UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

OFFICE  OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

PC Code: 058001

DP Barcodes: 311127, 311128

DATE:  25 October 2006

MEMORANDUM

SUBJECT:     Azinphos Methyl—OPP Response to Stakeholder Comments
Regarding Ecological Risks for the Proposed Decision for “Group 3”
Uses

FROM:  	Colleen Flaherty, Biologist (ERB 3)

		R. David Jones, Chemist (ERB 4)

		Environmental Fate and Effects Division (7507C)

THRU:	Daniel Rieder, Branch Chief (ERB 3)

		Elizabeth Behl, Branch Chief (ERB 4)

		Environmental Fate and Effects Division (7507C)

TO:		Katie Hall, Risk Manager (RRB 2)

		Special Review and Reregistration Division (7505C)

	Attached please find the Office of Pesticide Program’s (OPP’s)
response to stakeholder comments on the proposed decision regarding the
ecological risk assessment for the use of azinphos methyl on apples,
blueberries (low- and high bush), Brussels sprouts, cherries (sweet and
tart), grapes, nursery stock, parsley, pears, pistachios, and walnuts
(i.e. “Group 3 uses”).

 Bayer CropScience and Makhteshim Agan of North America

(EPA-HQ-OPP-2005-0061-0162)

Summary

1. Comment (page 2 of 17): “The agency relies on screening level
modeling to establish predicted environmental (exposure) concentrations
for AZM in the aquatic systems.  These estimates are extremely
conservative by design.”

OPP response:  The Agency’s estimates are conservative by design, but
not extremely so. The models themselves (PRZM and EXAMS) are
approximately best estimators; the conservatism comes dominantly from
five sources – scenario selection, hydrologic setting, chemical input
parameter selection, use pattern, and EEC return frequency. Tier 2
scenarios are selected by best professional judgment for each crop to
represent a location that would be expected produce EECs higher than 90%
of sites where a particular crop is grown. The hydrologic setting is a
pond high in the watershed where a single field dominates the land use
in the watershed. This watershed serves as a surrogate for a number of
small vulnerable water bodies that may be found at the top of a
watershed such as prairie potholes, playa lakes, vernal pools, some
wetlands, and zero and first order streams. Generally, best estimate
values are used for most chemistry input parameters. However, metabolic
degradation rates have high background variability, and the upper 90%
confidence bound on the mean value is used rather than the means as the
input parameters. The maximum application rate allowed on the label is
used for the application pattern, and in some cases, this can be
substantially greater than the typical use pattern for a given crop. In
the case of azinphos methyl, the typical use rates are consistent with
the maximum label rates.  Finally, a return frequency of 1 in 10 years
is used for the EEC. These conservatisms are expected to compensate for
the variability that occurs in the environment across the landscape and
through time, as well as a range of management practices, and
uncertainties due to a limited data set. We expect these exposures to
occur in some places at some times. It is unknown what proportion of
water bodies that border treatment areas exceed known effect levels and
how quickly azinphos methyl concentrations drop below effects thresholds
when traveling downstream.

2. Comment (page 2-3 of 17): “…the most recent (and relevant) data
provide(s) estimates that are far below the agency’s screening level
predictions...more weight should be given (to) these data as they offer
more realistic exposure estimates.”

OPP response: Monitoring data and modeling predictions have distinct
temporal and spatial differences, and these data cannot truly be
compared.  However, recent monitoring data indicate that actual surface
water concentrations are not inconsistent with model predictions.

For example, the United States Geological Survey NAWQA program has
collected 120 samples at discharge of the Granger Drain in Washington
from 1999 through 2004 and analyzed these for azinphos methyl. The
number of samples analyzed per year varied from 4 (2000) to 30 (2003).
The frequency of detection above the detection limit varied from 0 in
2000 to 80% is 2001. The lack of azinphos methyl detections in 2000 is
likely to be related to the limited number of samples in that year. In
three of the four years with detection, there was at least one sample
over the acute level of concern (LOC) for aquatic invertebrates (0.08
ppb). In the remaining year, 1999, the maximum measured concentration
was 0.076 ppb, just below the LOC. Because of the limited number of
samples, the measured samples are unlikely to have captured the actually
maximum concentration that occurred. For example, with weekly sampling
there is only a one in seven chance of collecting a sample on the day
when the peak concentration occurred. Furthermore, NAWQA uses a
multi-analyte method for pesticide analysis. The analytical efficiency
varies for each pesticide in the method. Unfortunately, azinphos methyl
is not efficiently measured with this analytical method. Only 13% of the
pesticide in a water sample is recovered on average (USGS NAWQA, 1999).
As a consequence, all reported detections of azinphos methyl are marked
with an ‘E’ for estimated, indicating that these values are of lower
reliability than other measurements made by the program. It also
indicates that actual concentrations in water are 8 to 10 times greater
than the measurements indicate. This would also result in the maximum
measured value of 0.179 ppb approximately 1.4 ppb, which is fairly close
to the EEC estimated for azinphos methyl use on apples in Washington,
4.1 ppb, particularly considering the difference in return frequency and
hydrologic setting for modeling versus the sampling location.

Also, USGS NAWQA data for Zollner Creek, OR detected concentrations up
to about 4 µg/L in June of 2005.  This level is within the range of
1-in-10 year peak PRZM/EXAMS modeled exposures for the use of AZM on
apples, which is from about 3 to 9 µg/L.

3.  Comment (page 3 of 17):  “…more weight should be given to these
(higher tiered field level toxicity) studies as they were conducted
under more realistic conditions and thus provide more realistic
estimates of aquatic toxicity.”

OPP response:  The ecological risk assessment of azinphos methyl is
based on a screening-level deterministic approach.  As described in the
Overview of the Ecological Risk Assessment Process document, at a
screening level, it is OPP policy to rely on the most sensitive species
tested to evaluate potential effects to non-target animals at a national
level.  The assessment endpoints for the azinphos methyl ecological risk
assessment were defined as reduced survival and/or reproductive
impairment for aquatic and terrestrial species from direct acute and
chronic exposures.  These data were obtained from registrant-submitted
studies and from the open literature.  Surrogate test species used in
toxicity studies are not selected based on their sensitivity to
pesticides, but rather on their ability to thrive under laboratory
conditions.  Therefore, OPP’s endpoint selection may not be
representative of the most sensitive species that may be exposed to
azinphos methyl, but rather it is the most sensitive species tested in
the laboratory.

Field effects data can be used as additional lines of evidence in
ecological risk assessments (as in case of the azinphos methyl).
However, field studies are limited in the ability to account for the
myriad combinations of physical, chemical, and biological variables that
may affect organism response to pesticides in the environment.
Consequently, field studies cannot conclusively validate screening risk
assessment predictions, but they can allow inferences on the
reasonableness of the assessment predictions. In the case of azinphos
methyl, the available aquatic field studies suggest that community-level
zooplankton effects occur at concentrations between 1 and 4 µg/L.
These studies, which were described in detail in the ecological risk
assessment (D307568), support the laboratory toxicity data, which
suggests that individual aquatic invertebrate mortalities can occur at
levels below 1 µg/L.

4.  Comment (page 3 of 17): “…the agency should strongly consider
exposure estimates from surface water monitoring and toxicity estimates
from aquatic field studies…the data demonstrate risk that is
acceptable and more predictive than the screening level assessment
conducted by the agency.”

OPP response:  Surface water monitoring data were considered and are
discussed in the assessment. The available monitoring data for azinphos
methyl show exposures above the Agency’s threshold of concern.
Furthermore, surface water monitoring data tends to underestimate
exposures, particularly acute exposures, because infrequent sampling
makes it unlikely that the highest concentrations that occur in any year
will be captured in any given sample.  In addition, the duration of most
monitoring studies is typically only a few years, and thus, information
to characterize less frequent events is limited.  The hydrologic setting
of most sampling sites in a monitoring program is downstream of
relatively more vulnerable sites in the same watershed. In most cases,
monitoring data serves as a lower bound for the potential exposures (and
consequent risk) and is useful on that basis.

5.  Comment (page 3 of 17): “…further weight should be given to the
lack of aquatic incidents entered into the agency’s tracking
system…The agency repeatedly cites dated aquatic incidents around the
use of AZM to substantiate the ecological risk assessment and proposed
decision but does not provide adequate weight to the recent trends in
this area.”

OPP response:  As discussed previously (DP barcode 307569), this
“trend” of decreasing adverse ecological incidents in the EIIS
database is not unique to azinphos methyl and is likely a function of
reduced reporting rather than a drastic decrease in pesticide risk to
fish and wildlife.  Further, since there is no nationwide, rigorous
incident monitoring program in place, reported incidents can only be
used as a line of evidence to support a risk conclusion that a given
taxon may be at risk from a particular pesticide use.  Given the
haphazard nature of incident reporting, lack of incident data cannot
suggest lack of ecological risk.

In the case of azinphos methyl, based on a deterministic ecological risk
assessment, risk to aquatic animals was concluded, and aquatic incidents
were used to support this conclusion.  The reported “fish kill”
incidents linked to azinphos methyl use suggest that when this
organophosphate insecticide is applied to various crops, exposures in
water bodies adjacent to or immediately downstream of the treated area
may be high enough to elicit mortality effects.

6.  Comment (page 3 of 17):  “Similar to trends in the aquatic area,
model predications (sp.) indicate dietary exposure via residues in
excess of mortality thresholds…these estimates are overly predictive
compared to likely dietary exposure residues.”

OPP response:  As mentioned in the ecological risk assessment for the
“Group 3” azinphos methyl uses (DP barcode 307568), field studies by
Johnson et al. (1989, MRID 41139701) and Sheeley et al. (1989, MRID
41195901) show that there is concordance between the predicted residues
based on the Kenaga nomogram and actual measured residues of azinphos
methyl in the field.  In some cases, measured residues from these
studies actually exceed those predicted by the Kenaga nomogram.
Residues on apple tree foliage were measured within 24 hours of spray
blast applications, and mean-measured residues were 199 (82-393) and 236
(105-476) ppm, for Washington and Michigan, respectively.  In
Washington, measured residues after the second and third application
were 312 ppm (123-564 ppm) and 328 ppm (122-611 ppm), respectively.  In
Michigan, residues measured after the second and third applications were
429 ppm (111-1499 ppm) and 536 ppm (208-1747 ppm), respectively.
Predicted residues based on the Kenaga nomogram range from 45-713 ppm
for the “upper-bound” estimate and from 21-253 ppm for the mean
estimate.

