but decisions must be made concerning the importance of some variables
(i.e., training, compared to others).  He suggested that a
point-by-point discussion of variable importance, with expert rationale,
be held.  Dr. Popendorf agreed, but stated that he was not sure this
conversation should be required before field studies begin.  Ranking of
variables can be developed during the observation phase of the studies
and field notes can be used to categorize exposures.  This information
could be entered into the database and would be useful for future
analyses.  Dr. Fenske countered that a structured list of variables to
observe would be needed beforehand to collect this information through
field notes.  Dr. Lebowitz suggested that the Board should emphasize a
need for both task forces to develop a set of questions and a checklist
to be used to gather this data.  Dr. Brimijoin noted that many potential
variables influence exposure and concluded that as much effort as
possible should be made to identify ahead of time the variables most
likely to be important, and a checklist to use in the field should be
developed.

Dr. Carriquiry opened discussion of the limitations of the scientific
usefulness of the data attributable to the choice of sampling strategy.
She disagreed that PDS was the best alternative for this work and stated
that it was untrue that PDS gives better results than random sampling.
PDS may be preferable for a unique group of people for which there is no
sampling frame, but this is an easy sampling exercise.  She commented
that Mr. Miller’s and Dr. Cohen’s presentations implied that many
factors impact exposure.  If this is the case, she recommended that EPA
not accept the assertion that a group of experts can identify all
possible factors and determine the effect of this on the PDS approach.

Dr. Carriquiry noted that PDS may be useful in applied social science
studies where the main objective is description; PDS is useful for
qualitative, not quantitative analyses.  PDS is inappropriate for
quantitative studies because it is impossible to measure the error for a
surrogate distribution.  The surrogate distribution itself could be a
good representative of the true exposure distribution or could be
significantly different, and there is no way of checking assumptions
when PDS is used.

Dr. Carriquiry addressed the sample size argument that PDS sometimes
generates better results than random sampling if the sample is small and
the “universe” also is very small and very well-known.  In the case
of the handler exposure studies, the “universe” is unknown, which
completely negates the advantages of PDS.  Sample sizes must be very
small, on the order of eight to 10, before non-random sampling is
preferable to random sampling.

Dr. Carriquiry suggested a way to use random sampling without greatly
increasing the cost of the studies.  She noted that the most expensive
part of the studies is gathering dosimetry data (approximately $20,000
per person per day) and also travel for study personnel.  A compromise
would be to systematically pick clusters or locations, which could be
defined as counties, states, or contiguous counties.  Within a location,
a list of farms could be easily developed based on information from
county extension offices, which have information on crop type, size, and
location of the farms.  The farms then would be stratified by size and
crop type and then one to three farms within a strata picked randomly
(depending on the number of observations in a cluster).  After this,
handlers at a farm would be randomly chosen.  This would be a more
defensible approach, especially if the data is intended for use for
regulatory issues.  She concluded that she supports the study, except
for the use of PDS; however, this is an easy issue to correct and using
the proper sampling approach will significantly improve the quality of
the data.

Dr. Brimijoin stated that Dr. Carriquiry’s analysis and suggestions
would constitute the Board’s recommendation in its report at this
time.

Dr. Dallas Johnson (Consultant to the Board) agreed with Dr. Carriquiry
concerning sampling.  He noted that certain factors, such as amount of
active ingredient handled, and equipment type can be controlled and
would be part of the fixed effect side of the model.  Factors, such as
location, time, and crop type, are less controllable and thus fall on
the random side of the model.  Purposely picking factors on the fixed
side of the model may be acceptable, but purposively picking from the
random side is problematic.  He agreed that there is no way to determine
the confidence interval (CI) if PDS is used.  Dr. Johnson speculated
that if the variances and estimated standard errors from the data are
overestimates of what would be determined using random sampling, PDS
exposure estimates would be conservative because of the wider CIs.

Dr. Carriquiry agreed with Dr. Johnson on the issue of fixed effects and
the number of factors.  Some of these must be accounted for, but at some
point factors must be sacrificed to avoid significantly increasing the
sample size.  The question is whether to poorly gather data for many
scenarios or reduce the number of scenarios by one or two and focus more
resources on generating sound data from the remaining scenarios.  Good
scenario data will allow extrapolation across multiple scenarios.

Dr. Chambers commented that scenarios constitute different activities,
so caution should be taken in reducing the number of scenarios.  She
asked whether the design of five MUs in a cluster, and five clusters per
scenario changed Dr. Carriquiry’s conclusions regarding PDS versus
random sampling.  Dr. Carriquiry responded that her conclusions would
not change because the relevant sample number for a scenario is 25,
which is large enough to justify random sampling.

Dr. Popendorf presented graphs depicting the differences in the two
sampling approaches.  The K value is driven by EPA and its approach that
it will be consistent with the amount of substance handled.  He assumed
that EPA has found this to be a successful approach from a regulatory
perspective.  If a log normal distribution is examined on a log scale,
the distribution becomes normal.  If this graph represented the amount
handled, the distribution would appear normally distributed and mean and
variation could be determined.  The purpose of PDS is to predefine
categories (i.e., amount handled) and then try to equalize this across
categories, which could generate an acceptable mean; however, the
standard deviation and 95th percentile values will be in error if the
amount handled is not a primary driver of the distribution.  This would
have implications for use of this data for regulatory purposes.  Dr.
Carriquiry agreed with this analysis.  Mr. Miller agreed with the
comments and that PDS is controversial.

Mr. Miller requested clarification of the random sampling strategy
described by Dr. Carriquiry.  He explained that needing to include
handling of a certain amount and certain chemical in a given scenario
had played a role in the decision to use PDS.  Dr. Carriquiry explained
that a compromise between random and purposive sampling can be reached.
Locations can be picked systematically (or purposively) to have defined
information on the types of crops and size of the farm.  Within a
location, a more random approach to sampling could be used.  Issues,
such as chemical identity and handled amount, are correlated with
characteristics of the location (i.e., large producers use different
types of equipment than smaller growers and also may use different
application procedures or chemical types).  Although it may require more
legwork to determine these parameters, several Board members noted that
this information should be easily available from extension offices or
clearinghouses.

Dr. Kim commented that the unwillingness of the sponsors to create a
sampling frame is problematic.  Scenarios will dictate the sampling
frame.  He stated that this issue needs to be considered or it will be
difficult to draw meaningful conclusions from the study.  Dr. Brimijoin
concluded that the Board believed a random sampling approach, in whole
or in part, would provide better data.

	Statistical Justification of the Number of Clusters

Dr. Kim opened discussion of the statistical justification of the number
of clusters.  If the assumption is that the surrogate sample represents
probability sampling, the sampling described in the governing documents
is adequate and the documents also provide a thorough discussion of the
justification for the number of clusters and MUs based on sensible
assumptions.  Especially for the AHETF, the design of five MUs per
cluster and five clusters per scenario is justified because of the
analysis performed using existing data from the PHED, ICC development,
and sensitivity analysis to determine the influence of clustering.  He
commended the AHETF’s mathematical derivation of sample size, rather
than basing sample size on traditional approaches.  He noted that the
AEATF also provided good justification of the design of three clusters
with six MUs per cluster based on a GSD of 2.4 and an ICC of 0.3.  His
only caveat was to caution the task forces to be attentive to specific
conditions that may require scenario-specific adjustments.  He concluded
that the cluster design was justified, but agreed that use of PDS was
problematic.

Dr. Fenske argued that although the task forces believe they can
identify and rank risk factors in terms of their impact on exposure and
apply this to the study to get an appropriate distribution of exposure,
there is no way to prove if the results of this exercise are correct.
He stated that although it is appropriate for task forces to trust in
their own knowledge base to rank risk factors, there is no way to
determine whether a truly representative miniature sample has been
created.  He recommended that EPA seriously investigate the feasibility
of random sampling within a defined sample frame.  He noted that Dr.
Carriquiry had described a feasible and practical plan for doing this.

Dr. Fenske concluded that field studies are similar to epidemiological
studies in that there is little control over conditions.  He suggested
that each study chose one goal around which they optimize what is
controllable.  He cautioned against weakening the design developed to
achieve the primary objective in hopes of addressing a secondary
objective.  The planned AHETF and AEATF activities include a survey that
will create usable exposure distributions for a number of scenarios.
The numbers will be used to inform risk assessment activities for many
chemicals and scenarios.  Attempts to answer questions concerning
amounts handled by changing or restricting the study design will require
assumptions that a sufficient range of active ingredient handled can be
examined.  He recommended optimizing the representativeness of scenario
data to optimize exposure, and agreed that random sampling would be
preferable.

