[Code of Federal Regulations]
[Title 16, Volume 2, Parts 1000 to end]
[Revised as of January 1, 1998]
From the U.S. Government Printing Office via GPO Access
[CITE: 16CFR1700]
[Page 661-676]
TITLE 16--COMMERCIAL PRACTICES
CHAPTER II--CONSUMER PRODUCT SAFETY COMMISSION
PART 1700--POISON PREVENTION PACKAGING
Sec.
1700.1 Definitions.
1700.2 Authority.
1700.3 Establishment of standards for special packaging.
1700.4 Effective date of standards.
1700.5 Noncomplying package requirements.
1700.14 Substances requiring special packaging.
1700.15 Poison prevention packaging standards.
1700.20 Testing procedure for special packaging.
Authority: 15 U.S.C. 1471-76. Secs. 1700.1 and 1700.14 also issued
under 15 U.S.C. 2079(a).
Source: 38 FR 21247, Aug. 7, 1973, unless otherwise noted.
Sec. 1700.1 Definitions.
(a) As used in this part:
(1) Act means the Poison Prevention Packaging Act of 1970 (Pub. L.
91-601, 84 Stat. 1670-74; 15 U.S.C. 1471-75), enacted December 30, 1970.
(2) Commission means the Consumer Product Safety Commission
established by section 4 of the Consumer Product Safety Act (86 Stat.
1210; 15 U.S.C. 2053).
(3) Dietary supplement means any vitamin and/or mineral preparation
offered in tablet, capsule, wafer, or other similar uniform unit form;
in powder, granule, flake, or liquid form; or in the physical form of a
conventional food but which is not a conventional food; and which
purports or is represented to be for special dietary use by humans to
supplement their diets by increasing the total dietary intake of one or
more of the essential vitamins and/or minerals.
(b) Except for the definition of ``Secretary,'' which is obsolete,
the definitions given in section 2 of the act are applicable to this
part and are repeated herein for convenience as follows:
(1) [Reserved]
(2) Household substance means any substance which is customarily
produced or distributed for sale for consumption or use, or customarily
stored, by individuals in or about the household and which is:
(i) A hazardous substance as that term is defined in section 2(f) of
the Federal Hazardous Substances Act (15 U.S.C. 1261(f));
(ii) A food, drug, or cosmetic as those terms are defined in section
201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321); or
(iii) A substance intended for use as fuel when stored in a portable
container and used in the heating, cooking, or refrigeration system of a
house.
(3) Package means the immediate container or wrapping in which any
household substance is contained for consumption, use, or storage by
individuals in or about the household and, for purposes of section
4(a)(2) of the act, also means any outer container or wrapping used in
the retail display of any such substance to consumers. ``Package'' does
not include:
(i) Any shipping container or wrapping used solely for the
transportation of any household substance in bulk or in quantity to
manufacturers, packers, or processors, or to wholesale or retail
distributors thereof; or
(ii) Any shipping container or outer wrapping used by retailers to
ship or deliver any household substance to consumers unless it is the
only such container or wrapping.
(4) Special packaging means packaging that is designed or
constructed to be significantly difficult for children under 5 years of
age to open or obtain a toxic or harmful amount of the substance
contained therein within a reasonable time and not difficult for normal
adults to use properly, but does not mean packaging which all such
children cannot open or obtain a toxic or harmful amount within a
reasonable time.
(5) Labeling means all labels and other written, printed, or graphic
matter upon any household substance or its package, or accompanying such
substance.
[[Page 662]]
(Pub. L. 92-573, sec. 30(a), 86 Stat. 1231; (15 U.S.C. 2079(a)))
[38 FR 21247, Aug. 7, 1973, as amended at 41 FR 22266, June 2, 1976; 48
FR 57480, Dec. 30, 1983]
Sec. 1700.2 Authority.
Authority under the Poison Prevention Packaging Act of 1970 is
vested in the Consumer Product Safety Commission by section 30(a) of the
Consumer Product Safety Act (15 U.S.C. 2079(a)).
Sec. 1700.3 Establishment of standards for special packaging.
(a) Pursuant to section 3 of the act, the Commission, after
consultation with the technical advisory committee provided for by
section 6 of the act, may establish by regulation standards for the
special packaging of any household substance if the Commission finds:
(1) That the degree or nature of the hazard to children in the
availability of such substance, by reason of its packaging, is such that
special packaging is required to protect children from serious personal
injury or serious illness resulting from handling, using, or ingesting
such substance; and
(2) That the special packaging to be required by such standard is
technically feasible, practicable, and appropriate for such substance.
(b) In establishing such a standard, the Commission shall consider:
(1) The reasonableness of such standard;
(2) Available scientific, medical, and engineering data concerning
special packaging and concerning childhood accidental ingestions,
illness, and injury caused by household substances;
(3) The manufacturing practices of industries affected by the act;
and
(4) The nature and use of the household substance.
(c) In the process of establishing such a standard, the Commission
shall publish its findings and reasons therefor and shall cite the
sections of the act that authorize its action.
(d) In establishing such standards, the Commission shall not
prescribe specific packaging designs, product content, package quantity,
or labeling except for labeling under section 4(a)(2) of the act.
Regarding a household substance for which special packaging is required
by regulation, the Commission can prohibit the packaging of such
substance in a package which the Commission determines is unnecessarily
attractive to children.
(e) Promulgations pursuant to section 3 of the act shall be in
accordance with section 5 of the act as to procedure.
Sec. 1700.4 Effective date of standards.
(a) The FR document promulgating a regulation establishing a child
protection packaging standard shall indicate the standard's effective
date. Section 9 of the act specifies that the effective date shall not
be sooner than 180 days or later than 1 year from the date the standard
is promulgated in the Federal Register unless the Commission, for good
cause found, determines that an earlier effective date is in the public
interest and publishes in the Federal Register the reason for such
finding, in which case such earlier effective date shall apply.
(b) Upon becoming effective, a child protection packaging standard
shall apply only to household substances packaged on and after its
effective date.
Sec. 1700.5 Noncomplying package requirements.
To make household substances that are subject to requirements for
special packaging readily available to elderly or handicapped persons
who are unable to use those substances in special packaging, section
4(a) of the act authorizes manufacturers and packers to package such
substances in noncomplying packaging of a single size provided that
complying packaging is also supplied and the noncomplying packages are
conspicuously labeled to indicate that they should not be used in
households where young children are present. The purpose of this
Sec. 1700.5 is to implement section 4(a) of the act by prescribing
requirements for the labeling of noncomplying packages.
(a) Labeling statement. (1) The statement ``This Package for
Households Without Young Children'' shall appear conspicuously, and in
accordance with all of the requirements of paragraph (a) of this
section, on the package of any
[[Page 663]]
household substance subject to the special packaging requirements of
this part 1700 that is supplied in noncomplying packaging under section
4(a) of the act, unless the package bears the substitute labeling
statement in accordance with all of the requirements of paragraph (b) of
this section.
