>> Elliot Kaye: Welcome back to
part 2 of this pubic meeting,
the United States Consumer
Product Safety commission.
CPSC staff will brief the commission on
proposed amendments to our fireworks regulation.
The CPSC staff members briefing us are;
Dr. Rodney Valliere, Chemist in the Office
of Hazard Identification and Reduction, Dr.
Arron Orland, Chemist and also Division Director
in the Office of Hazard Identification
and Reduction, Ms. Meridith Kelsch,
Attorney in the Office of the General
Council and Mr. Howard Tranoff,
Senior Council in the Office of
Compliance and Field Operations.
At the conclusion of the briefing, we'll
turn to questions from the commissioners
and we'll now start with the staff
briefing; who's going to start?
Mr. Valliere, please.
>> Rodney Valliere: Thank you Mr. Chairman.
Today, Meridith and myself
are happy to talk to you
about the proposed amendments
to fireworks regulations.
I will start off by giving a background
on fireworks and then I'm going to turn it
over to Meridith for a while and then
I'll discuss injury and death data,
and then I'm going to discuss relevant voluntary
standards when it comes to fireworks and,
as well as, staff recommendations to
revisions to CFR and then I'm going to talk
about the effect of adding
aluminum to interject materials,
then we'll go into an economic
analysis and then we will conclude.
So, in 1973 and 1974, the CPSC took over
fireworks regulations from the FDA and it wasn't
until 2006 that an MPR was issued
to conduct a fireworks rule review,
or look into changing the fireworks
regulations and it was under the 2014 Op Plan
that direct us towards a fireworks rule review,
and from that was completed in December of 2015
and from those findings, we directed
to prepare an MPR briefing package.
So, now I will turn it over to Meridith.
>> Meridith Kelsch: So, I'm going to walk
through the statutory requirements that apply
to this rulemaking just to
give everyone a framework
within which to view the recommended changes.
So, there are two statutes
that I'm going to walk through.
The first is the Administrative Procedure Act
and the second is the Federal
Hazardous Substances Act.
Rulemakings in general, are subject to
the Administrative Procedure Act or APA.
The APA generally requires an agency to
provide notice in comment; notice meaning,
provided to rested parties with notice
of what a requirement would be in advance
of actually creating a final rule, and comment
being the opportunity for interests the parties
to comment on the substance of
those proposed requirements.
The APA also provides for
judicial review of rulemaking,
so that when an agency adopts a requirement, for
example, a Corp is to set aside any requirement
that is "arbitrary or capricious"
as the standard for judicial review
and the APA provides, in other words,
a requirement that's not based on
or tied to supporting data or facts.
Turning to the Federal Hazardous
Substances Act, this is the statute
under which CPSC has authority
to regulate fireworks.
The FHSA allows CPSC to classify hazardous
substances as a banned hazardous substance
and provides additional rulemaking requirements
in addition to those provided in the APA.
So, the draft MPR includes three
categories of requirements and they are laid
out in the slides, specifically
clarifications to existing requirements,
easing of existing requirements
and new hazardous substance bans
which constitute bans under
the FHSA as times that.
The first two categories;
the clarifications and easing
of requirements do not create
hazardous substances bans,
so they need only comply
with the APA requirements.
The last category, however, not only has
to meet the APA requirements, but also,
additional rulemaking requirements
under the FHSA.
So, under the FHSA, the commission
can create hazardous substance bans,
can create specific requirements and
can create labeling requirements.
Looking at hazardous substance
bans specifically,
there is one general finding
that's required as a precursor.
The text of that requirement is
in the slide, but to summarize it,
not withstanding labeling required under the
FSHA, the degree or nature of the hazard is
such that the protection of the public health
and safety can be adequately served only
by keeping the substance
out of interstate commerce.
This is the first of four
requirements necessary under the FHSA.
In addition to creating hazardous
substance bans as part of that authority,
CPSC can also create performance
or design requirements
for products that are hazardous substances.
And finally, the FHSA also
provides for labeling requirements,
but our draft MPR doesn't
include any labeling requirements,
so I won't walk through those at this point.
In addition to the first finding I just
walked through regarding the degree in nature
of the hazard, there are three
additional findings that the FHSA requires
for the commission to adopt
a hazardous substance ban
or performance or design requirement.
The next three slides will
summarize these additional findings.
I will also give examples of the types
of information that staff consider
in assessing these findings, and in
addition, the draft MPR solicits comments
so that we can further information that
will be helpful in assessing those findings.
So, the first of these additional
findings relates to voluntary standards.
It deals with the adequacy and effectiveness
of an existing voluntary standard
to address the hazard that the
regulation seeks to address.
When there is a voluntary standard,
CPSC must find one of two alternatives
in order to proceed with the regulation.
The first of the alternatives
deals with the effectiveness
of the voluntary standard adequately reducing
the risk of injury, and the second deals
with the likelihood and extent
to which regulated entities will
comply with the voluntary standard.
There are three voluntary
standards that Rodney will cover
in his presentation making his finding relevant.
In evaluating whether a proposed requirement
has adequate support to meet this finding,
staff considered factors such as the percentage
of compliance with the voluntary standard,
the severity of the potential
injuries, injury rates,
and the vulnerability of population at risk.
The second finding, considers
the relationship between the cost
and benefits associated with the regulation.
The commission must consider
whether the benefits
of a regulation bear reasonable
relationship to its costs.
Benefits may include things like reductions
and severity and likelihood of injuries,
and costs include things like increases
to manufacturing costs, sales prices,
and decreases to availability
or usefulness for a product.
And the third finding looks at the
relative burdens and effectiveness
of alternatives to the regulation.
Finally, in addition to the substance
of findings, the FHSA also requires
that an MPR includes specific content.
First, the text of the proposed
rule has to be in the MPR,
including the latter three
findings we just discussed.
Secondly, any alternatives the commission may
adopt and this MPR includes some alternatives.
And finally, a preliminary regulatory
analysis discussing the costs and benefits
of the regulation whether monitory or otherwise,
the impacted parties, reasonable alternatives,
the cost and benefits of those alternatives
and why the commission is not proposing them.
I'll now turn it back over to Valliere.
>> Rodney Valliere: Thank you Meridith.
To start with, I'm going to
discuss some of the injury data
that staff has gathered during a special study
period from June 19th to July 19th, 2015.
