United States Office of Prevention, EPA-738-R-08-010
Environmental Pesticides and Toxic August 2008
Protection Agency Substances (7508P)
Amended Reregistration
Eligibility Decision (RED)
for Carbaryl
Revised August 2008
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AMENDED REREGISTRATION ELIGIBILITY
DECISION
for
Carbaryl
Case No. 0080
Revised August 2008
Approved by:
Steven Bradbury, Ph.D.
Director, Special Review and
Reregi strati on Division
Date
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TABLE OF CONTENTS
I. Introduction 1
II. Background 1
A. Regulatory History 1
B. Summary of Use Profile 2
III. Revised Human Health Risk Assessment 4
A. Summary of Changes to the Occupational Risk Assessment 4
1. New Data 4
2. Relevant Public Comments 6
3. New Toxicological Methodology 6
B. Summary of Revised Risk Assessments 9
1. Occupational Handler Exposure and Risk 9
2. Occupational Post-application Risks and Exposure 15
3. Poisoning Incident Data for Carbaryl 18
IV. Risk Management 19
A. Determination of Reregistration Eligibility 19
B. Occupational Risk Mitigation and Regulatory Rationale 20
1. Handler Risk Mitigation 20
2. Post-Application Risk Mitigation 25
3. Summary of Occupational Risk Mitigation and Comparison to 2004
Amended IRED Mitigation 27
V. What Registrants Need to Do 31
A. Label Changes Summary Table 32
11
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Carbaryl Reregistration Eligibility Decision Team
Office of Pesticide Programs
Health Effects Risk Assessment
Mike Metzger
Wade Britton
Kit Farwell
Biological and Economic Analysis Assessment
Donald Atwood
Timothy Kiely
Registration Support
John Hebert
Venus Eagle
Risk Management
Jacqueline Guerry
Christina Scheltema
Neil Anderson
in
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I. Introduction
The Environmental Protection Agency (EPA or the Agency) is amending the
Reregi strati on Eligibility Decision (RED) for Carbaryl, signed September 24, 2007, to
incorporate the revised occupational exposure and risk assessment. The 2007 RED amended the
Interim Reregistration Eligibility Decision (IRED) for carbaryl, which was completed by EPA on
June 30, 2003 and previously amended on October 22, 2004. This amendment updates the 2007 Red
to reflect the Revised Occupational Exposure and Risk Assessment, dated July 9, 2007. The
revised occupational risk assessment incorporates updates to the toxicological points of departure
(PoD); considers the mitigation measures required in the 2003 IRED and 2004 amended IRED;
and incorporates responses to submitted public comments and data submitted in response to the
Generic Data Call-In, issued in March 2005, which are applicable to the occupational risk
assessment.
This document summarizes the revised occupational handler and post-application risk
assessments, and presents the Agency's revised regulatory decision and risk mitigation for the
occupational uses of carbaryl. The document consists of five sections. Section I contains the
regulatory framework for reregistration; Section II provides a regulatory history of the chemical
and a profile of its use and usage; Section III gives an overview of the revised occupational risk
assessment; Section IV presents the Agency's decision on reregistration eligibility and risk
management, and compares the new mitigation to that required in the 2004 amended IRED; and
Section V summarizes the label changes necessary to implement the risk mitigation measures
outlined in Section IV. The revised occupational risk assessment for carbaryl and all other
supporting documents are available in the Office of Pesticide Programs (OPP) public docket
(http://www.regulations.gov.) under docket number EPA-HQ-2007-0941 and are available on the
Agency's web page http://www.epa.gov/pesticides/reregistration/carbaryl/.
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II. Background
A. Regulatory History
Carbaryl is an N-methyl carbamate (NMC) pesticide, which was first registered in 1959
for use on cotton. In 2001, the Agency identified the NMC pesticides as a group which shares a
common mechanism of toxicity. Therefore, the Agency was required to consider the cumulative
effects on human health resulting from exposure to this group of chemicals when considering
whether to establish, modify, or revoke a tolerance for pesticide residues in food, in accordance
with the Food Quality Protection Act of 1996 (FQPA).
The Interim Reregi strati on Eligibility Decision (IRED) for Carbaryl, signed on June 30,
2003, addressed the potential human health and ecological risks from carbaryl. The Agency
amended the IRED on October 22, 2004 to incorporate clarifications and corrections, updated the
residential risk assessment to reflect the voluntary cancellation of the liquid broadcast use of
carbaryl on residential turf to address post-application risk to toddlers identified in the 2003
IRED, and addressed issues regarding labeling of carbaryl formulations for mitigating potential
hazards to bees. In addition, the revised occupational risk assessment, which is summarized in
Section III of this document, also incorporates the mitigation measures required in the 2004
amended IRED applicable to potential occupational exposures, such as cancellation of certain
uses and application methods, reduction of application rates, application prohibitions, personal
protective equipment (PPE) and engineering control (EC) requirements, and extension of
restricted-entry intervals (REIs) for post-application exposure.
The Agency also issued generic and product-specific data call-ins (DCIs) for carbaryl in
March 2005. The carbaryl generic DCI required several studies for the active ingredient
carbaryl, including additional toxicology, worker exposure monitoring, and environmental fate
data. The product DCI required acute toxicity and product chemistry data for all pesticide
products containing carbaryl. EPA has received numerous studies in response to these DCIs,
and, where appropriate, these studies were considered in the revised occupational risk assessment
for this amendment to the carbaryl RED.
In response to the 2005 DCIs, many carbaryl registrants chose to voluntarily cancel their
carbaryl products. Approximately 80% of all of the carbaryl end-use products registered at the
time of the 2003 IRED have since been canceled through this process or other voluntary
cancellations.
On September 26, 2007, EPA published a revised NMC cumulative risk assessment
(docket number EPA-HQ-OPP-2007-0935), which concluded that the cumulative risks
associated with the NMC pesticides meet the safety standard set forth in the Federal Food, Drug,
and Cosmetic Act (FFDCA). Concurrently, on September 24, 2007, the Reregi strati on
Eligibility Decision (RED) for carbaryl was completed. The 2007 RED presents EPA's revised
carbaryl human health risk assessment under FQPA and the Agency's final tolerance
reassessment decision for carbaryl. The 2007 Carbaryl RED and its background/support
documents were published on October 17, 2007 and can be found at www.regulations.gov docket
number EPA-HQ-OPP-2007-0941.
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B. Summary of Use Profile
The insecticide carbaryl is used in agriculture to control pests on terrestrial food crops
including fruit and nut trees, many types of fruit and vegetables, and grain crops; cut flowers;
nursery and ornamentals; turf, including production facilities; greenhouses; golf courses; and in
oyster beds. Carbaryl is also registered for use on residential sites (e.g., annuals, perennials,
shrubs) by professional pest control operators and by homeowners on gardens, ornamentals and
turfgrass.
Carbaryl products are manufactured as granular, liquid, wettable powder, and dust
formulations. All dry flowable (water dispersible granule) products have been voluntarily
cancelled. Groundboom, airblast, and aerial applications are typical for agricultural uses. Other
applications can also be made using handheld equipment, such as low pressure handwand
sprayers, turfguns, and various ready-to-use products. Applications by aerosol cans, hand,
spoon, shaker can, and front- and back-mounted spreaders are prohibited.
In addition, the use of dust formulation in agriculture and backpack sprayers are not
being supported by Bayer CropScience, the carbaryl technical registrant, who is amending their
carbaryl registrations to delete these uses. EPA intends to publish a formal Notice of this action
in the Federal Register in August 2008.
Tables 1 and 2 summarize the best Agency's estimates of carbaryl usage on agricultural
crops and non-agricultural sites, respectively.
Table 1. Summary of Carbaryl Use Data for Agricultural Crops
Crop
Alfalfa
Almonds *
Apples
Apricots
Asparagus
Avocados
Beans, Green
Beetsf
Blackberries
Blueberries
Broccoli
Brussels Sprouts *
Cabbage
Caneberries
Cantaloupes
Carrots
Cauliflower
Cherries
Corn
Cotton
Estimated Pounds Active Ingredient (a.i.)
used per year
50,000
10,000
300,000
1,000
50,000
3,000
10,000
<500
3,000
20,000
4,000
<500
3,000
<500
10,000
3,000
<500
70,000
30,000
8,000
Percent Crop Treated
Estimated
Average
<1
<1
40
5
35
5
5
Not Calculated}
30
20
<1
Not Calculated}
5
<1
15
5
<1
20
<1
<1
Estimated
Maximum
<2.5
<2.5
55
15
45
5
5
5
35
25
5
Not Calculated}
10
<2.5
25
5
<2.5
25
<2.5
<2.5
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Table 1. Summary of Carbaryl Use Data for Agricultural Crops
Crop
Cranberries f
Cucumbers
Cucumbers, Pickles
Dry Beans/Peas
Eggplant
Grapefruit
Grapes
Hay, Otherf
Lemons
Lettuce
Nectarines
Olives
Onions
Oranges
Parsley f
Peaches
Peanuts
Pears
Pecans
Peppers
Pistachios
Plums
Potatoes
Prunes
Pumpkins
Rice
Sodt
Sorghum
Soybeans
Spinach
Squash
Strawberries
Sugar Beets
Sunflowers
Sweet Corn
Sweet Potatoesf
Tangelos
Tangerines
Tobacco
Tomatoes
Walnuts
Watermelons
Wheat
Estimated Pounds Active Ingredient (a.i.)
used per year
30,000
10,000
2,000
2,000
<500
30,000
70,000
600,000
4,000
6,000
5,000
6,000
<500
100,000
<500
50,000
20,000
4,000
200,000
7,000
20,000
7,000
10,000
6,000
20,000
10,000
2,000
10,000
40,000
<500
10,000
10,000
2,000
5,000
20,000
20,000
1,000
9,000
2,000
20,000
3,000
20,000
10,000
Percent Crop Treated
Estimated
Average
Not Calculated!
5
<1
<1
15
5
5
Not Calculated}
<1
<1
5
<1
<1
5
Not Calculated!
10
<1
5
10
5
5
5
<1
<1
15
<1
Not Calculated}
<1
<1
<1
15
10
<1
<1
<1
Not Calculated!
5
5
<1
5
<1
10
<1
Estimated
Maximum
20
10
<2.5
<2.5
15
10
5
<1
<2.5
<2.5
5
<2.5
<2.5
5
5
20
5
10
15
5
5
5
5
<2.5
25
<2.5
<1
<2.5
<2.5
<2.5
20
15
<2.5
<2.5
5
15
5
10
<2.5
10
<2.5
15
<2.5
*The only use data available for this crop is from California's Department of Pesticide Regulation, but 95% or more
of the U.S. acreage for this crop is in California, f Data from Crop Life America, National Pesticide Use Database
2002, because no other data are available. ! Not calculated due to insufficient data.
Table 2. Summary of Carbaryl Nonagricultural Use Data
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Use Category
Turf
Landscape and Horticulture
Uses in Category
Turf farms
Commercial turf
Golf courses
Lawn Care Operators
Nurseries
Annual Average Pounds
Applied
(active ingredient)
201,000
44,000
III. Revised Human Health Risk Assessment
The June 29, 2007 CARBARYL. HED Chapter of the Reregistration Eligibility Decision
Document (RED), which revised the February 2003 human health risk assessment, incorporates
changes to the hazard assessment, dietary assessment (including the drinking water exposure
assessment), residential assessment, and occupational assessment. The occupational exposure
portion of the 2003 occupational and residential exposure risk assessment was revised to
incorporate new data, relevant public comments, and new toxicological methods. The following
section summarizes the July 9, 2007, Carbaryl: Revisions to Occupational Exposure and Risk
Assessment.
A. Summary of Changes to the Occupational Risk Assessment
Since the Amended Carbaryl IRED (2004 amended IRED) was posted for public
comment in October 2004, EPA received numerous comments regarding the occupational and
residential exposure assessment portions. Those which are specific to the occupational portion,
and have not been addressed in the past, are considered and incorporated in the July 9, 2007,
Revisions to Occupational Exposure and Risk Assessment. Additionally, the revised
occupational assessment includes worker monitoring data required by the IRED through a
Generic Data Call-In, as well as additional toxicological studies, which revise the toxicological
PoD. Also, as discussed previously in Section II, the revised assessment also incorporates the
mitigation measures required in the 2004 amended IRED applicable to potential occupational
exposures.
1.
New Data
EPA issued a Generic Data Call-In (GDCI) for carbaryl in March 2005 (GDCI-056801-
21325). This DCI required several confirmatory studies, including exposure monitoring and
toxicology studies. In addition, the Agency received three occupational handler studies from
Bayer CropScience in response to the GDCI requirement for applicator exposure data. All of the
following studies submitted were conducted by the Agricultural Handler Exposure Task Force
(AHETF):
• "Determination of Dermal and Inhalation Exposure to Workers during Application of a
Liquid Pesticide Product by Open Cab Airblast Application to Orchard Crops" (MRID
464482-01);
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• "Determination of Dermal and Inhalation Exposure to Workers during Closed-System
Loading and ULV Application of a Liquid Pesticide Product to Cotton" (MRID 466341-05);
and
• "Determination of Dermal and Inhalation Exposure to Workers During Loading or
Application of Carbaryl Bait" (MRID 470516-01).
In addition, to the studies submitted in response to the GDCI, two key studies that were
incorporated into the revised occupational handler risk assessment include the following:
• Dermal penetration study for carbaryl. Bayer CropScience conducted an in vitro
comparative dermal penetration study using rat skin and human skin (MRID 471519-02).
These study data were used to determine the relative dermal absorption for carbaryl in rats
and humans and were used to derive the dermal PoD used in the carbaryl risk assessment.
• Comparative cholinesterase study. The EPA's Office of Research and Development
conducted a comparative cholinesterase (ChE) study to compare carbaryl-induced ChE
inhibition in adult and juvenile rats (MRID 471430-01). These data were used to establish
the occupational inhalation (short- and intermediate-term) PoD and the dermal PoD.
A residue dissipation study, "Carbaryl: Dissipation of Dislodgeable Foliar Residues from
Chrysanthemums" (MRID 468928-01), was submitted by the Interregional Research Project
Number 4 (IR-4) of Rutgers University in support of carbaryl use on chrysanthemums and was
considered in the revised post-application risk estimate for cut flowers. Other changes from the
February 2003 occupational risk assessment include changes in some transfer coefficients (TCs)
applicable to specific crop grouping/activity combinations. Required TC changes are as follows:
• Cut Flowers: The 2003 occupational risk assessment indicated that the Agricultural Re-Entry
Task Force (ARTF) was in the process of conducting a more definitive study in the cut-
flower industry which would likely be a more reliable source of information. Since that time,
the study was conducted and submitted to the Agency for review. Results of the ARTF study
are a TC of 5100 cm2/hour and 2700 cm2/hour for hand-harvesting activities.
• Evergreen Tree Fruit: The TC for pruning of evergreen tree fruit was reduced from 1500
cm2/hour to 1000 cm2/hour. This change was based upon an ARTF pruning study of apple
and olive trees. While not specific to the evergreen tree fruit crop grouping, the exposure
data is scenario- and chemical-specific.
• Turf/Sod: Based upon the results of ARTF studies on sod farm harvesting and golf course
maintenance, TCs for these activities have been changed. The TC for the sod farm
harvesting activity has been reduced from 16500 to 6800 cm2/hr. The existing TC for golf
course maintenance is 500 cm2/hr for mowing. This value has been used in addition to a TC
of 3400 cm2/hr from the ARTF study to assess post-application risk from golf course
maintenance activities.
