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July 6,2010

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Mr. Peter Caulkins, Acting Branch Chief

Pesticide Re-evaluation Division

Office of Pesticide Programs

U.S. Environmental Protection Agency

1200 Pennsylvania 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 ofthe 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 existing stocks 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 oftime 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

Agency has announced that any such products sold or distributed may be considered misbranded.

Your explanation was that the Agency expressly 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 Agency's objective in the RMD was to state that position, I submit that the revised

RMD not only fails to reflect that position but, to the contrary, expressly refers to such a six (6)

month existing stocks period.

6631381.1
Mr. Peter Caulkins

Pesticide Re-evaluation Division

U.S. Environmental Protection Agency

July 6,2010

Page 2 of3

Discussion ofImplementation Dates in the RMD

The RMD addresses the June 4, 2011 implementation date at two places. The first

instance appears at page 24 ofthe 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 ofthe 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 ofproduct 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 Agency'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 ofproduct with old labeling within six (6) months ofJune 4, 2011" directly contradicts the

statement that all sales ofsuch products by registrants must cease as ofthat date.

663J38 1.1
Mr. 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 ofJune 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 ofthe 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