FLUORIDE ACTION NETWORK
PESTICIDE PROJECT

Return to FAN's Pesticide Homepage

Return to Noviflumuron Index Page


Noviflumuron. February 11, 2004. Approval for use in NY State:
Recruit III
(EPA Reg. No. 62719-453)
Recruit III AG
(EPA Reg. No. 62719-454)


New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials
Bureau of Pesticides Management
Pesticide Product Registration Section
625 Broadway, Albany, New York 12233-7257
Phone 518-402-8768 FAX 518-402-9024
Website: http://www.dec.state.ny.us/website/dshm/pesticid/pesticid.htm
E-Mail: ppr@gw.dec.state.ny.us

February 11, 2004

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Raymond S. Brinkmeyer, PhD.
State Regulatory Leader
Dow AgroSciences, LLC
9330 Zionsville Road
Indianapolis, Indiana 46268-1054

Dear Dr. Brinkmeyer:

Re: Registration of Recruit III (EPA Reg. No. 62719-453) and Recruit III AG (EPA Reg. No. 62719-454) Containing the New Active Ingredient Noviflumuron.

The New York State Department of Environmental Conservation (Department) has completed its technical review of your application and data package submitted on 07/23/03, corrected confidential statement of formula (CSF) submitted on 08/22/03, nomenclature key submitted on 10/1/03, data evaluation record (DER) for acute toxicity studies on the technical product 98.6% noviflumuron submitted on 10/3/03, and the certificate of analysis for the test material, used for the above mentioned acute toxicity studies, submitted on 10/17/03. The active ingredient noviflumuron, had not been registered previously in New York State and as such, required technical review by the Department as a new active ingredient.

Noviflumuron is a structural analog of the active ingredient hexaflumuron, registered in 1995 by the Department. The Recruit III products are labeled for the protection of buildings, fences, utility poles, decking, landscape plantings and trees that can be damaged by termite feeding and foraging activity. The active ingredient is applied to shredded paper and placed in a child resistant bait station. The products are not applied by rodding or trenching as are other termiticides. Both pesticide products contain the new active ingredient noviflumuron and are labeled for use as either above (Recruit III AG) or below (Recruit III) ground termiticide baits for the elimination of subterranean termite colonies or protection of structures from subterranean termites, respectively. The noviflumuron contained in these baits, once consumed by feeding termites, disrupts normal exoskeleton formation, which ultimately causes the failure of the termite colony.

Pursuant to the review time frame specified in ECL §33-0704.2, a registration decision date of March 19, 2004 was established. The Department has conducted the following technical reviews with regard to the registration of Recruit III and Recruit III AG for impacts to human health, nontarget organisms, and the environment. Review summaries are provided below:

Human Health Review:

The active ingredient noviflumuron was not very toxic in acute oral, dermal or inhalation exposure studies in laboratory animals, nor was it very irritating to the eyes or skin (tested on rabbits). It also did not show skin sensitizing properties (tested on guinea pigs). Because the formulated product is comprised of paper impregnated with noviflumuron, and is difficult to administer to test animals, acute toxicity studies were conducted instead on the manufacturing use product (MUP) which is 50 percent noviflumuron. The results of these studies indicate that the MUP was not very acutely toxic by the oral, dermal or inhalation routes of exposure. It also was not irritating to the skin or eyes, nor was it a skin sensitizer.

Several subchronic toxicity studies were conducted on noviflumuron. In a 28-day oral toxicity study in rats, decreased food consumption in males was reported at 1,000 milligrams per kilogram body weight per day (mg/kg/day); the no-observed-effect level was 500 mg/kg/day. Mice fed noviflumuron for 28-days had increased liver weights and hepatocellular hypertrophy at a dose of 110 mg/kg/day; the NOEL was 10.8 mg/kg/day. In a 90-day dog study, dietary administration of noviflumuron resulted in altered red blood cell parameters characterized by a decrease in hematocrit, hemoglobin, erythrocytes and mean corpuscular volume at 113 mg/kg/day; the reported NOEL was 1 mg/kg/day.

The U.S. Environmental Protection Agency (U.S. EPA) waived the requirement for chronic feeding/oncogenicity studies and a multi-generation reproduction study because the formulated product is labeled for non-food use only. However, developmental toxicity and genotoxicity studies were conducted. These studies indicated that noviflumuron did not cause any developmental or maternal toxicity either in rats or rabbits at up to and including the highest dose tested, which was 1,000 mg/kg/day. This chemical also was negative in a number of genotoxicity studies. A current search of the toxicological literature did not find any significant new information on the toxicity of noviflumuron.

The U.S. EPA waived the requirement for an occupational risk assessment on the labeled use of noviflumuron because: "the bait stations are to be positioned by pest control operators (PCOs) only; no residential exposure is anticipated; and there is little to no anticipated exposure for professionals installing the devices."

There are no chemical-specific federal or State drinking water/groundwater standards for noviflumuron. Based on its chemical structure, noviflumuron falls under the 50 microgram per liter general New York State drinking water standard for an "unspecified organic contaminant" (10 NYCRR Part 5, Public Water Systems).

