# 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 CaliforniaBEVERIDGE &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 ofAmeribrom'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