Minutes of the

United States Environmental Protection Agency (EPA)

Human Studies Review Board (HSRB)

May 24, 2011 Public Teleconference Meeting

Docket Number: EPA–HQ–ORD–2011–0418

HSRB Web Site: http://www.epa.gov/osa/hsrb

Committee Members:	(See EPA HSRB Members list – Attachment A)

Date and Time:  	Tuesday, May 24, 2011, 1:00 p.m. – 3:00 p.m.

(See Federal Register Notice – Attachment B)

Location: 	Via teleconference

Purpose: 	The EPA Human Studies Review Board provides advice,
information, and recommendations on issues related to the scientific and
ethical aspects of human subjects research.

Attendees: 	Chair: 			Sean Philpott, Ph.D., M.S. Bioethics

Vice Chair:		Janice Chambers, Ph.D., D.A.B.T.

Board Members: 	George C.J. Fernandez, Ph.D.

Vanessa Northington Gamble, M.D., Ph.D.

Sidney Green, Jr., Ph.D., Fellow ATS

Dallas E. Johnson, Ph.D.

Michael D. Lebowitz, Ph.D., FCCP

Jerry A. Menikoff, M.D.

Rebecca Tyrrell Parkin, Ph.D., M.P.H.

William J. Popendorf, Ph.D.

Virginia Ashby Sharpe, Ph.D.

Linda J. Young, Ph.D.

Meeting Summary:	Meeting discussions generally followed the issues and
general timing as presented in the meeting Agenda (Attachment C), unless
noted otherwise in these minutes.

CONVENE MEETING AND IDENTIFICATION OF BOARD MEMBERS

Mr. Jim Downing (Designated Federal Officer [DFO], Human Studies Review
Board [HSRB or Board], Office of the Science Advisor [OSA], U.S.
Environmental Protection Agency [EPA or Agency]) opened the
teleconference meeting and welcomed Board members on behalf of the EPA
Science Advisor Dr. Paul Anastas and the Program in Human Research
Ethics. He noted that the Agency appreciates the Board members’ time
in preparing for the meeting. He also welcomed EPA colleagues and
members of the public. The purpose of this teleconference meeting was to
review the decisions made by the Board at the April 13-14, 2011, HSRB
meeting and to finalize the Board report from that meeting. In addition,
the Board considered a draft letter from an HSRB workgroup on providing
research participants with individualized study results measuring the
amount of antimicrobial cleaning products on participants’ skin and
the amount inhaled while mopping floors.

Meeting Administrative Procedures

As DFO, Mr. Downing serves as the liaison between the HSRB and EPA and
ensures that Federal Advisory Committee Act (FACA) requirements are met
with regard to the operations of the HSRB. As DFO, he also works with
the appropriate officials to ensure that all applicable ethics
regulations are satisfied. Each Board member has been briefed on the
provisions of the federal conflict of interest laws and has filed a
standard government financial disclosure form that has been reviewed to
ensure that all ethics disclosure requirements have been met.
Mr. Downing reminded participants that meeting times listed on the
Agenda would be approximate, and that Board members should state their
names before speaking. At the appropriate time, members of the public
may provide public comments; these must be limited to 5 minutes.

Copies of the meeting materials are available on regulations.gov under
the docket number EPA-HQ-ORD-2011-0418. According to FACA requirements,
meeting minutes, including descriptions of the discussions and
conclusions reached by the Board will be prepared. These minutes will be
certified by the Chair within 90 days of the meeting and posted at
www.regulations.gov and on the HSRB Web site.

Meeting Process

Dr. Sean Philpott explained that the Board would discuss the draft final
Board report, focusing on the charge questions presented to the Board at
the April 2011 meeting and summarizing the Board’s response. The
report is intended to be a summary of the HSRB’s consensus
recommendations and not a detailed document. The Agency and study
sponsors have access to detailed meeting minutes for additional
information.

Dr. Philpott noted that comments were received from seven HSRB members
and most of the changes have been incorporated into the draft final
Board report, resulting in a document version with pagination that may
differ from the pagination in the online draft final report. Dr.
Philpott requested all Board members to refer to paragraph introductions
within sections to facilitate information location during discussions.

	For each charge question, Board members will have an opportunity to
raise concerns they may have about Board conclusions and rationales.
Dr. Philpott requested that the HSRB focus on substantive changes to
the report that directly affect the Board’s recommendations. Board
members should submit typographical and grammatical corrections to Dr.
Philpott and Mr. Downing via e-mail, and they will be incorporated into
the final report.

Public Comments

Dr. Philpott invited public comment on the draft April 2011 HSRB meeting
report. No public comments were presented.

Board Discussion and Decision on Final Report

Assessment of Completed Agricultural Handler Exposure Task Force (AHETF)
Research Studies AHE62, AHE63 and AHE64: Determination of Dermal and
Inhalation Exposure to Workers During Airblast Applications of Liquid
Sprays Using Open-Cab Equipment (MRID 48289611, 48289612, 48289613,
48289614, 48289615, 48289616 and 48326701)

Dr. Philpott first addressed the AHETF study to determine exposure to
workers during airblast application of liquid sprays using open-cab
equipment. Dr. Philpott noted that the science charge to the Board had
asked whether the research reported in the completed AHETF study
monograph report and associated field study reports was faithful to the
design and objectives of the protocol, standard operating procedures
(SOPs) and governing documents. The Board concluded that the research
reported was conducted in a manner that was reasonably faithful to the
design and objectives of the protocol and governing documents of the
AHETF study. The Board also was asked to consider whether EPA had
adequately characterized, from a scientific perspective, the limitations
on these data that should be considered when using the data to estimate
exposure of those who apply pesticides with open-cab airblast equipment.
The HSRB concluded that the Agency has adequately, but not completely,
considered the limitations that should be considered when using these
data to estimate the dermal and inhalation exposure of those who apply
conventional pesticides with open-cab airblast equipment. The Board
members identified additional limitations and concerns, and suggested
that the ability to generalize these data requires further consideration
and analysis.

Dr. Linda Young suggested that the Board examine the changes from Dr.
Dallas Johnson that have been incorporated into the draft Board report.
Under detailed recommendations and rationale, in the paragraph that
begins “The third limitation is the possible exceptional status of one
monitoring unit involved in exposure monitoring for open-cab spraying of
Oklahoma pecans…”, Dr. Michael Lebowitz noted that a change had been
suggested by Mr. Matthew Crowley (EPA, Office of Pesticide Programs
[OPP]), and Dr. Johnson had agreed with the change. The suggested
changes were to add “The Board concluded that…” to the sentence
“Increasing nozzle pressure will cause a decrease in droplet size and
an increase in spray drift”, and to change “will” to “would
likely.” Dr. Philpott confirmed that this change had been made, but
that no reference was provided. Dr. William Popendorf noted that there
are references that could be provided based on research going back to
the 1970s; since the statement seemed to be broadly general knowledge,
he did not require a reference to be entered. Dr. Young expressed
concern that the suggested change indicates that the science is not as
strong as it is. Dr. Popendorf noted that the previous version of the
sentence had read “The Board recognized that increasing nozzle
pressure will cause a decrease in droplet size and an increase in spray
drift.” The Board members supported a change back to this language.
Mr. Jeff Dawson (EPA, OPP) suggested that the line end with “an
increase in the potential for spray drift” because other factors can
contribute to spray drift. Dr. Lebowitz suggested modifying that
suggested language to read as “… and will be one of the reasons for
an increase in spray drift.” Board members supported this change.

Dr. Philpott noted concerns about the next paragraph, which begins,
“The fourth limitation is the need to rely on model accuracy for
estimates to be interpretable.” Dr. Philpott commented that Mr.
Crowley had recommended changing the interpretation by including a more
detailed description of slopes and intercept in the equation, and asked
Dr. Young and Dr. Johnson if they agreed with this recommendation. Dr.
Young concurred, noting this was a special case of proportionality in
which the proportional constant is 1. Dr. Johnson suggested a change to
the second to last sentence in the paragraph that reads “Because
clusters are part of the study’s design, a random cluster effect
should be included in the model.” Dr. Philpott explained that the
sentence had been changed and now reads “Because clusters are part of
the study’s design, a random cluster effect was included in the
model.”

In the next paragraph, which begins, “In the Agency’s Review
(Crowley and Sarkar 2011)…”, Dr. Philpott stated that Dr. Johnson
had suggested that the text was unclear and cited as an example the
sentence that reads “First, the expectation of ln(exposure/AaiH) must
be linear.” Dr. Johnson explained that this either had to be a linear
function of the active ingredient handled (AaiH), or the AaiH must be a
constant. Dr. Young agreed. Dr. Philpott suggested that the sentence be
changed to read “the expectation of the ln(exposure/AaiH) must be
constant.” Dr. Johnson noted that this would imply that the log
exposure was a linear function of AaiH. In terms of the sentence,
“Second, for the approach to be valid, there cannot be a cluster
effect,” Dr. Johnson raised the concern that cluster effects are
assumed to be random with a mean of zero so that the mean would not
change with the cluster. Dr. Johnson commented that the variance between
clusters is over and above the variance within clusters. Dr. Young added
that, conditional on the cluster, the mean would not be the same.
Because the conditional mean may change, there will be more variation
than anticipated under the log normal distribution if only the “y”s
were modeled. The sentence should read “Second, for the approach to be
valid, the mean response for log normal exposure over AaiH should be the
same for every cluster.” The next sentence now reads “Otherwise the
conditional mean of the distribution would change with the cluster so
that a single log normal distribution would not describe the normalized
exposures.” Dr. Philpott asked if members had an alternate sentence to
propose. Dr. Young suggested that this sentence read “Otherwise, a
single log normal distribution would not describe the normalized
exposures.” Dr. Philpott noted that the HSRB members also were
concerned about the graphs not being labeled, making it difficult to
ensure that the data corresponded with the inhalation data for which
significant cluster effects were present. Dr. Philpott recommended that
the relevant sentence be changed to read as “the graphs as presented
to the Board,” instead of “the graphs.” Dr. Philpott asked if any
members had further comments on the statistical rationale provided to
the Agency. There were no additional member concerns or comments about
the recommendations or rationale for the science charge questions.

