Document ID: EPA-HQ-OPPT-2008-0785-0026
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-02-25T05:00Z

UNITED STATES OF AMERICA PRIVATE  

	ENVIRONMENTAL PROTECTION AGENCY

	+ + + + +

	PUBLIC MEETING TO DISCUSS

	ENHANCEMENTS TO ChAMP

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	Monday, December 8, 2008

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		The meeting came to order at 1:00 p.m. in room S-1204 of 2777 Crystal
Drive, Arlington, Virginia.  Charles Auer, Director of the Office of
Pollution Prevention and Toxics (OPPT), presiding.

PRESENT:

JAMES B. GULLIFORD, ASSISTANT ADMINISTRATOR,

Office of Prevention, Pesticides, and Toxic Substances

CHARLES AUER, DIRECTOR, OPPT

WENDY CLELAND-HAMNETT, ASSISTANT DIRECTOR,

	OPPT

LOUIS (GINO) SCARANO, OPPT RISK ASSESSMENT

	DIVISION

OSCAR HERNANDEZ, DIRECTOR, OPPT RISK

	ASSESSMENT DIVISION

JIM WILLIS, DIRECTOR, OPPT, CHEMICAL CONTROL

	DIVISION

KEN MOSS, OPPT CHEMICAL CONTROL DIVISION

	

TABLE OF CONTENTS

Description	Page

Introduction	3

Presentation by Jim Gulliford	5

Panel on Inorganics HPV Challenge Program

	Presentation by Dr. Scarano	21

	Comments and discussion	36

Panel on Resetting the TSCA Inventory

	Presentation by Mr. Willis	52

	Comments and discussion	66

Closing Comments	104

Adjourn

	P-R-O-C-E-E-D-I-N-G-S

	1:00 p.m.

		MR. AUER:  Good afternoon and welcome to EPA's public meeting on
several enhancements to the Chemical Assessment and Management Program. 
The two enhancements are the Inorganic High Production Volume Challenge
and the inventory reset concept. 

		This is a public meeting notified in the Federal Register and as such
we are interested in getting your oral comments here.  We will be
preparing a summary to put into the relevant dockets.  We are also very
interested in getting your written comments on these topics.  I would
encourage you to think about the discussion that occurs today and if
there are additional points that you would wish us to be aware of,
please submit them in writing.  The address can be found in the Federal
Register Notice for this public meeting and the information is also
provided in slides for each of inventory reset and Inorganic High
Production Volume Challenge Program.

		A couple of logistics.  We do have a number of people who are
participating by phone so we ask that if you have a question or a
comment to offer that you use a microphone and that will ensure that we
get good pickup.  		The structure of the meeting is different panels
will go through to discuss each of the topic areas and then during the
comment opportunity, if there are questions, either the panel or -- I
have Wendy Cleland-Hamnett.  Do you want to stand up, Wendy?  Wendy has
been named the Acting Office Director effective January 2nd.  So Wendy
is someone you want to get to know if you don't know her at this point. 

		We also have staff from our Office of General Counsel here as well, as
well as other staff who know the details of the inventory, the initial
inventory development process, or the Inorganics HPV Challenge and what
not and so we'll try to get you the best information that we can in
response to your questions.  

		So that's the meeting logistics.  We will begin with a presentation by
Jim Gulliford who is the Assistant Administrator  for the Office of
Prevention, Pesticides and Toxic Substances.

		Jim has been the AA for two and a half years and before that he was
the Regional Administrator in Region Seven which is in Kansas City.  He
did that for about five years before coming to Washington as the AA for
OPPTS.  Jim will offer an update on the ChAMP work.  Jim will be
followed by the HPV Inorganics Challenge panel and then the Inventory
Reset panel will come next.  We will have the relevant panels come up at
each point.  So, Jim why don't you take us through ChAMP.

		MR. GULLIFORD: Well thank you Charlie.  What I would like to do though
first is begin by also recognizing obviously my colleague Charlie.  The
reason that, as he mentioned Wendy is going to be acting in January, is
that Charlie has announced his retirement at the end of the year. 
Charlie has been a tremendous asset to the Office of Prevention,
Pesticides and Toxic Substances and the OPPT office for many, many years
and while we are certainly going to miss him, we wish him all the best
in his new career endeavors and we know that Wendy is well prepared to
step in and our programs will continue seamlessly.  That's our
commitment to you.

		Well, it’s my pleasure to be here this afternoon and to welcome you.
 I thank you for coming out and attending.  The attendance certainly
reflects the interest in this program.  For that we are grateful.  

		I offer one more logistical point.  Those of you that are on the
phone.  If you would mute your phones as well so that we don't hear the
shuffling of papers and the pets and the children crying in the
background.  That will be helpful to us because if we were to mute your
phones, then we wouldn't be able to get your comments and questions when
the appropriate time came.  So if you will mute your phones for us and
then break in when you have an opportunity to ask questions, we would
appreciate that.

		I want to talk a little bit about the ChAMP program as our commitment
to the Security and Prosperity Partnership; that was the framework under
which we initially put it together.  But I would also add something I
think that's very important because now it has become the ChAMP program,
a fundamental part of the Agency's chemical regulatory framework under
TSCA.  We think that is a very important role for it.  

		As you know at the Security and Prosperity Partnership Summit in
Montebello, Canada which was a year ago last August, President Bush and
his counterparts from Canada and Mexico announced a number of new
initiatives on chemical management for North America.  We believe that
these commitments will significantly contribute to the, what we know
about, the body of knowledge that we know about chemicals and their use
in all of our countries, but also will allow the Agency to pursue
mitigation and actions on chemicals as appropriate as well.

		We believe that not only will this commitment benefit all of our
countries as we cooperate together but then we will have actually some
of each of the individual nations on the basis of their commitments
under this agreement will benefit as well from that.  

		The US commitments under the Security Prosperity Partnership call for
EPA to assess and then initiate needed action on nearly 7,000 chemicals
produced above the threshold of 25,000 pounds per year.  So this
includes both our high production volume chemicals as well as our
moderate production volume chemicals.  The decisions that we make, the
risk-based prioritizations or hazard-based prioritizations that we make,
will be available to the public on our net like virtually all of our
actions and all of our decisions that we make.

		So the information is publically available and a part of that
commitment as well is that where we identify concerns or risk-based
prioritizations of our highest level and our highest interest, we will
begin to take actions on those chemicals as well.  So those high
priority, special concern RBPs will be the source of our initial actions
toward again making regulatory decisions, taking action and I'll speak
to some of those issues later how we would do that.  But again, it
becomes essential to the regulatory framework again, under TSCA that we
have for chemical management in the United States.

		EPA's efforts to meet these Security and Prosperity Partnership
commitments, that are referred to as ChAMP, as I have said before.  But
ChAMP, also from the initial time that we put together the concept of
ChAMP, we began looking at a couple of other initiatives that we might
make in addition to the commitments of the SPP.

		And those, as Charlie has already identified them for you and we will
have discussions from other staff and other panels at a later point in
time, would be to develop some type of a high production volume
challenge program similar to what we have done for the organics but this
would be for inorganic chemicals and secondly the consideration of a
TSCA inventory reset.

		This is a slide that you've already seen, almost.  It has changed just
a little bit, but if you take a look at, particularly at that second
bullet.  We plan to build, as I said, off of our HPV Challenge work. 
The thing that I would add to that is that we are committed.  We still
remain committed to completing the data sets for the high production
volume chemicals and the Agency is working now on our next test rule for
orphan chemicals under the HPV Program so you will be seeing that early
in the new year.  We also plan to benefit from the work of -- Canada's
work, their categorization work, as well, that they have used, and we
will use that particularly with respect to our moderate production
volume characterizations.

		And we also are looking at our inventory update reporting requirement
under our IUR rule which gives us exposure information that's very
important again to our HPV or our risk-based prioritization work.  And
again, EPA will release as always the screening level decisions and
initiate needed actions as appropriate. 

		So let me start and talk a little bit about our HPV chemicals.  We
developed, as I indicated, a screening process for assessing and
prioritizing these HPV chemicals using both our hazard data from our HPV
Challenge Program as well as the exposure information from the inventory
update reporting rule.  And for each then HPV chemical that we take
through this process, we are going to evaluate the potential risks
associated with it or identified with it.  And then, the process of
taking initial action whether they are, again, for those high-priority
special concern chemicals.

		We have the appropriate authorities under TSCA to ask for additional
data, additional testing, if necessary.  We can implement or require
control measures that are taken to address and reduce the risks, or the
exposures.  And the other option is, if a chemical is identified as a
low priority from a concern standpoint, we can set it aside with the
understanding that should additional information be generated to elevate
the concern for that chemistry at a later point in time, we can
re-examine it and take that up.  As I said, EPA is posting these
risk-based prioritizations including, then, the hazard data on which the
decision was made, the exposure information that's there, the risk
characterization assessments that we make.  All of that is being posted
to the agency's website.

		We've had a lot of interaction on those postings already but we're
actually moving to develop a more definitive process, an electronic
process to allow the public, again, to post comments that they might
have on these decisions right to us through that  website or that port
portal.  So it's a very, it will become a very interactive opportunity
for us as we move into the future.  

		Getting a little bit more specific on the types of actions or the
tools that we have to follow-up when we've made these risk-based
prioritizations, again, the high priority special concerns, we will move
immediately on.  And in fact we have begun on several of those that have
already been identified.  Starting from the bottom of this list, again
as I said, if it's a low prioritization, we can set it aside for future
consideration.