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Vine and Trellis: Based upon the results of an ARTF study which monitored blackberry
2
harvest, the resulting TC of 1100 cm /hr was used to assess risks for blackberry hand
harvesting in addition to existing TCs.
2. Relevant Public Comments
The occupational assessment was revised to include public comments received since the
carbaryl IRED that are specific to the occupational portion and have not been addressed in the
past. The Agency received comment from the United States Department of Agriculture (USD A),
Animal and Plant Health Inspection Service (APHIS), the National Grasshopper Management
Board, and state-run allied programs, regarding the application of carbaryl bait formulations for
suppression of Mormon cricket and rangeland grasshoppers, as well as a comment from Bayer
CropScience which addresses a new AHETF open-cab tractor airblast applicator exposure study
in orchards (MRTD 464482-01). Several other comments received (i.e., clarifications or
corrections for REI changes, application methods, or application rates for specific crops) have
been incorporated in the revisions in the revised occupational risk assessment.
The USD A APHIS submitted a comment (FDMS Docket # EPA-HQ-OPP-2003-0376-
0029) regarding the need to retain a maximum labeled treatment rate of 0.5 Ib ai/A for the bait
and liquid formulations to be effective for Mormon cricket and grasshopper suppression, which
was not considered in the 2004 IRED, and specifying that the risks from carbaryl bait
formulations are not necessarily the same as the risks from granular formulations of pesticides.
Additionally, in subsequent communication with the Agency, APHIS and program managers
from state-run allied programs provided additional information on the application of carbaryl bait
formulations for suppression of Mormon cricket and rangeland grasshoppers, including refined
use and usage data (i.e. pounds per acre, 2006 and 2007 acres treated, and hours of application
per day); specifics and characteristics of aerial and ground application equipment; and additional
information on seasonal application practices (i.e. applied once per season by local applicators).
In order to address USD A APHIS' concerns, the Agency assessed all bait and liquid
carbaryl aerial applications (mixer/loader and applicator) at the maximum labeled application
rate (0.5 Ib ai/A). To assess the potential exposure/risk from the use of the aerial bait
applications, the Agency used data for granular formulations applied aerially, which is the best
data available to the Agency.
3. New Toxicological Methodology
The mode of action of carbaryl, and all NMC insecticides, is carbamylation of
acetylcholinesterase. As described above, additional studies in adult and juvenile rats which
describe the time-course and dose-response for brain and red blood cell (RBC) ChE inhibition
have been received since the 2004 amended IRED. The occupational assessment for carbaryl
was updated to reflect the recent ChE data and resulting toxicological PoDs.
Table 3 summarizes the dermal, inhalation, and cancer dose and endpoints used in the
revised occupational risk assessment, and Table 4 compares the endpoints used in the 2003 and
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2007 carbaryl risk assessments. Further discussion of the changes in the dermal and inhalation
exposure scenarios follows.
Table 3. Dose and End points Used in the Revised Occupational Risk Assessment
Exposure
Scenario
Dermal
(short- and
intermediate-term)
Inhalation
(short- and
intermediate-term)
Cancer
Point of
Departure
(mg/kg/day)
86
1.1
Uncertainty
Factors
(UF)
UFA=10X
UF =10X
H
UFA=10X
UF =10X
11
LOC for Risk
Assessment
MOE = 100
(adult)
MOE = 100
Study and Toxicological Effects
Rat Adult Dermal Study (MRID
45630601), Brain ChE inhibition most
sensitive,
BMD1Q= 49.35 mg/kg and
BMDL1Q= 30.56 mg/kg
Adjusted by 2.8X to account for rat
skin permeability compared to human
skin (MRID 4715 1902)
Oral Comparative ChE Study- (MRID
47143001)
BMD1Q= 1.5 mg/kg and
BMDL1Q= 1.1 mg/kg, based on brain
ChE inhibition in post-natal day 1 1
(PNDll)pups
Classification: "Likely to be carcinogenic in humans"
Q* = 8.75 x 10~4 (mg/kg/day)"1
UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity
among members of the human population (intraspecies). MOE = margin of exposure. LOC = level of concern. BMD10= Bench
Mark Dose analysis using a 10% benchmark response for brain ChE inhibition. BMDL10= lower 95% confidence limit of the
benchmark dose.
Table 4. Comparison of Toxicological Endpoints Used in the 2003 and 2007 Carbaryl Occupational Risk
Assessment
Exposure Pathway
Dermal - short and intermediate
term
Dermal - long term
Inhalation - short term
Inhalation - long-term
Cancer, all routes of exposure
Toxicology Endpoint for Risk Assessment
2003/2004 IREDs
Rat 4-week dermal toxicity study
NOAEL of 20 mg/kg/day (LOAEL of
50 mg/kg/day for decreased RBC &
brain ChE)
Chronic dog study LOAEL of 3 . 1
mg/kg/day and 3X to account for data
deficiency (no NOAEL); dermal
absorption factor of 12.7%
Rat DNT study NOAEL of 1
mg/kg/day
Chronic dog study LOAEL of 50
mg/kg/day and 3X to account for data
deficiency (no NOAEL)
2007 Revision
Rat 4-week dermal toxicity study
BMDL10 of 30 mg/kg/day adjusted to
86 mg/kg/day using 2.8X dermal
penetration factor to account for
absorption across human skin
Long-term assessment is not
appropriate for carbaryl due to rapid
recovery of ChE inhibition
Rat CCA Study
Pup brain BMDLi 0 of 1 . 1 mg/kg/day
Long-term assessment is not
appropriate for carbaryl due to rapid
recovery of ChE inhibition
Qi* of 8.75 x 10"4 (mg/kg/day)"1 based on incidence of hemangiosarcomas in
mice; classified as C carcinogen
NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
population (intraspecies). MOE = margin of exposure. LOC = level of concern. . BMD10= Bench Mark Dose analysis using a
10% benchmark response for brain ChE inhibition. BMDL10= lower 95% confidence limit of the benchmark dose.
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For more detail on the revised hazard assessment, refer to the June 29, 2007, CARBARYL HED
Chapter of the Reregistration Eligibility Decision (RED).
a. Dose-Response Assessment
EPA has developed a benchmark dose analysis for carbaryl using the same modeling
methodology used in the NMC cumulative risk assessment. A benchmark dose analysis models
the dose-response relationship with a dose-response curve, which allows selection of doses
corresponding to a specified level of response, called a benchmark response. This analysis
allows EPA to determine a more appropriate PoD from a toxicology study rather than using the
study No Observable Adverse Effect Level (NOAEL) or Lowest Observable Adverse Effect
Level (LOAEL). For more information on benchmark dose modeling, please see the EPA draft
report, Benchmark Dose Technical Guidance Document (USEPA 2000).
b. Dermal Exposure
The 4-week dermal toxicity rat study with a NOAEL of 20 mg/kg/day established the
PoD for both the short- and intermediate-term dermal scenarios in the 2003 IRED. The LOAEL
of 50 mg/kg/day was based on significant decreases in RBC ChE in males and females and brain
ChE in males. The long-term dermal (months to a lifetime) scenario relied on the chronic dog
study that did not establish a NOAEL. The LOAEL of 3.1 mg/kg/day was based on plasma and
brain ChE inhibition in females. An additional uncertainty factor of 3 was applied to account for
the data deficiency.
Since the 2003 IRED, a benchmark dose (BMD) analysis from the same 4-week dermal
adult rat study has provided the central estimate (BMDio) and lower limit (BMDLio) of the ChE
data. As stated above, this BMD analysis is the same methodology used in the NMC cumulative
risk assessment for the dermal exposure scenario. The benchmark dose analysis allows for a
more accurate selection of a PoD than the previously used NOAEL approach, which is limited by
dose levels selected in a given toxicology study. The BMDio is 49 mg/kg, which corresponds
with the brain and RBC ChE inhibition observed at that LOAEL of 50 mg/kg. As in the NMC
cumulative risk assessment, the BMDLio is used as the PoD. Therefore, the BMDLio of 30.56
mg/kg is the PoD for adults in the dermal short- and intermediate-term scenarios. The 10X
intraspecies and 10X interspecies uncertainty factors are both applicable and an MOE of 100
defines the Agency's level of concern for dermal exposures. The FQPA factor is not applicable
to the occupational scenarios.
The long-term dermal exposure duration is not appropriate for carbaryl since peak
inhibition occurs rapidly with recovery occurring within hours. In 2003, EPA believed it was
appropriate to evaluate long-term (> 6 months) and chronic exposure. However, this revised risk
assessment does not include endpoints for long-term exposure because of the rapid recovery of
enzyme activity from inhibition by carbaryl. Recent data for carbaryl and the other NMCs show
that cholinesterase inhibition is reversible, with recovery in less than 24 hours and, therefore,
daily exposure is independent of the previous day's exposure. Thus, for the occupational risk
assessment, the daily exposure (short and intermediate-term) to carbaryl is the main duration of
concern. An in vitro dermal absorption study was also evaluated. The study showed that
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carbaryl was slowly absorbed through rat and human skin in vitro and that rat skin was about 2.8
times more permeable than the human skin at the low and mid dose. Therefore, the dermal PoD
was adjusted by 2.8X to account for the differences in permeability between human and rat skin.
c. Inhalation Exposure
Inhalation studies are not available for carbaryl; instead, PoDs from oral studies were
used. For the inhalation scenarios in the 2003 IRED, the NOAEL from a rat developmental
neurotoxicity study was used as the PoD for the short-term exposure while the NOAEL from the
rat subchronic neurotoxicity study was used for the intermediate-term exposure. The chronic
dog study NOAEL was relied on for the long-term inhalation scenario. The updated inhalation
PoD was selected from the recently conducted comparative cholinesterase study in which
cholinesterase activity was measured in both postnatal day 11 (PND 11) and 17 pups and adult
rats. The BMDLio of 1.1 mg/kg was selected for both children and adults. A 100% absorption
factor is appropriate. The 10X FQPA factor is reduced to IX since cholinesterase data from the
most sensitive subpopulation is the basis of the PoD. As discussed previously, due to the rapid
recovery of ChE inhibition a long-term inhalation assessment is not appropriate for carbaryl.
The 10X intraspecies and 10X interspecies factors are applicable and an MOE of 100 defines the
Agency's level of concern.
B. Summary of Revised Risk Assessments
Workers can be exposed to a pesticide through mixing, loading, and/or applying the
pesticide, and from entering areas previously treated with the pesticide. For dermal and
inhalation exposures, worker risk is estimated by a Margin of Exposure (MOE) which
determines how close the occupational exposure comes to the benchmark response discussed in
Section III.A.3 above. Refer to Table 3 for the toxicological PoDs used in the carbaryl
occupational assessment. The risk assessments for all durations (short and intermediate term) of
occupational exposures are similar because the toxicity PoDs are numerically the same and the
target MOE of 100 is the same for all durations. Since carbaryl is currently classified as a "likely
to be carcinogenic to humans," the Agency assessed both cancer and non-cancer risks for
occupational handlers and post-application workers.
For carbaryl, MOEs that are greater than 100 and cancer risks within the range of an
increased cancer risk of IxlO"6 generally do not exceed the Agency's level of concern. The
Agency generally considers occupational cancer risks within the range of 1 to 3xlO"6
(approximately 1-3 in 1 million persons) or less to be negligible. However, when occupational
MOEs are less than 100 or occupational cancer risks exceed 3xlO"6, EPA strives to reduce
worker cancer risks through the use of personal protective equipment and engineering controls.
1. Occupational Handler Exposure and Risk
Exposure of carbaryl to pesticide handlers (mixers, loaders, applicators and flaggers) is
likely with the type of equipment and techniques that can potentially be used. Twenty-two
occupational exposure scenarios were assessed based on registered labels, equipment, and
techniques that could be used for carbaryl applicators. The scenario numbers correspond to the
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non-cancer and cancer risk estimate tables presented in the Carbaryl: Revisions to Occupational
Exposure and Risk Assessment, June 9, 2007. The quantitative exposure/risk assessment
developed for occupational handlers is based on the following scenarios:
Mixer/Loader:
(la) Dry Flowable (DF) for Aerial/Chemigation in Agriculture;
(lb)DF for Airblast;
(Ic) DF for Groundboom;
(Id) DF for Applications;
(le) DF for Aerial Wide Area Uses;
(2a) Granular for Aerial;
(2b) Granular for Broadcast Spreader;
(3a) Liquids for Aerial/Chemigation;
(3b) Liquids for Airblast;
(3c) Liquids for Groundboom;
(3d) Liquids for Lawn Care Operators (LCO) Applications;
(3e) Liquids for Aerial Wide Area Uses;
(3f) Liquids for Ground Wide Area Uses;
(4a) Wettable Powder (WP) for Airblast;
(4b) WP for Groundboom;
(4c) WP for LCO Applications;
Applicator:
(5a) Aerial/Liquid Application;
(5b) Aerial/Liquid Wide Area Application;
(5c) Aerial/Granular Application;
(6a) Airblast Application;
(6b) Wide Area Ground Fogger (Airblast as surrogate);
(7) Groundboom Application;
(8) Solid Broadcast Spreader Application;
(9) Aerosol Can Application;
(10) Trigger Sprayer Ready-to-Use (RTU) Application;
(11) High Pressure Handwand Application (Right of Way Sprayer as surrogate) [Occupational
and Residential Exposure task Force (ORETF) Data];
Mixer/Loader/'Applicator:
(12) Turf gun Application;
(13a) WP, Low pressure handwand;
(13b) Liquid: Low Pressure Handwand;
(14) Backpack;
(15) Push-type Granular Spreader;
(16) Handheld Fogger;
(17) Powered Backpack;
(18) Granular Backpack;
(19) Tree Injection;
(20) Drenching/Dipping Seedlings for Propagation;
(21) Sprinkler Can;
10
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Flagger:
(22a) Flagging for Liquid Sprays; and
(22b) Flagging for Granular Applications.
As stated above, the 2004 amended IRED required various levels of PPE and EC for
handler activities. In conducting its revised occupational non-cancer and cancer handler risk
assessment, the Agency considered the following levels of PPE or EC:
• Baseline, or long-sleeve shirt, long pants, no gloves, and no respirator (Baseline).
• Baseline plus chemical-resistant gloves, and no respirator (SL/G/NR).
• Coveralls worn over long-sleeve shirt and long pants, chemical-resistant gloves, and no
respirator (DL/GL/NR).
• Baseline plus chemical-resistant gloves and a protection level 5 respirator (SL/GL/PF5)
or a protection level 10 respirator (SL/GL/PF10).
• Coveralls worn over long-sleeve shirt and long pants, chemical-resistant gloves, and an a
protection level 5 respirator (DL/GL/PF5) or a protection level 10 respirator
(DL/GL/PF10).
• Engineering controls, or closed mixing/loading system, enclosed cab, or enclosed cockpit
(EC).
