Chronic Hazard Advisory Panel: Phthalates Part 5

Chronic Hazard Advisory Panel: Phthalates Part 5


Good morning and welcome back to the
seventh chap meeting just repeat the message that this is a public meeting it’s being
webcast and recorded bill okay why don’t they talk about the schedule for the
rest of our existence as a chap here we are
February 17th Chaput coming to a conclusion and we’re getting down to the
point where we’re putting together the report and I think we’re making great
progress my thought was that and we attentively said we were going to
have something for the external reviewers by March 1st I think that’s
now not realistic particularly given the fact that Bern is not able to be with us
so I my thought was if if we gave ourselves as a committee another month
to do the revisions to do the additional writing assignments does that is that
sufficient first and then if we got those documents together the revisions
and the additional writings we could share those by email or we could if
necessary have another chat discuss issues but the idea would be then to
have a report ready for the external reviewers by April 15th and then they
would have a month who do their review and return it to us by by May 15th and
the idea would be for us and again this would be I think by email to respond to
those reviewers comments I think we could do this by email we all did that
by track changes to to Mike we should be able to to finalize the document and
again if if there were issues that were so important that we needed to meet as a
group I guess we could do that but yeah the goal would be then to have a report
to see a CPSC by June 15th this sounds very sensible to me and I I think I
would say personally I can bug to that can we be explicit the the deadline the
original one for getting the material to the peer reviewers was 1st of March so
you’re suggesting to put this back to 1st of April April 15th April 15th yes
yeah April 15th to send out to get it ready for the reviewers to yeah fine
lovely thank you that also takes that out beyond the SOT meeting so that
doesn’t interfere with their review because I know some of them are going to
that meeting and you’re saying that we wouldn’t get together again unless need
be and that would be hey well we could get together before we send out the
report to the reviewers if it was felt necessary do you think at this point
given where we are today that we would need another chat meeting before we send
out the report to the reviewers I don’t feel that we would need that I agree
I think we can do it by email yeah that’s my sense very much more efficient
user then we can reserve judgment remain needs need another one I’ve had yeah I
would be much more inclined it reason that respond to the reviewers yeah yeah
cuz we may get some real interesting comments we don’t know if this Begum III
I agree with that plan okay what happened okay I’ll I’ll send out an
email with that schedule then to you oh okay well let’s
could we just capture that a little bit if we they have it to the peer review
okay March 17th then revisions and all writing
assignments would be due to you that what that would be March 17th 17th okay
and then the peer review and then those would be distributed to everyone and
then a final I guess a penultimate yeah draft would be put together and
circulated among us we do final edits and if a report would go out to the
reviewers April 15th okay that would be bad back maybe
there’s the high schools protesting they have signs that say honk if you want
peace you walk if you don’t be silent the May 15th or report would go to the
review or come back from the reviewers and then we would have a month to
respond to reviewers and put together the final report sounds good and now that’s going to
require from me than a letter to you requesting it I think yeah that’s what
I’m told is is a letter from the chairman asking for a an extension okay any questions or comments about this
scheduled hearing none then let us proceed with the recommendations for the
phthalates substitutes and Mike are we going to have hard copies are we just
about the hard copies are coming shortly okay so we’ll start with okay this
reading from the screen okay and the first one is TX IB so again these we just have summary
reports for these correct right well there there are toxicity reviews for all
of the game this one was prepared by us the other five were prepared by verse
our well that is difficult these studies are
not published there’s no way to examine their quality
and there’s this ominous sentence there changes in epididymal and testicular
sperm counts were reported by the authors but considered not to be adverse
what does that mean well this is in one of those study it’s in the category of
we don’t have the actual study you have a summary and worse yet it’s high
exposure and well he I don’t know if you’re ready to scroll down yet but the
xib was we found it in a fair number of the toys that we tested it’s not a
plasticizer exactly it’s uh I think it’s used to reduce the viscosity but it’s
it’s present in a lot of things it’s it’s found a lot of products it’s found
in indoor air so there there are exposures other than from toys other than that we really don’t know
anything about its potential toxicity well let’s look at this part this material is in a variety locations
for exposure but we don’t have enough data to talk about the weight of
evidence or the true hazard of this compound now in you know this statement
this is desert you know it’s a drafted I don’t think this is yeah the chaps
wording so what’s written down and the experimental design seems to suggest
that our serious deficiencies in these Eastman studies if I understand this
correctly what does GL mean as we put it into GL
GL is guideline GLP I guess oh yeah the OECD L that guideline yeah all right so this is not a comment on
the Eastman studies it’s a comment on guideline four to one
yeah and actually I think this is from this might be from something Bern wrote
that actually yeah could sounds like something he would ya put in there limited information on toxicity we have
limited information on exposure both from the external side and we have no
information from internal exposures so we can’t make a determination or
anything at this point in time and as it says here that you know it’s been found
in well it says 50 percent of living or you know living rooms and bedrooms I’m
not sure if that of that it’s maybe dust particles yeah it does bar I know we
found we found it here and we were studying something else I mean T XIV was
there in in indoor air I think it was so you know there are other sources I think
it’s used in paints or something other kinds of products and we did see it a
fair number of the of the toys I think more more than I expected remind me
again the gestation days that are important this has 21 to 23 days that
too late well spotted that’s two like yeah at this point we just don’t have
any information well it’s too late for or not the right
period for anti and Renick effectors appropriate for other developmental
landmarks but not you know I’m not sure these were probably done a while back then you see from the chemical structure
or the identity of the chemical we have to broaden our mind here it’s not
necessarily that we expect an T and Renick effects it’s it’s yeah I mean
it’s not a it’s who knows it’s not Valley yeah we supposed to say something
well or see that can’t say something I don’t think we can’t but I really would
like to complain okay we’re saying it’s not a phthalates
we’re saying it is a phallic substitute in air dust there we all exposed to it
and we don’t know anything about it we’re gonna find some more of that this
morning too so but the point is I hate to just say oh we can’t say anything
about it if we can it’s really frustrating boys let’s do