Dr. Johnson agreed with Drs. Fenske and Kim.  He stated that the AHETF
had provided sound justification of its five clusters with five MUs
design and commended the sensitivity analysis.  Based on this, Dr.
Johnson concluded that he would not include more than five MUs per
cluster, but instead would increase the numbers of clusters to reach 25
MUs per scenario.  Dr. Johnson was less pleased with the AEATF’s
design of six MUs in each of three clusters, stating that five or more
clusters would be better.  AEATF should consider changing its study
design in this manner.

Dr. Kim recommended that in terms of the numbers of clusters needed for
the AEATF, as data accumulates in the database, a better estimate of ICC
could be developed.  Dr. Cohen clarified that an ICC of 0.3 was
considered the upper bound estimate.  If the ICC is as low as 0, the K
value will be 2, which is better.  It is true that in the document, the
idea is to use three clusters as a default; once data is available to
estimate a new ICC, cluster design can be re-visited.  In response to a
question from Dr. Johnson, Dr. Cohen clarified that the CV had been
derived from data from four existing studies, but there was no data to
support derivation of the ICC.

Dr. Lebowitz inquired why a cluster design was needed for AEATF studies.
 Mr. Miller replied that the original suggestion from the AEATF was to
monitor more individuals in one location.  EPA objected to this for fear
of being unable to obtain information on the ICC.  This led to the
development of the three MUs per each of six clusters design.  Dr.
Carriquiry noted that there was an expectation of less between-cluster
variability in the AEATF than in the AHETF.  The different numbers of
clusters responds to this, and thus use of fewer clusters in the AEATF
design is justifiable.  Dr. Johnson commented that estimating variance
using only three clusters was somewhat weak.  Depending on the cost,
increasing the number of clusters would be optimal.  Dr. Brimijoin
concluded that the cluster size of three was acceptable to the Board and
noted Dr. Johnson’s disagreement.

	Within-Worker Variability

Dr. Carriquiry opened discussion of within-worker variability.  She
noted that she would like to recommend replicates, because these can be
used to estimate within-person variance relative to between-worker
variance and exposure and gives a better estimate of the usual daily
exposure of workers in a scenario.  However, another way to determine
within-worker variability is to gather replicate measures of a
sub-sample of the same workers and averaging this value over all
workers.  This approach was used by NHANES in a survey to gather
replicate measurements of a food intake in a sub-sample of survey
respondents.  If replicate measures are not taken, the tails of the
exposure distribution may extend too far.  If only one day’s exposure
distribution is used to determine the 95th percentile level of exposure,
this estimate will be too high.  This would actually be protective of
workers because it will overestimate exposure and perhaps trigger
stricter protective regulations.  In this case, the main exposure
estimates will be accurate with or without replicates.

Dr. Carriquiry acknowledged that this issue was recognized in the SAP
report.  The report proposes to borrow information from another source,
assume a certain within-worker variability, and correct the distribution
using external estimates of variance.  It is permissible to do this, but
extra estimates of within-worker variability must be chosen carefully
because they can have a significant impact on the tails of the
distribution.  In the absence of replicates, EPA should be conservative
and use 1-day exposure without correction as the true 10-day exposure,
even though this results in overestimation of the distribution at the
tails.  EPA has recognized this problem and it is not a significant
limitation.  Errors can be easily estimated in the absence of replicate
measures.  Dr. Fenske suggested using data from PHED, which has many
repeated measures performed on the same work force and could be used to
inform variability issues for which there are no samples in the AHETF
database.

Dr. Johnson agreed that if the choice is between including many workers
with one measure each or few workers with many measures, EPA should opt
for many workers with one measurement.  This does not place limits on
the database, although the ability to separate within-worker and
between-worker variance is lost.

	Dr. Lebowitz inquired if within-subject variability would contribute to
the ability to generalize the exposure estimates made from the data.
Dr. Carriquiry responded that under the given resource constraints, a
limited total number of observations can be made.  If it were possible
to have a larger sample size, replicates of some workers would provide
uncertainties between estimates.  In this case, the estimate of the
95th percentile will be biased because of having only one observation
per worker, but this could be corrected using external information.

In response to questions from Mr. Miller, Dr. Carriquiry clarified that
EPA was interested in the distribution representative of one day’s
observations.  Given one observation per worker, the ideal approach
would be to have every worker observed over many days, and then take the
average of these observations to determine the distribution.  She
continued by reiterating that the estimates at the tails of the
distribution will be too long because of additional noise that cannot be
eliminated without replicates; thus, estimates at the 95th percentile of
exposure will be higher than the true exposure.  The overall result of
this will be protective of workers, and estimates at the center of the
distribution will not be biased.  Dr. Popendorf noted that slide 47 of
the Agency’s presentation described this effect.

Mr. Jordan clarified that EPA performs several types of risk assessment
for worker exposure including 1-day risk (exposure in a single day of
work) and short-intermediate term risk (4 to 5 days to 3 to 4 weeks of
exposure).  The value used for exposure components can differ between
these two levels of exposure because over multiple days, an individual
handler will receive more or less exposure, based on his activities.
Without data to characterize within-worker variability, use of a single
day’s exposure data will overstate the multiple day risk and the 95th
percentile of exposures for multiple days will be greater than that of
one day.  The 95th percentile of a single day measured by the task
forces will correspond to the 95th percentile of 1-day exposures.
Without repeated measures, EPA acknowledges that measures of
multiple-day exposure cannot be developed without making some
adjustments.

Dr. Johnson noted that the measure of 1-day exposure should include both
between-worker and within-worker variation.  An advantage of having
repeated measures is that the two components can be estimated and
parameter estimates that depend on the variance of these components can
be made.  Dr. Carriquiry noted that for the distribution sought by EPA,
within-worker variance is noise and between-worker variance is needed.
There are external sources of information to measure within-worker
variance (i.e., PHED data).

Subject Recruitment and Enrollment

Introduction

Mr. Carley presented EPA’s evaluation of subject recruitment and
enrollment issues.  His presentation focused on the AHETF monitoring
program, which is expected to be more complicated than that of the
AEATF.  The AHETF recruiting process begins with recruitment of
cooperating growers or landowners (hereafter known as cooperators).
Potential cooperators are identified; screening and selection begins
after final protocol approval.  Any proposed deviations from the final
protocol must be justified.  After this, cooperators identify a
potential worker pool.  The Study Director (SD) presents the proposed
research to the workers as a group and then seeks informed consent from
individual workers.

Mr. Carley provided detail on the grower recruitment process.  Scenario
designs specify the needed characteristics of a cluster.  Based on this,
the Local Site Coordinator (LSC) suggests potential sites and
cooperators to the SD.  The LSC also identifies needed equipment and may
be involved in the management of samples, although this is under
consideration.  The SD develops the protocol without final
identification of the site(s).  The protocol is then reviewed (i.e., by
IRB, CDPR, EPA, and HSRB), and after revision and final approval of the
protocol by the IRB, the LSC recruits potential cooperating growers.
The SD meets with potential cooperators to determine that the grower
meets the requirements specified in the scenario design (i.e.,
appropriate crop, equipment, skilled workers, and use of surrogate
chemicals), agrees to allow research on his/her property, promises
access to workers for recruitment, and promises not to influence
workers’ decisions.  Based on these criteria, the SD selects the study
cooperator(s) and adds any needed specifications to the protocol.

To recruit workers, the SD meets with workers as a group; the grower
will not attend this meeting.  The SD explains the research to the
workers and provides IRB-approved recruitment materials.  The SD also
may show IRB-approved videos illustrating the study procedures and use
of dosimeters.  After soliciting expressions of interest by individual
workers, the SD meets individually with interested candidates to review
informed consent documents, answer any questions, and solicit consent to
participate.  Because the SDs are primarily English-speaking and many of
the workers are expected to primarily speak Spanish, the assistance of
bilingual workers may be needed.

Preliminary EPA concerns include whether the study risks and benefits
can be fully assessed without knowing where a study will be conducted;
some study sites may employ a Spanish-speaking population of workers, so
it will be difficult to judge if the informed consent process is
adequate.  Also, although EPA has been promised study-specific
recruiting plans, the Agency questions whether such plans can be
developed before cooperators are finally identified.

