Doc ket Nu m be r EPA-HQ -O PP-20 13

- 0360 www.regulati ons.gov



# Abamectin Final Work Plan Registration Review

Case Number 7430

December 2013

Approved by:

### ~"')(..'~ 

# e**v~~~ ;'** **h** Richard P. Keigw i n, Jr. Director Pe stic ide R e - eva luation Di v isi on

Date:

### INTRODUCTION This is the En vi ronmental Protectio n Agency's (EPA or the Agency) Final Work Plan (FWP) for the r egistration review of abamectin. This work plan addresses public comments received concerni n g the Preliminary Work Plan (P WP), wh i ch was posted i n the abamectin registration review docket (EPA-HQ-OPP-2013

- 0360). Abamecti n i s an in sectic ide/miticide/nemati c ide i n the avermectin chemical family of macrocylic lactones iso l ated from the so il organism 

### Streptomyces avermitilis. It i s registered for u se on various agricultural and non - agricu ltural use s ites. Agri cultural use sites include vari ou s stone and pome fruits, citrus, tree nuts, herbs, cucurbi ts, f ru iting and leafy vegetables, cotto n , plums, oni ons, and beans. Non-agric ul tural use sites include poultry houses, forest tre es, ornamental plants , lawns and turf, woody shrubs and v i nes, private and commerc i al domestic dwellings, rec reational areas, commercial transportation fac ili ti es, food and feed process i ng plants , eating estab li shments, dairy cattle, and distribution facilities. The Agency i s imp lementing the registration review program pursuant to Section 3(g) of the Fe deral In secti c ide, Fun g i c ide, and Rodenticide Act (FIFRA), and will rev i ew each reg i stered pesticide every 15 years to determi n e w h ether it conti nues to meet the FIFRA standard for registration. Changes in science, public po licy, and pesticide use practices occur over time. The registration review p rogr am is intended to make s ure that , as the ability to assess risk evo lves and as policies and practices change, all registe red pesticides conti n ue to meet the statutory standard. The public phase of r egistration rev i ew begins when the i nitial docket is opened for each case. Informat i on o n th i s program is provi ded on the Age n cy's webs ite
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### The FWP begins wi th any updates since the PWP was issued. Next is a summary of substantive comments received during t he pub li c comment peri od fo r the PWP concerning antic ipated data needs, expected risk assessments, or the esti mated timeli ne identified in the PWP, and a summary of the Agency's resp onses to those comments. This section i s followed by regis tration review planned data needs, risk assessments expec ted to be co nduc ted, and the projected registration review timeline for abamectin. Lastly, there is a discussion of next steps. UPDATES SINCE THE PWP WAS ISSUED The Agency is requi r in g an add iti on al guide li ne 8 50 .1 350 aquatic invertebrate life cycle (saltwater) study fo r registration review. The Agency has revisi ted th e exis t ing mysid shri mp chronic toxici ty test, MRID 40856306, and found that it does not give a valid endpoint for reproduction because of a solvent effect. The projected registration review t ime li ne has been updated s i nce the PWP to reflec t impacts of recent Agency acti ons shortening the timeframe between FWP and DCI issuance and addin g a quarter in between p ost ing of PRAs and proposed decisions. SUMMARY OF COMMENTS AND AGENCY RESPONSES During the 60 -d ay public comment period on the Abamectin Preliminary Wor k Plan , which opened on June 26, 2013 and closed on August 26, 2013, the Agency received 8 submissio ns .

1 http: //www.epa.gov / oppsrrd 1 / registration

_ review/ 

### 2Comments were subm itted by the technical registrant, Syngenta Crop Protection, the Unive rsit y of Hawaii at Manoa , the Western Integrated Pest Management Center, the Northwest Horticultural Council, the Washington State Potato Commission , the W isconsin Potato & Vegetable Growers Association, the Idaho P otato Commission , and the FIFRA Endangered Species Task Force (FESTF). Syngenta's comments addressed the planned ecological ri sk assessment , tec l mica l corrections to the Agency ' s problem formulation , and the planned Endangered Spec ies Assessment. The University of Hawaii at Manoa , the Western Integrated Pest Management Center, the Northwest Horticultural Council, the Washington Sate Potato Commission , and th e Idaho Potato Commission submitted additional use and usage information and inf ormat ion on typical application rates which the Agency reque sted in its Preliminary Work Plan. The Washington State Potato Commission, the Wisconsin Potato & Vegetable Growers Assoc iatio n , and the Idaho Potato Commission all expressed s upport of the continu ed registration of abamectin products and highlighted abamec ti n's importance to the potato industry in the north-west. FESTF commented that the technical regis tr ants, Syngenta Crop Protection, Cheminova Inc., and Nufarm Limited are FESTF members an d are ent it le d to rely on FESTF data for the planned Endangered Species Assessment. In the PWP, EPA also solicited comments on the specific topics of env ironmental justice , water quality concerns , and trade irritants, but no comments or information were received on those issues. This se ction does not capture every comment made about the PWP nor all of the Agency's responses. Summarized be l ow are publi c comments that resulted in changes to the anticipated registration review data needs, ri sk assessments , o r timeline , or are of a broader r egulatory nature
. Public comments and EPA responses in their entirety are located in the docket, EPA

