# BEVERIDGE~

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Karen M. Hansen 1350 I Street, N.W. Suite 700 Washington, D.C. 20005-3311 Direct: (202) 789-6056 Fax: (202) 789-6190 khansen@bdlaw.com 

### March 1,2010



### Via Electronic Mail Mr. Philip 1. Ross U.S. Environmental Protection Agency Office of General Counsel 

### Pesticides and Toxic Substances Law Offce Ariel Rios North 1200 Pennsylvania Ave., N.W. Washington, D.C. 20460 Ms. Joan Harrigan-Farrelly Director, Antimicrobials Division Office of Pesticide Programs U.S. Environmental Protection Agency Mail Code: 751 OP Washington, D.C. 20460

Re: Request for Immediate Stop Sales Orders for Nalco's Unregistered Urea and Ammonium Sulfate Biocides
Dear Mr. Ross and Ms. Harrigan-Farrelly: On behalf of Ashland I would like to thank the Agency for meeting with us and the other

parties on February 16,2010. The purpose of this letter is to address one of the issues that EPA sought comment on, namely, whether the urea product being sold by Nalco should be treated in 

### the Agency's review process the same as Nalco's ammonium sulfate product. The answer is that (1) EPA should treat Nalco's two unregistered products -- the urea-based Nalcon 60615 and its ammonium sulfate product, Nalcon 60620 -- the same in terms of ordering their immediate removal from the marketplace, and (2) EPA should exclude urea from any public comment process on ammonium sulfate products that EPA still intends to pursue. 

### The Agency possesses substantial evidence that both ofNalco's products are being sold and used as biocides without FIFRA registration. In addition, the marketing materials submitted

by Nalco to EPA on February 22, 2010 demonstrate that Nalco is promoting use of both of these 

### products in a manner that violates FIFRA's labeling requirements. Specifically, Nalco's marketing materials for both Nalcon 60615 (urea) and Nalcon 60620 (ammonium sulfate) encourage combination with registered sodium hypochlorite products, including Nalco's Nalcon

60735, the labels for which 

### prohibit mixing with ammonia and other chemicals. Nalco's admitted practices violate FIFRA's requirement to use pesticides only in accordance with the product's approved labeL. We urge EPA to take the stop sales action now.

Washington, D.C. Maryland New York Massachusetts New Jersey Texas CalifornioBEVERIDGE & DIAMOND pc

Mr. Ross and Ms. Harrigan-Farrelly Via Electronic Mail Page 2
Furthermore, EPA's question, and the substantial evidence before the Agency demonstrating that both ofNalco's products are unregistered industrial biocides, continue to raise for us the fundamental propriety of EPA's plan to engage in a public comment process while these products are still in the marketplace and present undefined risks to the public, including people who work at the mills where these products are sold. As you know, Ashland's prior communications to EPA indicate our strongly held view that a opening a public docket to seek comment on an individual company's failure to seek FIFRA registration for its biocidal product is an unwarranted action, given the weight of evidence before EPA that Nalco's two products are biocides. We have stated that any such public comment process, if appropriate at 

### all, should occur only afer EPA first protects public safety by removing these unregistered biocides from the marketplace. Proceeding as EPA has stated it plans will encourage other companies to first initiate product sales and then demand that EPA engage in a public comment 

### period before seeking FIFRA registration. We doubt that EPA intends this result; FIFRA certainly does not countenance this sequence of action. Therefore, we continue to encourage EPA to reconsider its stated plans to open a public docket as its next step, in light of all of the information EPA possesses, including that presented

by all of the parties at the February 16,2010 meeting. Furthermore, if EPA still decides to pursue a public comment process, the docket should be limited to the ammonium sulfate issues on which EPA believes it needs further input from the public and should not include urea. The remainder of this letter summarizes the key reasons EPA should take these actions
now.
1. Stop sales order is the appropriate next step under FIFRA First and foremost, EPA possesses substantial evidence that N alco' s urea product, Nalcon 

### 60615, is a biocide. EPA is authorized to issue a stop sale, use, removal and seizure order ("SSURO") whenever the Agency has "reason to believe" that a pesticide has been or is intended 

### to be distributed or sold in violation ofFIFRA. FIFRA § 13(a). Ashland brought the urea biocide to EPA's attention in October 2008 and since that time has submitted substantive information to EPA that demonstrates that Nalcon 60615 is being sold and used as a biocide. By contrast, Nalco has provided EPA with no information regarding this product, according to EPA. 