7.  Comment (page 3 of 17):  “…the agency uses dated incident
reports to substantiate possible risk to terrestrial organisms…”

OPP response:  See above response to Comment #5.

8.  Comment (page 3-4 of 17):  “The agency also cites terrestrial
field studies performed in apple orchards to substantiate a position on
potential exposure and risk.  The agency should consider that these
studies performed were level 1 field studies which are designed to
provide only qualitative information about effects…They did not
include control or reference sites so it is not possible to directly
assess whether mortality rates at AZM treated sites was greater than
background rates.  The numbers of vertebrate mortalities found per unit
of search effort on treatment sites in the Michigan study cited were
similar to control sites of other avian field studies conducted by the
registrants.  The numbers of vertebrate mortalities found per unit
search effort in the Washington study was greater than control sites in
other studies, however, most of these mortalities occurred at 2 sites
where rodenticides were applied and were attributed by the authors to
the rodenticide applications rather than to AZM.”

OPP response:  The field studies conducted in apple orchards in Michigan
(Sheeley et al. 1989, MRID 41195901) and Washington (Johnson et al.
1989, MRID 41139701) demonstrated that some birds and small mammals are
at risk for acute mortality effects following azinphos methyl spray
applications at the current rate.  In both studies, the effects of
Guthion 35WP applications on wildlife were assessed by comparing the
number of casualties found before and after treatment, by examining
circumstances under which casualties were found, and residue levels in
carcasses.  The pre-treatment search served as the control.

In the Michigan study, two casualties were recorded pre-treatment and 27
were recorded post-treatment.  Of the 27 post-treatment mortalities
(tabulated below), 14 were considered highly likely to have been
treatment related, six were possibly treatment related, and seven were
not treatment related.  Most carcasses were found within the orchards
(38%) or along their perimeter (45%), but 17% were located in adjacent
areas outside the orchards.

In the Washington study, 173 casualties were recorded, including 59
birds of 14 species, 109 mammals of seven species, and five reptiles of
two species.  Of these, 162 (94%) were found after treatments began.
American robins and California quail accounted for 34% and 20%,
respectively, of the total avian casualties.  Meadow voles comprised 82%
of the mammalian casualties.  Only 40 of the 173 casualties were
analyzed for tissue residue, and 21 (53%) were considered treatment
related based on the detection of residue in carcasses.  Additionally,
117 other casualties might have been treatment related based on the
circumstances and/or time frames under which carcasses were found.  Only
35 casualties were considered not treatment related.  Of the carcasses
recovered, 46% were found along orchard perimeters, 41% in orchard
interiors, and 13% in areas adjacent to the orchards.

Several other terrestrial field studies (Edge et al., 1996; Peterson,
1996; Schauber et al., 1997; Matz et al., 1998) have been previously
described in the ecological risk assessment for the Group 3 azinphos
methyl uses.  These studies also indicated adverse effects to
terrestrial wildlife following azinphos methyl exposure.

Section 1. Screening Level Exposure Modeling and Monitoring Data

9.  Comment (page 4 of 17):  “With the extensive amount of monitoring
data available on AZM, the risk assessment can and should be based on
the actual concentrations seen in the environment…the monitoring data
are comprehensive enough (ca. 21,000 samples), in terms of number of
monitoring sites, location of the sites and length of sampling periods,
to be used in the risk assessment.”

OPP response:  We agree that the monitoring data are extensive. As
discussed in the response to comment #4, the available monitoring data
for azinphos methyl show exposure above the Agency’s threshold of
concern. Furthermore, surface water monitoring data tends to
underestimate exposures, particularly acute exposures, because
infrequent sampling makes it unlikely that the highest concentrations
that occur in any year will be captured in any given sample.  In
addition, the duration of most monitoring studies is typically only a
few years, and thus, information to characterize less frequent events is
limited.  The hydrologic setting of most sampling sites in a monitoring
program is downstream of relatively more vulnerable sites in the same
watershed. In most cases, monitoring data serves as a lower bound for
the potential exposures (and consequent risk) and is useful on that
basis.

10. Comment (page 4 of 17): “Literature studies have shown that the
standard modeling approach over-predicts residues by one to four orders
of magnitude (Jackson et al. 2005, Jones 2005)”

OPP Response: Both of these papers fail to account for the differences
in hydrologic setting, duration of monitoring versus modeling
assessment, frequency of sampling, and the relative vulnerabilities of
modeled versus monitored sites.  The studies make inappropriate
comparisons of modeled exposures and monitoring data estimates.

The estimates from Tier 2 modeling are by design, expected to be
somewhat higher than those found in the environment. However, EFED does
not agree with the conclusions reached by Jackson et al. (2005) and
Jones (2005) that the modeling is unrealistic.  The basis for
comparisons between modeling and monitoring in this article is unclear,
and the endpoints derived from the modeling and the reported monitoring
results are wholly different and are not comparable. The paper did not
provide adequate detail about (1) the differences in the endpoints for
modeling and monitoring, (2) the assumptions and inputs used in
modeling, or (3) the design of the monitoring study.  It did not
describe the nature of the EPA models, or how these models were used.
These details are important in interpretation of results, in supporting
both the author’s recommendations to develop adjustment factors and
the author’s judgment on the validity of the conceptual model.

Additionally, the authors’ description of how EPA’s endpoints (i.e.
1-in-10 year annual peaks at a 90% site) are derived was inadequate and
misleading. For a reasonable comparison to be made, key input parameters
used in modeling (application rates, application frequencies,
application dates, and percentage cropped area adjustment factors)
should represent actual pesticide use and usage in each of the
watersheds monitored. Similarly, monitoring intervals and duration
should match those used in modeling. This could not be determined
because the authors had not provided the information necessary to
interpret the monitoring study results, and such data are usually not
available. Additionally, the study authors compared a representative
monitoring dataset to the 1-in-10 year return frequency model estimates
and did not provide details of pesticide usage in the watershed.  As a
result, statistical analysis of the data cannot provide meaningful
results. Given the uncertainties in the overall methodology, the
authors’ conclusions about the adequacy of EPA’s conceptual model
for water modeling are not supported by their analysis.

11. Comment (page 5 of 17): “…the ca. 21,000 samples taken and
analyzed for AZM are significant value to the risk assessment.”

OPP Response: NAWQA data through 2000 was considered in ecological risk
assessment supporting the IRED. Other sources of monitoring data were
also considered and described in the assessment. For example, STORET is
a database of different data collected at different times for different
purposes. In most cases, it is difficult to establish the context (e.g.
why it was collected, how it was collected, sample QA/QC, environmental
conditions, etc.) for which the data was collected as this data is
usually not maintained in the database. Without context, it is not
possible to use the data in risk assessment. Additionally, the Pilot
Reservoir Monitoring Study was designed to establish the potential for
exposure to pesticides in reservoir-based drinking water. It was
targeted to reservoirs vulnerable to pesticide contamination, but not to
azinphos methyl use areas.

The assessment and conclusions of Makhteshim and Bayer CropScience are
based on an unscientific assessment of the monitoring data. Placing all
identified data regardless of source into a single distribution of
values results in conclusions that are not meaningful, for the following
reasons:

Aquatic organisms do not typically experience exposures from many
different streams, but only one stream at a time.

The analysis does not account for differences in sampling frequency and
duration at each sampling site.

The analysis does not account for the different total number of samples
at each site.

The analysis does not account for differences in analytical
methodologies (e.g. levels of detection, extraction efficiency) from
study to study.

The analysis ignores differences in hydrologic setting from study to
study and from site to site.

Since none of these factors have been accounted for, the combined
distribution of these monitoring values has no scientific value.  Hence,
any comparisons to this monitoring analysis are not useful
scientifically.

12. Comment (page 5 of 17):  “…special attention should be given to
the recent water monitoring and invertebrate toxicity study conducted by
Chelan County in Washington State...”

OPP response:  EPA has evaluated the monitoring data available from the
Chelan County Conservation District.  It would be difficult to conclude
that these samples represent high exposure conditions for azinphos
methyl.  Downstream sites in this study are at least 2nd and 3rd order
streams and do not represent the most vulnerable locations in the
watershed. It is not clear from the study the proximity of the various
orchards in the watershed to the creeks sampled. Surprisingly, while
there were detections in Mission Creek, the application data show no
applications of azinphos methyl to Mission Creek during June. Only
Yaksum Creek had applications of azinphos methyl made during the
sampling window.

It is not surprising that there were no significant mortality effects on
Daphnia pulex.  Laboratory data indicate that the LC50 for daphnids is
approximately 1 µg/L.  The detected levels in this study ranged from
less than 0.02 µg/L to 0.19 µg/L.

Section II. Aquatic Toxicity

13.  Comment (page 12 of 17): “…there is a low probability of
exposure exceeding the threshold value (1 ppb) derived from higher tier
aquatic studies.”

OPP response:  The study referenced in the comment was evaluated by EPA
and the “threshold value” cited (1 µg/L for aquatic organisms) was
determined to not be useful for EPA’s risk assessment, as it is not
adequately protective for azinphos methyl. The field studies that the
registrants refer to suggest that a single exposure of azinphos methyl
at 4 µg/L can elicit population-level effects in aquatic ecosystems.
Most of the remaining azinphos methyl uses allow more than one
application per season, and the magnitude of the population declines and
the time to recover would surely increase with increasing applications.
The EFED ecological risk assessment used a benchmark toxicity value of
0.16 µg/L for freshwater invertebrates based on the LC50 for the scud.

In addition, chronic toxicity studies indicate that significant
reproductive effects can occur at levels well below 1 µg a.i./L.  In a
21-day Daphnia magna chronic toxicity study, significant effects on
survivorship, length, and fecundity (mean number of young per adult per
reproductive day) were observed at a LOAEC of 0.40 μg a.i./L.

Further, we disagree with the conclusion of low probability of exposure
exceeding 1 μg a.i./L.  The analysis method for monitoring data used to
draw that conclusion was substantially flawed as discussed above in the
response to comment #11.