Those are bookends for right around where most
fireworks accidents occur, and this first slide
that I'm going to discuss has thirty-one
in-depth phone investigations done by staff
and as you can see here, almost all
of the injuries occurred due to
either misuse or malfunction.
Continuing on with this 2015 special study,
these are the estimated injuries
based on age group and type of device.
All estimated are rounded
to the nearest hundred.
You can see that most of the injuries occur in
the age group between twenty-five and forty-four
and some of the more notable devices that
cause the injuries are firecrackers, sparklers,
and reloadables aerial tubes that we are,
that I will discuss a little further here
because reloadable aerial tubes have been
the cause of the more catastrophic injuries
which brings me to the reported
fireworks related deaths in 2015.
In 2015, there were eleven non-occupational
fireworks related deaths reported to the CPSC;
seven of which, occurred from
holding a tube-mortar device,
approximated devices or approximated
to the body.
I believe it was five involved consumer
holding a device on top of their head
and igniting the shell and
then took off and then a,
a concussion of the action created
severe enough injuries to cause death.
And there was of those, approximated body
there was also two where it was being held
against the person's chest and it
came back and induced cardiac arrest.
There were two more deaths where it was from
overlooking a launch tube, so it can be assumed
that the consumer believed that the device was
a dud, failed to function, went back to check
on it, looked over the tube and
then unfortunately then that's
when the shell took off and
essentially decapitated the victim.
There were also two more injuries caused
from the manufacturing of illegal fireworks,
so basically they were making homemade
explosives which is under ATF jurisdiction.
When looking at revisions, we staff
looked at three voluntary standards.
The first of which was the
American Pyrotechnics Association,
APA-71 and that has been changed most recently
in 2001, and the DOT regulates transportation
of fireworks and requires
compliance with this standard.
This membership to the American Pyrotechnics
Association includes nearly 85% of injury,
or industry and it has requirements for
both consumer and commercial fireworks.
We also looked at the American
Fireworks Standards Laboratory,
voluntary standards or AFSL.
They are always ongoing with
updating their standards,
so staff has been attending regular meetings
and it's always a point to look at ways
to change the standard in the best
interest of the consumer for safety,
and it incorporates both
CPSC and DOT regulations.
It represents an estimated 85 to
90% of all US fireworks importers
and they're testing shows 95% of the tested
samples are compliant with their standard.
Staff also considered the European standard.
This is used by many countries
worldwide and it's based loosely on 87-1,
but the European standard considers many more
devices that aren't here in the United States.
So, summary of all of our recommended revisions,
so this is where staff came to the conclusion
that on many cases we should
be harmonizing with APA 87-1.
In the first section 1500.3, is a
definition section that are currently missing
in our regulation, but occur in
the other voluntary standards.
They are common terms used in the industry,
so we believe those should be included;
1500.1783 is probably the most
contentious of the revisions.
This is the, pretty much known as the audible
effects section and CPSC has been asked
by industry on several occasions to look
into modifying this part of the regulation,
so I will get into this in more
detail later, but staff believes
that we should adopt a quantifiable method
for identifying devices intended to improve,
intended to produce an audible effect and
going to defining that as having the presence
of metallic fuel less than a 100 mesh.
Okay, and without, throughout
the reg we recommend
that the audible effects portion be removed with
the burst charge requirement that if, you know,
metal fuel is present, metal fuel
less than 100 mesh is present
than the device is limited to
2 grains or 130 milligrams.
And 1517 A-14, currently we do have any
limits on things that are not intended
to produce an audible effect, so in
theory right now devices are limitless
in their pyrotechnic composition weights,
so staff believes that harmonizing
with APA 87-1 once again and setting limits on
the pyrotechnic composition and certain devices.
Once again, we recommend that we add
definitions to relevant terms used by industry
and in the prohibited chemicals section,
staff recommends adding lead in lead compounds
which are currently in APA 87-1, and as well as,
the addition of hexachlorobenzene which is HCB
which is found in the AFSL voluntary standard.
They also, we also recommend setting
contamination limits of 0.25%
for all the chemicals contained within
the parameter chemicals section,
as APA 87-1 also has and this a good
idea as well, because as a scientist,
zero is a very hard number to prove
and as instrumentation gets more sensitive
then it's going to become more costly
for the industry as that becomes closer
and closer to like a single atom.
The only exception for the 0.25 for the
prohibited chemicals would be the HCB,
which would be set at 0.01% which is
consistent with the AFSL voluntary standard.
Fifteen hundred, 1507.3 addresses
fuses and currently
in the Consumer's Fireworks Testing
Manual, we already test for site ignition,
so we still care about accidental ignition
and we just want to clarify this into the CFR,
so currently we, our test method is tested out;
we test out, we put a cigarette onto the side
of a fuse, test it out to 5 seconds even
though 3 seconds is what we enforce;
1507.4 we recommend which is consistent with
APA 87-1 defining what a base is, as well as,
requiring the bases remain attached
during normal usage of operation.
This would hopefully discourage consumers
from holding devices that they shouldn't be
and preventing things like tip over
which cause many injuries as well;
1507.6 staff recommends adding the APA
definitions of burnout and blowout.
These are terms commonly used in
industry; burnout is essentially
when a fireworks device just
explodes on the ground;
blowout was when basically a
flame shoots up out the side of it
or the other way around, I'm sorry.
And, the 1507.13, staff recommends
prohibiting devices from projecting fragments,
so we don't want like an aerial device to
go off and it be raining shards of glass
or rocks or hard pieces of plastic.
So, staff recommends adding
that requirement as well.
So, back to the audible effect
regulations, so and this slide,
this is the current CPSC regulation
compared to APA 87-1, and currently staff
when we are looking for devices intended
to produce an audible effect, there is,
it's a 2-part test where it is the
audible effects portion where you're,
a trained staff member goes out in the
field and listens for an audible effect.
Okay, when the staff member does this, they are
not listening for the, how loud the device is,
but rather they're listening for a distinct
noise made which is relates to the presence
of metallic fuels; if it is a black powder
device, it's more of a muffled noise, whereas,
if it's a, if there is the presence of metallic
fuel it will be more of a sharp, crisp sound
and that takes years to train staff
to listen for such a distinct sound.
And then, after that, that is the amount
test, so after it's been determined
that it has had an audible effect in the field,
then staff takes the device back and weighs it
and it, the device should have under 2 grams
or 130 milligrams of pyrotechnic material.
