Bifenthrin - Registration of a Major Label Change for Capture 11/00
New York State Department of Environmental Conservation Division of Solid & Hazardous Materials
Bureau of Pesticides Management, Room 498
Pesticide Product Registration Section
50 Wolf Road, Albany, New York 12233-7254 Phone: (518) 457-0300FAX: (518) 485-8836 Website:
November 21, 2000
RETURN RECEIPT REQUESTED
Mr. Dick L. Palmquist
FMC Corporation, Ag Products Group
1735 Market Street
Philadelphia, PA 19103
Dear Mr. Palmquist:
Re: Registration of a Major Change in Labeled Use Pattern for the Active Ingredient
Bifenthrin Contained in the Pesticide Product Capture® 2 EC
Insecticide/Miticide (EPA Reg. No. 279-3069)
The New York State Department of Environmental Conservation
("The Department") has completed review of your application and supplemental
information supplied to date regarding registration of the referenced pesticide
product in New York State. The subject application and data package were deemed
complete for purposes of technical review on June 23, 2000 following one
incompleteness determination. Pursuant to the review time frame specified in
ECL §33-0704.2, a registration decision date of November 21, 2000 was established.
Capture® 2 EC Insecticide/Miticide (EPA Reg. No. 279-3069) contains
25.1% bifenthrin and is labeled to control a variety of insects and mites on
cotton, field corn (grain and silage), popcorn, field corn grown for seed
(at plant use), sweet corn, succulent peas and beans, brassicas, cucurbits,
eggplant, canola, crambe and rapeseed. Label "Restrictions" limit the maximum
application rate as follows: 0.5 pounds a.i./acre/season for cotton and brassicas;
0.3 pounds a.i./acre/season including at plant plus foliar applications for field
corn and cucurbits; 0.2 pounds a.i.(12.8 ounces Capture® 2 EC)/acre/season for
sweet corn, succulent peas and beans, and eggplant; 0.08 pounds a.i.(5.12 ounces
Capture® 2 EC)/acre/season for canola, crambe and rapeseed.
Previously registered use patterns for the active ingredient
bifenthrin include products labeled for use on turf and ornamentals, in greenhouses,
as subterranean termiticides, for indoor pest control, and for use on strawberries
and hops. The additional major and minor food crop uses listed on the Capture® 2
EC label represent a major change in labeled (MCL) use pattern for bifenthrin in
New York State.
Capture® 2 EC is a federally "Restricted Use Pesticide" due to acute
toxicity to fish and aquatic organisms. The federal label contains spray drift
precautionary text intended to mitigate potential adverse impacts to aquatic
organisms. The Department's registration decision for another agricultural use
product containing bifenthrin (Brigade WSB Insecticide/Miticide) required
additional State-specific text to mitigate potential impacts to marine
invertebrates. FMC Corporation anticipated a similar requirement for the
subject product. Therefore, the Capture® 2 EC bears the following text which was
approved by the United States Environmental Protection Agency (USEPA) on October
26, 1999: "In New York State this product may not be applied within 100 feet
(using ground equipment) to 300 feet (using aerial equipment) of coastal marshes
or streams that drain into coastal marshes."
The Department conducted toxicological, ecological effects and
environmental fate risk assessments for bifenthrin and the Capture® 2 EC
TOXICOLOGICAL RISK ASSESSMENT:
On an acute basis, the
formulated product was moderately toxic to laboratory animals by the oral and
inhalation routes of exposure, but was not very toxic by the dermal exposure
route. Capture® 2 EC also was not very irritating to rabbit skin or eyes; however,
it did cause dermal sensitization (tested in guinea pigs).
On an acute basis, bifenthrin was fairly toxic by the oral route of
exposure, but was not very toxic by dermal exposure. It was not very irritating
to eyes or skin, nor was it a skin sensitizer. Other toxicological data on
bifenthrin indicate that it was relatively potent in chronic feeding and
reproductive/developmental toxicity studies. The United States Environmental
Protection Agency (USEPA) established an oral reference dose (RfD) of 0.015
milligrams per kilogram body weight per day (mg/kg/day) based on a no-observed-effect
level (NOEL) of 1.5 mg/kg/day from a one-year dog study and an uncertainty factor
of 100. Bifenthrin also caused some oncogenic effects in mice, and the USEPA
classified it as a Group C (possible human) carcinogen. The USEPA initially
derived a cancer potency slope factor of 5.4 x 10-2 (mg/kg/day)-1, but more
recently recommended that the RfD approach be used to estimate human cancer
The USEPA established tolerances for bifenthrin residues in or
on sweet corn at 0.05 parts per million (ppm), corn forage at 3.0 ppm brassicas
at 0.6 ppm, cabbage at 4.0 ppm, succulent peas and beans at 0.05 ppm, cucurbits
at 0.4 ppm; rapeseed at 0.05 ppm and eggplant at 0.05 ppm. The USEPA estimated
that the chronic dietary exposure to these residues would be 2.4 percent of the
RfD for the general United States population and 6.7 percent for children one to
six years old. This chronic dietary exposure analysis is based on the assumption
that 100 percent of crops are treated and contain tolerance level residues. If
one were to use the old USEPA cancer potency slope factor (5.4 x 10-2 (mg/kg/day)-1)
and the estimated chronic dietary exposure estimates for the general United States
population, the incremental increased lifetime cancer risk can be calculated as
being 1.9 x 10-5. However, given the conservative basis of estimated exposure
this is likely an overestimate of cancer risk.
