EPA ICR No. 1446.10; OMB Control No. 2070-0112

  SEQ CHAPTER \h \r 1 APPENDIX F-1

Copy of Consultations Message Sent by EPA to Potential Respondents

Subject: 	Request for Assistance; Renewal of "PCBs, Consolidated
Reporting and Record

		Keeping Requirements" ICR

From: 		Sara Kemme

To: 		Addressees

Date:		01/11/2011

Dear [addressee],

On December 29, 2010, EPA published a Notice in the Federal Register (75
FR 82007) titled “Agency Information Collection Activities; Proposed
Collection; Comment Request; PCBs, Consolidated Reporting and Record
Keeping Requirements; EPA ICR No. 1446.10, OMB Control No. 2070-0112.”
(See

  HYPERLINK
"http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2010-0910-000
1"
http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2010-0910-0001
). This

Notice refers to EPA's intention to request renewed Office of Management
and Budget (OMB) clearance of an information collection related to
reporting and/or recordkeeping requirements for individuals,
establishments or organizations that currently possess PCB items,
PCB-contaminated equipment, or other PCB waste.

In addition to public notice and comment requirement that the above
Notice initiates, OMB regulations at 5 CFR 1320.8(d)(1)) require
agencies to consult with potential respondents and data users about
specific aspects of an information collection request (ICR) before
submitting it to OMB for review and approval, regardless, in the case of
ICR renewals, of whether changes have or have not been made to the
collection activity.

As part of this required consultation, I am contacting you to solicit
your input.  Please note that if you take this opportunity to provide
input, your name, affiliation, e-mail address, phone number and any
information you provide (e.g., copies of e-mails) will be incorporated
and attached to the ICR supporting statement, which will be a public
document.  In addition, the OMB Desk Examiner for the ICR in question
may contact you to verify the accuracy of any comments EPA identifies in
the ICR.

EPA solicits your input on the following questions:

Are the data that EPA seeks under this ICR available from any public
source, or already collected by another EPA office or by another agency?
 If so, where can the data be found?

Is it clear what is required for data submission?  If not, are there any
suggestions for clarifying instructions?

Would you be interested in an electronic/data submission option?  What
type of alternative would you be most likely to utilize – web form,
diskette, CD-ROM?

For electronic submission, how should signature requirements be handled
– Private Key Infrastructure, PINS and passwords, signed paper cover
sheet?

How does TSCA CBI affect your choice or use of an electronic medium?
Would you be more inclined to submit TSCA CBI on diskette than on paper
and what benefits would you realize (e.g., burden reduction, greater
efficiency in compiling information, etc).

Do you agree with EPA's estimated burden and costs (the ICR addresses
only the costs associated with paperwork)?  Are the Bureau of Labor
Statistics (BLS) labor rates accurate?  If you have any reason to
consider the BLS labor rates as used by EPA inaccurate or inappropriate,
explain your rationale.

To access the Federal Register Notice, the ICR supporting document, and
any public comments received to date, go to:

o www.regulations.gov/

o enter EPA-HQ-OPPT-2010-0910 in the Enter Keyword or ID field

o click on "Search"

o then click on any of the documents listed within the docket to read
the document; you will be most interested in the Supporting Statement,
identified by its title beginning "Information Collection Request…"

Your response will be greatly appreciated.  If you have any comments in
response to the above questions, or with respect to any other part of
the information collection, please respond by return e-mail by February
12, 2011.  EPA will consider those responses, as well as any public
comments received in response to the Federal Register Notice identified
above, in preparing a final document for OMB review.

Thank you for your assistance.

Sincerely yours,

Sara Kemme

National Program Chemicals Division, Office of Pollution Prevention and

Toxics/Office of Prevention, Pesticides and Toxic Substances
Environmental

Protection Agency

Washington, DC 20460

(202) 566-0511


[Federal Register Volume 80, Number 74 (Friday, April 17, 2015)]
[Notices]
[Page 21242]
[FR Doc No: 2015-08924]

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

ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9020-5]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www.epa.gov/compliance/nepa/.

Weekly receipt of Environmental Impact Statements.
Filed 04/06/2015 Through 04/10/2015.
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html.

EIS No. 20150103, Final EIS, DOI, UT, Provo River Delta Restoration
Project, review period ends: 05/18/2015, Contact: W. Russ Findlay 801-
379-1084.

EIS No. 20150104, Final EIS, NPS, CA, Channel Islands National Park
Final General Management Plan and Wilderness Study, review period ends:
05/18/2015, Contact: Greg Jarvis<PHONE_NUMBER>.

EIS No. 20150105, Final EIS, USFS, MT, Greater Red Lodge Vegetation and
Habitat Management Project, review period ends: 05/18/2015, Contact:
Amy Waring<PHONE_NUMBER>.

EIS No. 20150106, Draft EIS, FERC, LA, Lake Charles Liquefaction
Project, comment period ends: 06/01/2015, Contact: Shannon Crosley 202-
502-8853.

Amended Notices

WITHDRAWN--EIS No. 20140277, Final EIS, USFS, MT, Greater Red Lodge
Vegetation and Habitat Management Project, Contact: Amy Waring 406-255-
1451.
    Revision to the FR Notice Published 09/24/2014; This document was
Officially Withdrawn by the preparing agency.

    Dated: April 14, 2015.
Cliff Rader,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2015-08924 Filed 4-16-15; 8:45 am]
 BILLING CODE 6560-50-P


communicate the hazard to the whole industry sector.  In this particular
case, the industry task force involved with the studies produced a
poster illustrating the findings that was distributed to seed treatment
facilities. The dissemination of this type of feedback as part of
stewardship could be seen as a benefit to pesticide handlers in general.
How such information will be communicated to participants and the
pesticide handler community in general should be described in the
protocol.

The discussion of benefits to growers, landowners, or commercial
applicators focused on the provision of free pesticide product for use
in the study. The Board agreed with the AHETF’s conclusion that the
magnitude of this benefit is not likely to result in coercion of
employees to volunteer to participate in a study. However, the timing
and conditions of how this free offer is made should be explained
explicitly as a part of each protocol’s discussion of recruitment.
This would permit the HSRB to evaluate the specifics of the arrangement,
and would permit the AHETF to assure some uniformity in how such offers
are being made in different studies (clusters) or/and scenarios.

The nature of risks is discussed thoroughly in the governing documents,
but the Board concluded that several issues warranted further clarity.
The first issue is related to the scripted nature of the studies, and
the possibility that workers may be asked to use equipment that they
would not normally use. Lack of familiarity with equipment could
increase the risk of injury; for example, a mechanical injury through
collapsing hydraulic systems or an electrocution through folded or
folding booms coming into close proximity or contact with overhead power
cables. The AHETF document indicates that workers need to be
“familiar” with the type of equipment the use. The Board was
concerned that familiarity with equipment was not sufficiently described
and might be inadequate. In the United Kingdom, for example, the
requirement would be that the workers should be “competent”. The
Board recommended that future AHETF protocols identify equipment use
requirements for workers and the steps that will be taken to ensure that
workers can operate the equipment unsupervised in a safe manner.

The second issue is related to potential heat stress. The AHETF document
outlines a strategy that includes encouraging participants to drink
water or sports drinks throughout the monitoring period. It is
considered bad practice in occupational hygiene to combine working with
hazardous substances and drinking (or eating and smoking). The document
provides no advice to minimize potential inadvertent exposure during
drinking. In fact the document states that hand washes are not
necessary. The document’s only guidance is for researchers to remind
workers just prior to participation about general ways to minimize
exposure to chemicals, such as washing their hands before eating and
before removing clothing. The Board recommended that the AHETF develop a
consistent policy regarding drinking water or sports drinks and personal
hygiene.

The Board commended the AHETF for developing clear stopping rules to
minimize the risk of heat-related health concerns based on the National
Oceanic and Atmospheric Administration's (NOAA) National Weather Service
heat index. In particular, the AHETF has proposed hourly measurement of
heat and humidity when the ambient air temperature exceeds 70oF, with
increasing vigilance for signs of heat exhaustion and sunstroke on the
part of study investigators as the heat index increases. A study would
be halted when the heat index exceeds 130oF, as severe heat-related
illness is likely with prolonged physical exertion under such
conditions. AHETF researchers also recognize that direct exposure to the
sun can contribute to heat-related illness, and have proposed adjusting
the heat index accordingly for agricultural handlers working in the
direct sun. The Board was very supportive of these efforts, but
concluded that further protection of study participants was warranted.

As calculated, the National Weather Service heat index assumes that the
person in question is 5' 7" tall, 147 pounds, Caucasian, clothed in long
trousers and a short-sleeved shirt, walking at a speed of 3.1 mph in the
shade in a breeze of 6 mph, and not dripping with sweat. It is unclear
whether or not these characteristics and conditions apply to the
agricultural handlers likely to be enrolled in the proposed studies. The
whole body dosimeter used for the proposed research, for example, is
described in study documents as "long underwear". The Board recommended
that the heat index threshold be adjusted to account for the increased
amount of clothing that volunteers will wear during study participation.
The Board further recommended that AHETF document the expected levels of
physical exertion in its protocols, and consider whether a further
adjustment to the heat index threshold would be appropriate.