For each of the 22 handler scenarios above, the Agency considered numerous crops or
target use sites with various application rates and area treated daily to reflect the way in which
carbaryl can be applied (approximately 98 various use patterns were assessed). In addition, as
discussed above, Bayer CropScience requested that the Agency consider a new AHETF open-
cab tractor airblast applicator exposure study (MRID 464482-01) for the assessment of carbaryl
airblast applications. The study considered two additional types of clothing/personal protective
equipment (wide brimmed "Sou'Wester" hat and hooded Tyvek® jacket) that are not currently
available in the PHED database. These additional 12 exposure scenarios are presented in the
non-cancer and cancer (private and commercial farm worker) risk estimate tables 5, 8, and 9,
respectively, in the Carbaryl: Revisions to Occupational Exposure and Risk Assessment, June 9,
2007.
a. Non-cancer Risk Summary
The non-cancer risk assessment considers all durations (both short- and intermediate-
term) exposure to carbaryl, and dermal and inhalation exposures are combined. The Agency did
not identify any new or additional risks of concern; non-cancer risks to workers are generally
lower than those assessed in the 2004 amended IRED.
All but one use pattern either meet or are below the level of concern (MOE > 100) at
some level of personal protection, and three use patterns did not have adequate data to quantify
the risk estimates. Over half of the non-cancer risk estimates (50 of the 98 use patterns) were
below the Agency's level of concern, MOEs ranged from 100 to 26,000, when baseline PPE and
chemical-resistant gloves were applied. Forty-four use patterns require additional PPE or
engineering controls before the risk estimates are below the Agency's LOG. These 94 use
11
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patterns are not tabulated in this document; however, a detailed discussion of the required risk
mitigation for all handler scenarios is in Section IV of this document. Additionally, all of the
occupational handler non-cancer risk calculations are included in Appendix A of the July 9, 2007
Revisions to Occupational Exposure and Risk Assessment.
Table 5 presents the four handler use patterns with no data or that result in an MOE < 100
at the maximum level of protection (engineering controls).
Table 5. Summary of Occupational Handler Scenarios with Non-cancer Risks of Concern Or No Data
Scenario
Rate (Ib ai/acre)
[unless noted]
Area Treated
(acres/
day)
[unless noted]
Risk Summary
MOE
(Baseline PPE)
PPE at which MOE >
100
Applicators
5c Aerial:
Agricultural Uses,
Granular
Applications
0.5 (APHIS
grasshopper)
3,300
36
(with EC)
MOE = 36 with EC
Mixer/Loader/Applicators
16 Handheld Fogger
17 Power Backpack
19 Tree Injection
1 (ornamentals)
0.15 (mosquito
adulticide)
2% solution
(ornamentals)
No Data
No Data
No Data
No Data
No Data
No Data
No Data
No Data
No Data
No Data
EC = Engineering Controls is the closed cab aircraft
As noted in Table 5 above, EPA did not have data to evaluate worker exposure from use
of a handheld fogger, power backpack sprayer, or tree injection. The Agency required worker
exposure monitoring studies for these scenarios, as well as for dust formulations used in
agriculture, in the March 2005 generic data call in for carbaryl. The sole technical registrant for
carbaryl, Bayer CropScience, decided not to develop the necessary data to support these use
scenarios and application methods for carbaryl. Bayer CropScience has requested that their
carbaryl registrations be amended to remove these uses and application methods. (EPA is
currently processing this request through the FIFRA 6(f) Process.) In addition, Bayer
CropScience has informed the Agency that they will not be supporting any agricultural dust
formulations of carbaryl, although Bayer CropScience does not have any such products. Bayer
CropScience is not conducting the necessary worker exposure monitoring study to support
carbaryl dust formulations used in agriculture.
Therefore, all carbaryl product registrants must also remove these uses and application
methods from their carbaryl product reregistrations for the products to be eligible for
reregi strati on. This will be addressed further in EPA's response to a petition from NRDC, which
will be finalized by September 30, 2008.
Based on a comment to the IRED from the technical registrant, Bayer CropScience, EPA
considered a new AHETF open-cab tractor airblast applicator exposure study for the assessment
12
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of carbaryl airblast applications. The study considered two additional clothing/personal
protective equipment scenarios (wide brimmed "Sou'Wester" hat and hooded Tyvek® jacket)
that are not currently available in the PHED database. Table 6 summarizes the non-cancer risk
estimates of the aerial airblast applicator exposure scenario using PHED data, as well as, from
the additional PPE (wide brim Southwester Hat and hooded tyvek jacket). The PPE worn during
the study included double layer, gloves, but no respirator. In comparison to estimates using the
PHED data, some of the crops assessed resulted in reduced risk (i.e., less levels of PPE required);
these MOEs are italicized in Table 6. The non-cancer risk calculations for airblast application
using PHED data and AHETF open-cab tractor airblast applicator exposure study results are
included in Appendix B of the July 9, 2007 Revisions to Occupational Exposure and Risk
Assessment.
Table 6. Summary of Non-cancer Risks For Carbaryl Airblast Applicators Based on AHETF and PHED data
Scenario
Rate (Ib ai/acre)
Acres/
day
Risk Summary
MOEs with PPE in
AHETF study
PPE at which MOE >
100 using PHED
Open Cab Airblast (Double Layer, Gloves, No Respirator, Wide Brimmed "Sou'Wester" Hat)
6a Airblast:
Agricultural Uses
12 (citrus trees, CA 24C)
8 (citrus trees, FL 24C)
7.5 (stone fruit (olives)
5 (citrus and nut trees)
3 (pome and stone fruit)
2 (grapes)
40
40
60
64
97
160
240
EC
DL/GL/PF10
DLHD/GL/PF5
DLHD/GL/PF5
SL/GL/PF5
Baseline
Open Cab Airblast (Double Layer, Gloves, No Respirator, Hooded Tyvek® Jacket)
6a Airblast:
Agricultural Uses
12 (citrus trees, CA 24C)
8 (citrus trees, FL 24C)
7.5 (stone fruit (olives))
5 (citrus and nut trees)
3 (pome and stone fruit)
2 (grapes)
40
84
130
130
200
340
500
EC
DL/GL/PF10
DLHD/GL/PF5
DLHD/GL/PF5
SL/GL/PF5
Baseline
Baseline, or long-sleeve shirt, long pants, no gloves, and no respirator. (Baseline).
Baseline plus chemical-resistant gloves, and no respirator (SL/G/NR).
Coveralls worn over long-sleeve shirt and long pants, chemical-resistant gloves, and no respirator (DL/GL/NR).
Baseline plus chemical-resistant gloves and a protection level 5 respirator (SL/GL/PF5) or a protection level 10
respirator (SL/GL/PF10).
Coveralls worn over long-sleeve shirt and long pants, chemical-resistant gloves, and a protection level 5 respirator
(DL/GL/PF5) or a protection level 10 respirator (DL/GL/PF10).
Engineering Controls, or closed mixing/loading system, enclosed cab, or enclosed cockpit (EC).
b. Cancer Risk Summary
Occupational handler cancer exposure and risk calculations and results are presented in
this section. Cancer risks were calculated using a linear low-dose extrapolation approach in
which a Lifetime Average Daily Dose (LADD) is first calculated and then compared with a Qi *
that has been calculated for carbaryl based on dose response data from the appropriate toxicology
study (Qi* = 8.75 x lO'^mg/kg/day)"1). Absorbed average daily dose (ADD) levels were used
as the basis for calculating the LADD values.
13
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In order to calculate cancer risk, ADD values are amortized over the lifetime of
occupational handlers resulting in LADD values. Product labels limit use to every 7 to 10 days
or a seasonal "Ib ai per acre" limit. Also, according to available use/usage data, on average,
carbaryl is applied more than once per year for most crops. Based on this information and due to
the number and variety of target insects and crops registered for carbaryl applications, the
Agency considered two distinct populations in the cancer risk assessment including private
growers at 10 use events per year and commercial farm workers that would have a more frequent
use pattern of 30 days per year. Therefore, cancer risks for occupational handler exposures are
calculated separately for private growers and for commercial applicators. A 35 year career and a
70 year lifespan were used to complete the calculations.
Occupational cancer risks equal to or less than 1 x 10"6 (1 in 1 million) are not of concern
to the Agency. However, the Agency generally considers occupational cancer risks within the
range of 1 to 3xlO"6 (approximately 1-3 in 1 million persons) or less to be negligible. Since the
Qi * was not altered since the IRED, many of the reassessed exposure scenarios are the same;
however, those scenarios which have changes in application rate, acreage, or unit exposure
required revision.
The Agency did not identify any new or additional risks of concern; cancer risks for
private growers and commercial farm workers are generally lower than those assessed in the
2004 amended IRED. Of the 98 use pattern combinations considered for private growers and
commercial applicators, all have risks less than or within the range of 1 to 3xlO"6 with various
amounts of PPE or with engineering controls. Therefore, these 98 use patterns are not tabulated
in this document; however, as stated previously, a detailed discussion of the required risk
mitigation for all handler scenarios is in Section IV of this document. For the complete
occupational handler cancer (private growers and commercial farm worker) risk calculations,
refer to Appendix A of the July 9, 2007 Revisions to Occupational Exposure and Risk
Assessment.
Further, as discussed previously, Bayer CropScience requested that EPA consider a new
AHETF open-cab tractor airblast applicator exposure study for the assessment of carbaryl
airblast applications. Table 7 summarize the cancer risk estimate results of the aerial airblast
applicator exposure scenario using PHED data, as well as cancer risk estimates resulting from
the additional equipment (wide brim Southwester Hats and hooded tyvek jackets) for commercial
growers. PPE worn during the study included double layer, gloves, and no respirator. In
comparison to estimates using PHED data, all of the crops assessed resulted in reduced risk (i.e.,
less levels of personal protection required); these risk estimates are italicized in Table 7. The
citrus tree, Florida (FL) 24C (8 Ibs ai/acre) and stone fruit, olive (7.5 Ibs ai/acre) crops resulted in
a reduction of the level of personal protection required for commercial growers for the hooded
jacket protective equipment scenario only.
14
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Table 7. Summary of Cancer Risks For Commercial Applicator Carbaryl Airblast Applicators Based on
PHED and AHETF study
Scenario
Rate (Ib ai/acre)
[unless noted]
Acres/
Day
Risk Summary
Commercial Growers
Risk with PPE in AHETF
study
Min. Req. PPE using
PHED for risk estimate
<3xl06
Open Cab Airblast (Double Layer, Gloves, No Respirator, Wide Brimmed "Sou'Wester" Hat)
6a Airblast:
Agricultural Uses
12 (citrus trees, CA
24C)
8 (citrus trees, FL 24C)
7.5 (stone fruit (olives)
5 (citrus and nut trees)
3 (pome and stone fruit)
2 (grapes)
40
3x1 ff6
2x1 ff6
2x1 ff6
1x1 ff6
7x1 ff7
5x1 ff7
EC
DL/GL/PF5
DL/GL/PF5
DL/GL/NR
Baseline
Baseline
Open Cab Airblast (Double Layer, Gloves, No Respirator, Hooded Tyvek® Jacket)
6a Airblast:
Agricultural Uses
12 (citrus trees, CA
24C)
8 (citrus trees, FL 24C)
7.5 (stone fruit (olives)
5 (citrus and nut trees)
3 (pome and stone fruit)
2 (grapes)
40
2x1 ff6
1x1 ff6
1x1 ff6
8x1 ff7
5x1 ff7
3x1 ff7
EC
DL/GL/PF5
DL/GL/PF5
DL/GL/NR
Baseline
Baseline
Baseline, or long-sleeve shirt, long pants, no gloves, and no respirator (Baseline).
Baseline plus chemical-resistant gloves, and no respirator (SL/G/NR).
Coveralls worn over long-sleeve shirt and long pants, chemical-resistant gloves, and no respirator (DL/GL/NR).
Baseline plus chemical-resistant gloves and a protection level 5 respirator (SL/GL/PF5) or a protection level 10
respirator (SL/GL/PF10).
Coveralls worn over long-sleeve shirt and long pants, chemical-resistant gloves, and a protection level 5 respirator
(DL/GL/PF5) or a protection level 10 respirator (DL/GL/PF10).
Engineering Controls, or closed mixing/loading system, enclosed cab, or enclosed cockpit (EC).
2. Occupational Post-application Risks and Exposure
The Agency uses the term "post-application" to describe exposures to individuals that
occur as a result of being in an environment that has been previously treated with a pesticide
(also referred to as reentry exposure). To assess post-application exposures and risks, the
Agency estimates the amount of contact with a treated surface a worker likely would have while
doing a specific post-application task or activity, such as hand harvesting, conducting scouting
activities, crop maintenance tasks (e.g., irrigating, hoeing, and weeding), and turf maintenance.
To determine the amount of post-application exposure for each crop and post-application
activity, the EPA used dislodgeable foliar residue (DFR) and turf transferable residue (TTR) data
in the post-application risk assessment. The Agency's standard TCs were also used to assess
worker reentry exposures. As discussed in Section III.A.I above, the occupational post-
application risk assessment was revised to incorporate a DFR study from chrysanthemums, and
changes in the TCs to the crop/activity groupings.
15
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Post-application exposures are calculated by multiplying the DFR or TTR concentrations
and TC factors by an 8 hour work day. Exposures are then normalized by body weight and
adjusted for dermal absorption (if necessary) to calculate absorbed doses. Risk estimates were
then calculated. Post-application risks diminish over time because carbaryl residues eventually
dissipate in the environment. As a result risk values were calculated over time based on
changing residue levels. Further, the durations of exposure anticipated for re-entry workers
exposed to carbaryl based upon use criteria are short- and intermediate-term. Inhalation
exposures are thought to be negligible in outdoor post-application scenarios because of the low
vapor pressure and due to the infinite dilution expected outdoors. Therefore, only dermal post-
application exposures are considered in this assessment.
Similar to the occupational handler risk assessment, the Agency considered both non-
cancer and cancer risks to post-application exposure to carbaryl. Post-application risk levels are
generally calculated in the risk assessment process on a chemical-, crop-, and activity-specific
basis. The Agency evaluates this information to determine the number of days following
application that must elapse before the pesticide residues dissipate to a level where worker
MOEs equal or exceed 100 and cancer risk estimates are less than or within the range of 1 to 3 x
10"6 while wearing baseline attire. Increasing levels of PPE is not considered a viable approach
for mitigating post-application risks, so PPE is not used when calculating MOEs or cancer risk
estimates; instead, an administrative approach is used to reduce the risks, referred to as the
restricted entry interval (REI). The REI is a measure of the amount of time required to pass after
application of a pesticide before engaging in a task or activity in a treated field. To establish
REIs, the Agency considers post-application risks on varying days after application. In the
IRED, the carbaryl REIs were largely extended beyond the current Worker Protection Standard
of 12 hours.
a. Occupational Postapplication Exposure and Non-cancer Risk
Estimates
All but one of the short-/intermediate-term post-application worker risk estimates resulted
in MOEs that either meet or reduce REIs established by the carbaryl IRED. The cut flower crop
groupings assessed using exposure data from the state of Washington resulted in MOEs which
increase previously established REI. The majority of the post-application scenarios assessed do
not exceed the Agency's non-cancer level of concern (MOEs > 100) on the day of application
approximately 12 hours following application. The MOEs range from 100 to 6,200 and are,
therefore, not tabulated in this document. A summary of the results for each post-application
crop/activity combination considered is detailed in the Appendix C of the Carbaryl: Revisions to
Occupational Exposure and Risk Assessment, dated July 9, 2007.
