New York State Department of Environmental Conservation

Transcription

1 New York State Department of Environmental Conservation Division of Solid & Hazardous Materials th Bureau of Pesticides Management, 11 Floor 625 Broadway, Albany, New York Phone: FAX: Website: July 29, 2008 Alexander B. Grannis Commissioner CERTIFIED MAIL RETURN RECEIPT REQUESTED Mr. John Pazdera International Paint, LLC 2270 Morris Avenue Union, New Jersey Dear Mr. Pazdera: Re: Registration of Trilux 44 Antifouling Paint White (EPA Reg. No ) Which Contains the New Active Ingredient Tralopyril (Chemical Code ) The New York State Department of Environmental Conservation (Department) has reviewed your application and data package, received November 2, 2007, with additional information submitted January 25, 2008, to register the pesticide product Trilux 44 Antifouling Paint White (EPA Reg. No ) in New York State. This pesticide product contains the new active ingredient tralopyril and is labeled for use as a marine antifouling paint in commercial or government shipyards only. Trilux 44 also contains the currently registered active ingredient zinc pyrithione. The New York State Department of Health (DOH), the Department s groundwater staff, and the Department s Bureau of Habitat (BOH) have reviewed the information submitted to date in support of the application for registration of Trilux 44 Antifouling Paint White. Toxicological Risk Assessment: DOH reviewed the application and supporting data submitted by International Paint, LLC to register the pesticide product Trilux 44 Antifouling Paint White in New York State. Trilux 44 Antifouling Paint was not very toxic in acute oral, dermal or inhalation exposure studies in laboratory animals. The formulated product was a moderate eye irritant, a mild skin irritant (tested on rabbits) and a skin sensitizer (tested on guinea pigs). DOH concurrently reviewed the toxicological properties of the active ingredient tralopyril for the manufacturing use product ECONEA Technical. Tralopyril was very toxic by the oral route of exposure, and slightly and moderately toxic via the dermal and inhalation routes of exposure, respectively. This chemical was also slightly irritating to eyes and skin, but was not a skin sensitizer. Data from the available subchronic animal studies indicate that tralopyril has the potential to cause some toxicity, including neurotoxicity. This active ingredient was neither genotoxic nor teratogenic. The United States Environmental Protection Agency

