UN ITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: August 20, 2015 

SUBJECT: Forchlorfenuroa. Response to Comments Received Regarding Preliminary 

Work Plan 

PC Code: 128819 

Decision No.: 507320 

Petition No.: Not Applicable 

Risk Assessment Type: Not Applicable 

TXR No.: Not Applicable 

MRID No.: None 

DP Barcode: 0428393 

Registration No.: Not Applicable 

Regulatory Action: Registration Review 

Case No.: NA 

CAS No.: 68157-60-8 

40 CFR: § 180.569 

FROM: Alexandra Gavelek, Biologist /2 .... ~ William Donovan, Chemist :}J. 

THRU: 

TO: 

Linda Taylor, Toxicologist c;::r-~.,,,.~~f.Jf' f 

Matthew Lloyd, Industrial Hygienist 

Risk Assessment Branch V NII 

Health Effects Division (7509P) 

Office of Pesticide Programs 

Michael Metzger, Branch Chief 

Risk Assessment Branch V NII 

Health Effects Division (7509P) 

Office of Pesticide Programs 

Wilhelmena Livingston, Chemical Review Manager 

Kevin Costello, Risk Manager 

Pesticide Re-evaluation Division (7508P) 

Office of Pesticide Programs 

Attached is the Health Effects 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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Comment: KIM-Cl. LLC notes that the l lASPOC conclusion re lati ve to the immunotoxicity 

and neurotoxicity studies is consistent with formal waivers submitted by KlM-C I, LLC for these 

two studies (Immunotoxiciry-MRID No. 4908050 1, submitted 3/ 12/ 13; Acute and Subchronic 

Neurotoxicity-MRID No. 4896606, submitted 10110/ 12). KIM-Cl , LLC is providing this 

information as it is not clear that the HASPOC review incorporated this most recently submitted 

information. 

HED Response: HED thanks the registrant for this information. The information in the waiver 

requests was considered. No changes to the PWP are required at this time. 

Comment: While European Union MRLs for forchlorfcnuron do exist according to a relevant 

European Commission Regulation, those MRLs are generally not accepted as Codex MRLs. 

KIM-Cl , LLC has worked toward harmonization of U.S. forchlorfenuron tolerances with 

European Union M RLs. As an example, on August 6, 20 12 the European Food Safety Authority 

(EFSA) published a '·Reasoned Opinion" (Question No. EFSA-Q-2008-555) ("Reasoned opinion 

on the review of the existing maximum residue levels (limits) (MRLs) for forchlorfenuron 

according to Article 12 of Regulation (EC) No. 396/2005'', EFSA Journal 2012; I 0(8): 2862). 

EFSA was proposing to lower the European Union (EU) MRL for forchlorfenu ron in/on grapes 

from 0.05 ppm to 0.0 1 ppm. At that time KlM-C 1, LLC undertook a review of the EFSA 

Opinion, the treatments utilized in the EU trials and the associated supporti ng residue data and 

the residue data used to establish the U.S. Tolerances for forchlorfenuron (0.03 ppm on grapes). 

Data from both sources demonstrated it was unlikely that treated grapes (berries) or juice from 

those berries would exceed the EFSA proposed lower EU MRL of 0.0 l ppm. Nevertheless, for 

the sake of "harmonization" of M RL 's and in an abundance of cautioned, while agreeing on the 

proposed lowering of the MRI:, KIM-C 1, LLG gg~s~ed establishment of one MRL at 0.03 ppm. 

While EFSA acknowledged KIM-Cl, LLC's comments, currently, based on the EFSA Reasoned 

Opinion the EU MRL for forchlorfenuron in/on grapes (and on some other crops as well) is 0.0 I 

ppm. 

HEO Response: HED thanks the registrant for this information. The U.S. grape tolerance of 

0.03 ppm was based on field trial data showing residues above 0.0 I ppm. Thus. harmonization 

with the EU MRL of 0.01 ppm for grape is not possible. No changes to the PWP are required at 

this time. 

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