Good afternoon we will now resume the briefing from staff to the commissioners
and we have one issue before us just as a reminder it is a prohibition of
children's toys and childcare articles containing specified phthalates a final
rule and at the table this morning is dr. Babbage dr. Carlson David DiMatteo
from the office of the General Counsel with that we will resume questions I
will start with myself I do not have any additional questions commissioner adler
not at this time thank you Fischer Robinson
yes I would only say that that was a very very abrupt break at first time in
four years that a breaks been taken for lunch without consultation with my
office I don't know about the other commissioners but I just want to make
sure in fairness to staff and to the other commissioners that if any of us
had a meeting with an outside party or their representative during this past
hours break I think that it should be revealed under our Open Meetings Act and
I will start by saying I did not Mission okay no meetings and no questions
fishermen aerobic I didn't have a meeting I had a sandwich at buoy mongers
with a guy that was in town for the ASTM if so meeting who has no business at all
relevant to this or anything else other than I've known him for 15 years and you
decide to show up and I said hey I got an hour let's go get a bike so I hope
that answers anybody's now what was observed but we'll take you for your
word that's not what was it observed for my lunch it's Irma Harvick thank you
madam chairman I want to get back to the discussion of the the risks in isolation
as they were argued on page 111 of the final rule again around comet 5.5 the
chaps recommendations and the Commission's rules are based on the
cumulative risk from D InP in combination with other phthalates and
that's the cumulative list risk not the risk and I
halation the briefing package states that the chaps and staff's
recommendations to the Commission were based on the conclusion that reasonable
certainty of no harm with an adequate margin of safety was not met because
susceptible individuals had h is greater than 1 but it's later noted that risk
and isolation while it has increased since the chap worked based on the N
Hanes 2013-2014 dataset the fr goes on to cite the mo E's for wor exposed to 2
di MP at the median and 95th percentile and I've explored the war the War
Information at length already and find no need to do that anymore but I do want
to explore the HQ standard dr. carlson testified earlier today that along with
nhi greater than 1 in HQ greater than 1 is representative of a of a risk of an
unacceptable risk of phthalates in isolation the fr states are currently a
certain proportion of wara individuals have a di n p HQ greater than 1 and yet
staff still find that the risk of di NP and isolation does not present an
unacceptable risk yet there are some war individuals in case two that have an HQ
greater than one so my question is while those results were for the HQ of greater
than one there was zero in case one 6 in case 2 and 0 in case 3 why wasn't that
enough to recommend banning di NP permanently because of its risk and
isolation I don't think we said that I did not wonder why you didn't we said
that di NP we in isolation is near the point where we might consider that that
it's presents that in isolation could no longer say what we said
previously that DNA NP in isolation does not present a hazard we didn't put it in
terms of reasonable uncertainty of no harm because that was based on the
cumulative risk that conclusion now why is it that it takes just a mere
existence of even one Ananas in a sample when evaluating the hi4 cumulative risk
over one to fail the reasonable certainty test but having h qs over one
and considering that lates and isolation does not fail the reasonable certainty
test in isolation well again we never set a specific number or percentage but
you did clearly say that the risk of di NP and isolation provides a reasonable
certainty of no harm it's clearly that the statues are based on the CRA not
risk in isolation but the I'm not sure where we said that I don't think we did
you want me to come up with where it says the chat based is findings on the
cumulative risk where it's where we said that the DI NP and isolation does not
exceed a reasonable certainty of real harm okay so you don't consider this the
second instance where staffs interpretation of the CPSIA standard a
reasonable certainty of no harm is inconsistent between evaluation of di NP
and isolation and di NP and a cumulative risk assessment well no because the
recommendations for you know to to me to make permanent the interim ban is based
on the cumulative risk which is based on the hazard index is based on the
percentage of or M we consider the percentage of the population with the
hazard index greater than 1 the mo EES approach was used to look at
phalates and other substitutes in isolation and that was separate from the
cumulative risk I just don't understand why there's a difference where in
looking at HQ any-any population within it with an HQ over one would be
considered unacceptable risk any of a population within a chai over one would
be considered an unacceptable risk but the FR provides is the basis of the rule
only the cumulative risk and not the risk in isolation
it's what I'm simply wondering is why would a handful of samples that fall
above the H I of 1 for a cumulative risk be something that can't be ignored and
failed a reasonable certainty test but yet when there is a handful that fall
over the HQ of one which has been identified as unacceptable risk that we
can ignore and not make as part of the rule if you're if it was consistent in
terms of looking at the outliers one would say the rule is based on the risk
of di NP and isolation because there are six individuals in case two there's none
in case one and none in case three but we have six in case two that fail our
test for acceptable risk such it much in the same way that there are two
individuals in case three and three individuals in case one and nine
individuals in case two that have h eyes over one I just don't understand why
there's a different application of that what's been determined to be a bright
line well there's there is no bright line we
did not set a bright line nor the the chaps at a bright line we'll get to the
two the bright line I think in a little bit um should I wait
I'm sorry check thank you I do not have any questions commissioner either no
questions at the moment Commissioner Robinson not yet mr. okay
all right now we should mow her over thank you madam chairman in looking at
the worid data from the front getting to the reasonable certainty of no harm
standard in looking at the war data from 2013-14
and Hanes data set the sample is a nationally representative sample correct
yes and the purpose is so that we can look at results and extrapolate them to
make risk decisions based on what the impact would be for in this case women
of a reproductive age in the u.s. population well I mean there are many
purposes for doing the NH study and I'm not sure whether this is one of their
purse purposes litter let alone what are their major ones whether or not we have
a nationally representative yeah well I mean it's done because it's it's good to
give good quality data it's not done necessarily for use in regulation
although it's useful in looking at the results from the Ann Haynes data set 13
and 14 and looking at the results the median there the 95th percentile
estimates can be drawn to determine how many women of a reproductive age in the
US population might be represented by those results is that correct
technically and statistically say say that again in looking at the results of
the Ann Haynes data at the median or at the 95th percentile estimates can be
drawn to determine how many women of a reproductive age in the US population
