65-667.Same; limiting quantities of certain substances added tofoods; regulations governing.(a) Any added poisonous or deleterious substance, any food additive, anypesticide chemical in or on a raw agricultural commodity, or any coloradditive, shall, with respect to any particular use or intended use bedeemed unsafe for the purpose of application of clause (2) (A) of K.S.A.65-664 (a) with respect to any food, K.S.A. 65-668 (a) with respect toany drug or device, or K.S.A. 65-670 (a) with respect to any cosmetic,unless there is in effect a regulation pursuant to subsection (b) ofthis section limiting the quantity of such substance, and the use orintended use of such substance, conform to the terms prescribed by suchregulation. While such regulation relating to such substance is ineffect, a food, drug or cosmetic shall not, by reason of bearing orcontaining such substance in accordance with the regulation, beconsidered adulterated within the meaning of clause (1), of subsection (a)of K.S.A. 65-664, subsection (a) of K.S.A. 65-668 or subsection (a) ofK.S.A. 65-670.
(b) The secretary, whenever public health or other considerations inthe state so require, is authorized to adopt, amend, or repealregulations whether or not in accordance with regulations promulgatedunder the federal act prescribing therein tolerances for any addedpoisonous or deleterious substances, for food additives, for pesticidechemicals in or on raw agricultural commodities, or for color additives,including, but not limited to, zero tolerances, and exemptions fromtolerances in the case of pesticide chemicals in or on raw agriculturalcommodities, and prescribing the conditions under which a food additiveor a color additive may be safely used and exemptions where such foodadditive or color additive is to be solely for investigational orexperimental purposes, upon its own motion or upon the petition of anyinterested party requesting that such a regulation be established, andit shall be incumbent upon such petitioner to establish by datasubmitted to the secretary that a necessity exists for such regulation,and that its effect will not be detrimental to the public health. If thedata furnished by the petitioner is not sufficient to allow thesecretary to determine whether such regulations should be promulgated,the secretary may require additional data to be submitted and failure tocomply with the request shall be sufficient grounds to deny the request.In adopting, amending or repealing regulations relating to suchsubstances, the secretary shall consider among other relevant factors,the following which the petitioner, if any, shall furnish:
(1) The name and all pertinent information concerning such substanceincluding where available, its chemical identity and composition, astatement of the conditions of the proposed use, including directions,recommendations and suggestions and including specimens of proposedlabeling, all relevant data bearing on the physical or other technicaleffect and the quantity required to produce such effect.
(2) The probable composition of, or other relevant exposure from thearticle and of any substance formed in or on a food, drug, or cosmeticresulting from the use of such substance.
(3) The probable consumption of such substance in the diet of manand animals taking into account many chemically or pharmacologicallyrelated substance in such diet.
(4) Safety factors which, in the opinion of experts qualified byscientific training and experience to evaluate the safety of suchsubstances for the use or uses for which they are proposed to be used,are generally recognized as appropriate for the use of animalexperimentation data.
(5) The availability of any needed practicable methods of analysisfor determining the identity and quantity of (i) such substance in or onan article, (ii) any substance formed in or on such article because ofthe use of such substance, and (iii) the pure substance and allintermediates and impurities.
(6) Facts supporting a contention that the proposed use of suchsubstance will serve a useful purpose.
(c) In adopting regulations under subsection (b) of this section,the secretary is authorized to adopt by reference those lists pertainingto or reflecting the same judgments which have been promulgated asregulations under the federal act and have been published in the federalregister, if the regulations adopted by reference are in effect on thedate adopted, and regulations so adopted shall remain the regulations ofthe secretary until changed by the secretary. In so doing, the secretaryadditionally may add to or delete from such lists, whenever in hisjudgment the statutory guidelines of this section so require.
History: L. 1953, ch. 286, § 13; L. 1965, ch. 377, § 4; L. 1974,ch. 352, § 107; July 1.