		But if we do conclude that there is an action that's appropriate on
the basis of the prioritization screening that we do, we have again all
of the authorities under TSCA but also the Pollution Prevention Act.  We
have opportunities to engage in positive interactions with industry to
either develop some type of a challenge program, to use a program like
Designed for the Environment to work on alternative products that could
be used, again to reduce the risk associated with use of any of these
chemicals.  So we have a whole suite of regulatory and non-regulatory
approaches or actions that could be taken under either TSCA or the
Pollution Prevention Act.  

		For moderate production volume chemicals, those produced between
25,000 and 1,000,000 pounds per year we're going to take a different
approach.  We don't have the HPV challenge data for these chemicals nor
do we have IUR reporting exposure information for these chemicals
either.  So we don't have the ability to produce a risk-based assessment
for each of these chemicals as we do for the HPV chemicals.  Thus we are
generally going to rely on the results of our hazard assessments and our
own initial, for our own initial MPV prioritizations.

		And this is a key difference between what we are doing with the
moderate production and the high production volume chemicals.  We'll be
using available data.  We'll be taking advantage of the chemical
categorization work that our Canadian colleagues are doing and we'll
have the opportunity to apply the structural activity relationship work
that we use as an agency to look at moderate production volume
chemicals.  So the hazard characterizations that will be used for our
moderate production volume chemicals, then, will allow us to bin these
chemicals again on a priority basis in those cases where we see the
highest priority identified under the basis of the hazard
characterization work that we do.  We'll have those same TSCA and
Pollution Prevention Act opportunities to address concerns that are
generated for the moderate production volume chemicals.  So the process
at that point can be very similar actually, although it might start by
generating the type of information that we have for our HPV chemicals as
well.  

		This slide outlines our progress to date and our plans for the coming
year.  You can see that the focus has been to develop process, to do
some initial screens on the basis of the development of this process. 
You can see the numbers that are there.  Today we posted -- to date
we've posted almost 300 hazard characterizations.  We've done risk-based
prioritizations for 150 HPV chemicals.  We've posted as well a small set
of hazard-based prioritizations for our moderate production volume
chemicals as well.  We expect to add to that even in the next several
weeks.  So we're completing some more in that category.  

		Our goal for 2009 is to continue to refine our process, again which
happens through the interaction with chemicals --  chemical industry,
with non-governmental organizations as well as they look at the postings
that we make, but also then to get us into a more production-oriented
higher volume kickout of these RBPs and HBPs for our moderate production
volume chemicals.

		Now to take us to the two important issues of the day, this past March
EPA Administrator Steve Johnson announced that we were going to engage a
wide array of stakeholders into a discussion on these two enhancements,
potential enhancements to ChAMP and we did a number of meetings around
the country and here in Washington D.C.  We did webcasts.  We met with
wide-ranging audiences.  We met with narrow constituency groups to come
up with input on whether or not it would be appropriate and how we might
engage these two issues of the inorganic HPV type of a challenge program
as well as a TSCA inventory reset.  And if you recall last September, I
announced the Administrator’s decisions on ChAMP to both move forward
on both of these programs.  First to move forward on a reset of the TSCA
inventory and second, at a phased in point in time, to develop some type
of an approach like the HPV Challenge for inorganic chemicals as well. 
And you'll be getting, we'll take those two up one at a time.  

		The last thing though that I want to talk about if we can go to the
next slide is that again to make the point that the ChAMP program is not
a substitute for the HPV Challenge Program.  As I indicated, it is our
intent to complete the data sets for the HPV Challenge Program and that
they will be folded into and will be an integral part of the screening
that is done under the ChAMP program.

		Secondly, it’s not a program that operates independently of
everything else that is happening around the world.  We will work very
closely with our Canadian and Mexican counterparts on our commitments to
the Security and Prosperity Partnership and as you can see from the
slide that the dates also match up pretty well with what's happening in
the European Union as well and we believe that there will be points in
time when the dossiers on chemicals that are submitted under the REACH
program to the EU will provide us very helpful information as well as we
look at the  chemicals again that rise to the surface through our
screening process under the ChAMP program.  

		So these programs, I think, will work very well together not only from
a content standpoint in terms of the actions that we are taking but also
from a timing standpoint that we will, we look forward in fact to taking
advantage of information that is generated under the REACH program as
they receive their data, dossiers as well.  

		So we can close.  Again, this is where you can find information on the
ChAMP program, additional information.  This is also a point where you
can be connected to the postings that come from the ChAMP program at the
EPA website.  

		With that, I thank you for your attention.  I'm going to turn it back
to Charlie and we'll get to our two panels of today's interest.  Thank
you.

		(Applause.)

		MR. AUER: Thank you Jim for that stage-setting presentation, which
sets up the two discussion items for this afternoon's public meeting. 
The first panel is on the inorganics HPV Challenge Program and if I
could get Gino and Oscar to join me up here at the head table.  Gino
will be offering the presentation.  His presentation will flow from the
document which was noted in the Federal Register Notice.  This is the
proposed approach for the Inorganic High Production Volume Challenge
Program.  And without further ado, I'll give you Dr. Scarano.

		DR. SCARANO: Good afternoon.  Thank you Charlie.  And as Charlie said,
this is going to speak to the proposal for the Inorganic High Production
Volume Challenge Program that OPPT, that is, part of the enhancements to
ChAMP.  

		(Slide 2) Just very quickly, I will go through the TSCA definition of
an inorganic.  And then speak to the proposal both in general terms and
then specific issues that we are thinking about and looking forward to
feedback from you on, and then the next steps as we see it over the next
year.  

		(Slide 3) This is the TSCA definition of an inorganic.  Without
reading it verbatim, I just think one of the interesting things was a
chalcogen, which I had no idea what one was.  As it turns out that's
group 16 on the periodic table.  There are six compounds there.  Oxygen
and sulfur, selenium, tolerium, polonium and one that I wasn't aware of,
the newest synthetic one, ununhexium with the wonderful acronym UUH.  

		(Slide 4) Now getting to the IHPV Challenge Program and the general
points that I spoke about earlier, as Jim Gulliford said, it's a recent
enhancement in the ChAMP program and the effort is to characterize the
toxicity and environmental, physical, chemical properties of inorganic
chemicals that are manufactured or imported in greater than a million
pounds, a definition of a high production volume material.  And thereby
allowing us to assess and initiate any needed follow-up action which is
the spirit of ChAMP and SPP.  

		(Slide 5) The challenge program over the past ten years has focused on
approximately 2,800 organic chemicals.  This past inventory, the 2006
inventory update rule, for the first time included reporting of
production volume for inorganic chemicals.  Some preliminary numbers
show that there are about 763 on the 2006 inventory and there's the
rough cut of the number of HPVs versus MPVs.  And the only other thing I
wanted to note in this slide is that in 2011, according to the IUR, use
and exposure information will be subject to the reporting rule.

		(Slide 6) As was mentioned, the current thinking on how we are going
to approach this proposal is in a document that is in the docket that
most you hopefully have already looked at.  We are interested in both
oral and written comments on this proposal. We are looking forward to
identifying work with stakeholders to develop and implement this
proposal.

		(Slide 7) Now, as we see it, looking at the big picture of timing and
association with SPP, we are looking at phase one being for the next
year: coming up with developing, launching and having the sign-up for
the challenge program.  And then phase two would be implementing the
challenge, where we would be receiving the data and reviewing the
information and this would speak to the 2010 to 2013 time frame.  We
would like to mention here that one of the lessons that we learned in
the HPV Challenge Program for organics is, I think, we will be
vigorously using Section 4 of TSCA to make sure that there will be test
information for HPV inorganics that have not been sponsored.

		And then lastly, phase three would be the dovetailing with the ChAMP
initiative and incentive to assess and initiate needed action once the
exposure information from the 2011 IUR and the hazard information that
came forward in the challenge program came together.  During this time
also as we are doing with the HPV Challenge Program in the spirit of
ChAMP, MPV, moderate production volume chemicals will be looked at in
the same fashion using information that's available on HPV inorganics
and using that to inform possible MPV hazard and screening level risks
evaluations.

		(Slide 8) The two main specific issues that we mentioned in our
proposal and that we wanted to present in this particular public meeting
setting was: (1) using the information that's out there in OECD, the
Canadian categorization process and REACH, that is specific to IHPV in
making sure that we can use that information in our IHPV challenge
effort; and (2) then in the MPV hazard-based prioritization process, a
cluster approach was used where structural analogies, structural
relationships between HPVs and MPVs are used to take advantage where
there is hazard information on the HPV and have it apply to the MPV and
we are going probably we are going to consider a similar approach with
inorganics where we cluster similar chemicals together.  And then at the
end I'm going to show a couple of other things that we are aware of that
will likely be useful as we go forward in this IHPV Challenge Program.  

		(Slide 9) In the OECD, which probably most of you know is the
Organization for Economic Cooperation and Development, there are well
over 30 countries that are active in this.  They are called member
countries.  And they were instrumental and started the HPV challenge
type program at the international level in 1991.  And that served as the
basis for the U.S. HPV Challenge Program a few years later.  And the
idea there is they developed an internationally agreed upon, what's
called a screening information data set, or SIDS, which is and I'll show
a couple of slides later, its essentially descriptors to look at the
hazard of a compound.  But I think one of the important things here is
to realize that to date, since `91 there have been 887 completed
assessments in this international forum where all these different
countries have gotten together and agreed on some conclusions.  But only
616 of them are actually posted.  That's the difference between getting
the work done and actually getting it out so that people can access it.