might be represented ah that depends on the particular value that you're looking
at and that's done on a case-by-case basis well the particulars I'm
interested in is the median values and the 95th percentile values my
understanding is that the the median values you can calculate a you can
extrapolate to the population in for certainly many of the 95th percentile I
don't know if that's true for all of them oh really for all of them what do
you mean for all of them well all the different Ann Haynes sets I was only
interested if it anything sets different cases I mean it's
it's uh that's for the epidemiologist to answer that okay
Burnley
oh I believe in a few just introduce yourself again
thank you my name is Violetta fedorovitch I work in epidemiology
I go by viola so I believe in our package in table a we actually put the
asterisks to the estimates that are unstable so unstable estimates it means
that their confidence interval is very wide we cannot really say that they have
a high variance so sometimes the estimates are not reliable and that was
mostly for 99 percentile because the sample size is small and the variance is
high so we got some numbers but it's not a not reliable numbers in for the median
yes you can use the median and you can estimate the percentage of the people
who have hazard index higher than one and for 95 percentile for some of them
you can but there is Asterix in the top a for those that would not recommend you
to use it as you mentioned it may renders those results unreliable yes yes
for this because the variance is sometimes very high or cannot be even
estimated and that's I cannot tell you you know what the confidence interval is
oh is it too wide so I'm giving you some number but you know it's in there
white range would you consider them unreliable for basing risk for risk
management purposes if we put the Asterix there I will consider from the
statistical point of view that they are not stable or not reliable we can yeah
you can say if you take another sample of enhance data you can get their
different results that's what means when it's unstable I see that is incredibly
helpful thank you what about a confidence interval I mean a lot of
times with risk assessments that I've seen in the private sector usually a
result is given around a confidence interval for instance in the testing
world with observances of a non can formerly in a pass/fail test if you did
that same test 20 times I would tell a customer if you did that same test 25 20
times and recognized no non-conformities all you could say about that work was
that you're 90% confident that your defect rate is under 10 percent even
with you know basically 20 straight passes in a row but that's something
that's actionable for management is there a reason why confidence intervals
weren't used in providing any of this data we use the confidence interval we
just didn't put them in the briefing packet but we use the confidence
interval we use the variance to tell you if those estimates are stable or not so
there is a asterisk by every estimate or sometimes there is Asterix by all the 99
percentile and it is in the footnote it is written that you should be cautious
using those estimates so I didn't put it in the memo because I thought it will be
more difficult to read the data if I put the confidence interval the tables who
are already you know by year by the PA so it's kind of you know going that
direction that direction so we just presented and Chopp presented that way
we also wanted to keep it consistent with the chart but yeah we could as well
provided those if you want I can over my time I'm sorry I want to pursue it but
thank you I do not have any questions commissioner
just to clarify and I I must admit I'm a little bit confused on this point as
well but I thought that the staff did say that in isolation di NP would not
fall within the realm of unacceptable and I'm looking on page 36 and 37 of the
NPR and it says the chap used a margin of exposure to assess the risks in
isolation and higher mo ease and can indicate lower risk but then it says the
chap found that within with the exception of deh P for all phthalates
that it evaluated in isolation the mo AI mo es were within acceptable ranges am I
miss reading what what the staff conclusion was a pages 36
and 37 in the NPR document I thought I did
that's what the chap concluded yes and so did the staff agree or disagree with
that yes okay so that I mean it's just a help my help me clear up any confusion
but the basic thesis that the staff was advancing with which I'm in complete
agreement is that it's the cumulative impact that would disqualify di NP now
keep in mind that that's from the chap report and given the new biomonitoring
data D InP bozer's have increased four so we after analyzing that data we would
no longer say that di NP and isolation does not present a hazard okay well yeah
that's very helpful I didn't see that in the briefing package you know I'm okay
but that's very helpful information I know first of all this is a rolling
process and so the fact that you have later required data is very useful so
thank you very much for clarifying that Thank You Commissioner Robinson I just
have one point of clarification as well I'm looking through the the the tab a
and perhaps I should be looking someplace else but are there any
asterisks by di NP because I don't I didn't see any and that in terms of
being unstable I think the the table that was being referred to as Table
seven and when you look at the knife at percentile 2013-2014 there are no
asterisk there but the 99th percentile has all asterisks
right okay thank you anything further Commissioner Robinson Commissioner K no
fishermen Rubik thank you madam chairman so getting back to the confidence
intervals you considered providing confidence intervals around those data
points but I think your answer was in terms of continuity with the chaps
approach it was considered and rejected is that something that could be provided
if they've already been done but just not made part of the materials or any of
the tabs yes ma'am as I said those aesthetics are based on the confidence
interval if that confidence interval was too wide when the variance was too high
there's Asterix by that and I can provide a number I can just you know
send the SAS output where their confidence interval so I just didn't put
it in the table once I told tribe didn't put it and from another side I was
thinking it will be easier to read if I make the table you know to be too
complicated it's just so B may be too difficult to follow but I understood
thank you and I think it would be helpful I think we'll I'll work with the
Chairman to see if we can get that made part of the public record because if in
fact we're making the basis of regulatory decisions on the 99th
percentile that have confidence intervals that do not in any way reflect
reasonable points of of confidence to be the basis of public policy decisions I
think that would be important I know it'll be important to inform my decision
I don't I don't know if it'll influence anybody else on the Commission but it
certainly would influence me and to respond no thank you I thought you
wanted to respond back to that thank you and getting on a little bit longer with
the reasonable certainty of no harm with the acceptable risk is H I less than or
equal to one the chap determined that approximately ten percent of pregnant
women and five percent of infants had an H I greater than one and
dr. Babbage you testified when we had a briefing on December 17th that 90% of
pregnant women had an H I less than 1 therefore 10% of pregnant women were at
risk you testified in the chat reported 10% of the US population so that's
correct because it was it was statistically valid to derive 10 percent
of the u.s. population from that given at the at the time a couple of years ago
I see you're not even correct I appreciate that in the NPR the
