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dimethenamid-P NYS DEC Letter - Registration of New Active Ingredient 11/03

New York State Department of Environmental Conservation
Division of Solid and Hazardous Materials

Bureau of Pesticides Management, 9th Floor
625 Broadway, Albany, New York 12233-7254
Phone: (518) 402-8788     FAX: (518) 402-9024
Website: www.dec.state.ny.us

November 6, 2003

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Ms. Judy Fersch
State Registration Specialist
BASF Corporation
P.O. Box 13528
Research Triangle Park, North Carolina 27709-3528

Dear Ms. Fersch:

Re: Registration of the New Active Ingredient (NAI) Dimethenamid-P Contained in the Pesticide Products Outlook®' Herbicide (EPA Reg. No. 7969-156) and G-Max Lite™ Herbicide (EPA Reg. No. 7969-200)

The New York State Department of Environmental Conservation (Department) has completed review of the applications (received 03/14/03) and supplemental information supplied to date regarding registration of the referenced products in New York State. Outlook® Herbicide (EPA Reg. No. 7969-156) and G-Max Lite™ Herbicide (EPA Reg. No. 7969-200) contain the new active ingredient (NAI) dimethenamid-P: (S)-2-chloro-N-[(1-methyl-2-methoxy)ethyl]-N-(2,4-dimethyl-thien-3-yl)-acetamide.

The Department hereby accepts Outlook® Herbicide (EPA Reg. No. 7969-156) and G-Max Lite™ Herbicide (EPA Reg. No. 7969-200) for registration as "Restricted Use" pesticide products in New York State. The New York State stamped "ACCEPTED" labels for Outlook® (coded NVA 2002-04-086-0137) and G-Max Lite™ (coded NVA 2003-04-183-0234) bear text which prohibits sale, distribution, or use in Nassau and Suffolk counties in New York State. A synopsis of the review follows.

Outlook® Herbicide is an emulsifiable concentrate containing 63.9.% dimethenamid-P or 6.0 pounds active ingredient per gallon. Product is labeled as a selective preemergence herbicide for controlling annual grasses, annual broadleaf weeds, and sedges in field corn, popcorn, seed corn, sweet corn, soybean, grain sorghum, peanut, dry bean crops and grass grown for seed. The Restrictions and Limitations section of the labeling bears the statement, "Do not apply more than a total of 21 fluid ounces of Outlook® herbicide per acre, per season." This is equivalent to a maximum of 0.98 pounds dimethenamid-P/acre/season.

G-Max Lite™ Herbicide is an emulsifiable concentrate containing 24.1% dimethenamid-P and 29.5% atrazine or 2.25 pounds and 2.75 pounds active ingredient per gallon, respectively. Product is labeled as a selective preemergence herbicide for controlling most annual grasses, many annual broadleaf weeds, and sedges in field corn, seed corn, sweet corn, popcorn, and grain sorghum. G-Max Lite™ Herbicide is classified as a federally RESTRICTED USE PESTICIDE due to ground and surface water concerns. The Restrictions and Limitations section of the labeling bears the statement, "Do not apply more than a total of 3.5 pints of G-Max Lite™ herbicide per acre, per season." This is equivalent to a maximum of 0.98 pounds dimethenamid-P and 1.20 pounds atrazine per acre, per season. There are also "prior to and after crop emergence (sequential applications)" restrictions when tank mixing or making sequential applications with atrazine.

The registration package was deemed complete for purposes of technical review on May 8, 2003. However, the completeness letter notified BASF Corporation that failure to submit validated analytical methodologies for measuring dimethenamid-P and its major degradates in water and soil could result in an unfavorable registration decision. Water and soil residue methods (received 07/07/03) were deemed complete/acceptable on August 22, 2003. Pursuant to the review time frame specified in Environmental Conservation Law (ECL) §33-0704.2, a registration decision date of October 5, 2003 was established.

