Good morning and welcome to this public meeting the United States Consumer
Product Safety Commission we have one item on our agenda this morning CPSC
staff will brief the Commission on final rule prohibition of children's toys and
childcare articles containing specified phthalates the CPSC staff members
briefing us today are from my left dr. Michael Babbage who was the director of
the division of toxicology and risk assessment dr. Kent Carlson toxicologist
and mr. David DiMatteo from the office of general counsel thank you all very
much for being here and I know you are all the face of a much larger team and I
know I speak on behalf of all the commissioners and thanking you for all
of the work that's gone into this package so welcome and thank you for
being here this morning at the conclusion of the staffs briefing we
will turn to questions from the commissioners and those rounds will last
five minutes each we will now begin with the staff briefing you may go ahead
thank you good morning thank you very much for the opportunity to present this
briefing on the final rulemaking for the prohibition of children's toys and
childcare articles containing specified phthalates today we'll be covering legal
aspects of the draft final rule first and then scientific aspects of the draft
final rule including new staff analyses public commentary and final
recommendations in addition to the draft final rule the staff is recommending
that the Commission published a notice of proposed rulemaking to revise the
existing notice of requirements the NMR for the phthalates prohibitions to
reflect the requirements of the final rule the Commission is required to issue
a notice of requirements for third-party testing for any children's product
safety rule the Commission previously issued an NMR for the phthalates
prohibitions in Section 108 the NPR would revise the NORAD matéo will now
cover the legal aspects of the proposed rule
I will give you a brief overview of the law that's applicable to this rulemaking
Section 108 at the Consumer Products Safety Improvement Act of 2008 commonly
known as the CPS ia permanently prohibits any children's toys or
childcare articles that contain concentrations of more than 0.1% of DEHP
D BP or BB P and the two terms used in the permanent provision children's toy
and childcare article are defined in Section 108 as reflected on the slide
before you additionally Section 108 has a prohibits on an interim basis any
children's toy that can be placed in a child's mouth or childcare article that
contains concentrations of more than 0.1% of the InP di D P or D NOP and
again the phrase toy that can be placed in child's mouths that's being used in
and the interim prohibition is also defined in Section 108 as described on
the slide statutory prohibitions in Section 108 became effective in February
of 2009 and the interim prohibitions remain in effect until the Commission
issues a final rule determining whether to make the interim pronation
prohibitions permanent section 108 requires the Commission to appoint a
chronic hazard advisory panel known as a chap to study the effects on all
children's health of all phthalates and phthalates alternatives as used in
children's toys and childcare articles
additionally section 108 directs the chap to report the results of its
examination to the Commission not later than 180 days after completing its
examination and to recommend to the Commission whether any phalates or
phthalates alternatives other than those permanently prohibited should be
declared banned hazardous substances section 108
also requires the Commission to promulgate a final rule under Section
553 of the Administrative Procedure Act also known as the APA and this is
commonly known as a notice and comment rulemaking not later than 180 days
after the commission receives the chap report and such a one-way provides two
specific standards that apply to this particular rulemaking the first standard
requires the Commission to determine based on such chap report whether to
continue in effect the interim prohibition in order to ensure a
reasonable certainty of no harm to children pregnant women or other
susceptible individuals with an adequate margin of safety additionally a second
requirement requires the Commission to evaluate the findings and
recommendations of the chap and declare any children's product containing any
phthalates to be a banned hazardous product under Section 8 of the CPS a as
the Commission determines necessary to protect the health of children and
finally the draft final will it should the Commission approve the draft
vulnerable it would be considered a consumer product safety standard under
the Consumer Product Safety Act as directed by section 108 at the CPSIA at
this point I will turn the briefing back over to my colleague to describe the
specifics of the draft final rule I will now present a brief overview of the
scientific and technical aspects related to the final rule will be referring to
specific terms in the presentation so in order to assure a mutual understanding
of the material we wanted to provide a few definitions up front fertility is an
organisms inherent ability to produce offspring
phalates syndrome acronym TS and rats and testicular genesis syndrome tds and
humans the phthalates induce spectrum of reproductive effects that ultimately
result in the impairment of fertility male reproductive developmental effects
mr de subsets of phthalates syndrome effects that relate to developmental
changes that affect fertility anti androgenic is a subset of mr de effects
in this case caused by phthalates that relates to the impairment of an
appropriate androgen response that's important in human development and
maintenance such as reductions in testosterone production
and Haynes the National Health and Nutrition Examination Survey is a u.s.
national survey that collects chemical bio monitoring and other data on a
representative sub sample of people in the United States approximately 2,500
individuals ages 6 to 80 which includes approximately 500 women of reproductive
age laura aged 15 to 45 are present in each n Hanes data cycle and have
associated urinary phthalates samples these samples have been directly
collected by qualified medical personnel associated with n Hanes women of
reproductive age these are women aged for 15 to 45 as represented in n Hanes
datasets were uh are our surrogate population for pregnant women and staff
exposure and risk analyses risk the potential the substance such as a
phthalates to induce an adverse health effect risk can be characterized by four
phthalates by comparing the individuals estimated exposure to the level of
exposure that has been found to cause an adverse health effect or no health
effect at all risk can be expressed in terms of a hazard quotient in HQ for a
single chemical or a hazard index H I for multiple chemicals if the HQ or H I
is less than 1 the expectation is that no adverse effects will result from
exposure but if the H qrh I is greater than 1 adverse effects are possible in
blood of risk assessment or the CRA is an analysis characterization and
quantification of the combined risks to human health from multiple phthalates in
this case as mr. G Mateo described the CPS AI a required the Commission to base
their prohibition determinations and declarations on findings and
recommendations from The Chap analysis the chap first met in April 2010 and in
total the chap had seven public meetings six teleconferences and ten invited
experts to inform and discuss issues associated with phthalates hazard
exposure and risk after considering all the health effects of phthalates the
chap decided to focus on male developmental effects and
phthalate syndrome in rats phthalate syndrome has many adverse effects in
common with human testicular disjoined asus syndrome the chap also identified
that male fetuses were the most sensitive target population followed by
newborns juveniles and adults and that phalates syndrome affects induced by 5/3
deh p di NP DB p BB p & dibp were appropriate for use in accumulative risk
assessment the chap used three different approaches to determine the phthalate
syndrome hazard values or potency estimates for anti-androgen isset ii
called PS the first approach case one use hazard values from a publication by
court and camp and Faust in that publication the authors performed a
cumulative risk assessment on phthalates using phthalates syndrome endpoints the
second approach case two used relative potency values for phthalates induced
testosterone reductions from a publication by Hannah set out relative
potency values were normalized to a phthalate syndrome effect induced by de
HP the third approach case 3 involved a de novo assessment of the hazard
literature that was hazard the chap assessed exposure using two methods and
the first approach total exposure for each individual from all sources was
assessed using human bio monitoring data for five Ballet's deh PTIN PP BPD BP and
dibp by a monitoring data from in Haines was
used to estimate exposures to pregnant women and bio monitoring data from the
study for future families or SFF was used to estimate exposure to infants in
the second approach the relative contribution of various sources such as
consumer products diet and cosmetics to the overalls Bossier exposure was
modeled using hypothetical exposure activity scenarios this approach
determined that most dallied exposure to women of reproductive age infants and
toddlers was from food exposure to children's toys and childcare articles
also contributed substantially to the all total exposure for infants and
toddlers the chap used a hazard quotient and hazard index approach to estimate
the phthalate risks for each individual in an Hansen SFF data sets the chap then
used percentiles to describe the distributions of individual risk and the
proportion of individuals in the population with risks above an H I of
one to describe the magnitude of the risk in the CRA methodology the chap
determined that up to 10% of pregnant women had an H I of greater than 1 up to
5% of infant's at an H I of greater than 1 and that D ehp was the primary
contributor to the hazard index or the risk the chap then made recommendations
for certain phthalates using results from the CRA and other analyses in a
weight of evidence framework daffy would like to reiterate that the best
available phthalate exposure data for infants in the United States is from the
SFF study this study obtained urinary thalli metabolites data for paired
mother and infants from 1999 to 2005 using this data the chap determined that
approximately 5% of infant's fed an H I of greater than 1 the NPR cited this
finding and the Commission agreed that up to 5% of infant's had an HIV greater
than 1 and to reiterate the chap identified that the fetus was the most
sensitive target population regards to phthalates syndrome
sali biomonitoring data did not exist for fetuses however so pregnant women
were used as a surrogate population for exposure and wrist estimation chemical
exposures to pregnant women passed directly to the fetus through their
shared circulatory systems and Hanes over sampled pregnant women in the 2005
2006 data cycle resulting in the availability of phthalates metabolites
data for a hundred and 30 pregnant individuals these 130 individuals
represented approximately 5 million pregnant women in the United States the
number of pregnant women in 2005 2006 data cycle was sufficient to
use for the chaps exposure and risk estimations and Haines data cycles after
2005 2006 contained approximately 18 to 26 pregnant women with phthalates
metabolite data for each cycle pregnant women were therefore not used for the
staff analyses for data cycles after 2005-2006 the notice of proposed
rulemaking for phthalates was published on December 30th 2014 in the Federal
Register the proposed rule was based on findings from the cumulative risk
analysis and recommendations outlined by the chap the NPR included a request for
public comment as well in the NPR the Commission proposed to permanently
prohibit children's toys that can be placed in a child's mouth and childcare
articles containing concentrations of more than 0.1%
dicen no no phthalates di NP and also to expand the prohibition involving di NP
to encompass all children's toys the Commission also proposed to prohibit
children's toys and childcare articles containing concentrations of more than