Commission proposed thalli prohibitions because quote the proportion of
populations not affected by cumulative explote exposure to phthalates did not
meet the standard of quote a reasonable certainty of no harm with an adequate
margin of safety of safety and quote in the briefing package to this final rule
it states that the Commission didn't establish directly that there was a
specific proportion of the US population that much must have an H I less than or
equal to the one the point I'm trying to make is the NPR and the chap
specifically were making decisions based on the impact to the US population they
had a large enough sample and large enough because of the data and no 5:06
of population that had H is greater than one that they were statistically valid
and extrapolating that out to a percentage of for instance women of a
reproductive age at risk in the general US population but the takeaway from the
CRA using the most recent data is that those with an H I greater than one in
the sample is so small that an extrapolation as we just heard testified
by our statisticians to understand what proportion of the u.s. women of
reproductive age are at rest it's impossible to derive so when we cannot
determine what percent of the US population of women of a reproductive
age are at risk how are we justified in recommending a ban well when they say
they can't extrapolate because the numbers are too small
what they're saying is that they can't give us the precise
value is a you know 1% half a percent and so on the fact that they found
individuals real actual people with hazard indices greater than 1 in such a
small sample suggests that there really are people in that war a population of
course the chap was looking at pregnant women but the war a population there are
people with the hazard index greater than one and very likely are more in the
general in that population out of you know you find individuals out in a
sample of 500 and something if you could look at the 60 whatever million wara in
the US you would likely find more we just can't say what that number is thank
you my time thank you um Commissioner II other I just observe and I don't know if
there's any relevance this but the trigger point that we and most other
agencies have for carcinogenicity is one in a million and that's why I was trying
to see if there any way if we could extrapolate from the 538 cases but if
you extrapolate that's that's well above whatever the level that of concern would
be with respect to carcinogenicity and is there any analog we could make
between those two approaches or they just stunts such separate points of
reference that I shouldn't be making that comparison well there again this is
about the definition of of reasonable certainty no harm is well it's not been
defined we use as the default for cancer one in a million
some people would put in terms of the hazard index would say you know if one
in a million so suppose you could measure that hazard
index in those 60 million and some people would say
if one in a million would have exceeded hazard in the next one they that would
be good enough it's but it is a different paradigm because we're not
giving a risk per se a likelihood of getting a disease but I get again what
what that whatever that percentage is it's it's in the eye of the beholder it
depends on a lot of factors and it's it's always evaluated on a case-by-case
basis and and you do point out correctly that that's in a sense that becomes a
policy judgment which is what we're uniquely assigned to do and so it's
clear to me that it's a risk above zero and probably a significant risk above
zero and so I'm always struck by the wording of the statute a reasonable
certainty of no harm it's not a reasonable certainty of minimal harm
it's a reasonable certainty of no harm and I guess it's up to each of us
consistent with the law to assess what those words mean and what that direction
to us is and I do think the staffs model is of is a particularly compelling one
so I thank you for that mr. Robinson I guess I would just ask that you know we
know we're dealing with data that aren't perfect and we would like more data but
we're doing the best we can because we have to make a critically important
decision about protecting our babies we can't protect the fetus with children's
toys but so we're really dealing with with young children but if we look at
our data sets in terms of exposures to these phalates we've got I know Ann
Haynes doesn't doesn't do study of under six years of age so we've got the future
family's survey we've got pregnant women and Haynes and then we've got women of
reproductive age and it seems to me that the best data on what the kids are
getting from the products that we are dealing with here would be the family
survey is that right yes okay and then the next step up would be women who are
pregnant with fetuses right and the furthest removed would be
reproductive age right yes okay thank you
Thank You commissioner okay thank you madam chair
I just want to also understand dr. Babbage that while Commissioner Maha
robic was talking about uncertainty that he might perceive in the data or in the
recommendations it sounds like from staffs perspective there's zero
uncertainty about whether there is actual harm because there are some
individuals in that study sample who have HIV one correct yes
and it really it comes back to how one interprets certainty of no harm but we
do know that there are some people who already are at an exposure level that
the staff would consider to be of concern harmful however you want to
characterize it yes and so at that point where there is uncertainty is the the
amount of people that are harmed not whether or not people are harmed there
is certainty that people are being armed correct correct in the you know the good
thing about the enhanced aid I mean these are actual people this is a
measured it's not modeled or predicted it's actual people so it's not that
there is reasonable certainty of no harm there's certainty of actual harm in this
case I believe that's accurate that the uncertainty is putting a number on it
correct and I think that's important to keep in mind thank you very much
Commissioner more horrific thank you madam chairman I'll follow the Chairman
Commissioner Kay's line of reasoning there with the no uncertainty because
some had H is greater than one the standard for for harm for risk of
phthalate and isolation was an HQ greater than one so while you find no
uncertainty because some had H is greater than one the the staff did not
come to the conclusion that di NP should be banned because of its health risk in
isolation yet even though the fact that there were some HQ is greater than one
so why is it that there is no question of certainty of harm when
there's just even maybe one with an H I greater than one but yet six with an HQ
greater than one does not yield staff to base this ban also not just with the
cumulative risk but also based on the risk of di NP in isolation well for one
thing are the recommendations including the recommendations in the NPR based on
the cumulative risk the fine the observation that di NP exposures have
increased is a something new that wasn't in the NPR we didn't say that on the
basis of the HQ that whether D I NP does or doesn't meet that standard of
reasonable certainty of no harm we simply said that the exposures are
increasing in the in there there if they're not there yeah we didn't draw
any conclusions but it's clear that it's if di NP exposures continue to increase
then it might be possible to make that conclusion but we didn't say it because
that's not what we that wasn't the basis of the NPR because it wasn't part of the
chaps finding and I realized that there's there's statutory language that
the conclusions be based on the chat but the chaps exposure estimates and di NP
using O 506 data would never have yielded one to recommend banning di NP