2 Mr. John Pazdera 2. (USEPA) did not require chronic animal studies due to the use pattern of the manufacturing use product, ECONEA, and the formulated product, Trilux 44 Antifouling Paint. The USEPA conducted an occupational risk assessment for short- (1-30 days) and intermediateterm (1-6 months) dermal and inhalation exposures to tralopyril from application to boat hulls in commercial shipyards. Exposure scenarios included tralopyril-containing paints being tendered (open pour mixing/loading), applied via an airless sprayer, and brushed or rolled on for touch-up. For determining margins of exposure (MOEs), the USEPA compared estimated combined short- and intermediate-term dermal exposures to a no-observed-effect-level (NOEL) of 1,000 mg/kg/day from the 90-day dermal toxicity study in the rat (lack of systemic toxicity). Combined short- and intermediate-term inhalation exposures for open pour and brush/roller use were compared to an estimated inhalation reference dose of 5.7 mg/kg/day derived from Phase I of the 90-day inhalation toxicity in the rat (local irritation of nasal tissues). Inhalation MOEs for airless spraying were estimated by comparing combined short- and intermediate-term 3 inhalation exposures to a LOEL of 20 mg/m from Phase I of the 90-day inhalation toxicity in the rat. For mixer/loaders open pouring tralopyril to support paint applications, combined short- and intermediate-term MOEs for dermal and inhalation exposures were estimated to be about 222,000 and 950,000, respectively. Short- and intermediate-term MOEs for workers applying tralopyril with a brush or roller were estimated to be about 1,490 for dermal exposures and 6,300 for inhalation exposures. For airless sprayer applications, MOEs for dermal and inhalation exposures were estimated to be about 830 and 400, respectively. These estimates assumed that workers wore the label required personal protective equipment (PPE), including a Tyvek hooded coverall, coveralls beneath the Tyvek outer layer, impervious gloves, impervious footwear that protects the lower legs, and a powered air-purifying respirator (PAPR), except for when applying by brush or roller. The MOE for inhalation exposure for airless spraying applications with the use of a supplied air respirator, a label alternative to PAPR, was estimated to be about 6,000. While the risk assessment assumed a paint concentration of 3.4% tralopyril, and the Trilux product contains 3.9% tralopyril, this discrepancy does not substantially alter the MOEs. The USEPA did not identify any post-application exposures of concern. The USEPA considered MOEs of 100-fold or greater for dermal exposures and 300-fold or greater for inhalation exposures (the additional 3-fold factor was used to account for a lack of a NOEL in the inhalation study) to provide adequate worker protection. There are no chemical specific federal or New York State drinking water/groundwater standards for tralopyril. Based on its chemical structure, tralopyril falls under the 50 microgram per liter ( g/l) New York State drinking water standard for unspecified organic contaminants (10 NYCRR Part 5, Public Water Systems). The available information on the formulated end product Trilux 44 Antifouling Paint indicates that it was not very toxic in acute oral, dermal or inhalation exposure studies in laboratory animals, but was an eye and skin irritant, as well as a dermal sensitizer. The active ingredient tralopyril is very acutely toxic via oral exposure, slightly to moderately toxic via inhalation and dermal exposures, but not irritating to the eyes and skin. Data from subchronic and developmental studies indicate that tralopyril has the potential to cause some local and systemic toxicity, including neurotoxicity. Although tralopyril has some toxic potential, the occupational risk assessment conducted by the USEPA indicates that risks posed by Trilux 44 Antifouling Paint to workers are generally within the range that is considered acceptable. The product label requires considerable PPE (Tyvek hooded coverall, coveralls beneath the Tyvek outer layer, impervious gloves, impervious footwear that protects the lower legs, and an air-purifying respirator) which mitigates risks from exposure to tralopyril during the application of this anti-fouling paint. Exposures of the general public to this chemical are not expected given its use pattern in commercial or government shipyards only. Therefore, DOH does not object to the registration of Trilux 44 Antifouling Paint in New York State.

3 Mr. John Pazdera 3. Environmental Fate Risk Assessment: International Paint, LLC is applying to register this active ingredient for use only in commercial or government shipyards as a marine anti-fouling paint. The product contains 3.9% by weight tralopyril and 4.12% by weight zinc 2-pyridenethiol 1-oxide* (*zinc pyrithione). Tralopyril (R or AC303,268) is a first order major metabolite of chlorfenapyr. It controls hard fouling organisms such as barnacles, mussels, and polychaetes found on the hulls of boats and vessels as well as on marine structures. Tralopyril breaks down rapidly into CL322,250 which further degrades into the debrominated form CL322,248 under certain conditions. The USEPA risk assessment focuses on these two degradation products rather than the parent; both are significantly less toxic than the parent compound. The inerts do not appear to be solvent carriers. Technical Review Solubility: The solubility of tralopyril is 0.16 mg/l. Hydrolysis: (MRID and ) In a study that USEPA said was in accordance with o the guidelines, at 25 C the half-life at ph 5 was 15 days, at ph 7 was 8 hours and at ph 9 was 2 hours. o In seawater at 25 C, the half-life was 3 hours. Degradate CL322,250 does not degrade under any ph or temperature. Aerobic Aquatic Metabolism: (MRID and ) Soil/Water type Parent Half-lives Fresh Water Degradates Fresh Water Water 4.43 days CL322, % Sediment 31 days CL322, % In a silt loam (ph 5.8, %OC 2.5) Parent Half-lives Sea Water Degradates Sea Water 1.95 days CL322, % Unknown B* 19.5% Unable to calculate System 13.5 days 20.5 days CL322, % Unknown B 10.8% In a sandy loam ph 7.7, %OC 0.8 *Unknown B debrominated CL 322,250

