 Good afternoon. My name is Mary Toro. I'm the Division Director for the Regulatory Enforcement Division in the Office of Compliance at CPSC. It's my pleasure to welcome you to the webinar on the Poison Prevention Packaging Act, what we call the PPPA and the Child Nicotine Poisoning Prevention Act, the CNPPA. Ms. Patricia Pollitzer, the Assistant General Counsel for Regulatory Affairs will provide an overview of the acts from the Office of Compliance. We have Dr. Stephanie Sinett, who will discuss the substances Sorry about that. Substances covered in the acts, exceptions, and special circumstances. Mr. Stephanie Lee will present the testing protocols under the Poison Prevention Packaging Act and Dr. John Bozier will present certification requirements for substances regulated under the act and Mr. Howard Tarnoff, Senior Counsel to the Director of the Office of Compliance, will discuss reporting requirements under section 15 of the CPSA and recalls. We will not have the ability to answer any questions during the webinar, but we are providing an email address for you for you to be able to submit questions during the webinar. After the webinar, we will spend time answering questions via email at a later date. We will try to address individual questions from people as soon as possible. So please submit your questions to Jay Bozier at cpsc.gov with the subject line PPPA webinar. And we will try to address those questions as soon as we can. I'd now like to ask Patty Palitzer to begin her presentation on the overview of the acts. As Mary said, I am going to start with a introduction. Hang on a second, let me get to the PowerPoint. Okay, I'm going to start with an introduction to the commissions, there we go, to the statutes that the commission uses, looks at when, under looking at special packaging, specifically the Poison Prevention Packaging Act and the Child Nicotine Poisoning Prevention Act, which is the most recent addition to our statutes. So first, the PPPA. The PPPA gives the commission the authority to issue regulations requiring special packaging for household substances. The statute itself does not actually provide for enforcement of the PPPA regulations, but other statutes that the commission administers, specifically the Consumer Product Safety Act and the Federal Hazardous Substances Act, do provide for enforcement. So, special packaging. As I said, the statute authorizes the commission to issue special packaging requirements for household substances. So the first question really is what is special packaging? And the statute provides a definition. It's really a two-part definition. So the first aspect is on the child resistance that the packaging is significantly difficult for children under five to open or obtain a toxic or harmful amount of the substance within a reasonable time. The second aspect, though, focuses on adults. The packaging has to be not difficult for normal adults to use properly. So, another thing we need to learn, know about the kinds of regulations the commission can issue under the PPPA. So what is a household substance? And that's another term that is defined in the statute. Under the statute, it's a substance that's customarily produced or distributed for sale for consumption or use, or customarily stored by individuals in or around the household. And it has to fit into one of three categories of substances. So either it's a hazardous substance as defined by the Federal Hazardous Substances Act or it's a food, drug, or cosmetic as defined by the Food, Drug, and Cosmetic Act or it's a substance that's intended for use as fuel when stored in a portable container and used in the heating, cooking, or refrigeration system of the house. So we've talked a little about the definitions of hazardous household substance and special packaging, but what is the package that actually would have to be in special packaging if the commission issues a special packaging regulation? So the statute also provides a definition of package and the focus is on the immediate container. So the package that would have to meet the special packaging requirements is the immediate container or wrapping of the substance of the product. So it's not a container that's used for shipping or transportation. It's not an outer wrapping if there is an outer wrapping. And this makes sense if you think about the purpose of the PPPA and focusing on protecting young children from getting into substances that would be in the household. So the expectation under the PPPA is that if a substance is subject to a special packaging rule that it will be in special packaging, but under Section 4 of the PPPA, there is a limited exception focused really on the elderly and disabled being able to have access to the substance. So under Section 4 of the PPPA, the manufacturer or packer who supplies a non-prescription substance can offer a single non-compliant size package. So every other size of the package except one would have to be in special packaging. And if they choose to do this, that one size of that one package has to be labeled that it's for households without young children. And then regarding prescription items, a physician can specify that an item for a prescription should not be in CR packaging and a patient can request non-CR packaging when they're filling a prescription. So the commission has the authority, as we said, to issue special packaging regulations under the PPPA, and the statute specifies findings that the commission has to make in order to issue such a rule. The commission has to determine that special packaging is required to protect children from serious personal injury or serious illness resulting from handling, using, or ingesting a household substance. That particular substance is the subject of the rulemaking. So when the commission is considering a PPPA rule, the staff prepares a briefing package with information for the commission that has information from which they could make these kinds of determinations, these findings. So the staff would provide information about the toxicity of the substance, about medical literature, incidents they might have learned of from FDA, or incidents that might be in CPSC's databases. So in addition to that finding concerning potential for injury or illness, commission also has to determine that special packaging is technically feasible, is practicable, and is appropriate for the particular substance that's the subject of the rulemaking. And according to legislative history, the technical feasibility means that technology exists or can readily be developed and implemented by the effective date of the rule to produce packaging that conforms to the special packaging standards under the PPPA. Practicability means special packaging that complying with the standards can use modern mass production and assembly line techniques. And as for appropriate, a packaging, a package is appropriate, special packaging is appropriate when it will adequately protect the integrity of the substance and not interfere with the substance's intended storage or use. In addition, or really kind of as part of those findings, the commission also needs to consider, under the statute specifies that the commission needs to consider the reasonableness of the standard, the available scientific, medical, and engineering data, manufacturing practices of the effective industry, and the nature and use of the substance. It's important to note that the special packaging requirements under the PPPA, it's a performance test. Others will go into that in more detail, but under the PPPA, the commission cannot prescribe specific packaging designs, product contents, the quantity it needs to go into a package, or labeling with that one exception that I mentioned under section four about labeling for items that don't meet