# 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 

### January 22,2010



### Via Electronic Mail Mr. Steven Bradbury Acting Director Offce of Pesticide Programs (7501 P) U.S. Environmental Protection Agency One Potomac Yard 2777 S. Crystal Dr., Room S-12622 Arlington, Virginia 22202 Ms. Joan Harrigan-Farrelly Director, Antimicrobials Division 

### Offce of Pesticide Programs U.S. Environmental Protection Agency Mail Code: 751 OP Washington, D.C. 20460

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

Re: EPA Consideration ofNalco's Two Biocides
Dear Mr. Bradbury, Ms. Harrigan-Farrelly, and Mr. Ross:

On behalf of Ashland, Inc., this letter responds to Nalco's letter dated January 20, 2010. First, Nalco has not registered with EPA as pesticides its urea and ammonium sulfate based industrial products and Nalco is selling these unregistered products to pulp and paper 

### mills. Nalco has been doing so since 2008 for the urea product and earlier for the ammonium

sulfate product, according to Nalco's own information. Therefore, if these products are biocides, as the overwhelming evidence before the Agency and in the marketplace demonstrates is the 

### case, then Nalco is not and has not been complying with FIFRA. Filing a petition with EPA to contest the registration of a competitor's product while continuing to sell, unregistered, the same product chemistry to the same customers, with knowledge of and despite EPA's precedent, is not consistent with FIFRA's registration scheme.

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

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Mr. Bradbury, Mr. Ross and Ms. Harrigan-Farrelly Via Electronic Mail Page 2

Second, Nalco's citation of the February 2008 letter from Frank Sanders as support for its actions is a non-starter. That letter by its own terms addresses only "ammonia and ammonia products." Nalco's decision to sell its unregistered urea product and its ongoing sale and marketing of this product is entirely outside the bounds of any "guidance" Nalco may claim that Mr. Sanders' letter provided. Moreover, despite plenty of time and opportunity to provide EPA with information about its urea product, Nalco has not, according to EPA, provided the Agency with any information about its claim in the marketplace that the urea-based product is not a biocide. In contrast, the Agency is in possession of substantial information supplied by Ashland demonstrating that the combination of urea and sodium hypochlorite produces a new active pesticide that is separate and distinct from sodium hypochlorite. This new active pesticide requires registration under FIFRA. Moreover, FIFRA prohibits the sale of pesticides before they are registered, and the Agency has no justifiable basis for allowing the sale ofNalco's unregistered urea-based biocide to continue. Regarding Nalco's ammonium sulfate product, Mr. Sanders' letter is factually and legally flawed, as Ashland and Buckman have pointed out on numerous occasions. In particular, Mr. Sanders' letter is fundamentally inconsistent with EPA's well-established legal test that a substance's pesticidal nature does not depend only on express pesticidal claims about a product. Nalco's professed avoidance of such claims - even if consistently applied and no matter how careful or sincere - would not and cannot be determinative of the status of its ammonium-based products under FIFRA. Instead, EPA's regulations provide that a substance is considered to be a pesticide requiring registration if the person who distributes or sells it "claims, states, or implies (by labeling or otherwise) (tJhat the substance (either by itself or in combination with any other substance) can or should be used as a pesticide" or "has actual or constructive knowledge that the 

### substance will be used, or is intended to be used for a pesticidal purpose." 40 C.F.R. 

### § 152.15(a), (c).i Even ifNalco were able to sell its products without expressly referring to them as biocides or pesticides, FIFRA grants no authority for EPA, via Mr. Sanders' letter or otherwise, to allow Nalco's sale of unregistered ammonium-based products when it is clear that 

### these products are used as biocides. As we have previously explained, paper mills use Nalco's two unregistered products essentially interchangeably with the FIFRA-registered ammonium salt

i See also 49 Fed. Reg. 37916, 37917 (Sept. 26,1984) (explaining that, even in the absence of express pesticidal
claims by a seller or distributor, "a product may be considered to be a pesticide if the seller or distributor is aware of

the intended uses of the product as a pesticide. . . . (which) may be the case either because there are no other
significant uses of the product, or because other circumstances of the sale or distribution are such that he should reasonably known the ultimate use of the product as a pesticide"); 53 Fed. Reg. 15952, 15954 (May 4, 1988) (emphasizing that "a producer who sells a product with full knowledge of its intended pesticidal use should be held responsible for its registration," including situations where a "producer sells what would ordinarily be considered a basic chemical to a user whose only purpose in acquiring such chemical would be to use it as a pesticide").

