Regulation - LGIC
Proposed Repeal of the Livestock Medicines Act and Replacement with Streamlined Regulation under the Animal Health Act, 2009 to continue the sale of designated livestock medicines in licensed Livestock Medicines Outlets
Regulation Number(s):
730
950
950
Instrument Type:
Regulation - LGIC
Bill or Act:
Livestock Medicines Act, Animal Health Act, Provincial Offenses Act, Better Serving People and Facilitating Business Act
Summary of Decision:
As part of regulatory burden reduction and to ensure uninterrupted licensing of Livestock Medicines Outlets:
- Section 14 and subsection 9(3) of Schedule 3 to the Better for People, Smarter for Business Act, 2019 has been proclaimed to repeal the Livestock Medicines Act (LMA) and amend the Animal Health Act, 2009 (AHA);
- Regulation 730 under the LMA has been revoked and replaced with new regulations 1) Licenses to Sell Livestock Medicines; 2) Livestock Medicines under the AHA; and
- Schedule 63.0.2 in Regulation 950 - Proceedings Commenced by Certificate of Offence, under the Provincial Offences Act has been revoked (as a consequence of revoking Regulation 730 under the LMA).
Regulatory changes include:
1. Simplified licensing:
a) Ask for a one-time permanent licence with no licensing fee for LMOs. Any person holding a licence to sell livestock medicines under the LMA on January 1, 2021 will receive a permanent licence based on the information they provided in the most recent licence application, which is 2018 for most businesses.
b) Removed requirements for a temporary LMO licence. A holder of a permanent licence can sell at multiple temporary locations as long as they display a copy of their permanent licence (e.g., shows, etc.) and over the internet, a copy of their permanent licence number must be displayed.
2. Removed requirements that
- Address content that is substantially addressed by existing federal requirements (e.g., advertising with respect to livestock medicines by a licensee).
- Are prescriptive and replace them with outcome-based. For example: conditions of sales (e.g., temperature controls, storage conditions etc.) and recordkeeping requirements.
- No longer needed in regulations since they already exist in the Animal Health Act (AHA), 2009. For example, procedures for when an inspector seizes, removes or detains any livestock medicines. The AHA already has inspector powers and allows for progressive compliance.
- Section 14 and subsection 9(3) of Schedule 3 to the Better for People, Smarter for Business Act, 2019 has been proclaimed to repeal the Livestock Medicines Act (LMA) and amend the Animal Health Act, 2009 (AHA);
- Regulation 730 under the LMA has been revoked and replaced with new regulations 1) Licenses to Sell Livestock Medicines; 2) Livestock Medicines under the AHA; and
- Schedule 63.0.2 in Regulation 950 - Proceedings Commenced by Certificate of Offence, under the Provincial Offences Act has been revoked (as a consequence of revoking Regulation 730 under the LMA).
Regulatory changes include:
1. Simplified licensing:
a) Ask for a one-time permanent licence with no licensing fee for LMOs. Any person holding a licence to sell livestock medicines under the LMA on January 1, 2021 will receive a permanent licence based on the information they provided in the most recent licence application, which is 2018 for most businesses.
b) Removed requirements for a temporary LMO licence. A holder of a permanent licence can sell at multiple temporary locations as long as they display a copy of their permanent licence (e.g., shows, etc.) and over the internet, a copy of their permanent licence number must be displayed.
2. Removed requirements that
- Address content that is substantially addressed by existing federal requirements (e.g., advertising with respect to livestock medicines by a licensee).
- Are prescriptive and replace them with outcome-based. For example: conditions of sales (e.g., temperature controls, storage conditions etc.) and recordkeeping requirements.
- No longer needed in regulations since they already exist in the Animal Health Act (AHA), 2009. For example, procedures for when an inspector seizes, removes or detains any livestock medicines. The AHA already has inspector powers and allows for progressive compliance.
Analysis of Regulatory Impact:
- This change does not impact livestock owners' access to designated livestock medicines. The sale of livestock medicines by Livestock Medicines Outlets continue to be exempt from the pharmacy requirements in the Drug and Pharmacies Regulation Act where the outlet is licensed under the Livestock Medicines Act.
- This regulatory amendment does not impose any upfront or ongoing operating costs to businesses, Ontarians or the government.
- As a result of these regulatory changes, it is estimated that the quantitative net benefit for the regulated sector would be up to $1.47M at a discounted rate over a ten-year period using a discount rate of 2.5%. For example, licensees no longer need to pay a licence fee, spend time and money to renew licence annually and they no longer need to apply and pay a fee for a temporary licence. In addition to direct savings related to licencing fees and reduced record keeping requirements, licensees will be able to sell designated livestock medicines online.
- This regulatory amendment does not impose any upfront or ongoing operating costs to businesses, Ontarians or the government.
- As a result of these regulatory changes, it is estimated that the quantitative net benefit for the regulated sector would be up to $1.47M at a discounted rate over a ten-year period using a discount rate of 2.5%. For example, licensees no longer need to pay a licence fee, spend time and money to renew licence annually and they no longer need to apply and pay a fee for a temporary licence. In addition to direct savings related to licencing fees and reduced record keeping requirements, licensees will be able to sell designated livestock medicines online.