based on the data that they produced for the chap staff found a couple of very
important scenarios to make recommendations outside of what the chap
what the chap did as well so I'm wondering why in this situation
banning di NP based on its risk in isolation wasn't included in that list
because it failed our very own test which all it takes is just one over an H
I of one or an HQ of one to render failing to provide a reasonable
certainty of no harm well because the the original recommendations from the
chap in the NPR were based on cumulative risk not risk in isolation we discussed
that issue but we didn't drop make any firm conclusions we didn't use that as
the basis for the final rule mm-hmm I guess I'm sorry I mean interrupts
continues okay thank you no I agree with that I totally recognize it I guess
that's the that's what puzzled with is why not based on a consistency and the
the approach to reasonable certainty of no harm but I'll move on the briefing
package in the preamble go to great lengths and dr. Babbage I think you've
mentioned this already today the state that neither the chap nor the NPR
indicated that the 95th percentile or any other part of the cumulative risk
distribution should be used to establish unacceptable risk for risk management
purposes but we know that by law the Commission must provide notice
enterprise interested parties with sufficient clarity to allow them to
participate in a meaningful and informed manner and I'll note that since the NPR
there have been two subsequent reports produced by the Commission in 2015 and
2017 subsequent to the publish of the NPR and our our briefing and decisional
on that matter why is it that we didn't provide any notice when we released
those data reports that we might make that this might that regulating at the
ninth 99th percentile is the possibility for us why did we choose to ignore that
if anybody looked at what happened in a briefing package for 14 subsequent data
in 15 subsequent data in 17 and then at the final stage where the final rule
we're saying up you know almost somebody would would say well we tricked you we
never told you was going to be 95 we know everybody thought it was gonna be
95 but we didn't rule out regulating at 99 why didn't we give more notice as we
were publishing you know data on the record that we might or it's a
possibility to to reasonable certainty of no harm is is
not provided if there's a risk at the 99th percentile that's that's a policy
or perhaps legal question I mean it's it's not a science question we published
the data it asked the results of our analysis and asked for public comment
Thank You mr. Morrow robic I just want asked for a little bit of clarification
because when we were going through the first round of questions it came up but
because the number of women in the pregnant women we couldn't extrapolate
because that number was too small and then we went from there to saying but
and I think the two words you used dr. Babbage were suggests and it's
likely that there would be harm in the women of reproductive age in that group
because of what we could or couldn't extrapolate from the group of pregnant
women so it's it's hard for me to understand how you can say there's
certainty that there's harm but then why do we use words like suggest and likely
rather than definite or there's a direct correlation or because of this than this
it just seems like we're using or interchanging words here well that's I
think another really a statistical question and but you know we know that
there are women in the affair in the war population who have hazard indices
greater than 1 but the statisticians say we can't give a precise estimate of the
number in the population or the percentage of the population we should
rather just need to clarify the question that Commissioner moja robic was saying
he said he's stating or at least implying that when we got these later
and Haines data we did not publish them and asked for comment or am I mistaken
what you're talking about yeah would you yield yes please do Thank
You commissioner no I'm not saying that we didn't go out
for comment I'm glad we did but I think what we there was a reasonable
understanding that the 95th percentile was the key percentile to evaluate
results what we didn't do and what we hadn't done through the whole
promulgation of this rule is give any indication that we might be able we
might be making regulatory decisions based on the 99th percentile that's
taking a lot of your time I apologize no that's a that's a fine point and it is
one that is debatable but I think the staff response was we never said that we
were going to use the 95th percentile we talked about it in the NPR but
ultimately that's a judgment for us to make and the staff has and made a
recommendation but ultimately we have to decide whether we want to do that but I
don't think we're taking anybody by surprise they sure do any other
questions commissioner Robinson nothing right now commissioner K nothing right
now thanks Monsieur Mereau glad we sped back up so I could continue this
Commissioner Adler I in response to that I would say that our NPR clearly said
based upon 10% of pregnant women and 5% of infants who would be at risk we're
going to promulgate this rule now somebody might look and say well what is
the smallest possible percent that the consistent that the Commission considers
unreasonable not 90 because then 95 when it's 95 would be the smallest so that's
why I believe that that people that were observers of this rulemaking felt very
clearly that there was 95 percent and also as I mentioned earlier that the
staff consistently said that the reason we find D InP and isolation not at risk
is because wara the mo e for wara at 95% we kept saying 2:20 at 95 percent to 20
at 90 95 percent we never said what is it at 99th and in fact they found out
that we never even calculated what it might be at 99 percent so anybody
reasonably would consider 95 percent is is what we're using so that's that's
that I'm sure you'll want to follow up on that I'm happy to die here would you
like to yell why don't you asking your questions Thank You
commissioner other so staff based its recommendation in part on the CRA for
wara the number of women the number of women with an H I the actual number in
the in the in the risk analysis in the 2013-2014 data that had an H I greater
than one in cases one to three were three nine and two in representation
right so in the briefing package it states that a reasonable certainty of no
harm with an adequate margin of safety requires a highly protective standard
but does not require 100% certainty of no harm further in the briefing package
Papes 38 the chaps and and staff's recommendations to the commission were
based on the conclusion that reasonable certainty of no harm with an adequate
margin of safety was not met because susceptible individuals had h is greater
than one so the results were three nine and two what would the CRA results have
to be for the staff to recommend that di NP and toys and children's products
provide a reasonable certainty of no harm if three nine and two is
unacceptable what would those numbers have to be for the staff to conclude the
DI NP and toys and children's products provides a reasonable certainty of no
harm again we never set a number we never intended to set an exact number it
it comes down to the definition or your interpretation of reasonable certainty
of no harm which we've interpreted to be an HQ greater than one or nhi greater
than one so we've determined that H cues greater than one at the number zero six
zero is acceptable provides a reasonable certainty of no harm otherwise we would
have based the rulemaking on the risk of di NP in isolation
well but we never we didn't have to because it was already the proposal was
based on the cumulative risk well you didn't have to also base it on a 20 year