Staff recommends harmonizing with APA 87-1
which would clearly just make this a
laboratory only test and reduce some of the,
or make it more objective and with this
it would be just looking for the presence
of metallic fuel using an
instrumentation like XRF or ICP analysis,
and if metallic fuel was found, then it
would be limited to the 130 milligrams.
Also, current CPSC regulations like I mentioned
previously, don't have any limit or the amount
of powder in devices if they did
not produce an audible effect,
so staff recommends putting limits on the total
pyrotechnic material for all fireworks devices.
Okay, so why is metal, why
are metal fuels a concern?
And that's why I have this slide up.
Okay, so this slide is a
graph taken from literature
and this is aluminum added
to trinitrotoluene or TNT.
So, TNT is the standard for which all explosives
are compared, so that's why they use this,
but you can imagine things like black
powder behaving very similarly, okay?
So, first of all the addition of metallic
fuels increase the sensitivity of the device,
so it would more sensitive to heat, shock,
friction and you can see on this graph,
so this is explosive power versus
aluminum content, percent aluminum.
And so, staff believes that with greater
explosive power there's a greater injury
potential, so more power
equals more ow if you will.
So, at 0% you can see on the far side, there
is a known explosive power value and then
as you move along you can see ideal for
having the most boom would be between 15 and,
right around between 15 and 20%
is for the optimal explosive power
that you can get out of an energetic material.
As you increase pass 20%, the
metallic fuel becomes ineffective.
It starts to quench the reaction, so you
have more fuel than oxidizer at that point.
Now, staff recommends that there be no
metallic fuel, but as I mentioned previously,
we understand that zero is
a hard number to prove,
so staff recommends a compliance
enforcement discretion of 1%
which is way far on the left-side.
At 1%, you only get roughly a 2% increase
in explosive power, but as you increase
that by percentage-by-percentage, so at 2%
you're going to have 4% increase in energy.
At 3 1/2%, you're going to get
roughly 7% increase and it increases.
At 1%, also, it can be considered, still at
that amount, a trace amount staff believes,
and at that point, it can still be a
contaminant; anything more than 1%,
staff believes that to start to
be an ingredient into the mixture.
Okay, so staff in the long-term, staff
expects no significant burden expected
with the proposed changes.
Staff expects fireworks suppliers to
comply with the new audible effects rule
by substituting cheaper black powder for
metallic or hybrid fuels; hybrid fuels meaning,
mixtures of, with metallic
fuels added to black powder.
So, in conclusion, staff's recommended
changes harmonize with the provisions
of voluntary standards APA 87-1 and AFSL,
most of which are already
required by DOT regulations.
CPSC testing a fireworks sample revealed that
greater than 85% did not comply with the limit
of pyrotechnical material when any metallic
fuel less than 100 mesh was present.
Most of staff's recommendations are
clarifications of existing requirements
and staff recommends published in the MPR
for comments on the proposed revisions
and staff also recommends a 30-day effective
date seeking comments on that as well.
And just at this time, I just want to thank the
team members involved like, Meridith, Robby,
Squib [phonetic] from ECON,
Jason Young from compliance,
Eric Hooker from Health Sciences
Toxicology, Matt Romer [assumed spelling]
and Priscilla Verdino [assumed spelling]
from LSC, and Yung Lan too from epidemiology,
and as well as, management for their support
and guidance throughout this process.
So, at this time, and I'm sorry if I forgot
anybody; I'm opening up for questions.
>> Elliot Kaye: Thank you Mr.
Valliere and I'm going to pick-up
where you left off thanking the rest of the team
as well including management, aka Dr. Orland,
and also I see back there Mr. Stadnick
[assumed spelling] who is our lab director.
I know that the staff has put in, really years,
into trying to find a way to evolve our standard
and this, it was captured earlier in your
presentation, this was triggered in large part
by Commissioner Robinson's amendment, I think
it was maybe the 2014 operating plan asking
for a full-blown rule review, and from
that of course, we have this package
and we're very grateful for that.
We are very eager I'm sure to explore
different parts of the package.
The area that I want to start with
is, is the core of why we're here,
recognizing that these are explosives,
fireworks are inherently dangerous products.
What are the safety benefits for
consumers that you or really anyone else
from the team see should the commission
move forward and make these changes?
>> Aaron Orland: Thank you Chairman.
The biggest piece of it is, as Rodney mentioned
in his discussion, right now there are types
of firework devices where
there's no limit in the CFR
on how much pyrotechnic material is allowed.
And so, by establishing limits, and
we're hoping that we can eliminate some
of the more dangerous devices and
keep them a little bit under control,
and also by eliminating the metallic fuels
that are very prevalent from our testing,
we can lower the explosive power of some of the
fireworks still keeping them effective and fun,
but eliminating the amount of explosive power so
that if they're accidentally or, heaven forbid,
intentionally used in close proximity to a
person than maybe we can limit the severity
of the injuries and make them a
little bit a, a little bit easier
for the emergency rooms to deal with.
>> Elliot Kaye: And Dr. Orland
thank you for that.
So, focusing on that part and, at any point
if I'm mischaracterizing where staff is,
please let me know, but I think I picked up from
the briefing that in essence we are taking this
from one of the voluntary standards;
that we would be, the staff is proposing
that the commission adopt a relevant provision
from the voluntary standard, is that accurate?
>> Rodney Valliere: Yes.
>> Elliot Kaye: And that
also if I heard correctly,
that voluntary standard is presumably very
much complied with according to representations
that we're talking about
high-levels of compliance supposedly
with that standard, is that correct?
>> Aaron Orland: It depends on which portions
of the standards you're talking about.
There are portions of the, of both the
APA standard and the AFSL standards
that are very well-complied with.
AFSL has an independent testing program
and so they have a method of validating
that their product is complied, is
complying with the standard, whereas,
the American Pyrotechnics
Association and the Department
of Transportation do not have an
independent testing program or capability.
All of those are self-certified that they
comply, so of course, the manufactures say
if they want to get their EX number from
transportation, they say our firework complies;
our testing shows it a little bit
differently depending on the product type.
But, the biggest hitter is these reloadable
aerial tubes and some of the mine shell devices
with a multi-tube, you know, aerial devices.
Most of those don't comply with that
metallic fuel component of the standard.
