Deltamethrin - Registration of Pesticide Products 6/98

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Deltamethrin - Registration of Pesticide Products 6/98

Deltamethrin - Registration of Pesticide Products 6/98

New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials
50 Wolf Road, Albany, New York 12233-7250
Phone 518-457-6934 FAX 518-457-0629

June 26, 1998

Mr. Joseph A. Conti
Director, Regulatory/Toxicology
AgrEvo Environmental Health
95 Chestnut Ridge Road Montvale, NJ 07645

Dear Mr. Conti:

Re: Registration of Pesticide Products Containing the Active Ingredient Deltamethrin:
Vikor Ant Killer (EPA Reg. No. 432-811)
Intercept H&G Insect Control Granules for Lawn and Home Invading Pests (EPA Reg. No. 432-811)
DeltaGard G Insecticide Granules (EPA Reg. No. 432-824)
DeltaGard T&O 5SC Insecticide (EPA Reg. No. 432-834)
DeltaGard GC 5SC Insecticide (EPA Reg. No. 432-835)
DeltaGard T&O Granular Insecticide (EPA Reg. No. 432-836)
DeltaGard G Insecticide Granule (EPA Reg. No. 432-836)
DeltaGard GC Granular Insecticide (EPA Reg. No. 432-837)

This Department has completed the review of your application received on January 27, 1998 to register a major change in labeling for DeltaGard G Insecticide Granules (EPA Reg. No. 432-824) in New York State. We have also completed the review of seven additional products submitted by AgrEvo Environmental Health for registration in New York State. All products contain the active ingredient deltamethrin.

We have determined that the referenced pesticide products are acceptable for registration in New York State. However, because of concerns identified by this Department regarding potential aquatic toxicity, the registration of the referenced products is subject to the conditions set forth in this letter. Specifically, certain products identified in this letter for use on turf may not be applied to areas that border coastal marshes and may not be reapplied within at least 14 days.

BACKGROUND
This Department previously evaluated deltamethrin as a new active ingredient contained in the products RUC 161 (EPA Reg. No. 432-763) and DeltaTech (EPA Reg. No. 432-762). RUC 161 is labeled to control various insect pests in and around residential, industrial and institutional structures and their immediate surroundings and on various modes of transportation. DeltaTech is labeled for formulation into insecticides for these uses. At the conclusion of the review of RUC 161, we determined that deltamethrin was potentially toxic, on an acute and chronic basis, to fish and invertebrates in both fresh and saltwater (reference letter from N. Nosenchuck to J. Stern, dated August 5, 1996). However, because on the limited outdoor use pattern for RUC 161, we concluded that use of the product as labeled would not likely result in adverse impacts to fish and wildlife resources in New York State. Both RUC 161 and DeltaTech were accepted for registration on August 5, 1996. The August 5, 1996 registration letter specified the data which would be needed if AgrEvo Environmental Health intended to apply for additional outdoor uses for deltamethrin in New York State.

An application to register DeltaGard G Insecticide Granules, EPA Reg. No. 432-824 was received from AgrEvo Environmental Health on October 24, 1996. DeltaGard G Insecticide Granules is labeled for outdoor use on home lawns and around other residential buildings to control insects that infest lawns. DeltaGard G Insecticide Granules expanded the outdoor use pattern for deltamethrin by adding broadcast applications to home lawns and should have been identified by AgrEvo Environmental Health as a major change in labeling. (We did not previously evaluate the use of deltamethrin on home lawns during the review of RUC 161 because broadcast use on home lawns was not an indicated use pattern for that product.) The application for DeltaGard G Insecticide Granules was not identified by AgrEvo as a major change in labeling and no supporting data (as specified in the August 5, 1996 registration letter) were submitted with the application. DeltaGard G Insecticide Granules was registered in error by this Department on October 30, 1996 as a new "routine" registration.

On November 18, 1997, this Department initiated proceedings to cancel the registration of DeltaGard G Insecticide Granules in New York State based upon AgrEvo's misclassification of the application type. [Note: It is worth noting that AgrEvo has maintained that there was no misclassification of the application type; that the application to register DeltaGard did not make a major change in the use pattern for the active ingredient; and that DeltaGard met the criteria for registration.] Staff from this Department met with AgrEvo on December 15, 1997 to discuss the issues related to the proposed cancellation and to seek a possible resolution. A resolution was not reached at the December 15, 1997 meeting. AgrEvo subsequently filed an objection to the cancellation action (dated December 15, 1997) and requested that the matter be referred to an advisory committee, and then to an administrative hearing, if necessary.

