November 28, Certified Mail (Co. No. 239) Mr. Sandy Simon The Ortho Group Scottslawn Road Marysville, Ohio Dear Mr.

Transcription

1 New York State Department of Environmental Conservation Division of Materials Management Bureau of Pest Management Product Registration & Pest Management Alternatives Section 625 Broadway, Albany, New York Phone: (518) Fax: (518) Website: Joe Martens Commissioner November 28, 2012 Certified Mail (Co. No. 239) Mr. Sandy Simon The Ortho Group Scottslawn Road Marysville, Ohio Dear Mr. Simon: Re: Denial of the Application to Register a Major Change in Labeling for the Active Ingredient Triticonazole as Contained in Ortho Rose & Flower Insect & Disease Control Concentrate (EPA Reg. No ) The New York State Department of Environmental Conservation (Department) has evaluated your application (received February 7, 2011) and supplemental materials received to date in support of the registration of the above-referenced pesticide product. Ortho Rose & Flower Insect & Disease Control Concentrate contains 0.78% triticonazole and 0.26% acetamiprid and is labeled for residential indoor and outdoor application to ornamentals, roses, flowers, trees, and shrubs to treat a variety of insects and fungal diseases. Triticonazole was initially registered by the Department on June 23, 2010 for use as a seed treatment in wheat and barley. The proposed use pattern for acetamiprid in this product is consistent with use patterns previously approved in New York State. However, the Department has determined that the use of triticonazole on ornamental plants (both indoors and outdoors) constitutes a major change in labeling in New York State. Determining maximum application rates for homeowner ornamental uses is often difficult. The subject product label directs the user to dilute 3 fluid ounces of product in 1 gallon of water and then to spray until the foliage is wet. The Department asked Ortho to estimate the coverage area of 1 gallon of the diluted spray solution. Ortho indicated that 1 gallon of spray solution would likely cover 300 square feet. The Department has accepted this estimate with the understanding that individual application rates could vary significantly. Therefore, the maximum application rate on a per application basis was calculated as 3.4 gallons of product (0.212 pounds of triticonazole) per acre per application. Given that five applications are allowed per year, the maximum yearly application rate is 17 gallons of product (1.06 pounds of triticonazole) per acre per year.

2 Mr. Sandy Simon 2. The application package was deemed complete for purposes of technical review on April 8, Pursuant to the review time frame specified in Environmental Conservation Law , a registration decision date of September 5, 2011 was established. Technical reviews of the proposed uses included on the Ortho Rose & Flower Insect & Disease Control Concentrate label were performed by the Department and the New York State Department of Health. These reviews encompassed the expected impacts of labeled use of the subject product with respect to human health, ecological effects, and environmental fate. The technical reviews concluded that the use of triticonazole as proposed by the Ortho Rose & Flower product poses unacceptable risks to the resources of New York State. On September 2, 2011, a technical issues letter was sent to Ortho outlining the Department s concerns. Ortho requested, and was granted a meeting with Department staff to discuss the issues. In addition, Ortho submitted additional information in support of the subject application on October 23, 2011, November 23, 2011, and May 24, The Department has evaluated all the information presented by Ortho in support of registration of the subject product. Please see the technical reviews shown below in addition to the discussion that follows the reviews. HUMAN HEALTH ASSESSMENT: The following technical review was produced by staff within the Bureau of Toxic Substance Assessment at the New York State Department of Health (DOH): Neither technical triticonazole nor the formulated product was very acutely toxic via the oral, dermal and inhalation routes of exposure in laboratory animal studies. The active ingredient was a mild eye irritant, but not a skin irritant (tested on rabbits) or skin sensitizer (tested on guinea pigs). The formulated product was not a skin or eye irritant, but was a skin sensitizer. The DOH recently reviewed the toxicological properties of the active ingredient triticonazole in the pesticide product Charter Fungicide. Triticonazole caused some effects in subchronic and chronic feeding studies, including adrenal and liver toxicity in all species evaluated (rat, mouse, rabbit and dog). This chemical caused some developmental and reproductive toxicity in rats and rabbits at levels that also caused maternal toxicity. Triticonazole was neither genotoxic nor carcinogenic and the U.S. Environmental Protection Agency (U.S. EPA) classified triticonazole as not likely to be carcinogenic to humans. The U.S. EPA Office of