the part see first and then we can one Oh regarding risk we could say oh no
unknown unqualified obviously there is an exposure right that’s well we don’t
know if it’s i we just know it’s exposure is there 60 percent of bedrooms
but there could be a little bit of stuff in 60% of beverages and we don’t know
what the endpoint health endpoint to hear that to have to exhume assume
exposures exposure well we know we know the incidence is there prevalence I’d
say yes better all right we don’t know the incidence we missed
prevalent prevalent but we don’t know whether it’s high whether it’s low
whether it’s transient whether it’s consistent it’s just like with the
toxicology we don’t have enough information to make a judgment on either
the hazard or the exposure to quantify risk we have neither model data no nor
biomonitoring data to quantify is what can we recommend we can
recommend nothing we can’t recommend anything they we should say that and
then add a clause saying that that does not mean an endorsement of this
substance for use in toys I don’t know what can we say it says that we need to
have tests done to before things like this happen I mean why the hell are we
dealing with this after the fact again you know we’ve looked at what 15 14
substances some of which are banned some which are not banned all of which have
come to our attention because they were in products and we have to make a
decision the fact that there is no product testing for exposure before you
put this into into commerce is to me negligence and I don’t know whose claim
it is it’s at EPA is an industry I have no clue but it is not the right way to
go I couldn’t agree more but books open to us in terms of options can we can we
recommend testing oh I don’t know it was in our remit we had some we had some
verbiage for some of the phthalates in terms of what thank you you could put it
very clearly the chaps on the chap is unable to make a recommendation due to
the lack of of published information or data on peer-reviewed peer-reviewed on
exposure and hazard yes but and then there’ll be another sentence after that
in terms of I think we had somewhere with one of the I think we had some
verbage that did follow that in terms of us because if you just say chop is
unable to come to any assessment then you know some people might say thank God
for that that’s right no no but I’m able to because of the lack of the data and
then you go on and write another sentence or two well the sentence should
be basically this is that this doesn’t mean that is an endorsement of this
chemical we’re saying that the appropriate organisations have to now
conduct the toxicity and exposure assessments to ensure that this would be
safe in children’s toys or it’s allowed in each horse toys yeah before either
before or maintain don’t know I don’t know if it
is until you put one concrete thing that the Commission can do is be it’s very
simple we can nominate it to the NTP for testing but the first thing that they
will ask is if it’s is it a commercial product in you know if is there a
possibility that the manufacturer would do these testing I mean you know they
won’t test something if they think that the there’s a likelihood that the
manufacturer will or the ante sugar or something but an AP is only part of the
issue because it deals with the hazard side yeah we have no idea what the
exposure issue is at this point we know that there’s prevalence we don’t have
presence is it this level or at that level and whether we are doing with de
minimis exposures and then des ministres risk or we’re dealing with something
that may have a quantifiable outcome we basically may have an unintended
consequence situation where we may have a you know a no consequence situation
but we don’t have the data to prove it one more any other if any idea whether
our previous recommendation might have an influence on future exposure levels
for their substance right we we have no idea are you asking so based on our
recommendations on the other chemicals is this chemical gonna be used in
substitution we don’t know what the plan is what it would substitute for don’t
even know because as my obviously it’s not its primary use is not as a
plasticizer but there’s something like a chelating agent or well I they call it
some sort of an additive or modifier I think someone told me it’s it reduces
the viscosity and especially in products where you need fine details and I think
possibly as they’re going to different kinds of plasticizers maybe they need
this to make the other plasticizers work and there might be some you know the
manufacturer probably tell us more about it some of the technical people we could
we can ask the point you just made is reasonable it’s just that we don’t have
enough information to decide how to proceed on this substance it’s not that
I’m saying that substance is bad or not bad it’s just without information we
don’t know how to deal with it you want to start coming up with some
text for the risk we did that but we need to start putting it on the screen something like it we have to exhume
assume exposures or would you put it inverts I think you have Bossier data the true in general that
children that toddlers are exposed to chemicals that are in dust more than
because they’re down in the floor playing around we call them the Rugrats
so the children are at the most risk of chemicals like this that are present in
Dawn’s dust you mean prove that I’ve done what multiple studies on that issue
in demonstrating clearly that the Rugrats are highest risk to materials
that are deposited in Rohtak for two reasons one the rug is a great reservoir
it’s a great reservoir for everything from peanut butter and jelly to is there
other materials multiplier can you say it’s twice as exposures twice as high it
depends upon how long the material has been in there like if you have a
material has been there a long long time you can have very large quantities and
it’s been a short period of time small quantities in other cases you know
that’s you give a range roughly it can be a factor of 2 to 20 you know it’s it
just depends upon the camera lead is our classic example where it can be
astronomical because of the fact that it’s in places where we find lead paint
you know flaking off of walls and tracking in lead paint from yards and
street dust you clearly get a high concentration so why don’t we let our
children be the guinea pigs on this I mean this is outrageous to me the
company needs to hold be responsible to show toxicity data for these chemicals
well an EPA knows all about these dust so where are they in this all is I mean
it’s it’s it’s a multitude of of errors here um this is the migration data that
we have for the plasticizers that we found in toys I mean this is TXI B it’s
it’s generally president lower levels than the other phthalates but you can
see the curve of this is the plasticizer concentration
down here in the migration rate the curve the curve is steeper but it’s the
migration rates are about the same because it’s usually it’s always present
with another plasticizer but we have data for TX I be a TBC D’Oench in de HT
the terephthalate eh T is the is a an isomer of de HP how can can you see that sorry I’m Mike explain to me the
migration you’re saying into saliva is that right well this is a this is
migration and to simulated saliva using a test that was developed by the
European Commission it’s a simulation but this is used to estimate exposure
from mouthing toys teethers and toys that kind of thing and so this is this
is di NP and ditch is very similar these others are a little bit higher but
overall but its course depends on concentration and overall the I mean the
absolute magnitude of the migration is probably about the same for T XIV as the
others because it’s not used alone but you know it shows that my exposure for
mouthing does occur and that we can estimate the magnitude of that exposure but what we don’t you know but really in
