Definitions.
Section 1
SECTION 1. Definitions.—For purposes of this Decree, the following terms are defined as follows: "Secretary" means the Secretary of Health. "Administrator" means the Food and Drug Administrator. "Person" means any individual, partnership, corporation or association, trust, government or governmental subdivision or any other legal entity other than the consumer. "Hazardous substance" means: (A) Any substance or mixture of substances which (i) is toxic, (ii) is corrosive, (iii) is an irritant, (iv) is a strong sensitizer, (v) is flammable or combustible, or (vi) generates pressure through decomposition, heat or other means, if such substance or mixture of substances may cause substantial injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable ingestion by children. (B) Any substance which the Secretary by regulation finds pursuant to the provision of this Decree, to be under the categories enumerated in sub-paragraph (1) (A) of this paragraph. (C) Any radioactive substance, if, with respect to such substance as used in a particular class of article or as packaged, the Secretary determines by regulation that the substance is sufficiently hazardous to require labeling in accordance with this Section in order to protect the public health. This term shall not apply to foods, drugs, and cosmetics nor to substances intended for use as fuels when stored in containers and used in the heating, cooking or refrigeration system of a house, but such term shall apply to any article which is not in itself a pesticide but which is a hazardous substance, as construed in paragraph (1) of this sub-section, by reason of bearing or containing such harmful substances described therein. "Toxic" means any substance (other than a radioactive substance) which can cause injury or illness or death to man through ingestion, inhalation, or absorption through any body surface. "Highly Toxic" means any substance which has any of the following effects: (1) produces death within four teen days to one half or more than one half of a group of ten or more laboratory white rats each weighing between two hundred and three hundred grams, at a single dose of fifty milligrams or less per kilogram of body weight, when orally administered; or (2) produces death within fourteen days to one half or more of a group of ten or more laboratory white rats each weighing between two hundred and three hundred grams, when inhaled continuously for a period of one hour or less at an atmospheric concentration of two hundred parts per million by volume or less of gas or vapor or two milligrams per liter by volume or less of mist or dust, provided such concentration is likely to be encountered by man when the substance is used in any reasonably foreseeable manner; or (3) produces death within fourteen days to one half or more of a group of ten or more rabbits, when tested in a dosage of two hundred milligrams or less per kilogram of body weight, or when administered through continuous contact with the bare skin for twenty-four hours or less. "Corrosive" means any substance which on contact with living tissue will cause destruction of tissue by chemical action, but shall not refer to action on inanimate surfaces. "Irritant" means any substance not corrosive within the meaning of subparagraph (g) of this section which, on immediate, prolonged, or repeated contact with normal living tissue will induce a local inflammatory reaction. "Strong sensitizer" means any substance which will cause on normal living tissue, allergy or photodynamic quality of hypersensitivity which becomes evident on re-application of the same substance, to be designated as such by the Secretary. Before designating any substance as a strong sensitizer the Secretary upon consideration of the frequency of occurrence and severity of the reaction shall find that the substance has a significant capacity to cause hypersensitivity. "Extremely flammable" means any substance which has a flash point at or below twenty degrees Fahrenheit as determined by the Tagliabue Open Cup Tester; the term "flammable" shall apply to any substance which has a flash point of above twenty degrees to and including eighty degrees Fahrenheit as determined by the Tagliabue Open Cup Tester; and the term "combustible" shall apply to any substance which has a flash point above eighty degrees Fahrenheit to and including one hundred and fifty degrees as determined by the Tagliabue Open Cup Tester; Provided, that the flammability or combustibility of solids and of the contents of self-pressurized containers shall be determined through methods found by the Secretary to be generally applicable to such materials or containers, respectively, and established by regulations issued by him Such regulations shall also define the terms "Flammable" "Combustible" and "Extremely Flammable" in accordance with acceptable methods. "Radioactive substance" means any substance which emits ionizing radiation. "Label" means a display of written, printed or graphic matter upon the immediate container of any substance, or in the case of an article which is not packaged in an immediate container but suitable for delivery to the consumer in such condition, a display of such matter directly upon the article involved or upon a tag or other suitable material affixed thereto. A requirement made by or under authority of this Section that certain words, statements, or other information appear on the label shall not be considered to have been sufficiently complied with unless such words, statements, or other information also appear (1) on the outside container or wrapper, if any there be, unless they are readable through the outside container or wrapper, and (2) on all accompanying literature where there are directions for use, written or otherwise. "Immediate container" refers to the container or package which is immediately after or near the substance excluding package liners. "Misbranded hazardous substance" means any hazardous substance intended, or packaged in a form suitable, for use in households, especially by children, the packaging or labeling of which is in violation of the special packaging regulation issued by the Secretary or if such substance fails to bear a label— which states conspicuously (A) the name and place of business of the manufacturer, packer, distributor or seller; (B) the common or usual name, or the chemical name (if there be no common or usual name) of the hazardous substance or of each component which contributes substantially to the harmfulness of the substance, unless the Secretary by regulation permits or requires the use of the recognized generic name: (C) the signal word "DANGER" on substances which are extremely flammable, corrosive, or highly toxic; (D) the signal word "WARNING" or "CAUTION" on all other hazardous substances; (E) a frank statement of the principal hazard or hazards involved, as "Flammable", "Vapor Harmful," "Causes Burns", "Absorbed Through Skin", or similar wording descriptive of the hazard; (F) precautionary measures describing the action to be followed or avoided, except when modified by regulation by the Secretary pursuant to Section 2 of this decree; (G) instructions, when necessary or appropriate, for first-aid treatment; (H) the word "poison" for any hazardous substance which is defined as highly toxic; (I) instructions for handling and storage of packages which require special care in handling or storage; and (J) the statement "Keep out of the reach of children", or its practical equivalent, if the article is intended for use by children and is not a banned hazardous substance, with adequate directions for the protection of children, from the hazard involved. The aforementioned signal words, affirmative statements, description of precautionary measures, necessary instructions or other words or statements may be in the English language or its equivalent in Pilipino, and on which any statement required under sub-paragraph (1) of this paragraph are located prominently and in conspicuous and legible type in contrast by typography, layout, or color with other printed matters on the label. "Banned hazardous substance" means (1) any toy or other articles intended for use by children, which are hazardous per se, or which bear or contain substances harmful to human beings; or (2) any hazardous substance intended, or packed in a form suitable, for use in the household, which the Secretary by regulation classifies as a "banned hazardous substance" notwithstanding the existence of cautionary labels, to safeguard public health and safety; Provided, That the Secretary, by regulation, shall exempt from this Section articles, which by reason of their functional purpose require the inclusion of the hazardous substance involved and which bear appropriate labels giving adequate directions and warnings for their safe use. Procedures for the issuance, amendment or repeal of regulations pursuant to paragraph (2) of this subsection shall be governed by the rules and regulations promulgated by the Secretary: Provided, That if the Secretary finds that the distribution for household use of the hazardous substance involved presents an imminent hazard to the public health, he may publish in a newspaper of general circulation a notice of such finding, and such substance shall be deemed to be a "banned hazardous substance" pending the issuance of regulation formally banning such substance.