EPA’s overarching concerns in recruiting, screening, and obtaining
consent include ensuring equitable subject selection, fully informed and
voluntary choice, and respect for subjects.  Equitable subject selection
must ensure representativeness, which hinges on the scenario-level
design and the choice of appropriate clusters and cooperators.  The
Agency considers the lists of appropriate inclusion/exclusion factors
(i.e., over 18 years of age, in good health, not nursing or pregnant,
and of normal intelligence to be appropriate).  The exclusion factors
also include those who habitually wear more than the typical PPE (these
workers would not be representative of the general worker population)
and also LSCs and employees of the SD.  One area in which EPA foresees
difficulties is the exclusion of parties with an interest in the
research.  The Agency may call for more extensive exclusion in this
regard for a particular study because of possible undue interest in the
data or influence on other subjects.

The involvement of vulnerable populations in this research also is a
concern of EPA.  Several vulnerable populations have been defined intask
force governing documents.  Language proficiency and dependent
relationships with the growers/employers are areas of specific concern.
To help mitigate these issues, the recruiting strategy will be defined
for each with input from the community.  Study personnel are encouraged
to develop ties to the community to help develop the recruiting
strategy.

Fully informed choice requires the capacity to make decisions; the SD
will assess this in the informed consent interview.  The recruitment
process has been designed with the assumption that English and Spanish
will be the main languages spoken by workers.  If the worker speaks only
Spanish, a translation of the ICF performed by the Western IRB will be
given to the worker, and an interpreter will be provided if the SD
speaks only English.  Literacy also is expected to be an issue.  If a
worker is illiterate, the ICFs will be read to him and a witness will be
required.  An interpreter will be needed if the worker speaks only
Spanish and the SD only English; a witness also will be needed if the
worker also is illiterate in Spanish.  The interpreter in this situation
could be an employee of the grower or a person chosen by the subject.
The SD must be certain that the interpreter can provide an adequate
description of the research and ICF.  The interpreter is not considered
to be part of the research team and will not sign the ICF.  The
witnesses must be fluent in the language in which the informed consent
discussion takes place.

EPA has concerns that the processes for English-speaking and
Spanish-speaking workers are not equivalent.  Depending on the
language(s) spoken by the SD and the worker, two or three parties may be
involved in the informed consent process.  The presence of an
interpreter may inhibit workers from asking questions.  In addition, the
interpreter may not understand the research well enough to translate
accurately, and it would be difficult for a non-Spanish speaking SD to
determine this.  The SD also will be unable to confirm worker
understanding.  The ability of study observers to communicate with
workers also will be impaired by language differences.

The complexity of the consent materials also presents a challenge.  The
AEATF wipe protocol informed consent was provided to Board members as an
example containing all required elements in an accessible form and
language.  A description of the development of these materials is
provided in the governing documents because preparation of appropriate
consent materials is an essential element of the study-specific
recruiting plan and different processes have been proposed for different
languages.  The wipe protocol also provides an example of how risks and
benefits will be communicated.  Confirming the subject’s full and
complete understanding of the protocol and risks and benefits is the
responsibility of the SD, which will be difficult if the worker speaks
only Spanish.

Fully voluntary choice also will require management of dependent
relationships; the nature of the relationships between workers and
growers will be site specific.  Cooperators must promise not to
influence workers and employees of interested entities will be excluded.
 To minimize peer pressure, no specific discussion of informed consent
will occur until a worker expresses interest.  Informed consent
discussions will be held in private, and pregnancy tests and discussions
of results also will be held privately.  Real alternatives to
cooperation will be provided by growers and explained by informed
consent documents.

An AHETF Employer Promise has been developed.  This promise calls for
the employer to allow AHETF to recruit any employees with applicable
training and experience in the tasks involved in the study, as
determined by the SD.  The employer acknowledges possible benefits, but
promises to neither encourage or discourage employees to participate in
the study, and promises that an employee’s decision to participate,
not to participate, or to withdraw from participation in the study will
have no impact on his/her employment status or pay.  Employees who
decide not to participate, who withdraw from participation, or who
complete participation in less than a typical work shift will be offered
alternative work at their usual pay to complete their usual work shift
and employees will receive their normal pay for days they participate in
the study.  Mr. Carley acknowledged that this promise had been
thoughtfully developed and covered most of his concerns.  He expressed
some concern that field investigators may need to be more involved in
recruitment and consent processes to alleviate some of the
responsibilities of the SD.

Mr. Carley described the AEATF consent process, which contains two
“fundamentally different” paradigms compared to the AHETF.  The
studies performed under the AEATF will be conducted either at an active
worksite, which will require supervisor agreement similar to that
described for the AHETF and will require interested workers to meet with
the SD at the workplace, or will recruit subjects to work at a site not
under their supervisor’s control.  In this case, flyers will be posted
at workplaces and interested workers will be instructed to contact the
Field Coordinator by telephone.  An IRB-approved script will be used to
explain the study and confirm workers’ interest; interested workers
will then meet with the SD at the SD’s office.

As part of respect for subjects, incentive payments ($20 for
participating in an informed consent interview and $80 for beginning
exposure monitoring) have been proposed.  These fees are subject to
refinement based on community input.  To ensure privacy and
confidentiality, no records of candidates who do not qualify or consent
to participate will be kept, data will be collected by subject code,
linkage of names and addresses to subject codes will be securely
maintained, and subjects will not be identified in reports or in
databases.  Given the potential benefit of providing feedback on work
habits and exposure to subjects, if a subject is interested in his or
her own data, they should be provided with the data.  The task forces
have been encouraged to incorporate a description of this process in the
SOP governing privacy of subject identity.

The Board was asked to consider whether the governing documents and
associated SOPs of the AHETF and AEATF research programs included
comprehensive and appropriate protections for human subjects of the
research and, if not, to describe overlooked issues.  The handling of
language differences was specified as an area requiring further
refinement and the Board was asked to determine whether EPA has
overlooked any other areas in need of revision.

Public Comments

	Dr. Brimijoin invited oral public comment on subject recruitment and
enrollment issues.  No oral public comments were received.

Board Discussion

Dr. Menikoff opened the discussion and complimented AHETF and EPA for
their thorough review of the recruiting process and incorporating Board
suggestions from previous meetings into the process.  He agreed with Mr.
Carley that only relatively minor refinements are needed.  Given the
vulnerability of the subjects, the involvement of worker representatives
could be emphasized more strongly.  Including subject advocates and
representatives will strengthen protection for workers and the governing
documents should include a discussion of this issue.  Dr. Menikoff
advised the task forces to consider the readability of consent
materials, because many potential subjects may have low literacy.

Dr. Chadwick noted that the AEATF documents describing the review
process had a table of contents that listed specific chapters describing
sampling, subject recruitment, and IRB review, but the pages in the
document read, “left intentionally blank.”  He found details on
these issues in Chapter 2 and thus advised AEATF to change “left
intentionally blank” to “described in Chapter 2.”  He also
complimented the task forces on their efforts and inclusion of
recommendations from HSRB and other agencies.

Dr. Chadwick specifically mentioned the age limit placed on pregnancy
testing (50 years) in the AEATF documents and recommended that an
exclusion based on menopause would be more appropriate than an age-based
exclusion.  AEATF also could consider testing all women, which is the
plan of the AHETF.  Dr. Chadwick also asked that the documents describe
more completely how documents, such as those related to pregnancy
testing, would be destroyed (i.e., shredded) to protect privacy.

Dr. Chadwick requested clarification on language issues.  For example,
AEATF states that if more than 15 percent of the sample is non-English
speaking, translated documents will be provided.  AHETF offers to
provide all documents in English and Spanish; this is the better
approach.  Other Agency guidelines require that ICFs be presented in the
potential subjects’ native language.  Regarding witnesses and
interpreters, Dr. Chadwick recommended that witnesses not serve as
interpreters and cautioned the task forces to be aware of the
qualifications of the interpreters.  He agreed that including more
bilingual study investigators would be valuable.

Dr. Sharp complimented the task forces on the documents.  He noted that
when specific studies are reviewed, a recurrent theme will be protecting
workers from undue influence by growers.  Although this is mentioned,
the task forces should have a management plan in place for each study
that will ensure workers’ right to decline to participate in the
study.  For example, if a grower has 50 workers who are all eligible to
participate, perhaps only 25 of the 50 would be selected to participate,
without revealing to the grower which workers wished to participate but
were not selected and which workers declined to participate.

