[Federal Register Volume 77, Number 208 (Friday, October 26, 2012)]
[Notices]
[Pages 65443-65444]
[FR Doc No: 2012-26328]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Commercial Space Transportation Advisory Committee--Public
Teleconference

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Commercial Space Transportation Advisory Committee
Teleconference.

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SUMMARY: Pursuant to Section 10(a)(2) of the Federal Advisory Committee
Act (Pub. L. 92-463, 5 U.S.C. App. 2), notice is hereby given of three
teleconferences of the Systems Working Group of the Commercial Space
Transportation Advisory Committee (COMSTAC). The teleconferences will
take place on: Tuesday November 13, 2012, Tuesday December 18, 2012,
and Tuesday January 15, 2013. All teleconferences will begin at 1:00
p.m. Eastern Standard Time and will last approximately one hour.
Individuals who plan to participate should contact Paul Eckert,
Designated Federal Officer (DFO), (the Contact Person listed below) by
phone or email for the teleconference call-in number.
    The purpose of these three teleconferences is to assist the FAA
early in its development of regulations to protect occupants of
commercial suborbital and orbital spacecraft. In a Federal Register
notice dated July 30, 2012, the FAA announced its desire to engage with
COMSTAC on a periodic basis, approximately once per month, on specific
topics. The three teleconferences announced today are a continuation of
the three announced in July.
    As we noted in the July Federal Register notice, the FAA has not
yet targeted a date for proposing regulations to protect the health and
safety of crew and space flight participants. However, the FAA believes
that the development of sound and appropriate regulations for human
space flight can only be achieved with a deliberate, multi-year effort,
and that early industry input into this regulatory effort before any
formal proposal by the FAA is critical.
    The topics for the first three teleconferences were: (1) What Level
of Safety Should FAA Target? (2) What Should FAA Oversight Look Like?
and (3) What Types of Requirements and Associated Guidance Material
Should FAA Develop? The topics for three follow-on teleconferences are
as follows:
    (1) Key Terms and Definitions for Commercial Human Space Flight
Safety Regulations. We would like to discuss key terms and definitions
relevant to commercial human spaceflight regulations, and characterize
their potential impacts to the various parties who have a vested
interest in the industry. Terms that will be discussed include:
    a. Abort.
    b. Contingency.
    c. Emergency.
    d. Early Flight Return.
    e. Landing Site.
    (2) Aborts and Abort Systems. Abort systems have in the past been
an

element of many government human space flight systems for the purpose
of enhancing occupant safety. We will discuss the following questions
from a regulatory perspective:
    a. Is an abort system a part of fault tolerance?
    b. Does an abort only apply to the launch/ascent phase, or does it
apply to other flight phases as well?
    c. Should certain types of orbital or suborbital vehicle designs
require a launch abort system?
    d. What should the reliability requirements be for an abort system?
    e. Is it acceptable to have a different level of care for occupants
during an abort?
    (3) Fault Tolerance, Margin, and Reliability. To allow for industry
innovation, the commercial human space flight industry wishes to be
free to the maximum extent possible to choose between fault tolerance,
design margin, and reliability. We will explore the extent of this
desire from a regulatory perspective with the following questions:
    a. What would be an acceptable rationale at a functional level for
a choice of fault tolerance, design margin, or high reliability to
protect the safety of spacecraft occupants?
    b. What is the minimum level of fault tolerance? Is it different
for orbital vs. suborbital?
    c. When is occupant risk high enough to necessitate additional
fault tolerance?
    d. What determines whether fault tolerance is handled at the
function level or system level?
    Interested members of the public may submit relevant written
statements for the COMSTAC working group members to consider under the
advisory process. Statements may concern the issues and agenda items
mentioned above or additional issues that may be relevant for the U.S.
commercial space transportation industry. Interested parties wishing to
submit written statements should contact Paul Eckert, DFO, (the Contact
Person listed below) in writing (mail or email) by November 6, 2012,
for the November 13 teleconference, December 11, 2012, for the December
18 teleconference, and January 8, 2013, for the January 15
teleconference. This way the information can be made available to
COMSTAC members for their review and consideration before each
teleconference. Written statements should be supplied in the following
formats: One hard copy with original signature or one electronic copy
via email. The FAA may schedule up to 6 more teleconferences in the
coming months to allow the U.S. commercial space transportation
industry to share views with the FAA on a number of specific topics
related to commercial human space flight safety.
    An agenda will be posted on the FAA Web site at http://www.faa.gov/go/ast and http://www.faa.gov/about/office_org/headquarters_offices/ast/COMSTAC_working_group/
    Individuals who plan to participate and need special assistance
should inform the Contact Person listed below in advance of the
meeting.

FOR FURTHER INFORMATION CONTACT: Paul Eckert (AST-5), Office of
Commercial Space Transportation (AST), 800 Independence Avenue SW.,
Room 331, Washington, DC 20591, telephone<PHONE_NUMBER>; Email
<EMAIL_ADDRESS>Complete information regarding COMSTAC is
available on the FAA Web site at: http://www.faa.gov/about/office_org/headquarters_offices/ast/advisory_committee/.

    Issued in Washington, DC, October 16, 2012.
George C. Nield,
Associate Administrator for Commercial Space Transportation.
[FR Doc. 2012-26328 Filed 10-25-12; 8:45 am]
BILLING CODE 4910-13-P


The documents in this group are related to OMB’s comments on the
proposed and/or final rule (the OMB exchange).


[Federal Register Volume 79, Number 117 (Wednesday, June 18, 2014)]
[Rules and Regulations]
[Pages 34626-34627]
[FR Doc No: 2014-14236]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-0214]

Safety Zones; Recurring Events in Captain of the Port Duluth
Zone--Point to LaPointe Swim

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the safety zone in 33 CFR 165.943
for the Point to LaPointe Swim in LaPointe, WI from 7:20 a.m. through
10 a.m. on August 2, 2014. This action is necessary to protect
participants and spectators during the Point to LaPointe swim. During
the enforcement period, entry into, transiting, or anchoring within the
safety zone is prohibited unless authorized by the Captain of the Port
Duluth or his designated on-scene representative.

DATES: The regulations in 33 CFR 165.943(b) will be enforced from 7:20
a.m. through 10 a.m. on August 2, 2014, for the Point to LaPointe Swim
safety zone, Sec.  165.943(a)(7).