Pesticide Programs derived a reference dose (RfD) of 0.17 milligrams per kilogram body weight per day (mg/kg/day) for triticonazole based on a no-observed-effect level (NOEL) of 17.4 mg/kg/day in the mouse feeding study (decreased body weight gain and liver toxicity) and an uncertainty factor of 100 (to account for intra- and interspecies variation). A current search of the toxicological literature did not find any significant new information on the toxicity of triticonazole. The U.S. EPA conducted a residential risk assessment for short-term inhalation exposures (1 30 days) to triticonazole for various homeowner application scenarios to turf, ornamentals and indoor house plants. For determining margins of exposure (MOEs), the U.S. EPA compared estimated short-term inhalation exposures to a NOEL of 25 mg/kg/day from the developmental toxicity study in rabbits (decreased body weight gain and food consumption and

3 Mr. Sandy Simon 3. increased mortality). Dermal risk scenarios were not conducted because a toxicity endpoint for this route of exposure was not identified in acute and subchronic dermal toxicity studies. The MOE for inhalation exposures from a ready-to-use hose end sprayer to turf was estimated to be 3.0 x The MOEs for mixers/loaders/applicators from application to turf were estimated to be 1.9 x 10 5 for a hose end sprayer (not ready-to-use) and 1.1 x 10 5 for a low-pressure handwand. For mixers/loaders/applicators to outdoor ornamentals, the MOEs were estimated to be 9.5 x 10 6, 7.5 x 10 7 and 1.9 x 10 8 for backpack sprayer, low-pressure handwand and hose end sprayer (not ready-to-use) applications, respectively. The U.S. EPA considered the outdoor ornamental lowpressure handwand scenario to be representative of indoor application to house plants since the application rates are the same and the amount of product handled for indoor application is expected to be less than the amount handled for outdoor applications. Post-application risks to toddlers following the application of triticonazole to home lawns were estimated for short- (1 30 days) and intermediate-term (1 6 months) incidental ingestion exposures. For estimating MOEs, the U.S. EPA compared estimated short-term exposures to a NOEL of 25 mg/kg/day from the developmental toxicity study in rabbits and intermediate-term exposures to a NOEL of 17.4 mg/kg/day from a chronic toxicity study in mice (decreased body weight gain and liver toxicity). The short- and intermediate-term MOEs for children from all incidental ingestion exposure pathways combined (hand-to-mouth, object-to-mouth, and soil ingestion) were 1,200 and 800, respectively. The U.S. EPA considered MOEs of 100-fold or greater to provide adequate protection from triticonazole for these exposure scenarios. Triticonazole has common metabolites (1,2,4-triazole, triazole alanine, triazole acetic acid) with a number of other triazole fungicides, including flutriafol, prothioconazole and tebuconazole, which have been recently reviewed for registration in the state on a variety of field crops and turf sites. Therefore, the potential exists for the additional uses of the Ortho Rose & Flower product to increase exposure to these metabolites, which have some toxic properties. In order to assess aggregate risks from all uses of registered triazole fungicides, the U.S. Triazole Task Force conducted a risk assessment for the common metabolites. The U.S. EPA did not update this risk assessment to include the homeowner uses of triticonazole, which were not originally included because it was not registered for these uses at the time. However, the U.S. EPA concluded in its human health risk assessment for triticonazole that the residential uses of this active ingredient would not result in significantly increased exposure to the common metabolites. The Task Force risk assessment concluded that, although the triazole metabolites have the potential to cause some toxicity, the MOEs for aggregate exposure (food, water and residential) are within the range that was considered acceptable (100-fold or greater for acute and short-term exposures, 900-fold or greater for chronic exposures). There are no chemical specific federal or New York State drinking water/groundwater standards for triticonazole. Based on their chemical structure, triticonazole and its degradates fall under the 50 microgram per liter (µg/l) general New York State drinking water standard for an unspecified organic contaminant (10 NYCRR Part 5, Public Water Systems). The available information on triticonazole and the formulated product Ortho Rose & Flower Insect & Disease Control Concentrate indicates that they were not very acutely toxic in laboratory animal studies. Triticonazole caused some toxicity, including adrenal and liver toxicity at relatively high doses in chronic feeding studies, but was not carcinogenic. In addition,