0.1% dye pentalpha late and deep NP dye hexyl phthalates DXP dye cyclohexyl
phthalates dchp and diastole butyl phthalates dibp
the commission also proposed to lift the interim prohibition on children's toys
that can be placed in a child's mouth and childcare articles containing more
than 0.1% of dioctyl phthalate Dino pee and dye so daesil phthalates di DP
following publication of the NPRM 2014 staff followed the commission's
direction to analyze newer Ann Haynes datasets in order to determine what
current evaluate exposures were these analyses culminated in the publication
of two staff reports one in 2015 and one in 2017 both of which were published in
the Federal Register and included requests for public comment in the first
analysis published in 2015 staff estimated phthalate exposure and
risk to a woman of reproductive age for four and Hanes datasets
2005 2006 2007 2008 2009 2 ten and 2011-2012 the first analysis
replicated the chats methodology for estimating exposure and risk validated
the staffs results against the chaps results and supported using wura we had
a reproductive age as a sub population or as a surrogate for pregnant women in
the second staff analysis published in 2017 staff applied the same methods as
we used in 2015 to establish an estimate exposure and risk to women of
reproductive age using the most recent and haynes phthalate dataset from 2013
and 2014 DAF notes that because more current
Dalai date on infants does not exist in the United States staff could not
estimate current hazard index for this population in addition after the NPR
staff also reviewed the 2017 na s report that applied an EPA approach for
systematic review to three endocrine active chemical groups one of which was
the lates fj's women of reproductive age as a surrogate population for pregnant
women in order to estimate exposure and risk with Ann Haynes datasets after
2005-2006 chemical exposures were similar for the two target populations
in the chapter port and published references validating this choice of a
surrogate population 538 women of reproductive age were available in the
in Haynes 2013 2014 data set to estimate exposure and risk these 538 women of
reproductive age represented approximately 64 million women of
reproductive age in the United States as mentioned staff performed to exposure
and risk analyses using more recent and hannes datasets these data include
urinary metabolite levels for multiple phthalates for hundreds of world
individuals overall staff determined that exposure to de HP has decreased and
exposure to di NP has increased when considering the world's subpopulation
the total exposure to all fali syndrome valley
has also risen in rural the InP is less toxic illogically potent than de HP
however so the median and 95th percentile h eyes risks have decreased
over time for whooaaa the analysis also indicated that
exposures to the other three phthalates in the CRA BBP DVP and dibp
changed minimally over time half also observed that the percent of whirl with
H is less than one has increased over time for example in 2005-2006 ninety
five point eight to ninety seven point one of wura had H is less than one there
on the far left side of the table there in 2013 and 2014
ninety eight point eight to ninety nine point six percent of Worrell had H is
less than one there on the far right side of the table staff believes
therefore that for an increasing proportion of whooaaa there is a
reasonable certainty of no harm from exposure to families in addition the
staffs cumulative risk assessment shows that between two and nine were
individuals in the 2013-2014 Ann Haynes central population of five hundred and
thirty-eight Laura had H is greater than one the range of individuals with an H I
greater than one is due to the chaps choice to evaluate risk using three
different sets of toxicological values for each phthalates Pia case is one two
and three staff emphasize that there were wara individuals with an H I of
greater than one using each of the three toxicology values staff also notes that
the risk from di NP alone the HQ was greater than one four six were
individuals using one of the three sets of toxicology values that was case two
public humus public comment was requested for the NPR and for both staff
biomonitoring analyses 109 public comments were received from the general
public industry or manufacturers of phthalates of products containing
phthalates non-government organizations and yos and other stakeholders comments
from the general public and NGO is supported and criticized the NPR
comments from the industry and other stakeholders were generally opposed to
the NPR especially the proposed permanent prohibition related to di M P
several comments supported the methods and conclusions of both the chap and the
staff anti-androgen isset e public comets covered a broad range of
technical non-technical and legal topics technical comments argued that di NP is
not an anti-androgen or as much less potent and other anti-angiogenic
phthalates and as such shouldn't be included in the CRA staff disagreed with
the commenters and concluded that an overwhelming weight of the evidence dis
demonstrate that di NP can induce mr de male reproductive developmental effects
and phthalate syndrome including reductions in testosterone in animals
and that it was less potent than deh P staff concluded therefore that it was
appropriate to have di NP in the cumulative risk assessment some
commenters also argued that the rat toxicology data is not applicable to
humans or that humans are much less sensitive to sallied effects than rats
these issues were raised in support of assertions that the evidence is weak for
di NP induce phthalate syndrome effects in humans or that the estimation of
quantitative risk using the rat model is too uncertain or conservative and thus
di NP should not be included in a cumulative risk assessment staff
disagreed with commenters again and concluded that while Hugh studies
suggests that humans may be less sensitive than rodents to valid effects
the majority of empirical evidence supports the use of rats as an
appropriate model for estimating phthalates risks in human
commenters also criticized the use of human bio monitoring data for risk
assessment they argued that the data the chap used to 2005 and six data was out
of date and that the use of spot urine samples and certain methods for
estimating exposure and individuals were inappropriate to conservative or
unrealistic half noted that new staff bio monitoring reports analyzed an
Haynes data for women of reproductive age from 2005 through 2014 and thus bio
monitoring estimates of exposure our current staff disagreed with commenters
and concluded that spot urine samples were adequate for assessing exposures
from mr de induced phthalates because short-term phthalates exposures which
are reflected in a single spot urine sample have been demonstrated to induce
mr de effects some commenters also criticized the cumulative risk
assessment approach claiming that the CRA methodology used by the chap was
novel or not widely user supported by other federal agencies or at best a
screening tool and not suitable for use in regulation they have disagreed with
commenters and concluded that the chap introduced a minor improvement to the
standard CRA methodology by estimating the risk for each individual in the Ann
Haynes dataset this was done in order to avoid overestimating the risk in
addition the chaps exposure assessment based on human bio monitoring data
exceeded what the who considers the w-h-o framework considers a refined
exposure assessment because it was based on exposure measurements in actual
people staff also concluded that the CRA of chemical mixtures has been an
established practice since the 1980s and has been used to support multiple
federal regulations these determinations supported the conclusion that the CRA as
used by the chap and staff was appropriate to estimate cumulative risk
from multiple phthalates
commenters argued that the human epidemiology data drawing associations
between actual phthalates exposures and adverse outcomes such as a decreased
anogenital distances or fertility was also weak or inconsistent for phthalate
syndrome phthalates daffy disagreed with commenters and concluded that there's a
growing body of studies showing an association of phthalate exposure with
mr de effects in infants and adult males staff agreed that there is limited
evidence demonstrating cause and effect however the chaps recommendations were
primarily based on animal data and therefore did not need the epidemiology
data to conclude that the substance or mixture is probably toxic to humans
commenters also noted that di NP contributes less than de HP to the
cumulative risk and that the phthalates regulation only addressed children's
toys and child care articles and questioned how regulating phthalates in
these products could make a difference in the overall risk which is likely
primarily due through to exposure through food commenters asserted that
the proposed prohibitions were based on risk that is not in CPSC's jurisdiction
staff concluded that the contribution of di NP to the cumulative risk was
substantial and has increased since the chap completed its analysis the InP now
contributes roughly as much as de HP to the cumulative risk exposures to DB PB
BP and de HP continue to occur from multiple sources not just toys and
childcare articles and therefore also contribute to the cumulative risk that
believes that mouthing and dermal exposure to children's toys and
childcare articles could contribute up to about 89 or 29% of the total di NP
exposure to infants if phthalates were allowed in these products
some commenters argued against the proposed prohibition of children's toys
that can be placed in a child's mouth in childcare articles containing di NP and
a change in scope from the interim prohibition involving di NP to all
children's toys commenters claimed that the rationale for making this change was
weak and also inconsistent with EU echo reports on di NP staff disagreed with
commenters and concluded that mouthing and handling of toys also occurs with
toys larger that can be placed in a child's mouth and so this exposure also
contributes to the cumulative risk staff also concluded that the echo report did
not state any conclusion about whether to expand the prohibition scope to all
children's toys and there was no indication not the issue of expanding
the scope to all toys was even considered public comments allowed staff
to consider many different views on the hazard exposure risk and regulation of
children's toys and child care articles containing specified phthalates staff
considerations regarding these comments are presented in detail in the briefing
package overall staff did not find the arguments presented in any of the
technical comments substantial enough to change the way in which risk was
estimated or interpreted daffy also did not find any of the non scientific
arguments substantial enough to question the process of the chap the NP R or the
staff analyses for these reasons staff recommends finally finalizing
prohibitions involving phthalates as stated in the proposed rule except that
staff recommends adding language from section 108 C of the CPS RA
regarding application of the rule so consistent with the Commission's
proposed rule staff recommends that children's toys that can be placed in a
child's mouth and child care articles containing more than 0.1% of di NP be
permanently prohibited this recommendation is based on information
including that di NP is anti-angiogenic and has effects on other Thalys
related endpoints related to fertility the InP exposure is increasing exposure
to di NP will increase further if the prohibition is not made permanent a
quantitative risk assessment has demonstrated that from two to nine
individuals in the 2013-2014 and Hanes sample population have an H I of greater
than one and an understanding that a reasonable certainty of no harm is not
met when were individuals in the Ann Haynes sample population have an H I or
HQ of greater than one therefore staff believes that the prohibition of
children's toys that can be placed in a child's mouth and childcare articles
containing more than 0.1% of di NP will result in a reasonable certainty of no
harm with an adequate margin of safety
