# BEVERIDGE~

&DIAMONDrcT

Karen M. Hansen
1350 I street, NW.

Suite 700 Washington, D.C. 20005-3311 Direct: (202) 789-6056 Fax: (202) 789-6190 khansen@bdlaw.com



### February 24, 2009

VIA HAND DELIVERY

Mr. Philip 1. Ross U.S. Environmental Protection Agency Office of General Counsel Pesticides and Toxic Substances Law Office 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Best regards, Re: Ashland-Hercules Concerns Regarding Industrial Biocides

Dear Mr. Ross:

As requested, enclosed please find two complete copies of the correspondence and background materials from Ashland-Hercules to U.S. Environmental Protection Agency (EPA) regarding the subject referenced above. Included in the package are the documents attached to my February 22, 2009 e-mails, with the addition of a January 14,2009 e-mail from Max Taytelbaum, Ashland-Hercules, to Michael Hardy, EPA, regarding additional information on nitrogen-hypochlorite chemistry. Per your request, the enclosed documents are organized in chronological order.

I appreciate your prompt attention and look forward to discussing the matter further with you at your earliest convenience.

Karen M. Hansen

Enclosures

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

### Page 1 of3

From: Karen M. Hansen

Sent: Sunday, February 22,2009 10:07 PM

To: Ross.Philip@epa.gov Subject: Ashland-Hercules Concerns re Industrial Biocides Attachments: Hercules 10-17-08 Letter to EPA.pdf; Hercules - EPA Meeting Minutes (10-02-08).pdf;

Jun08PaperChemReport.pdf; Nalco Oxi-PRO 41.2 - PaperCon08 - Macuch.pdf; Nalco OxiPRO Nov 2007.pdf; Nalco Chloramine Article 2003 Solutions Mag.pdf; Chloramines Chemistry Summary 10-17-08.pdf; Letter to EPA re Health and Safety Risks.pdf

Dear Mr. Ross,

Thank you for our conversation of February 18, 2009 regarding the concerns that Ashland-Hercules has raised with EPA's Antimicrobials Division with respect to the health and safety issues and the FIFRA registration status for certain ammonium-based industrial use biocides. As we briefly discussed, the products at issue are used for antimicrobial control in pulp and paper mill settings. At your request, I am forwarding the submittals to EPA that Ashland-Hercules has made in the last several months regarding the significant regulatory issues with ammonium-based biocide products being marketed either without FIFRA registration at all (Nalco Company) or with a FIFRA registration that appears to result in labeling discrepancies (Buckman Laboratories). Also, as we briefly discussed, and as is mentioned in the October 2008 materials included as attachments to this e-mail, it is Ashland's understanding that Nalco is now also marketing a urea-based biocide for pulp and paper industry application that also has not been subject to review for registration as a pesticide as required under FIFRA. I will forward more recent additional information submitted to EPA on this issue by separate e-mail.

Chronologically, Ashland's submittals to EPA begin with the June 2008 letter to EPA summarizing the health and safety risks associated with unregulated use of the Nalco ammonium-based product, which, like the FIFRA registered products, combines with sodium hypochlorite in an in-situ application. It is our understanding that Nalco explained its product technology to EPA as a mere "stabilizer," without pesticidal effect, and is marketing its ammonium-based and now its urea-based products as "adjuvants" exempt from FIFRA regulation. As Ashland's submittals explain, the product chemistry involved does not support such a claim. Thus, Nalco's products' unregistered status is not consistent with the rigorous FIFRA registration process applied to the Ameribrom ammonium bromide product for which Ashland is a supplemental distributor (Ameribrom Spectrum XD8899) or the FIFRA registration process for the Buckman Busan 1215 product (which, while registered, is being marketed with a label that fails to indicate the actual active ingredient). Further details about all of these issues were the subject of an October 2,2008 meeting between EPA and Ashland, and the bulk of the attachments here are related to the discussion at that meeting and the follow-up information requested by EPA.

