r/EPA
United States
Environmental Protection
Agency
Pesticide
Fact Sheet
Name of Chemical:
Reason for Issuance:
Date Issued:
Office of Prevention, Pesticides
and Toxic Substances
(7501C)
Nicarbazin
Conditional Registration
November 2005
i.
DESCRIPTION OF CHEMICAL
Chemical Name:
Common Name:
EPA PC Code:
Chemical Abstracts
Service (CAS)
Number:
Year of Initial
Registration:
Pesticide Type:
U.S. Producer:
Products:
Mode of
Action:
Nicarbazin (C19H18N6O6), a complex of two compounds, 4,4'-
dinitrocarbanilide (DNC) and 4,6-dimethyl-2-pyrimidinol (HDP)
Nicarbazin
085712
330-95-0
2005
Egg Hatch Reduction in Resident Canada Geese (Branta canadensis)
Innolytics, LLC.
OvoControl-G (EPA Reg. No. 80224-3; 0.25% bait)
Nicarbazin 30% Granulated premix (EPA Reg. No. 80224-2)
Nicarbazin interferes with the formation of the vitelline membrane,
separating the egg yolk and egg white. The exact mode of action is
unknown, although it is thought nicarbazin interferes with cholesterol
metabolism in the formation of the membrane. Eggs from treated
birds are described as mottled in appearance, reflecting a porous
vitelline membrane. The effect on hatchability is a function of time
and dose and the effect is reversible.
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2.
USE PATTERNS AND FORMULATIONS
Application Sites:
Types and Methods
of Application:
Application Rate:
The use of OvoControl G is limited to sites in urban areas such as office
parks, recreational parks, golf courses, schools, hospitals, restaurants, and
commercial and industrial sites. Urban is defined as a municipality and its
adjacent areas with a population of 50,000 or more. It may also be used at
land airports holding FAA certifications under 14 Code of Federal
Regulations 139.101 and having a wildlife hazard management plan under 14
Code of Federal Regulations 139.337.
Bait may be applied with bait pans, broadcast directly on the ground by hand
or with mechanical feeders (up to a 20 ft radius). Mechanical feeders must
be attended and triggered by the applicator daily, with the exception that
unattended mechanical feeders may be used at land airports which have FAA
certification under 14 CFR 139.101 and a wildlife hazard management plan
under 14 CFR 139.337.
Application rate is 50 grams per goose per day. Beginning three weeks prior
to first anticipated egg-laying, a small amount of bait is offered (7 grams per
goose), and the amount is increased each day, as geese become acclimated to
the bait. Baiting continues throughout the nesting period, which lasts 8 to 10
weeks.
3. SCIENCE FINDINGS
Nicarbazin product chemistry, toxicology, ecological effects and environmental fate data
necessary to support the registration and use pattern are discussed below.
Product Chemistry:
Nicarbazin (C19H18N6O6) is a complex of two compounds, 4,4'-dinitrocarbanilide (DNC,
302.25 molecular weight) and 4,6-dimethyl-2-pyrimidinol (FtDP, 124.14 molecular weight).
DNC is considered to be the active component, while HDP aids in absorption (Table 1).
Table 1: Nicarbazin - Product Chemistry Summary
Physical Properly
CAS Reg No.
Molecular weight
Color
Physical State
Melting point, °C
Nicarbazin Technical Grade
330-95-0
426.38
light yellow
fine powder
265-275 °C (with decomposition)
OvoControl-G
330-95-0
NA
yellowish-tan
solid, round to oblong, semi-soft
kibbles
NA
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Physical Property
Odor
Stability to normal and
elevated temperatures, metals
and metal ions
UV/VIS absorption max, nm
Aqueous solubility, ppm
pH
Vapor Pressure
Flammability/explodability
density
storage stability
corrosion characteristics
Nicarbazin Technical Grade
characteristic
nicarbazin is inherently stable
under extreme conditions
nicarbazin produces a band of
absorption in the range of 300-
360 mm
slightly soluble in
dimetylsulphoxide (DMSO) and
dimethylformamide (DMF);
insoluble in water and methanol,
however it decomposes slowly
when mixed with them
5-7 (1% suspension in water)
expected to be zero at ambient
temperatures (based on high
melting point)
NA
0.5 g/ml
NA
NA
OvoControl-G
None to slight grain odor
NA
NA
NA
NA
NA
neither flammable or explodable
based on formulation ingredients
25-33 Ibs/bushel
must be submitted upon
completion for both products
must be submitted upon
completion for both products
Toxicology:
Based on acute toxicity data, OvoControl-G and Nicarbazin 30% Granulated Premix are
Toxicity Category IV for oral, dermal, inhalation and primary dermal sensitization and
Toxicity category III for primary eye irritation. See toxicity endpoints in Table 2 below.
The following precautionary label language is required:
CA UTION: Causes moderate eye irritation. Remove and wash contaminated clothing before reuse. Avoid
contact with eyes or clothing. Wear protective eyewear. Wash thoroughly with soap and water after handling
and before eating, drinking, chewing gum, or using tobacco. Wear: Long-sleeved shirt and long pants, Socks,
Shoes, and gloves.
Nicarbazin has been a Food and Drug Administration (FDA) approved veterinary drug for
use as an anticoccidial agent in broiler chickens since 1955. FDA has established a
tolerance of 4 parts per million for nicarbazin residues in uncooked chicken muscle, skin,
liver, and kidney (21 Code of Federal Regulations 556.445). FDA has established a feed
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additive tolerance of 125 ppm in chickens (21 Code of Federal Regulations 558.366) for use
of nicarbazin in feed to prevent outbreaks of faecal and intestinal coccidiosis.
To address toxicity data requirements, EPA relied on the Joint Food and Agriculture
Organization/World Health Organization (WHO) Expert Committee on Food Additives
1988 nicarbazin summary report. Based on the WHO data summary, additional
toxicological testing on this chemical for use to reduce egg hatchability in resident Canada
geese is not required. The toxicology information summarized in the report is listed in
Table 2.
