UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D . C ., 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION MEMORANDUM

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To : PC Code: 111401 DP Barcode: 428847 August 27, 2015 Recla ss ification ofProfenofos Terrestr ial Plant and Chronic Avian Reproduction Ecotoxicol ogy Studies Michael Wagman, Biolo g is t



### ~~~'­ Environmental Risk Branc h 6 Environme nta l Fate and Effec ts Div ision (7507 P ) Mark Corbin , Branch Chief



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# n ((:,-L_f- ljEnv ironme nta l Ri sk Branch 6 

# \.i)( Environmental Fate and Effects Di v is i on (75 P) Christina Sc he ltema, Chemical Rev iew Manager Kelly Sherman, Branch Chi ef Ri sk Management an d Im plementatio n Branch 3 Pesticide Re-evaluation Di vis io n (7508P)
In preparation for the Reg is tration Revi ew draft risk assessment for profenofos (P C Code I 1 1401, 0414148 ), du e later thi s year, a revi ew of th e available ecotoxicologica l data was conducted
. While the c l ass ifi cat io n for many of the previously submitted s tudi es did not change after review (s till deemed "Acceptable") , th e cla ss ificati on for the available ter restrial plant (MRID s 41627 305 & 4 1 627307) and one avian c hro ni c reproduction (M RlD 00086661) studies d id change. The reaso n s for the change in the s tudy classifications was due to the use of t echnical grade active ingred ient (TGAI) as th e test subs tan ce in place of a typical end-use product (TEP) in th e t e rrest ri al plant studies and due to the lack of an acceptable N O AEC 

### in the avian reproducti on study. These study limitati ons introduce uncertainty in the ri sk assessment ' s ab ili ty to accurately assess ri s k to terrestrial plants an d c hronic ri sk to birds. EFED has reclass ifi ed the studies from "Acceptabl e" to "S uppl e mental " (e ither quantita tive or qualitativ e as described below)
. The li st of the studies and r ationale for reclassification of eac h study i s pro v ided below. Fo r terrestrial plants , add iti o na l data is not needed at this time. H owever , for c hronic risk to b irds , th e lack of an acceptable NOAEC results in the inability to determine a level of enviro nmental residues on d ietary items below wh ich risk could be precluded. Therefore, the lack of an acceptable chro ni c avian reprodu ctio n study wit h bobwhite quail is considered a majordata gap and new data would be needed in order to define an exposure leve l below which birds would not be considered to be at chronic risk. Table 1: Ecotoxicological dat a for Profenofos MRID GDLN & Study Title Stud y Remarks ' Classification 1 Study was previously identified as 850.4100 Supplemental acceptable. Study may be used 41627307 Seedling emergence quantitatively in risk assessment. See below for rationale for downgrade. Study was previously identified as 41627305 850.4150 Supplemental acceptable. This study may not be used Vegetative vigor quantitatively in risk assessment. See below for rationale for downgrade s. Sn1dy was previously identified as 00086661 2 850.2300 Supplemental acceptable. This study may not be used A vi an reproduction quantitatively in risk assessment. See below for rational e for downgrades. 1 O PPI N C lass ifi cat io n s : Acceptable; Acce ptable/Gu id e lin e; Acceptab l e/Non-Guideline; Cited; Confirmatory; Decision Deferred; Ext r aneous s ubmi ss ion ; G uid e lin e; In Review; minimum; No Decision ; Partia ll y Acceptable; Satisfacto r y; Screened-acceptab le for review; Sc r eened-not acceptable; S uppl eme nt a l ; S uppl e m e n taVNon-Gu id e lin e; Unacce pt ab le ; U n acceptab le/Guide lin e; U n acceptable/No n -G uid e lin e; Upgradea bl e. 2 EPA Accession Number; No MRlD number was ass igned for this study.
EFED has reviewed and reclassified the following studies submitted for profenofos (PC Code 111401):
• Chetram. R. 1990. Profenofos Tier 2 Vegetative Vigor Nontarget Phytotoxicity Study using Profenofo s Technical (Curacron) : Lab Project Number: LR90 -408. Unpub lished Study prepared by Pan-Agricultural Laboratories. Inc. 133 p . MRID 416273-05
. This Tier 2 vegetative vigor study, conducted with TGAI (90.4% purity) was initially determined to be acceptable with no effects observed at the highest dose tested ( 1.0 lbs a.i ./ A). However , EPA requires that terrestrial plant ecotoxicity studies be conducted with TEP formulations because the use of TGAI as the test substance may underestimate toxicity to plants. Typical end use products may include adjuvants or**surfac~ants** that increase the tox icity of the parent compound to terrestrial plants. Since this is a vegetative vigor test, designed to evaluate the effects to terrestrial p l ants from the spray drift of profenofos formulations where terrestrial plants are likely to be exposed to the entire fo rmulated product (i.e. profenofos plus any s urfactant s or adjuvants) , it is possible that terrestrial plants may be more sensitive than thi s stud y ind icates. Therefore , this study has been downgraded to supplemental and may only be used qualitatively in the risk assessment. However, a new study is not requested at this time since the available data indicate that profenofos i s comparatively less toxic to terrestrial plants than other taxa and would need be considerably more toxic than the available data indicates in order to result in a risk concern for terrestrial plants from spray drift.• Chetram, R. 1990. Profenofos: Tier 2 Seedl ing Emergence Nontarget Phytotoxicity Study using Profenofos Technica (Curacron): Lab Project Number: LR90-41 0. Unpublished Study prepared by Pan-Agricultural Laboratories, Inc. 135 p. MRID 416273-07. This Tier 2 seedling emergence study , conducted with TGAI (90.4% purity) was initially determined to be acceptable. However, EPA requires that terrestrial plant ecotoxicity studies be conducted with TEP formulations because the use of TGAI data may underestimate toxicity to plants, as is exp lained above
. TEPs may include adjuvants or surfactants that increase the tox icity of the parent compound to terrestrial p l ants . However , surfactants and other inert ingredients in TEP are like ly to disassociate from the test substance before reachin g the plant life stage tested in this study
. Therefore , this study has been downgraded to supplemental but may still be used quantitatively for risk assessment purposes.

• Fink, R
. and J.B
. Beavers
. 1978. Final Report: One-generation Reproduction Study

Bobwhite Quail: CGA-15324 Technical: Project No. 108-151. (Unpublished study received Nov. 6, 1981 under 100-598: prepared by Wildlife International. Ltd., submitted by Ciba

- Geigy Corp., Greensboro, N
. C
. ; COL: 246218-AB This chronic avian reproduction study was originally considered to be acceptable. However, EPA requires that chronic studies with avian species obtain a dose at which no s i gnificant adverse effects occur (the NOAEC). In this study , profenofos resulted in reproductive impairment (re duction in egg production and the viability of eggs) to bobwhite quail at all doses tested (lowest dose tested was 1 ppm). Therefore , this study has been downgraded to supplemental and may only be used qualitatively for risk assessment purposes. The lack of a valid NOAEC resu lt s in the inability to define a dose on dietary items below which no chronic effects would be expected. Therefore , this is considered a major data gap and a new avian reproduction study (OCSPP 850.2300 gu ideline) with bobwhite quail is needed
. 

### References: USEPA, 2015. Transm ittal of the Draft Environmental Fate and Eco logical Risk Assessment in Support ofthe Registration Review ofProfenofos (DP Barcode 414148). September, 2015
. USEPA/OCSPP/ OPP.