Document ID: EPA-HQ-RCRA-2013-0396-0012
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-07-14T04:00Z

DLA PCB Import Petition
                         July 8, 2014 Informal Hearing
                                       
                              Verbatim Transcript

William Noggle:  
Welcome to the hearing on the DLA PCB Import Petition.  I have a few slides to present which cover some general information on the PCB import exemption process and DLA's petition, as well as information on the objective, schedule, and format for the hearing.

PCB Petition Process -- TSCA 6(e)(3)(B) allows any person to petition EPA for an exemption from the §6(e)(3) ban on manufacturing (which includes imports), processing and distribution-in-commerce of PCBs.  An exemption granted by the EPA is limited to up to one year.  The exemption is granted through a notice and comment rulemaking which includes an opportunity for an informal hearing. 

On April 23, 2013, EPA received a petition from Defense Logistics Agency (DLA), a component of the United States Department of Defense (DOD), to import foreign-manufactured PCBs that DOD currently owns in Japan for disposal in the US.  The petitioned PCBs and PCB Items are currently in storage at U.S. military installations in Japan.  DLA estimates that as much as 1,014,222 pounds of waste contaminated with PCBs could be generated in Japan through the end of calendar year 2014. DLA also estimates that 94% of the waste is at concentrations below 50 ppm.  It is important to note that the PCB waste would be imported for proper disposal in the U.S.  -  in other words, disposal in accordance with the regulations set forth in 40 CFR 761.  Submission of the petition triggered EPA to review the petition and begin the rulemaking process.  Through a proposed rule, EPA has proposed to grant DLA the import exemption.

The objective for EPA of this hearing is to hear and receive your comments.  The proposed rule represents our preliminary conclusions based on the information we have.  EPA is here to gather any additional information that is available, and we will fully consider all the comments that are presented today.  At the hearing, participants may be asked to answer questions submitted by the audience (in writing to the Hearing Clerk) at EPA's discretion. However, EPA would prefer that all questions are raised and addressed through the cross examination procedure (40 CFR 750.20), where questions are submitted to the Hearing Clerk by July 22, 2014 (tentative) and responses are supplied back to EPA by August 12, 2014 (tentative).  

Here is our schedule for today.  In a few minutes, we'll hear from Dr. Rennae Anderson, and after that we'll open to the floor to anyone else that would like to present comments or information.

The hearing will be open for public comments from approximately 9:00 a.m. until 1:00 p.m.  If you would like to speak, please fill notify me.  We have one 15 minute break scheduled for approximately 11:00 a.m.  Doors will remain open, so feel free to come and go as needed.  However, please try not to interrupt presentations.

I am the contact for the hearing as well as the rulemaking, so if you have any questions please feel free to contact me either by phone or email.  Also, the website for the rulemaking will be updated over the next several weeks with information and presentations from the hearing, so please check the website for the most up to date information.  Does anybody have any questions about how the hearing will be conducted?  At this point I'd like to turn it over to Dr. Anderson.

Rennae Anderson:
Good morning. My name is Rennae Anderson. I am a practicing pathologist in Howard County, Maryland, and my way of introduction, I should tell you a little about myself, in case you are wondering why I am here. I actually was born in Jamaica and was there until I was about eight years old. I came to the United States where I completed both of my education including undergrad at the University of Miami, which is where I had met Kelly Greene, a person who worked with the EPA on this particular topic. From University of Miami, I went to Washington University School of medicine, and during my fourth year I did an internship at the NIH in pediatric oncology. It was during that time that I had to make the decision about where to rank my preferences for, spending the next five years of residency and fellowship, and I started having a love affair with the Baltimore blue crab, and I think I actually made my decision about my doing my residency and fellowship at Hopkins primarily because of blue crab and how much I loved them. So I actually spent the next 5 years at johns Hopkins department of pathology completing my residency and fellowship. I did anatomic pathology, clinical pathology, and then did a year of fellowship in surgical pathology which is primarily alphalogic (?) pathology. So I learned how to diagnose cancers. After finishing at Hopkins, I went out into the community to practice pathology. So my first job put me into Hampton Roads, Virginia where I worked in a large hospital system. In Hampton Roads, there were three hospitals at that time, I did surgical pathology, primarily, diagnosing cancers, and we were a very busy hospital. From there I actually went up to Elkton, Maryland, and did some work there for about 4 years. I also did some work in Burlington, North Carolina and I'm currently testing, as I mentioned, in Columbia, Maryland. 