special packaging. The statute also provides that the commission can prohibit packaging that is unnecessarily attractive to children. The commission has not actually issued a regulation on this to date. So the process for issuing a PPPA rule, the commission follows notice and comment rulemaking. That means that the commission would first propose a special packaging rule for a particular substance, would request and obtain comments on that, and then issue a final rule. As with any, pretty much any notice of proposed rulemaking, the commission would consider impact on small business, but the PPPA specifically states that there's no cost benefit analysis that's required for a special packaging rule. The statute also has provisions concerning the effective date. So the effective date of a special packaging rule cannot be sooner than 180 days from the issuance of the final rule unless the commission finds that it's in the public interest to have a shorter effective date. Also the effective date can't be later than one year from issuance of the final rule, and the statute provides that the effective date applies to products that are packaged on or after the effective date. So we've talked a little bit about what is a household substance that can be the subject of a PPPA requirement. Products that are not subject to PPPA requirements is sort of the flip side of that definition really. So things that are not customarily used in or around the household say something that is strictly a commercial product. Items that are specifically exempted under the commission's regulations. So for example, the commission has a special packaging regulation that requires special packaging generally for oral prescription drugs, but there are certain specific drugs that have been exempt, the commission has exempted from that requirement. So bulk packages of drugs sold to pharmacies would not be subject to requirements because of course they're repackaged. Similarly, bulk chemicals, containers of five gallons are more of substances for the most part. So again, this all kind of follows from the idea that the PPPA is looking at items that would be available to a child in the household. So moving on to the Child Nicotine Poisoning Prevention Act. As I said, this is the most recent addition to our statutes. It was enacted in January of this year. And this statute sets out a specific requirement that any nicotine provided in a liquid nicotine container sold, offered for sale, manufactured for sale, distributed in commerce or imported into the United States, has to be packaged in accordance with the standards, the special packaging standards that the commission has issued under the PPPA. The statute also states that this requirement is to be treated as a standard for special packaging of a household substance under the PPPA. So it can be enforced just as if it were a special packaging standard that the commission had issued. The Act also provided the effective date. It stated that the requirement is to take effect 180 days after enactment. The statute was enacted January 28th of this year. So the effective date is July 26th of this year. As many of you may know, the Food and Drug Administration has issued final regulations concerning various tobacco products, specifically concerning electronic cigarettes and related products and components. Liquid nicotine is included in that rulemaking and under the FDA's authority, under the statute that they issued those regulations under. So currently, there are, FDA does not have any regulations specifically on the package of liquid nicotine, but they do, as I said, have brought authority under the Family Smoking Prevention and Tobacco Control Act. So in recognition of FDA's role here too, the Child Nicotine Poisoning Prevention Act has a savings clause that allows FDA in the future to issue regulations or take other action, really, regarding liquid nicotine and that could include child-resistant packaging, labeling, various other types of actions. So in recognition of this role of both FDA and CPSC, the Act calls for consultation and coordination between CPSC and FDA, and we are and will endeavor to do that in the future and work with FDA. So that's it for me for an overview of the statutes and Stephanie will now go into more detail about the specific substances. Good afternoon. My name is Dr. Stephanie Sinnet and I'm a Compliance Officer in the Chemical Hazards Team. So in the previous presentation, we, the definition of household substances was supplied just as a review household substances are customarily produced or distributed for sale for consumption or use or customarily stored by individuals in or about the household and also meet one of the following. A hazardous substance as defined by the FHSA, a food drug or cosmetic as defined by the Federal Food, Food, Drug and Cosmetics Act, or substances intended for use as a fuel when stored in a portable container and used in heating, cooking, or refrigeration system of a house. More specifically, this slide shows a list of regulated drugs that must be in special packaging under the PPPA. So as a reminder, special packaging is one that is required to both be child resistant and senior friendly. I'm not going to go through all the regulated drugs that are listed here, but just to highlight a few, we see that immediate acetaminophen is listed, as well as ibuprofen, iron containing drugs and dietary supplements, oral prescription drugs, and over-the-counter switched drugs. On this side, there's also a list of substances that are required to be in special packaging under the PPPA. So again, I won't go through all of them, but examples include furniture polish. If a product contains a certain amount of hydrocarbons, as well as if a product, for instance, contains a certain amount of sodium or potassium hydroxide, it would require to be in special packaging. This list, as well as the regulated drugs, and the details on the requirements may be found at 16 CFR section 1700.14. As Ms. Pulitzer went into, there are some exceptions. So for items that are not to be used in or around the household are not required to be in special packaging under the PPPA. This includes items that might be found and used in hospitals or nursing homes. As well, if the products intended to be used for professional use would not be required to be in special packaging. There are also special circumstances for prescriptions. Bulk drugs that are intended to be repackaged by pharmacists do not need to be in special packaging. And as previously mentioned under section four, the PPPA, if it's requested by a patient or physician, there is the allowance for a non-compliant packaging to be issued. There is an option to petition for a prescription drug to be exempt from special packaging. The petition procedures is found at 16 CFR section 1702. And the list of prescription drugs that are exempt may be found at the citation noted here. As was also mentioned in the last PowerPoint presentation, for over-the-counter drugs that are available in multiple sizes, it is possible that for the least popular size to be in non-compliant packaging. This package must be labeled as quote, this package for households without young children. The packaging does not allow for this length of a label to be issued. There is a substitute labeling which reads package not child resistant. All the other sizes must be in child resistant, have child resistant closures. And in the future, if the firm realizes that what is in non-compliant packaging is no longer the least popular size, it's the firm's responsibility to notify CPSC of that. There is an exclusion to the one size allowance, and that's for drain cleaners. Under the Federal Hazardous Substance Act, drain cleaners are considered banned hazardous substances if they