4 Mr. Sandy Simon 4. the estimated risks posed by triticonazole to homeowners from use of this product are within the range considered acceptable by the U.S. EPA. The DOH expressed some concerns for registering the Ortho Rose & Flower product however, given its label directions and intended use by homeowners. According to the label, this product can only be applied via a tank sprayer (indoors and outdoors) or hose end sprayer (outdoors only). A tank sprayer does not seem like an appropriate or accurate indoor application device given that the label instructs users to Spray only until the surface of the foliage is wet. Also, the label for this product does not require the use of chemical-resistant gloves, even though it contains a warning that Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals and it can be used every 2 to 4 weeks. Finally, the DOH expressed reservations about registering products that have multiple pesticide functions, as does Ortho Rose & Flower Insect & Disease Control Concentrate. This pesticide product contains the active ingredients triticonazole and acetamiprid, which have fungicidal and insecticidal activity, respectively. Such pesticide products with dual activities have the potential to lead to unnecessary applications of the additional active ingredient (e.g., insecticide) when only one active ingredient (e.g., fungicide) may be needed. These excess applications would result in increased exposure of individuals to the active ingredients. Taken together, the toxicological properties of triticonazole, the application methods, the dual use nature of the product and the lack of any required personal protective equipment (PPE), raised concerns for the use of Ortho Rose & Flower Insect & Disease Control Concentrate by homeowners. Consequently, the DOH did not support registration of this pesticide product in New York State. The DOH indicated they would be willing to reconsider registration of the Ortho Rose & Flower Insect & Disease Control Concentrate product if the registrant can address the above stated concerns for the application methods for this product, the need for chemicalresistant gloves and the increased exposure and risk that result from dual use products. The registrant submitted information in response to DOH concerns about residential use of the Ortho product. The registrant has proposed several revisions to the label to minimize homeowner exposure to the product. The label would require the use of personal protective equipment (long sleeved shirt, long pants, shoes plus socks and chemical resistant gloves) and prohibit indoor application of the product, with specific instructions to bring indoor plants outdoors before use. The registrant additionally submitted information in regard to DOH concerns about the dual use nature of the product and the accompanying increased exposure and risk. According to the registrant, the Ortho product will be marketed to rose enthusiasts addressing a specific need to treat typical disease patterns with roses (and other flowers) that occur at similar times of the year (e.g. aphids and powdery mildew in the spring). Ortho indicated that the dual use product could benefit residential users by lowering the frequency of pesticide applications since only one application would be required instead of two. The registrant additionally stated that Ortho Rose & Flower Insect & Disease Control Concentrate is being introduced as a replacement for Ortho RosePride Disease Control Concentrate (EPA Reg. No ), which contains the active ingredient triforine. The Ortho RosePride product carries the signal word Danger and the label requires the use of goggles or a face shield due to the potential for irreversible eye damage. In contrast, the Ortho Rose & Flower product is of lower acute toxicity and carries the signal word Caution. Finally, the registrant noted that

5 Mr. Sandy Simon 5. there are several products currently registered in the state for home garden use that contain dual fungicide and insecticide active ingredients with similar or greater toxicity. Taken together, the registrant asserts that use of the Ortho Rose & Flower product is not expected to present adverse risk to residential users. The additional information submitted by the registrant along with the proposed label changes adequately addresses DOH concerns for Ortho Rose & Flower Insect & Disease Control Concentrate. The product has a very specific use pattern and may pose less risk to residential users than currently registered home garden use products, especially with the addition of personal protective equipment and the removal of indoor use from the label. Given the above, the DOH does not object to the registration of Ortho Rose & Flower Insect & Disease Control Concentrate in New York State. ECOLOGICAL EFFECTS ASSESSMENT: The following technical review was produced by staff within the Department s Division of Fish, Wildlife & Marine Resources Bureau of Habitat (BOH): Toxicity/Mutagenicity/Genotoxicity Summary: Triticonazole is classified as practically nontoxic to mammals and slightly toxic to birds on an acute basis. It can produce chronic toxicity with extended high dose exposures. It is, at most, moderately toxic to aquatic test organisms on