New York State Department of Environmental Conservation Division of Solid and Hazardous Materials Bureau of Pesticides Management, 11th Floor 625 Broadway, Albany, New York 12233-7254 Phone: (518) 402-8788 FAX: (518) 402-9024 Website: www.dec.ny.gov Alexander B. Grannis Commissioner October 9, 2007 CERTIFIED MAIL RETURN RECEIPT REQUESTED Osmegen, Inc. c/o Jean Killoren, Authorized Agent Killoren Regulatory Consulting 316 Highland Avenue Hartford, Wisconsin 53027 Dear Ms. Killoren: Re: Registration of a Major Change in Labeled (MCL) Use Pattern for the Active Ingredient Tralomethrin Contained in the Pesticide Product Dead-Fast Insecticide Chalk (EPA Reg. No. 75015-1-82197) The New York State Department of Environmental Conservation (Department) has completed a technical review of the application, received February 1, 2006, and supplemental information submitted to date regarding registration of the referenced product in New York State. Dead-Fast Insecticide Chalk (EPA Reg. No. 75015-1-82197) contains the active ingredient tralomethrin (Chemical Code 121501). Dead-Fast Insecticide Chalk (1.0% tralomethrin) is a ready-to-use, residual formulation for control of cockroaches and ants in residential, commercial, institutional and transportation facilities including homes, apartment buildings, buses, recreational vehicles, mobile homes, utility vaults, telephone booths, coin boxes, electrical switch boxes, behind switchplates and the nonfood/feed areas of hospitals, stores, warehouses, trucks, truck trailers, freight cars, storage bins, ships and boats, institutional and commercial buildings. The active ingredient tralomethrin is a component of a number of pressurized spray and bait formulations currently registered in New York State for use by homeowners. Registered products contain up to 0.09% tralomethrin. The application to register Dead-Fast Insecticide Chalk represents a major change in labeled (MCL) use pattern due to the potential for a significant increase in exposure to humans and domestic animals from the unique use pattern and the higher concentration of tralomethrin (1.0%) in the Dead-Fast product. The application package was deemed administratively complete on March 16, 2006 and complete for purposes of technical review on June 27, 2006 following one notice of incompleteness (5/2/06). Pursuant to the review time frame specified in Environmental Conservation Law (ECL) 33-0704.2, a registration decision date of November 24, 2006 was established.
Osmegen, Inc. 2. A toxicological risk assessment was conducted for Dead-Fast Insecticide Chalk. Due to the product s indoor use pattern, ecological effects and environmental fate risk assessments were not conducted. Samples of the Dead-Fast product (received 7/17/06 and 8/4/06) were forwarded to the New York State Department of Health (NYSDOH) for examination. Two subsequent registration decision dates (1/23/07, 5/23/07) were waived to accommodate the registrant s preparation, and the Department s review, of a response to the concerns/issues noted by NYSDOH regarding use of the Dead-Fast Insecticide Chalk product. NYSDOH also requested a comparison of the relative risks posed by the Dead-Fast product to those of alternative products registered for the same use (i.e., cockroach and ant household spray products). TOXICOLOGICAL RISK ASSESSMENT: The Dead-Fast product is essentially a stick of chalk that is packaged in a plastic dispenser in order to prevent direct skin contact when applying the product. The chalk remains in the dispenser until the cap is removed and a button is depressed allowing the chalk to advance forward for application. The formulated product, Dead-Fast Insecticide Chalk, was not very acutely toxic in laboratory animal studies by the oral, dermal or inhalation routes of exposure. This pesticide product was not very irritating to the eyes or skin (tested on rabbits) nor was it a dermal sensitizer (tested on guinea pigs). Tralomethrin, although moderately toxic by acute oral exposure to laboratory animals, was not very acutely toxic by the dermal or inhalation routes of exposure. This active ingredient also was not very irritating to skin or eyes (tested on rabbits) and did not demonstrate skin sensitizing properties (tested on guinea pigs). In addition, tralomethrin, although causing some toxic effects in subchronic and chronic animal feeding studies, did not cause reproductive, developmental or oncogenic effects, and yielded negative results in a number of genotoxicity studies. The United States Environmental Protection Agency s (USEPA) Integrated Risk Information System (IRIS) derived an oral reference dose (RfD) of 0.0075 milligrams per kilogram body weight per day (mg/kg/day) for tralomethrin, based on a no-observed-effect level (NOEL) of 0.75 mg/kg/day from a chronic rat feeding study and a rat multigeneration reproduction study (decreased body weight) and an uncertainty factor of 100. Tralomethrin is rapidly metabolized to deltamethrin, and according to the USEPA, the toxicology profiles of these two chemicals are virtually identical. While the USEPA has not classified the carcinogenic potential of tralomethrin, that agency has classified deltamethrin as not likely to be a human carcinogen. A search of the toxicological literature did not find any significantly new information on tralomethrin. To reduce the likelihood that children will have access to the insecticidal chalk (which they could mistake for common blackboard chalk) in the Dead-Fast product, the chalk itself is packaged in a plastic dispenser. Children s accessibility to the chalk was assessed in a laboratory accredited in testing packaging for child-resistance according to protocols and standards set forth in the Code of Federal Regulations Title 16, Part 1700, (16 CFR 1700). This study reported that under the conditions of the test, two children out of 50 children (42 to 51 months of age) were successful in gaining access to the chalk within the plastic dispenser. This result indicates that the Dead-Fast product fulfills the standards for poison prevention packaging (96% passing grade) according to current testing procedures (16 CFR 1700).