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Mr. Bradbury, Mr. Ross and Ms, Harrigan-Farrelly Via Electronic Mail Page 3
biocides sold by Ashland and Buckman. The pulp and paper mills use Nalco's products for the very same purpose that they use Ashland's and Buckman's products -- to control microorganisms (kil bugs) in high organic process water. Nalco has acknowledged that its ammonium sulfate (Nalcon 60620) and its urea (Nalcon 60615) product offerings operate as biocides,2 but Nalco seeks to avoid registering its precursor ammonium sulfate and urea products by asking EPA (while it sells these products) to accept the notion that the only active ingredient involved is sodium hypochlorite. Nalco thus argues that its precursor ammonium sulfate and urea products act only to "stabilize" sodium hypochlorite so that the biocidal effect of the hypochlorite occurs at a slower rate than it otherwise would. This theory is belied by the chemical reaction that occurs when ammonium salts and urea are combined with sodium hypochlorite. In each case, the reaction produces a separate and distinct biocide that is created in situ at the mils. EPA has acknowledged this chemical reality through its registrations of the Ameribrom and Buckman precursor ammonium salt products and, indeed, going back as far as the South Coast enforcement case EPA prosecuted nearly 24 years ago, See 

### In the Matter o.fSouth Coast Chemical, Inc., 1986 EPA App. LEXIS 34 (Mar. 11,1986). EPA's numerous registrations of sodium bromide, sodium chlorate and sodium chlorite products also

reflect the Agency's understanding of the core chemistry principles associated with the on-site generation of industrial biocides using precursor chemicals that may be non-pesticidal in other

uses. Nalco's actions and its arguments are at odds with this long line of precedent. Nalco states that it encourages customers to use its unregistered ammonium-based 

### products only with registered sodium hypochlorite. However, such practices overlook the fundamental question of whether the ammonium sulfate when reacted in-situ with hypochlorite creates a new pesticidal active ingredient, in this case chloramines, such that the precursor must 

### be registered. Nalco's instruction to its customers to use only registered hypochlorite is not only irrelevant to the pesticidal status of its unregistered products, but troubling from a worker safety perspective, as welL. As Ashland has previously indicated, we are not aware of any registered sodium hypochlorite products that provide instructions for safe combination and reaction with 

### ammonium or urea-based products. To the contrary, many registered sodium hypochlorite products expressly warn against mixing with ammonia or other chemicals because doing so "will

### release hazardous gases irritating to eyes, lungs, and mucous membranes." See, e.g., EPAapproved label for Nalco's registered sodium hypochlorite product, "Nalcon 60735," EPA Reg. 

### No. 1706-238 (Aug. 30,2007) (requiring users to "(mJix only with water according to label directions" and warning of physical and chemical hazards if mixed with ammonia and other 

### chemicals). The Agency addressed this safety concern in registering the ammonia salt biocides 

### sold by Ashland and Buckman -- no similar FIFRA protections exist for use ofNalco's unregistered products.

2 See, e.g., Correspondence from M. Boucher to D. Edwards, dated December 19,2008, Exhibit 2 (2008 Nalco PowerPoint presentation).

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Mr. Bradbury, Mr. Ross and Ms. Harrigan-Farrelly Via Electronic Mail Page 4
Finally, Ashland has never objected to EPA's receipt of input from "others potentially 

### impacted" by any EPA decision on the regulatory status ofNalco's two products. Rather, we have simply pointed out that FIFRA dictates a priority of action by EPA in this situation. First, EPA should remove Nalco's unregistered biocides from the market in order to protect public

safety and the integrity of the federal regulatory program, and to treat the parties selling FIFRAregistered products fairly. Once those basic actions occur, EPA can then conduct whatever

additional public review process the Agency deems helpful or necessary, including, if warranted, a public docket process. 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.
Best regards, 

# 1!~m~

Karen M. Hansen

cc: Marty Monell, EPA Dennis Edwards, EPA

Robert Perl is, EPA Jay Vroom, CropLife America Allan James, RISE (Responsible Industry for a Sound Environment) Michael Boucher, Counsel for Buckman Seth Goldberg, Counsel for Nalco