# BEVERIDGE6 &DIAONDp¿y

Karen M. Hansen 1350 I Street, NW. Suite 700 Washington, D.C. 20005-3311

Direct: (202) 789-6056 Fax: (202) 789-6190 khanseni:bdlaw.com
March 31, 2009
Via Electronic and Registered Mail Philip J. Ross, Esq. Pesticides & Toxic Law Substances Office of General Counsel U.S. Environmental Protection Agency Ariel Rios Building (North) 1200 Pennsylvania Avenue, N.W. 

### Mail Code: 2333A Washington, DC 20460
Ms. Joan Harigan-Farelly Director, Antimicrobials Division Office of Pesticide Programs U.S. Environmental Protection Agency Ariel Rios Building 1200 Pennsylvania Avenue, N.W. 

### Mail Code: 7510P Washington, DC 20460 Brenda F. Mosley, Ph.D. U.S. Environmental Protection Agency Office of Enforcement and Compliance Assurance Ariel Rios Building 1200 Pennsylvana Avenue, N.W. 

### Mail Code: 2240A Washington, DC 20460

Re: Nalco Sales of Unregistered Industrial Biocides


### Dear Mr. Ross, Ms. Harigan-Farrelly, and Dr. Mosley: 

### Hercules Incorporated, now a wholly owned subsidiar of Ashland Inc. and hereinafter referred to as "Ashland," has requested that EPA's Antimicrobials Divisions promptly review the 

### ongoing sale by Nalco Company oftwo unegistered biocide products used in pulp and paper mils to control microbial growth in water. Because neither product is registered under FIFRA, EP A has not reviewed any of their safety or environmental risks. These products involve in-situ chemical reactions to which people working at pulp and paper mils are being exposed without any prior regulatory review by EPA. On Ashland's behalf, I am writing to you together in order to emphasize the urgency with which we request the Agency complete its review and determinations regarding these specific issues.

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

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### In paricular, Ashland requests that EPA promptly:



### (1) Require Nalco to register its amonium- and urea-based pulp and paper mil biocide products under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) as mandated by law;

(2) Issue an order to Nalco to halt immediately its ongoing sales of these unegistered pesticides; and (3) Pursue appropriate enforcement action against Nalco, due to the seriousness of these FIFRA violations, the associated health and environmental risks, and the significant economic benefit Nalco is receiving from sellng its products without required FIFRA registrations. 

### This letter sumarizes Ashland's understanding of the background and issues. We

acknowledge our understanding that EPA's Offices of Pesticide Programs and Water may be engaged in an internal discussion about FIFRA applicability to ammonium-based disinfectants used in drinking water. However, the issues Ashland is raising with EPA are distinct and

separate from those being discussed with the Office of Water and involve a specific industrial application of biocides for which FIFRA registration is required. Ashland does not believe that EPA needs to connect these separate issues or decide any broader questions to address the clear noncompliance that we describe below, and we specifically request that EPA promptly address the matters raised by Ashland as a distinct matter. 

### A. Summar of Ashland/EPA Communications Ashland first alerted EP A to the safety, environmental and regulatory issues associated with the sale ofNalco's unegistered amonium-based pesticide product in May 2008. At that time, EPA informed Ashland it had already been alerted to the Nalco situation by another registered pulp and paper biocide company, Buckman Laboratories. EPA also informed Ashland that the Agency had discussed Nalco's product with the company and had issued a letter 

### indicating that Nalco could sell its amonium-based products as long as it did not claim a pesticidal purose for the product.

By way of background, and as Ashland has explained to EPA, Ashland distributes a fully 

### registered amonium-based biocide to pulp and paper mils, and Buckman markets a registered 

### amonium-based biocide to mils for the same purpose. Nalco markets its ammonium-based and urea-based products to these same mils, for the same purposes, though its products are not registered under FIFRA. All three companies' products are purchased by pulp and paper mills 

### for biocidal puroses; there is no other reason to buy these products. The Ameribrom product that Ashland distributes underwent a four-plus year FIFRA registration process; Buckman's product also went through a lengthy registration process under FIFRA. Thus, there is an obvious

level-playing field issue involved here, along with the integrity of EPA's pesticide registration

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### program. But there is more than that: because each of these three companies sells numerous 

### products at pulp and paper mils, mil employees -- as well as Ashland, Buckman and Nalco

employees -- are potentially at risk if 

### they are working in mils where Nalco's unregistered 

### products are being used in unegulated in-situ chemical reactions. Ashland submitted a letter to EPA detailing safety, environmental and regulatory concerns pertaining to Nalco's ammonium-based product in June 2008. After several attempts to follow-up with EPA, Ashland and EPA met on October 2, 2008 to discuss these issues in detaiL. At that time, Ashland also informed EPA that Nalco was now marketing a second unegistered

biocide, this one urea-based, purportedly on the basis of 

### EPA's original letter to Nalco. On the basis of the October 2, 2008 meeting, Ashland understood that EPA now believed it did not have 

### full information from Nalco about its amonium-based product when the Agency issued thereferenced letter to Nalco. EPA also indicated it was previously unaware ofNalco's new ureabased product. At the October 2 meeting, EPA also requested some follow-up information from Ashland, which Ashland promptly provided. In addition, as requested by the Agency, Ashland has continued to provide follow-up correspondence, including additional safety information about the in-situ chemical reactions. Ashland also responded to EPA's request for representative Nalco marketing materials, which demonstrate that Nalco is sellng these products for biocidal

purposes, namely, to control the growth of micro-organisms in water used in the papermaking process. By way of only one example, previously provided by Ashland to EPA, a June 2008 Paperchem trade industry report describes the intended use ofNalco's technology is to prevent "deposit formation by curbing microbial growth," and claims the system's relative safety and environmental impacts. This clearly indicates a pesticidal purpose for which FIFRA registration is required. Moreover, Nalco's claims of safety and environmental impact have not been tested by EPA pursuant to FIFRA's rigorous pesticide registration process. Out of concern that Ashland has received virtually no response regarding these important issues from EPA to date, Ashland has now submitted a complete set of Ashland's correspondence with EPA on this matter to the Antimicrobials Division, the Office of General Counsel and the Office of Enforcement and Compliance Assurance.