Finally, the Board was concerned with the use of the 130oF heat index
value as a threshold. According to the NOAA website,
"heatstroke/sunstroke [is] highly likely with continued exposure" under
such conditions (http://www.crh.noaa.gov/arx/heatindex.php). It is
important to note, however, that the website also states "sunstroke,
heat cramps or heat exhaustion [are] likely, and heat stroke [is]
possible with prolonged exposure and/or physical activity" with a heat
index of 105-129oF. The Board recommended that the AHETF revisit the
issue of heat stress, and develop a stopping point that will minimize
risk for the study participants.

HSRB Consensus and Rationale

The AHETF governing documents have provided the HSRB with a detailed and
thoughtful analysis of expected benefits and risks associated with the
conduct of human exposure monitoring. The Board concurred that study
participants would receive little if any direct benefit from
participation in these studies, although formalizing the nature of
safety feedback provided to participants might increase the potential
benefit. The Board also agreed that growers and landowners will receive
a modest benefit through the use of the test substances at no cost, and
that such a benefit was not unreasonable. The Board recommended that the
particular arrangements for providing the test substance be outlined in
the individual protocols. Finally, the Board concurred with the AHETF
judgment that the database developed from these studies will improve the
quality of risk assessments, and that this should be considered a
valuable societal benefit, provided that the data collected are
accurate, or at the least do not underestimate real-world exposures.

The Board recommended that AHETF pay more careful attention to the issue
of safety when asking participants to operate equipment with which they
do not normally work. In particular, AHETF should be more explicit about
the level of competency expected of workers when operating such
equipment. The Board commended AHETF for developing clear guidelines for
stopping work based on a heat index. However, the Board concluded that
the approach described in the governing documents was not fully
protective of workers, and recommended that additional attention be
given to this matter, including consideration of a lower heat index
threshold for stopping work.

	Addressing Potential Sources of Underestimation Bias

	Charge to the Board

1) Has EPA appropriately characterized the limitations on the scientific
usefulness of a handler database that does not include data
characterizing the efficiency of residue removal procedures?  If not,
what limitations have been overlooked?

Board Response

Introduction

The Agency presented its concerns regarding potential underestimation of
dermal exposure. It relied on the work of the January 2007 EPA
Scientific Advisory Panel (SAP) report, as well as a review of the
scientific literature. The SAP observed that whole body passive
dosimetry and biological monitoring comparisons did not seem to indicate
a systematic bias. The SAP concluded that bias may exist, but the extent
of potential bias between dermal exposure and biological monitoring
could not be detected because of the statistical uncertainty inherent in
the exposure and biomonitoring data.  The SAP also noted that passive
dosimetry can generate data that can be used to develop predictive
estimates of exposure for a number of different scenarios and
activities. The SAP suggested that biological monitoring could be a
useful check on passive dosimetry, but declined to suggest that require
biological monitoring be included in a protocol. EPA agreed with the
overall SAP conclusions and described some disadvantages to biological
monitoring including additional cost, logistical considerations (e.g.,
number of days required for metabolites to clear), and a lack of
acceptable biomonitoring methods for many of the surrogate compounds
proposed for the AHETF and AEATF studies.

The SAP gave particular attention to potential underestimation bias
resulting from the use of hand wash and skin rinse techniques. The
scientific literature indicates that hand wash/rinse performance can be
influenced by the chemical properties of the pesticide, such as
solubility, octanol/water partition coefficient, or formulation type;
residence time on the skin before hand rinsing is performed; type of
solvent used to rinse the hands (e.g., alcohol, soap and water);
concentration of the chemical on the skin (microgram/cm2); duration of
the exposure monitoring period; and nature of the residue (whether
exposed to pesticide concentrates, dilute sprays, or field residues).
Hand rinse removal efficiency values from several studies involving
human subjects ranged from approximately 70 to 90 percent; however, in
the case of chlorpyrifos the efficiency was approximately 20 to 40
percent).  An unpublished AEATF hand rinse efficiency study reported up
to 90 percent efficiency for didecyl dimethyl ammonium, but further
details were not provided.

Face/neck wipes were not specifically discussed at the SAP meeting. This
method was not among those recommended by the Agency in its 1987
Subdivision U Agency guidelines for pesticide handler exposure studies.
It was also not included in the later (1997) Agency 875 guidelines for
occupational and residential exposure assessment. Nor was wipe sampling
included as an appropriate method in the 1997 guidance document produced
by the Organization for Economic Cooperation and Development (OECD
1997). The Agency has concluded that exposure to the head/face and neck
is expected to be very low for the majority of exposure scenarios
planned by the AHETF.  The Agency pointed to an exception in the case of
the open-cab airblast application AHETF studies.

The SAP was equivocal about the need to correct the results from hand
washing for its efficiency at recovering pesticides from skin.  The SAP
would accept a rinse validation study if it could decrease the
uncertainty in exposure estimates at a reasonable cost, and be done
within approved human studies guidelines.

The AHETF argued that no correction was needed for any potential method
bias because of reasonable congruence in exposure estimates between
studies based on biological monitoring and those using passive
dosimetry.  AEATF argued that no correction was needed in studies where
individuals will not be wearing gloves and that the hand correction
factor was reasonable.

The EPA concluded that substantial underestimation by whole body
garments was unlikely, and that the most relevant methods to be
corrected for potential underestimations were the handwash and the
face/neck wipe. For the proposed AHETF studies, the Agency stated that
the contribution of hand exposure was expected to be minimal because all
subjects will be wearing chemical resistant gloves (CRG) during all
operations. The AEATF intends to collect data based on individuals not
wearing gloves (consumer products), but for most scenarios the Agency
again expects exposure to head, face, and neck to be low. The Agency
proposed two options to the task forces: biological monitoring could be
included as a check for potential breakthrough or other losses when
using surrogate chemicals that have well-established methods; cotton
gloves beneath the CRG and hat patches when measuring head, face, and
neck exposures could be used in scenarios for which exposures to these
body regions might be relatively high.

The Agency concluded that conditions should be established for
correcting hand rinse and face/neck wipe exposure values. The EPA
proposed a set of conditions for consideration by both task forces;
namely, if measured exposures from hands, face, and neck contribute less
than 20 percent of total exposure, no action is required; if measured
exposure contribution represents between 20 and 60 percent of total
exposure, an automatic 50 percent adjustment can be made or a validation
study can be submitted; if measured exposure contribution is greater
than 60 percent, a validation study is required.  Because validation
studies involve intentional exposure of human subjects, review of such
studies by the HSRB would be required.

Critique

Dermal exposure assessment methods are considered to be of three types:
interception, removal and visual. Interception methods use a collection
device on the skin to capture chemicals; removal methods use washing or
wiping to remove residues from the skin; visual methods use dyes or
fluorescent compounds to visualize chemical deposition patterns on skin
and clothing. Interception techniques can overestimate exposures because
they capture more material than the skin would normally collect. They
can also underestimate exposure if breakthrough occurs. Removal
techniques typically underestimate exposure, since they can only remove
chemicals that have not been adsorbed onto or absorbed into the skin.
Visual techniques have been most useful in qualitative evaluations of
exposure and worker education.

The use of the term “passive dosimetry” to describe the dermal
sampling methods proposed by AHETF and AEATF can lead to some confusion.
First, the approach relies on both interception (whole body garments)
and removal (handwash, face/neck wipe) techniques. It is difficult to
reconcile the very active procedures required to remove chemicals from
the skin with the notion of a “passive” measurement method. Second,
the term “dosimetry” is a misnomer, as it is exposure rather than
dose that is being measured.

The Board expressed some reservation regarding the SAP and Agency
conclusion that passive dosimetry does not underestimate dermal
exposure. The conclusion was based primarily on a recent article by Ross
et al. (2007). In that article it is stated, in regard to the methods
proposed by the AHETF and AEATF, that “the passive dosimetry methods
used have never been validated.” The article then analyzed 14
concurrent or consecutive passive dosimetry-biomonitoring studies, and
reported that this analysis produced “generally similar” estimates
of absorbed dose from these two methods. However, when these datasets
were examined in detail, this conclusion was not well-supported. For
some chemicals the passive dosimetry estimates under-predicted the
biomonitoring estimates, while in others the opposite was true (see
Table 3 of the article, with reference to chlorpyrifos and atrazine,
respectively). Dose estimates based on passive dosimetry measurements
were dependent on laboratory studies of dermal absorption. Dose
estimates from biomonitoring studies were based on laboratory studies of
urinary metabolite excretion. In each case, the laboratory data are
characterized by very high variability and uncertainty. Given the
variability of these data, the Board was not persuaded that this
analysis provided a validation of passive dosimetry measurements.

The Board was not clear as to the basis for the Agency’s conclusion
that exposure to the hands, face, and neck was likely to be minimal for
most scenarios. No scientific evidence was presented to support this
conclusion. Many studies of pesticide handlers have demonstrated that
hand exposure can be a major contributor to total dermal exposure. The
heretofore cited OECD guidance document states, “Monitoring of hand
exposure may be the most important measurement in a dermal exposure
study. The contribution of the hands to total exposure has been well
documented by many investigators, using a variety of methods.”