Section III. Incidence Reports

14. Comment (page 12 of 17): “What is not clearly presented is the
significant reduction in both aquatic and terrestrial incidences
reported in association to labeled uses.”

OPP response:  See above response to Comment #5.

Farm Worker Justice (EPA-HQ-OPP-2005-0061-0165)

This stakeholder has submitted a document entitled “Do Buffers Make
Good Neighbors? Minimizing Pesticide Exposure at the Ag-Urban
Interface” by Dr. Allan Felsot, an environmental toxicologist from
Washington State University.

Dr. Felsot has proposed using the AgDrift Model to estimate vegetated
buffer strips around dwellings to reduce exposure to populations living
in the vicinity of orchards. In general outline, we agree that Dr.
Felsot’s approach is sound, and we are considering a similar approach
to explore potential mitigation measures for the azinphos methyl risks.
A list of specific comments on Dr. Felsot’s approach follows.

1. Comment (page 6): “…I have concluded that simulations of orchard
spraying with AgDrift is conservative enough to allow its use for
designing no-spray buffer zones to protect bystanders.”

OPP response:  The orchard airblast component of AgDrift is a based on a
regression analysis of the measured drift from about 40 drift trials in
orchards. The AgDrift output is the mean estimator across these drift
trials, and thus, is a best estimate of the drift from orchards, not a
conservative one. Multiplying the drift estimate by three is used as a
surrogate for 90% of the drift curves.

2. Comment (page 6): “Although the creators of the AgDrift model claim
that wind is not a very important factor in drift from orchards… the
light winds blowing across the transect may have dampened drift away
from the orchard.”

OPP response:  It would be better to say there is no statistically
significant association of wind speed on drift magnitude found in the
spray drift data set. It is likely that this association was masked by
other confounding factors during the drift trials. We would agree with
Dr. Felsot that wind speed and direction are factors in spray drift from
air blast application in orchards.

3. Comment (page 8): “The effect of not spraying outside rows…the
no-spray buffer zone drops…”

OPP response:  We agree that not spraying the outer rows can reduce
spray drift, though it may provide refugia for the pests.

4. Comment (page 9): “Buffers: one strategy among many”

OPP response:  We agree that there a large number of other drift
reduction strategies available including shelter belts (lines of dense
trees at the edge of the orchard) and alternative pesticides.

American Farm Bureau Federation (EPA-HQ-OPP-2005-0061-0166)

1. Comment (page 1): “Relevant portions of the ecological data and
modeling are unrealistic and significantly overestimate risk.”

OPP response:  In the case of azinphos methyl, the deterministic
risk-quotient based approach is supported by various aquatic and
terrestrial monitoring data, field studies, and adverse ecological
incidents.

2. Comment (page 1): “…some relevant ‘lower risk’ incident data
may not have (been) fully considered.”

OPP response:  It is unclear which data are being referred to in this
comment.  Any additional data that stakeholders can provide regarding
this subject will be considered in future assessments. EPA has evaluated
and considered all available incident data in our assessment.

3. Comment (page 1): “…EPA should more thoroughly explore potential
risk mitigation measures that may allow for the continued use of AZM.”

OPP response:  Any mitigation proposals that stakeholders can provide
will be considered in future assessments.

Northwest Horticultural Council (EPA-HQ-OPP-2005-0061-0168)

1. Comment (page 4): “The outcomes predicted by the conservative
screening model used by the agency appear to overestimate real world
values…because…this model has never been adequately validated across
the range of environmental and site conditions where AZM is used.”

OPP response:  The two components of Tier 2 exposure analysis, PRZM and
EXAMS, have been repeatedly validated (see list below) and are
approximately best estimators of transport of pesticides in the
environment.  Tier 2 modeling is dominantly conservative because of
choices of scenario, return frequency, and chemical input parameters,
which are used to account for variation in the environment and the
uncertainties due to limited data sets.

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Development, U. S. Environmental Protection Agency, Athens, GA.

Durborow, T. E., N. L Barnes, S. Z. Cohen, G. L. Horst, A. E. Smith.
2000. Calibration and Validation of Runoff and Leaching Models for Turf
Pesticides, And Comparison with Modeling Results. Chapter 12 in Fate and
Management of Turfgrass Chemicals. ACS Symposium Series 743. American
Chemical Society.

Jones, R. David, Sidney Abel, William Effland, Robert Matzner, and
Ronald Parker. 1998. An Index Reservoir for Use in Assessing Drinking
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Estimation of Pesticide Concentration in Flowing Waters and Reservoirs
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Berlin

2. Comment (page 4): “Data collected in Washington state in 2003 and
2004 do not confirm the values used in the agency’s September 29, 2005
ecological risk assessment.”

OPP response:  As described above in the response to comment #12 from
Bayer CropScience and Makhteshim Agan of North America, it would be
difficult to conclude that these samples represent high exposure
conditions for azinphos methyl.  Downstream sites in this study are at
least 2nd and 3rd order streams and do not represent the most vulnerable
locations in the watershed. It is not clear from the study the proximity
of the various orchards in the watershed to the creeks sampled.
Surprisingly, while there were detections in Mission Creek, the
application data show no applications of azinphos methyl to Mission
Creek during June. Only Yaksum Creek had applications of azinphos methyl
made during the sampling window.

California Almond Board (EPA-HQ-OPP-2005-0061-0172)

1.  Comment (page 5):  “…we have doubts about relying on the very
conservative ecological risk assessment exclusively, especially as more
recent water quality monitoring data do not back up the numbers
calculated in the risk assessment.”

OPP response:  As described above in the response to Bayer CropScience
and Makhteshim Agan of North America comment #2, monitoring data and
modeling predictions have distinct temporal and spatial differences, and
these data cannot truly be compared.  However, recent monitoring data
indicate that actual surface water concentrations are not inconsistent
with model predictions.

For example, the United States Geological Survey NAWQA program has
collected 120 samples at discharge of the Granger Drain in Washington
from 1999 through 2004 and analyzed these for azinphos methyl. The
number of samples analyzed per year varied from 4 (2000) to 30 (2003).
The frequency of detection above the detection limit varied from 0 in
2000 to 80% is 2001. The lack of azinphos methyl detections in 2000 is
likely to be related to the limited number of samples in that year. In
three of the four years with detection, there was at least one sample
over the acute level of concern (LOC) for aquatic invertebrates (0.08
ppb). In the remaining year, 1999, the maximum measured concentration
was 0.076 ppb, just below the LOC. Because of the limited number of
samples, the measured samples are unlikely to have captured the actually
maximum concentration that occurred. For example, with weekly sampling
there is only a one in seven chance of collecting a sample on the day
when the peak concentration occurred. Furthermore, NAWQA uses a
multi-analyte method for pesticide analysis. The analytical efficiency
varies for each pesticide in the method. Unfortunately, azinphos methyl
is not efficiently measured with this analytical method. Only 13% of the
pesticide in a water sample is recovered on average (USGS NAWQA, 1999).
As a consequence, all reported detections of azinphos methyl are marked
with an ‘E’ for estimated, indicating that these values are of lower
reliability than other measurements made by the program. It also
indicates that actual concentrations in water are 8 to 10 times greater
than the measurements indicate. This would also result in the maximum
measured value of 0.179 ppb approximately 1.4 ppb, which is fairly close
to the EEC estimated for azinphos methyl use on apples in Washington,
4.1 ppb, particularly considering the difference in return frequency and
hydrologic setting for modeling versus the sampling location.

As another example, USGS NAWQA data for Zollner Creek, OR detected
concentrations up to about 4 µg/L in June of 2005.  This level is
within the range of 1-in-10 year peak PRZM/EXAMS modeled exposures for
the use of AZM on apples, which is from about 3 to 9 µg/L.

2. Comment (page 5):  “…AZM is never applied in March when there is
significant rainfall.  Applications occurred in mid-May through
mid-August (2000-2003), and now occur primarily in July (2004).”

OPP response: OPP has reviewed data from California DPR on the timing of
pesticide applications since 2002 and agrees that since that time, the
vast majority of applications have been made in June through August to
control navel orange worm.  To characterize these applications, EPA has
conducted additional modeling runs simulating applications on May 15 and
July 15, as suggested by the California Almond Board (see Appendix).
For comparison purposes, the simulation for a March 15 application was
rerun using the orchard option to generate spray drift. This is intended
to show the potential for drift when spray blast is not directed over
the canopy as stated on the label. (See D307569 for details). The
one-in-ten-year peak EEC for the March application is 6.3 ppb and is
reduced to 3.2 ppb for the May application and 3.1 for July application.
This modification to the application scheme substantially reduces the
estimated exposures; however, acute and chronic risks to aquatic animals
continue to exceed the Agency’s levels of concern.

While these additional simulations do more accurately reflect current
azinphos methyl usage for control of the navel orange worm, the previous
simulation modeling using March 15 as an application date is appropriate
for another pest, the peach twig borer.  The recommended application
timing of azinphos methyl for control of this pest is “post-bloom,”
which is mid-March, as documented in the ecological risk assessment for
the Group III uses (D307568).

3. Comment (page 5): “EPA claims that they cannot rely on the more
recent incident reports because incidents are underreported…EPA cannot
have it both ways.”

OPP response: As discussed in the above response to Bayer CropScience
and Makhteshim Agan of North America comment #5, since there is no
nationwide, rigorous incident monitoring program in place, reported
incidents can only be used as a line of evidence to support a risk
conclusion that a given taxon may be at risk from a particular pesticide
use.  Lack of incident data cannot suggest lack of ecological risk.

In the case of azinphos methyl, based on a deterministic ecological risk
assessment, risk to aquatic animals was concluded, and aquatic incidents
were used to support this conclusion.  The reported “fish kill”
incidents linked to azinphos methyl use suggest that when this
organophosphate insecticide is applied to various crops, exposures in
water bodies adjacent to or immediately downstream of the treated area
may be high enough to elicit mortality effects.

4. Comment (page 5): “The Regional Water Quality Board has had several
detections in the San Joaquin Valley, but they are well below any
toxicological levels of concern.”

OPP response:  OPP has not done a full review of these particular
monitoring data.  However, it appears that the AZM detections in San
Joaquin valley cited in this comment are incorrect.  According to
California State Water Resources Control Board, AZM was detected in July
2005 at concentrations of 0.165 and 0.33 parts per billion (µg/L) –
not parts per trillion as suggested by the CA Almond Board in this
comment.  These exposures do, in fact, exceed the Agency’s water
quality criterion for azinphos methyl (0.01 µg/L).