are not in special packaging. The next few slides will talk about physician samples. So as previously stated, oral prescription drugs are required to be in special packaging. And as we saw under the exclusions section 4B of the PPPA grants physicians the authority to order non-CR packaging for their patients in the written prescription. For the samples, the commission's policy is not to require manufacturers of regulated prescription drug samples to be in special packaging. Ultimately, the decision to provide special packaging is up to the physician on a case by case basis. Important to note that section 4B does not apply to regulated over-the-counter drugs because they are not dispensed by the order of a licensed practitioner. Same goes for samples of regulated over-the-counter drugs. They must be in special packaging as well. The last two slides are going to be specifically for what's covered under the CNPPPA. Again, this was recently effective in July 26, 2016. So for products of pure liquid nicotine when offered in a retail package for sale to consumers, they must be in special packaging. If the liquid nicotine is even diluted by the base liquid, which is often referred to as propylene glycol or vegetable glycerin, they must also be in special packaging. And for products that are referenced as e-juice or e-liquid, which is often a mixture of liquid nicotine, the base, and the flavoring, they must also be in special packaging. If the nicotine is inaccessible, then it does not need to be in special packaging. So for instance, sealed, pre-filled disposable cartridges meant for e-cigarettes or disposable e-juice tanks where the nicotine is inaccessible, that it's not required to be in special packaging. If the package contains only the base used for dilutions or the flavor extract, it does not need to be in special packaging. Empty packages or closures that are sold as an aftermarket product are not required to undergo testing or certification. However, it's very important to note that a non-special packaging enclosure may not be packaged with a liquid nicotine product that's offered for retail sale to a consumer. A non-special packaging enclosure may be sold separately, but it cannot be sold with the nicotine product. And finally, products that are not intended to be sold as is to consumers, meaning if the product is intended to be used by another manufacturer or a repackager, then it does not need to be in special packaging. Another example, this could be products that hold five gallons or more. They do not need to be in special packaging. So this concludes the substances that are covered under the PPPA and the CNPPA. I now turn your attention over to Stephanie Lee who will talk about testing requirements. Good afternoon. My name is Stephanie Lee and I will be going over the testing protocols of the Poison Prevention Packaging Act as well as the additional information for the testing and some questions that have arisen. So as you can see here, we'll be going over three different testing, the child tests, the senior adult tests, and the adult resecuring tests. This will be followed by the additional information and some frequently asked questions. Please note that there are special considerations for unit dose packaging that will be discussed in the following presentation. So the testing procedure for the child test is as follows. Panels of 50 children are tested up to four panels. The age range is 42 to 51 months old and broken down into the following. 30 percent of the children must be from 42 to 44 months, 40 percent from 45 to 48 months, and 30 percent from 49 to 51 months. The panel is split evenly into 50 percent girls and boys and there's also certain restrictions. There's a tester restriction to prevent tester bias and what this means is that each tester can only test up to 30 percent of the children. A site restriction allows for a more diverse sampling and this means that up to 20 percent of the children can be tested at a single site. The children are tested in pairs and the testing must be done in a location that is familiar to the children. This will be such a places such as a daycare center or preschool. The children are provided five minutes to open the package. If unopened within those five minutes the package is taken away and a demonstration is provided by the tester. This demonstration is the tester opens the package as if it would be opened in the household which means there's no exaggerated movements and no additional instructions given to the children. After the demonstration the children are again given the packages to open and additional five minutes of testing is provided. At this point if the children have not used their teeth they are instructed that they are able to use their teeth. Here we see the pass fail table for the child testing. The two time periods are separated out because they are representative of two different evaluations and it outlines the possible outcomes of the test results. Failure is defined as a child opening the package or gaining access to its contents through any means whether it be intended or unintended. An unintended use would be a child using their teeth to break open the cab rather than actually pushing and twisting. A leaking package would be considered as an automatic failure. So for example if four children from the first panel opened the package and no additional children were able to open the package in the second five minutes this would place the the results in the continue column for the first five minutes and then the pass column for the full ten minutes. However the testing should continue because of the fact that in the first five minutes the results fell in the continue column. The senior test procedures are very different there's a hundred adult panel there's no additional panels there the age range varies from 50 to 70 years old and are broken down as follows 25 percent from 50 to 54 years 25 percent from 55 to 59 years and 50 percent from 60 to 70 years. This panel is split up into 70 percent women and 30 percent men. The reason for this shift is that females tend to live longer and are the more likely caregiver therefore they have the higher probability to interact with the packaging in the household. There is again a tester restriction of 35 percent of the adults per tester and another site restriction of 24 percent of the adults per site. The seniors are provided a consent form and after which they are given the first package five minutes is provided to them to open and reclose this first package after which they are provided a second identical package and one minute is provided for them to open and reclose this package. The difference for the five and one minute is the first five minutes is to provide it as a learning curve for the adults to get an idea of what the package is like and the one minute is the application of that knowledge. A screening procedure is available if the adult cannot open the special packaging. The seniors are provided two non child resistant packaging to try and open. These are a continuously threaded closure and a snap top lid. One minute is a provided for them to open and close both of the packaging. If they are not able to complete both of the tasks the results of this panelist is not included in the final results and an additional panelist to be tested is required. So now we have the adult re-securing tests and this test is required when an objective determination that a package is properly re-secured cannot be made. This objective determination can be visual or mechanical in nature. For example, if you have to line up the arrows to open a package that would be a visual determination and aligning of the arrows would mean that it's not properly closed. A mechanical determination would be for lug fit tops