staff also recommends that the scope of the prohibition involving di NP be
expanded from children's toys that can be placed in a child's mouth to all
children's toys this recommendation is based on the observation that children's
mouthing the most important route of exposure also occurs with toys larger
that can be placed in their mouth and that this exposure and handling also
contributes to the cumulative risk that believes that if prohibitions involving
di NP are not made permanent mouthing and handling of children's toys and
childcare articles could ultimately contribute as much as 29 percent of the
total exposure to di NP from all sources for infants and toddlers based on an
analysis available in the chat report F believes therefore that expanding the
scope from children's toys that can be placed in a child's mouth and childcare
articles to all children's toys and childcare articles is necessary to
protect the health of children
consistent with the Commission's proposed rule staff also recommends that
the children's toys and child care articles containing more than 0.1% of
deep NP dxp dchp in dibp be permanently prohibited this
recommendation is based on information including the anti-androgen acidity of
these phthalates the toxicological potency of these
phthalates that is greater to or equal to that of the phthalates included
currently in the permanent prohibition de hp DBP and VBP and their contribution
to the cumulative exposure and risk staff believes that prohibition of
children's toys and child care articles containing more than 0.1% of these
phthalates is necessary to protect the health of children and also staff
recommends that the interim prohibition involving DN o P and di D P be lifted
this recommendation is based on a lack of anti androgenic mode of action a lack
of other mr de effects a lack of other fertility related effects in these two
phthalates low exposures as estimated from in haynes and exposure activity
scenarios and therefore negligible risks staff believes that these factors
demonstrate there is negligible risk from exposures and a reasonable
certainty of no harm with an adequate margin of safety for the exposed
populations under the regulatory flexibility Act in the NPR the
Commission certified that the proposed rule would not have a significant impact
on a substantial number of small entities overall staff recommends that
the effective date remain 180 days as proposed in the NPR this recommendation
is based on the determination that the rule would affect a relatively small
subset of children's toys that cannot be placed in a child's mouth that would be
4d InP the additional phthalates are not widely used in children's toys and child
care articles and that many manufacturers already comply with and
have established laboratory equipment and methods for testing phthalates and
that only small changes to laboratory identification and quantification
protocols and materials would be required to comply with the additional
requirements that believes that the Commission can continue to certify the
rule so overall staff recommends that the Commission prohibit children's toys
and child care articles with more than point one percent of anti-angiogenic
phthalate syndrome phthalates to keep exposure and thus potential risks low in
this way the Commission will ensure a reasonable certainty of no harm to
children pregnant women or other susceptible individuals with an adequate
margin of safety and protect the health of children I would like to thank staff
in Health Sciences lab Sciences human factors epidemiology economics and the
office of general counsel for their expert contributions to the staff
analysis and these this briefing report and now the staff will entertain
questions at this point thank you very much the Commission
commissioners will now begin a five minute rounds of questions and I will
begin the the first round on page 15 of our presentation and I believe it's
slide number 29 under the staff response if for a non-scientist if you could
explain to me it says staffs response while a few studies suggest that humans
may be less sensitive than rodents so this was in response to concerns that
rodents and and that data is not applicable to humans so it's the staff
response as well a few studies suggest that humans may be less sensitive than
rodents to phthalate effects the majority of empirical evidence so can
you define few studies versus the majority of the empirical evidence ones
a study ones the evidence how do you weigh that and what's from it for a non
scientist but there's been a few studies that have looked at I guess phthalates
induced effects and marmosets there's studies and then there's also been some
studies looking at testicular zina graphs meaning taking the tissue out and
putting it in culture so there's I guess less than less than a half dozen studies
that have been performed in animals that share similarities to humans or have a
similar response so there's six studies roughly that make that case that
the data is not applicable to humans I understand that correctly and how when
it says the majority of the empirical evidence what do we have on that side of
the equation well in the in the studies the xenograft studies of the morrow
marmoset studies all of these studies have limitations the marmoset studies
are limited by the the small number of animals but a duration of exposure in in
so on so it's difficult to draw any firm conclusions from them in the other
studies the xenograft studies where you transplant tissues from one species to
an other you just when you get negative results you just couldn't be never be
sure that you've properly recaptured the conditions the original conditions of
original animal in a case like that negative studies are not very status
satisfying they're not they're not proof there's a lot of things that could
happen that would prevent from the tissues transplanted tissues from
responding on the other hand what we have is you know years of experience
comparing animal data to humans for many chemicals and the experience is that
there's generally a general consistency between the animal studies including the
rats and other rodents and humans and even the you know the rodents and the
humans the basic biochemical biochemistry is the same
it's very similar it's not identical but it's overall very similar for the
species to species and our experience is is that if it causes something say an
effect on reproduction in animals it's like very likely to cause that same
effect in humans and it might not be the exact identical effect but the odds are
very high that it will cause a similar kind of effect so do when I hear that
that answer it seems like we're using animals and rat studies sort of
interchangeably well we're you know when we say animal studies it usually means
rats and mice sometimes other species but mammals in general you know the
basic biochemistry is the same it's like comparing you know one brand of a car to
another there are differences but there's a lot of savoia they have the
same basic parts yeah they do but there's a lot of differences as well
with different types of cars but I don't want to go down that road I'm less
knowledgeable about cars and I am about rats with regards to the very likely
term you just used how likely I think the in in my experience the the
exceptions are rare and you know there are for example some chemicals that only
cause tumors in male rat kidneys but in no other species but on the other hand
it's four chemicals that have been adequately tested in animals and humans
every
everything that's positive that that causes tumors and animals causes tumors
in humans sometimes it's a different it might be a different type of tumor or a
different site but there's a very high degree of correlation I mean the the
exception the exceptions are rare thank you I
apologize my time is up commissioner and l'heure
thank you madam chairman I want to join the Chairman and thanking staff for a
really superb and huge package I particularly want to thank folks that
the public will not read the report they did which is the General Counsel's
analysis which I also thought was really excellent so overall terrific package so
forgive me I'm also a non-scientist and so I may ask questions that don't come
from the most scientifically based framework but they're questions that I
had so the first question I had comes from page 33 of the NPR here this chap
noted that only certain phthalates produce anti androgenic effects and then
they say these are phthalates with certain structural characteristics which
they say 3 to 7 or maybe sometimes a carbon atoms on the backbone of alkyl
side chain so my question is does di NP share these structural characteristics
well so the thali if you can imagine it has two side chains or sir like arms
like this and if those arms are straight that rule about 2 to 6 or 7 or what 3 to
set em and 3 to 7 the edges are a little bit can be a little bit fuzzy that rule
applies for the straight that's for the straight chain ones for things like deh
P in di NP where the side chains are branched people look at the different
branches and if you know one of the branches fits
into that model it's that you would predict that it would be anti-angiogenic
and caused a light syndrome I'm not sure that you answered the question does di
NP share these same well actually yeah well the di NP is is a mixture of many
different structure so the the branching is different on you could look at a
hundred di e NP molecules and find different branching so you would have to
do that you know molecule by molecule but
presumably at least some of them fit this characteristic and then
alternatively do di D P and D NOP lack these structural characteristics well D
NOP lacks them because it's got nine carbon atoms in a straight chain so it's
too big too long di DP is another mixed year so there may be some individual
molecules that would fit in that fit within the structure activity
relationship but the observation is that di DP is doesn't cause these kinds of
effects so they're probably very few that would that would fit that model
okay I'm gonna dig myself even deeper because on page 126 one commenter noted
that di o P has a structural similarity to anti androgenic phthalates and staff
said yeah that may be so but there's no experimental data that would support the
conclusion that di o P causes mr de so I guess my question is how similar are the
structures between di o P and the anti androgenic val i'ts in a okay and I
think I think dia Opie is also one of probably a mixture of different side
chains but there there's just a lack of
empirical data in it it's just a judgment the chap recommended an interim
ban of dia Opie because of the lack of published studies but my hair is not an
action interrupt just for one second cuz I'm running out of time
the basic question is staff noted that they have these structural similarities
and so what I'm looking to have answered is is that a marker for anti-angiogenic
effects such that if we say they have these similar structures that therefore
they fit in the same way we should avoid action yeah we would predict that it
does cause these effects but we don't have empirical data okay
I'm more or less running out of time Thank You Commissioner Robinson thank
you I'm gonna come at this from a different point but first again want to
thank all the staff that were involved in this incredible effort to put
together this extensive and complex package and I thank you for all the time
that you spent with us and my stat with me and my staff and answering questions
and I'm sure we'll have more before next week's decisional but while arriving at
this proposed final rule took longer than Congress anticipated obviously in
the CPS I am delighted that we're finally at this point our chap I think
as I as I said in the NPR hearing did a very thorough and careful evaluation and
followed a robust and open process that fully complied with the instructions
from Congress and we continued this robust and open approach by reviewing
analyzing and publishing for comment additional analyses of the Ann Haynes
bio monitoring data sets I know there are very complex issues both from a
scientific perspective and from a policy perspective and I very much appreciate
your work in reviewing and analyzing the chap report in reviewing and responding
to multiple complex and thorough comments from our stakeholders and