As a surgical pathologist in the community, I get to work as a part of a multi-disciplinary team including radiation oncologists, radiologists, and two or more registrars. I have, often times in all these practice settings, been a cancer committee member, so I get to talk about cancer staging and the impact on patients. I am also a member of the college of American pathologists, a primary organization for pathologists in this country, and actually increasingly around the world. So I'll give you that background in case you are wondering why I am here. I am here to talk about cancer and at points this talk might get a little personal, but, cancer is actually a very personal thing, as many of you know. We talk about data, and talk about substances, but cancer is actually a very personal thing, and as a community pathologist I actually get to hear a lot about the impact of cancer on the lives of just regular people. When people hear that I am a pathologist they ask me, "Does that mean you're a doctor to dead people?" and the answer is no, actually 98% of my time I send diagnoses of cancer to very live people and get to see the impact of how that plays out in the lives of ordinary people. So what I would like to do over the next half an hour is just two simple things, I would like to present data which hopefully help the EPA update its current classification of PCBs from where it is now which is a probable human carcinogen, to what it actually should be, which is a known human carcinogen, or cancer causing agent. The second objective is if that happens, whatever we do with this petition that is before us should actually reflect that impact of the classification as a known human carcinogen. 

So the reaction, including packaging, exporting, treating, and disposing of PCBs should, reflect that.  I don't know how the EPA works, to be truthful.  Prior to several months ago I had no dealings with the EPA. So I don't know if there is a difference between what the EPA does when things are classified as a probable human carcinogen, versus what it does when it's classified as a known human carcinogen. I hope there is a difference, but to be honest I have not had the opportunity to really work that out, I am hoping all of you have already worked that out. So, just a little background, since I seem to be the only person presenting here, this is all data from an easily accessible source. American Cancer Society gives numbers, and these numbers are actually the overall cancer numbers. So estimated for 2014, new cases of cancer, 1,665,540, and also estimated deaths in 2014, is, 585,720. So cancer has a pretty big toll. Cancer prevalence according to numbers by the NCI as of January 1[st] this year there are 14.5 million Americans living with a history of cancer. If you project this info, the same organization says that by January 1[st] 2024, the population of cancer survivors will increase to 19 million: 9.3 million males', 9.6 million females. And there are quite a few reasons for that, life expectancy is increasing, we are doing a great job of taking care of people and so in 2010, life expectancy was 78.7 years, we have a rapidly aging population and our population is growing, and we are getting so much better at actually treating the people with cancer that they are staying alive, so that's why this number cancer prevalence is actually so high. We are treating and keeping people alive with cancer quite well, and that's what a lot of my colleagues in oncology which is the other specialty that pathologists deal with most often. We spend our time on the telephone and on the computer communicating with oncologists and they want to know can they order this test, can they order that test, so they can make treatment decisions for patients, so they're very busy people.

So a little bit more background, these numbers are from the Center for Disease Control. Cancer, as I'm sure many of you are aware, is the second most common cause of death in the US. 1 in 4 people who die in the US died of cancer, and in 2010 cancer was second to heart disease. You see the numbers there -- heart disease 597,689, and cancer 574,743, and chronic lower respiratory disease was a distant third.

Alright, so, cancer is very expensive, and if you will just take a minute to look at those numbers, they are actually pretty sobering, because the projection is that in 2010, medical expenditures for cancer treatment will amount to $158 billion and this is 2010 dollars. I'm not sure really what that is in 2020 dollars, but this number will actually reflect an increase of about 27% over those seen in 2010. It's also speculated that if newly developed tools for cancer diagnosis, treatment, and follow up, continue to be more expensive, the medical expenditures are actually going to be even more than that, $207 billion. And I'm here to tell you that, yes, newly developed tools for cancer diagnosis, treatment, and follow up, will continue, because that's what we do, we make things better. We find better tests. We find better drugs. And we follow people more closely; there is a huge emphasis now in medicine on survivorship. So we want people to stay alive as long as possible with their diagnoses. So that number, $207 billion, may actually be an underestimate. So, how is that money distributed? So, the highest costs are, depending on how you look at it, fortunately or unfortunately, in some of the very most common cancers.  Breast cancer is very expensive to treat; $60.5 billion is the number that I got. Cancers of the colon and rectum amount to about $14 billion and lymphoma about $12 billion. So the rest of the talk I am actually going to focus on two of those cancers, breast cancer and lymphoma, and then a third much rarer cancer called malignant melanoma. 