There are, however, ten use-sites and/or certain activities for some use sites that exceed
the Agency's non-cancer level of concern, and require an REI longer than 12 hours before the
MOE of > 100 is reached. Table 8 presents these post-application scenarios. A detailed
discussion of the required risk mitigation for all post-application scenarios is in Section IV of
this document.
16
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Table 8. Carbaryl Post-Application Non-Cancer Risk Estimates Where the MOE < 100 on Day of Application (REI
12 hours)
TC Group
[Crops]
(Ibs ai/A)
Bunch/Bundle
[Hops & Tobacco]
(2 Ib ai/A)
Cut Flowers
(2 Ib ai/A)
Field/row crop, tall
[Corn]
(2 Ib ai/A)
Turf/grass seed production
[Golf course & sod farm]
(8.2 Ib ai/A)
Vine/Trellis
[Grapes]
(2 Ib ai/A)
Post-Application Activity
Hand harvesting, stripping, training, thinning, topping,
mechanical hop harvest
Irrigation, scouting, thinning, weeding immature/low
foliage plants
Irrigation, scouting mature/high foliage plants
Hand harvesting, pruning, thinning, pinching
Hand harvesting or detasselling
Harvesting
Hand harvest, leaf pulling, thinning, pruning,
training/tying grapes
Cane turning and girdling
Non-Cancer Risk Estimate
(MOE when REI=12 hours)
88
48
30
23
6
98
63
31
b. Occupational Postapplication Exposure and Cancer Risk
Estimates
EPA assessed the post-application exposure to carbaryl to both hired hand and migrant
agricultural workers. The Agency assumed private growers and hired hands would perform post-
application activities 10 days per year and migrant workers would perform post-application
activities 30 days per year. As stated in the section above, the Agency generally considers
occupational cancer risks within the range of 1 to 3 x 10"6 (approximately 1-3 in 1 million
persons) or less to be negligible.
The use of dissipation data and the manner in which daily post-application dermal
exposure values were calculated are inherently different than with handler exposures.
Lifetime Average Daily Dose (LADD) levels were calculated by amortizing single day re-entry
exposures over a lifetime. For carbaryl, the Agency used the same values used in the short- and
intermediate-term assessment referred to above for private growers (10 days per year) and
migrant workers (30 days per year) to calculate the LADD.
Since the Ql* has not changed since the carbaryl IRED, the cancer risk for many of the
reassessed exposure scenarios remain the same. However, some scenarios have been revised
because of changes in application rate or revised TCs as discussed in Section III. A.I. Cancer
risks estimated for private growers (10 days/year) are generally in the 10"8 to 10"6 range. The
highest exposures for private growers are in the 10"6 range. Cancer risks estimated for
commercial farm workers (30 days/year) generally fall in the 10"7 to 10"6 range. The highest
exposures for commercial growers are in the 10"5 range. The post-application scenarios with
cancer risk estimates less than IxlO"6 are not tabulated in this document. A summary of the
17
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results for each post-application crop/activity combination considered is detailed in the Appendix
C of the Carbaryl: Revisions to Occupational Exposure and Risk Assessment, dated July 9, 2007.
There are, however, eleven use-sites and/or certain activities for some use sites that
exceed the Agency's cancer level of concern, and require an REI longer than 12 hours before the
cancer risk estimates are within the range of 1 to 3xlO"6. Table 9 presents the worst case cancer
risk estimates since the Agency assumed migratory workers are exposed to post-application
residues of carbaryl for 30 days per year for 35 years. A detailed discussion of the required risk
mitigation for all post-application scenarios is in Section IV of this document.
Table 9. Carbaryl Occupational Post-Application Cancer Risk Estimate for Migrant Workers Greater Than 3 x 10 6
on Day of Application (REI 12 hours)
TC Group
[Crops]
(Ibs ai/A)
Bunch/Bundle
[Hops & Tobacco]
(2 Ib ai/A)
Cut Flowers
(2 Ib ai/A)
Evergreen Fruit Trees
[Avocados, conifers, dates,
grapefruit, lemons, mangoes,
oranges, papaya]
(CA only- 12 Ib ai/A)
Field/row crop, tall
[Corn, sunflowers, sorghum,
sweet corn]
(2 Ib ai/A)
Nuts Trees
[Olives]
(7.5 Ib ai/A)
Vine/Trellis
[Grapes]
(2 Ib ai/A)
Post-Application Activity
Hand harvesting, stripping, training, thinning, topping,
mechanical hop harvest
Irrigation, scouting, thinning, weeding immature/low
foliage plants
Irrigation, scouting mature/high foliage plants
Hand harvesting, pruning, thinning, pinching
Harvesting, pollination, bagging, tying, misc. hand
labor, staking, topping, training
Scouting, irrigation, weeding mature/full foliage plants
Hand harvesting or detasselling1
Harvesting/poling, pruning, thinning
Hand harvest, leaf pulling, thinning, pruning,
training/tying grapes
Cane turning and girdling
Cancer Risk Estimate
(30 days/yr for 35 years)
4xlO'6
5xlO'6
8xlO'6
IxlO'5
4xlO'6
4xlQ-6
6xlO"5
4xlO'6
6xlO"6
IxlO"5
^andharvesting of sweet corn is prohibited per the 2004 amended IRED; the REI for hand detasseling is 30 days.
3. Poisoning Incident Data for Carbaryl
The Agency reviewed available sources of human incident data for incidents relevant to
carbaryl. The following sources were used: 1) The OPP's Incident Data System (IDS),
comprised of reports of adverse effects submitted by registrants, other federal and state health
and environmental agencies and the public through FIFRA 6(a)2 since 1992; 2) California
Department of Pesticide Regulation's pesticide poisoning surveillance program, comprised of
18
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reports from physicians of illness suspected of being related to pesticide exposure since 1982; 3)
National Institutes of Occupational Safety and Health (NIOSH) Sentinal Event Notification
System for Occupational Risks (SENSOR), which provides surveillance in seven states from
1998 through 2003; and 4) Poison Control Center (PCC) data covering the years 1993 through
2005 for all pesticides. Symptoms captured in these reports ranged from nervous/sensory
(headache, confusion, and dizziness), gastrointestinal (nausea), respiratory (pain/irritation,
shortness of breath, irritation), ocular symptoms (eye pain/irritation/ inflammation, and
lacrimation), dermal symptoms (erythema, rash, and pruritis), and miscellaneous (alkalosis).
EPA's review of the human incident data for carbaryl can be found in the September 21, 2007,
Review of Carbaryl Incident Reports.
The IDS reported 160 incident cases for carbaryl between the years 2000 and 2006. Of
these, 19 cases were the result of misuse (15) or suicide attempts (4). The California Pesticide
Illness Surveillance Program (PISP, 2000-2005) reported 11 cases for carbaryl. In 6 of these
cases, carbaryl was used alone or was judged to be responsible for the health effects. The
NIOSH SENSOR database reports 75 cases involving carbaryl alone (of 5,899 reported cases of
pesticide poisonings from 1998 to 2003). Most of the incidents involved residential uses of
carbaryl, which are not addressed in this document.
EPA investigated one reported incident in particular. At issue was an incident where
twenty-one farmer workers in Florida were taken to emergency rooms on April 9, 2003 after a
number of harvesters (fourteen) complained of difficulty breathing, headaches, dizziness, and
nausea. EPA conducted a comprehensive investigation of the incident and in particular the role
carbaryl may have played. The information available to the Agency does not appear to support a
conclusion that the severity of symptoms reported by Florida citrus harvesters in April 2003 can
be attributed to carbaryl exposure resulting from contact with foliar residues. During the
summer of 2005, EPA met with non-profit advocacy groups that were particularly concerned
with this incident to discuss these findings.
IV. Risk Management
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether or not products containing the active
ingredient are eligible for reregi strati on. The Agency has previously identified and required the
submission of the generic (technical or manufacturing-use grade) data required to support
reregi strati on of products containing carbaryl as an active ingredient. EPA has completed its
review of submitted data and its assessment of occupational risks associated with the use of
pesticide products containing the active ingredient carbaryl.
Based on the evaluation of the occupational uses of carbaryl described in this document,
the September 24, 2007 RED, and in the October 2004 carbaryl IRED amendment, the Agency
has determined it has sufficient information on the human health effects to make decisions as
part of the reregistration process under FIFRA, as amended by FQPA. The Agency has
determined that carbaryl-containing products are eligible for reregistration provided that: (i) the
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worker risk mitigation measures outlined in this document are adopted and (ii) label amendments
are made to reflect these measures. Label changes are described in Section V of this document.
Further, based on its evaluation of occupational uses of the active ingredient carbaryl, the
Agency has determined that carbaryl products, unless labeled and used as specified in this
document, would present risks inconsistent with FIFRA. Accordingly, should a registrant fail to
implement any of the risk mitigation measures identified in this document, the Agency may take
regulatory action to address the risk concerns from the use of carbaryl. If all changes outlined in
this document are incorporated into the product labels, then all current occupational handler and
post-application risks for carbaryl will be adequately mitigated for the purposes of this
determination under FIFRA.
B. Occupational Risk Mitigation and Regulatory Rationale
It is the Agency's policy to mitigate occupational risk to the greatest extent practical and
feasible. Occupational exposure assessments are completed by the Agency considering the use
of baseline PPE, and, if warranted, for handlers, increasing levels of PPE and engineering
controls in order to estimate the potential impact on exposure and risk. The target MOE for
carbaryl is 100, based on information provided in Section III of this document. For occupational
cancer risks, estimates within the negligible risk range of up to 3xlO"6 do not exceed the
Agency's level of concern. When occupational MOEs are estimated to be less than 100 or
occupational cancer risk estimates greater than the general range of 3xlO"6, EPA strives to reduce
worker risks through the use of PPE and engineering controls or other mitigation measures.
In addition, a wide range of factors are considered in making risk management decisions
for worker risks. These factors include, in addition to the estimated MOEs and cancer risk
estimates, incident data, the nature and severity of adverse effects observed in the animal studies,
uncertainties in the risk assessment, alternative registered pesticides, the importance of the
chemical in integrated pest management (IPM) programs, and other factors.
1. Handler Risk Mitigation
As stated in Section III, over half of the non-cancer and cancer risk estimates for
occupational handlers were mitigated through the use of baseline PPE and gloves, and almost all
could be mitigated with additional PPE or engineering controls. However, as summarized in
Table 5, some handler scenarios either did not have data to quantify the risk or could not be
mitigated with PPE or engineering controls. Therefore, additional discussion and consideration
of the risks and benefits of the use pattern is necessary. Following the implementation of the
formulation specific and activity specific risk mitigation measures for the scenarios, handler risks
will no longer be of concern to the Agency (see Table 11). The registrants have agreed to the
following mitigation:
Mixing, Loading, and Applying Liquid Formulations of Carbaryl
All handler scenarios of the liquid formulation of carbaryl (scenarios 3b, 3c, 3d, 3f, 7, 10,
11, 12, 13a, 13b, 14, 17, 20, and 21) except for those which utilize airblast equipment (6a, 6b)
and handheld foggers (16), and mixers and loaders supporting aerial or chemigation applications
20
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(3a, 3e), are below the Agency's non-cancer (MOEs >129) and cancer LOCs (<2.6xlO"6) with
baseline PPE and chemical-resistant gloves.
Additional risk mitigation specific to handlers utilizing airblast (6a, 6b) and handheld
foggers (16) and mixers and loaders supporting aerial and chemigation applications are discussed
below.
Airblast and Handheld Foggers Handler Scenarios
For applicators of the liquid formulation utilizing airblast equipment (6a), applying a rate
<5 Ib ai/A (pome and stone fruit, and grapes) the non-cancer (MOEs >161) and cancer (<5.3xlO"
7) risk estimates are below the Agency's LOG with baseline PPE, chemical-resistant gloves, and
a protection level 5 respirator (SL/GL/PF5). For applications >5 Ib ai/A (citrus, nut trees, and
olives) the non-cancer (MOEs>100) and cancer (481 and <6xlO"7, respectively.
The PPE and EC requirements for the airblast scenarios (6a) discussed above are
generally reduced compared to those required in the IRED (see Table 11 below). The Agency
did consider the exposure study submitted by the AHETF "Determination of Dermal and
Inhalation Exposure to Workers during Application of a Liquid Pesticide Product by Open Cab
Airblast Application to Orchard Crops" (MRID 464482-01) in Section III.B.l (Tables 6 and 7)
above. However, the Agency determined since it was able to achieve acceptable MOEs with the
standard suite of PPE or ECs, it did not need to require the additional burden to occupational
handlers of wearing wide brimmed Southwester Hats and hooded tyvek suits (with additional
headgear).
As previously mentioned, EPA does not have the necessary data to evaluate worker
exposure from use of a handheld fogger, power backpack sprayer, or tree injection, and therefore
cannot make a reregi strati on eligibility decision for these scenarios. Although worker exposure
For Carbaryl, the Agency believes an MOE in the mid-90s is not significantly different from an MOE of 100.
21
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monitoring studies were required for these scenarios in the March 2005 generic DCI for carbaryl,
the carbaryl registrant, Bayer CropScience, decided to delete these use scenarios from their
registered carbaryl products rather than develop these data. Therefore, all carbaryl product
registrants must remove the uses and application methods associated with these scenarios from
their carbaryl product reregistrations for the products to be eligible.
Aerial and Chemigation Handler Scenarios
Additional PPE is required for mixers and loaders supporting aerial or chemigation
applications (3a, 3e). In addition to baseline PPE and chemical resistant gloves, these handlers
must also wear a protection 5 level respirator (SL/GL/PF5). With this additional PPE, all
scenarios, except for one, are below the Agency's non-cancer (MOEs>120) and cancer (<2.9xlO-
6) LOCs. The MOE for scenario 3a, mixing and loading activities to support aerial or
chemigation applications at a rate of 1.5 Ib ai/A and 1,200 acres a day, is 80 with this level of
PPE. However, the Agency believes that the assumptions used for this scenario are highly
conservative. The rate assessed, 1.5 Ib ai/A, is the maximum application rate, where as the
average application rate of 1 Ib ai/A was also assessed and resulted in an MOE of 120 with PPE
of SL/GL/PF5. Additionally, the assumption of 1,200 acres treated a day is believed to be an
overestimation according to carbaryl use estimates. Based on Agency data (see Table 1),
approximately 30,000 Ib ai of carbaryl is estimated to be applied to less than 1% of all corn
acreage in the US2. Therefore, the Agency believes the area treated per day would actually be a
much smaller area than 1,200 acres and, therefore, a handler would not be mixing and loading
the amount of ai necessary for an application to an area of this size. Considering all of these
factors, and the fact that increasing the PPE to a full face respirator with a protection level of 10
would only slightly increase the MOE above 100 (MOE=103), the Agency does not feel the
additional PPE is warranted, and that PPE consisting of SL/GL/PF5 is protective for this
scenario.
For aerial applications (5a, 5b, 5c), pilots must be in an enclosed cockpit. Moreover,
human flagging (22a) is prohibited, except for flagging to support state sponsored aerial
applications and the USDA APHIS Rangeland Grasshopper and Mormon Cricket Suppression
Program. In these instances, human flaggers must wear the following PPE: baseline, chemical
resistant gloves, and a protection level 5 respirator (SL/GL/PF5) (MOE=144).
