856                               Laws of Maryland                      [Ch. 422

189A (a) with respect to any drug or device, or Section 190A (1)
with respect to any cosmetic, unless there is in effect a regulation
pursuant to Section 191B of this subheading or subsection (b) of
this section limiting the permissible quantity of such substance with
respect to the use, and the use or intended use of the substance
conforms to the terms prescribed by the regulation. While the regula-
tions relating to the substance are in effect, a food, drug, or cosmetic
shall not, by reason of bearing or containing such substance in
accordance with the regulations, be considered adulterated within
the meaning of clause (i) of Section 188B (1), Section 189A (1);
or Section 190A (1).

(b) The Secretary, whenever public health or other considera-
tions in the State so require, is authorized to adopt, amend, or repeal
regulations whether or not in accordance with regulations promul-
gated under the Federal Act, prescribing therein tolerances for any
added, poisonous or deleterious substances, for food additives, or for
color additives, including, but not limited to, zero tolerances, 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 experi-
mental purposes, upon his own motion or upon the petition of any
interested party requesting that the regulation be established. The
petitioner shall establish by data submitted to the Secretary 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 are not sufficient to allow the Secretary to determine
whether the regulation should be promulgated, the Secretary may
require additional data to be submitted and failure to comply with
the request shall be sufficient grounds to deny the request. In adopt-
ing, amending or repealing regulations relating to the substances
the Secretary shall consider among other relevant factors, the follow-
ing which the petitioner, if any, shall furnish:

(1)    The name and all pertinent information concerning the sub-
stance including where available, its chemical identity and composi-
tion, 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 the effect.

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

(3)    The probable consumption of the substance in the diet of
man taking into account any chemically or pharmacologically related
substance in the diet.

(4) Safety factors which, in the opinion of experts qualified by
scientific training and experience to evaluate the safety of the sub-
stances for the use or uses for which they are proposed to be used,
are generally recognized as appropriate for the use of animal ex-
perimentation data.

(5) The availability of any needed practicable methods of analysis
for determining the identity and quantity of (i) the substance in or
on an article, (ii) any substance formed in or on the article because
of the use of the substance, and (iii) the pure substance and all
intermediates and impurities and