So, why am I really here? I have been actually practicing pathology since 1995. And as you saw from my introductory slide I have been at this for actually a long time, I know I look young, but actually 20 years. When I started practicing pathology, we were trained to find a recurrence. If a patient came in with a second nodule of some kind and a biopsy was performed, we were trained to think that that biopsy was probably just a recurrence of their original cancer, and so at the time of my training in 1995 we basically just kind of made the assumption that the new nodule was going to be a recurrence, and so we approached the diagnosis quite a bit different. What has been happening over the years I've practiced pathology is that, that is no longer true, and the oncologists are very aware of that. So when we now approach a patient who has had a previous diagnosis of a malignancy and has come back with a new nodule somewhere else, we are told to make the assumption this is the second cancer. It is not a recurrence of the first cancer. It could very well be an entirely different cancer. So that is the first point up here you're seeing, is that over the years, the 20 or so years that I have been practicing, the field of pathology has shifted. And the assumption is now that a patient will have multiple cancers. And it's not that the patients are living longer, and that they are now just developing a second cancer because they happen to be alive longer, this could be a patient that has a diagnosis and then five years later they develop another nodule, and it's a second cancer. That would have been a surprise to me in 1995 when I first trained. 

The second observation, one of my personal observations over the years, is that cancers, that were typically thought of as cancers that older people get, are now more and more becoming cancers that young people get, so, I'm in a multidisciplinary team and in Howard County we have, for breast cancer, once a week, a working conference where we present all of the patients that have come to the attention of oncologists as being diagnosed with cancer. And in real time we are all making decisions about what the best approach is for that particular patient.

So one of the most disturbing things that comes out of this conference once a week is that patients are just younger and younger and we're having discussions about whether to harvest eggs of patients that are 30 that have never had children, and they want to spare their fertility through their chemotherapy. Those discussions were not discussions that happened when I first started pathology in 1995, but they are very common now. Breast cancer, melanoma, which is a very rare cancer, is happening to younger and younger patients, and that is just now a part of the landscape of what I practice in. 

Alright so turning attention to more specifics, so that was just general information, a little bit of background. Looking at breast cancer, so breast cancer is very common. The data that I am going to show you is data that is collected through the NCI and it is age adjusted data which typically means that they round the kind of finding you can see if you speculate that the reason that cancer numbers are getting higher is because patients are getting older and that old people get cancer. Then you might assume that these numbers are higher because of that, but this data removes those other factors. So new cases of breast cancer that the NCI have published are that between 2003 and 2011, per 100,000 births in the population the numbers range from 126.9 to 130.5. During those 8 years the deaths from breast cancer, we're particularly here talking about female breast cancer, is down from 25.3 to 21.9. That just highlights the fact I told you earlier, we're doing a much better job of treating people with cancer and so patients are not dying as frequently, and they're living longer with breast cancer.

So the numbers are broken down in various ways in this data set and one of the ways it's broken down is by state. And the numbers that you see on that first line, 109-140, are again the same numbers, per 100,000 of the US population. It turns out New Mexico is a pretty good place to live for breast cancer, because it has the lowest number of cancer incidents, while Washington, DC is not such a great place to live, 140 deaths per 100,000 of the population with breast cancer. And just for fun because I have so much time on my hands, I wrote down the EPA regions with the lowest incidence of breast cancer, and regions 4, 6, 8, and 9 are where you see the lower numbers, and regions 1, 2, 3, and 10 are where you see the highest numbers. And those numbers again correspond to the number of female breast cancers.

So doing the research for this talk, I came across something again dear to me because I was not really -- EPA was not on my radar, truthfully. So this right to know organization, and I have a right to know -- I looked at the numbers they have published on their website and the same regions that I just mentioned to you have on the left side there, the EPA regions with the lowest incidence of breast cancer 4, 6, 8 and 9, and below that what I looked at is the aggregate number of waste handlers. I added up all the numbers in those regions, all the states in those regions, and came up with that number 287,363. And then there is another set of numbers they have that have to do with penalties for violations and below that you see the number 4,030. I thought that was pretty interesting, because on the right hand side of the screen what you see is EPA regions with the highest incidence of breast cancer, 1, 2, 3 and 10, again I added up all the numbers and the aggregate number of handlers 263,351. So that number is actually lower than on the left side, and the aggregate number of penalties is lower, I mean significantly lower. And I wondered what the numbers actually mean. The first thing that came to mind is that either the people who are in the EPA regions with the lower cancer incidences are just doing a phenomenal job of  getting people to be really, really careful.  They're penalize a lot more people and maybe that is having an impact. The other thing is that they have a lot more people who are handlers so maybe there less overworked and more careful because there not as stressed out as the EPA regions where the numbers are high. That's just pure speculation. So breast cancer and PCBs. You should have, or you will have at some point after this, access to a whole packet of information that I forwarded, including all these articles, full text articles. So if you don't get these articles and all the nuts and bolts please feel free to review all that which will be available on the website and the docket, I am told. 