old data on infants you could have used more recent data but you based it on
pregnant women and infants so surprised that you didn't just need one day 2.1
population at risk to suggest banning why wouldn't why would then what is even
the evaluation worth if they found to look at the risk of di NP and isolation
have it fail the staffs own task but yet yield it doesn't provide a reasonable so
you never we never applied that test to the di NP and isolation in the data the
SFF data are simply the only data available and they're not quite 20 years
old the if the CRA results were 0 6 0 for cases 1 2 & 3 would the staff have
found that there is a reasonable certainty of no harm and therefore no
need to ban di NP and toys and children's products I don't know and you
know one consideration might be if you have for exibições it's across three
different of three of the cases you know that sort of additional confirmation
additional confidence in the in the result ok let me try this in a different
way I actually watched the decisional meeting in the briefing meeting from
2014 over the weekend and I recognized as a takeaway doctor Babbage you were
mentioning a concern of a bright line that the CPSC I'm paraphrasing but you
didn't want to provide a bright line and in fact in the briefing from December
5th 2014 you were asked the following from Commissioner Robinson you were
asked from Commissioner Robinson quote generally was risk with respect to
hazard index we want to keep it as low as possible in making decisions about
these phthalates right and you answered well yes although certainly if you're at
or near one you may not be as worried lower is better so with regards to the
CRA results at three nine and two with the N Haines 2013-2014 data of those
data points would you consider them now those are by
definition over an HIA one are they close to one of the individuals
in those data points were ranging anywhere from 1.2 to 2.6 1.2 2.6 but
that in relation to if you could please to the chaps results when they found
that 10% of pregnant women had h is greater than 1 were many of those
results of the H is greater than 1 far in far north of 2.6 I'm not aware that
the actual H eyes were aid available to us that effect is that right but you
know that for the 2013-14 because you're the one that actually did do the staff
did the work on it is that a fact could we is that something that we could we
could get for the record and find out what the H eyes were because I'm also
having a concern with a with a bright line whether you're right at 1 or just
over 1 but if there was great proportions far north of 1 as dr.
Babbage testified that you said that certainly if you're at or near one you
may not be as worried lower is better okay oh I'm sorry I I do not have any
questions Commissioner either I don't want to debate the point endlessly that
you've raised but I am looking at the staff briefing package on page 111 and
what they're saying is that D InP exposure and isolation may approach the
level of concern in other words as it's increasingly used in the marketplace
we're increasingly as dr. Babbage has said coming to the point where we might
be able to say that with respect to di NP and isolation that we would have a
problem in the fact is that as far as we can tell it's exposure is growing and so
again I'll read a sentence current analysis suggests therefore the DI and
PMO ease in isolation are below the upper limit and then you say and are
nearing the lower limit considered adequate for protecting the public
health I would substitute the word and with but but I think that's making the
point that this is a dynamic issue before us and I think what the
staff is doing is entirely consistent with the precautionary principles set
forth in the statute and we can I'm sure we will debate this at the decisional as
well commissioner Robinson yeah I just want to make sure this is perfectly
clear Commissioner Moore Harvick said quote you didn't have to use 20 year old
data on children is there more recent biometric
measurement of the of children than the future family survey no there's no more
recent data at least up that's available to us and that's the latest data
available and just and I'm following up a little bit on what commissioner Adler
was saying but just I just want to tell you what my understanding is and tell me
if I'm wrong that you did not conclude that the risk of di NP in isolation is
not a reason to ban but you simply made your recommendations based on cumulative
risk is that fair to say right in and because it's consistent with the NPR
thank you okay nothing right now Thanks we should more
harvick thank you madam chairman I wanted to get into whether a question a
comment comment comment 5.3 if you want to get to that point I'm in terms of the
answer that I read in comment 5.3 the commenter asked the following or the the
staff in terms of putting several comments into I think buckets is the way
we describe them right so this is a quote from tab B many commenters noted
that diet is the primary source of exposure for D InP and other phthalates
and infants and children and the children's toys and childcare articles
contribute very little to overall phthalate exposure especially for women
of a reproductive age contribute very little to overall phthalate exposure
especially for women of a reproductive age and fetuses permanent prohibition
would have a little little effect on their their
overall risk in thus the prohibition is not supported staff's response as we can
all read in common 5.30 says quotes that disagree that the contribution from
sources other than diet are negligible for di NP then staff refers exclusively
to di NP exposure from the product category subject to the DI NP ban under
CPSC jurisdiction but to infants not to women of a reproductive age in the
answer talks about dermal Malvin and handling etc from infants further along
in the comment discretion discussion it talks about the e use infant exposure to
di NP and again reciting the chap and staff's considered exposure from
mouthing toys as a route of di NP exposure to infants and toddlers nothing
about the exposure to women of a reproductive age from the subject
products toys and childcare article so I don't want to lose the forest through
the trees on this comment we all know our obligation to respond to comments
the commenter was asking about the exposure to women of a reproductive age
we gave them great answers about exposure to infants you know I'm looking
at the 5.3 in the in the in the briefing memo I think no ok 5.3 the question is
about the relative impact of dietary the comment was about the relative impact of
dietary exposure versus teethers and toys and our response to that was that
that the if ballots were allowed you know into either in in toys and child
care articles then that could contribute up to 29% as we discussed earlier so
that while diet may be the biggest source of exposure the potential
contribution from phthalates from toys and childcare articles is
small it's more than a it could be more than a quarter of the total exposure to
infants to infants in what we're by really we're proposing to make the
interim ban permanent I mean all the proposals involve toys and childcare
articles in the prop that's primarily to attempt to protect the infants not the
parents but we recommend recommended the band based on the women of a
reproductive age this commenter is pointing out the fact and the part that
I underlined on page 85 for those playing along at home at tad be it says
especially for women of reproductive age and fetuses we're basing a ban based on
the exposure and the contribution that it could have to women of a reproductive
age this commenter put that into question and said well I really
questioned the exposure path to women of a reproductive age to be the basis for a
ban if we if we chose to just ban this based on the potential exposure to
