2023 Montana Code Annotated › Title 50. Health and Safety › Chapter 31. Montana Food, Drug, and Cosmetic Act › Part 1. General Provisions › 50-31-108. Regulations concerning additives

50-31-108. Regulations concerning additives.
(1) The department, upon its own motion or upon the petition of any interested party requesting that a rule be established, whenever public health or other considerations in the state require, is authorized to adopt, amend, or repeal rules, whether or not in accordance with regulations promulgated under the federal act, prescribing tolerances for any added poisonous or deleterious substances for food additives, for pesticide chemicals in or on raw agricultural commodities, or for color additives, including but not limited to zero tolerances and exemptions from tolerances in the case of pesticide chemicals in or on raw agricultural commodities, and prescribing the conditions under which a food additive or a color additive may be safely used and exemptions when the food additive or color additive is to be used solely for investigational or experimental purposes.
(2) A petitioner shall establish by data submitted to the department that a necessity exists for the rule and that its effect will not be detrimental to the public health. If the data furnished by the petitioner is not sufficient to allow the department to determine whether the regulation should be promulgated, the department may require additional data to be submitted and failure to comply with the request is sufficient grounds to deny the request.
(3) In adopting, amending, or repealing rules relating to the substances, the department shall consider among other relevant factors the following, which the petitioner, if any, shall furnish:
(a) the name and all pertinent information concerning the substance, including, when available:
(i) its chemical identity and composition;
(ii) a statement of the conditions of the proposed use, including directions, recommendations, and suggestions and including specimens of proposed labeling; and
(iii) all relevant data bearing on the physical or other technical effect and the quantity required to produce the effect;
(b) the probable composition of or other relevant exposure from the article and of any substance formed in or on a food, drug, or cosmetic resulting from the use of the substance;
(c) the probable consumption of the substance in the diet of humans and animals taking into account any chemically or pharmacologically related substance in the diet;
(d) safety factors that, in the opinion of experts qualified by scientific training and experience to evaluate the safety of the substances for the use or uses for which they are proposed to be used, are generally recognized as appropriate for the use of animal experimentation data;
(e) the availability of any needed practicable methods of analysis for determining the identity and quantity of:
(i) the substance in or on an article;
(ii) any substance formed in or on the article because of the use of the substance; and
(iii) the pure substance and all intermediates and impurities; and
(f) facts supporting a contention that the proposed use of the substance will serve a useful purpose.
(4) The department may not establish rules related to food additives under this section for homemade food or a homemade food product sold pursuant to Title 50, chapter 49, part 2.
History: En. Sec. 13, Ch. 307, L. 1967; amd. Sec. 107, Ch. 349, L. 1974; R.C.M. 1947, 27-713(b); amd. Sec. 1842, Ch. 56, L. 2009; amd. Sec. 7, Ch. 320, L. 2021.