So this study which is entitled "exposure to PCB congeners measured shortly after giving birth and subsequent risk of maternal breast cancer before age 50" was published in 2012. What this study did was it took a group of women and this was during the years before the PCB manufacturer stopped. They took blood in the women who had recently delivered, and they followed these women for about 17 years after they delivered. It turned out that about 1 in 4 of them developed breast cancer before the age of 50. So the conclusion of this study, and it was actually pretty elegant if you read the details, demonstrated that there was a net association of PCB exposure was nearly a 3 fold increase in risk for early breast cancer, and so that's what I'm mentioning to you about my personal observation. People are getting breast cancer earlier, and so that article actually highlights that point in particular. So if you get a moment to read through that, that probably would be very helpful because I won't spend a lot of time going through all the articles because there are so many of them. 

The first two times that this particular importation of PCB happened in 2003 and 2007, this data was not actually available. They published it in 2012. There is a lot of data that has come out since 2007.  That is another reason I'm here.

So moving now from breast cancer to a second kind of malignant neoplasm, non-Hodgkin lymphoma. Now, the lay public thinks that this diagnosis, non-Hodgkin lymphoma, is a specific kind of cancer, but it's not. It's actually a group -- a really, really long list of specific tumors of the hematopoietic system that's broken down just for one reason alone. There is a kind of lymphoma that is called Hodgkin lymphoma, and all the rest of them are called non-Hodgkin lymphoma. So you may get a specific diagnosis of t-cell lymphoma [?] or b-cell lymphoma [?] and those are all classified as non-Hodgkin lymphoma. So this is a huge bag of neoplasms, it's not a specific kind. But what's interesting is that this particular kind of neoplasm, when you look at the data from 1975 to 2011, it has been steadily rising. In 1975, 11.1 per 100,000 population, and in 2010 it was up to 21.1. Now the malignancies of the hematopoietic system tend to reflect things that happen a little bit more quickly than tumors let's say of the breast. Breast tumors for the most part are what we call epithelial malignancies. Lymphomas are cancers of the cells that are typically used to respond to infection. So lymphoma is kind of a fast forward type of cancer, unlike breast cancer which has a much longer lag time. So you may have an incident which starts the process in the female breast and it will take years, decades to develop. Lymphoma happens, I think, a little bit more quickly than that, and there are several things that can impact that. One interesting thing, which I won't really bring out, is that there are many, many articles that talk about the relationship between Epstein-Barr virus and PCBs and lymphomas now, increasingly, are EBVs, that virus that I mentioned, is a big player in this whole area of non-Hodgkin lymphoma, so much so that many times as a pathologist when I make a diagnosis that would fall into this group of non-Hodgkin lymphomas, the oncologist want to have to test the tissue to see if there is EBV there. And we do, we have markers that can document that in the actual malignant tumor in whatever category of lymphoma it is under. So, people do die from lymphoma, from non-Hodgkin lymphoma. There are lower numbers you're seeing now, the numbers actually are a little better now, and again for the same reason, we are doing a great job of treating people with non-Hodgkin lymphoma, that tumor, that group of tumors that actually something that requires very aggressive intervention, because non-Hodgkin lymphomas can grow very rapidly. So when we suspect lymphoma, there is a very specialized test that pathologists and oncologists do, and we act very quickly. They are actually considered rush diagnoses when we are on call, if they are suspecting a lymphoma, that is one of the things that we have to come in on nights and weekends to make diagnoses of. Because if they do have a diagnosis of lymphoma then often times radiation or chemotherapy starts very quickly. This tumor tends to move at a much more rapid rate than the one I was talking about before. 