FOR FURTHER INFORMATION CONTACT: If you have questions on this
document, call or email LT Judson Coleman, Chief of Waterways
Management, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
for the annual Point to LaPointe Swim in 33 CFR 165.943(a)(7) from 7:20
a.m. through 10 a.m. on August 2, 2014 on all waters between Bayfield,
WI and Madeline Island, WI within an imaginary line created by the
following coordinates: 46[deg]48'50.97'' N, 090[deg]48'44.28'' W,
moving southeast to 46[deg]46'44.90'' N, 090[deg]47'33.21'' W, then
moving northeast to 46[deg]46'52.51'' N, 090[deg]47'17.14'' W, then
moving northwest to 46[deg]49'03.23'' N, 090[deg]48'25.12'' W and
finally running back to the starting point.
    Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port Duluth or his
designated on-scene representative. The Captain of the Port's
designated on-scene representative may be contacted via VHF Channel 16.
    This document is issued under authority of 33 CFR 165.943 and 5
U.S.C. 552(a). In addition to this publication in the Federal Register,
the Coast Guard will provide the maritime community with advance
notification of the enforcement of this safety zone via Broadcast
Notice to Mariners. The Captain of the Port Duluth or his on-scene
representative may be contacted via VHF Channel 16.

    Dated: June 4, 2014.
A.H. Moore, Jr.,
Commander, U.S. Coast Guard, Captain of the Port Duluth.
[FR Doc. 2014-14236 Filed 6-17-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 194 (Tuesday, October 10, 2023)]
[Notices]
[Pages 69932-69935]
[FR Doc No: 2023-22390]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4202]

Revocation of Two Authorizations of Emergency Use of In Vitro
Diagnostic Devices for Detection and/or Diagnosis of Mpox; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocations of the Emergency Use Authorizations (EUAs) (the
Authorizations) issued to Life Technologies Corp. (a part of Thermo
Fisher Scientific Inc.), for the TaqPath Monkeypox/Orthopox Virus DNA
Kit, and Becton, Dickinson and Co., for the VIASURE Monkeypox virus
Real Time PCR Reagents for BD MAX System. FDA revoked these
Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) as requested by these Authorization holders. The revocations,
which include an explanation of the reasons for each revocation, are
reprinted in this document.

DATES: The Authorization for the Life Technologies Corp. (a part of
Thermo

Fisher Scientific Inc.)'s, TaqPath Monkeypox/Orthopox Virus DNA Kit is
revoked as of April 18, 2023. The Authorization for the Becton,
Dickinson and Co.'s, VIASURE Monkeypox virus Real Time PCR Reagents for
BD MAX System is revoked as of May 24, 2023.

ADDRESSES: Submit written requests for a single copy of the revocations
to the Office of Policy, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive
label to assist that office in processing your request or include a Fax
number to which the revocations may be sent. See the SUPPLEMENTARY
INFORMATION section for electronic access to the revocations.

FOR FURTHER INFORMATION CONTACT: Kim Sapsford-Medintz, Office of
Product Evaluation and Quality, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 3216, Silver Spring, MD 20993-0002,<PHONE_NUMBER> (this is not a
toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, radiological, or nuclear agent or agents. Among
other things, section 564 of the FD&C Act allows FDA to authorize the
use of an unapproved medical product or an unapproved use of an
approved medical product in certain situations. On December 13, 2022,
FDA issued the Authorization to Life Technologies Corp. (a part of
Thermo Fisher Scientific Inc.) for the TaqPath Monkeypox/Orthopox Virus
DNA Kit, subject to the terms of the Authorization. Notice of the
issuance of this Authorization was published in the Federal Register on
January 11, 2023 (88 FR 1587), as required by section 564(h)(1) of the
FD&C Act. On December 23, 2022, FDA issued the Authorization to Becton,
Dickinson and Co. for the VIASURE Monkeypox virus Real Time PCR
Reagents for BD MAX System subject to the terms of the Authorization.
Notice of the issuance of this Authorization was published in the
Federal Register on January 31, 2023 (88 FR 6262), as required by
section 564(h)(1) of the FD&C Act. Subsequent updates to the
Authorizations were made available on FDA's website. The authorization
of a device for emergency use under section 564 of the FD&C Act may,
pursuant to section 564(g)(2) of the FD&C Act, be revoked when the
criteria under section 564(c) of the FD&C Act for issuance of such
authorization are no longer met (section 564(g)(2)(B) of the FD&C Act),
or other circumstances make such revocation appropriate to protect the
public health or safety (section 564(g)(2)(C) of the FD&C Act).

II. Authorizations Revocation Request

    In a request received by FDA on April 13, 2023, Life Technologies
Corp. (a part of Thermo Fisher Scientific Inc.), requested the
revocation of, and on April 18, 2023, FDA revoked, the Authorization
for the Life Technologies Corp. (a part of Thermo Fisher Scientific
Inc.)'s TaqPath Monkeypox/Orthopox Virus DNA Kit. Because Life
Technologies Corp. (a part of Thermo Fisher Scientific Inc.), notified
FDA that it is not commercially supporting the TaqPath Monkeypox/
Orthopox Virus DNA Kit and no kit reagents were distributed in the
United States and requested FDA revoke the Life Technologies Corp. (a
part of Thermo Fisher Scientific Inc.)'s TaqPath Monkeypox/Orthopox
Virus DNA Kit, FDA has determined that it is appropriate to protect the
public health or safety to revoke this Authorization.
    In a request received by FDA on May 22, 2023, Becton, Dickinson and
Co., requested the withdrawal of, and on May 24, 2023, FDA revoked, the
Authorization for the Becton, Dickinson and Co.'s VIASURE Monkeypox
virus Real Time PCR Reagents for BD MAX System. Because Becton,
Dickinson and Co., notified FDA that it is not commercially
manufacturing the VIASURE Monkeypox virus Real Time PCR Reagents for BD
MAX System and no reagents were distributed in the United States and
requested FDA revoke the Becton, Dickinson and Co.'s VIASURE Monkeypox
virus Real Time PCR Reagents for BD MAX System, FDA has determined that
it is appropriate to protect the public health or safety to revoke this
Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the
revocations are available on the internet at https://www.regulations.gov/.