5. Comment (page 6): “EPA does not mention that the pyrethroids may
have ecological issues of their own, especially with regard to aquatic
species.”

OPP response:  EPA acknowledges that there are potential ecological
risks associated with any pesticide, including synthetic pyrethroids.  A
comparative ecological risk assessment for azinphos methyl and all
possible alternatives has not been performed.  However, the Agency’s
understanding of the ecological risks associated with the remaining uses
of azinphos methyl is that the pesticide poses both acute and chronic
risks to aquatic and terrestrial animals and that at least some of the
alternatives, e.g., phosmet, are less toxic and less persistent and
mobile than azinphos methyl, and as such, pose less of a risk to the
environment.

6. Comment (page 6): “…OP-consuming enzyme…This may be one way of
reducing both the concern with run-off and for terrestrial non-target
species.”

OPP response:  An OP-consuming enzyme sounds like it has the potential
to be a promising risk mitigation option.  However, the feasibility of
this option in the context of azinphos methyl application to various
fruit and nut crops is unknown.  It is also unknown to what extent
aquatic and terrestrial exposures may be reduced as a result of
application of this OP-consuming enzyme in conjunction with azinphos
methyl.  Any references that can be provided regarding this subject
would be considered in future assessments.

U.S. Apple Association (EPA-HQ-OPP-2005-0061-0163)

1. Comment (page 7): “The model overestimates the amount of drift into
the farm pond because the wind speed will not be 10 mph all the time and
the wind will not blow in the direction of the pond for every
application.  Growers prefer applications with minimal wind speed for
most effective target coverage.”

OPP response: OPP acknowledges that assuming that the wind always blows
directly at the water body and that the wind speed is 10 mph will
overestimate exposure. An improved spray drift modeling capability that
can account for wind speed and direction effects on aquatic exposure is
currently be developed. Note that wind speed effects cannot be simulated
for air blast applications since there was no statistically significant
effect of wind speed in the air blast drift trials used to develop
AgDrift model.

2. Comment (page 7): “The model overestimates the amount of spray
drift because fine droplets will be carried a farther distance from the
target.  Additionally, growers are directed by the label to use larger
droplet sizes and will likely follow the recommendation.”

OPP response: For apples, the model only considers droplet sizes for the
aerial application allowed on the 24(c) label in Idaho. The portion of
AgDrift that simulates air blast application does not use droplet size
spectrum as an input parameter. Consequently, this label recommendation
does not affect the simulation results for this application method.

3. Comment (Page 7): “The model overestimates the drift calculation
because an orchard canopy with full vegetation is dense and will capture
a much higher percentage of the application than a dormant tree.
Additionally, dormant applications are prohibited.”

OPP response: In recognition of the statements on the label prohibiting
application to dormant orchards and disallowing spray over the top of
the canopy, the orchard used in AgDrift to simulate airblast
applications was changed from ‘sparse orchard’ to ‘orchard’ for
the additional simulations performed in response to the comments on the
Group 3 risk assessment (D307577).  Thus, spray drift is not
overestimated in the latest assessment.

4. Comment (Page 8): “By not using buffers in its water run off model,
the model greatly overestimates the actual pesticide runoff into water
sources.”

OPP response: Based on recommendations from the Natural Resources
Conservation Service (USDA NRCS, 2000), OPP only considers reduction in
pesticide loading from buffers that are constructed and maintained to
control runoff. Buffers that are not maintained tend to develop a
‘hump’ at the front edge of the buffer as runoff that slows down
drops it sediment. After a few years, runoff begins to flow along the
leading edge of the buffer rather than across it. At a low point, the
runoff then moves across the buffer as concentrated flow, resulting in
little reduction of pesticide movement across the strip. Consequently,
OPP does not consider buffers for reduction of runoff unless buffers are
constructed and maintained according to the above referenced NRCS
document.

5. Comment (Page 8): “The model overestimates the amount of pesticide
runoff by as much as 83 percent by not considering the effect of buffers
with vegetative cover that reduce pesticide loading even though buffers
with vegetative cover are common in apple production.”

OPP response: See the response to comment 4.

6. Comment (Page 9): “The model overestimates the amount of pesticide
that would run off into water sources because some orchards are planted
on soils that are not prone to high runoff potential.”

OPP response:  Tier 2 simulations use scenarios that are more vulnerable
than most sites on which a particular crop can be grown. This is
necessary in order to assure that there is a margin of protection at
most sites when the pesticide is used.

7. Comment (Page 9): “The model uses a rainfall value that is 6 times
greater than the actual rainfall in majority of Washington orchards.
Using this value will lead the modeler to predict a greater amount of
pesticide entering waterways.”

OPP Response: OPP does not routinely base risk assessments on
“typical” use scenarios because a large fraction of the sites (50%,
if typical means median) will be more vulnerable and would not be
adequately protected. The Oregon apple scenario is more vulnerable than
most sites in the Pacific Northwest used to grow apples and is thus
expected to be protective of aquatic life in those areas. However, to
further characterize the potential risks, a scenario for Washington
apples was simulated using weather data from Yakima (D307577). The peak
1-in-10 year EEC for the Washington scenario was 4.8 ppb compared to 5.2
ppb for the Oregon scenario. In both cases, all LOCs for aquatic life
were exceeded.

8. Comment (Page 9): “Despite the conservative choices already made
for the model’s inputs, EPA makes the drift value even more
conservative by multiplying the generated value by three.  Tripling the
drift value is unreasonable and unnecessary.”

OPP Response:  The spray blast model in AgDrift is a regression model,
and as such, predicts the mean estimate across the trials that were used
in the regression calculation. Consequently, about half of the time, the
spray drift deposition will be higher; the other half of the time, it
will be lower. Multiplying the pond deposition accounts for this
background variability and assures that the screening estimate will be
conservative.

9. Comment (Page 9): “The agency’s preliminary decision document
indicates soil particle runoff is the primary pathway for azinphos
methyl entry into its model farm pond, and that this element is a
significant driver in the calculated aquatic risk.  Important factors in
determining the amount of runoff would be the amount of rainfall, the
distance the particles would have to travel to the pond and the ease at
which the particles travel the distance to the pond.  In this regard,
the agency’s approach seems particularly conservative and
unrealistic.”

OPP Response:  The Agency assessment indicates that azinphos dominantly
moves dissolved in runoff, not on the sediment suspended in the runoff.

10. Comment (Page 9): “In the Western scenario, the agency uses a site
with an average annual rainfall of 36 inches, when the primary apple
production region receives annual rainfall of 6 inches.”

OPP response:  See the response to comment #7.

11. Comment (page 9):  “Regarding the distance soil particles would
travel to the pond, the model assumes applications are made at the edge
of the pond and residues are on the edge of the pond poised for rain to
wash the particles into the hypothetical pond, even though the label
states applications must be made 25 feet from permanent bodies of
water.”

OPP Response: See the response to comment #4.

12. Comment (page 9): “Regarding the ease at which soil particles will
move, the agency’s model assumes the ground is bare and free of
vegetation when in reality; grass covers the orchard floor, except for
the herbicide strip directly under trees, in nearly all apple orchards.
EPA maintains it uses “high runoff potential soils in its model so the
simulation will account for the most sensitive areas where there are
apple orchards in general.”  USApple contends that nearly all apple
orchards are covered in grass and other dense vegetation at the
perimeter of orchards, and this vegetation will prevent soil erosion and
movement of soil particles and pesticides into bodies of water.”

OPP Response: OPP considered the reduction of movement with eroded
sediment due to the vegetation maintained on the orchard floors in the
western orchards. OPP agrees that the erosion from the Pennsylvania
apple scenario is excessive as the C factors for the scenario were set
assuming no cover below the orchard which is very uncommon in eastern
apple orchards. This scenario is currently being revised, and a more
appropriate cover will be used in the new scenario. While new
simulations have not been run, a scenario with more appropriate erosion
would likely have 20 to 30% less azinphos methyl loaded to surface
water.  Such a decrease in EECs would still result in RQs that exceed
the Agency’s LOCs.  Also, see the response to comment #9.

13. Comment (page 9): “Extensive research has been done on the
movement of pesticides using various vegetative barriers.  Attached
below in Table 3 are thirty studies that conclude that vegetative
buffers do prevent movement of pesticides.”

OPP Response: See the response to comment #4.

14. Comment (page 10):  “Attached for your consideration is a study
titled “Pesticide Use and Toxicity Assay in Mission, Bender and Yaksum
Creeks” prepared in 2003 by the Chelan County Conservation
District.”

OPP response: EPA has given special attention to the monitoring data
available from the Chelan County Conservation District.  Based on a
cursory analysis, it would be difficult to conclude that these samples
represent high exposure conditions for azinphos methyl.  Downstream
sites in this study are at least 2nd and 3rd order streams and do not
represent the most vulnerable locations in the watershed. It is not
clear from the study the proximity of the various orchards in the
watershed to the creeks sampled. Surprisingly, while there were
detections in Mission Creek, the application data show no applications
of azinphos methyl to Mission Creek during June. Only Yaksum Creek had
applications of azinphos methyl made during the sampling window.

It is not surprising that there were no significant mortality effects on
Daphnia pulex.  Laboratory data indicate that the LC50 for daphnids is
approximately 1 µg/L.  The detected levels in this study ranged from
less than 0.02 µg/L to 0.19 µg/L.

U.S. Apple Association, September 22, 2006

1. Comment (pages 3-4): “In the Western scenario, the agency uses a
site with an average annual rainfall of 36 inches, when the primary
apple production region receives annual rainfall of 6 inches.”

OPP response: OPP does not routinely base risk assessments on
“typical” use scenarios because a large fraction of the sites (50%,
if typical means median) will be more vulnerable and would not be
adequately protected. The Oregon apple scenario is more vulnerable than
most sites in the Pacific Northwest used to grow apples and is thus
expected to be protective of aquatic life in those areas. However, to
further characterize the potential risks, a scenario for Washington
apples was simulated using weather data from Yakima (D307577). The peak
1-in-10 year EEC for the Washington scenario was 4.8 ppb compared to 5.2
ppb for the Oregon scenario. In both cases, all LOCs for aquatic life
were exceeded.

