Telisport W. Putsavage Partner
Dire ct Dial: 202- 623-570-1 E-mail : p utsavage @cl m. com 

### CARTER LEDYARD 

## & MILBURN LLP Counselors at Law
7

01 8th Street, N. 

### w. , Su ite 410 Washington, DC 20001-3893

T el (2 02) 898- 15 15 Fax (202) 8 98-152 1

July 6,2010 2 W all Stree t N

ew York, NY 10005-20 72 (212) 732-3200
5 7

0 lexington Ave nue New York

. N Y 10022-6856 (2 12) 371 -2 720

Sent Via Electronic Mail
Mr. Peter Caulkins , Acting Branch Chief Pesticide Re-evaluation Division Office of Pesticide Programs U .S. Environmental Protection Agenc y 1200 Penns ylvania Avenue , N.W. Washington , DC 20460 Dear Mr. Caulkins: I write in response to your letter of May 11 , 2010, responding to my inquiry concerning the final implementation date for products for which labels are being revised in accordance with the directions of the revised Risk Management Decision for Ten Rodenticides ("RMD ")(May 29 , 2008 , revised June 24, 2008 ). My inquiry pertains to products for which a label amendment was filed by December 4 ,2009. I sought to confirm that a six (6) month exi sting stock s period would follow the June 4 , 2011 implementation date established by the RMD

. Your response paraphrased my inquiry inaccurately , including a reference that I suggested that existing stocks could be sold for "some indefinite period of time thereafter," which was not the case. Your replied that "EPA intended that the June 4 , 2011 date listed in the RMD would be the last date on which registrants would 

### release for shipment, distribute or sell rodenticide products that do not incorporate the risk mitigation measures described in the RMD. " Thus June 4 , 2011 is not only the final release for shipment date , but also the date after which the Agenc y has announced that any such products sold or distributed may be considered misbranded. Your explanation was that the Agency expressl y structured the revised RMD so as to allow registrants " more flexibility in deciding when to cease production in order to cease distribution and sale by June 4, 2011."
If the Agenc y's objective in the RMD was to state that position, I submit that the revised RMD not only fails to refle ct that position but, to the contrary, expressly refers to such a six (6) month existing stocks period.

6631 3 81 .1Mr. Peter Caulkins Pesticide Re-evaluation Division U.S. Environmental Protection Agency July 6,2010 Page 2 of3



### Discussion of Implementation Dates in the RMD
The RMD addresses the June 4 , 2011 implementation date at two places. The first instance appears at page 24 of the RMD: 

### 3. Last Day for "Release for Shipment" of Product Not Complying with Risk Mitigation Decision (Deadline: June 4, 2011; 3 years from issuance of decision)
Pursuant to the terms of the voluntary cancellations, June 4 , 2011 would be the last day for registrants to "release for shipment" (sell or distribute) rodenticide products not complying with the Risk Mitigation Decision. This limitation would apply to those registered both on and after the publication of the Federal Register announcing availability of the decision (June 4 , 2008). 

### Rodenticide products that do not comply with this Risk Mitigation Decision that a registrant releasesfor shipment after June 4, 

### 2011, would be considered misbranded. [emphasis added]. While the conjoined use of the two distinct, defined regulatory terms "' release for shipment' (sell or distribute) " is ambiguous , under this provision a producer of affected rodenticides would be free at a minimum to release for shipment product bearing a pre-RMD label until June 4 ,2011

. The other statement of the June 4 , 2011 date in the RMD appears in Table 1 at page 30. Table 1 states: 

### Table 1 3 Years after Publication of the 

### Federal Register Notice Announcing the Availability of the Decision (June 4, 2011) If compan y has a product for which it requested revised labeling on or before December 4,2009, then it must 

### cease production of product with the old labeling and use up existing stocks of product with old labeling within six (6)months. Note: Failure to cease sale and distribution of existing stocks of product on this date would be unlawful acts under FIFRA subject to civil and/or criminal penalties. [emphasis added].
Your statement of the Agenc y's intention that all registrant sales must cease on June 4, 2011 is at odds with the text of Table 1

. The statement that registrants must " use up existing stocks of product with old labeling within six (6) month s of June 4, 2011 " directly contradicts the statement that all sales of such products by registrants must cease as of that date

.

6 63 J 38 1.1Mr. Peter Caulkins Pesticide Re-evaluation Division U.S. Environmental Protection Agency July 6 , 2010 Page 3 of3

The end result is that many registrants do not understand the Agency's position to be as you have stated it. Given the express statement that registrants must 

### " use up existing stocks of product with old labeling within six (6) 

### months of June 4, 2011, " I urge you to revise the position taken in your letter, recognize the existing stocks period prescribed in the RMD, and issue a confirmation of this clarification to registrants, directly and through the Agency rodenticide website. Whatever the Agency's ultimate position , a clarification of this ambiguity to registrants , directly and on the Agency rodenticide website, would appear to be a necessary component of the Agency 's transparency. Given the threat of misbranding actions if non-amended labels are sold beyond the prescribed, I suggest that it is incumbent upon the Agency to give affected rodenticide registrants a clear statement of the Agency's intentions. I would be happy to discuss this matter at your convenience.

cc: Scott Garrison, Esq., EPA Ms. Laura Parsons, EPA 

### Mr

. Russell Wasem , EPA Mr. Neal Anderson, EPA

663138 1.1