Dr. Philpott explained that the ethics charge question for this protocol
asked whether the available information supported a determination that
the studies were conducted in substantial compliance with 40 Code of
Federal Regulations (CFR) Part 26, subparts K and L. The Board concluded
that it concurred with the Agency’s assessment that the study was
conducted in substantial compliance with subparts K and L. Dr. Philpott
noted that this study was conducted, for the most part, in a way that
did not deviate significantly from the protocol, the SOPs, or the
governing documents. There were no additional member comments about the
recommendations or rationale for the ethics charge question.

Assessment of Completed Antimicrobial Exposure Assessment Task Force
(AEATF II) Research Study AEA02: Measurement of Potential Dermal and
Inhalation Exposure During Application of a Liquid Antimicrobial
Pesticide Product Using Trigger Spray and Wipe or Ready-to-Use Wipes for
Cleaning Indoor Surfaces

During the April 2011 HSRB meeting, the Board was asked to address two
science charge questions regarding the completed AEATF II study. The
first charge question asked whether the research reported in the
completed AEATF II wipe study report was faithful to the design and
objectives of the protocol and governing documents of the AEATF II
study. The Board concluded that the research reported in the completed
study report and associated supplemental documents was conducted in a
manner that was reasonably faithful to the design and objectives of the
protocol and governing documents of the AEATF II study. The second
charge question asked whether the Agency had adequately characterized,
from a scientific perspective, the limitations on these data that should
be considered when using the data to estimate the exposure of those who
clean indoor surfaces with antimicrobial pesticides using a trigger
bottle and wipes or ready-to-use wipes. The Board concluded that the
Agency had adequately, but not completely, considered the limitations on
these data when using the data to estimate the dermal and inhalation
exposures of antimicrobial handlers who are applying pesticides using a
trigger spray and wipes or ready-to-use wipes. Dr. Philpott received
comments from Board members on this section, all of which have been
incorporated into the draft final Board report, including Dr.
Johnson’s question about whether “amount used” was meant rather
than “amount.”

	The final sentence in the first paragraph under the detailed
recommendations and rationale states that “The Agency’s analysis of
the data, especially their use of adjustments for the fortified samples
(of which there were more than a few) was an improvement.” Dr. Sidney
Green suggested to Dr. Janice Chambers that the word “adjustment”
was vague, especially to someone who had not seen EPA’s science
review, and commented that the wording could be more explicit. Dr.
Chambers stated that the sentence referred to the use of the level of
quantitation (LOQ) or half LOQ, which is part of the Agency’s standard
way of addressing non-detectable results. Dr. Lebowitz noted that EPA
had recalculated some of the values based on what was found in the
fortified samples and not just the half LOQ. The study accounted for
samples with readings that were not expected, and so the actual estimate
of exposure calculation used an adjustment based on what was done in the
quality assurance/quality control (QA/QC). This is what the sentence was
trying to explain using as few words as possible. Dr. Chambers noted
that non-detectable results needed to be mentioned, and Dr. Lebowitz
responded that it was a different issue. Mr. Tim Leighton (EPA, OPP)
stated that the data were corrected for the field recovery samples. The
Board agreed to changes that included the removal of the parenthetical
clause and mention of QA/QC. Dr. Philpott noted that the sentence now
reads “The Agency’s analysis of the data, especially their use of
adjustments in the QA/QC field recovery samples, was an improvement in
estimating exposure based on actual monitoring.”

	Dr. George Fernandez noted that on page 16 of the draft final Board
report, the first sentence of the paragraph that begins “The results
of the non-parametric bootstrap…”, seemed unclear. Dr. Young
commented that the difference between the non-parametric and parametric
bootstrap is that in one, a distribution is assumed. Dr. Lebowitz stated
that this sentence came directly from the EPA review report in which EPA
stated acceptance of the parametric bootstrap results in terms of the
confidence intervals (CIs); the CIs using the non-parametric bootstrap
were smaller and tighter. He noted that using the tighter CIs with the
non-parametric bootstrap method would be more appropriate, but that EPA
chose to reject the tighter CIs. Dr. Philpott noted that Dr. Lebowitz
had recommended that the Agency may want to use the non-parametric
bootstrap results. Mr. Leighton stated that EPA had taken the comments
and had run both a non-parametric and a parametric bootstrap. Dr.
Philpott noted his concern that the matter was not discussed in detail
at the April 2011 Board meeting, and asked Dr. Fernandez, Dr. Young and
Dr. Johnson if they agreed with this conclusion, as it appears that the
Agency already is acting on the recommendation. Dr. Young commented
that the limitations of the study were discussed at the April 2011 Board
meeting. She asked about the log normal distribution, and how much
information the Board needs to repeat, because statistically, many of
the ideas go from one study to the next. Dr. Philpott answered that he
did not want the Agency or the sponsors to think that this is not a
concern, and suggested the addition of the following sentence toward the
end of the detailed discussion and rationale: “The same concerns about
the use of a log normal distribution raised by the Board in its
discussion of the AHETF open cab airblast study also apply here.”
Dr. Young asked whether it would be better to cite both log normal
distribution and cluster effects. The Board agreed to amend the proposed
sentence to add “single” to log normal distribution.

The ethics charge question asked whether available information regarding
the AEATF II study supports a determination that the study was conducted
in substantial compliance with 40 CFR Part 26, subparts K and L. The
Board concurred with the Agency’s assessment that the study was
conducted in substantial compliance with the applicable requirements.
The Board noted that there were some minor protocol deviations,
including two unreported deviations, but concluded that they did not
compromise either the informed consent process or put the study
participants at additional risk. Dr. Vanessa Northington Gamble noted
that on page 19 of the draft final Board report, Ms. Kelly Sherman (EPA,
OPP) had suggested changing the term “patient” to “subject.” Dr.
Philpott explained that a change was made, substituting the word
“participant” for “patient” throughout the report.

Assessment of Published Research Study by Gulson et al. (2010): Small
Amounts of Zinc From Zinc Oxide Particles in Sunscreens Applied Outdoors
Are Absorbed Through Human Skin

Dr. Philpott noted that the study status had been changed from
“completed study” to “published study.” He received a number of
minor comments and corrections from both Board members and the Agency,
and most of these comments and corrections had been incorporated into
the draft final Board report. The HSRB was asked to address two
scientific charge questions. The first charge question asked whether the
Gulson et al. study was scientifically sound and provided reliable data.
The second charge question asked that, if the answer to the first
question was affirmative, whether the Gulson et al. study was relevant
for qualitative use in support of an assessment of the absorption of
zinc oxide through the skin. The Board concurred with the Agency’s
assessment that the Gulson et al. study provides some potentially useful
data on the dermal absorption of zinc from zinc oxide nanoparticles in
sunscreen applied to human skin despite the multiple limitations
identified by the HSRB. The Board advised the Agency to proceed with
caution in using these data for risk assessment as they cannot be used
as a stand-alone data set to assess dermal absorption of zinc oxide.
Limitations and concerns included: not accounting for certain variables
such as frequency and time of garment changes, activities affecting
exposure and, in particular, potential contamination of urine samples
with sunscreen from the participants’ hands (supported by the fact
that the applicator also exhibited evidence of dermal absorption of the
zinc). There were a number of other methodological and statistical
concerns raised that led the HSRB to question the statistical validity
of the data and the researcher’s conclusions. Thus, the Board
recommended that the data be treated as exploratory in nature and that
the Agency look for further studies to confirm the conclusion that zinc
oxide formulated as nanoparticles can be absorbed through the skin in
this manner.