Osmegen, Inc. 3. A number of chalk-type products intended to control cockroaches and other insects in residences have been illegally sold under various trade names including Chinese Chalk and Miraculous Insecticide Chalk. The USEPA has noted that several children were hospitalized after eating such illegally sold chalk. In addition, Purdue University reported that between 1992 and 1995, poison control centers nationwide received 668 calls involving pesticide chalk. Ninety-four percent of cases were from eating chalk, 87% of which involved children under age six. According to Killoren Regulatory Consulting correspondence dated March 14, 2006, Dead- Fast Insecticide Chalk is not manufactured or marketed in association with any of the illegal chalks. Nevertheless, the Dead-Fast Insecticide Chalk product is similar in some respects to the illegally sold chalks, and precautions are needed to minimize as much as possible children s exposure to the Dead-Fast product. Killoren Regulatory Consulting submitted an efficacy study on the Dead-Fast Insecticide Chalk product. In this study, field tests were conducted on a total of ten apartments. Each apartment had one or two bedrooms, living room, kitchen and bathroom. According to the study s author, the product provided a 79.6% reduction in roaches for at least eight weeks using a relatively small amount of chalk (average of 4.3 grams containing 0.043 grams tralomethrin) per apartment. There are no chemical specific federal or New York State drinking water/groundwater standards for tralomethrin. Based on its chemical structure, tralomethrin falls under the 50 microgram per liter New York State drinking water standard for unspecified organic contaminants (10 NYCRR Part 5, Public Water Systems). Several measures have been taken to reduce the likelihood that children will directly ingest the Dead-Fast Insecticide Chalk, as has been a concern for the illegal insecticide chalk. The Dead-Fast product is formulated as a stick of chalk that is packaged in a plastic dispenser in order to reduce direct skin contact when applying the product. A child-resistant packaging study indicated that the Dead-Fast product meets the criteria for child-resistant effectiveness (96% effective) according to current testing procedures (16 CFR 1700.20). In addition, a bittering agent is included in the chalk with the objective of reducing ingestion of the chalk if it does become accessible to a child. Also, the product label instructs users not to apply the product where children are likely to come in contact with treated surfaces, and not to attempt to remove the chalk from its dispenser or to remove the dispenser s cap when the product is not in use. While the above measures addressed some issues for Dead-Fast Insecticide Chalk, NYSDOH still had concerns about this product. A test of a sample of the Dead-Fast product found that the chalk was quite breakable, thereby resulting in the broken-off piece becoming readily accessible to direct skin contact and ingestion. Furthermore, there are questions about how effective the bittering agent is in deterring children from eating this insecticidal chalk if an opportunity arises to ingest it. There is also a lack of information on the potential risks associated with post-application exposure to Dead-Fast residues from inhaling household dust containing tralomethrin, ingestion of residues from hand-to-mouth activities and mouthing, or dermal contact with residues as applied or present in household dust. Finally, the product label statement, Do not apply where children and pets are likely to come in contact with treated surfaces, while appropriate, presents somewhat of a conflict in that certain surfaces (e.g., baseboards, around windows and doors) identified for treatment by the label would be readily
Osmegen, Inc. 4. accessible to children and pets. NYSDOH recommended that the registrant satisfactorily address the above concerns before Dead-Fast Insecticide Chalk was considered further for registration. A comparison of the relative risks posed by the Dead-Fast product to those of alternative products registered for the same use (i.e., cockroach and ant household spray products) was also recommended. In a technical issues letter, dated October 26, 2006, the Department notified Killoren Regulatory Consulting of the concerns/issues identified by NYSDOH, given that this product is applied in a novel manner and is contained in unique packaging. In response to these concerns, the agent for the registrant submitted (November 21, 2006) some additional information for consideration. While this response discussed the concerns, it did not provide adequate information to address all points. Subsequently, the agent for the registrant requested a description of the material that would provide an adequate basis for determining risks to those who occupy dwellings treated with the Dead-Fast product. For clarification, NYSDOH requested that the registrant address the following points using information on how the product is applied in dwellings. The assessment may need to be based on estimates, as experimentally-derived data for all parameters may not be available. The below pathways of exposure are particularly relevant to children, but adult exposures should be evaluated as well: Estimate potential tralomethrin exposure via chalk dust inhalation during application and as present in household dust; Estimate potential tralomethrin exposure via dermal contact with chalk residue at the site of application and as present in household dust; Estimate potential tralomethrin exposure via incidental ingestion of applied chalk residue (e.g., through direct mouthing) and as present