While no worker exposure studies were submitted in the registration
package, the label requires that applicators wear long-sleeved shirt and long
pants, chemical-resistant gloves, shoes and socks and protective eyewear. The
maximum application rate of Capture® 2 EC is relatively low (15 to 45 grams
bifenthrin per acre per application to an annual maximum of 225 grams bifenthrin
per acre). This product also is a federally "Restricted Use Pesticide"
and can only be applied by certified applicators.
There are no chemical-specific federal or State drinking
water/groundwater standards for bifenthrin. Based on its chemical structure,
bifenthrin falls under the 50 microgram per liter (mg/L) general New York
State drinking water standard for an "unspecified organic contaminant"
(10 NYCRR Part 5, Public Water Systems). Based on the RfD for bifenthrin
(0.015 mg/kg/day) and USEPA procedures for determining maximum contaminant
level goals for Group C carcinogens (Federal Register 55: 30374-30375, July 25,
1990), a potential drinking water standard of 10 micrograms per liter can be
calculated for bifenthrin.
Bifenthrin has a relatively high toxic potency in animal studies
and has demonstrated some oncogenic potential. However, given the low
application rate of Capture® 2 EC and the required personal protective equipment,
exposure and risks to workers is expected to be relatively low. Similarly,
conservative estimates of dietary exposure also indicate that levels are
considerably below the RfD and should not pose unacceptable non-cancer risks.
However, using the old USEPA cancer potency slope factor an incremental increased
lifetime cancer risk of 1.9 x 10-5 can be calculated. This level exceeds the
cancer risk level of 1 x 10-6 or less that USEPA generally considers to be
acceptable for such exposures. In general, the New York State Department of
Health (NYSDOH) recommends against the registration of pesticide products that
have oncogenic potential and which are used on food crops unless the needs for
such products are great. Given these concerns, NYSDOH conducted a limited
comparison of bifenthrin against other insecticides (e.g., carbaryl, malathion,
methyl-parathion, permethrin) that Cornell Cooperative Extension recommends for
use on corn, beans and cucurbits (some of the crops for which Capture® 2 EC is
labeled). Based on a comparison of the RfDs and evidence of oncogenic potential
for this group of compounds, bifenthrin does not appear to be significantly more
toxic overall. The NYSDOH concluded that the need for Capture® 2 EC should be
considered before registering the product in New York State.
ECOLOGICAL EFFECTS RISK ASSESSMENT:
The single and
maximum seasonal application rates for Capture® 2 EC Insecticide/Miticide are
the same as, or less than, the application rates for the bifenthrin product
Brigade® WSB Insecticide/Miticide. Therefore, the technical review (reference
correspondence from M. Serafini to D. Palmquist, July 27, 1999) for
Brigade® WSB is applicable to Capture® 2 EC.
The Capture® 2 EC label contains the same restrictions as
Brigade® WSB; i.e., "Do not apply directly to water, to areas where surface
water is present or to intertidal areas below the mean high water mark"; "Do
not apply by ground equipment within 25 feet, or by air within 150 feet of
lakes, reservoirs, rivers, permanent streams, marshes or natural ponds, estuaries,
and commercial fish farm pond"; "Do not cultivate within 10 feet of the aquatic
area so as to allow growth of a vegetative filter strip"; and the State-specific
restriction of "In New York State this product may not be applied within 100
feet (using ground equipment) to 300 feet (using aerial equipment) of coastal
marshes or streams that drain into coastal marshes." In addition, the Capture® 2
EC label contains a new federal restriction which states: "Use of Capture® 2 EC
on corn is prohibited in all coastal counties."
Bifenthrin clearly has the potential to be acutely toxic to
marine invertebrates. The federal spray drift precautionary text and the New
York State specific text regarding coastal marshes mitigates this concern. When
used as labeled, Capture® 2 EC should not adversely impact wildlife, fish or
ENVIRONMENTAL FATE RISK ASSESSMENT:
Bifenthrin has a water
solublity of <0.1 ppb at 20°C. It is stable to hydrolysis at pH 5, has a
half-life of 34 days at pH 7, and has a half-life of seven hours at pHs 5, 7
and 9. Bifenthrin has an aqueous photolysis half-life of 209-300 days and a
soil photolysis half-life of >30 days. Aerobic soil metabolism half-lives on
several soils ranged from 97 to 250 days. The anaerobic metabolism half-life
was 61 days. Soil partitioning coefficients (Kocs) ranged from 130,000 to
300,000, which indicates that bifenthrin is strongly sorbed to organic carbon.
