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December 29, 2005

Comments submitted to US EPA on Tetraconazole:
Conditional Approval of Two Pesticide Product Registrations.

Via email: jones.lisa@epa.gov
Lisa Jones, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001

Docket No. EPA-HQ-OPP-2004-0388

From:
Ellen Connett
Fluoride Action Network Pesticide Project
82 Judson Street, Canton NY 13617
Tel: 315-379-9200
Email: pesticides@fluoridealert.org

Dear Lisa Jones,

I tried, unsuccessfully, to submit these comments via the new "enhanced federal-wide electronic docket management and comment system located at
http://www.regulations.gov". While I was able to access the docket and documents for "EPA-HQ-OPP-2004-0388" there was no link available at these sites to submit comments on the December 21, 2005, Notice on tetraconazole. Thus, I am submitting these comments to you and ask that you add this submission to this Docket.

I request that EPA revoke its conditional approval of the two tetraconazole pesticide products it announced on December 21, 2005, until it is prepared to engage the public in a more informed discussion than what was presented in the Federal Register Notice. The pesticide products are:

• Tetraconazole Technical, (EPA File Symbol: 60063-RR). Active
ingredient: Tetraconazole: at 97.0%. The application for the product
Tetraconazole Technical was approved for manufacturing or formulating
purposes on April 14, 2005, to use for formulation into end-use
products for use on sugar beets (EPA Registration Number 60063-11).

• Eminent 125SL Fungicide, (EPA File Symbol: 60063-RE). Active
ingredient: Tetraconazole: at 11.6%. The application for the product
Eminent 125SL was approved on April 14, 2005 for the control of
Cercospora leaf spot and powdery mildew disease of sugar beets (EPA
Registration Number 60063-12).

The public deserves the opportunity to submit comments on any approval for tetraconazole pesticide products because tetraconazole is classified as "likely to be carcinogenic to humans."

EPA states that the "public interest" is served because they performed "basic health and safety determinations" that substantiates this conditional approval. However, no presentation of these "determinations" were available to the public in this Notice, nor were any references for these determinations cited.

If EPA is not prepared to rewrite this Notice with the following information, it should still revoke any conditional approval for tetraconazole pesticide products until the public has had the opportunity to FOIA the necessary documents that will allow informed comments to be submitted on any approval of the use of the two tetraconazole pesticide products.

An open and transparent discussion of the use of tetraconazole is in the public interest. However, the public was not afforded this. EPA is wrong to state that the "public interest" is being served without allowing the public to comment on EPA's "determinations" for approval, especially as tetraconazole is classified as "likely to be carcinogenic to humans."

The Notice for Conditional Approval of two tetraconazole products in the December 21, 2005, Federal Register, was less than adequate for the public's understanding of this chemical and EPA's conditional approval of it. For example:

1. The Notice states that

"A paper copy of the fact sheet, which provides more detail on this registration,
may be obtained from the National Technical Information Service (NTIS), 5285
Port Royal Rd., Springfield, VA 22161."

1.1 Is this the Pesticide Fact Sheet on New Active Ingredients that EPA issued in April 2005 for tetraconazole?

1.2 If it is the same April 2005 Fact Sheet, which is available on EPA's web at http://www.epa.gov/opprd001/factsheets/tetraconazole.pdf why did EPA not make this link accessible in the Notice, or attach it to the docket?

1.3 Or is the Fact Sheet you refer to a new and updated version of the April 2005 Fact Sheet?

1.4 Why was this information not placed in the electronic version of the Public Docket?

2. EPA also states in this Notice,

"a copy of the approved label, the list of data references, the data and other scientific information used
to support registration, except for material specifically protected by section 10 of FIFRA, are also available
for public inspection. Requests for data must be made in accordance with the provisions of the Freedom
of Information Act and must be addressed to the Freedom of Information Office (A-101), 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001. The request should: Identify the product name and registration
number and specify the data or information desired."

2.1 FOIA requests are generally time-consuming lengthy processes. In this particular instance, it was unnecessarily complicated to ask the public to FOIA this information. This information should have been included in the electronic docket for this Notice.

2.3 Why was this information not placed in the electronic version of the Public Docket?

3. EPA states,

"Based on these reviews, the Agency was able to make basic
health and safety determinations which show that use of tetraconazole
during the period of conditional registration will not cause any
unreasonable adverse effect on the environment, and that use of the
pesticide is, in the public interest."

3.1 EPA should have discussed its rationale for its health and safety determinations in the Notice of December 21. Without such a discussion the public was not afforded the opportunity to review EPA's assessment and submit relevant comments.

3.2 EPA should have included in this Notice, at a minimum, the references for its "health and safety determinations."

3.3 Why didn't EPA include the documents on its "health and safety determinations" in the electronic version of the docket?

3.4 In its April 2005 Fact Sheet on tetraconazole, EPA states that it is "likely to be carcinogenic to humans." EPA needed to explain in this Notice why the "public interest" is benefited by the conditional approval of two pesticide products that are classified as carcinogenic.

4. EPA has made available at its website of "Index of Cleared Science Reviews: Tetraconazole (Pc Code 120603)" the titles of the following documents:

October 5, 1999. Memorandum. 135 Pages.
Sanjivani Diwan. Health Effects Division.
Cancer Assessment Review Committee Meeting on
Tetraconazole. (Tetraconazole: Evaluation of
the Carcinogenic Potential). MRID 44305304...

December 9, 1999. Memorandum. 25 Pages.
Sanjivani Diwan. Health Effects Division.
Review of Draft Cancer Assessment Document on Tetraconazole.

January 11, 2000. Memorandum. 26 Pages.
Sanjivani Diwan. Health Effects Division.
Tetraconazole - Report of the Cancer Assessment Review
Committee. Tox review 013948.

4.1 Why were these "cleared" documents not included in the electronic Docket?

5. This Notice is clearly inadequate for soliciting substantive and relevant public input on EPA's conditional approval of two tetraconazole pesticide products.

5.1 All available information on tetraconazole should have been made accessible with this Notice. EPA needs to explain to the public why the relevant information that it has readily available on tetraconazole was not made available in this Notice.

In the interests of transparency, this submission is available online at http://www.fluorideaction.org/pesticides/tetraconazole.sub.dec.05.html

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Note: See FOIA request for tetraconazole documents submitted on December 29, 2005