Table 2: Nicarbazin Toxicity Profile
Study Type
Acute Inhalation Toxicity - rat
Acute Dermal Toxicity - rat
Primary Eye Irritation - rabbit
Primary Dermal Irritation - rabbit
Dermal Sensitization - guinea pig
Chronic Feeding, 2 year - dog
Chronic Feeding, 2 year - rat
Reproductive Toxicity - rat
Developmental Toxicity - rat
Mutagenicity
Carcinogenicity
Results
LC50>0.147mg/L
LD50 > 5,000 mg/kg
moderate irritant (category III)
not an irritant
not a contact sensitizer
NOEL 240 mg/kg/day based on slij
effect
NOEL 400 mg/kg/day based on no
highest dose tested
NOEL 400 mg/kg/day based on no
highest dose tested
NOEL 200 mg/kg/day for maternal
toxicity
*ht bile-duct
effects at
effects at
and fetal
Not mutagenic
Not carcinogenic
Metabolism studies were reviewed by the Joint Food and Agriculture Organization/World
Health Organization (WHO) Expert Committee on Food Additives. Residue depletion
studies in chickens showed rapid elimination from the birds at five to seven days after
withdrawal.
The potential for human exposure and mammals (e.g. dogs) is anticipated to be low from the
use of nicarbazin fed to resident Canada geese. The WHO studies indicate that non-target
mammals (including humans) would have to consume prohibitively large amounts of the
product to produce any toxic effects. Based on the rat acute oral LD50 toxicology data, an
acute single ingestion for a child (15kg or 331bs) would have to exceed 60 kilograms (132
pounds) of bait and for a dog (10kg or 231b.) 40kg (881bs) of bait to cause lethal effects in
50% of the population.
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On a chronic basis, using the results of a 2 year chronic study in rats (NOEL = 400 mg/kg
bw/day, based on HDT no treatment related toxicity), the no-effect quantities of bait on a
daily consumption basis are 2.4 kg (5.2 Ibs) and 1.6 kg (3.5 Ibs) for the rest of their lives.
Again, the consumption of bait on a daily basis is not realistic and consumption values are
not physically possible.
Label restrictions markedly reduce inadvertent exposure to children and pets because
uneaten bait is not expected and any leftover bait must be removed. Also, once geese are
acclimated to the bait, consumption typically takes place quickly and completely. By the
end of the initial 21 day period, the daily dose (based on flock size) must be entirely
consumed within 2 hours of application or treatment must cease.
Ecological Effects:
Terrestrial Animal Routes of Exposure:
Feeding on nicarbazin bait placed in terrestrial environments is expected to be a route of
primary exposure to non-target species. Exposure via this route is expected to occur
primarily to birds and mammals, although it is possible for other terrestrial animals such as
reptiles and terrestrial amphibians to be exposed if they consume the bait. Terrestrial
species may also ingest nicarbazin and DNC by drinking contaminated water (e.g.,
rainwater in bait pans, puddled water on the ground, pond water). Bait deposited in water
bodies may also be directly consumed by terrestrial species that feed in water (e.g., non-
target waterfowl).
Secondary exposure is also possible, but the extent to which this may occur is unknown.
Since it is expected to remain in soil, nicarbazin and DNC released into the terrestrial
environment from bait or feces will be available to soil macroinvertebrates for uptake or
consumption. Terrestrial animals that feed on soil macoinvertebrates may receive exposure
via this pathway. Secondary exposure may also occur to predators and scavengers
consuming tissues and/or eggs of animals that have ingested bait. This exposure may raise
the potential for risk to species that consume eggs of animals that have consumed the bait.
Terrestrial Animal Exposure Assumptions:
For the screening level assessment, very conservative assumptions were made. It was
assumed that 2500 ppm nicarbazin bait would be available for a nontarget animal to
consume on a 24 hour basis, and up to 13 weeks as the sole food source.
Terrestrial Animal Toxicity and Risk:
Nicarbazin is characterized as practically non-toxic to the Northern bobwhite and slightly
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toxic to the mallard on an acute/sub acute basis (Table 3)
Table 3. Nicarbazin Acute Avian Toxicity to Birds
Test species
Mallard
Northern bobwhite
Percent Nicarbazin
>99
(both moieties)
Toxicity value
LC50 = 3680 ppnf
LC50 >5720 ppmb
LD50 >2250 mg/kg bw
a mortality was 80% at 5720 ppm ai, 10% at 1968 ppm nicarbazin, andO% at the control and <802 ppm aitest levels;
treatment-related signs of toxicity were evident by day 2
b single mortalities (10%) were observed at the 1968 and 5720 ppm nicarbazin levels and may have been caused by exposure;
effects were first observed between Days 5 and 6 and included wing droop, ruffled appearance, and/or foot lesions
(from picking)
The acute risk quotient (RQ = 0.7) for acute effects to birds slightly exceeds the acute high
risk level of concern (LOG = 0.5) based on the conservative, screening level risk
assessment. The risk estimate assumes exposure.
The likelihood of this exposure occurring is minimized by label restrictions. Several label
restrictions are imposed which will ensure a markedly reduced exposure to non-target birds,
reptiles and mammals. (See Labeling Restrictions).
Terrestrial Animal Chronic Toxicity and Risk:
Although there are no guideline reproduction studies available for nicarbazin, several
laboratory and field studies have shown that this chemical causes reproductive effects in
several bird species. These data clearly demonstrate that low concentrations of nicarbazin
fed in the diet will adversely impact avian reproduction (which is to be expected given its
mode of action). For example, significantly reduced egg production and hatchability of
fertile eggs was reported at a dietary concentration of 25 ppm when fed to chickens for only
four days, and eggshell pigmentation was reduced after only two days of feeding. These
effects were even more pronounced at dietary concentrations of 50 and 100 ppm. In several
studies, negative impacts on egg hatchability in chickens fed 20 ppm nicarbazin in the diet
for only 9 to 10 days have been reported in several studies. In another study, mortality
occurred in chickens fed 1600 and 2500 ppm nicarbazin in food ration, and depressed
growth and reduced egg hatchability was seen at lower concentrations.