>> Elliot Kaye: And are these made
by manufacturers that are stating
that they do comply, or these are the carts that
you see on July 2nd by the side of the road?
>> Aaron Orland: The, any of them that
are shipped within the United States
and interstate commerce have to
comply with the DOT regulations.
In order for them to get their permit
they have to self-certify that they comply
with the regulations, so it's all of the above.
>> Elliot Kaye: Okay, so if I
understand correctly, we're only,
we would only be proposing that industry comply
with something that they at least are saying
that their own voluntary
standard requires them to comply,
but then they're saying they comply with now.
So, from a market disruption standpoint,
this should not in theory cause
a lot of market disruption?
>> Correct.
>> Elliot Kaye: In theory?
>> In theory.
>> Elliot Kaye: Okay.
Is there, so you did an excellent job
Mr. Valliere explaining how you came
up with the 1%, that threshold.
Do we have any sense, and it's fine if the
answer is no, I'd just be curious to know
where we go from there as to hoe wo translate
that, that explosive power into risk of injury.
Do we have any data on that
or any theories about that?
>> Rodney Valliere: Well, I might have to
talk to one of my toxicology and epidemi,
or I mean health sciences people, but the issue
with that is there is no such
thing as a safe explosion.
So any explosion in proximity to the human
body is not good, and that we're just trying
to reduce that by lowering that explosive power.
>> Elliot Kaye: Do we have any sense
that 1% is very different than 2%
or 3% from the work that you've done?
I see the chart.
>> Rodney Valliere: Yeah.
From the chart and from the fit, so as you
go up; each percentage you go up it doubles.
So, doubles explosive power.
So, 1%, 2% and 2% to 4 and then like 3, 3 1/2
it becomes this, the more exponential it becomes
like 8 or 9% and that's we believe
is a significant amount of energy.
>> Elliot Kaye: Got it.
And the last thing I want to ask at this point
is, and we just covered this that it's covered,
that we are in essences nearing the
current APA standards in large part, 87.1.
Is that currently under revision,
and if so, what might that mean?
>> Aaron Orland: So, the APA 87-1
is currently undergoing revision.
They're actually taking; they're
totally revamping the document.
They're taking it from a single document that
covers consumer fireworks, commercial fireworks
and articles pyrotechnic and putting it into
three different standards, basically an A,
B and C. We have been involved with APA and in
reviewing of writing comments on that document.
It's currently I believe on hold.
I don't know what the exact status is, but I
think they're waiting for us to do something.
From our interaction with them and from
what we've seen on the drafts, it's,
there's not anything that's a real
game changer that's going to, you know,
if we come out with what
we've proposed in the MPR,
we're not going to contradict
them or vice-versa.
The most of, most of what they've done
with changing the standard around,
at least on the drafts we've seen
so far have been more administrative
in changing the way it's laid out
and formatting, and then separating
out the three different very different types
of fireworks into their own individual pieces
in hopes that helps make it easier on
the permanent process with the Department
of Transportation, so and
they've also been involved
with Pipeline Hazardous Material Safety Agency,
PHMS over at DOT and reviewing that as well, so.
The exact status of it right now is kind
of unknown and I think that we're both us
and them are sitting around waiting
to see what the other guy does,
you know, in a little standoff.
So, hopefully we can move things forward
and provide a little bit better clarity.
>> Elliot Kaye: And that helped alleviate
my concerns that we might be moving
in one direction and they might
move in a different direction,
but it sounds like that's
not a concern that's valid.
Thank you very much.
Commissioner Robinson.
>> Marietta Robinson: I just really, really
want to thank the entire team individually
and together for the excellent
work that you've done on this.
This is really highly technical and complicated
or as we called it in my office, "wonky",
and it was, it's very much appreciated
how much effort went into this
and as Chairman Kaye mentioned, when I
got, shortly after I got back from China
with John Rogers sitting back there from AFSL,
and one of the things that I did there is visit
where they make, it's hard to call them
factories, but where they make fireworks
and I know a lot of our staff
has visited them as well.
When you combine that with what I've seen in
our laboratory in terms of the kinds of dangers
that we're trying to protect consumers from,
it's a really, really challenging problem.
And I knew that our, we all knew, that our
standards were out-of-date and it was really,
really important that we get this
right, so shortly after I got back,
we introduced the amendment to the fiscal year
2015 operating plan asking for a thorough review
of the fireworks regulations regarding whether
the CPSC should maintain revised clarifier
update, the regulations related to fireworks
and then at the end of 2015 a year later,
you presented us with an outstanding
comprehensive package that I really appreciate
with your recommendations and how
we can improve our regulations.
And then obviously, in our 2016 fiscal
year operating plan, we asked you to come
up with this briefing package
and I also would just
like to thank Commissioner Mark Rowvick [assumed
spelling] and I worked together very closely.
We've both been very focused on fireworks
for some time and we came up with
in the interim a proposed
interpretive rule for fireworks.
I think based on my discussions with him
before, we proposed this interpretative rule
to our fellow commissioners that we weren't
expecting the large volume of comments
that we got in, but my understanding
is, and I hope it's correct,
that those comments were
helpful in terms of you coming
up with this package that's before us today.
So, I also thank you for looking
at those voluminous comments.
So, my question and I just want to
follow-up on what Chairman Kaye was talking
about with respect to the APA, the first thing
is that I remember being out at the lab with,
when some things were being examined
that had the DOT's self-certification
and I understand we've got some problems with
this, which in terms of when we test the things
that are self-certified, that
a lot of them aren't compliant.
So, do I understand correctly that it's even;
this makes it even more important that we come
up with something that's really
enforceable on behalf of the CPSC?
>> Rodney Valliere: Yes, absolutely.
>> Marietta Robinson: Okay.
And I also, in talking to Dr. Borlase [assumed
spelling] in our weekly meetings and I just want
to make sure I'm clear on this because I think
all of us are concerned with what APA is doing
in terms of their revamping their standard,
and Dr. Orland you said that they, you,
I don't remember your exact verb there, but you
thought that they were on hold and were waiting
for us and I understand from Dr. Borlase
that indeed they are on hold waiting for us.
Is that your understanding
of where we are on that?
>> Aaron Orland: Yes it is.
>> Marietta Robinson: Okay, good.
>> Aaron Orland: That was the last discussion
we had with them was they were waiting,
waiting for us and DOT is waiting until
after the political climate settles out.