IV. The Revocations

    Having concluded that the criteria for revocation of the
Authorization under section 564(g)(2)(C) of the FD&C Act are met, FDA
has revoked the EUA of Life Technologies Corp. (a part of Thermo Fisher
Scientific Inc.)'s TaqPath Monkeypox/Orthopox Virus DNA Kit, and
Becton, Dickinson and Co.'s VIASURE Monkeypox virus Real Time PCR
Reagents for BD MAX System. The revocations in their entirety follow
and provide an explanation of the reasons for revocations, as required
by section 564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P

[GRAPHIC] [TIFF OMITTED] TN10OC23.020

[GRAPHIC] [TIFF OMITTED] TN10OC23.021

    Dated: October 4, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22390 Filed 10-6-23; 8:45 am]
BILLING CODE 4164-01-C


                            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.


[Federal Register Volume 77, Number 87 (Friday, May 4, 2012)]
[Notices]
[Pages 26548-26549]
[FR Doc No: 2012-10725]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0988; FRL-9347-5]

Issuance of an Experimental Use Permit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: EPA has granted an experimental use permit (EUP) to the
following pesticide applicant. An EUP permits use of a pesticide for
experimental or research purposes only in accordance with the
limitations in the permit.

FOR FURTHER INFORMATION CONTACT: Mike Mendelsohn, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. Although this
action may be of particular interest to those persons who conduct or
sponsor research on pesticides, the Agency has not attempted to
describe all the specific entities that may be affected by this action.
If you have any questions regarding the information in this action,
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0988. Publicly available
docket materials are available either in the electronic docket at
http://www.regulations.gov, or, if only available in hard copy, at the
Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The hours of operation of this Docket Facility are from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

II. EUP

    EPA has issued the following EUP:
    29964 EUP-11. Issuance. Pioneer Hi-Bred International, P.O. Box
1000, Johnston, IA 50131-1000. This EUP allows the use of combined and
single trait corn containing one or more of the following plant-
incorporated protectants (PIPs): (1) [Bt11] Bacillus thuringiensis
Cry1Ab delta-endotoxin and the genetic material (via elements of vector
pZO1502) necessary for its production in corn (SYN-BT[Oslash]11-1), (2)
[DAS-59122-7] Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and
the genetic material necessary for their production (PHP17662 T-DNA) in
event DAS59122-7 corn (Organization for Economic Co-operation and
Development (OECD) Unique Identifier: DAS-59122-7), (3) [MIR162]
Bacillus thuringiensis Vip3Aa20 and the genetic material necessary for
its production (vector pNOV1300) in event MIR162 maize (SYN-IR162-4),
(4) [MIR604] Modified Cry3A protein and the genetic material necessary
for its production (via elements of pZM26) in corn (SYN-

IR604-8), (5) [TC1507] Bacillus thuringiensis Cry1F protein and the
genetic material (plasmid insert PHI8999A) necessary for its production
in corn event DAS- [Oslash]15[Oslash]7-1, and (6) [MON810] Bacillus
thuringiensis Cry1Ab delta-endotoxin and the genetic material necessary
for its production (Vestor PV-ZMCT01) in event MON 810 corn (OECD
Unique Identifier: MON- [Oslash][Oslash]81[Oslash]-6). The focus of the
EUP are the three breeding stacks: (1) MIR604 x 1507 x 59122 x MON 810,
(2) MIR604 x 59122 x MON810, and (3) MIR604 x1507. 0.0184 pounds (lbs.)
of MON810 Cry1Ab, 0.0585 (lbs.) of Bt11 Cry1Ab, 5.513 (lbs.) of
Cry34Ab1, 0.754 (lbs.) of Cry35Ab1, 0.123 (lbs.) of Vip3Aa20, 0.147
(lbs.) of mCry3A, and 0.170 (lbs.) of Cry1F, are authorized on, 2,672
PIP acres. 664 acres of non-PIP and border row corn are also
authorized. Two protocols will be conducted, including: Insect
resistance management and efficacy/expression. The program is
authorized only in the States of Arkansas, California, Colorado,
Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Louisiana, Michigan,
Minnesota, Mississippi, Missouri, Nebraska, New York, North Carolina,
Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota,
Tennessee, Texas, Washington, and Wisconsin. The EUP is effective from
March 3, 2011, to June 30, 2012. One comment was received in response
to the January 26, 2011, notice of receipt in the Federal Register, 76
FR 4683, FRL-8856-2. One comment was received from an anonymous
individual who objected in general terms to EPA granting this
experimental use permit with Bacillus thuringiensis-based plant-
incorporated protectants claiming that insufficient safety testing has
been required. The Agency understands that some individuals are opposed
to all biotechnology based pesticide use. Pursuant to section 5 of the
Federal Insecticide, Fungicide, and Rodenticide Act, EPA may issue a
permit for experimental use of a pesticide if the Agency determines
that such experimental use may be conducted in such a manner as to not
result in unreasonable adverse effects on the environment. EPA has
conducted a comprehensive analysis of data and information related to
the requested experimental uses and, based on that analysis, EPA has
determined that the experimental uses, if conducted in accordance with
the terms of the permit, will not result in unreasonable adverse
effects on the environment.

     Authority:  7 U.S.C. 136c.

List of Subjects

    Environmental protection, Experimental use permits.

    Dated: April 24, 2012.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2012-10725 Filed 5-3-12; 8:45 am]
BILLING CODE 6560-50-P


Request for Information  -  Methane Emissions Reduction Program

DOCKET 3: Methane Emissions Reduction Program [60113]
EPA received $1.55 billion to reduce methane emissions from the oil and gas sector by providing financial assistance (grants, rebates, contracts, loans, and other activities) and technical assistance as well as implementing a statutorily required waste emissions charge. Eligible recipients for these funds include but are not limited to air pollution control agencies, other public or nonprofit private agencies, institutions, and organizations, and individuals. The program specifies that at least $700 million must be used for activities at marginal conventional wells. Section 60113 also requires EPA to implement a waste emission charge on methane emitted from applicable oil and gas facilities that emit over 25,000 metric tons of CO2e and that exceed statutorily specified waste emissions thresholds beginning in 2024. The waste emissions charge will start at $900 and increase to $1,500 per metric ton.