an acute basis, but may produce chronic toxicity at environmentally relevant concentrations. Triticonazole did not cause gene mutations or chromosomal aberrations in mammalian test species in 5 reported studies. Terrestrial Environmental Fate Summary: Triticonazole and its degradation products are expected be highly persistent and at least moderately mobile post application. In aerobic soil microbial metabolism studies, the only terrestrial route by which any significant transformation occurs, the core parent molecule remains unchanged. The resulting transformation products are the parent molecule hydroxylated at 4 different positions. It is essentially stable to other degradation processes. Environmental dissipation will occur primarily through dilution. Aquatic Environmental Fate Summary: Triticonazole aquatic fate is expected to be similar as that in terrestrial systems. With the exception that under aerobic aquatic study conditions it did slowly degrade, T ½ =210 days, to minor unidentified compounds. Metabolite Concerns: Persistent triticonazole degradation products ecotoxicological properties are not well defined. As with all compounds in this chemical family, formation of the persistent degradate 1,2,4 triazole is possible. Exposure Modeling & Risk Assessment: Standard BOH screening level modeling was conducted for both active ingredients over a season s use. Overall it does not appear there will be major impacts to non-target organisms from a season s use of the subject product. There are, however, significant uncertainties with respect to the extent of use and the effects of probable year to year accumulation of triticonazole parent and transformation products. The acetamiprid content in Ortho Rose & Flower should not adversely impact natural resources when used as labeled. Acetamiprid readily degrades via microbial metabolism. The only

6 Mr. Sandy Simon 6. significant toxicity identified during exposure modeling was for marine/estuarine aquatic invertebrates with chronic exposures. This is unlikely to occur under field conditions given the relatively rapid degradation of acetamiprid. The triticonazole exposure model results show that there is potential for fish chronic toxicity to occur. Slight model parameter refinement, adjusting target plant foliar intercept values and field runoff rate to more probable levels, reduces the predicted exposures but still results in thresholds being slightly exceeded. Mammalian chronic feeding NOEL thresholds are exceeded for the food types expected to retain the highest residues. No LOEL thresholds are exceeded. The triticonazole content in the Ortho Rose & Flower product has the potential to negatively impact fish on a chronic basis in use areas. Therefore, the BOH did not support the registration of this pesticide product in New York State. Ortho s response addressed the opposition to registration by the Bureau of Habitat. First they introduce a new revised estimated application rate for the product which was derived after the initial BOH review, and secondly they present some refined PONDTOX modeling using more realistic assumptions which they feel better represents the product s use. Ortho also identified an error in the chronic fish study NOEC value used by BOH. BOH staff used a NOEC of ppm instead of the correct ppm in PONDTOX modeling. It was a recording error on the reviewer s part and has been corrected. Additionally, Ortho reports that they have completed a new fish chronic life-cycle study which has been submitted to the EPA for evaluation. The new study, species not identified, yielded LOEC and NOEC values higher than the validated Fathead Minnow study which EPA and BOH used in their assessments. Ortho then argues for use of this less sensitive species when assessing risk to non-target organisms. It is standard risk assessment protocol to use the most sensitive species there are validated test results for when estimating ecological risk. All study results are considered but use of the most sensitive species compensates for the very limited number of species that are tested. The new application rate estimate is roughly 40% that of the rate previously reported and used by BOH and EPA EFED reviewers. Using the new lower application rates in PONDTOX runoff scenarios results in lower predicted model pond triticonazole concentrations as would be expected. The primary problem with the Ortho argument is that it is based on one year s use. It doesn t account for the persistence of both parent triticonazole and multiple major and minor degradates of toxicological concern that will accumulate over time. This topic was briefly addressed in the initial BOH review as a significant uncertainty and concern but apparently bears repeating and some expansion. The U.S. EPA EFED Ecological Risk Assessment dated August 31, 2010 summarizes the triticonazole degradate issue on pages The only significant triticonazole transformation mechanism is aerobic microbial metabolism. Parent compound environmental dissipation will occur primarily through dilution.

