BUCKMAN LABORATORIES, INC.’S REPLY TO NALCO COMPANY’S DEC. 4, 2007 

REQUEST THAT EPA RECONSIDER ITS REGISTRATION FOR AMMONIA 

PRODUCTS AS PRECURSORS TO CHLORAMINE USED IN WATER TREATMENT

AND

BUCKMAN LABORATORIES, INC.’S REQUEST THAT EPA IMMEDIATELY 

PROHIBIT FURTHER DISTRIBUTION AND SALE OF UNREGISTERED AMMONIA 

FOR WATER TREATMENT

Michael Boucher

MCKENNA LONG & ALDRIDGE LLP

1900 K Street, NW

Washington, D.C. 20006

(202) 496-7729

Counsel to

Buckman Laboratories, Inc.

September 2, 2008
TABLE OF CONTENTS

Page

-iI. Overview ....................................................................................................................... 1

II. Both Nalco and Buckman sell ammonia for use in proprietary systems in which 

ammonia and sodium hypochlorite react to form MCA, which is the active 

ingredient supplied by each system for water treatment.................................................. 4

III. Registration of ammonia is necessary, because MCA is too unstable to exist as a 

marketable commodity, no EPA-approved sodium hypochlorite label has 

instructions for use with ammonia to safely produce MCA, and the continued use 

of unregistered ammonia to produce MCA presents unnecessary and potentially 

unreasonable risks to human health and the environment................................................ 7

IV. Ammonia does not sequester or release “chlorine” and is not an adjuvant; 

ammonia does react with sodium hypochlorite to produce an entirely new active 

ingredient, MCA, which has distinct properties from hypochlorous acid. ....................... 9

V. EPA should promptly deny Nalco’s Petition to revoke Buckman’s ammonia 

registrations, because the Agency has properly registered Buckman’s ammonia as 

a precursor of MCA for water treatment....................................................................... 11

VI. EPA should immediately prohibit further distribution and sale of unregistered 

ammonia for water treatment, because the continued sale of unregistered 

ammonia to the same customers for, and for the same uses as, Buckman’s 

registered ammonia presents unnecessary and potentially unreasonable risks to 

human health and the environment, contradicts and undermines the Agency’s 

proper registration of Buckman’s ammonia, and unfairly damages the commercial 

value of Buckman’s registrations. ................................................................................ 12

VII. Conclusion................................................................................................................... 14

EXHIBIT A Food additive petition of the Zentox Corporation to provide for the safe 

use of MCA as an antimicrobial agent in poultry process chiller water

EXHIBIT B Label of Nalcon 60620

EXHIBIT C Nalco Company proposal for OxiPRO microbiological control program

EXHIBIT D Nalco Company slide presentation, “PM■ Biocide Trial Operator 

Overview”

EXHIBIT E EPA-registered label of Busan 1215

EXHIBIT F Photograph of Busan 1215 Feed System

EXHIBIT G Line drawing of Busan 1215 Feed System
TABLE OF CONTENTS

(continued)

-iiEXHIBIT H Process diagram of Busan 1215 Feed System

EXHIBIT I In the Matter of: South Coast Chemical, Inc., 2 E.A.D. 139, 145 (1986)

EXHIBIT J EPA-registered labels of Nalco Company’s sodium hypochlorite products

EXHIBIT K EPA-registered label of Sunny Sol 150

EXHIBIT L February 2, 2008 letter from Frank Sanders to Seth Goldberg
-1-

I. Overview

Nalco Company’s (hereinafter, “Nalco’s”) December 4, 2007 “Request That EPA 

Reconsider Its Registration for Ammonia Products as Precursors to Chloramine Used in Water 

Treatment and Provide Assurance That There Is No Risk of Enforcement during the 

Reconsideration and Any Necessary Transition Period” (hereinafter, “Nalco’s Petition”) is a

tirade against EPA’s registrations of BCMW (EPA Reg. No. 1448-432) and Busan 1215 (EPA 