Loading and Applying Granular and Bait Formulations of Carbaryl
All handler scenarios assessed for the granular and bait formulations of carbaryl (2b, 8,
and 15) except for scenarios involving aerial applications, are below the Agency's non-cancer
(MOEs > 109) and cancer (<8xlO"6) LOCs with baseline PPE.
Applications by hand, spoon, shaker can, and backpack spreaders (front and back
mounted) are prohibited per the 2004 Amended RED. Additionally, all aerial applications of the
granular or bait formulations of carbaryl are prohibited, except for aerial applications through the
2 An average of approximately 75 million acres of field corn were grown in the US between 2003 and 2007 (USDA
National Agricultural Statistics Service).
22
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USDA APHIS Rangeland Grasshopper and Mormon Cricket Suppression Program (2a), and
state-run allied programs.
Aerial Applications
The Agency assessed the maximum application rate of 0.5 Ib ai/A for handlers loading
bait formulations into aircraft for use in Rangeland Grasshopper and Mormon Cricket
Suppression Programs (2a), and the following PPE is required: baseline PPE, chemical resistant
gloves, and a protection level 5 respirator (SL/GL/PF5).
In addition, as presented in Table 5 previously, the non-cancer risk estimate for
applicators applying the bait formulation aerially (5c) is the only handler scenario that cannot be
mitigated to an MOE>100 through PPE or engineering controls (MOE=36). Alternative
mitigation measures, such as reduction in application rate or daily treated area are also not an
option for this use scenario. The application rate and area treated daily are specific to the success
and effectiveness of these suppression programs.
As stated in the Agency's response to comments, BEAD's Response to Comments
Submitted by Stakeholders on EPA's Impact Assessments for Carbaryl, dated December 15,
2006, a review of available literature and recent FIFRA Section 18 Emergency Exemptions
indicates that the most effective baits for controlling both immature and adult populations of
grasshoppers and Mormon crickets are based on carbaryl as the active ingredient. Therefore, the
Agency recognizes the need for the continued use of carbaryl, and has not prohibited this activity
for APHIS and related state programs. In addition, there are several factors the Agency believes
reduces the actual applicator exposure, and thus decreases the subsequent risk estimate (i.e. MOE
>36).
First, the Agency anticipates the actual handler exposure to be less than assessed due to
the nature of the bait formulation used in these Programs. A carbaryl pelletized bait product is
used, which is expected to produce much less dust than typical granular formulations. In
granular formulations, the active ingredient is applied to the surface of a carrier (the granule) and
bound to the surface of that carrier with a binder or sticking agent that will keep most of the
active ingredient on the carrier in transit, but will allow the active ingredient to release when the
granular is applied. However, unlike a granular in which the active ingredient is applied to the
surface of the carrier, pellet formulations are homogenous blends (the active ingredient is
incorporated throughout the pellet) of the active ingredient carrier. The materials are tightly
compressed, and are typically extremely dense. Therefore, the active ingredient is not
anticipated to separate from the pellet during application and, thus, the product is less dusty.
However, the Agency does not have specific exposure information for baits to include in its
assessment. Instead, the Agency relied upon exposure data in PHED for typical granular
formulations for use in its risk assessment. While the exposure information in the PHED is
considered to be the best available, the Agency recognizes that both the inhalation and dermal
exposure to carbaryl from the bait is most likely less than what is currently available in PHED.
A flaky bran wheat bait formulation has also been applied by APHIS and state Agencies
in the Rangeland Grasshopper and Mormon Cricket Suppression Programs. However, all flaky
wheat registrations have been voluntarily canceled per the registrant during the product
23
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reregi strati on process following the 2004 Amended RED. The Agency does not have the same
level of confidence that the flaky bran wheat formulation would produce less dust that a
traditional granular formulation. Therefore, if this formulation were to be registered in the
future, the Agency would require a perceived dust study to support its use.
Further, the aircraft used and application practices associated with this Program are likely
to result in reduced exposure as well. According to APHIS3, cockpits are enclosed with air
intake into the cockpit from above the bait release point, and the bait bin is completely separate
from the cockpit. Finally, according to APHIS, workers employed in the APHIS and state-run
allied programs are highly trained, making inadvertent exposure due to mishandling of the
products during loading and application activities less likely as well.
Although the current MOE for this use scenario is above the Agency's non-cancer LOG,
EPA believes that this is an overestimation of risk. EPA expects actual worker exposure, and
risk, to be much lower, due to the formulation type, aircraft features, and extensive training of
handlers, although this cannot be quantified. Therefore, the Agency has determined that carbaryl
bait products that are applied aerially are eligible for reregi strati on given the following
eengineering control requirements:
"Pilots must use an enclosed cockpit that meets the requirements listed in the Worker
Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(6)]. In
addition, the air intake into the cockpit must be located above the bait release point and
the bait bin must be completely separate from the cockpit."
Loading and Applying Wettable Powder and Dry Flowable Formulations of Carbaryl
Based on the risk mitigation established in the 2004 amended IRED, all wettable powder
and dry flowable products must be formulated in water-soluble packaging. The use of water-
soluble packaging was considered in the risk assessment, and as such resulted in a reduction in
PPE for occupational handlers. For all use scenarios assessed, the non-cancer and cancer risk
estimates were below the Agency's LOCs with baseline PPE and chemical resistant gloves
(MOE>100and<2xlO'6).
All dry flowable (water dispersible granule) products have been voluntarily canceled by
the registrant, and a prohibition statement has been added to the Manufacturing Use Product
label (see table 13).
Applying Ready-to-Use Dust Formulations of Carbaryl
In response to the 2004 data call-in, the registrants voluntarily canceled dust formulations
with agricultural use. Residential use dust formulations were assessed in the 2007 RED.
However, there are ready-to-use dust formulations that can be applied by both pest control
operators and homeowners. The Agency referred to the risk assessment completed for the 2007
RED, and revised the scenario to assume 2 dust containers applied (versus 1 container used for
residential applications). The combined dermal and inhalation MOE was 278 and the cancer risk
! USDA APHIS comments to the amended carbaryl IRED; see docket EPA-HQ-OPP-2005-0077-029 for details.
24
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estimate was in the 10" range with baseline PPE and, therefore, below the Agency's level of
concern.
2. Post-Application Risk Mitigation
For all post-application risk scenarios assessed, with one exception for cut flowers, the
short-/intermediate-term post-application worker risk estimates result in higher MOEs than those
reported in the 2004 amended IRED. As a result, EPA has reduced most REIs to the minimum
12 hours established by the worker protection standard. However, as summarized in Tables 8
and 9 previously, eleven crop/post-application activities were above the Agency's non-cancer
and cancer LOCs, respectively, with an REI of 12 hours. These scenarios require extended REIs,
ranging from 24 hours to 23 days. Table 10 summarizes the REI needed for both the non-cancer
and cancer risk estimates to be below the Agency's LOCs. In most cases, both the non-cancer
and cancer risk estimates required an extended REI; however, to be protective, the longer REI
(bolded below) will be established to ensure the REI is protective of both non-cancer and cancer
risks. In addition, the REI established for the highest exposure scenario for each crop, or crop
grouping, will also be selected in order to be protective of all post-application activities for that
group.
Table 10. Carbaryl Post-Application Non-Cancer Risk Estimates MOE < 100 on Day of Application (REI
12 hours)
TC Group
[Crops]
(Ibs ai/A)
Bunch/Bundle
[Hops & Tobacco]
(2 Ib ai/A)
Cut Flowers
(2 Ib ai/A)
Evergreen Fruit Trees
[Avocados, conifers,
dates, grapefruit, lemons,
mangoes, oranges,
papaya]
(CA only- 12 Ib ai/A)
Field/row crop, tall
[Corn]
(2 Ib ai/A)
Nut Trees
[Olives]
(7.5 Ib ai/A)
Post-Application Activity
Hand harvesting, stripping, training,
thinning, topping, mechanical hop harvest
Hand harvesting, pruning, thinning,
pinching
Harvesting, pollination, bagging, tying,
misc. hand labor, staking, topping, training
Scouting, irrigation, weeding mature/full
foliage plants
Detasselling
Hand harvesting J
Harvesting/poling, pruning, thinning
REI for
MOE > 100
24 hours
18 days
12 hours
12 hours
21 days
REI for cancer risk
estimate < 3x10 6
2 days
15 days
3 days
24 hours
9 days
Prohibited
12 hours
3 days
25
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Table 10. Carbaryl Post-Application Non-Cancer Risk Estimates MOE < 100 on Day of Application (REI
12 hours)
TC Group
[Crops]
(Ibs ai/A)
Turf/grass seed
production
[Golf course & sod farm]
(8.2 Ib ai/A)
Vine/Trellis
[Grapes2]
(2 Ib ai/A)
Post-Application Activity
Harvesting
Hand harvest, leaf pulling, thinning,
pruning, training/tying grapes
Cane turning and grape girdling
REI for
MOE > 100
24 hours
East3 - 2 days
West3- 6 days
East3 - 6 days
West3- 6 days
REI for cancer risk
estimate < 3x10 6
12 hours
East3 - 2 days
West3- 6 days
East3 - 6 days
West3- 6 days
:Hand harvesting of sweet and field corn is prohibited per the 2004 amended IRED.
2With REIs of 2 and 6 days, the cancer risk estimates are 8xlO"6 and 6xlO"6, respectively.
3East and West of the Rocky Mountains.
Hand harvesting of sweet and field corn is prohibited per the 2004 amended IRED, and
the REI for detasseling is 30 days. Detasseling is the process of removing the tassel from the
corn plant so the plant cannot pollinate itself. This is only practiced on corn hybrids developed
for seed production. Per the revised risk assessment, an REI of 21 days is required to protect
workers for both hand harvesting and detasseling. Carbaryl is sometimes applied to sweet corn
grown for fresh market consumption and during periods when harvesting occurs. The preharvest
interval for ear harvest is 2 days; therefore, a 21 day REI for hand harvesting is impractical.
Therefore, this activity will continue to be prohibited.
In addition, for brassica crops, leafy vegetables, table beets, and turnips when harvested
for greens, use was restricted to applications only within 30 days of crop
emergence/transplanting in the 2004 amended IRED. This was due in part to the extended REIs
associated with higher exposure activities such as scouting and hand harvesting. In addition, as
stated in the IRED, carbaryl is used early in the season and generally only within 30 days of
planting and, therefore, carbaryl applications only coincide with low-exposure activities such as
weeding and irrigation. However, the revised risk assessment resulted in a reduced REI for these
activities. Therefore, the Agency is removing the use restriction of application only within 30
days of crop emergence/transplanting for leafy vegetables, table beets, and turnips, but not for
Brassica crops. The registrants elected to maintain the use restriction for Brassica crops to
ensure that high exposure activities, where MOE exceedences still occurred, were not feasible.
Therefore, for Brassica crops, the application restriction of use of carbaryl only within 30 days of
crop emergence/transplanting will remain and a 12 hour REI will apply for all activities.
The Agency is maintaining an REI of 2 days for grape production east of the Rocky
Mountains and prohibiting very high contact activities, such as grape girdling and cane turning
until 6 days after application of carbaryl. With a 2 day REI for all re-entry activities except for
grape girdling and cane turning, which will require a 6 day REI, both the MOE and cancer risk
estimates for all re-entry activities in grapes will be below the Agency's level of concern. The
Agency does not anticipate the extended REI for very high contact activities will impact grape
growers east of the Rocky Mountains since these post-application activities are not commonly
26
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practiced. In addition, based on the revised post-application risk assessment, the Agency is
decreasing the REI for grape production west of the Rocky Mountains from 7 days to 6 days.
For more detail on the benefits of carbaryl on grapes, refer to the Amended CarbaryllRED, dated
October, 22, 2004.
3. Summary of Occupational Risk Mitigation and Comparison to 2004
Amended IKED Mitigation
Table 11 summarizes the occupational risk mitigation for mixer, loaders, and handlers of
carbaryl formulations, and compares the current risk mitigation to that outlined in the 2004
amended IRED. The risk mitigation for all handler scenarios assessed, except for scenario 6b
Airblast: Wide Area Uses, Ground Fogger, either remain the same as the mitigation in the 2004
amended IRED, or are reduced. The PPE for scenario 6b was increased due to an increase in the
application rate assessed from 0.016 Ib ai/A to 0.15 Ib ai/A. The last column in Table 11
specifies if the mitigation is the same, increased, or decreased. An explanation of the PPE
abbreviations is at the end of the table.
Table 11. Occupational Handler Risk Mitigation Summary
Handler Scenario
2004 Amended IRED
Risk Mitigation
Current Risk
Mitigation
No Change, Increase, or
Decrease
Mixer/Loaders
laDryFlowables(DF):
Aerial/Chemigation
IbDF:
Airblast
IcDF:
Groundboom
IdDF:
Turfgun (LCD)
leDF:
Wide Area Aerial
2a Granular:
Aerial Application
2b Granular:
Broadcast Spreader
3a Liquid:
Aerial/Chemigation
3b Liquid:
Airblast Application
3c Liquid:
Groundboom
3d Liquid:
LCO Applications
3e Liquid:
Wide Area Aerial
3e Liquid:
Wide Area Aerial
(MRID 46634105)
3f Liquid:
Prohibited
EC
EC
EC
Prohibited
Prohibited (except
APHIS)
SL/GL/PF5
SL/GL/PF5
EC
SL/GL/PF5
SL/GL/PF5
SL/GL/PF5
EC
EC
SL/GL/PF5
Voluntarily Canceled
Prohibited (except
APHIS and state
programs)
SL/GL/PF5
Baseline
SL/GL/PF5
SL/GL/NR
SL/GL/NR
SL/GL/NR
SL/GL/PF5
SL/GL/PF5
SL/GL/NR
N/A
No Change
PPE Reduction
PPE Reduction
PPE Reduction
PPE Reduction
PPE Reduction
PPE Reduction
PPE Reduction
PPE Reduction
27
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Table 11. Occupational Handler Risk Mitigation Summary
Handler Scenario
Wide Area Ground
4a Wettable Powder (WP):
Airblast
4b WP: Groundboom
4cWP:
Turfgun (LCD)
2004 Amended IRED
Risk Mitigation
EC
EC
EC
Current Risk
Mitigation
EC
EC
EC
No Change, Increase, or
Decrease
No Change
No Change
No Change
Applicators
5a Aerial: Agricultural Uses,
Liquid Sprays
5b Aerial: Wide Area Uses,
Liquid Sprays
5b Aerial: Wide Area Uses,
Liquid Sprays
(MRID 46634105)
5c Aerial: Agricultural Uses,
Granular Applications
6a Airblast:
Agricultural Uses
6b Airblast: Wide Area Uses,
Ground Fogger
7 Groundboom
8 Solid Broadcast Spreader
(Granular)
9 Aerosol Can
10 Trigger Pump Spray
1 1 High Pressure Handwand
(ROW) (ORETF Data)
EC
EC
EC
EC
EC -Citrus (CA) &
Olives
DL/GL/PF5
DL/GL/PF5
SL/GL/PF5
SL/GL/PF5
Prohibited
SL/GL/PF5
DL/GL/PF5
EC
EC
EC
EC with additional
aircraft requirements
EC- Citrus (CA)
DL/GL/PF5 (>5 Ib
ai/A)
SL/GL/PF5 (<5 Ib ai/A)
EC
SL/GL/NR
Baseline
Prohibited
SL/GL/NR
SL/GL/NR
No Change
No Change
No Change
Increase engineering
control requirements
PPE Reduction
No Change for >5 Ib ai/A
Increase
PPE Reduction
PPE Reduction
No Change
PPE Reduction
PPE Reduction
Mixer/Loader/Applicators
12 Turfgun (LCD)
13aWP:
Low Pressure Handwand
13b Liquids,
Low Pressure Handwand
14 Backpack Sprayer
15 Granular, Push-Type
Spreader
16 Handheld Fogger
17 Power Backpack
18 Granular, Backpack
19 Tree Injection
20 Drench/Dripping/
Forestry /Ornamentals
21 Sprinkler Can
SL/GL/PF5
SL/GL/PF5
SL/GL/PF5
SL/GL/PF5
SL/GL/NR
DL/GL/PF5
SL/GL/NR
Prohibited
SL/GL/NR
SL/GL/PF5
SL/GL/PF5
SL/GL/NR
SL/GL/NR
SL/GL/NR
SL/GL/NR
Baseline
DL/GL/PF5
SL/GL/NR
Prohibited
SL/GL/NR, plus
protective eye wear
SL/GL/NR
SL/GL/NR
PPE Reduction
PPE Reduction
PPE Reduction
PPE Reduction
PPE Reduction
No Change
No Change
No Change
No Change
PPE Reduction
PPE Reduction
Flaggers
22a Flagger: Liquid Sprays SL/GL/PF5 SL/GL/PF5 No Change
28
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Table 11. Occupational Handler Risk Mitigation Summary
Handler Scenario
22b Flagger: Granulars
2004 Amended IRED Currei
Risk Mitigation Mitig
Baseline Baseline
it Risk No Change, Increase, or
ation Decrease
No Change
SL- Baseline PPE (long sleeves, long pants, shoes plus socks)
DL- Coveralls worn over baseline PPE
GL- Chemical resistant gloves
NR- No respirator
PF5- Respirator with a protection level of 5
PF10- Respirator with a protection level of 10
EC- Engineering Control
Table 12 summarizes the occupational risk mitigation for post-application activities in
areas treated with carbaryl, and compares the new REIs established in this document to those
established in the 2004 amended IRED. The REIs for all post-application scenarios assessed,
except for Cut Flowers, either remains the same as the mitigation in the 2004 amended IRED, or
are reduced. The last column in Table 12 specifies if the REIs remained the same, increased, or
decreased.