>> Marietta Robinson: When's
that going to be, in my lifetime?
[ Laughter ]
Okay. So, we should go ahead, as I understand
it, without concern that they're going
to do something while we're in our process?
>> Aaron Orland: That's correct.
>> Marietta Robinson: Since we know that
the political climate won't settle down.
The other concern that I have is that this is
a very, this is an unusual package in a lot
of respects, but one of the things that makes it
really unusual is that there's almost five pages
of items that we are requesting comments
on, and indeed, I was reminded of the RFI's
that we most recently did on crib bumpers
in terms listing a lot of areas that,
that we need more information on and in the
reg flex analysis you noted that a number
of the recommended requirements that
would create new hazardous substances ban
that there's not sufficient information to make
a finding to support a final rule on a number
of items, specifically, adding to
chemicals, to listed prohibited chemicals,
adapting a test method to evaluate
side ignition and prohibiting devices
from projecting fragments when functioning.
For the, my first question on this is for these
items, do you anticipate that you're going
to get enough information in response
to this MPR that we're going to be able
to formulate a final rule or do the analysis
we need to do to do a formulate a final rule?
We're looking back at ECON,
I know [brief laughter].
>> Hi. Thank you for your
question Commissioner Robinson.
For the regulatory flexibility analysis, as
far as findings go, it's only necessary for us
to produce findings in the event we are
recommending that the commission is certified.
The rule will not have substantial
impact on a significant number of firms.
And so we don't, in the initial regulatory
flexibility analysis, make such a recommendation
and so depending on the comments we receive, if
we see, if we receive specific comments to make
such a recommendation, then we would do so.
If we do not, we'll proceed with a
final regulatory flexibility analysis,
the same thing as, in which we did the
initial regulatory flexibility analysis.
>> Marietta Robinson: Thank you.
That's very helpful.
And, the other, the other concern I have given
that how much information we've asked for,
is have you guys as a team sort of come up
with a plan and what resources are going
to be required for the next step, because
I just want to make sure you have enough
because I think this rule is very important?
>> Aaron Orland: So, yes.
I mean probably a little bit more complex
to provide exact details on, you know,
how we're planning on shoring up some of the
technical details of what we're going to do.
We're still ongoing with collecting
data and looking at things.
There's a lot of, a lot of areas where we wish
we knew more information and there's a hope
that maybe somebody in industry will provide
us with some of the data that we need.
If not, then we'll go out and collect it
ourselves, but it's a probably a little bit
out of scope of the timetable we have here
to talk in detail, but we can provide that.
>> Marietta Robinson: Okay.
>> Aaron Orland: As a follow-up.
>> Marietta Robinson: Just please
let us know what resources are needed
and I will do everything I can to make sure
you have them, and thanks again so much.
>> Elliot Kaye: Ms. Buerkle.
>> Ann Marie Buerkle: Thank you
Mr. Chairman and thank you to all
of the staff today for the presentation.
As my colleague said, this is a highly technical
case and I'm relying on your expertise.
I do want to compliment my colleagues,
Commissioner Robinson and Mohorvic
for all the work they have done and the
attention they've paid to the fireworks issues
and we have heard from many in the outside
community regarding in the one problem
that you mentioned is this audible effect issue.
So, I look forward to learning more
about that package and getting some
of my questions answered now, but I'm sure we'll
have additional questions as we go forward.
So, one of the things I wanted
to talk about is the data.
On page 7, no I'm sorry on page 6, the
fireworks injury data and the hazard patterns;
so that's not traditional nice data
because it was just a very short
period of time from June to July.
So, how, how do we go about gathering that data?
And I, yeah we need probably,
we need someone from epi.
>> It's part, it's [inaudible]
from the nice data.
So, each year we conduct special study around
the July 4th, because of the average each year;
like two-thirds or three-quarter injuries;
fireworks-related injuries
occurred around that time period.
So, we conduct special study
during that time period.
We pick out the most severe injuries like
hospital measures and the eye injuries,
finger and hand amputations
and then the head injuries.
We assign those cases to telephone interviews
and those 31 cases are the ones
[inaudible] for 2015 special study period.
>> Ann Marie Buerkle: Okay.
So, you're reviewing the
nice data on a daily basis.
>> Yes.
>> Ann Marie Buerkle: As it
comes in and then you follow-up
with the fireworks-related injury
follow-up with phone calls to.
>> Yes.
>> Ann Marie Buerkle: The hospital, okay.
Okay, I wasn't clear about how that all works.
And then with regards to the, that same
diagram, the other, what are the other injuries?
It says there's 13, or 4 number
of cases, but 13% of the injuries;
it says at the bottom, "other"
and then "debris"?
>> Not this slide.
>> Ann Marie Buerkle: It's slide, it's page 6.
>> Well, it's 4 cases from
the incident scenarios.
We cannot pinpoint problem.
It's the victim just said they
felt something go into their eyes.
>> Ann Marie Buerkle: Okay.
>> So, they can now say there's some
issues with malfunctions, so it's like a.
>> Ann Marie Buerkle: Okay.
>> Other categories.
>> Ann Marie Buerkle: Alright,
thank you very much.
And then on page 7, and again, and this
may be an epi question, just, I'm saying 7,
but when I look up at the screen that
number is different; but it also has to do
with the fireworks-related deaths in 2015,
again, is the sole source of this are nice data
or do we have any other sources of this?
We talked about the?
>> No, these are from the news articles
and then from the field reports.
>> Ann Marie Buerkle: So, this is
from like the clips that we subscribe
to when you say news articles
and what was the second source?
>> The news articles and then some of them,
I think most of them from news articles.
>> Ann Marie Buerkle: Okay.
Okay, thank you.
On the next page it talks about
voluntary standards and it says,
"APA membership includes nearly 85%
of the industry", and then it says,
"AFSL represents an estimated
85 to 90% of the importers."
Can you just clarify that for me?
>> Aaron Orland: So, that AFLS is
the, their numbers saying 85 to 90%,
that's of the people importing
stuff from mostly China.
>> Ann Marie Buerkle: Okay.
>> Aaron Orland: And, because China is
where most of the fireworks originate,
they publish their, you know, their
membership based upon, you know,
the percentage of the people who
are importing from other countries.
>> Ann Marie Buerkle: Okay.
>> Aaron Orland: Whereas, APA they report
their membership based on fireworks retailers
and sales and, you know, the
entire industry as a whole.
