What we heard report – Consultation on the proposed Feeds Regulations, 2022, Canada Gazette Part I

Comments related to how documents incorporated by reference (IBR) will be updated

The CFIA will be providing specific guidance as it relates to the process for updating the 9 IBR documents, including how often they will be updated, at the time of publication in CGII. The CFIA is committed to the principles of accessibility, transparency, consistency, reasonableness, and clarity when using IBR in regulations. The CFIA Incorporation by Reference Policy sets out the CFIA's roles and responsibilities related to IBR. This includes, public consultation for any changes to the IBR documents. Any changes made to these IBR documents, whether changing the maximum levels for contaminants or nutrients or adding a new or modified SIF description to the Canadian Feed Ingredients Table (CFIT), will be consulted on before the change is made.

Comments related to which permissible claims are found in the IBR document and how to add other claims to this document

The CFIA received a number of comments on the Tables of Permissible Claims for Feed Labels IBR document with respect to what claims are found in the proposed IBR document and how to add other claims to the document. The CFIA will be working with interested stakeholders to ensure the permissible claims and the conditions for the feed and label are relevant for that particular claim. The CFIA has clarified that a livestock feed label can contain more than 1 permissible claim.

Additional details on the frequency of updating this document and process of adding a permissible claim will be included in the guidance document on updating IBR documents. At the time of CGII, the list of permissible claims allowed on livestock feed labels will be relatively small with opportunities for the list of permissible claims to be expanded over time.

Comments related to the bilingual labels

Stakeholders raised concerns that the requirement for bilingual labelling is challenging and will result in additional information to be included on the label. In addition, stakeholders requested other ways to provide the information (for example, QR codes, bar codes). Bilingual labelling is a requirement under the Official Languages Act (OLA). In accordance with the OLA, health and safety information must be provided in both official languages. To meet these requirements, the new regulations will require that health and safety information appear on the principal display panel of livestock feed labels. It may not be provided separately or in another format. To help stakeholders meet this requirement, most of the information that will be required in both languages can be found in the CFIT, the Compendium of Medicating Ingredients Brochures (CMIB) or in guidance provided by the CFIA. In addition, the regulations provide some flexibility with respect to labelling and do not require certain label information such as directions for use, guaranteed analysis statements and lists of ingredients to be provided on the principal display panel.

Comments related to feeds for horses not intended for human consumption. Stakeholders suggested that these should be exempt from the proposed regulations, and that horse feeds should not require record keeping.

Horses are considered livestock species and their feed is regulated under the current and proposed regulations. Differentiating feed for horses intended for human consumption or not intended for consumption would be challenging and complex. The CFIA is recommending that there be no exemptions for horse feeds in the proposed regulations. This would be consistent with the regulatory requirements for all livestock species, there would still be controls in place for all horse feeds, and it recognizes that many horses can enter the feed and food chains. Under the proposed regulations, most standard horse feeds (for example, complete feeds and supplements) will be exempt from registration, but will still need to meet standards for safety and labelling.

The CFIA is recommending changes to the record-keeping requirements for complete feeds, supplements and treats for horses in packages of 25 kg or less. Sales records will not need to be kept for these types of horse feeds. These feeds are often sold for horses that are being kept as pets or for show and which are not intended for human consumption. These changes maintain important safety and consumer protection components of the regulations, while addressing some of the concerns received from retailers about keeping sales records for livestock feeds that are not typically fed to animals intended for human consumption.

Comments related to the proposed maximum level of zinc allowed in feed for starter swine and how this does not align with industry practices

The CFIA, Health Canada, as well as the feed and swine industries have been involved in discussions on this issue. The CFIA is working on a policy that will provide more details on an approach to provide some flexibility. It is proposed that a phasing out approach will be used that will allow stakeholders to continue using the current zinc levels for a period of time. This phasing out approach allows stakeholders time to explore alternative options, including changes to their management practices or pursuing a pathway for access to alternative drug products with Health Canada.

Comments related to the regulatory requirement for Salmonella

Stakeholders commented on the outcome-based requirement that livestock feeds may not contain bacteria of the genus Salmonella that present a risk of harm to human or animal health. They were seeking further clarification on what this requirement means.

The CFIA has been working on guidance respecting prevention, control and mitigation of Salmonella in livestock feeds. This guidance will provide stakeholders with additional information on how to comply with the regulatory requirements for Salmonella in livestock feeds.

Comments related to the appropriateness of the methods the CFIA used to set levels that ensure feed safety. More specifically, the levels set for dioxins in livestock feeds and whether the proposed regulations are based on science and whether the levels set for contaminants will create barriers in marketplace access.