After several meetings between staff from this Department and AgrEvo, a negotiated settlement was reached. The abbreviated terms of the settlement were as follows:

AgrEvo would temporarily withdraw the request for a hearing and an advisory panel review of the cancellation of DeltaGard G Insecticide Granules until further notice.
AgrEvo would voluntarily suspend distribution/sale of the DeltaGard product in New York State until a review of the product could be conducted. AgrEvo was to inform its customers not to sell or distribute DeltaGard G Insecticide Granules in New York State until further notice.
AgrEvo would submit an application for a major change in labeling for DeltaGard, along with the data necessary to conduct an assessment of potential aquatic impacts.
This Department would not take action on the cancellation of DeltaGard until completion of an ecological assessment by this Department's Division of Fish, Wildlife, & Marine Resources (DFW&MR). If, at the end of the review process, we had determined that the product should not be registered, AgrEvo could re-initiate the request for an advisory panel and hearing on the cancellation.
This Department would review the data and make a completeness determination for DeltaGard within 40 days of receipt of the application. We would begin discussions with AgrEvo on technical issues by April 15, 1998.

The application and supporting data to register a major change in labeling for DeltaGard G Insecticide Granules were received on January 27, 1998. Applications to register other deltamethrin products were received from AgrEvo Environmental Health on February 12, 1998 for Vikor Ant Killer (EPA Reg. No. 432-811), Intercept H&G Insect Control Granules for Lawn and Home Invading Pests (EPA Reg. No. 432-811), Deltagard T&O 5SC Insecticide (EPA Reg. No. 432-834), Deltagard GC 5SC Insecticide (EPA Reg. No. 432-835), Deltagard T&O Granular Insecticide (EPA Reg. No. 432-836) and Deltagard GC Granular Insecticide (EPA Reg. No. 432-837); and on April 8, 1998 for DeltaGard G Insecticide Granule (EPA Reg. No. 432-836). All products were reviewed simultaneously.

ECOLOGICAL ASSESSMENT
The ecological assessment prepared by the DFW&MR for DeltaGard G Insecticide Granules (EPA Reg. No. 432-824) is presented below. The outcome of the review of the other products proposed for registration will be discussed later.

CHEMICAL DESCRIPTION: DeltaGard G Insecticide Granules contain 0.1 % of the active ingredient (AI) deltamethrin, a synthetic pyrethroid insecticide. This product is labeled for use on home lawns and around other residential buildings only. It is used to control ants, armyworms, Bermudagrass mites, adult billbugs, boxelder bugs, centipedes, chiggers, chinch bugs, clover mites, cockroaches, crickets, cutworms, darkling ground beetles, digger wasps, essex skipper, European crane fly larvae, field crickets, fiery skipper, fire ants, flea beetles, fleas, grasshopper, hyperodes, Japanese beetle, lawn moths, leafhoppers, scorpions, silverfish & firebears, sod webworms, sowbugs, spiders, spittlebugs, springtails, ticks, and vegetable weevils. DeltaGard is applied at a rate of two to three pounds per 1,000 ft, which is equivalent to an application rate of 0.13 lb AI per acre, or 59.3 grams per acre.

For flea and tick control, treatments should be applied once a month from May-June to September - October (at most, six monthly applications). For Chinch bug control, the label states: treat "when the temperature reaches 80 ° F, a second treatment may be necessary in six weeks." The application instructions for the majority of the targeted pests includes the statement "retreat when necessary." The label does not specify a minimum time interval between applications, a maximum number of applications, or a maximum seasonal application rate.

The label instructions require that DeltaGard be watered-in when applied. Deltamethrin had an average field dissipation half-life of 57 days. Based on this half-life, the maximum seasonal application rate using the flea and tick control instructions (six applications, at 30 day intervals), the maximum seasonal application rate is 0.42 lbs. A I/acre.

MODEL PARAMETERS: The single and maximum application rates modeled were 0.13 and 0.42 lbs AI per acre. Because deltamethrin is applied to turf, it is assumed that 30% of the runoff water in the AQUALIFE model would reach the pond water.

MODEL RESULTS: (see worksheets enclosed) NOTE: The term "percentage of runoff' refers to the percentage of the volume of active ingredient applied to a ten acre field transported off the field by a runoff event.

At the single and maximum application rates, deltamethrin did not exceed any freshwater acute toxicity thresholds.

At the single and maximum application rates, deltamethrin exceeded the mysid shrimp LC50 and acute No Observed Effects Concentration (NOEL) in all three pond depths (one foot, three feet, and six feet) at all three percentages of runoff (0.25%, 0.5%, and 1.0%). Deltamethrin exceeded the sheepshead minnow LC50 and acute NOEC in the one- and three-foot deep ponds at all three percentages of runoff.

