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 considerati on 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) r odenticide products not complying with the Risk Mitigation D ecision. This limitation would apply to those registered both on and after the publica tion of the Federal Register announcing availability of the decision (June 4, 2008). R odenticide 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 ar e 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 fo r shipment unless subsequent activities, such as relabeling or repackaging, constitute produc tion." 40 CFR 152.3

As you see releasing a product for sh ipment means that production has been completed, but does mean that the product be so ld or distributed; in fact, absent any express requirement to the contrary, a pr oduct 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 parent hetical reference to "sell or distribute," the use of the defi ned term "released for shipment" three times in the criticalparagraph is evidence that the Agency has alr eady determined that the critical date is a "released for shipment" date, and not a "sell or di stribute" 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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