BEVERIDGE~

&DIAMONDpcT

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
BEVERIDGE&DIAMONDrc

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").
BEVERIDGE &DIAMONDrc

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).
BEVERIDGE &DIAMONDrc

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,

Karen M. Hansen

1!~m~

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