Concerning the translation processes, Dr. Sharp noted that the task
forces proposed that materials be translated by the IRB, but speculated
that more materials will likely need to be translated than an IRB may be
willing to translate.  Dr. Chadwick informed Dr. Sharp that Western IRB
specifically provides a translation service.  Dr. Sharp continued with
his discussion of language issues and commended the task forces on their
thorough discussion of these issues.  He stated that ensuring that all
volunteers have access to all documents (ICFs, pamphlets, etc.) in both
English and Spanish is important.  He agreed with Mr. Carley on the need
to employ bilingual study staff.  Volunteers may have questions both
before and after undergoing the informed consent process and there will
be a continuing need for bilingual staff during the course of the study.
 Dr. Sharp expressed concern about the phrase “translators of
convenience,” which could mean co-workers or family members.  Using
such translators is discouraged in clinical research because these
people are unlikely to be familiar enough with the research to properly
inform the subject.  Dr. Sharp was supportive of the task forces’ plan
to include an impartial third-party witness for subjects who are unable
to read.  A clarification of the procedures used to recruit such
witnesses is needed; Dr. Sharp noted that it would be inappropriate for
the translators to also serve as witnesses.  Another option is to hire
dedicated consent monitors or research subject advocates who are
specifically trained to determine whether consent is fully voluntary.
Dr. Sharp also recalled Dr. Fenske’s comment concerning the likelihood
of encountering workers who speak languages other than Spanish or
English and suggested that EPA consider if it would be appropriate to
restrict eligibility to only English and/or Spanish speakers, unless
this would introduce bias.

Dr. Fitzpatrick agreed that the potential for bias needs to be addressed
if EPA considers restricting the studies to only English and/or Spanish
speakers.  She supported EPA’s proposal to employ Spanish-speaking
investigators to assist with consent processes.  She inquired how the
task forces would perform QA on consent processes that include
interpreters, since the interpreters do not sign the ICF, thus there
would be no evidence of use of an interpreter.  She suggested that EPA
ask for a certified translation (translation forward and back to the
original language of the document) to ensure accuracy.

Dr. Fitzpatrick addressed the medical compensation, noting that the task
forces agreed to compensate for reasonable medical costs if subjects do
not have insurance.  She stated that “reasonable medical costs” need
to be defined more specifically, for example, do these include initial
treatment, long-term care, or missed days of work.  She also noted that
subjects self-report their levels of health—most people tend to report
themselves as healthy—and asked how the task forces would handle
injury that occurred because of an unreported health condition.
Dr. Fitzpatrick acknowledged the task forces’ plans for adverse event
reporting and inquired how decisions to modify ICFs would be made if new
risks are identified as a result of adverse event reporting.  She added
that ICFs also should inform subjects that if new information related to
risk arises as a result of the study; subjects will be given this
information so they can re-evaluate their consent to participate.  She
commented that if the task forces plan to permit subjects access to
their own data, the task forces also must provide assistance with
interpretation of the data.  Dr. Fitzpatrick concluded by noting that
subjects will be asked to show a driver’s license or workers card to
prove immigration status and asked if the task forces have plans in
place to protect the privacy of illegal workers.  She also asked, while
acknowledging that EPA has no control over this request, why California
requested review of the studies by the Florida IRB.

Mr. Carley clarified for Dr. Fitzpatrick that because these are largely
one-day studies, the issue of withdrawing consent because of adverse
events is minor.  Dr. Fitzpatrick requested task force response to this
matter if an adverse event potentially affecting participation occurred
at another site.  Mr. Carley considered this to be unlikely.

Dr. Popendorf noted that the records of subjects who decline to
participate are destroyed, but said that this data may be useful for
populating a distribution of conditions if a random sampling approach is
used.  He expressed concern that if EPA continues with its proposed PDS
approach, future users of the database may not be aware of this and may
assume a random sampling approach was used; to prevent this, the
database should contain a statement indicating that PDS was used.  Dr.
Carriquiry remarked that she believed EPA will adopt a randomized
sampling strategy, which also will help protect workers from coercion.
A list of possible workers would be provided to investigators, but the
grower will not know which workers were selected or which declined to
participate.

Dr. Brimijoin summarized that the Board was impressed with the
consideration of the recruitment process and complimented the level of
detail and careful thinking.  He stated that it is likely these studies
will achieve a high standard of scientific and ethical performance.
Board members described some areas for improvement, including involving
worker representatives early in the recruitment process and describing
this in the governing documents; reconsideration of privacy protection
and exclusion factors for pregnancy tests; ways to manage and reduce
potential grower influence on subject participation; attention to
language issues and Board endorsement of the plan to involve bilingual
investigators with appropriate knowledge and expertise; technical points
concerning relying on translators of convenience; identification of
appropriate witnesses; clarification of covered medical costs in case of
adverse events; issues of confidentiality for illegal workers; and plans
for ICFs to alert subjects to newly discovered risks.

	Dr. Lewis thanked Dr. Brimijoin for serving as chair of this meeting.
He also thanked the Board members for their efforts and his EPA
colleagues for their preparation and the presentations given at this
meeting.  He stated that a Federal Register notice will be published to
inform the public about the availability of the Board’s report for
this meeting.  Dr. Lewis also stated that review of the April 2007
report would be conducted by teleconference and that a Federal Register
notice would be published to inform the public of this event.

Dr. Brimijoin adjourned the meeting.

Respectfully submitted:

Paul I. Lewis, Ph.D.

Designated Federal Officer

Human Studies Review Board

United States Environmental Protection Agency

Certified to be true by:

William S. Brimijoin, Ph.D.

Vice Chair

Human Studies Review Board

United States Environmental Protection Agency

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

Attachments

Attachment A 		List of HSRB Members

Attachment B 		Federal Register Notice Announcing Meeting

Attachment C 		Meeting Agenda

Attachment A

EPA HUMAN STUDIES REVIEW BOARD MEMBERS

Chair

Celia B. Fisher, Ph.D. *

Marie Ward Doty Professor of Psychology

Director, Center for Ethics Education

Fordham University

Bronx, NY

Vice Chair

William S. Brimijoin, Ph.D. **

Chair and Professor

Molecular Pharmacology and Experimental Therapeutics

Mayo Foundation

Rochester, MN

Members

Alicia Carriquiry, Ph.D.

Professor

Department of Statistics

Iowa State University

Ames, IA

Gary L. Chadwick, PharmD, MPH, CIP

Associate Provost

Director, Office for Human Subjects Protection

University of Rochester

Rochester, NY

Janice Chambers, Ph.D., D.A.B.T.

William L. Giles Distinguished Professor

Director, Center for Environmental Health Sciences

College of Veterinary Medicine

Mississippi State University

Mississippi State, MS

Richard Fenske, Ph.D., MPH

Professor

Department of Environmental and Occupational Health Sciences

University of Washington

Seattle, WA

Susan S. Fish, PharmD, MPH

Professor, Biostatistics & Epidemiology

Boston University School of Public Health

Co-Director, MA in Clinical Investigation

Boston University School of Medicine

Boston, MA

Suzanne C. Fitzpatrick, Ph.D., DABT

Senior Science Policy Analyst

Office of the Commissioner

Office of Science and Health Coordination

U.S. Food and Drug Administration

Rockville, MD

KyungMann Kim, Ph.D., CCRP

Professor and Associate Chair

Department of Biostatistics & Medical Informatics

School of Medicine and Public Health

University of Wisconsin-Madison

Madison, WI

Kannan Krishnan, Ph.D. *

Professor

Département de santé environnementale et santé au travail

Faculté de médicine

Université de Montréal

Montréal, QC  Canada

Michael D. Lebowitz, Ph.D.

Research Professor of Medicine & Epidemiology/Public Health

University of Arizona

Tucson, AZ

Lois D. Lehman-Mckeeman, Ph.D.

Distinguished Research Fellow, Discovery Toxicology

Bristol-Myers Squibb Company

Princeton, NJ

Jerry A. Menikoff, M.D.

National Institute of Health

Office of Human Subjects Research

Bethesda, MD

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

Policy and Ethics Director

Global Campaign for Microbicides

Program for Appropriate Technology in Health

Washington, DC

Richard Sharp, Ph.D.

Assistant Professor of Medicine

Center for Medical Ethics and Health Policy

Baylor College of Medicine

Houston, TX

* Not in attendance

**Served as Chair at meeting

Attachment B

Federal Register Notice Announcing Meeting

Human Studies Review Board; Notice of Public Meeting

[Federal Register: June 6, 2007 (Volume 72, Number 108)]

[Notices]

[Page 31323-31325]

[DOCID:E7-10859]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2007-0403; FRL-8322-7]

Human Studies Review Board; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The U.S. Environmental Protection Agency's (EPA or Agency)
Office of the Science Advisor (OSA) announces a public meeting of the
Human Studies Review Board (HSRB) to advise the Agency on EPA's
scientific and ethical reviews of human subjects' research.