The Board concurred with the Agency’s concerns regarding potential
under-estimation of exposure by the handwash and face/neck wipe methods.
No justification has been given to support the validity of AHETF’s
proposal to use “AOT” (or of the AEATF’s proposal to use either
propanol or “AOT”) in the hand wash or/and face/neck wipe sampling
methods to assess dermal exposure.  A great deal of information is
available suggesting that wash data can significantly underestimate
exposure and wipe data can be worse than wash data.  The Board
recommended that the task forces either generate data supporting the
efficiency of removing their surrogate pesticides from skin by washing
and by wiping, or accept the automatic adjustments being proposed by the
Agency; in fact, the adjustment for wipes could even be increased beyond
that being proposed for washing. This recommendation is consistent with
the advice provided in the 1997 OECD guidance document: “The best that
can be achieved for a hand wash or hand rinse method is a laboratory
validation of the efficiency of recovery of material from the hands of
human volunteers.”

Existing data clearly indicate that adsorption (more than absorption) of
certain pesticides can occur within a matter of minutes after the
exposure has occurred.  For example, data presented in Fenske and Lu
(1994) show that several handwashings recovered less than 50% of
chlorpyrifos from the skin immediately after exposure, and recovered
only about 20% from the hands one hour after exposure.  The handwashing
efficiency data summarized in Table 1 of a review by Brouwer et al.
(2000) range from 23 to 96%, an even wider range than the values
summarized in the Agency’s presentation.  These data indicate that the
results from washing can range from negligibly biased to a four-fold
underestimation of the true exposure, although the frequent washings
indicated within the preliminary protocols may limit the bias to about
two-fold.

In contrast to hand washing, much of the hand wipe data presented (such
as the 10% mean recovery with a CV of 33% for azinphos-methyl from
Fenske et al. (1999) and the many chemicals with circa 50% mean recovery
with a similar CV in Table 2 of the review by Brouwer et al. (2000))
indicate that head/neck wipes may be both more biased and more variable
than hand washes. The above data support the Agency’s proposal that,
lacking a validation study of the wash method, a 50% adjustment
(multiply the results by 2x) should be applied.  The above data support
an even larger adjustment (of circa 3x) for unvalidated wipe data.  In
both cases, a validation study for recovery efficiency of wash or wipe
samples can be tested in vitro and would not require human exposure
testing. Some Board members also recommended that the Agency explore the
use of modeling to adjust hand exposure, and offered as an example an
algorithm based on some of the literature cited by the Agency in the SAP
documentation.

HSRB Consensus and Rationale

Charge to the Board

2) Has EPA identified the relevant scientific and practical
considerations affecting the choice to include biomonitoring, and has
EPA appropriately characterized the limitations on the scientific
usefulness of the resulting data if no biomonitoring is conducted?  If
not, what other considerations should bear on a decision to conduct
biomonitoring in addition to WBD?

Board Response

The HSRB discussed the perspective that, although inclusion of
biomonitoring data in the conduct of the AEATF and AHETF research
programs was intellectually satisfying, this was not an easy task.
Furthermore, the difficulties in assessing the utility of biomonitoring
in the conduct of the Task Force’s programs were evidenced by the
response previously provided by the EPA’s Scientific Advisory Panel.
After lengthy discussion, the HSRB recommended that biomonitoring did
not need to be included in the AEATF and AHETF programs.  The Board felt
that the EPA had not fully characterized the scientific and practical
issues and considerations relative to the use of biomonitoring.  If
anything, the HSRB added to the reasons to not use biomonitoring, with
the following points emphasized:

The goal of the Task Force programs is to describe exposure from a
particular use scenario.  Biomonitoring provides data that is
chemical-specific rather than scenario-specific.  Hence, whole body
dosimetry is the most appropriate measure by which to provide an
estimate of exposure under a specific use condition.

Given the list of surrogate chemicals provided by the Task Forces, it is
not clear whether biomonitoring is technically feasible and would
provide reliable data.  Technical feasibility requires that there are
well-established analytical methods in place along with knowledge of the
metabolism and kinetics of a given compound in order to accurately
assess internal dosimetry.  Such studies would also increase the
complexity of the design and execution, as they would require pre- and
post-exposure sample collection, with the post-exposure time period
determined by the kinetic properties of the compound.

Biomonitoring is important to understanding, determining and estimating
risk.  The Task Force programs are focused on establishing exposure so
as to assess risk, and any risk assessment would be performed in a
chemical-specific manner.

Additional points raised during Board discussion included observations
that requiring concurrent biomonitoring would impose additional burdens
on participants and would severely restrict study participants to those
with no recent prior or immediately subsequent exposure to the chemical,
a restriction that has the potential to seriously bias the results.
Inclusion of biomonitoring would also restrict the range of surrogate
chemicals that have sufficiently sensitive metabolites to be useful at
the low levels expected in these studies.  Furthermore, the variability
implicit in back-calculating any detectable biomonitoring data to dermal
dose (necessary for use in the data base) is likely to add as much
uncertainty as clarity to the conclusions.  .

HSRB Consensus and Rationale

The HSRB was comfortable with not including concurrent biomonitoring in
the protocols.  In fact, the Board recommended that the use of
additional monitoring units was more appropriate than the inclusion of
biomonitoring in these programs.

QA and QC Controls

Charge to the Board

Do the Task Forces’ Standard Operating Procedures appear adequate to
ensure that the data resulting from the proposed research will be of
high quality?  If not, what other Quality Assurance or Quality Control
procedures need to be addressed?

Board Response

The HSRB noted that the volume of Standard Operating Procedures (SOPs)
provided by the Task Forces represents a significant effort to develop
the infrastructure required to develop the procedures that govern this
work. To this point, it was noted that several of the governing
documents provided to the Board contained information that was relevant
to the SOPs, and should be added as appropriate.  Overall, the SOPs
outlining the overall administration, report generation and quality
assurance (QA) oversight seem reasonably complete.   The HSRB reviewers
noted two major areas that should be expanded and/or revised for
additional clarity, namely the SOPs that focused on data quality and
sample integrity and compliance.  Specific recommendations were as
follows:

The SOPs need to define what represents a “good sample.”  What
general guidance will be provided to define sample quality?  How long
after completion of work is a sample collected?  What tolerances are
allowed in targeted airflow or environmental conditions?  What
conditions determine whether a sample is to be “weathered” and how
will “weathering” be performed?

On-site spiking of samples is intended to be used for analytical
standardization and reliability.  No details were provided on how such
samples were generated, and how they were handled to simulate actual
exposure conditions.

The roles of the study director and the principal investigator are
unclear and should be expanded.

There was a recognized need for training in the execution of these
studies along with information detailing how compliance to the protocol
would be established.

The SOPs should provide for the means by which incidents relating to
lack of compliance or possible negligent conduct can be reported.

HSRB Consensus and Rationale

Design of scenario-level sampling strategies

Charge to the Board

With regard to the AHETF and AEATF plans to conduct their proposed
handler research using purposive diversity sampling strategies:

1) Has EPA identified the relevant scientific and practical
considerations affecting the choice of a strategy for sample selection?
If not, what other considerations should bear on the choice?

Board Response to the Charge

The Agency has proposed a study design that is focused on scenario-level
sampling. The target population was considered to be the set of all
possible handler-days in which scenario-specific tasks would be
performed. It was estimated that this would include approximately 1.1
million handlers and approximately 2 million handler-days. The Agency
considered two approaches for gathering a probability sample: a simple
random sample and a complex probability sample.  The Agency indicated
that complex probability sampling is more typical for these types of
projects.  For example, the National Health and Nutrition Examination
Survey (NHANES) has used complex probability sampling to sample a
representative U.S. population.  Complications associated with complex
probability sampling include its high cost, the absence of a sampling
frame, and issues related to selection bias.  Selection bias is a
particular issue for these protocols because the studies will only use
volunteers, increasing chances of bias.

In light of these issues, the Agency and the task forces have considered
two alternative sampling strategies: purposive representative sampling
and purposive diversity sampling (PDS). Purposive representative
sampling captures a small sample of handler-days that is a
“miniature” of the target population, with respect to important
factors concerning the range and extent of exposure, while PDS captures
a small sample of handler-days that are diverse with respect to factors
related to the range and extent of exposure.  The task forces have
proposed PDS as the strategy more likely to reflect a broad range of
heterogeneous conditions. PDS can be diversified on the amount of active
ingredient handled, the individual (MU), location and time, and other
factors (such as equipment type, crops, rates, and micro-location).
Site selection will emphasize more common conditions and the task forces
will be required to provide a rationale and/or justification for
selection of sites or site conditions based on diversity criteria.

The Agency has indicated that PDS permits a non-random sample to perform
at least as well as a small, same-sized probability sample.  It provides
greater assurance of obtaining a sample that reflects a broad range of
conditions, and makes it less likely that high end or low end exposure
conditions would be missed.  Augmenting scenario data with new clusters
in the future would be straightforward, and conditions of interest would
be easier to target. Nonetheless, the Agency acknowledged that PDS is
not a probability-based sample and can only be used to establish a
surrogate distribution of exposures. A surrogate distribution cannot be
equated to the actual distribution in a target population using pure
statistical sampling theory; however, PDS can capture major aspects of
an actual distribution. Results using this type of sample are not
expected to be substantially different from those derived using a small,
same-sized cluster random sample.  PDS also is considered to be adequate
for practical regulatory purposes.