At the single and maximum application rates, deltamethrin exceeded the fathead minnow and Daphnia magna chronic Lowest Observed Effects Concentration (LOEC) and chronic NOEC in all three pond depths at all three percentages of runoff, except the fathead minnow LOEC was not exceeded in the six foot pond depth at any percentage of runoff.

MODEL ANALYSIS: No avian or mammalian concerns were identified for DeltaGard. The labels require that the granules be watered in upon application, and the manufacturer submitted data showing that the granules would dissolve in 2.5 - 16 minutes. It is highly unlikely that birds or mammals would be able to consume granules, and the residues on treated vegetation did not exceed toxicity thresholds.

The AQUALIFE model shows that deltamethrin, when used as labeled, is not likely to be acutely toxic to aquatic life, based on the bluegill, rainbow trout, and Daphnia magna data reviewed. Deltamethrin does appear, however, to be highly toxic to both marine fish and invertebrates. Deltamethrin has the potential to be chronically toxic to freshwater fish and invertebrates.

A microcosm study completed by AgrEvo showed that deltamethrin would degrade in water in one to two days, even though the laboratory study-based fate data showed much higher half lives. AgrEvo also conducted a mesocosm study with a different active ingredient, tralomethrin. Deltamethrin is a degradation product of tralomethrin. In water, tralomethrin degraded rapidly to deltamethrin, and the deltamethrin then degraded with a half-life in one to two days. The degradation of both tralomethrin and deltamethrin was substantiated by the mesocosm study. During the mesocosm study, test ponds were dosed every week for ten weeks by direct application, simulating spray drift. The ponds were also treated every other week with a simulated runoff slurry. Water samples were taken approximately an hour after dosing, and before the next dose was applied. The difference in concentration between a post-dose water sample and the next pre-dose water sample shows the degradation of the combined concentration of tralomethrin, deltamethrin, and trans-deltamethrin, another tralomethrin degradation product. These samples show that deltamethrin either degraded or sorbed to bottom sediments where they were biologically unavailable during the seven days between test applications. Sediment samples showed that deltamethrin did accumulate in sediment before being degraded. The extent of the accumulation was difficult to evaluate because runoff applications were simulated by the addition of pesticide-treated soil. The deltamethrin in the surficial sediments degraded as the mesocosm study progressed.

Because of the degradation and soil sorption of the compound, it is unlikely that deltamethrin would be biologically available long enough in the aquatic environment to cause chronic toxicity.

RISK ASSESSMENT: DeltaGard G Insecticide Granules, applied as labeled, does not appear to present a hazard for acute toxicity to aquatic life exposed via runoff. While this product exceeds chronic toxicity thresholds, the degradation of deltamethrin in water has been shown to occur before chronic toxicity would be likely to occur. Deltamethrin is highly acutely toxic to marine fish and invertebrates, particularly those found in coastal marshes. DeltaGard does not appear to cause harm to aquatic life when used as labeled. However, the ambiguous labeling which states "retreat as necessary," without specifying the number of re-application, time interval between applications, or maximum seasonal or annual application rate, could allow DeltaGard to be applied in a manner that could result in harm to aquatic life exposed via runoff. The tralomethrin mesocosm study that was submitted by AgrEvo showed that the average total concentration of tralomethrin, trans-deltamethrin, and deltamethrin immediately following the simulated spray drift application was 0.036 ,ug/l, and that this concentration, repeated ten times during the study, caused significant ecological impacts. The AQUALIFE model estimates that a deltamethrin water concentration of 0.040 ,ug/l following a runoff event is a reasonable expectation. These data suggest that if deltamethrin were repeatedly reapplied during a period of time that experienced frequent rainfall events, ecological damage to a water body adjacent to a treated lawn or turf area could result. For that reason, more specific limitations on the re-application of deltamethrin need to be specified.

ISSUES/MITIGATION:
As stated above, we are concerned that the repeated use of DeltaGard G Insecticide Granules over a period of time may cause significant ecological impacts to a water body adjacent to a treated lawn or turf area. Staff from this Department and AgrEvo have discussed these concerns and were able to reach an agreement on how the concerns could be mitigated. AgrEvo agreed to add statements to the label of each product, as applicable, prohibiting use on turf areas that border coastal marshes and specifying the interval between applications (14 days).