DATES: The public meeting will be held from June 27-June 29, 2007
approximately from 8:30 a.m. to approximately 5:30 p.m., Eastern Time.

    Location: Environmental Protection Agency, Conference Center—Lobby
Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Drive, Arlington,
VA  22202.

    Meeting Access: Seating at the meeting will be on a first-come
basis. To request accommodation of a disability please contact the
person listed under FOR FURTHER INFORMATION CONTACT at least 10 business
days prior to the meeting, to allow EPA as much time as possible to
process your request.

    Procedures for Providing Public Input: Interested members of the
public may submit relevant written or oral comments for the HSRB to
consider during the advisory process. Additional information concerning
submission of relevant written or oral comments is provided in Unit I.D.
of this notice.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes
further information should contact Paul Lewis, EPA, Office of the
Science Advisor, (8105R), Environmental Protection Agency, 1200
Pennsylvania Ave., NW, Washington, DC 20460; telephone number: (202)
564-8381; fax:<PHONE_NUMBER>; e-mail address:   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>. General information
concerning the EPA HSRB can be found on the EPA Web site at   HYPERLINK
"http://www.epa.gov/osa/hsrb/"  http://www.epa.gov/osa/hsrb/ .

ADDRESSES: Submit your written comments, identified by Docket ID No.

EPA-HQ-ORD-2007-0403, by one of the following methods:

    Internet:   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov : Follow the on-line instructions for
submitting comments.

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

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

    Hand Delivery: The EPA/DC Public Reading Room is located in the EPA
Headquarters Library, Room Number 3334 in the EPA West Building, located
at 1301 Constitution Ave., NW, Washington DC. The hours of operation are
8:30 a.m. to 4:30 p.m. Eastern Standard Time (EST), Monday through
Friday, excluding Federal holidays. Please call<PHONE_NUMBER> or e-mail
the ORD Docket at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>for instructions. Updates to Public Reading Room
access are available on the Web site (  HYPERLINK
"http://www.epa.gov/epahome/dockets.htm"
http://www.epa.gov/epahome/dockets.htm ).

    Instructions: Direct your comments to Docket ID No.
EPA-HQ-ORD-2007-0403. EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov , including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  or e-mail. The
  HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov
Web site is an “anonymous access” system, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA,
without going through   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov , your e-mail address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the Internet. If you submit an
electronic comment, EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or
CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.

SUPPLEMENTARY INFORMATION:

I. Public Meeting

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may,
however, be of interest to persons who conduct or assess human studies,
especially studies on substances regulated by EPA or to persons who are
or may be required to conduct testing of chemical substances under the
Federal Food, Drug, and Cosmetic Act (FFDCA) or the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). Since other entities may also be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of This Document and Other Related
Information?

    In addition to using regulations.gov, you may access this Federal
Register document electronically through the EPA Internet under the

“Federal Register” listings at   HYPERLINK
"http://www.epa.gov/fedrgstr/"  http://www.epa.gov/fedrgstr/ .

    Docket: All documents in the docket are listed in the

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

    EPA's position paper(s), charge/questions to the HSRB, and the
meeting agenda will be available by early June 2007. In addition, the
Agency may provide additional background documents as the materials
become available. You may obtain electronic copies of these documents,
and certain other related documents that might be available
electronically, from the regulations.gov Web site and the HSRB Internet
Home Page at   HYPERLINK "http://www.epa.gov/osa/hsrb/"
http://www.epa.gov/osa/hsrb/ . For questions on document availability or
if you do not have access to the Internet, consult the person listed
under FOR FURTHER INFORMATION CONTACT.

C. What Should I Consider as I Prepare My Comments for EPA?

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

    a. Explain your views as clearly as possible.

    b. Describe any assumptions that you used.

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

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

    e. To ensure proper receipt by EPA, be sure to identify the docket

ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal

Register citation.

D. How May I Participate in this Meeting?

    You may participate in this meeting by following the instructions in
this section. To ensure proper receipt by EPA, it is imperative that you
identify docket ID number EPA-HQ-ORD-2007-0403 in the subject line on
the first page of your request.

    a. Oral comments. Requests to present oral comments will be accepted
up to June 20, 2007. To the extent that time permits, interested persons
who have not pre-registered may be permitted by the Chair of the HSRB to
present oral comments at the meeting. Each individual or group wishing
to make brief oral comments to the HSRB is strongly advised to submit
their request (preferably via email) to the person listed under FOR
FURTHER INFORMATION CONTACT no later than noon, Eastern Time, June 20,
2007 in order to be included on the meeting agenda and to provide
sufficient time for the HSRB Chair and HSRB Designated Federal Officer
(DFO) to review the agenda to provide an appropriate public comment
period. The request should identify the name of the individual making
the presentation, the organization (if any) the individual will
represent, and any requirements for audiovisual equipment (e.g.,
overhead projector, LCD projector, chalkboard). Oral comments before the
HSRB are limited to five minutes per individual or organization. Please
note that this limit applies to the cumulative time used by all
individuals appearing either as part of, or on behalf of an
organization. While it is our intent to hear a full range of oral
comments on the science and ethics issues under discussion, it is not
our intent to permit organizations to expand these time limitations by
having numerous individuals sign up separately to speak on their behalf.
If additional time is available, there may be flexibility in time for
public comments. Each speaker should bring 25 copies of his or her
comments and presentation slides for distribution to the HSRB at the
meeting.

    b. Written comments. Although you may submit written comments at any
time, for the HSRB to have the best opportunity to review and consider
your comments as it deliberates on its report, you should submit your
comments at least five business days prior to the beginning of the
meeting. If you submit comments after this date, those comments will be
provided to the Board members, but you should recognize that the Board
members may not have adequate time to consider those comments prior to
making a decision. Thus, if you plan to submit written comments, the
Agency strongly encourages you to submit such comments no later than
noon, Eastern Time, June 20, 2007. You should submit your comments using
the instructions in Unit I.C. of this notice. In addition, the Agency
also requests that person(s) submitting comments directly to the docket
also provide a copy of their comments to the person listed under FOR
FURTHER INFORMATION CONTACT. There is no limit on the length of written
comments for consideration by the HSRB.

E. Background

    A. Topics for Discussion. The HSRB is a Federal advisory committee
operating in accordance with the Federal Advisory Committee Act (FACA) 5
U.S.C. App.2 section 9. The HSRB provides advice, information, and
recommendations to EPA on issues related to scientific and ethical
aspects of human subjects research. The major objectives of the HSRB are
to provide advice and recommendations on: (a) Research proposals and
protocols; (b) reports of completed research with human subjects; and
(c) how to strengthen EPA’s programs for protection of human subjects
of research. The HSRB reports to the EPA Administrator through EPA’s
Science Advisor.

    The June 27-29, 2007 meeting of the Human Studies Review Board will
address scientific and ethical issues surrounding:

    • A research proposal from Carroll-Loye Biological Research to
evaluate the efficacy of two conditionally registered products
containing picaridin in repelling mosquitoes in the field.

    • A research proposal from Insect Control & Research, Inc. to
evaluate the efficacy of two unregistered products containing picaridin
in repelling mosquitoes in the field.

    • A completed study measuring the effects on human subjects of
acute inhalation exposure to acrolein. Acrolein is an active ingredient
used in biocides in agricultural and industrial water supply systems and
is currently undergoing reregistration.

    • Three completed clinical studies of the efficacy and side
effects of 4-aminopyridine when used as a therapeutic agent to treat
neurological

Symptoms in patients with either spinal cord injury or multiple
sclerosis, 4-aminopyridine is an active ingredient used in bird
repellents that is currently undergoing reregistration.

   • Extensive background materials concerning research to quantify
the level of exposure received by people who mix, load, and apply
pesticides. These materials, which were prepared by the Agricultural
Handlers Exposure Task Force and by the Antimicrobial Exposure
Assessment Task Force, generally explain the scope of the research
programs being proposed by the Task Forces and describe the general
scientific framework for conducting the research. In addition, each Task
Force has provided Standard Operating Procedures which will guide the
conduct of the studies.

