Docket Number EPA-HQ-OPP-2014-0780 www .regulations
.gov



# Ethoxyquin Final Work Plan Registration Review: Initial Docket Case Number 3

Approved by:

Date: 

# June 2015

# ,~ Richard P. Keigwin, Jr. Director Pesticide Re-evaluation DivisionThese and other supporting documents for the ethoxyquin registration review case may be found in the docket EPA-HQ-OPP-2014-0780 at http: //www .regulation s. gov. 

### INT ROD UCT IO N This is the Environmental Protection Agency's (EPA or the Agency) Final Work Plan (FWP) for the registration review of ethoxyquin. This work plan addresses public comments received concerning the Preliminary Work Plan (PWP), which were posted in the ethoxyquin registration review docket (docket number EPA-HQ-OPP-20 14-0780). Ethoxyquin (1 ,2-dihydro-6-ethoxy2 ,2,4-trimethylquinoline) is an antioxidant registered for use as a deterrent of scald (browning) in pears. Ethoxyquin is applied through post-harvest indoor application via a drench/in-line spray treatment , thermal fogging , and/or impregnated wraps. All applications are made to pears in storage and prior to packing. There are no registered residential uses of ethoxyquin
. The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide , and Rodenticide Act (FIFRA), and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. Changes in science, public policy , and pesticide use practices occur over time
. The registration review program is intended to make sure that , as the ability to assess risk evolves and as policies and practices change , all registered pesticides continue to meet the statutory standard. The public phase of registration review begins when the initial docket is opened for each case. Information on this program is provided on the Agency ' s website
. The FWP begins with any updates since the PWP was issued. Next is a summary of substanti ve comments received during the public comment period for the PWP concerning planned data needs , expected risk assessments , or the estimated timeline identified in the PWP , and a summary of the Agency ' s responses to those comments . This section is followed by regi stration review planned data needs , risk assessments expected to be conducted , and the projected registration review timeline for ethoxyquin. Lastly , there is a discussion of next steps. 

### UPDATES SINCE THE PWP WAS ISSUE D There are no updates on the ethoxyquin registration review case since issuance of the PWP. 

### SUMMARY OF COMMENT S AND A GEN CY RE SPONSES During the 60-day public comment period on the Ethoxyquin Preliminary Work Plan , which opened on December 17 , 2014 and closed on February 17 , 2015 , the A gency received two public comments . Comments were submitted by the Northwest Horticultural Council (NHC) and the Physicians Committee for Responsible Medicine (PCRM)
. In the PWP , EPA also solicited comments on the specific topic of environmental justice but no comments or information were received on those issues. Summarized below are the public comments. The full comments in their entirety are located in the docket, EPA-HQ-OPP-2014-0780.

2Comment submitted by NHC in EPA-HQ-OPP-2014-0780-0007. 1. Comment: NHC commented on behalf of the Pear Bureau Northwest, representing pear growers, packers and shippers in the states of Oregon and Washington. The comment provided information on the use of ethoxyquin in pear packinghouses. NHC included a general waste water permit and an example of the NPDES waste discharge permit issued to pear packers
. They noted waste discharge permits issued to other pear packers are similar or identical to the one provided. Response: The agency thanks NHC for its comments. While the provided permits clarified questions for the agency, it did not negate the need for the requested risk assessments . The agency will keep its risk assessments requirements as is for the registrant Comment submitted by PCRM in EPA-HQ-OPP-2014-0780-0008. 1. Comment: PCRM agreed with EPA's request for a dermal penetration study. They suggested the use of the 

### in vitro method for this study. Response: The Agency thanks PCRM for its comment. Currently, HED policy does not accept the 

### in vitro dermal penetration data by itself as a substitute for the 

### in vivo dermal penetration data. PCRM is referred to the EPA guidelines in conducting an 

### in vivo dermal penetration study.

3PLANNE D D ATA NEE D S Table 1 below summarizes the planned data needs for ethoxyquin based on the 

### Registration Review : Preliminary Problem Formulation for Environmental Fate, Ecological Risk , Endangered Sp ecies, and Human H ealth Drinking Water Expo s ure Asse ssm entsfor Ethox y quin and 

### Ethoxyquin. Human Health Assessment Scoping Document to Support Registration Review . The planned data needs have not changed from what was included in the PWP. Ta ble 1 : Pl ann ed D ata Need s for th e E tho xy quin Regis trati on Review Estim ated Gu idelin e Study Title 1 Tim eframe Numb er1 Test Material (Month s from receipt of D CI) 835
. 1230 Leaching and adsorption/desorption TGAI 12 835
. 1240 835
.2120 Hydrolysis TGAI 12 835.2240 Photodegradation in water TGAI 12 835.4300 Aerobic aquatic metabolism TGAI 24 850
. 1300 Aquatic invertebrate life cycle (freshwater) TGAI 12 850
. 1400 Fish early-life stage (freshwater) TGAI 12 850.4400 Aquatic plant growth (aquatic va scular plant T EP 12 toxicity) , tier II 850.4500 Aquatic plant growth (non-vascular aquatic plant TEP 12 toxicity) , tier II 870.3465 90-day inhalation (rat) 2 TGAI 24 870 .7 600 Dermal penetration TEP 24 TGAI = techntcal grade active m gredient ; TEP = typical end-use product ;

RI SK ASSESSMENTS FOR REGI STRATION RE VIEW Table 2 below summarizes the planned registration review risk assessments based on the EFED Problem Formulation and HED Scoping Document. The planned assessments have not changed from what was included in the PWP.

