### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D
. C

. 20460



### MEMORANDUM Date: 08-JUL-2015 OFFICE OF C H EM I CA L SAFE TY AND POLLUTION PREV ENTIO N



### SUBJECT : Spiromesifen; Response to comments from B ayer Crop Science regarding HED 's most recent Human H ealth Registration Review Scoping Document. 

### PC Code: 024875 

### DP Barcode: 0427623 

### Decision No.: 505572 

### Registration No
. : NIA 

### Petition No.: NIA 

### Regulatory Action: NIA 

### Risk Assessment Type: NIA 

### Case No.: 7442 

### TXR No.: NIA 

### CAS No.: 283594-90-1 

### MRID No.: N IA 

### 40 CFR: §180

. 607 

### FROM: Sarah J. Levy , Chemist

# ~**~** \.(}_

# ~ 7<. /) / James S. Miller , Environmental

# He~\ th

# l§~**t ~**  ir- 

# )/Q/**~** Risk Assessment Branch I (RAB I) Health Effects Division (HED) (7509P) 

### THROUGH: Thurston G. Morton, Acting Branch Chief 

# C2 !:::::::za George F. Kramer, Ph.D., Senior

### Chemist**~~** RABl/HED (7509P)

### ~ TO: Julia Stokes, Risk Review Manager Registration Division (7505P) I. 

### CONCLUSIONS HED has read and acknowledged Bayer Crop Science's comments noted in its correspondence. The errors noted regarding spiromesifen usage will be changed. 

### II. ACTION REQUESTED Please address Bayer's comments regarding EPA 's most recent Human-Health Assessment Scoping Document in Support of Registration review (EPA Docket JD: EPA -HQ-OPP-2014- 0263).

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### III. BACKGROUND HED recently generated a Human Health Assessment Scoping Document in Support of Registration review for Spiromesifen (Memo, S
. Levy el 

### al., 15-JA N-2015; D422438). Bayer reviewed and generated comments/feedback related to HED's scop in g document. HED ' s responses are below. 

### IV
. HED'S RESPONSE TO COMMENTS Comment #1 (Human Safety Section): " Introdu ction, page 4: States that spiromes if e n is currently registered for use on a variety of crops and ornamentals as well as for use in homeowner /residential settings. The uses of spiromesifen products in residential are limited to professional applicators whether in nursery, gree nh ouse, commercial or residential landscapes
. Our label clearly states that applications s hould be made only by professional app lic ators. We would suggest removing any reference to homeowner. We agree with the lan guage used in the Use and Usage table (Page 7) of the preliminary work plan." HED ' s Response: HED agrees that app li cat ion in a ll registered settings are limited to professional applicators. This will be more clearly reflected in the registration review assessment. 

### Comment #2 (H um an Safety Section): "I ntrodu c ti on. page 4: Document indicates SLN r egistrati o ns wit h ornamentals. The r e are both agricultural and non-agricultural SLN registrations with sp iromesifen. Please see above list that reflects our understanding of cmrently SLN registrations." HED ' s Response: HED sta te d th at the current reg istrations also includ e special local ne ed (SLN) registrations on g reenhouse and nur sery ornamentals. In the registration review assessment , HED will clearly reflect that both agricultural and non-agricultural SLN's are registered. 

### Comment #3 ( Hum an Safety Section): "Attachmen t 4 Summary of Registered Uses page 22 : This table contains many inaccuracies even regarding product formulat i o n, uses , and applicati on methods. We subm it that it may have been er roneo us ly included and ha s too many errors to indi vidu ally correct. The HED Master Label report is fairly accurate and conside rin g the above comments s ho uld be used for any assessments. Our s umm ary use tables have been included in this document to assist th e agency . Those are attached in Appendix l
. " H ED ' s Response: HED acknowledges that this Table was erroneously included and will inclu de an accurate summary table in the registration rev iew assessment. 

### Comment # 4 (Tier 1 Review of Human Incidents): "We ag ree wi th th e EPA assessment th at the low frequency and low severity of incidents reported with sp irome sifen indicate that there does not appear t o be a concern at this time . " HED ' s Response: HED appreciates the feedback from Bayer.

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