So what about non Hodgkin lymphoma and PCBs, this article by three men and colleagues entitled, "Plasma Levels of PCBs, non-Hodgkin Lymphoma, and Causation" was published in 2012 in the Journal of Environmental and Public Health. What they did is they actually looked at not new data but data that had already been published. They reviewed the results of previously published case control studies to assess the strength of the association between non-Hodgkin lymphoma and PCBs. By the methods they used, they found that there was a strong general causal association between non-Hodgkin lymphoma and PCB exposure. So again this information is new to us, not only that there is just an association, but there is a very strong likelihood that PCB exposure causes non-Hodgkin lymphoma. Now the mechanism for what happens with that, again you'll have to refer to the article, because there is just a lot of detail that I don't have time to touch on in this talk, but PCBs are known to interact with multiple different systems and one of them is our immunologic response. There is very much reason to believe that this makes sense biologically, that there would be a causal association between non-Hodgkin lymphoma and PCB exposure. 

So what is even more compelling is that the incidence of non-Hodgkin lymphoma is rising more rapidly than the incidence of virtually all other human cancers. This particular study that I just mentioned also noted that there was a high degree of correlation observed for other cancers, breast which I already mentioned and the other one is liver and bile duct cancers. I actually had to think really hard about whether to use the data that is available for that because that is also very compelling. But there are [?] numbers with liver and bile duct cancer, kidney cancer and then skin, melanoma, soft-tissue and hard. All of these kinds of cancers have a high degree of correlation that has been observed. These cancers that I was telling you in the beginning, patients are coming in with new nodules.  They may have had a diagnosis five years ago of breast cancer, and they come back with these nodules in their kidney. When I was practicing in 1995, we would have assumed that that was a metastasis of the patient's breast cancer, but low and behold you do a biopsy of the kidney nodule and it's an entirely different kind of cancer, a cancer now of the cells of the kidney. Same story for liver and bile duct cancer. You have a diagnosis of one cancer, 5 years later you come back and you have a nodule in your liver.  In 1995, I would have assumed that that was a metastasis of your lung cancer.  You do a biopsy and it's not.  It's the cancer now of the cells of the liver. So it's a second kind of neoplasm, not just a recurrence of the original neoplasm that you had. 

I have saved the most compelling for last. Even though melanoma is one of the rarest of cancers that I have mentioned thus far and only represents less than 5% of the malignant neoplasm diagnosed in this country, melanoma used to be rare. And again when I was in medical school, we were taught that you should always think of melanoma, because that diagnosis makes a huge difference, because at the time there was nothing you could do about that diagnosis. There was no treatment for melanoma, you basically got a death sentence when you got a diagnosis of melanoma. We were told as residents and fellows that we should be very careful to make the correct diagnosis, because that would have a huge impact on people. Make sure that you ruled out that it was a carcinoma or lymphoma because at least those other two had treatment. Melanoma did not. Well, sad to say, but at this point in history, melanoma is probably one of the cancers where we have come the least far. There is still no good treatment for melanoma and as many rabbit trails that oncologists have gone down to try to make these numbers better, you see there that in 1975, the number of people who died from melanoma per 100,000 was 2.1 and in 2009 - 2.8, that number has stayed steady. I actually have a piece of paper that we were supposed to hand out to people with the numbers for melanoma, I don't know if anybody got that. But what you see on that sheet of paper that looks like this (points). The line on the [?] which is a steady state indicated that things have not changed significantly. But the number of cases, new cases, has just skyrocketed. In 1975, we were at 7.9 per 100,000 and in 2010 we were up to 23.8 per 100,000. It took a while for these numbers to be manifested. If you look at this piece of paper closely you see that between 2003 and the present that the numbers have kind of gone up and down, up and down and we are now in a down swing, just a tad bit of a down swing. If we don't do anything differently with this particular petition that is before us, that's going to be an experiment. As we come back here in about 4 years and I suspect that we are going to see that down swing become an upswing again. Melanoma is actually, of all the cancers that I have just shared with you, the most convincing that PCBs are known human carcinogens, not just probable, but they are actually cancer causing agents, because melanoma is all of the pieces of the puzzle together. This data actually came together very recently; it came together in March of 2013, when a few folks from the international agency for research on cancer met in France, 26 experts from 12 countries, to talk about PCBs. At the conclusion, the working group decided that they were going to change the classification of PCBs to what I just indicated, that they are a known carcinogen. Again, the working group looked at more than 70 independent studies and concluded that there is sufficient evidence, particularly in melanoma in humans, for the carcinogenicity of PCBs. They also looked at lots of other kinds of cancers, some of them too which I have just discussed and concluded that, yes, there was an increased risk of non-Hodgkin lymphoma and breast cancer, but the most compelling evidence was in melanoma. They published this online in "The Lancet Oncology" in March 2013. In March I sent an email to find out if the details of all the studies they used to make this conclusion, but as of now the volume 107 has not become public, but that will happen very soon. 

