§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".