### UN IT E D STATES EN VIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 

### OFFICE OF CHEMICAL SAFETY AND POLLUTION PR EVENTION
MEMORANDUM
Date: August 20, 2015
SUBJECT: 

### Forchlorfenuroa. Response to Comments Received Regarding Preliminary Work Plan

PC Code: 128819 Dec is ion No.: 507320 P eti t ion No.: Not Applicable Risk Assessment Type: Not Applicable TX R No. : Not Applicable MRID No. : None DP Barcode: 04 28393 Registration No.: Not Appl icab le Regulatory Action: Registration Review Case No.: NA CAS No.: 68157-60-8 40 CFR: § 180.569



### FROM: Alexandra Gave lek, Biologist 

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....**~** W illi am Donovan , Chemist

# :}J.

THRU:

TO: Linda Taylor, Toxicologist

### c;::r-**~.,,,.~~f.Jf' f**  Matthew Lloyd, Indu strial Hygienist Risk Assessment Branch V 

### NII Hea lth Effects Division (7509P) Office of Pesticide Programs
Michael Metzger , Branch Chief Risk Assessment Branch V 

### NII Health Effects Division (7509P) Office of Pestic ide Programs
Wilhelmena Livingston, Chemica l Review Manage r Kevin Costello, Risk Manager Pesticide Re-evaluation Division (7508P) Office of Pesticide Programs

Attached is the Health Effec ts Division 's (HED) response to comments received regarding the human health section of the Preliminary Work Plan (PWP) for forchlorfenuron to support the registration review process.

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### Co mm ent: K IM-Cl. LL C n otes that the l lAS POC conclusion r e la ti ve to th e immunoto xici t y and neurotoxicity stud ies i s co n s i sten t with formal waivers s ubmitted by KlM- C I , LLC 

### fo r these tw o s tudi es ( Immun o to x ic ir y-M RID No. 4908050 1 , s ubmitted 3/ 12/ 1 3; Acute and Subch r onic Neurotox icity-MRID No. 4896606, submitted 10110 / 1 2). KIM- C l , LLC is pro vid ing thi s in formation as it is not cl ea r that the HA S PO C re v i ew inc o rporat ed this mo s t recently s ubmitted information.


### HE D R es p on se : H E D thank s the regi stra nt for thi s in fo rmation. T he inform at ion in the waiver requ es t s wa s considered. 

### No c hange s to th e PWP 

### are req uired at thi s time. 

### Co mm e n t : Wh il e European Uni o n MRLs for forchlorfcnuron do exist according to a relevant European Commi ss io n Regu lation, those MRLs are ge n erally not accepted as Codex MRL s. KIM -C l , LLC h as worked towa rd harm o ni zation of U.S. forchlorfenuron to le r a n ces with E uro p ea n Union M RLs. As a n ex ampl e, o n August 

### 6, 20 12 the Eu r opea n F ood Safe ty A uth o rit y (EFSA) published a '· R easo n e d Opinion " (Questio n No. EFSA

- Q-2008-555) (" Reasoned opinio n o n the review of the ex i st in g maximum resid ue le vels ( limits ) (MRLs) for forc hl orfen u ron according to Article 

### 12 of Regu lation ( E C) No

. 396 /2005'', EFSA J o urnal 2012; 

### I 0(8): 2862). E FSA was pro p os in g to lower the European Union (E U) MRL for forchlorfenu r o n in/on g rap es from 0.05 ppm to 0

. 0 1 ppm
. At that tim e KlM- C 1 , LLC und ertook a review of the EFSA Opinion , the treatments utili zed in the EU tri a ls and th e associated suppo rti ng residue data and th e residue d ata u sed to es tab li sh the U.S. To le ran ces for fo rc hl orfe nuron (0.03 ppm on grapes). Data from both so urces dem o n s trated it was un likely that treate d g ra p es (berries) or juice from th ose berries would excee d the EFSA prop ose d lower EU MRL of 0.0 l ppm. Neve rthel ess, 

### fo r the sake of " h a rm on izati on" of M 

### RL 's and 

### in a n abu nd a nce o f caut ione d , w hil e agree in g on the proposed lowering of the MRI:, KIM-C 1 , LLG**gg~s~ed** establi shme nt of o n e MRL a t 0.03 ppm. While E FSA acknow led ged K IM-Cl, LL C's comments , c urre nt ly, based o n th e EFSA R easo n ed Opinion the EU MRL for forchlorfenuron in / on grapes (and on so m e othe r crops as well) is 0.0 I ppm. 

### HE O R es p o n se : HED thanks the re gistran t for this information. The U .S

. grape tolerance of 0.03 ppm was based on field tr ia l data s howing re s idu es above 0.0 I ppm
. Thu s. harmoni zat io n wi th th e EU MRL of 0.01 ppm fo r grape i s no t po ss ibl e. No changes to the PWP a r e requir ed a t thi s tim e.

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