(2) The statement required by paragraph (a)(1) of this section shall
appear on the principal display panel of the immediate container as well
as on the principal display panel of any outer container or wrapping
used in the retail display of the substance. If a package bears more
than one principal display panel, the required statement shall appear on
each principal display panel of the immediate container as well as on
each principal display panel of any outer container or wrapping used in
the retail display of the substance. The principal display panel is the
part of the labeling most likely to be displayed, presented, shown, or
examined.
(3) The required labeling statement shall appear within the
borderline of a square or rectangle on the principal display panel in
conspicuous and easily legible capital letters, shall be in distinct
contrast, by typography, layout, color, or embossing, to other matter on
the package, and shall appear in lines generally parallel to the base on
which the package rests as it is designed to be displayed.
(4) The declaration shall be in letters in type size established in
relationship to the area of the principal display panel of the package
and shall be uniform for all packages of substantially the same size by
complying with the following type-size specifications:
(i) Not less than \1/16\ inch in height on packages the principal
display panel of which has an area of 7 square inches or less.
(ii) Not less than \3/32\ inch in height on packages the principal
display panel of which has an area of more than 7 but not more than 15
square inches.
(iii) Not less than \1/8\ inch in height on packages the principal
display panel of which has an area of more than 15 but not more than 25
square inches.
(iv) Not less than \3/16\ inch in height on packages the principal
display panel of which has an area of more than 25 but not more than 100
square inches.
(v) Not less than \1/4\ inch in height on packages the principal
display panel of which has an area of more than 100 square inches.
(5)(i) For the purpose of obtaining uniform type size for the
required statement for all packages of substantially the same size, the
area of the principal display panel is the area of the side or surface
that bears the principal display panel, which shall be:
(A) In the case of a rectangular package where one entire side
properly can be considered to be the principal display panel, the
product of the height times the width of that side.
(B) In the case of a cylindrical or nearly cylindrical container, 40
percent of the product of the height of the container times the
circumference.
(C) In the case of any other shape of container, 40 percent of the
total surface of the container; however, if such container presents an
obvious principal display (such as the top of a triangular or circular
package), the area shall consist of the entire area of such obvious
principal display panel.
(ii) In determining the area of the principal display panel exclude
tops, bottoms, flanges at the tops and bottoms of cans, and shoulders
and necks of bottles or jars. In the case of cylindrical or nearly
cylindrical containers, the labeling statement required by this section
to appear on the principal display panel shall appear within that 40
percent of the circumference most likely to be displayed, presented,
shown, or examined.
(b) Substitute labeling statement. If the area of the principal
display panel, as determined in accordance with paragraph (a)(5) of this
section, is too small to accommodate the statement required by paragraph
(a)(1) using the type size required by paragraph (a)(4), the substitute
statement ``Package Not Child-Resistant'' may be used. This substitute
statement must comply with all of the requirements for size, placement,
and conspicuousness prescribed by paragraph (a) of this section.
[40 FR 4650, Jan. 31, 1975]
[[Page 664]]
Sec. 1700.14 Substances requiring special packaging.
(a) Substances. The Commission has determined that the degree or
nature of the hazard to children in the availability of the following
substances, by reason of their packaging, is such that special packaging
meeting the requirements of Sec. 1700.20(a) is required to protect
children from serious personal injury or serious illness resulting from
handling, using, or ingesting such substances, and the special packaging
herein required is technically feasible, practicable, and appropriate
for these substances:
(1) Aspirin. Any aspirin-containing preparation for human use in a
dosage form intended for oral administration shall be packaged in
accordance with the provisions of Sec. 1700.15 (a), (b), and (c), except
the following:
(i) Effervescent tablets containing aspirin, other than those
intended for pediatric use, provided the dry tablet contains not more
than 15 percent aspirin and has an oral LD-50 in rats of 5 grams or more
per kilogram of body weight.
(ii) Unflavored aspirin-containing preparations in powder form
(other than those intended for pediatric use) that are packaged in unit
doses providing not more than 15.4 grains of aspirin per unit dose and
that contain no other substance subject to the provisions of this
section.
(2) Furniture polish. Nonemulsion type liquid furniture polishes
containing 10 percent or more of mineral seal oil and/or other petroleum
distillates and having a viscosity of less than 100 Saybolt universal
seconds at 100 deg.F., other than those packaged in pressurized spray
containers, shall be packaged in accordance with the provisions of
Sec. 1700.15 (a), (b), and (d).
(3) Methyl salicylate. Liquid preparations containing more than 5
percent by weight of methyl salicylate, other than those packaged in
pressurized spray containers, shall be packaged in accordance with the
provisions of Sec. 1700.15 (a), (b), and (c).
(4) Controlled drugs. Any preparation for human use that consists in
whole or in part of any substance subject to control under the
Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C.
801 et seq.) and that is in a dosage form intended for oral
administration shall be packaged in accordance with the provisions of
Sec. 1700.15 (a), (b), and (c).
(5) Sodium and/or potassium hydroxide. Household substances in dry
forms such as granules, powder, and flakes, containing 10 percent or
more by weight of free or chemically unneutralized sodium and/or
potassium hydroxide, and all other household substances containing 2
percent or more by weight of free or chemically unneutralized sodium
and/or potassium hydroxide, shall be packaged in accordance with the
provisions of Sec. 1700.15 (a) and (b).
(6) Turpentine. Household substances in liquid form containing 10
percent or more by weight of turpentine shall be packaged in accordance
with the provisions of Sec. 1700.15 (a) and (b).
(7) Kindling and/or illuminating preparations. Prepackaged liquid
kindling and/or illuminating preparations, such as cigarette lighter
fuel, charcoal lighter fuel, camping equipment fuel, torch fuel, and
fuel for decorative or functional lanterns, which contain 10 percent or
more by weight of petroleum distillates and have a viscosity of less
than 100 Saybolt universal seconds at 100 deg.F., shall be packaged in
accordance with the provisions of Sec. 1700.15 (a) and (b).
(8) Methyl alcohol (methanol). Household substances in liquid form
containing 4 percent or more by weight of methyl alcohol (methanol),
other than those packaged in pressurized spray containers, shall be
packaged in accordance with the provisions of Sec. 1700.15 (a) and (b).
(9) Sulfuric acid. Household substances containing 10 percent or
more by weight of sulfuric acid, except such substances in wet-cell
storage batteries, shall be packaged in accordance with the provisions
of Sec. 1700.15 (a) and (b).
(10) Prescription drugs. Any drug for human use that is in a dosage
form intended for oral administration and that is required by Federal
law to be dispensed only by or upon an oral or written prescription of a
practitioner licensed by law to administer such drug shall be packaged
in accordance with
[[Page 665]]
the provisions of Sec. 1700.15 (a), (b), and (c), except for the
following:
(i) Sublingual dosage forms of nitroglycerin.
(ii) Sublingual and chewable forms of isosorbide dinitrate in dosage
strengths of 10 milligrams or less.
(iii) Erythromycin ethylsuccinate granules for oral suspension and
oral suspensions in packages containing not more than 8 grams of the
equivalent of erythromycin.
(iv) Cyclically administered oral contraceptives in manufacturers'
mnemonic (memory-aid) dispenser packages that rely solely upon the
activity of one or more progestogen or estrogen substances.
