Sec. 5. (a) Any added poisonous or deleterious substance, any food additive, any pesticide chemical in or on a raw agricultural commodity or any color additive, with respect to any particular use or intended use, are considered unsafe for the purpose of application of:

(1) section 2(a)(2) of this chapter with respect to any food;

(2) IC 16-42-3-3(1) through IC 16-42-3-3(5) with respect to any drug or device; or

(3) IC 16-42-4-2(1) with respect to any cosmetic;

unless there is in effect a rule under IC 16-42-1-2 or this section limiting the quantity of the substance and unless the use or intended use of the substance conforms to the terms prescribed by rule. While the rules regarding the substance are in effect, a food, drug, or cosmetic is not, by reason of bearing or containing the substance in accordance with the rules, to be considered adulterated within the meaning of section 2(a)(1) of this chapter, IC 16-42-3-3(1) through IC 16-42-3-3(5), or IC 16-42-4-2(1).

(b) The state department may, whenever public health or other considerations in Indiana require and upon the state department's own motion or upon the petition of an interested party, adopt, amend, or repeal rules (whether or not in accordance with regulations promulgated under the Federal Act) that do the following:

(1) Prescribe tolerances for any of the following:

(A) Any added, poisonous, or deleterious substances.

(B) Food additives.

(C) Pesticide chemicals in or on raw agricultural commodities.

(D) Color additives.

This includes zero tolerances and exemptions from tolerances in the case of pesticide chemicals in or on raw agricultural commodities.

(2) Prescribe the conditions under which a food additive or a color additive may be safely used and exemptions where the food additive or color additive is to be used solely for investigational or experimental purposes.

(c) It is incumbent upon an interested party who petitions that a rule be adopted under subsection (b) to establish, by data submitted to the state health commissioner or the commissioner's legally authorized agent, that:

(1) a necessity exists for the rule; and

(2) the rule's effect will not be detrimental to the public health.

(d) If the data furnished by an interested party who petitions that a rule be adopted under subsection (b) is not sufficient to allow the state department to determine whether the rule should be adopted, the state department may require additional data to be submitted. Failure to comply with such a request is sufficient grounds to deny the request.

(e) In adopting, amending, or repealing rules regarding such substances, the state department shall consider, among other relevant factors, the following items that are required to be furnished by the interested party who petitions for the adoption of a rule, if any:

(1) The name and all pertinent information concerning the substance, including if available the following:

(A) The chemical identity and composition of the substance.

(B) A statement of the conditions of the proposed use, including directions, recommendations, and suggestions, and specimens of proposed labeling.

(C) All relevant data bearing on the physical or other technical effect and the quantity required to produce that effect.

(2) The probable composition of any substance formed in or on a food, drug, or cosmetic resulting from the use of that substance.

(3) The probable consumption of the substance in the diet of man and animals, taking into account any chemically or pharmacologically related substance in the diet.

(4) Safety factors that, in the opinion of experts qualified by scientific training and experience to evaluate the safety of the substances for the use for which the substances are proposed to be used, are generally recognized as appropriate for the use of animal experimentation data.

(5) The availability of any needed practicable methods of analysis for determining the identity and quantity of the following:

(A) The substance in or on an article.

(B) Any substance formed in or on such article because of the use of that substance.

(C) The pure substance and all intermediates and impurities.

(6) Facts supporting a contention that the proposed use of the substance will serve a useful purpose.

[Pre-1993 Recodification Citation: 16-1-29-17.]

As added by P.L.2-1993, SEC.25.