Stephanee Synnott, PhD (SSynnott@cpsc.gov) 
Stephen Lee (SLee@cpsc.gov)

If you are a domestic manufacturer or importer and put a regulated substance into the market, you need to publish a General Certificate of Conformity (GCC). Requirements for completing a GCC can be found at www.cpsc.gov. Note that your GCC does not need to be submitted, verified, or approved by the CPSC–it is a self-issued document that must be available for review on demand. The easiest way to satisfy CPSC’s requirement is to publish the GCC on your company website. If you only produce the package or packaging material, you do not need to publish a GCC.

Due to differences in testing procedures and requirements, the US CPSC does not accept testing according to ISO/EN regulations. GLM is accredited to test according to ISO and EN regulations for clients that sell outside of the United States.

Report data should be retained by the company and be made available if requested by the Commission.  The CPSC does ask that data be submitted for new packaging innovations. 

The regulation does not account for testing a sampling of the packages that will be used for regulated substances. The CPSC believes that the size and shape of a container can affect the performance of a package during testing. CPSC staff recommends testing all possible combinations. However, some manufacturing firms rely on expert opinions to extrapolate test results from one package size to another based on protocol data of similar packaging (i.e., same package with a different size cap or different size container). Bracket testing is commonly done by testing the two extremes (e.g., the smallest and largest sizes), but CPSC staff recommends testing in between intervals as well. If the CPSC staff were ever to question the compliance of a package, staff would evaluate the entire testing program utilized when determining if the package in question complies.

There is no expiration date on protocol tests and no requirement to retest as long as the tests adequately reflect the current packaging being used for the hazardous substance. It is suggested to retest when there is an incident or complaint that the company becomes aware of, a change in the manufacturing process or location, a change in materials used for the packaging, or if concerns exist that molds are wearing. For unit dose packaging, it is also suggested to retest if the substance is altered (i.e.,  such as the tablet form, size or shape of the tablet, hardiness, etc.).  These changes may impact how the package is opened. 

16 CFR 1700.20 says that the torque should be the same as the assembly line. If you do not know this information, a good rule of thumb is to torque to one-half the size of the closure (e.g., 24mm = 12 inch-pounds). The application torque must be included in the report.

For packages that can be opened and closed:  The package is opened at least one time by Great Lakes Marketing before it is tested with the child for a child panel.  This is not done in the presence of the child.  (See 16 CFR 1700.20, Standardized Child Test Instructions, Point 3.)  [NOTE:  This is done for a child panel only, NOT a resecuring panel test.]

The failure rate is based on the toxicity of the product that will be sold in the package. If the toxicity is not known, the regulation states that access to a maximum of nine doses constitutes a failure. If it is determined later that the product being used would be toxic at less than nine doses, the pass/fail results for any toxicity level can be calculated from the report that Great Lakes Marketing produces. Data are collected and reported for all units accessed during the 10-minute test period.

For a child panel, the package is opened at least one time before it is tested with children. Therefore, tamper-evident materials are removed. Tamper evident materials are not considered part of the child-resistant material.

The testing is conducted on the primary package. The child is given the package that is the primary barrier for the substance.  Blister cards that are not attached to the box or holder are removed from the box for testing (if the blister card contains the child-resistant feature).

Yes, for senior panels or the senior portion of a resecuring test, the directions for the seniors must appear either on the package or on an accompanying instruction sheet. Instructions must be the same font type, font size, etc., as they will appear on the retail package. For child panels, opening instructions are recommended, but not required.

The children/seniors tested count toward a full protocol test if the package and instructions are identical to the items tested as part of the mini test.

The children are not given a tool unless the tool is sold as part of the retail package. Typically, “tools,” such as scissors or screwdrivers, are not part of the retail package and are not  given to the children during the test. However, the tool is used to demonstrate opening the package to the children if a tool is suggested as part of the opening instructions.  (Note that the adults are given all tools that are suggested in the opening directions.)

According to the protocol, children may be tested in groups of 50 (up to 200) until a package passes or fails. Depending on how many failures occur, a package may either pass, fall in the continue range (meaning an additional group of 50 children is necessary), or fail.  Sequential panels use statistical modeling to reduce the number of children exposed to packaging, which also makes testing quicker and more cost effective.  It has been our experience that a package will perform at about the same pass rate for each panel of 50 children.

The SAUE is a combination of two test scores: the senior adult panel and the child panel.  The goal of the test is to be sure the seniors can open and properly resecure the package.  When it is not visually or audibly evident that the package has been closed correctly, it is necessary to test the closing of the package with a panel of children.

The first step is to test 100 seniors.  All packages opened and assumed to be closed by the seniors are given to a panel of children.  At least 90 seniors must have passed the senior test (90% pass rate) to continue the testing to the child panel.  Between 90 and 100 packages are then tested with the children (i.e., all of the packages closed by the senior panel). 

It is assumed that even a properly closed package can be opened by up to 20% of the children.  (The packages are child resistant, not child proof.)  Therefore, the first 20% of the child openings are not used to assess how well the senior closed the package.  Each opening in excess of the 20% is considered a failure of the senior to close the package.  Based on this logic, the SAUE formula is: 100 – (adult failures) – (child failures in excess of 20%).  The minimum passing level is 90%.

An example: 100 seniors are tested, 3 are not able to open the package; 97 packages are given to the children, 22 children open the package.  The SAUE is 100 – 3 – 2.6 = 94.4%.  (Note that 20% of 97 = 19.4 so only 2.6 child failures indicate a potential senior closing error.)

In another example, if 100 seniors open and appear to close the package, all 100 packages are given to the children.  If 30 children open the package, the SAUE is 90% (100 – 0 -10 = 90%).  These data indicate a passing SAUE but call into question the child resistance of the package. 

In some cases, a packaging system will pass the SAUE test at 90% or higher; however, the data could indicate that the package may not be child resistant per the standard. In these cases, a child panel is completed in addition to the SAUE. The CPSC expects data to show the package is child resistant.

A package must be child resistant for the expected lifetime of the package.  To test for this, packages should be cycled (opened and closed) the approximate number of times the package will be used. For example, if the bottle will contain 30 single doses, the cap should be removed and replaced at least 30 times.

For unit dose packages, the tablet/pill/caplet should be the same size and density as what will be inserted in the cavity.  For pouches, the placebo should be the same size, thickness and density as the intended substance. For bottles intended for solid dose forms, typical placebo material is dried beans.  For bottles intended for liquids, water is typically used (unless the substance is unlike water).

Placebo material must never be candy or something that could be an allergen (i.e., cookies, peanuts, any foodstuffs, etc.).  These sample packages are taken into nursery schools and child care centers, and senior centers.