On the top of page 22 of the draft Board report, the Agency raised some
questions and included some comments in highlighted areas. Dr. Philpott
observed that the OPP rightfully noted that the study investigators, not
the Agency, speculated as to how contamination of the urine samples
could have occurred and the Agency simply included that speculation in
its report. Dr. Chambers noted that the paragraph that begins
“Regarding gender-related differences in dosing…”, also has a
highlighted section at the end. In this paragraph, the Agency added
information not discussed at the April 2011 Board meeting; Dr. Philpott
and Dr. Chambers agreed that this additional language should not be
included. The Board members agreed with the proposed deletion. Dr.
Jessica Ryman (EPA, OPP) noted that the comment had been added because
the start of the paragraph suggests that the authors provided
insufficient information for readers to determine whether there was any
interaction between an individual’s body weight and a significant
difference in the dose. The proposed sentence was added because the
calculation of the change in the percentage of the 68Zn isotope included
a body mass index calculation in the study review; that body mass index
calculation would take into account individual body weights and gender.
Dr. Ryman did not recall discussion at the April HSRB meeting regarding
insufficiency of data to reach conclusions about differences between the
genders, but the study  results discuss how both gender and body weight
were considered in the calculations. Dr. Philpott expressed
understanding of the Agency’s position on this matter, and
acknowledged that the EPA analysis did note that there was an accounting
for differences in gender and body weight by adjusting for fat-free body
mass. Dr. Popendorf added that the sentence right before the proposed
addition states “…but not when comparing their total Zn content in
whole blood using the subject’s weight”, and that this sentence says
the same thing (without including gender). Dr. Philpott stated that
this comment means that the Board did consider the impact of both weight
and gender, and asked if a change to the sentence could be made that
would accurately reflect the HSRB’s conclusions without incorporating
additional material that was not discussed at the April 2011 meeting.
Dr. Popendorf suggested the following change: “…but not when
comparing their total Zn (Δ68Zn %) content in whole blood using the
subject’s weight and gender.”

The Agency also recommended clarification of the sentence in the next
paragraph that states “The researchers performed a log transformation
to correct this high degree of skewedness, which may be caused by this
single outlier,” by adding “This transformation revealed that values
from subject 7 were within the range of similarly transformed values
from other subjects.” Dr. Philpott asked if this was an accurate
assessment of the Board’s discussions and conclusion on the skewedness
caused by the data on subject 7. Dr. Fernandez stated that it was not
clear how this calculation was being made and it was not discussed
explicitly at the April 2011 Board meeting. Dr. Young suggested that the
proposed addition should not be included, and Dr. Fernandez agreed. Dr.
Lebowitz asked if the additions and changes in that paragraph made by
the Agency have been removed, and Dr. Philpott answered that they had.

In its ethics charge, the Board was asked to consider whether there was
adequate information to determine that the Gulson et al. study was
conducted in substantial compliance with procedures at least as
protective as those in EPA regulations at 40 CFR Part 26, subparts A
through L. This is a challenging question because this is the first
post-rule study from the published literature, this study was conducted
in Australia and the HSRB is asked to consider the question of whether
or not there is sufficient information to determine whether the study
was conducted in substantial compliance with procedures at least as
protective as the EPA regulation. The HSRB concluded that currently
there is insufficient information to determine whether the Gulson et al.
study was conducted in substantial compliance with procedures at least
as protective as those in 40 CFR Part 26, subparts A through L. The
Board recommended that the Agency seek additional information from
Macquarie University where the study originated, including acquisition
of a copy of the research protocol and an unsigned consent form to
enable the Board to conclude whether the study was conducted in
substantial compliance with procedures as least as protective as those
in the EPA regulations. Dr. Philpott noted that the Board recognizes
that the research was reviewed and approved by Macquarie University
Human Research Ethics Committee, which is registered with the Australian
National Health and Medical Research Council, and that the HSRB believes
that the study likely was conducted in substantial compliance with very
protective regulations, but the Board does not have enough information
at this time to determine the answer to this question.

Regarding the paragraph on page 25 of the draft final Board report that
begins “The HSRB determined that most of the information that the
Board has about the ethical conduct of the Gulson et al. (2010) study is
without supporting documentation and is thus inferential,” Dr.
Popendorf asked whether “inferential” referred to the information or
the conclusions. Dr. Philpott asked Dr. Sharpe for wording to clarify
“inferential.” The affected portion of the sentence will be changed
to read “…is without supporting documentation and thus any
conclusions about the ethical conduct of the study would be
inferential.” There were no further Board member comments on the
ethical charge.

Reconsideration of Two Concerns Previously Raised by the HSRB in Its
June 2009 Review of a Pre-Rule Intentional Human Dosing Study Involving
Chlorpyrifos (Kisicki et al. 1999)

Dr. Philpott received a number of clarifying comments and edits from
Board members on the Kisicki et al. study and they have been
incorporated into the final version of Appendix I of the draft final
Board report. Dr. Chambers explained that the Board revisited two
concerns from a study discussed in the June 2009 Board meeting: whether
the urine may not have been hydrolyzed and therefore the urinary
metabolite was inaccurate and whether, because of that fact, lower
absorption made sense. The Dow Chemical Company presented some
scientifically plausible information on both of those points. Therefore,
the HSRB is revisiting the conclusions on those two points: that it was
logical for the larger particles of chlorpyrifos to be absorbed more
slowly, which could have explained the difference in absorption, and
that quantitation of the urinary trichloropyridinol (TCP) was accurate
because the procedure was correct. Dr. Philpott added that the Board
concluded that the two other concerns discussed at the June 2009 Board
meeting, although not as substantial, remain unaddressed and there are
still concerns about the reliability and utility of the blood and urine
measurements of chlorpyrifos and TCP in the Kisicki et al. study if used
for risk assessment purposes.

Dr. Popendorf noted that the following sentence is factually correct:
“The quantitation of urinary TCP was accurate because the urine was
subjected to acid hydrolysis and heat to liberate conjugated TCP.”
However, Dr. Popendorf further noted that, in the original June 2009
report, the Board reached a conclusion that the handling contributed to
the differences in the two studies, and what is not mentioned is that
the conclusion was changed. He would like to clarify that, with new
information received, a different conclusion was reached. Dr. Chambers
asked if  Dr. Popendorf was proposing to add a sentence that the urinary
TCP data do not contribute to the differences. If so, Dr. Chambers
remarked that she was uncomfortable with the proposed change because the
study was not reanalyzed in its entirety. Dr. Lebowitz agreed with Dr.
Chambers. Dr. Philpott noted that the main concern was that the June
2009 meeting report, which is published and public, potentially contains
some erroneous information. The goal of the proposed change is to
correct that report, not reevaluate the Board’s earlier conclusions or
the study in its entirety. He agreed that the statement should not be
added. Dr. Green also agreed.

Draft Letter from an HSRB Workgroup on Providing Research Participants
with Individualized Study Results

The AEATF II mop study promised to provide individualized exposure data
to the participants, upon request. The Board convened a workgroup to
examine this issue and the broader question of reporting individualized
exposure results to participants in intentional exposure studies. The
workgroup continues to examine the broader issue, but because the AEATF
II mop study has been completed, the workgroup has developed a draft
letter for AEATF II mop study participants.

Dr. Sharpe presented to the Board  a draft letter for the mop study
participants (dated April 27, 2011) to be forwarded the AEATF II. The
letter was developed to be sensitive to the reading level of the
participants, be simple and clear, provide information about individual
exposure results relative to others in the study and provide some
context for the individual. Dr. Sharpe left several comments in the
draft letter for discussion. One sentence in the draft letter states
that everyone who participated in the study had different exposures, but
all had exposures that EPA considers safe. She asked Dr. Rebecca Parkin
to discuss whether it was appropriate to include the word “safe” or
“acceptable” in this letter. Dr. Parkin commented that the word
“safe” has been controversial in environmental protection and health
issues because it means different things to different people. There has
been a trend toward the word “acceptable” rather than “safe”
because it does not imply total safety, but only that the various
aspects of exposure have been considered and the exposure has been
determined to be acceptable. Dr. Green agreed that “acceptable” is
a better choice than “safe” because safety cannot be guaranteed.
Other Board members agreed. Dr. Philpott will make the change in the
draft letter.

Dr. Sharpe noted that the draft letter included a bar chart to provide a
scale of lowest to highest exposure; this will be marked with a vertical
line to show the individual participants where their skin and breathing
exposure are on the continuum of lowest to highest exposure.
Instructions were provided in the margins of the draft letter as to how
to complete the bar chart to communicate with each individual. Dr.
Chambers commented that if most participants were on one end of the
scale and one person on another, then the bar chart might provide a
skewed idea to the person requesting the information. Dr. Young agreed.
Dr. Chambers added that an outlier at the highest or lowest point might
give participants a false sense of alarm or security if the individual
did not know where all the others are located. Dr. Sharpe asked if Dr.
Chambers would agree that it is not advisable in a letter like this to
note everyone’s exposure. Dr. Chambers responded that participants
would not know how the group is arranged if everyone’s exposure were
not included. Dr. Parkin noted that she had proposed that letters be
pretested, because the Board could be wrong about their assumptions for
the target audience. She noted that what was drafted was a proposal, or
suggestion, for how the results could be presented, and the AEATF II mop
study needs to test the letter before using it. Dr. Young agreed that
field testing would be useful, but the Board should answer this issue
otherwise there might need for a different bar graph on every letter
depending on whether there are outliers. Dr. Popendorf suggested a
straight line without the “dumbbells” at each end, and insertion of
a triangle for the average or mean to provide more information. Dr.
Young suggested that if the median were used instead of the mean, that
would be acceptable. Dr. Sharpe added that the letter would need to
explain the median if it were to be used. Dr. Philpott noted that the
Board likes the simplified graphic approach, and suggested adding a
point on the bar chart that identifies the median. Arrows could show
dermal and breathing exposure on two different graphs.

A recommendation could be made to the AEATF II mop study that the letter
be field tested among people similar to the study participants. Dr.
Sharpe asked whether the Board should have a role in testing the draft
letter to study participants or to review the letter the AEATF II mop
study would produce as a result of the feedback from draft letter
testing. Dr. Philpott responded that the Board could offer to do this,
but the sponsors and the Agency are under no obligation to come back to
the HSRB to do so.