    The Board may also be reviewing draft HSRB reports for subsequent
Board approval. Finally, the Board may also discuss planning for future
HSRB meetings.

    b. Meeting Minutes and Reports. Minutes of the meeting, summarizing
the matters discussed and recommendations, if any, made by the advisory
committee regarding such matters will be released within 90 calendar
days of the meeting. Such minutes will be available at   HYPERLINK
"http://www.epa.gov/osa/hsrb/"  http://www.epa.gov/osa/hsrb/  and
HYPERLINK "

http://www.regulations.gov"

http://www.regulations.gov . In addition, information concerning a Board
meeting report, if applicable, can be found at   HYPERLINK
"http://www.epa.gov/osa/hsrb/"  http://www.epa.gov/osa/hsrb/  or from
the person listed under FOR FURTHER INFORMATION CONTACT.

Dated: May 31, 2007.

Kevin Teichman,

Acting EPA Science Advisor

[FR Doc. E7-10859 Filed 6-6-07; 8:45 am]

BILLING CODE 6560-50-P

Attachment C

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD (HSRB)

PUBLIC MEETING

June 27-29, 2007*

ONE POTOMAC YARD

ARLINGTON, VA

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

Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA-HQ-ORD-2007-0403

BOARD REVIEW OF ITS DRAFT APRIL 18-20, 2007 HSRB MEETING REPORT,
ORIGINALLY SCHEDULED AT THE BEGINNING OF THIS MEETING, MAY BE
RESCHEDULED EITHER LATER DURING THE MEETING OR AT A SUBSEQUENT
TELECONFERENCE.  IN ADDITION, TODAY’S MEETING MAY START EARLIER THAN
LISTED ON THE AGENDA*

Wednesday, June 27, 2007

11:30 a.m.	Convene Meeting and Identification of Board Members

			William Brimijoin, Ph.D. (HSRB Vice Chair)

11:40 a.m.	Welcome

			George Gray, Ph.D. (EPA Science Advisor)

11:50 a.m.	Opening Remarks

			Debbie Edwards, Ph.D. (Director, Office of Pesticide Programs, [OPP])

12:00 p.m.	Meeting Administrative Procedures

		Paul Lewis, Ph.D. (Designated Federal Officer [DFO], HSRB, OSA, EPA)

12:05 p.m.	EPA Follow-up on HSRB Recommendations

		Mr. William Jordan (OPP, EPA)

Carroll-Loye Picaridin Mosquito Repellency Protocol LNX-001

12:15 p.m.	Science and Ethics of Carroll-Loye Protocol

		Mr. Kevin Sweeney (OPP, EPA) and Mr. John Carley (OPP, EPA)

1:00 p.m.	Lunch

2:00 p.m.	Public Comments

2:30 p.m.	Board Discussion

a. 	If the proposed research described in Protocol LNX-001 from
Carroll-Loye Biological Research is revised as suggested in EPA’s
review, does the research appear likely to generate scientifically
reliable data, useful for assessing the efficacy of the test substances
for repelling mosquitoes?

b. 	If the proposed research described in Protocol LNX-001 from
Carroll-Loye Biological Research is revised as suggested in EPA’s
review, does the research appear to meet the applicable requirements of
40 CFR part 26, subparts K and L?

ICR Picaridin Mosquito Repellency Protocol

3:30 p.m.	Science and Ethics of ICR Protocol

		Mr. Kevin Sweeney (OPP, EPA) and Mr. John Carley (OPP, EPA)

4:15 p.m.	Public Comments

4:45 p.m.	Break

5:15 p.m.	Board Discussion

a. 	If the proposed research described in ICR’s proposed picaridin
protocol is revised as suggested in EPA’s review, does the research
appear likely to generate scientifically reliable data, useful for
assessing the efficacy of the test substances for repelling mosquitoes?

b. 	If the proposed research described in ICR’s proposed picaridin
protocol is revised as suggested in EPA’s review, does the research
appear to meet the applicable requirements of 40 CFR part 26, subparts K
and L?

6:15 p.m.	Adjournment

Thursday, June 28, 2007

8:30 a.m.	Convene Meeting

		Steven Brimijoin, Ph.D. (HSRB ViceChair)

8:40 a.m.	Follow-up From Previous Day’s Discussion

			Mr. William Jordan (OPP, EPA)

Acrolein

8:50 a.m.	Acrolein

Abdallah Khasawinah, Ph.D. (OPP, EPA) and Mr. John Carley (OPP,

EPA)

9:45 a.m.	Public Comments

10:15 a.m.	Break

10:30 a.m.	Board Discussion

a.  	The Agency has concluded that this study contains information
sufficient for assessing human risk resulting from potential acute
inhalation exposure.  Please comment on whether the study is
sufficiently sound, from a scientific perspective, to be used to
estimate a safe level of acute inhalation exposure to acrolein.

b. 	Please comment on the following:

(1) Is there clear and convincing evidence that the conduct of the study
was fundamentally unethical?

(2) Is there clear and convincing evidence that the conduct of the study
was significantly deficient relative to the ethical standards prevailing
at the time the research was conducted?

4-Amino Pyridine

11:30 a.m.	4-Amino Pyridine

Abdallah Khasawinah, Ph.D. (OPP, EPA) and Mr. John Carley (OPP,

EPA)

12:15 p.m.	Public Comments

12:30 p.m.	Lunch

1:30 p.m.	Board Discussion

a.	The Agency’s weight-of-evidence (WOE) document for 4-aminopyridine
describes the study design and results of three clinical trials
(Grijalva et al. 2003, Segal et al. 1999, and Van Diemen et al. 1993).
The WOE document also discusses the Agency’s conclusion that these
studies provide sufficient information to establish a point of departure
for the assessment of the risk to humans resulting from all potential
durations of exposure to 4-AP.  Please comment on whether the studies
are sufficiently sound, from a scientific perspective, to be used to
derive a point of departure for estimating risk to humans from exposure
to 4-AP.

b.	Please comment on the following:

	(1) Is there clear and convincing evidence that the conduct of any of
the clinical studies was fundamentally unethical?

	(2) Is there clear and convincing evidence that the conduct of any of
the clinical studies was significantly deficient relative to the ethical
standards prevailing at the time the research was conducted?

2:30 p.m.	Break

AEATF and AHETF Research Programs

2:45 p.m.	Introduction – EPA Presentation

William Jordan (EPA, OPP)

2:50 p.m.	Overview / Risks and Benefits of Handler Research – EPA
Presentation

Mr. John Carley (OPP, EPA)

3:30 p.m.	Public Comments

3:45 p.m.	Board Discussion

Risks and Benefits of Handler Research

1. Will the Task Forces’ Governing Documents considered in conjunction
with the additional study- and scenario-specific information specified
above provide an adequate basis for assessing whether the risks of
conducting a particular study are justified by the expected benefits of
the proposed research?  If not, what additional information should be
provided for an IRB, EPA, and the HSRB?

5:00 p.m.	Addressing Potential Sources of Underestimation Bias/QA and QC
Controls 			– EPA Presentation

		Mr. Jeff Dawson (OPP, EPA)

5:30 p.m.	Public Comments

5:45 p.m.	Adjournment

Friday, June 29, 2007

8:30 a.m.	Convene Meeting

		Steven Brimijoin, Ph.D. (HSRB Vice Chair)

8:40 a.m.	Follow-up From Previous Day’s Discussion

		Mr. William Jordan (OPP, EPA)

AEATF and AHETF Research Programs: Addressing Potential Sources of
Underestimation Bias; QA and QC Controls (continued)

8:50 a.m.	Board Discussion

Addressing Potential Sources of Underestimation Bias

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?

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?

QA/QC Controls

1. 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?

10:00 a.m.	Break

10:15 a.m.	Design of Scenario-Level Sampling; Statistical Justification
of Number of 			Clusters; and Monitoring Units and Within Worker
Variability – EPA 			Presentation

Mr. David Miller (OPP, EPA)

11:00 a.m.	Public Comments

11:15 a.m.	Board Discussion

Design of Scenario-Level Sampling

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?

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?

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?

Statistical Justification of Number of Clusters

1. 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?

Within-Worker Variability

1. 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?

12:15 p.m.	Lunch

1:15 p.m.	Subject Recruitment and Enrollment Issues – EPA Presentation

Mr. John Carley (OPP, EPA)

1:45 p.m.	Public Comments

2:00 p.m.	Board Discussion

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?

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?

