(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(b) Except for the definition of “Secretary,” which is obsolete, the definitions given in section 2 of the act are applicable to this part and are repeated herein for convenience as follows: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.

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)).

(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.

(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.

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 § 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 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.

(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 § 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 § 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 °F., other than those packaged in pressurized spray containers, shall be packaged in accordance with the provisions of § 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 § 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 § 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 § 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 § 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 °F., shall be packaged in accordance with the provisions of § 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 § 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 § 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 the provisions of § 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 not more than 110 milligrams of sodium fluoride (the equivalent of 50 mg of elemental fluoride) per package or not more than a concentration of 0.5 percent elemental fluoride on a weight-to-volume basis for liquids or a weight-to-weight basis for non-liquids and containing no other substances subject to this § 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 § 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 § 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 § 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 § 1700.14(a)(10).

(xix) Medroxyprogesterone acetate tablets.

(xx) Sacrosidase (sucrase) preparations in a solution of glycerol and water.

(xxi) Hormone Replacement Therapy Products that rely solely upon the activity of one or more progestogen or estrogen substances.

(xxii) Colesevelam hydrochloride in powder form in packages containing not more than 3.75 grams of the drug.

(xxiii) Sevelamer carbonate in powder form in packages containing not more than 2.4 grams of the drug.

(xxiv) Baloxavir marboxil tablets in packages containing not more than 80 mg of the drug.

(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 § 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 § 1700.15 (a), (b), and (c).

(13) Dietary supplements containing iron. Dietary supplements, as defined in § 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 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 § 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 °F., shall be packaged in accordance with the provisions of § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 1700.15 (a) and (b).

(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 § 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 § 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 § 1700.15 (a), (b) and (c).

(27) Fluoride. Household substances containing more than the equivalent of 50 milligrams of elemental fluoride per package and more than the equivalent of 0.5 percent elemental fluoride on a weight-to-volume basis for liquids or a weight-to-weight basis for non-liquids shall be packaged in accordance with the provisions of § 1700.15(a), (b) and (c).

(28) Minoxidil. Minoxidil preparations for human use and containing more than 14 mg of minoxidil in a single retail package shall be packaged in accordance with the provisions of § 1700.15(a), (b) and (c). Any applicator packaged with the minoxidil preparation and which it is reasonable to expect may be used to replace the original closure shall also comply with the provisions of § 1700.15(a), (b) and (c).

(29) Methacrylic acid.Except as provided in the following sentence, liquid household products containing more than 5 percent methacrylic acid (weight-to-volume) in a single retail package shall be packaged in accordance with the provisions of § 1700.15(a),(b) and (c). Methacrylic acid products applied by an absorbent material contained inside a dispenser (such as a pen-like marker) are exempt from this requirement provided that: (i) the methacrylic acid is contained by the absorbent material so that no free liquid is within the device, and (ii) under any reasonably foreseeable conditions of use the methacrylic acid will emerge only through the tip of the device.

(30) Over-the-Counter Drug Products. (i) Any over-the-counter (OTC) drug product in a dosage form intended for oral administration that contains any active ingredient that was previously available for oral administration only by prescription, and thus was required by paragraph (a)(10) of this section to be in special packaging, shall be packaged in accordance with the provisions of § 1700.15(a),(b), and (c). This requirement applies whether or not the amount of that active ingredient in the OTC drug product is different from the amount of that active ingredient in the prescription drug product. This requirement does not apply if the OTC drug product contains only active ingredients of any oral drug product or products approved for OTC marketing based on an application for OTC marketing submitted to the Food and Drug Administration (FDA) by any entity before January 29, 2002. Notwithstanding the foregoing, any special packaging requirement under this § 1700.14 otherwise applicable to an OTC drug product remains in effect.

(ii) For purposes of this paragraph (30), active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of humans; and drug product means a finished dosage form, for example, tablet, capsule, or solution, that contains a drug substance (active ingredient), generally, but not necessarily, in association with one or more other ingredients. (These terms are intended to have the meanings assigned to them in the regulations of the Food and Drug Administration appearing at 21 CFR 201.66 (2001) and 21 CFR 314.3 (2000), respectively.)

(31) Hazardous substances containing low-viscosity hydrocarbons. All prepackaged nonemulsion-type liquid household chemical products that are hazardous substances as defined in the Federal Hazardous Substances Act (FHSA) (15 U.S.C. 1261(f)), and that contain 10 percent or more hydrocarbons by weight and have a viscosity of less than 100 SUS at 100 °F, shall be packaged in accordance with the provisions of § 1700.15(a), (b), and (c), except for the following:

(i) Products in packages in which the only non-child-resistant access to the contents is by a spray device (e.g., aerosols, or pump-or trigger-actuated sprays where the pump or trigger mechanism has either a child-resistant or permanent attachment to the package).

(ii) Writing markers and ballpoint pens exempted from labeling requirements under the FHSA by 16 CFR 1500.83.

(iii) Products from which the liquid cannot flow freely, including but not limited to paint markers and battery terminal cleaners. For purposes of this requirement, hydrocarbons are defined as substances that consist solely of carbon and hydrogen. For products that contain multiple hydrocarbons, the total percentage of hydrocarbons in the product is the sum of the percentages by weight of the individual hydrocarbon components.

(32) Drugs and cosmetics containing low-viscosity hydrocarbons. All prepackaged nonemulsion-type liquid household chemical products that are drugs or cosmetics as defined in the Federal Food, Drug, and Cosmetics Act (FDCA) (21 U.S.C. 321(a)), and that contain 10 percent or more hydrocarbons by weight and have a viscosity of less than 100 SUS at 100 °F, shall be packaged in accordance with the provisions of § 1700.15(a), (b), and (c), except for the following:

(i) Products in packages in which the only non-child-resistant access to the contents is by a spray device (e.g., aerosols, or pump-or trigger-actuated sprays where the pump or trigger mechanism has either a child-resistant or permanent attachment to the package).

(ii) Products from which the liquid cannot flow freely, including but not limited to makeup removal pads. For the purposes of this requirement, hydrocarbons are defined as substances that consist solely of carbon and hydrogen. For products that contain multiple hydrocarbons, the total percentage of hydrocarbons in the product is the sum of the percentages by weight of the individual hydrocarbon components.

(33) Imidazolines. Any over-the-counter or prescription product containing the equivalent of 0.08 milligrams or more of an imidazoline (tetrahydrozoline, naphazoline, oxymetazoline, or xylometazoline) in a single package, must be packaged in accordance with the provisions of § 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.

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 § 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 § 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 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 § 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 § 1700.20(a)(4). The senior-adult panel test of § 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 § 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.

(a) Test protocols—(1) General requirements—(i) Requirements for packaging. As specified in § 1700.15(b), special packaging is required to meet the child test requirements and the applicable adult test requirements of this § 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. 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.,

(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 × 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 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.

(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:

(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 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±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± 1/2 ounce for the CT-type closure and 8 drams±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:

(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 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.

(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:

(3) Report format for adult-resecuring test.