The EPA’s Scientific Advisory Panel (SAP) has expressed concern with
the proposed purposive nature of sample selection because PDS assumes
underlying random selection can be used to estimate sample sizes.  In
Appendix C of its January 2007 report, the SAP provided a discussion of
potential for bias and an alternative stratified approach.  The SAP
expressed concern that use of a non-probability sample would essentially
preclude consideration of appropriate weighting to estimate
distributional parameters including means, standard deviations, upper
percentiles, etc.  Thus, the SAP recommended an informal approach for
identifying top factors and for assigning probability weights to
approximate frequencies. In response to the SAP concerns, the task
forces have outlined the constraints regarding available data and
resources. The Agency plans to evaluate the data and documentation that
will be submitted by the task forces to support their approach.
However, given the unique aspects of this monitoring program and its
relatively small size, the Agency continues to believe that PDS is
adequately representative of the target population and can be used to
develop exposure assessments of occupational handler populations.

	Critique

The Board commended the Agency and the task forces for the work they
have conducted over the past year to develop a viable sampling strategy
for pesticide handler and consumer exposures. However, the Board had a
number of questions regarding the sampling strategy, and in particular
the selection of purposive diversity sampling as the foundation for
these studies. The more practical aspects of the sampling strategy are
addressed in this section of the Board’s report, while certain
scientific aspects are addressed below in response to specific charge
questions put forth by the Agency.

A central consideration in the sampling strategy design is the choice of
key variables that will define the scenarios and the particular tasks
carried out by workers within these scenarios. The Board was not clear
as to the criteria by which these variables would be selected. One
variable that appeared central to the proposed study design was the
amount of active ingredient handled. The Agency currently normalizes
exposure based on this variable. The task forces would like to collect
data sufficient to test whether or not this is a sound scientific
practice. Thus, the study design calls for collecting data over a wide
range of values for this variable. It was not clear to the Board whether
this particular scientific question should be the primary driver of the
study design. There may be other factors equally worthy of study; for
example, crop, type of equipment, or mixing and loading procedures. One
variable – farm size -- was of particular concern to the Board based
on practical experience. Farm size tends to be correlated with many
other factors that can influence exposure, such as different sizes of
equipment used, different training procedures, behaviors, and
application details. Larger farms tend to have larger and more modern
equipment with more technical/engineering controls, make more timely
applications, and use more innovative application practices. The Board
also indicated that the level of training of study participants was an
important variable to consider in the study design. In the United
States, pesticide handlers do not need to be certified to mix, load and
apply pesticides in many situations; instead they work under the
supervision of a certified applicator. There are important differences
in training by a supervisor versus certification training. The Board
concluded that any attempt at diversity sampling should include an
appropriate number of non-certified applicators.

The Board recommended that the Agency develop a process whereby the
critical variables associated with exposure are ranked, accompanied by
an appropriate rationale and justification for the ranking. This ranking
would then inform the study design in terms of how sampling sites and
individual participants are selected.

HSRB Consensus and Rationale

The Board acknowledged the great complexity of study design development,
given the many variables associated with exposure and the practical
constraints that arise in the conduct of human exposure studies. The
Board commended the Agency and the task forces for their efforts in
developing a detailed discussion of sampling strategies. The Board
remained concerned that the number of variables is large, and that the
relative importance of these variables has not yet been defined
adequately. The Board recommended that the Agency develop a process
whereby the critical variables associated with exposure are ranked,
accompanied by an appropriate rationale and justification.

Charge to the Board

2) Does the HSRB agree with EPA that the Task Forces should provide
scenario-specific information about the availability of data to identify
significant variables (other than AaiH) potentially influencing exposure
and about the feasibility of developing a sampling strategy to address
those variables quantitatively?   If not, what additional information is
needed?

Board Response to the Charge

To be scientifically assessed, and for the Board to provide its
scientific advice, scenario-specific information needs to be provided.
This information would necessarily include significant variables that
would potentially influence exposure and its effect, in addition to
AaiH, and a feasible sampling strategy, that would be essential to meet
the scientific criteria to provide reliable and useful data. Such would
reaffirm the EPA Scientific Advisory Panel’s  recommendation that all
major factors of importance be included in each scenario-specific study
to be conducted. The information could be provided briefly for the Board
to consider, not necessarily to the extent provided by the AEATF
example.  It could be presented as one would a study design for the
scenario-specific study to be evaluated (with appropriate references)
and would contain in such design not only the specifics of the
population (including its size) to be studied but also the list of
variables and how they were to be collected and analyzed.  It could also
briefly respond to the scientific criteria proposed previously by the
Board.

Critical to the Board’s evaluation, and to the representativeness and
usefulness of the exposure data collected and provided, would be the
information as to the relationship between the scenario-specific
exposure assessment and the representative exposure in such scenarios in
the target population.

In terms of the relevant variables, one could group them into those that
are essential or less so, and whether they would significantly affect
the exposure (or exposure scenario and data collection) or might be
important to have. Description of the target population and the subjects
selected are essential, including inclusion and exclusion criteria.
Description of the primary measuring instruments and how they are to be
used is essential.  Because environmental conditions are significant
determinants of exposure, essential environmental variables (e.g., site
description, temperature and humidity) would have to be measured, and
others (e.g., wind speed, microclimatic conditions [including, presence
of significant factors that affect airflow]) might or might not be
necessary. The subjects’ type of external clothing could be considered
essential, and the subjects’ work history with the type of application
and pesticide would be important, whereas minor differences between the
subjects would not; gender and age would be necessary. It might be
important to record, if possible, the subjects’ health status and any
physical deformities that might influence how they handle the pesticide
and perform the application required.  It would be worth noting by
observation and recording significant features of the handling and
application.  Of course, prior experience and documented studies of this
nature will illustrate what was and should have been critically
measured.

Known variability in similar data previously collected, including inter-
and inter-subject variability in exposures, would even help design the
study and determine the type and size of the population to be studied.
Finally, and repetitiously, how one would analyze these variables is
important to know.

HSRB Conclusion and Rationale

Charge to the Board

3) Has EPA appropriately characterized the limitations on the scientific
usefulness of the resulting data attributable to the choice of the
sampling strategy?  If not, what has EPA overlooked?

Board Response

The AHETF and AEATF reports make an persuasive argument in favor of
purposive sampling. The reports are very well written and the issue of
sampling has clearly received much  of attention. The task forces should
be commended for a thorough and rather sophisticated analysis. Many of
their points are well taken. The limitations of the proposed sampling
strategy have not been fully discussed.

No one knows what factors affect exposure. It appears that not only are
there a myriad factors but that their importance is not so clear. The
only way to protect against potentially significant biases introduced by
unknown or unaccounted for factors is through randomization.

Purposive sampling has a definite role to play in qualitative research
and in fact is most popular in applied social sciences applications. The
goal in qualitative studies is often to explore and describe a universe.
In quantitative studies, in contrast, the goal is typically to obtain a
point estimate of some quantity and also a measure of the uncertainty
around that estimate. Because purposive sampling includes no random
mechanism, the machinery of probability theory is not available to the
researcher and thus an estimate of the uncertainty around point
estimates cannot be computed. As a consequence, results from a purposive
sample cannot be generalized beyond the sample except on faith. An
example of faith is the discussion in the reports that state that the
estimated exposure distributions obtained from the purposive samples
will approximate the true exposure distributions at least in the major
attributes.

It is true that purposive sampling or its close relative, judgment
sampling, is sometimes justifiable when the sample is very small.
However, this is true if in addition, the universe is also small and its
characteristics are known to the investigator. One argument given
against the use of a probability sample in the report is that the
sampling frame (the universe) is unknown and difficult to characterize.
Unfortunately, this fact also diminishes considerably the advantages of
purposive sampling even in small samples (see, e.g., Jessen, 1978,
Statistical Survey Techniques one of the standard reference survey
sampling books).

A basic question arises is how small does the sample have to be before
non-random selection is a better option.  The answer is very small. It
has been argued (again, see Jessen and others) that with sample sizes as
small as about 8 or 10, the advantages of the non-random sampling
mechanism vanish.

The sample size that we are concerned with in these studies is 25 and
not 5 as is argued in the Governing Documents. If all MUs collected from
the five clusters will be combined to estimate the distribution of
exposures, then the sample size we must focus on is that of the combined
(across clusters) sample which here is 25 or so. By the time we have
reached that number there is no real excuse for not carrying out at
least a semi-random selection procedure at the handler-day level.

In most cases of judgment or purposive selection, a bias will occur. The
bias can be negligible or very large, depending on the person actually
carrying out the selection. Regretfully, the bias will always be
unknown. This is not obvious from the very nice simulations shown in
Appendix B of the AHETF report. From some of those simulation studies,
it would appear that the biases associated with purposive sampling can
be small. This is true if we average over a conceptually large number of
purposive samplers. However, a single sampler (even over repeated
sampling exercises) can introduce very large biases that are very
difficult (or impossible) to quantify or anticipate.

