- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Veterinary MedicineOffice of Regulatory Affairs
*CVM* has recently had to consider the status of ingredients intended for use in silage. Some of these are clearly intended for pesticide use on raw agricultural commodities such as growing and otherwise unprocessed plant material. These are registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) by EPA. EPA has also registered some preservatives such as acetic and propionic acid for use on corn and grain before ensiling. EPA has not registered any pesticides for use on fermented ensilage.
While there is thus specific precedent for EPA approval of some silage additives, the largest portion now on the marketplace, particularly those intended for use in silage for such uses as acidification aids, fermentation aids or for nutrient purposes fall under the jurisdiction of FDA. A silage ingredient is either generally recognized as safe (GRAS) or, if not generally recognized as safe, a food additive which cannot be used unless there is a regulation for its safe use. Therefore, a silage ingredient may fall in one of the following categories:
- A pesticide or preservative subject to EPA jurisdiction
- A GRAS food ingredient
- A food additive requiring a regulation for safe use and legal marketing
- An animal drug
- A new animal drug
Food additive regulations are promulgated and published in the Federal Register on the basis of scientific data and other information submitted in the form of a food additive petition (FAP). The FAP must contain data adequate to establish that the additive is safe and will accomplish its intended effect in food (silage) whether it be added for a nutritional, chemical, technical, or mechanical purpose. Therefore, a food additive petition should have data to show that there is a need for the additive for the purpose, and that it is safe at the lowest level at which it accomplishes its intended effect in the target species. The concept of safety includes a showing that the additive leaves no unsafe residues in edible products of animals.
A silage ingredient bearing therapeutic claims may be a new animal drug requiring the approval of a new animal drug application (NADA) for the labeled purposes. Without the approved NADA the drug would be adulterated under Section 501(a)(5) of the Act.
A silage ingredient must either be GRAS (21 CFRa) or otherwise prior sanctioned or must be the subject of an approved food additive petition for its labeled purpose. In either case, data should show that there is a need for the additive for its intended purpose and that it is safe at the lowest level at which it accomplishes its intended effect in the target species. The concept of safety includes showing that the additive leaves no unsafe residues in edible products of animals. A food additive which does not meet these criteria is adulterated under Section 402(a)(2)(C) of the Act in that it is unsafe within the meaning of Section 409(a). Also, making questionable claims for such benefits as non-existent or exaggerated nutritional benefits, unwarranted fermentation or other ensiling benefits, etc. would cause the silage ingredient to be misbranded within the meaning of Section 403(a) of the Act.
Silage ingredients registered by EPA as preservatives, which are not GRAS and are not the subject of an approved food additive petition will be considered by the *Center for* Veterinary Medicine on a case-by-case basis.
a 21 CFR 582
*Material beteween asterisks is new or revised*
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2021-D-0641.