		(Slide 10) Now taking the OECD HPV Challenge Program and trying to get
a handle on how many inorganics are involved in that, that can be useful
in our effort: there are about 160 inorganics in the OECD HPV program
and 109 of them have gone through the process and about another 50 are
getting through the process where they are still collecting the hazard
information and there hasn't been a review or conclusions or
recommendations made.  When we take a look at the 700 -- I know I said
763 earlier, but it's roughly a little over 750 2006 IUR inorganics;
about 115 of them have actually been through the OECD HPV Challenge
Program and about 74 of that 115 are actually HPVs.  So we're looking
forward to looking at this information closely and seeing how we can use
it in our IHPV challenge effort and it will be useful to all
stakeholders as well.

		Now, the OECD existing guidance is a useful starting point but of
course inorganic chemicals are not organic chemicals and we'll speak to
that a little bit.  But we're also looking to the inorganics for a
useful way to approach -- the way the OECD is looking at inorganics as a
useful way to approach inorganics in our U.S. program.  

		(Slide 11) The only reason I show this slide is, this is a snapshot
from a spreadsheet that shows all the inorganics in the OECD HPV
Challenge Program.  And there are 19 compounds listed here.  The way
that the OECD approached this was there were four -- just a few -- that
were considered as individual compounds.  But then there are two groups,
the zinc groups and the iron groups that were clustered together and
considered as a category in going through the analysis of what
information should be used to describe the hazard.  And the whole idea
behind a category is if you have some hazard information on one member,
it might be applicable to another at least for this SIDS level, OECD
screening level hazard characterization purpose.  So that's something
that we've been using for a while and will continue to.

		(Slide 12) And as I said earlier, this is the OECD hazard set for
organic chemicals, four basic parameters: physical-chemical properties,
environmental fate, environmental or eco-testing, and human health.  You
can see the different individual properties that fall under each of the
four major groups.  Now a quick look at this, I think most people who
know inorganic chemistry will realize some of this won't be applicable. 
So I think that's one of the things that we are looking for comments on.
 

		Now the OECD in some of their recent guidance in looking at grouping
categories, also understands the basic difference between inorganic and
organic chemicals and they are starting to try to come up with different
ways to measure hazard than what was done for organic chemicals. 

		(Slide 13) These are some of the properties that they believe are more
important in an inorganic, for an inorganic chemical, and something that
we are going to look at closely when we are coming up with the best data
set to look at for inorganic chemicals: the disassociation of the
metal-containing compound, speciation and valency, crystalline
structure, particle size and in vitro solubility.  And the idea with the
in vitro solubility is trying to get a handle on bioavailability and
that can be from the human health side as well as the eco side.  On the
human health side, you can think about perhaps doing some studies with
different inorganics that look at lung fluid, gastric juices, synthetic
sweat, that kind of stuff.  		So we are looking at this information that
the OECD has brought forth and we are thinking about how we can use that
to try and come up with the best way to describe the hazard of an
inorganic.  

		(Slide 14)) We will probably be focusing on p-chem (physical chemical
properties) and environmental fate and bioavailability will be the key
thing for human health and eco: to notice how much of the inorganic is
actually going to be coming away from the matrix or the setting its in
so that it can perform or that it may be an adverse affect on the
organism that's exposed.

		So that's the OECD.  One of the other things that is happening in the
world theater for chemical regulations has been the Canadian
categorization where in 1999 (Slide 15) the Canadian Environmental
Protection Act required the government of Canada to screen their
Domestic Substances List which is similar to our inventory.  In that
process they looked at some IHPV chemicals as well.  So we are looking
forward to getting the results, looking more closely at the results of
that categorization effort to see what IHPVs were involved and how they
were treated in this particular process. 

		(Slide 16) And then on the EU side of things, I'm sure most of you are
aware of the recent passing of REACH, which went into effect a little
over a year and a half ago, but these past six months from June to
December of 2008, companies were required to pre-register if they wanted
to and that allowed for quite a few companies to bring forward the
chemical that they would likely be sponsoring and its an opportunity to
see what other companies are doing it, so there can be a sharing of
information.  This will be very useful to us as well and we're looking
forward to taking advantage of that work.  

		So that was the OECD, Canada and the EU effort.  Those three are all
kind of the same thing, taking advantage of information that's out in
the regulatory world.  (Slide 17) This cluster approach is something
that the U.S. EPA is doing in the moderate production volume
hazard-based prioritization effort and chemicals are grouped on clusters
based on structure.  And as we said, data rich chemicals which are HPVs,
which have hazard information largely based on OECD or the U.S. HPV
Challenge Program will inform the hazard of the MPVs which don't have as
much hazard information but, based on structural analogy, we think its
going to be useful.  Now, for inorganics we are considering a similar
approach.  But the big difference is going to be that we are considering
-- we'll develop the clusters and then bring it back to you for
comments.  

		(Slide 18) Now what I've done here is just looked at the 2006 IUR and
I just picked out five, six chemicals, they are all barium compounds and
I think many people will look at this and say well the six of these can
possibly be considered together.  There is a range of, you know,
titanium is on one end of the spectrum.  You have the chloride and the
oxide on the other.  So I mean I think there's a way that we can look at
these six compounds and perhaps use some information on one that will
apply to all.  But this is the concept of the cluster approach just
based on the metal and then we'll have to go a little bit further to
look at and see if it’s applicable in a category setting.

		(Slide 19) So those are the four issues that we wanted to talk about
here.  The two other things that we think are important is the EPA, in
the Risk Assessment Forum, which is like an umbrella group across EPA
that looks at risk assessment procedures and guidance to inform all
parts of the Agency, has spent a considerable amount of time in the past
five or six years looking at metals, understanding that in a risk
assessment framework, metals are going to be different.  Now I
understand the inorganic definition of TSCA is a little bit wider but we
do know that there's a lot of good information in this document and set
of documents.  They have a lot of subject or issue papers associated
with this particular risk assessment guidance that we are going to look
at carefully over the next year.  What we've done here is put the web
address for this framework for metal risk assessment and in that link is
also all the issue papers that speak to fate, properties, health and
eco.  

		And then lastly is the OECD guidance on categories that I already
mentioned.  This also is recent (2007) and that has some information
that will be useful. 

		(Slide 20) Now the next steps, and this just focuses on the next year,
where we're going to develop and launch and have a sign-up for the IHPV
Challenge Program.  We expect from now until the Summer of 2009 to
review all the information that I presented here and propose clusters
for inorganics for the IHPV.  And, in the Fall of 2009, we'll host a
workshop that will present this stuff and look to further elaborate on
issues and refine the approaches.  And then after that we plan to
initiate the sponsor sign-up and implement the challenge as described on
the second or third slide.  And that's it.  Thank you.  Looking forward
to your comments.  There's the docket number and e-mail address.

		(Applause.)

		MR. AUER:   Thank you Gino.  Why don't we begin with any clarifying
questions that you would like to pose and after that we can get to -- I
would like to begin with several people who have signed up to offer
comment at this meeting and then we will open it up for general
discussion thereafter.  So any clarifying questions?  Gino needs his
pen. There you go.  Are there any questions from any of the participants
on the phone?  

		Okay.  Why don't we take comment now.  I'm not sure in all cases which
topic individuals wanted to offer comment on but I've tried to guess a
bit and one name is Kristie Sullivan from the Physicians Committee for
Responsible Medicine.  Kristie, are you on the phone and did you have a
comment on the inorganics HPV Challenge?

		DR. SULLIVAN: Yes I am on the phone.

		MR. AUER:   Would you like to offer your comment?

		DR. SULLIVAN:   Yes.  I actually was just trying to ask a question.

		MR. AUER:   If you could, we're trying to pick you up.  If you could
perhaps pick up the receiver and speak directly into the phone.

		DR. SULLIVAN:   I am.  

		MR. AUER:   All right.  We could hear you very well now.  Okay, good,
thank you.

		DR. SULLIVAN:   Okay, I'll try to speak more loudly.  You know I
really have, I signed up to give comments just in case but I don't have
super extensive comments.  What I just wanted to say was PCRM definitely
supports the clustering approach and we're looking forward to the summer
seeing the clusters that you are planning to propose.  And I also have a
question on Gino's presentation.  When you were talking about the in
vitro solubility studies and you said something about lung fluid and
stomach fluid or intestinal fluid, could you clarify whether you meant
that there would be like an in vivo study, like an inhalation study
where then you would collect lung fluid or did you mean in an in vitro
study using some substance similar to lung fluid?  Do you know what I'm
asking?

		DR. SCARANO: Yes I understand Kristie.  Thanks for the question.  It
is in vitro.  

		DR. SULLIVAN:   Okay.  

		DR. SCARANO:   Yes and I think, although I don't know the specifics
but I'm guessing its synthetic.  

		DR. SULLIVAN:   Okay, all right.  Thank you.  That's all I have for
now.  I'll probably submit some written comments.

