l{ew York State Department of Environmental Conservation Division of Materials Management Bureau of Pest Management Pesticide Product Registration Section 625 Broadway, Albany, New York 12233-7251 Phone: (518) 402-8768. Fax: (518) 402-9024 Website: www.dec.ny. gov/chemical/8528.html E-Mail: ppr@dec.ny.eov J Joe Martens Commissioner - September 17,2074 Control Solutions, Inc. 5903 Genoa-Red Bluff Pasadena, Texas 77507 Re Registration of the Major Change in Labeling Application for the Active Ingredient Novaluron Contained in Tekko Pro (EPA Reg. No. 53883-335) Chemical Code: 124002 Dear Ms. Cooley: The New York State Department of Environmental Conservation (Department) has completed its technical assessment of the active ingredient novaluron for the additional use pattérn of indoor residential/institutional/commercial applications. Tekko Pro (EPA Reg. No. 5 SA:-: S) is labeled for use indoors for general use on hard surfaces, crack and crevices, fumiture and carpets and in food handling establishments, as well as use outdoors in kennels, and poultry houses to control fleas, ticks, flea eggs, chewing lice, mosquitoes and other insect pests. The pioduct is applied as a solution containing up to 2 ounces Tekko Pro diluted into 1 gallon of water and sprayêd on an area of 1000 square feet which is the equivalent of 0,0016 pounds of novaluron per 1,000 square feet, The product is an insect growth regulator for long term control of listed insects. The Department received the application to register Tekko Pro on April 21, 2014. Novaluron was registered in New York State for use on companion animals and for agricultural uses to control listèd insects on potatoes, apples, and ornamentals, but not for indoor uses. The broadcast use of novaluron specifically indoors in domestic dwellings was determined to be a major change in labeled use þattern. The submitted materials were reviewed and the application was found t-o be complete for the purposes of technical review on June 6,2014. The application was reviewed by the New York State Department of Health to determine potential impacts to human health from indoor/outdoor broadcast application. Environmental fate and non-target organism impact reviews were not necessary to repeat for this particular use pattem. The Department hereby registers Tekko Pro (EPA Reg. No. 53883-335) for indoor use in New York State with support from the New York State Department of Health (DOH). Please find the complete human health risk assessment in the Appendix to this letter. Enclosed for your records is a copy of the New York State stamped "Accepted for Registration" label and New York State Certificate of Pesticide Registration for Tekko Pro (EPA Reg. No. 53883-335). Please note that a proposal by Control Solutions Inc., or any other
2 registrant, to register a product that contains novaluron and whose labeled uses are likely to increase the potential fcrr significant impact to humans, non-target organisms, or the environment, would constitute a major change in labeled use pattern. Such an application must be accompanied by a new application fee and meet the requirements listed in Appendix 1.8. of "New York State Pestic,ide Product Registration Procedures" (April 2009). Such information, as well as forms, can be accessed at our website as listed in our letterhead. Please be aware that any unregistered product or labeling may not be sold, offered for sale, distributed, or used in New York State. Please contact Paula McBath, of the Pesticide Product Registration Section, at (51 8) 402-8768, if you have any questions. Sincerely, Enclosures ;f "*æ-,føf*,***w- Scott Menrath., P.E. Director Bureau of Pest Management
a J APPENDIX Human Health Risk Assessment The New York State Department of Health (DOH) received the application and supporting data submitted by Control Solutions, Inc. to register the pesticide product Tekko Pro (EPA Reg. No. 53883-335) in New York State. This product contains the active ingredients pyriproxyfen and novaluron and is labeled for control of various biting insects (fleas, ticks, chewing lice, mosquitoes) and their eggs in residential, institutional and commercial settings. Pyriproxyfen is currently registered in the state for this use pattem whereas novaluron is currently registered for use on ornamentals and as a monthly spot-on treatment for domestic animals. The proposed use of novaluron on various indoor surfaces (fumiture, carpets, etc.) as well as kennels and poultry houses has been determined to represent a major change in labeled use pattern for this active ingredient in New York State. Toxicity Review DOH previously reviewed the toxicological properties of the active ingredient novaluron for registration of the pesticide products Pedestal and more recently PetArmour Plus IGR for Dogs. Neither the active ingredient novaluron nor the formulated product was very acutely toxic to laboratory animals by the oral, dermal or inhalation routes of exposure. In addition, both the active ingredient and the formulated product were not eye and skin irritants (tested on rabbits) or skin sensitizers (tested on guinea pigs). Novaluron was not teratogenic, oncogenic or genotoxic, but did cause some hematological effects at relatively low doses in laboratory animal studies. The U.S. Environmental Protection Agency (U.S. EPA) Office of Pesticide Programs calculated an oral reference dose (RÐ) for novaluron of 0.011 milligrams per kilogram body weight per day (mg/kg/day) based on a no-observed-effect-level CIOEL) of 1.1 mglkglday in a chronic feeding/oncogenicity study in rats (red blood cell damage and tumover resulting in mild anemia) and an uncertainty factor of 100. Search of the toxicological literature found no additional data on the toxicity of novaluron. Occupational Risk Assessment The U.S. EPA reported the results of an occupational risk assessment for short-(1-30 days)/intermediate-term (1-6 months) inhalation exposures to novaluron from several application methods (stationary fogger, backpack sprayer, manually pressurized handwand, and mechanically pressured handgun). Dermal risks were not addressed because a dermal toxicity endpoint was not identified for novaluron. For determining margins of exposure (MOEs), the U.S. EPA compared estimated short-/intermediate-term inhalation exposures to a NOEL of 4.38 mglkglday from a 90-day feeding study in rats (clinical chemistry and histopathology). The inhalation MOEs for mixer/loader/applicators were 5.1 x 107, 2.1x 107,5.1 x 103 and 2.8 x 103 for applications made by stationary fogger, backpack sprayer, manually pressurized handwand and mechanically pressured handgun, respectively. These scenarios assumed workers wore base line personal protective equipment (long-sleeved shirt and long pants, shoes plus socks). The U.S. EPA considered MOEs of 100-fold or greater to provide adequate worker protection.