where you hear an audible snap when properly closed. That would be a mechanical determination. Packages that have been opened and appear to be re-secured by the adults from the senior test are provided to the children to open. The test instructions that are outlined in the child test are followed for the second part of this test. So the children and seniors are provided different things. The children are provided packages that are presented in the form in which they will enter or be stored in the homes. This means that any tamper proof features are removed prior to giving to the children. Tools are only provided if it is included with the packaging. Seniors are provided any required tools to open this packaging as well as instructions on how to open and properly re-secure the package as it will appear on the packaging itself. This means that these instructions cannot be provided larger on a different sheet of paper. The worst case scenario should be simulated and this can be conditioned prior to the testing where you provide old packaging to kids because old packaging is generally easier to open and new packages are provided to seniors because a new packaging is generally harder to open. There are additional requirements for the PPPA. The substance that is packaged inside cannot compromise or interfere with the function of the special packaging. Examples of this would be sugar solidifying around the closure of the threading or a solvent that's actually dissolving the packaging itself. The special packaging is also required to continue to function so that it meets these requirements for the life of the product. So for example, if you had a bottle that contains 100 counts of a certain pill, it would have to function effectively for 100 opening and closings. Generally, we recommend that the firm test these way well beyond that 100 count. So what do you submit for testing? If the packages are of the same material but are different sizes, multiple testing may be required. So this can be done through bracket testing for different closures or bottle sizes. For example, if you have five different sizes that are increasing in size, you may wish to test the first, the smallest size, the largest size, and one in the middle with the assumption that the other two in the middle will have the same functionality as the ones that have been tested. So this means that the size of the packages that have not been tested basically wouldn't be taken into consideration or a child wouldn't be able to open it easier based on that size difference. Generally, there are times where bracket testing may be appropriate. However, guidance and consultation from CPSD staff should generally be sought out. If the packages use the same closure but the bottles are different materials, testing both of these packages is necessary. So for example, plastic and glass bottles that are using the same exact closure require two separate tests for the final certification. So who can perform the testing? Well, there's no provisions in the law or in the regulations that restrict who can perform the testing. However, there may be some state requirements that exist. For example, some states require background checks for testers prior to interacting with the children. The testing is valid as long as the protocols that are outlined in that, in 16 CFR section 1700.20 are followed. A firm should think about retesting for various different reasons. So if there's a change in the package's manufacturer, for example, a change in the raw materials for that packaging, a change in the manufacturing process of that packaging, or if they're developing or designing a new package, they should have that retested. If the firm is using a tested closure on a different or new bottle, additional testing is required. In addition, when a firm is receiving incident reports or complaints, or if the firm becomes aware of a manufacturing or materials defect, these should be taken into consideration that a firm should be retesting their bottles. As noted earlier, there are special considerations for unit dose packaging, which will be covered in the following presentation by Dr. Stephanie Senate. And Mr. Stephanie Lee just talked about the testing procedures. I will now be talking about the special considerations when we're specifically addressing unit dose packaging. So unit packaging, as shown in the picture, is packaging that contains single dose or use. So the common examples are blister packs or pouches. So as Mr. Lee has highlighted on when to test, what to test, the package should have a configuration that results in the worst case scenario. Specifically for unit dose packaging, units should be in the form in which they will enter the home. So, for example, the units are going to enter the home as an intact group. That should be how they are tested, unless testing separated units presents the worst case scenario. It's also important to test the number of units that the consumer would typically bring into the home at once. For example, if a retail box contains three blister cards, then three units should be what's supplied to the children during the testing. As Mr. Lee pointed out, for tools, tools should be provided to adults if the instructions are to use one on the packaging. However, tools should not be supplied to the children unless it comes with the packaging. So a common example with this would be if the packaging shows a dotted line with a pair of scissors. Adults would receive the scissors to use, but the children would not. Again, unless it comes with the package. So during testing, it's important to understand what's considered a test failure. When conducting the test for children resistance on unit package, test failures when a child opens or gains access to either the number of individual units that constitutes the amount that may produce serious personal injury or serious illness or more than eight individual units. Whichever number is lower and above two scenarios will determine what is considered a test failure when testing during the full 10 minutes. So in the previous slide, I used the terms opened or gained access to. So that's interpreted as the individual units from which the product can be removed or can be removed either in whole or in part. So in the picture that's shown here, we see that the blister is breached, but even if the contents are not removed, this should generally still be considered access gained. Another example would be that access gain can be something resulting from as small as a pinhole, depending on what the contents are of the package. So if there's a quick dissolve pill or liquid that's in the package and there's a pinhole, it's understood that a child would be gaining access to the contents. When speaking with the office compliance, you might hear us say the term F values. The number of individual units to which access is considered a test failure is commonly and unofficially referred to as F. So if the toxicity of a substance requires access to three units to be considered a test failure, the substance is said to require an F equals three package. So for instance, when conducting the children test, if an individual child is able to open or gain access to three units and the F value is three, then that would be considered a test failure. So the determination of the F value is the amount of a substance that would produce serious personal injury or serious illness and it's based on a 25 pound child. Manufacturers or packages intending to use unit packaging for a substance requiring special packaging are requested to submit such toxicological data to the CPSC office of compliance. And just to go back to the test failure for a moment, if the toxicological data indicates that a substance has an F equal 12 level, remember under the definition