Dr. Sharpe noted that, during Working Group discussions, Dr. José
Manautou had commented that if the participants were being told to
improve their mopping technique then the letter should provide some
information on how to do so. This raised the question whether there is
EPA guidance about mopping, such as a brochure that could be included
with the letter, or instructions from the product manufacturers that
could be included. Mr. Downing concurred with the comment and thought
that the AEATF II mop study had some suggested techniques to lessen
exposure that could be included. Dr. Chambers suggested that if the
exposure of most participants was similar, the letter should just
acknowledge that the participant’s exposure was similar to most and
the participants should not receive different letters. Dr. Philpott
responded that if a person received a lower exposure than most, the
Board does not want them to relax and to cease protecting themselves. He
commented that there had to be different letters: one that recommends
the participant maintain current techniques and another that suggests
ways to improve. Dr. Sharpe suggested adding another sentence to the
draft letter (below the specific information about the individual’s
exposure) that states, for example: “For your information, we are
including material about mopping techniques to keep exposures as low as
they can be.” However, such an approach would mean that all
participants would get the same information in the letter, whether they
were above or below the median. Alternatively, the letter could note
whether the participant was above, below, or “near the middle” of
most of the participants in terms of exposure. Dr. Popendorf added that
there could be a sentence describing the middle mark. Dr. Sharpe
commented that a sentence would be needed to explain the median.
Dr. Philpott suggested that he and Dr. Sharpe craft this sentence.

Dr. Green noted that the sentence after “Your exposure was higher than
most…” further stating that “This does not put you at any
short-term risk…” is too definite. Dr. Green suggested revising
“does not” to “may not”, because it would be more accurate.
Dr. Philpott agreed to make this change.

Dr. Philpott noted that two votes needed to be taken. The first vote was
to approve the draft final Board report as amended during this
teleconference meeting. All Board members present on this teleconference
meeting approved the report except for Dr. Parkin who abstained as she
was not present at the April meeting. The second vote was whether to
send to the draft letter, including changes suggested in this
teleconference meeting, to the AEATF II mop study with the strong
recommendation that it be field tested before use. All Board members
present on this teleconference meeting approved the draft letter, with
the changes identified, and the pretesting recommendation. Dr. Philpott
and Dr. Sharpe, along with Dr. Parkin, will make the changes.

Summary and Next Steps

Mr. Downing noted that the next face-to-face HSRB meeting would be held
on October 18-21, 2011.

Dr. Philpott thanked the Board members for their participation. The
teleconference meeting was adjourned by the Chair at 3:09 p.m.

Respectfully submitted:

Jim Downing

Designated Federal Officer

Human Studies Review Board

United States Environmental Protection Agency

Certified to be true by:

Sean Philpott, Ph.D., M.S. Bioethics

Chair

Human Studies Review Board

United States Environmental Protection Agency

NOTE AND DISCLAIMER: The minutes of this public teleconference meeting
reflect diverse ideas and suggestions offered by Board members during
the course of deliberations within the meeting. Such ideas, suggestions
and deliberations do not necessarily reflect definitive consensus advice
from the Board members. The reader is cautioned to not rely on the
minutes to represent final, approved, consensus advice and
recommendations offered to the Agency. Such advice and recommendations
may be found in the final report prepared and transmitted to the EPA
Science Advisor following the public meeting.

Attachments

Attachment A 		HSRB Members

Attachment B 		Federal Register Notice Announcing Meeting

Attachment C 		Meeting Agenda

Attachment A

EPA HUMAN STUDIES REVIEW BOARD MEMBERS

Chair

*Sean Philpott, Ph.D., M.S. Bioethics	Term: 3/27/2006-10/31/2011

Director, Research Ethics

The Bioethics Program

Union Graduate College-Mt. Sinai School of Medicine

Schenectady, NY

Vice Chair

*Janice Chambers, Ph.D., D.A.B.T.	Term: 3/27/2006-10/31/2011

William L. Giles Distinguished Professor

Director, Center for Environmental Health Sciences

College of Veterinary Medicine

Mississippi State University

Mississippi State, MS

Members

*George C.J. Fernandez, Ph.D.	Term: 5/1/2010-8/31/2013

Director, Center for Research Design and Analysis

University of Nevada – Reno

Reno, NV

*Vanessa Northington Gamble, M.D., Ph.D.	Term: 10/19/2009-10/31/2012

University Professor of Medical Humanities

Gelman Library

The George Washington University

Washington, DC

*Sidney Green, Jr., Ph.D., Fellow ATS	Term: 10/19/2009-10/31/2012

Department of Pharmacology

Howard University College of Medicine

Howard University

Washington, DC

*Dallas E. Johnson, Ph.D. 	Term: 8/31/2007-8/31/2013

Professor Emeritus

Department of Statistics

Kansas State University

Manhattan, KS

*Michael D. Lebowitz, Ph.D., FCCP	Term: 3/27/2006-8/31/2012

Retired Professor of Public Health

(Epidemiology) & Medicine & Research Professor of Medicine

University of Arizona

Tucson, AZ

*^José E. Manautou, Ph.D.	Term: 5/1/2010-8/31/2013

Associate Professor of Toxicology

Department of Pharmaceutical Sciences

School of Pharmacy, University of Connecticut

Storrs, CT

Jerry A. Menikoff, M.D. 	Term: 3/27/2006-8/31/2012

Director, Office for Human Research Protections

Department of Health and Human Services

Rockville, MD

*Rebecca T. Parkin, Ph.D., M.P.H	Term: 10/1/2007-8/31/2013

Professorial Lecturer (EOH)

School of Public Health and Health Services

The George Washington University

Washington, DC

*William J. Popendorf, Ph.D.	Term: 10/19/2009-10/31/2012

Professor Emeritus

Department of Biology

Utah State University

Logan, UT

Virginia Ashby Sharpe, Ph.D.	Term: 5/1/2010-8/31/2013

National Center for Ethics in Health Care

Veterans Health Administration

Department of Veterans Affairs

Washington, DC

*Linda J. Young, Ph.D.	Term: 3/28/2008-8/31/2012

Department of Statistics

Institute of Food and Agricultural Sciences

University of Florida

Gainesville, FL

*Special Government Employee (SGE)

^Not in attendance at the May 24, 2011 teleconference

Attachment B

FEDERAL REGISTER NOTICE ANNOUNCING MEETING

[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]

[Notices]

[Pages 25686-25688]

From the Federal Register Online via the Government Printing Office [
HYPERLINK "http://www.gpo.gov"  www.gpo.gov ]

[FR Doc No: 2011-11001]

=======================================================================

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2011-0418; FRL-9302-4]

Human Studies Review Board (HSRB); Notification of a Public
Teleconference

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The U. S. Environmental Protection Agency (EPA) Office of the
Science Advisor (OSA) announces a public teleconference of the HSRB to
discuss its draft report from the April 13-14, 2011 HSRB meeting, and
consider a draft letter from an HSRB workgroup on providing research
participants with individualized study results measuring the amount of
antimicrobial cleaning products on participants' skin and the amount
they breathe in while mopping floors.

DATES: The teleconference will be held on Tuesday, May 24, 2011 from
approximately 1 p.m. to approximately 3 p.m. Eastern Time.

ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2011-0418, by one of the following methods:

    Internet:   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov : Follow the Web site instructions for
submitting comments.

    E-mail:   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

    Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC),
ORD Docket, Mail Code 28221T, 1200 Pennsylvania Ave., NW, Washington, DC
20460.

    Hand Delivery: The EPA/DC Public Reading Room is located in the EPA
Headquarters Library, Room Number 3334 in the EPA West Building, located
at 1301 Constitution Avenue, NW, Washington, DC 20460. The hours of
operation are 8:30 a.m. to 4:30 p.m.

Eastern Time, Monday through Friday, excluding Federal holidays. Please
call<PHONE_NUMBER> or e-mail the ORD Docket at<EMAIL_ADDRESS>for
instructions. Updates to Public Reading Room access are available online
at   HYPERLINK "http://www.epa.gov/epahome/dockets.htm"
http://www.epa.gov/epahome/dockets.htm .

    Instructions: Direct your comments to Docket ID No.
EPA-HQ-ORD-2011-0418. EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov , including any personal information
provided, unless the comments includes information claimed to be
Confidential Business Information (CBI) or other information the
disclosure of which is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  or e-mail. The
  HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov
Web site is an “anonymous access” system, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA
without going through   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov , your e-mail address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the Internet. If you submit an
electronic comment, EPA recommends that you include your name and other
contact information in the body of your comments and with any disk or
CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.

FOR FURTHER INFORMATION CONTACT: Any members of the public who wish to
receive further information should contact Jim Downing at telephone
number:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail address:   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>, or Lu-Ann Kleibacker
at telephone number:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail
address:   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>; mailing address: Environmental Protection
Agency, Office of the Science Advisor, 8105R, 1200 Pennsylvania Ave.,
NW., Washington, DC 20460. General information concerning the EPA HSRB
can be found on the EPA Web site at   HYPERLINK
"http://www.epa.gov/osa/hsrb"  http://www.epa.gov/osa/hsrb .