(v) Anhydrous cholestyramine in powder form.
(vi) All unit dose forms of potassium supplements, including
individually-wrapped effervescent tablets, unit dose vials of liquid
potassium, and powdered potassium in unit-dose packets, containing not
more than 50 milliequivalents of potassium per unit dose.
(vii) Sodium fluoride drug preparations, including liquid and tablet
forms, containing no more than 264 milligrams of sodium fluoride per
package and containing no other substances subject to this
Sec. 1700.14(a)(10).
(viii) Betamethasone tablets packaged in manufacturers' dispenser
packages, containing no more than 12.6 milligrams betamethasone.
(ix) Pancrelipase preparations in tablet, capsule, or powder form
and containing no other substances subject to this Sec. 1700.14(a)(10).
(x) Prednisone in tablet form, when dispensed in packages containing
no more than 105 mg. of the drug, and containing no other substances
subject to this Sec. 1700.14(a)(10).
(xi)-(xii) [Reserved]
(xiii) Mebendazole in tablet form in packages containing not more
than 600 mg. of the drug, and containing no other substance subject to
the provisions of this section.
(xiv) Methylprednisolone in tablet form in packages containing not
more than 84 mg of the drug and containing no other substance subject to
the provisions of this section.
(xv) Colestipol in powder form in packages containing not more than
5 grams of the drug and containing no other substance subject to the
provisions of this section.
(xvi) Erythromycin ethylsuccinate tablets in packages containing no
more than the equivalent of 16 grams erythromycin.
(xvii) Conjugated Estrogens Tablets, U.S.P., when dispensed in
mnemonic packages containing not more than 32.0 mg of the drug and
containing no other substances subject to this Sec. 1700.14(a)(10).
(xviii) Norethindrone Acetate Tablets, U.S.P., when dispensed in
mnemonic packages containing not more than 50 mg of the drug and
containing no other substances subject to this Sec. 1700.14(a)(10).
(xix) Medroxyprogesterone acetate tablets.
(11) Ethylene glycol. Household substances in liquid form containing
10 percent or more by weight of ethylene glycol packaged on or after
June 1, 1974, except those articles exempted by 16 CFR 1500.83, shall be
packaged in accordance with the provisions of Sec. 1700.15 (a) and (b).
(12) Iron-containing drugs. With the exception of: (i) Animal feeds
used as vehicles for the administration of drugs, and (ii) those
preparations in which iron is present solely as a colorant,
noninjectable animal and human drugs providing iron for therapeutic or
prophylactic purposes, and containing a total amount of elemental iron,
from any source, in a single package, equivalent to 250 mg or more
elemental iron in a concentration of 0.025 percent or more on a weight
to volume basis for liquids and 0.025 percent or more on a weight to
volume basis for liquids and 0.05 percent or more on a weight-to-weight
basis for nonliquids (e.g., powders, granules, tablets, capsules,
wafers, gels, viscous products, such as pastes and ointments, etc.)
shall be packaged in accordance with the provisions of Sec. 1700.15 (a),
(b), and (c).
(13) Dietary supplements containing iron. Dietary supplements, as
defined in Sec. 1700.1(a)(3), that contain an equivalent of 250 mg or
more of elemental iron, from any source, in a single package in
concentrations of 0.025 percent or more on a weight-to-volume basis for
liquids
[[Page 666]]
and 0.05 percent or more on a weight-to-weight basis for nonliquids
(e.g., powders, granules, tablets, capsules, wafers, gels, viscous
products, such as pastes and ointments, etc.) shall be packaged in
accordance with the provisions of Sec. 1700.15 (a), (b), and (c), except
for the following:
(i) Preparations in which iron is present solely as a colorant; and
(ii) Powdered preparations with no more than the equivalent of 0.12
percent weight-to-weight elemental iron.
(14) [Reserved]
(15) Solvents for paint or other similar surface-coating material.
Prepackaged liquid solvents (such as removers, thinners, brush cleaners,
etc.) for paints or other similar surface-coating materials (such as
varnishes and lacquers), that contain 10 percent or more by weight of
benzene (also known as benzol), toluene (also known as toluol), xylene
(also known as xylol), petroleum distillates (such as gasoline,
kerosene, mineral seal oil, mineral spirits, naphtha, and Stoddard
solvent, etc.), or combinations thereof, and that have a viscosity of
less than 100 Saybolt universal seconds at 100 deg.F., shall be
packaged in accordance with the provisions of Sec. 1700.15 (a) and (b).
(16) Acetaminophen. Preparations for human use in a dosage form
intended for oral administration and containing in a single package a
total of more than one gram acetaminophen shall be packaged in
accordance with the provisions of Sec. 1700.15 (a), (b), and (c), except
the following--
(i) Effervescent tablets or granules containing acetaminophen,
provided the dry tablet or granules contain less than 15 percent
acetaminophen, the tablet or granules have an oral LD-50 of 5 grams or
greater per kilogram of body weight, and the tablet or granules contain
no other substance subject to the provisions of this section.
(ii) Unflavored acetaminophen-containing preparations in powder form
(other than those intended for pediatric use) that are packaged in unit
doses providing not more than 13 grains of acetaminophen per unit dose
and that contain no other substance subject to this Sec. 1700.14(a).
(17) Diphenhydramine. Preparations for human use in a dosage form
intended for oral administration and containing more than the equivalent
of 66 mg diphenhydramine base in a single package shall be packaged in
accordance with the provisions of Sec. 1700.15 (a), (b), and (c), if
packaged on or after February 11, 1985.
(18) Glue removers containing acetonitrile. Household glue removers
in a liquid form containing more than 500 mg of acetonitrile in a single
container.
(19) Permanent wave neutralizers containing sodium bromate or
potassium bromate. Home permanent wave neutralizers, in a liquid form,
containing in single container more than 600 mg of sodium bromate or
more than 50 mg of potassium bromate.
(20) Ibuprofen. Ibuprofen preparations for human use in a dosage
form intended for oral administration and containing one gram (1,000 mg)
or more of ibuprofen in a single package shall be packaged in accordance
with the provisions of Sec. 1700.15 (a), (b), and (c).
(21) Loperamide. Preparations for human use in a dosage form
intended for oral administration and containing more than 0.045 mg of
loperamide in a single package (i.e., retail unit) shall be packaged in
accordance with the provisions of Sec. 1700.15 (a), (b), and (c).
(22) Mouthwash. Except as provided in the following sentence,
mouthwash preparations for human use and containing 3 g or more of
ethanol in a single package shall be packaged in accordance with the
provisions of Sec. 1700.15 (a), (b), and (c). Mouthwash products with
nonremovable pump dispensers that contain at least 7% on a weight-to-
weight basis of mint or cinnamon flavoring oils, that dispense no more
than 0.03 grams of absolute ethanol per pump actuation, and that contain
less than 15 grams of ethanol in a single unit are exempt from this
requirement. The term ``mouthwash'' includes liquid products that are
variously called mouthwashes, mouthrinses, oral antiseptics, gargles,
fluoride rinses, anti-plaque rinses, and breath fresheners. It does not
include throat sprays or aerosol breath fresheners.
