1. (a) Prior to use or sale of commercial feed containing any additive (including any drug, food additive, or other special purpose additive, or non-nutritive additive) the distributor shall submit evidence to the secretary to show the safety and efficacy of the commercial feed when used according to the directions stated on the label.

2. (b) In determining whether satisfactory evidence of safety and efficacy is shown, the secretary will consider:

   1. (1) Whether each additive conforms to the requirements of the applicable regulations in Title 21, Code of Federal Regulations, Parts 570, 573 and 582 or are “prior sanctioned” or “generally recognized as safe (GRAS)” for stated uses.

      1. (A) “Prior Sanctioned” is defined in Title 21, Code of Federal Regulations, Part 570.3, as an explicit approval granted with respect to use of a substance in food prior to September 6, 1958, by the Food and Drug Administration or the United States Department of Agriculture pursuant to the Federal Food, Drug and Cosmetic Act, the Poultry Products Inspection Act, or the Meat Inspection Act.
      2. (B) “Generally Recognized as Safe (GRAS)” is defined in Title 21, Code of Federal Regulations, Part 570.3, definition of safe, as a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use, and Part 570.30, where general recognition of safety may be based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food.
   2. (2) Whether the feed itself is a drug as defined in Section 14928 of the Food and Agricultural Code and is generally recognized as safe and effective for the label use, or is approved by the Food and Drug Administration under 21 United States Code 360 b.

Note: Authority cited: Sections 407 and 14902, Food and Agricultural Code. Reference: Sections 14903, 15011, 15031 and 15041, Food and Agricultural Code.

History

1. Amendment of subsection (b) filed 7-2-82; effective thirtieth day thereafter (Register 82, No. 27).

2. Amendment of subsection (b) filed 10-26-82; effective thirtieth day thereafter (Register 82, No. 44).

3. Amendment of subsections (a) and (b), new subsections (c)-(c)(3) and amendment of Note filed 1-30-2002; operative 1-30-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 5).

4. Amendment of subsection (c) filed 4-20-2004; operative 4-20-2004 pursuant to Government Code section 11343.4 (Register 2004, No. 17).

5. Certificate of Compliance as to 5-12-2025 order, including repealer of subsections (c)-(c)(3), transmitted to OAL 6-10-2025 and filed 7-1-2025; amendments effective 7-1-2025 pursuant to Government Code section 11343.4(b)(3) (Register 2025, No. 27).