SUPPLEMENTARY INFORMATION:

    Location: The meeting will take place via telephone only.

    Meeting access: For information on access or services for
individuals with disabilities, please contact Lu-Ann Kleibacker at least
ten business days prior to the meeting using the information under FOR
FURTHER INFORMATION CONTACT, so that appropriate arrangements can be
made.

    Procedures for providing public input: Interested members of the
public may submit relevant written or oral comments for the HSRB to
consider during the advisory process. Additional information concerning
submission of relevant written or oral comments is provided in section
I, ``Public Meeting,'' under subsection D, ``How May I Participate in
this Meeting?'' of this notice.

I. Public Meeting

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of particular interest to persons who conduct or assess
human studies, especially studies on substances regulated by EPA, or to
persons who are, or may be required to conduct testing of chemical
substances under the Federal Food, Drug, and Cosmetic Act (FFDCA) or the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since other
entities may also be interested, 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 applicability of this action to
a particular entity, consult Jim Downing or Lu-Ann Kleibacker listed
under FOR FURTHER INFORMATION CONTACT.

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

    In addition to using   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov , you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at   HYPERLINK "http://www.epa.gov/fedrgstr/"
http://www.epa.gov/fedrgstr/ .

    Docket: All documents in the docket are listed in the   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, will
be publicly available only in hard copy. Publicly available docket
materials are available either electronically in   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  or in hard
copy at the ORD Docket, EPA/DC Public Reading Room. The EPA/DC Public
Reading Room is located in the EPA Headquarters Library, Room Number
3334 in the EPA West Building, located at 1301 Constitution Avenue, NW,
Washington, DC 20460. The hours of operation are 8:30 a.m to 4:30 p.m.
Eastern Time, Monday through Friday, excluding Federal holidays. Please
call<PHONE_NUMBER>, or e-mail the ORD Docket at<EMAIL_ADDRESS>for
instructions. Updates to the Public Reading Room access are available on
the Web site (  HYPERLINK "http://www.epa.gov/epahome/dockets.htm"
http://www.epa.gov/epahome/dockets.htm ).

C. What should I consider as I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:

    1. Explain your views as clearly as possible.

    2. Describe any assumptions that you used.

    3. Provide copies of any technical information and/or data you use
that support your views.

    4. Provide specific examples to illustrate your concerns and suggest
alternatives.

    5. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date and Federal
Register citation.

D. How may I participate in this meeting?

    You may participate in this meeting by following the instructions in
this section. To ensure proper receipt by EPA, it is imperative that you
identify docket ID number EPA-HQ-ORD-2011-0418 in the subject line on
the first page of your request.

    1. Oral comments. Requests to present oral comments will be accepted
up to Tuesday, May 17, 2011. To the extent that time permits, interested
persons who have not pre-registered may be permitted by the

Chair of the HSRB to present oral comments during the meeting. Each
individual or group wishing to make brief oral comments to the HSRB is
strongly advised to submit their request (preferably via e-mail) to Jim
Downing or Lu-Ann Kleibacker under FOR FURTHER INFORMATION CONTACT no
later than noon, Eastern Time, Tuesday, May 17, 2011, in order to be
included on the meeting agenda and to provide sufficient time for the
HSRB Chair and HSRB Designated Federal Official (DFO) to review the

meeting agenda to provide an appropriate public comment period. The
request should identify the name of

the individual making the presentation and the organization (if any) the
individual will represent. Oral comments before the HSRB are generally
limited to five minutes per individual or organization. Please note that
this includes all individuals appearing either as part of, or on behalf
of, an organization. While it is our intent to hear a full range of oral
comments on the science and ethics issues under discussion, it is not
our intent to permit organizations to expand the time limitations by
having numerous individuals sign up separately to speak on their behalf.
If additional time is available, further public comments may be
possible.

    2. Written comments. Submit written comments prior to the meeting.
For the HSRB to have the best opportunity to review and consider your
comments as it deliberates on its report, you should submit your
comments at least five business days prior to the beginning of this
teleconference. If you submit comments after this date, those comments
will be provided to the Board members, but you should recognize that the
Board members may not have adequate time to consider those comments
prior to making a decision. Thus, if you plan to submit written
comments, the Agency strongly encourages you to submit such comments no
later than noon, Eastern Time, Tuesday, May 17, 2011. You should submit

your comments using the instructions in section I, under subsection C,
``What Should I Consider as I Prepare My Comments for EPA?'' In
addition, the Agency also requests that persons submitting comments
directly to the docket also provide a copy of their comments to Jim
Downing or Lu-Ann Kleibacker listed under FOR FURTHER INFORMATION
CONTACT. There is no limit on the length of written comments for
consideration by the HSRB.

E. Background

    The HSRB is a Federal advisory committee operating in accordance
with the Federal Advisory Committee Act (FACA) 5 U.S.C. App.2 section 9.
The HSRB provides advice, information, and recommendations to EPA on
issues related to scientific and ethical aspects of human subjects
research. The major objectives of the HSRB are to provide advice and
recommendations on: (1) Research proposals and protocols; (2) reports of
completed research with human subjects; and (3) how to strengthen

EPA's programs for protection of human subjects of research. The HSRB
reports to the EPA Administrator through the EPA Science Advisor.    1.
Topics for Discussion. The HSRB will be reviewing its draft report from
the April 13-14, 2011 HSRB meeting. The Board may also discuss planning
for future HSRB meetings. Background on the April 13-14, 2011 HSRB
meeting can be found at Federal Register Volume 76, Number 59 (Monday,
March 28, 2011), pages 17121-17123) and at the HSRB Web site   HYPERLINK
"http://www.epa.gov/osa/hsrb/"  http://www.epa.gov/osa/hsrb/ . The April
13-14, 2011 meeting draft report is now available. You may obtain
electronic copies of this document and certain other related documents
that might be available

electronically from the   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov  Web site and the HSRB Internet home page at
 HYPERLINK "http://www.epa.gov/osa/hsrb"  http://www.epa.gov/osa/hsrb .
The HSRB will also review and consider a draft letter providing
participants with individualized study results that was provided at a
previous HSRB meeting. The HSRB was asked to provide feedback on the
letter that will be sent to the participants from the Antimicrobial
Exposure Assessment Task Force II that measured the amount of
antimicrobial cleaning products on participants' skin and the amount
they breathe in while mopping floors.

    For questions on document availability or if you do not have access
to the Internet, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

    Dated: April 29, 2011.

Paul T. Anastas,

EPA Science Advisor.

[FR Doc. 2011-11001 Filed 5-4-11; 8:45 am]

BILLING CODE 6560-50-P

Attachment C

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 HUMAN STUDIES REVIEW BOARD (HSRB)

 PUBLIC TELECONFERENCE MEETING AGENDA

Tuesday, May 24, 2011

1:00 pm - 3:00 pm (Eastern Time)*

HSRB MEETING FOR REVIEW AND APPROVAL OF THE

DRAFT APRIL 13-14, 2011 HSRB MEETING REPORT AND A DRAFT LETTER FROM AN
HSRB WORKGROUP ON PROVIDING RESEARCH

PARTICIPANTS WITH INDIVIDUALIZED STUDY RESULTS

HSRB WEB SITE http://www.epa.gov/osa/hsrb/

Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA–HQ–ORD–2011–0418

Meeting location via telephone only

Dial in number<PHONE_NUMBER>; conference code<PHONE_NUMBER>

1:00 PM	Convene Meeting and Identification of Board Members – Jim
Downing (Designated Federal Officer, HSRB, OSA, EPA)

1:10 PM*	Meeting Administrative Procedures – Jim Downing, DFO

1:15 PM	Meeting Process –Sean Philpott, Ph.D. (HSRB Chair)

1:20 PM	Public Comments

1:30 PM	Board Discussion and Decision on Final Report – Sean Philpott,
Ph.D.

(HSRB Chair)

The Board’s response to EPA charge questions presented at the April
13-14, 2011 meeting.

Completed AHETF research on exposure of workers applying pesticide
sprays using open‐cab airblast equipment.

Charge to the Board:

•	Was the research reported in the Agricultural Handler Exposure Task
Force (AHETF) completed monograph report and associated field study
reports faithful to the design and objectives of the protocol, SOPs, and
governing documents?

•	Has EPA adequately characterized, from a scientific perspective, the
limitations on these data that should be considered when using the data
in estimating exposure of those who apply pesticides with open cab
airblast equipment?

•	Does the available information support a determination that the
studies were conducted in substantial compliance with subparts K and L
of 40 CFR Part 26?

*Note that agenda times are approximate. For further information, please
contact the Designated Federal Officer for this meeting, Jim Downing via
telephone:<PHONE_NUMBER> or email<EMAIL_ADDRESS>
Completed AEATF research on exposure of professional janitorial workers
when

wiping indoor surfaces with an antimicrobial pesticide.

Charge to the Board:

• 	Was the research reported in the Antimicrobial Exposure Assessment
Task Force

	II (AEATF) completed wipe study report faithful to the design and
objectives of

	the protocol and governing documents of AEATF?

• 	Has EPA adequately characterized, from a scientific perspective,
the limitations

	on these data that should be considered when using the data in
estimating

	exposure of those who clean indoor surfaces with antimicrobial
pesticides using a

	trigger-spray bottle and wipes or ready-to-use wipes?