(23) Lidocaine. Products containing more than 5.0 mg of lidocaine in
a single package (i.e., retail unit) shall be packaged in accordance
with the provisions of Sec. 1700.15 (a) and (b).
[[Page 667]]
(24) Dibucaine. Products containing more than 0.5 mg of dibucaine in
a single package (i.e., retail unit) shall be packaged in accordance
with the provisions of Sec. 1700.15 (a) and (b).
(25) Naproxen. Naproxen preparations for human use and containing
the equivalent of 250 mg or more of naproxen in a single retail package
shall be packaged in accordance with the provisions of Sec. 1700.15 (a),
(b), and (c).
(26) Ketoprofen. Ketoprofen preparations for human use and
containing more than 50 mg of ketoprofen in a single retail package
shall be packaged in accordance with the provisions of Sec. 1700.15 (a),
(b) and (c).
(b) Sample packages. (1) The manufacturer or packer of any of the
substances listed under paragraph (a) of this section as substances
requiring special packaging shall provide the Commission with a sample
of each type of special packaging, as well as the labeling for each size
product that will be packaged in special packaging and the labeling for
any noncomplying package. Sample packages and labeling should be sent to
the Consumer Product Safety Commission, Office of Compliance, 4330 East
West Highway, Washington, DC 20207.
(2) Sample packages should be submitted without contents when such
contents are unnecessary for demonstrating the effectiveness of the
packaging.
(3) Any sample packages containing drugs listed under paragraph (a)
of this section shall be sent by registered mail.
(4) As used in paragraph (b)(1) of this section, the term
manufacturer or packer does not include pharmacists and other
individuals who dispense, at the retail or user level, drugs listed
under paragraph (a) of this section as requiring special packaging.
(c) Applicability. Special packaging standards for drugs listed
under paragraph (a) of this section shall be in addition to any
packaging requirements of the Federal Food, Drug, and Cosmetic Act or
regulations promulgated thereunder or of any official compendia
recognized by that act.
(Pub. L. 91-601, secs. 2(4), 3, 5, 85 Stat. 1670-72; 15 U.S.C. 1471(4),
1472, 1474; Pub. L. 92-573, 86 Stat. 1231; 15 U.S.C. 2079(a))
[38 FR 21247, Aug. 7, 1973]
Editorial Note: For Federal Register citations affecting
Sec. 1700.14, see the List of CFR Sections Affected in the Finding Aids
section of this volume.
Sec. 1700.15 Poison prevention packaging standards.
To protect children from serious personal injury or serious illness
resulting from handling, using, or ingesting household substances, the
Commission has determined that packaging designed and constructed to
meet the following standards shall be regarded as ``special packaging''
within the meaning of section 2(4) of the act. Specific application of
these standards to substances requiring special packaging is in
accordance with Sec. 1700.14.
(a) General requirements. The special packaging must continue to
function with the effectiveness specifications set forth in paragraph
(b) of this section when in actual contact with the substance contained
therein. This requirement may be satisfied by appropriate scientific
evaluation of the compatibility of the substance with the special
packaging to determine that the chemical and physical characteristics of
the substance will not compromise or interfere with the proper
functioning of the special packaging. The special packaging must also
continue to function with the effectiveness specifications set forth in
paragraph (b) of this section for the number of openings and closings
customary for its size and contents. This requirement may be satisfied
by appropriate technical evaluation based on physical wear and stress
factors, force required for activation, and other such relevant factors
which establish that, for the duration of normal use, the effectiveness
specifications of the packaging would not be expected to lessen.
(b) Effectiveness specifications. Special packaging, tested by the
method described in Sec. 1700.20, shall meet the following
specifications:
(1) Child-resistant effectiveness of not less than 85 percent
without a demonstration and not less than 80 percent after a
demonstration of the proper
[[Page 668]]
means of opening such special packaging. In the case of unit packaging,
child-resistant effectiveness of not less than 80 percent.
(2) Ease of adult opening. (i) Senior-adult test. Except for
products specified in paragraph (b)(2)(ii) of this section, special
packaging shall have a senior adult use effectiveness (SAUE) of not less
than 90% for the senior-adult panel test of Sec. 1700.20(a)(3).
(ii) Younger-adult test. (A) When applicable. Products that must be
in aerosol form and products that require metal containers, under the
criteria specified below, shall have an effectiveness of not less than
90% for the younger-adult test of Sec. 1700.20(a)(4). The senior-adult
panel test of Sec. 1700.20(a)(3) does not apply to these products. For
the purposes of this paragraph, metal containers are those that have
both a metal package and a recloseable metal closure, and aerosol
products are self-contained pressurized products.
(B) Determination of need for metal or aerosol container.
(1) Criteria. A product will be deemed to require metal containers
or aerosol form only if:
(i) No other packaging type would comply with other state or Federal
regulations,
(ii) No other packaging can reasonably be used for the product's
intended application,
(iii) No other packaging or closure material would be compatible
with the substance,
(iv) No other suitable packaging type would provide adequate shelf-
life for the product's intended use, or
(v) Any other reason clearly demonstrates that such packaging is
required.
(2) Presumption. In the absence of convincing evidence to the
contrary, a product shall be presumed not to require a metal container
if the product, or another product of identical composition, has
previously been marketed in packaging using either a nonmetal package or
a nonmetal closure.
(3) Justification. A manufacturer or packager of a product that is
in a metal container or aerosol form that the manufacturer or packager
contends is not required to comply with the SAUE requirements of
Sec. 1700.20(a)(3) shall provide, if requested by the Commission's
staff, a written explanation of why the product must have a metal
container or be an aerosol. Manufacturers and packagers who wish to do
so voluntarily may submit to the Commission's Office of Compliance a
rationale for why their product must be in metal containers or be an
aerosol. In such cases, the staff will reply to the manufacturer or
packager, if requested, stating the staff's views on the adequacy of the
rationale.
(c) Reuse of special packaging. Special packaging for substances
subject to the provisions of this paragraph shall not be reused.
(d) Restricted flow. Special packaging subject to the provisions of
this paragraph shall be special packaging from which the flow of liquid
is so restricted that not more than 2 milliliters of the contents can be
obtained when the inverted, opened container is taken or squeezed once
or when the container is otherwise activated once.
(Secs. 2(4), 3, 5, 84 Stat. 1670-72; 15 U.S.C. 1471(4), 1472, 1474)
[38 FR 21247, Aug. 7, 1973, as amended at 60 FR 37734, July 21, 1995]
Sec. 1700.20 Testing procedure for special packaging.
(a) Test protocols--(1) General requirements--(i) Requirements for
packaging. As specified in Sec. 1700.15(b), special packaging is
required to meet the child test requirements and the applicable adult
test requirements of this Sec. 1700.20.
(ii) Condition of packages to be tested. (A) Tamper-resistant
feature. Any tamper-resistant feature of the package to be tested shall
be removed prior to testing unless it is part of the package's child-
resistant design. Where a package is supplied to the consumer in an
outer package that is not part of the package's child-resistant design,
one of the following situations applies:
(1) In the child test, the package is removed from the outer
package, and the outer package is not given to the child.