7 Mr. Sandy Simon 7. In aerobic soil metabolism studies, 4 of the 5 degradates produced in the greatest amounts are simply the parent compound hydroxylated at one of 4 locations. Neither the degradation nor the toxicity of these degradates has been defined but what is known is that they appear to be very persistent. To account for the persistence and undefined but likely toxicity, based on similarity to the parent compound, EFED reviewers simply used stable as the input value in their PRZM/EXAMS modeling for all environmental fate parameters. This, in effect, sets the toxicity of the degradates equal to the parent compound. The EFED review also makes the statement that The addition of a hydroxyl moiety to a chemical often increases its potential for leaching and runoff by reducing its affinity for soil. For this reason, the runoff modeling included in this review uses the higher of the possible runoff rates. The hydroxylated degradates and their concentrations in aerobic soil metabolism studies at various times as described by EFED reviewers are given in the following table. Degradate Day of Study Percent of Parent RPA RPA RPA RPA Total 35.5% Also included in the Ortho submission are the results of a spray trial conducted to determine the amount of product actually deposited on target plants during a typical homeowner application. In a single application roughly 33% of the applied material was retained on the target vegetation. This deposition rate is used in the PONDTOX modeling. If the EFED approach of assuming no degradation to represent degradate and parent accumulation over time is used, residues increase similar to the rate shown in Case 1. Case 2 is another slightly less conservative approach. In Case 2, the mean terrestrial field dissipation rate is assumed to be the degradation rate of the parent compound. 35.5% of the parent is converted to OH degradates which are assumed to be as toxic as the parent and have a half-life of 10 years. Resulting degradates are left in the field over subsequent years. Both cases illustrate the accumulation of triticonazole mass, parent + OH degradates, over time. Even the less conservative Case 2 results show a 1 foot depth mysid shrimp chronic LOEC being exceeded in the 3 rd year of use and the freshwater fish chronic LOEC being exceeded the following year. Residues will continue to build in the landscape for as long as triticonazole is applied. The modeling results do not show an alarming immediate impact to resources but do suggest that, if registered, this product has the potential to adversely affect resources over long periods. It should be kept in mind that although these compounds are evaluated individually, they do not occur individually in the environment after application. There is no means currently available to assess how these compounds that are present and building in perpetuity once registered interact

8 Mr. Sandy Simon 8. with other compounds and metabolites also present. The toxicity and fate profiles of the persistent triticonazole degradates should be established before this type of use pattern is allowed. Therefore, the Bureau of Habitat maintains the objection to registration of the Ortho Rose & Flower product. ENVIRONMENTAL FATE ASSESSMENT: The following technical review was produced by the Department s Engineering Geology staff within the Bureau of Pest Management: Triticonazole is a mixture of two optical isomers, and EPA indicated that since limited data was available on individual isomers, they are assumed in this assessment to have similar properties to the mixture. According to the Environmental Fate and Ecological Risk Assessment for Triticonazole (undated), EPA indicated that due to the absence of adequate data on the occurrence, quantity and toxicity of triazole degradates, risks associated with degradates were not evaluated. Major transformation products: BAS 595 F (Z) = 5Z-5-(4-chlorobenzilidene)-2,2-dimethyl-1-(1H-1,2,4-triazole-1-ylmethyl) cyclopentanol RPA = 2-(4-chlorobenzylidene)-1,4-dihydroxy-5,5-dimethyl-1-(1,2,4-triazol-1- ylmethyl) cyclopentane *RPA = (metabolite 6) = (1RS)-E-2-(4-chloro-3-hydroxybenzilidene)-5,5-dimethyl-1- (1,2,4- triazol-1-ylmethyl)pentan-1-ol *RPA = E-2-(4-chlorobenzilidene)trans-1,3-dihydroxy-5,5-dimethyl-1-(1,2,4-triazol-1- ylmethyl) cyclopentane (Same as ά-hydroxy triticonazole) *RPA = E-2-(4-chlorobenzilidene)-5,5-dimethyl-1-((1H)-1,2,4-triazol-1- ylmethyl)cyclopentan-1,3-diol (Same β-hydroxy triticonazole) Solubility: Triticonazole has a solubility of 9.9 mg/l. The product contains a significant percentage of an inert that could enhance the solubility of the product in groundwater. Hydrolysis: (MRID acceptable) Triticonazole was stable in phs 5, 7, and 9 aqueous buffer solutions. Aqueous Photolysis: (MRID ) In a study that EPA found acceptable, at ph 5 the environmental phototransformation half-life was about 48 days in the combined labels. In the Z- isomer label, the environmental phototransformation half-life was about 70 days. Major transformation product BAS 595 F (Z) was found at 40.7%. (MRID scientifically valid but supplemental) Triticonazole had a transformed halflife of 7.5 hours at equilibrium. Both triticonazole and the cis-isomer concentrations appear to approach a plateau, which would indicate that the major photolytic degradation mechanism of triticonazole involves isomeric conversion, and, had the study duration been extended, data might have indicated the establishment of equilibrium between the two isomers.

