1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460

OFFICE OF PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES

May 14, 2009

MEMORANDUM

SUBJECT: Response to Comments, Revised Label Ta ble, and Appendices. The Special Review and Reregistra tion Division’s (SRRDs) Response to

Comments and Attachments on EPA’s Reregistration Eligibility Decision (RED) Document for MGK-264 (OPP Docket #OPP-2005-0040).

FROM: Cathryn O’Connell, Chemical Review Manager Reregistration Branch II Special Review and Re registration Division

Through: Margaret Rice, Branch Chief Reregistration Branch II Special Review and Reregistration Division

TO: Richard P. Keigwin, Jr.

Director Special Review and Re registration Division

This document is EPA’s response to public comments that were directed towards product labeling, risk mitigation, or the upcom ing registration review process for the pyrethroids, pyrethrins, and synergist chem icals. These comments were submitted during the post-RED period of the public participation process of the MGK-264 RED.

The documents responding to public comments on the human health and ecological risk assessments can be located in the MGK-264 docket.

Comments were received from the Ca lifornia Regional Water Quality Control Board, California Stormwater Quality Associ ation (CASQA), County Sanitation Districts of LA County, MGK Company, as well as individuals.

The following comments and responses have been grouped by these topic areas: (1) water contamination, (2) registration revi ew of pyrethroid chem icals, and (3) other comments and (4) labeling changes. A re vised label table along with complete appendices accompanies this document and reflects the changes to the RED.2 Attachments:

• MGK-264 Revised Label Table

• Appendix A: Uses Supported for Reregistration

• Appendix B: Generic Da ta Requirements Table

• Appendix C: Technical Support Documents

• Appendix D: Data base Citations

• Appendix E: EPA’s Acut e Toxicity Batching3 SRRD’s Response to Public Comments to the MGK-264 Reregistration Eligibility Decision

I. 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 MGK-264 RED was finali zed, 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 was required in the MGK-264 RED, and the intention is the same for both statements, to help consumers use thes e products correctly

in order to minimize environmental risks. Therefore, the MGK-264 RED labeling will be 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 MGK-264 products for professional use should have language on the labels to pr event the run-off of MGK-264 residues down storm drains. Therefore, in addition to the revisions made to the Environmental Hazards statements, the following statements have been added to the amended MGK-264 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 pyrethroids and synergists down the drain after using pet shampoos, discharging of water used to clean surfaces that were treated with MGK-264, and washing materials that have been treated 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 treatment4 agencies for uses that may result in a discharge down-the-drain, and how to dispose of water containing MGK-264.

SRRD Response: Through various labeling initiativ es (some discussed below), OPP hopes to reduce the overall amount of MGK-264 discharged into both storm water and sewage drainage systems. However, at this time, the Agency does not believe additional aquatic environmental hazard statements, sim ilar to the environmental hazard statements on outdoor products, is appropria te on indoor use products since local sewage treatment plants may not be equipped to deal with many consumer calls.

II. 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 and synergists are not scheduled for Re gistration Review until 2010, and mitigation would not occur until 2011. They state that this puts municipalities in an untenable position because they must comply with th e Clean Water Act immediately. CASQA requested Registration Review be initia ted immediately for the pyrethroids and synergists, or a special review be initiate d. Additionally, according to the Water Board, pyrethroids are anticipated to be the caus e 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 it would be prudent to initiate the Registra tion Review of the PPS chemicals any earlier than currently scheduled.5 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 trans port of pyrethroids and synergists to surface water, the conceptual model of how urban transport should be simulated will be more

focused.

Comment: CASQA commented that U.S. EPA may be generating a “Data Call-In” (DCI) for pyrethroids and synergists to provide data for future pyrethroids and synergist reviews. They appreciate that U.S. EPA recognizes that data critical to managing risks from pyrethroids is currently not available and that EPA intends to require that pyrethroid manufacturers provide the needed data. Among data needed for pyrethroids water quality management, CASQA believes the following inform ation is high priority: data to support urban runoff modeling, application instructions , and aquatic sediment data. In addition, the California Department of Pesticide Regulation (DPR) has initiated a data call in process 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 recommends that U.S. EPA coordinate with DPR in developing the DCI. CASQA asks U.S. EPA to request, obtain, and review all data submitted to DPR. CASQA stands ready to provide formal 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 and synergist 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 synerg ists 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, and6 Rodenticide Act’s goal of preventing unreasonable adverse impacts from pesticide use. The CA Regional Water Control Board, San Fr ancisco 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 disc uss 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 MGK-264, 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 MGK-264. The Agency also recognizes that it need s 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.

III. Other Comments

Comment: MGK Company submitted several comm ents related to data that have already been submitted to fulfill some of the listed outstanding data requirements.

SRRD Response: At the time of the RED these da ta had not yet been reviewed and determined to be acceptable. Registrants may cite these data when responding to the

Data Call-In.7 Comment: The use of metered release devi ces was limited in the MGK-264 RED to areas where children and other sensitive populat ions may be present like day-care centers and schools. MGK Company requests EPA clar ify that use of these devices is still permitted in kitchens of these sites, just not in any area where children or the elderly may be present.

SRRD Response: The purpose of the RED mitigation to restrict application of metered release products was to prevent sensitive populations from being exposed to these

devices. Other areas of these institutions wh ere children, the elderly, or other sensitive populations are not present, which may incl ude kitchens, are not subject to this restriction. The Agency has included two labeling statements to clarify how these devices may be used. The two statements are copied below and included in the label

table.

“Not for use in residential areas.”

“Do not use in nurseries or rooms wher e infants, ill, or aged persons are present.”

IV. Labeling Changes:

Dermal Mitigation

Based on a review of a 21-day dermal t oxicity study which was required in the MGK-264 RED, no dermal risk assessments ar e needed for exposures to MGK-264. All dermal mitigation specified in the 2006 RED is no longer required and the label table has been revised to reflect these changes. Please see the HED Response to Comments on

MGK-264 (Donovan, W. and Doherty, J ., 3/6/2007) for details.

Other 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.

• In the 2006 RED some label language was developed for metered release systems indoors (for barn or industri al type areas). Although the risk assessments were complete, some additional uses that did not fit into this categ ory were brought to the Agency’s attention after the RED. In order to provide a co mplete set of label instructions for the other kinds of systems being developed, additional labeling is

included in this label table for indoor misting systems that may be used in commercial barns, stables, and animal quarters.