Reliability (defined as the closeness of each observation to its own
average over repeated trials) is typically higher in purposive samples
than in random samples of similar size. Accuracy (also known as
validity, a combination of bias and sampling error and a measure of
closeness of an estimator to the targeted value) however is difficult to
forecast and can be quite low. Because non-random samples provide no
means for computing accuracy, the value of such samples is rather
questionable.

One major argument against at least a quasi-random selection of MUs
appears to be the cost of selection.  However the Board believed the
argument is not convincing. Major expenses would be incurred if MUs were
to be randomly selected from the entire universe of MUs for a given
scenario. But if a stratification step is carried out purposively (as
proposed here) the random selection of MUs within cluster should not
significantly add to the cost. Suppose that the five clusters are
selected purposively. Given a cluster and relative to the actual cost of
collecting the dosimetry data, it should be possible for example to
first randomly select firms and within firms, randomly select
handler-days. Not everyone will agree to participate and not everyone
might be handling the desired products on the selected dates, but all
that will require is a few additional visits or phone calls to the
selected firms.

Random sampling is no more impractical and/or costly than the purposive
diversity sampling.  To assist the Agency, the Board recommended the
following  approach:

Purposively select locations (e.g., counties or group of counties).

Within location, list farming operations. These data are available such
as through  NASS, extension agents, etc.

Roughly stratify producers by crop and by size.

Randomly select producers within sub-stratum and within producers,
randomly select handler. Observe them next time they apply the chemical
of interest.

The Agency might consider focusing on fewer scenarios such that
exposures can be better estimated.

HSRB Consensus and Rationale

The major limitation of non-random sampling is that it provides no means
for estimating the error associated with any estimate based on the
sample. The exposure distributions based on this type of sample might or
might not be anywhere close to the true exposure distributions and there
is no way to tell if the results are representative or not.  If the
estimated exposure distributions will be used for regulatory purposes it
is particularly important to base those estimates on samples that at
least approximate a random sample and that permit obtaining data-driven
estimates of uncertainty around quantities of interest. Error estimates
and other estimates relevant to determination quantities in the AEATF
and AHETF reports are based on strong and un-testable assumptions.

Statistical justification for number of clusters and monitoring units

	Charge to the Board

What additional information, if any, would the HSRB need to assess the
adequacy of the justification for the number of clusters and number of
MUs in specific AHETF and AEATF study proposals?

	Board Response to the Charge

The primary objective of the AHETF and AEATF II human exposure
monitoring programs is to collect sufficient data for each handler
scenario to characterize the distribution of the exposure level, both
dermal and inhalation.  In other words, both programs are interested in
knowing the statistical distribution of the exposure level within an
acceptable bound (K) for their relative accuracy.  The fold relative
accuracy (fRA) measures how far the sample estimate is from the true
parameter in a relative sense.  The sample size estimation for both
programs is based on the same justification of a 3-fold accuracy (K=3),
i.e. fRA is less than or equal to 3, for the parameter of interest.

In both programs, the purposive sampling is used to select clusters and
MUs within clusters, and as such the sampling of the clusters and the
MUs within clusters is not random.  Therefore it requires a set of
assumptions for the “surrogate sampling model”:

Observed exposures are viewed as arising (at least approximately) from a
random sample of clusters and then from a random sample of MUs within
each cluster.

The sampling distribution of normalized exposures within and between
clusters is, at least approximately, lognormal.

The second assumption is reasonable, and even if it is violated, its
impact should be minimal.  However, the first assumption is problematic.
 Depending on how the clusters and the MUs within clusters are selected,
bias can be introduced in a way that cannot be corrected.

Therefore the sample size justification based on Monte Carlo simulations
has its limits.

Under these assumptions, the sample size is estimated based on the
nested variance component model for the normalized exposure level.  In
order to determine the relative accuracy of the estimates of the
parameters associated with the statistical distribution for the exposure
level, one needs as design parameters reasonable estimates for the
geometric standard deviation (GSD) of the exposure level and the
“intra-cluster” correlation coefficient, i.e. intraclass correlation
coefficient (ICC) due to cluster sampling.

Nested lognormal variance component assumptions were used in a
surrogate-sampling model to determine the sample sizes necessary to
achieve a 3-fold relative accuracy of distributional parameter
estimates. Reasonable values for the GSD and the ICC of exposure
normalized by the amount of ai handled were obtained from an analysis of
existing data.

The Board provides specific comments to each task force proposal as
noted below

AHETF: The GSD and ICC were estimated respectively as 3.8 and 0.26 for
normalized dermal exposure and 4.2 and 0.37 for inhalation exposure from
the AHETF monitoring data based on the nested variance component model.
For planning purposes, a GSD of 4.0 and ICC of 0.3 seems reasonable
defaults for both dermal and inhalation exposure. Simulation analyses
indicate that Nc=5 clusters with Nm=5 MUs per cluster will achieve the
desired benchmark goal and is more cost-effective than other feasible
configurations.  As long as a cluster size of 5 is not exceeded, the
same total number of MUs (N=25) will also achieve this same level of
relative accuracy even if the number of MUs per cluster varies.

AEATF II: A GSD of 2.86 was derived from four dermal exposure monitoring
studies (three by the Chemical Manufacturers Association in wipe, mop
and aerosol-hands setting and one by the Pesticide Handlers Exposure
Database in aerosol), a coefficient of variation 1.42 was derived from
the log-scale standard deviation under the assumption of a lognormal
distribution, and an ICC between 0 (independence among observations
within a cluster) and 0.3 (a moderate dependence) was assumed.
Simulation analyses indicate that Nc=3 clusters with Nm=6 MUs per
cluster will achieve the desired benchmark goal and is more
cost-effective than other feasible configurations.

The recommended sample size of five clusters with five MUs per cluster
for the AHETF program and three clusters with six MUs per cluster for
the AEATF II program is considered a ‘default’ or ‘standard’
configuration only.  It strictly applies only to scenarios without
existing data and when the default variability is GSD=4 or 2.86 and
ICC=0.3, respectively, for the AHETF and AEATF II program, and benchmark
accuracy (K=3) is considered reasonable.  In other cases, the simulation
techniques can be used to develop optimal sampling plans for each
scenario it addresses.

The AHETF and AEATF II human exposure monitoring programs have done an
outstanding job of considering the effects of both the numbers of
clusters and the numbers of MUs within each cluster.

Given the assumptions made regarding the surrogate sampling, the
Governing Documents from the AHETF and the AEATF II human exposure
monitoring programs provide a very thorough justification for the sample
size in terms of the number of clusters and the number of MUs per
cluster in specific AHETF and AEATF II study proposals.  The sample size
justification includes determination of feasible values of Nc and Nm,
optimal configuration of Nc and Nm based on relative cost of sampling
cluster vs MUs, sensitivity of the relative accuracy bound to the GSD
and ICC, and the impact of unequal number of MUs per cluster which may
be expected when MUs drop out.  It also recognizes its limitations and
suggests scenario-specific simulation studies to estimate adequate
sample size.

AHETF's initial conclusion that a total of 25 MUs is needed provided
that there is no more than 5 MUs per cluster appears valid and likely to
be very useful.  However, the choice of only three clusters by the AEATF
seems risky and it should be increased if at all possible.  Three
clusters will only give 2 degrees of freedom for estimating the cluster
variance component, and making statistical inferences based on samples
of size 3 would be considered less than desirable.  It seems that the
major cost associated with the protocols for the AEATF database is with
analyzing the measurement data, and using only three clusters is a
matter of convenience.  The AEATF II program should give strong
consideration to increasing the number of monitoring units to 25 with no
more than 5 MUs per cluster, which results in at least five clusters per
scenario.

HSRB Consensus and Rationale

If the purposive sampling method is selected as a surrogate for a
probability sampling, no additional information seems to be needed for
the HSRB to assess the adequacy of the justification for the number of
clusters and the number of MUs in specific AHETF and AEATF II study
proposals (however, as noted previously, the Board raised serious
concerns about the purposive sampling strategy).  Unless the surrogate
sampling method of purposive sampling is changed to the more
statistically appropriate clustered random sampling, the sponsors should
consider monitoring the potential bias resulting from such surrogate
sampling.

As the sample size justification for the AEATF II program is based on
the ICC estimate from the AHETF program, it is recommended that the
AEATF II program update the proposed sample size based on their study in
the future to verify whether the ICC estimates agree with that from the
AHETF program.

	Within-Worker variability

	Charge to the Board

Has EPA appropriately characterized the limitations on the scientific
usefulness of a database that does not include repeated measures?  If
not, what limitations has EPA overlooked?

	Board Response

A database that does not include repeated measures will have limited
usefulness in the context of some analysis goals but not in the context
of others.

With a dataset that includes one observation per person it is not
possible to obtain an estimate of the within-person variance in
exposure. This variance reflects the variability in exposures of a
handler across different days, even if using the same product and the
same application equipment and can be quite large. The impact of
ignoring the within-person variance is directly proportional to the
relative sizes of the within to the between person variance in exposure.

If the objective of the study is to obtain an estimate of the mean
exposure of workers in a given scenario, then a single observation per
person will suffice. This is true even when the quantity of interest is
a median, a geometric mean or in general, any distributional attribute
associated with the center of the distribution.