Terrestrial field dissipation studies yielded low concentrations of bifenthrin
in the 6-12 inch sampling interval at 90 days, but there was no clear pattern of
leaching in five studies. Several degradates were detected, the highest reaching
only 6% of applied.
In a review dated May 17, 1993, the USEPA's Environmental Fate and
Groundwater Branch (EFGWB) stated that "Based on acceptable and supplemental
data in EFGWB files, bifenthrin is relatively immobile and moderately persistent
in terrestrial environments. Bifenthrin dissipation appears to be dependent on
soil binding followed by microbial-mediated degradation. Because of the high
binding potential of bifenthrin, there is little expectation of groundwater
contamination and any surface water movement of bifenthrin is likely to occur on
The Department's groundwater model (LEACHP) was run on
Riverhead soil using a Koc of 130,000, an aerobic half-life of 250 days and
an application rate of 0.5 pounds bifenthrin/acre/year. The model projected
no bifenthrin in the leachate.
Based on the environmental fate data, the USEPA's comments and
the LEACHP modeling, Capture® 2 EC, when used as labeled, should not have an
impact on groundwater resources in New York State.
Because of the oncogenic potential of bifenthrin, the
grower need for Capture® 2 EC was considered before registering the product in
New York State. The Cornell Pesticide Management Education Program (PMEP)
supports registration of Capture® 2 EC for use on snap and dry beans.
Organophosphate pesticides uses are being re-evaluated under the Food Quality
Protection Act of 1996. Bifenthrin is compatible with IPM and a potential
alternative to organophosphates for all labeled crops.
When used as labeled, Capture® 2 EC should not cause
unreasonable adverse effects to humans or the environment.
The Department hereby accepts Capture® 2 EC Insecticide/Miticide
(EPA Reg. No. 279-3069) for registration as a "Restricted Use" pesticide
product in New York State. Enclosed for your files are the Certificate of
Pesticide Registration and New York State stamped-"ACCEPTED" labeling.
Capture® 2 EC, as noted in the "RESTRICTION" column on the
Certificate, is classified as "Restricted Use" under rules and regulations
6 NYCRR 326.23(e). As such, this product is restricted in its purchase,
distribution, sale, use and possession in New York State.
According to the New York State Department of Environmental
Conservation Regulations 6 NYCRR 326.3(a): "It shall be unlawful for
any person to distribute, sell, offer for sale, purchase for the purpose
of resale, or possess for the purpose of resale, any restricted pesticide
unless said person shall have applied for, and been issued a commercial permit."
The Pesticide Reporting Law (PRL) requires all certified
commercial pesticide applicators to report information annually to the Department
regarding each pesticide application they make. Commercial pesticide retailers
are required to report all sales of restricted pesticide products and sales of
general use pesticide products to private applicators for use in agricultural crop
production. If no sales are made within New York State, a report still must
be filed with the Department indicating this is the case.
If you need information relating to the Pesticide Reporting Law,
or annual report forms, please visit the Department's website at
http://www.dec.state.ny.us or call 1-888-457-0110 (toll free within New York
Out-of-State callers may contact the Pesticide Reporting Section at
Should you require information to obtain a commercial permit,
please contact Mr. Al Muench, Chief, Pesticide Certification Section, at (518)
Please note that a proposal by the FMC Corporation or any other
registrant to register a product containing bifenthrin, whose labeled uses are
likely to increase the potential for significant impact to humans, property or
the environment, would constitute a major change in labeled (MCL) use pattern.
Such an application must be accompanied by a new application fee and meet the
requirements listed in Appendix 1.B. of "New York State Pesticide Product
Registration Procedures" (August 1996).
Please contact Frank Hegener, Chief of our Pesticide Product
Registration Section, at (518) 457-7446, if you have any questions.
Maureen P. Serafini
Bureau of Pesticides Management
cc: w/enc. - N. Kim/D. Luttinger, NYS Dept. of Health
J. Leach/J. Kaplan, NYS Dept. of Health
R. Zimmerman/R. Mungari, NYS Dept. of Ag. & Markets
G. Good/W. Smith, Cornell PMEP
bcc: w/enc. - S. Sanford/T. Martin, DFW&MR
SPCS I, Reg. 1
PCS II's, Regions 2-7 & 9
D. Rollins, Region 8
M. Radzevich (2)
FMC Corporation File
bcc: w/o enc. - M. Serafini