2. Comment (page 4): “The modelers go beyond that to use an annual
value of 39.7 inches to capture the 90th percentile of the maximum
annual peak concentration in 30 years to calculate the risk.”

OPP response: OPP does use the 1-in-10 year return frequency EECs at a
site that is intended to be more vulnerable than 90% of sites used to
grow a particular crop on a national basis. U. S. Apple is also correct
that simulations generally use 30 years of simulation to estimate the
1-in-10 year peaks.

3. Comment (page 4): “In the Eastern Scenario, the agency’s model
estimates the 90th percentile of annual erosion to be 121 tons/ha. (49
tons/acre).  The U.S. Department of Agriculture’s (USDA) National
Resources Conservation Service (NRCS) estimates average annual erosion
from Pennsylvania orchards from 2.1 tons/acre in average soils to 5.9
tons/acre in highly erosive soil in Adams County, Pennsylvania using its
widely accepted universal soil erosion model.  Additionally, the 2003
NRCS National Resources Inventory Survey estimates New England/Mid
Atlantic average soil erosion to be 3.2 tons/acre.”

OPP response:  OPP agrees that the erosion from the Pennsylvania apple
scenario is excessive as the C factors for the scenario were set
assuming no cover below the orchard which is very uncommon in eastern
apple orchards. This scenario is currently being revised, and a more
appropriate cover will be used in the new scenario. While new
simulations have not been run, a scenario with more appropriate erosion
would likely have 20 to 30% less azinphos methyl loaded to surface
water.  Such a decrease in EECs would still result in RQs that exceed
the Agency’s LOCs.

4. Comment (page 4): “The orchards visited by EPA staff during the
week of Sept. 11, 2006 clearly demonstrate that virtually continuous sod
cover crops in these orchards are playing a major role in reducing
run-off.  We would argue that a continuous cover crop in orchards and
between orchards and the water body offer significant protection when
compared to the agency’s model which greatly underestimates this
protection.”

OPP response:  OPP agrees that cover crops reduce onsite runoff. The
scenarios for the western orchards considered the sod cover in
estimating exposure.  However, azinphos methyl aquatic exposures in the
West are dominated by spray drift, and the benefit of cover crops under
the orchard in the west is reduced due the decreased rainfall that
occurs during the growing season.

5. Comment (page 4): “EPA’s STORET (STOrage and RETrieval Database)
and U.S. Geological Survey (USGS) monitoring data indicate azinphos
methyl concentrations are mostly 1 ppb or less, with two peak values of
less than 4 ppb between 1990 and 2005.  After 2001, the highest
concentrations from actual monitoring data were 0.75 ppb in Oregon and
less than 0.05 ppb in Pennsylvania.  However, EPA’s predictive model
estimates the concentrations to be 9.9 ppb in Oregon and 15.1 ppb in
Pennsylvania.”

OPP response:  As discussed in the response to Bayer CropScience and
Makhteshim Agan of North America comment #4, the available monitoring
data for azinphos methyl show exposures above the Agency’s threshold
of concern. Furthermore, surface water monitoring data tends to
underestimate exposures, particularly acute exposures, because
infrequent sampling makes it unlikely that the highest concentrations
that occur in any year will be captured in any given sample.  In
addition, the duration of most monitoring studies is typically only a
few years, and thus, information to characterize less frequent events is
limited.  The hydrologic setting of most sampling sites in a monitoring
program is downstream of relatively more vulnerable sites in the same
watershed. In most cases, monitoring data serves as a lower bound for
the potential exposures (and consequent risk) and is useful on that
basis.

6. Comment (page 4): “USApple believes the real concentrations are
likely to diminish over time because of the industry’s voluntary
mitigation, which proposes to reduce total annual applications from 8
lbs. to 6 lbs. of formulated product.”

OPP response:  As described in a previous evaluation of risk mitigation
proposals (D307577), the mitigation practices suggested by the U. S.
Apple Assoc. (2 applications, 60 foot buffer) along with consideration
of different spray drift scenario reduce the EECs from the 15.1 to 8.8
µg L-1 in Pennsylvania, and from 9.9 to 3.6 µg L-1 in Oregon for the
1-in 10 year peak concentration, reductions of 42 and 67% respectively.
However, in neither case does the reduction lower the risk below the
level of concern for acute risk of 0.3 µg L-1 for fish and 0.15 µg L-1
for freshwater aquatic invertebrates. In addition to the 60 ft buffers
suggested by U. S. Apple Association, a 100 ft buffer was also
simulated, with 1 in10 year peak EECs of 6.5 and 3.1 µg L-1 for
Pennsylvania and Oregon respectively. In fact, assuming no drift in the
lower exposure Oregon scenario still results in a 1 in 10 year peak EEC
of 2.1 µg L-1. So, while these suggested changes do substantially
reduce the estimated exposure for the use of azinphos methyl, they do
not mitigate the risk below the level of concern.

7. Comment (page 5):  “Attached for your consideration is a study
titled “Pesticide Use and Toxicity Assay in Mission, Bender and Yaksum
Creeks” prepared in 2003 by the Chelan County Conservation
District.”

OPP response: EPA has evaluated the monitoring data available from the
Chelan County Conservation District.  It would be difficult to conclude
that these samples represent high exposure conditions for azinphos
methyl.  Downstream sites in this study are at least 2nd and 3rd order
streams and do not represent the most vulnerable locations in the
watershed. It is not clear from the study the proximity of the various
orchards in the watershed to the creeks sampled. Surprisingly, while
there were detections in Mission Creek, the application data show no
applications of azinphos methyl to Mission Creek during June. Only
Yaksum Creek had applications of azinphos methyl made during the
sampling window.

It is not surprising that there were no significant mortality effects on
Daphnia pulex.  Laboratory data indicate that the LC50 for daphnids is
approximately 1 µg/L.  The detected levels in this study ranged from
less than 0.02 µg/L to 0.19 µg/L.

8. Comment (page 5):  “Monitoring of the Sulphur Creek Wasteway
indicate that maximum concentrations of azinphos methyl ranged from
0.023 ppb in 2003 to 0.14 ppb in 2005.”

OPP response: It is interesting that the median and maximum
concentrations increased over this period, though we believe that a
single site and three years of sampling with 18 to 31 samples per year
is insufficient to characterize the exposures associated azinphos methyl
in any general sense. Also, if that the monitoring point was at the
mouth of the wasteway then the watershed was over 100,000 acres, and the
measurements would hardly represent a vulnerable case.

9. Comment (page 5): “An analysis of the Lower Neel (sp) Creek in
Oregon during the period of summer azinphos methyl use indicates that
average concentrations of azinphos methyl were reduced from
approximately 0.33 ppb to 0.02 ppb in 2005.”

OPP response: It is difficult to determine the relevance of this
information for the azinphos methyl aquatic exposure characterization
since no ancillary data were provided.References

Flaherty, C.M. and R.D. Jones. 2005. Azinphos-methyl Insecticide:
Ecological Risk Assessment for the Use of Azinphos-methyl on Almonds,
Apples, Blueberries (Low- and Highbush), Brussels Sprouts, Cherries
(Sweet and Tart), Grapes, Nursery Stock, Parsley, Pears, Pistachios, and
Walnuts. September 29. DP Barcode 307568.

Flaherty, C.M. and R.D. Jones. 2006. Azinphos Methyl—EFED Response to
Stakeholder Comments on the Ecological Risk Assessment for “Group 3”
Uses. May 30. DP Barcode 307569.

Jones, R. David. 2006. Evaluation of Risk Mitigation Proposals from the
U. S. Apple Assoc. for Use of Azinphos methyl. Internal EPA memorandum
to Katie Hall dated July 12, 2006. D307577.

USDA NRCS. 2000. Conservation Buffers to Reduce Pesticide Losses.
Natural Resources Conservation Service. Fort Worth TX. 21 pp.

USGS NAWQA. 1999. PESTICIDES ANALYZED IN NAWQA SAMPLES:

Use, Chemical Analyses, and Water-Quality Criteria.   HYPERLINK
"http://ca.water.usgs.gov/pnsp/anstrat/"
http://ca.water.usgs.gov/pnsp/anstrat/

Appendix – Aquatic Exposure Model Input File Names tc \l1 "Appendix A
– Aquatic Exposure Model Input File Names

Input files archived for azinphos methyl applied to pome fruits.

File Name

Date

Description

W23232.dvf

weather for CA almonds scenarios (Sacramento, CA)

Caalmond0C.txt

June 17, 2004

PE4 scenario file for CA almonds, unirrigated

Pond298.exv

August 29, 2002

standard pond
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ਁ䐃愀϶D瑹㘣.܀058001 CA almond 05

September 14, 2006

CA almonds, 25 ft buffer, 7/15 app

 http://www.epa.gov/oppfead1/endanger/consultation/ecorisk-overview.pdf

 www.waterboards.ca.gov/centralvalley/tentative/0509/irr-lands/info-rpt-
program/info-program-staff-rpt.pdf

 Federal docket reference number unassigned at time of this publication

 PAGE

 PAGE   21


[Federal Register: July 29, 2009 (Volume 74, Number 144)]
[Notices]
[Page 37705-37706]
[DOCID:fr29jy09-66]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-0352; FRL-8936-9]

Final Risk and Exposure Assessment Report for Sulfur Dioxide
(SO[bdi2])

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability of final report.

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

SUMMARY: On or about July 31, 2009, the Office of Air Quality Planning
and Standards (OAQPS) of EPA is making available a final report, Risk
and Exposure Assessment to Support the Review of the SO2
Primary National Ambient Air Quality Standard: Final Report. This
document presents the approaches taken to assess exposures to ambient
SO2 and to characterize associated health risks, and
presents the results of those assessments. This document also contains
a staff policy assessment regarding the adequacy of the current
SO2 NAAQS and potential alternative primary SO2
standards.

