UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

Date: 08-JUL-2015 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

SUBJECT: Spiromesifen; Response to comments from Bayer Crop Science regarding HED's 

most recent Human Health 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.: NIA 40 CFR: §180.607 

FROM: Sarah J. Levy, Chemist ~ ~ \.(}_ ~ 7<. /) / 

James 

Risk Assessment 

S. Miller, E

Branch 

nvironmental 

I (RAB 

He~\ I) th l§~t ~ ir- )/Q/ ~ 

Health Effects Division (HED) (7509P) 

THROUGH: Thurston G. Morton, Acting Branch Chief C2 !:::::::za 

George 

RABl/HED 

F. Kramer, 

(7509P) 

Ph.D., Senior Chemist

~ 

~~ 

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: EP A-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-JAN-2015; D422438). Bayer 

reviewed and generated comments/feedback related to HED's scoping document. HED's 

responses are below. 

IV. HED'S RESPONSE TO COMMENTS 

Comment #1 (Human Safety Section): " Introduction, page 4: States that spiromesifen 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, greenhouse, commercial or residential landscapes. 

Our label clearly states that applications should be made only by professional applicators. We 

would suggest removing any reference to homeowner. We agree with the language used in the 

Use and Usage table (Page 7) of the preliminary work plan." 

HED's Response: HED agrees that application in all registered settings are limited to 

professional applicators. This will be more clearly reflected in the registration review 

assessment. 

Comment #2 (Human Safety Section): "Introduction. page 4: Document indicates SLN 

registrations with ornamentals. There are both agricultural and non-agricultural SLN 

registrations with spiromesifen. Please see above list that reflects our understanding of cmrently 

SLN registrations." 

HED's Response: HED stated that the current registrations also include special local need (SLN) 

registrations on greenhouse and nursery ornamentals. In the registration review assessment, 

HED will clearly reflect that both agricultural and non-agricultural SLN's are registered. 

Comment #3 (Human Safety Section): "Attachment 4 Summary of Registered Uses page 22: 

This table contains many inaccuracies even regarding product formulation, uses, and application 

methods. We submit that it may have been erroneously included and has too many errors to 

individually correct. The HED Master Label report is fairly accurate and considering the above 

comments should be used for any assessments. Our summary use tables have been included in 

this document to assist the agency. Those are attached in Appendix l ." 

HED's Response: HED acknowledges that this Table was erroneously included and will include 

an accurate summary table in the registration review assessment. 

Comment #4 (Tier 1 Review of Human Incidents): "We agree with the EPA assessment that the 

low frequency and low severity of incidents reported with spiromesifen indicate that there does 

not appear to be a concern at this time." 

HED's Response: HED appreciates the feedback from Bayer. 

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