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 ris k 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 da te is "released for shipment" date. I have attached an excerpt from Table 1 of the Risk Mitigation Decision, appearing at page 30, which pert ains to products for which revised labeling was requested by D ecember 4, 2009. The Table's statement that as of June 4, 2011 registrants of such products must "cease production of product w ith 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 st op sale date. Ceasing production is the same as no longer rel easing 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 releasi ng 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

p utsavage@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 pertin ent parties in the Pesticide Programs Office agree.before we giv e 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 

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9/21/2010 file://C:\Documents and Settin g s\rwasem\Local Settin g s\Tem p \notesFCBCEE\~web8056.htmp utsavage@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 Miti gation 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 Fe deral Register announcing availability of the decision (June 4, 2008). Rodenticide products that do not comply with this Risk Mitiga tion 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

p hysically separated and marked as not yet released for shipment . Once a product becomes released for shipment, the product rema ins 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 pr oduction has been completed, but does mean that the product be sol d or distributed; in fact, absent any express requirement to the contrary,

a
p roduct released for shipment may be held indefinitely. With particular regard to rodenticide products for which required amen dments were submitted by December 4, 2009, the determination of whether the rodenticide risk mitigation measures require non-confor ming product not to be released for shipment after June 4, 2 011, 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 f or shipment" three times in the critical paragraph is evidence that the Agency has already determined that the critical date is a "rel eased 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

p utsavage@clm.com
www.clm.com

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9/21/2010 file://C:\Documents and Settin g s\rwasem\Local Settin g s\Tem p \notesFCBCEE\~web8056.htm

# 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.