(2) In both the adult tests, if the outer package bears instructions
for how to open or properly resecure the package, the package shall be
given to the test subject in the outer package.
[[Page 669]]
The time required to remove the package from the outer package is not
counted in the times allowed for attempting to open and, if appropriate,
reclose the package.
(3) In both the adult tests, if the outer package does not bear any
instructions relevant to the test, the package will be removed from the
outer package, and the outer package will not be given to the test
subject.
(B) Reclosable packages--adult tests. In both the adult tests,
reclosable packages, if assembled by the testing agency, shall be
properly secured at least 72 hours prior to beginning the test to allow
the materials (e.g., the closure liner) to ``take a set.'' If assembled
by the testing agency, torque-dependent closures shall be secured at the
same on-torque as applied on the packaging line. Application torques
must be recorded in the test report. All packages shall be handled so
that no damage or jarring will occur during storage or transportation.
The packages shall not be exposed to extreme conditions of heat or cold.
The packages shall be tested at room temperature.
(2) Child test. (i) Test subjects. (A) Selection criteria. Use from
1 to 4 groups of 50 children, as required under the sequential testing
criteria in table 1. No more than 20% of the children in each group
shall be tested at or obtained from any given site. Each group of
children shall be randomly selected as to age, subject to the
limitations set forth below. Thirty percent of the children in each
group shall be of age 42-44 months, 40% of the children in each group
shall be of age 45-48 months, and 30% of the children in each group
shall be of age 49-51 months. The children's ages in months shall be
calculated as follows:
(1) Arrange the birth date and test date by the numerical
designations for month, day, and year (e.g., test date: 8/3/1990; birth
date: 6/23/1986).
(2) Subtract the month, day, and year numbers for the birth date
from the respective numbers for the test date. This may result in
negative numbers for the months or days. (e.g.,
[GRAPHIC] [TIFF OMITTED] TC14NO91.026
(3) Multiply the difference in years by 12 to obtain the number of
months in the difference in years, and add this value to the number of
months that was obtained when the birth date was subtracted from the
test date (i.e., 4 x 12 = 48; 48 + 2 = 50). This figure either will
remain the same or be adjusted up or down by 1 month, depending on the
number of days obtained in the subtraction of the birth date from the
test date.
(4) If the number of days obtained by subtracting the days in the
birth date from the days in the test date is +16 or more, 1 month is
added to the number of months obtained above. If the number of days is
-16 or less, subtract 1 month. If the number of days is between -15 and
+15 inclusive, no change is made in the number of months. Thus, for the
example given above, the number of days is -20, and the number of months
is therefore 50 - 1 = 49 months.
(B) Gender distribution. The difference between the number of boys
and the number of girls in each age range shall not exceed 10% of the
number of children in that range. The children selected should have no
obvious or overt physical or mental handicap. A parent or guardian of
each child shall read and sign a consent form prior to the child's
participation. (The Commission staff will not disregard the results of
tests performed by other parties simply because informed consent for
children is not obtained.)
(ii) Test failures. A test failure shall be any child who opens the
special packaging or gains access to its contents. In the case of unit
packaging, however, a test failure shall be any child who opens or gains
access to the number of individual units which constitute the amount
that may produce serious personal injury or serious illness, or a child
who opens or gains access to more than 8 individual units, whichever
number is lower, during the full 10 minutes of testing. The number
[[Page 670]]
of units that a child opens or gains access to is interpreted as the
individual units from which the product has been or can be removed in
whole or in part. The determination of the amount of a substance that
may produce serious personal injury or serious illness shall be based on
a 25-pound (11.4 kg) child. Manufacturers or packagers intending to use
unit packaging for a substance requiring special packaging are requested
to submit such toxicological data to the Commission's Office of
Compliance.
(iii) Sequential test. The sequential test is initially conducted
using 50 children, and, depending on the results, the criteria in table
1 determine whether the package is either child-resistant or not child-
resistant or whether further testing is required. Further testing is
required if the results are inconclusive and involves the use of one or
more additional groups of 50 children each, up to a maximum of 200
children. No individual shall administer the test to more than 30% of
the children tested in each group. Table 1 gives the acceptance (pass),
continue testing, and rejection (fail) criteria to be used for the first
5 minutes and the full 10 minutes of the children's test. If the test
continues past the initial 50-child panel, the package openings shown in
table 1 are cumulative.
Table 1--Number of Openings: Acceptance (Pass), Continue Testing, and Rejection (Fail) Criteria for the First 5
Minutes and the Full 10 Minutes of the Children's Protocol Test
----------------------------------------------------------------------------------------------------------------
Package openings
Cumulative -----------------------------------------------------------------
Test panel number of First 5 minutes Full 10 minutes
children -----------------------------------------------------------------
Pass Continue Fail Pass Continue Fail
----------------------------------------------------------------------------------------------------------------
1................................. 50 0-3 4-10 11+ 0-5 6-14 15+
2................................. 100 4-10 11-18 19+ 6-15 16-24 25+
3................................. 150 11-18 19-25 26+ 16-25 26-34 35+
4................................. 200 19-30 ......... 31+ 26-40 ......... 41+
----------------------------------------------------------------------------------------------------------------
(iv) Test procedures. The children shall be divided into groups of
two. The testing shall be done in a location that is familiar to the
children, for example, their customary nursery school or regular
kindergarten. No child shall test more than two special packages. When
more than one special package is being tested, each package shall be of
a different ASTM type and they shall be presented to the paired children
in random order. This order shall be recorded. The children shall be
tested by the procedure incorporated in the following test instructions:
Standardized Child Test Instructions
1. Reclosable packages, if assembled by the testing agency, shall be
properly secured at least 72 hours prior to the opening described in
instruction number 3 to allow the materials (e.g., the closure liner) to
``take a set.'' Application torques must be recorded in the test report.
2. All packages shall be handled so that no damage or jarring will
occur during storage or transportation. The packages shall not be
exposed to extreme conditions of heat or cold. The packages shall be
tested at room temperature.
3. Reclosable packages shall be opened and properly resecured one
time (or more if appropriate), by the testing agency or other adult
prior to testing. The opening and resecuring shall not be done in the
presence of the children. (In the adult-resecuring test, the tester must
not open and resecure the package prior to the test.) If multiple
openings/resecurings are to be used, each of four (4) testers shall open
and properly resecure one fourth of the packages once and then shall
open and properly resecure each package a second, third, fourth, through
tenth (or other specified number) time, in the same sequence as the
first opening and resecuring. The packages shall not be opened and
resecured again prior to testing. The name of each tester and the
package numbers that he/she opens and resecures shall be recorded and
reported. It is not necessary for the testers to protocol test the
packages that they opened and resecured.
4. The children shall have no overt physical or mental handicaps. No
child with a permanent or temporary illness, injury, or handicap that
would interfere with his/her effective participation shall be included
in the test.
