Rodenticides: "Released for Shipment" Deadline 

Putsavage, Telisport W. 

to: 

Laura Parsons 

04/20/2010 05:53 PM 

Cc: 

Scott Garrison, Russell Wasem 

Show Details 

Ms. Parsons, 

 I write to follow up on our earlier exchange regarding the meaning of the iimplementation date for the rodenticide risk mitigation measures. The period of time being taken to confirm the 

Agency's position suggests to me that perhps everyone was not of the same mind on this point. 

 I w anted to also point out another aspect of the document that conforms to the interpretation that the June 4, 2011 date is "released for shipment" date. I have attached an excerpt from Table 1 

of the Risk Mitigation Decision, appearing at page 30, which pertains to products for which revised labeling was requested by December 4, 2009. The Table's statement that as of June 4, 2011 

registrants of such products must "cease production of product with the old labeling and use up existing stocks of product with old labeling within six (6) months" is consistent with the position that 

the June 4, 2011 date is a "released for shipment" date, not a stop sale date. Ceasing production is the same as no longer releasing product for shipment. The Table does add an existing stocks date of 

6 months after June 4, 2011, which is not mentioned in the body of the Decision. That would make December 4, 2011 the stop sale date for existing stocks released for shipment as of June 4, 2011.

 We look forward to the Agency's confirmation that as to this class of products June 4, 2011 is the deadline for releasing product for shipment. 

 Thank you again for following up on this matter. 

Regards, 

Telisport Putsavage 

Telisport W. Putsavage 

Partner 

Carter, Ledyard & Milburn LLP 

701 8th Street NW, Suite 410 

Washington DC 20001 

V 202.623.5704 

F 202.898.1521 

M 202.466.3700 

putsavage@clm.com 

www.clm.com 

-----Original Message----- 

From: Parsons.Laura@epamail.epa.gov [mailto:Parsons.Laura@epamail.epa.gov] 

Sent: Monday, April 05, 2010 5:23 PM 

To: Putsavage, Telisport W. 

Cc: Garrison.Scott@epamail.epa.gov; Wasem.Russell@epamail.epa.gov 

Subject: Re: Rodenticides: "Released for Shipment" 

Mr Putsavage, 

I should be able to get back to you in the next few days. 

My managers want to discuss it to make sure that all the pertinent parties in the Pesticide Programs Office agree.before we give you an answer for your clients. 

Best regards, 

Laura Parsons 

Pesticide Re-evaluation Division 

Office of Pesticide Programs 

. 

 From: "Putsavage, Telisport W." <Putsavage@clm.com> 

 To: Laura Parsons/DC/USEPA/US@EPA 

 Cc: Scott Garrison/DC/USEPA/US@EPA 

 Date: 04/05/2010 05:11 PM 

 Subject: Rodenticides: "Released for Shipment" 

Ms. Parsons, 

 I am writing to see if you have made any headway consulting with Scott Garrison on this matter. 

Telisport Putsavage 

Telisport W. Putsavage 

Partner 

Carter, Ledyard & Milburn LLP 

701 8th Street NW, Suite 410 

Washington DC 20001 

V 202.623.5704 

F 202.898.1521 

M 202.466.3700 

Page 1 of 2

file://C:\Documents and Settings\rwasem\Local Settings\Temp\notesFCBCEE\~web8056.htm 9/21/2010
putsavage@clm.com 

www.clm.com 

From: Putsavage, Telisport W. 

Sent: Thursday, March 25, 2010 6:40 PM 

To: 'parsons.laura@epa.gov' 

Subject: Rodenticides: "Released for Shipment" 

Ms. Parsons, 

 Thank you for taking time today to speak with me regarding the 

implementation of the Rodenticide Risk Decision. As part of your 

consideration and consultation with Scott Garrison, I thought I would pass along the following points. 

 The critical text of the Decision with respect to my inquiry appears at Section VII A, Timeline for Compliance: 

 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 releases for shipment after June 4, 2011, would be considered misbranded. [Italics added] 

 The EPA definition of released for shipment reads as follows: 

"Released for shipment . A product becomes released for shipment when the producer has packaged and labeled it in the manner in which it will be distributed or sold, or has stored it in an area where 

finished products are ordinarily held for shipment. Products stored in an area where finished products are ordinarily held for shipment, but which are not intended to be released for shipment must be 

physically separated and marked as not yet released for shipment. Once a product becomes released for shipment, the product remains in the condition of being released for shipment unless 

subsequent activities, such as relabeling or repackaging, constitute production." 40 CFR 152.3 

 As you see releasing a product for shipment means that production has been completed, but does mean that the product be sold or distributed; in fact, absent any express requirement to the contrary, 

a 

product released for shipment may be held indefinitely. With particular regard to rodenticide products for which required amendments were submitted by December 4, 2009, the determination of 

whether the rodenticide risk mitigation measures require non-conforming product not to be released for shipment after June 4, 2011, or no longer be sold after that date, is a critical distinction. I 

would contend that notwithstanding the parenthetical reference to "sell or distribute," the use of the defined term "released for shipment" three times in the critical paragraph is evidence that the 

Agency has already determined that the critical date is a "released for shipment" date, and not a "sell or distribute" date. 

 I look forward to hearing back from you on this matter. Thank you again for looking into it. 

Telisport Putsavage 

Telisport W. Putsavage 

Partner 

Carter, Ledyard & Milburn LLP 

701 8th Street NW, Suite 410 

Washington DC 20001 

V 202.623.5704 

F 202.898.1521 

M 202.466.3700 

putsavage@clm.com 

www.clm.com 

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Page 2 of 2

file://C:\Documents and Settings\rwasem\Local Settings\Temp\notesFCBCEE\~web8056.htm 9/21/2010
Excerpt from EPA Risk Mitigation Decision for Ten Rodenticides 

[June 24, 2008] 

Table 1 

3 Years after Publication of the Federal Register Notice Announcing the 

Availability of the Decision (June 4, 2011) 

If company ... 

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.