SRRD’s Response to Public Comments and Amendments to the Cypermethrin Reregistration Eligibility Decision and Label Table Outdoor Residential, Industrial, and/or Institutional Use Comment #1: The California Regional Water Quality Control Board of San Francisco Bay (CRWQ) and the California Stormwater Quality Association (CASQA) recommended the Agency clarify the additional application restrictions for outdoor residential products on the label table intended to prevent the release of cypermethrin into urban run-off. CRWQ and CASQA stated the language would more fully meet this intent if modified as shown below (additions in italics, deletions in strikeout): Requirements for Products labeled or intended for outdoor use: “Do not apply directly into sewers or drains, or to any area like a gutter where drainage to storm sewers, water bodies, or aquatic habitat can occur.” “After application, do not over-water the treated area to the point of runoff. Do not apply when raining or when rain is expected within 8 48 hours of application.” “Rinse application equipment over turfgrass (lawn) area, planted areas, or soil only.” The San Francisco Department of the Environment (SFE) submitted comments supporting the specific language recommended by CRWQ. Valent BioScience Corporation recommended similar language for outdoor residential use products, including the following additional statements: “Do not apply within 25 feet of rivers, fish ponds, lakes, streams, reservoirs, marshes, estuaries, bays and oceans.” “Do not apply when windy.” SRRD Response: The Agency generally agrees that cypermethrin should not be applied when raining or when rain is expected, but realizes that rainfall cannot be predicted with absolute certainty. The Agency believes 24 hours will provide sufficient degradation and therefore, a 48 hour window is not required. The following statement is included in the label table: “Do not water the treated area(s) to the point of run-off or apply when raining or when rain is expected that day.” Comment #2: Valent BioScience Corporation recommended the following statements regarding residential lawns: “All out door applications are limited to spot and crack and crevice treatments only except for: 1) treatments to soil or vegetation around structures; 2) applications to lawns, turf, and other vegetation; 3) applications to building foundations up to a maximum height of 3 feet.” SRRD Response: The Agency has amended the label table to include language based on the comment submitted by Valent BioSciences. Comment #3: FMC Corporation commented that the cypermethrin label table includes conflicting statements regarding the rinsing of application equipment. On page 68 of 116, the sentence reads, “Rinse application equipment over tufgrass (lawn) area only,” while on page 74 it reads, “rinse application equipment over treated area only.” SRRD Response: The Agency agrees that these two sentences should be consistent with one another. The aforementioned inconsistencies have been remedied with new language under the new heading “Requirements for Liquid, Dust, and Ready to Use Formulations: products labeled or intended for outdoor residential uses,” where the related statement reads: “Rinse application equipment over treated area only.” Comment #4: CASQA and CRWQ also commented that cypermethrin products labeled for control of nuisance insects around structures (e.g., ants) often call for a barrier, perimeter, or band application around a structure and up the walls of the structure. They noted that label instructions vary, but commonly call for a band up to 6 to 10 feet away from the building and up to 3 feet up the walls of the building. CASQA and CRWQ also commented that the exact width of the band does not appear to be based on scientific studies showing that such large applications are necessary for the application to be effective. To afford flexibility to professional pest control operators who do not believe such wide bands are necessary, CASQA and CRWQ request that product labels be required to clarify that widths narrower than those specified on the label are permitted. CRWQ and CASQA stated the language regarding building foundation applications would more fully meet this intent if modified as shown below (additions in italics): Clarify impervious surface treatment exception for building foundation applications “Band applications may be made to building walls (vertical surfaces only), starting at the foundation, up to a maximum height of 3 feet.” SFE stated their preference that the Agency not provide the exception that applications will be allowed to up to 3 feet up the walls of buildings, but that if the exception is permitted, clarification is necessary to ensure the understanding that the exception applies only to the walls of buildings. SRRD Response: The Agency believes that the use directions referenced above, which call for a band up to 6 to 10 feet away from the building and up to 3 feet up the walls of the building allow for applications less than the maximum height and width specified on the label. However, in order to ensure this flexibility is clear to all applicators, the following statement has been added to the amended label table. Products labeled for use on and around buildings and other structures:
“For Band applications to and around buildings foundations, band up to a maximum of 10 feet away from the building and up to a maximum of 3 feet up the walls of the building.” Comment #5: FMC Corporation commented that on page 75 of 116 under “Application In and On Boats,” the sentence needs to be modified for consistency with the following sentence on page 70, “Use inside boats, ships, and other vessels is permitted.” SRRD Response: The Agency agrees with the comment above, and the suggested revisions have been made to the referenced label statements in the amended cypermethrin label table. Indoor Residential Use
Comment #6: Valent BioScience Corporation suggested the following language for homeowner products used indoors: “Do not apply to pets.” “Cover and turn off aquarium systems before application.” “In the home, cover all food processing surfaces and utensils during treatment or thoroughly wash before use. Cover or remove exposed food.” “Do not apply this product in any room being used as a living, eating or recovery area by patients, the elderly or infirm when they are in the room.” “Do not use in greenhouses where crops for food or feed are grown.” Valent BioScience Corporation also recommended the following language for indoor residential use except for total release foggers: “Do not use as a space spray.” “Use only in well-ventilated areas.” SRRD Response: The above restrictions are included under the occupational use section of the cypermethrin label table, and while some of these restrictions will apply to residential products on a case by case basis, they are not repeated under the section entitled “end use products primarily intended for consumer and residential use.” Since some restrictions covered in the occupational section of the table will apply to residential products, the entire label table should be reviewed when amending product labels. The product manager in the Registration Division will determine which restrictions are appropriate when the final label is submitted. Comment #7: Valent BioScience Corporation suggested the following statements are not appropriate for homeowner use products:
“During any application to ceilings of a structure, cover surface below with plastic shielding or similar material.” “Do not apply to classrooms when in use.” “Do not apply to areas of institutions (including libraries, sport facilities, etc.) when occupants are present in the immediate treatment area.” “Not labeled for use in food areas. Do not use in food areas of food handling establishments, restaurants, or other areas while food is exposed or facility is in operation. Serving areas are areas where prepared foods are served, such as dining rooms, but excluding areas where foods may be prepared or held.” “Do not use concentrate or emulsion in fogging equipment.” SRRD Response: The Agency agrees with the recommendations provided by Valent BioSciences. The cypermethrin label table has been amended accordingly. Comment #8: Valent BioSciences Corporation noted that no specific ventilation and re- entry requirements were listed for total release foggers, and suggested the following language: “Do not remain in treated area. Leave the area immediately and remain outside until vapors and/or mists have dispersed. Do not allow adults, children or pets to enter until vapors have dispersed and the area has been thoroughly ventilated.” SRRD Response: The Agency appreciates the suggestions provided by Valent BioSciences on ventilation and re-entry requirements for total release foggers. The Agency has amended the cypermethrin label table to include the following language in order to be consistent with the language that appears in other REDs: “Wait two (2) hours after application, then open windows, vents and doors for two hours. If an odor is still detected, additional ventilation is required.” Agricultural Use Comment #9: FMC Corporation commented that the Notice of Availability and Reregistration Eligibility Decision (RED) incorrectly state minor uses of cypermethrin on peanuts and sweet corn. SRRD Response: The Agency agrees with FMC Corporation’s comment as zeta- cypermethrin is registered for use on peanuts and sweet corn, not cypermethrin. The RED has been amended accordingly. Comment #10: FMC Corporation commented that the maximum seasonal application rate of 0.6 lbs a.i./A should be modified to 0.4 lbs a.i./A for leafy brassica and 0.5 lbs