As indicated, I will forward by separate e-mail a few other updates following the October 2,2008 meeting. We have not received any response from EPA since that meeting and remain quite concerned with obtaining a satisfactory resolution of the issues raised. Ashland remains available to discuss this set of issues further with EPA. I appreciate your prompt attention to this matter and look forward to discussing the issues further with you at your earliest convenience.

Best regards,

Karen

Karen M. Hansen, Esq. Beveridge & Diamond, PC 1350 I Street, NW, Suite 700 Washington, D.C. 20005 (202)-789-6056 Direct (202) 789-6190 Fax khansen@bdlaw.com www.bdlaw.com



### 6/2412009

### Page 2 of3

CONFIDENTIALITY STATEMENT: This electronic message contains information from the law firm of Beveridge & Diamond, P.C. that is privileged and confidential. The information is intended solely for the use of the individual (s) or entity(ies) named above. If you are not the intended recipient, be aware that any disclosure, copying, distribution or use of the contents of this message is prohibited. If you have received this e-mail in error, please notify us immediately at (202) 789-6000 or bye-mail reply and then immediately delete this message. Thank you.

From: LChaney@Herc.com [ma ilto: LChaney@Herc.com] 

### Sent: Friday, October 17, 2008 3:49 PM To: hardy.michael@epamail.epa.gov; harrigan-farrelly.joan@epamail.epa.gov Cc: MTaytelbaum@Herc.com; TKavanaugh@Herc.com; baraky@attglobal.net 

### Subject: Summary 

### & Follow-up - October 2, 2008 meeting.

Dear Joan and Michael,

Since Dr. Taytelbaum is traveling today, I am sending information attached below to your attention, so as to meet our targeted response time as you previously requested.

Once again, we would like to thank you for taking the time to meet with us on October 2nd to review market activity and safety/health/environmental concerns regarding chloramine programs currently promoted as biocidal technologies in the pulp and paper industry.

Per your request, you will find the minutes from the meeting held on Oct. 2nd, a technical discussion of chloramine chemistry, marketing material distributed by Nalco that promotes chloramine technologies for biocidal purposes (i.e., OxiPRO platform, including both biomonitoring equipment and chemical products like Nalcon 60615 (15% active urea, combined with sodium hypochlorite) and Nalcon 60620 (20% active ammonium sulfate, combined with sodium hypochlorite)) and a cover letter that states our concern with this particular kind of competitive activity.

If possible, we would like to contact you in a few weeks (perhaps during the week of Nov. 3rd, or whenever it is convenient for you) after you have had a chance to review all attached material and answer any questions you may have.

Please do not hesitate to contact either Dr. Taytelbaum or myself if you should have any questions in the meantime.

Nalco marketing material------->

Michael - we found several email addresses for Director Harrigan-Farrelly on the EPA's website, so if the address we used above is incorrect, could you please be so kind as to send this along to her attention? Thanks in advance.

Thank you again, and have a good weekend.



### 6/2412009

### Page 3 of3

Best Regards,

Linda L. Chaney Business Manager - Microbiological Control, Americas Hercules PTV Office - 859-331-5122 Cell - 513-368-1035

"This information being provided to you herein is considered "Confidential Company Property". As such, you should not reproduce, distribute, or communicate any of the contents herein to any person outside Hercules Incorporated or its affiliates without approval from the Law Department, nor should this information be reproduced or forwarded in any other medium (including computer, e-mail, or other electronic means) without such approval".



### This e-mail contains information which may be privileged, confidential, proprietary, trade secret and/or otherwise legally protected. If you are not the intended recipient, please do not distribute this e-mail. Instead, please delete this e-mail from your system, and notify us that you received it in error. No waiver of any applicable privileges or legal protections is intended (and nothing herein shall constitute such a waiver), and all rights are reserved. In addition, no information or statements set forth in this e-mail shall be deemed to legally bind Hercules Incorporated (or its affiliated companies) ("Hercules") unless the intent to bind Hercules is expressly and specifically set forth herein, and other required elements to constitute a legally binding agreement are present.