Reg. No. 1448-433), Buckman Laboratories, Inc.’s (hereinafter, “Buckman’s”) manufacturinguse and end-use ammonia products, respectively. The violence of Nalco’s protest tacitly 

acknowledges Nalco’s need to register its own current end-use ammonia product, Nalcon 60620, 

because Nalcon 60620 and Busan 1215 essentially have the same composition, are used by the 

same industrial users in the same manner for water disinfection, and are considered 

interchangeable products in the marketplace. Nalco’s Petition ignores the unknown and 

potentially unreasonable risks presented by the ongoing use of unregistered ammonia to produce 

monochloramine (hereinafter, “MCA”), including human health risks from unapproved residues 

of MCA in paper used for food packaging and toxicity to aquatic organisms from MCA residues 

in industrial waste water.1 Not surprisingly, Nalco also ignores the significant and ongoing 

damage being done unfairly to the commercial value of Buckman’s ammonia registrations – and 

to Buckman’s ability to recoup its investment in such registrations – by Nalco’s ongoing sale of

unregistered ammonia with EPA’s “temporary” permission, which has lengthened to seven 

months with no end in sight.

1 Coincidentally, we have obtained a pre-publication Federal Register notice, attached hereto as Exhibit “A,” which 

reports that Zentox Corporation has petitioned the Food and Drug Administration to use MCA as a food additive, 

specifically, “as an antimicrobial agent in poultry process chiller water” (emphasis added), even though EPA has not 

registered MCA or ammonia for any such use. This food additive petition underscores the urgent need for EPA to 

publicly affirm its jurisdiction over MCA – specifically, to prohibit the further distribution and sale of unregistered 

ammonia for any water treatment use, including poultry processing. 
-2-

To justify the status quo, Nalco offers a series of increasingly erratic and unfocused 

arguments. Initially, Nalco alleges that ammonia cannot be registered, because it is not an active 

ingredient (Nalco’s Petition at 6-7), but later flip-flops and acknowledges that, in fact, EPA can 

register a precursor of an active ingredient, where registration of the active ingredient itself is not 

practical (Nalco’s Petition at 9) – exactly as EPA has done with BCMW and Busan 1215, 

because the registration of MCA itself for water treatment is impractical. Then, Nalco agrees 

that combining ammonia and sodium hypochlorite produces MCA (Nalco’s Petition at 4), in a 

chemical reaction known since the early 1900s, but alleges that MCA is not an active ingredient 

that is separate from “chlorine” (hypochlorous acid) (Nalco’s Petition at 8-9, 11), even though 

the production of MCA is a reaction that is not considered reversible (i.e., once formed, MCA

does not readily break down into, or otherwise produce, ammonia and hypochlorous 

acid/hypochlorite ions), and despite that EPA and industry recognize MCA as a distinct active 

ingredient with valuable properties that are different from those of hypochlorous acid. Nalco 

also plays variations on the foregoing theme, specifically, that ammonia “sequesters” and 

releases “chlorine” by a novel chemical process that Nalco never explains (Nalco’s Petition at 4, 

6-7, 11-12), and that ammonia is only an adjuvant used with “chlorine” and, thus, requires no 

registration (Nalco’s Petition at 15), even though ammonia reacts completely with sodium

hypochlorite to form a new active ingredient, MCA, and, thus, does not hold or release

hypochlorous acid and does not resemble any adjuvant.

For the foregoing reasons, as articulated and explained in this petition, we respectfully 

request pursuant to section 553(e) of the Administrative Procedures Act (5 U.S.C. § 553(e)) that 

EPA deny Nalco’s Petition and immediately prohibit further distribution and sale of unregistered 

ammonia for water treatment. Nalco has asked for time to register ammonia but neither needs 
-3-

nor deserves any additional time. Nalco has had notice of EPA’s policy on the registration of 

ammonia for water treatment since the Agency’s registration of Buckman’s ammonia products 

on March 6, 2007. Since then – a period of 18 months – Nalco has found ample time to make 

two lengthy and duplicative submissions and one responsive submission to EPA in order to 

subvert the Agency’s registration of Buckman’s ammonia products. Neither of Nalco’s original 

filings ever had a likelihood, much less a certainty, of persuading EPA to revoke its considered 

registrations of ammonia, which Nalco knew at the time of its filings. Indeed, as recently as 

July 15, 2008, the Agency amended Buckman’s registration of Busan 1215 to add a new use 

(industrial water systems), which suggests no intent by EPA to grant either of Nalco’s original 

requests to revoke Buckman’s ammonia registrations. Accordingly, in addition to filing petitions

with EPA, Nalco also should have filed or, at a minimum, prepared itself fully to file an 

application to register ammonia sometime during the past 18 months. If, as it appears, Nalco has 

chosen instead to focus wholly on a speculative petition effort intended to manipulate EPA into 

allowing Nalco to remain on the market without an ammonia registration and, thereby, to 

continue to compete with Buckman unfairly and, specifically, to erode its customer base, the 

Agency should not now reward Nalco for its gamesmanship with any additional time to register 

ammonia. 

