries.
Q15. What concerns should honey exporters be aware of?
Exporters of honey are reminded that some countries have a zero tolerance for residues in honey and should be aware of the destination countries' regulations in this regard.
Q16. Can a person with allergies to antibiotics (sulfa, tetracycline etc.) still eat honey?
Yes, honey containing antimicrobial residues within the WRLs is considered by Health Canada not to pose an undue risk to human health. There have been no reports that honey with residues at these levels causes allergic reactions in humans. The antimicrobials on the WRL list are approved for use in other food-producing animals and permitted residue levels in meat, milk and eggs would result in higher exposure of consumers to their residues.
Q17. Are the WRLs, in honey higher or lower than the MRL/AMRL for the same residue in other foods?
The WRLs are lower because they are incorporating additional safety margins Since Health Canada does not have the data for use of these drugs in honey bees, these conservative safety margins ensure that there is no undue risk to human health.
Q18. Do other countries use WRLs?
WRLs are unique to Canada. However, many other countries use some type of limit or threshold to guide their enforcement procedures. Canada's WRLs are a more open and transparent version of action thresholds, which are usually not publicized by other countries.
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