When the objective is to characterize the entire distribution or at
least quantities in the tails of the distribution (e.g., the 95th
percentile) then the need for replicated measurements on at least a
sub-sample of subjects becomes more pressing.

For regulatory purposes, the EPA needs an estimate of the exposure
distribution for a given scenario whose variability reflects the
between-person variance in exposure. We refer to this as the
distribution of usual exposures under a given scenario. Ideally, this
usual exposure distribution would be estimated from the mean handler
exposures computed from observing each handler during a large number of
randomly selected days. This is clearly an impractical approach.
Alternatively, it can also be estimated from a database that includes at
least one replicate observation on at least a randomly selected
sub-sample by fitting the appropriate random effects model (see, e.g.,
Nusser, Carriquiry, Dodd and Fuller, Journal of the American Statistical
Association, 1996; Carriquiry, Public Health Nutrition, 1999;
Carriquiry, Journal of Nutrition,2003). This approach has been
recommended by both the US National Academy of Sciences (2002) and by
the World Health Organization (2006) for estimating the distributions of
usual exposures to components in food and drinking water.

The estimated distribution that is based on a single measurement,
however, has a variance that includes the between-person variance and
the within-person (or day-to-day) variance. The latter is problematic
and inflates the overall variance of the exposure distribution by an
amount that can be quite significant. As a consequence, upper-tail
quantiles of the exposure distribution tend to be overestimated. We
refer to this estimate as the one-day estimate of the distribution.

From a regulatory stand-point, using the one-day distribution in lieu of
the usual exposure distribution tends to be conservative. That is,
estimated percentiles such as the 95th percentile will typically be
larger than what they would be if estimated using the distribution with
the correct variance. In this sense, the one-day distribution is
protective.  If the sample of MUs in each scenario were large enough to
allow estimation of the one-day distribution, then using the one-day
distribution as a proxy for the usual exposure distribution would be
acceptable.

The reports by the AHETF and AEATF argue strongly against collecting
replicate observations. The two main arguments are the following:

Cost: given the already rather small sample sizes per scenario,
collecting replicate observations would imply increasing the number of
measurements since reducing the number of MUs is not reasonable.

The distribution of mean exposures can be analytically derived given
information about the one-day distribution of exposures.

It is difficult to argue with issues of cost. While any experiment
involving replication would indeed be more costly, it is possible to
minimize the additional cost by using an efficient design. The gain in
information is likely to more than compensate for the increased cost.

The second argument, however, is not convincing. First, it is not at all
a given that the log-normal is the correct probability model for
exposures under all possible scenarios. Even if the log-normal model was
the appropriate model, the report confuses the distribution of
within-person means with the distribution of the mean of a log-normal.
Those two distributions are in general not the same unless we are
willing to believe that the within-worker exposure distribution (i.e.,
the distribution of exposures in a worker observed during a very large
number of days) is also log-normal.  Thus, without imposing the
log-normal model at the worker level as well, the Board was not sure it
is possible to analytically derive the distribution of the conditional
expectation of daily exposure given handler (which is the distribution
of interest).

The task forces propose “borrowing” an estimate of the intra-class
correlation in order the “correct” the one-day distribution so that
it will better approximate the usual exposure distribution. In
principle, using an external estimate of the within-person variance (or
of the ICC) might be reasonable, but the actual estimate needs to be
carefully selected and very well justified. Is it reasonable to expect,
for example, that the within-person variance in exposure will be the
same across scenarios?

The limitations introduced by the lack of replication and the assumed
model are compounded by the very small sample sizes. Without imposing
the log-normal model on the data it would not even be possible to obtain
a point estimate of the 95th percentile (at least a reliable one) let
alone get an estimate of its standard error.  In addition to allowing
for estimation of the two relevant variance components, replicate
observations would increase the sample size even after accounting for
correlation between observations collected from the same person.

	HSRB Conclusion and Rationale

	Subject recruitment and enrollment issues

	Charge to the Board

1) Does the Board agree that the Governing Documents and associated SOPs
of the AHETF and AEATF research programs include comprehensive and
appropriate protections for human subjects of the research?  If not,
what has been overlooked?

Board Response

The Board was very impressed with the quality of the work done, and the
amount of effort that has clearly gone into producing these documents.
The Board had only a few suggestions:

The documents might provide greater clarity regarding input from
organizations that represent the subjects (such as farm labor
organizations or advocates). For example, at page 94 of 468 of the AHETF
materials, it indicated that such organizations “might” be invited
to provide input with regard to a particular study. It could be helpful
to provide some guidance regarding those situations in which the
participation of such organizations would be especially important. In
addition, such organizations could also provide useful advice with
regard to the Governing Documents and associated SOPs themselves, and
not merely limited to particular protocols.

The sample consent form that was provided would benefit from increased
attention to the reading level. In a variety of places (e.g., in
discussing how compounds will be applied to “vertical” and
“horizontal” surfaces), the language could be rewritten at a lower
reading level (e.g., by including examples referring to floors, walls,
and blinds), particularly given the likely educational background of
many of the subjects.

With regard to pregnancy testing of subjects, the AEATF and AHETF
documents appear to take different approaches. The former group tests
only subjects under age 50, while the latter group tests all female
subjects. It would seem appropriate to use the same standard in both
types of studies, or else to provide a justification for the difference.

Also on the issue of pregnancy testing, the documents mention that if a
pregnancy test is positive, the records relating to that person would be
discarded. It would be better to use a word such as “shredded,” to
make it clearer that the documents will be destroyed, not merely put
aside or thrown out where they could be accessed by others.  .

Given the vulnerability of many of the prospective subjects, it would be
appropriate for the documents to consider additional specific measures
that might better protect a worker’s right to say no. For example,
protocols might be designed so that substantially less than 100% of an
employer’s workers can participate in the study (e.g., only 25 out of
50). By taking this measure, it would decrease the likelihood that an
employer could determine which employees chose not to participate,
because the employer could not be sure that some of them were merely
unable to participate due to the limit on participation.

	HSRB Consensus and Rationale

The Board agreed that the Governing Documents and associated SOPs do
include comprehensive and appropriate protections for human subjects.

Charge to the Board

2) In singling out the handling of language differences as an area
requiring further refinement, has EPA overlooked other areas in need of
revision?  If so, what?

	Board Response

The Board reaffirmed the importance of making all paper and electronic
documents distributed to study volunteers available in both English and
Spanish. The Board also expressed strong support for the need for both
Spanish- and English-speaking study staff to be available at study sites
to answer any questions that research volunteers may have regarding the
study or their participation in the study. Spanish- and English-speaking
staff should also be available during other study interactions with
research volunteers, including data-collection encounters and via
telephone lines that are made available to subjects who may have
questions about their participation in the study or rights as a research
volunteer. The Board expressed concerns about reliance on translators of
convenience, such as co-workers and others who may lack sufficient
familiarity with the study.

The Board expressed support for the Agency's proposal to have impartial
third-party witnesses observe the consent process when a research
subject is unable to read relevant study documents. As specific studies
are proposed, however, it will be important for investigators to
describe the procedures to be employed in recruiting these witnesses. It
would be inappropriate, for example, to ask translators to serve as
witnesses (as suggested in the materials reviewed by the Board), because
one of the main purposes of employing a witness is to ensure that the
communication of study-related materials is adequate (and the translator
would be conflicted with regard to that assessment). If feasible, the
Agency may wish to consider using impartial "consent monitors" or
"research subject advocates" as witnesses, as is increasingly done in
certain clinical studies.

The Board also returned to an issue raised at the last Board meeting. At
that earlier meeting the Board suggested that in many areas of the U.S.,
agricultural workers often speak neither English nor Spanish but instead
speak another language, such as one of several indigenous languages of
Northern Mexico. The Agency may wish to consider this possibility (and
its implications for sample bias and just distribution of research
benefits and risks) in deciding whether to restrict eligibility to
English- and Spanish-speaking subjects.

HSRB Consensus and Rationale

The Board agreed that the handling of language differences is an area
requiring further refinement and is appropriate to protections for human
subjects.  Related issues include mechanisms to ensure understanding and
voluntariness in the consent process.

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55(5):425-432.

Fenske, RA Simcox, NJ, Camp, JE, Hines, CJ (1999). Comparison of three
methods for assessment of hand exposure to azinphos-methyl (Guthion)
during apple thinning. Appl. Occup. Env. Hyg. 14:618-623.

OECD. 1997. Guidance Document for the Conduct of Studies of Occupational
Exposure to Pesticides During Agricultural Application. OECD
Environmental Health and Safety Publications, Series on Testing and
Assessment, No. 9. Environment Directorate. Organization for Economic
Cooperation and Development. Paris. [Accessed at (  HYPERLINK
"http://www.oecd.org/ehs/"  http://www.oecd.org/ehs/ ]

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*e 27-29, 2007; EPA Docket ID: EPA-HQ-ORD-2007-0403. Unpublished letter
submitted to Dr. Paul Lewis, Designated Federal Officer, Human Studies
Review Board. Prepared by toXcel, LLC, dated June 18, 2007.