a.i/A for bulb vegetables since these reflect the maximum application rates from the crop residue trials which, in turn, support the tolerances for each of these crops/groups. FMC Corporation noted that if these are not corrected, potential over-tolerance issues may arise from over application. SRRD Response: The Agency agrees that the maximum seasonal application rate of 0.6 a.i./A should be changed to 0.4 lbs a.i./A for leafy brassica and 0.5 lbs a.i/A for bulb vegetables. The cypermethrin label table has been amended accordingly. Registration Review of Pyrethroid Chemicals Comment #11: CASQA and the CA Regional Water Control Board, San Francisco Bay stated concern that the pyrethroids are not scheduled for Registration Review until 2010, and mitigation would not occur until 2011. They noted that this puts municipalities in an untenable position because they must comply with the Clean Water Act immediately. CASQA requested Registration Review be initiated immediately for the pyrethroids, or a special review be initiated. Additionally, according to the Water Board, pyrethroids are anticipated to be the cause of impaired water bodies, listed on the 2008 303(d) list. SFE submitted similar comments. SRRD Response: The Permethrin, Resmethrin, Cypermethrin, Pyrethrins, PBO, and MGK-264 Reregistration Eligibility Decisions were signed in Spring/Summer 2006, and decisions for non-food pyrethroids are due in 2007 and 2008 (allethrin stereoisomers, tetramethrin, and sumethrin). Therefore, the 2010 date for registration review to begin for the pyrethoid, pyrethrins, and synergists (PPS) group of chemicals allows additional time for the risk mitigation and label changes identified in these REDs to be incorporated. Further, in the recent PPS REDs, the Agency identified a number of limitations in the reregistration of these chemicals, such as no urban/residential model available to assess potential ecological risks from residential uses; and an inability to assess (or compare) ecological impacts from PPS chemicals as a group because a large majority were registered after 1984. In order to address these limitations and allow the registration review risk assessments to be more refined, there is an on-going effort several years in advance to prepare for registration review of the PPS chemicals. This effort includes determining whether the pyrethroids share a common mode of action; revise spray drift language for pyrethroid agricultural labels; identifying a model and appropriate scenarios for use in urban run-off modeling; compiling detailed use and usage information about the PPS chemicals, both agricultural and residential uses; and identifying data needs and possible group data call in. Additionally, the Agency is coordinating with the California Department of Pesticide Regulation (CDPR), which is currently conducting its reevaluation of pyrethroids. The reevaluation includes calling in new and additional data, which will be useful to the Agency’s registration review process of the PPS chemicals. These studies have not yet been conducted or submitted to CDPR. Therefore, the Agency does not believe it would be prudent to initiate the Registration Review of the PPS chemicals any earlier than currently scheduled. Comment #12: CASQA, the CA Regional Water Control Board, San Francisco Bay, and SFE stated that OPP needs to initiate development of an urban run-off model as soon as possible and that an empirical model should be used rather than the mechanistic model OPP typically uses. SRRD Response: The Agency recognizes the need to identify a screening-level model for urban pesticide uses and has begun to discuss the state of urban modeling and the potential avenues for future advances internally and with stakeholders. Improvements in the resolution of GIS databases may allow better representation of the impervious and pervious portions of a typical urban landscape. For example, as the uses most likely to lead to transport of pyrethroids to surface water become clearer, the conceptual model of how urban transport should be simulated will become more focused. Comment #13: CASQA and SFE commented that U.S. EPA may be generating a “Data Call-In” (DCI) for pyrethroids to provide data for future pyrethroids reviews. CASQA and SFE believe the following information is high priority: data to support urban runoff modeling, application instructions, and aquatic sediment data. CASQA and SFE anticipate the California Department of Pesticide Regulation’s (CDPR’s) initiation of a data call in process for pyrethroids will generate information that would be useful to U.S. EPA, and recommend that the Agency coordinate with DPR in developing the DCI. CASQA and SFE ask the Agency to review all data submitted to DPR and CASQA noted they would provide formal support for U.S. EPA’s request to review data submitted to DPR. SRRD Response: The Agency appreciates the recommendations provided by CASQA and SFE, and is in the process of planning for the pyrethroid registration review process, which may include a special group DCI for the pyrethroids. The Agency also recognizes that it needs to achieve a greater understanding of the residential and urban application of pyrethroids, to identify an urban run-off model, and more aquatic sediment data. The Agency is coordinating with the CDPR, and the two organizations have agreed to share data reviews. Comment #14: CASQA stated that in reviewing pesticide ingredients, coordination between Agency offices is essential to Clean Water Act implementation and that it provides an appropriate method of meeting FIFRA’s goal of preventing unreasonable adverse impacts from pesticide use. The CA Regional Water Control Board, San Francisco Bay submitted similar comments. SRRD Response: The Office of Pesticide Programs (OPP) agrees that coordination is essential between OPP and the Office of Water (OW). In its effort to plan for the upcoming registration review of the pyrethroid case of chemicals, OPP has initiated discussions with OW to address issues that affect both Offices. Comment #15: The CA Regional Water Quality Control Board, San Francisco Bay Region included steps to be taken in the near term in their comments to the Agency. The