in household dust; and Estimate potential acute and chronic risks from the above exposures. Once the above risks had been characterized, it was beneficial for NYSDOH assessment of the product if the registrant compared such risks to those posed by other active ingredients from competing products such as resident-applied insecticidal sprays, foggers, etc. On May 17, 2007, the registrant s agent submitted a risk assessment for tralomethrin in the Dead-Fast product and for other active ingredients from alternative products selected as being representative of resident-applied insecticide sprays, foggers and baits. Because little empirical data are available for evaluating exposure of residents to these products when used to treat living spaces, much of this analysis was based on estimates, the values of which have considerable uncertainty. The risk assessment estimated large margins of exposure (MOEs) for acute inhalation, dermal and oral exposure of toddlers and adults to the Dead-Fast product in residential settings. Lower MOEs (indicating greater risk) were calculated for the alternative products. Thus, the registrant s assessment concluded that the use of the Dead-Fast product does not pose significant risks, and that the alternate products pose greater risks. Acknowledging the complexities and uncertainties inherent in assessing the risks from these types of products, NYSDOH identified significant limitations in the registrant s assessment that decrease their confidence in the risk estimates. For example, one limitation is that the
Osmegen, Inc. 5. analysis did not evaluate chronic exposures as requested; only short-term exposures were evaluated. The registrant s assessment also did not evaluate incidental household dust ingestion, which can be a significant pathway of exposure in children. The assessment also used some unconventional values to estimate exposure (e.g., inhalation rates of 15.1 cubic meters per hour for adults) and to measure exposure (e.g., presenting inhalation doses as milligrams per liter per day). The basis of the toxicity values used in developing the risk assessment were also not well described and supported. Nevertheless, the registrant has taken several measures to reduce the exposure potential to Dead-Fast Insecticide Chalk for both applicators and children. For example, the Dead-Fast product is formulated as a stick of chalk that is packaged in a plastic dispenser to reduce direct skin contact when applying the product. A child-resistant packaging study indicated that the Dead-Fast product meets the criteria for child-resistant effectiveness (96% effective) according to current testing procedures (16 CFR 1700.20). In addition, a bittering agent is included in the chalk with the objective of reducing ingestion of the chalk if it does become accessible to a child. Also, the product label instructs users not to apply the product where children are likely to come in contact with treated surfaces, and not to remove the chalk from its dispenser or to remove the dispenser s cap when the product is not in use. The unique formulation and application method, along with the exposure reduction measures stated above, indicate that the Dead-Fast product may be a lower risk alternative to the competing products for controlling certain insect pests in residences and the other labeled use settings. However, because of the uncertainties in the registrant s risk assessment and the potential attractive nature of the chalk formulation that could result in accidental ingestion in children, NYSDOH continued to have some reservations for registering the Dead-Fast product without some means of monitoring any adverse exposures. NYSDOH recommended that the registrant develop a tracking system (possibly through the use of FIFRA 6(a)(2) reports) to provide information on any adverse effects to children or adults from product use. Additionally, the registrant should provide sales data for this product so that any adverse effects can be evaluated in terms of the amount of product use. DISCUSSION: Killoren Regulatory Consulting notified the Department that Osmegen, Inc. has agreed to submitting FIFRA 6(a)(2) reports and product sales data (national and New York State specific) for a registration of Dead-Fast Insecticide Chalk. Please note that, pursuant to 6 NYCRR Part 326.14(f), the submission of unreasonable adverse effects information is a general requirement for applicants and registrants of pesticide products in New York State. REGISTRATION ACTION: The Department accepts Dead-Fast Insecticide Chalk (EPA Reg. No. 75015-1-82197) for registration in New York State. Enclosed for your files are the Certificate of Pesticide Registration and New York State stamped ACCEPTED labeling. As a condition of registration, Osmegen, Inc. must file any factual information regarding unreasonable adverse effects of Dead-Fast Insecticide Chalk within thirty (30) days after the registrant first possesses or knows of reportable information. Product sales data must be submitted on an annual basis. Please note that a proposal by Osmegen, Inc., or any other registrant, to register a product containing tralomethrin, whose labeled uses are likely to increase the potential for significant
Osmegen, Inc. 6. exposure to humans or impact to 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 specified in 6 NYCRR Part 326.17. Please contact Samuel Jackling, Chief of our Pesticide Product Registration Section, at (518) 402-8768, if you have any questions. Enclosures Sincerely, Maureen P Serafini Maureen P. Serafini Director Bureau of Pesticides Management cc: w/enc. - R. Mungari, NYS Dept. of Ag. & Markets W. Smith, Cornell University, PSUR