		MR. AUER:   Okay, very good.  Thank you Christie.  One of the points
to emphasize and Gino brought this out in his presentation is that as
opposed to the HPV Challenge where the sponsors were enabled to create
whatever categories of organic chemicals they wish to sponsor.  One of
the lessons that we've learned is that when you do that you sometimes
end up with categories that don't quite fit as well as you would wish
across the chemicals that are at play in whatever segment of the
industry you are talking about.  So under the proposed approach that we
outlined here, EPA would take it upon itself to develop the clusters. 
We would take those clusters through a workshop to get input into the
clusters that we have formed.  And then we would be asking the industry
to agree to sponsor some or all of the chemicals within a given cluster.
 We recognize that this could cause groups and industry who don't always
work together in a particular area, you know, it may be certain
chemicals in a cluster are relevant to one industry segment.  Other
chemicals in the cluster could be relevant to other industry segments. 
We recognize that could present some issues or challenges.  But we are
interested in the concept, exploring the concept of does it make sense
for EPA to structure these clusters in a way that we think might better
serve the ultimate purpose of the work.  If so, what are the issues and
problems that would be encountered.  We can identify those issues.  We
can undertake to try to see if there is a way to work beyond them. So
that's an aspect that we would be interested in really more general
comment today.  And then in the workshop that we plan to hold in the
fall of the year, there will be opportunity for really specific comment
on what works, what doesn't work, what solutions might be available. 

		DR. SULLIVAN:   This is Christie again.

		MR. AUER:   Yes Christie go ahead.

		DR. SULLIVAN:   I can speak to that really quickly.  Actually, from an
animal protection perspective, we would definitely support this sort of
reinterpretation of the categorization process because what we found
with the HPV Program is we commented on many different test plans and so
we had a more broad view of what companies were submitting but many
times companies didn't realize that their chemical and other very
similar chemicals were being submitted independently in different test
plans.  So that's one of the problems that we saw and I think this would
address that, so we would support it generally.

		MR. AUER:   Very good.  Thank you Christie.  I have Jim Cooper from
National Petroleum Refiners Association.  Jim, did you have comment on
this or the reset?  Or both?  Yes, he says yes.  Okay, here he gets the
floor.  And there are a few seats up in the front for those of you who
are in the way, way back like Jim.

		MR. COOPER: I'm sure there are.  First off Charlie, I want to take
advantage of my position as a taxpayer with this being a public meeting
and all, to just let you know of my appreciation for the fine work
you've accomplished in protection of health and the environment over the
years.  Its been a pleasure working directly with you, obviously with
your staff as well and I'm not going to say you will be missed.  I'm
going to say I will personally miss you and interacting with you.  So,
thank you Charlie for all that you have done.  

		(Applause.)

		MR. COOPER: For the IHPV, I'm very encouraged because I had a little
to do with way back when working with EPA staff and we  were still
talking about what a robust summary would look like and I know Gino
remembers that as well as so does Oscar.  I'm very encouraged by the
fact that you are looking at the past and that we're going to take
lessons learned from the HPV challenge as we are looking forward and
applying those to other chemical groupings and especially I like the
idea of clustering. I assume that's the same as we used to call
categories and I'm kind of glad we cleaned up the language a little bit
and generalized it to clustering.  I think it fits a little bit better. 
I'm hoping that a similar stakeholder process is used as we move forward
because I thought that that was a very valuable experience bringing in
various points of view in the initial stages of the program.  I think
that it designed a better all around program in the future.  I am hoping
as we look toward the past, we look at timelines, especially when we
look at some of the chemicals that may not be as straightforward or easy
to test as others.  Some of those timelines, I think EPA undeservedly
took a bashing over some of the time line slipping because people really
didn't understand some of the complexities involved with setting up the
test plans and I got to experience that firsthand with some very
difficult-to-test products.  

		The other thing is I would assume there's going to be great
consistency among both programs where one doesn't diverge and become
something that wasn't envisioned when the original program was even
designed.  So I would assume that.  And I also like the idea of allowing
arguments for certain endpoints based on physical properties especially
because obviously we don't want to have a large impact and an
unnecessary impact on animals when we are looking at these test plans
and how to move forward.  So, thank you very much for the opportunity.

		MR. AUER:   Okay, good.  Thank you Jim.  Randy Beyer from the Battery
Council International.

		MR. BEYER: I have nothing at this time.

		MR. AUER:   Okay, thanks Randy.  And I think Nelson, your comment was
on the reset or did you have one here too.  Okay.  So those are all of
the people who have signed up to offer comment.  The floor is now open
for other comment or discussion, questions or comments on the Inorganic
HPV Challenge.  Any takers?  Pat Cosano, GE Plastics, I think. 
Corporate Environmental Program.  I'll let you introduce yourself. 
That's safer.

		MS. COSANO: Pat Cosano, Corporate Environmental Programs.  I just have
some questions Charlie.  There have been some questions asked about the
existing ChAMP effort relating to what the criteria are by which
chemicals are being evaluated, opportunities for public input, and
opportunities for public comment.  And I understand that EPA is working
on those issues  with respect to the current ChAMP program.  In the
announcement of the IHPV Program, the formal announcement, will you be
addressing those issues specifically because I think that would be
helpful to participants or potential participants?

		MR. AUER:   If I could get a little clarification.  Are you asking for
direct comment opportunity off of a website or what exactly are you
suggesting?

		MS. COSANO: Well, for example, in the current program, risk-based
prioritizations are posted on the website and I haven't had this
instance personally and my company hasn't but if you have a situation
where information is posted and a company has additional relevant
information or relevant that -- or information that is -- contradicts or
is inconsistent with something that's been said in the RPB, how do you
go about getting a correction, for example, if a correction is
warranted, that kind of thing?  And then to the extent that people have
information that is relevant to a particular chemical, is there  an --
will there be an opportunity to submit it before EPA actually posts the
RPB? That sort of thing Charlie.

		MR. AUER:   Okay, yes.  Thanks for the clarification.  We -- as Jim
briefly noted, Jim Gulliford, we will be releasing our enhanced website
where you will have a direct comment opportunity on specific RBPs or
HPVs, so yes that will be available.  I think the plan is to get it out
some time relatively soon.  Do you know the date, Jim Willis?  But
sometime, I may not see it while I am still at EPA but soon thereafter. 

		And then on, what was your second question Pat?  Oh, the criteria.
Yes, one of the things that EPA will be working to do in 2009 is to post
the chemicals that we plan to assess in a forthcoming quarter or six
month period.  We think that, this is a comment that we've gotten from
several commenters.  We think that that would be useful for EPA to allow
us to plan our work.  It would also be useful for those of you in
industry or NGOs, others, to be in a position to anticipate when given
chemicals are likely to come through.  And so we will begin doing that. 
We've hesitated to do it to this point because we're still trying to get
our arms around the overall process for assessing and developing the
documentation, finalizing it, getting it posted, developing the
commenting opportunity and various other things.  Now that we think
we've got our arms around a lot of the logistics, we will be working in
2009 to begin announcing in advance the chemicals that will be coming up
within given future windows of time.  So we look forward to your
reactions to that when that is available.  

		Are there other comments, discussion on any of the aspects of the
Inorganic HPV Challenge?  Yes, back of the room.

		MR. CONRAD: Yes, James Conrad with Conrad Law and Policy Council.  Two
questions.  The first relates to slide 15 which talks about Canada's
categorization information.  The second bullet says EPA will look and
apply the results of the Canadian Categorization where relevant.  That
doesn't mean just an automatic carryover of whatever Canada has
concluded necessarily?

		MR. AUER:   Well, we would look and judge, then apply.  So yes, we
will consider as information that we would consider from any source.

		MR. CONRAD: The second question on the next slide talking about the EU
and REACH the last bullet says REACH HPV registration data sets would
more than meet IHPV challenge needs, which suggest that at least with
respect to chemicals that REACH has taken into account, which I would
assume probably include many if not all of the U.S. ones, the only
accomplishment of the IHPV initiative would be to speed up the process
of generating and releasing the data in the early analysis part of it
perhaps.

		MR. AUER:   Yes, well I think we will know more once the EChA,
European Chemicals Agency sorts out the pre-registration information
that they've received.  We will be very interested in understanding
those chemicals which would come in at whichever tier within the EU's
registration scheme because that will tell us the type of information
that will be made available as well as the timing of that information. 
So we would be looking to cross that list of chemicals with the U.S.
list.  We think there's likely to be a lot of overlap.  Is it going to
be 40 percent or 70 percent?  I don't think we know at this point.  We
know that many of these chemicals are common to both the European EINECS
and the TSCA inventory but the volume may differ from jurisdiction to
jurisdiction.  So, as with the Canadian information, we think that that
would be a very valuable source of information and to the extent these
are in the highest production tier in Europe.  Yes, that information
would be available to the EU, December 2010 and we would expect to get
it shortly thereafter.  

		MR. CONRAD: Thanks.

		MR. AUER:   Any other comments or discussion?  On the phone?  No. 
Okay.  So if there is nothing more, this is your last chance.  Nothing
more on the Inorganic HPV Challenge?  Going once, going twice, closed. 

		We will now go to the proposed approach for resetting the TSCA
inventory.  Thank you Gino and Oscar.  Jim Willis will join me up at the
front table.  The inventory reset was discussed in the document noted in
the Federal Register Notice.  This is titled - background discussion
piece.  EPA's TSCA inventory reset.  Jim Willis, the Director of the
Chemical Control Division in OPPT, will walk us through that and set us
up for a discussion opportunity.

		MR. WILLIS: Thank you Charlie.  And let me join those who have said in
various ways that you will be missed, because its hard to picture a
leadership other than the leadership that both you and Jim Gulliford
have provided that would create an environment where we could be talking
about resetting the TSCA inventory, now 30 years after its creation.  I
think this has been a refreshing challenge for many of us to think about
doing something like this.  Plus I do share something with Jim other
than first names, and that's inability to use this thing.  Gino.  There
we go.  