HQ

- OPP-2013-0360. Summarized public comments and Agency responses related to the antici p ated ecological risk assessment or data needs are in the EFED Response to Public Comm e nts Submitted in Response to the Abamectin Registration Review Problem Formulation PWP wh il e those relevant to use and usage or those that address th e general registration review program for abamectin are in the Abamectin (PC Code 122804): PRD Response to Comments on Registration Review Preliminary Work Plan. There were no comments pertinent to the health effect s seepi ng document on the planned human health ri sk assessments. 

### Comments submitted by Syngenta Crop Protection in EPA

-HQ

- OPP-EPA -HQ-OPP -2 013

- 0360-0017. 1. Comment: The NOAEC value for the mysid shrimp should be 

### 0. 0035 #g a i l L rather than 

### 0. 00035 f-ig a i l L. Response: For MRlD 40856306, the stated NOAEC of 0.00035 )lg ai/L was based on reproduction whe n compa red to the negat ive control ; the NOAEC of 0.0035 )lg ai!L was bas ed on surviva l. EPA has revisited this study and determ ined that the s u rvival qata were acceptable , but the reproduction data were invalid because a solvent effect on reproduction w a s observed. Reproduction is the most sensitive endpoint for risk assessment and EPA i s requiring another guide line 850.1350 aquatic invertebrate life cycle (saltwater) study for a va lid NOAEC fo r reproduction.

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### PLANNED DATA NEEDS Table I below summarizes the planned data needs for abamectin based on the EFED 

### Registration Review Problem Formulation for Abamectin and the Abamectin. Human Health Assessment Scoping document in Support of Registration Revi ew. The tab le has been updated since the PWP to reflect the addition of guideline 850.1350 aquatic invertebrate life cycle (saltwater) to the data needs. Table 1: Anticipated Data Needs for the Abamectin R egistration Review Estimated Gu id eline Study Title 1 Timeframe Number2 Test (Months from Material receipt ofDCI) 835.2240 Photodegradation in water TGAI 12 835.2410 Photodegradation in soil TGAI 12 835.4100 Aerobic soil metabolism TGAI 24 835.4300 Aerobic aquatic metabolism TGAI 24 835.4400 Anaerobic aquatic metabolism TGAI 24 850.1300 Aquatic invertebrate life cycle (freshwater) TGAI 12 850.1350 Aquatic invertebrate life cycle (saltwater) TGAI 12 850.1400 Fis h early- life stage (saltwater) TGAI 12 850.2100 A vi an oral toxicity (passerine species) TGAI 12 850.2300 Av ian reproduction (bobwhite quail) TGAI 24 850.3030 Honey bee toxicity of residues on foliage T EP 12 850.3040 Field testing for pollinators T EP 24 850.4100 Seedling emergence TE P 12 850.4150 Vegetative vigor TEP 12 850.6100 Analytical method in water and sed iment3 TEP 12

Special Acute honey bee larval feeding study TGAJ 12 study Special Acute oral honey bee adult toxicity TGAI 12

study Special Whole se diment: chron ic invertebrates freshwater and TGAI 12

study marine 4 TGAI = techn1cal grade act1ve mgred1ent; TEP = typ1cal end-use product ;

2 On June 27 , 2012, EPA announced certain rev isi ons in harmonized guideline series 850

- Ecological Effects Tests

- including renumbering and other designations or changes for some gu ideline studies. See "Final Test Guidelines; OCSPP 850 Series; Notic e of Availability" 77 FR 38282, June 27 , 2012. http: //www . regulatio ns.gov/# ! documentDetaii;D = EP A-1-1 0-0PPT-2009-0 154-0028 3 Independent laboratory validations are needed for submitted env ironmental chemistry methods in water and

sediment. 4 Pl e ase refer to draft guidelines 850.1760 (Chironomus dilutus), 850 .1770 (H y ale/la azte ca), and 850

. 1780 (Leptocheirus plumulosus) for guidance pertaining to this anticipated data need. 

