10 Guam Code Ann. § 40113
unsafe for the purpose of application of clause (2) of ‘40109 with respect to
any food, ‘40114 with respect to any drug or device or ‘40118 with respect
to any cosmetic, unless there is in effect a regulation pursuant to ‘40122 of
this Act or Subsection (b) of this Section limiting the quantity of such substance, and the use or intended use of such substance conforms to the terms prescribed by such regulation. While such regulations relating to such 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 (1), ”40109, 40114 or
40118.
(b) The Director, whenever public health or other considerations in this Territory so require, is authorized to 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 such food additive or color additive is to be used solely for investigational or experimental purposes, upon his own motion or upon the petition of any interested party requesting that such a regulation be established. It shall be incumbent upon such petitioner to establish by data submitted to the Director that a necessity exists for such regulations, 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 such substance including where available, its chemical identity and
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10 Guam Code Ann. HEALTH AND SAFETY
CH. 40 GUAM FOOD, DRUG AND COSMETIC ACT
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 man and animals taking into account any chemically or pharma- cologically 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 (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; and
(6) Facts supporting a contention that the proposed use of such substance will serve a useful purpose.
SOURCE: GC § 9720.12.