		Okay, as you TSCA mavens know, TSCA Section 8(b) requires EPA to
compile, keep current and publish the TSCA inventory.  And, up until
now, we've considered "keep current" to be generally add chemicals as
they come through the new chemicals program and where there has been a
notice of commencement.  The initial inventory had about 62,000
chemicals on it.  We are now up almost to 84,000 chemicals, with 21,000
to 22,000 having been added through the new chemicals program since
1979.  We've taken a step beyond just maintaining the inventory
beginning in 1986 with the Inventory Update Rule which we now require
reporting on every five years.  And I think anything we do with the
inventory has to factor in that as part of the process.  

		The inventory reset was recently announced as Jim Gulliford mentioned
as one of the enhancements to ChAMP, and our current thinking is in the
background document that hopefully you've downloaded from the web. 
We're interested here in oral comments, and subsequently, certainly
written comments that you might have.

		Let me just check and make sure I'm not skipping over anything.  This
moves a bit quickly when I click it.

		The inventory supports many-- almost all of our office's regulatory
functions.  In fact, it’s at the heart of what we are.  We have -- our
new chemical program is based on the existence of the inventory.  Many
of our existing chemical activities-- the IUR and subsequently the ChAMP
data reviews that come from that-- rely on the inventory.  So it’s
very important for us in the office to have a current inventory.  We
also think it’s important for the public to actually know which
chemicals are being manufactured in the country.  The IUR says the
25,000 pounds and up, but of those more than 75,000 chemicals we don't
really have a picture of what's still in production and what is not in
production.  We also think that having an accurate and online inventory
would be useful to stakeholders in general and could help companies
comply with various reporting regulations.  For example, in the last IUR
reporting cycle, there were a substantial number of incorrect chemical
name or CAS number reports that still haven't been processed because of
the difficulties here.  So having an online inventory could greatly aid
with such matters.  

		We are calling the approach a clean reset, and I'll explain that in a
minute, but it would give us a better tool to protect human health and
the environment from chemicals that may present a risk.  One would be
the ability to use the new chemicals program to look at chemicals that
might be coming back into commerce having been out of commerce for a
long period of time.  And that would also give us the ability, if
appropriate, to take action: to control risks or to require additional
testing.  

		We wanted to apply a number of design considerations before going too
far.  We thought an inventory and the effort to produce the inventory
reset should be useful to EPA's mission of protecting human health and
the environment.  It should be useful to stakeholders.  I described a
little bit of that in the preceding slide.  It shouldn't penalize
companies.  What do I mean by that?  Well, there may be cases, for
example, where a company is processing existing stocks and has been
processing those existing stocks for a while, and we don't necessarily
want to create a situation where abruptly, because they are not a
manufacturer or importer, they are put out of compliance.  So we need to
figure out how to accommodate such situations.  There may also be cases
of, for want of a better term, "intermittent manufacturer" by companies
where the idea here is not to penalize companies, but rather to maintain
as accurate of an inventory as we can.  So we are really looking for a
number of comments on workability of approaches and options for
designing the most workable reset program.  It should be fast and easy
to implement.  It should be low burden both on EPA as well as on
companies that might be engaged in reporting, and my lawyers keep
telling me it has to be done consistent with TSCA and other laws that we
have to implement.

		Now what we have not really done in the papers is explain kind of
where we are in the process.  So let me do that now.  We're seeking very
initial reactions to some general ideas.  We are not locked into any
particular course of action here.  And so, really any idea for a reset
and your thoughts about some of the things we've put on the table are
what we are after.  At a later stage, in about six months down the road
or so, we will propose an approach and seek comments on that.  And then
we will finalize the approach.  So this is an early round of comment,
but because we would like to synchronize this with the next IUR
reporting cycle, so that we don't have two out of alignment processes. 
We will need to move forward over the course of the next year in
proposing and finalizing this approach.

		The general approach would be that we would put a public version of
the current TSCA inventory online. Chemical CAS numbers, chemical names
that were not confidential would be put there.  Generic names if the
chemical was confidential along with the accession numbers.  Then
companies would have a period of time to certify on a secure website
that they have manufactured-- and that includes importation of a
chemical listed on that inventory within a specified time frame.  Now,
we're not wedded to any particular specified time frame.  We suggested
three years because that is the initial inventory reporting time frame. 
But we're open to comments on time frames.

		I see this as being fairly simple, hopefully.  Maybe it's a matter of
companies checking or flagging the inventory-- or the term I would like
to use is "drag and drop."  So, you click on an entry and move it over
into your reporting form.  We think it needs to be very simple and easy
to use.  Once the end of the certification period had run its course,
EPA would process those certifications, publish a new version of the
online inventory that any chemical certified by one or more companies
would be on that inventory.  Then persons would have some limited time
opportunity to make corrections.  We recognize it's not necessarily
going to be perfect the first time through.  What we want is to make
sure that it is accurate.  And then after that, a PMN or other Section 5
notice would be required prior to manufacture of a non-exempt chemical
substance after it had been removed from the inventory.  I mentioned the
need to coordinate with the IUR.  The next IUR reporting period for
chemicals manufactured during 2010 calendar year, the reporting period
is June 1 through September 30, 2011.  It seems like a long time away
except in regulatory terms.  It's right around the corner for us.  

		There are, I think, two considerations.  We would like to see this
reset inventory online in advance of the actual reporting deadline for
IUR, and that would help alleviate the Chem ID reporting problem and
allow us to get the inventory-- the IUR data-- out to the public much
faster than has been possible.  So this is one of our design objectives.
 We'd like comment on how far in advance we should do this, and how best
for companies that would have to both certify and report-- how best to
do this to reduce burden on you?

		We'd also like to consider subsequent periodic reset efforts that
could occur then in conjunction with the IUR.  We think this may open up
a number of areas that we've not gotten a lot of comments on in the
past, and so I think we would expect to go through a number of
correction exercises where companies may be unable to find their
chemical on the inventory, or they might not be the same company that
originally reported.  And so we understand that there would be a need
for EPA to really have a bit of clearing house function here to
accommodate an increase in inquiries, possibly including an increase in
so-called bona fide submissions.  The areas where we're looking for
comment, the certification approach is proposed as an 8(a)-only
approach.  We could, as an alternative, issue a rule under Section 8(a)
basically compelling companies to fill out a report and submit it. 
There may be more burden associated with this sort of approach.  Clearly
every company producing a chemical would be, would have to report-- as
opposed to the certification approach where only one company basically
would be enough to get a chemical on the reset inventory.  Another
potential weakness of relying on 8(a) is that there is a small business
exemption and so using 8(a) alone may not capture all of the chemicals
that are in commerce, and so this could create a set.  I'm not sure how
big the set is of chemicals that didn't get on the reset inventory.  It
might then lead to a longer correction cycle and so forth.   

		We also looked at approaches, alternatives to simply removing
chemicals from the inventory and requiring a PMN.  One would be to
basically issue a Significant New Use Rule for all of them.  That might
be done by maintaining an active inventory and an inactive inventory,
and then having a Significant New Use Rule for everything on the
inactive inventory.  I'm not sure that that's simpler for anyone, and it
is probably considerably more burden for many of us.  It also has
Section 12(b) export notification implications too.  So another-- some
reasons why this was not our preferred approach but we would like
comment on this.  

		Another area we'd like comment on is, are there approaches other than
some past manufacture, say the past three years, where certification
could be based?  For example, if manufacturer, if a company said, "I
intend to manufacturer in the next year or next six months or next time
period"-- and if we were to pursue an approach like that, what should--
how should the Agency implement that?  So do we need companies to submit
something like a notice that says "Yes, we did commence," and if we
don't get that notice then in a year's time those come off or so forth. 
So, comments on how we might implement a forward looking certification
period-- if that is even desirable-- would be welcome. 

		I mentioned the sort of in passing the potential issue of errors
inadvertently introduced in doing the final inventory.  Should we
provide such a correction cycle?  If so, what sorts of time frames or
procedures should we request before allowing such corrections to be
made?  Another area we would like comment on.

		And lastly, let me take up processors.  We sort of hoped to keep this
simple and focus our initial thinking on manufacturers and importers.
But indeed 8(b), if you read beyond the "compile and keep current part,"
says a list of each chemical substance which is manufactured or
processed in the United States.  And so the question we'd like feedback
on is, how should EPA address chemicals that are processed only?  I
mentioned this could be an issue with existing stocks, for example.  Is
this a realistic scenario?  Should we create a scheme for processors to
also certify?  Some of you, I'm not sure any of you were around-- maybe
Charlie was almost here at the initial inventory.  We did have a
separate process, a second reporting period which allowed processors to
report.  So, this is another area we would welcome comments on.  

		Last slide please.  I think that's about it.  We'd very much welcome
your comments on the thoughts.  Charlie.

		(Applause.)

		MR. AUER:   Thank you Jim.  And Jim and I have been joined by Ken Moss
up here at the front table.  So now it is an opportunity for comments
and discussion on the inventory reset.  As Jim noted, we are at an early
stage in our thinking.  I don't know that we are necessarily looking for
final answers at this point.  We are particularly interested in
understanding issues or approaches, other options that we have not
identified so that we can consider those issues or options as we take
our thinking forward with an eye towards having another turn of the
wheel in this process some time during 2009.   

		I'd like to begin by asking if there are any clarifying questions on
any of the elements in Jim's presentation.  Yes sir. 

