>> Mary Toro: 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 Synnott,
who will discuss the substances-- sorry
about that, substances covered in the acts,
exceptions and special circumstances.
Mr. Stephen Lee will present
the testing protocols
under the Poison Prevention Packaging Act
and Dr. John Boja 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 your--
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 at-- as soon as possible.
So please submit your questions to John--
jboja@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 Pollitzer to begin
her presentation on the overview of the acts.
>> Patricia Pollitzer: OK.
As Mary said, I am going to
start with an introduction.
Hang on a second, let me get to the PowerPoint.
OK. I'm going to start with an
introduction to the commissions--
there we go, to the statutes that
the commission uses-- looks at when--
if 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-- 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 child-resistance that
the packaging is significantly difficult
for children under five to open or
obtain a toxic or harmful amount
of a 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, the-- 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 a house.
So we talked a little about
the definitions of hazardous--
of 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
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-complying 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 prescriptions 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 that's
the subject of 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 the
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, especially
means special that complying
with the standards can 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 a 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 that the
commission needs to consider the reasonableness
of the standard, the available
scientific, medical and engineering data,
manufacturing practices of the affected industry
and the nature and use of the substance.
It's important to note that the
special packaging requirements
under the PPPA is 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 that
needs to go into a package, or labeling,
with that one exception that I mentioned
under Section 4 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 the
impact on small business but the PPA--
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 could-- 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's strictly a commercial
products, items that are specifically exempted
under the commission's regulations.
So for example, the commission
has 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 or 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
child in the household.
So, moving on to the Child Nicotine
Poisoning Prevention Act and as I said,
this is the most recent addition to our
statutes, was enacted in January of this year.
And this statute sets out a specific
requirement that any nicotine provided
in 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 this requirement is to
be treated as a standard for special packaging
of a household substance under the PPPPA--
PPPA, excuse me, so it can be enforced as just
as if it were a special packaging
standard that the commission issued.
The act also provided the effective
date, 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 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 as 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 broad 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 in the mood that we're 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.
>> Stephanie Synnott: Good afternoon.
My name is Dr. Stephanie Synnott 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, 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.
But 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.
And I don't have to go through all the
regulated drugs that are listed here,
but just to highlight a few, we see that
acetaminophen is listed, as well as ibuprofen,
iron-containing drugs and dietary
supplements, oral prescription drugs,
and over-the-counter switch drugs.
On this slide, there's also a list
of substances that are required to be
in special packaging under the PPPA.
But 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,
we would require it to be in special packaging.
This list as long as-- as well as
the regulated drugs and the details
on the requirements may be
found at 16 CFR Section 1700.14.
And as Ms. Pollitzer 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 that might be found and
used in hospitals or nursing homes,
as well as 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 4
of the PPPA, if it's requested by a patient
or a physician, there is the allowance for
a non-complying 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-complying packaging.
This package must be labeled as "This Package
For Households Without Young Children".
The packaging that 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 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 Substances Act,
drain cleaners are considered being hazardous
substances if they are not in special packaging.
The next few slides will talk
about physician's samples.
As previously stated, oral prescription drugs
are required to be in special packaging.
And as we saw on the-- under the exclusions,
Section 4(b) 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 regulated prescription
drug samples to be in special packaging.
Ultimately, the decision to
revise special packaging is
up to the physician on a case by case basis.
Important to note that Section 4(b) 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-- CNPPA.
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.
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-tanks, E-juice tanks
where the nicotine is inaccessible,
that is not required to be in special packaging.
If the package contains only the base
use for dilutions or the flavor extract,
it does not need to be in special packaging.
Empty packages or closures that are sold
as an after-market product are not required
to undergo testing or certification.
However, it's very important to note
that a non-special packaging
closure may not be packaged
with a liquid nicotine product that's
offered for retail sale to a consumer.
A non-special packaging closure
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 of 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 Stephen
Lee who will talk about testing requirements.
>> Stephen Lee: Good afternoon.
My name is Stephen 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 test,
the senior-adult test, and
the adult-resecuring test.
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% of the children must
be from 42 to 44 months,
40% from 45 to 48 months and
30% from 49 to 51 months.
A panel is split evenly into 50% 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% of the children.
A site restriction allows for a more diverse
sampling and this means that up to 20%
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 set to places such as
a daycare center or a 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 cap 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 results in the
continue column for the first five minutes
and then the pass column
for the full 10 minutes.
However, the testing should continue
because of the fact that the first--
in the first five minutes, the
results fell in the continue column.
The senior test procedures are very different.
There's 100 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% from 50 to 54 years, 25% from 55 to
59 years and 50% from 60 to 70 years.
This panel is split up into
70% women and 30% men.
The reason for this shift is that females tend
to live longer and are the more likely caregiver
and therefore they have the higher probability
to interact with the packaging in the household.
There's again a tester restriction
of 35% of the adults per tester
and another site restriction
of 24% of the adults per site.
The seniors are provided the 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 from 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 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 panel is not included
in the final results and an additional
panelist to be tested as required.
So now we have the adult-resecuring test.
