PART 1700—POISON PREVENTION 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. § 1700.1 Definitions. (a) As used in this part: (1) Act (2) Commission (3) Dietary supplement (b) Except for the definition of “Secretary,” which is obsolete, the definitions given in section 2 of the act are applicable to this part and are repeated herein for convenience as follows: (1) [Reserved] (2) Household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 (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 (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 (5) Labeling (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] § 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)). § 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. § 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 Federal Register (b) Upon becoming effective, a child protection packaging standard shall apply only to household substances packaged on and after its effective date. § 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 § 1700.5 is to implement section 4(a) of the act by prescribing requirements for the labeling of noncomplying packages. (a) Labeling statement. (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 (ii) Not less than 3/32 (iii) Not less than 1/8 (iv) Not less than 3/16 (v) Not less than 1/4 (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. [40 FR 4650, Jan. 31, 1975] § 1700.14 Substances requiring special packaging. (a) Substances. (1) Aspirin. (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. (3) Methyl salicylate. (4) Controlled drugs. et seq. (5) Sodium and/or potassium hydroxide. (6) Turpentine. (7) Kindling and/or illuminating preparations. (8) Methyl alcohol methanol (9) Sulfuric acid. (10) Prescription drugs. (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. (12) Iron-containing drugs. (13) Dietary supplements containing iron. (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. (16) Acetaminophen. (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. (18) Glue removers containing acetonitrile. (19) Permanent wave neutralizers containing sodium bromate or potassium bromate. (20) Ibuprofen. (21) Loperamide. (22) Mouthwash. (23) Lidocaine. (24) Dibucaine. (25) Naproxen. (26) Ketoprofen. (27) Fluoride. (28) Minoxidil. (29) Methacrylic acid. (30) Over-the-Counter Drug Products. (ii) For purposes of this paragraph (30), active ingredient drug product (31) Hazardous substances containing low-viscosity hydrocarbons. (i) Products in packages in which the only non-child-resistant access to the contents is by a spray device ( e.g., (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. (i) Products in packages in which the only non-child-resistant access to the contents is by a spray device ( e.g., (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. (b) Sample packages. (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 (c) Applicability. (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 www.govinfo.gov. § 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 § 1700.14. (a) General requirements. (b) Effectiveness 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 Senior-adult test. (ii) Younger-adult test When applicable. (B) Determination of need for metal or aerosol container 1 Criteria. ( i ( ii ( iii ( iv ( v ( 2 Presumption. ( 3 Justification. (c) Reuse of special packaging. (d) Restricted flow. (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] § 1700.20 Testing procedure for special packaging. (a) Test protocols General requirements Requirements for packaging. (ii) Condition of packages to be tested Tamper-resistant feature. ( 1 ( 2 ( 3 (B) Reclosable packages—adult tests. (2) Child test Test subjects Selection criteria. ( 1 ( 2 ( 3 ( 4 (B) Gender distribution. (ii) Test failures. (iii) Sequential test. 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 Test panel Cumulative number of children Package openings First 5 minutes Full 10 minutes 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. 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. 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 Test subjects. (ii) Screening procedures. 1/2 (iii) SAUE. (iv) Test procedures. 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 § 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 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. (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. (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. 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. 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. 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]