Table 12. Occupational Post-Application Risk Mitigation Summary
TC Group
(Ibs ai/A)
Brassica
(2 Ib ai/A)
Bunch/Bundle
(2 Ib ai/A)
Cucurbit Vegetables
(1 Ib ai/A)
Cut Flowers
(2 Ib ai/A)
Pome Fruit/Deciduous Fruit
Tree
Stone Fruit/Deciduous Fruit
Tree
(3 Ib ai/A)
(CA only- 4 Ib ai/A)
2004 Amended IRED-
REI
Application Restriction -
use only within 30 days
of planting/transplanting
Low exposure activities-
5 days
8 days
3 days
Cut flowers (except
roses) - 12 hours
Roses- 7 days
12 hours
12 hours
7 days for hand thinning
CA only- 3 days
7 days for hand thinning
Current REI
Application Restriction -
use only within 30 days of
planting/transplanting
Low exposure activities-
12 hours
2 days
12 hours
12 hours (including roses)
EXCEPTION: 18 days
for ornamentals grown for
cuttings (cut flowers or
cut foliage) where
production is in outdoor
areas where annual
rainfall average is less
than 25 inches a year.
12 hours
12 hours (all activities and
states)
No Change, Increase,
or Decrease
Decrease for low
exposure activities
Decrease
Decrease
Decrease for roses
Increase for cut
flowers/foliage in arid
areas (<25 inches of
rain/year)
No change
Decrease
29
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Table 12. Occupational Post-Application Risk Mitigation Summary
TC Group
(Ibs ai/A)
Citrus Crop
Grouping/Evergreen Fruit
Trees
(5 Ib ai/A)
(FL- 8 Ib ai/A)
(CA- 12 Ib ai/A)
Evergreen Crop
Grouping/Evergreen
Fruiting Trees
[Conifers]
(5 Ib ai/A)
Field/row crop, tall
(2 Ib ai/A)
Field/row crop, tall
[Sunflower]
(1.5 Ib ai/A)
Fruiting Vegetables
(2 Ib ai/A)
Leafy Vegetables
(2 Ib ai/A)
Low Berry
(2 Ib ai/A)
Low/Medium Field/Row
Crops
(1.5 Ib ai/A)
2004 Amended IRED-
REI
24 hours
FL- 5 days
CA- 5 days
12 hours
Corn and Sorghum-
4 days
Seed Corn-
4 days
Sweet Corn-
3 days
Hand detasseling-
30 days
Current REI
12 hours
CA- 3 days
12 hours
24 hours
Hand detasseling-
21 days
Prohibition on hand harvesting
24 hours
Eggplant, Bell/chili
Peppers, Tomatoes-
2 days
Okra-
12 hours
Application Restriction -
use only within 30 days
of planting/transplanting
Low exposure activities-
12 hours
12 hours
Strawberries-
4 days
String Beans, Dry
Beans/peas, Chick Peas
and Green Peas-
5 days
Alfalfa, Forage, Flax,
12 hours
12 hours
12 hours (all activities)
12 hours (for all crops)
12 hours (for all crops)
No Change, Increase,
or Decrease
Decrease
No change
Decrease REI
Decrease REI
Same
Decrease
Decrease
No change, but
elimination of use
restriction
Decrease
Decrease
30
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Table 12. Occupational Post-Application Risk Mitigation Summary
TC Group
(Ibs ai/A)
Nursery/Ornamentals
(2 Ib ai/A)
Nut Trees
(5 Ib ai/A)
(Olives- 7.5 Ib ai/A)
Root Vegetables
(2 Ib ai/A)
Stem/Stalk Vegetables
(asparagus preharvest
application- 1 Ib ai/A)
(2 Ib ai/A)
Sugarcane
(1.5 Ib ai/A)
Turf/grass seed production
[Golf course & Sod farm]
(8.2 Ib ai/A)
Vine/Trellis
(2 Ib ai/A)
Vine/Trellis
[Grapes]
(2 Ib ai/A)
2004 Amended IRED-
REI
Peanuts, Rice, and Sugar
beets-
2 days
12 hours
Pecans-
12 hours
Almonds, Hazelnuts
(Filberts), Macadamia,
Pistachios, Walnuts- 10
days
Olives-
14 days
Application Restriction -
use only within 30 days
of planting/transplanting
Table Beets and Turnips
(harvested for greens)-
12 hours
Table Beets, Carrots,
Potatoes, Sweet Potatoes,
Turnips (harvested for
roots)-
4 days
24 hours
N/A- not a registered use
12 hours
Sod farm harvesting-
9 days
2 days
Rocky Mountains
East- 2 days
West- 7 days
Current REI
12 hours
12 hours
Olives- 3 days
12 hours (all crops and
activities)
12 hours
12 hours
12 hours
Sod farm harvesting-
24 hours
12 hours
Rocky Mountains
East- 2 days
*Very high contact
activities (grape girdling
and cane turning)- 6 days
West- 6 days
No Change, Increase,
or Decrease
No Change
Decrease
Over all decrease and
elimination of use
restriction
Decrease
REI established
Decrease
Decrease
East of Rocky
Mountains- Increase
REI for very high
contact activities only
West of Rocky
Mountains- Decrease
V. What Registrants Need to Do
-------
The Agency has determined that products containing carbaryl are eligible for
reregi strati on provided that the required label amendments are made. Below are the label
amendments that the Agency intends to require for carbaryl to be eligible for reregi strati on.
A. Label Changes Summary Table
In order to continue to be eligible for reregistration, all products labels are to be amended
to incorporate the risk mitigation measures outlined in label table that follows. Table 13
describes how language on the labels should be amended.
32
-------
Summary of Labeling Changes for Carbaryl
In order to be eligible for reregi strati on, amend all product labels to incorporate the risk mitigation measures outlined in
Section IV. The following table describes how language on the labels should be amended.
Table 13. Summary of Label Changes for Carbaryl
Description
Amended Labeling Language
Placement on Label
Manufacturing Use Products
For all Manufacturing Use
Products
"Only for formulation into an insecticide for the following use(s) [fill blank only with those uses that are being
supported by MP registrant]."
The following uses are cancelled: seedling drench/dipping use, wheat, pets (except for pet collars) and all pet-
related uses. Revise technical and end-use product labels to delete all references to and use-directions for these
cancelled use patterns.
"Carbaryl cannot be formulated into end-use products labeled for seedling drench/dipping use, wheat, pets
(except for pet collars) and all pet-related uses."
The following formulations are canceled: dust (for use on agriculture) and dry flowables.
"Carbaryl cannot be formulated into any dry flowable end-use products, or dust end-use products for use on
agricultural sites. "
The following application methods are prohibited: hand, spoon, backpack spreaders (front and back
mounted), power backpacks, tree injection, and power handheld foggers.
"Carbaryl cannot be formulated into any end use products unless the following application methods are
prohibited: hand, spoon, backpack spreaders (front and back mounted), power backpack sprayers, tree
injection, and power handheld foggers."
"All carbaryl end use product wettable powder formulations must be packaged in water-soluble packets."
"All carbaryl end use products packaged into aerosol can formulations is prohibited."
Directions for Use
33
-------
Table 13. Summary of Label Changes for Carbaryl
Description
Amended Labeling Language
Placement on Label
Liquid and wettable powder formulations labeled for use on turfgrass must limit broadcast applications to
turfgrass on golf courses, sod farms, cemeteries, and commercial landscapes. Applications to all other turfgrass
or lawns must be limited to spot treatments of less than 1000 square feet.
End Use Products Intended for Occupational Use (WPS and Non-WPS)
Determining PPE labeling
requirements for end-use
products containing this
active ingredient
The PPE, if any, that would be established on the basis of the acute toxicity category of each end-use product
must be compared to the active-ingredient specific personal protective equipment specified below. The more
protective PPE must be placed on the product labeling. For guidance on which PPE is considered more
protective, see PR Notice 93-7.
PPE Requirements for sole-active-ingredient end-use products that contain carbaryl: The product labeling
must be revised to adopt the handler personal protective equipment and/or engineering control requirements set
forth in this section. Any conflicting PPE requirements on the current labeling must be removed.
PPE Requirements for multiple-active-ingredient end-use products that contain carbaryl: The handler personal
protective equipment and/or engineering control requirements set forth in this section must be compared to the
requirements on the current labeling and the more protective must be retained. For guidance on which
requirements are considered more protective, see PR Notice 93-7.
Precautionary
Statements under
Hazards to Humans and
Domestic Animals
PPE Requirements
for Liquid Products that
do NOT contain direction
for use for the federal
(APHIS) or affiliated state
Rangeland Grasshopper
and Mormon Cricket
Suppression Program
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are (registrant inserts correct chemical-resistant
material). If you want more options, follow the instructions for category" [registrant inserts A,B,C,D,E,F,G,or
H] on an EPA chemical-resistance category selection chart.
Note to registrant: if the label does not contain directions for use for airblast applications at>5lb ai/A, the
following sections may be eliminated and drop the "other" in the section below starting "All other mixers,
loaders", etc.)
Handlers applying with open cab airblast equipment at application rates equal to or greater than (registrant
insert the application rate in terms of pints, quarts, or gallons of end-use product formulation per acre that is
equivalent to 5 pounds active ingredient) must wear:
- Coveralls over long-sleeved shirt and long pants,
- Chemical-resistant gloves,
- Chemical-resistant footwear plus socks,
- Chemical-resistant headgear, and
- NIOSH-approved dust/mist filtering respirator with NIOSH/MSHA approval number prefix TC-21C or
Immediately
following/below
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
34
-------
Table 13. Summary of Label Changes for Carbaryl
Description
Amended Labeling Language
Placement on Label
NIOSH- approved respirator with any N, R, P or HE filter
All other mixers, loaders, applicators, and handlers must wear:
- Long-sleeved shirt and long pants,
- Shoes plus socks, and
- Chemical-resistant gloves.
In addition, mixers and loaders supporting aerial or chemigation applications must wear
> a NIOSH-approved dust/mist filtering respirator with NIOSH/MSHA approval number prefix TC-21C or
> a NIOSH-approved respirator with any N, R, P or HE filter
"Human flagging is prohibited. Flagging to support aerial application is limited to use of the Global Positioning
System (GPS) or mechanical flaggers."
See engineering controls for additional requirements and exceptions.
PPE Requirements
for Liquid Products that
contain direction for use
for the federal (APHIS) or
affiliated state Rangeland
Grasshopper and Mormon
Cricket Suppression
Program
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are (registrant inserts correct chemical-resistant
material). If you want more options, follow the instructions for category" [registrant inserts A,B,C,D,E,F,G,or
H] on an EPA chemical-resistance category selection chart.
Note to registrant: if the label does not contain directions for use for airblast applications at>5lb ai/A, the
following sections may be eliminated and drop the "other" in the section below starting "All other mixers,
loaders", etc.)
Handlers applying with open cab airblast equipment at application rates equal to or greater than (registrant
insert the application rate in terms of pints, quarts, or gallons of end-use product formulation per acre that is
equivalent to 5 pounds active ingredient) must wear:
- Coveralls over long-sleeved shirt and long pants,
- Chemical-resistant gloves,
- Chemical-resistant footwear plus socks,
- Chemical-resistant headgear, and
- NIOSH-approved dust/mist filtering respirator with NIOSH/MSHA approval number prefix TC-21C or
NIOSH- approved respirator with any N, R, P or HE filter
All other mixers, loaders, applicators, and handlers must wear:
- Long-sleeved shirt and long pants,
35
-------
Table 13. Summary of Label Changes for Carbaryl
Description
Amended Labeling Language
Placement on Label
- Shoes plus socks, and
- Chemical-resistant gloves.
In addition, mixers and loaders supporting aerial or chemigation applications must wear
> a NIOSH-approved dust/mist filtering respirator with NIOSH/MSHA approval number prefix TC-21C or
> a NIOSH-approved respirator with any N, R, P or HE filter
See engineering controls for additional requirements and exceptions.
PPE Requirements
for Wettable Powder
Products
(Note: these formulations
must be sold in water-
soluble packaging)
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are (registrant inserts correct chemical-resistant
material). If you want more options, follow the instructions for category" [registrant inserts A,B,C,D,E,F,G,or
H\ on an EPA chemical-resistance category selection chart.
Note to registrant: if the label does not contain directions for use for airblast applications at>5lb ai/A, the
following sections may be eliminated and drop the "other" in the section below starting "All other mixers,
loaders", etc.)
Handlers applying with open cab airblast equipment at application rates equal to or greater than (registrant
insert the application rate in terms of pints, quarts, or gallons of end-use product formulation per acre that is
equivalent to 5 pounds active ingredient) must wear:
- Coveralls over long-sleeved shirt and long pants,
- Chemical-resistant gloves,
- Chemical-resistant footwear plus socks,
- Chemical-resistant headgear, and
- a NIOSH-approved dust/mist filtering respirator with NIOSH/MSHA approval number prefix TC-21C or a
NIOSH- approved respirator with any N, R, P or HE filter
All other mixers, loaders, applicators, and handlers must wear:
- Long-sleeved shirt and long pants,
- Shoes plus socks,
- Chemical-resistant gloves, and
- Chemical-resistant apron when mixing, loading, or cleaning up spills or equipment.
