Guam § 40113 - Unsafe Substances.

§ 40113. Unsafe Substances.

(a) Any added poisonous or deleterious substance, any 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 (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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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.