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 to

continue 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
(NH2CL), 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 industry
about 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 density
listed 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 Nalco
marketing 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.