QUESTIONS:

Incentives Program
          The Methane Emissions and Waste Reduction Incentive Program provides up to $1.55 billion to EPA to issue grants, rebates, contracts, loans, and other activities for a number of statutorily specified purposes.  How can EPA structure the financial and technical assistance to ensure the greatest possible public health and environmental impact?
          How can EPA ensure that the financial and technical assistance provided under the Methane Emissions and Waste Reduction Incentive Program complements rather than duplicates other federal and state programs, including funding through other IRA programs?
          The Methane Emissions and Waste Reduction Incentive Program can provide technical assistance to owners and operators of facilities.  What kinds of technical assistance would be most valuable?  How might technical assistance evolve over time?
          The Methane Emissions and Waste Reduction Incentive Program has funding that is allocated for marginal conventional wells.  For the purposes of financial and technical assistance specified in the IRA, are there unique considerations related to marginal conventional wells that EPA should consider?  How can EPA ensure that relevant stakeholders are engaged, including owners and operators of marginal conventional wells and those affected by marginal wells and their emissions?
          What should EPA consider in the design of the program to encourage grantees to support high quality jobs and adhere to best practices for labor standards, consistent with guidance such as Executive Order 14063 on the Use of Project Labor Agreements and the Department of Labor's Good Jobs Principles?
          What metrics should this program use for measuring success and ensuring accountability?

Waste Emissions Charge
          The IRA establishes a waste emissions charge for methane from applicable facilities that report more than 25,000 metric tons of CO2 equivalent per year to the Greenhouse Gas Reporting Program (GHGRP) petroleum and natural gas systems source category (GHGRP Subpart W) and that exceed statutorily specified waste emissions thresholds.  The IRA specifies certain exemptions and flexibilities related to the charge.  What issues should EPA consider related to waste emissions charge implementation?
          The IRA requires EPA to revise the requirements of GHGRP Subpart W to ensure that reporting is based on empirical data and accurately reflects total methane emissions.  What revisions should EPA consider related to GHGRP Subpart W?

      Responses must be received by 11:59 PM ET on January 18, 2023 :: Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2022-0875, to the Federal eRulemaking Portal: www.regulations.gov.

Follow the instructions on the website for submitting comments. Once submitted, comments cannot be edited or removed from the docket. You do not need to address every question and should focus on those where you have relevant expertise or experience. Please identify the question(s) you are responding to by question number when submitting your comments. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. In all cases, to the extent possible, please cite any public data related to or that support your responses. If data are available, but non-public, describe such data to the extent permissible. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). FOR FURTHER INFORMATION CONTACT<EMAIL_ADDRESS>


                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                       SCIENTIFIC ADVISORY PANEL (SAP)
              August 25, 2020, Public Virtual Preparatory Meeting
           September 15-18, 2020, Public Virtual Peer Review Meeting
 Food Quality Protection Act (FQPA) Science Review Board Biographical Sketches
                      Docket Number: EPA-HQ-OPP-2020-0263

Veronica J. Berrocal, PhD

 Affiliation: Associate Professor, Department of Statistics, University of California, Irvine, California.

 Expertise: Statistical methods for environmental exposure assessment (e.g., characterize environmental exposure) and effect of environmental exposure on health.

 Education: PhD, Statistics, University of Washington; MSc, Statistics, Michigan State University; Diplôme d'études approfondies (DEA) en Mathematiques, Université Joseph Fourier, Grenoble (now part of Université Grenoble Alpes), France; Laurea, Mathematics, Sapienza Università di Roma, Italy.

 Experience Summary: Dr. Veronica Berrocal is Associate Professor of Statistics at the University of California (UC), Irvine, California. She joined the Department of Statistics at UC, Irvine, in Fall 2019, after having been on the faculty at the University of Michigan in the Department of Biostatistics (first as Assistant Professor, then as Associate Professor; 2010-2019). Dr. Berrocal's research focuses on the development of statistical methods to characterize individuals' exposure to environmental risk factors (e.g., air pollution, weather, climate, built environment, etc.) and in estimating the effect of environmental exposure on health. Because of her research accomplishment in spatial and environmental statistics, Dr. Berrocal received the Early Investigator award from the Section on Statistics and the Environment of the American Statistical Association in 2015. Dr. Berrocal served and is currently serving as Associate Editor for: (i), the Journal of the American Statistical Association (2016-2018), the flagship journal for the American Statistical Association; (ii) the Journal of Agricultural, Biological and Environmental Statistics (2011-2018); and (iii) Bayesian Analysis (2018-present). She is currently also a statistical reviewer for the Journal of the American Medical Association (JAMA) Network Open (2018-present) and Lancet Psychiatry (2019-present).

 Panel Experience: Dr. Berrocal has served as ad-hoc member on the US Environmental Protection Agency (EPA) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel four times (December 2014; May 2015; November 2017; November 2019). She has served as external peer reviewer for the US EPA on the "Environmental Relative Moldiness Index (ERMI)" (October 2016), and on "Significant Impact Levels (SILs) for ozone and fine particle pollution" (September 2016). Besides these experiences, Dr. Berrocal has served as a member on panels reviewing grant applications to National Institutes of Health (NIH) (ad-hoc member of the Biostatistical Methods and Research Design (BMRD) study section; June 2017); to National Institute of Environmental Health Sciences (NIEHS) for superfund centers (October 2016); the Health Effects Institute (2018); National Science Foundation (NSF) (May 2019) and National Aeronautics and Space Administration (NASA) (July 2019).

Harvey J. Clewell, PhD, DABT, FATS

 Affiliation: Principal Consultant, Ramboll US Corporation, Raleigh, North Carolina.
 Expertise: Incorporation of in vitro data, in silico modeling, and mode-of-action evaluation into chemical risk and safety assessment.
 Education: PhD, Toxicology, University of Utrecht, the Netherlands; MA, Chemistry, Washington University.
 Experience Summary: Dr. Harvey Clewell has gained an international reputation for his work on the incorporation of mechanistic data and mode of action information into chemical risk assessments, having played a role in the first uses of physiologically based pharmacokinetic (PBPK) modeling in cancer and non-cancer assessments by EPA, Agency for Toxic Substances and Disease Registry (ATSDR), Occupational Safety and Health Administration (OSHA), and Food and Drug Administration (FDA).
 Panel Experience: Dr. Clewell has previously served on external peer review panels for a number of EPA guidelines, including those for cancer risk assessment, risk characterization, benchmark dose modeling, and dermal absorption, and has participated in a number of chemical-specific reviews conducted by the EPA Science Advisory Board (SAB) and the FIFRA Scientific Advisory Panel (SAP). He also served as a member of the European Center for the Validation of Alternative Methods (ECVAM) Scientific Advisory Panel from 2012-2016. He is currently a member of the EPA Science Advisory Board (SAB) Chemical Assessment Advisory Committee.