So, both of the two organizations
represent overwhelming majority
of the fireworks industry in the United States.
>> Ann Marie Buerkle: Good, thank you.
>> Aaron Orland: As, but AFSL also
represent, you know, some of the importers
where they're located in China sending
stuff here as opposed to companies
in the United States that are
pulling fireworks from China.
>> Ann Marie Buerkle: Thank you.
Thank you very much.
How did staff decide what the pyrotechnical
image should be for the fireworks
that are not intended to
produce the audible effect?
>> Rodney Valliere: We looked at APA 87-1
and those values are mentioned there.
>> Ann Marie Buerkle: Okay, so
that just mirrors that standard?
>> Rodney Valliere: Yep.
>> Ann Marie Buerkle: Okay, alright.
And has the staff revisited
whether the two grains
of pyrotechnic composition is
the right amount or is that?
>> Aaron Orland: That's another one where it
becomes a question of what's the safe level
for an explosion in close
proximity to the human body
and becomes a very difficult
question to answer, right?
For me that number is zero.
On firecrackers, which result in
a large number of hand injuries,
the limit on those currently is 50 milligrams
and we recognize that they create, you know,
a lot of a, a lot of damage to the fingers
if you hold them in your hand instead of,
instead of letting them go in time.
So, the 2 grain limit is it applies to things
that are not typically going to be held
in your hands and those are going to be
used further away from the body so we say
that that's a long historical one, but it's one
that's really difficult to answer is whether
or not that's good, bad or anything else.
It's kind of a difficult question to answer.
>> Ann Marie Buerkle: Okay.
That's all I have for now.
Thank you Mr. Chair.
Thank you all very much.
>> Elliot Kaye: Commissioner Mohorovic.
>> Joe Mohorovic: Thank you Mr. Chairman.
I want to compliment all of the
staff who contributed to this effort
and especially our Executive Director; thank
you for also making staff available to me
on several occasions given all the, all
the work that you have in front of you.
Thank you for spending that time with me
to help me better understand what is
incredibly thoughtful, comprehensive proposal.
It's obviously the recommendations.
It's obvious to me the recommendations that
you make are sound and in the public interest.
I also want to demonstrate my appreciation
to my colleague Commissioner Robinson
for her leadership in this area, and also
to compliment the dedication and the time
that she has spent personally
to get a better understanding
of this industry far beyond
my understanding from going
and seeing the way these products are
manufactured and sharing those learnings with me
and with the rest of the commission, so thank
you for your dedication on a smart product
to product category to spend time on.
Fireworks, as the chairman mentioned, is one of,
one of if not the most dangerous
products we regulate.
So, I think all of this work and the time
spent on it is perfectly appropriate.
I do have some questions for
staff if you'll indulge me.
The first set of questions I have
relate to the proposed changes
in 1500.17 A-3, so the audible effects test.
Could you, and appreciate all of the work and
the corresponding memorandum which is available
to the public too which demonstrates
transparently some
of the preliminary testing that's been done
to prepare this package, could you provide,
because I do think it's important for the
public to understand a general explanation
of the audible effects test as it stands today
in terms of some of the preliminary testing
that you've done, as well as, some of
the results of your work with regards
to potential compliance rates, what you've seen
with the proposed suggestion
and adopting the APA language?
Don't make my pick one of you to
answer [background brief laughter].
>> Rodney Valliere: Okay, so
currently as I mentioned in briefing,
the test that we currently
conduct is a two-part test.
Okay, so that is, there's a field
portion where a staff member listens
for a distinct sound and if it has this sharp.
>> Aaron Orland: Sharp report.
>> Rodney Valliere: Sharp report that
I mentioned, then it is taken back
so that is the field portion
and then once if it's determined
that it did have an audible
effect, if we do hear that sharp,
crisp noise then it is take back to the lab, cut
open, and mass is made of pyrotechnic material
and if it's at 130 milligram; if it's
less than 130 milligrams, it will pass;
if it's greater, then it would fail.
And, what was the?
>> Joe Mohorovic: Well, what I'm really
just generally looking for in terms
of what the expectations are, so I understand
the change is really going to clarify
or change the method with
which, with which intended
to produce an audible effect will be determined,
moving from a technical staff expertise
determination to the presence of metallics.
If you could just generally
related for the commission
and for the audience paying attention; what
would we expect to see in terms of the amount
of product that would be rendered
under the new proposal as intended
to produce the audible effect and then,
therefore, subject to the 2 grain limit
which you did mention, but of course it's stated
clearly, the 2 grain limit will stay the same.
It's really just getting at what
product is intended to produce
that audible effect other changes aside.
>> Aaron Orland: So, the crucks of the
difference, our current test is we go
out in the field and we listen and then if
it's determined that it is [inaudible] result,
we come back to the laboratory, we sieve out
the less than 100 mesh portion of it, weigh that
and if it's over 130 milligrams and
the device is violative and then,
or potentially violative depending on how
compliance decides and then if it's less
than 130 milligrams it's just fine.
From the technical piece of the proposed test,
what the laboratory would do is we wouldn't rely
on listening which the fireworks industry
has complained about for years that it's kind
of a subjective test and they
have difficulty repeating it.
So, the change would be that we would use
the presence or absence of metallic fuel
which is currently banned
by the voluntary standards.
We would adopt a very similar provision to
what's already; the industry already accepts
as intended [inaudible] audible effect
which is the presence of metallic fuels.
If the metallic fuels are present, we would
weigh it out, sieve it, weigh it out and if it's
over 130 milligrams we still
recommend compliance
if it's relative, and if not, then it's okay.
>> Joe Mohorovic: Understood.
Thank you.
Maybe from a compliance point of view,
I don't think I'm doing a good
job of answering my questions.
So, Mr. Tarnoff if you can stay with me.
And from some of the preliminary testing
not statistically, you know, valid samples,
but just from the preliminary work that we've
done, from a compliance point of view in terms
of our expectations in the impact
that this may have on the market.
Do we think that there will be fewer
or less product rendered intended to be
to produce an audible effect and, therefore,
subject to the 2 grain limit under our,
under the proposed revision or as it
currently stands with the field testing?
>> Howard Tarnoff: I think it's hard to predict.
I think some of the products we currently
find violative may not be violative
and other products that we pass may
not be passed, so we don't know.
