Retail Marijuana and Retail Marijuana Products in Colorado and Washington State are Required to be dispensed in Child Resistant Packaging.


The State of Colorado has enacted Administrative Procedure Act, Title 24, Article 4, C.R.S. (2013). The Washington State Liquor Control Board has issued rules to implement Intitiative 502.

The purpose of these new rules are to ensure that all Retail Recreational Marijuana and Retail Recreational Marijuana Product are sold and delivered to lawful consumers in packaging that is not easily opened by children.

Colorado R 1005 – Packaging and Labeling of Retail Marijuana by a Retail Marijuana Store

Packaging of Retail Marijuana by a Retail Marijuana Store. A Retail Marijuana Store must ensure that all Retail Marijuana is placed within a Container prior to sale to a consumer. If the Container is not Child-Resistant, the Retail Marijuana Store must place the Container within an Exit Package that is Child-Resistant.

R 1007 – Packaging and Labeling of Retail Marijuana Concentrates by a Retail Marijuana Store

Packaging of Retail Marijuana Concentrates by a Retail Marijuana Cultivation Facility. A Retail Marijuana Store must ensure that all Retail Marijuana concentrates are placed within a Container prior to sale to a consumer. If the Container is not Child-Resistant, the Retail Marijuana Store must place the Container within an Exit Package that is Child-Resistant.
The State of Washington Liquor Control Board in its supplemental rules require:
Packaging and label requirements including dosage and warnings;
Child Resistant packaging for marijuana in solid and liquid forms;
Defined serving sizes and package limits on marijuana in solid form.


eBottles offers Pharmaceutical Grade Opaque White High Density Polyethylene Wide Mouth Jars with Child Resistant Closures which meet the requirements for retail Marijuana packaging in Colorado and Washington State.

All of the Child Resistant closures we stock are made in the USA and meet the standard of Child Resistant Packaging as set forth by the Consumer Product Safety Commission Federal Regulation 16 C.F.R. 1700.20. Copies of Protocol tests are available for review upon request.


The details of legalized Marijuana for recreational use and the packaging requirements in the State of Colorado:


On November 6, 2012, Colorado voters approved an amendment to the Colorado Constitution, Article XVIII, Section 16, popularly known as “Amendment 64,” which directed the Colorado Department of Revenue to promulgate rules governing businesses that cultivate and sell Retail Marijuana. The amendment was proclaimed into the Colorado Constitution on December 10, 2012.

The Colorado General Assembly adopted three bills during the 2013 legislative session to implement Amendment 64, and Colorado Governor John Hickenlooper signed those bills into law on May 28, 2013. Amendment 64 and the implementing legislation (particularly, House Bill 13?1317) required that the State Licensing Authority, the Executive Director of the Colorado Department of Revenue, promulgate certain rules on or before July 1, 2012. To comply with those requirements within the short period between adoption of the legislation and required promulgation of rules, the State Licensing Authority adopted emergency rules governing Retail Marijuana in the state of Colorado.
Immediately after adopting the emergency regulations, the Department of Revenue convened five
representative groups, known as working groups, which provided input and substantive suggestions regarding proposed rules governing Retail Marijuana Establishments and Medical Marijuana Businesses in Colorado. Each working group discussed a different set of issues, broken down as follows: Licensing, Licensed Premises, Transportation, and Storage; Licensed Entities and Inventory Tracking; Record Keeping, Enforcement and Discipline; Labeling, Packaging, Product Safety & Marketing; and Medical Differentiation.
Representatives from law enforcement, the Governor’s Office, the Attorney General’s
Office, the Department of Public Health and Environment, local authorities, industry members, trade industries, child protection advocates, and subject matter experts in the fields of substance abuse, toxicology, pharmacology and marketing participated in the working groups.