The discussion which follows summarizes the concerns/issues that were identified by this Department for each product, and the mitigative actions that were taken by AgrEvo to address our concerns:

1. DeltaGard G Insecticide Granules (EPA Reg. No. 432-824): Description: See above. Issue: DeltaGard G Insecticide Granules is potentially toxic to marine and estuarine fish and invertebrates. Coastal marshes are the most vulnerable marine waters because they are nursery habitat for a large number of species. The impacts to marine and estuarine fish and invertebrates could be mitigated by not allowing DeltaGard to be applied to lawns that directly border coastal marshes. The other problem with the DeltaGard label is the ambiguous label directions that state "retreat as necessary." If the appropriate limitations regarding possible repeat treatments were specified, the concern would be mitigated. Mitigation: AgrEvo has added the following use restrictions to the label: "In New York State, this product may not be applied to lawns that directly border coastal marshes." AND "For control of insects other than fleas and ticks in New York State, a second application may be made after two weeks if target insect activity persists." General use registration granted.

2. Vikor Ant Killer (EPA Reg No. 432-811): Description: This product is labeled strictly for ants, and is limited to a spot treatment application on nests or mounds only. Issue: There are no concerns regarding use of this product as labeled. Mitigation: No conditions on the registration of this product. General use registration granted.

3. Intercept H&G Insect Control Granules (EPA Reg No. 432-811): Description: This product allows for applications to lawns exactly the same as DeltaGard G Insecticide Granules. Issue: Because of potential toxicity to marine/estuarine fish and invertebrates, this Department concluded that this product requires a statement on the label prohibiting application to turf areas that border coastal marshes. Furthermore, this label contains the same ambiguous language regarding re-applications (i.e. "Re-treat as necessary"). The label must be modified to provide more specific information about the maximum number of applications, interval between repeat applications, or the maximum seasonal application rate. Mitigation: AgrEvo has added the following use restrictions to the label: "In New York State, this product may not be applied to lawns that directly border coastal marshes." AND "For control of insects other than fleas and ticks in New York State, a second application may be made after two weeks if target insect activity persists." General use registration granted.

4. DeltaGard T&O 5SC Insecticide (EPA Reg No. 432-834): Description: This product is a liquid suspension concentrate. It contains 0.42lbs AI (deltamethrin)/gallon. The application rate is slightly less than DeltaGard G Insecticide Granules. It is applied to commercial and residential turf and ornamental plants. Issue: Because of potential toxicity to marine/estuarine fish and invertebrates, this Department concluded that this product requires a statement on the label prohibiting application to lawns that border coastal marshes. Furthermore, this label contains the same ambiguous language regarding re-applications (i.e. "Re-treat as necessary"). The label must be modified to provide more specific information about the maximum number of applications, interval between repeat applications, or the maximum seasonal application rate. The additional treatment language for fire ant suppression is satisfactory. For very large turf areas such as parks, athletic fields, and recreational areas, the label must prohibit the use of DeltaGard T&O 5SC Insecticide within 100 feet of a coastal marsh or a stream that drains directly into a coastal marsh. Mitigation: AgrEvo added the following use restrictions to the label: "In New York State, this product may not be applied to turf within 100 feet of a coastal marsh or a stream that drains directly into a coastal marsh." AND "For control of turf insects in New York State, a second application may be made after two weeks if target insect activity persists." General use registration granted.

5. DeltaGard™ GC 5SC Insecticide (EPA Reg No. 432-835): Description: This product is a liquid suspension concentrate. It contains 0.42 Ibs AI(deltamethrin)/gallon. The application rate is slightly less than DeltaGard granules. It is applied to golf courses, sod farms parks, athletic fields, and recreational areas. Issue: Because of potential toxicity to marine/estuarine fish and invertebrates, this Department concluded that this product requires a label statement prohibiting application to turf areas such as golf courses, sod farms, parks, athletic fields, and recreational areas within 100 feet of a coastal marsh or a stream that drains directly into a coastal marsh. Furthermore, this label contains the same ambiguous language regarding re-applications (i.e. "Repeat as needed"). The label must be modified to provide more specific information about the maximum number of applications, interval between repeat applications, or the maximum seasonal application rate. The additional treatment language for fire ant suppression is satisfactory. Mitigation: AgrEvo added the following use restrictions to the label: "In New York State, this product may not be applied to turf within 100 feet of a coastal marsh or stream that drains directly into a coastal marsh." AND "For control of turf insects in New York State, a second application may be made after two weeks if target insect activity persists." Restricted use registration granted (due to federal restriction).