And this test is required when
an objective determination
that a package is properly
resecured 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 resecured 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 resecure 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 harder--
easier to open and new packages
are provided to seniors
because the 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.
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 opens-- 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 CPSC
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.
Firms 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,
an 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 Synnott.
>> Stephanie Synnott: Mr. Stephen Lee
just talked about the testing procedures.
I'll 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 common examples are blister packs or pouches.
So as Mr. Lee has highlighted on
what to test, the package should be--
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, if 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 will 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.
And 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's what 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 the 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 in the
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 gained
can be something resulting from as a small
as a pinhole, depending on what
the contents are of the package.
So if there is 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 of 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 3 package.
So for instance, when we're--
when conducting the children test,
if an individual child is able to open or gain
access to three units and the F value is 3,
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 packagers
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 shown here, in this case, more
than one PPPA 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 2, another one has F equals 4,
and the third one has F equals 8, the most toxic
PPPA 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 2.
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 5 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 presented
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 acces to the package,
19 children opened or gained
access to only one unit each.
That means each of the 19 children
were able to open one unit.
Eight children opened or gained access to a
total of two units each, five children opened
or gained access to a total of three
units each and none of the children opened
or gained 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 1, the data is being represented
to show exactly how many units
were opened by each child.
So if we look at table 1, we see that for
instance, 19 children opened exactly one unit,
whereas five children opened
exactly three units.
Now in example 2, the same data is being
represented but just being shown differently.
The report-- 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 1,
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 examples 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 open exactly that number of units.
So if we want to determine how the package would
perform at F equals 1, 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 open two,
they're 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 want to then determine if this package
would pass, need to go under further testing,
or fail for an F equals 1 level,
we would go to our pass/fail table
and see that for the panel 1, when a total of 50
children were tested and if there's 32 openings,
this package would fail because 15 or
more openings would constitute as a fail.
So where will the outcome be if this
package was-- had an F equals 2 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 looked to see if this
package, how it performed at F equals 3,
we would now go to see that for
three units, five children opened
or gained access and there's no more after that.
So we would that at F equals 3 or
greater, this package would pass
because passing is from zero to five.
So in example 2, you'll notice that
the sums are already calculated for you
in 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 1, 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 2, we see a total of 13
children accessed at least two units
and thus you will need to continue testing.
And at an F equals 3 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 request 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, if the test data shows that
the package passes with a given substance
at F equals 3, and you have no way of knowing
whether the packaging would pass if you wanted
to package a similar substance
requiring F equals 1.
And in the scenario that we just
went over, we saw that in fact,
in this example, it failed at F equals 1.
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, if the cavity size of the
blister changes, this might change the--
how it performed for-- in the children test.
If the materials used in the
packaging change, for instance,
the foil backing on the blister pack was
thicker or thinner, or the plastic used
and 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 of--
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 harness, for example,
if 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.
And as we previously mentioned, the F
value of a new substance differs from that
of the substance the package was tested
and the test reports do not provide enough
information than 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 Boja who
will talk about certification requirements.
>> John Boja: 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.
And my presentation here will get going.
So once again, I will be talking about
certification requirements under the PPPA.
As you heard from Ms. Pollitzer,
we defined the PPPA, what it does.
Dr. Synnott talked about
the substances required.
She also spoke about how
to test for unit packaging.
Stephen Lee 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 15 CFR 1700.14(a)
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 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
a special packaging must issue a certificate,
certifying that that product meets the special
packaging requirements of 16 CFR 177.15.
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.
So 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 US 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.
Element 6 and 7 have to deal with the testing of
that product, so element 6 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 7 is identification
of any laboratory whose testing upon
which the certification depends.
Unlike rules for toys and children's
products, there 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 aid.
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 at the--
after the presentations are over.
Element number 1 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 that covers and no other product.
So if you're making aspirin in 100
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 2 is citation 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 3 is identification of
the US importer or domestic manufacturer.
You need to provide the full name, full
mailing address and telephone number
of the importer or US 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
US manufacturer would issue this certificate.
Element number 4 is the contact information for
the individual maintaining the test records.
And this has to be a person.
This cannot be corporate
address or it cannot be--
you can't put there whoever
is 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 is maintaining the records
that support the certificate must
be provided in element number 4.
Element number 5 is the date and place
where the product was manufactured.
So, this is the date and place
where the package was filled.
It's 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-- whoever 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, 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 the street address.
So, it should be record so people will
know exactly where that product came from,
when it was manufactured, and
where it was manufactured.
Element number 6 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 Stephen 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've already tested it,
it's where the product was
tested for that manufacturer.
And finally, element number 7 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 6, 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 questions is
who must issue the certificate?
And as I mentioned, it's the
importer or domestic party
that packages a PPPA regulated substance.
They're 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 the
special packaging manufacturer?
And yes, the protocol data that was
obtained with the procedures outlined
in 16 CFR 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 14375,
and EN826-- or I'm sorry, 862, to be equivalent
of the tests required by the CPSC regulations.
There are some subtle differences in the
European tests as compared to the US 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.
Synnott, there's no expiration on these tests
and no requirement to retest as long
as the product you packaged is adequately
reflected by the test that was conducted.