that case what’s lacking is the hazard information and this is just a pie chart
I mean T xib was present in you know say 15 percent of the things that we tested
just a sort of a grab sample but this is what we have essentially on exposure
for the substitutes when was this done Mike this was done in 2010 oh yeah about
these samples a month or two before the new regulations went into effect we were
going to do a four before and after but I mean there was only two
phthalates that we saw so we did never follow it up and of those two phthalates
one of them is actually allowed because it’s it was a toy that can’t fit in it
the DI NP is in a bigger rubber ball and it will can’t fit the kids mouth yeah
which is fine understandable and the de HP was some I
some kind of toy that or some product at the time I guess in the pasty it was
outside the scope of the products that we were considering there any way to get more information
from Eastman Chemical about this 2001 study where they say that they observed
well I think it’s the similar situation with D’Oench is that they have the data
they’re willing to share it but they don’t want it to become public this is
my understanding I think it’s it’s essentially in the same boat as those
other chemicals and you know the chap talked about this at the early meetings
in about transparency and so on and it’s you know it’s a decision look at the FDA
model of companies coming and showing data I mean it’s all kept confidential
yeah at least there’s a regulatory agency involved in reviewing the data I
mean could a process like that be recommended by chap
maybe that’s pie in the sky but to have more transparency between the regulator
and the company otherwise it’s not a cry mean I know that’s a big deal but this
is ridiculous to let this just go on and on nicely with our children I do think
that the issue needs an airing with all parties involved to come up with a I’d
say a logical plan of action so that one the public doesn’t feel it’s at risk to
the industry feels that’s got a fair hearing to get things done and three we
the scientists can sit and evaluate the data in such a way that we can come up
with or concrete conclusions at times rather than being in the position we are
today this is a much broader issue than just what we’re dealing with today it’s
a very major I realize that I realize that but I’m what I’m trying to say is
you know it’s not acceptable to me for this to keep going on like this if the
if the company’s doing studies we have no way of evaluating the quality of the
studies but and in my ranking I would much prefer them having the opportunity
to come talk to a regular body than for us to have transparency
right well I’m obviously the model is different for things like drugs in drugs
and pesticides it’s a very different model in in that case the government
couldn’t demand a whole list of studies and they have control over that but the
data are kept confidential and that’s one model I mean the way we’ve always
done it here is to have it all public but obviously there are disadvantages to
that and you know this this proceeding is not a routine regulatory process like
a pesticide registration or something like that this kind of a process maybe
does need to be much more transparent and like something like reach
registration or or you know Tosca notice I mean it’s it’s a complicated issue i I
think it is broader it’s a lot broader than the chap in just CPSC and I don’t
know the answers or the best way to do do this but I think we have I don’t
think there’s a an overarching system I mean we have the different agencies and
the different responsibilities well I would propose that we write in a
strongest language as possible and I report a recommendation for some sort of
a change in process and you know Lobby that to Congress because it’s ridiculous
that this keeps going on and on environmental chemicals are here to stay
and we need to have regulatory you know yeah I would suggest a minute I think
you’re all agreeing that we go back and draft some text recommendation section I
just already did for the broader scope stuff from yesterday from
you know uncertainty in gaps and all this stuff is captured in it I just more
forcefully add a few more words to deal with Chris’s comments because I think
we’ve got a pathetically another way of doing this but I know whether we’re
overstepping our mark but hypothetically we could say an interim ban until data
are provided I don’t think I would it’s a stimulus it’s an incentive I don’t
think I’ll hold up hold up what nobody’s gonna be able I’m just saying look I
don’t want to look foolish to make a point but I wanna make more emendation
song Paul we’re only making recommendations I mean CPSC is the one
that’s gonna make the decision to either go with that recommendation or not but
we have to have a reason well we’re gonna give it I mean being unknown
doesn’t necessarily mean it’s a reason it could be a reasonable that’s not the
reason the reason is the lack of data and the fact there has to be data before
we can make a decision and until that time there has to be a ban problem is
though we like our plastics yeah you know I you know so I don’t want to get
rid of all you know I like the things I have that are plastic but I also don’t
want my children exposed to this crap and that’s the bottom line
if it’s bad stuff get rid of it you know if it’s good stuff show us it’s good
right but I don’t want to end up in the courts with somebody saying well it’s
good versus bad and an old concept of what we want to have done is lost right
that that’s the problem I see if we want a college I’ll point it out we’re
practically dealing with a situation where to use this analogy where someone
starts flying an aeroplane takes off and the airport at the other end isn’t built
yet so got clever pilots I don’t know I I don’t
have any answer to this it’s from something that’s it’s struggled with for
years because Tosca doesn’t cover this issue either
it covers rural chemicals and it’s it’s a conundrum but looking at the states
are given here I think we have to be aware that the exposure the relevant
exposure for the children and the pregnant mothers might be higher to
these substances than the delights we investigated yesterday but we don’t know
if it’s in kids toys obviously it’s there no it’s in the dust
no no boys I know it’s in the toys but it’s probably I think the data does show
it’s there I mean if you’re not using a B and C and now you’re using x y&z
mm-hmm no yesterday you said most of the flights are not relevant for toys now we
have the case that these substances are obviously of relevance for toys I don’t
know the kind of thing we would I maybe it’s too late in the game to even
entertain this thought but is this the kind of thing where we could request and
for make more information from Eastman to review and if it’s not up to our you
know if we can’t get enough information from that then we would ban it well I
think in concept for practical reasons I mean I I don’t know some of these
studies can be very voluminous so at this time depending on how many pages
there are it might be too late for that and it’s the issue I think you know it
we’ve had the same discussions with bas in there willing to share the data as
long as it’s kept confidential I mean they’re they’re open to to something
like that and they have been but it’s but it wouldn’t it likely would not be
public the actual studies probably would not be public obviously it is it is to
do with a with a structural or systemic problem here in the legislation and I
mean what I what I floated hypothetically this idea of of proposing
an interim ban in these cases may indeed look out of place in the sense that here
the chap tail tries to wiggle the entire big dog off of that big problem yeah it
may may indeed look out of place but yeah I think you I don’t know what do