exhaustively reviewing all of the available relevant research and reports
I would just like to say that my starting point for this analysis is that
we're talking about a very very limited number of products
here children's toys and however we ultimately choose to define that and
child care articles defined as products manufactured to facilitate sleep or
feeding or help with sucking or teething for children under three so the
population that Congress has tasked the CPSC with protecting is our babies
infants and very young children who along with fetuses are the most
vulnerable to the effects of phthalates and with that in mind I next look at the
very protective standards that Congress set forth in Section 108 B three of the
CPSIA that governs is proceeding and I think it's important that we follow the
language of that statute carefully while you pointed it out I would just like to
emphasize how how different that language is than any language we've
dealt with since I've been a commissioner with respect to those
phthalates which are subject to that we're subject to the interim ban the
CPSC is to determine based on the chap report whether to continue in effect the
interim prohibition quote in order to ensure a reasonable certainty of no harm
to children and while it lists other individuals with since we're dealing
with the limited number of products we are it's the children that we're dealing
with respect to other phthalates evaluated by the chap our standard for
determining whether to ban them is that such a ban is quote necessary to protect
the health of children and additionally the chap was and now the CPSC is
required to address cumulative risk of any phthalates or combination of valleys
and not just the risk of each phthalates in isolation it seems to me that
combining limited products which with which we are dealing the vulnerable
population whom we are charged with protecting and the very protective
instructions given to us by Congress leaves us no choice but to err on the
side of protecting the health and avoiding potential injuries and babies
and young children and that we must take a holistic view of how phalates
contribute to chronic injuries which means that the prospect of regretable
regrettable substitutions in our industry may increase its use of certain
phthalates to replace banned phthalates are relevant and important
considerations you've walked through with us that not that concerning health
health effects and although we know some phalates can also cause cancer and
developmental and behavioral problems I appreciate that you and the chap have
focused on the the cumulative effect on male reproductive development known as
stay late they late syndrome the effects of anti-angiogenic phallic SAR additive
or cumulative meaning that multiple phthalates can work together to cause
phthalates syndrome and the lab studies and animals have shown that the
phthalates proposed to be banned in this rule are all anti-angiogenic and can all
contribute to this cumulative effect and the phthalates on which you have
recommended that we lift the ban are not anti-angiogenic so do not present a
cumulative risk i recognize that our biomonitoring data on humans are limited
but we can only do our very best with what we have to protect our babies our
infants and our small children with what and do what Congress has told us to do I
do not have any questions at this point but again I just want to thank you all
for this incredible effort that has taken place before in putting together
this package thank you Thank You commissioner okay thank you madam chair
thank you as well to the staff it's obviously been a very massive effort all
across the board but it certainly is a significant public service
dr. Babbage and Commissioner Robinson touched on a little bit of this and dr.
Carlson also feel free to jump in while the chap focused on when it looked
at these chemicals on the effects on male reproductive systems that's not the
only effect that these chemicals have on humans is it there's also liver and
kidney toxicity and other issues can you just expand a little bit on that please
sure the chap use two different approaches for assessing I guess
exposure and risk they looked at using the potency estimates for anti-androgen
isset II looking at just the phthalate syndrome endpoints and they also looked
at other toxicity endpoints for a different exposure and risk kind of
characterization and for those like with DN o P they looked at liver effects and
then combine that with exposures calculated in Hanes to come up with a
margin of exposure estimate they also looked at live effects for di di NP as
well so it was consideration of more than just anti-angiogenic endpoints in
the in the chat report but safe to say that just because we're focusing on
effects on male reproductive systems doesn't mean that these chemicals are
not harming other parts of humans body especially children and women
well that's true especially mostly based on the animal studies the phthalates
have many different endpoints the chap looked at as they were were required by
the CPS I he looked at all of the health effects of of Val aids what they found
was that for most phthalates the male reproductive effects are the most
sensitive endpoint and of course that's usually the subject of a risk assessment
they also noted that this was a common endpoint among phthalates they don't all
cause these effects but it is a common for many phthalates and also important
to note that because they were doing a cumulative risk assessment they were
aware that there was empirical data showing that for the developmental
effects these male effects that the phalates do act in concert with one
another to cause accumulative effect for most other endpoints we didn't have
those data don't exist the chap would have had to make assumptions and again
and that's not as strong a case in the in this case where there's empirical
data that's strong strong evidence for doing a cumulative risk assessment and
that makes perfect sense and it sounds like with the chapt it was totally
appropriate but I do think that as the public considers these issues and
certainly when it intersects with Congress's direction to be as protective
as possible it's important to keep in mind that there is some evidence it
sounds like that it's not just male reproductive systems that are impacted
by these chemicals but there are other parts of the body and that may not be
able to be defined specifically but it's not those there is other harm that's in
play here that's that's absolutely true and perhaps you know given enough you
know time I mean this was a huge project for the chap to take on the biggest
assessment that any chap has done before and perhaps you know given enough
resources and time either you know we or another agency may well consider other
endpoints make sense and mr. DiMatteo when you went through the statutory
requirements there is an additional legal obligation that exists via court
order in this case as well correct and this rulemaking are you can you expound
on what that is what our obligations are under that court order to please are you
referring to the timeliness suit that we had in the occurrence and obviously all
the public whatever you can discuss that's public and not legal advice
related to that but that that's a public court order yes basically the Commission
agreed to a court order that you would vote on the package by October 18th
which is a week from today and then within a week from that we would send to
the Federal Register for publication not only is the Commission under a statutory
obligation to finish this rulemaking but also a specific court order to do so
correct that is correct great thank you very much either Thank You Commissioner
mamuro vaq thank you madam chairman and thank you also staff for all the time
that you've spent commissioner robinson mentioned with with with her and with
her staff i want to reiterate the same from meetings on
Friday and Monday I appreciate the staffs candor and it was a professional
exercise that I was am very proud to have been a part of so thank you very
much for all that including questions right up until today and before I start
with some of my other questions I wanted to follow up on a matter mr. de Matteo
that that commissioner cage is brought up and it has to do with the court order
then are we as a commission we're not able to provide any other amendments or
motions with regards to seeking perhaps if the Commission approved seeking
additional notice and comment Amina we to what extent are we hamstrung in our
ability and our authority as a commission to advance this rule in in
different ways well what the court order says and the consent review says is that
the Commission is obligated to vote by October 18th it actually doesn't specify
what you vote for if there were an issue there's an additional at this point
those are questions that I would prefer not to discuss in this forum and I'm
happy to answer those questions before you have an opportunity to vote next
week I don't understand why this isn't something that could be discussed in the
public I think mr. de Matteo accurately described the public consent order which
the court administered in terms of advice to you on what procedures and
amendments are appropriate in terms of death legal advice that I would prefer
to give not no public setting okay so I guess in the absence of seeking any
legal advice for an answer if this commission found that sufficient
notice and comment was not found was not provided to the public which then would
subject this rule to judicial rule to judicial scrutiny and therefore being
struck down we would be unable to be able to provide to go out to seek
additional notice in comment if this final rule is not a logical outflow from
the proposed rule even if this commission came to that consideration in
came to that conclusion we would be prohibited by the court order from being
able to have a rule that can and would stand up in court by getting the
appropriate notice in comment and and therefore we're kind of in a stuck
position is what I find here which is unfortunate and I think it's I wasn't
planning on asking that but Commissioner K's question kind of begged the question
so that's a that's unfortunate so I'll move on to you know what I'm gonna wait
to the next round because my next question is still lardo I'll wait to get
into a question about in the next round and the discussion of risks in isolation
so thank you thank you will now begin the second round of questions I wanted
to call your attention on slide 31 throughout the course of since the NPR
came out and the chap report there has been a significant amount of criticism
about using the cumulative risk assessment and on slide 31 there is
staffs response to some of those criticisms and I wanted to just hear and
maybe you could explain this a little bit further to avoid all of our
estimating risk the chap introduced a minor improvement to the standard CRA
methodology if you could by estimating risk for each individual in the inset
can you just expound on that and how did that improve the cumulative risk
assessment but in other data sets you're not awarded the opportunity to
have individual level data so you have to make assumptions regarding you know
population here you could actually estimate or was actually estimated
individuals risk though whereas you'd be estimating risk for the population and
the other case here you didn't have to do that so that was the minor
improvements a theory of to use individual level data instead of just
estimating you know via the population and do you feel that
that affected the outcome or the analysis that was done by using the
individual vigils from in Hannes you actually were doing the most highly
refined exposure assessment that you could do no well what it what they did
by looking at the individual data you know the actual hazard index of each
individual in the population you otherwise if you only had a summary data
for example the average exposure to all fives
say all of the phalates and the in the 95th percentile exposure to all of the
phthalates the only way to combine those that information from the summary data
would be to assume to add them and that could very well lead to an
overestimation of the risk especially at the upper percentiles by looking at the