9 Mr. Sandy Simon 9. Soil Photolysis: ( acceptable) Triticonazole had a half-life of 92.4 days in a sandy loam soil (ph 5.1, %OM 3.79). No major transformation products were found. Aerobic Soil Metabolism: (MRID ) In a study that EPA found unacceptable, in a sandy loam soil (ph 7.0, %OM 3.4) the observed half-life was 105 days. Major transformation product RPA was found at 10.1%. In a clay loam soil (ph 7.9, %OM 4.6) the observed half-life was 130 days. (MRID partially acceptable) At 10 o C, in a sandy loam soil (ph 6.30, % OM 1.43), the calculated half-life was 359 days, was 224 days in a clay loam soil (ph 6.08, % OM 5.65), and was 691 days in a loamy sand soil (ph 6.24, % OM 32.24). In the sandy loam soil, transformation product RPA was found at a maximum of 10.5% and RPA was found at a maximum of 10.5%. In the clay loam soil, RPA was found at a maximum of 13.9% and RPA at 11.1%. No major transformation products were found in the loamy sand at 10 o C. At 22 o C in the loamy sand soil (ph 6.24, % OM 32.24) the half-life was 344 days and transformation product RPA was found at 14.8%. (MRID acceptable) At 22 o C, the half-life in a sandy loam (ph 6.42, % OM 1.24) was 301 days and 141 days in a clay loam soil (ph 6.18, % OM 9.76). RPA was found at 10.6% in the sandy loam soil, and at 10.4% in the clay loam soil. (MRID supplemental but upgradeable) At 25 o C, the half-life in a clay soil (ph 6.5, % OM 2.04) was 715 days with RPA found at 11.52% and RPA found at 10.19%. Aerobic Soil Metabolism RPA : No MRID. In a study that EPA found acceptable, the half-life in a clay loam (ph 7.6, % OC 4.7) was 165 days, 193 days in a sandy loam (ph 6.0, % OC 1.8), and was 330 days in a loam (ph 6.9, % OC 1.9). No major transformation products were detected. Aerobic Soil Metabolism RPA : No MRID. In a study that EPA found acceptable, the half-life in a clay loam (ph 7.4, % OC 4.1) was 0.5 days, 0.8 days in a sandy loam (ph 7.9, % OC 2.3), and 1.1 days in a loam (ph 6.8, % OC 1.3). One unidentified major transformation product was detected. Anaerobic Soil Metabolism: (MRID supplemental) There was no evidence of degradation and the compound can be considered stable to anaerobic soil metabolic processes. Anaerobic Aquatic Metabolism: (MRID scientifically valid) There was no evidence of degradation and the compound can be considered stable to anaerobic aquatic metabolic processes. Aerobic Aquatic Metabolism: (MRID ) In a study that EPA found acceptable, in a pond water-silt loam sediment system the observed half-life in the water was 15 days. It was stable in the sediment, and the observed half-life was >30 days in the total system. No major transformation products were found.