### Indeed, Nalco's presentation at EPA's February 16,2010 meeting failed to address its urea product chemistry and instead discussed urea only in the unrelated context of agricultural crop adjuvants. Nalco's urea product, Nalcon 60615, is not used as an adjuvant; it is used in chemical

reaction with sodium hypochlorite to produce the active biocide chI oro urea, as Ashland's 

### February 16, 2010 presentation and prior submittals consistently demonstrate. Thus, the weight of evidence before the Agency clearly indicates that Nalcon 60615 is a biocide, that Nalco is selling this product without a FIFRA registration, and that EPA has ample basis for acting, now,

### BEVERIDGE &DIAMONDpc

Mr. Ross and Ms. Harrigan-Farrelly Via Electronic Mail Page 3

to stop the sale of 

### this product by Nalco.l Any doubts EPA may still possess about this product should be resolved in favor of public safety, not Nalco. 2. Public comment process, if any, should follow stop sales and exclude urea EP A has had this issue under advisement for well over a year without taking this action, as Ashland has requested from the start. Subsequent to providing the initial information to EPA about this unregistered product in October 2008 and, as requested by EPA at that time, Ashland has consistently updated the Agency when additional information about the biocidal nature of this product became available. In contrast, Nalco has submitted no information to the Agency explaining its claims regarding this product, according to EPA. Even at the parties' recent February 16 meeting with the Agency -- specifically arranged by EPA to allow each party an express opportunity to frame its positions and claims -- Nalco's presentation failed to include any explanation of its urea product chemistry or why Nalco is claiming it as a stabilizer (indeed, Nalco's presentation contained no apparent scientifically based support for the position that its products are something other than biocides). Buckman also has not commented specifically on Nalco's urea product. Under these circumstances, inviting public comment on the urea biocide issue is inappropriate. Instead, EPA should act on the substantial evidence before it that Nalcon 60615 is sold and used as a biocide. Other reasons exist for EPA to act on this issue now and to limit the public docket to the ammonium sulfate issues. Although EPA has stated that the drinking water concerns raised by Nalco for the ammonium sulfate product are not among the issues the Agency intends to decide in this proceeding, we expect Nalco to continue to raise these extraneous issues, just as it 

### attempted to do at the EPA meeting on February 16th. Urea is not used in drinking water disinfection, including Nalco's Nalcon 60615 product. Nalco's continuing silence regarding its own urea-based product, notwithstanding repeated opportunities to provide information to EPA, renders unwarranted and unnecessary any Agency effort to solicit wider public comment on this issue.
3. Requested actions

In sum, Ashland hereby urges EPA to immediately order 

### Nalco to stop sales ofNalcon 60615 and Nalcon 60620 pursuant to the authority vested in EPA to protect public health and the 

### environment under FIFRA. We also request that EPA decide any other issues regarding Nalcon 60615 separately from any public docket that the Agency intends to open to take comment on any ammonium sulfate issues.

i Each of these statements applies with equal force to Nalco's ammonium sulfate product, Nalcon 60620. As noted above, Ashland believes the proper and prudent course is for EPA to remove both products from the marketplace immediately.

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Mr. Ross and Ms. Harrigan-Farrelly Via Electronic Mail Page 4
Thank you for your time and attention to this matter. Please let me know if you have any questions regarding the information in this letter.

cc: Dennis Edwards, EPA William Jordan, EPA Melba Moore, EPA Michael Boucher, Counsel for Buckman Seth Goldberg, Counsel for Nalco

1328210vl Washington 013421 

# BeskClI~

Karen M. Hansen