individual level data the chap avoided that we're not they didn't do both
analyses so I can't say you know it would have been probably a good example
to look at and say how much difference would that have made I don't know but
the point is the chap did it the most accurate way possible do do either one
of you want to comment we've heard this over and over again that the cumulative
risk assessment is just novel it's not used very often and it was a novel
approach I think that the novel approach was in reference to using the individual
level data before and Hannes provided information on individuals you didn't
have you didn't have that luxury of having the data on you know how that
metabolites in a person so you had to sort of estimate based on the population
yeah in terms of it being novel the CRA has been used by EPA to regulate
organophosphates and methyl carbamates triazines cloris at Tilghman elides
pyrethrins and pyrethroids and past and it's pesticides and they also the CRA
has also been used to assess risks under Superfund and
ATSDR is published 11 final and 3 draft CRA s called interaction profiles so
they have been used by other federal agencies to you know the approximate
time frame for those for the use of the cumulative risk assessment we have a
citation of 2015 so but I think the the the a lot of the uses under the food
quality Protection Act for example I think go back to nineties mm something
like that so that's been done for a long time that ATSDR for the Superfund it
probably goes back about the same time but you know these are with the
phthalates we're looking at mixtures of chemicals and the EPA first issued
mixtures guidelines in the 1980s so this is not novel chemists of risk assessment
can also apply to cases where for example York um combining chemical
exposures with some other source of stress or some other injury to the body
so that EPA has started developing in the in the late 1990s as well but the
mixtures come of chemicals goes back much farther
thank you I apologize my time is up Commissioner Adler thank you thank you
madam chair I want to again ask technical questions that I'm not sure
fit within your framework but they're at least questions that popped up to me so
I was looking on page 33 of the NPR and I see that the chap concluded that
the phthalate syndrome effects are largely due to the suppression of
testosterone production as well as reduced expression of the insulin
insulin like hormone 3 gene so my question is does di NP suppress insulin
production like other phthalates and conversely did di DP and DN o P not
suppress testosterone production and I'm sure you can just you know the
information on the incident of like hormone receptor is a growth factor is
I'm not sure exactly which phthalates that was tested in but if di NP causes
these effects then it likely X the same way
and since di D P and D NOP don't cause the effects then I would would not
expect them to to affect the I n SL 3 in the same way as other phthalates and I
don't think there's anything I don't think there's been any published
literature that has demonstrated that DN o P and D I D P reduce it to a faster
yeah in other words this is a further elaboration of why you're including di
NP and not including the others and I'm just trying to figure out the exact
theory for that I'd like to you direct to direct you to page 12 slide 24 and I
see that with respect to the 2013-2014 and Hanes data you found that 538 warez
represents 64 million in the US are there to your best your knowledge is
that an accurate extrapolation that there probably are roughly 64 million
women of reproductive age in the United States
I think we've used 60 and you've used six kids that I see it to 60 or so
somewhere in there 60 to 64 million okay well they
the N Haynes also found between two and nine women in that category showed an H
I greater than one can you extrapolate from the two to nine figure the same way
you're extrapolating from the 538 figure because I seem to remember you said we
didn't feel comfortable doing that correct because the sample size was
small and the number of individuals that actually had an H I have greater than
one was small it made statistical extrapolation to the
national population if you had to guess would that come out as probably too low
or too high or we really and truly can't tell it would be reasonable to expect
that the population of affected individuals would be Niner yeah I would
assume the same - and to me that's not de minimis and that's not trivial that's
that's reasonably significant
commissioner K pointed out that there are additional effects beyond
anti-androgen isset ii and i just wanted to ask for the whole spectrum of
phthalates that you looked at did you simply find that things and you
mentioned hazards like I hope I pronounced this properly supernumerary
ribs or the systemic effects on liver thyroid and the immune system are those
just not occurring with sufficient numbers or sufficient potency to warrant
Commission action is that in other words they may exist for some of these other
phthalates but there's just not enough there to warrant well then actually the
mr de the male reproductive effects are for most of the phthalates the most
sensitive in other words these effect happened these effects happen at the
lowest doses so if you have a rule that protects against this you should protect
against the other hazards as well the chap didn't do risk assessments for
those other things that they didn't say for example that you know under a
certain exposure you would get so many other effects of various kinds I mean
that perhaps could be done but when the you know within the
timeframe is I'm just gonna row so on because my question goes to not the ones
that you included but the ones that you excluded and the ones you excluded like
di D P and D NOP I guess what you're saying is these effects either didn't
show up or didn't show up sufficiently so that you felt they ought to be
included in a band well for the time just expired for okay but I'll come back
to that okay Thank You Commissioner Robinson I just
want to ask a couple questions about the Beaubourg study there were comments that
were made about perceived deficiencies in the study on di MP by Beaubourg l
that concluded that di NP is anti-angiogenic my first question is did
the chap rely on the ballpark study to determine the HQ for di NP or the H I
the Beaubourg study was not relied on in any of the cases for determining the PIA
the potency estimate for anti-androgen isset II so I think that answers my
second question that the chaps a conclusion that di NP is anti-angiogenic
stands independently of the Beaubourg study correct okay I mentioned in my
comments during the last round about what we're trying to do the best we can
with the data that we have on by the biomonitoring and my question about I
know we see we went from the N Haines of 2005-2006 had a significant enough
cohort of pregnant women that we could make some conclusions and I know that
after that we went with women of reproductive age and my question is does
a decrease in the in the H I with women of reproductive age in the more recent n
Haynes data mean that there's a decreased a decrease in h1 for children
or pregnant women
well you you know you can't necessarily predict what happens in one group one
age group from what happened from another
so yes the the risks to the women of reproductive age have gone down we don't
really know what what what what happened to the infants one to three years old or
because they have different exposure patterns it's always better to have the
data and yeah there's a good chance that the exposures to infants have also gone
down but not necessarily by the same amount and for example we do know that
on average children's exposures tend to be higher than their parents and so
while there if it's exposures may have gone down we don't know by how much we
suspect that they're still higher than the women of reproductive age
particularly I assume with the products that we're we're dealing with here the
children are going to be mouthing them and touching them more than their moms
and moms yes the end with respect is to just to make this clear the enhance data
as I understand it doesn't deal with children under six so the information
the biometric information we have with children themselves is this future
family survey from 1999 2005 is that right correct for infants thank you I
have nothing further at this time thing Thank You commissioner okay
no questions right now thank you Thank You Commissioner mamuro vaq I wasn't
prepared for that speedy turn around the corner thank you madam chairman I wanted
to get it to the discussion about risk at the risk in isolation and we've had
some private conversations are with the team about it to stop the question the
preamble states that the chap did not indicate that the 95th percentile or any
other part of the cumulative risk distribution should be used to establish
onyx double risk for risk management purposes
but a look at the discussion of risks in isolation it was the results at the 95th
percentile that led staff to conclude that di NP and isolation does not result
in unacceptable risk from the final rule page 37 the chap found that with the
exception of deh P for all phthalates that it evaluated in isolation the mo
EES were within acceptable ranges final rule page 98 quote CPSC agrees with the
chaps analysis that the MOS mo EES for di NP and isolation did not present risk
a risk now not to be the dead horse about the conclusion that di NP in
isolation is not the basis for a permanent ban on di NP and the rule but
what I think is what's important is what led the chap and staff to agree that is
important to explore here further staff identifies the 95th percentile as
appropriate to assess chemicals in isolation the briefing package page 34
quote current analysis suggests that di NP margin of exposure in isolation
parenthetically m OE is 224 case 2 and parentheses is below the upper limit in
nearing the lower limit limit considered adequate for protecting the public
health furthermore there are countless references to the mo e 220 that's the
95th percentile the entire analysis of whether di NP and isolation presents an
unacceptable risk risk is predicated on the results at the 95th percentile
furthermore tab B page 87 to 88 and respond to comment 5.5 even when
evaluating as a commenter suggested the result of theoretically doubling the DI
Enic di NP exposure staff provided what that risk what that result might be
again at the 95th percentile so why wasn't there consideration into the
risks posed by di NP and isolation among the most highly
individuals at the 99th percentile and I only asked it that way because staff
just told me today that the the work was not done to evaluate MOA at 99th
percentile so that's why I had to adjust but why weren't we looking at
you know consideration to the risks and I'm quoting because this is the same
language used to justify regulating at 99th percentile for the CRA why wasn't
there consideration into the risk posed by d-i NP and isolation among the most
highly exposed individuals
well the the chap reported median 50th percentile 95th and 99th percentile
values of exposure and risk they those are numbers that are convenient 95th 5th
and 99 those are convenient numbers everybody uses them statisticians use
them that does not mean that anyone setting you know a level threshold for
regulation at the 95th level or the 99th percentile level they're just convenient
commonly used measures of exposure in risk and mr. Bannion document act we
neither the staffed or the chap specified a level like you have to
regulate if it's a above or below some percentile I'm just like can I just that
for a moment please if you don't mind dr. Carlson I'm sorry for interrupting
but dr. Babbage when you were mentioning that the chap evaluated at the median
95th and 99th just to be clear because I'm drawing a distinction between the
evaluation of di NP and isolation that 99 percent evaluation was done for the
CRA correct but not done for the mo e and that's what that's what I'm
exploring a little bit further here today that why wasn't the mo e for the
most highly exposed individuals found for the 99th percentile thank you I
apologize for the interruption dr. Carlson oh and you'll have to hold that
socks I'm just now out of time I beg pardon thank you thank you dr.