		MR. JOHNSTON: Tom Johnston, McKenna, Long & Aldridge.  Jim, I just had
a question about the concept of an inactive inventory section.  That is
an intriguing idea.  I wondered if you had-- if you created  a category
of inactive chemicals for the inventory which were not in categories of
concern-- if the Agency would also create some sort of expedited process
for resurrecting those chemicals and putting them back on the inventory?
If that was under consideration, as opposed to sending them through the
PMN process?

		MR. WILLIS:   Yes, indeed the thought came up in deliberations about
whether we should offer up maybe a shorter review period or less than a
PMN or something like that, to move things from one place-- basically
from one list to another.  And so yes, it's certainly something we would
consider during comment.

		MR. AUER:   I think the other point to note is concept of an active
versus an inactive list.  That seemingly has several ways that it could
work.  It could be strictly an informal listing, which is really more
for program management purposes-- understanding the set of chemicals
which are in commerce at any point in time ranging to an approach where
it could serve as the selection set for Significant New Use Rules and
their various other alternatives along the way in an approach that would
use an active versus inactive listing of chemicals on the inventory.

		Other clarifying questions?  Any on the phone?  We have one more in
the room?  		DR. THIAGARAJAN: Ted Thiagarajan, MBC of Malaysia.  Could
you comment on the how foreign manufacturers could get involved in this
exercise?  I guess it's just the involvement would be similar to U.S.
manufacturers, or do they need some sort of an agent to participate in
the process?

		MR. AUER:   I think-- do you want to go ahead, Jim?

		MR. MOSS: I was just going to say  I'll give it my best shot.

		MR. AUER:   Sure go ahead.

		MR. MOSS: Wish me luck.   This is a generic question about submitting
new chemicals.  In the first place, you do need a domestic
representative or agent in order to supply a pre-manufactured
notification in the first place.  So it would be the same thing in this
case.  

		MR. AUER:   Yes, a lot of times it's the importing entity will act,
and so the foreign manufacturer who is exporting to the U.S. would work
with whoever the importing entity might be, and they could then handle
that information as appropriate.  So I mean I think our general thought
is that we would try to apply approaches consistent with those that
already exist, and in that way hopefully make it easy for foreign
manufacturers to get their information in.

		Another question?

		MR. BOUMA: Dirk Bouma, BMT REACH program.  Just curious as to a
following question to that, as to whether the U.S. would consider
developing only representatives?

		MR. AUER:   We haven't thought about that.  We'll see how it works and
consider, but I think that we would have-- we would develop an approach
that would ensure that foreign companies are not disadvantaged in seeing
that any chemicals which are imported into the U.S. during the reporting
period are accurately reflected on the inventory.

		We have another question.

		MR. DUVALL: Mark Duvall from Beveridge and Diamond.  Have you given
any thought as to documentation requirements to back up the
certification of manufacturers during the reporting period?  Presumably
you wouldn't need submission of that documentation, but would there be
some kind of criteria for a company to be able to justify later on in
the future that they had actually manufactured during that reporting
period?  Also, outside of the possibility of inventory corrections
dating back to 1979, do you see any need for maintenance of proof of
manufacture during the original inventory reporting period?

		MR. WILLIS:   Yes, we probably have not gotten-- given a lot of
thought at this point about documentation requirements for the
certification process.  We would assume in the normal course of business
that the companies would maintain records when they are making
statements to the government on things like that to support those
statements.  So, we have not spent any time thinking about prescribing
any specific record maintenance for this.  And your second question? I'm
sorry, I missed it.

		MR. DUVALL: Outside of the possibility of an inventory correction
going back to 1979, in this inventory reset, do you see any role or any
need for companies to be able to produce documentation that they
produced chemicals, imported or manufactured chemicals during the
original inventory reporting period?

		MR. WILLIS:   Not specifically, although I can -- because technically
speaking anything can happen.  There may be cases where companies try to
certify a chemical that is not actually on the inventory.  And that may
then lead to considerable work with the company to find out what exactly
happened and why it’s not on the inventory to make sure that a
correction takes place.  

		MR. AUER:   Another question in the back of the room?

		MR. ESTREICHER: Hi, Herb Estreicher, Keller, and Heckman.  Any
consideration on carving out those categories of substances that are
exempt from IUR such as polymers and bio chemicals, micro-organisms?  I
see that you keyed in one of the rationales here as the IUR.

		MR. WILLIS:   Sure, we could consider that, and if anyone has specific
suggestions on what we might basically exclude from this-- we would
welcome comment on this.  		MR. ESTREICHER: And then one other point. 
Someone said something about the participation by foreign manufacturers.
 A lot of times a U.S. importer might rely on a certification by foreign
manufacturer.  There should be some mechanism for that manufacturer to
provide the chemical composition information directly to EPA without
disclosing the identify of the customer.

		MR. AUER:   Okay and I think we have some webinar questions, so if you
could bring it up, Greg, Pam will handle those.  Trying this new
technology.

		MS. BUSTER: This is from the webinar for MPVs: hazard-based
prioritizations would be listed publically.  I guess that's the
question.  That's the first question.

		MR. AUER:   Yes they would be, if I understand the question correctly.

		MS. BUSTER: And could you give industry an opportunity to contribute
in-house to safety data?

		MR. AUER:   Yes, I think this is similar to the question that Pat
Cosano from GE offered, so yes that will be made.  Those opportunities
are available.  Are there other questions?

		MS. BUSTER:   Having experienced multiple errors during the initial
inventory compilation in the late 1970s-- the action, or maybe it is, is
any action should provide for at least two correction periods to date if
that is either erroneously submitted by companies or erroneously as
processed by EPA.  I'm not sure that I understand.

		MR. AUER:   Okay, what would be -- as Jim indicated what we are trying
to do here is develop a process which will be as simple but adequate for
the purpose as we can get to it.  We do not want to penalize anyone by
inappropriately removing chemicals from the inventory and thus we
recognize the value of a correction process.  At the same time, we don't
think that any such correction process can be an open-ended process.  I
think we need to bring it to a close and then work from that list and
then go on from there.  This is an area where I would encourage, perhaps
we could have discussion in this meeting.  If not, please think about
what such processes might look like.  It could be very useful to get
that kind of thinking so that we can put in place an approach which
would meet the needs of the regulated industry, also meet EPA's needs
and ensure that we could bring the process to a timely but high
confidence conclusion.  

		Jim?

		MR. WILLIS:   Just one additional observation on this point.  The
current inventory consists of the initial inventory which has gone
through multiple correction cycles.  So presumably it has been pretty
well reviewed as well chemicals coming in through the new chemical
program with notices of commencement.  This would be our starting point,
is the current inventory.  So there may be some errors associated with
the current inventory but the starting point has been reviewed by
stakeholders and the Agency multiple times.  So we would hope it
wouldn't take multiple additional times to re-review it.  But we
certainly want to make sure that we aren't inadvertently taking off
chemicals that are in commerce or leaving on chemicals that aren't in
commerce.

		MR. AUER:   Okay.  We may now be to the point of getting to the
discussion.  So why don't we begin the discussion with a question at the
back of the room.  

		MR. CULLEEN: I didn't hear anyone speak to timing, and I don't know if
you intend to go through that with any greater rigor and then the second
comment I'll make, which really is in the form of a question.  There are
several activities I think that are underway that are sort of open
issues with respect to inventory listings for categories of substances
and I don't know the way in which those efforts that are ongoing would
be factored into the reset.  And you may want to consider whether or not
there's a mechanism for also confronting and dealing with issues that
are similar in nature as they arise.  I think of the phosphors and other
products that are subject to some discussion with inventory listing
mechanisms and standards presently and it’s not clear how that would
fit in.

		MR. WILLIS:   Thanks, Larry.  And indeed I think if your latter point
was, we're going to actually have to deal with a number of the inventory
corrections and other related issues while we are doing this.  I think
you are correct that we want to be able to do deal with some of these
things in this time period, so that when we do the reset inventory, the
guidance is pretty clear to everyone.  

		In terms of timing it, I mean-- our initial thinking would be that it
would be nice to have the reset inventory available at the beginning of
the one-year period where companies report for IUR.  So that period is
basically the year 2010.  So I think ideally we would want to have the
final program rolled out at about this time next year.  That would give
people the chance to see what's on the inventory, the final reset
inventory, make any corrections that are necessary to ensure that their
chemicals on that inventory and then maintain their records for that
year. Presumably, companies are maintaining records in 2010 for their
2011 reporting.  That would have us proposing the reset in about the
April 2009 time frame.  Now, I think kind of the last minute for doing
this is probably right around the start of the actual IUR reporting. 
So, there's a year and a half variability there and, that's why this is
one of the areas we are keying on getting comments.  Should we shoot for
having this available in final form at the beginning of the year that
IUR data are compiled for, the beginning of 2010, or should are target
be to synchronize this with the IUR reporting itself and that's, what,
June of 2011?  June through September of 2011.  And that'll change how
quickly we move forward on this.  

		MR. AUER:   Okay, we did get a couple of requests in advance to offer
public comment.  So I would like to recognize those individuals.  The
first is Nelson Lawson from Pine Chemicals Association, up in the front
of the room.