you think about that I think if we make a strong statement about the need for
research bold flashing lights neon lights I think it I think it would give
enough attention yeah well it will be without any consequence yeah it’s just
it kicks it down the road we’ve said it bla bla bla but we don’t know what we’re
kicking down the road that’s the issue where are we kicking down the road
something that is a serious problem we’re a non-problem I mean I don’t want
to be in a position where two years and now they becomes a non probable problem
and then we’ve kicked something down the road which we shouldn’t even touched
well just I mean Tosca reform I think has been on Congress’s agenda for the
last couple of congresses and you know it’s it’s a huge it would be a huge
undertaking what about if we asked if Phil could go talk to Congress I know I think it’s a bit okay but it is
a much bigger much broader I mean that the scope of this chap is incredibly
broad in but to talk about these kinds of issues is is is a much broader in
much higher you know in clearly when Congress gave us this mandate there was
great concern about phthalates and by extension the substitutes they wanted us
to look at everything and what is the the most effective way that we as a
committee can transmit our concern concerns if we have any to them is it by
just saying that for this kind of a chemical that we have concerns because
we can’t interpret the significance of the limited data we have and we’re very
concerned about the fact that there’s a lack of critical data that we need to
make a informed decision and that’s all we say or do we want to buttress that by
saying because of that we feel we have to recommend interim banned until those
concerns are addressed that’s that’s that’s the question we have to answer I
could relate to that but that and that puts the burden on the companies which
may be where it should be but I think that I think what’s we’re really seeing
is the process is broken it needs to be reformed and and that’s not just the
company’s problem that’s the whole system that’s the system maybe it would
look out of place if these were sort of small potato chemicals but some of them
really high production volume things it’s not small potatoes I don’t know
which will give us more realistic attention if we propose a banal
obscenities goes on the lament about the Tosca reform etc etc feels a little like
barking at the moon oh sure I wouldn’t want to put that in but us I’m not
suggesting to to put that in but but a lot of the comments that were made I
mean I can’t detect a political will here to reform Tosca at the moment so it
is a little fields like barking at the moon so I to Philips way of looking at
it the only option open to us if we take this responsibly is to indeed say
interim bonds until data are available have the option of for some of these
chemicals not having the the transparency can we can we
I mean I mean it’s up to the chap you discuss this at the first couple of
meetings especially I think the second meeting way back yeah and you know it’s
it’s really it’s up to you seems to me we have a small window of
opportunity that you know with at least the threat of a band we might have an
opportunity to communicate with the different manufacturers and what we see
we’re not happy with in terms of toxicity then we’ll know what but if the
chemical is in fact safe enough I don’t know how we can do this I’m reluctant I
really am because I don’t know what I haven’t got plan of action beyond it and
I don’t know what we’re what we’re the landmines are at all or even to consider
a set of steps next steps if we recommend it but the case as put by
Chris and by Phil well there is some the arguments carry some force these are
high production volume chemicals so if you’re uncomfortable with this
can you put some rational arguments on the table why you’re uncomfortable or is
it just a feeling just a feeling I emotion hmm it’s hard it’s hard to
quantify I mean the point is is that it’s there are so many other issues
beyond this chap that one has to deal with in this particular case regulations
of other agencies there are other other regulatory bodies there’s the whole
process of how one gets things to market which are so confusing when you’re
dealing with consumer products that I don’t really don’t really feel that I
have enough background put too much an intellectual decision at this point but
we’re not tasked with that are our charge is to make recommendations in
terms of actions and bans interim bans and what goes on after our reports
written and the processes and market forces and industry excetera is
not something we can control or something that’s in our charge to
consider we’re to consider exposure hazard risk exactly make a decision and
I seems to me the worst thing is if these products get into high volume per
ton you know continue in high volume production and our children are at risk
I mean that’s an opportunity made to see what we’re dealing but I think we are
owed down what what our charge is which is what we did yesterday we went through
you know exposure hazard risk make a recommendation realizing that it’s
really complex as as Paul was mentioning you know what if we do make you know a
recommendation for an interim ban there’s there’s no other alternatives
potentially to replace these chemicals so nothing may happen or you know
whatever in terms of you know the Congress’s view or industry’s view but I
think we should ignore that and focus on what our charge is and what we’re asked
to do in terms of where our expertise is it’s not in understanding Congress or
tosco reform etc but it’s hazard exposure risk make a recommendation
because I think if we try to couch what our recommendations are and then think
about how it’s going to be used or the political system you know etc we we
can’t predict that and we probably shouldn’t be doing that as scientists we
should be focusing on the data at hand so for the lack of data at hand and that
in this case yes do you be comfortable with that approach in terms of how we
make our recommendations in that’s always the best approach
it’s just right now I I’m struggling with a recommendation of banning interim
ban at this point because I’m so it’s terrible there’s so little information but that’s that’s not anything that is
is part of our that we can respond to I mean we don’t control that it’s not part
of our charge or a right he’s you know is like hypotheticals and you know to
almost be like you know we were invited as an expert panel to Ruth to view these
chemicals and this is all completely hypothetical may sound ridiculous but
you know in terms of hazard exposure risk and we were asked to do this in you
know a vacuum of system you know another country or another civilization where we
have we shouldn’t have any regard for what’s next in terms of how that data is
used but we’re just asked to focus on science the the data or the lack of data
and the hazard exposure and risk all right oh I’m going to compromise I’m
going to go to the issue that we could propose it this but if the Commission
means that what you mean by this this idea of proposing an interim ban all
right I’m going to do that as long as something’s written in a proviso as a
provider that if in fact the Commission doesn’t agree with the need for the
desire to have this interim ban they must they must ensure that data is
collected before the next time a chap is convened on these issues to ensure that
the data is available to make an adequate risk assessment I’m willing to
go for a ban but I need to have that other statement because I just don’t
want it to sit there yeah but yeah again I think we can recommend that but but
the word must time yet think we have that well are we’re we’re
recommending an interim banned because there’s no data right we can say that
