|New York State Department of Environmental
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) 457-7446FAX: (518) 485-8990
|June 9, 2000|
RETURN RECEIPT REQUESTED
Ms. Teresa K. Hass
State Registration Coordinator
Uniroyal Chemical Company
74 Amity Road
Bethany, CT 06524-3402
Dear Ms. Hass:
Re: Registration of FloramiteTM (EPA Reg. No. 400-481) Containing the New Active Ingredient Bifenazate
The New York State Department of Environmental Conservation ("The Department") has completed review of your application for registration of the referenced pesticide product in New York State. FloramiteTM (EPA Reg. No. 400-481) contains the new active ingredient bifenazate (hydrazine carboxylic acid, 2-(4-methoxy-[1,1-biphenyl]-3-yl)-1-methylethyl ester).
FloramiteTM (50% bifenazate) is labeled as a selective miticide for the control of a variety of mite pests on greenhouse, shadehouse, nursery, field, landscape and interiorscape grown ornamentals. The recommended application rate is two to four ounces of product mixed in 100 gallons of water and applied as a full coverage spray to foliage using a minimum volume of one to two quarts of final solution per 100 square feet (0.14 - 0.27 pounds bifenazate/acre/application). The FloramiteTM label does not prohibit multiple applications and the interval between applications is not specified. However, the following restriction is listed under the "Use Rates and Recommendations" section of the label: "Do not use Floramite in successive applications. Apply only one application of Floramite before rotating to products of an alternative chemical class. Use at least two alternative products between treatments of Floramite."
The subject application and data package were deemed complete for purposes of technical review on January 13, 2000. Pursuant to the review time frame specified in ECL ß33-0704.2, a registration decision date of June 11, 2000 was established.
The Department conducted toxicological, ecological effects and environmental fate risk assessments for bifenazate and the FloramiteTM formulation.
TOXICOLOGICAL RISK ASSESSMENT:
Neither the active ingredient nor the formulated product were very toxic in acute oral, dermal or inhalation studies in laboratory animals, nor were they dermal sensitizers or very irritating to the eyes or skin.
Bifenazate caused some toxicity in subchronic dermal and feeding studies in laboratory animals. In a 21-day dermal study in rats, bifenazate caused a decrease in body weights, and urinalysis (decrease in urinary volume and an increase in urinary ketone) and pathology findings (extramedullary hematopoiesis in the spleen) at 400 milligrams per kilogram body weight per day (mg/kg/day); the no-observed-effect level (NOEL) was 80 mg/kg/day. In a 90-day feeding study in rats, decreased body weight gain, increased liver weights, hematological changes and histopathological findings in the liver, spleen and adrenal cortex were reported in males at a dose level of 27.7 mg/kg/day. A decrease in body weight gain, as well as an increase in spleen weight, hematological and histopathological liver changes, were reported in females at 16.3 mg/kg/day; the respective NOELs for males and females were 13.8 and 3.2 mg/kg/day. In a 90-day dog feeding study, changes in hematological parameters (decrease in red blood cells and hemoglobin), increased liver weight and microscopic changes in the liver occurred at 10.4 mg/kg/day in males and 10.7 mg/kg/day in females; the NOELs were 0.9 and 1.3 mg/kg/day, respectively.
Since FloramiteTM was not being evaluated for food uses and no chronic exposures were expected, the United States Environmental Protection Agency (USEPA) waived the requirement for chronic toxicity/carcinogenicity studies on bifenazate. Genotoxicity tests on bifenazate were negative.
Bifenazate did not cause developmental effects in offspring of either pregnant rabbits or rats administered this compound during organogenesis at doses up to 200 and 500 mg/kg/day, respectively (the highest dose levels tested). Maternal toxicity in rats which was characterized by reduced body weight gain, reduced food consumption and lower absolute body weight, occurred at exposures of 100 mg/kg/day; the NOEL was ten mg/kg/day. No maternal toxicity was observed in the rabbit developmental toxicity study. In a two-generation reproduction study in rats, no reproductive effects were reported at ten mg/kg/day (the highest dose tested). Parental toxicity manifested as a reduction in body weight gain was reported at ten mg/kg/day; the NOEL was four mg/kg/day.
