2 (4) other comments and changes. A revised label table along with complete appendices accompanies this document and reflect the changes to the RED.

Attachments:

• Pyrethrins Revised Label Table

• Appendix A: Uses Supported for Reregistration

• Appendix B: Generic Data Requirements Table

• Appendix C: Technical Support Documents

• Appendix D: Database Citations

• Appendix E: EPA’s Acute Toxicity Batching

• Appendix F: Supplement for PDCI Special Study for Arthropods: Pests of Public Health Importance and Structural Pests3 SRRD’s Response to Public Comments to the Pyrethrins Reregistration Eligibility Decision

I. Public Health Uses

Comment: The Delaware Mosquito Control Section (DMCS) of the Division of Fish and Wildlife, Delaware Department of Natu ral Resources and Environmental Control

commented that the environmen tal hazard statement, which appears on wide area public health pyrethrins products, is no t applicable to public health uses of pyrethrins. Further, the DMCS proposed adding the following statemen t to the label: “if used in accordance with the label, pyrethrins pose no unreasonabl e risk to human hea lth, aquatic organisms, wildlife, or the environment.” The Maryl and Mosquito Control Section submitted similar

comments.

SRRD Response: The environmental hazard statement (EHS) for adult mosquito control programs is in accordance with EPA’s Pes ticide Registration (PR) Notice 2005-1 (link: http://www.epa.gov/PR_Notices/pr2005-1.pdf ), “Labeling Statements on Products Used for Adult Mosquito Control.” After consid erable public input and discussions with stakeholders the Agency has adopted this la nguage for all products used in wide area adult mosquito control, not just the labels fo r products with pyrethrins. Therefore, the

environmental hazard statement will not be re moved or revised to include the suggestion above for pyrethrins products used for wi de area adult mosquito control.

Comment: The DMCS commented the following part of the EHS, “(w)hen applying as a wide area mosquito adulticide, do not appl y over bodies of water (lakes, rivers, permanent streams, natural ponds, comme rcial fish ponds, swamps, marshes or estuaries), except when...weather conditi ons will facilitated movement of applied material away from the water in order to mi nimize incidental deposition into the body of water,” should be advisory, not mandatory, sinc e pyrethrins will cause very little to no adverse effects to non-target organisms. The Maryland Mosquito Control Section

submitted similar comments.

SRRD Response: See response above.

Comment: The DMCS also stated that the bodies of water identified in the environmental hazard statement need to be better defined. The Maryland Mosquito

Control Section submitte d similar comments.

SRRD Response: See response above.

Comment: The group Beyond Pesticides commented that pyrethrins are toxic to bees, and the protection of pollinators should be the highest priority for EPA.

SRRD Response: EPA supports protecting pollinators, especially bees. The pyrethrins are toxic to bees, and so EPA has required bee hazard statements to be added to all products containing pyrethrins app lied outside when bees would be present. The original4 pyrethrins RED only required the bee statemen t for professionally applied products, but as a result of this comment, this bee statement is also being added to all residential products applied outdoors as well. The bee hazard language states:

“This product is highly toxic to be es exposed to direct treatment on blooming crops or weeds. Do not apply this product or allow it to drift to blooming crops or weeds while bees are actively visiting the treatment

area.”

Comment: AMCA recommended that the label language included for mosquito control be changed to clarify the restri ctions over bodies of water and that they be moved from
the Environmental Hazards section to the Dire ctions for Use section of the label.

SRRD Response : The label statements pertaining to bodies of water for adult mosquito control programs are in accordance with th e PR Notice 2005-1, Labeling Statements on Products Used for Adult Mosquito Control. The Agency is adopting this language on all products used for wide area adult mosquito cont rol, not just the labels for products with pyrethrins. Therefore, the label statements will not be revised for pyrethrins products used for wide area adult mosquito control.

Comment: AMCA requested that the droplet size restrictions for mosquito misting systems be explicitly disti nguished from droplet size re strictions for agricultural applications.

