§328-13  Adding of poisonous or deleterioussubstance, regulation of.  (a)  Any added poisonous or deleterioussubstance, and food additive, any pesticide chemical in or on a rawagricultural commodity, or any color additive, shall, with respect to any particularuse 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) withrespect to any drug or device, or section 328-18(1) with respect to anycosmetic, 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, andthe use or intended use of the substance conform to the terms prescribed by theregulation. While the regulation relating to such substance is in effect, afood, drug, or cosmetic shall not, by reason of bearing or containing thesubstance in accordance with the regulation, be considered adulterated withinthe meaning of section 328-9(1)(A), section 328-14(1), or section 328-18(1).

(b)  The director of health, whenever publichealth or other considerations in the State so require, may adopt, amend, orrepeal regulations whether or not in accordance with regulations promulgatedunder the Federal Act prescribing therein tolerances for any added poisonous ordeleterious substances, for food additives, for pesticide chemicals in or onraw agricultural commodities, or for color additives, including, but notlimited to, zero tolerances, and exemptions from tolerances in the case ofpesticide chemicals in or on raw agricultural commodities, and prescribing theconditions under which a food additive or a color additive may be safely usedand exemptions where the food additive or color additive is to be used solelyfor investigational or experimental purposes, upon the director's own motion orupon the petition of any interested party requesting that such a regulation beestablished.  It shall be incumbent upon the petitioner to establish by datasubmitted to the director that a necessity exists for the regulation, and thatits effect will not be detrimental to the public health.  If the data furnishedby the petitioner is not sufficient to allow the director to determine whethersuch regulation should be promulgated, the director may require additional datato be submitted and failure to comply with the request shall be sufficientgrounds to deny the request.  In adopting, amending, or repealing regulationsrelating 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 concerningthe 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 thequantity required to produce such effect;

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

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

(4)  Safety factors which, in the opinion of expertsqualified by scientific training and experience to evaluate the safety of suchsubstances for the use or uses for which they are proposed to be used, aregenerally recognized as appropriate for the use of animal experimentation data;

(5)  The availability of any needed practicablemethods of analysis for determining the identity and quantity of (A) suchsubstance in or on an article, (B) any substance formed in or on such articlebecause of the use of such substance, and (C) the pure substance and allintermediates and impurities; and

(6)  Facts supporting a contention that the proposeduse 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".