The State Licensing Authority has also considered the direction provided by the United States
Department of Justice through an August 29, 2013 letter from United States Attorney General Eric Holder to Governors John Hickenlooper of Colorado and Jay Inslee of Washington, and an accompanying memorandum to all United States Attorneys from Deputy Attorney General James M. Cole. Through this correspondence, the United States Department of Justice has clarified that it will continue to enforce the Controlled Substances Act in Colorado, but that it will not challenge Colorado’s ability to regulate the Retail Marijuana industry in accordance with state law, based upon the expectation that the state and local governments will implement strong and effective regulatory and enforcement systems that address public safety, public health and other law enforcement interests.
Some of those federal law enforcement priorities of particular relevance to these rules include preventing the distribution of marijuana to minors, preventing the diversion of marijuana from states where it is legal under state law to other states, and preventing the exacerbation of adverse public health consequences associated with marijuana use.
As an illustration, Deputy Attorney General Cole noted that the federal interest in
preventing the distribution of marijuana to minors “would call for enforcement not just when an
individual or entity sells or transfers marijuana to a minor, but also when marijuana trafficking takes place near an area associated with minors; when marijuana or marijuana?infused products are marketed in a manner to appeal to minors; or when marijuana is being diverted, directly or indirectly, and purposefully or otherwise, to minors.”

In adopting these rules, the State Licensing Authority is complying with the mandates and objectives set forth by the people of the State of Colorado through Amendment 64 and the Colorado General Assembly through House Bill 1317. These rules are designed not to make the operation of Retail Marijuana Establishments unreasonably impracticable, but also promote public safety and ensure compliance with constitutional and statutory guidelines. These rules must implement the extensive regulatory requirements set forth in Amendment 64 and House Bill 13?1317. Above all though, these rules accomplish the state of Colorado’s guiding principle through this process: to create a robust regulatory and enforcement environment that protects public safety and prevents diversion.


Administrative Procedure Act, Title 24, Article 4, C.R.S. (2013)
New Permanent Rules, Retail Marijuana – Rule R 1000 Series – Labeling, Packaging and Products Safety


The purpose of this rule, and the rules in this series, is to ensure that all Retail Marijuana and Retail Marijuana Product are sold and delivered to lawful consumers in packaging that is not easily opened by children. Further, the State Licensing Authority believes based on written and oral comments it has received through the rulemaking process that prohibiting labels that are intended to target individuals under the age of 21 and requiring child-resistant packaging is of a state wide concern and would assist in limiting exposure and diversion to minors.


R 1000 Series – Labeling, Packaging, and Product Safety ....................................................................................................... 92
R 1001 – Labeling and Packaging Requirements: General Applicability ............................................................................ 92
R 1002 – Packaging and Labeling of Retail Marijuana by a Retail Marijuana Cultivation Facility or a Retail Marijuana
Products Manufacturing Facility ............................................................................................................................................. 93
R 1003 – Packaging and Labeling of Retail Marijuana Concentrates by a Retail Marijuana Cultivation Facility or a
Retail Marijuana Products Manufacturing Facility. ............................................................................................................... 94
R 1004 – Packaging and Labeling Requirements of a Retail Marijuana Product by a Retail Marijuana Products
Manufacturing Facility ............................................................................................................................................................. 96
R 1005 – Packaging and Labeling of Retail Marijuana by a Retail Marijuana Store ........................................................... 99
R 1006 – Packaging and Labeling of Retail Marijuana Product by a Retail Marijuana Store .......................................... 101
R 1007 – Packaging and Labeling of Retail Marijuana Concentrates by a Retail Marijuana Store ................................. 104




R 1001 – Labeling and Packaging Requirements

C. Packaging May Not Be Designed to Appeal to Children. A Retail Marijuana Establishment shall not place any content on a Container holding Retail Marijuana, Retail Marijuana concentrates, or a Retail Marijuana Product in a manner that specifically targets individuals under the age of 21, including but not limited to, cartoon characters or similar images.

D. Health and Benefit Claims. Labeling text on a Container may not make any false or misleading statements regarding health or physical benefits to the consumer.
E. Font Size. Labeling text on a Container must be no smaller than 1/16 of an inch.
F. Use of English Language. Labeling text on a Container must be clearly written or printed and in the English language.
G. Unobstructed and Conspicuous. Labeling text on a Container must be unobstructed and conspicuous. A Licensee may affix multiple labels to a Container, provided that none of the information required by these rules is completely obstructed.

Basis and Purpose – R 1005
The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(IV), 12-43.4- 202(3)(a)(VII), 12-43.4-402(4), and 25-4-1614(3)(a), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VI). The purpose of this rule is to ensure that the labeling on each Container of Retail Marijuana includes necessary and relevant information for consumers, does not include health and physical benefit claims, is easily accessible to consumers, and is clear and noticeable. In addition, this rule clarifies basic
packaging requirements. Further, the State Licensing Authority believes based on written and oral comments it has received through the rulemaking process that prohibiting labels that are intended to target individuals under the age of 21 and requiring child-resistant packaging is of a state wide concern and would assist in limiting exposure and diversion to minors. The State Licensing Authority wants to ensure the regulated community employs proper labeling techniques to all Retail Marijuana as this is a public health and safety concern.