SRRD Response: The droplet size information for th ese two very different types of applications is clearly separated in the la bel table. In addition, EPA encourages registrants to separate labels with use for wi de area mosquito abatement from labels with other uses, as explained fu rther in PR Notice 2005-1.

II. Outdoor Use

A. Water Contamination Comments

Comment: The California Stormwater Quality Association (CASQA ) recommended the Agency clarify the additional application restri ctions for outdoor residential products on the label table intended to prevent run-off of pyrethrins into urban sewers and streams. CASQA stated t he language would more fully meet this intent if modified as stated in the

comments.

SRRD Response : Since the pyrethrins RED was fina lized, the Agency has finalized PR Notice 2008-1 that allows registrants to vol untarily change their environmental hazard statements on residential products so users will be able to better understand how to apply consumer products to minimize environmental hazards. The statements included in this PR Notice are similar to the language that wa s required in the pyrethrins RED, and the intention is the same for both statements, to help consumers use thes e products correctly

in order to minimize environmental risks. Th erefore, the pyrethrins RED labeling will be5 updated to require the same environmental hazar d statements for residential products that

are included in PR Notice 2008-1.

Comment: CASQA also stated that professional products for urban use (i.e., products for landscaping, rights of way, etc.) should have stewardship language on their labels. CASQA included labeling suggestions in their comment s. The CA Regional Water Quality Control Board, San Francisco Bay Region submitted similar comments.

SRRD Response: The Agency agrees that pyrethr ins products for professional use should have language on the labels to preven t the run-off of pyrethrins residues down storm drains. Therefore, in addition to the revisions made to the Environmental Hazards statements, the following statements have b een added to the amended pyrethrins label table for end use products primarily intende d for occupational use by commercial pest control operators.

Products labeled for use around or near floor drains or sewer drains:

“Do not apply directly into sewers or drains, or to any area like a gutter where drainage to storm sewers, wa ter bodies, or aquatic habitat can

occur.”

Comment: The County Sanitation Districts of Los Angels County and the California Stormwater Quality Association (CASQA) comment ed that environmental hazard statements, similar to the required outdoor environmental hazard statements, be added to all indoor products. The reasons are that there is potential exposure to pyrethrins down the drain after using pet shampoos, discharging of water used to clean surfaces that were treated with pyrethrins, and washing materials that have been treated with pyrethrins in a washing machine. The Sanitation Districts and CASQA be lieve toxicity statements should be added to indoor use products, along with statements about consulting with the local sewage treatment agencies for uses that may result in a discharge down-the-drain, and how to dispose of water containing pyrethrins.

SRRD Response: Through various labeling initiatives (some discussed in the Section IV below), OPP hopes to reduce the overall amount of pyrethrins discharg ed into both storm water and sewage drainage systems. However, at this time, the Agency does not believe additional aquatic environmental hazard statem ents, similar to the environmental hazard statements on outdoor products, is appropriate on indoor use products since local sewage treatment plants may not be equipped to deal with many consumer calls.

B. Outdoor Residential Misting System Comments

Comment: MGK Company submitted various co mments on the label language for outdoor residential misting systems. Many of the comments supported or provided more rationale for the language that EPA is requi ring. One comment was concerned with people being able to access their mis ting systems if emergencies occur.6 SRRD Response: EPA is requiring reservoir tanks to be locked, mainly to ensure children or others who may tamper with th e devices are not expos ed to the tank of pesticide. Homeowners who install these systems should have a mechanism for turning off the misting systems in case of an accident. However, the requirement to keep systems locked still applies to help ensure others are not exposed to the pesticide in the tank.

Comment: The New York State Department of Pesticide Management commented about adding other label language for mosquito misti ng systems that would ensure applications were efficacious by setting temperature lim its and requiring the pr oduct to be agitated periodically. They also requested that buffer zones be added to labels.

SRRD Response: The Agency has not required langua ge for the misting systems that may influence the efficacy of the system, since each system and chemical may have a different set of requirements. EPA has require d labeling so these systems may be used in

a manner that does not cause unreasonable advers e effects to humans or the environment. If registrants or system manufactures have specific requirements for their systems in order for them to work effectively, they must add them to either the end use product, or the misting device system, whichever is more appropriate. EPA has not set buffer zones for these misting systems, but there is label language that requires all nozzles to spray toward the target area.