In preparing this petition on behalf of Buckman, we consulted with scientists and 

regulatory consultants at Technology Sciences Group Inc., namely, Dr. Robert Stewart, Vice 

President and Managing Director, and Dr. David Brookman, Director of Environmental 

Chemistry. Drs. Stewart and Brookman have reviewed and concur in our technical 

representations in this petition. 
-4-

II. Both Nalco and Buckman sell ammonia for use in proprietary systems in which 

ammonia and sodium hypochlorite react to form MCA, which is the active 

ingredient supplied by each system for water treatment.

Use of either Nalco’s or Buckman’s end-use ammonia product, as labeled, generates the 

same main active ingredient, MCA (monochloramine), which is formed by a chemical reaction 

that occurs at the time of use. The general reaction is as follows:

Figure 1

HOCl/OCl

- + NH3/NH4+ NH2Cl NHCl2 NCl3

Hypoclorous acid/

hypochlorite ion

Ammonia/

ammonium ion

base

Monochloramine Dichloramine Nitrogen

trichloride

The reaction is normally terminated at the stage where MCA is formed, but dichloramine and 

nitrogen trichloride also may occur. 

The nominal active ingredient in Nalco’s end-use ammonia product (Nalcon 60620) is 

“ammonium sulfate” and in Buckman’s end-use ammonia product (Busan 1215) is “ammonia 

(total),” which derives from an aqueous mixture of ammonia and ammonium sulfate. Therefore, 

both products provide ammonia or ammonium ions in the reaction shown in Figure 1 above, and 

both lead to the in-situ generation of one or more chloramines. 

According to its label, attached hereto as Exhibit “B,” Nalcon 60620 is an unregistered 

formulation consisting of 20% ammonium sulfate and 80% “constituents ineffective as spray 

adjuvants,” presumably water. Nalco sells Nalcon 60620 as part of its “OxiPROTM Deposit 

Control Technology” and, specifically, for use in Nalco’s “OxiPRO Feed System,” which is 

illustrated and described in a Nalco proposal and a Nalco slide presentation attached hereto as 

Exhibits “C” and “D,” respectively. Nalco’s label for Nalcon 60620 and Nalco’s materials on 

the OxiPRO Feed System describe a process in which a Nalco technician adds Nalcon 60620 to 
-5-

sodium hypochlorite in a molar ratio between 1:1 and 2:1, at a controlled temperature, under 

alkaline conditions to produce a “stabilized oxidant,” which Nalco does not identify but which is 

MCA, upon examination.

Based upon the available information, use of Nalco’s OxiPRO Feed System involves the 

following preparative steps:

(1) Aqueous sodium hypochlorite (12.5%) is added to aqueous sodium hydroxide (50%) 

to produce an initial mixture of sodium hypochlorite, sodium hydroxide, and water (pH 3 7). 

(2) To this initial mixture, aqueous ammonium sulfate (20%) is added in a molar ratio 

between 1:1 and 2:1 to produce a second mixture containing chloramines, sodium sulfate, 

sodium chloride, and water.

2

(3) The second mixture is diluted with additional water to produce a lower concentration 

of MCA, presumably 10-12 parts per million (hereinafter, “ppm”) measured as total chlorine, 

which is the target stated in Nalco’s June 23, 2008 slide presentation (Ex. D at 9). The diluted 

mixture is promptly added to the customer’s process water at the desired point(s).