In addition, mixers and loaders supporting aerial or chemigation applications must wear
> a NIOSH-approved dust/mist filtering respirator with NIOSH/MSHA approval number prefix TC-21C or
> a NIOSH-approved respirator with any N, R, P or HE filter.
(Aerial and chemigation applications are prohibited.)
Immediately
following/below
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
36
-------
Table 13. Summary of Label Changes for Carbaryl
Description
Amended Labeling Language
Placement on Label
See engineering controls for additional requirements and exceptions."
PPE Requirements
for Granular and Bait
Formulations with
Directions for Use for
Broadcast Applications
that do NOT contain
direction for use for the
federal (APHIS) or
affiliated state Rangeland
Grasshopper and Mormon
Cricket Suppression
Program
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant inserts correct chemical-resistant
material). "If you want more options, follow the instructions for category" [registrant inserts
A,B,C,D,E,F,G,or H] "on an EPA chemical-resistance category selection chart."
Loaders, applicators, and other handlers must wear:
- Long-sleeved shirt and long pants,
- Chemical-resistant gloves, and
- Shoes plus socks.
Aerial application is prohibited.
See engineering controls for additional exceptions."
Immediately
following/below
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
PPE Requirements
for Granular and Bait
Formulations that contain
direction for use for the
federal (APHIS) or
affiliated state Rangeland
Grasshopper and Mormon
Cricket Suppression
Program
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant inserts correct chemical-resistant
material). "If you want more options, follow the instructions for category" [registrant inserts
A,B,C,D,E,F,G,or H] "on an EPA chemical-resistance category selection chart."
Loaders, applicators, and other handlers must wear:
- Long-sleeved shirt and long pants,
- Chemical-resistant gloves, and
- Shoes plus socks.
In addition, handlers loading bait formulations into airplanes under the auspices of the Animal and Plant Health
Inspection Service (APHIS) Rangeland Grasshopper and Mormon Cricket Suppression Program, and allied
state programs must wear a NIOSH-approved dust/mist filtering respirator with NIOSH/MSHA approval
number prefix TC-21C or a NIOSH- approved respirator with any N, R, P or HE filter
Aerial application is prohibited, except for aerial applications under the auspices of the Animal and Plant
Health Inspection Service (APHIS) Rangeland Grasshopper and Mormon Cricket Suppression Program, and
allied state programs.
See engineering controls for additional requirements and exceptions."
Immediately
following/below
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
37
-------
Table 13. Summary of Label Changes for Carbaryl
Description
Amended Labeling Language
Placement on Label
PPE Requirements for
RTU Dust Formulations
for Use in Commercial
and Residential Areas.
(Note: Dust end use
products for use on
agricultural sites are
prohibited)
"Personal Protective Equipment (PPE)"
"Loaders, applicators, and other handlers must wear:
- Long-sleeved shirt and long pants, and
- Shoes plus socks. "
Aerial application is prohibited.
User Safety Requirements
If coveralls are not listed as a PPE requirement for handlers, use the following statement:
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables exist,
use detergent and hot water. Keep and wash PPE separately from other laundry."
If coveralls are listed as a PPE requirement for handlers, use the following in addition to the above statement:
"Discard clothing and other absorbent materials that have been drenched or heavily contaminated with this
product's concentrate. Do not reuse them."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals immediately
following the PPE
requirements
Engineering Controls for
Liquid Formulations that
permit aerial application
"Engineering Controls:
Pilots must use an enclosed cockpit in a manner that is consistent with the WPS for Agricultural Pesticides [40
CFR 170.240(d)(6)]."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals (Immediately
following User Safety
Requirements.)
Engineering Controls for
Liquid or Wettable
Powder formulations with
directions for use to citrus
in California and for wide
area mosquito adulticide
applications,
"Engineering Controls:
Applicators using airblast equipment for application to citrus in California and for wide area mosquito
adulticide applications, must use an enclosed cab that meets the definition in the Worker Protection Standard
for Agricultural Pesticides [40 CFR 170.240(d)(5)] for dermal protection. In addition, such applicators must:
~ wear long-sleeve shirt, long pants, shoes, and socks;
~ either wear a NIOSH-approved dust/mist filtering respirator with NIOSH/MSHA approval
number prefix TC-21C or a NIOSH- approved respirator with any N, R, P or HE filter or use an
Precautionary
Statements: Hazards to
Humans and Domestic
Animals (Immediately
following User Safety
Requirements.)
38
-------
Table 13. Summary of Label Changes for Carbaryl
Description
Amended Labeling Language
Placement on Label
enclosed cab that is declared in writing by the manufacturer or by a government agency to provide at
least as much respiratory protection as this type of respirator;
~ be provided, have immediately available for use, and wear in an emergency when they must exit
the cab in the treated area coveralls, chemical-resistant gloves, chemical-resistant footwear, and
chemical-resistant headgear (if overhead exposure) plus - if not already using one - the respirator
specified above-- take off any PPE that was worn in the treated area before reentering the cab, and
~ store all such PPE in a chemical-resistant container, such as a plastic bag, to prevent contamination
of the inside of the cab.
Engineering Controls for
Liquids that contain
direction for use for the
federal (APHIS) or
affiliated state Rangeland
Grasshopper and Mormon
Cricket Suppression
Program
"Engineering Controls:
Human flagging is prohibited, except for flagging to support ultra low volume aerial applications for Rangeland
Grasshopper and Mormon Cricket Suppression through the Animal and Plant Health Inspection Service
(APHIS) Program or affiliated state programs. Flagging to support aerial application for all other use patterns is
limited to use of the Global Positioning System (GPS) or mechanical flaggers.
Flaggers supporting ultra low volume aerial applications for Rangeland Grasshopper and Mormon Cricket
Suppression through the Animal and Plant Health Inspection Service (APHIS) Program or affiliated state
programs must use an enclosed cab that meets the definition in the Worker Protection Standard for Agricultural
Pesticides [40 CFR 170.240(d)(5)] for dermal protection. In addition, flaggers must:
~ wear long-sleeve shirt, long pants, shoes, and socks,
~ either wear a NIOSH-approved dust/mist filtering respirator with NIOSH/MSHA approval number prefix
TC-21C or a NIOSH- approved respirator with any N, R, P or HE filter or use an enclosed cab that is declared
in writing by the manufacturer or by a government agency to provide at least as much respiratory protection as
this type of respirator;,
~ be provided, have immediately available for use, and wear in an emergency when they must exit the cab in
the treated area: chemical-resistant gloves and chemical-resistant headgear, and, if using an enclosed cab that
provides respiratory protection, a respirator of the type specified above,
~ take off any PPE that was worn in the treated area before reentering the cab, and
~ store all such PPE in a chemical-resistant container, such as a plastic bag, to prevent contamination of the
inside of the cab."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals (Immediately
following User Safety
Requirements.)
Engineering Controls for
Wettable Powders
Formulations
Water-Soluble Packaging
is required for all
"Water-soluble packaging when used correctly qualifies as a closed mixing/loading system under the Worker
Protection Standard for Agricultural Pesticides [40 CFR 170.240(d)(4)]. Mixers and loaders using water
soluble packets must:
-wear the personal protective equipment on this labeling for mixers/loaders, and
-be provided, have immediately available, and use in an emergency, such as a broken package, spill, or
equipment breakdown, chemical-resistant footwear and a NIOSH-approved dust/mist filtering respirator with
Precautionary
Statements: Hazards to
Humans and Domestic
Animals (Immediately
following User Safety
Requirements.)
39
-------
Table 13. Summary of Label Changes for Carbaryl
Description
Wettable Powder
Formulations
Engineering Control
Requirements for
Granular/Bait Formulation
Labeled for Use for
Rangeland Grasshopper or
Mormon Cricket Control
Additional Engineering
Controls Statement for all
liquid, wettable powder,
and for granular and bait
formulations with
directions for broadcast
application.
(Note: this statement is
not needed for the 0.03%
granula^ait formulation)
User Safety
Amended Labeling Language
NIOSH/MSHA approval number prefix TC-21C or a NIOSH-approved respirator with any N, R, P or HE filter.
"Engineering Controls:
Pilots applying applications under the auspices of the Animal and Plant Health Inspection Service (APHIS)
Rangeland Grasshopper and Mormon Cricket Suppression Program or related state programs must use an
enclosed cockpit in a manner that is consistent with the WPS for Agricultural Pesticides [40 CFR
170.240(d)(6)].
Flaggers supporting aerial applications permitted above must use an enclosed cab that meets the definition in
the Worker Protection Standard for Agricultural Pesticides [40 CFR 170.240(d)(5)] for dermal protection. In
addition, flaggers must:
~ wear long-sleeve shirt, long pants, shoes, and socks,
~ either wear a NIOSH-approved dust/mist filtering respirator with NIOSH/MSHA approval number prefix
TC-21C or a NIOSH- approved respirator with any N, R, P or HE filter OR use an enclosed cab that is declared
in writing by the manufacturer or by a government agency to provide at least as much respiratory protection as
this type of respirator,
~ be provided and have immediately available for use in an emergency when they must exit the cab in the
treated area: chemical-resistant gloves and chemical-resistant headgear and, if using an enclosed cab that
provides respiratory protection, a respirator of the type specified above,
~ take off any PPE that was worn in the treated area before reentering the cab, and
~ store all such PPE in a chemical-resistant container, such as a plastic bag, to prevent contamination of the
inside of the cab."
"When applicators use enclosed cabs in a manner that meets the requirements listed in the Worker Protection
Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(5), the handler PPE requirements may be
reduced or modified as specified in the WPS."
"User Safety Recommendations
Placement on Label
Precautionary
Statements: Hazards to
Humans and Domestic
Animals (Immediately
following any other
engineering control
requirements.)
Placed in a box in the
40
-------
Table 13. Summary of Label Changes for Carbaryl
Description
Amended Labeling Language
Placement on Label
Recommendations
Users should wash hands thoroughly with soap and water before eating, drinking, chewing gum, using tobacco,
or using the toilet.
Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put on
clean clothing.
Users should remove PPE immediately after handling this product. Wash the outside of gloves before
removing. As soon as possible, wash thoroughly and change into clean clothing."
Precautionary
Statements under
Hazards to Humans and
Domestic Animals
immediately following
Engineering Controls.
Restricted-Entry Interval
"Do not enter or allow worker entry into treated areas during the "Restricted-entry interval (REI). The REI for
each crop is listed in the directions for use associated with each crop."
Directions for Use,
Inside the Agricultural
Use Requirements Box
Early Entry Personal
Protective Equipment
"PPE required for early entry to treated areas that is permitted under the Worker Protection Standard and that
involves contact with anything that has been treated, such as plants, soil, or water, is:
- Coveralls over short-sleeve shirt and short-pants,
- Chemical-resistant footwear plus socks,
- Chemical-resistant gloves made of any waterproof material, and
- Chemical-resistant headgear if overhead exposure."
Directions for Use,
Inside the Agricultural
Use Requirements Box
NonWPS Entry
Restrictions for
applications applied as a
spray
"Do not enter or allow others to enter the treated area until sprays have dried."
NonWPS Entry
Restrictions for granular
applications
"Do not enter or allow others to enter the treated area until dusts have settled. In addition, if directions for use
require watering-in, do not enter or allow others to enter the treated area (except those involved in the watering-
in) until the watering-in is completed and the area has dried."
If no WPS uses are on
the label - Place the
NON -WPS entry
restrictions in the
Directions for Use,
under the heading
"Entry Restrictions."
If WPS uses are also on
the label - Follow the
instructions in PR
Notice 93-7 for
establishing a Non-
Agricultural Use
Requirements box, and
place the appropriate
41
-------
Table 13. Summary of Label Changes for Carbaryl
Description
General Application
Restrictions
Application Restrictions
for all Products
Application Restrictions
for Wettable Powder
Products
Application Restrictions
for Liquid and Wettable
Powder Products
containing instructions for
application to turfgrass or
lawns
Application Restrictions
Amended Labeling Language
"Do not apply this product in a way that will contact workers or other persons, either directly or through drift.
Only protected handlers may be in the area during application. For any requirements specific to your State or
tribe, consult the agency responsible for pesticide regulation."
"The following application methods are prohibited: hand, spoon, shaker can, backpack spreaders (front and
back mounted), power backpack sprayers, tree injection, and ALL handheld foggers."
"Aerial application is prohibited."
"Broadcast applications to turfgrass are permitted only on golf courses, sod farms, cemeteries, and commercial
landscapes."
Labels must be amended to reflect the
restrictions currently on labels.
following application restrictions which supersede or are in addition to
Placement on Label
Non-WPS entry
restrictions in that box.
For WPS products and
products with both
WPSandNonWPS
uses, place directly
above the Agricultural
Use Requirements box.
For Non-WPS products,
place in the Direction
for Use under General
Precautions and
Restrictions.
Directions for Use in a
prominent place near
the beginning
Directions for Use
associated with the
lawn/turf grass
directions
Directions for Use,
Under Application
Instructions for Each
Crop
42
-------
Table 13. Summary of Label Changes for Carbaryl
Description
Amended Labeling Language
Placement on Label
Alfalfa
"Restricted-entry interval (REI) = 12 hours"
Almonds
"Restricted-entry interval (REI) =12 hours"
Apples
"Restricted-entry interval (REI) =12 hours"
Apricots
"Restricted-entry interval (REI) =12 hours"
Asparagus
"Restricted-entry interval (REI) =12 hours"
For preharvest application, apply a maximum of 1 pound active ingredient per acre (registrant state this in
amount of formulation per acre).
For postharvest application to the plants remaining in the field, apply a maximum of 2 pounds active ingredient
per acre (registrant state this in amount of formulation per acre)."
Application Restrictions
Beans
String beans and Dry Beans
"Restricted-entry interval (REI) =12 hours"
Blueberries (Lowbush)
"Restricted-entry interval (REI) =12 hours"
Blueberries (Highbush)
"Restricted-entry interval (REI) =12 hours"
Boysenberry
"Restricted-entry interval (REI) =12 hours"
Brassica (bok choy, broccoli, Brussel sprouts, cabbage [including Chinese], cauliflower, collards,
Hanover salad, kale, kohlrabi, mustard greens, napa)
"Restricted-entry interval (REI) =12 hours
Application is permitted only within 30 days from the date of crop emergence or the date of transplanting.'
Directions for Use,
Under Application
Instructions for Each
Crop
43
-------
Table 13. Summary of Label Changes for Carbaryl
Description
Amended Labeling Language
Placement on Label
Application Restrictions
Carrots
"Restricted-entry interval (REI) =12 hours"
Chestnuts
"Restricted-entry interval (REI) =12 hours"
Cherries
"Restricted-entry interval (REI) =12 hours
Citrus (citron, grapefruit, kumquats, lemons, limes, oranges, tangelos, tangerines, and hybrids)
California only:
"Restricted-entry interval = 3 days
Do not apply more than 12 pounds active ingredient per acre per application (registrant states this in amount of
formulation per acre per application."
All States other than California:
"Restricted-entry interval = 12 hours
Do not apply more than 5 pounds active ingredient per acre per application (registrant states this in amount of
formulation per acre per application."