Comment: Valent BioSciences commented that th e statement, “not for use in outdoor residential misting syst ems,” should not be required for all products since it implies that the product was once register ed for use in these syst ems and could be misleading.

SRRD Response: This label language is a part of EPA’s goal to ensure that only pesticides that have been ev aluated for use in misters are used in misters. EPA has included this statement on the label of products not approved for use in misters to prevent any improper use in residential misting system s, since Section 2(ee) of FIFRA, permits the use of any applica tion methods that are not specifica lly prohibited by the pesticide’s labeling.

C. Other Labeling Comments

Comment: Valent BioSciences recommended revising the last sentence of the environmental hazard statements to delete refe rences to other precautions, since that is a separate part of the label.

SRRD Response: The suggested change has been made and updated in the revised

version of the label table.

Comment: Valent BioSciences recommended that th e statements for outdoor residential use be revised to state “application equipment” instead of “applicator ” in the Directions for Use Section.7 SRRD Response: The outdoor residential statem ents have been updated with the language from the new Pesticide Registra tion Notice 2008-1, which includes language similar to that which Valent suggests.

Comment: Valent BioSciences recommended that the “User Safety Recommendations” section of the labeling should not be incl uded for household consumer products. They commented that these statements should only be required on products if the acute toxicity profile of the form ulation shows they are warranted.

SRRD Response: The User Safety Recommendations ha ve been removed from the label table since the statements could vary dependi ng on the results of the acute toxicity data.

III. Registration Review of Pyrethroid Chemicals

Comment: The California Stormwater Quality Association (CASQA) and the CA Regional Water Control Board, San Francisco Ba y stated concerns that the pyrethroids are not scheduled for Registration Review until 2010, and mitigation would not occur until 2011. They state that this puts municipal ities in an untenable position because they must comply with the Clean Water Act i mmediately. CASQA requested Registration Review be initiated immediately for the pyreth roids, or a special review be initiated. Additionally, according to the Water Board, pyrethroids are an ticipated to be the cause of impaired water bodies, listed on the 2008 303(d) list.

SRRD Response: The Permethrin, Resmethrin, Cype rmethrin, Pyrethrins, Piperonyl Butoxide, and MGK-264 Reregistration E ligibility Decisions were signed in Spring/Summer 2006, and decisions for non- food pyrethroids, including allethrin stereoisomers, tetramethrin, and sumethrin, were completed in 2008. Therefore, the 2010 date for Registration Review to begin for th e pyrethoid, pyrethrins, and synergists (PPS) group of chemicals allows time for the risk mitigation and label ch anges identified in these REDs to be incorporated. Further, in the recent PPS REDs, the Agency identified a number of limitations in the reregistra tion 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 of the pyret hroids were registered after 1984.

In order to address these limita tions and allow the registration review risk assessments to be more refined, there are several on-going effo rts to prepare for re gistration review of the PPS chemicals including: determine wh ether the pyrethroids share a common mode of action; revise spray drif t language for pyrethroid agricu ltural labels; id entify a model and appropriate scenarios for use in urban run-off modeling; compile detailed use and usage information about the PPS chemicals, both agricultural and re sidential uses; and identify data needs. Additionally, the Ag ency is coordinating with the California Department of Pesticide Regulation (CDP R), which is currently conducting its reevaluation of pyrethroids. The reevaluati on includes calling in new and additional data, which will be useful to the Agency’s Registration Review process of the PPS chemicals which begins in 2010 for some chemicals. Therefore, the Agency does not believe it8 would be prudent to initiate the Registra tion Review of the PPS chemicals any earlier than currently scheduled.