		DR. LAWSON: Thank you.  Good afternoon.  My name is Nelson Lawson.  I
am chairman of the Environmental Health and Safety Committee of the Pine
Chemicals Association.  PCA is an international trade association of
about 55 producers of natural chemical products derived from trees that
end up in products such as inks, paints, adhesives, lubricants, diesel
fuel, fragrances, and even cholesterol reducing agents for human
consumption.  We probably have some 300 or 400 or more products that are
on the TSCA inventory, mainly resins and polymers.  We've had a long
history of positive interactions, we feel, with U.S. EPA on a number of
regulatory issues especially those concerned with TSCA and we appreciate
the opportunity to be able to comment on this TSCA inventory reset.  

		In general, the PSA supports the goal of cleaning up the TSCA
inventory for a number of different reasons.  But we are concerned
though about the time requirements to do this.  The poor economy and
industry consolidation have led to significant reductions in regulatory
staff just as REACH has descended upon us and one more program will be
difficult for us to handle unless it’s done very efficiently.  

		Now more specifically, we support your concept of a simple online
certification for chemicals manufactured, imported or processed in or
into the United States.  We would prefer a past time limit of five years
 rather than three, mainly because of the types of specialty products we
manufacture sometimes go away and have a habit of coming back as
customers change and the ability to be able to move back into the plant
quickly as a matter of efficiency for our industry.  

		We would also like to be able to certify a chemical expected to be
active within the next 12 months and thus retain it on the active
inventory list.  It seems to us  it could be separately flagged if this
were done online and if you didn't receive a notice of commencement
within the 12-month time period you could automatically move it to the
inactive list.  That would be one way to control that.  The ability to
scan both these active and inactive lists for online for errors is
obviously very important and the ability to file corrections online
would also be solved.  As to how long it should take to get this right,
I don't think it should take any more than three to six months at the
most for people to take a look and see what's been put on there and the
corrections.  

		Now our major concern though is as one of the gentleman in the back
mentioned, this question of how chemicals on an inactive  list can be
moved to the active list in a quick and cost effective way.  And perhaps
there needs to be two inactive lists, and let me explain why.  It seems
reasonable to us to require the full PMN process to reactivate a
chemical that was originally submitted to the original inventory without
any supporting data.  If you wanted you could move these to a fully
inactive list.  We do not think, though, that it is reasonable to
require a company that submitted a chemical to the full PMN approval
process and paid the fees to have to do this a second time.  It would
seem to us that these chemicals could go on a partially inactive list
and it would be only necessary to submit a notice of commencement, "bona
fide and intent to manufacture," or some similar simple document to
return these chemicals to the active TSCA inventory list.  It also seems
to us that U.S. EPA has ample resources to require more test data if it
feels that they are needed during this kind of process.  And again, the
kinds of resins and things that we make, it's very helpful to us.  As an
example, if you are producing a particular ink resin and you need to
adjust it by the addition of say, maleic anhydride or something like
that to bring it into specification, it’s very nice that you haven't
created a new chemical substance if there is a TSCA inventory listing
for that.  That makes our lives very, very much more easily.  

		Finally, at the risk of possibly complicating this, PCA suggests that
the online flagging process might also allow submitters to point out
voluntarily multiple entries for the same substance, of which we know
there are lots.  U.S. EPA may not want to tackle this issue immediately,
but it would be useful to know about this for future inventory entry
consolidation and perhaps even for combining IUR reporting volumes.  In
the past, as you know Charlie, PCA was successful in convincing you
folks to consolidate the several TSCA entries for rosin and for dimer
acid, and we think that this resulted in significant efficiencies for
our industry, and we think also it would probably be helpful to you
folks at EPA.  So that's my comment.

		MR. AUER:   Thank you for that, Nelson.  Very thoughtful comment. 
Other comments or discussion?  Anything on the phone? Anything via the
web, Pam?

		MR. FREERKSEN: This is Bob Freerksen from Dupont.  I have a question
or comment.

		MR. AUER:   Go ahead.

		MR. FREERKSEN: Can you hear me?

		MR. AUER:   Yes, we can.

		MR. FREERKSEN: Okay.  I certainly appreciate Jim's comments about
wanting to find a procedure that is fast.  I do have some current
concerns about the time line that is proposed, and I do think there is
maybe some underestimate of the burden that it will actually take for us
to confirm substances that are being manufactured and imported in the
kind of time frame that we are talking about.  And you know, as we
heard, not looking to have a final regulation in place until maybe the
end of 2009, and then, you know, a final goal no later than some time
mid-2011 to have the reset inventory in place.  Certainly with respect
to the IUR we already have to understand all of the substances that we
are manufacturing.  That's clearly already in place.  But this
requirement for the inventory reset isn't necessarily a parallel with
respect to what's required for the IUR in that at least that in space it
seems to require that polymers would also have to be identified and
there's certainly no volume threshold for anything that we would
manufacture or import.  And so systems, information systems that would
allow us to quickly identify those chemicals that we would use for the
IUR aren't necessarily in place to do the kind of work we are looking
for in the inventory reset.

		I'd also note that the timing that's envisioned basically falls right
on top of the same time frame under which we are doing data collection
for the IUR, that is 2010.  In that upcoming IUR there's an increased
requirement of around collecting new information that we've not
collected before around uses of inorganic materials and we've even heard
rumors that there could be changes to the IUR rules in terms of what's
to be required under the IUR.  Likewise, I'd certainly agree with Jim's
expectation that you may need to staff up for increase in inquiry
processes around bona fide intent to manufacture or clarification or
even obtaining accession numbers for substances that were on the
confidential inventory, all of which I think will require time.  

		I guess the biggest concern I have about the timing has to do with our
suppliers of things that we are using in the United States, that is for
which we are processors and not manufacturers.  In those cases, we're
going to want to assure ourselves that our suppliers have certified the
chemicals that are important to us to keep them on the inventory so that
we don't have a disruption in our supply chain.  Some of these suppliers
can be small companies.  They may not have placed the chemical on their
inventory themselves and may not really be aware of what's happening
around them, and may take some time for them to get geared up, be able
to do this kind of inventory reset activity that we are relying on them
to do, with the expectation that there could be back and forth with our
suppliers to confirm that they haven't dropped the ball. That will also
take time. So, while I think it's, you know, a reasonable goal to say
that we want to try to mesh this with the timing for the IUR, I don't
think that the reasons are necessarily compelling, and certainly have
some concerns that we may be getting into a situation where we are
losing that goal of being a low burden and being an easy process.

		I guess just one final comment on your-- the comment about potentially
allowing processors to certify.  I think that makes sense for the
practical reasons that you've already identified.  It certainly seems
consistent with the language of the statute, and also could help us in
some ways with the concern I raised before about dealing with our
suppliers.  If we were able to certify that we were using a material in
the United States that was on the TSCA inventory as a processor and
allowing us to certify it and maintain its status on the inventory, that
would certainly alleviate some of that fear that we have that our
suppliers will not do their certification in a timely way.  Thank you.

		MR. AUER:   Thank you for that.  A number of good points for us to
bear in mind as we go forward.  Other comments or discussion?  Yes sir? 
Do you want to just come right up here?  You can use my microphone.

		MR. HERZ: Thank you.  Bill Herz, Vice President of Scientific Programs
for The Fertilizer Institute.  In the world of commodity chemicals, the
role of the broker/trader, at least with fertilizers, has increased
dramatically.  For example, over 60 percent of the nitrogen fertilizer
now is imported into this country, while over 90 percent of
potassium-based fertilizer also is imported into the country.  I have
found in my almost ten years of dealing with TSCA and helping our member
companies meet TSCA and TSCA related requirements that both domestic and
foreign manufacturing entities but actual physical entities end up
meeting probably 95 or 97 percent of the costs and logistical burden in
meeting regulatory compliance.  I am requesting-- and I don't have this
fully thought through-- but I am requesting that EPA give thought to how
you might level the playing field in regard to sharing the burden or the
joy, so to speak, of meeting upcoming IHPV requirements as well as any
further additional enhancements to TSCA or otherwise.

		MR. AUER:   Okay.  I think those are interesting perspectives that
says that we do need to try to figure out how those would operate in the
context of the Inorganics HPV Challenge.  Ideally, you want everyone who
is involved in the introduction into commerce of these materials to be
contributing to developing that information.  It is one of the things we
tried to do with the original HPV Challenge.  Sometimes it worked,
sometimes it didn't.  I would encourage you to think a little more about
the particular issue and to submit at least a written comment where you
might try to crystallize the issue.  If you have any thoughts as to how
it might be dealt with, that would be good.  But at a minimum, we could
bring it up and offer our thoughts and get additional discussion at the
workshop later on this year.   And your discussion comments may also be
relevant to the reset as well.

		MR. DUVALL: Mark Duvall from Beveridge and Diamond.  Following up on a
couple of previous comments about polymers.  Since the EINEC inventory
does not include polymers and the inventory update does not include
polymers, and we are looking to reduce administrative burden on both the
regulated community and the Agency, it might make sense  to exclude
polymers from the inventory-- from the reset inventory.  That would be a
decided policy shift for the Agency, and one that probably should not be
undertaken just out of administrative convenience.  Is the Agency
thinking at all about eliminating polymers from the reset inventory?  Is
that an issue on which you are specifically requesting comment? Because
it certainly raises issues that seem relevant to inventory reset. 