By mutual agreement, the registration decision date was subsequently waived to October 31, 2003 in order to accomodate: 1) preparation and review of revised Outlook® Herbicide labeling per the United States Environmental Protection Agency (USEPA) stamped label, dated June 18, 2003 and 2) preparation and review of revised G-Max Lite™ Herbicide labeling (received 10/30/03) per USEPA stamped label and comment letter, dated October 27, 2003. Product labeling was updated per USEPA requested spray drift language, USEPA mandated atrazine language and to clarify Long Island prohibition text.

Toxicological, ecological and environmental fate risk assessments were conducted for dimethenamid-P and the Outlook® and G-Max Lite™ end-use products.

TOXICOLOGICAL RISK ASSESSMENT: Dimethenamid, which is a racemic mixture (50/50 ratio) of s-dimethenamid and r-dimethenamid, was previously reviewed in the pesticide product Frontier Herbicide; this product was subsequently registered (reference correspondence from N. Nosenchuck to S. White/BASF Corp., dated May 15, 1997). According to the cover letter accompanying the current application, the herbicidal activity of dimethenamid is mainly attributable to the s-dimethenamid isomer. Consequently, the application rate of s-dimethenamid in the Outlook® and G-Max Lite™ products is about two-thirds that of the racemic dimethenamid in the Frontier product.

In order to determine whether s-dimethenamid has similar toxicological properties to those of the racemic mixture, the registrant was required to conduct several "bridging" studies. The bridging studies that were required are the battery of acute toxicity studies, a 90-day study in rats, a rat developmental toxicity study and several genotoxicity studies. The results of these studies indicate that both s-dimethenamid and the racemic mixture caused very similar effects at comparable dose levels. Accordingly, the results of these "bridging" studies in conjunction with the previously reviewed toxicological studies for the racemic mixture in Frontier Herbicide provide a basis to review both the Outlook® and G-Max Lite™ products.

On an acute basis, Outlook® Herbicide was not very toxic to laboratory animals by the oral, dermal or inhalation routes of exposure. It also was not very irritating to rabbit skin. However, it caused weak dermal sensitization (tested on guinea pigs) and was a moderate eye irritant (tested on rabbits). According to the registrant, the United States Environmental Protection Agency (USEPA) granted a waiver for the battery of acute toxicity studies for G-Max Lite™ Herbicide. The acute toxicity studies on s-dimethenamid showed that this active ingredient, while moderately toxic by the oral route of administration, was not very acutely toxic by either the dermal or inhalation exposure routes. This chemical also was not very irritating to rabbit skin or eyes. It, however, was a skin sensitizer (tested on guinea pigs).

Racemic dimethenamid caused some effects in laboratory animals in chronic feeding studies. The USEPA Office of Pesticide Programs established a reference dose (RfD) for dimethenamid, and now for dimethenamid-P, of 0.05 milligrams per kilogram body weight per day (mg/kg/day) based on a no-observed-effect level (NOEL) of 5.1 mg/kg/day from a two-year rat chronic feeding/oncogenicity study and using an uncertainty factor of 100. This RfD value has not yet been placed in USEPA's Integrated Risk Information System (IRIS).

The USEPA recently reevaluated the issue of dimenthamid's oncogenic properties and maintained the classification of this chemical as a Group C carcinogen (possible human carcinogen). This classification is based on the occurrence of a slight increase in liver tumors observed only in male rats at the highest dose tested (maximum tolerated dose). The USEPA determined that a quantitative cancer risk assessment was not required and, consequently, a cancer potency slope factor was not calculated.

The USEPA established a tolerance for the residues of dimethenamid in or on corn (fodder, grain, sweet), peanuts, grain sorghum, dry beans and soybeans at 0.01 parts per million for each of these crops. The USEPA estimated that chronic dietary exposure to these residues would be less than 1.0 percent of the RfD for both the general U.S. population and non-nursing infants less than one year old. This chronic exposure analysis is based on the assumption that 100 percent of crops are treated and contain tolerance level residues. This analysis was deemed to be valid for s-dimethenamid as well.