infants I would completely agree with the nature of the very long answer but
the long answer spit meant said nothing about the exposure to women of a
reproductive age they asked about exposure from these products and we told
them we gave them a ton of great information about infants that the
comment it's as many combinators noted that diet is the primary source of
exposure for di NP and other phthalates in infants and children and that
children's toys and child care articles contribute very little to the overall
fali exposures especially for women of reproductive age and fetuses you know
where we base the recommendations for toys and child care articles on the on
exposure to infants we looked at the data in wara because they were the only
newer data available we also based the ban because of the h eyes for women of a
reproductive I don't I don't think so
hmm based on these considerations and explained in the briefing package staff
conclude that the chaps CRA using an Haines data on pregnant women and the
staffs analysis of more recent and haynes data for wara demonstrate that
between two and nine individuals of an Haines sample of wara have h is greater
than one there's no discussion in there then fence and now I don't disagree that
the staff that the recommendation is also based on infants but part of the
recommendation is based on women of a reproductive age and that particular sub
segment of the population is important because we have recent data that is post
CPSIA and post the permanent bans that went into place so if the women of a
reproductive and in realize thank you I didn't have any questions Commissioner
Adler well picking up on Commissioner moja robux point the comment did not say
Adler could I interrupt just one second I really apologize I would have been
happy to work through lunch had I been consulted but I wasn't and I have a
prior commitment I just want to apologize profusely this is a hugely
important issue to me and I'm very very sorry that I have to leave early maybe
next time you'll ask my office and we can work through lunch I apologize
Commissioner Handler I'd be delighted to yield if you need if you okay any well
back to the point that I was making and I just don't read the comment the same
way Commissioner Moe Harvick does it wasn't asking exclusively about wara it
said infants and children and contribute very little especially for women of a
reproductive age but let's go back to the essential what we're worried about
is infants and what the worid a to do provide a surrogate for us to assess the
risk with respect to infants but this response to the comment very clearly
focuses as it should on infants di and XB p exposure and they say primarily
from diet but then as dr. Babbage was saying over 1/4 of it could be due to
the presence of di n P and the evaluated toys in child care articles so I guess
I'm not certain why we want to be so focused on the worid data when the
actual concern is with respect to infants Thank You commissioner kay
nothing right now thank you mission more heroic thank you madam chairman
commissioner Adler I think you might have misspoken when you were talking
about a surrogate the war being a surrogate you said for infants I believe
you probably met surrogate for pregnant women
oh you yes that's why I thought so too sure everybody else had that same
understanding as well thank you I want to talk about the the infant data now
the final rule on page 63 to 64 describes the median total exposure to
wara went down 20% but there's no new data on infants or pregnant women that
are available to quantify the effect of changing exposures staff suggests quote
if the overall phthalate risk to wara has declined since 2005 2006 it is
possible that exposure and thus risk to infants has also declined however no new
urinary phthalates data on infants are available to quantify these changing
exposures we've heard about the tides data set is the does the tides data set
involve infants and could that provide a source of data recognizing that we don't
have anything else that is more recent or let's say we don't have anything post
CPSIA to evaluate clearly the phthalates cumulative risk or exposure to infants
is the tides data a possibility and if not why not
thank you
the tides data does not cover any infants it has pregnant pregnant mothers
yes so no yeah and nothing else is planned as far as we know from infants
oh so I don't dispute why we looked at the SFF data and I think we also the
packages continue to do recognize also that those results were pre CPSIA but we
also recognize that the wara exposure between oh five zero six and thirteen
fourteen went down 20 percent in the cumulative risk
assessment what a week I'm wondering really what we expect to have happened
to the infant total exposure perhaps using our best professional judgment in
relation to infants so if we know that women of a reproductive age that their
cumulative risk went down a total of twenty percent from pre CPSIA to post
CPSIA wouldn't we expect infants to to have an even steeper decline given their
given the the proportion of their impact and exposure to child care articles and
toys that pre CPSIA which the SFF data is pre CPS up is pre CPSIA in those
bands on the most potent phthalates wouldn't we expect the infant total
exposure to go down even more so because of their their their their their
exposure to those particular product categories which don't have nearly the
contribution and exposure for for women mouthing toys and childcare articles I
don't think it's possible to extrapolate from women of reproductive age to
infants directly because you have differences as you mentioned and
exposure routes and the exposure activities so just saying that there's a
precipitous decline I don't think we're able to say that well we couldn't say
with any confidence whether we think it would be more than the twenty percent
that we evaluated and witnessed within women of a reproductive age oh and what
confounds it a little bit too is that infants and children sometimes have
higher exposures than adults oh okay get back to that the SFF data was that
that I don't believe what that was not a representative representative sample
correct nationally representative sample that's correct that's correct okay so in
the briefing from December 5th 2014 there's a staff slide that appeared
twice the said up to ten percent of pregnant women
and up to five percent of infants have a hazard index greater than one how could
we say I could understand with em Hannes be nationally representative sample and
we had a large at least with the chap data we had a large enough group of
women in an H I over than one that we can then draw that national
extrapolation and then yield with confidence ten percent or pregnant women
and hence ten percent of pregnant women in the US population but if the SFF data
was not a national representation then how can we say with confidence that five
percent of infants had an H I greater than one wouldn't you need to start with
the national representation and have enough samples that would provide you
know the statistical confidence to then maybe then to make a national
extrapolation so the SFF data is data statistically representative sample it's
not a stratified random sample in the sense that the in haynes study is or our
nice data are however it was a multicenter study conducted across
multiple you know multiple medical centers across the United States it's a
good study and as much as we would like to we don't always have that level of
statistical certainty and it's also remember that these are actual again
their actual measurements in actual mothers and their infants these are not
models they're not like the scenario estimates which you know a few years ago
we wouldn't have dreamed of having that quality of data so you know the bar
keeps going up in people's expectations keep going up the fact is it's still a