[[Page 671]]
5. The testing shall take place in a well-lighted location that is
familiar to the children and that is isolated from all distractions.
6. The tester, or another adult, shall escort a pair of children to
the test area. The tester shall seat the two children so that there is
no visual barrier between the children and the tester.
7. The tester shall talk to the children to make them feel at ease.
8. The children shall not be given the impression that they are in a
race or contest. They are not to be told that the test is a game or that
it is fun. They are not to be offered a reward.
9. The tester shall record all data prior to, or after, the test so
that full attention can be on the children during the test period.
10. The tester shall use a stopwatch(s) or other timing devices to
time the number of seconds it takes the child to open the package and to
time the 5-minute test periods.
11. To begin the test, the tester shall hand the children identical
packages and say, ``PLEASE TRY TO OPEN THIS FOR ME.''
12. If a child refuses to participate after the test has started,
the tester shall reassure the child and gently encourage the child to
try. If the child continues to refuse, the tester shall ask the child to
hold the package in his/her lap until the other child is finished. This
pair of children shall not be eliminated from the results unless the
refusing child disrupts the participation of the other child.
13. Each child shall be given up to 5 minutes to open his/her
package. The tester shall watch the children at all times during the
test. The tester shall minimize conversation with the children as long
as they continue to attempt to open their packages. The tester shall not
discourage the children verbally or with facial expressions. If a child
gets frustrated or bored and stops trying to open his/her package, the
tester shall reassure the child and gently encourage the child to keep
trying (e.g., ``please try to open the package'').
14. The children shall be allowed freedom of movement to work on
their packages as long as the tester can watch both children (e.g., they
can stand up, get down on the floor, or bang or pry the package).
15. If a child is endangering himself or others at any time, the
test shall be stopped and the pair of children eliminated from the final
results.
16. The children shall be allowed to talk to each other about
opening the packages and shall be allowed to watch each other try to
open the packages.
17. A child shall not be allowed to try to open the other child's
package.
18. If a child opens his/her package, the tester shall say, ``THANK
YOU,'' take the package from the child and put it out of the child's
reach. The child shall not be asked to open the package a second time.
19. At the end of the 5-minute period, the tester shall demonstrate
how to open the package if either child has not opened his or her
package. A separate ``demo'' package shall be used for the
demonstration.
20. Prior to beginning the demonstration, the tester shall ask the
children to set their packages aside. The children shall not be allowed
to continue to try to open their packages during the demonstration
period.
21. The tester shall say, ``WATCH ME OPEN MY PACKAGE.''
22. Once the tester gets the children's full attention, the tester
shall hold the demo package approximately two feet from the children and
open the package at a normal speed as if the tester were going to use
the contents. There shall be no exaggerated opening movements.
23. The tester shall not discuss or describe how to open the
package.
24. To begin the second 5-minute period, the tester shall say, ``NOW
YOU TRY TO OPEN YOUR PACKAGES.''
25. If one or both children have not used their teeth to try to open
their packages during the first 5 minutes, the tester shall say
immediately before beginning the second 5-minute period, ``YOU CAN USE
YOUR TEETH IF YOU WANT TO.'' This is the only statement that the tester
shall make about using teeth.
26. The test shall continue for an additional 5 minutes or until
both children have opened their packages, whichever comes first.
27. At the end of the test period, the tester shall say, ``THANK YOU
FOR HELPING.'' If children were told that they could use their teeth,
the tester shall say, ``I KNOW I TOLD YOU THAT YOU COULD USE YOUR TEETH
TODAY, BUT YOU SHOULD NOT PUT THINGS LIKE THIS IN YOUR MOUTH AGAIN'' In
addition, the tester shall say, ``NEVER OPEN PACKAGES LIKE THIS WHEN YOU
ARE BY YOURSELF. THIS KIND OF PACKAGE MIGHT HAVE SOMETHING IN IT THAT
WOULD MAKE YOU SICK.''
28. The children shall be escorted back to their classroom or other
supervised area by the tester or another adult.
29. If the children are to participate in a second test, the tester
shall have them stand up and stretch for a short time before beginning
the second test. The tester shall take care that the children do not
disrupt other tests in progress.
(3) Senior-adult panel. (i) Test subjects. Use a group of 100 senior
adults. Not more than 24% of the senior adults tested shall be obtained
from or tested at any one site. Each group of senior adults shall be
randomly selected as to
[[Page 672]]
age, subject to the limitations set forth below. Twenty-five percent of
the participants shall be 50-54 years of age, 25% of participants shall
be 55-59 years of age, and 50% of the participants shall be 60-70 years
old. Seventy percent of the participants of ages 50-59 and ages 60-70
shall be female (17 or 18 females shall be apportioned to the 50-54 year
age group). No individual tester shall administer the test to more than
35% of the senior adults tested. The adults selected should have no
obvious or overt physical or mental disability.
(ii) Screening procedures. Participants who are unable to open the
packaging being tested in the first 5-minute time period, are given a
screening test. The screening tests for this purpose shall use two
packages with conventional (not child-resistant (CR) or ``special'')
closures. One closure shall be a plastic snap closure and the other a CT
plastic closure. Each closure shall have a diameter of 28 mm
<plus-minus> 18%, and the CT closures shall have been resecured 72 hours
before testing at 10 inch-pounds of torque. The containers for both the
snap- and CT-type closures shall be round plastic containers, in sizes
of 2 ounce <plus-minus> \1/2\ ounce for the CT-type closure and 8 drams
<plus-minus> 4 drams for the snap-type closure. Persons who cannot open
and close both of the screening packages in 1-minute screening tests
shall not be counted as participants in the senior-adult panel.
(iii) SAUE. The senior adult use effectiveness (SAUE) is the
percentage of adults who both opened the package in the first (5-minute)
test period and opened and (if appropriate) properly resecured the
package in the 1-minute test period.
(iv) Test procedures. The senior adults shall be tested
individually, rather than in groups of two or more. The senior adults
shall receive only such printed instructions on how to open and properly
secure the special packaging as will appear on or accompany the package
as it is delivered to the consumer. The senior-adult panel is tested
according to the procedure incorporated in the following senior-adult
panel test instructions:
Test Instructions for Senior Test
The following test instructions are used for all senior tests. If
non-reclosable packages are being tested, the commands to close the
package are eliminated.
1. No adult with a permanent or temporary illness, injury, or
disability that would interfere with his/her effective participation
shall be included in the test.
2. Each adult shall read and sign a consent form prior to
participating. Any appropriate language from the consent form may be
used to recruit potential participants. The form shall include the basic
elements of informed consent as defined in 16 CFR 1028.116. Examples of
the forms used by the Commission staff for testing are shown at
Sec. 1700.20(d). Before beginning the test, the tester shall say,
``PLEASE READ AND SIGN THIS CONSENT FORM.'' If an adult cannot read the
consent form for any reason (forgot glasses, illiterate, etc.), he/she
shall not participate in the test.
3. Each adult shall participate individually and not in the presence
of other participants or onlookers.
4. The tests shall be conducted in well-lighted and distraction-free
areas.
5. Records shall be filled in before or after the test, so that the
tester's full attention is on the participant during the test period.