The registrant submitted an occupational risk assessment for workers involved in the mixing/loading/application of either Outlook® Herbicide or G-Max Lite™ Herbicide. For workers wearing long-sleeved shirt, long pants and gloves (required by the product label), margins of exposure (MOEs) for combined short-term dermal and inhalation exposures ranged from about 220 to 560. These MOEs were based on a daily application rate of 0.98 pounds (445 grams) active ingredient per acre by ground boom from an open cab to 200 or 80 acres, respectively. A dermal absorption of 26 percent was also assumed. The NOEL used in estimating the MOEs was ten mg/kg/day, apparently from a chronic dog study. A more appropriate NOEL to use in estimating MOEs for short-term exposures to s-dimethenamid might be 25 mg/kg/day from the rat developmental toxicity study. Using this NOEL and a dermal absorption factor of 26 percent, the MOEs would range from about 550 to 1,400. In either case, these estimated MOEs are greater than the 100-fold level generally considered acceptable by the USEPA for worker risks.

The New York State Department of Health (NYSDOH) briefly reviewed the environmental fate data on s-dimethenamid. These data indicate that this chemical has the potential to leach through certain soil types and contaminate groundwater; the adsorption coefficients (Koc), depending on soil type, were reported to range from 110 to 609. These values suggest that s-dimethenamid has a high mobility through some soils. The Outlook® and G-Max Lite™ labels contain the Environmental Hazards statement: "Dimethenamid-P has properties that may result in groundwater contamination. Application in areas where soils are permeable or coarse and groundwater is near the surface could result in groundwater contamination."

There are no chemical specific federal or State drinking water/groundwater standards for s-dimethenamid. Based on its chemical structure, s-dimethenamid falls under the 50 microgram per liter (ug/L) general New York State drinking water standard for an "unspecified organic contaminant" (10 NYCRR Part 5 - Public Water Systems). According to USEPA procedures for calculating maximum contaminant level goals for Group C carcinogens (Federal Register 55: 30374-5, July 25, 1990), s-dimethenamid would have a maximum contaminant level goal of 35 ug/L. In accord with the 6 NYCRR Part 702.4 procedures for deriving ambient water quality standards and guidelines based on oncogenic effects, the ambient water value would be five ug/L, using the dose-response data for combined benign and malignant liver tumors from the two-year rat feeding study.

The available information indicates that the Outlook® and G-Max Lite™ products are not very acutely toxic, although they have the potential to cause eye irritation and some skin sensitization. To reduce the risk of these adverse health effects, the labels of both products require the use of personal protective equipment including protective eyewear, chemical-resistant gloves and long-sleeved shirt and pants. While s-dimethenamid caused some toxicity and is expected to have some oncogenic potential, a reduced risk rationale for s-dimethenamid submitted by the registrant indicates that the alternative active ingredients are overall no less toxic than s-dimethenamid, particularly in regard to oncogenic properties. Furthermore, the application rates for the alternative products exceed that for the Outlook® and G-Max Lite™ products. Also, racemic dimethenamid is currently registered in the State as Frontier Herbicide and, given the lower application rates of the Outlook® and G-Max Lite™ products, their registration could reduce the overall use of dimethenamid. This reduction in application rate should in turn reduce potential exposure to workers and the general public, as well as decrease loading to the environment. The issue of groundwater/drinking water contamination potential posed by s-dimethenamid in vulnerable areas of the State has been addressed for these products by the label statement, "The New York State Department of Environmental Conservation prohibits use in Long Island, NY." Given the above, NYSDOH did not object to the labeled use of Outlook® Herbicide and G-Max Lite™ Herbicide in New York State provided that the Department determined that adequate measures have been taken to protect groundwater/drinking water in upstate New York.