• 	Does the available information support a determination that the
study was

	conducted in substantial compliance with subparts K and L of 40 CFR
Part 26?

Assessment of Published Research Study by Gulson et al. (2010): Small
Amounts of

Zinc From Zinc Oxide Particles in Sunscreens Applied Outdoors Are
Absorbed

through Human Skin.

Charge to the Board

• 	Is the Gulson et al. (2010) study scientifically sound, providing
reliable data?

• 	If so, is the Gulson et al. (2010) study relevant for qualitative
use in support of an

	assessment of the absorption of zinc oxide through the skin?

• 	Is there adequate information to determine that the Gulson et al.
(2010) study was

	conducted in substantial compliance with procedures at least a
protective as those

	in subparts A - L of EPA’s regulation at 40 CFR Part 26?

Reconsideration of two concerns previously raised by the HSRB in its
June 2009

review of an intentional human dosing study with chlorpyrifos (Kisicki
et al., 1999);

additional pertinent information was made available by the sponsor
related to these

two concerns.

Issues for Discussion:

• 	Do the recommendations provided by the HSRB at its June 2009
meeting and in

	its subsequent report regarding the reliability of data on the urinary
metabolite

	trichloropyridinol in the Kisicki et al. (1999) study change in light
of the new

	information provided?

• 	Do the
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2:30 PM Draft letter from an HSRB workgroup on providing research

participants with individualized study results

2:55 PM Summary and Next Steps – Sean Philpott, Ph.D. (HSRB Chair) and
Jim

Downing (DFO)

3:00 PM Adjournment

*	Note that agenda times are approximate. For further information,
please contact the Designated

	Federal Officer for this meeting, Jim Downing via telephone: (202)
564-2468 or email:

<EMAIL_ADDRESS>
  PAGE  21

  PAGE  22


[Federal Register Volume 76, Number 95 (Tuesday, May 17, 2011)]
[Notices]
[Pages 28501-28502]
[FR Doc No: 2011-11993]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. DOT-NHTSA-2011-0019, Notice 1]

Notice of Receipt of Petition for Decision That Nonconforming
2005 Mercedes-Benz 350 CLS Passenger Cars Are Eligible for Importation

AGENCY: National Highway Traffic Safety Administration, DOT

ACTION: Notice of receipt of petition for decision that nonconforming
2005 Mercedes-Benz 350 CLS passenger cars are eligible for importation.

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

SUMMARY: This document announces receipt by the National Highway
Traffic Safety Administration (NHTSA) of a petition for a decision that
2005 Mercedes-Benz 350 CLS passenger cars that were not originally
manufactured to comply with all applicable Federal Motor Vehicle Safety
Standards (FMVSS) are eligible for importation into the United States
because they have safety features that comply with, or are capable of
being altered to comply with, all such standards.

DATES: The closing date for comments on the petition is June 16, 2011.

ADDRESSES: Comments should refer to the docket and notice numbers above
and be submitted by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>
    Instructions: Comments must be written in the English language, and
be no greater than 15 pages in length, although there is no limit to
the length of necessary attachments to the comments. If comments are
submitted in hard copy form, please ensure that two copies are
provided. If you wish to receive confirmation that your comments were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    How to Read Comments submitted to the Docket: You may read the
comments received by Docket Management at the address and times given
above. You may also view the documents from the Internet at http://www.regulations.gov.
    Follow the online instructions for accessing the dockets. The
docket ID number and title of this notice are shown at the heading of
this document notice. Please note that even after the comment closing
date, we will continue to file relevant information in the Docket as it
becomes available. Further, some people may submit late comments.
Accordingly, we recommend that you periodically search the Docket for
new material.

FOR FURTHER INFORMATION CONTACT: Coleman Sachs, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(B), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS, and has no
substantially similar U.S.-certified counterpart, shall be refused
admission into the United States unless NHTSA has decided that the
motor vehicle has safety features that comply with, or are capable of
being altered to comply with, all applicable FMVSS based on destructive
test data or such other evidence as NHTSA decides to be adequate.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notices
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    G&K Automotive Conversion, Inc. of Santa Ana, California (G&K)
(Registered Importer 90-007) has petitioned NHTSA to decide whether
nonconforming 2005 Mercedes-Benz 350 CLS passenger cars are eligible
for importation into the United States. G&K believes that these
vehicles are capable of being modified to meet all applicable FMVSS.
    In its petition, G&K described the nonconforming 2005 Mercedes-Benz
350 CLS as the same model as the U.S.-certified 2006 Mercedes-Benz CLS
class. Because the 350 CLS model was introduced in Europe as a new
model in 2005, prior to the introduction of the

U.S-certified introduction of the CLS class in 2006, the petitioner
acknowledged that it could not base its petition on the substantial
similarity of the 2005 Mercedes-Benz 350 CLS to the U.S.-certified 2006
Mercedes-Benz CLS class due to the model year discrepancy and the
petitioning requirements of 49 U.S.C. 30141(a)(1)(A), as set forth in
49 CFR part 593. Instead, the petitioner chose to establish import
eligibility on the basis that the vehicles have safety features that
comply with, or are capable of being modified to comply with, the FMVSS
based on destructive test data or such other evidence that NHTSA
decides to be adequate as set forth in 49 U.S.C Part 30141(a)(1)(B).
The petitioner contends that the 2005 Mercedes-Benz 350 CLS utilizes
the same components as the U.S.-certified 2006 Mercedes-Benz 350 CLS in
virtually all of the systems subject to the applicable FMVSS.
    G&K submitted information with its petition intended to demonstrate
that non-U.S. certified 2005 Mercedes-Benz 350 CLS passenger cars
conform to many FMVSS and are capable of being altered to comply with
all other standards to which they were not originally manufactured to
conform.
    Specifically, the petitioner claims that non-U.S. certified 2005
Mercedes-Benz 350 CLS passenger cars, as originally manufactured,
conform to: Standard Nos. 102 Transmission Shift Lever Sequence,
Starter Interlock, and Transmission Braking Effect, 103 Windshield
Defrosting and Defogging Systems, 104 Windshield Wiping and Washing
Systems, 106 Brake Hoses, 109 New Pneumatic Tires, 113 Hood Latch
System, 116 Motor Vehicle Brake Fluids, 118 Power-Operated Window,
Partition, and Roof Panel Systems, 124 Accelerator Control Systems, 135
Light Vehicle Brake Standard, 201 Occupant Protection in Interior
Impact, 202 Head Restraints, 204 Steering Control Rearward
Displacement, 205 Glazing Materials, 207 Seating Systems, 209 Seat Belt
Assemblies 210, Seat Belt Assembly Anchorages, 212 Windshield Mounting,
214 Side Impact Protection, 216 Roof Crush Resistance, 219 Windshield
Zone Intrusion, and 302 Flammability of Interior Materials.
    The petitioner also contends that the vehicles are capable of being
altered to meet the following standards, in the manner indicated:
    Standard No. 101 Controls and Displays: Installation of U.S.-model
instrument cluster and U.S.-version software.
    Standard No. 108 Lamps, Reflective Devices and Associated
Equipment: Installation of U.S.-model: (a) Headlamps; and (b) front
side marker lamps with reflex reflectors.
    Standard No. 110 Tire Selection and Rims and Motor Home/
Recreational Vehicle Trailer Load Carrying Capacity Information for
Motor Vehicles with a GVWR of 4,536 Kilograms (10,000 pounds) or Less:
Installation of a tire and rim information placard.
    Standard No. 111 Rearview Mirrors: Installation of a U.S.-model
passenger side rearview mirror, or inscription of the required warning
statement on the face of that mirror.
    Standard No. 114 Theft Protection: Installation of U.S.-version
software, or a supplemental key warning system to meet the requirements
of this standard.
    Standard No. 206 Door Locks and Door Retention Components:
Inspection of all vehicles and installation of a conforming door lock
and door retention components on vehicles not already so equipped.
    Standard No. 208 Occupant Crash Protection: Installation or
activation of U.S.-version software to ensure that the seat belt
warning system meets the requirements of this standard.
    Standard No. 225 Child Restraint Anchorage Systems: Installation of
U.S.-model child restraint anchorage system components that meet the
requirements of FMVSS No. 225.
    Standard No. 301 Fuel System Integrity: Inspection of all vehicles
and installation of U.S.-conforming components on vehicles not already
so equipped to ensure that the fuel system meets the requirements of
this standard.
    Standard No. 401 Interior Trunk Release: Installation of U.S.-model
interior trunk release components to ensure that the vehicle meets the
requirements of this standard.
    All comments received before the close of business on the closing
date indicated above will be considered, and will be available for
examination in the docket at the above addresses both before and after
that date. To the extent possible, comments filed after the closing
date will also be considered. Notice of final action on the petition
will be published in the Federal Register pursuant to the authority
indicated below.

    Authority: 49 U.S.C. 30141(a)(1)(A) and (b)(1); 49 CFR 593.8;
delegations of authority at 49 CFR 1.50 and 501.8.