FOR FURTHER INFORMATION CONTACT: Dr. Michael J. Stewart, Office of Air
Quality Planning and Standards (Mail Code C504-06), U.S. Environmental
Protection Agency, Research Triangle Park, NC 27711; e-mail:
<EMAIL_ADDRESS>telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

General Information

A. How Can I Get Copies of This Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
Docket ID No. EPA-HQ-OAR-2007-0352. Publicly available docket materials
are available either electronically through http://www.regulations.gov
or in hard copy at the EPA Docket Center (EPA/DC), EPA West, Room 3334,
1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the Office
of Air and Radiation Docket is<PHONE_NUMBER>.
    2. Electronic Access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
    Under section 108(a) of the Clean Air Act (CAA), the Administrator
identifies and lists certain pollutants which ``cause or contribute to
air pollution which may reasonably be anticipated to endanger public
health or welfare.'' The EPA then issues air quality criteria for
listed pollutants, which are commonly referred to as ``criteria
pollutants.'' The air quality criteria are to ``accurately reflect the
latest scientific knowledge useful in indicating the kind and extent of
all identifiable effects on public health or welfare which may be
expected from the presence of [a] pollutant in the ambient air, in
varying quantities.'' Under section 109 of the CAA, EPA establishes
national ambient air quality standards (NAAQS) for each listed
pollutant, with the NAAQS based on the air quality criteria. Section
109(d) of the CAA requires periodic review and, if appropriate,
revision of existing air quality criteria. The revised air quality
criteria reflect advances in scientific knowledge on the effects of the
pollutant on public health or welfare. The EPA is also required to

periodically review and, if appropriate, revise the NAAQS based on the
revised criteria.
    Air quality criteria have been established for sulfur oxides
(SOX) and NAAQS have been established for sulfur dioxide
(SO2), an indicator for gaseous SOX. Presently,
EPA is in the process of reviewing the NAAQS for SO2. As
part of its review of the NAAQS, EPA prepared an assessment of
exposures and health risks associated with ambient SO2. A
plan describing the proposed approaches to assessing exposures and
risks was described in Sulfur Dioxide Health Assessment Plan: Scope and
Methods for Exposure and Risk Assessment. This document was released
for public review and comment in November 2007 and was the subject of a
consultation with the Clean Air Scientific Advisory Committee (CASAC)
on December 5-6, 2007. Comments received from that consultation were
considered in developing a draft document, Risk and Exposure Assessment
to Support the Review of the SO2 Primary National Ambient Air Quality
Standard: First Draft, which was released for public review and comment
in July 2008 and was the subject of a CASAC review on July 30-31, 2008.
Comments received from that review were considered in developing a
second draft document, Risk and Exposure Assessment to Support the
Review of the SO2 Primary National Ambient Air Quality Standard: Second
Draft, which was released for public review and comment in March 2009
and was the subject of a CASAC review on April 16-17, 2009. In
preparing the final risk and exposure assessment report, EPA considered
comments received from CASAC and the public at and subsequent to that
meeting.
    The Risk and Exposure Assessment to Support the Review of the SO2
Primary National Ambient Air Quality Standard: Final Report being
released at this time conveys the approaches taken to assess exposures
to ambient SO2 and to characterize associated health risks,
and presents the results of those assessments. This document also
contains a staff policy assessment that considers the health evidence
presented in an EPA document, Integrated Science Assessment for Oxides
of Sulfur (available at: http://www.epa.gov/ttn/naaqs/standards/so2/s_
so2_cr_ isa.html), and the exposure and risk characterization
results, as they relate to the adequacy of the current SO2
NAAQS and consideration of potential alternative primary SO2
standards. The Risk and Exposure Assessment to Support the Review of
the SO2 Primary National Ambient Air Quality Standard: Final Report
will be available online at: http://www.epa.gov/ttn/naaqs/standards/
so2/s_so2_cr_rea.html.

    Dated: July 22, 2009.
Jenny Noonan Edmonds,
Acting Director, Office of Air Quality Planning and Standards.
[FR Doc. E9-18005 Filed 7-28-09; 8:45 am]

BILLING CODE 6560-50-P


43rd EXECUTIVE COMMITTEE FACE-TO-FACE MEETING

AGENDA

February 4 - 5, 2010

Marriott at Metro Center

775 12th Street, NW

     Washington, DC  20005

Phone:<PHONE_NUMBER>

Thursday, February 4, 2010

8:30 a.m. – 9:00 a.m.		Registration

9:00 a.m. – 9:15 a.m.		Welcome and Introductions		Dr. Gary S. Sayler, Chair,

- Review of September 		Executive Committee

	Meeting Minutes

- Overview of Agenda

9:15 a.m. – 9:30 a.m.	BOSC DFO Remarks			Mr. Greg Susanke, Designated

	- Administrative Issues			Federal Officer (DFO), Office 						of Research and Development 						(ORD)

9:30 a.m. – 10:15 a.m.		AA/ORD Remarks			Dr. Paul Anastas, Assistant 	 								Administrator for ORD

10:15 a.m. – 10:30 a.m.		Break

10:30 a.m. – 10:45 a.m.		Subcommittee Updates

				- Drinking Water Program Review	Dr. Chuck Haas,

									Subcommittee Chair

				- Global Change Program Review	Dr. Henry Falk,

									Subcommittee Vice Chair

	10:45 a.m. – 12:00 p.m.		Computational Toxicology		Dr. Dennis Paustenbach, Chair, 						Letter Report				CompTox Subcommittee

				- Presentation

				- Discussion

12:00 p.m. – 1:00 p.m.		Lunch

1:00 p.m. – 1:30 p.m.		EPA Science Advisory Board 		Dr. Vanessa Vu,

				(SAB) Activities			Director SAB

1:30 p.m. – 2:30 p.m.		Decision Analysis Workgroup Report	Dr. Katherine von Stackelberg,

									Workgroup Chair, Executive 											Committee

	2:30 p.m. – 2:45 p.m.		Break

	2:45 p.m. – 3:15 p.m.		Program Review Process: 		Mr. Greg Susanke, DFO, ORD

					Recommendations and Changes

	3:15 p.m. – 3:45 p.m.		Subcommittee Charge Question 		Mr. Greg Susanke, DFO, ORD

					Revisions

	3:45 p.m. – 4:15 p.m.		BOSC Guidance for Development 	Mr. Greg Susanke, DFO, ORD

					of Program Review Reports and

					ORD Mid-Cycle Progress Reports

	4:15 p.m. – 5:00 p.m. 		Executive Committee Open Forum: 	Dr. Gary Sayler, Chair,

					Roles and Issues			Executive Committee

	5:00 p.m.			Recess

Friday, February 5, 2010

8:30 a.m. – 9:00 a.m.		ORD Update				Dr. Kevin Teichman, Deputy 						 			Assistant Administrator for 										Science for ORD

9:00 a.m. – 10:00 a.m.		ORD Response to Clean Air Report	Dr. Dan Costa,

									National Program Director,

									Clean Air Research Program

	10:00 a.m. – 10:15 a.m.		Public Comment

10:15 a.m. – 10:30 a.m.		Break

	10:30 a.m. – 11:30 a.m.		Executive Committee Open Forum:	Dr. Gary Sayler, Chair,

					Roles and Issues (cont’d	)		Executive Committee

	11:30 a.m. – 12:00 p.m.		Future Discussion/Future Business	Dr. Gary Sayler, Chair,

	- EC Meetings in 2010			Executive Committee

					- Future Work

12:00 p.m.			Adjourn

 Agenda for February 4 - 5, 2010 Executive Committee Meeting

 PAGE

 PAGE   2

            A Federal Advisory Committee for the U.S. Environmental Protection Agency’s Office of Research and Development


[Federal Register Volume 79, Number 54 (Thursday, March 20, 2014)]
[Rules and Regulations]
[Page 15541]
[FR Doc No: 2014-05882]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2014-N-0002]

Zoetis Inc., Withdrawal of Approval of New Animal Drug
Applications; Chlortetracycline; Sulfathiazole; Penicillin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the withdrawal of approval of a new animal
drug application (NADA) and two abbreviated new animal drug
applications (ANADAs) for three-way, fixed-ratio combination drug Type
A medicated articles containing chlortetracycline, sulfathiazole, and
penicillin. This action is being taken at the sponsor's request because
these products are no longer manufactured or marketed.

DATES: This rule is effective March 31, 2014.

FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Zoetis Inc., 333 Portage St., Kalamazoo, MI
49007 has requested that FDA withdraw approval of the following NADA
and two ANADAs because the products are no longer manufactured or
marketed:

------------------------------------------------------------------------
                NADA/ANADA                        Proprietary name
------------------------------------------------------------------------
039-077...................................  CSP 250 (chlortetracycline,
                                             sulfathiazole, and
                                             penicillin) Type A
                                             medicated article.
200-140...................................  AUREOZOL (chlortetracycline,
                                             sulfathiazole, and
                                             penicillin) Type A
                                             medicated article.
200-167...................................  AUREOZOL 500 Granular
                                             (chlortetracycline,
                                             sulfathiazole, and
                                             penicillin) Type A
                                             medicated article.
------------------------------------------------------------------------

    The NADAs listed were identified as being affected by guidance for
industry (GFI) 213, ``New Animal Drugs and New Animal Drug
Combination Products Administered in or on Medicated Feed or Drinking
Water of Food-Producing Animals: Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use Conditions with GFI 209'',
December 2013.
    Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADA 039-077, ANADA 200-140, and ANADA 200-167, and
all supplements and amendments thereto, is withdrawn, effective March
31, 2014. As provided in the regulatory text of this document, the
animal drug regulations are amended to reflect these voluntary
withdrawals of approval.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority: 21 U.S.C. 360b, 371.

Sec.  558.4  [Amended]

0
2. In Sec.  558.4(d), in the ``Category II'' table, remove the entry
for ``Sulfathiazole'' and its respective following entries.

Sec.  558.155  [Removed]

0
3. Remove Sec.  558.155.

    Dated: March 12, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-05882 Filed 3-19-14; 8:45 am]
BILLING CODE 4160-01-P


Supporting Statement

for

Waterfront Facilities Handling Liquefied Natural Gas (LNG)

and Liquefied Hazardous Gas (LHG)

OMB No.: 1625-0049

COLLECTION INSTRUMENTS:  Instruction

A.  Justification

1.  Circumstances which make the collection of information necessary.

The Coast Guard has regulations that provides safety standards for the
design and construction, equipment, operations, maintenance, personnel
training, and fire protection at waterfront facilities handling
liquefied natural gas (LNG) and liquefied hazardous gases (LHG) (33 CFR
Part 127).  These regulations implement the Ports and Waterways Safety
Act of 1972 (PWSA), as amended by the Port and Tanker Safety Act of 1978
(33 U.S.C. 1225), and are necessary to prevent or mitigate the results
of an accidental release of LNG or LHG at a waterfront facility.  They
would reduce the probability that an accident could occur, and would
reduce the damage and injury to persons and property should an accident
occur.