steps include OPP completing a cumulative environmental risk assessment for pyrethroids; completing an alternatives assessment that considers both low risk and non- pesticide alternatives; completing a cluster assessment for problematic outdoor urban insecticide application; and assessing whether urban uses of pyrethroids pose unreasonable risks, taking into account the above information and the cost of non- compliance with the Clean Water Act. SRRD Response: The Agency appreciates the suggestions provided by the CA Regional Water Board, San Francisco Bay Region. As stated above, OPP is in the process of planning for the registration review of pyrethroids, pyrethrins, and synergists chemicals. As part of its planning effort, OPP is working closely with CDPR as its conducts its reevaluation or pyrethroids, as well as coordinating with EPA Office of Water. As the planning progresses, OPP will discuss the feasibility of conducting the assessments suggested above by CRWQ. General Comments Regarding labeling Comment #16: Valent BioSciences Corporation suggested the word “precautions” should be deleted from the last sentence of the environmental hazards portion of the label table as it is confusing: “See directions for use for additional precautions and requirements.” The comment states that furthermore, the header “precautionary statements” is used for other types of statements and the environmental hazards section does not include statements that would be pertinent. SRRD Response: The Agency agrees with the suggestion provided by Valent BioSciences and the cypermethrin label table has been amended accordingly.
Reregistration Eligibility Decision Comment #17: FMC Corporation made several comments regarding the studies cited in Appendix B and D in the RED: A. FMC Corporation noted that MRID# 133028 is listed in several locations but is not
B. MRID# 45121822 is listed for GLN 850.1400, but FMC Corporation questioned its
applicability to cypermethrin as in the citation reference, the subject is for MKH 3586 Technical, which is an amicarbazone.
C. MRID# 132149 is listed for GLN 850.2200 (71-2), but FMC Corporation
questioned its applicability to cypermethrin as in the citation reference, the subject is for Dantion DMDMH-55, which is not a pyrethroid.
D. FMC Corporation questioned the applicability of MRID# 98036 for GLN 850.2300
(71-4) as the citation reference is for Amaze-Technical, which is not a pyrethroid.
E. FMC Corporation suggested a review of the MRID#s within the citation column for
GLN 860.1300, 860.1340, 860.1500, 860.1520, 860.1540, as it appears that many of the citations are not placed within the proper category.
F. FMC Corporation questioned the applicability of the references for MRID#s 34562,
35127, 58170, and 89415 listed in Appendix D, as they are associated with the fungicide Dodine.
G. FMC Corporation questioned the applicability of MRID 70562 in Appendix D, as it
is for the efficacy of Glossyplure, which is not a pyrethroid.
H. FMC Corporation suggested the phrase “Apple (juice and wet pomace)” should be
removed from the description for 860.1520 as the MRID is for cotton. FMC Corporation also noted that there are other processing studies for this GLN.
SRRD Response: The Agency agrees with FMC Corporation’s comments and will amend the RED accordingly. Comment #18: FMC noted that for GLN 850.2300 (71-4) Avian Reproduction, the stated data gap had previously been addressed by FMC and responded to by the Agency, and that no data gap exists for this guideline. SRRD Response: The Agency agrees that no data gap exists for this guideline as surrogate toxicity data from permethrin is being used instead of requiring the avian reproduction study for cypermethrin. The RED has been amended accordingly. Additional Amendments to the Cypermethrin Label Table A number of updates have been made to the 2006 Cypermethrin Label Table for purposes of clarification. Among the updates are the following: 1.
The appropriate table number was added to the label table.
Spray drift language has been amended as follows:
Wind Direction and Speed “Only apply this product if the wind direction favors on-target deposition.” “Do not apply when the wind velocity exceeds 15 mph.” Temperature Inversion “Do not make aerial or ground applications into temperature inversions.”