Comment: CASQA and the CA Regional Water Control Board, San Francisco Bay

stated that OPP needs to initiate devel opment of an urban run-off model as soon as possible. An empirical model should be us ed opposed to the m echanistic 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 internal ly and with stakeholders. Improvements in the resolution of GIS databases may allow be tter representation of the impervious and pervious portions of a typical urban landscap e. For example, as it becomes more clear which uses are most likely to lead to tran sport of pyrethroids to surface water, the conceptual model of how urban transport shou ld be simulated will be more focused.

Comment: CASQA commented that U.S. EPA may be generating a “Data Call-In” (DCI) for pyrethroids to provide data for future pyrethroids reviews. They appreciate that U.S. EPA recognizes that data critical to managing risks fr om pyrethroids is currently not available and that EPA intends to require that pyrethro id manufacturers provide the needed data. Among data needed for pyrethroids water quality management, CASQA believes the following information is high priority: data to support urban runoff modeling, application instructions, and aquatic sediment data. In add ition, the California Department of Pesticide Regulation (DPR) has initiated a data call in pr ocess for pyrethroids called “re-evaluation”. CASQA anticipates that this process will generate a substantial amount of information that would be useful to U.S. EPA. CASQA recomm ends that U.S. EPA coordinate with DPR in developing the DCI. CASQA asks U.S. EPA to re quest, obtain, and review all data submitted to DPR. CASQA stands ready to provide form al support for U.S. EPA’s request to review

data submitted to DPR.

SRRD Response: The Agency appreciates the recommendation provided by the CASQA, and is in the process of planning for the pyrethroid Registration Review process. As part of the initial phase of registration review a preliminary work plan will provide an opportunity for stakeholders to comment on the anticipated data the Agency will require in order to complete a risk assessment. Since this will be the first chance to evaluate all of the pyrethroids, pyrethrins, and synergists at once it will be a good opportunity to call in data necessary to assess the chemicals together. The Agency also recognizes that it needs to gain a better understanding of the residential and urban application of pyrethroids, to identify an urban run-off model, and more aquatic sediment data. The Agency is continuing to coordinate with the CDPR, and the two organizations have continued to share data and

reviews on these chemicals.

Comment: CASQA stated U.S. EPA has taken important steps toward protecting water quality throughout its various reregistration processes. However, CASQA stated that U.S. EPA needs to better integrate surface water quality protection into its pesticide registration and regulatory review programs. CASQA stated that coordination between U.S. EPA offices in reviewing pesticide ingredients is essentia l to Clean Water Act implementation; it also provides an appropriate method of meeting the Federal Insecticide, Fungicide, and9 Rodenticide Act’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. 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: The CA Regional Water Control Boar d, San Francisco Bay Region included steps to be taken in the near term in thei r comments to the Agency. The steps include OPP completing a cumulative environmental ri sk assessment for pyrethroids; completing

an alternatives assessment that considers both low risk and non-pe sticide alternatives; completing a cluster assessment for problemat ic outdoor urban inse cticide app lication; and assessing whether urban uses of pyreth roids pose unreasonable risks, taking into account the above information and the cost of no n-compliance with the Clean Water Act.

SRRD Response: The Agency appreciates the sugges tions provided by the CA Regional Water Board, San Francisco Bay Region. As stated above, OPP is in the process of planning for the registration revi ew of pyrethroids, pyrethrins, and synergists chemicals. As part of its planning effort, OPP is work ing closely with CA DPR as it conducts its reevaluation of pyrethroids, as well as coordi nating with EPA’s Office of Water. As the planning progresses, OPP will continue to discuss these issues and the feasibility of the

various assessments with the Water Board and other stakeholders.

Comment: Various comments from the California Regional Water Quality Control Board, California State Water Resources Control Boar d, and the County Sanitation Districts of LA County state that additional data should be called in to help assess the potential ecological risks from residential use of pyrethrins, and other compounds.

SRRD Response: The Agency appreciates the recommendation provided in the comments and is in the process of planning fo r the pyrethroid registra tion review process, which includes PBO. The Agency also r ecognizes that it needs to gain a better understanding of the residential and urban uses of this group of chemicals, to identify an urban run-off model, and evaluate more aquatic sediment data. The Agency is coordinating with the CDPR, and the two or ganizations have been sharing data and reviews when possible.