6/2412009

# .HERCULES Hercules Incorporated Research Center 500 Hercules Road Wilmington, DE 19808-1599 (302) 995-3000



### October 17, 2008

Via Electronic and U.S. Mail

Joan Harrigan Farrelly Director, Antimicrobials Division, Mail Code 751 OP U.S. Environmental Protection Agency Office of Pesticide Programs 1200 Pennsylvania Ave., N.W. Washington, D.C. 20460

Dear Ms. Harrigan Farrelly:

We would like to once again express our appreciation to you and each of the other members of EPA's Antimicrobials Division ("AD") who participated in the October 2, 2008 meeting with Hercules, Inc and AY Labs. We sincerely appreciate the time and attention devoted by the AD team to Hercules' concerns regarding the ongoing sale and use of Nalco Company's unregistered ammonium-based antimicrobial product at pulp and paper mills in the United States.

As we discussed, Nalco's ammonium source product is combined with sodium hypochlorite at pulp and paper mills in an on-site reaction to produce a biocide to control the growth of microorganisms in the papermaking process. Because Nalco's product is not registered pursuant to FIFRA, EPA has not evaluated - and little information is known about - the actual chemistry involved in this reaction, the degree to which the reaction is controlled and the related identification of byproducts formed from the reaction, or the potential risks to workers and the environment associated with use of Nalco's product. In addition, Hercules understands that Nalco has recently expanded its sale of unregistered biocide products to pulp and paper mills by marketing an unregistered urea-based biocide that is similarly intended for on-site combination with hypochlorite.

In light of the potentially serious risks related to the combination of Nalco's unregistered products with sodium hypochlorite - including the potential formation of nitrogen trichloride and other hazardous gases - we have asked that EPA immediately halt all sales of Nalco's products unless and until Nalco obtains a FIFRA registration based on a demonstration that the intended on-site reaction is appropriately controlled and all claimed byproducts are understood and appropriately managed. Such action will also ensure a level playing field for commercial products subject to FIFRA regulation.

Importantly, as emphasized at our October 2 meeting, significant distinctions - including the concentrations of the chemicals used - exist between the use of ammonium source products in the pulp and paper mill industry and use of ammonium-based products in potable water

### disinfection. The pulp and paper uses are subject to regulation for safety and environmental

effects under FIFRA, while the drinking water uses are regulated pursuant to the Safe Drinking Water Act ("SDWA"). The protections in place under the SDWA should allow EPA tocontinue its ongoing assessment of the appropriate FIFRA regulatory status of ammoniumbased products used by drinking water facilities while simultaneously requiring that all unregistered uses of such products in industrial processes at pulp and paper mills - which uses are not subject to SDWA regulation - be immediately halted and resumed only after completion of the FIFRA registration process.

As requested by EPA at our meeting, we have enclosed several items for AD's further consideration as it continues to review this issue:

1. Meeting Minutes (Enclosure 1). We have prepared a detailed summary of our October 2 meeting, describing the issues raised and discussed together by Hercules, AY Labs, and EPA. This summary includes:

• information related to Nalco's unregistered ammonium source product, and particularly the risks to human health, worker safety, and the environment implicated by the use of Nalco's product at pulp and paper mills in combination with sodium hypochlorite for biocidal purposes; • confirmation that EPA provided Nalco with a letter indicating that FIFRA registration of Nalco's product is required if pesticidal claims about the product are made, but without any classification of Nalco's product as an "adjuvant." We discussed the contrast between the extensive review of and scrutiny EPA applied to the application for registration of Ameribrom Inc.'s Fuzzicide Solution (EPA Reg. No. 8622-64) and the lack of information about the actual chemistry, use, or effects of Nalco's product presented by Nalco in obtaining this letter from EPA; • Hercules and AY Labs' specific concerns regarding use of Nalco's ammonium source product as a component of an uncontrolled on-site reaction with sodium hypochlorite, with the resulting potential formation of nitrogen trichloride and other hazardous gases; • information relevant to the distinctions between ammonium products used by the pulp and paper mill industry, which generally are registered by EPA pursuant to FIFRA, and ammonium products used in drinking water disinfection under the SDWA, the regulatory status of which is under Agency review; • Hercules' request that EPA halt sales of Nalco's unregistered ammonium sulfate/hypochlorite system until Nalco applies for a registration and EPA has completed its review and evaluation of Nalco's data under FIFRA and determined the conditions under which Nalco's biocide may be used in pulp and paper mills to ensure human health and environmental protection; and • in response to EPA's inquiry concerning Buckman Laboratories, Inc.'s Busan 1215 (EPA Reg. No. 1448-433), Hercules explained that Buckman has registered ammonia as its product's active biocidal ingredient, rather than the precursor ammonium salt ingredient that we understand is actually used in Buckman's product.