they must initiate an interim ban we can just recommend that they do and we can
recommend as well that they do what you ask but we can’t all right words the
wording will wordsmith it but if you’re willing to do it with those two concepts
in mind I’m going to do I think that’s perfectly reasonable then we’ve done
that same thing in our wording for some of the other phthalates as I remember we
encourage the relevant agencies to when we try to but this is much just to be my
word longer my can we go up to one of the phthalates where we recommend an
interim ban but we also asked made a statement to the effect that we
encourage the relevant agencies to georgia ii keep my brother wait wording
i think we also have to consider that we have to be consistent with if the
approaches for some of the other states we discussed yesterday like the NOP and
di DP because looking at the data apart from the anterior antigenic effect we
don’t have much more data for these substances either and we kind of said
well they are all of this window of activity so there’s minimal reason for
concern in this respect here inside the window the question we don’t know but we
don’t have much other data for the other so we have to be consistent if the
approach we go but I think what Chris said before it’s important is that here
there is exposure you know then the other instance that weren’t so I don’t
see that it’s equivalent here there is an exposure but we don’t know
have to assume the same exposure when we lift the pen for these substances so in
a couple of years time it might be the IDP and the NOP again on the on the list
in the pie chart yes it was the one before that thing
called ER what you’re saying is in terms of the the hazard the requirements or
what we interim baskets gestured a relative and relevant and consistent
statement about with today encourage the relevant agencies are you giving me a headache but I would
propose that I would propose I also have a look what I wrote for the NLP and di D
P what just for consistency check because let’s go to issue yeah that’s
what I was wrong look into well I think the immediate difference that leaps to
the eye here is that a couple of these substances indeed are not currently used
in toys and that’s a big difference just the point I was making but if you
propose to lift the inner in ban they can be used again we have the same
situation as for the substitutes we are talking about the day yeah and the
recommendation for this one was was tending very differently from the one
we’re contemplating here which was this last sentence is however there is no
evidence for of anti anti training if it’s FX observed with some other than
aids or are you suggesting that we’re better D to deal with chemicals we know
something about than chemicals we don’t know anything about is that what your
point is yeah I I think I agree with Olga we need to take care of this and
make sure we’re consistent can subpoena I try that one I’m not sure
which one it is that it’s the next one was one year the beginning yeah there it is yeah like this is DBP but
that had some wording that was LD DBP was probably better I mean Oh does that statement there chap
recommends that US agency responsible for dealing with this case TXI be
modified that would that that be a statement that would end to address your
concerns I would say that not only other agencies but also CPSC including well I
think that in this case it would be including it would be including CPS a
say modifying it with that that would help if we could copy that because the
reason why is because the fact we don’t know who is in this particular we
wouldn’t know whether it’s the dust from toys whatever
it’s the highest exposure so CPSC has to be part of the equation in this instance
I was thinking of the other statement the one who down below one above that
one whoops we lost you which one we talking about now for the articles and
to go back to the did you did you cut and you’re gonna paste it
oh I you haven’t tasted it yet I did paste but not they’re not the one we
were not the right one oh wait so that the chap recommends right here yeah modify yet appropriately exposures would be primarily concerned
would be I think I probably just leave it at exposures or even dat XIV or who
have jurisdiction I’m not just that you have to conduct
the research I mean that’s what we’re missing here is research conduct the
necessary research that would support risk assessment report hazard assessment
exposure assessment and then ultimately the risk assessment right because right
now we’re just living in the dark it’s a Cerie research or research work
as an assessment and exposure assessment necessary or wherever is for risk
assessments to support risk management decisions yeah that’s awkward but yeah I
know but we can always modify that I don’t like to whit the view to support
is fine you mean with the view that’s in essence
what I’d like to see you know you can or even obtain valid if we use the word of
tain because not necessarily the government who would okay actually by that’s strong enough while this this resuming is gonna follow
that we recommend an Arab and interim ban that would be our opening statement
mm-hmm after we complete the risk we need to doubt what in the factors that
are of concern to us that lead to our recommendation so let’s start doing that
well first of all there are exposures in the real environment and that CPSC has
found this comp this material in children’s toys xib however magnitude and extent of exposures with respect to health
outcomes is unknown and then andreas maybe you can put in a statement or
Chris on what you want to see done in toxicology help us guide you on the
exposure it’s stronger not just that it’s in the environment the bet that
it’s a proper one indoor environment in the home environment and it’s you know
even I would rate it I mean sixty percent of homes are you kidding me
that’s huge that’s a lot of things but there are a lot of things there in six
percent of the homes it’s just a matter the problem we have is gonna know the
intensity I mean that’s that’s the issue where I get a little bit concerned
because prevalence doesn’t mean a hazard but the children are exposed everything
in the dust exposure than adults yeah for everything
could you say EXO he is a frequent contaminant in the home environment
prevalent prevalent or but it we don’t know the intensity of it okay that’s
fine but a prevalent contaminant say that children could be at greater
risk we don’t know I don’t know what the risk
is that’s the issues and the dust you know I mean you mean an exposure that
greater yeah we know that because kids spend time on the much more of the time
on the floor then adults that their exposures would be higher that’s about
all we can say we can you can say that yeah if you want put that in considering
the fact considering fact that children spend
much more time in close contact to dust deposit on the floor and playing with
toys right their exposures would be higher or likely higher no they would be
higher it doesn’t mean that it they’re consequential but they’re higher is it more exposure to dirt than adults
why because they go in the backyard and they play in the dirt but doesn’t mean
that it’s toxic matter of fact that the exposures are
there it’s a matter of the quantity of the material and the duration and the
all these other parameters which determine whether or not and it made me
toxic so do you want to change would be to is higher yeah it’s higher now the
connection to the lack of toxicology data is really crucial how do you say
that well but I’m no but this Eastman 2001 study where they observe some sort
of aren’t these anti-angiogenic effects we don’t know they could be but the the
epididymal and suggesting their sperm counts yeah oh no strong statement on the need for have
research on identifying whether or not is a anti-angiogenic a hazard is
