This is a request for information
from the SRIPMC. Please note the following
request for information on aldicarb (Temik) use on a number of crops. Since comments must be submitted to EPA by
Darrell Hensley
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The email address for EPA's Sherrie Kinard is incorrect on the Federal
Register Notice. Please send your comments to the EPA Pubic
Docket,
teung.f.chin@usda.gov AND (not sherrie.kinard@epa.gov).
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On May 17, EPA released its health
effects risk assessment for aldicarb and
related documents for a 60-day public comment period. Public comments on
the
risk assessment must be received by the EPA Public Docket by
part of its Reregistration Eligibility
Decision (RED) for the pesticide.
All the EPA risk assessment documents may be reviewed in the EPA
docket
under Docket Identification Number "EPA-HQ-OPP-2005-0163" at
http://www.regulations.gov
. Enter the Docket identification
Number into
the appropriate space in the "Advanced Search" tab and in
the "Docket ID"
space.
EPA considered the use or proposed
use of aldicarb on the following crops:
Bananas (proposed imported tolerance)
Citrus, Other (includes kumquats,
limes, tangelos and tangerines),
Grapefruit, Lemons,
Potatoes, Sweet Potatoes, Yams, Beans/Peas,
Dry, Beans/Peas, Green,
Sorghum, Alfalfa, Peanuts, Soybeans, Sunflower, Cotton, Sugar Beets,
Sugarcane, Coffee
(imported), and Tobacco.
The following benefits information is
needed:
In what regions (state/county, etc.)
of the
occurring?
What is the percent crop treated in
the states where aldicarb
is used? (this
is especially important information for potatoes)
What are the pests that aldicarb is critical for controlling?
What are the details of typical usage
patterns (e.g., number of
applications per season, use rate per application, acres treated, and time
of application in the season?)
What worker activities typically
occur when aldicarb is applied?
What alternatives, if any, are
available to replace aldicarb?
Please provide as much detail and
documentation in your comments as
possible so that the Agency is fully informed in its decision-making.
The EPA May 17 Federal Register
provides additional information including
how to submit your comments to the docket:
http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/E6-7496.htm
Besides submitting your comments directly
to the EPA public docket, please
also send a copy to teung.f.chin@usda.gov and kinard.sherrie@epa.gov
[NOT sherrie.kinard@epa.gov] so USDA
and EPA may better coordinate.
For your information, EPA is also
requesting interested parties:
1.
To provide comments and input on the Agency’s risk assessments for
aldicarb. Such comments
and input could address, for example, the
availability of additional data to further refine the risk assessments,
such as, additional toxicological data, worker exposure data, and
usage
information, or could address the Agency’s risk assessment
methodologies
and assumptions as applied to this specific pesticide.
2.
To provide risk management proposals for aldicarb.
Risks of concern
associated with the use of aldicarb are: acute
dietary risk estimates for
the general
percentile of exposure; acute aggregate food and water risk estimates for
adults and children; and worker risk estimates for most mixers, loaders
and
applicators.
3.
To submit risk management proposals for ecological risks of concern
including those to birds, mammals, fresh water and marine fish and
invertebrates. In targeting these risks of concern, the Agency solicits
information on effective and practical risk reduction measures."
(See attached file: Aldicarb Quantitative Usage Analysis (QUA) 1999 and
2000.doc)
Please do not hesitate to contact me
if you have any questions or comments.
Teung F. Chin, Ph.D.
Biological Scientist
Office of
Agricultural Research Service
United States Department of
Agriculture
LOCATED AT:
USDA Animal & Plant Health
Inspection Service
Phone (301)
734-8943 Fax (301) 734-5992
Teung.F.Chin@usda.gov
http://www.ars.usda.gov/opmp
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Request for Additional Information
and Suggestions for the Reregistration of
Aldicarb Public Comment Period:
Dear Reader:
The purpose of this document is to
summarize the current human health risk
picture for aldicarb and solicit mitigation
options. The preliminary human
health risk assessments will be released for 60-day public comment
period May
17, 2006, and will end
Human Studies Review Board
\A human toxicity intentional dosing
study was used in the aldicarb risk
assessment. EPA’s use of a human toxicity study
in the aldicarb risk
assessment is in accordance with the Agency’s
Final Rule promulgated on
Review Board determination for the adicarb-specific study used in the risk
assessment, refer to EPA’s website at
http://www.epa.gov/osa/hsrb/.