The available information on noviflumuron indicates that this chemical is not very acutely toxic in laboratory animal studies. Subchronic laboratory animal studies indicate that noviflumuron ingestion at relatively high doses can cause some liver and hematological effects. However, no residential exposure to this chemical is anticipated from its use in the Recruit III bait station products. Furthermore, because of the design of these products (e.g., solid material containing a limited amount of active ingredient, housed in tamper-resistant bait stations) and their labeled use by pest control operators only, little or no exposure of workers to noviflumuron is anticipated.

Non-Target Organism Review:

The New York State Department of Environmental Conservation Bureau of Habitat has reviewed the materials submitted in support of the Recruit III and Recruit III AG product registration. Use of these products is limited to commercial applicators licensed to apply termiticides. The bait containing the active ingredient is enclosed within two different station designs, one for in-ground deployment and one for above-ground use, which are removed once the targeted termite colonies are destroyed. If label precautions regarding protection of aquatic resources are followed, no fish or wildlife exposure is likely.

Environmental Fate Review:

Solubility: Noviflumuron has a solubility of 0.194 mg/L.
Hydrolysis: According to the DER, noviflumuron is stable to hydrolysis at pHs 5 and 7, and has a half-life of 19 days at pH 9 at 25oC. There are four major degradates at pH 9: XDE-007 urea, XDE-007 amine, XDE-007 amide, and XDE-007 DFBA. On Long Island, where it is expected that this product will be used, the soils and water have a pH of less than 5.5.

Aerobic Soil Metabolism: EPA found this study acceptable. According to the DER provided, noviflumuron has a half-life of 231-344 days in a silt loam, 202-251 days in a loam, and 263-399 days in a silty clay loam. XDE-007 amine was a major degradate in all three soil types.

Label Language: Under the Environmental Hazards Statement on the label, the text states "This product is highly toxic to aquatic invertebrates and possibly to fish. Do not use Baitube devices in depressions, low areas, near ponds, streams, springs, other water sources, or near downspout openings when the bait or its noviflumuron contents could be washed out of the Baitube into the water or near the surface of the ground." Given the extremely high Kocs, this warning is meant for aquatic invertebrates and fish, not for groundwater contamination.

Adsorption/Desorption: EPA found this study acceptable. Noviflumuron has very high Kocs, but they are not dependent upon percent organic matter:

US Soil Types Adsorption Kocs Desorption Kocs
Indiana loam 159,776-197,432 201,207-280,494
Sand 53,673-89,783 53,618-115,827
N. Dakota loam 211,237-412,004 319,951-658,639
Clay 376061-469335 469017-599390
European Soil Types Adsorption Kocs Desorption Kocs
Silt loam 98,315-20,7641 163,652-224,369
Silty clay loam 32,162-68,981 73,780-86,713
Sand 199,721-306,050 319,278-738,634
Sandy clay loam 231,330-311,353 221,070-354,898

In conclusion, only three DERs were submitted: hydrolysis, aerobic metabolism and adsorption-desorption. However, the active ingredient is enclosed in a bait station, so that when the product is used according to the label, photolysis, anaerobic metabolism and field dissipation are not a concern. Even though the aerobic metabolism half-lives are fairly long and range from 202 to 399 days, given the extremely high Kocs, it is very unlikely that groundwater contamination could occur even if the product were exposed to water.

Registration Summary:

The Department has registered Recruit III and Recruit III AG for use as labeled in New York State. Please note that because the label requires that the product be sold in conjunction with a service provided by a professional applicator, the Department has determined that the product, as noted on the "restriction" column on the Certificate, is to be classified as "restricted use" under rules and regulations 6NYCRR 326.2(g):

As such, this product is restricted in its purchase, distribution, sale, use and possession in New York State.

According to New York State Department of Environmental Conservation Regulations 6NYCRR 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 contact the Pesticide Reporting Section at (518) 402-8765.

Should you require information to obtain a commercial permit, please contact
Thomas Lynch, Chief, Pesticide Certification Section, at (518) 402-8748.

Enclosed for your record is a copy of the stamped accepted label and the Certificate of Registration for Recruit III (EPA Reg. No. 62719-453) and Recruit III AG (EPA Reg. No. 62719-454). Please note that a proposal by Dow AgroSciences LLC or any other registrant, to register a product that contains noviflumuron, and whose labeled uses are likely to increase the potential for significant impact to humans, nontarget organisms, 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). Such information, as well as forms, can be accessed at our website as listed in our letterhead.

Please be aware that any unregistered product may not be sold, offered for sale, distributed, or used in New York State.

If you have any questions on this matter, please contact our Pesticide Product Registration Section, at (518) 402-8768.

Sincerely,

Maureen P. Serafini
Director
Bureau of Pesticide Management

cc: w/enc. - N. Kim/D. Luttinger - NYS Dept. of Health
        R. Zimmerman/ R. Mungari - NYS Dept. of Ag. & Markets
        W. Smith - Cornell University, PMEP