		MR. AUER:   We are not considering such scope changes to the inventory
as we outlined in the paper and described here.  We are essentially
trying to get a current status understanding of the chemicals which are
manufactured or processed in the United States, and that does include
polymers.  So we would be looking to get a certification from polymer
manufacturers that these polymers have been manufactured, imported,
processed, whatever the case might be, within the reporting period. 
Several have brought up the question of chemicals which are produced
under 25,000 pounds per year as well.  These are not currently subject
to the inventory update rule, and so this is another group of chemicals
where those manufacturers, importers, processors would need to recognize
this, and we would need to get that information.  This is an area that
is of particular concern to us in reaching out to those entities and
ensuring that to the extent you did use, that is manufacture or process,
 that chemical in the reporting period-- that we are aware of that.  And
so any suggestions that people have as to ways that could be done more
efficiently to ensure that, you know, all interests are appropriately
maintained, we would be quite happy.  I think that this is one of the
aspects where I think the certification approach has real benefit, and
Jim mentioned this.  If any one entity indicates in their certification
that a given substance has been in commerce in this period, that
suffices.  Whereas if you were to go to the 8(a) approach, every entity
within the reporting period other than small businesses would have to
provide that information.  And in many ways it’s more information than
EPA believes we need for this purpose.  Clearly understanding it in a
more comprehensive way, the flux of chemicals in the economy would be
useful information.  But it does go beyond the kind of information that
we believe is needed for this purpose.  

		Jim Cooper at the back?  Sorry I didn't recognize you before, Jim.

		MR. COOPER: Thanks, Charlie.  First off, NPRA does appreciate the
goals of the inventory reset.  I think industry would in general benefit
by an accurate reflection of the chemicals actually in commerce.  We've
been trying to tell folks on the Hill for years that there are not
82,000 chemicals in commerce right now of which we know nothing.  That's
not and never has been the case.  So I think it would go a long way in
helping that.  		Basically I've got, I guess, three comments.  The first
one being we may want to keep separate issues separate for this purpose
so you can meet your deadline if you are going to undertake something
like this.  If you start confusing this with things like nomenclature
issues that-- some of these things, you know, folks have been-- and I
know you have been dealing with for years, and so to try to tackle all
of this in a short amount of time, I just don't see it happening.  I
don't -- the feasibility just diminishes pretty quickly.  

		Also, as far as the timing, the three years, I would-- I think our
organization would probably also suggest five years would be consistent
with IUR reporting requirements for one thing.  And you know, looking to
future resets as well, that would be very consistent with IUR reporting
at that point.  And plus in certain markets, it is true what the
gentleman from PCA said, that basically a lot of these things are
customer driven.  You can have a customer that evaporates and then all
of a sudden that customer comes back and, you know, there's a demand for
that product.  I know in other sectors where I've worked, I've seen that
time and time again.  

		And I do appreciate the consideration for modifications for chemicals 
that have already been through the new chemical review process.  One way
perhaps of clearing those folks out a little more quickly is to ask if
there have been any changes in the manufacturing processes or the use
activity scenarios.  Because, you know, that would really be the only
thing that would warrant further scrutiny-- is actual changes to
processes or changes to uses.  Beyond that, I think EPA does a pretty
good job of evaluating those substances already.  That's it.  Thank you.

		MR. AUER:   Thank you, Jim.  Another comment?

		MR. GRENDA: Mark Grenda with Afton Chemical.  I disagree.  Where did
Jim go?  With my esteemed colleague-- my esteemed colleague Jim
suggested that maybe nomenclature issues, it would be best to leave
those aside for now. 

		I think it is important that nomenclature issues as we know them are
corrected.  In the 1980s, when EPA said-- those of us who have been
around awhile, when EPA did a TSCA section for nonylphenol and various
isomers, they found out that nonylphenol in all its various isomers did
not exist in its commercial.  That and some inventory corrections. I
think as Kent would probably be able to say maybe not in public, there's
been corrections that are still trickling in, nonylphenol.  Back, what,
in the 1990s when we had the diisocyanates.  That was a nomenclature
issue that needed to be corrected, and it was corrected.  Over 1,000
corrections were made to the TSCA inventory, I believe, over that.  What
EPA did in that case though is they did simplify the procedure for doing
corrections. And I'm not exactly sure what the simplified procedure
should be in this case, but it should retain a simplified approach for
corrections to nomenclature as was done with the diisocyanates.  We may
need a little more simpler, because in all cases we're not going to find
the original nominator to the inventory of several substances that are
on the TSCA inventory, but perhaps still in commerce.  So I would like
to see that the nomenclature issue is addressed, but that a very
simplified approach through the comment period that will ensue for ideas
on how to approach that, but encourage it to be simplified.

		MR. AUER:   I think we are always interested in simpler, although when
you talk about inventory nomenclature, it’s often times not as simple
as it appears at the outset. 

		Other comment?  Yes sir?

		MR. WHITE: Hi.  I am Russ White with the American Petroleum Institute,
and we've actually provided our written comments already.  They were
sent in to the docket just a little while ago, and I did put 30 copies
out on the table, but I'm not sure they are there yet. But they are
available.  

		For the verbal comments really today I would just like to highlight a
few of the key issues that we've had.  I want to just preface it by
saying I really enjoyed the presentations that were made, because I'm
going to echo a lot of the themes that were there.  So it's great to see
that there's a similar thinking on some of the key potential problems
that might be exist.  So, with that, I'm going to talk really very brief
comments on the three different aspects, the reset of the inventory, the
inorganic HPVs and the overall  implementation of ChAMPS.  

		On the reset inventory, API encourages EPA to design a TSCA reset
program that minimizes disruptions to the marketplace and burden for
both industry and EPA.  Because EPA is already prioritizing HPV and MPV
chemicals, which would not be affected by the reset, the benefits of an
inventory reset are relatively small.  However, the burden and confusion
that will result from such an effort could be very high.  So EPA should
consider the development of a TSCA inventory reset program a lower
priority than the other components of ChAMP.  Moving forward at a
reduced pace would help EPA design a better process and would be
successfully implemented in practice and would be supported by industry.
 To help improve the process we recommend that EPA not only require
certification of chemicals that are manufactured or imported, but we
would like the Agency to also publish in the Federal Register the list
of chemicals that would be removed from the inventory. We would find
this very helpful to know what's not going to be there in the future.  

		We also suggest that the Agency provide a period of time during which
substances could be reinstated to the inventory without penalty and
without going through the PMN process.  This time period should
encompass at least one IUR reporting period, which would be a five-year
period.  

		And finally on the reset, any reset efforts should include an
exemption for the petroleum process streams that are listed under the
CFR citation, 40 CFR 710.  They are known to be in commerce, and we do
not consider any of them to be obsolete.  

		On the inorganic HPVs, just a couple of quick comments. First, having
a list of the affected chemicals would help stakeholders greatly in
understanding the scope and implementations of the -- implications of
the program.  We also note that the inorganics were well characterized
under the OECD HPV program, and we should really make full use of that
existing data before moving on to any other phase of data gathering or
testing.  

		API is supportive of the Agency using the clustering category
approaches, and we encourage EPA to provide the regulated community with
an ample notice of the Fall 2009 meeting where this cluster approach for
certain chemicals will be discussed.  That's a critical point for that
whole program.

		And finally, a few comments really on the overall implementations of
ChAMP.  API encourages EPA to include more transparency and clarity in
this program to assess the HPVs and MPV chemicals, and assign the
risk-based priorities under ChAMP.  To those ends we believe EPA needs
to do the following: first, EPA should produce and share with the public
information on the Agency’s and methodology for drafting the various
documents.  There is some information about characterization and
prioritization, and EPA has already issued some of those risk-based
prioritizations.  However, EPA needs to provide additional information
on its methodology for its risk-based prioritizations.  

		Second, EPA should produce a list of current MPVs and HPVs.  We
understand EPA is working hard on releasing a 2006 inventory update
report.  We just urge you to redouble your efforts and get that out to
the public. 

		Third, EPA should publish and give notice of the groups and chemicals
that will be assessed similar to the batch notices provided under
Canada's chemical management program.  

		And lastly, EPA would benefit-- and all of us benefit-- from a
user-friendly online repository or docket for each chemical.  I know
that's on your plans, so each stakeholder can review the comments on the
various SPP documents.  This would greatly improve the transparency of
the program, and if it was user-friendly, it could increase the number
of people that go to the site and actually use it.  So we are very
encouraged that would be a very valuable addition.  

		And that is the highlight reel, and the more detailed comments and
examples are considered in the long paper we submitted.

		MR. AUER:   Excellent. Thank you, Russ.  We are working towards are
first release of the IUR, non-CBI database. We hope to do that this
calendar year.  We have a few things that we have to finish up in order
for that to happen but that is what our goal is.  We recognize that is
critical information, and believe that you and others in the public
should have that information.  I appreciate your other comments as well.
 Those are points we've heard from others, in addition.

		Other comments or discussion on any of the topics that were relevant
to today's public meeting?  The floor is open for any and all comments
relevant to the issues?  Anything on the phone?  Anything from the web?

		Okay.  Well, thank you for your active participation in today's public
meeting.  I think EPA saw its objectives of this meeting met.  We got a
number of new points being raised that we hadn't fully considered, and
we can now go back and think about that.

		Also got reaction to a number of the points that we had raised, such
as what might the reporting period be for purposes of the reset as well
as various other issues that are going to be important for us to sort
through: timing and procedure, role of corrections, etc.  So, let me on
behalf of EPA, thank you for the very active discussion, and the Office
of Pollution Prevention and Toxics looks forward to working with you in
the future as we go forward in realizing these enhancements under the
ChAMP program, as well as the ChAMP assessments themselves.  So without
further ado, this meeting is concluded.  Thank you.  

		(Whereupon, the above-entitled matter concluded at 3:07 p.m.)

 

 

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