1 On June 27 , 2012 , EPA announced certain revisions in harmonized guideline se rie s 850

- Ecolo gic al Ef f ects Tes ts

- including renumbering and other designations or chan ges for some guid eline studie s. See " Fin al Tes t Guideline s; OCSPP 850 Series ; Notice of Avail ability " 77 FR 38282 , June 27 , 201 2. http ://www .r eg ul ati ons. gov/# ! doc um entD etail; D= EP A-HQ-OPPT

-2009-0 15 4-0028 2 A 2 8-day inhalation study is expected to be required in lieu of a full 90-d ay inhalation to xicity study. 

### 4

### Tab le 2: Plann ed Ri sk Assess ments for th e Eth oxyq uin Registratio n Review Type of Risk Assess ment Co ndu ct? No tes Ecological and E nvironmental Fate Comprehensive ecological 

### y The limited nature of the application of ethoxyquin (species to be assessed may preclude the possibility of ecological exposure. include terrestrial and aquatic However, until uncertainties regarding wastewater organisms), including disposal and vapor ventilation at pear treatment endangered species facilities are addressed, the Agency will presume the need to assess ecological exposure and risk during registration review (see page 2 of the Problem Formulation for additional information)
. Incidents Will check for There were no reported ecological incidents for updates ethoxyquin, see page 7 ofthe Problem Formulation for additional information. 

### Human Health**'k"~ '~1'**  , '**~** Dietary Food N The 2004 human health risk assessment did not identify dietary risks of concern (from food only). An updated dietary risk assessment may be conducted during registration review if there are changes to endpoints, points of departure , safety factors, and/or exposure estimates
. Drinking water N The Agency anticipates evaluating the need for a drinking water assessment during registration review to incorporate any updates to the current use information
. Occupational Handlers (mixers, loaders, 

### y The most recent occupational assessment (2008) did app Iicators) not identify risks of concern . An updated Post-application 

### y occupational handler and post-application assessment is anticipated during registration review to incorporate information from the anticipated dermal and inhalation toxicity studies
. Residential Handlers N There are currently no registered residential uses for Post-application N ethoxyquin. A quantitative residential exposure assessment is not anticipated during registration review. The Agency anticipates evaluating the need for spray drift and volatilization risk assessment during registration review.

· Other Aggregate N An aggregate assessment is not anticipated during registration review because ethoxyquin is not registered for residential use .

5Cumulative 

### N Ethoxyquin has not been identified as a member of a cumulative group that shares a common mechanism of toxicity , therefore , a cumulative risk assessment is not planned. Tolerances 

### y EPA anticipates updating the US tolerance expression for ethoxyquin during registration review to reflect current policy. Incidents Will check for There were no reported human incidents for updates ethoxyquin. See page 8 of the Scoping Document and the 

### Ethoxyquin: Tier I Review of Human Incidents for more information
. Additional 

### human health and ecological information is requested for this registration review case. Areas of particular interest to EPA are described below:

• Although ethoxyquin is only applied indoor in pear storage and packing facilities , such facilities may be hosed down for cleaning purposes and may generate wastewater containing residues of ethoxyquin. Inform ation on the cleaning process and disposal of wastewater at treatment facilities is requested. • Ethoxyquin is applied via thermal fogging, and exposure to non-target organisms via residues in vapor and/or aqueous solution may occur as a result of ventilation
. Information on venti lation standards and practices at treatment facilities is requested. • Ecological incidents (non-target plant damage and avian , fish , reptilian , amphibian and mammalian mortalities) not already reported to the Agency. • Water quality monitoring data
. • Human incidents not reported to the Agency.
TIMELINE EPA has created the following estimated timeline for the completion of the flonicamid registration review in Table 3 below
. The projected timeline has not changed since the PWP
.

Table 3: Registration Review for Ethoxyquin- Projected Registration Review Timeline Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period 2014

- December Close Public Comment 2015

- February Case Development Final Work Plan 2015

- June Issue DCI 2015 Jul y- Sept. Data Submission 2017 July- Sept. 60-day Public Comment Period for Draft Risk 2019 Jan. -March Assessments 6Table 3: Registration Review for Ethoxyquin- Projected Registration Review Timeline Activities Estimated Date Registration Review Decision 60-day Public Comment Period for Proposed 2019 Oct.

- Dec. Registration Review Decision 3 Registration Review Decision and Begin Post-Decision 2020 Follow-up Total (years) 6
NEXT STEPS As noted previously, the Agency plans to require several environmental fate, ecological effects , and human health studies for ethoxyquin through a Data Call-In Notice, expected to be issued by September 2015.

3 The regulations governing Registration Review generally require the Agency to provide a public comment period of at least 30 calendar days for draft risk assessments ; see 40 CFR Part 155
. 53(c). For conventional pesticides , the Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments . 7