3:00 p.m.	Adjournment

	Steven Brimijoin, Ph.D. (HSRB Vice Chair) and Paul Lewis, Ph.D. (DFO,
HSRB, OSA, EPA)

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 PAGE

  PAGE  2  of   NUMPAGES  101


EPA also reviewed the issue of updating burden estimates to reflect anticipated regulatory conditions for the upcoming ICR renewal period. Historically, EPA has taken a "placeholder" approach in which a set of generic assumptions are used for calculations, with the understanding that actual conditions can appreciably differ. Periodically -- typically during ICR Renewals -- updates to counts for number of actions and number of chemicals tested per action (or simply "number of chemicals tested within a type of action") are applied to estimates to reflect the intensity of the regulatory conditions. For purposes of this methodology discussion, these updates are referred to as "load projections," which differ from methodology changes to standardized estimates and generic assumptions. In this stage of the methodology evolution, EPA makes changes to methodology to address the two of overlap estimation and load projections. EPA implements a new standardized estimate for overlap, the overlap model. The model constitutes a new standardized estimate designed to capture the activity patterns shown in Figure 1, as applicable to the requirements of TSCA section 4 actions. EPA is also revising the definition for load projection updates to the number of chemicals undergoing testing in new actions initiated annually. Further details are provided below. As an overview of methodology components, the standardized estimates and generic assumptions of ICR estimates (defined to meet Objective 1 -- reflect the nature of the information collection) must be highly inclusive of the considerations in Figure 1, including the complexity of multiple activities of varying frequencies associated with activities per single chemical tested, as well as the complexity of multiple actions (of the same type) in effect asynchronously. To better address Objective 2 -- provide ease in future updates, the dynamics of carry-over and overlap on total burden are separated from load projection for the ICR period and handled in a standardized overlap model. The new definition for load projection as number of new rules initiated per year with an average of number of chemicals undergoing testing or more simply, chemicals newly tested in TSCA section 4 actions. This change in methodology replaces the complex load projection that requires EPA program staff to consider both factors (load projection and overlap) lumped together. The next section provides a comprehensive summary of methodology features by objective. Objective 1 -- reflect the nature of the information collection -- is met by extending work from previous ICR renewals to improve upon the standardized estimate. The key estimate is a standardized unit burden that is generic for test rules, test orders, and ECAs. The unit burden contains activities bundled according to a chemical undergoing testing in a TSCA section 4 action. The unit of analysis for this unit burden chemical tested is a TSCA section 4 action pertaining to the overall submission from a sponsor for the rule, order, or ECA. Prior to this ICR revision (EPA, 2016, 2018a), key features include: Define response unit as "per chemical tested within an action (e.g., test rules, test orders, ECAs)." Bundling activities to a basis of "per chemical" combines activities of irregular occurrence and differing frequencies to a single metric. This feature shifts the analytical focus away from individual activities and considers a sponsor's overall submission as a bundle of activities, providing a roll-up for the submission. The bundled approach has several advantages. In bundling activities, the irregular frequencies are appropriately weighted across the whole submission. Analysts do not have to repeatedly revisit calculations activity-by-activity. The method minimizes sources of error and document production costs. Additionally, the resultant unit burden estimates are useful for communication purposes, as shown, for example in Table 2's total burden estimate.  Apply the standardized unit burdens per submission for use in multiple types of actions (rules, orders, ECAs). Simplify with the standardized unit burden with generic assumptions:  One sponsor per chemical, and Battery of seven tests per chemical with an associated cost at $58,177 (see details in Appendix A) As a new enhancement in this ICR revision, EPA employs a model for overlap to account for carry-over burden from previous ICR periods plus the additive effect of concurrent actions' burden effects on the total burden (see illustration in ). EPA is using a standardized estimate for overlap derived based on three years' duration per action with each new action staggered by one year, which leads to an overlap factor of 2.8 (see details in Appendix B). When the factor is applied, for example, the number of chemicals tested in a TSCA section 4 action is multiplied by 2.8 to account for the effect of staggered intermittent burden as portrayed in Figure 2. Use of this new model adds to the list of key features above: Account for carry-over and overlap effects separately from new action initiations/load projections. Objective 2 -- provide ease in future updates -- is related to the new model for overlap described above. Historically, load projections for the ICR required the program staff to consider overlap dynamics as part of the specification set for "number of actions (i.e., rules) per year" and "number of chemicals per action." The input is rather subjective, requiring a knowledge of specific rules in progress at the same time as considering potential future rules and probability of implementation. In this ICR revision, the input metric is simplified, for example, to "number of rules initiated each year" and "average number of chemicals per (new) rule" without need to consider carry-over and overlap which is handled via a standard overlap model.  Objective 3 -- enable minimal changes during the ICR period -- is accomplished by making the estimate comprehensive and sufficiently inclusive of all known considerations for the three-year ICR renewal period. The continued implementation of key principles employed in previous ICR renewals, plus accounting for overlap specifically (as described for Objective 1), the use of concise metrics for updating load projections work in concert to assure that Objective 3 is met.    The revised methodology of this ICR revision reflects a continued shift to standardized estimates and generic assumptions in recognition that the estimates are being used to provide a placeholder function in the OMB burden inventory pending possible further revision based on data from TSCA section 4 actions. In future ICR renewals, when loads projections are updated, the standardized estimates and generic assumptions can be revised (i.e., calibrated) to better reflect the actual conditions and EPA experience (e.g. number of tests per chemical undergoing testing, test durations, and test costs). In this plan for continued methodology revisions with updates to standardized estimates and generic assumptions, EPA provides accurate burden estimates, but avoids conveying a false sense of precision in ICR estimates themselves. Beyond methodology enhancements, this ICR revision contains analyses for purposes specific to changes anticipated in the upcoming ICR period:    Analysis of the conditions used for the Fees for the Administration of the Toxic Substances Control Act rule (2018) and translation to load projections for this ICR (provided in Appendix C)    Incorporation of new activities related to the Lautenberg Act requirements       Respondent substantiation of confidentiality claims       Agency reviews of confidentiality claims For reference, the respondent burden estimates are organized in this section according to the following types of information collection activities:    CDX Registration for e-Reporting    Initial Response, Test Rules    Study Plan, Test Rules    Test Results, Test Rules    Initial Response, Test Orders    Study Plan, Test Orders    Test Results, Test Orders    Voluntary Initial Contact, ECAs    Study Plan, ECAs    Test Results, ECAs    Voluntary Robust Summaries for Test Rules, Test Orders    Voluntary Data Submissions    Testing Costs (Non-Labor Costs) Appendix F: Specific Data Items Requested EPA may require any type of health or environmental effects testing necessary to address unanswered questions about the effects of the chemical. Regarding testing pursuant to TSCA section 4(a)(1), EPA need not limit the scope of testing required to the factual basis for the TSCA section 4(a)(1)(A)(i) or 4(a)(1)(A)(ii) findings, as long as EPA finds that there is insufficient information and experience upon which the effects of the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any combination of such activities on health or the environment can reasonably be determined or predicted, and that testing is necessary to develop the information. This approach is explained in more detail in EPA's statement of policy for making findings under TSCA section 4(a)(1)(B) in the Federal Register of May 14, 1993 (58 FR 28736, 28738-39; FRL-4059-9). Note that the TSCA sections that were previously enumerated as 4(a)(1)(A) and (B) are now enumerated as 4(a)(1)(A)(i) and 4(a)(1)(A)(ii), respectively. In addition to submitting the specified information to EPA, respondents may also need to submit a letter of intent, study plans and progress reports, or an exemption application. Respondents must also maintain certain records related to the testing. The specific requirements and procedures governing testing ECAs, test rules, and exemption from test rules are found in 40 CFR part 790. The requirements regarding Good Laboratory Practice standards (GLPs) are found in 40 CFR part 792, the various test guidelines that are incorporated into the individual test rules are in 40 CFR parts 795 through 799, and the chemical specific testing requirements are in 40 CFR part 799. The following is an overview of the specific requirements for each type of activity: Test Rules  -  EPA may promulgate a rule describing what type of testing must be performed on the chemical and specifying specific test guidelines that have been published by the EPA or alternative methods proposed by industry and approved by EPA as test methods. In combination with the GLPs requirements, these guidelines or methods provide the TSCA-mandated standards (TSCA section 4(d)) for development of adequate and reliable information. Records concerning information developed according to these standards must be retained for a minimum of ten years, as described in GLP standards. Information collections under TSCA section 4(c) are designed to reduce the burden of duplicative testing under test rules. As such, test rules generally require testing of only a single representative chemical and all chemicals subject to the test rule are assumed to be equivalent to it. Test Orders  -  EPA may promulgate an order describing what type of testing must be performed on the chemical and specifying specific test guidelines that have been published by the EPA or alternative methods proposed by industry and approved by EPA as test methods. In combination with the GLPs requirements, these guidelines or methods provide the TSCA-mandated standards (TSCA section 4(d)) for development of adequate and reliable information. Records concerning information developed according to these standards must be retained for a minimum of ten years, as described in GLP standards. Information collections under TSCA section 4(c) are designed to reduce the burden of duplicative testing. As such, test orders generally require testing of only a single representative chemical and all chemicals subject to the test order are assumed to be equivalent to it. Enforceable Consent Agreements (ECAs) -  EPA may negotiate an ECA under which manufacturers agree to conduct specific testing and submit the information to EPA. The ECA describes what type of testing is to be performed on the chemical and which test guidelines need to be followed to generate the information sought.  As with test rules, the test guidelines have either been published by EPA or another organization (e.g., OECD), or involve alternative methods proposed by industry and approved by EPA as test methods. In combination with the GLPs requirements, these guidelines or methods provide the TSCA-mandated standards (TSCA section 4(d)) for development of adequate and reliable information. Records concerning information developed according to these standards must be retained for a minimum of ten years, as described in GLP standards. Information collections under TSCA section 4(c) are designed to reduce the burden of duplicative testing. As such, test rules and ECAs generally require testing of only a single representative chemical and all chemicals subject to the ECA are assumed to be equivalent to it. Testing Exemption Applications  -  TSCA section 4 allows an entity subject to a test rule or test order to apply for an exemption from the testing requirement if that testing will be, or has been, conducted by another party. Any manufacturer or processor subject to a test rule or order may submit an application to EPA for an exemption from performing any or all of the tests required under the test rule or order. The exemption application process and requirements for test rules are set out in 40 CFR Part 790, Subpart E. The exemption application, which generally must be filed within thirty days after the effective date of the test rule, must identify the test rule, the chemical, and the Chemical Abstract Service Registration Number (CASRN) of the test substance on which the application is based, and the specific testing requirement(s) from which an exemption is sought, along with the basis for the exemption request. An exemption application will generally be approved if a letter of intent to conduct the testing has been received from another party; if a study plan submitted by another party has been approved; or if the data needs identified in the test rule have been satisfied by another party. A procedure is provided for the appeal and hearing of the denial of an exemption application. Exemptions are also only relevant for testing requirements in test rules. Voluntary Data Submissions  -  Unrelated to any test rule or other testing requirement or agreement, chemical manufacturers may voluntarily submit data to EPA at any time. Historically, voluntary data submissions have been provided as paper submissions. However, these submissions may be provided electronically through CDX, and it is anticipated that such submissions would be provided electronically in the future when applicable. Should submitters decide to do so, EPA simply asks that submitters follow the same procedures for preparing their package and completing their submission as test rule respondents. Since such data submissions are entirely voluntary and based on decisions in which EPA is not a participant, EPA can only provide a general estimate of potential burden and costs associated with such submissions, guided generally by past such submissions, which have been rare. In doing so, EPA believes that the potential costs and burdens for such voluntary submissions are captured in this information collection request.