What we've done is a preliminary look at it
and I think on Rodney's last slide he showed
that there are currently a high percent
that have some presence of a metallic fuel,
but I think we found that
most of those are under 1%.
In fact, most are under .4%.
So, we think the majority of products
would comply, which is what they should do
since they have a voluntary standard which has
been adopted by DOT as a mandatory standard.
So, we're not really asking for anything
other than what is the current standard
in the industry, and we would be allowing
for the enforcement discretion up to 1%.
>> Joe Mohorovic: Excellent.
Thank you very much.
A slightly different subject, but still
staying with 1500.17 A-3; with regards to some
of the tables that were referenced
in the lab/sciences memo,
specifically I think it was table 6
was provided showing some demonstration
of some preliminary testing and
the results as they were determined
by using XRF instrumentation versus ICP.
Was the purpose of providing that, 1; to
ensure that XRF technology would be applicable
and fit for use as proposed under
our, under the new proposed changes?
>> Rodney Valliere: Yes, a table 6 basically
what we did was correlated our XRF data
with our ICP data and if the XRF is under the
right conditions, if you use it correctly,
it would be a very viable screening
process and we think you could use XRF
as opposed to a more expensive technique.
ISP, it would a very effective
screening analysis.
>> Joe Mohorovic: Excellent.
Thank you very much.
I think I have time for just one more
question and this brings up tables 7
and 8 with which Miss Kelsch brought to my
attention and I think it's important to relate.
It has to do with some of the findings there,
and maybe Miss Kelsch, you can, or someone,
or one of the other panelists might
elaborate on the significance of that data,
because if we do propose to move to the APA
approach for determining an audible effect,
and if in fact we move to
a 1% contamination limit,
then that would require a significant amount
of quality control and quality assurance
with regards to potential
contamination of aluminum or magnesium
and that had always troubled me somewhat.
Commissioner Robinson based on, and I haven't
seen, I have not visited a fireworks factory,
but I think I know with confidence that they're
largely handmade, hand-constructed products.
And with that method of manufacturing, that
introduces the potential for great variability
and variation, so I was really
troubled with whether or not if we move
to a 1% contamination level, whether or not
that's even possible under the current dynamic
of how these products are produced?
I mean, can somebody making a handmade firework
limit to 1% or less, a contamination limit,
but maybe you can describe what you've found
in table 7 and 8 and how you have confidence
that you believe the industry
can get there reasonably.
>> Aaron Orland: So, I share.
>> Joe Mohorovic: In 15 seconds.
>> Aaron Orland: I shared concerns about whether
or not the industry could do this as well.
We've heard some concern from the
industry that this was possible.
So, we went in and we looked at; one of the
allegations was that the visual effects,
which also have aluminum powder in them a lot of
the times, were contaminating the break charges
and we wanted to go in to either
prove that was the case or disprove
that that was the case and we looked at it.
It was very difficult because most of the, as we
said, most of the break charges that we looked
at had aluminum present, so it
was very difficult to find ones
that the aluminum wasn't intentionally added.
As a short-term fill-in the gap, we
looked at the other metallic that are
in the visual effects, so strontium makes nice
red colors, barium makes nice green colors
and copper makes nice blue
colors, is that right?
>> Rodney Valliere: Yep.
>> Aaron Orland: Dyslexia makes
me mix those up sometimes.
We looked at the effects that
should not be in the break charges,
because there's no reason for them to be there.
They're expansion, there's no reason
they would add them and we looked at them
and what we see is that when there's a couple
of percent of strontium or copper or barium
in the effects, we see very small amounts,
less than a percent, usually around a quarter
to a half of a percent of these
metals contaminating the break charges
and we have confidence that with
aluminum when it's not intentionally added
to the break charge, it's also not going
to contaminate the break
charges from the effects as well.
>> Joe Mohorovic: Excellent.
Thank you.
I thought that was a point well worth
making and I apologize for going over.
Thank you.
>> Elliot Kaye: Commissioner Robinson.
>> Marietta Robinson: Nothing further.
>> Elliot Kaye: Commissioner Buerkle.
>> Ann Marie Buerkle: Nothing further.
>> Elliot Kaye: Mr. Mohorovic, back to you.
>> Joe Mohorovic: I do.
I apologize.
Just on two other subjects and
first it gets to 1507.3 is that the,
where the proposed change
side ignition test resides?
The side ignition test, it occurred to me
that that doesn't reside in our regulation,
but it resides in our test manual.
So then is the test manual considered a defacto;
I guess I'm going to try to use everything
but the word "backdoor" rulemaking.
How we got a side ignition fuse test into a
test manual; do we consider that as substantial;
well that, that question can't be answered.
I'm interested in; well, let me ask this.
When did that get inserted, if
you know, into the test manual,
the side ignition cigarette fuse test?
>> Aaron Orland: It's been
there for a very longtime.
The current regulation that, and correct if I'm
wrong Meridith, but I believe it says something
to the effect of the fireworks
must resist side fuse ignition.
It doesn't describe how.
>> Rodney Valliere: How.
>> Aaron Orland: How.
It just says they must resist.
>> Joe Mohorovic: I see.
>> Aaron Orland: And so the
interpretation of that
in the test manual has been 3 seconds
which is the industry standard.
>> Joe Mohorovic: Right.
>> Aaron Orland: It's been in our test manual
since the current revision which is 2000.
>> Rodney Valliere: Five?
>> Aaron Orland: Five, 2004.
>> Joe Mohorovic: Okay.
>> Aaron Orland: I forget
off the top of my head,
but it's been there for you know a decade or so.
It's not, I don't think it's what
you call "backdoor" rulemaking,
it's we have to have a test method for
determining what is resist side fuse ignition,
so it's, that's what's currently there
and that's what the industry standard
is is a cigarette held on the side
of the fuse for 3 seconds or longer.
>> Joe Mohorovic: Right.
But side fuse ignition resistance does not
reside in our regulations, is that correct?
>> Meridith Kelsch: The regulation
does provide the general provision.
>> Joe Mohorovic: It does.
>> Meridith Kelsch: It has
[inaudible] side ignition.
It does not spell out how to assess
whether it resists side ignition.
>> Joe Mohorovic: I appreciate it.
>> Meridith Kelsch: So, that's what lays in the.
>> Joe Mohorovic: Yeah, that's
perfectly appropriate.
Thank you.
I didn't know that until this
very moment, so thank you.