“Inversions are characterized by stable air and increasing temperatures with height above the ground. Mist or fog may indicate the presence of an inversion in humid areas. The applicator may detect the presence of an inversion by producing smoke and observing a smoke layer near the ground surface.” Droplet Size “Use only Medium or coarser spray nozzles (for ground and non-ULV aerial application) according to ASAE (S572) definition for standard nozzles. In conditions of low humidity and high temperatures, applicators should use a coarser droplet size”. Additional Requirements for Ground Applications “Wind speed must be measured adjacent to the application site on the upwind side, immediately prior to application.” “For ground boom applications, apply using a nozzle height of no more than 4 feet above the ground or crop canopy.” “For airblast applications, turn off outward pointing nozzles at row ends and when spraying the outer two rows. To minimize spray loss over the top in orchard applications, spray must be directed into the canopy.” Additional Requirements for Aerial Applications
“The spray boom should be mounted on the aircraft as to minimize drift caused by wingtip or rotor vortices. The minimum practical boom length should be used and must not exceed 75% of the wing span or 80% rotor diameter.” “Flight speed and nozzle orientation must be considered in determining droplet size.” “Spray must be released at the lowest height consistent with pest control and flight safety. Do not release spray at a height greater than 10 feet above the crop canopy unless a greater height is required for aircraft safety.” “When applications are made with a cross-wind, the swath will be displaced downwind. The applicator must compensate for this displacement at the downwind edge of the application area by adjusting the path of the aircraft upwind.”
Application rates were incorrect for leafy brassica and bulb vegetables. The related language, located under “Other Application Restrictions,” has been amended as follows:
Head and Stem Brassica and Head Lettuce:
Maximum application rate of 0.1 lbs a.i./A
Maximum seasonal application rate of 0.6 lbs a.i./A
Maximum application rate of 0.1 lbs a.i./A
Maximum seasonal application rate of 0.4 lbs a.i./A
Maximum application rate of 0.1 lbs a.i./A
Maximum seasonal application rate of 0.5 lbs a.i./A
Entry restrictions for products applied as a total release fogger and space spray products have been amended as follows:
Total release foggers and space sprays labeled for indoor use must contain the following entry restriction:
“Wait two (2) hours after application, then open windows, vents and doors for two hours. If an odor is still detected additional ventilation is required.”
General application restrictions have been amended as follows:
Products applied as a spray:
“Do not apply this product in a way that will contact any person or pet, either directly or through drift. Keep people and pets out of the area during application. Exit area immediately and remain outside the treated area until sprays have dried.” Total Release Fogger Products:
“Do not apply this product in a way that will contact any person or pet, either directly or through drift. Keep people and pets out of the area during application. Exit area immediately and remain outside the treated area until the area is thoroughly ventilated and until aerosols, vapors, and/or mists have dispersed.” Products applied dry (granulars):
“Do not apply this product in a way that will contact any person or pet, either directly or through drift. Keep people and pets out of the area during application. Exit area immediately and remain outside the treated area until dusts have settled.”
Application restrictions for end-use products labeled for use or that can be used for outdoor applications have been amended as follows:
“Restrictions for Outdoor Uses” “All outdoor applications must be limited to spot or crack-and-crevice treatments only, except for the following permitted uses:
Treatments to soil or vegetation around structures;
Applications to lawns, turf, and other vegetation;
Applications to building foundations up to a maximum height of 3 feet
Broadcast application to building foundations
All outdoor applications to impervious surfaces such as sidewalks, driveways, patios, porches and structural surfaces (such as windows, doors, and eaves) are limited to spot treatments or crack-and-crevice applications, only.”
Products labeled for use around or near floor drains: “Do not apply directly into sewers or drains, or to any area like a gutter where drainage to storm sewers, water bodies, or aquatic habitat can occur. Do not allow the product to enter any drain during or after application.” Requirements for Granular Formulations labeled or intended for outdoor residential uses:
“Do not apply directly to or near water, storm drains, gutters, sewers, or drainage ditches. Do not apply when windy. Apply this product directly to your lawn or garden, and sweep any product landing on the driveway, sidewalk, gutter, or street, back onto the treated area. Do not water the treated area to the point of run-off or apply when raining or when rain is expected that day.” Requirements for Liquid, Dust, and Ready to Use Formulations products labeled or intended for outdoor residential uses: “Do not apply directly to or near water, storm drains, gutters, sewers, or drainage ditches. Do not apply when windy. Do not water the treated area(s) to the point of run-off or apply when raining or when rain is expected that day. Rinse application equipment over treated area only.”