essential to clarify whether or not these exposures are anything meaningful
or inconsequential I think we should we could add that right I think that’s a
funny question here and risks up by higher additional research this also
required simultaneously require exposures to TX ib are associated with
shaded with anti-angiogenic hibbity prefix x i don’t think you want to just
limit it to anti-angiogenic right anti-angiogenic and other health effects
to to it’s necessary to determine or to assure safe use of the chemical ISM have
it really broad it’s I agree it’s can’t just for exaggerating right great we go
back to the famous unintended conscious of consequences of MTBE are associated
with a disease you adverse health effects or or put make that in or or
replace let’s say with Angie anti-angiogenic or other other health
effects before you say the sentence of additional research is required wouldn’t
you want to make a statement about the black
of data is the first two three line or two lines are about exposure and then
you need to basically say Kappas is concerned about the lack of factual that
there’s a lack of I mean but that’s a concern to us right in our making this
decision we’re right we haven’t used concern you know terminology and the
others just to keep it with us we’re not gonna use concern we’re not gonna use
concern notes chop chop notes I’m so he’s your notice
notes a lack of publicly available hazard information hazard information or
TX IV therefore very good add something though under the
recommendations just a minute and I know we’re supposed to be talking about risk
and hazard and exposure and I agree with what Russ is saying but could we add
something under recommendations that the consideration of you know some sort of
communication with the company even there may be an advantage to not having
everything in the public in order to get the information that’s needed because in
this case there have been studies done but we were unable to assess their
quality without that but the point I’m trying to get to is I think it I would
like to say something about the process the process isn’t working we’re gonna
say that in another section totally different but we repeat it time
and time again under the recommendations here as well not just a recommendation
for this chemical I understand that but that’s that I think is is one of the
biggest statements we can make and maybe that needs to be in the executive
summary or someplace I think I think that’s where it’s most I think it’s more
effective there Chris because there you know the people only read three pages
will read that they’re not gonna read over the other part of the document is
everyone happy with the risk statement as it’s written yeah I just had a few
clarifications so hazard we say unknown minimal data do not demonstrate hazard
is that correct as you know we’re basically saying that there’s lack of
data published data we’re only viewing the summary basically
do we want to say that the minimal data do not demonstrate a hazard or do we
want I don’t then because the way we registered I think why are we
recommending an interim ban because the you know the the question we have at
least about the the reproductive talks today is right but that my hazard mind
there was written months ago before our discussions today so I just want to
make sure that we don’t miss that you know in terms of the minimal data do not
demonstrate a hazard and this time that Part B Part B on yeah I wouldn’t start
our discussion I would not think so okay so I would revise that and then the
other comment I had for my CPSC where you we say it’s prevalent in the home
environment and CPSC has found this in toys mm-hmm can you put a qualifier on
that has has found this widely in toys has found this I don’t think we that’s
not known I’m just asking Mike I think it’s it’s it’s not a hard number but I
wouldn’t go that way went that way with the prevalent in the home environment so
the data suggested that you tested well we cover 4000 boys 13 I would say in
some toys or in you know 15 percent of them had of the PVC toys well a hundred
and some toys and you know maybe 30 something were PVC in 15 percent of
those had TXI be so it’s it’s it’s a soft number want to work on Part B but B just isn’t
that your point Russ that it’s difficult to evaluate with minimal data what the
hazard is but there it just doesn’t seem consistent with our discussion in the
last half hour and then to say it’s unknown but minimal data do not
demonstrate a hazard and then we’re going on to saying something much
stronger in the risk and recommendations later and even pointing out that the the
gestation window isn’t appropriate for measuring anti antigenic effects and the
study that’s reported limited data we have I would modify that just to say
minimal data available yeah that’s fine leave it at that
but the point I think to into to emphasize here is that these data do not
enable us to to make any conclusions about hazards at I indeterminate it’s in
determinant why I was concerned where we say do not demonstrate a hazard I mean
we could modify it to say minimal data available that do not allow a hazard
determination could modify it that way as well do not allow I’m okay daddy broke game we thought about this a year ago and we
had more time it seems to me that an opportunity for the chap that perhaps
we’ve missed is to be able to say there are some chemicals with data there are
chemicals without data and actually try to funnel towards chemicals that we know
something about what do you mean by funnel well I mean we you know we can’t
rank the the ballots that we seen some of them are much worse than others
use chemicals you lose the ones that we know something about that are less
hazardous set of ones that we don’t know anything about which is what we tend to
do you’re asking for logic and unfortunately it doesn’t always exist
when we’re dealing with these things we’ve seen instances where there have
been unintended consequences as views of other chemicals and it’s you know cost a
lot of money for all side these chemicals that we’re looking at now may
very well be very good chemical very safe but that’s my point they don’t know
it and so there’s no but that’s my point also Chris because that’s why I’m so
reluctant about banning something that I don’t know anything about but the fact
in absence of data do I allow a kid to stick this thing in his mouth there is
the public health conundrum with didn’t desire not to ban all chemicals move that we take a 15-minute break and
come back okay so we’ll be back at 10:20 hey way
to get a sense of from the manufacturer what other kinds of tox data that might
be available and how much and it’s something I’ll I’ll get back to with the
chap in a in a week or so I don’t know if it’s you know because of where we are
in the process like we’d have to see how much information there is and so on but
we’ll we’ll get back to the chap on that and will that be true for the other five
substitutes well as far as I know this this only applies to the TX IBS me or
the I so butyrate given what we we have here what what modifications chap like
to make if any odor do you want to modify the recommendation I think in a way we have to be more
precise about the recommendations birding I would propose would maybe like
something like you want to begin with that up at the beginning yeah okay we
begin with it yeah I would say something like tapped no I would take all the
recommend the chap does not own the use of the xip in children’s voice and child
care articles for the reasons they because of the
reasons stated above don’t even have to be don’t have to repeat it that leads I think if you started the
next sentence with a moreover that would tie that into the next sentence want to say something in the hazard
section about the fact that since this is not Bali that elf or the hazard