Babbage if you'd like to answer that question while that thought is still up
lingering in the air well you know the data the underlying data are they
reported at the at three levels what they put in their you know
recommendation section they they refer to the 90
if you know that's what they chose to do and the you know they were obviously the
CPSIA required him to look at both cumulative risks and risks and isolation
and they chose a different method to look at the risk in isolation or a
different way of expressing the risks and in terms of what staff did with the
response to comments staff was responding directly to the comment or
that only cited medians in ninety so we didn't use me thank you I just want to
go back to because I hadn't heard that before when you talked about the 95th
and the 99th percentile as convenient numbers can you explain that a little
bit more I mean you say they're commonly used what what what does that mean
convenient numbers they're descriptive terms that allow you to compare
different data sets like with the in Haynes data in order to look at the
trends we had to look at some common percentile to see if that percentile
changed over time so we've looked the 50th and the median in the 95th
percentile and would you have done that if the chap hadn't done it we would have
had to validate to the chaps results so we would have used the median and the
95th yeah to look at the trends over time I mean in in the past there we've
looked at medians 95th and 99th percentile Zhou ourselves so if there's
a little confusion because I think statisticians often use 95th in 99th
percentile or 90th percentiles when they talk about statistical significance and
I think it's just sort of a habit and so when we talk about a reasonable
certainty of no harm does that measure up with those convenient numbers the 99
or the 95th percentile no those are those are descriptive terms only a
reasonable certainty of no harm is related more to
hazard index of greater than one in the individual population and the number of
individuals that have a hazard index of greater than one thank you I wanted to
just clear up a question I had because I've heard from my colleagues about the
other possible adverse effects from some of the phthalates and I wasn't clear
because it sounded to me like one I heard that the chap did not do any kind
of risk assessment on these other liver toxicity on the the rib super-new her
have the extra rib and some of these other hazards but yet we're alluding to
them what the did the chap address those did they study those or was this purely
for the anti anti antigenic effects but the chap did consider all of health
endpoints for the purpose of the cumulative risk assessment they focused
on male reproductive development however for the risks and isolation they also
considered for a given chemical whatever the most sensitive endpoint was so for
example and that's especially true for the for the Val AIDS and phthalates
alternatives that do not cause the male reproductive effects so for example they
for all of the phthalates alternatives they simply looked at the since they
were not anti androgenic they sit at the most sensitive endpoint and in the case
of di and P which is anti-angiogenic however for di NP because it's a little
less potent than the other phthalates the liver toxicity is actually a little
bit more sensitive so when they looked at DN InP and isolation they considered
both the reproductive effects as well as the liver endpoint thank you my time is
almost expired so I won't ask my next question
well I doctor go back to the question I was asking it's consistent with the
question that the chair was asking and that is granted that I think you've made
a compelling case on di NP and I'm just curious again about di D P and D NOP was
it the case that any effects such as these extra ribs are the effects on the
liver thyroid her immune system were simply not there or were so slight that
they would not bring the h I above one
well that did address that in the chat report they found that instead of
looking at it using an H I approach they used the margin of exposure approach and
they found that when looking at the margin of exposures that they were
higher than the recommended level of a hundred to a thousand and higher margin
of exposure actually translate to lower risk so they were well within the bounds
there well outside the bounds of their not saying those effects don't exist
they saying that they're so rare or so minimal that it's not worthy of
Commission action to put it on simpler terms okay I'd like to return to D InP
exposure and I did note that staff said that up to 29% of infant's exposure
could be from di NP and toys and child care articles and I'm just curious about
that 29% figure is that based on actual studies of di NP in the marketplace or
is that assuming that all toys and child care articles would have di NP in other
words with its theoretical or empirical that is from the chaps scenario-based
exposure assessment remember they did two methods the biomonitoring tells you
total exposure but doesn't tell you where it's coming from
the scenario-based looks at the different potential sources of exposure
and estimates the the exposure from each one in the relative contribution
so now that 29% assumes that all toys and child care articles have di NP which
is probably not a totally realistic assumption is that fairness well today
no because of the CPSIA right in 1998 or thereabouts when we looked at the InP a
long time ago di NP was the prevalent plasticizer used
in these products in toys and childcare articles at that time I think 90% of the
products that we tested did contain di NP in you know it used to be de HP then
I guess it was the 80s when it was replaced by di NP so that was if you
turn back the clock that's a realistic assumption if we were to say lift the
ban we don't know how many manufacturers would go back to using di NP in on that
point you did note that di NP exposure is growing even though we have this
interim prohibition I guess my question is first of all where's it coming from I
presume a lot of its in the diet but can we rule out that it's coming from other
products like raincoats footwear backpacks school supplies those that
some commenter said that we should be addressing as part of our action I mean
you know the nature of the bio monitoring data is we don't know where
it's coming from as far as those things backpacks and so
on that chap consider those other kinds of exposures and there just wasn't
enough data to make an estimate they just couldn't estimate the exposures
other people have tried in Europe some people have looked at things like rain
coats and backpacks and so on and it's in the echo report that's
some of the public comments referred to and again based on of the little bit of
data available the echo report concluded that there wasn't enough exposure from
these other sources to to merit for example expanding the scope to halt like
all other children's products beyond toys and childcare articles so it's it's
limited data it but that's the best we can do thank you very much my times
expired Commissioner Robinson I just want to
follow up on that a little bit even though we don't know what products
phthalates might be coming from let me just talk for a minute with respect to
babies infants and young children in the manner in which they're exposed we we
have we certainly know that if they mouthed something with Daleks that's an
exposure and it also can come through the skin right and having just spent a
weekend with a baby they I assume it's also can be hand hand to mouth yes I
hear that right okay let me also I made a you made a
good point doctor Babbage that the the data that we have with respect to
children that was from 1919 of the my biometric data was during the years of
1999 to 2005 and that was before the ban on D InP right correct and for the last
nine years its di NP has not been in children's products actually what's not
supposed to be in in 1999 when we were looking at the IEP the Commission asked
manufacturers if they would while we study the issue remove phthalates from
teethers and toys a narrower scope than the the CPSIA
and they agreed to do that for what they just described as toys
what they consider it intended to be mouth so it would be it was things like
teethers and tom toys rubber ducky squeaky toys that the
smallest you know infants play with and so after that when we tested in about
2000 or so we found that the frequency of toys with di NP had already gone or
for that narrow range of products went down from you know ninety percent to
forty percent something like that so it was already declared the use of di NP
was already declining now phthalates were still in things like dolls and
action figures that older children would play with so and then we tested again
just a really a few months before the prohibitions went into effect and we
found very little in the way of phalates and most of the products that we tested
would have complied with almost all of them would have complied with the new
regulation so during that time period there was probably a gradual decline in
Fallot use and when you say during the time period you're talking about when
the biomonitoring data yeah between yeah during that timeframe and when you say
tested just to be perfectly clear you're talking about testing the toys not
biometric to we were talking about testing the toys and they were not
necessarily statistically representative see I mean there's so many toys you
probably couldn't do a statistically representative sample if you wanted to
do that's right thank you I have nothing further Thank You commissioner okay
thank you madam chair dr. babbit you're talking about a little bit of the
history which i find very interesting because presumably we're not here from
for some random purpose obviously phthalates came on the radar and started
to concern public health experts for a reason can you give us a sense of when
they started to become an issue of concern and whether you feel like those
concern still valid in light of all the work
that's been done on studying them oh you know it's I think the Commission's work
started in the 1980s when the National Toxicology program reported that deh P
was a animal carcinogen and at that time deh P was the predominant valley in toys
and childcare articles we started a rulemaking but ultimately the industry
voluntarily removed dhp that evolved into a voluntary standard that's now
part of the toys a SDM toy standard the replacement was di NP and of course as
these things go there was very little data on di NP but due to you know EPA's
efforts they have arrangements where the companies well you can use this chemical
but you have to get data so eventually in about 1990 late 1990s we began to get
data on di NP and that's when some of the NGOs began to be concerned about di
NP because it caused the same tumors and many of the same health effects as de HP
so ultimately we received a petition ultimately we had a chap and did a risk
assessment on di NP the conclusion was that di NP exposure from just from
mouthing teethers and soft plastic toys not considering any other sources did
not present a hazard however it became apparent at that time that's it was an
interesting time because that's when an hain started measuring valleys and a lot
of people I think it actually started in Europe were concerned about
exposures to multiple phthalates from multiple sources so there are
recommendations that when the data become available that we or someone
should look at cumulative risk and then this but that well that those data
became available you know in the meet in the intervening time so that resulted in
the CPSIA and here we are and thank you for that and as a public health expert
do you believe that the that concern regarding this class of chemicals are at
least some of these chemicals is legitimate