                               Holly Davies, PhD
 Affiliation: Washington State Department of Health, Tumwater, Washington.

Expertise: Sustainability, human health and ecological risk assessments; scientific studies supporting state chemical policy.

Education: PhD, Genetics, University of Washington; BS, Biology, Cornell University.

Experience Summary: Dr. Holly Davies is a senior toxicologist at the Washington State Department of Health. She is an experienced professional in chemical policy, scientific research, and teaching. Her work has focused on evaluating uses of toxic chemicals, including chemicals of emerging concern and persistent, bioaccumulative, and toxic chemicals (PBT), and identifying actions needed to protect human health and the environment. Dr. Davies is a member of the Association for the Advancement of Alternatives Assessment and actively participates in the Children's Environmental Health Working Group within the Washington Chapter of the Collaborative on Health and the Environment. Her postdoctoral research (2000-2004) is on mammalian reproduction and development, transcription factors, and genomics.

Panel Experience: Dr. Davies has served on the Peer Review of the Draft Risk Assessment for Toxic Substances Control Act (TSCA) Work Plan Chemical 1-Bromopropane (CASRN-106-94-5) [May 24-25, 2016] advisory panel. and on the Chemical Safety Advisory Committee (CSAC) Orientation Session on Toxic Substances Control Act (TSCA) [May 11, 2016] advisory committee. Dr. Davies is currently a member of the TSCA Science Advisory Committee on Chemicals.

                     Marion F. Ehrich, RPh, PhD, DABT, ATS

 Affiliation: Professor, Pharmacology/Toxicology, Virginia Maryland College of Veterinary Medicine, Virginia Polytechnic Institute and State University, Blacksburg, Virginia.

 Expertise: General and veterinary pharmacology, general toxicology, neurotoxicology, pesticide toxicology, and veterinary diagnostic toxicology.

 Education: PhD, Pharmacology/Toxicology, University of Connecticut, Storrs; MS Pharmacology/Toxicology, The University of Chicago; BS, Pharmacy, South Dakota State University.

 Experience Summary: Dr. Marion Ehrich is a professor at Virginia-Maryland College of Veterinary Medicine (VMCVM) in Blacksburg, Virginia. In addition to teaching pharmacology and toxicology to veterinary, medical and graduate students, her professional responsibilities include serving as relief pharmacist in the Veterinary Medical Teaching Hospital Pharmacy as well as consultant in the Veterinary Toxicology Diagnostic Laboratory. Dr. Ehrich has been teaching at VMCVM since 1980, the year in which she became a member of the Society of Toxicology and a Diplomate of the American Board of Toxicology (DABT). Pharmacology teaching at the new medical school encompassed 2010-2017. She was elected a fellow of the Academy of Toxicological Sciences (ATS) in 1999. The Society of Toxicology provided Marion Ehrich with its Merit Award in 2010. She has served on numerous committees for that organization and was its president in 2003-2004.

 Panel Experience: US EPA FIFRA Scientific Advisory Panel, 2012-2019 (member of the permanent panel 2012-2018; invited ad hoc panel member 2019, 2010, 1996).
 National Institutes of Health (NIH), Special Study Sections, 2020 (1), 2019 (1), 2018 (3),
 2017, 2016, 2013 (2), 2009, 2008, 2004, 2002, 2000 (2), 1999, 1997, 1996 (2), 1995
 (2), 1986. Member of the National Academy of Sciences (NAS), Engineering and Medicine Review panel 2020. Chair of Committee for review of risk assessment processes for pesticides done by the California Department of Pesticide Regulations (DPR), 2014-2015. Member on Committee on Toxicology, 2005-2011. Other NAS/National Research Council (NRC) reviews (Gulf War, 2001-2002; Low Dose Chemical Mixtures, 2003-2004; Great Lakes Pollutants, 2008). Integrated Risk Information System (IRIS), US EPA, Review of science topics for hexahydro-1,3,5- trinitro-1,3,5-triazine, RDX), May 2016. United States Pharmacopia (USP) Expert Committee on Toxicology, 2010-2015. Veteran's Administration (VA) research grants, Chair, Study Section, 2012. Scientific Advisory Committee on Alternative Toxicological Methods (SACATM), NIH, NIEHS, 2006-2010.

 Penelope A. Fenner-Crisp, PhD Affiliation: Independent Consultant, North Garden, Virginia.
 Expertise: Toxicology and risk assessment; execution and/or management oversight of the development of human health and ecological risk assessments for environmental substances and for the risk assessment guidelines that support the development of these chemical-specific assessments.

 Education: Postdoctoral Fellowship, Georgetown University School of Medicine; PhD and MA, Pharmacology, University of Texas Medical Branch; BS, Zoology, University of Wisconsin-Milwaukee.

 Experience Summary: Dr. Penelope Fenner-Crisp has been an independent consultant since retiring from the International Life Sciences Institute as Executive Director of the Risk Science Institute (2000-2004). Prior to that, Dr. Fenner-Crisp served in a variety of capacities at US EPA, beginning her career in the Office of Drinking Water (ODW) as a Senior Toxicologist. Her responsibilities included managing the Health Advisory program, in which non-regulatory guidance was developed for contaminants in drinking water (1978-1987). From 1987-1989, she served as the Director of the Health and Environmental Review Division (now the Risk Assessment Division) in the Office of Pollution Prevention and Toxics (OPPT). For the balance of her career (1989-2000), she served as the Director of the Health Effects Division in the Office of Pesticide Programs (OPP), then its Deputy Office Director and Senior Science Advisor, as well as the official responsible for creating the Office of Science Coordination and Policy in the Office of Chemical Safety and Pollution Prevention.
 During these years, she was responsible for management oversight of the FIFRA Scientific Advisory Panel. Dr. Fenner-Crisp has served as a member of the boards of the Toxicology Forum (1991-2000), the Midwest Center for Environmental Science and Public Policy (2001-2006), GreenBlue (2006-2020) and the EPA Alumni Association (2017-present).