Based on worst-case findings of the published literature studies, a no observable adverse
effect concentration (NOAEC) of 10 ppm is presumed due to adverse affects on egg
hatching at 20 ppm.
Based on the reproductive NOAEC of 20 ppm, the avian chronic effects RQ is X250. The
concentration of nicarbazin in the bait (2500 ppm) exceeds the level shown to cause adverse
reproductive effects in chickens, quail, and mallards after exposures of a few days to two
weeks in the laboratory.
The chronic risk estimate is very conservative, as it assumes that the bait would be available
for nontarget animals to consume on a 24 hour basis, up to 13 weeks as the sole food source.
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The likelihood of this exposure is low, and is further minimized by label restrictions.
Several label restrictions are imposed which will ensure a markedly reduced exposure to
non-target birds, reptiles and mammals. (See Labeling Restrictions).
Aquatic Animal Routes of Exposure:
Nicarbazin and DNC deposited on land may reach aquatic environments and standing water
via runoff. Unconsumed bait deposited on the ground or in water will likely undergo
physical breakdown, releasing nicarbazin and/or DNC into the water column in both water
bodies and standing water. DNC will be deposited in the aquatic environment through
defecation by treated Canada geese. In addition, aquatic species may ingest nicarbazin and
DNC by drinking contaminated water, or may be exposed via uptake through
gills/integument. Bait deposited in water bodies may also be directly consumed by aquatic
species (fish, invertebrates, and aquatic phase amphibians). Secondary exposure may occur
to predators and scavengers consuming tissues and/or eggs of animals that have ingested
bait.
Aquatic Animal Exposure Assumptions:
Based on conservative aquatic modeling (Table 4), predictions are that DNC will
accumulate over time in the pond. In the water column, yearly average DNC concentrations
rise to between 2 and 4 ppb in a FL turf and PA turf scenario. Benthic pore water
concentrations are similar. Concentrations in benthic sediment show approximately the
same pattern, rising to about 0.20 to 0.25 ppm. Concentrations from 70 daily applications
(rather than 26, as modeled) can be expected to be proportionately (3 times) higher.
Table 4: Input Parameters for Aquatic Exposure Modeling for Dinitrocarbanilide (DNC)
Input Parameter
Aqueous Solubility, ppb
Organic Carbon Partitioning
Coefficient, mL/g
Chemical Application
Method (CAM)
Incorporation Depth, cm
Application Rate, kg/ha
Application Efficiency, %
Value
520
1650
4
1
0.0248 kg/ha
(0.022 Ib/acre)
50
Reference
lOx value at pH7; to ensure that
PRZM-EXAMS runs correctly.
estimated by EPI Suite
reflects granular application
(soil applied, user-defined
incorporation depth, uniform
with depth)
assumed: must be > 0.0 for
CAM =4
Label: max. 200 ounces (12.5
Ib) product/acre/day, adjusted
for 0.25% nicarbazin content;
71% DNC content in nicarbazin
Assumes geese consume all bait
expressed, and 50% of applied
bait (DNC) is excreted in feces
onto ground, of that a small
percentage (approx. 5%) runs
off into water.
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Input Parameter
Number of Applications,
interval
Hydrolysis Half-life
Soil Half-life, days
Water Half-life, days
Value
26 at 1-day intervals; 70 implied by
daily feeding for 10 weeks
stable
301
602
Reference
26 is the maximum number
allowed by pe4v01 graphical
user interface for
PRZM/EXAMS
MRID 46445305
MRTD 464 16449
2x soil value as per Input
Parameter Guidance, if no data
available; benthic half-life
assumed to be the same
The modeling above is based on results of an acceptable hydrolysis study of the separate
components DNC and HDP, and two supplemental field dissipation studies. The DNC
portion degrades slowly in soil with half-life of approximately one year, and does not
volatilize or leach through the soil. It may run-off with storm water, probably sorbed to soil
particles. Once the nicarbazin complex is separated, it is likely that DNC and HDP will
have different fate profiles, as HDP is far more water-soluble than DNC. It is highly
hydophilic (logKow of-0.94). HDP absorbs visible light, and so may be photodegraded.
Aquatic Animal Toxicity and Risk:
Based on the results of these acute toxicity studies, nicarbazin is practically nontoxic to
aquatic animals on an acute basis (Table 5). The acute risk quotient is not exceeded. Acute
effects in fish and invertebrates are not expected based on submitted data. The main
potential risk to aquatic animals is likely to be to sediment-dwelling organisms and also
chronic exposure of aquatic organisms. There are no data to assess those potential risks.
Table 5: Nicarbazin - Acute Aquatic Toxicity
Test
species
Rainbow
trout
Bluegill
Water flea
Percent Nicarbazin (moiety)
99.4 (HDP)
98.0 (DNC)
99.4 (HDP)
98.0 (DNC)
99.4 HDP
98.0 DNC
Toxicity
96-hLC50>110ppm
96-h LC50 >69 ppb
96-h LC50 >122 ppm
96-h LC50 >72 ppb
48-hEC50>107ppm
48-h EC50 >93 ppb
There is uncertainty as to the potential exposure to aquatic ecosystems due to runoff of bait
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or fecal deposition.
The significance of any such potential impacts needs to be considered in the context of the
ecological value of urban water bodies that presumably are associated with populations of
resident geese that exceed the urban ecosystem's carrying capacity. Aquatic loading from
goose defecation (untreated) probably represents much more of an ecological risk than
would nicarbazin entering the aquatic environment. The environmental exposure from the
use of nicarbazin to reduce egg hatchability will be small when compared to the poultry use.