65-667.Same; limiting quantities of certain substances added tofoods; regulations governing.(a) Any added poisonous or deleterious substance, any food additive, anypesticide chemical in or on a raw agricultural commodity, or any coloradditive, shall, with respect to any particular use or intended use bedeemed unsafe for the purpose of application of clause (2) (A) of K.S.A.65-664 (a) with respect to any food, K.S.A. 65-668 (a) with respect toany drug or device, or K.S.A. 65-670 (a) with respect to any cosmetic,unless there is in effect a regulation pursuant to subsection (b) ofthis section limiting the quantity of such substance, and the use orintended use of such substance, conform to the terms prescribed by suchregulation. While such regulation relating to such substance is ineffect, a food, drug or cosmetic shall not, by reason of bearing orcontaining such substance in accordance with the regulation, beconsidered adulterated within the meaning of clause (1), of subsection (a)of K.S.A. 65-664, subsection (a) of K.S.A. 65-668 or subsection (a) ofK.S.A. 65-670.
(b) The secretary, whenever public health or other considerations inthe state so require, is authorized to adopt, amend, or repealregulations whether or not in accordance with regulations promulgatedunder the federal act prescribing therein tolerances for any addedpoisonous or deleterious substances, for food additives, for pesticidechemicals in or on raw agricultural commodities, or for color additives,including, but not limited to, zero tolerances, and exemptions fromtolerances in the case of pesticide chemicals in or on raw agriculturalcommodities, and prescribing the conditions under which a food additiveor a color additive may be safely used and exemptions where such foodadditive or color additive is to be solely for investigational orexperimental purposes, upon its own motion or upon the petition of anyinterested party requesting that such a regulation be established, andit shall be incumbent upon such petitioner to establish by datasubmitted to the secretary that a necessity exists for such regulation,and that its effect will not be detrimental to the public health. If thedata furnished by the petitioner is not sufficient to allow thesecretary to determine whether such regulations should be promulgated,the secretary may require additional data to be submitted and failure tocomply with the request shall be sufficient grounds to deny the request.In adopting, amending or repealing regulations relating to suchsubstances, the secretary shall consider among other relevant factors,the following which the petitioner, if any, shall furnish:
(1) The name and all pertinent information concerning such substanceincluding where available, its chemical identity and composition, astatement of the conditions of the proposed use, including directions,recommendations and suggestions and including specimens of proposedlabeling, all relevant data bearing on the physical or other technicaleffect and the quantity required to produce such effect.
(2) The probable composition of, or other relevant exposure from thearticle and of any substance formed in or on a food, drug, or cosmeticresulting from the use of such substance.
(3) The probable consumption of such substance in the diet of manand animals taking into account many chemically or pharmacologicallyrelated substance in such diet.
(4) Safety factors which, in the opinion of experts qualified byscientific training and experience to evaluate the safety of suchsubstances for the use or uses for which they are proposed to be used,are generally recognized as appropriate for the use of animalexperimentation data.
(5) The availability of any needed practicable methods of analysisfor determining the identity and quantity of (i) such substance in or onan article, (ii) any substance formed in or on such article because ofthe use of such substance, and (iii) the pure substance and allintermediates and impurities.
(6) Facts supporting a contention that the proposed use of suchsubstance will serve a useful purpose.
(c) In adopting regulations under subsection (b) of this section,the secretary is authorized to adopt by reference those lists pertainingto or reflecting the same judgments which have been promulgated asregulations under the federal act and have been published in the federalregister, if the regulations adopted by reference are in effect on thedate adopted, and regulations so adopted shall remain the regulations ofthe secretary until changed by the secretary. In so doing, the secretaryadditionally may add to or delete from such lists, whenever in hisjudgment the statutory guidelines of this section so require.
History: L. 1953, ch. 286, § 13; L. 1965, ch. 377, § 4; L. 1974,ch. 352, § 107; July 1.