ECOLOGICAL RISK ASSESSMENT:

CHEMICAL DESCRIPTION: Outlook® and G-Max Lite™ are preemergence (and early postemergence) herbicides to control grasses and broadleaf weeds in corn (field, pop, seed, and sweet), dry bean, grass grown for seed, peanut, grain sorghum, and soybean crops. Outlook® contains 64% dimethenamid-P, and G-Max Lite™ contains 24% dimethenamid-P and 30% atrazine. Both products are applied at a maximum seasonal application rate of 0.98 lbs ai/acre (the corresponding maximum application rate of atrazine is 1.21bs/acre).

Dimethenamid was originally reviewed by the Bureau of Habitat (BoH) in 1995-1997 as the active ingredient in the herbicide Frontier. The BoH was originally opposed to registration of Frontier because dimethenamid was found to be somewhat mobile, persistent in water, and extremely toxic to nontarget aquatic macrophytes exposed via runoff from treated fields, as represented by duckweed (Lemna ibba). The registrant worked with the BoH to develop and conduct a microcosm test that looked at plant recovery after a short-tern exposure to dimethenamid. The results of the microcosm test showed that not only did aquatic macrophytes recover after a short-tern exposure, the overall growth of exposed plants was indistinguishable from the control plants within three to six weeks after the exposure. Long-term impacts to aquatic macrophytes from exposure to dimethenamid from runoff were considered to be very unlikely.

The original formulation of dimethenamid was a racemic (50/50) mixture of s- and r-stereoisomers. The herbicidally-active stereoisomer is the s-dimethenamid stereoisomer. Dimethenamid-P is a purified formulation that is approximately 95% s-stereoisomer. Outlook® and G-Max Lite™ are applied at a lower application rate than Frontier (0.98 lbs ai/acre vs. 1.5 lbs ai/acre) because of the higher concentration of the herbicidally-active stereoisomer.

MODEL PARAMETERS: The significant data variables used in the BoH Pesticide Screening System (PSS) models are as follows: water solubility 1,449 mg/L (ppm), aqueous photolysis half-life (T1/2) = 25.7 days, anaerobic aquatic metabolism T1/2= 36 days, soil photolysis T1/2 = 44.7 days, aerobic soil metabolism T1/2= 31 days, anaerobic soil metabolism T1/2= 54 days, field dissipation T1/2= 18 days. No Kow for dimethenamid-P was provided, so a value of one was entered. Multiple applications of Outlook® and G-Max Lite™ are allowed on the label. However, the applications must be made fairly close together because these are preemergence herbicides. The correct application rate is dependent upon the organic carbon content and cation exchange capacity (CEC) of the treated soil. Rather than model single application scenarios, PSS models evaluated a single application at the maximum seasonal application rate of 0.98 lbs dimethenamid-P/acre. Since these products are preemergence herbicides, they are typically applied to bare ground. No allowance was given for foliar intercept in the aquatic runoff modeling.

MODEL RESULTS: The PSS AVTOX and MAMTOX models showed that when applied at the maximum seasonal application rate, treatments of Outlook® and G-Max Lite™ are unlikely to harm birds or mammals. The PSS PONDTOX model showed that in both direct application and runoff scenarios, neither herbicide would be harmful to freshwater fish, freshwater invertebrates, or marine/estuarine fish or invertebrates. However, significant impacts were noted for the nontarget aquatic plants. Green algae (Selenastrum capriconutum) was selected as the representative algae because it was the most sensitive of the four algae families for which data were available. All algae are very sensitive to dimethenamid-P. Because of the low Kow, PONDTOX selects one percent, three percent, and five percent as the percentages of total applied herbicide likely to be dissolved in runoff. At the five percent runoff rate, both LC50s and NOECs were exceeded for green algae and aquatic macrophytes at all pond depths. Data were provided for green algae, blue-green algae, freshwater diatoms, marine diatoms, and aquatic macrophytes. At the one percent runoff rate, the green algae LC50 was not exceeded in three-foot and six-foot pond depths and the aquatic macrophyte LC50 was not exceeded in the six-foot pond depth. All other risk thresholds were exceeded. At a runoff rate of 0.125%, the green algae and aquatic macrophyte NOECs were marginally exceeded only in the one-foot pond depth.