good study thank you I just want to ask clarification we were talking and I
think those may be around and a half ago about the recent the question was asked
I think Commissioner Robinson asked about do we have more recent
biometric SFF data and you said I didn't hear your answer said it what you said
it wasn't available to us does that mean there is more recent data but we just
don't have access to it or it's somewhere but we you know it doesn't
cost money to get the data what is that what did you mean by that come yes so we
looked actually both when the chap first started we looked for sources of data on
infants we also looked after the NPR to see if there was anything new that might
may have come out and as far as I can recall Kent Kent might know the doctor
Carlson I think is more familiar with this there is a study in Canada but we
can't get the data and there's also the question of whether that's relevant
right the data would not be able to be made transparent or public so and and
it's Canadian data versus into the best year knowledge that's the most recent
data that's the only other data out there that's more recent than what we've
relied on I mean they're there we also looked at California the state of
California has been doing some small studies but there are small studies
they're limited to California but it's the same issue we don't have access to
the data and when we ask researchers one of the their concerns is is HIPAA
because they don't want anyone to be able to identify the participants I mean
that's probably not the only reason it's it's a reason that they mentioned okay I
guess I'm why wouldn't that apply in every case why wouldn't we run into that
obstacle in every situation well it is an obstacle and to get the data on from
the SFF study they had to do a lot of work to make sure the chap got the data
they needed but no personal identifying information I mean they they put a lot
of effort into that Thank You commissioner Edler no questions at this
time thank you
mr. K seems to be an abstention commissioner maha robic we will get back
to him thank you madam chairman I wanted to get to a point back to carlson
mentioned in terms of the exposure of infant's the final rule materials do
consistently represent that infants and children's exposure generally greater
than their parents exposure and what's mentioned throughout the materials are
two or three times is that correct correct thank you
then I wonder why that wasn't represented in the original chap results
twice as many pregnant women were found to be at risk in evaluating the
cumulative risk than infants in looking at the N hands o 506 when we started to
evolve to using women of a reproductive age as a surrogate we found that 3% were
at risk and infants at 5% so if infants are two to three times more susceptible
to risk then why didn't that bear out in the same data used in the same time
period etc because the it doesn't the the data does not reflect that infants
have two or three times more exposure and I know that wasn't of their parents
but two to three times did you mean specifically means specifically just
their parents or two to three times greater exposure than say for instance
pregnant women and women of a reproductive age so the the two to
threefold is again it's it's like the 29% it's based on the average exposure
that's not doesn't necessarily translate to the the percentiles or the percentage
with the hazard index of one most of these studies that we cite in in the in
in in the package are looking at just exposure and they're looking they're not
doing calculating hazard indices that that's a whole different analysis but
there is you know data with phthalates in other chemicals where
people look at parent-child pairs and Jenner on average the children do have
higher exposures as I just I'll fail to understand why that's the case when the
cumulative rest the point of the community cumulative risk is to find out
the total risk and we found that half as many infants were at we're at a higher
risk exposure than pregnant women but yet the qualitative material says that
infants are two to three times have two or three times more the exposure it
should be the opposite it should be pregnant women at ninety five and
infants at ninety and therefore there would be twice as many infants at the at
the unacceptable risk range well that's a that that's a consequence of looking
at a distribution as opposed to averages and in other point estimates and it's
also a consequence of the individual exposures at different levels because
you know the phthalate exposures you know when we say that for example if di
and P and de HP are contribute roughly the same amount to the to the risk
that's again that's an average value but each individual has a different exposure
to a different mix or exposed to phthalates at different proportions so
there's a lot of these factors which is why it it on the surface doesn't make
sense because things aren't always proportionate or things are always
linear thank you thank you very much I'm I'm not over my time a quick question on
the additionally banned phthalates staff concurs with chap's recommendation to
ban dibp DPE NPD h exp and dchp because they caused the same phthalates syndrome
effects or mr de and that is what informed the decision
the chap also concluded a dibp is as toxic as the permanently banned
DBP was the toxicity and the potency of the three permanently banned phthalates
a benchmark of what should be banned in terms of the additionally banned
phthalates was a big Sun was it based on do they have to be of high toxicity and
high potency such as what the chap described in relating dibp - DBP no I
think they're just saying that by the way these are as potent as the other
permanently banned ones all of them are just that one well actually the the the
dye pintle is yeah I think that's even more potent than than the others I think
that's the most potent one is that right of the four yeah okay so it so it had
something information about the potency of dibp and you're testifying now that
de MP is a highly is actually more potent more potent even actually would
you consider D H exp and dchp to be highly potent I think they're roughly
the same as de HP and in DB p and dibp okay were there any phthalates that
demonstrated mr de were any phthalates not banned or recommended
sorry recommend it to be banned that demonstate demonstrate mr d apologized
to me yep german times i it's as far as we're aware those are the ones that are
anti-angiogenic and that caused these effects there may be others but that's
but we do know well thank you very much dr. Babbage I apologise chairman Thank
You commissioner Adler no questions at this time thank you acting commissioner
harvick madam chairman the the chap decided on five phthalates to contribute
to the cumulative risk assessment de HP de HB di NPD BP b BP and dibp now I
recognize that in the EPA study the EPA's
looked at the same five is was that the basis of the chaps decision in terms of
you know what what phthalates are we going to quantify H cues to contribute
to the CRA was it based on the EPA report or some other some other ret
rationale for selecting those five mr de active phthalates well it's not based on
any single report as explained in the chap report the NPR in probably this
briefing package they looked for does it call the chap consider does it cause
these mr de effects and is there biomonitoring data in that that was okay
it was the combination of the two because it doesn't biomonitoring data
then okay so that gets my next choice so the the other phthalates that are
suggested for band that were not part of the cumulative risk assessment so that
then the 3r d PE NP d h exp dchp they have been shown to cause phthalates
syndrome mr de but is that the problem that in the end haynes data did not have
a human by biomonitoring data on those particular phthalates for them to be