Ross J, Chester G, Driver J, Lunchick C, Holden L, Rosenheck L, Barnekow
D. 2007. Comparative evaluation of absorbed dose estimates derived from
passive dosimetry measurements to those derived from biological
monitoring: Validation of exposure monitoring methodologies. J Expo Sci
Environ Epidemiol. Jun 27; [Epub ahead of print]

Spero, N. (2007) Protocol for Conducting Insect Repellent Field Efficacy
Testing on Mosquitoes Including Supporting Materials Satisfying 40 CFR
§26.1125 for Test Materials 1003715-019 & 1003715-020. Unpublished
document prepared by Insect Control & Research, Inc., under Protocol ID
G0590307001A044, dated April 11, 2007.

Weber-Tschopp, A.; Fischer, T.; Gierer, R.; and Grandjean, E. (1977)
Experimentally Induced Irritating Effects of Acrolein on Man
(unpublished English translation of “Experimentelle Reizwirkungen von
Akrolein auf den Menschen”) International Archives of Occupational and
Environmental Health 1977 (40): 117-130.

  PAGE  1  of   NUMPAGES  65


[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Notices]
[Pages 2914-2915]
[FR Doc No: 2010-799]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61322; File No. SR-CHX-2010-01]

Self-Regulatory Organizations; Chicago Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Implement a Tiered Fee Schedule

January 11, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 4, 2010, the Chicago Stock Exchange, Inc. (``CHX'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. CHX
filed the proposal pursuant to Section 19(b)(3)(A) of the Act \3\ and
Rule 19b-4(f)(2) thereunder,\4\ which renders the proposal effective
upon filing with the Commission. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The CHX proposes to amend its Schedule of Participant Fees and
Assessments (the ``Fee Schedule''), effective January 4, 2010, to
implement a tiered rate of fees when removing or providing liquidity on
the Exchange. The text of the proposed rule change is available on the
Exchange's Web site at http://www.chx.com/rules/proposed_rules.htm, on
the Commission's Web site at http://www.sec.gov, at CHX, and at the
Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Through this filing, the Exchange would amend its Fee Schedule,
effective January 4, 2010, to provide for a tiered schedule of fees and
rebates for Participants for trade executions of single-sided orders in
securities priced over $1 in the event that certain volume thresholds
are achieved. The volume thresholds are based on the Participant's
Average Daily Volume (``ADV''), which is determined, with respect to a
given Participant, by the number of shares such Participant has
executed as a liquidity provider in any and all trading sessions on
average per trading day (excluding partial trading days) across all
tapes on the trading facilities of the CHX (excluding all cross
transactions) for the calendar month in which the executions occurred.
    According to this proposal, a Participant entering a single-sided
(i.e., not a cross order type) order in Tape A and C securities would
be charged a fee of $0.003/share when removing liquidity from the
Matching System if its monthly ADV (as defined above) is 500,000 shares
or less. Such Participants would also receive a rebate of $0.0026/share
when they provided liquidity to the Matching System. Participants which
had a monthly ADV of greater than 500,000 up to and including 5,000,000
shares would be charged a fee of $0.0029 when removing liquidity.
Participants falling into this category would also receive a rebate of
$0.0028/share when providing liquidity to the Matching System. Finally,
Participants which had a monthly ADV of greater than 5,000,000 shares
would pay a fee of $0.0028 when removing liquidity from the Matching
System and a rebate of $0.003 when they provided liquidity.
    For Tape B securities, a Participant entering a single-sided (i.e.,
not a cross order type) order would be charged a fee of $0.003/share
when removing liquidity from the Matching System if its monthly ADV is
500,000 shares or less. Such Participants would also receive a rebate
of $0.0028/share when they provided liquidity to the Matching System.
Participants which had a monthly ADV of greater than 500,000 up to and
including 5,000,000 shares would be charged a fee of $0.0029 when
removing liquidity. Participants falling into this category would also
receive a rebate of $0.003/share when providing liquidity to the
Matching System. Finally, Participants which had a monthly ADV greater
than 5,000,000

shares would pay a fee of $0.0028 when removing liquidity from the
Matching System and a rebate of $0.0032 when they provided liquidity.
    Under this program, Participants which, on a net basis, provide
Tape A and C securities would pay fees at lower volume levels but, as
their monthly ADV increases, this rate structure will ultimately
invert. Through this mechanism, the Exchange seeks to maximize revenue
at lower volume levels while incenting all Participants to provide
greater liquidity to the Matching System. Furthermore, the Exchange
believes that the increased rebate will help attract additional orders
to be displayed and executed on our trading facilities. The Exchange
notes that a number of other exchanges have tiered fee schedules which
offer different rates depending on the monthly ADV of liquidity-
providing executions on their facilities, and our proposed fee
structure will help us remain competitive with these entities.\5\ The
Exchange believes that the implementation of a tiered fee schedule may
incent firms to display their orders on our trading facility and
increase the volume of securities traded here.
---------------------------------------------------------------------------

    \5\ See, e.g., Nasdaq Stock Market (``Nasdaq'') Rule 7018;
National Stock Exchange (``NSX'') Fee Schedule; NYSE Arca Fee
Schedule; International Securities Exchange (``ISE'') Fee Schedule
(equity mid-point match orders).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act \6\ in general, and furthers the
objectives of Section 6(b)(4) of the Act \7\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among its members. Among other things, the change to the
fee schedule would provide incentives to Participants to increase the
amount of liquidity provided on our trading facilities, which may
contribute to an increase in trading volume on the Exchange and in the
income derived therefrom.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing proposed rule change is effective upon filing
pursuant to Section 19(b)(3)(A)(ii) of the Act \8\ and Rule 19b-4(f)(2)
thereunder.\9\ At any time within 60 days of the filing of the proposed
rule change, the Commission may summarily abrogate such rule change if
it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \9\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CHX-2010-01 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-CHX-2010-01. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro/shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, on official business
days between the hours of 10 a.m. and 3 p.m. Copies of such filing will
also be available for inspection and copying at the principal office of
the Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File No. SR-CHX-
2010-01 and should be submitted on or before February 9, 2010.
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-799 Filed 1-15-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: November 16, 2006 (Volume 71, Number 221)]
[Notices]
[Page 66774-66776]
[DOCID:fr16no06-68]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No.: 2232-522]

Duke Power Company LLC; Notice of Application Accepted for Filing
and Soliciting Motions To Intervene and Protests

November 9, 2006.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: 2232-522.
    c. Date filed: August 29, 2006.
    d. Applicant: Duke Power Company LLC.
    e. Name of Project: Catawba-Wateree Hydroelectric Project.
    f. Location: On the Catawba River, in Alexander, Burke, Caldwell,
Catawba, Gaston, Iredell, Lincoln, McDowell, and Mecklenburg Counties,
North Carolina, and on the Catawba and Wateree Rivers in Chester,
Fairfield, Kershaw, Lancaster, and York counties, South Carolina.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: Jeffrey G. Lineberger, Catawba-Wateree Hydro
Relicensing Manager (or E. Mark Oakley, Catawba-Wateree Relicensing
Project Manager), Duke Energy, Mail Code EC12Y, P.O. Box 1006,
Charlotte, NC 28201-1006.
    i. FERC Contact: Sean Murphy at<PHONE_NUMBER><EMAIL_ADDRESS>    j. Deadline for filing motions to intervene: 60 days from the
issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    Motions to intervene and protests may be filed electronically via
the Internet in lieu of paper. The Commission strongly encourages
electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions
on the Commission's Web site (http://www.ferc.gov) under the ``e-

Filing'' link.
    k. This application has been accepted, but is not ready for
environmental analysis at this time.
    l. The existing Catawba-Wateree Project consists of eleven
developments:
    (1) The Bridgewater development consists of the following existing
facilities: (1) the Catawba dam consisting of: (a) A 1,650-foot-long,
125-foot-high earth embankment; (b) a 305-foot-long, 120-foot-high
concrete gravity ogee spillway; and (c) an 850-foot-long, 125-foot-high
earth embankment; (2) the Paddy Creek dam consisting of: a 1,610-foot-
long, 165-foot-high earth embankment; (3) the Linville dam consisting
of: a 1,325-foot-long, 160-foot-high earth embankment; (4) a 430-foot-
long uncontrolled low overflow weir spillway situated between Paddy
Creek Dam and Linville Dam; (5) a 6,754 acre reservoir formed by
Catawba, Paddy Creek, and Linville with a normal water surface
elevation of 1,200 feet above msl; (6) a 900-foot-long concrete-