MODEL ANALYSIS: The models clearly show that when applied at the maximum seasonal rate, applications of Outlook® and G-Max Lite™ have the potential to harm nontarget aquatic macrophytes and algae. Dimethenamid-P was classified by the USEPA as moderately mobile in soil, suggesting that the appropriate runoff rate is between one to three percent. However, harmful impacts to nontarget plants were noted at runoff rates well below one percent. No harmful impacts were noted to mammals, birds, fish, or invertebrates.

RISK ASSESSMENT: Dimethenamid-P is a highly potent herbicide that clearly has the potential to be harmful to nontarget aquatic plants, even in the reduced concentrations likely to occur in runoff. The active ingredient is moderately mobile in soil, and very soluble. The field dissipation rates of dimethenamid-P ranged from half-lives of eight to 43 days, with a geometric mean of around 18 days. This indicates that dimethenamid-P is likely to remain available on treated fields for long enough a period of time that it is likely a precipitation event will occur before the substance can dissipate. Some impact to nontarget aquatic plants in water bodies adjacent to treated fields is anticipated.

MITIGATION/ALTERNATIVES: As stated above, when Frontier with the racemic dimethenamid was originally submitted for registration, BoH objected because of the high likelihood of harmful impacts to nontarget aquatic plants. The registrant worked with BoH to develop a microcosm test that examined the long-term impacts to aquatic plants from exposure to dimethenamid. The study showed that at the highest concentration tested, 0.044 mg/L (a concentration approximately equivalent to runoff at the five percent rate into a three-foot deep pond), the plant growth as measured by stem length was inhibited about 22% compared to the controls. However, during the recovery phase of the study, the plants showing the greatest inhibition fully recovered and their overall average growth was the same as that of the controls. No other impacts, including chlorosis or necrosis, were noted. The microcosm test showed that dimethenamid might reduce plant growth for a short period of time immediately after a runoff event, but no lasting damage or harm was likely to result. Also, because the dimethenamid-P products are preemergence, dimethenamid will only occur in runoff for a short period of time.

ENVIRONMENTAL FATE RISK ASSESSMENT: Dimethenamid-P is also known as s-dimethenamid. It is replacing the 50:50 r/s dimethenamid mixture. S-dimethenamid is the herbicidally active isomer and the purified mixture of 95% s-dimethenamid and 5% r-dimethenamid. The application rate of the new products is lower, but they contain more of the herbicidally active isomer. Outlook® Herbicide contains 63.9% dimethenamid-P by weight (or six lb/gal) and is labeled for weed control in field, seed, pop and sweet corn, soybeans, dry beans and lentils. The maximum application rate is 21 oz Outlook®e/a/yr, or 0.984 lb dimethenamid-P/a/yr. The label contains text prohibiting the use of this product on Long Island, NY. The product contains 21.75% petroleum distillates.

G-Max Lite™ Herbicide contains 24.1 % dimethenamid-P by weight (or 2.25 lb/gal) and 29.5% atrazine by weight (or 2.75 lb/gal) and is labeled for weed control in field, seed, pop and sweet corn, and sorghum (grain). The maximum application rate is 3.5 pints product/a/yr, or 0.9841b dimethenamid-P/a/yr and 1.2 lb atrazine/a/yr. The label contains text prohibiting the use of this product on Long Island, NY. This product is classified by the USEPA as a RESTRICTED USE PESTICIDE due to Ground and Surface Water Concerns. The inerts do not appear to be solvent carriers.

Solubility: P-dimethenamid is highly soluble at 1,174 + 12 ug/mL (ppm).

Hydrolysis: USEPA found this study scientifically valid. Dimethenamid-P was hydrolytically stable in pH 5, 7, and 9 aqueous buffer solutions.

