EMPOWERING THE SECRETARY OF HEALTH TO REGULATE THE LABELING, SALE AND DISTRIBUTION OF HAZARDOUS SUBSTANCES.

WHEREAS, the Food, Drug and Cosmetics Act (Republic Act No.
3720) establishes standards and quality measures for food, drugs and
cosmetics;

WHEREAS, there are substances other than food, drugs and
cosmetics that are hazardous to the health and safety of the public;

WHEREAS, there is no law at present that regulates the
labeling, sale and distribution of hazardous substances;

WHEREAS, there is an urgent need to adopt appropriate
measures designed to protect the people against other hazards to their
health and safety;

NOW, THEREFORE, I, FERDINAND E. MARCOS, President of the
Philippines, by virtue of the powers vested in me by the Constitution,
do hereby order and decree, as part of the law of the land, the
following:

SECTION 1. Definitions.—For purposes of this Decree,
the following terms are defined as follows:

1. “Secretary” means the Secretary of Health.
2. “Administrator” means the Food and Drug Administrator.
3. “Person” means any individual, partnership, corporation or
   association, trust, government or governmental subdivision or any other
   legal entity other than the consumer.
4. “Hazardous substance” means:
   1. (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.

2. 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.

5. “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.
6. “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.
7. “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.
8. “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.
9. “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.
10. “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.
11. “Radioactive substance” means any substance which emits ionizing
    radiation.
12. “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.
13. “Immediate container” refers to the container or package which
    is immediately after or near the substance excluding package liners.
14. “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—

1. 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
2. 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.

15. “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.

SEC. 2. Regulations declaring hazardous substances
and establishing variations and exemptions.—

The Administrator, upon approval by the Secretary, shall
promulgate the rules and regulations governing the implementation of
this decree.

To resolve uncertainty as to the coverage of this
decree, the Secretary may by regulation declare as hazardous any
substance or mixture of substances which he finds meets the requirements
of paragraph (1) (A) of Section 1 (d).

If the Secretary finds
that for good and sufficient reasons, full compliance with the labeling
requirements otherwise applicable under this Decree is impracticable or
is not necessary for the adequate protection of the public health and
safety, he shall promulgate regulations exempting such substances from
these requirements to the extent he deems consistent with the objective
of adequately safeguarding public health and safety, and any hazardous
substance which does not bear a label in accordance with such
regulations shall be deemed to be a misbranded hazardous substance.

SEC. 3. Grounds for seizure and condemnation of misbranded
hazardous substances.—

1. Any misbranded hazardous substance or banned hazardous
   substance when introduced into commerce or while held for sale shall be
   liable to be proceeded against while in commerce or at any time
   thereafter and condemned upon order of the Administrator in accordance
   with existing procedure for seizure and condemnation of articles in
   commerce: Provided, That this Section shall not apply to a
   hazardous substance intended for export to any foreign country if it (1)
   is in a package branded in accordance with the specifications of the
   foreign purchaser, (2) is labeled in accordance with the laws of the
   foreign country, (3) is labeled on the outside of the ship ping package
   to show that it is intended for export, and (4) is so exported.
2. Any hazardous substance condemned under this Section shall,
   after entry of the order be disposed of by destruction or sale as the
   Administrator may direct and the proceeds thereof, if sold, less
   the legal costs and charges shall be paid into the Treasury of the
   Philippines; but such hazardous substance shall not be sold under any
   order which is contrary to the provisions of this Decree: Provided,
   That, after entry of the order and upon the payment of the costs of
   such proceedings and the execution of a good and sufficient bond
   conditioned that such hazardous substance shall not be sold or disposed
   of contrary to the provisions of this Decree, the Administrator may
   direct that such hazardous substance be delivered to the owner thereof
   for destruction or for alteration to comply with the provisions of this
   Decree under the supervision of an officer or employee duly designated
   by the Administrator. The expenses for such supervision shall be paid by
   the person obtaining release of the hazardous substance under bond.
3. All expenses in connection with the destruction provided for in
   subsection (a) of this Section and all expenses in connection with the
   storage and labor with respect to such hazardous substance shall be paid
   by the owner or consignee, and default in such payment, shall
   constitute a lien against any importation by such owner or consignee.