According to its label, attached hereto as Exhibit “E,” Busan 1215 is an EPA-registered 

formulation (EPA Reg. No. 1448-433) consisting of 7.59% ammonia and 92.41% “inert 

ingredients.” Buckman sells Busan 1215 as part of a proprietary water disinfection system for 

pulp and paper mills and industrial cooling systems mill, specifically, Buckman’s “Busan 1215 

Feed System.” The Busan 1215 Feed System is illustrated in a photograph, a line drawing, and a 

process diagram attached hereto as Exhibits “F,” “G,” and “H,” respectively. 

2 Nalco’s process description does not permit estimation of the exact composition of the second mixture, which may

contain dichloramine and possibly even nitrogen trichloride in addition to MCA. 
-6-

In the Busan 1215 Feed System, a Buckman technician adds 0.5 oz. of Busan 1215 to 

1 oz. of sodium hypochlorite (≤ 15% wt/wt) to produce MCA under conditions of controlled 

temperature and pH. Specifically, use of the Busan 1215 Feed System involves the following 

preparative steps:

(1) Aqueous ammonia (pH > 9) is diluted with water. Unlike the OxiPRO Feed System, 

the Busan 1215 Feed System does not require the addition of a base, such as sodium hydroxide, 

because basic conditions are maintained by the ammonia. 

(2) The initial mixture is added to aqueous sodium hypochlorite (12.5%) at a minimum 

3:2 molar ratio of sodium hypochlorite to ammonia to produce a second mixture of MCA, 

sodium chloride, and water. 

(3) The second mixture is diluted with additional water to achieve a concentration of 0.5 

to 1 ppm of MCA in excess of the system oxidant demand (maximum of 5 ppm measured as total

chlorine), and the diluted mixture is promptly added to the customer’s process or cooling water 

at the desired point(s).

When Busan 1215 is used as directed in the Busan 1215 Feed Process, the sodium

hypochlorite/hypochlorous acid is completely consumed, and chloramines other than MCA do 

not form readily. For this reason, MCA is the sole oxidant (i.e., active ingredient) in solutions 

prepared from Busan 1215. 

In sum, a careful examination of Nalco’s OxiPRO Feed System and Buckman’s Busan 

1215 Feed System shows that in both systems, ammonia and sodium hypochlorite react to 

produce chloramines. The Buckman system generates MCA, and the Nalco system generates 

MCA and possibly also other chloramines. The basic chemistry underlying both processes is 

familiar and has been known since the early 1900s (U.S. Envtl. Protection Agency, Office of 
-7-

Water, “Alternative Disinfectants and Oxidants Guidance Manual” (April 1999) at 6-1, available 

at http://www.epa.gov/OGWDW/mdbp/alternative_disinfectants_guidance.pdf; hereinafter, 

“Oxidants Manual”). In its December 4, 2007 petition, Nalco does everything but explain in 

accurate chemical terms how ammonia is used in Nalco’s and Buckman’s water treatment 

systems. Accordingly, Nalco’s avoidance of chemistry obscures the fact that MCA is the 

pesticidal active ingredient that results from both Nalco’s and Buckman’s use of ammonia for 

water treatment.

III. Registration of ammonia is necessary, because MCA is too unstable to exist as a 

marketable commodity, no EPA-approved sodium hypochlorite label has 

instructions for use with ammonia to safely produce MCA, and the continued use of 

unregistered ammonia to produce MCA presents unnecessary and potentially 

unreasonable risks to human health and the environment.

Over a period of a day or so, without any modification of pH or Cl2:N ratio, MCA will 

degrade slowly to dichloramine, specifically, to a ratio of 43% MCA to 57% dichloramine, 

which is itself unstable and also has an unpleasant taste and odor to humans (Oxidants Manual at 

6-2 to 6-3). For this reason, it is impractical to bottle and sell MCA as a commercial pesticide

product, and we have been unable to find any EPA registration of MCA, past or present. Instead, 

since the 1930s, the universal practice has been to generate MCA in situ (i.e., at the site of use) 

for use as a water disinfectant (Oxidants Manual at 6-1). 

