RG-1 Regulatory guidance:
Chapter 2 - Data requirements for single ingredient approval and feed registration
2.9 Data flexibility for production performance endpoints and associated claims

The CFIA is introducing flexible approaches to the data required to fulfill the efficacy portion of a pre‑market submission. This guidance explains the flexibility being allotted with regards to the studies required to support production performance claims.

Previously, in order to make a specific production performance claim for a feed, an applicant had to provide data to support the claims from at least 3 independent studies per species and production class. Some examples (not an exhaustive list) of specific endpoints for which production performance claims may be made are:

• feed efficiency or feed conversion ratio
• feed intake or dry matter intake
• growth or average daily gain
• egg production
• milk production
• reproductive performance (return to estrus, % pregnant; % farrowing)
• weaned piglets (number weaned; litter weight)
• proportion of growing animals below target body weight
• carcass weight; carcass and/or meat quality

There are now three ways where flexibility may be gained to support these types of claims without compromising the safety of a product.

1. Combining specific endpoints to make a general production performance claim
2. Extrapolating data between similar physiological species
3. Strength of claim – adding more flexibility with the p-value

In all cases, the applicant is responsible for clearly describing to the CFIA how their efficacy data will utilize these flexibilities. This means that the submission package must include a summary detailing any linkages between the studies submitted and the proposed claims. In no case can these flexibilities be considered in place of submitting required safety studies/data.

I. Combining specific endpoints to make a general production performance claim

Consistency in the reporting of, or significance of, specific endpoints across different studies (in-house or published) in relevant species and/or production classes of livestock can make it difficult to meet the 3-study threshold for a specific claim. However, it is now possible to make a general production performance claim. Where at least 3 independent studies demonstrate significant beneficial endpoints, even if they are different, a general production performance claim can be made. Some examples of how specific and non-specific/general claims may be assessed are presented in Table 1.

II. Extrapolating data between similar physiological species

An approach for some feed claims where the extrapolation of efficacy data from certain species to other physiologically related species could be used to reduce the total number of studies needed to substantiate a claim for multiple physiologically similar species.

In general, conclusions from studies in animals raised for meat can be extended to include animals of the same species that are reared for reproduction but before reproduction occurs (e.g., from broiler chickens to replacement chickens reared for laying/breeding (pre-layers/replacement hens pre-breeding), from beef cattle to replacement heifers intended for breeding or milking, but before reproduction or milk production occurs). Efficacy data cannot generally be extrapolated between categories of the same species at different production classes (e.g., from broiler chickens to laying or breeding hens).

When a feed application covers several target species in the same production class, it is recognized that it may be unrealistic to expect studies in all potential target species for which an application is made. Therefore, interspecies extrapolation of data can be applied.

In principle, data can be extrapolated between physiologically similar species (Table 2) in the same production class. The degree to which species are physiologically related is judged predominantly in terms of gastrointestinal physiology and function. Similarities in metabolism are also considered. Interspecies extrapolation can be applied in cases where:

1. the animals are raised for the same purpose, i.e., meat production or reproduction (including milk or egg production)
2. the product mode of action can reasonably be presumed to be the same between species
3. the effect(s) claimed is(are) the same
4. the minimum effective in-feed concentration in the physiologically related species must be the same as that established in the species/category from which data was extrapolated

When the application covers multiple species/classes, the minimum number of independent studies showing the intended effect is shown in Table 3. For applications covering all food-producing animal species, efficacy should be demonstrated in species with different digestive systems. Therefore, studies should be provided to support efficacy for all pigs, all poultry, all ruminants and all fin fish, according to Table 3. Companies can apply to have applications expanded over time to add additional species/classes of livestock as data becomes available.

III. Strength of claim – adding more flexibility with the p-value

Historically, the CFIA has followed the standard used by peer-reviewed scientific journals for research when defining the statistical significance p ≤ 0.05 (α=0.05). Considering the following points will allow for flexibility in the significance level and reduced endpoint specificity and allow a predictable strength of claim approach.

• Statistical significance at p ≤ 0.05 in each of 3 studies will allow for definitive claims
• Scientific journals involved in animal science allow researchers to characterize results with 0.05 < p ≤ 0.10 as trends or a tendency. These findings will allow for less defined claims making use of “may”
• The flexibility offered by the strength of claim can be further layered with the flexibility provided by combining specific production endpoints to make a general production performance claim as discussed in Section I above

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