Dietary Risks
Under the Food Quality Protection Act
(FQPA), all food and drinking water
risks for a given pesticide must fit within the pesticide’s
“risk cup”.
The risk cup can be simply defined as
the “acceptable level of exposure”
to an individual from a pesticide, on an acute or chronic basis.
When dietary
risks are of concern, EPA is required to mitigate the risks down to
acceptable
levels.
The current dietary (food only) risk
assessment utilizes PDP and the Carbamate
Task Force (CTF)
market-basket data for potatoes and citrus, respectively.
Field trial data were used for all
other commodities (except sorghum, sugar
beet and sugar cane); however, residues were either very low or
non-detectable. Percent crop treated information and processing/cooking data
were also utilized where appropriate. It’s
important to note that since
aldicarb is systemic,
typical food preparation practices such as washing and
peeling are not expected to significantly reduce residues.
Sugar beet and sugarcane were excluded
from the assessment since aldicarb
residues are not expected in the processed commodities as consumed. A low
tolerance level was used for sorghum as well as percent crop treated but
resulting estimates did not contribute to risk.
Estimated acute dietary exposure and
risk from food alone exceed EPA’s level
of concern (i.e., >100 % of the aPAD)
for children 1-2 years and children 3-5
years old when compared to the rat red blood cell (RBC) cholinesterase
inhibition (ChEI) endpoint. The estimated dietary
risks for these two
population subgroups at the 99.9th percentile of exposure were 159% and
129%,
of the acute population adjusted dose (aPAD),
respectively. For the general
below EPA's level of concern (i.e., <100 % of the aPAD) at the 99.8th
percentile for both children 1- 2 years old and children 3-5 years old.
Because dietary exposure estimates
were above EPA’s level of concern at the
99.9th percentile of exposure, an
analysis was conducted to determine which
food or food forms made the greatest contribution to dietary risk. For
all
population subgroups, aldicarb residues in
potatoes were the most significant
source of di!
etary
exposure. When potatoes are removed from the dietary exposure
assessment, all remaining risk estimates are below EPA’s
level of concern.
Drinking Water Risks
Since acute dietary risks from food
alone were above EPA's level of concern
(i.e., >100 % of the aPAD), a drinking water only assessment was conducted. If
all of the allowable exposure occurred through drinking water, EPA
would not
have concerns for acute exposure to aldicarb
residues in surface water. Acute
surface water risk estimates for infants, the most highly exposed
population
subgroup, range from 1% of the aPAD [potatoes]
to 15% of the aPAD [cotton] at
the 95th percentile of exposure. Acute surface water risk estimates
for the
general
the aPAD to 7% of the aPAD.
Seven regional ground water
monitoring residue levels were used to derive an
acute dietary exposure estimate for ground water alone. The data
indicate that
acute exposure from ground water sources of drinking water is of
concern, with
acute risk estimates ranging from 20% of the aPAD
to 945% of the aPAD.
Drinking water risks based on ground
water monitoring data overestimate the
risks for all but those who obtain their drinking water from wells in
vulnerable aldicarb use areas. However, since
acute food only exposures exceed
the aPAD, EPA is concerned about any
additional exposure (to all
subpopulations) through drinking water, regardless of the source.
Occupational Risks
The occupational risk assessment for aldicarb is based on potential exposure
to agricultural workers during loading and application of granular
products.
Aldicarb is applied early in the growing season, and labels require
immediate
soil incorporation of granules; postapplication
exposures are not expected for
workers, so a quantitative postapplication risk
assessment has not been
conducted.
Unlike some pesticides, aldicarb has worker exposure data that has been
conducted with aldicarb and mirrors how aldicarb is packaged, handled, and
used in agriculture. This study was used to conduct the occupational
risk
assessment for aldicarb. Pesticide Handler's
Exposure Data (PHED) were also
used in conducting the risk assessment since the aldicarb-specific
study did
not quantify potential risks from closed loading and closed cab
scenarios.
Therefore, for the portion of the
occupational assessment which used the
aldicarb-specific worker exposure data, risks
were not of concern for most
loader and applicator exposure scenarios. However, risks for loaders
were
identified for two scenarios (MOEs for loaders
range from 14 to 130 and MOEs
for applicators range from 34 to 324).