4 Mr. John Pazdera 4. Anaerobic Aquatic Metabolism: (MRID ) In a study that USEPA found acceptable: Soil/Water type Half-lives Fresh Water Degradates Fresh Water Water Not provided CL322, % Sediment 71 CL322, % In a silt loam (ph 5.8, %OC 2.5) Half-lives Sea Water Unable to calculate Unable to calculate System 63 Unable to calculate Degradates Sea Water CL322, % CL 325, % CL322, % In a sandy loam ph 7.7, %OC 0.8 Debrominated 322,250 did not decline and was found primarily in the water phase. Adsorption/Desorption: (MRID ) In a study that USEPA found acceptable: Soil ph %OC Adsorption Koc Desorption Koc Sandy loam Silt loam Sand Loam soil (MRID ) In a study that USEPA found acceptable on the adsorption/desorption of the hydrolysis product of the parent: Soil ph %OC Adsorption Koc Desorption Koc Sandy loam Silt loam Sand Loam Adsorption/Desorption CL322,250: In sea water, the adsorption Kocs were and the desorption Kocs were In fresh water, the adsorption Kocs were and the desorption Kocs were

5 Mr. John Pazdera 5. USEPA Comments: USEPA concluded that the parent degrades rapidly to CCL322,250 (parent minus fluorines and remaining carbon hydrated). CL322,250 further degrades by losing a bromine to debrominated CL322,250, only under anaerobic conditions or in sea water. Metabolism studies show CL322,250 and debrominated CL322,250 to be primarily in the water phase, however, mobility data show partitioning to sediments. No mobility data is available for debrominated CL322,250. CL322,250 degrades to CL322,248. Summary: This product is painted onto water craft and marine structures. Given the high Kocs once the product is applied, any active ingredient that leaches out into the water will tend to absorb onto bottom sediments and suspended sediment in the water column and not be available to impact groundwater. Therefore, groundwater staff have no objection to the registration of this product as labeled. Ecological Risk Assessment: The BOH has reviewed the materials submitted in support of the new active ingredient tralopyril and the end use product Trilux 44 Antifouling Paint and has no objection to their registration. Having its use limited to commercial and government shipyards only, plus the rapid tralopyril degradation via hydrolysis, particularly in sea water, mitigate concerns for significant nontarget impacts from this use pattern. This active ingredient is extremely toxic to aquatic organisms and degrades more slowly in fresh water. Any expansion in use which includes application to pleasure boats, especially those that may use brackish or fresh water areas, will require a separate assessment. Conclusion: The Department has accepted Trilux 44 Antifouling Paint White (EPA Reg. No ) for registration as a Restricted Use Pesticide product in New York State. Trilux 44 Antifouling Paint White is classified as Restricted Use due to the fact that the product label requires the use of extensive personal protective equipment (Tyvek hooded coverall, coveralls beneath the Tyvek outer layer, impervious gloves, impervious footwear that protects the lower legs, and an air-purifying respirator) and it s use is limited to commercial or government shipyards only. Enclosed for your files are the Certificate of Pesticide Registration and New York State stamped ACCEPTED labeling. Trulux 44 Antifouling Paint White contains a YES in the RESTRICTION column on the Certificate of Pesticide Registration and is classified as a Restricted Use Pesticide under rules and regulations 6 NYCRR Part 326.2(g). As such, this product is restricted in its purchase, distribution, sale, use and possession in New York State. According to Department regulations specified in 6 NYCRR 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. If you require information regarding a commercial permit, please contact the Pesticide Reporting and Certification Section, at (518) Mr. John Pazdera 6.

6 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. If no sales are made within ew York State, a report still must be filed with the Department indicating this is the case. Information relating to the PRL or annual report forms is available at the Department s website at or from the Pesticide Reporting and Certification Section, at (518) Please note that a proposal by International Paint, LLC or any other registrant to register a product that contains tralopyril, 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 use pattern. Such use would include application to pleasure boats, especially those that use brackish or fresh water areas. If you have any questions, please contact Cyndi Crowley of our Pesticide Product Registration Section, at (518) Sincerely, Maureen P. Serafini Enclosures ecc: w/enc. - A. Grey/E. Horn, NYSDOH R. Mungari, NYS Dept of Ag & Markets W. Smith, Cornell University, PMEP Maureen P. Serafini Director Bureau of Pesticides Management

7

8