Recording the test times to open and resecure the package are the only
exceptions.
6. To begin the first 5-minute test period, the tester says, ``I AM
GOING TO ASK YOU TO OPEN AND PROPERLY CLOSE THESE TWO IDENTICAL PACKAGES
ACCORDING TO THE INSTRUCTIONS FOUND ON THE CAP.'' (Specify other
instruction locations if appropriate.)
7. The first package is handed to the participant by the tester, who
says, ``PLEASE OPEN THIS PACKAGE ACCORDING TO THE INSTRUCTIONS ON THE
CAP.'' (Specify other instruction locations if appropriate.) If the
package contains product, the tester shall say, ``PLEASE EMPTY THE
(PILLS, TABLETS, CONTENTS, etc.) INTO THIS CONTAINER.'' After the
participant opens the package, the tester says, ``PLEASE CLOSE THE
PACKAGE PROPERLY, ACCORDING TO THE INSTRUCTIONS ON THE CAP.'' (Specify
other instruction locations if appropriate)
8. Participants are allowed up to 5 minutes to read the instructions
and open and close the package. The tester uses a stopwatch(s) or other
timing device to time the opening and resecuring times. The elapsed
times in seconds to open the package and to close the package are
recorded on the data sheet as two separate times.
9. After 5 minutes, or when the participant has opened and closed
the package, whichever comes first, the tester shall take all
[[Page 673]]
test materials from the participant. The participant may remove and
replace the closure more than once if the participant initiates these
actions. If the participant does not open the package and stops trying
to open it before the end of the 5-minute period, the tester shall say,
``ARE YOU FINISHED WITH THAT PACKAGE, OR WOULD YOU LIKE TO TRY AGAIN?''
If the participant indicates that he/she is finished or cannot open the
package and does not wish to continue trying, skip to Instruction 13.
10. To begin the second test period, the tester shall give the
participant another, but identical, package and say, ``THIS IS AN
IDENTICAL PACKAGE. PLEASE OPEN IT ACCORDING TO THE INSTRUCTIONS ON THE
CAP.'' (Specify other instruction locations if appropriate.) If the
package contains product, the tester shall say, ``PLEASE EMPTY THE
(PILLS, TABLETS, CONTENTS, etc.) INTO THIS CONTAINER.'' After the
participant opens the package, the tester says, ``PLEASE CLOSE THE
PACKAGE PROPERLY, ACCORDING TO THE INSTRUCTIONS ON THE CAP.'' (Specify
other instruction locations if appropriate.)
11. The participants are allowed up to 1 minute (60 full seconds) to
open and close the package. The elapsed times in seconds to open and to
close the package are recorded on the data sheet as two separate times.
The time that elapses between the opening of the package and the end of
the instruction to close the package is not counted as part of the 1-
minute test time.
12. After the 1-minute test, or when the participant has opened and
finished closing the package, whichever comes first, the tester shall
take all the test materials from the participant. The participant shall
not be allowed to handle the package again. If the participant does not
open the package and stops trying to open it before the end of the 1-
minute period, the tester shall say, ``ARE YOU FINISHED WITH THAT
PACKAGE, OR WOULD YOU LIKE TO TRY AGAIN?'' If the participant indicates
that he/she is finished or cannot open the package and does not wish to
continue trying, this shall be counted as a failure of the 1-minute
test.
13. Participants who do not open the package in the first 5-minute
test period are asked to open and close two non-child-resistant
screening packages. The participants are given a 1-minute test period
for each package. The tester shall give the participant a package and
say, ``PLEASE OPEN AND PROPERLY CLOSE THIS PACKAGE.'' The tester records
the time for opening and closing, or 61 seconds, whichever is less, on
the data sheet. The tester then gives the participant the second package
and says, ``PLEASE OPEN AND PROPERLY CLOSE THIS PACKAGE.'' The time to
open and resecure, or 61 seconds, whichever is less, shall be recorded
on the data sheet.
14. Participants who cannot open and resecure both of the non-child-
resistant screening packages are not counted as part of the 100-seniors
panel. Additional participants are selected and tested.
15. No adult may participate in more than two tests per sitting. If
a person participates in two tests, the packages tested shall not be the
same ASTM type of package.
16. If more adults in a sex or age group are tested than are
necessary to determine SAUE, the last person(s) tested shall be
eliminated from that group.
(4) Younger-adult panel. (i) One hundred adults, age 18 to 45
inclusive, with no overt physical or mental handicaps, and 70% of whom
are female, shall comprise the test panel for younger adults. Not more
than 35% of adults shall be obtained or tested at any one site. No
individual tester shall administer the test to more than 35% of the
adults tested. The adults shall be tested individually, rather than in
groups of two or more. The adults shall receive only such printed
instructions on how to open and properly resecure the special packaging
as will appear on the package as it is delivered to the consumer. Five
minutes shall be allowed to complete the opening and, if appropriate,
the resecuring process.
(ii) Records shall be kept of the number of adults unable to open
and of the number of the other adults tested who fail to properly
resecure the special packaging. The number of adults who successfully
open the special packaging and then properly resecure the special
packaging (if resecuring is appropriate) is the percent of adult-use
effectiveness of the special packaging. In the case of unit packaging,
the percent of adult-use effectiveness shall be the number of adults who
successfully open a single (unit) package.
(b) The standards published as regulations issued for the purpose of
designating particular substances as being subject to the requirements
for special packaging under the act will stipulate the percent of child-
resistant effectiveness and adult-use effectiveness required for each
and, where appropriate, will include any other conditions deemed
necessary and provided for in the act.
(c) It is recommended that manufacturers of special packaging, or
producers of substances subject to regulations
[[Page 674]]
issued pursuant to the act, submit to the Commission summaries of data
resulting from tests conducted in accordance with this protocol.
(d) Recommendations. The following instructions and procedures,
while not required, are used by the Commission's staff and are
recommended for use where appropriate.
(1) Report format for child test.
A. Identification
1. Close-up color photographs(s) clearly identifying the package and
showing the opening instructions on the closure.
2. Product name and the number of tablets or capsules in the
package.
3. Product manufacturer.
4. Closure model (trade name--e.g., ``KLIK & SNAP'').
5. Closure size (e.g., 28 mm).
6. Closure manufacturer.
7. Closure material and color(s) (e.g., white polypropylene).
8. Closure liner material.
9. TAC seal material.
10. Opening instructions (quote exactly, e.g., ``WHILE PUSHING,
DOWN, TURN RIGHT''). Commas are used to separate words that are on
different lines.
11. Symbols, numbers, and letters found inside the closure.
12. Package model.
13. Package material and color.
14. Net contents.
15. Symbols, numbers, and letters on the bottom of the package.
16. Other product identification, e.g., EPA Registration Number.
B. Procedures
1. Describe all procedures for preparing the test packages.
2. Describe the testing procedures.
3. Describe all instructions given to the children.
4. Define an individual package failure.
C. Results
1. Openings in each 5-minute period and total openings for males and
for females in each age group.