R 1005 – Packaging and Labeling of Retail Marijuana by a Retail Marijuana Store

A. Packaging of Retail Marijuana by a Retail Marijuana Store. A Retail Marijuana Store must ensure that all Retail Marijuana is placed within a Container prior to sale to a consumer. If the Container is not Child-Resistant, the Retail Marijuana Store must place the Container within an Exit Package that is Child-Resistant.

B. Labeling of Retail Marijuana by a Retail Marijuana Store. A Retail Marijuana Store must affix all of the information required by this rule to every Container in which Retail Marijuana is placed prior to sale to a consumer:

1. A Retail Marijuana Store must include the following information on every Container:
a. The license number of the Retail Marijuana Cultivation Facility(-ies) where the Retail
Marijuana was grown;
b. The license number of the Retail Marijuana Store that sold the Retail Marijuana to the
consumer;
c. The Identity Statement and Standardized Graphic Symbol of the Retail Marijuana Store
that sold the Retail Marijuana to the consumer. A Licensee may elect to have its Identity
Statement also serve as its Standardized Graphic Symbol for purposes of complying with
this rule. The Licensee shall maintain a record of its Identity Statement and Standardized
Graphic Symbol and make such information available to the State Licensing Authority
upon request;
d. The Harvest Batch Number(s) assigned to the Retail Marijuana within the Container;
e. The date of sale to the consumer;
f. The net weight, in grams to at least the tenth of a gram, of the Retail Marijuana prior to its
placement in the Container;
g. The Universal Symbol, indicating that the Container holds marijuana, which must be no
smaller than . of an inch by . of an inch;
h. The following warning statements:
i. “There may be health risks associated with the consumption of this
product.”
ii. “This product is intended for use by adults 21 years and older. Keep out of
the reach of children.”
iii. “This product is unlawful outside the State of Colorado.”
iv. “There may be additional health risks associated with the consumption of
this product for women who are pregnant, breastfeeding, or planning on
becoming pregnant.”
v. “Do not drive or operate heavy machinery while using marijuana.”
i. A complete list of all nonorganic pesticides, fungicides, and herbicides used during the
cultivation of the Retail Marijuana.


R 1006 – Packaging and Labeling of Retail Marijuana Product by a Retail Marijuana Store
A. Packaging of Retail Marijuana Product by a Retail Marijuana Store. A Retail Marijuana Store must ensure that each Retail Marijuana Product is placed within a Container prior to sale to a consumer. If the Container is not Child-Resistant, the Retail Marijuana Store must place the Container within an Exit Package that is Child-Resistant.



R 1007 – Packaging and Labeling of Retail Marijuana Concentrates by a Retail Marijuana Store
A. Packaging of Retail Marijuana Concentrates by a Retail Marijuana Cultivation Facility. A Retail Marijuana Store must ensure that all Retail Marijuana concentrates are placed within a Container prior to sale to a consumer. If the Container is not Child-Resistant, the Retail Marijuana Store must place the Container within an Exit Package that is Child-Resistant.


Child Resistant Testing Protocol requirement of 16 CFR 1700.20

The cost to perform this battery of tests is quite high. Further, not every testing laboratory is accredited to perform this type of test.

Simply because a manufacturer or distributor has labelled their product “Child Resistant” is not sufficient. The closures must be PROVEN through very specific protocol testing that their closures meet the standard. All successful manufacturers have copies of their protocol testing on file and available for review by potential customers.


CPSC Poison Prevention Packaging Standards:
To protect children from serious personal injury or serious illness resulting from handling, using, or ingesting substances, the Commission has determined that packaging designed and constructed to meet the following standards shall be regarded as?‘‘special packaging’’ ?
(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.
The packaging required by the PPPA must be designed or constructed to be significantly difficult for children under five years of age to open within a reasonable time, and not difficult for normal adults to use.

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 shall have a senior?adult use effectiveness of not less than 90% for the senior-adult panel test.


§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. 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).
(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]


§1700.20 Testing procedure for special packaging.
(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.
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. 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.
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 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:
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. (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.
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.
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]