The USEPA conducted a risk assessment for dermal and inhalation exposure of workers to bifenazate based upon its labeled use in the FloramiteTM product. For mixer/loader/applicators, margins of exposure (MOEs) were estimated to range from 2,200 - 17,000 for dermal exposure and from 5,600 - 100,000 for inhalation exposure. These estimates assume that the workers wore long-sleeved shirt and long pants which is the only personal protective equipment required by the label (other than shoes and socks). An MOE for post-application dermal exposure of workers involved in cutting and sorting ornamentals was estimated to be 114. This estimate assumes that there is no restricted entry interval whereas the label requires at least a 12-hour period before entering treated areas. The NOEL used for estimating MOEs from dermal exposure is 80 mg/kg/day (apparently based on the 21-day dermal study in rats) and the NOEL used for estimating MOEs from inhalation exposure is ten mg/kg/day (apparently based on the 90-day dog feeding study). If the exposure estimates for inhalation exposure of mixer/loader/applicators is compared to the NOEL from the chronic rat study (one mg/kg/day), an MOE of 560 can be calculated. Generally, the USEPA considers MOEs of 100-fold or greater to provide adequate protection.
There are no chemical specific federal or State drinking water/groundwater standards for bifenazate. Based on its chemical structures, this compound falls under the 50 micrograms per liter (mg/L) New York State drinking water standard for "unspecified organic contaminants" (10 NYCRR Part 5, Public Water Systems).
The available information on bifenazate and the formulated product FloramiteTM indicates that they were not very acutely toxic in laboratory animal studies. Although data from subchronic studies on bifenazate showed that this chemical has the potential to cause certain hematological and other effects, the expected exposure from using bifenazate for non-food uses should not pose a significant risk to the general public or workers.
ECOLOGICAL EFFECTS RISK ASSESSMENT:
Bifenazate has a solubility in water of 3.8 mg/L at 20°C, and a log octanol-water partitioning coefficient of 3.4. When applied, bifenazate binds rapidly to the surface of the vegetation or degrades. Because it binds to the surface of the target plant, it provides about 21 days of residual control. On soil, bifenazate degrades almost immediately. The toxicity of the primary degradate is approximately the same as bifenazate, so the combined field dissipation half-life of both the applied product and primary degradate is about five days. In water, bifenazate has a photolytic half-life of 0.67 days. The rate of hydrolysis is pH dependent; 2.7 days, 0.32 days and 0.02 days at pHs of 5, 7, 9, respectively.
Ecological impacts of Floramite were modeled using the Departmentís MAMTOX, AVTOX and AQUALIFE models. Since bifenazate should not accumulate when multiple applications were separated by a 21-day interval, only a single application scenario was modeled. A 21-day interval was selected because the Floramite label claimed that the product had residual activity for 21 days. For AQUALIFE modeling, 100% of the runoff was assumed to reach the receiving water ponds with no mitigative reductions such as the percentage intercepted by foliage.
The MAMTOX model showed that residues from a single bifenazate application exceeded several chronic or reproductive no-observable-effects concentrations (NOECs) for mammals. However, the feeding study thresholds were based upon 90-day feeding studies. When applied to foliage, a considerable portion degrades quickly. The remainder binds to the leaf surface where it continues to degrade, albeit much more slowly. A 90-day exposure to bifenazate treated foliage would not be likely to occur.
Similarly, the AVTOX model predicted that a single bifenazate application at the labeled rate would exceed chronic reproductive toxicity thresholds for birds. Bifenazate will degrade too quickly for birds to consume a chronically toxic dose, and very few birds consume ornamental vegetation. FloramiteTM is not labeled for turf treatment.
No aquatic life toxicity thresholds were exceeded by bifenazate in AQUALIFE modeling. When used as labeled, Floramite is unlikely to be harmful to fish or wildlife.
ENVIRONMENTAL FATE RISK ASSESSMENT:
Given the low application rate (4.35 ounces bifenazate/acre/application) and the high Koc values (2011 - 7453), FloramiteTM, when applied as labeled, should not have an impact on ground or surface water in New York State.
When used as labeled, FloramiteTM should not cause any unreasonable adverse effects to humans or the environment. The Department hereby accepts FloramiteTM (EPA Reg. No. 400-481) for registration in New York State. Enclosed for your files are the Certificate of Pesticide Registration and New York State stamped-"ACCEPTED" labeling.
Please note that, a proposal by Uniroyal Chemical Company, or any other registrant, to register a product containing bifenazate, 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, Acting 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. - T. Sinnott, DFW&MR
SPCS I, Reg. 1
PCS IIís, Regions 2-7 &9
D. Rollins, Region 8
M. Radzevich (2)
Uniroyal Chemical Company File
bcc: w/o enc. - M. Serafini