A label restriction "Do not apply within 20 feet of any body of water, including lakes,
ponds or rivers." is required for this product
Endangered Species Assessment
The endangered species assessment is incomplete at this time. Given that the label
instructions control to a great degree the availability of the product to nontarget species, the
Agency believes risks to threatened and endangered (T&E) species are low.
In order to avoid and minimize potential impacts to Threatened and Endangered (T&E)
species, it is a requirement that the permit applicant must contact the local United States
Fish and Wildlife Service (USFWS) Ecological Services Office for assistance in
determining the likelihood of effects to T&E species.
Landowners or wildlife management agencies must first contact the USFWS Migratory Bird
Permit Office responsible for the region where the geese are located to ontain a federal
permit before bait is dispensed. Information on any T&E species that occur in the area must
be provided to the USFWS Migratory Bird Permit Office with the application. The permit
applicant must also identify the Certified Applicator who will apply the bait.
Product Efficacy:
OvoControl-G is intended for use in reducing egg-hatchability in resident Canada geese.
The applicator initiates baiting a minimum of 21 days prior to first nesting, which is in mid-
February to early March depending on locality. During initial baiting, as geese become
accustomed to the bait and delivery system, a small amount of bait is administered per
goose (about 7 grams). The amount is increased each day until the rate of 50 gram per
goose is attained. The amount of bait administered per site is based on visual observation of
flock size. If the geese cannot be acclimated to the bait site, use is to be discontinued.
Applicators should feed geese at daybreak in close proximity to where they feed Bait is
administered throughout the entire nesting season, which lasts 8 to 10 weeks.
The application rate is 50 grams (2 oz) per goose per day, and is supported by numerous
laboratory and small plot studies conducted by the National Wildlife Research Center
(NWRC) of the Animal and Plant Health Inspection Service (APHIS). In order to be
effective, female geese must feed on the bait consistently during the time the eggs are being
formed. A 2004 field study conducted by the NWRC in the state of Oregon showed an
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overall reduction in resident Canada geese egg-hatch of approximately 36% - 50% when
compared to controls.
OvoControl-G is not intended to be used alone, but rather as part of an integrated pest
management program for the control of resident Canada geese.
4. SUMMARY OF REGULATORY POSITION AND RATIONALE
In many urban and suburban areas and for reasons not fully understood, Canada geese
populations have become resident - remaining year round. Geese have been classified a
public health pest by EPA due to the potential spread of disease through feces, possible
human injury from attacks, and threat to public safety from encounters with aircraft. Geese
can also cause large amounts of property damage. Burgeoning populations of resident
Canada geese have become a serious environmental and public health issue.
Typically, conflicts with Canada geese have been resolved through trapping and relocation,
egg addling, aversive conditioning strategies (e.g., dogs harassing birds), physical and
natural barriers, and lethal controls. There is significant controversy on current Canada
geese management, particularly the killing of adult and juvenile birds during molting.
Animal welfare groups and often the public have questioned the rationale and justification
for lethal controls. Other than several repellents/deterrents, EPA does not have any
currently registered products for Canada geese control.
Nicarbazin provides a new tool for pest control operators and wildlife management
personnel. It is not intended nor will it be effective as a sole means of controlling
populations of resident Canada geese. When used with other control methods, nicarbazin
will aid in long-term population control.
Nicarbazin has been approved for use in the poultry industry since 1955 and approximately
10 million kilograms of the active ingredient has been fed to 80 billion broiler chickens in
the U.S. During 2003, broiler chickens in the U.S. consumed approximately 250,000
kilograms of nicarbazin. If 100,000 resident Canada geese are treated with 50g of 2500
ppm nicarbazin bait/goose/day for 10 weeks, the total amount of nicarbazin would be 350
kilograms annually. The environmental exposure from the use of nicarbazin to reduce egg
hatchability will be small when compared to the poultry use.
The registration of nicarbazin has strong support from organizations such as the U.S.
Department of Agriculture (APHIS/NWRC), the Birdstrike Committee (a volunteer
organization directed by a steering committee consisting of 2-3 members from each of the
Federal Aviation Administration, Department of Defense, USDA and aviation industry), and
the Humane Society of the United States.
Based on the limited use pattern/exposure scenario, the submitted data are deemed adequate
to support nicarbazin registration.
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Avoiding nontarget exposure is the primary concern with use of OvoControl-G. Reduction
in egg hatchability is the primary concern if nontarget birds are exposed to nicarbazin. On
the basis of label requirements, it can be reasonably assumed that exposure and resultant
risk to non-target and endangered species would be low. Labeling requirements include:
! restricted-use classification;
! applicator must obtain a permit for use from the USFWS prior to use;
! applicator must monitor site and keep daily written records of nontargets
observed feeding on the bait;
! use is restricted to urban areas and approved airports. Urban is defined as a
municipality with a population of 50,000 or more and its adjacent areas.
! unattended mechanical feeders may only be used at approved airports, the
applicator must be present to trigger feeder on a daily basis;
! several label directions and restrictions designed to minimize nontarget
exposure (see Labeling Requirements)
! bait cannot be applied within 20 feet of any body of water, including lakes,
ponds or rivers.
Labeling Restrictions
To mitigate risk to nontarget animals, the following label requirements have been
imposed:
! Restricted-use classification of OvoControl-G due to potential risk to nontarget
species. OvoControl-G label requirements are:
Restricted Use Pesticide (Due to Potential Risk to Nontarget Wildlife Species)
For retail sale to and use only by Certified Applicators or persons under their direct supervision
and only for those uses covered by the Certified Applicator's certification.
\ Requiring a Migratory Bird Treaty Act permit and consultation with wildlife
officials to determine if listed species occur in a proposed use area. Applicators
must obtain a permit from the U.S. Fish and Wildlife Service prior to any
applications. USFWS will evaluate the potential adverse impacts on the
constituent elements of critical habitats prior to issuing a permit. OvoControl-G
label requirements are:
Federal Permit Requirement and Threatened or Endangered Species Considerations
In order to avoid and minimize potential impacts to Threatened and Endangered (T&E) species,
the permit applicant must contact the local USFWS Ecological Services Office (contact
11
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information can be found at http://www.fws.gov/endangered) for assistance in determining the
likelihood of effects to T&E species.