Retesting should be considered when there's
been a material change made to the packaging.
A material change can be a change
in the manufacturing process,
a change in the component parts,
something that changed in the packing--
the packaging that would impair its ability
to meet the performance specifications
of 16 part 1700.15.
Do I have to certify my empty vials or caps?
No, an empty container is not regulated-- 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 pack-- 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 CPSIA
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 so substances,
as Dr. Synnott mentioned, might include
acetaminophen or diphenhydramine.
Those substances are regulated substances
and would require certification and--
because they are regulated by us.
We don't regulate the things such as
dosing cups or the dosing droppers.
As Dr. Synnott 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.
And finally, that's the end of my
presentation and I'd like to take this time
to introduce Mr. Howard Tarnoff of-- he's
our Legal Counsel at the Office of Compliance
and he will be going over regulatory issues.
Thank you.
>> Howard Tarnoff: Thank you Dr. Boja and
good afternoon everybody who's listening in.
Again, my name is Howard Tarnoff.
I'm in the Office of Compliance.
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 could 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 incidence or injuries that occur
because of that products problems.
So, well, let's talk about the
requirements under Section 15.
A firm must file a report with the
agency when a product it sells, imports,
or distributes for manufacturers fails to
comply with the 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 it 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.
A must in here-- something 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,
nondrug 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, you know,
that a reasonable conclusion can be drawn
that the reporting triggers were met.
A firm can conduct its own investigation.
It has to be reasonable.
And we don't really-- Our regulations
says that you have about 10 days
to conduct the investigation but
we expect you to be I contact
with the agency before that
or at the 10-day mark.
So, what we provide in the Office of Compliance
is a firm a question about whether it needs
to report, it should call-- it
can email us, it can call us,
it doesn't actually have to file a report.
I mean, there's many good
resources to contact the agency
to discuss whether a report needs to be files.
We 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 still gathering information
about the potential problem.
And then ultimately, it can file
a much more comprehensive report.
The key is contact the 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 compliance, you know,
we often take a really good look at that
because that's sometimes tip-- that
sometimes tips off a firm to the issues.
But there's not always going to be
claims or incidents or problems,
those are the things that
can happen for a product.
And-- So you have to be on
top of any design changes
from your suppliers, any material changes.
All those things, a firm needs to monitoring the
entire range of things that could be occurring
with these products to keep on touch--
keep on top of whether there are
anything that could trigger a report.
In addition, we recommend that
you signup with the agency.
There's a safe-- There's a business tab and
under that, you can register at Safer Products.
I have to actually get reports that come into
the agency and when they come into the agency,
we-- if you're registered and it's
pertaining to your specific firm, we will--
you will automatically get a copy
of the report to saferproducts.gov.
So, what can happen if you don't report?
Well, I'm going to talk about the legal
obligations in a second but again,
if you don't report, that
could lead to the product being
in the market longer without it being addressed.
And that can lead to more, you know,
possibility of injuries or worse injury.
So that's the 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 could 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 $15.5 million
for related series of violations.
In addition, under certain circumstances, we
can pursue criminal penalties that can lead
to possible felony, five years in prison.
Here's some recent examples of civil penalties.
These are up dramatically in the last few years
since CPSIA record-- thresholds kicked in.
We have obviously, with Gree, gotten the
maximum penalty and for other related--
for other similar companies, we've been
getting around $5 million per penalty.
I wanted to point out the Best Buy
penalty because that involved a retailer
who was selling recalled products.
So it's not just the 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 dialog with
the firm, we're going to do an investigation
and not all of our end results
would be a recall.
So, we want-- 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.
But if we're calling you to conduct an
investigation, 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 are some basic do's
and don'ts for reporting.
You should not assume that a failure or
non-compliance or an incident with a product
that doesn't lead to an injury
doesn't mean there'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.
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.
OK. 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 or 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.
We will 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 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 corrective action.
That usually means a press release for any
recall but it also means 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
not to be overlooked is reverse logistics.
This means, what is the firm going to do
with the products that are A, you know,
stopped in its distribution chain or
retail chain or even that will come back
from consumers, as I mentioned earlier, it's
against the law to sell a recalled product.
So a firm has to have a very
good reverse logistics program
to ensure these products are
quarantined, that it has in its possession,
and the ones that are coming back
from consumers and other parts
of the distribution chain are secured.
You have to 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 taking
out of the 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
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 repair 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 whether it's the best
under the circumstances.
So, the 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 a 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,
that-- 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
but 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 the correct
future production and stop sale.
That's for a low level hazard.
We'll make a determination based on the hazard
in the distribution chain pattern,
what the appropriate remedy is.
So we're-- 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's plenty
of resource material available
about reporting and recalls.
The CPSC has a lot of information on its
website and I provided you some of the links
to both reporting and recalls that should
cover this in much more depth than this.
I'll get to that in a second.
But there's also-- you heard a lot
of presentations today, a lot
of information to take in.
We have extensive guidance on
our website about the PPPA.
But of course, you can always contact us.
In fact, Dr. Boja recommended-- 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.