36-905. Tolerances for added poisonous ingredients

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 be deemed unsafe for the purpose of paragraphs 2, 3 and 13 of section 36-904, unless there is in effect a regulation pursuant to 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. A food shall not, by reason of bearing or containing such substance in accordance with such regulation, be considered adulterated within the meaning of paragraph 1 of section 36-904.

B. The director may adopt, amend or repeal regulations, whether or not in accordance with regulations promulgated under the federal act, prescribing tolerances, including zero tolerances, for any added poisonous or deleterious substances, for food additives, for pesticide chemicals in or on raw agricultural commodities or for color additives 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. In prescribing tolerances in the case of pesticide chemicals in or on raw agricultural commodities consideration shall be given to the persistence of background count due to prior applications of the pesticide chemical, and such rules and regulations may allow for any background count and consideration shall be given to restrictions, or lack of restrictions, on pesticide chemical use established pursuant to law. In prescribing tolerances in the case of pesticide chemicals, such tolerances shall not be more restrictive than those established pursuant to the federal act. The director may take action under this subsection upon his own motion or upon the petition of any interested party requesting that such action be taken. The petitioner, if any, shall establish by data submitted to the director that a necessity exists for such action and that its effect will not be detrimental to the public health. If the data furnished by the petitioner is not sufficient for the director to determine whether such action should be taken, the director may require additional data to be submitted and failure to comply 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 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 effect, and the quantity required to produce such effect.

2. The probable composition of any substance formed in or on a food resulting from the use of such substance.

3. The probable consumption of any such substance in the diet of man and animals, considering any chemically or pharmacologically 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 for which they are proposed, 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:

(a) Such added substance in or on a food.

(b) Any other substance formed in or on a food because of the use of such added substance.

(c) The added substance and all its intermediates and impurities.

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

36-905. Tolerances for added poisonous ingredients

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 be deemed unsafe for the purpose of paragraphs 2, 3 and 13 of section 36-904, unless there is in effect a regulation pursuant to 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. A food shall not, by reason of bearing or containing such substance in accordance with such regulation, be considered adulterated within the meaning of paragraph 1 of section 36-904.

B. The director may adopt, amend or repeal regulations, whether or not in accordance with regulations promulgated under the federal act, prescribing tolerances, including zero tolerances, for any added poisonous or deleterious substances, for food additives, for pesticide chemicals in or on raw agricultural commodities or for color additives 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. In prescribing tolerances in the case of pesticide chemicals in or on raw agricultural commodities consideration shall be given to the persistence of background count due to prior applications of the pesticide chemical, and such rules and regulations may allow for any background count and consideration shall be given to restrictions, or lack of restrictions, on pesticide chemical use established pursuant to law. In prescribing tolerances in the case of pesticide chemicals, such tolerances shall not be more restrictive than those established pursuant to the federal act. The director may take action under this subsection upon his own motion or upon the petition of any interested party requesting that such action be taken. The petitioner, if any, shall establish by data submitted to the director that a necessity exists for such action and that its effect will not be detrimental to the public health. If the data furnished by the petitioner is not sufficient for the director to determine whether such action should be taken, the director may require additional data to be submitted and failure to comply 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 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 effect, and the quantity required to produce such effect.

2. The probable composition of any substance formed in or on a food resulting from the use of such substance.

3. The probable consumption of any such substance in the diet of man and animals, considering any chemically or pharmacologically 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 for which they are proposed, 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:

(a) Such added substance in or on a food.

(b) Any other substance formed in or on a food because of the use of such added substance.

(c) The added substance and all its intermediates and impurities.

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