IV. Other Comments and Changes

Comment: The Agency received comments from Beyond Pesticides about including the effects of synergists in all applicable exposure scenarios for both human health and ecological impacts. The comment states: “EPA did not consider the possible effects of

these chemicals in combination.”

SRRD Response: The Agency has completed risk assessments and Reregistration Eligibility Decisions (REDs) for the pyreth rins, and two synergists commonly found in products with pyrethrins, including pipe ronyl butoxide (PBO) and MGK-264. The10 synergist active ingredients were evaluated separately because evidence indicates that these chemicals do not effectively act as a synergist in mammals. For example, PBO inhibits microsomal enzymes in insects and evidence indicates that enzyme inhibition in mammals is transient and occurs at high dos es. Additionally, th e Agency requires and reviews product specific data that would take into account effects of the combined ingredients for a number of studies, incl uding acute toxicity, efficacy, and product chemistry. The Agency has included these studies in the Data Call-Ins (DCIs) for products containing these active ingredients.

Other Labeling Changes:

• Due to the proposed revocation of tolerances for food stored in bags, all directions for use on “food stored in bags” have b een removed from the label table and Appendix A.

• A ventilation statement requiring ventilation for at least 2 hours for total release foggers was added that was similar to ot her ventilation statements required for

other chemicals with a similar use. If re gistrants provide data to support different ventilation periods this ti me duration may be changed on a case-by-case basis.

• The label table included with the Pyreth rins RED in 2006 was quite lengthy and could be confusing to read. In an effort to simplify and clarify the label changes, all of the rates that are being supported by the Pyrethrin Joint Venture, and were

used in the risk assessments are included in Appendix A only. Only changes that are specifically included as risk mitigati on in Chapter 4 of the RED will be listed

in the label table.

• A letter from the Pyrethrin Joint Ve nture was received on January 21, 2009 requesting changes to three rates us ed in the risk assessments.

o The PJV requested the space spray rate used for food handling establishments be changed from 0.00033 lbs ai/1000 cubic feet to 0.0033

lbs ai/1000 cubic feet. Since this rate was already included in the Phase 3 risk assessment and was only changed at the request of the registrant at the end of the RED process, and there ar e no risk concerns with this rate change, the space spray rate for food ha ndling establishments will be set at 0.0033 lbs ai/1000 cubic feet. The space spray rate for residential areas

will remain at 0.00033 lbs ai/1000 cubic feet.

o The PJV requested that the metere d release rate be changed from 0.00046 lbs ai/1000 cubic feet to 0.0046 lbs ai/1000 cubic feet. The Agency

identified risks of concern for some metered release scenarios in the RED and required a rate reduction. In subs equent conversations with the PJV they agreed to keep the space spray rate at 0.00046 lbs ai/1000 cubic feet.

o The PJV requested that the post-harves t application rate be changed from

0.0001 lbs ai/1000 cubic feet to 0.001 lb s ai/ 1000 cubic feet and supplied a data reference supporting the rate. The Agency has reviewed the study11 and agrees the maximum rate may be change to 0.001 lbs ai/1000 cubic

feet.

• A letter from Wellmark to Valent Bios ciences was forwarded to EPA on January 5, 2007. The letter requested a clarification on the rate used in the risk assessment for pet sprays.

o The Agency had assumed the maximum amount of pyrethrins in a pet spray product was 0.01% ai. After revi ewing the data a nd considering the new rate ( ORE Review D347780, Aggregate Review D347781 ), the Agency is allowing pet spray products to be formulated up to 0.20% ai.

• In the 2006 RED some label language was developed for metered release systems indoors (for barn or indust rial type areas), and for outdoor residential misting systems. Although the risk assessments we re complete, some additional uses that

did not fit into thes e two categories were brought to the Agency’s attention after the RED. In order to provide a complete set of label instructions for the other kinds of systems being developed, additional labeling is included in this Amendment for metered release devices in outdoor areas, and for indoor misting systems that may be used in commercial barns, stables, and animal quarters.