 Panel Experience: Some of Dr. Fenner-Crisp's post-EPA peer review experiences include the NAS expert group which published "Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services" (2005-2006), the Food Advisory Committee of FDA's Center for Food Safety and Applied Nutrition (2008-2011), EPA's Science Advisory Board's Drinking Water Committee (2003-2009) and Committee on Science Integration in Decision-making (2009-2013). As an ad hoc member of the FIFRA Scientific Advisory Panel, Dr. Fenner-Crisp reviewed: 1) the status of the in utero through lactational assay in the EDSP (2007); 2) the Agency's activities related to the assessment of pyrethroid pesticides (2009 and 2010); and assessment activities related to atrazine (2010 and 2011) . In addition, she has participated in the review of: 1) the draft EPA Integrated Risk Information System (IRIS) document "Toxicological Review of Trichloroacetic Acid", 2) a Health Canada Regional Branch's "Evaluation of the Priority Substance List Assessment Report for Acrylonitrile," 3) the draft EPA Risk Assessment Forum "Framework for Human Health Risk Assessment to Inform Decision-making," 4) EPA OPPT's 2013 draft Trichloroethylene risk assessment (Chair), and 5) EPA's Physiologically-based Pharmacokinetic (PBPK) Model for Deltamethrin and Permethrin and PBPK-Pharmacodynamic (PBPK-PD) Model for Carbaryl (2018).

                     Helena T. Hogberg, PhD

 Affiliation: Deputy Director, Center for Alternatives to Animal Testing (CAAT), Environmental Health & Engineering, at Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.

 Expertise: Research in developmental neurotoxicity and neurological disorders using in vitro approaches.

 Education: PhD, Toxicology and Physiology, Stockholm University, Sweden; MS, Molecular Biology, Stockholm University, Sweden; BS, Biology, Stockholm University, Sweden.

 Experience Summary: Dr. Helena Hogberg is faculty at Johns Hopkins Bloomberg School of Public Health (2010-present) teaching and researching neurotoxicology. Her PhD thesis aimed to develop in vitro approaches to evaluate chemical induced developmental neurotoxicity (DNT). The experimental work was performed at the European Centre for the Validation of Alternative Methods (ECVAM), Joint Research Centre, European Commission, Ispra, Italy (2005-2009). Dr. Hogberg is the Specialty Chief Editor for Neurotoxicology, Frontiers in Toxicology; Associate Editor for Predictive Toxicology, Frontiers in Pharmacology; and Member of Editorial Board of Elsevier Journal NeuroToxicology. Dr. Hogberg is currently the Secretary/Treasurer for the In Vitro and Alternative Methods Specialty Section of the Society of Toxicology (2020- present) and the councilor of the International Neurotoxicology Association (2017- present). She has been on the scientific steering committee for three of the five International Conferences on Alternatives for DNT (2010-present, Chair 2012-2014).
 She is currently appointed to the expert group on DNT of the International Council on Animal Protection in OECD Programs (2018-present) and member of the International Stakeholder Network for creating a (Developmental) Neurotoxicity Testing Roadmap (2013-present). Her primary research interests are NAMs for DNT using 3D models, Induced Pluripotent Stem Cells (iPSCs) and omics approaches.

 Panel Experience: Dr. Hogberg is directing the grants program of CAAT, Alan and Helene Goldberg In Vitro Toxicology Grants peer reviewed by CAATs board (2012- present). Dr. Hogberg is peer reviewer of grants for the Netherland Organisation for Scientific Research and Alternatives Research & Development Foundation (2015- present). She is on the Scientific Advisory Board for the European Commission funded Horizon 2020 grant - Novel Testing Strategies for Endocrine Disruptors in the Context of Developmental NeuroToxicity (2019-present) and of AxoSim (2019-present).

                     David A. Jett, PhD

 Affiliation: Program Director, NIH, National Institute of Neurological Disorders and Stroke, Bethesda, Maryland.

 Expertise: Neurotoxicology, pesticides, and translational toxicology.

 Education: PhD, Neuropharmacology and Toxicology, University of Maryland School of Medicine; MS, Zoology and Toxicology, University of Maryland at College Park; BA, Biology, Hampton Institute (now Hampton University).

 Experience Summary: Dr. David Jett is Director of the NIH Countermeasures Against Chemical Threats (CounterACT) Program, a program supported by a specific Congressional appropriation to the NIH for the development of new drugs and diagnostic tools for treating victims of chemical exposures during an emergency. He also serves as Program Director and Scientific Team Leader within the Division of Translational Research at the National Institute of Neurological Disorders and Stroke (NINDS). After receiving a PhD in Neuropharmacology and Toxicology at the University of Maryland School of Medicine, Dr. Jett conducted post-doctoral research and subsequently joined the faculty at Johns Hopkins University's Bloomberg School of Public Health where he conducted research as a university professor for several years. Dr. Jett has authored many scientific articles and book chapters in the area of neurotoxicology and has chaired sessions and given keynote addresses at many national and international scientific meetings. He holds the position of Professor Adjunct of Chronic Disease and Epidemiology within the Yale School of Public Health. Dr. Jett has served on White House and intergovernmental committees that set the nation's research priorities. Dr. Jett's other major interest at NIH is training and diversity.

 Panel Experience: EPA FIFRA Scientific Advisory Panel (member of Permanent panel), two terms (2014-2018).

                             Mark S. Johnson, PhD

Affiliation: Director of Toxicology, US Army Public Health Center at Aberdeen Proving Ground, Maryland.

Expertise: Toxicology, risk assessment, and ecology.

Education: PhD, Veterinary Science, Virginia-Maryland College of Veterinary Medicine; MSc, University of Delaware; BS, Biology, Towson State University.

Experience Summary: Dr. Johnson currently serves as the Director of Toxicology, US Army Public Health Center at Aberdeen Proving Ground, Maryland where he is responsible for the operational and technical arm of the Army Surgeon General and the Assistant Secretary of the Army for toxicological matters. He has worked extensively in the evaluation of the toxicity of military unique compounds and development and evaluation of a phased approach to the gathering of toxicity data for new compounds under development. Dr. Johnson has been a member of the Society of Environmental Toxicology and Chemistry (SETAC) since 1997 and is a Steering Group Member of several World Interest Groups (e.g., Wildlife Toxicology World Interest Group, Ecological Risk Assessment World Interest Group, and Science Committee for SETAC North America). Dr. Johnson is the chair of the Tri-Service Toxicology Consortium and has over 100 published peer-reviewed publications, technical reports, and book chapters on toxicology and risk assessment.

