Page 1 of 3 Reader’s Guide to the Pyrethrins/Pyrethroid Cumulative Risk Assessment Docket # EPA

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Publication Date : November 9 , 2011

Purpose of this Reader’s Guide

The purpose of this note to reader is to provide an overview of the key information in EPA’s Pyrethrins/Pyrethroids Cumulative Risk Assessment and next steps associated with this group of chemicals. As noted, the Agency is requesting comment on this highly conservative cumulative assessment , inc luding additional information or data that may be used to further refine the assessment.

Summary of the Cumulative Risk Assessment

**•** EPA’s recently completed cumulative risk assessment indicates that exposure s from the many current uses of pyrethrins and pyrethoid insecticides do not pose risk concerns for children or adults.

**•** Further, there is ample room in the pyrethrins/pyrethroid cumulative “ risk cup ” to support consideration of new uses.

**•** EPA therefore is issuing th is final pyrethins/pyrethroid cumul ative risk
assessment and requesting comment, including information that may be used to further refine the assessment.

**•** Once EPA completes and approves pyrethroid single chemical assessments, it is likely that new uses of these pesticides will be added, t hat may alleviate challenging new pest management situations such as the invasive stink bug and bed bugs

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**•** EPA will update the individual pyrethrins and pyrethroid risk assessments as they come up for review. Endpoints for single chemicals may be differen t than those used in the cumulative assessment, since single chemical assessment endpoints are selected by analyzing the most sensitive effect observed in studies analyzing all body systems. By comparison, in evaluati ng the cumulative risk from pyrethroid s, EPA has selected an endpoint that reflect s the mode of action for this class of pesticides, specifically neurotoxicity.

**•** EPA’s screening level cumulative risk assessment c onsider s all registered uses of pyrethrins/pyrethroids and includ es exposure from f ood, drinking water and residential settings from the oral, dermal and inhalation routes of exposure.

**•** The Agency considers this cumulative risk assessment to be highly conservative because the assessment assumes that people are going to be exposed to the highest levels of residues in food, water, and in their homes all on the same day. For example

, in estimating residential exposure, t his screening level assessment assumed no dissipation of the chemicals, all individuals were exposed on the day of application, and exposure for each scenario occurred as a result of the pyrethroid with the highest risk estimate registered for that scenari o . ThePage 2 of 3 assessment also assumed co

- occurrence of certain residential scenarios as worst

case situations.

**•** The assessment shows that even if the highest levels of exposure were to occur, risk estimates for adults and children would be well below the Agency ’s level of

concern

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**•** The Agency has also reevaluated the need for a 10X FQPA safety factor for human health risk assessments for pyrethroid pesticides. Based on information available in the database of pyrethroid guideline studies and in the open literature, EPA is reducing the safety factor to 1X for adults, including pregnant wom e n. However, EPA is retaining a 3X for children based on age

- dependent toxico kinetics. Details of this decision are captured in a sep arate document available in the docket

, "Reevaluation of the FQPA Safety Factor for Pyrethroid Pesticides, D381210, June 27, 2011".

Current Status and Next Steps

While taking comment on the pyrethrins/pyrethroid cumulative risk assessment, EPA will beg in to finalize the evaluation of pending pyrethroid registration actions and process new requests for registration . EPA is working with registrants individually on timelines for completing their respective actions.

How to Submit Comments

EPA is providing an opportunity for interested parties to submit comments and input including any information or data that may be used to further refine the assessment. Submit c omments identified by docket number EPA

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, by one of the following methods.

**•** Federal eRulemaking Portal, http://www.regulations.gov : Follow the on

- line instructions for submitting comments

. Mail: Office of Pesticide Programs (OPP), Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Avenue, NW, Washington, DC 20460

- 0001.

**•** Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Room S

- 4400, One Potomac Yard (South Building), 2777 S. Cry stal Drive, Arlington, VA. Deliveries are accepted only during the Docket’s normal hours of operation (8:30 a.m. to 4:00 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is 703

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Related Information

The Pyrethrins/Pyrethroid Cumulative Risk Assessment and related documents are available in docket EPA

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- 0746 at Regulations.gov. The cumulative risk assessment is also available on the EPA Web page, Assessing Pesticide CumulativePage 3 of 3 Risk/ Common Mechanism Groups; Cumulative Exposure and Risk Assessment

, http://epa.gov/pesticides/cumulative/common_mech_groups.htm

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Contact for Additional Information

Ms. Dana Friedman Pesticide Re

- evaluation Division (7508P) Office of Pesticide Programs Environmental Protection Agency 1200 Pennsylvania Ave., NW Washington, DC 20460

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- 7070 E mail address : friedman. dana@epa.gov