The federal Migratory Bird Treaty Act protects Canada geese. Landowners or wildlife
management agencies seeking to control resident Canada geese using OvoControl G must
contact the U.S. Fish and Wildlife Service (USFWS) Migratory Bird Permit Office responsible
for the region where the geese are located for a federal permit before bait is dispensed. Permit
application forms and contact information are available at http://www.fws.gov/forms/3-200-
13.pdf. Information on any T&E species that occur in the area must be provided to the USFWS
Migratory Bird Permit Office with the migratory bird application. Once it has been determined
that no additional permits (e.g., for take of T&E species) will be required, allow 90 days for
processing. The permit applicant must also identify the Certified Applicator who will apply the
bait.
Limiting application to urban areas only and certain land airports. OvoControl-
G label requirements are:
The use of OvoControl G is limited to sites in urban areas such as office parks, recreational
parks, golf courses, schools, hospitals, restaurants, and commercial and industrial sites. Urban
is defined as a municipality and its adjacent areas with a population of 50,000 or more. May
only be used at land airports holding FAA certifications under 14 Code of Federal Regulations
139.101 and a wildlife hazard management plan under 14 Code of Federal Regulations
139.337.
\ Limitations on use of unattended mechanical feeders. Unattended mechanical
feeders may only be used at airports (as described above). For all other sites,
mechanical feeders must be triggered by the applicator on a daily basis.
OvoControl-G label requirements are:
Mechanical feeders must be attended and triggered by the applicator daily. Unattended
mechanical feeders may be used at land airports which have FAA certification under 14 CFR
139.101 and a wildlife hazard management plan under 14 CFR 139.337. "
\ Limitations on geographical use. OvoControl-G label requirements are:
Not for use in Hawaii, Guam, American Samoa, Northern Mariana Islands, Puerto Rico and US
Virgin Islands.
\ Precautions limiting aquatic exposure. OvoControl-G label requirements are:
Do not apply within 20 feet of any body of water, including lakes, ponds or rivers.
\ Non-target observations and written records. OvoControl-G label requirements
are:
The applicator must maintain daily and weekly records on baiting and document the amount of
bait applied and confirm that bait is consumed within 2 hours. Records must also document an
estimate of the amount of bait remaining after two hours or the amount of a previous day's bait
observed prior to baiting. The records must also document the method used to clean and
remove uneaten bait.
For the migratory bird permitting, written records must be kept regarding date, time, number
and identification of non-target species feeding on the bait. These records must be provided to
the landowner.
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Reducing the likelihood of nontarget exposure to uneaten bait. The applicator
must follow label instructions to minimize the potential for nontarget wildlife to
feed on the bait. OvoControl-G label requirements are:
By the end of the initial 21 day period, the daily dose (based on flock size) must be entirely
consumed within 2 hours of application. If uneaten bait remains after 2 hours of application,
cease treatment.
If geese cannot be habituated to the feeding program (at least 1 ounce (25 grams) OvoControl
G/goose/day) within 21 days, discontinue treatment at that particular site.
Do not apply more OvoControl-G than the geese will eat in a single feeding, as this may result
in non-target species exposure to left over bait. Do not apply bait at sites where non-target
wildlife are observed feeding on OvoControl-G during the first 21 days.
If non-targets consistently feed on bait during treatment, delay baiting until local wildlife
authorities can determine if unacceptable risks exist to non-target species. It may be a violation
of state and federal law to feed treated bait to protected nontarget species.
After the initial 21 days of baiting, observations must be made to ensure that the geese are
continuing to consume the bait within 2 hours of application. After the initial 21 day
acclimation period, target population estimates and 2 hour observations for nontarget species
must be made weekly. The amount of bait being applied must be increased or decreased
according to the number of geese observed at the site during the target population estimate.
During treatment (day 22+), if the applicator finds uneaten bait left over at the site from the
previous day's feeding, the applicator must remove it, a target population estimate must be
performed, and the daily application rate must be adjusted accordingly. Additionally, the
applicator must resume 2 hour observation for nontarget species, every two days, until the bait
is again consumed within 2 hours of application. If uneaten bait is found at the site for five
consecutive observations, cease treatment.
This product will reduce hatchability and adversely affect other aspects of
reproduction in all avian species.
! Use in grass that is typically mowed to increase bait consumption and allow observation of
uneaten bait. OvoControl-G label requirements are:
Application to grass must be made in grass that is typically mowed to increase access to bait.
5. CONFIRMATORY DATA REQUIREMENTS
There are no confirmatory data requested for nicarbazin based on the labeled uses.
6. CONTACT PERSON AT EPA
Joanne Edwards, Entomologist
Insecticide-Rodenticide Branch
Registration Division (7505C)
Office of Pesticide Programs
Environmental Protection Agency
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Ariel Rios Building
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
Office Location and Telephone Number
Room 211, Crystal Mall Building #2
1921 Jefferson Davis Highway
Arlington, VA 22202
(703)305-6736
E-mail: edwards.joanne@epa.gov
DISCLAIMER: The information presented in this Pesticide Fact Sheet is for informational
purposes only and may not be used to fulfill data requirements for pesticide registration and
reregi strati on.
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Appendix I
GLOSSARY OF TERMS AND ABBREVIATIONS
CAS Chemical Abstracts Service
DNC 4,4'-dinitrocarbanilide
EPA U.S. Environmental Protection Agency
FAA Federal Aviation Administration
g/ml grams per milliliter
HDP 4,6-dimethyl-2-pyrimidinol
Kow Octanol-Water Partition Coefficient
kg/ha Kilogram Per Hectare
Ib/acre Pound Per Acre
Ibs Pounds
LC50 Median Lethal Concentration. A statistically derived concentration of a
substance that can be expected to cause death in 50% of test animals. It is
usually expressed as the weight of substance per weight or volume of water, air
or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to
cause death in 50% of the test animals when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a weight of substance per unit
weight of animal, e.g., mg/kg.
