105 CMR 650.004
Statutory Definitions
Banned Hazardous Substance, any toy, or other article intended for use by children, which is a
hazardous substance, or which bears, contains a hazardous substance susceptible of access to a
child, or is otherwise hazardous because it presents electrical, mechanical or thermal hazards;
or any hazardous substance intended or packaged in a form suitable for use in households, which
the commissioner by regulation classifies as a "banned hazardous substance" on the basis of a
finding that notwithstanding cautionary labeling required under 105 CMR 650.000, the degree
or nature of the hazard involved in the presence or use of the substance in households is such that
the protection of the public health and safety can be adequately served only by keeping the
substance out of the channels of commerce. The commissioner, by regulation, shall, however,
exempt articles, such as chemical sets, which by reason of their functional purpose, require the
inclusion of the hazardous substance involved or necessarily present an electrical, mechanical,
or thermal hazard, and which bear labeling giving adequate direction and warnings for safe use
and are intended for use by children who have attained sufficient maturity and who may
reasonably be expected to read and heed these warnings.
Children's Reusable Food or Beverage Containers Containing Bisphenol-A means reusable
bottles or cups that contain bisphenol-A and that are designed and intended by a manufacturer
to be filled with food or liquid and used by children age three or younger.
Combustible, any substance or mixture of substances which has a flash point from 80° to and
including 150°F, as determined by the Tagliabue Open Cup Tester.
Commerce, any and all commerce within the commonwealth, including the operation of any
business or service establishment.
Commissioner, the Commissioner of Public Health.
Corrosive, any substance which when in contact with living tissue will cause destruction of such
tissue by chemical action.
Department, the Department of Public Health.
Electrical Hazard, an article which in normal use, or when subjected to reasonably foreseeable
damage or abuse by its design or manufacture, may cause personal injury or illness by electrical
shock.
Extremely Flammable, when used with respect to a substance, any substance which has a flash
point at or below 20° as determined by the Tagliabue Open Cup Tester.
Flammable, when used with respect to a substance, any substance which has a flash point of
above 20° to and including 80°F, as determined by the Tagliabue Open Cup Tester; when used
with respect to all items of wearing apparel in sizes 0 through 6X intended to be worn primarily
for sleeping or activities related to sleeping and for fabric or related material intended or
promoted for use in such wearing apparel, which exceeds the acceptance criteria specified in the
federal children's sleepwear standard, DOC FF 3-71, and determined by an appropriate test
performed in accordance with said standard; or when used with respect to all items of wearing
apparel in sizes seven through 14 intended to be worn primarily for sleeping or activities related
to sleeping and for fabric or related material intended or promoted for use in such wearing
apparel, which exceeds the acceptance criteria specified in the federal children's sleepwear
standard, FF 5-74, and determined by an appropriate test performed in accordance with said
standard; provided, that the flammability of solids and of the contents of self-pressurized
containers shall be determined by methods generally recognized as applicable to such containers
and established by regulations issued by the commissioner.
Hazardous Substance, any substance or mixture of substances which is toxic, corrosive, an
irritant, a strong sensitizer, flammable or which generates pressure through decomposition, heat,
or other means, if such substance or mixture of substances may cause substantial personal injury
or substantial illness during or as a proximate result of any customary or reasonably foreseeable
handling or use, including reasonable foreseeable ingestion by children, or any toy or other
article intended for use by children which presents an electrical, mechanical or thermal hazard.
It shall include any radioactive substance if, with respect to such substance as used in a particular
class of article or as packaged, the commissioner determines by regulation that the substance is
sufficiently hazardous to require labeling in accordance with 105 CMR 650.000 in order to
protect the public health. It shall not include economic poisons subject to the Federal Insecticide,
Fungicide and Rodenticide Act, unless the Commissioner finds that such economic poison is not
adequately labeled for the protection of the public health, nor foods, drugs and cosmetics subject
to the Federal Drug and Cosmetic Act or M.G.L. c. 94 nor substances intended for use as fuels
when stored in containers and used in heating, cooking, or refrigeration systems. It shall include
any article which is not itself an economic poison within the meaning of the Federal Insecticide,
Fungicide and Rodenticide Act but which is a hazardous substance within the meaning of this
definition by reason of bearing or containing such economic poison.
Hazardous Substances Intended or Packaged in a Form Suitable for Use in the Household,
means any hazardous substance, whether or not packaged, that under any customary or
reasonably foreseeable condition of purchase, storage, or use may be brought into or around a
house, apartment, or other place where people dwell, or in or around any related building or shed
including, but not limited to, a garage, carport, barn, or storage shed.
Highly Toxic, when used with respect to a substance, any substance which:
(a) produces death within 14 days in half or more than half of a group of ten or more
laboratory white rats each weighing between 200 and 300 grams, at a single dose of 50
milligrams or less per kilogram of body weight, when orally administered; or
(b) produces death within 14 days in half or more than half of a group of ten or more
laboratory white rats each weighing between 200 and 300 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 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
(c) produces death within 14 days in half or more than half of a group of ten or more rabbits
tests in a dosage of 200 milligrams or less per kilogram of body weight, when administered
by continuous contact with the bare skin for 24 hours or less; provided that if the com
missioner finds that available data on human experience with any substance indicate results
different from those obtained on animals with the aforesaid dosages or concentrations, the
human data shall take precedence.
