§ 25-5-413 — Limit of adulteration - rule or regulation

(1) Any added
poisonous or deleterious substance, food additive, pesticide chemical in or on a raw
agricultural commodity, or color additive, with respect to any particular use or
intended use, shall be deemed unsafe for the purpose of application of section 25-5-410 (1)(b) with respect to any food, section 25-5-414 (1)(a) to (1)(f) with respect to
any drug or device, or section 25-5-416 (1)(a) with respect to any cosmetic, unless
there is in effect a regulation pursuant to section 25-5-419 or subsection (2) of this
section limiting the quantity of such substance and the use or intended use of such
substance is within the limits prescribed by such regulation. While such a regulation
relating to such substance is in effect, a food, drug, or cosmetic, by reason of
bearing or containing such substance in accordance with the regulations, shall not
be considered adulterated within the meaning of section 25-5-410 (1)(b), 25-5-414
(1)(a) to (1)(f), or 25-5-416 (1)(a).

(2) The department, whenever public health or other considerations so
require, is authorized to adopt, amend, or repeal regulations upon its own motion or
upon the petition of any interested party, whether or not in accordance with
regulations promulgated under the federal act. Such regulations may prescribe
tolerances for any added poisonous or deleterious substances, food additives,
pesticide chemicals in or on raw agricultural commodities, or color additives,
including but not limited to zero tolerances. The department may prescribe
exemptions from tolerances in the case of pesticide chemicals in or on raw
agricultural commodities. The department may also promulgate regulations
prescribing the conditions under which a food additive or a color additive may be
safely used and exemptions if such food additive or color additive is to be used
solely for investigational or experimental purposes. It shall be incumbent upon any
petitioner to establish that a necessity exists for such regulation and that its effect
will not be detrimental to the public health. If the data furnished by the petitioner
are not sufficient to allow the department to determine whether such regulation
should be promulgated, the department may require additional data to be
submitted, and failure to comply with the request shall be sufficient grounds for
denial of the request. In adopting, amending, or repealing regulations under this
section, the department shall consider, among other relevant factors, the following,
which the petitioner, if any, shall furnish:

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

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

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

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

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

(I) Such substance in or on an article;

(II) Any substance formed in or on such article because of the use of such
substance; and

(III) The pure substance and all intermediates and impurities;

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

Legislative History

Source: L. 57: p. 433, � 13. CRS 53: � 66-22-13. C.R.S. 1963: � 66-20-13. L. 70: p. 203, � 7.