BEVERIDGE &

&DIAMOND~

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

October 2, 2009

VIA ELECTRONIC MAIL

Dennis H. Edwards

Chief, Regulatory Management Branch I

Antimicrobials Division

U.S. Environmental Protection Agency

Ariel Rios Building

1200 Pennsylvania Avenue, N.W.

Mail Code: 7510P

Washington, DC 20460

Re: Copies of Ashland's Submittals to EPA Regarding Unregistered Nalco, Inc.

Biocides

Dear Mr. Edwards,

In follow-up to our telephone conversation on September 24, 2009 concerning potential

dates to meet with EPA, I understand that you wil be coordinating a meeting among the parties

and EPA, as well as the distribution of the parties' documents. We appreciate your observation

that there have been a number of submissions by the parties at various times to a variety of EP A

personnel, and I wanted to ensure that you had a complete set of the materials submitted by and

on behalf of Ashland to EPA regarding this matter. We have prepared an updated CD that we

can provide to you, if this would be helpful to your efforts, so please let me know if we should

send this to you.

Although the record before the Agency in this matter may contain many materials, at its

core, the Agency is being asked to address three essential and straightforward questions:

Question 1: For what purpose are Nalco's unregistered products (Nalcon 60615 and

Nalcon 60620) used by pulp and paper mils?

Answer: The sole purpose of these products at pulp and paper mils is to function as a

biocide by achieving control of high-organic process waters. Mils have no other

Washington, D.C. Maryland New York Massachusetts New Jersey Texas California
BEVERIDGE & DIAMOND PC

Dennis H. Edwards

October 2, 2009

Page 2

reason to use these products. The same is true for the registered ammonium-based

products sold by Ashland and Buckman. Recognizing this fact, Nalco has made

claims expressly indicating the pesticidal purpose of its products. See Attachment

i to Ashland Letter to EPA dated June 30, 2009, at pages 4-9 (and prior

submittals referenced therein).

Question 2: Are Nalco's unregistered products pesticides requiring registration under

FIFRA?

Answer: Yes. Nalco's products are intended and used for a pesticidal purpose and

therefore must be registered as pesticides under FIFRA. See Attachment i to

Ashland Letter to EPA dated June 30, 2009, at pages 31-33. Nalco's products

entail the in-situ chemical reaction of ammonium sulfate (N alcon 606 i 5) or urea

(Nalcon 60620) with sodium hypochlorite. Contrary to Nalco's claim that sodium

hypochlorite is the only active pesticide in this in-situ chemistry, distinct

pesticidal products are formed in each case. The ammonium sulfate-hypochlorite

reaction produces a separate biocide, monochloramine; the Agency has

recognized this active ingredient twice before, in the FIFRA registrations of

Ameribrom's ammonium-based product (Fuzzicide) and Buckman's ammoniumbased product (Busan 1215).1 In the case of urea-hypochlorite, this chemical

reaction produces a different biocide (e.g., not sodium hypochlorite, and not

monochloramine), as explained in the proprietary analysis contained in Ashland's

June 30, 2009 submittaL. See Ashland Letter to EPA dated June 30, 2009, at

pages 8-29 (CBI-redacted to protect proprietary Ashland data). As such, Nalco's

ammonium sulfate and urea products are precursors to in-situ biocides, and they

require FIFRA registration; registration of the sodium hypochlorite alone is

insufficient.

Question 3: Are Nalco's products otherwise exempt from regulation under FIFRA?

Answer: No. There are no recognized FIFRA exclusions or exemptions applicable to

Nalco's unregistered products. Unlike FIFRA-exempt "adjuvants," which

"function simply to enhance or prolong the activity of an active ingredient by

physical action," 40 C.F.R. § 153.125(a)(2) (emphasis added), Nalco's products

involve an in-situ chemical reaction that forms a new biocide that is then fed into

See, e.g., Memorandum from S. Mostaghimi, Ph.D., Antimicrobials Division, EPA to M. Swindell,

Antimicrobials Division, EPA (describing use of Ameribrom's ammonium bromide product "in conjugation" with

sodium hypochlorite "to produce the biocide") (Jan. 28, 2002) (Attachment 2(a) to Ashland Letter to EPA dated

June 30, 2009); Memorandum from S. Gowda, Antimicrobials Division, EPA, to V. Noble, Antimicrobials Division,

EPA (describing the generation of mono chloramine by reaction of Buckman's Busan 1215 product with sodium

hypochlorite, and evaluating its environmental fate) (Mar. 10,2008) (Attachment 2(c) to Ashland Letter to EPA

dated June 30, 2009).
BEVERIDGE & DIAMOND PC

Dennis H. Edwards

October 2, 2009

Page 3

the mil process waters for pesticidal use. See Attachment 1 to Ashland Letter to

EPA dated June 30, 2009, at page 34. Neither ammonium sulfate nor urea

stabilize sodium hypochlorite or exert any physical action on sodium

hypochlorite, contrary to Nalco's claims. There are no other recognized FIFRA

exclusions or exemptions that apply to Nalco's products, despite Nalco's

endeavor to invent one (e.g., by calling its products stabilizers, halogens, and the

like). See Attachment 1 to Ashland Letter to EPA dated June 30,2009, at pages

33-35.

Answering these three questions accurately leads to the conclusion that Nalco's products

are biocides that require FIFRA registration.

Nalco has attempted to significantly broaden and unnecessarily confuse the scope of this

matter by trying to focus EPA's attention on the use of ammonia2 for drinking water treatment

(an application for which Nalco's products are not used). This issue is not only irrelevant to the

question of whether Nalco's industrial products are pesticides requiring registration under

FIFRA, but it has been characterized in an entirely misleading way by Nalco. EPA need only

ask and answer the following additional question to reaffrm that the Agency can and must

resolve Nalco's specific FIFRA compliance issues without any further delay.

Question 4: Does the use of ammonia for drinking water treatment undermine FIFRA's

requirement to register biocides utiized in pulp and paper mils?

Answer: No. The fact that a similar ammonium-based chemistry is employed to disinfect

drinking water in no way alters the FIFRA analysis for Nalco's industrial biocides

outlined above. Drinking water disinfectants differ from industrial biocides in the

concentration and manner in which they are used. Also, drinking water

disinfectants may be regulated not only under FIFRA but also under the Safe

Drinking Water Act. We are merely asking EPA to apply FIFRA consistently to

industrial biocides. The fact that different ammonium-based products are used for

drinking water treatment does not change EPA's or Nalco's obligations under

FIFRA. See Attachment 1 to Ashland Letter to EPA dated June 30, 2009, at

pages 38-42.

We hope this brief synopsis of the issues is helpful in framing the upcoming meeting and

EPA's analysis of the parties' submittals. Please note that this letter is in follow-up to our

conversation on September 24, 2009; a response to EPA's September 18th letter will be

separately provided on October 5, 2009.

2 The ammonium-based products sold by Ashland, Buckman and Nalco to pulp and paper mills contain ammonium

salts, not ammonia.
BEVERIDGE &DIAMONDpc

Dennis H. Edwards

October 2, 2009

Page 4

Thank you for your time and continued attention to this matter. Please contact me if you

have any questions. Bi:'m~

Karen M. Hansen

cc: Joan Harrigan Farrelly

Phil Ross

Tina Woods

1290661v3 Washington 013421