LOG Level of Concern
LOD Limit of Detection
LOQ Limit of quantitation
mg/kg Milligram Per Kilogram
mg/kg/bw Milligram Per Kilogram Per Bodyweight
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
ml Milliliter
MOE Margin of Exposure
MRID Master Record Identification (number), EPA's system of recording and tracking
studies submitted
NA Not Applicable
NOEC No Observable Effect Concentration
NOEL No Ob served Effect Level
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NOAEL No Observed Adverse Effect Level
NOAEC No Observed Adverse Effect Concentration
GLOSSARY OF TERMS AND ABBREVIATIONS (Continued)
ppb Parts Per Billion
ppm Parts Per Million
PRZM/EXAMS Tier II Surface Water Computer Model
RQ Risk Quotient
jig micrograms
Hg/L Micrograms Per Liter
|iL/g Microliter per gram
USDA United States Department of Agriculture
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Appendix II
CITATIONS CONSIDERED TO BE PART OF THE DATA BASE SUPPORTING THE
REGISTRATION OF NICARBAZIN
MRID
Citation
46416400 Innolytics, LLC (2004) Submission of Product Chemistry, Toxicity, Fate,
Efficacy and Environmental Fate Data in Support of the Application for
Registrations of OvoControl-P, Nicarbazin 30% Granulated Premix, and
OvoControl-G. Transmittal of 43 Studies.
46416401 Wolf, E.; MacDonald, A. (2004) Product Identity and Composition,
Certification of Ingredient Limits, and Discussion of Impurities of Nicarbazin
and Nicarbazin 30% Granulated Premix. Project Number:
NICARBAZIN/04/22. Unpublished study prepared by Exponent. 51 p.
46416402 Wolf, E.; MacDonald, A. (2004) Product Identity and Composition,
Certification of Ingredient Limits, and Discussion of Impurities of OvoControl-
G and OvoControl-P. Project Number: NICARBAZIN/04/34. Unpublished
study prepared by Exponent. 16 p.
46416403 Wolf, E.; MacDonald, A. (2004) Description of Materials Used to Produce the
Product, Description of Production Process, Description of Formulation
Process, Prelimiary Analysis for Nicarbazin and the Manufacturing Use Product
Nicarbazin 30% Granulated Premix. Project Number: NICARBAZIN/04/08/03.
Unpublished study prepared by Exponent. 130 p.
46416404 Wolf, E.; MacDonald, A. (2004) Description of Materials Used to Produce the
Product, Description of Production Process, Description of Formulation
Process, and Prelimonary Analysis for OvoControl-G and OvoControl-P.
Project Number: NICARBAZIN/04/37. Unpublished study prepared by
Exponent. 77 p.
46416406 Wolf, E.; MacDonald, A. (2004) Description and Validation of Analytical
Method for the Determination of Nicarbazin in Goose Baits by HPLC/UV.
Project Number: NICARBAZIN/04/36, P0000814, P0000545. Unpublished
study prepared by Exponent. 38 p.
46416407 Wolf, E.; MacDonald, A. (2004) Description of Color, Physical State, Odor,
Melting Point, Specific Gravity, Solubility, Vapor Pressure, Dissociation
Constant, pH, Stability, and Particle Size for Nicarbazin. Project Number:
NICARBAZIN/04/31. Unpublished study prepared by Exponent. 31 p.
46416408 Wolf, E.; MacDonald, A. (2004) Description of Color, Physical State, Odor,
Bulk Density, pH, Flammability, Explodability, Particle Size and Shape,
Storage Stability, and Corrosion Characteristics for Nicarbazin 30% Granulated
17
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Premix. Project Number: NICARBAZIN/04/32. Unpublished study prepared by
Exponent. 8 p.
46416409 Wolf, E.; MacDonald, A. (2004) Description of Color, Physical State, Odor,
Bulk Density, pH, Flammability, Explodability, Particle Size and Shape,
Storage Stability, and Corrosion Characteristics for OvoControl-G and
OvoControl-P. Project Number: NICARBAZIN/04/33. Unpublished study
prepared by Exponent. 6 p.
46416410 Wolf, E. (2004) The Determiation of the Distribution Coefficients of the
Components of Nicarbazin Between 1-Octanol and Aqueous Buffers (ADM-
56). Project Number: NICARBAZIN/04/08/05. Unpublished study prepared by
Exponent. 17 p. 46416411 McCracken, B. (2004) Water Solubility of DNC and
HDP. Project Number: P0000936. Unpublished study prepared by Exygen
Research. 26 p.
46416412 Habig, C.; Messina, J.; Daniels, C. (2004) Nicarbazin Support Documentation.
Project Number: NICARBAZIN/04/30. Unpublished study prepared by
Exponent. 112 p.
46416413 Messina, J. (2004) Nicarbazin Acute Oral Toxicity LD50: (Rat). Project
Number: NICARBAZIN/04/12. Unpublished study prepared by Exponent. 7 p.
46416414 Messina, J.; Daniels, C. (2004) Nicarbazin Waiver Request from Further
Testing: Acute Dermal Toxicity LD50. Project Number: NICARBAZIN/04/29.
Unpublished study prepared by Exponent. 8 p.
46416415 Brooker, A. (2001) Koffogran: Acute (Four-Hour) Inhalation Study in Rats.
Project Number: CYT/044/014207, NICARBAZIN/04/02. Unpublished study
prepared by Huntingdon Life Sciences, Ltd. 35 p.
46416416 Blanchard, E. (2001) Koffogran: Eye Irritation to the Rabbit. Project Number:
NICARBAZIN/04/02, CYT/002/013543/SE. Unpublished study prepared by
Huntingdon Life Sciences, Ltd. 16 p.