The maximum levels set for dioxins and other contaminants in livestock feed in the proposed IBR document (Tables of Maximum Contaminant Levels in Feeds) are based on science in which a risk assessment approach was used. The maximum levels for dioxins were established to limit dioxin accumulation in foods of animal origin, thereby reducing human exposure. The CFIA's goal in setting the standards for dioxins in SIFs is to continually reduce unnecessary sources of contaminants in livestock feeds and, in turn, food. Recently, the Government of Canada has published a report on the Performance Measurement Evaluation for Risk Management of Dioxins and Furans, which states having controls in place for livestock feed, along with other actions, can help reduce human exposure to these contaminants. This regulatory objective aligns with that of international food safety and animal health bodies, such as the Codex Alimentarius Commission (CAC/RCP 62-2006), the World Organisation for Animal Health (Chapter 6.4 WOAH Terrestrial Animal Health Code), the Food and Agriculture Organization of the United Nations (FAO 2008), and the World Health Organization (WHO 2016 Dioxins and their effects on human health).

The maximum contaminant levels are set out in an IBR document. This means that these levels can be updated in a more timely manner as new scientific literature becomes available. As mentioned above, a process and timelines for updating IBR documents will be published to help stakeholders navigate requesting changes when new information becomes available.

Comments related to the feed type definitions and clarity on what requires registration under the proposed regulations

The CFIA received comments on the definitions for certain feed types, including the definitions for mineral feed, premix, supplement and specialty feed. Comments were also provided on the content of a mixed feed as well as the content of a mineral feed and premix (that is, Section 37 to 39) of the proposed regulatory text.

The CFIA has reviewed the comments received during the CGI consultation and intends to update some of the definitions to reflect the feedback received.

• complete feed – minor changes to better clarify the definition
• mineral feed – clarify that it is predominately minerals but may contain other ingredients
• premix – clarify that this feed type is a source of nutrients but may contain other ingredients
• speciality feed – clarify that a specialty feed may contain ingredients that do provide some nutritional value and ensure all of the appropriate technical functions are included in the definition

Some additional revisions to the standards for certain feed types and the related IBR document (Tables of Nutrient Guarantees and Conditions for Feed Labels) may also be required.

This will help clarify how each of the different feed types are defined. Additional guidance at the time of publication in the CGII will help stakeholders understand how these feed types work together and what they mean from a registration perspective.

Comments related to feed manufacturers providing the list of ingredients upon request

Stakeholders indicated that the requirement to provide the list of ingredients upon request would be burdensome and may impact proprietary formulations. The CFIA recognizes some of these concerns and intends to update the requirement. It is intended that the list may only be requested by a purchaser of the livestock feed, and that businesses will have 5 business days to provide that list. This would help to ensure that customers have access to the list of ingredients used in livestock feeds and continue to support consumer protection. However, feed manufacturers are encouraged to provide the list of ingredients on the livestock feed label or upon request to anyone who requests it.

Comments related to the guaranteed amount being within 10% of the actual amount found in the feed (Section 54)

The CFIA intends to remove Section 54 from the regulatory text. Guarantees on livestock feed labels must be accurate and when a minimum or maximum is guaranteed, it should reflect the composition of the livestock feed. It is important to understand that over-formulating or under-declaring the vitamin or mineral levels in SIFs, premixes or supplements may result in issues as these feed types are used to formulate subsequent livestock feeds. The CFIA will provide further guidance on labelling livestock feeds and may provide further guidance on guaranteed actual amounts compared to guaranteed minimum or maximum amounts.

Comments related to the period for which records need to be kept or retained and ability to keep electronic records instead of paper-based ones

After further consideration of the implications of the proposed 3 year record retention period, it is anticipated that such period will be amended to 2 years. Records may be kept as physical records or electronically. Regardless of the format, records must be made available to inspectors upon request. If records are kept electronically inspectors may require access to the electronic system.

In addition, based on feedback from stakeholders about challenges for smaller feed businesses, the CFIA intends to update the record keeping requirement for retail sales to indicate that the lot number does not need to be recorded. This will allow flexibility for businesses where the livestock feed may be paid for in one part of the facility and loaded into the customer's vehicle in another part. However, the CFIA encourages businesses to record lot numbers wherever possible. If lot numbers are not recorded, the scope of a recall may be much larger and impact more customers as it may not be possible to determine exactly who received the impacted lot.

Comments related to the new PCP requirements. Feed businesses that have implemented other quality systems are concerned about the need to develop and implement a whole new program to comply with the PCP requirements within proposed Feeds Regulations.

In addition, feed operators are concerned about the expenses involved in implementing new PCP requirements especially building design, washing trailers, and hiring new staff.

Operators are responsible for developing, implementing and maintaining measures to achieve compliance with the regulatory requirements outlined in the proposed Feeds Regulations, including PCP requirements. The new PCP requirements can be met by developing and implementing new operational measures, improving existing ones, or adopting those already in place as they are. It is the operator's responsibility to assess that new, improved or existing measures bring their operations into compliance with the proposed regulations. If an operator already has a HACCP or other feed safety program in place, they will need to review their existing program to ensure it meets the outcomes described in the Feeds Regulations. If it does, no additional changes will be needed.