of a test failure, we would still consider more than eight units a test failure because that's the lower number of the two. So there's a couple examples and one trying to determine the F level. So in the picture showing here, in this case, more than one PPA regulated substance is packaged in one unit dose. And so the failure level is determined by the most toxic unit of the contents. So for instance, of the three drugs shown, if one has F equals two, another one has F equals four, and the third one has F equals eight, the most toxic PPA regulated drug should determine the level of child resistance for the packaged unit as a whole. So in this case, that would be F equals two. In another example, some unit packages comply with child resistant requirements if the package contains fewer units of substance than the determined F value. So for instance, if the substance is said to be F equals five, but the retail package has fewer than five units in it, then we would say that the package meets the child resistant requirements. In the next few slides, I'll be going over how to interpret the test data from a sample scenario. The data will be presented in two different test report formats, even though they will be representing the same data set. In the end, you'll see that the outcomes are the same, even though the data may be present differently in the two tables. So in this scenario, we're saying that there were 50 children tested for the full 10 minutes. And the sample data indicates that 18 children failed to open or gain access to the package. 19 children opened or gain access to only one unit each. That means each of the 19 children were able to open one unit. Eight children open or gain access to a total of two units each. Five children open or gain access to a total three units each, and none of the children opened or gain access to four or more units. So on this slide, we see that the data that I just explained is being presented in two different formats. Remember, 50 children were tested in each of the examples, and they were tested for the full 10 minutes. In example one, the data is being represented to show exactly how many units were opened by each child. So if we look at table one, we see that, for instance, 19 children opened exactly one unit, whereas five children opened exactly three units. Now in example two, the same data is being represented but just being shown differently. The data is being reported so that the total number of children to open that number of units is being shown. So for instance, if we look under unit one, it's saying that 32 children were able to open at least one unit. And if we think about it, if a child is able to open two units or three units, then it's also able to open one unit. So the second table is showing you the total number of children that's able to open at least that number of units. And we'll go into more, we'll go into further example in a moment. Let's concentrate on the first example and how we would potentially interpret the test results. So again, this data is showing the number of children that opened exactly that number of units. So if we wanted to determine how the package would perform at F equals one, we would not be able to go to the table and directly take the value that's shown there. Instead, we need to calculate the total number of children that were able to open one package. So to do this, we would sum up how many children opened one unit, how many children opened exactly two units, because again, if they opened two, they were able to open one as well, and how many children opened three units. So in this example, we would see that a total of 32 children were able to access at least one unit. If we wanted to then determine if this package would pass, need to go under further testing or fail for F equals one level, we would go to our pass fail table and see that for the panel one, when a total of 50 children were tested, that if there was 32 openings, this package would fail because 15 or more openings would constitute as a fail. So what would the outcome be if this package was at an F equals two level? So we would need to again, sum up the total number of children that were able to open at least two units. So we would see that eight children opened two units and five children opened more than that, so a total of 13 children were able to access at least two units. And going back to our table, we see that if we have 13 openings, that falls under the continue column. Thus, you would have to panel an additional 50 children to see what the outcome would potentially be. And so if we look to see if this package, how it performed at F equals three, we would now go to see that for three units, five children opened or gained access and there was no more after that. So we would see that at F equals three or greater, this package would pass because passing is from zero to five. So in example two, you'll notice that the sums are already calculated for you and the way that the data is presented. So we can go directly to the table to determine how the package performed at each F value. So for F equals one, the outcome is going to be the same. We see that a total of 32 children accessed at least one unit and thus we saw that would be a failure. For F equals two, we see a total of 13 children accessed at least two units and thus you would need to continue testing. And at F equals three or greater, it would pass because only five children gained access. So the conclusion from the two report formats that I showed you is that both of them are acceptable. However, staff requests that the report explicitly states if the data represents exactly the number of units accessed or at least the number of units because you can see you won't be able to, you may not be able to directly take the data from the table. The advantages of including this explicit language is having a more complete picture of how the package performed in the test and having the potential to use the data to support the use of the package for other drugs of different toxicity. On the other side, if the number of units the children accessed is not reported, you only know whether the package passed or failed at a certain F level. So for instance, the test data shows that the package passes with a given substance at F equals three and you have no, you have no way of knowing whether the packaging would pass if you wanted to package a similar substance requiring F equals one. And in the scenario that we just went over, we saw that in fact, in this example, it failed at F equals one. So Mr. Lee went over some examples on when to retest and the same would be for unit dose packaging. So if you're, so if the firm is developing or designing a new package, receives incident reports or complaints or is aware of manufacturing or material defects, these would all trigger the need for a retest. Specifically for unit dose packaging, a change in the package may result in a change in the child resistance. So for instance, at the cavity size of the blister changes, this might change how it performed for in the children's test. If the materials used in the packaging change, for instance, the foil backing of the blister pack was thicker or thinner or the plastic used in the cavity size was to change, this might change the child resistance performance and it should be retested. And as previously mentioned, if there's a change in the manufacturing process, so for instance, the cutting blades were dulled over time, this might result in substantially different performance between the blisters in the children or even the adult testing. And finally, if there's a change in the substance, that might warrant a retest as well. So if the new substance has a different form, size, shape, or hardness, for example, you test with a round pill