Proposed new livestock feed ingredient – 3-Nitrooxypropanol (3-NOP): Closed Consultation

About the consultation

The Canadian Food Inspection Agency (CFIA) was seeking comments on the following proposed new single ingredient feed (SIF) description for 3-nitrooxypropanol (3-NOP).

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.

Approved SIFs are currently listed and defined in Schedules IV and V of the Feeds Regulations, with appropriate guarantees, standards, and labelling requirements. The CFIA will be transitioning to the Canadian Feed Ingredients Table (CFIT) that will be incorporated by reference into the Feeds Regulations, 2024 when they come into effect. In preparation for this new approach, the CFIA is consulting on new or amended SIFs so they can be added to the CFIT once it comes into effect. More information on this is available in the Notice to industry: Consultations on new or amended single ingredient feed descriptions.

About the evaluation

The CFIA's Animal Feed Program has completed a detailed evaluation of an application for the approval of a new SIF: 3–nitrooxypropanol (3-NOP), which reduces rumen methane emissions when used as a component of a gut modifier product for cattle.

The evaluation considered information related to:

• the safety of feeding this SIF to livestock with respect to animal health
• the safety of foods derived from livestock that eat this SIF
• the safety of workers/bystanders exposed to this SIF
• environmental safety and reduction of methane emissions
• an evaluation of the fit-for-purpose and efficacy for this SIF, for the intended livestock species

The results of the CFIA's evaluation of available scientific data supports the safety and efficacy of 3-NOP and its intended purpose to reduce rumen methane emissions from cattle when used as a component of gut modifier products.

Therefore, the CFIA recommends 3-NOP be approved as a new SIF and added to the CFIT, accordingly.

Proposed SIF description

The CFIA intends to add 3-NOP to the CFIT under the renamed 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 with the following description:

3-Nitrooxypropanol (or (3-NOP) or 3-hydroxypropyl nitrate)

is 3-hydroxypropyl nitrate, generally expressed as HOCH₂CH₂CH₂ONO₂, and having the CAS# 100502-66-7. This ingredient has the potential to reduce rumen methane emissions from cattle and is approved for use as a component of gut modifier products for cattle. This ingredient is approved for use at an amount not to exceed 100 mg/kg of the total diet on a dry matter basis for dairy cows and 200 mg/kg of the total diet on a dry matter basis for cattle for meat production.

It shall be labelled with the following statements:

"This ingredient has the potential to reduce rumen methane emissions from cattle and is approved for use as a component of gut modifier products at an amount not to exceed 100 mg/kg of the total diet on a dry matter basis for dairy cows and 200 mg/kg of the total diet on a dry matter basis for cattle for meat production.

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. »

It shall be labelled with a guarantee for minimum percent 3-nitrooxypropanol.

An ingredient number will be assigned at the time the SIF is added to the CFIT.

Additional information

3-NOP is obtained through chemical synthesis, and it is not anticipated that there would be concerns arising from differing sources of this SIF. Therefore, this SIF is to be placed into part 1 of the CFIT.

This SIF has the potential to reduce rumen methane emissions when fed to cattle and is approved as a component of gut modifier products. These gut modifier products are then formulated with other SIFs and mixed feeds and incorporated on the farm in the total mixed ration (TMR) for cattle.

3-NOP specifically targets methyl-coenzyme M reductase (MCR) in rumen methanogenesis and inhibits the growth of methanogenic archaea at concentrations that do not affect the growth of non-methanogenic bacteria in the rumen. Therefore, it has the potential to reduce rumen methane (CH₄) produced during fermentation of livestock feed in the rumen. No negative impacts of the use of 3-NOP were observed on rumen microbial population, rumen pH, dry matter intake, fibre digestion or production, when fed to cattle. Note that there is a caution statement (to address animal health concerns) in the description that indicates that this SIF is not to be fed to male ruminants intended for breeding.

Who was the focus of this consultation

Animal feed stakeholders, including:

• suppliers of feed ingredients
• commercial feed manufacturers
• feed importers, distributors and retailers
• industry associations
• other government departments
• international trading partners
• veterinarians

All comments were welcome from industry, governments, the public, or other organizations or individuals.

How to participate

The CFIA is seeking feedback on the proposed description for 3-NOP.

Stakeholders were encouraged to share comments if there was:

• concerns about the accuracy of SIF description
• additional scientific data that should be considered before the SIF is approved

Scientific questions or information will be reviewed by the CFIA evaluators for consideration in the assessment. Non-scientific input will be evaluated and appropriate ways of addressing it will be explored.

Comments can be sent by email to the Animal Feed Program at cfia.afp-paa.acia@inspection.gc.ca. Please use "3-NOP" in the subject line of the email. The CFIA was asking for comments and feedback by [December 16, 2023], 30 days from the date of this posting.

Next steps

The CFIA will review all of the comments received, if no significant scientifically valid concerns are raised, the CFIA will finalize the approval of 3-NOP and issue the approval to the applicant. If there are significant concerns raised, the CFIA will evaluate the additional information and may, subject to the commenters consent, forward the comments to the applicant for their response. A what we heard report that summarizes the feedback received will be published.

The SIF will be added to the CFIT at the next update, following publication of the Feeds Regulations, 2024.

Related information

• Feeds Regulations
• Feeds Act
• Consultations on proposed regulatory and policy changes
• 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