2. Data Summary Describing Chemical Reactions of a Sodium Hypochlorite Product with an Ammonium Source Product (Enclosure 2). As described in the enclosed data summary prepared by AY Labs, when sodium hypochlorite and ammonia are combined, a number of reaction products may form. The main reaction is chlorination of ammonia, depending on the conditions (temperature, pH, concentration, ratios) yielding chloramine

### (NH2

### CL), potentially dichloramine (NHCL2), 

### and nitrogen trichloride (NCI3). These reaction

byproducts are very irritating to eyes and lungs and may cause asthma and other respiratory illnesses. In addition, nitrogen trichloride is highly explosive.

As discussed at our October 2 meeting, Nalco has not yet been required to characterize and demonstrate the safety and environmental effects of its ammonium source product or the intended on-site reaction with sodium hypochlorite, because it has apparently sought to avoid FIFRA regulation and the registration process altogether by stating that it is making no pesticidal claims for its product (see item 3, below, for information from Nalco making such pesticidal claims for its ammonium source product). As a result, neither Hercules nor EPA have knowledge of the actual byproducts resulting from use of Nalco's unregistered product.

However, Hercules understands that Nalco claims that the combination of its unregistered ammonium source product with sodium hypochlorite at pH levels greater than 8.0 produces only monochloramine ("MCA"). As described in more detail in the enclosed summary, recognized principles of chemistry indicate that formation of MCA at a pH greater than 7.0 is only assured for very dilute solutions of an ammonia product. This scientific fact is tacitly acknowledged by Nalco's own FIFRA hypochlorite label (Nalcon 60735), which includes a warning against combination with ammonia because it "will release hazardous gases irritating to eyes, lungs and mucous membranes."



## 3. Nalco Marketing Materials (Enclosure 

## 3). We have collected and enclosed a representative package of Nalco marketing materials making pesticidal claims for its unregistered ammonium source product and an industry trade paper describing Nalco's product and the purpose for which it is being used by the pulp and paper industry. As provided by EPA's regulations at 40 CFR Section 152.15, a substance must be registered as a pesticide pursuant to FIFRA if it is the subject of either express or implied claims of pesticidal purpose, as well as actual or constructive knowledge that a product will be used for pesticidal purpose. Nalco appears to be marketing its product as a "halogen stabilizer," while simultaneously emphasizing its biocidal qualities when used at pulp and paper mills.

These enclosed materials are:

• a June 2008 Paperchem report (trade industry paper) describing at Page 14 Nalco's OxiPro Technology as preventing "deposit formation by curbing microbial growth," and claiming the system's relative safety and minimized environmental impact; • a May 2008 Nalco presentation detailing Nalco's biocide program and deposit control technology; • a November 2007 Nalco product brochure emphasizing use of OxiPro to "control microbial growth in papermaking systems;" • a March 2003 Nalco article describing the benefits of combined halogen products for biocidal purposes.

In closing, we wish to restate our thanks to EPA for its continued attention to the issues raised in our October 2 meeting concerning Nalco's unregistered biocide. We remain

### available to address any additional questions or concerns that may be raised during the

Agency's review of the enclosed materials.