Florida SLN FL-890037 only:
"Restricted-entry interval = 12 hours
Do not apply more than 8 pounds active ingredient per acre per application (registrant states this in amount of
formulation per acre per application."
Directions for Use,
Under Application
Instructions for Each
Crop
Application Restrictions
Corn (field, sweet, seed, and pop)
"Restricted-entry interval = 24 hours.
Prohibition: Do not enter or allow workers to enter treated areas to perform hand detasselling tasks until 21
days after application. You must notify workers of this prohibition. Hand harvesting is prohibited. Notify
workers of the hand harvesting prohibition."
Crabapples
"Restricted-entry interval (REI) =12 hours"
Caneberries (blackberry and raspberry)
"Restricted-entry interval = 12 hours"
Directions for Use,
Under Application
Instructions for Each
Crop
44
-------
Table 13. Summary of Label Changes for Carbaryl
Description
Application Restrictions
Application Restrictions
Amended Labeling Language
Cranberries
"Restricted-entry interval = 12 hours"
Cucurbits (cantaloupe, cucumber, gourds, melon, pumpkins, squash, watermelon, zucchini, Chinese
okra)
"Restricted-entry interval (REI) =12 hours"
Dewberry
"Restricted-entry interval (REI) =12 hours"
Eggplant
"Restricted-entry interval (REI) =12 hours"
Flax
"Restricted-entry interval (REI) =12 hours"
Forest Trees, Conifers, and Christmas Trees
"Restricted-entry interval (REI) =12 hours
Grapes
East of the Rocky Mountains:
"Restricted-entry interval (REI) = 2 days for all activities except for grape girdling and cane turning which
requires 6 days"
West of the Rocky Mountains:
"Restricted-entry interval (REI) = 6 days"
Grass grown for Seed Production
"Restricted-entry interval = 12 hours"
Hazelnuts (Filberts)
"Restricted-entry interval (REI) =12 hours"
Horseradish
"Restricted-entry interval = 12 hours"
Placement on Label
Directions for Use,
Under Application
Instructions for Each
Crop
Directions for Use,
Under Application
Instructions for Each
Crop
45
-------
Table 13. Summary of Label Changes for Carbaryl
Description
Amended Labeling Language
Placement on Label
Lentils
"Restricted-entry interval (REI) = 12 hours"
Leafy vegetables (celery, dandelion, endive, escarole, lettuce, romaine, parsley, Swiss chard, spinach,
carrot tops)
"Restricted-entry interval (REI) =12 hours"
Loganberry
"Restricted-entry interval (REI) =12 hours"
Longan
"Restricted-entry interval (REI) =12 hours"
Loquat
"Restricted-entry interval (REI) =12 hours"
Application Restrictions
Macadamia
"Restricted-entry interval (REI) =12 hours"
Nectarines
"Restricted-entry interval (REI) =12 hours
Okra
"Restricted-entry interval (REI) =12 hours"
Olives
"Restricted-entry interval (REI) = 3 days"
Ornamentals and Nursery Plants
"Restricted-entry interval (REI) =12 hours
"EXCEPTION: the restricted-entry interval is 18 days for ornamentals grown for cuttings (cut flowers or cut
foliage) where production is in outdoor areas where average annual rainfall is less than 25 inches a year. Notify
workers of the application and restricted-entry interval by warning them orally and by posting warning signs at
entrances to treated area. Note: information on average annual rainfall for your area is available from any
nearby weather bureau, such as one located at a local airport or one affiliated with the National
Oceanographic and Atmospheric Administration. ".
Directions for Use,
Under Application
Instructions for Each
Crop
46
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Table 13. Summary of Label Changes for Carbaryl
Description
Amended Labeling Language
Placement on Label
Parsnip
"Restricted-entry interval (REI) = 12 hours"
Application Restrictions
Peas (dry peas, field peas, southern peas, succulent peas, blackeyed peas, chick peas, green peas,
cowpeas, sitao, and oriental peas)
"Restricted-entry interval (REI) =12 hours"
Peaches
"Restricted-entry interval (REI) =12 hours"
Peanuts
"Restricted-entry interval (REI) =12 hours"
Pears (including Oriental Pears)
"Restricted-entry interval (REI) =12 hours"
Pecans
"Restricted-entry interval (REI) = 12 hours"
Peppers (bell/chili)
"Restricted-entry interval (REI) = 12 hours"
Pistachio
"Restricted-entry interval (REI) = 12 hours"
Directions for Use,
Under Application
Instructions for Each
Crop
Application Restrictions
Plums/Prunes
"Restricted-entry interval (REI) =12 hours"
Potatoes (White and Irish)
"Restricted-entry interval (REI) =12 hours"
Proso millet
Directions for Use,
Under Application
Instructions for Each
Crop
47
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Table 13. Summary of Label Changes for Carbaryl
Description
Application Restrictions
Application Restrictions
Amended Labeling Language
"Restricted-entry interval (REI)
Quince
"Restricted-entry interval (REI)
Radish
"Restricted-entry interval (REI)
Raspberries (Black and Red)
"Restricted-entry interval (REI)
Rice
"Restricted-entry interval (REI)
Rutabaga
"Restricted-entry interval (REI)
Salsify
"Restricted-entry interval (REI)
Strawberries
"Restricted-entry interval (REI)
Sorghum
"Restricted-entry interval (REI)
Soybeans
"Restricted-entry interval (REI)
Sugarbeets
"Restricted-entry interval (REI)
Sugarcane
"Restricted-entry interval (REI)
Sunflower
"Restricted-entry interval (REI)
= 24 hours"
= 12 hours"
= 12 hours"
= 12 hours"
= 12 hours"
= 12 hours"
= 12 hours"
= 12 hours"
= 12 hours."
= 12 hours"
= 12 hours"
= 12 hours"
= 12 hours"
Placement on Label
Directions for Use,
Under Application
Instructions for Each
Crop
Directions for Use,
Under Application
Instructions for Each
Crop
48
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Table 13. Summary of Label Changes for Carbaryl
Description
Amended Labeling Language
Placement on Label
Sweet Potatoes
"Restricted-entry interval (REI) = 12 hours"
Table Beets
"Restricted-entry interval (REI) = 12 hours"
Tobacco
"Restricted-entry interval (REI) = 48 hours"
Tomatoes
"Restricted-entry interval (REI) =12 hours"
Trefoil
"Restricted-entry interval (REI) =12 hours"
Turf Grown for Sod Production
"Restricted-entry interval (REI) = 12 hours
Restricted-entry interval (REI) for harvesting = 24 hours"
Turnips
"Restricted-entry interval (REI) =12 hours"
Walnuts (English and Black)
"Restricted-entry interval (REI) = 12 hours"
Application Restrictions
Mosquito control
"Do not apply more than 0.2 pounds active ingredient per acre per application (registrant state this in amount of
formulation per acre per application). Not for use in public health programs."
NOTE: At this time, neither EPA nor CDC are aware of any uses of carbaryl in public health programs.
Current labels for ultra-low volume application are labeled solely for non-urban forested areas, non cropland,
and rangeland uses.
Directions for Use
Associated with the Use
Pattern
1 PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more protective PPE must be placed in the product
labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
If the product contains oil or bears instructions that will allow application with an oil-containing material, the "N" designation must be dropped.
Instructions in the Labeling section appearing in quotations represent the exact language that should appear on the label.
Instructions in the Labeling section not in quotes represents actions that the registrant should take to amend their labels or product registration
49
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APPENDICES
I. SIMMARY of CARBARYL DATA REQUIREMENTS FROM 2005 Generic DCI
II. Bibliography of Studies used in Amended RED
50
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Appendix I:
Status of Guideline Studies
OPPTS
Guideline
Number
Study Title/Description
Required Sceneries
MRID
Number
WORKER EXPOSURE MONITORING STUDY
875.1100
875.1300
Dermal Exposure - Outdoor
Inhalation Exposure - Outdoor
Airblast, open cab, hat & full PPE
Aerial mixer/loader for large acreage (i.e., grasshopper use)
Aerial applicator (pilot) for large acreage (i.e., grasshopper use)
Dust application in agriculture
Power handheld fogger
Power backpack application
Tree injection
Drenching/dipping seedlings
Airblast, open cab, hat & full PPE
Aerial mixer/loader for large acreage (i.e., grasshopper use)
Aerial applicator (pilot) for large acreage (i.e., grasshopper use)
Dust application in agriculture
Power handheld fogger
Power backpack application
Tree injection
Drenching/dipping seedlings
46448201
47051601
46634105
47051601
46634105
n/a
46448201
47051601
46634105
47051601
46634105
n/a
POST APPLICATION EXPOSURE DATA REQUIREMENTS
875.2100
Foliar Dislogeable Residue
Cut flower greenhouse study
46892801
51
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OPPTS
Guideline
Number
875.2400
Study Title/Description
Dissipation
Dermal Exposure
Required Sceneries
Dog collar transferable residues
Turf transferable residues
Hand press turf transferable residues
Cut flower greenhouse study
Dog collar transferable residues
MRID
Number
Study
underway,
submission
pending
(6/2009)
46673901
46673901
46892801
Study
underway,
submission
pending
(6/2009)
ENVIRONMENTAL FATE DATA REQUIREMENTS
835.4100
835.4300
Aerobic Soil Metabolism
Aerobic Aquatic Metabolism
Additional studies required on a range of soil types
Additional studies required on a range of aquatic environments
46580700
46580701
46580702
PRODUCT CHEMISTRY DATA REQUIREMENTS
830.1800
Enforcement Analytical Method
Analytical Method
46699101
RESIDUE CHEMISTRY DATA REQUIREMENTS
860.1380
Storage Stability
Oilseed and processed commodities of oily crop.
Sugarbeets. Previous study upgraded with data on sampling
intervals.
Dried fruit stored up to 10 months.
Submission
Pending
(10/2008)
46936301
Submission
52
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OPPTS
Guideline
Number
860.1500
Study Title/Description
Crop Field Trials
Required Sceneries
Alfalfa commodities - 18 month storage interval.
Potatoes - 15 month storage interval.
Cottonseed - 17 month storage interval
Wheat commodities - 22 month storage interval.
Rangeland grass- 33 month storage interval.
Wheat, hay
Pea and bean, succulent
Pineapple (3 trials in Costa Rica, 2 in Mexico)
Vegetable, leafy, except Brassica
MRID
Number
Pending
(12/2008)
Submission
Pending
(12/2008)
Submission
Pending
n/a
n/a
Submission
Pending
n/a
n/a
47087901
n/a
ECOLOGICAL EFFECTS DATA REQUIREMENTS
850.3040
Field Testing for Pollinators
Sevin XLR, Hybrid Poplars in Minnesota
Study
waived;
labeling
required
TOXICOLOGICAL DATA REQUIREMENTS
870.3465
Inhalation Study
Two short term inhalation studies
Submission
Pending
n/a- Not applicable because the use pattern/scenario is not being supported by the registrant. Cancelation is in progress.
53
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Appendix II:
Bibliography
MRID Number
45732201
46015001
46075601
46448201
46580700
46580701
46580702
46634105
46673901
46699101
46892801
Study Name
Emlay, D.; Rudolph, R. (1977) Determination of the Quantity of
Carbaryl Removed by Petting Dogs Wearing 16% Carbaryl Dog
Collars: Lab Project Number: TR-506. Unpublished study prepared
by Zoecon Industries, Inc. 14 p. (OPPTS 875.1500}
Rudolph, R.; Moorman, R. (2003) Determination of the Quantity of
Carbaryl Removed by Petting Dogs Wearing 16% Carbaryl Dog
Collars. Project Number: TR/506. Unpublished study prepared by
Wellmark International. 23 p.
Wayne, R. (1974) Rate of Release Evaluation of a Four Mouth
Carbaryl Dog Collar (F-68-118-1). Project Number: TR/337.
Unpublished study prepared by Thuron Industries Research &
Development. 14 p.
Smith, L. (2004) Determination of Dermal and Inhalation Exposure
to Workers During Application of a Liquid Pesticide Product by
Open Cab Airblast Application to Orchard Crops. Project Number:
AHE07. Unpublished study prepared by Stewart Agricultural
Research Services. 448 p.
LaRochelle D. (2005) Carbaryl; 90 Day Response to the Interim
Reregi strati on Eligibility Decision and Generic Data Call-In.
Oddy, A.; Dobie, M. (2003) [Carbon-14] - Carbaryl: Degradation and
Retention in Two Water/Sediment Systems. Project Number:
CX/02/047, C031658. Unpublished study prepared by Battelle
Agrifood, Ltd. 131 p.
Doble, M.; Oddy, A. (2004) [Carbon-14] - Carbaryl:
Characterisation/Identification of Unknowns from a Water/Sediment
Study. Project Number: CX/03/068, C/043396. Unpublished study
prepared by Battelle Agrifood, Ltd. 52 p.
Klonne, D. (2005) Determination of Dermal and Inhalation Exposure
to Workers During Closed-System Loading and ULV Application of
a Liquid Pesticide Product to Cotton: Malathion. Project Number:
AHE13, GR04/487, 040165. Unpublished study prepared by
Agricultural Handlers Exposure Task Force, Grayson Research, Ltd.
and Golden Pacific Laboratories, LLC (GPL). 460 p.
Krolski, M. (2005) Sevin 2G - Determination of Transferable
Residues from Turf. Project Number: RACAX015, CA25TF01,
CA001/03D. Unpublished study prepared by Bayer Corp., Analytical
Bio-Chemistry Labs., Inc. and Bayer CropScience. 268 p.
Forntain, L. (2005) Product Chemistry of Sevin Brand Technical
Carbaryl Insecticide. Project Number: PAO 1/061, ANR/19505,
PA01/051. Unpublished study prepared by Bayer Corp. 43 p.
Barney, W. (2006) Carbaryl: Dissipation of Dislodgeable Foliar
Residues From Chrysanthemums. Project Number: 08636,
-------
MRID Number
Study Name
08636/DF/BER05, 08636/DF/WA/52. Unpublished study prepared
by Interregional Research Project No. 4 and U.S. Dept. of
Agriculture. 242 p.
46936301
Larochelle, D. (2006) "SEVIN Brand Carbaryl Insecticide Sugar Beet
Processing Study". Project Number: 801R11. Unpublished study
prepared by Bayer Crop Science LP. 22 p.
47007001
Moser, G. (2006) Report on Cholinesterase Comparative Sensitivity
Study of Carbaryl. Unpublished study prepared by U.S.
Environmental Protection Agency, ORE), NHEERL. 35 p.
47051601
Collier, K.; Honeycutt, R. (2007) Occupational and Residential
Exposure: Determination of Dermal and Inhalation Exposure to
Workers During Loading or Application of Carbaryl Bait. Project
Number: AHE25. Unpublished study prepared by Agricultural
Handlers Exposure Task Force and U.S. Department of Agriculture.
222 p.
47087901
Hoag, R.; Seymour, B. (2007) Sevin XLR 48 SC (Sevin XLR Plus) -
Magnitude of the Residue in/on Pineapple. Project Number:
RACAS001. Unpublished study prepared by Bayer Corp. and Morse
Laboratories, Inc. 110 p.
47151902
Dick, I. (2001) [Carbon-14]-Carbaryl: Comparative in Vitro Dermal
Penetration Study Using Human and Rat Skin. Project Number:
AES/033/012804, AES/033, C/016768. Unpublished study prepared
by Huntingdon Life Sciences, Ltd. 118 p.
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