Panel Experience: Dr. Johnson has served on multiple North Atlantic Treaty Organization Science and Technology Organization (NATO STO panels) (e.g., Applied Vehicle Technology (AVT) 322 Combustion Products, Exposure and Related Risks, AVG-276-RLS-042 on Environmental Management of Munition and Greener Approaches to Design) and The Technical Cooperation Program (TTCP) Panels (WPN/Technical Panel 4, Energetic Materials and Propulsion Technology, Environmental Aspects of Energetic Materials, U.S. Area of Interest Annual Reports; TTCP Technical Report CP 4-42, Assessing the Potential Environmental and Human Health Consequences of Energetic materials: A Phased Approach, TR-WPN-TP04-15-2014). He is a Steering Group Member of the Wildlife Toxicology World Interest Group, Chair of Ecological Risk Assessment World Interest Group, and a member of the Science Committee for SETAC North America. Dr. Johnson was the past chair of the Terrestrial Toxicity Subcommittee of the Biological Fate and Effects Committee of the American Society for Testing and Materials (ASTM), and the past president of the American Board of Toxicology (ABT) and current chair of the Tri-Service Toxicology Consortium. He also serves as a government liaison on the National Research Council (NRC)/National Academy of Sciences (NAS) Committee on Emerging Science for Environmental Decision Making. Dr. Johnson is currently a member of the TSCA Science Advisory Committee on Chemicals.

                     John C. Lipscomb PhD, DABT, FATS

 Affiliation: Senior Toxicologist at CTEH, LLC, North Little Rock, Arkansas and Adjunct Professor of Toxicology, University of Louisville, Louisville, Kentucky.

 Expertise: Dr. Lipscomb has received recognition for his research into the toxicology and risk assessment of single chemicals and chemical mixtures. He has experience in developing and applying US EPA-level guidance for the conduct of quantitative health risk assessments.

 Education: PhD, Interdisciplinary Toxicology, University of Arkansas for Medical Sciences; MS and BS, Biology, University of Central Arkansas.

 Experience Summary: Dr. John Lipscomb is a Senior Toxicologist at CTEH, LLC, and Adjunct Professor of Toxicology at the University of Louisville. He is certified in toxicology (DABT) by the American Board of Toxicology and is a Fellow of the Academy of Toxicological Sciences (FATS). He is/has been an associate Editor for Toxicology Reports, Toxicology Mechanisms and Methods and Toxicological Sciences; has led regional chapters and specialty groups for the Society of Toxicology and the Society for Risk Analysis, served on Council for the Society of Toxicology and as President of the American Board of Toxicology. His research interests include developing non-default, quantitative (protective) risk values for public health protection and weight of evidence based (predictive) risk values for application in emergency response. He has over 100 peer reviewed publications, government technical reports and book chapters on topics including developmental toxicology, in vitro to in vivo extrapolation, toxicokinetics, drinking water disinfection byproduct toxicity and risk, mixtures and cumulative risk assessment, quantitative risk assessment and health guidance (risk) values. Dr.
 Lipscomb retired in 2019 from a 21-year career in US EPA's Office of Research and Development, where he co-led the development of Agency guidance for Data-Derived Extrapolation Factors.

 Panel Experience: None to date.

                             Kenneth Portier, PhD

Affiliation: Consulting Biostatistician, Athens, Georgia (Retired, National Cancer Society).

Expertise: Statistical applications in agriculture, natural resources, environmental sciences and environmental health. More recently providing administrative and statistical support on design and analysis of cross-sectional and longitudinal sample surveys, program evaluations, models of cancer mortality and incidence, text mining and Geographical Information System (GIS) in cancer program planning. Specific expertise in statistical aspects of environmental sampling, toxicology, program evaluation, and geographical information systems.

Education: PhD, Biostatistics and MS, Statistics, University of North Carolina-Chapel Hill; BS, Mathematics, Nicholls State University.

Experience Summary: Dr. Ken Portier has served as Vice President (2015-2017), Managing Director (2010-2015), Director of Statistics (2006-2010), Statistics and Evaluation Center, Intramural Research Department, American Cancer Society (ACS), Atlanta, Georgia. Affiliate Professor of Biostatistics, School of Public Health, Emory University (2006-2017). Assistant Research Scientist (1979-1981), Assistant Professor (1981-1986), Associate Professor (1986-2006), Experiment Station Statistician (1979-2006), Institute of Food and Agricultural Sciences and College of Agriculture, University of Florida, Gainesville. Courtesy faculty (2001-present), Center for Environmental and Human Toxicology, College of Veterinary Medicine, University of Florida, Gainesville.

Dr. Portier's research interests include statistical issues in environmental and human health risk assessment, applied statistical methods, multivariate data analysis, data and text mining, GIS applications in environmental and public health, use of technology in the learning of statistics, survey methodology including data imputation.

Panel Experience: Dr. Portier has participated in over 60 US Environmental Protection Agency (US EPA) FIFRA Scientific Advisory Panel meetings (1999 to 2013) and five EPA Science Advisory Board Review Panels (2012 to 2015). In addition, Dr. Portier served on expert and advisory panels for the National Institutes of Health (NIH); National Institute of Environmental Health Sciences (NIEHS); National Toxicology Program (NTP), and the World Health Organization Food and Agriculture Organization (WHO/FAO). Other panels Dr. Portier has served on include: NIH/NIEHS; Breast Cancer & Environmental Research Coordinating Committee (2010-2012); World Health Organization, Expert Panel, Toxicological and Health Aspects of Bisphenol A (2010); American Statistical Association, Section on Risk (2010); NTP/NIEHS/NIH Board of Scientific Counselors (2007-2009, Chair (2009); NTP/NIEHS/NIH, Center for the Evaluation of Risks to Human Reproduction, Expert Panel (2003 and 2008); Biometric Society (ENAR & WNAR) representative to the Ag and Life Sciences Committee of the American Association for the Advancement of Science (AAAS) (2005-2007). Dr. Portier previously served as Chair for the Chemical Safety Advisory Committee (CSAC) reviewing the Draft Risk Assessment for Work Plan Chemical 1-Bromopropane (2016). Dr. Portier is currently the Chair of the TSCA Science Advisory Committee on Chemicals.