Sincerely,

Dr. M. P. Taytelbaum Director, Global Regulatory Affairs

Enclosures

cc: M. Hardy (EPA) A. Barak (AY Labs) T. Kavanaugh (Counsel, Hercules Incorporated) K. Hansen (Outside Counsel, Beveridge & Diamond, P.C.)Summary of Hercules/AY Labs Meeting with EPA, October 2,2008

Attendees:

EPA - Antimicrobials Division Joan Harrigan Farrelly - Director Betty Shackelford - Assistant Director (attended first portion of meeting) Michael Hardy - Ombudsman Dennis Edwards - Branch Manager Najam Shamim - Chemist Emily Mitchell - Team Leader PM Team 32 _____ -- Risk Assessment

Hercules Incorporated

Max Taytelbaum - Global Director, Regulatory Affairs Linda Chaney - Business Manager, MBC - Americas

AY Labs

Dr. Ayala Barak

Meeting Summary Michael Hardy asked that Hercules take notes and prepare and send to EPA a summary of the meeting. Everyone at the meeting introduced themselves.

Hercules began the discussion by stating its concern, as set forth in its June 27,2008 letter to EPA, with regard to potential health and safety issues related to the commercial activity in the pulp and paper industry involving an unregistered pesticidal product sold by Nalco. This product involves mixing an unregistered ammonium based material with sodium hypochlorite to create a biocide. Because the biocide is not registered with EPA, a risk exists that these materials are being used at pulp and paper mills in an uncontrolled manner. Hercules pointed out that this risk does not exist with the Ameribrom/Hercules Fuzzicide program, due to the control features of the feeder, which, along with the product chemistry, were carefully reviewed by EPA as part of the FIFRA registration process (1998-2003).

In response to EPA questions, Hercules further explained that (1) the Fuzzicide feed system is patented, (2) the active ingredient is not HOBr, and (3) that there is no chance for HOBr to form from use of the Fuzzicide feed system, due to the specific controls included in that system. Hercules explained that the active ingredient formed upon combination of Fuzzicide with sodium hypochlorite is referred to as "BAC," and this entire process is controlled using the Fuzzicide feed system to prevent oxidation of the bromide into HOBr.

Hercules and EPA next reviewed the Nalcon 60735 label for Nalco's EPA-registered sodium hypochlorite product and focused on the "Physical Properties" section of the Nalcon 60375 label, which provides a warning about the risk of forming hazardous gases when Nalco's hypochlorite product is combined with an ammonia source. Hercules provided EPA with a copy of the Nalco label. EPA asked several questions about Nalco's process, including the type and quantity of gases, such as nitrogen trichloride, that may form in the reaction of sodium hypochlorite and an ammonia source; the temperature during this reaction when done with Nalco's feed system; and the type of risks posed (e.g., explosion, worker safety) by this reaction. AY Labs explained that it is not known for certain which gases may form, nor what quantities or at what temperatures, since this information has never been characterized by Nalco for its program pursuant to the EPA's FIFRA registration process. Based on what is understood within the pulp and paper industryabout the Nalco product and process, however, and applying chemistry knowledge, Hercules believes that heat can and will drive the reaction to form nitrogen trichloride in quantities that are currently unknown and that the quantities of ammonium-based and sodium hypochlorite materials fed into Nalco's system will vary. Hercules and AY Labs explained that EPA's questions were the same ones that prompted the June 27,2008 letter requesting that EPA review the Nalco situation. Because there is a chemical reaction that takes place when sodium hypochlorite and ammonia products are combined, the various products and byproducts that may be formed need to be identified, quantified, and evaluated through EPA's registration process. Nalco has not done this.

EPA requested that Hercules and AY Labs provide reference information on the formation of nitrogen trichloride from the combination of concentrated ammonium and sodium hypochlorite.

Hercules further explained that where a biocide product is generated in-situ at a mill site, the use specifications on the product's FIFRA label should limit the use rates, the process, and the ratios of precursors applied to protect human health and the environment and to ensure worker safety. In this case, the biocide is created in-situ at the paper mill and the products should require the same level of analysis that has been used to evaluate similar biocides under FIFRA. The lack of FIFRA registration and a FIFRA label means EPA has not had an opportunity to review the safety of Nalco's system.

