BEVERIDGE ~

&DIAMOND~

Kathryn E.Szmuszkovicz

1350 I Street, N.W.

Suite 700

Washington, D.C. 20005-3311

Direct: (202) 789-6037

Fax: (202) 789-6190

kes@bdlaw.com

July 30, 2010

By E-Mail And Hand Delivery

Stephen A. Owens

Assistant Administrator

Office of Chemical Safety and

Pollution Prevention

U.S. Environmental Protection Agency

Washington, DC

Colin Scott Fulton

General Counsel

Office of General Counsel

U.S. Environmental Protection Agency

Washington, DC

Re: Special Review Status of EPA's Current Atrazine Review

Dear Mr. Owens and Mr. Fulton:

Thank you in advance for considering and responding to this letter. I am writing on

behalf of Syngenta Crop Protection, Inc. (Syngenta) to request that EPA clarify and confirm the

special review status of EPA's current atrazine review and thus that the current review is subject

to the special procedures that Congress enacted and EPA promulgated for special reviews.

Respecting these procedures is an important part of ensuring that EPA's scientific and regulatory

evaluations and proposals are developed and implemented in an exacting and fair way, and that

Syngenta's procedural rights as a regulated party are fully protected.

The Agency's actions involving atrazine confirm the special review status of the current

evaluation. EPA initiated a special review of atrazine in November 1994. EPA stated that it was

doing so based on its concerns about the potential carcinogenicity of atrazine and other triazine

pesticides, the potential for exposure through food and drinking water, and the potential for

exposure to applicators, mixers/loaders, and users of products containing those chemicals. EPA

stated that it would incorporate ecological concerns into the special review if information

indicated such a review was appropriate. See Atrazine, Simazine, and Cyanazine; Notice of

Initiation of Special Review, 59 Fed. Reg. 60412 (November 23,1994). EPA's public records

show the Agency's special review activities through the intervening years. During this time,

EPA reregistered atrazine under FIFRA Section 4 with the issuance of its final atrazine

Washington, D.C. Maryland New York Massachusetts New Jersey Texas California

BEVERIDGE &

&DIAMOND~

Kathryn E. Szmuszkovicz

1350 I Street, N.W.

Suite 700

Washington, D.C. 20005-3311

Direct: (202) 789-6037

Fax: (202) 789-6190

kes@bdlaw.com

July 30, 2010

By E-Mail And Hand Delivery

Stephen A. Owens

Assistant Administrator

Offce of Chemical Safety and

Pollution Prevention

U.S. Environmental Protection Agency

Washington, DC

Colin Scott Fulton

General Counsel

Office of General Counsel

U.S. Environmental Protection Agency

Washington, DC

Re: Special Review Status of EPA's Current Atrazine Review

Dear Mr. Owens and Mr. Fulton:

Thank you in advance for considering and responding to this letter. I am writing on

behalf of Syngenta Crop Protection, Inc. (Syngenta) to request that EPA clarify and confirm the

special review status of EPA's current atrazine review and thus that the current review is subject

to the special procedures that Congress enacted and EPA promulgated for special reviews.

Respecting these procedures is an important part of ensuring that EPA's scientific and regulatory

evaluations and proposals are developed and implemented in an exacting and fair way, and that

Syngenta's procedural rights as a regulated party are fully protected.

The Agency's actions involving atrazine confirm the special review status of the current

evaluation. EPA initiated a special review of atrazine in November 1994. EPA stated that it was

doing so based on its concerns about the potential carcinogenicity of atrazine and other triazine

pesticides, the potential for exposure through food and drinking water, and the potential for

exposure to applicators, mixers/loaders, and users of products containing those chemicals. EPA

stated that it would incorporate ecological concerns into the special review if information

indicated such a review was appropriate. See Atrazine, Simazine, and Cyanazine; Notice of

Initiation of Special Review, 59 Fed. Reg. 60412 (November 23,1994). EPA's public records

show the Agency's special review activities through the intervening years. During this time,

EP A reregistered atrazine under FIFRA Section 4 with the issuance of its final atrazine

Washington, D.C. Maryland New York Massachusetts New Jersey Texas California
BEVERIDGE &DIAMONDl'c

Mr. Owens and Mr. Fulton

July 30,2010

Page 2

Reregistration Eligibility Decision (RED) in April 2006. Even so, the Agency has continued to

indicate through the years, including recently, that the special review remains open and ongoing. I

In the fall of2009, EPA announced its plans to conduct what it called a comprehensive

evaluation of atrazine over the next year. October 7, 2009 Press Release, "EPA Begins New

Scientific Evaluation of Atrazine." EPA described the current evaluation as "a special

comprehensive scientific re-evaluation." Atrazine Science Reevaluation: Potential Health

Impacts (October 7, 2009).

Despite the obviousness of the special review status of its evaluation, EPA has not been

consistently, explicitly clear about this. It placed minutes of its calls with stakeholders about the

initiation of the current review into the Agency's Special Review docket. Yet, the Atrazine

Updates portion of EPA's website does not reference the ongoing special review, and EPA's

discussion on that site of the "Atrazine Evaluation Process" asserts only that "[a]trazine's reevaluation process has always been dynamic, not static." See Atrazine Updates, available at

http://www.epa.gov/oppsrrdl/reregistrationlatrazine/atrazine_update.htm.

