What we heard report: Proposed new livestock feed ingredient – 3 Nitrooxypropanol (3-NOP)

Introduction

The Canadian Food Inspection Agency (CFIA) led a 30-day consultation on a new single ingredient feed (SIF) description for 3-Nitrooxypropanol (3-NOP) from November 16, 2023 to December 16, 2023.

The purpose of the consultation was to seek comments and feedback on the proposed addition of 3-NOP to the Canadian Feed Ingredients Table (CFIT) under Subclass 6.19.4 (Gut modifier ingredients: Ingredients for the mitigation of environmental impacts related to livestock production) of Class 6 (Non-nutritive ingredients) in part 1 of the CFIT.

A summary of the comments received during this consultation period is available below.

Background

The Feeds Regulations require a proponent to submit a pre-market application for SIFs that are new, have been modified such that they differ from an approved SIF, or are for a new purpose. The CFIA evaluates the information in the application to establish that the SIF is safe, effective, and labelled correctly. 

The CFIA completed a detailed evaluation of an application seeking approval for the use of 3-NOP as a component of gut modifier products in the total diet of dairy and beef cattle.  

The evaluation considered information related to:

• the safety of feeding this SIF to livestock with respect to animal health
• the safety of people who consume food derived from livestock that eat this SIF
• the safety of workers/bystanders exposed to this SIF
• environmental safety
• an evaluation of the fit-for-purpose and efficacy of this SIF for the intended livestock species

Following the evaluation, the CFIA consulted on the new description for 3-NOP.

What we heard

The CFIA received a total of 13 sets of comments and feedback from stakeholders during the 30-day consultation period from the following categories:

• 6 agricultural associations/groups
• 3 animal feed companies
• 3 individuals
• 1 Government of Canada department

The CFIA appreciates the feedback received on this consultation.

Comment: the majority of respondents provided their enthusiastic support for 3-NOP as a new tool with the potential to aid the beef and dairy cattle industries in achieving methane emission reduction goals and contributing to their ongoing methane reduction and sustainability efforts.

CFIA response: the enthusiasm from the beef and dairy cattle industries is welcomed. Once 3‑NOP is approved as a gut modifier ingredient for the mitigation of environmental impacts related to livestock production, it will allow for the registration of gut modifier products, a type of specialty feed, that contain 3-NOP as an active ingredient. Specialty feeds formulated with 3-NOP can be registered with claims once they have demonstrated efficacy specific to their formulation and directions for use.

Comment: some respondents requested clarification of the need for, and wording of, the following caution statement that is included in the proposed description and why it is for "male ruminants" instead of only "male cattle":

Caution: "Do not feed to male ruminants (for example, bulls, bucks, rams) intended for breeding. / Ne pas donner aux ruminants mâles (par exemple, taureaux, boucs, béliers) destinés à la reproduction."

CFIA response: some small editorial and translation adjustments to the caution statement have been made in the final SIF description found below. This caution is required because of a lack of safety information for male animals meant for breeding, specifically intact male ruminants. This is based on some findings in studies on the reproductive health of male laboratory mammals and related in vitro cell lines. It is important to know that despite not having enough information for these target animals, which limits the approval range, the information provided shows :

• no residue transfer concerns were identified for people consuming foods of animal origin (for example, milk and meat) from beef cattle (steers or heifers) and dairy cows fed 3-NOP
• no animal health or production issues were identified across the many studies provided for beef cattle (steers or heifers) and dairy cows fed 3-NOP

Intact male cattle intended for breeding are a very small proportion of the dairy and beef herd in Canada as dairy farms typically only keep heifers and cows, and most beef cattle operations are cows with calves, heifers and steers (castrated).

Although 3-NOP is not approved for all ruminants at this time, the CFIA opted to have the caution statement include "male ruminants intended for breeding" rather than "male cattle intended for breeding" to be clear that the animal health concern extends to all male ruminants intended for reproduction. Many feed mills manufacture livestock feeds for multiple species, and cattle feeds, such as supplements and premixes, are sometimes repurposed for use in feeds for minor ruminant species (for example, sheep and goats). A caution statement on the label of a SIF must be carried forward to the label of subsequent livestock feeds in which the SIF is used. Including all ruminants in the caution statement will ensure that any mixed feed that contains 3-NOP also carries the caution statement that it cannot be fed to male ruminants intended for breeding. This will help to prevent feeds containing 3-NOP from being inadvertently used for other ruminants. In addition, livestock feeds containing 3-NOP for species or classes of ruminants other than those approved in the SIF description would be considered non-compliant and subject to enforcement.

Comment: 1 respondent asked for clarification on the approved species and use rates for goats and sheep since maximum use rates were only provided for dairy and beef cattle, but the caution statement (discussed above) encompassed all ruminants.