10 Mr. Sandy Simon 10. (MRID unacceptable) No aerobic aquatic degradation half-lives could be calculated. However, evidence does suggest that very slow degradation took place. Adsorption/Desorption: No DER for parent. (PMRA submission , RHQ) Soil ph % OC K oc adsorption K oc desorption Sandy loam Clay loam Loamy sand Sand Speyer EPA indicated in the EFED memo that sorption to soil does not correlate well with organic content. They also indicated that the reported K oc values ranged from 344 to 812. Adsorption/Desorption RPA : (No MRID, acceptable with clarifications) Adsorption decreased with increasing test concentration: Soil ph % OC K oc adsorption K oc desorption 1 st cycle K oc desorption 2 nd cycle Silt loam Sandy loam Loam Clay loam Sandy clay loam Adsorption/Desorption RPA : (No MRID, acceptable with clarifications) Adsorption decreased with increasing test concentration. Soil ph % OC K oc adsorption K oc desorption 1 st cycle K oc desorption 2 nd cycle Silt loam Sandy loam Loam Clay loam Sandy clay loam Terrestrial Field Dissipation: (MRID / conditionally acceptable) In a sandy loam soil, bare ground plot, triticonazole dissipated with a calculated half-life of 925 days during the 18 months following the applications. From a turf grass plot, for the four-month period following the applications the calculated first order half-life was 61 days. The dissipation of the triticonazole from the soil of the turf plot did not fit a first-order model. Insufficient data prevented the calculation of an overall dissipation rate from the combined turf grass and soil values for the turf plot site. In a sandy loam soil, bare ground plot, triticonazole dissipated with a calculated half-life of 116

11 Mr. Sandy Simon 11. days during the 18 months following the applications. From a turf grass plot, for the four-month period following the applications the calculated first order half-life was 64 days. In a loamy fine sand soil, bare ground plot, triticonazole dissipated with a calculated half-life of 160 days during the 18 months following the applications. From a turf grass plot, for the four-month period following the applications the calculated first order half-life was 140 days. The dissipation of the triticonazole from the soil of both of the turf plots did not fit a first-order model. Insufficient data prevented the calculation of an overall dissipation rate from the combined turf grass and soil values for the turf plot sites. (MRID unavailable, supplemental) In a coarse sandy loam (ph 7.4, % OM 1.3), the half-life from the seed treatment study could not be calculated. In the pre-incorporation study, the halflife was 69 days. No major transformation products were detected. (MRID unavailable, supplemental) In a second study on a coarse sandy loam (ph 7.4, % OM 1.3), the half-life from the seed treatment study could not be calculated. In the pre-incorporation study, the half-life was 163 days. No major transformation products were detected. EPA comments: Triticonazole s long environmental persistence and moderate mobility contribute to the environmental risk by increasing potential exposure and movement off-site. In addition to being persistent, several of triticonazole s most common degradates (e.g. several hydroxylated stereo-isomers) are structurally similar to the parent and thus are expected to be similar to triticonazole in persistence and toxicity. Computer Modeling: Running LEACHP on Riverhead soil (using the parameters used by the EPA in SciGrow), a K oc of 533, a half-life of 665 days, and an application rate of 1.06 lb ai/a/yr (the rate indicated by the registrant), the model predicted accumulation, reaching about 15 ppb after 10 years. Modeling the transformation product at 14.8% of applied or 0.16 lb ai/a/yr, a K oc of 214, a half-life of 193 days, the model projected cyclical peaks ranging between about 0.75 and 1.7 ppb. Modeling the transformation product at 11.1% of applied or 0.12 lb ai/a/yr, a K oc of 1305, and a half-life of 1.1 days, the model projected no leaching. Discussion of Modeling Parameters: The Ortho Group proposed that the Department include both percent treated area and interception modifications to the LEACHP modeling. Specifically, Ortho proposed that the Department employ a treated area factor of 10.5% and an interception factor of 28.75%. Ortho submitted a foliar interception study in support of the use of the proposed interception factor. The study appears to be well designed and performed, applying the product to typical annual bedding ornamentals (geraniums, dusty miller, etc.). The results from the study using the labeled application rate indicated a foliar interception rate of 32.8%, which is similar to the 28.75% value proposed by the registrant. The leaching potential derived by Ortho when employing both percent treated area and interception modifications in the modeling was 0.90 ppb. The Department has always employed conservative modeling parameters to ensure that use scenarios for potentially vulnerable areas in New York State are included in the modeling outcome. These conservative parameters include the use of a bare-ground application scenario (no interception) and modeling of the application at the full rate and treatment area allowed by