                             Daniel M. Quinn, PhD

Affiliation: Emeritus Professor, Adjunct Professor; Department of Chemistry, University of Iowa, Iowa City, Iowa.

Expertise: Chemistry, biochemistry, and medicinal chemistry.

Education: PhD, Bioorganic Chemistry, The University of Kansas; BS, Chemistry, Quincy College.

Experience Summary: Dr. Quinn is an Emeritus Professor of Chemistry and Adjunct Professor at the University of Iowa. He has 38 years of teaching in organic chemistry and biotechnology; and research on the mechanism and inhibition of lipases and enzymes of the cholinergic neurotransmission system. Among the cholinergic enzymes studied in the Quinn lab were acetylcholinesterase and butyrylcholinesterase.

Panel Experience: Dr. Quinn has served on the NIH Countermeasures Against Chemical Threats (CounterACT) study section since 2012 and has served as co-chair since 2014.
He has also been a member of the following NIH study sections: Training and Workforce Development (ad hoc) (2015), Biomedical Research Training (permanent member) (2008-2014), Biochemistry and Biophysics of Membranes (2005), Macromolecular Structure and Function (ad hoc), Physical Biochemistry Study Section (ad hoc) (2004, 2002, and 1996-1999), and Neurological Sciences Subcommittee (1989). Dr. Quinn has also served on grant review and fellowship committees for the following organizations: National Science Foundation (2014), Alzheimer's Association (2003), NIH Chemistry and Biophysics Fellowship Panel (2003), and US Army Medical Research and Material Command (2001).

                     Pamela J. Spencer, PhD, DABT

 Affiliation: Vice President, Regulatory, Product Stewardship & Quality, ANGUS Chemical Company, Buffalo Grove, Illinois.

 Expertise: Expertise in general toxicology, human health risk assessments and predictive toxicology; Extensive experience in regulatory toxicity testing and research to define human health risks, with publications in the areas of neurotoxicology, genetic toxicology, carcinogenicity and green chemistry.

 Education: Honorary Doctor of Science, Central Michigan University; PhD, Toxicology, University of Michigan, School of Public Health; MS, Biology, Central Michigan University; BS, Biology, Saginaw Valley State University.

 Experience Summary: Dr. Pamela Spencer is the Vice President of Regulatory, Product Stewardship & Quality at ANGUS Chemical Company, in Chicago, Illinois (2016
 - present). Prior to this role, she worked for the Dow Chemical Company for 30 years, retiring as the Scientific Director of Dow's Toxicology Environmental Research & Consulting function which included leading capability development for Dow's Predictive Toxicology Center (1985-2016). Dr. Spencer was a member of the Board of Directors for Center for Alternative Test Methods, Johns Hopkins School of Public Health (2013- 2016); Board of Directors for International Life Sciences Institute, Health and Environmental Sciences Institute (2016-present), Board of Directors for the Center for Contemporary Science (2019-present) and served on the Executive Council for the Society of Toxicology In Vitro and Alternative Methods (2016-present) and Sustainable Chemicals through Contemporary Toxicology (2019-present) Specialty Sections. Her research interests have focused on the protection of human health as it relates to solvent neurotoxicity, rapid carcinogen screening models and more recently on evaluation and application of predictive toxicology screening approaches to inform early screening safety assessments in new product development/reformulation and substitution of chemicals of high concern.

 Panel Experience: Dr. Spencer was appointed to the National Institute of Environmental Health Sciences (NIEHS), Scientific Advisory Committee on Alternative Toxicological Methods (2015-2019). She served as Chair of the committee from 2017-2019.

 Lisa M. Sweeney, PhD, DABT, CHMM Affiliation: Risk Assessment Toxicologist, UES, Inc., Dayton, Ohio. Expertise: Risk assessment, toxicokinetics, and toxicology.
 Education: BSE, Chemical Engineering, Case Western Reserve University; PhD Chemical Engineering, Cornell University.

 Experience Summary: Dr. Lisa Sweeney has a broad range of experience in the application of toxicology, chemistry, and engineering to problems in the health and environmental sciences. She has over 25 years of experience in risk assessment, pharmacokinetics, and biochemical engineering from private sector, non-profit and government perspectives. She is an author of over 50 peer-reviewed publications, with 30 as first author. Her experience has focused on the development and refinement of physiologically based pharmacokinetic (PBPK) models and their application to risk assessment and experimental design. Other risk assessment experience includes preparing toxicological reviews and calculating human health risks from exposure to compounds found in manufacturing and maintenance environments in accordance with US EPA guidance. She has also served as the principal investigator/project manager for in vivo acute toxicity and toxicokinetic studies.

 Panel Experience: Dr. Sweeney has experience with US EPA FIFRA SAP meeting, FQPA Science Review Board Member, Evaluation of a Proposed Approach to Refine Inhalation Risk Assessment for Point of Contact Toxicity: A Case Study Using a New Approach Methodology (NAM) (2018); US EPA FIFRA SAP meeting, FQPA Science Review Board Member, Review of Scientific Issues Associated with Chlorpyrifos: Analysis of Biomonitoring Data (2016); ATSDR manuscript review: Concentration-time extrapolation in the development of protective action criteria for airborne Hazardous Chemicals (2016); US EPA PPRTV review: ethylene cyanohydrin, On behalf of Eastern Research Group, under contract to US EPA (2012); US EPA IRIS review: methanol noncancer toxicity reference values, On behalf of Eastern Research Group, under contract to the US EPA (2011); ITERate review: Manganese RfC, On behalf of Toxicology Excellence for Risk Assessment (2011); US EPA PPRTV review: methacrylonitrile, On behalf of Eastern Research Group, under contract to US EPA (2011); US EPA IRIS review: ethyl tert-butyl ether toxicity reference values, On behalf of Eastern Research Group, under contract to the US EPA (2010); TERA Peer Consultation: Draft frame work to evaluate adult-child differences in inhalation dosimetry of gases: application to selected systemically-acting volatile organic chemicals (2007).