The regulations contain information collection requirements in the
following sections:

	A.	127.007			Letter of Intent (LOI)

	B.	127.015			Appeals

	C.	127.017			Alternatives

	D.	127.019,	127.305,	127.1305	Operations Manual

	E.	127.019,	127.307,	127.1307	Emergency Manual

	F.	127.301,	127.1301		Certification of person in charge

	G.	127.317,	127.1317		Declaration of Inspection

	H.	127.409,	127.1409		Records of maintenance

	I.               127.007
Waterway Suitability Assessment (WSA)

This information collection supports the following strategic goals:

Department of Homeland Security

Prevention

Protection

U.S. Coast Guard

Safety

Protection of the Natural Resources

Prevention Policy & Response Policy Directorates (CG-5P & CG-5R)

Reduce crewmember deaths and injuries on U.S. commercial vessels

Reduce the amount of chemicals entering the environment

Reduce the consequences of pollution incidents

2.  Purpose of the information collection.

A.  The LOI is needed to alert the U.S. Coast Guard Captain of the Port
(COTP) that a waterfront facility plans to conduct transfers of LNG or
LHG, in bulk.  It also provides a point of contact at the facility.
Once a letter has been received, the COTP can direct the necessary
enforcement activity to ensure that the operator complies with the other
requirements in 33 CFR 127.  The LOI also provides the information used
by the COTP to determine the suitability of the waterway, on which the
waterfront facility is located, for LNG or LHG vessel traffic.  Changes
to the information in the LOI are required to be submitted whenever they
occur.  Without the LOI, COTPs would not learn of the opening or
reopening of a waterfront facility handling LNG or LHG far enough in
advance to allocate resources, to enforce construction and design
standards, and to plan enforcement strategy.  Also, COTPs would not have
the information necessary to properly evaluate the suitability of a
waterway for vessels carrying LNG or LHG.

B.  Any person directly affected by an action taken under these
regulations may appeal that action to the District Commander.  If still
not satisfied with the Coast Guard's decision, that person may appeal
the decision to the Assistant Commandant for Prevention Policy, in
Washington, DC.  If the appeal is not made in writing, the operator's
request for an appeal cannot be properly evaluated.

C.  If it is impractical for the operator of a waterfront facility
handling LNG or LHG to comply with the requirements in these
regulations, and an alternative is available that provides at least the
same degree of safety as the regulations, the operator may request
permission to use an alternative procedure, method, or equipment
standard.  The operator must submit the request for an alternative in
writing to the COTP.  Without a written request the COTP cannot properly
evaluate the proposed alternative.

D.  The owner or operator of a waterfront facility handling LNG or LHG
must develop and submit to the COTP two copies of the facility’s
Operations Manual.  If the manual is found not to be in compliance with
section 127.305 or 127.1305 of the regulations, transfer operations
cannot be conducted at the facility.  The Operations Manual is a
critical part of the enforcement strategy. Without it, the COTP cannot
determine if safe operating procedures and an effective training program
are set up by the waterfront facility operator.

E.  The owner or operator of a waterfront facility handling LNG or LHG
must develop and submit to the COTP two copies of the facility's
Emergency Manual.  If the manual is found not to be in compliance with
section 127.307 or 127.1307 of the regulations, transfer operations
cannot be conducted at the facility.  The Emergency Manual is a critical
part of the enforcement strategy. Without it, the COTP cannot determine
if effective procedures have been set up by the waterfront facility
operator to respond to emergencies (such as fires and releases of LNG or
LHG) on the facility.

F.  The operator of an LNG or LHG waterfront facility must certify in
writing that each person in charge of shoreside transfer operations
meets the qualifications set forth in the regulations.  A copy of each
certification must be made available for inspection at the facility.
During routine inspections of the facility, the COTP examines these
certifications to ensure that the persons in charge of shoreside
transfer operations are qualified.  Without these certifications, the
COTP would have to develop and administer tests or would have to observe
qualification training in order to verify that the person in charge is
properly qualified.  Both of these means would create a greater burden
than operator certification.

G.  Before LNG or LHG transfer operations begin, the person in charge of
shoreside transfer operations must complete, with the person in charge
of vessel transfer operations, a Declaration of Inspection.  The
Declaration of Inspection is a check-off list of transfer requirements
which helps to reduce human error and equipment failure, thereby
preventing accidental releases of LNG and LHG.  It identifies each
person in charge, who must sign it, and places the responsibility for
safely conducting the transfer on that person.  The Declaration of
Inspection must be retained for 30 days after completion of the
transfer.  During routine inspections of the facility, the COTP will
examine these Declarations of Inspection to ensure that they have been
completed properly before each transfer.  The COTP also uses this
information to identify the responsible person in charge when a
violation of the requirements occurs.  Without the Declaration of
Inspection, the COTP could not verify that persons in charge are
following proper transfer procedures and the probability of human errors
or equipment failures resulting in LNG or LHG releases will increase.

H.  Tests and inspections of the LNG and LHG transfer system must be
conducted on a regular basis to ensure that these systems will not fail
and release LNG or LHG.  Records of these tests and inspections must be
retained at the facility for 24 months.  During routine inspections of
the facility, the COTP examines these records to ensure that the
required tests have been completed.  Without these records the operator
would have to wait for a Coast Guard inspector to witness the tests to
verify that they were done, thereby increasing the burden on both the
operator and the Coast Guard.  If the tests and inspections are not
conducted, the incidence of LNG and LHG releases due to equipment
failures will increase.

I.  All LNG owners and operators seeking authorization to site,
construct, and operate new LNG import or export facilities or those
seeking authority to make modifications to existing or approved LNG
import or export facilities must file a request to participate in the
pre-filing process with FERC.  The FERC regulation requires LNG owners
or operators to file their LOI and WSA with the Coast Guard at the same
time they make their initial filing with FERC per their pre-filing
procedures in 18 CFR 157.21.

3.  Considerations of the use of improved technology.

Information may be submitted by mail, fax or electronically via e-mail
to the COTP at the local CG Sector Office.  Contact info for CG Sector
Offices can be found at—  HYPERLINK "http://www.uscg.mil/top/units/"
http://www.uscg.mil/top/units/ .  At this time, we estimate that 67% of
reporting requirements are done electronically.

4.  Efforts to identify duplication.

The Coast Guard monitors State and local regulatory activity in this
field.  To date no equivalent State or local programs have been
identified that require similar information, and no other Federal
agencies have equivalent regulatory requirements.

5.  Methods used to minimize the burden to small businesses if involved.

The Coast Guard believes that these requirements do not have a
significant economic impact on small entities.  Few, if any, small
entities are involved in the costly and highly technical operations of
LNG and LHG waterfront facilities.  All existing LNG waterfront
facilities are owned and operated by multi-million dollar corporations
and all are large companies based on industry size standards available
at the Small Business Administration’s website.  Most LHG waterfront
facilities are also operated by large entities.  Those LHG facilities
operated by small entities generally handle small quantities of LHG and
can avoid the burdens of this regulation by receiving packaged shipments
of LHG instead of bulk shipments.

The appeal and alternatives requirements are intended to reduce the
burden on small entities by allowing them to request less burdensome
procedures where justified by small scale or simplified operations at a
small waterfront facility.

6.  Consequences to the Federal program if collection were conducted
less frequently.

A,D,E,F.  The LOI, the Operations Manual, and the Emergency Manual are
submitted only once, before the facility begins transferring LNG or LHG.
 The certification for persons in charge is completed each time a new
individual is qualified as a person in charge.  Less frequent collection
of this information would have the same consequences as not collecting
the information.

B,C.  Appeals and alternatives are submitted whenever the operator makes
a request.  Less frequent collection would prevent the waterfront
facility operator's requests from being considered.

G.  Declarations of Inspection are collected for each transfer.  Less
frequent collection would prevent the COTP from verifying that persons
in charge are following proper transfer procedures for each transfer.
This would increase the probability of human errors or equipment
failures resulting in LNG or LHG releases will increase.  It would also
make identification of the responsible person in charge more difficult
when a discharge does occur.

H.  The recordkeeping requirements are recorded whenever each event
occurs.  If they were reported and recorded less frequently, facility
operations would be delayed until the COTP sent his representative to
obtain the information needed to verify compliance, evaluate the
request, or witness the procedure.

I.  A WSA is a risk-based assessment process designed to document and
address all safety and security concerns related to the movement of LNG
in U.S. ports and waterways.  Since 2005, FERC regulations have required
that prospective applicants for FERC authorization to site, construct
and operate LNG terminals submit WSAs to the Coast Guard.  Less frequent
collection would prevent the waterfront facility operator's requests
from being considered.

7. Special collection circumstances.

This information collection is conducted in manner consistent with the
guidelines in 5 CFR 1320.5(d)(2).

8.  Consultation.

A 60-day Notice will be published in the Federal Register to obtain
public comment on this collection.

9.  Provide any payment or gift to respondents.

There is no offer of monetary or material value for this information
collection.

10.  Describe any assurance of confidentiality provided to respondents.

There are no assurances of confidentiality provided to the respondents
for this information collection.

11.  Additional justification for any questions of a sensitive nature.

There are no questions of sensitive language.

12.  Estimates of annual hour and cost burdens to respondents.

The estimated number of respondents is 156.

The estimated number of responses is 4,729.

The estimated hour burden is 5,019 hours.

The estimated cost burden is $460,059.

There are a number of facilities in the United States that handle LNG
and LHG.  Many of these facilities also handle dangerous cargos or oil
in bulk, and are therefore also regulated under 33 CFR 126 or 154,
respectively.  The annualized costs and burden to the respondents for
the collection of information is based upon the following assumptions:

an hourly wage rate for management personnel equivalent to O-5 (Out
Gov’t)

an hourly wage rate to perform a WSA equivalent to O-4 (Out Gov’t)

an hourly wage rate to review WSA and write LOR equivalent to O-4 (In
Gov’t)

an hourly wage rate for technicians equivalent to O-3 (Out Gov’t)

an hourly wage rate for clerical personnel equivalent to E-4 (Out
Gov’t)

The calculations for each reporting/recordkeeping element of this
collection for LHG and LNG facilities are found in Appendixes A and B
respectively.  The appendixes include the annual number of respondents
and responses, as well as the estimated annual hour burden and cost
(totals may not sum due to independent rounding).  A description of
assumptions for each collection element is below.