versus an oblong oval pill, you might see that the package performs differently. This is why it's always recommended that you use placebo pills or liquid or powder when you're submitting your packaging for testing. As we previously mentioned, if the value of the new substance differs from the substance the package was tested and the test reports do not provide enough information, then you might have to retest. And this is why we always stress that it's important to include as much data as possible. So this concludes the presentation on unit dose packaging. And I'll now turn it over to Dr. John Bozier. We'll talk about certification requirements. Thank you, Stephanie. And I'd like to thank everybody for sticking with us so far. I will be talking about the certification requirements for the PPPA on my presentation here. We'll get going. So once again, I'll be talking about certification requirements under the PPPA. As you heard from Ms. Pollitzer, we defined the PPPA, what it does. Dr. Sinet talked about the substances required. She also spoke about how to test for unit packaging. Stephanie talked about how to test for conventional packaging or in the testing process in general. And I will talk about the final step and that is the certification requirements under the PPPA and also the CNPPA. Manufacturers and importers of products that require special packaging must certify with a general certificate of conformance that their products comply with the special packaging requirements under the PPPA. So that would be if you package a substance mentioned in 16 CFR 1700.14A or liquid nicotine under the CNPPA. You must certify with a certificate that this product has been tested or has been subject to a reasonable testing program. And that's enacted. The citation there is for the Consumer Product Safety Act. So under the Consumer Product Safety Act, you are required to certify. Because the PPPA requires special packaging for certain substances and these packages must meet the performance specifications of 16 CFR 1700.15, that means that special packaging is a rule that requires certification. So the importer of the product or the domestic package, party that packages a substance that requires special packaging must issue a certificate certifying that that product meets the special packaging requirements of 16 CFR 1700.15. There are seven elements to a general certificate of conformity and I will go through those elements briefly and then once again in greater detail. The first element is you have to identify what the product is. The next element would be what exactly are you certifying? So you have to cite the certification to the specific CPSC safety rule that you're certifying your product to. The third element is identification of the U.S. importer or domestic manufacturer. The fourth element is the contact information for the individual maintaining the test records. The fifth element for a GCC is the date and place where the product was manufactured. And notice I said product and not the package and I'll go into that in greater detail in a moment. Elements six and seven have to deal with the testing of that product. So element six is the date and place where the product was tested in compliance with the regulations cited above and once again that regulation is 16 CFR 1700.15. And finally element number seven is identification of any laboratory who's testing upon which the certification depends. Unlike the rules for toys and children's products that have to be a recognized CPSC accepted lab that's been certified or accredited I should say the PPPA does not require the accreditation and acceptance of a laboratory. So there are a number of laboratories listed on our website but these are for your benefit and a inclusion on our website does not mean that there has been any kind of accreditation or endorsement of said laboratory. For more information I've provided a link down below. Don't worry if you can't write it down really fast this will be recorded and you will be able to catch it after the presentations are over. Element number one is the identification of the product and this description of the product that you're covering with your certificate should be in enough detail to match the certificate with each product it covers and no other product. So if you're making aspirin in a hundred count you should put your company name and then the aspirin and then the number in each container. If you have a certificate if you make several different sizes and they use different packaging you'll need a certificate for each individual product you make. Element number two is certification of the CPSC product safety regulation. In the case of packaging you're certifying to the performance specifications found in 16 CFR 1700.15. Element number three is identification of the U.S. importer or domestic manufacturer. You need to provide the full name full mailing address and telephone number of the importer or U.S. domestic manufacturer. If the manufacturer of the product is done overseas then the importer must issue the general certificate of conformity and again if it's made here in the states the U.S. manufacturer would issue this certificate. Element number four is the contact information for the individual maintaining the test records and this has to be a person this cannot be a corporate address or it cannot be you can't put down whoever's maintaining the records. It has to be an individual a specific individual a specific name has to be given their full mailing address an email address and the telephone number. So whoever's maintaining the records that support this certificate must be provided in element number four. Element number five is a date and place where the product was manufactured. So this is a date and place where the package was filled. It is not the date and place where the container was manufactured. So if you again going back to my example of aspirin and if you're using a bottle to package your aspirin you would not put down the date and place where the bottle was manufactured rather you would put down the date and place where the aspirin was actually introduced into that bottle. So it's whomever puts the regulated substance into the package that will go off to retail that is the date and place where it was manufactured. If there is a range a production range so if you start producing aspirin say in January of 2016 and you're having continuous production you could put that range from January 2016 to present on your certificate. For the place of manufacture you have to at least have the city and country and if you have more than one location in a particular city or country you should also then provide a street address. So it should be records so people will know exactly where that product came from when it was manufactured and where it was manufactured. Element number six is the date and place where the product was tested. So when the product is tested according to the performance specifications of 16 CFR 1700.15 using the test protocols that Stefan mentioned that are found in 16 CFR 1700.20 This is where the testing was actually done. So if you commissioned the testing you'll have that date and place. If you're buying product from a manufacturer and they have already tested it it's where the product was tested for that manufacturer. And finally element number seven is identification of the laboratory upon whose testing the certificate depends. So if a product was tested by Tom's testing in Peoria Illinois you would list the name of the company that did the testing and in element six when they did the test. Some of the frequently asked questions again you will have time after the webinar to submit questions to us but I wanted to go over some of the questions that we get frequently and some of the answers and