evaluation should be broader than just anti-androgen a city or do we do we say these criteria and
somewhere else it says here or other adverse effects up
and night I was thinking in the hazard part put up in hazard that that chap notes
that TXI be is not a phthalates per me and therefore it stacked its toxicity all they say that it’s up at the taxes
of the assessment is unclear yes that’s very good thank you
mmm-hmm can I suggest that under those
recommendations I think well at the moment this is this is rough and I’m I
really think we need to polish it more but we can’t do this now that we just
indicate in in rough English what we’re going to say it has to be polished later
I’m did the choice of words with condone it said twice probably not ideal sounds
a bit like a magisterial or something I agree I mean I think it captures the
essence of what we want to say but you can use something like does not support
these I mean something different but I don’t know what does not support I think
it should say I propose we condone that this recommendation expresses very
clearly the situation that here where we where chap sees the problem the
situation is that there’s a widely used chemical intimate use but untested and
that’s the problem yeah so can you I mean right between
moreover above and for moreover the other
statement should be made yes what was exactly what you were saying
this this is a an abundant chemical intimate use pattern high exposure
potentially but no toxicity data and no toxicity data is wrong but insufficient adequate here available or just ended you confuse that sentence if you said
the chap does not whatever the use of T XIV in children’s toys and child care
articles because T xib is an abundant chemical within him and use patterns and
potentially high exposure but inadequate toxicity data are available but then we
should go on if therefore the chap strongly recommand therefore I would
even put in strongly I have no difficulty with that strongly recommends
Mike okay so then in recommendation for interim
Barnett’s at rice they’re not made right and I think that’s a reasonable way to
go yeah this get rid of this believe it leave it in and say not applicable I think in some cases we just deleted it do you want to add another sentence to
the recommendation Andreas say don’t does this stage but button it will need
polishing but that’s edit editing and we shouldn’t waste our time with that now the female you can just copy that well
to to a degree like Mike II AJ was a chemical you did not find in there well
we didn’t see it I think we saw it in the past that’s why it was on the list
we didn’t see it this time one of the things we did notice in the food studies
is that there is exposure from food I mean the micrograms per day or higher
than the phthalates I don’t know what that means but you know there is
exposure from food because I think it is approved for use in food packaging the focus of these reports has been
based on reproductive and developmental can’t summaries in the adverse effects
section about other endpoints available oh well let’s see I know we that we the
staff did do touch review we have tax reviews available for all of these that
cover the spectrum of effects but I think what the chap has written so far
covers reproduction and development that’s largely because we’ve been
focusing on thali so for they grow for the case of substitute chemicals that
are not phthalates would it be reasonable to have a more general tox
evaluation in these sections I don’t want to ask for it do we want to talk about more general
guidelines criteria for these substitute chemicals that aren’t phthalates instead
of spending our time now on evaluating single chemicals yes especially if we’re
gonna if we agree and I’m not sure we all agree but if we agreed to ask for
additional information on the TOC studies then our review would should
consider those I think we need I think it’s a better use of our time right now
then things can be put together and make some decisions later the logic is and
you guys know more about this holder than I do that when it’s a thali we have
certain focus because it’s a ballet we know something about dollies if it’s not
a valid just focus on the anti-angiogenic effects it’s not it’s
not adequate relative criteria do we need do we need to go back to other
chemicals that aren’t phthalates and what we’ve already done
besides these substitutions other chemicals that aren’t but now that we’ve
we’ve come to an agreement well we here’s the consensus in the
panel that we’re very uncomfortable with these data gaps and having to make
recommendations in these situations and essentially the risks are indeterminate
so since we’re not tying this now with any recommendation in terms of interim
ban or whatever why but precisely I’ll be needing criteria for now we can note
these concerns every time that’s appropriate and that’s it think about it it makes sense so you’re
saying the recommendation throughout would just be we don’t have any data we
can’t make a recommendation well let’s just see what we do it requesting more
data well I think well this is yeah yeah we have data just as an example deha is
probably one of the more data rich ones and there are data this is just part of
a table on repeat dose studies so some of these do have data looks like I know
this deha there’s been two year studies so they’re they’re older studies but
they have most of them but they have been done so many of these are looks
like many of these are so and we have the reviews are done we could in a short
time summarize the non reproductive developmental data in the same format
that we have okay I mean that could be done in not probably not by noon but but
in early next week and we do have some data on the leachability of these nan Valley substitutes from toys some
studies been done by CPSC so at least we have something to work with
again it’s not totally sufficient but at least it’s something to start the
discussion yeah and here’s here’s one where the D H a there’s at least one
developmental talk study of sufficient rigor that at least at the doses that
they used at the highest dose there was no anti androgenic effect noted and it
was done at the appropriate gestational stages now that this is a summary of what we
have TX I be no I mean there is information but I you
know we don’t have the underlying studies they’ve got repeat those studies
up to 90 days I at least reproductive and developmental studies see some of the end points where they’re
noted okay all right well if you can get these
summarized for us then we can work on it big address I think let’s go back to
this point you know do we need criteria doing feel that it’s comfortable going
the wrong way we’re going with these other chemicals as we did in the past or
do we need to do something else well I think I think we were in agreement that
as with TXI B we’re going to look at production whether they were in toys and
personal care items criteria we developed there and and others if
necessary and we can certainly put those together for the other valid substitutes
and and send them around to the chap and we can develop I think recommendations excuse me I think my criteria would be
the same yeah apart from the fact that these are not phthalates so we would
need to not just focus on anti-angiogenic rates and I think the
criteria in terms of exposure and risk and our exposure hazard risk cetera will
carry forward I’m okay okay so and and I guess also if if there’s information
about exposure in terms of children if there’s migration information if there’s
great we have that for several of them and that’s gonna be in in Paul’s section
of the report Tim that’s done yep it’s already done the question is is that the question I
had before is that it’s really insufficient and that’s why I was
troubled by it before I even walked in the room this morning