46416417 Blanchard, E. (2001) Koffogran: Skin Irritation to the Rabbit. Project Number:
NICARBAZIN/04/03, CYT/001/013542/SE. Unpublished study prepared by
Huntingdon Life Sciences, Ltd. 15 p.
46416418 Coleman, D. (2001) Koffogran: Skin Sensitization to the Guinea-Pig (Buehler
Method - 9 Inductions). Project Number: NICARBAZIN/04/04,
CYT/003/013699/SS. Unpublished study prepared by Huntingdon Life
Sciences, Ltd. 28 p.
46416419 Messina, J. (2004) Nicarbazin Chronic Toxicity Rat. Project Number:
NICARBAZIN/04/08. Unpublished study prepared by Exponent. 184 p.
46416420 Messina, J. (2004) Nicarbazin Chronic Toxicity Dog. Project Number:
NICARBAZIN/04/07. Unpublished study prepared by Exponent. 184 p.
46416421 Messina, J. (2004) Nicarbazin Developmental Toxicity. Project Number:
NICARBAZIN/04/10. Unpublished study prepared by Exponent. 50 p.
46416422 Messina, J. (2004) Nicarbazin Multigeneration Reproduction Toxicology.
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Project Number: NICARBAZIN/04/05. Unpublished study prepared by
Exponent. 48 p.
46416423 Messina, J. (2004) Nicarbazin Genotoxicity. Project Number:
NICARBAZIN/04/09. Unpublished study prepared by Exponent. 20 p.
46416424 Innes, D. (2001) Nicarbazin: Micronucleus Test in Bone Marrow of CD-I Mice
0 h + 24 h Oral Dosing and 48 h Sampling. Project Number: 20677,
NICARBAZIN/04/11, 767115. Unpublished study prepared by Inveresk
Research International. 31 p.
46416425 Messina, J. (2004) Nicarbazin Metabolism. Project Number:
NICARBAZIN/04/06. Unpublished study prepared by Exponent. 252 p.
46416426 Gallagher, S.; Beavers, J. (2004) Nicarbazin Technical: An Acute Oral Toxicity
Study With the Northern Bobwhite. Project Number: 573/103. Unpublished
study prepared by Wildlife International, Ltd. 30 p.
46416427 Gallagher, S.; Beavers, J. (2004) Nicarbazin Technical: A Dietary LC50 Study
with the Northern Bobwhite. Project Number: 573/101, P0000736. Unpublished
study prepared by Wildlife International, Ltd. 89 p.
46416429 Habig, C.; Messina, J.; Daniels, C. (2004) Nicarbazin Waiver Request From
Further Testing: Wild Mammal Toxicity. Project Number:
NICARBAZIN/04/28. Unpublished study prepared by Exponent. 8 p.
46416431 Palmer, S.; Krueger, H. (2004) 2-Hydroxy-4,6 Dimethypyrimidine (HDP): A
96-Hour Static Acute Toxicity Test With The Rainbow Trout (Oncorhynchus
mykiss): Final Report. Project Number: 573 A/109, P997, V0002054/3.
Unpublished study prepared by Exponent. 90 p.
46416432 Palmer, S.; Krueger, H. (2004) 4,4'-Dinitrocarbanilide (DNC): A 96-Hour Static
Acute Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss): Final
Report. Project Number: 573 A/106. Unpublished study prepared by Wildlife
International, Ltd. 89 p.
46416433 Palmer, S.; Krueger, H. (2004) 2-Hydroxy-4,6 Dimethylpyrimidine (HDP): A
96-Hour Static Acute Toxicity Test with the Bluegill (Lepomis macrochirus):
Final Report. Project Number: 573 A/108. Unpublished study prepared by
Wildlife International, Ltd. 89 p.
46416434 Palmer, S.; Krueger, H. (2004) 4,4'-DinitroCarbanilide (DNC): A 96-Hour
Static Acute Toxicity Test with the Bluegill (Lepomis macrochirus): Final
Report. Project Number: 573 A/105. Unpublished study prepared by Wildlife
International, Ltd. 90 p.
46416435 Palmer, S.; Krueger, H. (2004) 2-Hydroxy-4,6 Dimethylpyrimidine (HDP): A
48-Hour Static Acute Toxicity Test with the Cladoceran (Daphnia magna):
Final Report. Project Number: 573A/107C. Unpublished study prepared by
Wildlife International, Ltd. 90 p.
46416436 Palmer, S.; Krueger, H. (2004) 4,4'-Dinitrocarbanilide (DNC): A 48-Hour Static
Acute Toxicity Test with the Cladoceran (Daphnia magna): Final Report.
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Project Number: 573A/104A. Unpublished study prepared by Wildlife
International, Ltd. 91 p.
46416437 Wolf, E. (2004) Nicarbazin Acute Freshwater Fish, Aquatic Invertebrates, Alga
Toxicity. Project Number: NICARBAZIN/04/19. Unpublished study prepared
by Exponent. 16 p.
46416438 Habig, C.; Messina, J.; Daniels, C. (2004) Nicarbazin Waiver Request from
Further Testing: Acute LC50 Estuarine and Marine Organisms, Fish Early Life
Stage and Aquatic Invertebrate Life-Cycle, Fish Life-Cycle, Aquatic Organism
Accumulation, and Simulated or Actual Field Testing-Aquatic Organisms.
Project Number: NICARBAZIN/04/21. Unpublished study prepared by
Exponent. 9 p.
46416439 Habig, C.; Messina, J.; Daniels, C. (2004) Nicarbazin Waiver Request from
Further Testing: Seedling Emergence, Vegetative Vigor and Aquatic Plant
Growth. Project Number: NICARBAZIN/04/20. Unpublished study prepared by
Exponent. 8 p.
46416440 Habig, C.; Messina, J.; Daniels, C. (2004) Nicarbazin Waiver Request from
Further Testing: Honey Bee Acute Contact LD50, Honey Bee Toxicity of
Residues on Foliage, and Field Testing for Pollinators. Project Number:
NICARBAZIN/04/20. Unpublished study prepared by Exponent. 8 p.