I think it's legitimate yes and I've been advocated for the need to look at
the cumulative effects and that's an important point in I don't know if you
were here for dr. Birnbaum testimony a few weeks ago on organo halogens our
second testimony in front of the Commission and of course Linda Birnbaum
represents is the director of the National Institutes Environmental Health
Sciences which is part of NIH and also the director of the national toxicology
program so certainly one of the top toxicologist in the country if not in
the world and her view was that you have to look at the real world application
and exposure scenarios and that's where human of risk assessment comes in and
I'm I take it you believe that that's a valid approach I think the time has come
yes and you know I in the 30 years I've been here every chemical we work on you
get it from consumer products medical devices workers are exposed it could be
in the environment we've done a lot of work with other agencies on chemicals of
common interest yes okay thank you no more questions Thank You Commissioner
aerobic thank you madam chairman and dr. Carlson I know I'll give you an
opportunity to answer I was cut off at the last time but just by virtue of
continuity as we're talking about phthalates and teethers and dr. Babbage
thanks for helping us out with the with with the many decades of history and
looking at these I was also looking back at at some of the congressional
testimony from the hearing on phthalates and bee
pa but before I get to that I'll notice that in the final rule it states that
the the chap examined exposures to various phthalates from these sources
the chap found that infants toddlers and children were primarily exposed to DI
NPD e HP and di DP for instance up for instance for infants exposure to di NP
was primarily from diet but exposure was also due to di NP in teethers and toys
so the teethers you know was something that was a bit of a surprise to me I
know in the congressional testimony in response to representative Schakowsky
dr. Babbage you cited in 2002 there were no phthalates and teethers rattles or
pacifiers consistently in response to mr. Whitfield right now there are no
phthalates and teethers rattles or pacifiers and then in response to MS
hooli again you responded okay first of all teethers and rattles have no
phthalates so what's the deal with di NP and teethers have they come back into as
di NP come back into teethers since 2002 since that study work what's the
situation with with teethers well know what the CPSIA did section 108 is ensure
that they don't come back from them teethers toys and it you know in the
earlier studies and the earlier commission actions I think we were
focusing on a narrow a narrower range of toys at least so the CPSIA it in my mind
expanded the you know to all children's toys but also but the teethers question
the chap concluded that di NP in teethers and I'm wondering if that
wasn't the case in 2002 you know you specifically mentioned
teethers I don't know how the chap would come to the conclusion that that infants
or infants have exposure to di NP from teethers again that's from the chat
scenario-based exposure assessment and you know there they were the CPSIA said
evaluate exposures from all of these products and so what the chap chose to
do was to look at the hypothetical exposure that would occur if these
phalates were allowed in these products and you know if they were used and that
would be was the case in the late 1990s okay so it wasn't based on any testing
results or evidence that di NP is in teethers it was based on well it could
be in Tegel well it was based on if it weren t there's I mean there's we had
data from but but at the at that time except for the few non-compliant
products that no there would have been no phthalates okay I guess I'll never
really understand why the chap said for instance for infants exposure to di NP
was primarily from diet but exposure was also due to di NP and teethers and toys
if there's evidence of di NP exposure in diet but not in teethers I guess I'll
move off at that point dr. Carlson I know you were prohibited by virtue of
time from answering in the last round would you like to do so I think we
answered that the staff analysis in response to comments was directly in
relation to the comments submitted so they assessed mo EES at the median and
the 95th percentile and we did the same and responded like okay well the
standard for applying reasonable certainty of no harm ships between
chemicals and isolation and in cumulative risk for consideration of
establishing unacceptable risk for di NP in isolation for risk management
purposes staff concluded that since mo e for di NP at the 95th percentile is
within the acceptable risk range di NP and isolation provides a reasonable
certainty of no harm with an adequate margin of safety but in consideration of
establishing optimal risk for di NP an accumulative
risk assessment for risk management purposes staff concluded that even
though all hazard indices at the 95th percentile were within the acceptable
risk range di NP fails to provide a reasonable certainty of no harm with an
adequate margin of safety so if you could Maul on that one for my next round
for an answer I'd appreciate it thank you thank you doctor Babbage would you
like to answer that question roads yeah I'm not sure I understood the question
the recommendations for di NP and the other in anti-angiogenic phalates were
based on the cumulative risks not the risks and isolation thank you I want to
just go back to my colleague commissioner K was talking about
phthalates and the adverse effects of phthalates and started speaking about
them generally and I thought I heard you say there is a need to study further
maybe you could just clarify when you said there was a need to study were you
referring to phthalates or at that point organic halogens were introduced into
the conversation I was talking about in in the past when we looked at only di n
P people began to recognize that there was a need to look at the effects of
multiple valleys for multiple sources so that that was in the past okay
the only other comment I have really not a question is the irony of the
painstaking work that staff has done to look at these phthalates individually
and not as a class to understand which ones have adverse effects which ones
don't and how we will handle them going forward whether we continue the interim
ban or we don't and how what a different approach we took with organic halogens
commissioner adler I agree that and what you see is we've
been looking at phthalates for 30 years when I was at the Commission in 1984 and
I left we were exploring phthalates and it's been whack-a-mole ever since which
is why you try to look at these sometimes as a class and not just as
individuals what I would like to ask is it's correct that we are looking at di
NP and other phthalates for their cumulative effect and so I'm just going
to pose a rather bizarre hypothetical suppose we were to assume that the
cumulative effect of di NP to total phthalate exposure was de minimis and it
shouldn't be banned what implication would that have for other phthalates
such as di b pd p en pd h exp or dchp in other words would that have some kind of
presidential effect or the risks so different from those that your
recommendation would remain the same the difference between these phthalates and
di NP is the fact that they have a higher potency than di NP does and some
studies deep NP has been shown to be from 8 to 15 times as potent as deh P oh
that's okay that's a very welcome answer I want to go back then to this notion of
di NP having much less potency and I'm still struggling with this notion it
says di NP now contributes as much to the cumulative risk as de HP but di NP
is less potent so when you say contributes as much to the cumulative
risk what are we talking about are we talking about quantity or hazard or what
what's the underlying concept there and that would be the quantification of risk
yes oh okay the the other point about regrettable
substitution that we've been hearing I guess my question is do you happen to
know what is being used as a substitute today for
cisors in toys and childcare articles and you have any concerns about the
phthalates if there are any that are being used we do have information on
what's being used we that did that we we looked at these products in about what
two thousand and just before the the rule went into effect and provided that
data to the chap what we found was in a lot of cases they're using multiple
plastic well there's one they can not use plastic two they could use a plastic
other than PVC that doesn't require a plasticizer so there's a significant
number of that when they do have PVC we found that they're using multiple
plasticine many cases multiple plasticizers instead of one the
substitutes are there's a terephthalate which is different from the phthalates
we're talking about there's something called we call the di NX it's a
derivative of di NP and and so on a few other plasticizers that are known in the
chap had this information and the chap reviewed the toxicity and risks from all
of these substitutes and there are concerns in some cases there's a lack of
data on the toxicity in some cases there's a lack of exposure data for one
of these in particular the data exists but we don't have it the chap and
generally the staff only use data that's publicly available and the company has
data but would not make it publicly available with respect to the one that's
the derivative of di NP does it share similar structural properties such that
that would be one that you would be particularly concerned about
guess the other point would be would we see the return of di DP or the addition
of dia NOP to child care articles and toys or we just don't know well
regarding the one that's a derivative dia it's it's very similar to di NP
except instead of the the middle part not the arms the middle part is a little
bit different so we it's we don't think it causes the same effects as di and P
and the other angiogenic phthalates but we its we simply don't know because we
don't have the data as I think di DP could come back the NOP it's it's not
people don't make DD NOP per se they make things called linear' phthalates
and D NOP is part of those so we may see that but that's more of us
I'm told that those kinds of things are used when you something is exposed to
cold weather and you need to stay flexible so I don't boo I don't expect
to see a lot of that Commissioner Robinson nothing more at this time
commissioner okay nothing more at this time either Thank You chairman talked
about it I'll try to do a better job of providing this question again about the
comparison between evaluating di NP and isolation versus di NP as part of a
cumulative risk assessment and evaluating di NP in a value in isolation
we looked at the mo e results at the 95th percentile at the 95th percentile
they all fell within the acceptable risk range therefore staff concluded that
there's a reasonable certainty of no harm in contrast in evaluating di NP as
part of a cumulative risk assessment we looked at the CR in looking at the CRA
results at the 95th percentile once again all fall within the
acceptable range but somehow we come to a different conclusion that that
therefore but but it fails to provide a reasonable certainty of no
reasonable certainty of no harm so how is it that the 95th percentile results
are satisfactory to conclude a reasonable certainty of no harm for di
NP and isolation but when they at the 95th percentile all the results fall
into the acceptable risk range it fails to provide a reasonable certainty of no
harm there's an inconsistency there with the application of the 95th percentile
and that is the nature of my question I'd like to understand why staff takes a
different look and comes to different conclusions and evaluating a reasonable