so at least now we will have some data and we’ll be able to at least I think
make some reasonable judgments on the level of science we have available to us project steps in the timeline and well
the the timeline so you’re taking something out of your pocket yeah and I
will I will send this around by email but all the writing assignments that we
agreed to and for example I will I will redo the DN LP and the DI DP we will
complete the recommendations for the the thali substitutes
we will mike has done the recommendations for all the phthalates
all these things will be communicated to the chap will be due by the 17th of
March ok the recommendations for the other alternatives how are we going to
we’re gonna do that by phone call or email I think by email yeah so I’ll send
those around as soon as I can get those together and then hopefully we’ll have a
final phone call though if it’s possible to schedule it just because I think
there is value in having a discussion you want that done after we develop something to look at yeah okay we’ll do
that that would be the only way otherwise it would be not the most
productive you severe yep okay so we get the data and we can do it
on our own emails and we decide to cancel but I
think it’d be good so would that be like in early March phone call just to
confirm what we said yesterday the structure of each of these is going to
be different you’re not gonna have a bullet for every talk study in every
human study it’s gonna be a summary yes and I’ve got and I’ll do the human yep
oh and that’s another point holger you were going to provide me with
summaries of exposure okay and I don’t know Paul you were gonna provide me with
but were they the phthalate recommendations where there’s
information about exposure that was relevant to your information yeah I
thought we discussed yesterday I’ll make sure that it’s complete in each one of
the recommendations yeah you’re gonna send me anything you two things that I
did provide to Mike one was the connecting paragraph with at that table
with the nond table of inter comparison table and we’ll just have to review it
and then there was a table that was that the three or four paragraphs I sent now
both this morning and I sent you an update on this entire issue of data
sources gaps and what’s needed to go to make this a better process of that and
before before we conclude sherry fall via our general counsel wants to come
down and talk a little bit to the chap so ten minutes so I think we can do that
now Hey okay she’s on her way down cuz we have the kitchen
1130 unplugs and I won’t interrupt her when is SOT 2nd week of March okay Commerce called me for that well
we’re gonna have the it’s going to be based the conference call is going to be
about the the Thalia substitute recommendations God okay and those we
can have ready mm-hmm by the end of the month yeah Oh we’ll
send those around in that I mean do you do you want to set a date for that I have a medical issue that deal with that
week so I’m not sure so week the week of March 5th well anybody have times they
can’t meet or about March 2nd than Paul before Friday March 2nd I mean I’m Way
that mean me too about March first you see you on holiday
as well well let’s let’s just michael send out an email and we’ll get your
calendars and set up a time that way what about Friday the 16th or March yes
so that’d be just after SRT ok I can do 16 to 16 about the next week now we’re
getting too late then maybe able to do at the end of the week
of the eighth the fifth the first week before SOT but I’m not sure yet I have
to finalize a couple things I’ll just the that week of the fifth
look for other people I could do the sixth or seventh Chris Thursday six is
okay yesterday the six hmm I to be I’d only have like an 11 to 12 o’clock
window I’m the six the seventh I’d have more time in the morning just cuz I have
a student committee meeting and then a seminar on the sixth
they’d have 11 to 12 on the sixth and then pretty much any time till about two
on the seventh up all year of you’re out for that I’m not sure yet oh you were
saying maybe the eighth or ninth in the morning the end of the week may be
better for Paul no not for a hugger okay yeah I think we’ll we’ll do this by
email Mike you okay um when it whenever you ready the
role of the Commission in policy and the chap on science and I haven’t been
listening to this morning session but those in my office who have thought it
might be helpful for me to come down and talk to you about I know it’s
challenging when the science is not complete and you want more science you
always want more science but we need scientific recommendations that’s why I
took the time to write out that with regard to the substitutes with regard to
these other phthalates it’s really the Commission’s decision whether to to ban
them we don’t really have interim bana thority Congress can do that but we have
a regulatory structure that’s pretty straightforward and is driven by science
and the Commission’s looking for that science from you now if the science
isn’t there and there’s need for additional study there’s no reason you
couldn’t recommend with regard to a particular phthalates or phthalates in
particular we really just can’t give you a recommendation on that we recommend
that you continue to study it vigorously and and and in a timely manner but you
can’t really just I mean you could say whatever you feel from a policy basis
I’m not going to tell you can express your views of course you can but what
we’re really looking for is science and so I just want to you know if you have
any specific questions I know two people have to leave we can also continue this
dialogue you can send written questions I can respond written in written manner
or we could I can participate on your next conference
oh okay anything you’d like but but while you’re here now and we just
drafted a few lines I mean is it worth Mike just showing her what we wrote if
that’s become the realm in charge of because we wrote it you’re here might as
well okay what you said I think that’s where we are yet you can take more time
if you don’t want a response I’m looking but based upon what you just said I
think we’re in the same place good okay we struggled but we’re in the same place recommendation is and it’s short so
short to the point yeah uh-huh right that’s exactly where I am okay
okay I also know there was some discussion about confidential data it’s
really hard for us to do a rulemaking with not without being completely open
about science and I know you’re relying on someone
I think Shona Swan is that right some data that maybe is going to be made
public eventually as part of this and so you know we would be if we were relying
on that and didn’t make that public we’d be criticized and you know anything we
rely on we need to give the people who want to comment to us on the science the
ability to see what you relied on and respond to that and so that’s my concern
about that and I just wanted to make sure you all understood that we can
continue to wrestle with that issue but isn’t that basically because of the
Shelby Act the Shelby I’ve basically said anything used for regulations has
to be able to be reviewed by all parties a variety differently but that’s the
most recent I think regulation or congressional law that came out of that
and we we’ve made we’ve made an effort of basing our recommendations on data
published in a peer-reviewed literature and I don’t think Shana swans name was
not mentioned at all in that connection that’s published okay you know maybe the
individual values for each child a pregnant woman or not but the data is
published and more of a summary measure yeah and I think everything else to that
we’ve considered yeah thank you oh thank you bye thanks Russ so are we adjourned
you’re adjourned okay we’re adjourned thank you

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