[Federal Register Volume 80, Number 206 (Monday, October 26, 2015)]
[Rules and Regulations]
[Pages 65126-65128]
[FR Doc No: 2015-26612]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-0933; Directorate Identifier 2014-NM-098-AD;
Amendment 39-18297; AD 2015-21-05]
RIN 2120-AA64

Airworthiness Directives; Fokker Services B.V. Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
Fokker Services B.V. Model F.27 Mark 200, 300, 400, 500, 600, and 700
airplanes. This AD was prompted by a design review, which revealed that
no controlled bonding provisions are present on a number of critical
locations inside the fuel tank or connected to the fuel tank wall; and
no anti-spray cover is installed on the fuel shut-off valve (FSOV) in
both wings. This AD requires installing additional bonding provisions
in the fuel tank, installing an anti-spray cover on the FSOV, and
revising the airplane maintenance program by incorporating fuel
airworthiness limitation items and critical design configuration
control limitations. We are issuing this AD to prevent an ignition
source in the fuel tank vapor space, which could result in a fuel tank
explosion and consequent loss of the airplane.

DATES: This AD becomes effective November 30, 2015.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2015-0933 or in person at the
Docket Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all Fokker Services B.V.
Model F.27 Mark 200, 300, 400, 500, 600, and 700 airplanes. The NPRM
published in the Federal Register on May 4, 2015 (80 FR 25247).
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2014-0099, dated April 30, 2014 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Fokker Services
B.V. Model F.27 Mark 200, 300, 400, 500, 600, and 700 airplanes. The
MCAI states:

    Prompted by an accident * * *, the FAA published Special Federal
Aviation Regulation (SFAR) 88 [(66 FR 23086, May 7, 2001)], and the
Joint Aviation Authorities (JAA) published Interim Policy INT/POL/
25/12.
    The review conducted by Fokker Services on the Fokker 27 design
in response to these regulations revealed that no controlled bonding
provisions are present on a number of critical locations, inside the
fuel tank or connected to the fuel tank wall, and no anti-spray
cover is installed on the Fueling Shut-Off Valve (FSOV) in both
wings.
    This condition, if not corrected, could create an ignition
source in the fuel tank vapour space, possibly resulting in a fuel
tank explosion and consequent loss of the aeroplane.
    To address this potential unsafe condition, Fokker Services
developed a set of bonding modifications and anti-spray covers,
[and] introduced with Service Bulletin (SB) SBF27-28-071 Revision 1
(R1), that require opening of the fuel tank access panels. More
information on this subject can be found in Fokker Services All
Operators Message AOF27.043#03.

    For the reasons described above, this [EASA] AD requires
installation of additional bonding provisions, and of anti-spray
covers on the FSOV, that require opening of the fuel tank access
panels.

Required actions also include revising the airplane maintenance program
by incorporating fuel airworthiness limitation items and critical
design configuration control limitations. You may examine the MCAI in
the AD docket on the Internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2015-0933.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (80 FR 25247, May 4, 2015)
or on the determination of the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting this AD as proposed, except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (80 FR 25247, May 4, 2015) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (80 FR 25247, May 4, 2015).

Costs of Compliance

    We estimate that this AD affects 15 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Installation of bonding provisions,    70 work-hours x $85 per              $0           $5,950          $89,250
 anti-spray cover, and maintenance      hour = $5,950.
 program revision.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2015-0933; or in person at the
Docket Management Facility between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The AD docket contains this AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone 800-647-
5527) is in the ADDRESSES section.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2015-21-05 Fokker Services B.V.: Amendment 39-18297; Docket No. FAA-
2015-0933; Directorate Identifier 2014-NM-098-AD.

(a) Effective Date

    This AD becomes effective November 30, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Fokker Services B.V. Model F.27 Mark 200,
300, 400, 500, 600, and 700 airplanes, certificated in any category,
all serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

(e) Reason

    This AD was prompted by a design review, which revealed that no
controlled bonding provisions are present on a number of critical
locations inside the fuel tank or connected to the fuel tank wall;
and no anti-spray cover is installed on the fuel shut-off valve
(FSOV) in both wings. We are issuing this AD to prevent an ignition
source in the fuel tank vapor space, which could result in a fuel
tank explosion and consequent loss of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Installation of Bonding Provisions and Anti-spray Cover

    At the next scheduled opening of the fuel tanks after the
effective date of this AD, but no later than 84 months after the
effective date of this AD: Install additional bonding provisions at
the applicable locations, and install an anti-spray cover on the
FSOV in both wings, using a method approved by the Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA.

(h) Revision of Maintenance or Inspection Program

    Within 30 days after installing the bonding provisions and anti-
spray cover specified in paragraph (g) of this AD: Revise the
airplane maintenance or inspection program, as applicable, by
incorporating fuel airworthiness limitation items and Critical
Design Configuration Control Limitations (CDCCLs), using a method
approved by the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA.

(i) No Alternative Actions, Intervals, and/or CDCCLs

    After accomplishing the revision required by paragraph (h) of
this AD, no alternative actions (e.g., inspections), intervals, or
CDCCLs may be used unless the actions, intervals, or CDCCLs are
approved as an alternative method of compliance (AMOC) in accordance
with the procedures specified in paragraph (j)(1) of this AD.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Tom
Rodriguez, Aerospace Engineer, International Branch; ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA;
or Fokker Services B.V.'s EASA Design Organization Approval (DOA).
If approved by the DOA, the approval must include the DOA-authorized
signature.

(k) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI)
EASA Airworthiness Directive 2014-0099, dated April 30, 2014, for
related information. This MCAI may be found in the AD docket on the
Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-
0933-0003.

(l) Material Incorporated by Reference

    None.

    Issued in Renton, Washington, on October 11, 2015.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-26612 Filed 10-23-15; 8:45 am]
 BILLING CODE 4910-13-P