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US EPA-Pesticides; Profenofos UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF CH EMICAL SAFETY AN D POLLUTION PREVENTION MEMORAND UM DATE: 19-OCT-2016 SUBJECT: AMENDMENT TO: Profcnofos: Human Health Draft Risk Assessment (ORA) for Registration Review. PC Code: 111401 DP Barcode: D43547 1 Decision No.: 520865 Registration No.: 180-669 Petition No.: NA Regulatory Action: Registration Review RiskAssessment Type: Single Chemical/Aggr egate Case No.: 2540 TXRNo.: NA CAS No.: 41 198-08-7 MRJD 10.: A 40 CFR: §180.404 FROM: Sarah J. Levy, Chemist ~~~ . ~ Monique M. Perron, Sc.D., Toxicologist ~ Risk Assessment Branch I (RAB I) Health Effects Division (HED; 7509P) THROUGH: Christina Olinger, Acting Branch Chief / J,£~--z., George F. Kramer, Ph.D., Senior Chem~$ .:::::::: ;;.------ RAB 1/HED (7509P) TO: Christina Scheltema/Kelly Sherman Ri sk Management and Implementation Branch 53 Pesticide Re-Evaluation Division (PRO; 7508P) A human health draft risk assessment for registration review was conducted for the organophosphate (OP) profenofos [ 0-(4-bromo-2-chlorophenyl)O-ethyl-S-propyl phosphorothioate] on I 5-SEP-2015 (Memo, M. Perron, et al.; D4 I 4150). S ince th is assessment, the registrant has requested the following: cancellation of the sole technical and end-use product (EPA Registration Number 180-669) registered for profenofos in the U.S. and conversion ofthe established tolerances fo r residues in/on cotton commodities to tolerances without a U.S. registration. The registrant confirmed that Mexico is the only country that has a profenofos registered product where there could be potential for import (Letter and electronic correspondence from C. Levey ofSyngenta to C. Scheltema of PRD/HED; 28-SEP-2016 and I 5- JUL-2016). This document is an update to the previous assessment. Page I of39 Profenofos Dietary Exp sure and Ri sk Assessment DP umber: D4J547 I Table of Content 1.0 -- xeculive Summary ............................................................................................................. 4 2.0 1-iED R com1n ndatjon ...................................................... ....... .......................................... 5 2. 1 Data Defici ncies .. ........... .. .............................................................................................. r 2.2 Tolerance Considerations ...... ...... ... .... .... .... ....... ... ... ......................................................... 5 2.2. l nforcement nalytical Method ......... ... .................. ................................................. 5 2.2.2 lntemati nal Harmonizati n ............................ ....... ............. ................ ... .................. 6 2.2.3 Revisions to Estab li shed To leranc s... ...... ...... ...... ..... .. .. .................. .............. .. ... .... .. 6 2.3 Lab I Recommendati n ............... .. ................................................... .. ... .......... ... ............ 7 3.0 Introduction .. ............. ........................ .. ............................................................................... .. 7 3. I Chen1ical Id ntity .. ..... .......... ..... ..... ....... ........... .. .......... .............. ... ..... ......... ..................... 7 3.2 Ph ical/Ch mica] haract ri tics ............. ... ........................ ... ........................................ 8 3.3 Pesticide se Pattern ....... .... ............... ............................. ...... ........ ...... .. ............ .. ............. 8 3.4 Anticipated "' xposure Pathways ..................................................................................... .. 8 3.5 Consideration of En ironmental Justice ........ ...................................... .. ......... .. ............... 8 4.0 Hazard Characterization and Do e-Resp nse Ass sment ................. ................................. 9 4. 1 Toxicology Studies Availabl fo r Analys is .......... ... ........................................................ 9 4.2 Ab orption Distribution Metaboli sm & Excr tion (ADME) ................... ....... .. ........ .. 10 4.2.1 Dermal bsorpli n......... ...... .......... .. ........... ........... ...... ......... ..... ............................. 10 4.3 Tox ico logical Effect .. .. .... ........ ........ ..... ...... ....... .... ..... ...... ... .. ....................................... 11 ..., . I ritical Duration of Exposure ............. ~ .... ...................................... ..................... .. l 1 4.4 Literature R iew on eurod velopm nt ffect ................... .. .... ... ........ ...................... 12 4.5 Safety Factor for Infants and hildren (FQPA F)............ ..................... .. .. ........... .. ..... 17 4.5.1 omplet ness of the Toxicology Databa .............................................. ... ............ l 8 4.5.2 Evidence of eurotoxicity .. ...... ....... .... .............. ... .................................................. 1 4. 5.3 vidence of Sensitivity/ u cepti bi Iity in the Developing or Young Animal ......... 18 4.5.4 Residual · ncertaint in the Expo ure Database ..................................................... 18 4.6 Toxicity Endpoint and Point of Departure Selections .................................................... 18 4.6. 1 Dose-Re ponse Assessment. ............................. .. .................................................... 18 4.6.2 Recommendation for Combining Routes of Exposur s for Risk Ass ment.. ...... 20 4.6.3 ancer lassification and Risk sessment Recommendati n .... ........... .. ............. 20 4.6.4 ummary of Points of Departure and Tox icity Endpoints ed in Human Ri sk es 111 nt ................... ...... ..................................................................... .... ...... ....... ..... .. ...... 2 I 4.7 Endocrine Di ruption ................................................................................................... .. 22 5.0 Dietary Ex posure and Ri sk As essment ........ .. ................. ... .... .... ... ..... .. ... ... .. .. ... ..... .. ........ 23 5.1 Metabolite/Degradate Residue Profile ................................................ ........................... 23 5. l .1 ummary of Plan t and An imal M tabolism tudies ............................................... 23 5.1.2 ummary of Environmental Degradation ... .......... ..... ...... ... .... .... ... ... ...... .. .... ........ .. 24 5.1.3 ompari on of tabolic Pathwa s ....................................................................... 24 5. l.4 Residu of Concern ummary and Rationale ...... .. .... ... ......................... ..... ......... .. 24 5.2 Food Residu Profile ...................................................................................................... 25 5.3 at r Residue Profil ............................... ............ ......... ...... ......... ............ ... ......... ..... .... 25 5.4 Dietary Risk ssessment. .... ...... ....... ... ...... ...... .. .... ............... .. ........................................ 25 5.4.1 Description of Residue Data Used in Dietary Asse ment. .................................... 25 ~ .4.2 Percent rap Tr ated d in Di tary s ment ..... ........ ...... ........ ..... ........ ..... ... 25 5.4 .3 cute Dietar Ri k sses ment.. ............................................................................ 25 5.4.4 teady- late Di tary Ri sk Assessment ... ............ ... ........ .. .............. .............. ....... .... 26 5.4.5 ancer Di tar Ri k s ment.. ... ....................................................................... 26 6.0 Residential xposur /Risk haracterization .................................... 26 Pag 2 of 39 Profenofos Dietary Exposure and Risk Assessment DP Number: D435471 7.0 Residential Bystander Post-Application Inhalation Exposure ........................................... 27 8.0 Spray Drift ......................................................................................................................... 27 9.0 Aggregate Exposure/Risk Characterization ....................................................................... 27 10.0 Cumulative Exposure/Risk Characterization ..................................................................... 27 11.0 Occupational Exposure/Risk Characterization .................................................................. 27 12.0 References .......................................................................................................................... 28 Appendix A. Toxicology Profile.................................................................................................. 30 Appendix B. Summary of OPP’s Cholinesterase Policy & Use of BMD Modeling ................... 35 Appendix C. Summary Tables of Benchmark Dose (BMD) Analyses ....................................... 36 Appendix D. Physical/Chemical Properties ................................................................................. 38 Appendix E. International Residue Limits................................................................................... 39 Page 3 of 39 Profenofos Dietary Exposure and Risk Assessment DP Number: D435471 1.0 Executive Summary Background Profenofos is an organophosphate (OP) insecticide-miticide used for insect and mite control on cotton. There is only one end-use product label registered with profenofos as the active ingredient (ai) (EPA Reg. #100-669; Curacron® 8E Insecticide-Miticide). This product is formulated as an emulsifiable concentrate (EC), containing 73% ai or 8 lb ai/gallon. The
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