65-667.Same; limiting quantities of certain substances added tofoods; regulations governing.(a) Any added poisonous or deleterious substance, any food additive, anypesticide chemical in or on a raw agricultural commodity, or any coloradditive, shall, with respect to any particular use or intended use bedeemed unsafe for the purpose of application of clause (2) (A) of K.S.A.65-664 (a) with respect to any food, K.S.A. 65-668 (a) with respect toany drug or device, or K.S.A. 65-670 (a) with respect to any cosmetic,unless there is in effect a regulation pursuant to subsection (b) ofthis section limiting the quantity of such substance, and the use orintended use of such substance, conform to the terms prescribed by suchregulation. While such regulation relating to such substance is ineffect, a food, drug or cosmetic shall not, by reason of bearing orcontaining such substance in accordance with the regulation, beconsidered adulterated within the meaning of clause (1), of subsection (a)of K.S.A. 65-664, subsection (a) of K.S.A. 65-668 or subsection (a) ofK.S.A. 65-670.
(b) The secretary, whenever public health or other considerations inthe state so require, is authorized to adopt, amend, or repealregulations whether or not in accordance with regulations promulgatedunder the federal act prescribing therein tolerances for any addedpoisonous or deleterious substances, for food additives, for pesticidechemicals in or on raw agricultural commodities, or for color additives,including, but not limited to, zero tolerances, and exemptions fromtolerances in the case of pesticide chemicals in or on raw agriculturalcommodities, and prescribing the conditions under which a food additiveor a color additive may be safely used and exemptions where such foodadditive or color additive is to be solely for investigational orexperimental purposes, upon its own motion or upon the petition of anyinterested party requesting that such a regulation be established, andit shall be incumbent upon such petitioner to establish by datasubmitted to the secretary that a necessity exists for such regulation,and that its effect will not be detrimental to the public health. If thedata furnished by the petitioner is not sufficient to allow thesecretary to determine whether such regulations should be promulgated,the secretary may require additional data to be submitted and failure tocomply with the request shall be sufficient grounds to deny the request.In adopting, amending or repealing regulations relating to suchsubstances, the secretary shall consider among other relevant factors,the following which the petitioner, if any, shall furnish:
(1) The name and all pertinent information concerning such substanceincluding where available, its chemical identity and composition, astatement of the conditions of the proposed use, including directions,recommendations and suggestions and including specimens of proposedlabeling, all relevant data bearing on the physical or other technicaleffect and the quantity required to produce such effect.
(2) The probable composition of, or other relevant exposure from thearticle and of any substance formed in or on a food, drug, or cosmeticresulting from the use of such substance.
(3) The probable consumption of such substance in the diet of manand animals taking into account many chemically or pharmacologicallyrelated substance in such diet.
(4) Safety factors which, in the opinion of experts qualified byscientific training and experience to evaluate the safety of suchsubstances for the use or uses for which they are proposed to be used,are generally recognized as appropriate for the use of animalexperimentation data.
(5) The availability of any needed practicable methods of analysisfor determining the identity and quantity of (i) such substance in or onan article, (ii) any substance formed in or on such article because ofthe use of such substance, and (iii) the pure substance and allintermediates and impurities.
(6) Facts supporting a contention that the proposed use of suchsubstance will serve a useful purpose.
(c) In adopting regulations under subsection (b) of this section,the secretary is authorized to adopt by reference those lists pertainingto or reflecting the same judgments which have been promulgated asregulations under the federal act and have been published in the federalregister, if the regulations adopted by reference are in effect on thedate adopted, and regulations so adopted shall remain the regulations ofthe secretary until changed by the secretary. In so doing, the secretaryadditionally may add to or delete from such lists, whenever in hisjudgment the statutory guidelines of this section so require.
History: L. 1953, ch. 286, § 13; L. 1965, ch. 377, § 4; L. 1974,ch. 352, § 107; July 1.
