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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: www.dec.state.ny.us/website/dshm/pesticid/pesticid.htm


November 21, 2000

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Dick L. Palmquist
Registration Manager
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 formulation.

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 risk.

    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 aquatic invertebrates.

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 entrained sediments."     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.

DISCUSSION:

    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.

CONCLUSION:

    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 State). Out-of-State callers may contact the Pesticide Reporting Section at (518) 457-3542.

    Should you require information to obtain a commercial permit, please contact Mr. Al Muench, Chief, Pesticide Certification Section, at (518) 457-7482.

    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.

Sincerely,

Maureen P. Serafini
Director
Bureau of Pesticides Management

Enclosures

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
Chemical File
Active File

bcc: w/o enc. - M. Serafini
T. Lynch
F. Hegener
L. Whitbeck
R. Hackett
PPRS Daybook

MJR:scy