contributing included in the cumulative risk assessment all right I mean in
Haynes can't test for everything agree uh they say that they can detect the pen
tool but it's not part of their routine assay and the I think the dchp
may have been dropped I mean it was in some cycles I think they dropped it
because it was the exposures you know it wasn't detected as often as the others
okay either because it wasn't detected or
there wasn't the human bio monitoring well I think they dropped it from this
dchp they draw I think they in Haynes dropped it because they didn't see it in
as many people as the other thises in Haines dropped it not the chap and right
right right okay the reason I the reason I was I was exploring that is because
some of these some of these values contributing to the
are very small some of the samples that are found at very very close to one and
if we had other phthalates that demonstrate mr de that's why I wanted to
know definitively because if we had human bio monitoring
data perhaps they would have pushed some subject you know there could be other
phthalates that would raise the hazard index a little bit there we know it's in
the chat report that there are other kinds of chemicals that also contribute
to mr de and they're not part of just because of the fact that they are not
phthalates and they're not they were not measured in the same people so that's
why the chap had to treat them a little bit differently understand completely
thank you madam chairman I have no further questions but I do absolutely
want to thank that staff or the depth the professionalism the quality of your
answers they were important to me and I appreciated your patience and coming
back to answer my question so thank you very much thank you
colleagues also for your patience and putting up with me Thank You
Commissioner Commissioner Adler to have any additional questions I just want to
join in thanking the staff again for their incredibly thoughtful answers the
in-depth work you've done and just for your endurance for sitting here today
again thank you from the bottom of my heart
mr. Kay thank you madam chair I'm gonna have to test that endurance just a teeny
bit more dr. babbit because there's something that Commissioner motor avec
had asked you about earlier that I couldn't figure out what was going on
and trying to understand it for myself and he was talking about the difference
between the 99th percentile in the 95th percentile do you recall that
conversation a little bit yes so what I would like to understand is and I think
maybe you can help me tease it out it seems that there's a difference between
the 95th percentile the 99th percentile and saying that 95% of women of a
reproductive age have an H i below one and 5% have an h i above money following
me so far and similarly there's a difference between saying
99th percentile and 99% of women of a reproductive age of nhi below 1 and 1%
have an H I above 1 correct well that's I think we're getting into the realm of
the statisticians but those are two different concepts correct it to talk
about actual numbers between 95 percent of women not having an H I above one and
five percent having that's different than talking about the 95th percentile
for instance in the way the chap talked about it and in in fact it says in the
briefing package somewhere staff notes that while the chap presented the
distribution statistics described above meaning 50th 95th 99 the chap focused on
the proportion of the population with H eyes exceeding one not only particular
percentile of the distribution in other words those again the 95th 99th are you
you got to report something and and that's consistent with how other people
report data like this but that doesn't necessarily mean that we're regulating
at the 95th or the 99th correct and that was actually the point that I wanted to
make that ultimately as I understand it in the NP R we didn't say that we're
regulating at the 95th percentile what we said is that we find that a 5% of
women of a reproductive age have an H I over one that does not constitute a
reasonable certainty of no harm with an adequate safety margin and similarly we
could can be consistent with that and say even if a smaller group than that
based on later n same data let's say you go from 5% to 1% that still as a policy
matter can still qualify as not being a reasonable certainty of no harm does
that make sense well it's exactly what our intention was and I think perhaps
some commenters misinterpreted that but it was not not our intention to do that
it's exactly we were not saying that 90 by any means saying that 90
I percent is as far as we're going to go you could say that it's week but sort of
a minimum that we could go higher but you know we didn't say that was it and I
think that and you can tell me if you're wrong I think what you're saying is that
while five percent of the women of reproductive age and that survey is was
enough to trigger no reasonable certainty or reasonable certainty of no
harm meaning it didn't meet that threshold that that what you weren't
saying that was the line for it you were saying and and dr. Carlson you're
nodding I assume that you're saying that's in the affirmative you agree with
me that with that was never saying that was the cutoff writing that ultimately
it is a policy call for the Commission and nobody should have read that into it
and that the Commission still has that latitude to find as we may or may not
that 1% of women out of that sample also doesn't provide a reasonable certainty
of no harm so that makes sense okay great thank you no more questions Thank
You commissioner thank you madam chairman to continue this and it's not
to get the last word Commissioner Kay because I think it's important in the
NPR as well as in the testimony and I would recommend many people to go back
and watch that those two December hearings and decisional meetings we
based a rule on women of a reap 5% of women of a reproductive age in the US
population because the number was big enough that we could say with
statistical accuracy and validity these results from these tests are
extrapolated out we could say with confidence it represents 5% of women of
a reproductive age and that is a significant number the point that I'm
trying to draw here with these numbers being so small is that we can't even say
1% we're not saying based on 1% of us women of a reproductive age in the u.s.
population the notes numbers are so small we can't even say that with any
consistency sure we can say it was two in case three and it was nine in case
two and it was three in case one but we can't
say anything about what that means to the US population I would imagine that's
what this commission is really going to be making decisions on what's going on
what can we learn and derive in terms of the US population that were charged to
to protect so that is the the significant difference here and as you
heard from our statistician coming in saying those those numbers are so
unstable that they provide no confidence and the estimates are uh not reliable
it's obvious I'm happy to yell please I think that we've now moved into what
we'll certainly be discussing at length in the decisional next week and it's a
good preview but hopefully if we don't have any more questions we can put
everybody out of their misery but I'm ready to continue this discussion with
you next week and I'm sure in the interim thank you mr. Adler thank you I
believe all of the questions are completed again thank you to dr. Babbage
dr. Carlson and mr. de Matteo and to all of the staff who stayed behind in the
rows behind the steering table thanks for your patience in your diligence and
we do appreciate all the work that has gone into this package and no doubt we
all are looking forward to next week's decisional with that we will end this
briefing Consumer Product Safety Commission