CFIA response: at this time, 3-NOP is only approved as a component of gut modifier products for dairy cows and cattle for meat production, with the exception of bulls intended for reproduction. 3-NOP has not been approved for sheep or goats at this time. The CFIA evaluates new and amended SIFs based on the information supplied by the applicant. If a stakeholder would like a SIF approved for additional livestock species, they will need to submit an application to amend the SIF description. Refer to RG-1 Regulatory Guidance-Regulation of Livestock Feeds. The application must include data or information to support such amendments, including data to support any additional livestock species. It would follow the normal SIF approval process, including consultation.

Comment: 1 respondent asked for confirmation that the consumption of 3-NOP will have no impact on the individual cow's production ability or the quality, food safety or nutritional value of milk or milk products.

CFIA response: feeding 3-NOP to cattle did not adversely nor beneficially impact production performance parameters in dairy or beef cattle. The quality, safety and nutritional value of milk and meat derived from cattle fed 3-NOP were not adversely affected and deemed as safe and nutritious as those derived from cattle fed conventional diets.

Comment: 1 respondent asked if other sources of greenhouse gas emissions (for example, manure emissions) were considered in evaluating the environmental benefit of 3-NOP or just rumen methane emissions.

CFIA Response: the efficacy evaluation verified that 3-NOP has the potential to reduce rumen methane emissions. The impact that 3-NOP has on the net reduction of all greenhouse gas sources throughout production was out of scope for this evaluation and could vary with many factors.

Comment: 1 respondent was concerned about the word "potential" in the description.

CFIA response: this SIF is being approved as a component of a gut modifier product having the potential to reduce rumen methane emissions. Therefore, 3-NOP is not intended to be fed on its own. The ability and extent of a gut modifier product containing 3-NOP to reduce rumen methane emissions will depend on how it is fed (in other words, added in total mixed rations). Companies must demonstrate the efficacy of their individual gut modifier product formulations containing 3-NOP and proposed directions for use (for example, rates and timing) for feeding before registration.

Comment: 1 respondent asked if the methane reduction was due to reduced feed intake or 3-NOP. They indicated that studies they had seen showed that feed intake was reduced by supplementation of 3-NOP and had no benefit in livestock production parameters and questioned the benefit to producers. They further stated that if this is forced on producers, it would be a tax on the beef industry.

CFIA response: efficacy studies did not demonstrate any adverse or beneficial impact of feeding 3-NOP to production performance parameters including feed dry matter intake. As such, the potential to reduce rumen methane emissions was not attributed to a reduced feed intake. While no production benefits were found, 3-NOP is an optional tool available to producers for reducing rumen methane emissions and can be used in addition to other strategies to help mitigate greenhouse gas emissions.

Comment: 1 respondent asked if ionophores would be able to get the same claim as 3-NOP.

CFIA response: The scope of the application was limited to 3-NOP. The CFIA did not evaluate the efficacy or safety of ionophores, a class of veterinary drugs, for the purpose of reducing rumen methane emissions.

Comment: 1 respondent asked that the CFIA provide the data submitted in the application package to determine if they had additional scientific data the CFIA should consider.

CFIA response: the CFIA will not provide data to respondents as part of the consultation process. The CFIA will review any information received during the consultation. If a stakeholder believes they have relevant information related to the safety or efficacy of the SIF within the scope of the proposed description (for example, species and class of livestock), they should submit this information with context for review.

Comment: 1 respondent commented that adding chemicals for this purpose to livestock feeds is greenwashing the cattle production industry, which is destroying forest, prairie and wetland ecosystems, and that the only environmentally friendly diet is a vegan one.

CFIA response: beef and dairy cattle production provide safe and nutritious sources of nutrients, including protein, vitamins and minerals, to the food supply. Canadians are free to choose the diets they consume. 3‑NOP is an optional tool with the potential to aid the beef and dairy cattle industries in their ongoing methane reduction and sustainability efforts.

Final SIF description

Following the CFIA's evaluation and determination of the safety and efficacy of this SIF, and since no significant concerns were raised during consultation, the CFIA has finalized the SIF description and has approved the use of 3-NOP with the following description:

This new description will be added to the CFIT at the next update.

Next steps

The CFIA would like to thank everyone who participated in the consultation process for contributing their time and sharing their views.

We are committed to reviewing any new scientific information on the safety of any SIF. Anyone who becomes aware of new scientific information respecting the safety of 3-NOP is encouraged to contact the CFIA.

This new SIF (with the finalized description above) will be added to the CFIT at the next update, following the publication of the proposed Feeds Regulations, 2024.

Related information

• Feeds Regulations
• Feeds Act
• Consultations on proposed regulatory and policy changes
• Proposed new livestock feed ingredient – 3-Nitrooxypropanol (3-NOP): Closed Consultation
• Notice to industry: Consultations on new or amended single ingredient feed descriptions

Contact us

Animal Feed Program (AFP)
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario K1A 0Y9
Email: cfia.afp-paa.acia@inspection.gc.ca