A.  LOI:  Only one LOI is required during the lifetime of the facility
unless the owner or operator plans new changes on an existing facility
or the facility is deactivated or the owner /operator changes.  Past
experience with bulk liquid facilities indicates that approximately 6%
of the facilities submit a new or resubmit a LOI each year.

B.  Appeals:  Appeals are very rare, but to account for their
possibility, we assume an average of 1% of respondents will submit an
appeal per year.

C.  Alternatives:  Past experience with bulk liquid transfer facilities
indicates that approximately 1% of the facilities submit an alternative
request per year.

D.  Operations Manual Development:  Operations Manuals only need to be
developed once during the lifetime of a facility.  Based on our
experience, we assume that approximately 3% of facilities will be
replaced by newer facilities in a given year.

E.  Operations Manual Amendments:  Certain changes to facility systems
will require facility owners to amend their Operations Manual.  We
assume that 6% of facilities will update their Operations Manual
annually.

F.  Emergency Manual Development:  Same as paragraph D.

G.  Emergency Manual Amendment:  Same as paragraph E.

H.  Person in Charge Qualification and Certification:  An employee need
only demonstrate the required qualification and be certified as a Person
in Charge once for the duration of his or her employment with a
facility.  New qualification and certification must therefore only be
conducted to for the new employees.  Large facilities, operating with
three shifts, will typically employ three Persons in Charge plus one
alternate.  Using the conservative estimate of employee turnover at 33%,
facilities must recertify, on average, one-third of their four Persons
in Charge.  Restated, each facility will, on average, conduct
certification of 1.33 Persons in Charge each year.  Each facility is a
respondent, and the number of responses is the population of LNG and LHG
facilities multiplied by 1.33.

I.  Declaration of Inspection:  The Coast Guard estimates that LHG
facilities will, on average, each conduct approximately 26 transfers per
year.  Each facility is therefore a respondent, and the number of
responses may be calculated by multiplying the population of LHG
facilities by 26.  We estimate that LNG facilities make on average 46
transfers per year.

J.  Maintenance Records:  Each LHG and LNG facility must conduct and
record a series of tests and inspections.  Both the number of
respondents and the number of responses is therefore equal to the
population of LNG and LHG facilities.

K. Waterway Suitability Assessment:  The WSA requirements have been in
place for several years.  As a WSA is required when an owner/operator
seeks authorization to site, construct, and operate new facility or
seeks authority to make modifications to existing facility, we assume an
average of 1 submission per year.  We estimate that it takes about 704
hours per WSA.

13.  Total of annualized capital and start-up costs.

There are no capital, start-up or maintenance costs associated with this
information collection.

14.  Estimates of annualized Federal Government costs.

The estimated annual Federal Government cost is $40,444 (see Appendix
C).  This wage rate for officers was derived by averaging the standard
“in government” rates for pay grades O-3 and O-2.  The rate for
enlisted time uses the average standard “in government” rates for
pay grades E-6 and E-5.

15.  Explain the reasons for the change in burden.

The change in burden is an ADJUSTMENT due to a change (i.e., decrease)
in the estimated annual number of respondents.  There is no proposed
change to the recordkeeping requirements of this collection.  The
recordkeeping requirements, and the methodology for calculating burden,
remain unchanged.

16.  Plans for tabulation, statistical analysis, and publication.

This information collection will not be published for statistical
purposes.

17.  Approval to not display expiration date.

The Coast Guard will display the expiration date for OMB approval of
this information collection.

18.  Exception to the certification statement.

The Coast Guard does not request an exception to the certification of
this information collection.

B.  Collection of Information Employing Statistical Methods

This information collection does not employ statistical methods.

  Of the active LNG facilities in the United States (including storage
facilities), this collection is relevant to the current shoreside
facilities (including expansion projects) as well as proposals for new
facilities that require an initial LOI.

  In addition, this collection accounts for the cost and time that is
required for an LNG or LHG facility to conduct and perform a WSA.  On
October 18, 2005, the Federal Energy Regulatory Commission (FERC)
published a final rule in the Federal Register (70 FR 60426)
implementing the Energy Policy Act of 2005 and requiring pre-filing
procedures for reviewing LNG terminals and other natural gas facilities.
 The FERC rulemaking amended the regulations in 18 CFR parts 153 and 157
by requiring LNG and other natural gas facility owners and operators
(referred to collectively herein as “LNG owners and operators”) to
submit a WSA to the U.S. Coast Guard pursuant to 33 CFR 127.007 and 18
CFR 157.21(a) and (d).

  Upon receiving an LNG owner or operator’s request to participate,
the Director of the Commission’s Office of Energy Projects (Director)
determines whether the LNG owner or operator has adequately addressed
the requirements of 18 CFR part 157 and may begin the pre-filing
process.  The FERC regulation requires LNG owners or operators to file
their LOI and Preliminary WSA with the Coast Guard at the same time they
make their initial filing with FERC per their pre-filing procedures in
18 CFR 157.21.  The LNG owner or operator must submit the LOI and the
Preliminary WSA to the COTP.  Under the rules, the LOI submission
requirements for an LHG facility will differ from an LNG facility.
Applicants for LHG facilities must submit an LOI to the COTP no later
than the date when the applicant files their permit application with the
lead State or Federal agency having jurisdiction.  However, in all cases
it must be at least 1 year prior to the start of construction.  At the
time the applicant submits an LOI, the applicant must also submit a
Preliminary WSA to the COTP.  Finally, a Follow-on WSA must be submitted
to the COTP at least 180 days prior to the start of construction.

  Hourly wage rates taken from COMDTINST 7310.1 (series)

  See Appendix B.

  Hourly wage rates taken from COMDTINST 7310.1 (series)

1625-0049

  PAGE  1  of   NUMPAGES   6


[Federal Register: November 18, 2005 (Volume 70, Number 222)]
[Proposed Rules]
[Page 69922]
[DOCID:fr18no05-15]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 271

[FRL-7998-7]

Massachusetts: Extension of Interim Authorization of State
Hazardous Waste Management Program Revision

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The EPA is proposing to extend the expiration date from
January 1, 2006 to January 1, 2011 for the interim authorization under
the Resource Conservation and Recovery Act, of the Massachusetts
program for regulating Cathode Ray Tubes (``CRTs''). Massachusetts was
granted interim authorization to assume the responsibility under the
Toxicity Characteristics Rule (``TC Rule'') for regulating CRTs on
November 15, 2000, with an expiration date of January 1, 2003. This
expiration date was subsequently extended until January 1, 2006. As
this interim authorization is soon due to expire, an extension is
needed for the reasons explained elsewhere in today's Federal Register.
In the ``Rules and Regulations'' section of this Federal Register, EPA
is publishing a rule to authorize the extension without a prior
proposal because we believe this action is not controversial and do not
expect comments that oppose it. Unless we get written comments which
oppose this extension during the comment period, the decision to extend
the interim authorization will take effect. If we get comments that
oppose this action, we will publish a document in the Federal Register
withdrawing this rule before it takes effect and this separate document
in this proposed rules section of this Federal Register will serve as
the proposal to authorize the changes. We will then respond to public
comments in a later final rule based on this proposal. You may not have
another opportunity for comment. If you want to comment on this action,
you must do so at this time.

DATES: Send your written comments by December 19, 2005.

ADDRESSES: Send any written comments to Robin Biscaia, EPA New England,
One Congress Street, Suite 1100 (CHW), Boston, MA 02114-2023;
telephone:<PHONE_NUMBER>. Documents related to EPA's previous decision
to grant interim authorization (regarding regulation of CRTs) and the
materials which EPA used in now considering the extension (the
``Administrative Record'') are available for inspection and copying
during normal business hours at the following locations: Massachusetts
Department of Environmental Protection, Business Compliance Division,
One Winter Street--8th Floor, Boston, MA 02108, business hours: 9 a.m.
to 5 p.m., telephone:<PHONE_NUMBER>; or EPA New England Library, One
Congress Street--11th Floor, Boston, MA 02114-2023, business hours: 10
a.m. to 3 p.m., Monday through Thursday, telephone:<PHONE_NUMBER>.
    Comments may also be submitted electronically or through hand
delivery/courier; please follow the detailed instructions in the
ADDRESSES section of the immediate final rule which is located in the
Rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Robin Biscaia, Hazardous Waste Unit,
Office of Ecosystems Protection, EPA New England, One Congress Street,
Suite 1100 (CHW), Boston, MA 02114-2023, telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: For additional information, please see the
immediate final rule published in the ``Rules and Regulations'' section
of this Federal Register.

    Dated: November 9, 2005.
Robert W. Varney,
Regional Administrator, EPA New England.
[FR Doc. 05-22892 Filed 11-17-05; 8:45 am]

BILLING CODE 6560-50-P


 Forwarded by Dave Svendsgaard/ RTP/ USEPA/ US on 08/ 20/ 03 02: 42 PM  Bill Harnett 08/ 15/ 03 03: 02 PM To: Arthur_ G._ Fraas@ omb. eop. gov, Amy_ L._ Farrell@ omb. eop. gov cc: Bill Wehrum/ DC/ USEPA/ US@ EPA, Jeff Holmstead/ DC/ USEPA/ US@ EPA, Dave Svendsgaard/ RTP/ USEPA/ US@ EPA Subject: Revised ERP Preamble and Rule and first draft of TSD Dear Amy and Art,

Attached for your weekend reading pleasure at the beach are clean and redline copies of the revised Preamble and Rule for the ERP. Also attached is a draft of Technical Support Document ( aka response to comment document). Related to the TSD, we have been pulling language from the Preamble into that document and it is one iteration behind on some of the changes. The Preamble and Rule should be viewed as the latest language at this stage. If you have questions, please call me on my cell phone ( XXX) xxx xxxx. Hope you have fun at the beach. Talk with you on Monday.

Thanks.

Bill