I do have some other questions; the last ones
commissioners and panelists to bear with.
It has to do with 1507.2,
the recommended changes
to add some elements to the
prohibited chemicals.
For those that are not familiar
with hexachlorobenzene,
can you provide a little bit more information in
terms of the potential risks associated with it
and why staff is recommending it be
added to the prohibited chemicals list?
>> Aaron Orland: Hexachlorobenzene
is a particularly toxic chemical.
It's banned from global production in
almost every country including China,
but it has traditionally been used
in fireworks because the addition
of chlorine helps makes the
colors brighter and flashier.
It makes the visual effects more appealing.
>> Joe Mohorovic: What is
the nature of its toxicity?
How is it, in what way is it toxic?
I think we must have somebody from Health
Sciences that might be able to contribute
to a better understanding of
the nature of its toxicity.
>> Sorry, I have to refer to my own memo here.
Well, since several agencies have
determined that it's a carcinogen
and has developmental toxicity,
reproductive toxicity, toxicity to the liver
and hepatocellular carcinoma,
so more cancer, so.
>> Joe Mohorovic: And I noticed also
that staff is recommending adding lead,
and we're all very familiar with lead and its
toxicity, could, does staff have an opinion
in terms of the what might be
intermittent exposure to lead from fireworks
and whether the fireworks pose that hazard?
Is there, can you explain maybe the
exposure scenario that we're concerned
about which is why we would consider adding or
prohibiting lead from being in the fireworks?
>> Well, we have no information about
exposure with fireworks and any compounds.
You know, we just, we can hypothetically
imagine it's dispersed in the air,
settles on the ground, and it can be
inhalable, it can settle on surfaces.
>> Joe Mohorovic: Hand to mouth.
>> Hand to mouth contact, yes.
>> Joe Mohorovic: Exposure.
Understood.
Thank you.
Now, was this proposed regulation; I know
that that what Commissioner Robinson had done
to jumpstart it again, did
this begin within ANPR?
>> Meridith Kelsch: Not exactly.
>> Joe Mohorovic: Okay.
>> Meridith Kelsch: There was an ANPR issued
in 2006 which explored a couple of issues,
one of the most broad being, you know, are
there things we should add to our regulations?
>> Joe Mohorovic: Right.
>> Meridith Kelsch: But, it wasn't a regulatory
review and it didn't go through specific areas
in the way that this package does.
So, to some extent, you can say that this
is a follow-up on the ANPR, but not really.
Some of the issues addressed in the ANPR had
since been resolved such as certifications.
>> Joe Mohorovic: Okay.
So, and then that matter was not resolved
or withdrawn so it remained on our agenda,
our rulemaking agenda, the fireworks ANPR?
>> Meridith Kelsch: I don't know
that it stayed on the agenda.
It's um.
>> Joe Mohorovic: It did.
>> It did.
>> Meridith Kelsch: Oh.
>> It's on the regulatory agenda
if that's what you're asking.
>> Joe Mohorovic: It is and it has been.
>> Correct.
>> Joe Mohorovic: Prior to the rule review.
>> Yes.
>> Joe Mohorovic: Action of the commission.
>> Correct.
>> Joe Mohorovic: Great.
Now, so we did have an ANPR and I
recognize that the ANPR at that time
in 2006 was somewhat wide open,
but I do recognize in section 31
of the Consumer Products Safety Act that the
commission may not issue an ANPR for regulations
under section 2Q1 of the Federal Hazardous
Substances Act relating to a risk of cancer,
birth defects or gene mutations from a consumer
product unless a Chronic Hazard Advisory Panel
established under section 28 has in accordance
with paragraph 2 etcetera, submitted a report
to the commission with respect
to whether a substance contained
in such product is a carcinogen,
mutagen or teratogen;
I hope I pronounced that correctly, teratogen.
So, with the CPSC recommending adding
HCB and lead as a prohibited chemical
because of its concern as a carcinogen,
we would be doing so without
having had assembled the panel,
a CHAP and does that create any problem?
Are there any designs to put a CHAP together
so that, I know the statute requires that we do
that in advance of the ANPR, but we already
had; that's why I was getting to procedurally
where we are, you know, do we
have an ANPR on the books already?
So, we do, so we're kind of picking
that up from; now see things happen
when we release these things out
there for decades and decades.
So, we have an ANPR already out there which
perhaps I would imagine in 2006 didn't,
didn't really envision the carcinogenic
effect or hazard, so therefore,
the CHAP wasn't, wasn't put together.
Has anybody thought about CHAP
as it relates to section 31,
CPSA as it relates to FHSA rulemaking?
>> Meridith Kelsch: We can
certainly look into that further.
My initial reaction would be that this section
31 that you're referencing falls within CPSA
and [inaudible] would fall under the FHSA.
>> Joe Mohorovic: Right.
>> Meridith Kelsch: But that's
certainly something we can.
>> Joe Mohorovic: That's a
good [multiple speakers].
>> Meridith Kelsch: Examine
in more detail for you.
>> Joe Mohorovic: But it does say the commission
may not issue a rulemaking section 31 B1C
in an ANPR rulemaking for regulations under
section TQ, 2Q1 of the FHSA [multiple speakers].
>> Mary Boyle: Excuse me Commissioner
Mohorovic, I think we are venturing
into some legal analysis that we
should provide to you in another arena.
>> Joe Mohorovic: Okay.
Is it the Chairman or the Commission's
desire to according to our DMPs to go
into executive session or do
we want to put this matter off?
>> Mary Boyle: And I think it was clear
that we haven't done full legal
analysis yet, so I don't want to.
>> Joe Mohorovic: So that would be.
>> Mary Boyle: Be off the cuff and I
think we need to follow-up with you.
>> Joe Mohorovic: Okay.
Thank you, that's all I have.
>> Elliot Kaye: Comissioner
Robinson anything else?
>> Marietta Robinson: Nothing further.
>> Elliot Kaye: Commissioner
Buerkle anything else?
>> Ann Marie Buerkle: Nothing.
>> Elliot Kaye: Commissioner
Mohorovic anything else?
All righty.
Having heard no further questions,
this concludes the second part
of the, of this public meeting.
Thank you again to the staff for all this work.
We look forward to follow-up discussions on it.
Thank you for those who have
attended or are watching online.
This concludes this meeting.
[ Gavel Hitting Podium Sound ]