6. DeltaGard T&O Granular Insecticide (EP Reg No. 432-836): Description: This product allows for the application of granular deltamethrin on turfgrasses, landscape ornamental plantings, and perimeters around commercial, residential, and recreational areas. Issue: Because o ntial toxicity to marine/estuarine fish and invertebrates, this Department concluded that this product requires a label statement prohibiting application to turf areas such as parks, athletic fields, and recreational areas within 100 feet of a coastal marsh or a stream that drains directly into a coastal marsh. This label does not include statements about re-treatment when applied to turfgrass, other than the flea and tick control application (monthly treatments) which is acceptable. Mitigation: AgrEvo added the following use restrictions to the label: "In New York State, this product may not be applied to turf within 100 feet of a coastal marsh." AND "For control of turf insects other than fleas and ticks in New York State, a second application may be made after two weeks if target insect activity persists." General use registration granted.

7. DeltaGard G Insecticide Granule (EPA Reg. No. 432-836): Description: This product allows for the application of granular deltamethrin on turfgrasses, landscape ornamental plantings, and perimeters around commercial, residential, and recreational areas. Issue: Because of toxicity to marine/estuarine fish and invertebrates, this Department concluded that this product requires a label statement prohibiting application to turf areas such as parks, athletic fields, and recreational areas within 100 feet of a coastal marsh or a stream that drains directly into a coastal marsh. This label does not include statements about re-treatment when applied to turfgrass, other than the flea and tick control application (monthly treatments) which is acceptable. Mitigation: AgrEvo added the following use restrictions to the label: "In New York State, this product may not be applied to turf within 100 feet of a coastal marsh." AND "For control of turf insects other than fleas and ticks in New York State, a second application may be made after two weeks if target insect activity persists." General use registration granted.

8. DeltaGard GC Granular Insecticide (EP Reg No. 432-837): This product allows for the application of granular deltamethrin on golf courses and sod farms in addition to turfgrasses, landscape ornamental plantings, and perimeters around commercial, residential, and recreational areas. Issue: Because of potential toxicity to marine/estuarine fish and invertebrates, this Department concluded that this product requires a label statement prohibiting application to turf areas such as golf courses, sod farms, parks, athletic fields, and recreational areas within 100 feet of a coastal marsh or a stream that drains directly into a coastal marsh. This label does not include statements about re-treatment when applied to turfgrass, other than the flea and tick control application (monthly treatments) which is acceptable. Mitigation: AgrEvo added the following use restrictions to the label: "In New York State, this product may not be applied to turf within 100 feet of a coastal marsh." AND "For control of turf insects other than fleas and ticks in New York State, a second application may be made after two weeks if target insect activity persists." Restricted use registration granted (due to federal restriction).

CONCLUSION The above mentioned conditions are acceptable for registration of the referenced products in New York State. We understand that AgrEvo has chosen in the interim to sticker the New York State-specific text to existing container labels intended for sale, use or distribution in New York State. The sticker will contain both statements, as applicable, and will be located in the Directions for Use section of the product label. The sticker must be visible and legible, but must not cover or obscure any other words or symbols on the federal label. If the shipping carton/case is opened and individual containers/ pouches/bottles are sold separately, then each separate commercially-available unit must be stickered as previously described. It is AgrEvo's responsibility to ensure that each container is stickered as appropriate.

We also understand that the required text will be incorporated into the final labeling for each product and that new "revised" labels will be printed for each product as soon as possible. The revised labels containing the New York State-specific language should be available for distribution in the channels of trade as soon as possible, but in all instances by December 15, 1998. AgrEvo must submit copies of the final printed "revised" product label to this Department for each product as soon as they are available.

We have received from AgrEvo the necessary documents for notifying the United States Environmental Protection Agency of the revisions to the federal label. We are also in receipt of the proposed product labels for each product. These labels, in conjunction with the required sticker statement, are acceptable as submitted.

By adopting the mitigative measures proposed by this Department, and filing the proper documents to the USEPA, AgrEvo has met all of the requirements for registration of the referenced products in New York State. This concludes all issues related to the cancellation order for DeltaGard G Insecticide Granules in New York State, and rescinds the conditional registration status previously imposed on the product by this Department in our May 12, 1998 letter (reference correspondence from M. Serafini to M. Phoenix, dated May 12, 1998.).

Enclosed are the New York State Certificate of Pesticide Registration and the New York State stamped "accepted" labels for your records.

If you have any questions, please contact Maureen Serafini, Chief of the Pesticide Product Registration Section, at (518) 457-7446.

Stephen Hammond, P.E.
Director, Division of Solid & Hazardous Materials

Enclosures
cc: w/enc - D. Rutz/W. Smith, Cornell University, PMEP
E. Biel/R. Mungari, Ag & Markets

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