Application restrictions for all end-use products labeled for outdoor termite control have been amended as follows: “Termite Control” “All leaks resulting in the deposition of termiticide in locations other than those prescribed on this label must be cleaned up prior to leaving the application site. Do
not allow people or pets to contact contaminated areas or to reoccupy the contaminated area until the clean up is completed.” “Use anti-backflow equipment or procedures to prevent siphonage of pesticide back into water supplies.” “Care should be taken that the treatment solution is not introduced into the gravel and/or pipe drainage system which may be located on the exterior of the foundation in close proximity to the footing of the structure.” “Do not treat soil that is water-saturated or frozen.” “Do not treat when raining.” “Do not allow treatment to runoff from the target area.” “Do not apply within 10 feet of storm drains. Do not apply within 25 feet of aquatic habitats (such as, but not limited to, lakes; reservoirs; rivers; permanent streams; marshes or natural ponds; estuaries; and commercial fish farm ponds). “Do not make on-grade applications when sustained wind speeds are above 10 mph (at application site) at nozzle end height.”
Application restrictions for all end-use products labeled for indoor termite control have been amended as follows: “All leaks resulting in the deposition of termiticide in locations other than those prescribed on this label must be cleaned up prior to leaving the application site. Do not allow people or pets to contact contaminated areas or to reoccupy the contaminated area until the clean up is completed.” “Use anti-backflow equipment or procedures to prevent siphonage of pesticide back into water supplies.”
Application restrictions for all end-use products labeled for subterranean termite control have been amended as follows: “Products Labeled for Subterranean Termite Control”
“Do not treat soil beneath structures that contain wells or cisterns.” “Whenever possible, make termite control applications near the structure foundation using soil injections.”
10. Application restrictions for all end-use products labeled for preconstruction termite
“Products Labeled for Preconstruction Applications for Termite Control”
“The applicator must insure the treatment site is covered. The applicator can cover the soil him/herself or notify the contractor on the site that: 1) if the concrete slab cannot be poured over the treated soil within 24 hours of application the treated soil should be covered with a waterproof covering (such as polyethylene sheeting), and 2) that the contractor should cover the treated soil if precipitation occurs before the concrete slab is poured.” “Whenever possible, make termite control applications near the structure foundation using soil injection.”
11. Application restrictions for end-use products labeled for use or that can be used for
outdoor applications have been amended as follows: Products labeled for use around or near floor drains. Products labeled for use in drains or sewers are excluded from this label requirement:
“Do not apply directly into sewers or drains, or to any area like a gutter where drainage to storm sewers, water bodies, or aquatic habitat can occur. Do not allow the product to enter any drain during or after application.”
Requirements for Granular Formulations labeled or intended for outdoor residential uses: “Do not apply directly to or near water, storm drains, gutters, sewers, or drainage ditches. Do not apply when windy. Apply this product directly to your lawn or garden, and sweep any product landing on the driveway, sidewalk, gutter, or street, back onto the treated area. Do not water the treated area to the point of run-off or apply when raining or when rain is expected that day.” Requirements for Liquid, Dust, and Ready to Use Formulations products labeled or intended for outdoor residential uses:
“Do not apply directly to or near water, storm drains, gutters, sewers, or drainage ditches. Do not apply when windy. Do not water the treated area(s) to the point of run-off or apply when raining or when rain is expected that day. Rinse application equipment over treated area only.”
12. Application restrictions for end-use products labeled for or that can be used in or on
“Applications In and On Boats”
The use site “Application in and on boats” should be listed separately from other use sites on the label, along with these restrictions. “Do not apply to boat surfaces which contact water. Broadcast applications to exterior surfaces of boats are prohibited. Spot treatments may be made to exterior surfaces that do not contact water.” “Use inside boats, ships, and other vessels is permitted. Do not allow product to drain or wash off into water.”
Attachment 1: Reregistration Eligibility Decision (RED) for Cypermethrin, revised
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