UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASH IN GTON , D.C

. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM 

### Jan 13 , 2016 SUBJECT: Thiram: Response to Comments on the Human Health Risk Scop ing Document in Support of Registration Review
PC Code: 07980 I DP Barcode: 430994 Deci s ion No.: 512617 Regi strati o n No.: NA Petition No.: A Regu latory Action: Registration Review Risk Assess ment Type: Single Chemical Aggregate Case No.: 0122 TXR No.: NA CAS No.: 137-26-8 MRID No. : NA 40 CFR: § 180. 132 

### FROM : Dennis McNeilly, Chemist/Risk Assessor 

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# ~~ Kelly O ' Rourke , Occupational/Residential Exp sure Assessor

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# fr(,(?**Yh~~** Hannah Pope-Varsalona, PhD, Toxicologist ·**~** 

### Risk Assessment Branch IV 

# l_ · - Health Effects Division (7509P)

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### THROUGH: Thurston Morton, Senior Chemist 

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Risk Assessment Branch 4 Health Effects Division (7509 P) /I Al ./J / 

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# Reave;:1~hD. Branch Chief 

# <fY !\/&{/ Ri sk Assessment Branch 4 , HED (7s09P) TO: Wilhelme na Livingston , PMT 60 Risk Management and Implementation Branch 4 Pesticide Reevaluation Division (7508P)

Attached is Health Effects Division's (HED) response to comments submitted on the human health risk assessment status update for thiram conducted as part of the Registration Review process (D42781 l, 8/20/15). A summary of submitted comments followed by HED ' s response is provided below. Comment : The Thiram Task Force recognizes the need for many of the studies listed as Anticipated Data Needs for the Thiram Registration Review. however, there are a few studies that the Thiram Task Force would like the Agency to reconsider. A turf transferable residue study is not needed.

Page l of 2Dislodgeable foliar residue studies in strawberries have been conducted for thiram. Usi ng conservative default values for turf transferabl e residues (TTR) in the human health risk assessment, post-application dermal margins of ex posure (MOEs) ranged from 850 to 1000 for children 6 to < 1 I years old, children 11 to < 16 years old, and adu lts. Th ese MOEs are well above the level of concern of I 00. It was further noted that the estimated residential turf post application exposure for golfing on treated go lf courses using default TTR was not minimal in comparison to the level of concern as the calculated MOE was not greater than 10 times hi gher than the level of concern. The TTF request that the Agency reconsider this data requirement as the lowest MOE was 850. Although not 10-fold higher , this MOE approaches I 0-fold greater than the level of concern based on conservative default values. Conducting this expensive study would not be expected to s ignificantly add to an already conservative risk assessment and the requirement for the TTF study s hould be recon sidered. HED Resp o n se: At the registrant' s request , EPA has reconsidered the requi rement for the turf tran sferrable residue s tud y and has confirmed that the data are necessary. In accordance with the updated (2007) Part 158 data requirements of the 40 CFR , turf transferrable res idue (TTR) data are required for all turf uses that could result in post-application exposure to treated turf. The g uidance for waiving these data was developed in consultation with the Office of General Council, with consideration given to the conservative nature of the standard/default res idue transfer values. The waiver criterion, requiring that MOEs are 10 times greater than the level of concern (LOC), was based on the data used to develop these standard/default residue transfer val ues. In the case of thiram , the LOC is 100; therefo r e , all MOEs would need to be 1000 or above in order for the TTR data waiver to be granted. The assessment of thiram ' s turfuse (go lf cou rse) yields an MOE of 850 for Children 6 to < 11 years old , which does not meet the criterion; therefore, the waiver may not be granted. Co mm en t: An error correction is requested , Taminco was granted an import tolerance for thiram on or in avocado in June 2015. Pages 4 , 9 and 11 shou ld indicate that this was an import tolerance. As written , it appears that a tolerance was granted for avocado applications in the US

. HED Respo n se: HED concurs that it could be clarified that the tolerances for avocado is for imported avocadoes only , i.e. , no US regi strations.

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