AND POLLUTION PREVENTION 

MEMORANDUM 

DATE: 

SUBJECT: 

TO: 

FROM: 

August 21, 2014 

Antimicrobial Division's Response to Public Comments on the Registration 

Review Preliminary Work Plan for Thiabendazole (PC Code 060101) 

Registration Review Docket 

Docket Number: EPA-HQ-OPP-2014-0175 

www.regulations.gov £~ 

James 

Thao Pham, 

Parker, 

Chemical 

Acting Team 

Review 

Leader 

Manager -;;:/£-..,/;c,t--- ~ ~ 

Regulatory Management Branc I 

Antimicrobials Division 

Najm 

Timothy 

Shamim, 

Leighton, 

PhD, 

Senior 

Chemist 

Hum~eal)h 

~~ 

ientist 

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William Erickson, Biologist ?h/f-.___ .. , . , 

Patricia 

Srinivas 

Jennings, 

Gowda, Microbiologist~~~-v 

Senior Enviro ental .... ~ Eng~· eer ~ ~~ 

Nathan Mottl, Biologist AI~ vwvr1 !"' 

Risk 

Jenny 

Assessment 

Tao, Toxicologist 

and Science 

~ 

Support Branch 

Antimicrobials Division 

THROUGH: Lance Wormell, Chief 

Regulatory Managemen Branch II 

Antimicrobials Division 

On March 28, 2014 EPA opened a 60-day public comment period on the preliminary work plan 

(PWP) for the registration review of thiabendazole. The comment period ended on May 27, 

20.14. During the public comment period the agency received two comments for the 

antimicrobial uses of tlll.abendazole. The comments received did result in a modification to the 

anticipated data needs in the Thiabendazole PWP. 

1 
surfaces/surface residues will be covered by the study referenced. 

AD Response: The indoor residue data (875.2300) is an ORE (occupational and residential 

exposure) study, as indicated by the table on page 7 of the PWP. However the specific uses 

that require this data (e.g., carpets) were not footnoted in the table. The table on page 12 of 

the PWP indicates that the study for indoor residue is based on the carpet use. On page 10, 

the first bullet indicates that the uses for carpets must be clarified as to whether the use is to 

treat carpet backing only. If that is the case, then no data are required. However, if the plush 

of the carpet is treated then a residue study is needed. Note: If no risks of concern are 

determined at 100% residue transfer, a data waiver request would be granted. 

2. Luanne Jeram, Lanxess Corporation 

Comment: Test protocol for Special Study, Non-guideline (Leaching from treated 

textiles): Submitter inquired if the special study would be a migration_ or leaching type test 

and if data developed from a European laboratory test method (EN 161 05) would be 

acceptable to satisfy the requirement. In addition, the submitter asked if any other test 

methods and protocols are recommended by the agency. 

AD Response: The leaching from treated textiles (i.e., clothing) is captured on page 7 as a 

"special study, non-guideline". The agency used this classification until recently, but now 

classifies the textile leaching studies as 875.2300. For the Final Work Plan the agency plans 

to change the textile study to 875.2300 and also list the two studies in the table (i.e., carpet 

plush and clothing). The agency recommends that the data submitter provide a protocol for 

review prior to conducting a study. The agency is available to discuss protocols as needed. 

Below are to two examples of leaching protocols that are available online. 

http:/ /pubs.acs.org/ doi/abs/ 1 0.1 0211 es40 15 844 

http:/ /publicationslist.org/data/nowack/ref-126/Lorenz%20%2820 12%29 .pdf 

2