Hercules next expressed its understanding that Nalco had requested from EPA "adjuvant" status for its ammonia source product. Hercules asked for more information from EPA to understand the basis for this classification of Nalco's product. Hercules indicated its understanding that Nalco is now also marketing a urea-based biocide in combination with their hypochlorite for pesticidal purposes without any registration-a situation similar to Nalco's approach with its ammonium-based product.

In response, EPA indicated that it has never stated or concluded that Nalco's ammonia source product is an adjuvant under FIFRA. EPA explained that Nalco has never sought registration of its ammonia source product under FIFRA, and the Agency has never reviewed any information about Nalco's product, or the Nalco ammonia source product label itself, that could serve as the basis for EPA's classification of Nalco's product as an adjuvant. Instead, EPA explained that it provided a letter to Nalco indicating that, as long as no biocidal claim was made by Nalco, then EPA would not require registration. EPA also mentioned that Nalco may be using another additive in the mixture, possibly to stabilize the product.

EPA then raised a concern within the Agency that requiring FIFRA registration of the Nalco ammonium-based material might have unintended implications for drinking water disinfection, and that this issue is still under review at EPA. EPA also stated, however, that if Nalco's product is a biocide, registration under FIFRA is necessary.

Hercules explained that the use of ammonium-based products in drinking water disinfection is very different from the biocidal application of ammonium-based products in a pulp and paper mill. In particular, the reactions in each setting are conducted under very different conditions, with very dilute solutions used in the case of potable water versus much more concentrated uses at a paper mill. EPA added that, in the case of drinking water disinfection, the ammonia hypochlorite system is used only as secondary treatment and acknowledged it is very dilute in this use.

EPA asked whether there were any issues with the Buckman registration of its ammonium-based biocide. Hercules indicated that, while its June 27,2008 letter to the Agency focused exclusively on the Nalco situation, Hercules also has concerns regarding the identity of the active listed on the FIFRA label of the Buckman product. Hercules explained its understanding that FIFRA requires registration of a precursor, as opposed to the breakdown from the precursor. Although Buckman's label identifies Ammonia as the active ingredient, Hercules understands that the Buckman product is actually a blend of ammonium salts, which is supported by the high densitylisted on their product label. Use of Buckman's product in pulp and paper mills would indicate that the product contains salts. Hercules provided a copy of the Buckman label to EPA.

Next, EPA asked whether Hercules had reviewed all data associated with the registration of Nalco's registered sodium hypochlorite product, Nalcon 60735. Hercules confirmed that it had reviewed the publicly available information. EPA also asked Hercules' purpose in bringing this situation to EPA for review. Hercules explained that the Fuzzicide system uses both registered hypochlorite and ammonium bromide. Product stewardship and safety concerns arise for Hercules when a similar biocide is being used in an industrial setting without consistently applied FIFRA registration and label requirements, since the process of obtaining registration and label approval under FIFRA will dictate how the product is to be applied and controlled to ensure it is safe for use. Absence of registration creates a risk of mills operating under conditions that could be very hazardous. EPA acknowledged its understanding that Hercules is requesting that the Agency require Nalco to register its ammonia source product under FIFRA. Hercules confirmed this and also asked that EPA halt sales of Nalco's product pending proper registration.

EPA asked for further clarification regarding how Nalco's technology differed from drinking water disinfectant applications that have been in use for many years. AY Labs explained that although the application of chloramine to disinfect drinking water has been in use for approximately 100 years, there is an important distinction between the disinfection of drinking water and use of a pesticide in paper mill environments. In particular, the ammonia and hypochlorite are applied in drinking water facilities at a concentration of about (or under) 4 ppm, while the concentration of the Fuzzicide biocide prior to injection into the process is 2000 - 4000 ppm. Based on industry information, it is believed that the Nalco system may use concentrations as high as 22% (220,000 ppm).