certainty of no harm well again so you're talking about
falyse in isolation versus the 95th percentile for for deep for evaluating
di NP as part of accumulative risk assess again the definite well first of
all reasonable certainty of no harm is not defined in any of the statutes that
use that term and ultimately it's the commission that has to make that
determination whether that standard is met our recommended ations the chaps
recommendations were were based on the data that the chap presented and they
presented in terms of various percentile values that's not we we never said that
any of those values of what the chap report is 95th or 99th we never said per
say that that that is the cutoff you know we never set a a limit we never set
a value percentile value that you have to be above or below but in terms of di
NP and isolation and looking at the results of the 95th percentile you find
that it does provide a reasonable certainty of no harm and the staff goes
through a very excellent interpretation of reasonable certainty of no harm in
light with our in in acknowledgement of our chronic hazard guidelines to be
acceptable risk which is dr. Carlson pointed
out with vhq S&H i under one but the the disconnect here is we came to disc
different conclusions while results all fell within the
acceptable acceptable range at the 95th percentile I see you I see you squinting
so I don't know why where is the disconnect you know again looking at the
risks in isolation for example the 95th percentile exposure values were there
and you could calculate the MOA and that's the way the chap reported now in
the cumulative risk we looked at 95th and 99th percentile values but the chap
also estimated the percentage of people in a population of bubba rupee low
hazard index of 1 and again when other agencies for example look at this issue
what percentile it's on a case-by-case basis it's it's a judgment and you know
ultimately that's for the Commission we're presenting the risk information
the best way we can but ultimately that's for the Commission to determine
mm-hmm well that's why I asked whether or not
why the mo II wasn't considered at the 99th percentile because if you found
that at the 99th percentile it fell below 100 which was determined to be the
tolerable level of exposure for risk and isolation then there would have been
consistency between the application of reasonable certainty of no harm between
looking at di NP and isolation versus di NP in a cumulative risk and that is a
contrast and an inconsistency which will I predict the devil this agency moving
forward out of time currently thank you I don't have any questions at this time
Commissioner Adler winding down and thank you for your endurance and sitting
there I greatly appreciate it so I guess one question I have is most of the
discussion about the risks and I understand why you're
focusing on anti-androgen isset II but that is in many respects a male syndrome
I'm assuming that you're not telling us that phthalates don't present a risk of
harm to women and to females so what are they if not analogs but what risks are
there that that we saw with respect to women or female rats well the same any
there of course are effects in female animals and of course things like the
developmental delays supernumerary ribs the liver toxicity that applies to both
sexes there are effects in people have been studied I think dr. Carlson will
elaborate a little more on the effects and females yeah one of the effects
they've seen a delayed vaginal opening and other developmental kind of effects
but those happen at much higher doses than actual the male reproductive
elemental Thanks no I understand that but I guess what
we're saying is that it's not that this is a male only risk from Stylites and I
think you've confirmed it I guess I just have one last question and this is just
a question of curiosity does California require hazard warnings for anything
under prop 65 if you know yes California requires clear in-person reasonable
warning for a de HPB BPD BP the ID PD InP and a dye hexyl Valley all right
thank you very much I have no further questions Thank You Commissioner
Robinson nothing for Commissioner K nothing more I just want to thank you
again I think you guys have done a phenomenal job throughout this process
and again today Thank You Commissioner morovich thank you madam chairman so
staying with the scenario-based exposure assessment and I'm referring to page 72
from the final rule it does make a ton of sense to me that the chap considered
the following quote although certain phthalates had not been permitted in
children's toys and childcare articles since 2008 the exposure assessment can
what contribution these products could make to overall phthalate exposure if
those phthalates were allowed in children's toys and child care articles
I think that's a very smart approach and evaluation so as commissioner Adler I
think pointed this out the analysis was able to determine that under this
scenario based exposure that these products could in the hypothetical case
contribute as much as 29 percent of the overall of the total overall DNP
exposure to infants and correct about that yes now if it can be terminus
pacifist II that 29% of the total exposure for int for infants well let me
hold off on that if it's 29% for infants what would be the contribution to the
total exposure for women of a reproductive age of course the for the
women of reproductive age mothers handling exposure to these products is
is much less intense than the child's the chapter dat estimated but it's a
it's a small contribution for them now they're very specific about giving about
giving percentages and I think of tenths of a percentages which are added
together to yield you 29% of the total so if you don't mind can you give me
what we consented provided we can look it up is it is it somewhere in the is it
in the chat oh it's it's in the appendix II won at the very back is the
information you would have to do a little bit of math divide some numbers
to get the percentage okay well maybe I can provide that as a follow-up to the
hearing to find out what that is for women of a reproductive age but then
staying with infants on the same scenario based exposure why can't the
potential incremental contribution to the cumulative risk assessments for the
subpopulations be determined if they can be determined with such certainty that D
InP would contribute 29% of the total CR ice
if you have very accurately 29% of the total cumulative risk how is it that we
can't understand what theoretically might be or hypothetically might be the
increased incremental risk if di NP were allowed in child care articles and toys
we don't in a few places in the briefing package that and I'll quote here staff
cannot determine how much a twenty nine percent increase in average exposure
would translate to the percentage of those with an H I have greater than one
and we we say that in a few places but twenty nine doesn't sound like much of a
guess it sounds like it's pretty specific figure based on specific
exposure estimates so why can't those exposure estimates be plugged back into
the cumulative risk to then determine how many other infants I'm just
wondering why I mean if if it didn't come up with the twenty nine percent I
completely understand it say well hypothetically it's rational to imagine
di NP with exposure could go up among infants if all of a sudden di NP is then
allowed in those particular products that completely recognize that but we
were able or I think the chap was able to write this was a chap figure the chap
was able to determine very specifically twenty nine percent so if they can
figure very specifically what twenty nine percent is what's important in
making my decision this whole purpose here is about whether or not we should
allow it in these particular products so not about what's happening with diet or
with other products not under our jurisdiction or maybe not under
consideration with this rule but what is the potential incremental increase
should we lift the ban on di NP in these products and what vexes me is how it can
be determined with such specificity in terms of 29% of the total cumulative
risk but we can't define with specificity what that incremental risk
would be which what we've laid out is in terms of a standard of reasonable
certainty of no harm that to me would be a very important figure so help me
understand why it can be done in the one case and a percentage of the total but
that it can't be plugged back in to determine what the incremental increase
might be okay thanks that was a mouthful iPod that's a tough one
the two exposure assessments you're talking about comparing the exposure
activity scenarios versus the bio monitoring scenarios have different
levels of respond refinement exposure estimates for were using the bio
monitoring data are highly refined and reflect the state of art and exposure
assessment while the exposure estimates using the activity scenarios are less
refined and have often limited data in association with determining those
exposure estimates and so that's one reason why you probably wouldn't want to
combine your 29% from the exposure activity scenarios with your estimates
of a chai from active average before you chiming did you miss peak when you said
wara because we're talking about infants did you mean infants you know when you
mentioned you said the word war but I think perhaps if you meant infants
that's right well that's just general comparators between the two exposure
assessment okay thank you I'm sorry dr. babbit and they also have
different overall purposes the bio monitoring data was used to in desta
mate individual individuals and the exposure activity scenarios are
primarily looking at populations and and they have different purposes the bio
monitoring data would be used to estimate individual infant or other
exposures whereas the exposure activity scenarios are primarily used to look at
the relative contribution of different sources to the overall total exposures
three reasons why it might not be that great of an idea to combine 29% with
risk and it's just to be clear the 29% is on average and the the bio monitoring
data is a distribution and there's just no way to predict how that average would
be applied you could maybe apply it to the average exposure in the from the bio
monitoring but you there's no way to predict what it would do at each
percentile or for each individual in the in the popula it would be speculation if
we were using if we were looking at the percentage a chai above
one among more stable populations like the median or the 95th percentile then
could the staff determine how many potential candidates would fall above H
I of one I mean does this have a factor with dealing with the 99th percentile
being so relatively and so unstable compared to the 95th or median well with
it we're one of the things that the chap in the staff who looked at was the
percentage of the population with the hazard index greater than one and so
it's I mean that's a number you that you calculate it's not you don't do it at a
specific percentile let's say it's a number on its own and it's just a matter
of the sample sizes and so on that for the latest round of wara data for
example we we can't put a exact number on it I'm sorry for going so far over
our time got away thank you I believe that the other commissioners do not have
any additional questions but Commissioner Moe Harvick does so at this
point I'd like to take a five-minute break and then we will resume this
hearing thank you
thank you we're going to reconvene the briefing
for about one minute in what has been decided is there are
additional questions so we will take an hour break for lunch and then resume
it's it's 12:15 now it's 12:11 but we'll say it's 12:15 so we will resume this
briefing at 1:15 to allow any of the commissioners who have remaining
questions to go through those questions thank you