Further Information:
Appendix A: Regulation 730 Burden Reduction Comparison Chart of Key Proposed Regulatory Changes
(Download Adobe Reader)
Proposal Number:
19-OMAFRA001
Posting Date:
January 22, 2019
Summary of Proposal:
As part of its red tape and regulatory burden reduction actions, Ontario proposes to modernize oversight of designated livestock medicines while maintaining rules that support animal and public health. Specifically, OMAFRA is proposing a new regulation under the Animal Health Act, 2009 (AHA) which would replace the existing Regulation 730 and the Livestock Medicines Act (LMA).
The goal of the proposal is to protect animal health and ensure livestock owners have ongoing access to designated, non-prescription livestock medicines, while reducing administrative burden and simplifying rules for Livestock Medicines Outlets (LMOs).
As of December 1, 2018, based on the changes by Health Canada, medically important antimicrobials are no longer designated livestock medicines and the LMA now governs a smaller segment of lower-risk, non-prescription livestock medicines. The current level of regulation of LMOs is no longer warranted relative to the risk of the designated livestock medicines.
For over 60 years, the LMA has permitted Livestock Medicines Outlets (LMOs) to be licensed under the LMA and to sell designated livestock medicines to livestock owners. These sales by LMOs are exempt from the Drug and Pharmacies Regulation Act (DPRA).
However, both the LMA and Regulation 730 are outdated, and in some instances, duplicative, with requirements that create burden without a risk mitigation objective and are not reflective of the current business environment (e.g., online sales).
The new regulation under AHA would include:
1. Transfer of the December 1, 2018 updated list of lower-risk designated non-prescription livestock medicines (current section 2 in Reg 730), to the new regulation in its entirety.
2. Simplified licensing requirements that would:
a. Include a one-time permanent licence with no licensing fee for LMOs. Current business operators would receive a permanent licence based on the information they provided in the 2018 licence application (i.e. current licensees would be 'grandfathered' into the new licensing scheme).
b. Remove requirements for a temporary LMO licence; a holder of a permanent licence would be allowed to sell at multiple temporary locations (e.g., shows, competitions, etc.,) and over the internet, as long as they display a copy of their permanent licence, or the licence number if online.
3. Removal of all of the current requirements that are prescriptive or overlap with the existing federal requirements. Examples include storage and temperature requirements, expired products, etc.
4. Removal of some requirements that are no longer needed, for example, procedures for when an inspector seizes, removes or detains any livestock medicines. The AHA already has inspector powers and allows for progressive compliance.
5. No provision for the re-establishment of the current Livestock Medicines Livestock Advisory Committee. There are more effective mechanisms to seek stakeholder input.
Please see the attached summary table of proposed regulatory changes.
We encourage stakeholders to provide feedback on these proposed changes during the consultation period.
The goal of the proposal is to protect animal health and ensure livestock owners have ongoing access to designated, non-prescription livestock medicines, while reducing administrative burden and simplifying rules for Livestock Medicines Outlets (LMOs).
As of December 1, 2018, based on the changes by Health Canada, medically important antimicrobials are no longer designated livestock medicines and the LMA now governs a smaller segment of lower-risk, non-prescription livestock medicines. The current level of regulation of LMOs is no longer warranted relative to the risk of the designated livestock medicines.
For over 60 years, the LMA has permitted Livestock Medicines Outlets (LMOs) to be licensed under the LMA and to sell designated livestock medicines to livestock owners. These sales by LMOs are exempt from the Drug and Pharmacies Regulation Act (DPRA).
However, both the LMA and Regulation 730 are outdated, and in some instances, duplicative, with requirements that create burden without a risk mitigation objective and are not reflective of the current business environment (e.g., online sales).
The new regulation under AHA would include:
1. Transfer of the December 1, 2018 updated list of lower-risk designated non-prescription livestock medicines (current section 2 in Reg 730), to the new regulation in its entirety.
2. Simplified licensing requirements that would:
a. Include a one-time permanent licence with no licensing fee for LMOs. Current business operators would receive a permanent licence based on the information they provided in the 2018 licence application (i.e. current licensees would be 'grandfathered' into the new licensing scheme).
b. Remove requirements for a temporary LMO licence; a holder of a permanent licence would be allowed to sell at multiple temporary locations (e.g., shows, competitions, etc.,) and over the internet, as long as they display a copy of their permanent licence, or the licence number if online.
3. Removal of all of the current requirements that are prescriptive or overlap with the existing federal requirements. Examples include storage and temperature requirements, expired products, etc.
4. Removal of some requirements that are no longer needed, for example, procedures for when an inspector seizes, removes or detains any livestock medicines. The AHA already has inspector powers and allows for progressive compliance.
5. No provision for the re-establishment of the current Livestock Medicines Livestock Advisory Committee. There are more effective mechanisms to seek stakeholder input.
Please see the attached summary table of proposed regulatory changes.
We encourage stakeholders to provide feedback on these proposed changes during the consultation period.
Contact Address:
Vicky Grahovac
Food Safety and Environmental Policy Branch, OMAFRA
1 Stone Road West; 2nd Floor SW
Guelph, ON
N1G 4Y2
Food Safety and Environmental Policy Branch, OMAFRA
1 Stone Road West; 2nd Floor SW
Guelph, ON
N1G 4Y2
Effective Date:
January 1, 2021
Decision:
Approved