When using the PHED data for the
closed loading and closed cab scenarios,
similar results to those found with the aldicarb-specific
study were noted for
loaders. However, when using PHED data for applicators, all scenarios
exceeded
EPA’s level of concern (MOEs for loaders
range from14 to 139; MOEs for
applicators range from 1 to 13).
Environmental Risks
The environmental risk assessment is
based on maximum rates and average usage
rates of aldicarb. The environmental risk
assessment includes risks to
terrestrial and aquatic organisms. Using multiple lines of evidence (such as
use scenarios, average or “typical”
application rates, registrant
submitted toxicity studies, open literature data, and field monitoring
data),
aldicarb poses acute
risks (mortality) to birds, mammals, and aquatic
organisms. In addition, there is the potential for chronic reproductive
effects in fish and invertebrates.
Terrestrial Organisms
For terrestrial organisms, acute
levels of concern are consistently exceeded
by a factor of greater than 100x and are frequently exceeded by more
than
1000x. Granules left exposed on the
surface
appear to be the main source of exposure, but other sources such as
residues
taken up by plants and contaminated earthworms may also serve as a
means of
exposure.
Aquatic Organisms
For aquatic organisms, there are acute
risks for freshwater fish and
invertebrates and estuarine/marine fish and invertebrates for all of the
registered uses with the exception of potatoes for freshwater fish and
invertebrates and estuarine/marine fish.
The chronic level of concern is
exceeded for freshwater invertebrates
(reproductive
effects) and estuarine/marine invertebrates (average number of
offspring endpoint) for all of the registered uses. Chronic concerns
(larval
and juvenile survival) also exist for freshwater fish for soybean,
cotton, and
pecan use patterns.
Aldicarb residues are most likely to exceed levels of concern for fish and
aquatic invertebrates in low-order streams because these streams are
dominated
by base flow conditions (where 100% of stream flow consists of
discharged
groundwater), and most of the toxic residues are believed to form within the
subsurface (especially within the saturated zone). In addition, much larger
contributing land areas sustain higher-order streams, so there is a greater
dilution effect. In addition to risk based exposure estimates from
modeling,
there were also exceedances of the Agency
levels of concern based on
monitoring data.
Solicitation for Benefits Information
and Risk Management Suggestions
At this time the dietary and
occupational risks from aldicarb are of concern
for some registered uses. In addition, the Agency has performed
preliminary
alternatives analyses, to identify available alternatives for the uses of
aldicarb that pose the
highest risks (see “Preliminary Impact Analysis for
Aldicarb on Potatoes”, “Preliminary
Impact Analysis for Aldicarb on Major
Citrus Crops”, and “Impact Analysis
for Aldicarb on Cotton”). It is
important to note that FQPA does not allow for the consideration of
benefits
analyses for risks associated with dietary exposure assessments;
therefore,
benefits analyses play an important role in only non-dietary
considerations,
such as ecological and worker risks. Alternative analyses for
potatoes, citrus
and cotton are available in the docket, and show that although there
are
alternatives available for aldicarb, they tend to be
more costly and less
effective. At this time, the Agency has not been able to identify many viable!
options for effectively mitigating the dietary
risks from aldicarb. Thus,
EPA is soliciting input from
interested stakeholders on benefits information
(i.e.
critical uses of aldicarb, and impacts to growers
from the loss of
aldicarb), as well as risk
management suggestions. If you would like to
provide this type of input, please submit your comments directly to the
docket.
Here is a list of sample questions
that may help you in preparing comments:
(1) In what regions (state/county,
etc.) of the
occurring?
(2) What are the pests that you feel aldicarb is critical for controlling?
(3) What are the details of typical
usage patterns (e.g., number of
applications per season, use rate per application, acres treated, and time of
application in the season?)
(4) What worker activities typically
occur when aldicarb is applied?
(5) What alternatives, if any, do you
believe are available to replace
aldicarb?
Please provide as much detail and
documentation in your comments as possible
so that the Agency is fully informed in its decision-making.
Please respond online using the following URL:
http://www.sripmc.org/requests/answer.cfm?RID=157
See the attached file for more information: Aldicarb Document in MS-Word format