Aqueous Photolysis: This study did not meet Subdivision N Guidelines. The registrant-calculated half-life was 25.7 days with four minor degradates. Although the study did not meet Subdivision N Guidelines, USEPA stated that photodegradation in water was not expected to be a major route of degradation.

Soil Photolysis: USEPA found this study acceptable. Dimethenamid-P degraded with a half-life of 44.7 days in Elliot clay loam soil with five minor degradates. R,S-dimethenamid degraded with a half-life of 29.9 days in Elliott clay loam soil with five minor degradates. Aerobic Soil Metabolism: USEPA found this study acceptable. This study was a comparison of s-dimethenamid and r/s dimethenamid. S-dimethenamid degraded with a linear half-life of 31 days. R,S-dimethenamid degraded with a half-life of 30 days. Six minor degradates were noted. Oxalamide is one of the six, found at < eight percent. The oxalamide degradate was >14% in the original r/s dimethenamid aerobic metabolism study.

Adsorption/Desorption: USEPA found these studies acceptable. In U.S. soils, dimethenamid-P had adsorption Kocs in clay (pH 8.0), clay loam (pH 6.4), sandy loam (pH 7.0), silt loam (pH 6.7), and loam (pH 7.3), of 212, 105, 247, 396 and 129, respectively. Dimethenamid-P had desorption Kocs 328, 139, 319, 401, and 138, respectively. In European soils, dimethenamid-P had adsorption Kocs in sandy clay loam (pH 5.6), clay loam (pH 8.0), sandy loam (pH 5.5), silt loam (pH 6.6), and sand (pH 3.9), of 474, 123, 90, 101, and 393 respectively. Dimethenamid-P had desorption Kocs of 596, 118, 110, 215, and 609, respectively.

Terrestrial Field Dissipation: Field dissipation studies performed with the r/s dimethenamid mixture showed half-lives ranging from eight to 42 days.

Label Language: The Outlook® and G-Max Lite™ labels bear extensive text under the Environmental Hazards statement indicating that dimethenamid-P has properties that may result in ground and surface water contamination. G-Max Lite™ herbicide is a federal RESTRICTED USE PESTICIDE due to ground and surface water concerns associated with the active ingredient atrazine. Label text indicates that atrazine can leach through soil and has been found to result in contamination of water supplies by way of ground water.

NYSDOH Comments: The NYSDOH indicated that there are no chemical specific federal or State drinking water/groundwater standards for s-dimethenamid. Based on its chemical structure, s-dimethenamid falls under the 50 microgram per liter (ug/L) general New York State drinking water standards for an "unspecified organic contaminant" (10 NYCRR Part 5 - Public Water Systems). According to USEPA procedures for calculating maximum contaminant goals for Group C carcinogens (Federal Register _55: 30374-5, July 25, 1990), s-dimethenamid would have a maximum contaminant level goal of 35 ug/L. In accordance with the NYCRR Part 702.4 procedures for deriving ambient water quality standards and guidelines based on oncogenic effects, the ambient value would be five ug/L, using the dose-response data for combined benign and malignant liver tumors from the two-year rat feeding study.

USEPA Comments: Based on the moderate persistence and laboratory-derived mobility parameters of dimethenamid-P, it has high potential to move from the application site to groundwater or surface water. However, due to the lower application rate (relative to the racemic mixture), this contamination should be lower than that expected from the currently registered mixture.

Computer Modeling: The Department's groundwater model (LEACHM) was run using a Koc of 110 (for European loamy sand, which has a pH closest to Riverhead), a half-life of 31 days and the maximum application rate of 0.984 lb dimethenamid-P/a/yr. The model projected irregular peaks between 0.3 and 0.6 ppb.