It is important that EPA confirm the special review status of the current evaluation at this

time. A new Scientific Advisory Panel (SAP) meeting on atrazine will begin -September 14,

2010. EPA has stated that it plans to issue its "charge" documents to the SAP for that meeting in

mid-August. While there are also two additional SAPs which EPA has stated will occur in 2011,

we understand from EPA's public statements that its submission to the September SAP may

include proposed determinations on which EPA would seek the SAP's review and advice. In

that regard, public statements by EPA officials, including comments offered on June 15,2010 by

EPA's Deputy Associate Administrator of the Office of Policy, Economics, and Innovation, have

indicated that EPA plans to present its "conclusions" with respect to atrazine for review by the

September SAP.

It is critical to the integrity of EPA's review that the Agency be transparent about the

procedural status of the current evaluation so that the ground rules of the proceedings and the

implications of the proceedings are well understood and appreciated by all involved. In light of

the upcoming mid-August time line for EPA's charge submission for the September SAP,

Syngenta requests that EPA confirm the special review status of the current evaluation within 14

days of receipt ofthis letter. Syngenta also requests that EPA promptly post this letter on the

atrazine special review docket.

I See, e.g., Transcript of November 3, 2009 SAP Hearing pp. 111-112 (testimony of Dr.

Bradbury stating that the 1994 atrazine special review remains open pending the final results of

the Agricultural Health Study); Letter from Stephen Owens to Rep. Melancon (April 15, 2010)

(stating that the 1994 special review remains open); Letter from Stephen Owens to Rep. Peterson

(April 6, 2010) (same).

BEVERIDGE &DIAMONDl'c

Mr. Owens and Mr. Fulton

July 30,2010

Page 2

Reregistration Eligibility Decision (RED) in April 2006. Even so, the Agency has continued to

indicate through the years, including recently, that the special review remains open and ongoing. i

In the fall of2009, EPA announced its plans to conduct what it called a comprehensive

evaluation of atrazine over the next year. October 7, 2009 Press Release, "EPA Begins New

Scientific Evaluation of Atrazine." EPA described the current evaluation as "a special

comprehensive scientific re-evaluation." Atrazine Science Reevaluation: Potential Health

Impacts (October 7,2009).

Despite the obviousness of the special review status of its evaluation, EPA has not been

consistently, explicitly clear about this. It placed minutes of its calls with stakeholders about the

initiation of the current review into the Agency's Special Review docket. Yet, the Atrazine

Updates portion of EPA's website does not reference the ongoing special review, and EPA's

discussion on that site of the "Atrazine Evaluation Process" asserts only that "(a)trazine's reevaluation process has always been dynamic, not static." See Atrazine Updates, available at

http://www.epa.gov/oppsrrdl/reregistration/atrazine/atrazine_update.htm.

It is important that EPA confirm the special review status of the current evaluation at this

time. A new Scientific Advisory Panel (SAP) meeting on atrazine wil begin -September 14,

2010. EPA has stated that it plans to issue its "charge" documents to the SAP for that meeting in

mid-August. While there are also two additional SAPs which EPA has stated wil occur in 2011,

we understand from EPA's public statements that its submission to the September SAP may

include proposed determinations on which EPA would seek the SAP's review and advice. In

that regard, public statements by EPA officials, including comments offered on June 15,2010 by

EPA's Deputy Associate Administrator of the Offce of Policy, Economics, and Innovation, have

indicated that EPA plans to present its "conclusions" with respect to atrazine for review by the

September SAP.

It is critical to the integrity of EPA's review that the Agency be transparent about the

procedural status of the current evaluation so that the ground rules of the proceedings and the

implications of the proceedings are well understood and appreciated by all involved. In light of

the upcoming mid-August timeline for EPA's charge submission for the September SAP,

Syngenta requests that EPA confirm the special review status of the current evaluation within 14

days of receipt of this letter. Syngenta also requests that EPA promptly post this letter on the

atrazine special review docket.

i See, e.g., Transcript of 

November 3, 2009 SAP Hearing pp. 111-112 (testimony of Dr.

Bradbury stating that the 1994 atrazine special review remains open pending the final results of

the Agricultural Health Study); Letter from Stephen Owens to Rep. Melancon (April 15, 2010)

(stating that the 1994 special review remains open); Letter from Stephen Owens to Rep. Peterson

(April 6, 2010) (same).
Mr. Owens and Mr. Fulton

July 30, 2010

Page 3

BEVERIDGE &DIAMONDl'c

We look forward to EPA's response, and thank you in advance for your consideration of

and response to this letter.

Sincerely,

Kathryn E. Szmuszkovicz

Counsel to Syngenta Crop Protection, Inc.

cc: Dr. Steven Bradbury (Director, Office of Pesticide Programs)

Mr. Rick Keigwin (Director, Pesticide Re-Evaluation Division)

Ms. Leslye Fraser (EPA Office of General Counsel)

BEVERIDGE &DIAMONDl'c

Mr. Owens and Mr. Fulton

July 30, 2010

Page 3

We look forward to EPA's response, and thank you in advance for your consideration of

and response to this letter.

Sincerely,

Kathryn E. Szmuszkovicz

Counsel to Syngenta Crop Protection, Inc.

cc: Dr. Steven Bradbury (Director, Offce of Pesticide Programs)

Mr. Rick Keigwin (Director, Pesticide Re-Evaluation Division)

Ms. Leslye Fraser (EPA Offce of General Counsel)