lined intake tunnel; (7) a powerhouse containing two vertical Francis-
type turbines directly connected to two generators, each rated at
10,000 kW, for a total installed capacity of 20.0 MW; and (8) other
appurtenances.
    (2) The Rhodhiss development consists of the following existing
facilities: (1) The Rhodhiss dam consisting of: (a) A 119.58-foot-long
concrete gravity bulkhead; (b) an 800-foot-long, 72-foot-high concrete
gravity ogee spillway; (c) a 122.08-foot-long concrete gravity bulkhead
with an additional 8-foot-high floodwall; and (d) a 283.92-foot-long
rolled fill earth embankment; (2) a 2,724 acre reservoir with a normal
water surface elevation of 995.1 feet above msl; (4) a powerhouse
integral to the dam, situated between the bulkhead on the left bank and
the ogee spillway section, containing three vertical Francis-type
turbines directly connected to three generators, two rated at 12,350
kW, one rated at 8,500 kW for a total installed capacity of 28.4 MW;
and (5) other appurtenances.
    (3) The Oxford development consists of the following existing
facilities: (1) The Oxford dam consisting of: (a) A 74.75-foot-long
soil nail wall; (b) a 193-foot-long emergency spillway; (c) a 550-foot-
long gated concrete gravity spillway; (d) a 112-foot-long embankment
wall situated above the powerhouse; and (e) a 429.25-foot-long earth
embankment; (2) a 4,072 acre reservoir with a normal water surface
elevation of 935 feet above msl; (4) a powerhouse integral to the dam,
situated between the gated spillway and the earth embankment,
containing two vertical Francis-type turbines directly connected to two
generators, each rated at 18,000 kW for a total installed capacity of
35.7 MW; and (5) other appurtenances.
    (4) The Lookout Shoals development consists of the following
existing facilities: (1) The Lookout Shoals dam consisting of: (a) A
282.08-foot-long concrete gravity bulkhead section; (b) a 933-foot-long
uncontrolled concrete gravity ogee spillway; (c) a 65-foot-long gravity
bulkhead section; and (d) a 1,287-foot-long, 88-foot-high earth
embankment; (2) a 1,155 acre reservoir with a normal water surface
elevation of 838.1 feet above msl; (3) a powerhouse integral to the
dam, situated between the bulkhead on the left bank and the ogee
spillway, containing three main vertical Francis-type turbines and two
smaller vertical Francis-type turbines directly connected to five
generators, the three main generators rated at 8,970 kW, and the two
smaller rated at 450 kW for a total installed capacity of 25.7 MW; and
(4) other appurtenances.
    (5) The Cowans Ford development consists of the following existing
facilities: (1) The Cowans Ford dam consisting of: (a) A 3,535-foot-
long embankment; (b) a 209.5-foot-long gravity bulkhead; (c) a 465-
foot-long concrete ogee spillway with eleven Taintor gates, each 35-
feet-wide by 25-feet-high; (d) a 276-foot-long bulkhead; and (e) a
3,924-foot-long earth embankment; (2) a 3,134-foot-long saddle dam
(Hicks Crossroads); (3) a 32,339 acre reservoir with a normal water
surface elevation of 760 feet above msl; (4) a powerhouse integral to
the dam, situated between the spillway and the bulkhead near the right
embankment, containing four vertical Kaplan-type turbines directly
connected to four generators rated at 83,125 kW for a total installed
capacity of 332.5 MW; and (5) other appurtenances.
    (6) The Mountain Island development consists of the following
existing facilities: (1) The Mountain Island dam consisting of: (a) A
997-foot-long, 97-foot-high uncontrolled concrete gravity ogee
spillway; (b) a 259-foot-long bulkhead on the left side of the
powerhouse; (c) a 200-foot-long bulkhead on the right side of the
powerhouse; (d) a 75-foot-long concrete core wall; and (e) a 670-foot-
long, 140-foot-high earth embankment; (2) a 3,117 acre reservoir with a
normal water surface elevation of 647.5 feet above msl; (3) a
powerhouse integral to the dam, situated between the two bulkheads,
containing four vertical Francis-type turbines directly connected to
four generators rated at 15,000 kW for a total installed capacity of
55.1 MW; and (4) other appurtenances.
    (7) The Wylie development consists of the following existing
facilities: (1) The Wylie dam consisting of: (a) A 234-foot-long
bulkhead; (b) a 790.92-foot-long ogee spillway section that contains 2
controlled sections with a total of eleven Stoney gates, each 45-feet-
wide by 30-feet-high, separated by an uncontrolled section with no
gates; (c) a 400.92-foot-long bulkhead; and (d) a 1,595-foot-long earth
embankment; (2) a 12,177 acre reservoir with a normal water surface
elevation of 569.4 feet above msl; (3) a powerhouse integral to the
dam, situated between the bulkhead and the spillway near the left bank,
containing four vertical Francis-type turbines directly connected to
four generators rated at 18,000 kW for a total installed capacity of 69
MW; and (4) other appurtenances.
    (8) The Fishing Creek development consists of the following
existing facilities: (1) The Fishing Creek dam consisting of: (a) A
114-foot-long, 97-foot-high uncontrolled concrete ogee spillway; (b) a
1,210-foot-long concrete gravity, ogee spillway with twenty-two Stoney
gates, each 45-feet-wide by 25-feet-high; and (c) a 214-foot-long
concrete gravity bulkhead structure; (2) a 3,431 acre reservoir with a
normal water surface elevation of 417.2 feet above msl; (3) a
powerhouse integral to the dam, situated between the gated spillway and
the bulkhead structure near the right bank, containing five vertical
Francis-type turbines directly connected to five generators two rated
at 10,530 kW and three rated at 9,450 kW for a total installed capacity
of 48.1 MW; and (4) other appurtenances.
    (9) The Great Falls-Dearborn development consists of the following
existing facilities: (1) The Great Falls diversion dam consisting of a
1,559-foot-long concrete section; (2) the Dearborn dam consisting of:
(a) A 160-foot-long, 103-foot-high, concrete embankment; (b) a 150-
foot-long, 103-foot-high intake and bulkhead section; and (c) a 75-
foot-long, 103-foot-high bulkhead section; (3) the Great Falls dam
consisting of: (a) A 675-foot-long, 103-foot-high concrete embankment
situated in front of the Great Falls Powerhouse (and joined to the
Dearborn dam embankment); and (b) a 250-foot-long intake section
(within the embankment); (4) the Great Falls bypassed spillway and
headworks section consisting of: (a) A 446.7-foot-long short concrete
bypassed reach uncontrolled spillway with a gated trashway (main
spillway); (b) a 583.5-foot-long concrete headworks uncontrolled
spillway with 4-foot-high flashboards (canal spillway); and (c) a 262-
foot-long concrete headworks section situated perpendicular to the main
spillway and the canal spillway, containing ten openings, each 16-feet-
wide; (5) a 353 acre reservoir with a normal water surface elevation of
355.8 feet above msl; (6) two powerhouses separated by a retaining
wall, consisting of: (a) Great Falls powerhouse: containing eight
horizontal Francis-type turbines directly connected to eight generators
rated at 3,000 kW for an installed capacity of 24.0 MW, and (b)
Dearborn powerhouse: Containing three vertical Francis-type turbines
directly connected to three generators rated at 15,000 kW for an
installed capacity of 42.0 MW, for a total installed capacity of 66.0
MW; and (7) other appurtenances.
    (10) The Rocky Creek-Cedar Creek development consists of the
following existing facilities: (1) A U-shaped concrete gravity overflow
spillway with (a) A 130-foot-long section (on the east side) that forms
a forebay canal to the Cedar Creek powerhouse and contains

two Stoney gates, each 45-feet-wide by 25-feet-high; (b) a 1,025-foot-
long, 69-foot-high concrete gravity overflow spillway; and (c) a 213-
foot-long section (on the west side) that forms the upper end of the
forebay canal for the Rocky Creek powerhouse; (2) a 450-foot-long
concrete gravity bulkhead section that completes the lower end of the
Rocky Creek forebay canal; (3) a 748 acre reservoir with a normal water
surface elevation of 284.4 feet above msl; (4) two powerhouses
consisting of: (a) Cedar Creek powerhouse (on the east): containing
three vertical Francis-type turbines directly connected to three
generators, one rated at 15,000 kW, and two rated at 18,000 kW for an
installed capacity of 43.0 MW; and (b) Rocky Creek powerhouse (on the
west): containing eight horizontal twin-runner Francis-type turbines
directly connected to eight generators, six rated at 3,000 kW and two
rated at 4,500 kW for an installed capacity of 25.8 MW, for a total
installed capacity of 68.8 MW; and (5) other appurtenances.
    (11) The Wateree development consists of the following existing
facilities: (1) The Wateree dam consisting of: (a) A 1,450 foot-long
uncontrolled concrete gravity ogee spillway; and (b) a 1,370-foot-long
earth embankment; (2) a 13,025 acre reservoir with a normal water
surface elevation of 225.5 feet above msl; (3) a powerhouse integral to
the dam, situated between the spillway and the earth embankment,
containing five vertical Francis-type turbines directly connected to
five generators, two rated at 17,100 kW and three rated at 18,050 kW
for a total installed capacity of 82.0 MW; and (4) other appurtenances.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''

link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-
866-208-3676, or for TTY,<PHONE_NUMBER>. A copy is also available for
inspection and reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. Anyone may submit a protest or a motion to intervene in
accordance with the requirements of Rules of Practice and Procedure, 18
CFR 385.210, 385.211, and 385.214. In determining the appropriate
action to take, the Commission will consider all protests filed, but
only those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any protests
or motions to intervene must be received on or before the specified
deadline date for the particular application.
    All filings must (1) Bear in all capital letters the title
``PROTEST'' or ``MOTION TO INTERVENE;'' (2) set forth in the heading
the name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-19357 Filed 11-15-06; 8:45 am]

BILLING CODE 6717-01-P