4. Residential Risk Assess;ment The U.S. EPA r:eported the results of a residential risk assessment for short-term inhalation exposures to novaluron from indoor (broadcast/spot/crack and crevice via manually pressurized handwand) and turf (manually pressurized handwand, hose-end sprayer, backpack sprayer and sprinkler can) application scenarios. For determining MOEs, the U.S. EPA compared estimated short-term inlhalation exposures to a NOEL of 4.38 mglkglday from the 90-day feeding study in rats. For homeowner mixer/loader/applicators, the inhalation MOE for indoor applications was 4.1 x lt05 and the MOEs for outdoor applications ranged from 9.4 x 10s to 2.4.x 107, depending on the application method. The U.S. EPA considered MOEs of 100-fold or greater to provide adequate homeowner protection for these scenarios. The U.S. EPA additionally reported the results of a residential post-application risk assessment for inhalation and incidental oral exposures to novaluron from application to indoor environments and turf fbr adults and children (1 to <2 years old). For determining MOEs, the U.S. EPA compared estimated short-term inhalation and short-/intermediate-tetm incidental oral exposnres to a NOEL of 4.38 mglkglday from the previously mentioned 90-day feeding study in rats. The short-term pos;t-application inhalation MOEs for i.ndoor applications were 1.1 x 106 and 2.7 x 70s for adults and children, respectively. The post-application short-term, MOEs for incidental oral exposure (hand-to-mouth and object-to-mouth) to children ranged from 9.8 x 102 to 1 x 10s depending orlthe material treated (carpet or hard surfaces) and application method (broadcast, coarse and pin stream, crack and crevice) to indoor surfaces. The MOEs for postapplication, short-term incidental oral exposures (hand-to-mouth, object-to-mouth, and ingestion) to children ptaying on turf the day of application ranged from 8.5 x 103 to 3.8 x 106. The U.S. EPA considered MOEs of 1O0-fold or greater to provide adequate residential postapplication protection for these scenarios. Efficacy Data Review The U.S. EPA r,eported the results of several efficacy studies conducted with the formulated product Tekko Pro against cat fleas, flies (house, stable and horn) and German cockroaches. These sturfies were conducted to test the efficacy of the formulated product against immature stages of these insects on various surfaces (sand, soil, carpet, wood, vinyl and ceramic tiles). Overall, the U.S. EPA determined that the effrcacy data for the formulated Tekko Pro product adequately supiported the label control claims against cat fleas, flies and cockroaches. Drinkine'V/aterlGrounclwater Standards There are no chemical specific federal or New York State drinking water/groundwater standards for novaluronl. Based on its chemical structure, this chemical falls under the 50 micrograms per liter (pgll-) New York State drinking water standard for "unspecified organic contaminants" (10 NYCRR Part 5, Public Water Systems). In addition, the U.S. EPA has established a chronic, non-cancer Ftruman F{ealth Benchmark concentration (i.e., level in drinking water at or below which adverse health effects are not anticipated from lifetime exposure) for novaluron of 77 t gll. llhese Benchmark guideline values have been developed for pesticide active ingredients that rnay be found in surface or ground water sources of drinking water to enable "stakeholders to better determine whether the detection of a pesticide in drinking water or source waters for drinkjlng water may indicate a potential health risk."
Ms. Sharuron Cooley 5 Summary/Recommendation The available information on novaluron and Tekko Pro indicates that neither the active ingredient nor the formulated product is very acutely toxic in laboratory animal studies. Furthermore, novaluron did not demonstrate developmental toxicity properties, nor was it carcinogenic in mice and rats. Although this chemical can cause adverse hematological effects at relatively low doses, the estimated residential and occupational risks from the use of Tekko Pro are well within the range that is generally considered acceptable by the U.S. EPA. In addition, air impacts from use of Tekko Pro indoors are not expected to be a concern as the active ingredient has a low vapor pressure (1.2 x 10-7 mm Hg at 22 degrees Celsius) and the product does not contain significant amounts of volatile organic solvents. Given the above, the DOH does not object to the registration of Tekko Pro in New York State.