SEC. 4. Imports: regulations on imported hazardous
substances.—

1. The Commissioner of Customs shall deliver to the Administrator,
   upon his request, samples of hazardous substances being imported or
   offered for export to the Philippines, giving notice thereof to the
   owner or consignee who may appear before the Administrator and exercise
   the right to make testimony. If it appears from the examination of such
   samples that such hazardous substance is a misbranded hazardous
   substance or banned hazardous substance, then such hazardous substance
   shall be refused admission except as may be provided in an order issued
   by the Administrator authorizing delivery of the refused articles under
   the requirements imposed therein. The Commissioner of Customs shall
   cause the destruction of any hazardous substance refused admission
   unless such hazardous substance is exported, under regulations issued by
   the Commissioner within ninety days from the date of notice of such
   refusal or within such additional time as may be fixed by him.
2. Pending decision on the admissibility of a hazardous substance
   being imported or offered for import, the Commissioner of Customs may
   authorize delivery of such hazardous substance to the owner or consignee
   upon execution by him of a good and sufficient bond providing for the
   payment of such liquidated damages in the event of default. If it
   appears to the Administrator that the hazardous substance can, by
   relabeling or other action, be made to comply with the requirements of
   this Decree, final determination as to the admission of such hazardous
   substance may be deferred, and upon filing of a timely written
   application by the owner or consignee and the execution by him of a bond
   as provided in the provisions of this subsection. The Administrator,
   may in accordance with regulations, authorize the applicant to perform
   such relabeling or other action specified in such authorization
   (including destruction or export of such rejected hazardous substance).
   All such relabeling or other action pursuant to such authorization shall
   be in accordance with regulations and shall be under the supervision of
   an officer or employee of the Bureau of Customs and the Food and Drug
   Administration.

SEC. 5. Examination and investigation for purposes of
enforcement of this Decree.—Officers or employees duly designated by
the Administrator upon presenting appropriate credentials to the owner,
operator, or agent in charge are authorized (1) to enter at reasonable
hours, any establishment or warehouse in which hazardous substances are
manufactured, labeled, packed or held for introduction into domestic
commerce or are held after such introduction, or to enter any vehicle
being used to transport or hold such hazardous substance in domestic
commerce; (2) to inspect, in a reasonable manner, such establishment or
vehicle, warehouse and all pertinent equipment, finished or unfinished,
materials and labeling therein; and (3) to obtain samples of such
materials or packages therein or of such labeling, issuing proper
receipts for them.

SEC. 6. Prohibited acts and
penalties.—

1. Prohibited acts.—The following acts and the causing thereof are
   prohibited:

1. The introduction or delivery for introduction into commerce
   of any misbranded hazardous substance or banned hazardous substance.
2. The alteration, mutilation, destruction, obliteration, or
   removal of the whole or any part of the label of a misbranded hazardous
   substance or banned hazardous substance, if such act is done while the
   substance is in commerce or while the substance is held for sale
   (whether or not it is the first sale)
3. The receipt in commerce of any misbranded hazardous substance
   or banned hazardous substance and the delivery or proffered delivery
   thereof at cost or other wise.
4. The giving of a guarantee or undertaking referred to in
   Section 3(b) and Section 4(b) if such guarantee or undertaking is false,
   except by a person who relied upon a guarantee or undertaking which he
   received in good faith.
5. The introduction or delivery for introduction into commerce,
   or the receipt in commerce and subsequent delivery or proffered delivery
   at cost or otherwise, of a hazardous substance in a reused food, drug,
   or cosmetic container or in a container which, though not a reused
   container, is identifiable as a food, drug, or cosmetic container by its
   labeling or by other identification. The use of a used food, drug, or
   cosmetic container as a container for a hazardous substance does not
   diminish the danger posed by the hazardous substance involved, therefore
   such substance shall be deemed a misbranded hazardous substance. As
   used in this paragraph, the terms “food,” “drug,” and “cosmetic” shall
   have the same meaning as in the Food, Drug and Cosmetic Act (Republic
   Act No. 3720).

2. Penalties, exception.—(1) Any person who violates any of the
   provisions of subsection (a) shall, upon conviction, be subject to
   imprisonment of not less than six months and one day, but not more than
   five years, or a fine of not less than one thousand pesos, or both, such
   fine and imprisonment to be at the discretion of the court; (2) no
   person shall be subject to the penalties of paragraph (1) of this
   subsection, (i) for having violated subsection (a) (3) of this Section
   unless he refuses to furnish upon request by the Administrator or his
   representative the name and address of the person from whom he purchased
   or received such hazardous substance, (ii) for having violated
   subsection (a) (1) of this Section, if he establishes a guarantee or
   undertaking signed by, and containing the name and address of, the
   person from whom he received in good faith, the hazardous substance to
   the effect that the hazardous substance is not a misbranded hazardous
   substance or banned hazardous substance within the meaning of that term
   in this Decree.

SEC. 7. Effectivity.—This Decree shall take effect
immediately.

Done in the City of Manila this 30th day of January in the
year of Our Lord nineteen hundred and seventy-six.