12 Mr. Sandy Simon 12. the label. Given that the Ortho Rose & Flower label does not prohibit application to a percentage of the homeowner s total land area, the Department does not feel that modeling on a percentage of the total land area is appropriate. For instance, it is likely that many homeowners have ornamentals on greater than 10.5% of their property that would reasonably be treated with the subject product. Given the above, staff rejects the use of percent treated area and interception modifications in the LEACHP modeling for this product. Environmental Fate Summary: Modeling of the parent triticonazole was performed using the yearly maximum application rate of 1.06 lb ai/a/yr, a K oc of 533 and a half-life of 665 days. The model projected significant leaching reaching 15 ppb when used as labeled for ten consecutive years. Ortho proposed altering the LEACHP modeling by using percent treated area and interception modifications. Staff does not support such modifications because they are not sufficiently inclusive of conservative use scenarios. Transformation product was found at 10.19% in one study, and apparently EPA did not require further studies. According to the DER for transformation product , it was found at 13.9%. In the Ecological Risk Assessment for the Triticonazole Proposed Section 3 Registration for Use on Ornamentals and Turf dated August 31, 2010, EPA indicated on page 18 that this transformation product was considered minor and found at only 8.4%. No further studies were done on either transformation product. Without adsorption/desorption data and aerobic metabolism data, staff are unable to model the impact they may have on groundwater when the product is used as labeled. Given the above, staff objects to the registration of this product in all of New York State based on the potential for groundwater contamination. ISSUES SUMMARY The Department s Bureau of Habitat expressed concerns regarding the potential of triticonazole to impact fish and shrimp on a chronic basis in addition to a general concern about the long-term ecological impacts of yearly use of an active ingredient with the persistence characteristics of triticonazole and its metabolites. Additional information provided by Ortho did not serve to alleviate these concerns. Additionally, the Environmental Fate Assessment indicated that the leaching potential of triticonazole was approximately 15 ppb using the Department s conservative modeling estimates. Ortho proposed a different modeling scenario as described in the Discussion of Modeling Parameters section of this letter, resulting in a leaching potential of approximately 1 ppb. However, the Department asserts that the use of conservative modeling parameters provides the most comprehensive approach to protecting the vulnerable areas of New York State. The Department invited Ortho to discuss and present any information in support of the perceived need of this product in the homeowner market. Ortho indicated that triticonazole could be a substitute for the active ingredient myclobutanil. The Department s research concluded that there is a multitude of both insecticidal and fungicidal products that are available

13 Mr. Sandy Simon 13. for home garden use, including some that have been designated for organic gardening. Some of the active ingredients that are viable substitutes for the triticonazole or acetamiprid in the Ortho Rose & Flower product include sulfur, potassium salts of fatty acids (insecticidal soap), pyrethrins, lambda-cyhalothrin and permethrin. While the Department recognizes the need for new chemistries (especially in agricultural production), we do not feel that the minimal benefit provided by triticonazole in residential ornamental gardens outweighs the expected risk to the ecological and water resources of New York State. REGISTRATION DECISION The Department continues to have unmitigated concerns regarding the expected impact of the proposed registration of Ortho Rose & Flower Insect & Disease Control Concentrate on the ecology and water resources of New York State. The Ortho Group has not provided sufficient evidence to alleviate these concerns or to demonstrate that the benefits of this product outweigh these concerns. Therefore, your application for registration of Ortho Rose & Flower Insect & Disease Control Concentrate (EPA Reg. No ) has been denied. Please be reminded that any unregistered product may not be sold, offered for sale, distributed, or used in New York State. If you wish to pursue registration of the above-listed product, you will be required to submit a new application with the required documentation and fees, or pursue the options available under Article of the New York State Environmental Conservation Law. A copy of this and other documents are available at the Department s website at the address listed in our letterhead. The Department invites The Ortho Group to reapply for registration when more information about the real-world impact of the use of triticonazole becomes available. Groundwater studies are generally more informative than computer modeling and therefore could help to alleviate the Department s concerns. Please contact Shaun Peterson, at (518) , if you have any questions regarding this letter. Sincerely, Scott Menrath Scott Menrath, P.E. Director Bureau of Pest Management