Immediate Container, excludes a package liner.
Irritant, any substance not corrosive which on immediate, prolonged or repeated contact with
normal living tissue will induce a local inflammatory reaction. "Irritant" includes "primary
irritant to the skin" as well as substances irritant to the eye or to mucous membranes. "Primary
irritant" means a substance that is not corrosive and that human experience data indicate is a
primary irritant. "Eye irritant" means a substance that human experience data indicate is an
irritant to the eye.
Label, a display of written, printed or graphic matter upon the immediate container of any
substance, or in the case of an article which is unpackaged or is not packaged in an immediate
container intended or suitable for delivery to the ultimate consumer, a display of such matter
directly on the article involved or on a tag or other suitable material affixed thereto. A
requirement made by or under the authority of 105 CMR 650.000 that any word, statement, or
other information appear on the label shall not be considered to be complied with unless such
word, statement or other information also appears on the outside container or wrapper, if any
there be, unless it is easily legible through the outside container or wrapper and on all
accompanying literature where there are directions for use, written or otherwise.
Mechanical Hazard, an article which, in normal use or when subjected to reasonable foreseeable
damage or abuse, by its design or manufacturer presents an unreasonable risk of personal injury
or illness from fracture, fragmentation or disassembly of the article, from propulsion of the
article or any part or accessory thereof, from points or other protrusions, surfaces, edges,
openings or closures, from moving parts, from lack or insufficiency of controls to reduce or stop
motion, as a result of self-adhering characteristics of the article, because the article or any part
or accessory thereof may be aspirated or ingested, because of instability, or any other aspect of
the article's design or manufacture.
Misbranded Package or Misbranded Package of a Hazardous Substance, a hazardous substance
in a container, or not in a container if the substance can be handled or transported without one,
which is intended or suitable for household use or personal use and which, except as otherwise
provided by or pursuant to 105 CMR 650.002, fails to bear a label which states prominently in
the English language, in conspicuous and legible type in contrast by typography, layout or color
with other printed matter on the label,
(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 its
hazard, unless the commissioner by regulation permits or requires the use of a recognized
generic name;
(c) the signal word "DANGER" on substances which are corrosive, extremely flammable
or highly toxic;
(d) the signal word "WARNING" or "CAUTION" on all other hazardous substances;
(e) an affirmative statement of the principal hazard or hazards, such 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 regulations of the commissioner pursuant to 105 CMR 650.002;
(g) instructions, when necessary or appropriate, for first-aid treatment;
(h)
the word "POISON" for any hazardous substance which is defined as "HIGHLY
TOXIC" by 105 CMR 650.004;
(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.
Person, includes an individual, partnership, corporation, association, or legal representative or
agent.
Proximate Result means a result that follows in the course of events without an unforeseeable,
intervening, independent cause.
Radioactive Substance, a substance which emits ionizing radiation.
Reasonably Foreseeable Handling or Use includes the reasonably foreseeable accidental handling
or use, not only by the purchaser or intended user of the product, by all others in a household,
specially children.
Snuff, is a form of smokeless tobacco, often referred to as such, which is a finely ground or cut
tobacco mixture that is intended to be placed in the oral cavity.
Strong Sensitizer, a substance which will cause on normal living tissue, through an allergic or
photodynamic process, a hypersensitivity which becomes evident on reapplication of the same
substance and which is designated as such by the commissioner. Before designating any
substance as a strong sensitizer, the commissioner, upon consideration of the frequency of
occurrence and severity of the reaction, shall find that the substance has a significant potential
for causing hypersensitivity.
(a) Strong Allergic Sensitizer, is a substance that produces an allergenic senitization in a
substantial number of persons who come into contact with it. An allergic sensitization
develops by means of an "antibody mechanism" in contradistinction to a primary irritant
reaction which does not arise because of the participation of an "antibody mechanism". An
allergic reaction ordinarily does not develop on first contact because of necessity or prior
exposure to the substance in question. The sensitized tissue exhibits a greatly increased
capacity to react to subsequent exposures of the offending agent. Subsequent exposures may
therefore produce severe reactions with little correlation to the amount of excitant involved.
(b) Photodynamic Sensitizer, is a substance that causes an alteration in the skin or mucous
membranes in general or to the skin or mucous membrane at the site of contact so that when
these areas are subsequently exposed to ordinary sunlight (or equivalent radiant energy) an
inflammatory reaction will develop.
Substantial Personal Injury or Illness means any injury or illness of a significant nature. It need
not be severe or serious. What is excluded by the word "substantial" is a wholly insignificant or
negligible injury or illness.
Thermal Hazard, an article which, in normal use or when subjected to reasonably foreseeable
damage or abuse, by its design or manufacture presents an unreasonable risk of personal injury
or illness because of heat as from heated parts, substances or surfaces.
Toxic, when used with respect to a substance, any substance, other than a radioactive substance,
which has the capacity to produce personal injury or illness to man through ingestion, inhalation,
or absorption through any body surface.