Summary: Given the above, Engineering Geology staff were reluctant to support the registration of this new active ingredient without requiring a groundwater monitoring program as a condition of registration. In a subsequent review, Engineering Geology staff withdrew their objection to the registration of Outlook® and G-Max Lite™ herbicides since dimethenamid is already registered for use in upstate New York at a higher application rate and the use of the new dimethenamid-P products could result in a net reduction in use of this active ingredient.

DISCUSSION: The registrant has demonstrated that dimethenamid-P and the old form of dimethenamid (Frontier) have equivalent physiochemical properties. The Department's review of Frontier' Herbicide expressed a concern for groundwater/drinking water contamination in sandy soil conditions such as exist on Long Island. To address this concern, Frontier was registered with a Long Island prohibition statement.

Acknowledging the Department's previous concerns regarding the potential for dimethenamid to impact groundwater on Long Island, the registrant modified the federal labels for Outlook® and G-Max Lite™ prior to submission of the subject applications. Product labeling for both products contained the statement, "The New York State Department of Environmental Conservation prohibits use in Long Island, NY." Per the Department's request, the registrant revised the federal label and final product labeling for Outlook® and G-Max Lite™ to prohibit sale, distribution, or use in Nassau and Suffolk counties in New York State.

There are a number of remaining concerns regarding use of dimethenamid products in upstate New York. The potential for dimethenamid-P and its degradates to adversely impact groundwater/drinking water resources in New York State cannot be discounted. Outlook® and G-Max Lite™ labeling contain extensive text indicating that dimethenamid-P has the properties that may result in ground and surface water contamination. The FIFRA Sec. 3(c)(7)(C) conditional registration of BAS 656 03 H (Outlook®' Herbicide), dated May 10, 1999, specified certain data/studies, including a Small Scale Prospective Monitoring Groundwater Study, which were due by March 31, 2003. In September 2002, BASF Corp. submitted "A Prospective Groundwater Study Waiver Rational and Environmental Fate Summary for dimethenamid-P." To date, USEPA has not reviewed the waiver request.

Given the lower application rates of the Outlook® and G-Max Lite™ products, their registration could reduce the overall use of dimethenamid. The registrant has indicated that products containing dimethenamid-P will replace dimethenamid (Frontier). In order to track this changeover and to ensure more accurate reporting of dimethenamid sales and use under the Pesticide Reporting Law (PRL), Outlook®, G-Max Lite™, and Frontier will be classified "Restricted Use" in New York State. In addition, dimethenamid and its significant degradates will continue to be monitored in upstate New York by the United States Geological Survey in their "Water Quality Monitoring for Pesticides" program.

REGISTRATION ACTION: The Department hereby accepts Outlook® Herbicide (EPA Reg. No. 7969-156) and G-Max Lite™ Herbicide (EPA Reg. No. 7969-200) for registration as "Restricted Use" pesticide products in New York State. The acceptable Outlook® (coded NVA 2002-04-086-0137) and G-Max Lite™ (coded NVA 2003-04-183-0234) labels bear text which prohibits sale, distribution, or use in Nassau and Suffolk counties in New York State. Enclosed for your files are the Certificate of Pesticide Registration and New York State stamped "ACCEPTED" labeling.

Outlook® Herbicide and G-Max Lite™ Herbicide, as noted in the "RESTRICTION" column on the Certificate, are classified as "Restricted Use" under rules and regulations 6 NYCRR Part 326.23(e) and 6 NYCRR Part 326.2(e), respectively. As such, these products are restricted in their 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 Thomas Lynch, Chief, Pesticide Certification Section, at (518) 402-8748.

The 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. Information relating to the PRL or annual report forms is available at the Department's website at http://www.dec.state.ny.us or from the Pesticide Reporting Section, at (518) 402-8765.

Please note that a proposal by BASF Corporation, or any other registrant, to register a product containing dimethenamid-P, whose labeled uses are likely to increase the potential for significant exposure to humans or impact to 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 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.

Sincerely,

Maureen P. Serafini
Director
Bureau of Pesticides Management

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