§328-13  Adding of poisonous or deleterious substance, regulation of.  (a)  Any added poisonous or deleterious substance, and food additive, any pesticide chemical in or on a raw agricultural commodity, or any color additive, shall, with respect to any particular use or intended use, be deemed unsafe for the purpose of application of clause (B)(i) of section 328-9(1) with respect to any food, section 328-14(1) with respect to any drug or device, or section 328-18(1) with respect to any cosmetic, unless there is in effect a regulation pursuant to section 328-19.1, or subsection (b) of this section limiting the quantity of the substance, and the use or intended use of the substance conform to the terms prescribed by the regulation. While the regulation relating to such substance is in effect, a food, drug, or cosmetic shall not, by reason of bearing or containing the substance in accordance with the regulation, be considered adulterated within the meaning of section 328-9(1)(A), section 328-14(1), or section 328-18(1).

     (b)  The director of health, whenever public health or other considerations in the State so require, may adopt, amend, or repeal regulations whether or not in accordance with regulations promulgated under the Federal Act prescribing therein 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 where the food additive or color additive is to be used solely for investigational or experimental purposes, upon the director's own motion or upon the petition of any interested party requesting that such a regulation be established.  It shall be incumbent upon the petitioner to establish by data submitted to the director that a necessity exists for the regulation, 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 director to determine whether such regulation should be promulgated, the director may require additional data to be submitted and failure to comply with the request shall be sufficient grounds to deny the request.  In adopting, amending, or repealing regulations relating to such substances the director shall consider among other relevant factors, the following which the petitioner, if any, shall furnish:

     (1)  The name and all pertinent information concerning the substance including where available, its chemical identity and composition, a statement of the conditions of the proposed use, including directions, recommendations, and suggestions and including specimens of proposed labeling, all relevant data bearing on the physical or other technical effect and the quantity required to produce such effect;

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

     (3)  The probable consumption of such substance in the diet of humans and animals taking into account any chemically or pharmacologically related substance in such diet;

     (4)  Safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of such 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;

     (5)  The availability of any needed practicable methods of analysis for determining the identity and quantity of (A) such substance in or on an article, (B) any substance formed in or on such article because of the use of such substance, and (C) the pure substance and all intermediates and impurities; and

     (6)  Facts supporting a contention that the proposed use of such substance will serve a useful purpose. [L 1941, c 318, §9; RL 1945, §2213; RL 1955, §51-13; am L 1967, c 152, §6; HRS §328-13; am L 1972, c 151, §7; gen ch 1985, 1993]

Revision Note

  In subsection (a), "328-19.1" substituted for "328-18.1".