B. EP A's Letter to N alco Pursuant to a request to EPA under the Freedom of Information Act (FOIA), Ashland 

### recently received a copy ofthe letter EPA sent to Nalco, as referenced above. This letter, dated

Februar 7,2008 (a copy of 

### which is enclosed for your convenience) was sent by Fran Sanders,

then-Director of 

### the Antimicrobials Division, to counsel for Nalco. EPA's letter was in apparent response to a December 4, 2007 e-mail communication from Nalco's counsel requesting 

### reconsideration of the "registration for two amonia products used in connection with chlorine to treat water." We have requested a copy of this e-mail from EPA but have not yet received it.

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EPA's February 7, 2008 letter to Nalco is very troubling. As EPA has already acknowledged, this letter appears to have been based on information provided to EP A by N alco 

### which led to the Agency's incomplete understanding ofNalco's products. However, the letter

also contains a gross misstatement of EPA's well-established requirements for registration of

pesticides. We do not understand at all the basis for this aspect of EPA's letter, but it appears to have been interpreted by Nalco as a "green light" to market its industrial biocides products as non-pesticides as long as it does explicitly claim a pesticidal purpose. This is contrary to FIFRA's requirements and EP A's regulations interpreting that statute.

We paricularly draw your attention to the last paragraph of EPA's February 7, 2008 letter, which states:

the Offce of Pesticide Programs would regard Nalco's sale and 

### distribution of amonia and amonia products for use in connection with chlorine water to treat water to require registration 

### under FIFRA only ifNalco makes a pesticidal claim for such products.(emphasis added). This statement cannot be reconciled in any way with clear and wellestablished principles of FIFRA providing that:

( a) substance is considered to be intended for pesticidal purose, 

### and thus to be a pesticide requiring registration if . . . the person who distributes or sells the substance has actual or constructive 

### knowledge that the substance wil be used, or is intended to be used, for a pesticidal purpose. 40 C.F.R. § 152.15( c ) (emphasis added). In direct contrast to the position expressed in EPA's letter that Nalco would have to "make() a pesticidal claim" in order to trigger FIFRA registration requirements, this regulation instead provides explicitly that actual or constructive knowledge of a substance's intended use for a pesticidal purpose triggers FIFRA's registration requirements. Moreover, FIFRA's requirements cannot be evaded by simply dropping or masking an express pesticidal claim. See, e.g., N Jonas & Co. v. Us., 666 F.2d 829, 833 (3d Cir. 1981) ("Industry claims and general public knowledge can make a product pesticidal notwithstanding the lack of express pesticidal claims by the producer itself. Labeling, industry representatives, advertising materials, effectiveness and the collectivity of all the circumstances are therefore relevant"); id at 832 ("EPA takes the statute and regulations to mean that a product is a pesticide if a reasonable consumer - given the label, accompanying circulars, advertising representations and the collectivity of circumstances - would use it as a pesticide").

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In light of EPA's clear regulatory position on this issue, we find the Agency's statement in its letter to Nalco inexplicable. We also note that the quoted statement from EPA's letter contains an important factual error: the amonium-based products are reacted in-situ with sodium hypochlorite, not with "chlorine." In addition, EPA's letter states the Agency's 

### understanding that Nalco's product wil be used to "treat water" without identifying the purose( s) of the product that may have been stated by N alco to EP A. As noted above, however, there is no reason other than biocidal use in industrial water for pulp and paper mils to use the Nalco products discussed in this letter. In sum, while Nalco may be taking pains in its general marketing approach to not make

express claims about the pesticidal puroses of its products on the basis of EPA's incomplete statement ofFIFRA's registration requirements, there is no question based on the information Ashland has submitted to EPA that Nalco fully understands the true purpose and intended use of its products as industrial biocides.
C. Conclusion

Nalco's sales of unregistered pesticides in the United States are direct violations of

FIFRA § 12(a)(1)(A), which prohibits the distribution or sale of "any pesticide that is not registered" in accordance with the requirements of FIFRA. EPA must not ignore or endorse this apparent noncompliance. In addition, there are potentially serious hazards posed to people 

### working at pulp and paper mils where Nalco's unegulated products are being used in in-situ chemical reactions. Ashland believes EPA should act to protect public health and the environment by immediately stopping the sale of these unregistered products and requiring Nalco to comply with FIFRA. There is also a serious level-playing field issue here that EPA is uniquely authorized to redress through enforcement. Nalco should not be allowed to reap significant commercial advantages and the economic windfall of avoiding FIFRA registration costs associated with its failure to comply with FIFRA. If EPA's letter to Nalco was based on incomplete or inaccurate information from Nalco -- and we emphasize here that we do not yet know what the full communications were between EPA and N alco -- then prompt enforcement action is even further 

### waranted. Thank you for your time and consideration of this important matter. We look forward to your prompt response. 

# i:y'

Karen M. Hansen

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cc: Kathryn E. Szmuszkovicz Steven A. Herman Kristina Woods Max P. Taytelbaum, Ph.D. Linda L. Chaney