§ 16-42-2-5 — Poisonous or deleterious substances; regulations

Indiana § 16-42-2-5

• Jurisdiction: Indiana
• Title 16: HEALTH
• Art. 42: REGULATION OF FOOD, DRUGS, AND
• Ch. 2: Uniform Food, Drug, and Cosmetic Act: Adulteration or

Text

(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.]

Legislative History

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