    Issued on: May 6, 2011.
Claude H. Harris,
Acting Associate Administrator for Enforcement.
[FR Doc. 2011-11993 Filed 5-16-11; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 77, Number 152 (Tuesday, August 7, 2012)]
[Proposed Rules]
[Pages 46990-46994]
[FR Doc No: 2012-19173]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2008-0930; FRL-9711-6 ]

Approval and Promulgation of Air Quality Implementation Plans;
Delaware; Attainment Demonstration for the 1997 8-Hour Ozone National
Ambient Air Quality Standard for the Philadelphia-Wilmington-Atlantic
City Moderate Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve the attainment demonstration
portion of the attainment plan submitted by the State of Delaware
through the Delaware Department of Natural Resources and Environmental
Control (DNREC) as a State Implementation Plan (SIP) revision that
demonstrates attainment of the 1997 8-hour ozone national ambient air
quality standard (NAAQS) for the Philadelphia-Wilmington-Atlantic City,
PA-NJ-MD-DE, moderate nonattainment area (Philadelphia Area) by the
applicable attainment date of June 2011. EPA has determined that
Delaware's SIP revision meets the applicable requirements of the Clean
Air Act (CAA). This action is being taken in accordance with the CAA.

DATES: Written comments must be received on or before September 6,
2012.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2008-0930 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2008-0930, Donna Mastro, Acting Associate
Director, Office of Air Planning Program, Mailcode 3AP30, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2008-0930. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any

personal information provided, unless the comment includes information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Do not submit
information that you consider to be CBI or otherwise protected through
www.regulations.gov or email. The www.regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA without
going through www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Delaware Department of Natural Resources and
Environmental Control, 89 Kings Highway, P.O. Box 1401, Dover, Delaware
19903.

FOR FURTHER INFORMATION CONTACT: Rose Quinto,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. The following is provided to
aid in locating information in this preamble.

I. What action is EPA proposing to take?
II. What is the background for EPA's proposed action?
III. What are the CAA requirements for a moderate 8-hour ozone
nonattainment area?
IV. What is included in Delaware's SIP submittal?
V. What is EPA's review of Delaware's modeled attainment
demonstration and weight of evidence analysis for the Philadelphia
area?
VI. Proposed Action
VII. Statutory and Executive Order Reviews

I. What action is EPA proposing to take?

    EPA is proposing to approve the attainment demonstration element of
a SIP revision submitted by DNREC to EPA on June 13, 2007. The June 13,
2007 SIP revision consisted of Delaware's attainment plan for the 1997
8-hour ozone NAAQS for the Philadelphia Area. The ozone attainment plan
submitted on June 13, 2007 included the attainment demonstration for
the Philadelphia Area and its associated motor vehicle emission budgets
(MVEBs) used for transportation conformity purposes in all three
Delaware counties (New Castle, Kent and Sussex Counties). The Delaware
attainment plan also included a 2002 base year emissions inventory, an
analysis of the reasonably available control measures/reasonably
available control technology (RACM/RACT), the 2008 rate of progress
(ROP) plan and its associated MVEBs, and contingency measures. The ROP
plan and its MVEBs, 2002 base year emissions inventory, RACM/RACT
analysis, and contingency measures (elements of the June 13, 2007
attainment plan) were approved on April 8, 2010 (75 FR 17763).
Therefore, in this action, EPA is only proposing to approve the
attainment demonstration for the 1997 8-hour ozone NAAQS for the
Philadelphia Area.
    In a separate and concurrent process, EPA is conducting a process
to find adequate the MVEBs for New Castle, Kent, and Sussex Counties
which are associated with the Delaware attainment demonstration for the
Philadelphia Area. Concurrently with EPA's proposal to approve the SIP,
a notice will be posted on EPA's Web site at http://www.epa.gov/otaq/stateresources/transconf/currsips.htm for the purpose of opening a 30-
day public comment period on the adequacy of the MVEBs for New Castle,
Kent and Sussex Counties in the June 13, 2007 SIP revision's attainment
demonstration for the Philadelphia Area. That notice will inform the
public of the availability of the Delaware SIP revision on DNREC's Web
site. Interested members of the public could access Delaware's June 13,
2007 SIP revision on line at www.regulations.gov, Docket No. EPA-R03-
OAR-2008-0930. Following EPA's public comment period, responses to any
comments received will be addressed.
    EPA has determined that Delaware's attainment demonstration meets
the applicable requirements of the CAA because it demonstrates
attainment by the applicable date of June 15, 2011.\1\ EPA's analysis
and findings are discussed in this proposed rulemaking. In addition, a
technical support document (TSD) for this proposal entitled ``Technical
Support Document for the Modeling and Weight of Evidence Portions of
the State of Delaware's Ozone State Implementation Plan,'' dated May 2,
2012 (referred to herein as the Attainment TSD) is available on line at
www.regulations.gov, Docket No. EPA-R03-OAR-2008-0930. The Attainment
TSD provides additional explanation on EPA's analysis supporting this
proposed approval of the attainment demonstration.
---------------------------------------------------------------------------

    \1\ As explained in detail in Section II, EPA approved on
January 21, 2011 a one-year extension of the Philadelphia Area's
attainment date from June 2010 to June 2011. 76 FR 3840 (Jan. 21,
2011).
---------------------------------------------------------------------------

II. What is the background for EPA's proposed action?

    On June 13, 2007, DNREC submitted a comprehensive SIP revision to
meet the requirements for an attainment plan for the 1997 8-hour ozone
NAAQS for the Philadelphia Area. On May 8, 2009 (74 FR 21599), EPA
proposed to disapprove the ozone attainment demonstration element of
the June 13, 2007 attainment plan of the comprehensive SIP revision.
EPA proposed to disapprove the attainment demonstration of the 1997 8-
hour NAAQS for the Philadelphia Area because EPA determined that the
photochemical modeling did not demonstrate attainment, and the weight
of evidence analysis used to support the attainment demonstration did
not provide sufficient evidence that the Philadelphia Area would attain
the 1997 8-hour ozone NAAQS by the June 2010 deadline for the ozone
nonattainment areas classified as moderate. On December 9, 2011 (76 FR
76929), EPA withdrew the May 8, 2009 proposed disapproval of the
attainment demonstration for the Philadelphia Area based on ambient air
quality monitoring data demonstrating attainment.
    Moderate areas are required to attain the 1997 8-hour ozone NAAQS
by no later than six years after designation. Therefore, the
Philadelphia Area was to attain by June 15, 2010. See 40 CFR 51.903 and
69 FR 23951 (April 30,

2004). However, the Philadelphia Area qualified for a one year
extension of its attainment date, based on the complete, certified
ambient air quality data for the 2009 ozone season. See 40 CFR 51.907.
On January 21, 2011 (76 FR 3840), EPA approved a one year extension of
the Philadelphia Area's attainment date from June 15, 2010 to June 15,
2011, based in part on air quality data recorded during the 2009 ozone
season.
    On March 26, 2012 (77 FR 17341), EPA published two determinations
regarding the 1997 8-hour ozone NAAQS for the Philadelphia Area. First,
EPA made a clean data determination that the Philadelphia Area had
attained the 1997 8-hour ozone NAAQS. This determination was based upon
complete, quality assured, and certified ambient air monitoring data
that showed the Philadelphia Area had monitored attainment of the 1997
8-hour ozone NAAQS for the 2008-2010 monitoring period. Ambient air
monitoring data for the 2009-2011 monitoring period is consistent with
continued attainment. Second, pursuant to section 181(b)(2)(A) of the
CAA, EPA made a determination of attainment that the Philadelphia Area
had attained the 1997 8-hour ozone NAAQS by its attainment date of June
15, 2011.

III. What are the CAA requirements for a moderate 8-hour ozone
nonattainment area?

    In 1997, EPA revised the health-based NAAQS for ozone, setting it
at 0.08 parts per million (ppm) averaged over an 8-hour time frame. EPA
set the 1997 8-hour ozone standard based on scientific evidence
demonstrating that ozone causes adverse health effects at lower ozone
concentrations and over longer periods of time than was understood when
the pre-existing 1-hour ozone standard was set. EPA determined that the
1997 8-hour standard would be more protective of human health,
especially for children and adults who are active outdoors, and
individuals with a pre-existing respiratory disease, such as asthma.
    On April 30, 2004 (69 FR 23951), EPA finalized its attainment/
nonattainment designations for areas across the country with respect to
the 1997 8-hour ozone standard. These actions became effective on June
15, 2004. In addition, on April 30, 2004 (69 FR 23951), EPA promulgated
its Phase 1 Implementation Rule which provided how areas designated
nonattainment for the 1997 8-hour ozone standard would be classified.
Among those nonattainment areas is the Philadelphia Area, which
includes all three counties in Delaware, five counties in eastern
Pennsylvania, one county in Maryland, and eight counties in southern
New Jersey. Therefore, the Philadelphia Area includes New Castle, Kent
and Sussex Counties in Delaware. EPA's Phase 2 Implementation Rule
published on November 29, 2005 (70 FR 71612) specifies that states must
submit attainment demonstrations for their nonattainment areas to EPA
by no later than three years from the effective date of designation,
that is, by June 15, 2007. See 40 CFR 51.908(a).
    Pursuant to the Phase 1 Implementation Rule, an area was classified
under subpart 2 of Title I of the CAA based on its 8-hour design value
if it had a 1-hour design value at or above 0.12 ppm. Based on this
criterion, the Philadelphia Area was classified under subpart 2 as a
moderate nonattainment area. The Phase 2 Implementation Rule addressed
the control obligations that apply to areas classified under subpart 2.
Among other things, the Phase 1 and 2 Implementation Rules outline the
required SIP elements and deadlines for those various requirements in
areas designated as moderate nonattainment.