AY Labs noted again that Nalco has not identified or characterized the reactions that take place with this chemistry at these high concentrations. Yet, on the basis of industry information, Nalco appears to be asserting that, under conditions where pH is greater than 8.0, only monochloramine (MeA) can form when its ammonia source product reacts with sodium hypochlorite. However, recognized principles of chemistry indicate that formation of MeA at a pH of greater than 7.0 is only assured for very dilute solutions of an ammonia product. AY Labs pointed out that Nalco's own hypochlorite label (Nalcon 60735) warns against combination with ammonia because hazardous gases can form. Essentially, Nalco appears to be claiming that formation of MeA is assured, while separately acknowledging the formation of hazardous gases. As MeA is not a gas, both assertions cannot be correct. Because EPA has not had an opportunity to conduct an extensive review of the chemicals and concentrations actually being used with Nalco's system, the chemical reactions actually taking place, and conditions for the control of these reactions, it is not clear how safe use of Nalco's system is assured.

Hercules explained that these circumstances form the basis for its request that EPA halt sales of Nalco's unregistered ammonium sulfate/hypochlorite system until Nalco applies for a registration and EPA has completed its review and evaluation of Nalco's data under FIFRA and determined the conditions under which Nalco's biocide may be used in pulp and paper mills to ensure human health and environmental protection. This is the only result consistent with EPA's requirements regarding Fuzzicide. Hercules provided a copy of key historic correspondence between EPA and Ameribrom related to the Fuzzicide registration. Hercules pointed out that there was considerable communication with EPA regarding process control and that, only after EPA was satisfied with safety and other requirements, did it grant the FIFRA registration for Fuzzicide.

EPA inquired about how Nalco was presenting its system in the marketplace, noting again that it provided Nalco with a letter stating generally that Nalco would not be required to register its product if no claims of pesticidal activity are made on the product's label. Hercules explained that, based on industry information, Nalco is making claims to mills that its product is pesticidal, but only states that the product is a "halogen stabilizer" on the label. However, available Nalcomarketing literature shows that Nalco is promoting its product as a biocide. EPA requested that Hercules send EPA information indicating that Nalco is claiming its product works as a pesticide.

EPA mentioned that Nalco wrote a letter to EPA asking that the registration for the Buckman's Busan 1215 be canceled.

EPA asked whether the reference in Nalco's hypochlorite product label to the formation of hazardous gases reflected an understanding by Nalco that use conditions must be controlled. AY Labs noted that, to satisfy FIFRA's registration requirements, it is not enough to simply assert that control is required when combining ammonium compounds and hypochlorite. Rather, a registrant must demonstrate to EPA's satisfaction under FIFRA that any conditions under which the biocide may be used are effectively controlled. In Nalco's situation, if it were to assert to EPA that only one specific biocidal species is formed, such as MeA, this claim would need to be substantiated in data provided in the registration process. In Hercules opinion, the same should also be required of Buckman.

EPA indicated that the discussion with Hercules and AY Labs made clear that Nalco did not provide full information about its ammonia source product to EPA at its meeting with the Agency and, as a result, EPA's subsequent letter to Nalco indicating that Nalco's ammonium sulfate product did not require FIFRA registration as long as no biocidal claim is made was not based on a complete understanding of the product. EPA said it was also now clear that the Agency did not realize the parallels between the Fuzzicide chemistry and that of Buckman and Nalco, nor the degree of information provided to the EPA in the case of Fuzzicide.

In conclusion, EPA outlined its requested next steps:

1. Hercules will send a reference for the potential for production of nitrogen trichloride from combining ammonium-based and hypochlorite materials. 2. Hercules will prepare and send a summary of the meeting.3. Hercules will send marketing information Nalco has used to promote its ammoniumbased hypochlorite system as a pesticide. EPA asked Hercules to submit the requested information within 10 days of the meeting, if possible. 4. EPA will review all of the above mentioned information and get back to Hercules on its requests. 5. For future questions, EPA will contact Hercules. AY Labs will continue to assist with technical issues.