That is actually the conclusion of my prepared remarks. We are back to where we started. I think that there is compelling data that we should change what we are doing to reflect the body of literature that is out there now. In 2007 when this last happened, we did not have the information that we have now. With the data that is available to us now it actually would be quite catastrophic if we just proceeded as if we didn't know. We do know. There is no excuse to think that PCBs should be just classified as probable. They are actually known carcinogens. I think as a result of having that information, we should do something with it. In conclusion I think that this discussion is actually pretty timely given this typhoon that is currently in Japan today, and I'm assuming that the military installations are helping the PCBs that are under discussion here and not being affected by that typhoon in Japan right now. I did not talk about the mechanism of carcinogenicity at all in this talk, because I do think that it is important that everyone knows how PCBs affect the body in that when they are broken down they can contaminate water sources and as such marine animals and anything that is exposed to PCBs will actually, that tissue will have formed a PCB that are much more bio-available, but we ingest them and so it's pretty important that we actually do the right thing when it comes to PCBs because I mentioned to you, one of the things that I told you brought me to Maryland was the Maryland blue crab. I actually love seafood in general, I love sushi, and I have been consuming for the most part just fish and seafood because we are told that its healthier for us, that it's better to not have a lot of red meat in your diet. So as a good, health conscious decision, I have been eating a lot of fish, and unfortunately as a result of going through this information I have cut down on my consumption of fish and plan to go back to eating red meat, because when you look at the data for cancer incidence in those other parts of the country where fish is not such a big part of the diet those numbers are actually lower. So between moving to New Mexico and eating less fish and more red meat and telling everybody that I love about this information, I think we should go a step further than that. I think we should just, actually, do the right thing. So if anyone has questions I would be happy to entertain them. 

William Noggle:
Thank you

Rennae Anderson:
You're welcome 

William Noggle:
Is there anyone else who would like to speak? Well we will be here until at least 1 in this room if anybody else comes by, you're welcome to stay. Thank you Dr. Anderson

Rennae Anderson:
Sure. I actually have a question. So exactly what happens now, I mean, I noticed that on July 1[st] is when if all of this had gone according to plan, July 1[st] is when this petition would have taken effect. 

William Noggle:
Correct.

Rennae Anderson:
Did that actually happen?

William Noggle:
It did not.

Rennae Anderson:
And so, for this process, when it actually happens, how does that material, like what is going to happen with the transfer of the material?

William Noggle:
Right, it will happen in accordance to their petition and it will be put in (?). We go through these steps --we go through the hearing and a whole bunch of stuff after the hearing in accordance with TSCA regulations, and afterwards we will have an official transcript go on the docket so you can read word for word the presentations online.  After that we have a cross examination procedure where people will have an opportunity to submit questions in writing to me and it will be passed along, if appropriate, to any other people, and then we get responses back on the questions and those get put in the docket as well. After that we have another reply comment period, which is a full blown public comment period again for anyone, which is a week tentatively from August 12[th] to August 19[th] and after that we will decide everything and go through with the final rule where the exemption will or will not be granted.

Rennae Anderson:
So the mechanism of what actually happens with the materials that are in Japan, how does that happen?

William Noggle:
The final rule, if we grant the exemption, it will specify that we need to do this in accordance with the United Nations, international, all those regulations for those materials. It will specify in there what they should do.

Rennae Anderson:
And does it make a difference what that classification is as far as this goes?

William Noggle:
I don't know if I can..., well, our regulations specify disposal and the threshold of disposal. We have different thresholds of disposal, so one that we abide by most of the time and is also the most common is 50 parts per million. So, and then, there are regulations for if it's going to a landfill or if it's going to an incinerator. So those regulations will be followed.

Rennae Anderson:
So basically the toxic waste is not sub-stratified based on what's in there, it's just a group of toxic waste as an entity.

William Noggle:
I don't know how to speak on how the carcinogen aspect would possibly change the threshold level, but from what I understand of how it works is that we would not be able to change the regulation based off whether it's a carcinogen when it isn't as it is today. We might take a look at that and say ok maybe we need to come up with a better number because data out there shows that the level of 50 needs to come down a little lower, and that would be a whole other rulemaking and that would be a whole other regulatory process. And that would be a considerable effort. There is an effort being taken by another office at EPA, our toxics office, which is doing another rule, and I don't know if they are working in lowering levels. I can get back to you on that.

Rennae Anderson: I would like to go on all day; I have like a billion questions.

William Noggle: well you can feel free to submit them all to me.