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PRESIDENTIAL DECREE NO. 881
PRESIDENTIAL DECREE NO. 881 -
EMPOWERING THE SECRETARY OF HEALTH TO REGULATE THE LABELING, SALE AND
DISTRIBUTION OF HAZARDOUS SUBSTANCES
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WHEREAS,
the Food, Drug and Cosmetics Act (Republic Act No. 3720) establishes
standards and quality measures for food, drugs and cosmetics;chanroblesvirtualawlibrary
WHEREAS, there are no substances other than food, drugs and cosmetics
that are hazardous to the health and safety of the public;chanroblesvirtualawlibrary
WHEREAS, there is no law at present that regulates the labeling, sale
and distribution of hazardous substances; chanroblesvirtualawlibrary
WHEREAS, there is an urgent need to adopt appropriate measures designed
to protect the people against other hazards to their health and safety;chanroblesvirtualawlibrary
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:cralaw:red
Section 1. Definitions. — For purposes of this
Decree, the following terms are defined as follows:cralaw:red
(a) "Secretary" means the Secretary of Health.
(b) "Administrator" means the Food and Drug
Administrator.
(c) "Person" means any individual, partnership,
corporation or association, trust, government or governmental
subdivision or any other legal entity other than the consumer. chanroblesvirtualawlibrary
(d) "Hazardous substance" means:cralaw:red
(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.
(e) "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.
(f) "Highly Toxic" means any substance which has any
of the following effects: (1) produces death within fourteen 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.
(g) "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.
(h) "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.
(i) "Strong sensitizer" means any substance which
will cause on normal living tissue, allergy or photodynamic quality of
hypersensitivity which becomes evident on reapplication of the same
substance, to be designated as such by the Secretary. Before
designating any substance as a strong sensitizer the Secretary upon
reconsideration of the frequency of occurrence and severity of the
reaction shall find that the substance has a significant capacity to
cause hypersensitivity.
(j) "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
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 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.
(k) "Radioactive substance" means any substance which
emits ionizing radiation.
(l) "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.
(m) "Immediate container" refers to the container or
package which is immediately after or near the substance excluding
package liners.
(n) "Misbranded hazardous substance" means any
hazardous substance intended, or package 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 hear a label —chanroblesvirtualawlibrary
(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.
(o) "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 substance intended, or packaged 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
safety 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.
Section 2. Regulations declaring hazardous substances
and establishing variations and exemptions. — chanroblesvirtualawlibrary
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 be regulation declare as hazardous any substance or mixture of
substances which he finds the requirements of paragraph (1) (a) of
Section 1 (d). chanroblesvirtualawlibrary
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 which such regulations shall
be deemed to be a misbranded hazardous substance.
Section 3. Grounds for seizure and condemnation of
misbranded hazardous substances. —chanroblesvirtualawlibrary
(a) 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 shipping
package to show that it is intended for export, and (4) is so exported.
(b) 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. chanroblesvirtualawlibrary
(c) 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 information by such owner
or consignee.
Section 4. Imports: regulations on imported hazardous
substance. —
(a) 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 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.
(b) Pending decision on the admissibility of
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.
Section 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 labeling therein; and (3)
to obtain samples of such materials or packages therein or of such
labeling, issuing proper receipts for them.
Section 6. Prohibited acts and penalties. —
(a) Prohibited acts. — The following acts and the
causing thereof are prohibited:cralaw:red
(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 otherwise.
(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 meanings as in the
Food, Drug and Cosmetic Act (Republic Act No. 3720). chanroblesvirtualawlibrary
(b) 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.
Section 7. Effectivity. — This Decree shall take
effect immediately. chanroblesvirtualawlibrary
Done in the City of Manila this
30th day of January in the year of Our Lord nineteen hundred and
seventy-six.
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