these questions are available at the web location located below but I'll go over some of them from that site and then some additional others. So one of the question is who must issue the certificate and as I mentioned it's the importer or domestic party that packages a PPPA regulated substance. They are the person that must issue the GCC. So whoever puts the regulated substance into the bottle is the person responsible for the certification. Can I use the data supplied by a special packaging manufacturer and yes the protocol data that was obtained with the procedures outlined in 16-1700.20 can be used by the importer or domestic packaging manufacturer to support the certificate. You may rely on that packaging as the basis of a reasonable testing program. I should note that the commission staff does not consider the European tests ISO 8317 EN 14 375 and EN 826 or I'm sorry 862 to be equivalent of the tests required by the CPSC regulations. There's some subtle differences in the European tests as compared to the U.S. tests and those differences are enough to make it so that these tests are not the equivalent to our tests. When should you retest? Well as both you heard from Mr. Lee and Dr. Sinnet there's no expiration on these tests and no requirement to retest as long as the product you package is adequately reflected by the test that was conducted. Retesting should be considered when there's been a material change made to the packaging and material change can be a change in the manufacturing process, a change in the component parts, something that changed in the packaging that would impair its ability to meet the performance specifications of 16 parts 1700.15. Do I have to certify my empty vials or caps? No. An empty container is not subject to the special packaging requirements of the PPPA because it doesn't contain a regulated substance when you sell it empty. However a manufacturer of packaging may certify the product prior to you using it in your manufacturing process or your refilling process. Does the CPSC regulate children's drugs and do they need to be certified to the CPSI or the Consumer Product Safety Improvement Act standards? No. The CPSC does not regulate children's drugs per se. We regulate certain substances that may be included in children's drugs. Substances, as Dr. Sennett mentioned, might include acetaminophen or diphenhydramine. Those substances are regulated substances and require certification because they are regulated by us. We don't regulate the things such as dosing cups or the dosing droppers. As Dr. Sennett mentioned we do not regulate bulk drugs that are sold to pharmacy because these will be repackaged by the pharmacist and the packaging that the pharmacist uses must meet the certification special requirements of the PPPA so no certificates required for bulk drugs. Finally that's the end of my presentation and I'd like to take this time to introduce Mr. Howard Tarnoff. He's our legal counsel at the Office of Compliance and he will be going over regulatory issues. Thank you. Thank you Dr. Bozia and good afternoon everybody who's listening in. Again my name is Howard Tarnoff. I'm in the Office of Compliance and I'm the senior counselor to the director of compliance and field operations. I'd like to talk to you today about two key elements of the compliance program reporting and recalls. Reporting is not just mandatory under the section 15 of the Consumer Product Safety Act. It's also the right thing for a firm to do. When a firm meets its obligations to report it's helping both itself and the agency to do an early investigation of a potential problem. It can lead to discovery of more problems and it can lead to the early addressing of problems with that product which can then ultimately reduce any incidents or injuries that occur because of that product's problems. So let's talk about the requirements under section 15. A firm must file a report with the agency when a product that sells imports or distributes or manufactures fails to comply with a Consumer Product Safety Act rule or any similar rule ban standard or regulation enforced by the agency. In addition a firm must report to the agency when a product that it sells contains a defect which could create a substantial product hazard and finally a firm must report when a product that sells or imports or manufactures creates an unreasonable risk of serious injury or death. This does not require a defect. Because we're talking about the PPPA specifically, many of the triggers for reporting are going to be because of violations of the PPPA regulations. I'm listing here broken down into four major categories where we've seen over the last five to six years the violations occurring. As you can see a majority of the violations are occurring in prescription drugs but there's also many hazardous substances non-drug products that are found in the home. In addition there's over-the-counter drugs and dietary supplements so it's a wide range and we're seeing them across the board. So what is the trigger for reporting? A firm must report immediately and we've defined that to mean 24 hours. When it obtains information that a reasonable conclusion can be drawn that the reporting triggers are met. A firm can conduct its own investigation. It has to be reasonable and we don't really... Our regulation says that you have about 10 days to conduct an investigation but we expect you to be in contact with the agency before that or at the 10-day mark. So what we provide in the office of compliance is a firm who has a question about whether it needs to report, it can email us, it can call us, it doesn't actually have to file a report. There's many good resources to contact the agency to discuss whether a report needs to be filed. We'd prefer to have that discussion rather than have the firm try to figure it out on itself. The earlier the discussion takes place the more we can get on top of a problem. And the reporting system itself is set up so that a firm can provide some initial information while it's still gathering information about the potential problem and then ultimately it can file a much more comprehensive report. The key is contacting agency getting us started on our investigation while you're conducting your own investigation. So the kinds of things that a firm needs to monitor for its own products. Clearly consumer complaints, we often take a really good look at that because that sometimes tips off a firm to the issues. But there's not always going to be claims or incidents or problems. There's other things that can happen for a product. So you have to be on top of any design changes from your suppliers, any material changes, all those things. A firm needs to be monitoring the entire range of things that could be occurring with its products to keep on touch, keep on top of whether there are anything that could trigger a report. In addition, we recommend that you sign up with the agency. There's a business tab and under that you can register at saferproducts.gov to actually get reports that come into the agency. And when they come into the agency, if you're registered and it's pertaining to your specific firm, you'll automatically get a copy of the report to saferproducts.gov. So what can happen if you don't report? Well, I'll talk about the legal obligation in a second. But again, if you don't report, that could lead to the product being on the market longer without it being addressed. And that could lead to more possibility of injuries or worse injuries. So that's sort of the moral imperative for why you should report. But there's also legal consequences. If you don't report, there's penalties that the commission can seek, not just civil but also criminal penalties. In 2008, Congress increased our penalty authority. We now can pursue a penalty