The CFIA recognizes that there will be additional costs associated with these regulatory changes and has outlined those in the regulatory impact analysis statement that was part of the CGI consultation. However, it is not anticipated that operators will need to build new facilities or purchase new equipment. Operators are expected to ensure that existing facilities and equipment prevent, eliminate or reduce to an acceptable level any risk of contamination of the livestock feed. Operators may opt for using a combination of existing infrastructure, newly introduced design features, and innovative measures that would bring their operations into compliance with those PCP requirements. The CFIA appreciates the feedback on these components and would like to clarify that the elements that must be a part of a PCP are linked to where there is a risk of contamination of a livestock feed. For example, if a facility does not use any water in the manufacture of their livestock feed there is no need to have any controls related to water quality or safety.

Comments related to regulatory requirements for on-farm feed mills and whether these regulatory requirements will meet existing on-farm food safety programs

The new requirements respecting hazard analysis and preventive control plans will apply to farms that manufacture medicated feed or farms that sell feed. The CFIA recognizes that many farms are already part of an on-farm food safety program that includes hazard analysis and preventive control plans for many aspects of food safety. The CFIA heard from many of the producer groups that they would like to work with the CFIA to review whether the existing food safety programs would also address the new feed safety requirements. The CFIA looks forward to working with these organizations to help ensure producers are able to meet the feed safety requirements.

Comments related to the licensing requirements

Stakeholders requested clarification on a number of items related to licensing including whether each facility needs a licence, and if inspections will be required. The CFIA intends to provide additional guidance on livestock feed licences before the new licensing requirement comes into effect.

The new regulations will require facilities that perform prescribed activities with prescribed feeds to have a licence. Flexibility is provided to allow feed businesses to decide if they would like 1 licence that covers all of their facilities and activities or multiple licences that cover multiple prescribed activities in multiple facilities. Feed businesses can choose the approach that best suits their needs and their business.

Once the proposed Feeds Regulations come into force, the CFIA anticipates that an inspection prior to issuing an initial livestock feed licence will not be required. However, the CFIA does have the authority to conduct an inspection prior to issuing or renewing a licence. Future program development may set up criteria for when an inspection would be required. Guidance on when an inspection is required would be communicated before implementing that requirement.

At this time, the CFIA estimates that the holder of a Safe Food for Canadians Regulations (SFCR) licence will still need a livestock feed licence. However, the CFIA will explore options for combining food and livestock feed licences in the future.

Comments related to whether an exporter who needs an export certificate or other document issued for a livestock feed to be exported will have to have a licence

A number of comments were received indicating that additional CFIA support for export and market access would be beneficial. A licence will be required to conduct prescribed activities (manufacturing, storing, processing, packaging, labelling and selling) with a livestock feed that is to be exported. Regardless of whether the exporter needs a certificate or other document for a livestock feed that is being exported, the exporter will need a licence. However, the livestock feed does not have to meet all of the Canadian requirements and may instead meet the requirements of the importing country.

Comments related to Administrative Monetary penalties (AMPs) under the proposed Feeds Regulations

At this time the Feeds Act and regulations are not included in the Agriculture and Agri-Food Administrative Monetary Penalties Act (AAMPA) and regulations. The CFIA may issue administrative monetary penalties (AMPs) as notices of violation with warning or financial penalty, depending on the nature of the violation, as an enforcement measure for acts and their associated regulations that are listed in the AAMPA and regulations.

After publication of the Feeds Regulations in CGII, the CFIA will further consult with stakeholders on AMPs. This will include more information on which provisions in the Feeds Act and regulations that AMPs could be applied to. AMPs will not be used prior to consultation and amendments to the AAMP regulations.

Comments related to guidance materials for Canada Gazette, Part II (CGII) publication

The CFIA appreciates the offer from multiple stakeholders to work with us on guidance materials in support and implementation of the proposed Feeds Regulations. In the near future, the CFIA will be reaching out to stakeholders to determine the best way to engage with various groups on the development of guidance materials. The CFIA anticipates that industry guidance will be published in phases to align with when the provisions come into effect. Initial guidance materials will focus on the provisions that come into effect at the time of publication in CGII. This includes approval and registration provisions as well as labelling, and general and safety standards. For the labelling and standard provisions, there is a transition period of up to 1 year to allow stakeholders to follow the former regulations or the new regulations.

More detailed guidance materials related to PCPs and licencing will follow later when the provisions come into effect, so 12 months and 18 months after CGII publication, respectively. The CFIA will be providing some guidance related to PCPs and licencing at the time of CGII publication.

With regards to questions and comments related to service standards, these will be developed through a consultation process with interested stakeholders. The CFIA will be undertaking a review of its service standards for livestock feed in the future. It is important to note that no service standards will be placed in the regulatory text, but will be placed into policy instead.