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### RISK ASSESSMENTS FO R REGISTRATION REVIEW During registration review, t he Agency will conduct a comprehensive eco log i ca l risk assessment, includi ng an endangered species asses sment , for all uses of a bamect i n. For human health, EPA will co nduc t a revised d i eta ry, occupational, and aggregate ris k assessments durin g registration review. I f toxicological endpoi nts or points of departure are revised for regis tr ation review, they will b e considered in the new assessments, as well as any changes to the standa rd operating procedures or default exposure assumptions. The Agency will also revise the abarnectin label s for consistency with re spec t to the restricted e ntry interval for grapes, environmental hazards l anguage, us e directions for fire ant bait /gr anules, and other ap p lication pa rameters as part of registration review. Table 2 be low summarizes th e registration review risk assessments th at w ill be co nducted based on the EFED Problem Formulatio n and HED Scoping Doc ument. 

### Table 2: Anticipated Risk Assessments for the Abamectin Re g is tration Review Type of R isk Assess m ent Conduct? No t es Ecological and Environmenta l Fate Compreh ensive eco lo gical 

### y (spec ie s to be assessed include terres trial and aquatic o rganism s), including endangered species Incidents 

### y For a d i scussion of re po rted ecolog ical incidents for abamectin, see page 1 2 of the Problem Formulation. Th e Agency will check for updates if ne w inc id ents occur. 

### Human Health Dietary Food N Acute an d chronic dietary exposure estimates for food Drinking water 

### y and drinking water from the 2012 r isk assessment were below the Agency's level of concern. Revised drinking water exposure estimates may be requi red with current modeling methods; estimates are not expected to change substantia ll y o r to result in dietary risks of concern. O c cupational Hand ler s (mixer s, loaders , 

### y The most recent occ upationa l assess ment s were applicators) p rotective of previously unassessed scenar i os. An upPost -application 

### y to-date quant itative occupational risk assessment may be required to account for any changes in application rates, unit exposures , transfer coeffic ients, endpoints , and safety fac t ors. Res identia l

5Handlers N There are no registered products that would lead to any residential handler risks. Pos t-application N Residential post-application exposure to adul ts and children are unlikely for all registered uses of abamectin. Other Aggregate 

### y Evaluates th e combined risk from dietary and res i dential exposures. The 2012 risk assessment did not identify exposure estimates of concern. A new aggregate risk assessment is not anticipated unless toxicological endpoints/points of departure are ' revised , the drinking water exposure estima te s change substantially, or the Agency develops new policies/procedures to calculate residential postapplication inhalation exposure. Cumulative 

### N Abamectin has not been identified as a member of a cumulative group that shares a common mechanism of tox i city

. Tolerances N Tolerances were re vised for several commodities in March 2013. No additional tolerance revisions are anticipated for registration review. Incidents Will check for For a discussion of reported human incidents for updates abamectin, see page 9 of the Scoping Document and the 

### Abamectin: Review of Human Incidents.

6TIMELINE EPA has created the following estimated timeline for the completion of the ab amecti n registration review i n Table 3 below. The projected timelin e has been updated since the PWP to refl ect imp acts of recent Agency actions shortening the timeframe between FWP and D C I issuance and adding a quarter in between posting of PRA s and proposed dec i sions

. Tab le 3: Registration Review for Abamectin- Projected Registration Review Timeline Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period June 20 I 3 -Compl et ed C lose Public Comment August 20 I 3

- Com pleted Case Development Final Work P lan December 2013

- Comp leted I ss ue DC I 20 14 January

-- March Data S ubmi ss i on 20 16 January

-- March 60-day Publi c Comment P eriod for Draft Ri sk Assessments ) 2017 Jul y- September Re g i stration R ev iew D ecision 60-day Publi c Co mment Period for Proposed Regi stration Re view 20 18 January

-- March Deci sion Registration Rev iew Decision and Begin Post-D ecision Follow-up 2019 T otal (yea rs) 6

N E XT STEPS As noted prev iously , the Age ncy plan s to r e quire several environme n ta l fate, e cological effects, and human health studie s for abamectin through a D ata Call

- In Notice , expected to be issued in ea rl y 2 014.

5 Th e reg ulations gove rning Registration Review generally require the Agency to provide a publ ic comment period of at l east 30 calendar days fo r draft ri sk assessments ; see 40 CF R Part 155 .53(c ). For conventional pesticides , the Age ncy plans to provi de a 60 calendar day public comment period ge nerally for draft risk assessments
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