for $100,000 per violation up to $15 million for a related series of violations. In addition, under certain circumstances, we can pursue criminal penalties that can lead to possible felony five-year imprisonment. Here's some recent examples of civil penalties. These are up dramatically in the last few years since CPSIA thresholds kicked in. We have obviously with Griga in the maximum penalty. And for other similar companies, we've been getting around $5 million per penalty. I wanted to point out the best bipenalty because that involved a retailer who was selling recall products. So it's not just a manufacturer who puts products on the market. There's a legal obligation for a retailer not to sell or anybody, but retailers in particular, not to sell a product that's previously been recalled. So you need to pay attention. The mantra you'll hear, not just in my presentation, but anyone who's ever attended a CPSC presentation on reporting, is when in doubt report. Not all reports wind up in recalls. As I said, we want to start a dialogue with the firm. We're going to do an investigation, and not all of our end results will be a recall. The threshold for reporting is less than the threshold for determining whether a recall is necessary. And really, you shouldn't wait for us to call you. If we're calling you to conduct investigations, it's much more likely to wind up being a civil penalty than if you contact us initially. We really want to get on top of these issues at the earliest possible time. Here's some basic dos and don'ts for reporting. You should not assume that a failure, a non-compliance, or an incident with a product that doesn't lead to an injury, doesn't mean that it's a problem. It could be just that you got lucky in that particular circumstance, or the user got lucky. It certainly is an indication of a potential problem, and you should do a diligent investigation of that problem. You should evaluate product failures to determine what could have occurred in the worst case. A lot of circumstances have to happen for a product to fail, and maybe lead to an injury, but you shouldn't assume that the worst can't happen. In addition, we don't want a firm to wait for an incident to occur. If it's aware of a defect, say on the manufacturing line, some problem, you should do an investigation of that. And finally, as I said earlier, don't wait for yourself. A firm should not wait until an exhaustive investigation is completed before it tells the CPSC. As I mentioned earlier, the trigger is far earlier than that. Okay, so I mentioned that not all reports lead to recalls from the market, but however some do. So I want to talk a little bit now about what the recall process is. The main objective of a recall is to locate the hazardous products as quickly as possible and remove them from the distribution chain. The goal is, as I said, to remove the incorrect hazardous products. In order to achieve that goal, the manufacturer, the retailer, the distributor, and the agency need to communicate that information to the public in a timely manner that describes a hazard and gets the public to act upon that hazard. Here are the key elements of a recall. When we engage in initial discussions with a firm, the first thing we like to see is a stop production and distribution. That limits the problem while we're doing the investigation. If a decision is made to do the recall, we would have limited the amount of products that need to be recalled. If a product is ultimately decided that we don't need to do the recall, you can go back on sale, but we'll make that decision together. If a decision is made that a recall is going to happen, a firm needs to submit a corrective action plan to the agency that contains the remedy, which is going to be a refund, a replacement, or a repair. Also in negotiations with the agency, a firm will need to come upon the firm and the agency need to reach an agreement as to the public notice for a corrective action. That usually means a press release for any recall, but it also means a website notice on the firm's website, direct mail if that's possible, or email, and this point has been emphasized in recent years. We expect the firms to engage in social media outreach on its social media platforms. In addition, a key element of a recall and not to be overlooked is reverse logistics. This means what is the firm going to do with the products that are stopped in its distribution chain or retail chain or even that come back from consumers. As I mentioned earlier, it's against the law to sell a recall product. So a firm has to have a very good reverse logistics program to ensure that its products are quarantined, that it has in this possession, and the ones that are coming back from consumers in other parts of the distribution chain are secured. You'll ultimately work with the agency on a disposal plan for those products. Finally, the agency closely monitors recall results. That means how many people are responding to the recall, how many products were taken on a distribution chain. If it's a high-risk recall and there's a low response rate, the agency may work with the firm to take additional remedy means, including possibly more notice or a rethinking of what the remedy is. Perhaps a replacement wasn't sufficient, a refund might be adequate, that kind of thing. We'll work with the firm based on the facts of the response rate. As I mentioned earlier, a firm can propose a refund replacement or a pair to address the hazardous products it has in the distribution chain. The agency will work with the firm based on the circumstances of a particular product to see what is the best of the circumstances. So a key to a successful recall is that the firm needs to have a plan in place before the recall occurs. When a product problem is discovered and you're in negotiations with the agency, there's a lot going on and it's best to not be in sort of panic mode about what to do. It's best to have a plan in place so you know what to do if the unfortunate happens. Another good planning mode element is for a firm to have labeling on its models and batches, date codes and other identification, so that if a problem is discovered and it can be limited, the products that are in the distribution chain or with consumers can be readily identified. This can help limit the scope of a potential recall. So I mentioned earlier that not all reports lead to recalls. Well not all corrective actions are recalls. As you can see on this chart, there are many things that the agency can work with a firm to agree to in a corrective action plan. Recalls is actually one of the lower number of corrective actions that take place. The most frequent is a correct future production in stop sale. That's for a low-level hazard. We'll make a determination based on the hazard and the distribution chain pattern, what the appropriate remedy is. So we'll work with you on that. Recall is part of this but it's not always the remedy that we're seeking in a corrective action plan. Well, I went through this pretty quickly and I want to show you that there is plenty of resource material available about reporting and recalls. The CPSC has a lot of information on its website and I provide you some of the links to both reporting and recalls that should cover this in much more depth and I'll get to that in a second but there's also, you've heard a lot of presentations today, a lot of information taken. We have extensive guidance on our website about the PPPA but of course you can always contact us. In fact, Dr. Bozier requested that you submit any questions to him through his email address for the presentations that were made today. Again, thank you for listening to the presentations and we look forward to working with you and answering your questions moving forward.