IV. What is included in Delaware's SIP submittal?

    On June 13, 2007, Delaware submitted a comprehensive attainment
plan as a SIP revision for the 1997 8-hour ozone NAAQS. The SIP
revision included an attainment demonstration with MVEBs, the ROP plan
with MVEBs, a RACM/RACT analysis, the 2002 base year emissions
inventory, and contingency measures. The attainment demonstration of
the June 13, 2007 SIP submittal is the only subject of this proposed
rulemaking. In a separate and concurrent process, EPA is proposing an
adequacy determination for the 2009 MVEBs associated with the ozone
attainment demonstration for all three counties of Delaware. The other
elements of the June 13, 2007 SIP submittal were approved by EPA on
April 8, 2010 (75 FR 17863).

V. What is EPA's review of Delaware's modeled attainment demonstration
and weight of evidence analysis for the Philadelphia area?

    Section 110(a)(2)(K) of the CAA requires states to prepare air
quality modeling to show how they will meet ambient air quality
standards. EPA determined that areas classified as moderate or above
must use photochemical grid modeling or any other analytical method
determined by the Administrator to be at least as effective to
demonstrate attainment of the ozone health-based standard by the
required attainment date (November 29, 2005, 70 FR 71612, and 40 CFR
51.908). On April 30, 2004 (69 FR 23951 and 40 CFR 51.903), EPA
specified how areas would be classified with regard to the 8-hour ozone
standard set by EPA in 1997. On April 30, 2004 (69 FR 23858), EPA
followed these procedures and classified the Philadelphia Area as
moderate, and the nonattainment area was required to attain the 1997 8-
hour ozone standard by June 2010. Because the attainment date was June
2010 for moderate areas, states had to achieve emission reductions by
the ozone season of 2009 in order for ozone concentrations to be
reduced and show attainment during the last complete ozone season
before the 2010 deadline.

A. EPA Guidance for Using Models To Determine Attainment

    EPA's photochemical modeling guidance is found at Guidance on the
Use of Models and Other Analyses for Demonstrating Attainment of Air
Quality Goals for Ozone, PM 2.5, and Regional Haze, EPA-454/
B-07-002, April 2007. The photochemical modeling guidance is divided
into two parts. One part describes how to use a photochemical grid
model for ozone to assess whether an area will come into attainment of
the air quality standard. A second part describes how the user should
perform supplemental analyses, using various analytical methods, to
determine if the model over predicts, under predicts, or accurately
predicts the air quality improvement projected to occur by the
attainment date. The guidance indicates that states should review these
supplemental analyses, in combination with the modeling analysis, in a
``weight of evidence'' assessment to determine whether each area is
likely to achieve timely attainment.
    A description of how the attainment demonstration from the June 13,
2007 SIP revision addresses this EPA modeling guidance for a modeled
attainment demonstration can be found in the Attainment TSD, available
on line at www.regulations.gov, Docket number EPA-R03-OAR-2008-0930.
    In the June 13, 2007 SIP revision, the photochemical grid model
used projected emissions for 2009, including emission changes due to
regulations Delaware and its neighboring states were planning to
implement and expected growth by the 2009 ozone season. Meteorological
conditions from 2002, the same as the base year modeling, were used in
the projection modeling for 2009. Using the base case meteorology
allows the effect of changes in states' emissions to be determined

without being influenced by yearly fluctuations in meteorology and is
consistent with EPA guidance.
    The attainment test used in the Philadelphia Area modeling
demonstration involved the application of model-based relative response
factors (RRFs) to base year design values at each monitor to produce
projected future year design values (2009). The projected 2009 design
values represent design values that should result from emission
controls Delaware and other states planned to have in place in 2009. As
discussed in the Attainment TSD, the 2009 design values should be less
than or equal to 84 parts per billion (ppb) at all monitoring stations
to meet the attainment test. The SIP modeling predicts that in 2009,
the Philadelphia Area will not pass the attainment test since design
values are projected to be over the 84 ppb standard.
    In summary, the basic photochemical grid modeling presented in the
Delaware SIP revision meets EPA's guidelines and when used with the
methods recommended in EPA's modeling guidance, is acceptable to EPA.
However, when EPA's attainment test is applied to the modeling results,
the 2009 ozone design value is predicted to be 91 ppb in the
Philadelphia Area. Thus, based on EPA's modeled attainment test, the
Philadelphia Area has not demonstrated that it will reach attainment of
the 1997 8-hour ozone standard in the attainment year with the modeled
emission reduction strategies committed to by Delaware and the
neighboring states in the Ozone Transport Region (OTR). Therefore, a
weight of evidence (WOE) analysis was used by Delaware and reviewed by
EPA to demonstrate attainment of the 1997 8-hour ozone standard in the
Philadelphia Area.

B. Weight of Evidence Demonstration

    EPA's modeling guidance describes how to use a photochemical grid
model and additional analytical methods to complete a WOE analysis to
estimate if emissions control strategies will lead to attainment of the
1997 8-hour ozone NAAQS. A WOE analysis is a supporting analysis that
helps to determine if the results of the photochemical modeling system
are correctly (or not correctly) predicting future air quality.
    The WOE analysis presented in the Delaware SIP revision describes
the analyses performed, databases used, key assumptions and outcomes of
each analysis, and why the evidence, viewed as a whole, supports a
conclusion that the Philadelphia Area will attain the NAAQS despite the
model prediction that some monitors' future design values exceed the
1997 8-hour ozone NAAQS.
    EPA's review of the WOE analysis in the Attainment TSD included the
following: (1) A comparison of model-predicted 2009 ozone design values
to monitored design values for 2006-2011; (2) an analysis of recent
ozone trends in the Philadelphia Area; and (3) alternative methods for
calculating the 2009 ozone design value. As discussed in detail in the
Attainment TSD, the 2009 model over predicted ozone design values for
2006-2011 for most cases. Further, in the Attainment TSD, EPA's
analysis concurs with Delaware's analysis of significant declining
trends in the Philadelphia Area ozone design values. The Attainment TSD
concluded that additional emissions reductions have continued to occur
due mostly to local controls in each nonattainment area and to a few
reductions in major sources due to initiatives in the OTR. The
Attainment TSD noted that monitored ozone design values for each of the
Philadelphia Area monitors continued to decline and to show attainment
in 2010 and 2011.
    As discussed in detail in the Attainment TSD, Delaware's attainment
demonstration also asserted an alternative baseline concentration could
be used to demonstrate attainment. However, EPA determined in the
Attainment TSD that the modeling would still show nonattainment even
with this alternative baseline value. Likewise, EPA determined in the
Attainment TSD that Delaware's recalculation of 2009 modeled ozone
design values with a relative response factor in Delaware's June 13,
2007 SIP revision reduced the modeled 2009 ozone design values slightly
but the model still over predicts the actual monitored 2009 design
values. In conclusion, in the Attainment TSD, EPA determined with the
benefit of 2009 monitored design values that the model in Delaware's
June 13, 2007 SIP revision over predicts actual concentrations even
when model adjustments are made as discussed herein to attempt to
account for model over prediction.
    EPA has determined that the Delaware photochemical grid modeling
results predict a 2009 projected design value well above the 1997 8-
hour ozone NAAQS for the Philadelphia Area. However, after taking into
account WOE arguments regarding model over prediction of the 2009
monitored design values and recent ozone design value trends, which
show attainment of the standard by 2010, EPA determined that the
Delaware SIP has demonstrated attainment of the ozone standard by the
extended attainment date of June 2011 as discussed in detail in the
Attainment TSD.

VI. Proposed Action

    EPA is proposing to approve the 1997 8-hour ozone NAAQS attainment
demonstration, included in Delaware's June 13, 2007 attainment plan SIP
revision, as demonstrating attainment for the Philadelphia Area by the
applicable attainment date of June 15, 2011. EPA is soliciting public
comments on the issues discussed in this document. These comments will
be considered before taking final action.

VII. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and

     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule, pertaining to the 1997 8-hour
ozone attainment demonstration for the Philadelphia Area submitted by
Delaware on June 13, 2007, does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Nitrogen dioxide,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: July 26, 2012.
W.C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2012-19173 Filed 8-6-12; 8:45 am]
BILLING CODE 6560-50-P


Date:	July 29, 2015

To:	Docket, EPA-HQ-OAR-2014-0738

From:	Andrew Bouchard

Subject:	Meeting Record for July 29, 2015, Meeting Between the U.S. EPA and ExxonMobil Chemical Company

On July 29, 2015, representatives of the U.S. Environmental Protection Agency (EPA) participated in a meeting with ExxonMobil Chemical Company. The purpose of the meeting was to have a technical discussion with ExxonMobil about the MPGF testing information that was submitted to the docket during the comment period on the initial MPGF AMEL notice. See Attachment 1 for the names and affiliations of the meeting participants.

Attachment 1

Participants in July 29, 2015 EPA/ExxonMobil Meeting

ExxonMobil Chemical Company Representatives

Benjamin Hurst

Gary Robbins

Roger Martella (on the phone)

U.S. EPA Representatives

Andrew Bouchard

Brenda Shine

Penny Lassiter

 PAGE

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