2. Opening methods (e.g., normal opening, teeth, etc.).
3. Mean opening times and standard deviation for each 5-minute test
period.
4. The percentage of packages tested at each site as a percentage of
total packages.
5. The percentage of packages tested by each tester as a percentage
of total packages.
6. Child-resistant effectiveness for the first 5-minute period and
for the total test period.
(2) Standardized adult-resecuring test instructions. CPSC will use
the adult-resecuring test where an objective determination (e.g., visual
or mechanical) that a package is properly resecured cannot be made. The
adult-resecuring test is performed as follows:
Adult-Resecuring Procedure
1. After the adult participant in either the senior-adult test of 16
CFR 1700.20(a)(3) or the younger-adult test of 16 CFR 1700.20(a)(4) has
resecured the package, or at the end of the test period (whichever comes
first), the tester shall take the package and place it out of reach. The
adult participant shall not be allowed to handle the package again.
2. The packages that have been opened and appear to be resecured by
adults shall be tested by children according to the child-test
procedures to determine if the packages have been properly resecured.
The packages are given to the children without being opened or resecured
again for any purpose.
3. Using the results of the adult tests and the tests of apparently-
resecured packaging by children, the adult use effectiveness is
calculated as follows:
a. Adult use effectiveness.
1. The number of adult opening and resecuring failures, plus the
number of packages that were opened by the children during the full 10-
minute test that exceeds 20% of the apparently-resecured packages,
equals the total number of failures.
2. The total number of packages tested by adults (which is 100)
minus the total number of failures equals the percent adult-use
effectiveness.
(3) Report format for adult-resecuring test.
A. Identification
1. Close-up color photograph(s) clearly identifying the package and
showing the top of the closure.
2. Product name and the number of tablets or capsules in the
package.
3. Product manufacturer.
4. Closure model (trade name).
5. Closure size (e.g., 28 mm).
6. Closure manufacturer.
7. Closure material and color(s) (e.g., white polypropylene)
8. Closure liner material.
9. Symbols, numbers, and letters found inside the closure.
10. TAC seal material.
11. Opening instructions (Quote exactly, e.g., ``WHILE PUSHING,
DOWN, TURN RIGHT''). Commas are used to separate words that are on
different lines.
12. Package model.
13. Package material and color.
14. Net contents.
[[Page 675]]
15. Symbols, numbers, and letters on the bottom of the package.
16. Other product identification, e.g., EPA Registration Number.
B. Procedures
1. Describe all procedures for preparing the test packages.
2. Describe the testing procedures in detail.
3. Describe all instructions given to participants.
4. Define an individual package failure and the procedures for
determining a failure.
C. Results
Adult Test
1. Total packages opened and total packages resecured; packages
opened by males and by females; and packages resecured by males and by
females.
2. Mean opening times and standard deviation for total openings,
total openings by females, and total openings by males.
3. Mean resecuring times and standard deviation for total
resecurings, total resecurings by females and total resecurings by
males.
4. The percentage of packages tested at each site as a percentage of
total packages.
5. The percentage of packages tested by each tester as a percentage
of total packages.
6. Methods of opening (e.g., normal opening, pried closure off,
etc.)
Child Test
1. Openings in each 5-minute period, and total openings, for males
and females in each age group.
2. Opening methods.
3. Mean opening times and standard deviation for each 5-minute test
period.
4. The percentage of packages tested at each site as a percentage of
total packages.
5. The percentage of packages tested by each tester as a percentage
of total packages.
(4) Consent forms. The Commission uses the following consent forms
for senior-adult testing reclosable and unit-dose packaging,
respectively.
1. Reclosable packages.
[Testing Organization's Letterhead]
Child-Resistant Package Testing
The U.S. Consumer Product Safety Commission is responsible for
testing child-resistant packages to make sure they protect young
children from medicines and dangerous household products. With the help
of people like you, manufacturers are able to improve the packages we
use, keeping the contents safe from children but easier for the rest of
us to open.
Effective child-resistant packages have prevented thousands of
poisonings since the Poison Prevention Act was passed in 1970. The use
of child-resistant packages on prescription medicines alone may have
saved the lives of over 350 children since 1974.
As part of this program, we are testing a child-resistant package to
determine if it can be opened and properly closed by an adult who is
between 50 and 70 years of age. You may or may not be familiar with the
packages we are testing. Take your time, and please do not feel that you
are being tested--we are testing the package, not you.
Description of the Test
1. I will give you a package and ask you to read the instructions
and open and properly close the package.
2. I will then give you an identical package, and ask you to open
and properly close it.
3. I may ask you to open some other types of packages.
4. The packages may be empty or they may contain a product.
5. I will ask you whether you think the child-resistant package was
easy or hard to use.
Consent Form for Child-Resistant Package Testing
The Consumer Product Safety Commission has been using contractors to
test child-resistant packages for many years with no injuries to anyone,
although it is possible that a minor injury could happen.
I agree to test a child-resistant package. I understand that I can
change my mind at any time. I am between the ages of 50 and 70,
inclusive.
Birthdate______________________________________________________________
Signature______________________________________________________________
Date___________________________________________________________________
Zip Code_______________________________________________________________
Office Use
Site:__________________________________________________________________
Sample Number:_________________________________________________________
Test Number:___________________________________________________________
Package Number:________________________________________________________
2. Unit-dose packages.
[Testing Organization's Letterhead]
Unit Dose Child-Resistant Package Testing
The U.S. Consumer Product Safety Commission is responsible for
testing child-resistant packages to make sure they protect young
children from medicines and dangerous household products. With the help
of people like you, manufacturers are able to improve the packages we
use, keeping the contents safe from children but easier for the rest of
us to open.
[[Page 676]]
Effective child-resistant packages have prevented thousands of
poisonings since the Poison Prevention Act was passed in 1970.
The use of child-resistant packages on prescription medicines alone
may have saved the lives of over 350 children since 1974.
As part of this program, we are testing a child-resistant package to
determine if it can be opened by an adult who is between 50 and 70 years
of age. You may or may not be familiar with the packages we are testing.
Take your time, and please do not feel that you are being tested--we are
testing the package, not you.
Description of the Test
1. I will give you a package and ask you to read the instructions,
open one unit, and remove the contents.
2. I will then give you an identical package, and ask you to open
one unit and remove the contents.
3. I may ask you to open some other types of packages.
4. I will ask you whether you think the child-resistant package was
easy or hard to use.
Consent Form for Child-Resistant Package Testing
The Consumer Product Safety Commission has been using contractors to
test child-resistant packages for many years with no injuries to anyone,
although it is possible that a minor injury could happen.
I agree to test a child-resistant package. I understand that I can
change my mind at any time. I am between the ages of 50 and 70,
inclusive.
Birthdate______________________________________________________________
Signature______________________________________________________________
Date___________________________________________________________________
Zip Code_______________________________________________________________
Office Use
Site:__________________________________________________________________
Sample Number:_________________________________________________________
Test Number:___________________________________________________________
Package Number:________________________________________________________
[38 FR 21247, Aug. 7, 1973, as amended at 60 FR 37735, 37738, July 22,
1995]