46416441 Messina, J. (2004) Nicarbazin, HDP, and DNC Acute Earthworm Toxicity.
Project Number: NICARBAZIN/04/16. Unpublished study prepared by
Exponent. 58 p.
46416442 Messina, J. (2004) Nicarbazin Pigeon Efficacy Information. Project Number:
NICARBAZIN/04/17. Unpublished study prepared by Exponent. 15 p.
46416445 Habig, C.; Messina, J.; Daniels, C. (2004) Nicarbazin Waiver Request from
Further Testing: Aqueous Photolysis. Project Number: NICARBAZIN/04/25.
Unpublished study prepared by Exponent. 10 p.
46416446 Wolf, E. (2004) A Study to Determine the Rate of Depletion of lonophore and
14-C Nicarbazin in a Field Soil Plot. Project Number: NICARBAZIN/04/13.
Unpublished study prepared by Exponent. 7 p.
46416447 Wolf, E. (2004) Mobility of 14-C DNC on Soil Thin-Layer Plates. Project
Number: NICARBAZIN/04/15. Unpublished study prepared by Exponent. 8 p.
46416449 Manthey, J. (1985) A Study to Determine the Rate of Depletion of Narasin and
14-C Nicarbazin in a Field Soil Plot. Project Number: ABC/0284. Unpublished
study prepared by Exponent. 55 p.
46445300 Innolytics, LLC (2005) Submission of Product Chemistry, Toxicity,
Environmental Fate Data in Support of the Application for Registrations of
LLC/Nicarbazin 30% Granulated Premix, Ovocontrol P and Ovocontrol G.
Transmittal of 6 Studies.
46445301 Wolf, E.; MacDonald, A. (2004) Description of Analytical Methods for
Nicarbazin and the Manufacturing Use Product Nicarbazin 30% Granulated
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Premix, Impurities, and Quality Control Processes. Project Number:
NICARBAZIN/04/24. Unpublished study prepared by Exponent. 82 p.
46445302 Gallagher, S.; Beavers, J. (2004) Nicarbazin Technical: A Dietary LC50 Study
with the Mallard. Project Number: 573/102. Unpublished study prepared by
Wildlife International, Ltd. 89 p.
46445303 Messina, J. (2004) Nicarbazin Avian Reproduction. Project Number:
NICARBAZIN/04/18. Unpublished study prepared by Wildlife International,
Ltd. 35 p.
46445304 Bynum, K.; Eisemann, J.; Miller, L.; et. al. (2004) Efficacy of 2500 ppm
Nicarbazin for Reproductive Inhibition in Canada Geese. Unpublished study
prepared by US Dept. of Agriculture, APHIS, WS. 37 p.
46445305 McCracken, B. (2004) Aqueous Hydrolysis of Nicarbazin Under Laboratory
Conditions Amendment 1. Project Number: EXP/108/002, P0000693.
Unpublished study prepared by Exygen Research. 55 p.
46445306 Manthey, J. (1984) A Greenhouse Study to Determine the Rate of Decline of
Soil Incorporated Narasin and 14C Nicarbazin Singly and in Combination.
Project Number: ABC/0209. Unpublished study prepared by Exponent. 58 p.
46459800 Innolytics, LLC (2005) Submission of Toxicity and Fate Data in Support of the
Application for Registration of Nicarbazin. Transmittal of 2 Studies.
46459801 Habig, C.; Messina, J.; Daniels, C. (2005) Nicarbazin Waiver Request from
Further Testing. Project Number: NICARBAZIN/04/40. Unpublished study
prepared by Exponent. 10 p.
46459802 Habig, C.; Messina, J.; Daniels, C. (2005) Nicarbazin Waiver Request from
Further Testing. Project Number: NICARBAZIN/04/39. Unpublished study
prepared by Exponent, lip.
46471700 Innolytics, Inc. (2005) Submission of Environmental Fate Data in Support of
the Application for Registration of Nicarbazin. Transmittal of 1 Study.
46471701 Wolf, E. (2005) Determination of the Toxicity of Nicrazin (Nicarbazin) and
Supacox (Pancoxin Plus) to Eight Higher-Plant Species by Soil Application.
Project Number: NICARBAZIN/04/38, WD00775/000. Unpublished study
prepared by Exponent. 47 p.
46497100 Innolytics. LLC. (2005) Submission of Toxicity and Efficacy Data in Support of
the Application for Registration of Ovocontrol P. Transmittal of 3 Studies.
46497101 Wolf, E. (2005) Nicarbazin Avian Reproduction Support Documentation.
Project Number: QA/737, QA/774, QA/850. Unpublished study prepared by US
Dept. of Agriculture, APHIS, WS, University of Georgia and Clemson
University. 115 p.
46497102 Habig, C.; Messina, J.; Daniels, C. (2005) Nicarbazin Waiver Request from
Further Testing: Fish Accumulation. Project Number: NICARBAZIN/03/15.
Unpublished study prepared by Exponent. 9 p.
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46497103 Bynum, K.; Eisemann, I; Weaver, G.; et. al.; (2005) QA-1102: Multi-center
Field Study of Nicarbazin Bait for use in the Reduction in Hatching of Eggs
Laid by Local Canada Goose (Branta canadensis) Flocks. Project Number:
QA/1102. Unpublished study prepared by US Dept. of Agriculture, APHIS, WS
and Innolytics, LLC. 130 p.
46645600 Innolytics, LLC (2005) Submission of Toxicity Data in Support of the
Application for Registration of OvoControl G. Transmittal of 1 Study.
46645601 Messina, J.; Daniels, C. (2005) Nicarbazin Waiver Request from Further
Testing: Acute Inhalation Toxicity LC50. Project Number:
NICARBAZIN/05/01. Unpublished study prepared by Exponent. 8 p.
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