In 1986, EPA’s Environmental Appeals Board affirmed the Agency’s authority to register 

a “parent chemical” or “immediate precursor” that “does not itself have pesticidal properties” but 

“produces pesticidal action at the site of application,” when “the actual pesticide required to be 

regulated under the Federal Insecticide, Fungicide... cannot exist as a marketable commodity,” 

and when the parent chemical/immediate precursor is “the only logical chemical through which 

the use of the [actual] pesticide can be regulated” (In the Matter of: South Coast Chemical, Inc., 

2 E.A.D. 139, 145 (1986); included as Exhibit “I” hereto). Under the foregoing rationale, 
-8-

ammonia should be registered, despite its lack of pesticidal properties, because ammonia 

produces pesticidal action at the site of application, i.e., produces MCA at the use site; because 

MCA cannot exist as a marketable commodity, due to its instability; and because ammonia is the 

only logical chemical through which the use of MCA can be regulated.

Nalco proposes, in effect, that the registration of sodium hypochlorite alone is sufficient

to regulate the use of MCA, but there is no EPA registration of sodium hypochlorite that 

addresses use with ammonia to produce MCA. Nalco’s five sodium hypochlorite registrations 

(EPA Reg. Nos. 1706-171, -179, -238, -20001, -20002), attached hereto as Exhibit “J,” are silent 

about any use with ammonia, as is the registration of “Sunny Sol®150” (EPA Reg. No. 1744-

20001), attached hereto as Exhibit “K,” a registered sodium hypochlorite product that Nalco 

recommends for use with ammonia in Nalco’s OxiPRO Feed System. Thus, maintaining the 

status quo – Nalco’s plan – will not ensure that users of ammonia and sodium hypochlorite to 

produce MCA will have appropriate labeling, including warnings, precautions, and directions for 

use, that EPA has reviewed and approved to ensure the safe use of MCA as a pesticide.

A theoretical alternative to the status quo is to amend all existing sodium hypochlorite

registrations either to prohibit use with ammonia or to specifically address such use to produce 

MCA, but this is an impractical solution, because there are 211 registrants with 379 registrations 

of sodium hypochlorite. On the other hand, ammonia has only one registrant, Buckman, and 

only one end-use registration, for Busan 1215, which is registered specifically for use with

sodium hypochlorite to produce MCA; indeed, ammonia currently has no other “pesticidal” use. 

Accordingly, to regulate the use of MCA, EPA’s best and only practical option is to register 

ammonia as a precursor of MCA, as the Agency has done in Buckman’s case and now needs to 

do in the case of Nalcon 60620 and all other unregistered ammonia for water treatment. 
-9-

EPA also needs to register ammonia to ensure that the use of MCA does not present 

unreasonable adverse effects on the environment. In the case of Busan 1215, for example, EPA 

required Buckman, as a condition of registration, to obtain a letter from the Food and Drug 

Administration regarding whether MCA requires a food additive tolerance under section 409 of 

the Federal Food, Drug, and Cosmetic Act for any residues of MCA in paper used for food 

packaging. In addition, MCA is toxic to aquatic organisms, and Buckman’s label includes 

directions for use that limit the quantity of MCA added to the customer’s process or cooling 

water to a maximum of 5 ppm measured as total chlorine and that tell users how to neutralize any

MCA detected in effluent. In other words, by registering Busan 1215, EPA was able to ensure 

that the MCA produced with Busan 1215 was used safely, specifically, so as to prevent 

unapproved residues in food packaging and aquatic toxicity from residues in effluent. 

Conversely, EPA has not evaluated the use of any unregistered ammonia product to 

produce MCA, and has no assurances with respect to any residues of MCA in food packaging or 

waste water. Thus, unnecessary and potentially adverse risks to human health and the 

environment remain. For example, Nalco’s OxiPRO Feed System releases 10-12 ppm of MCA 

measured as total chlorine to the customer’s process water, which is more than twice the 

concentration of MCA permitted by EPA on Buckman’s end-use ammonia label (Ex. D at 9). 

IV. Ammonia does not sequester or release “chlorine” and is not an adjuvant; ammonia 

does react with sodium hypochlorite to produce an entirely new active ingredient, 

MCA, which has distinct properties from hypochlorous acid.

Nalco identifies chemical substances (cyanuric acid, diethanolamine, disodium zinc 

ethylene diamine tetracetate dehydrate, ammonium carbamate) and product types (stabilizers, 

sequestrants, synergists) that allegedly “perform similar functions” as ammonia but are not 

registered, implying that EPA has acted irrationally in registering Busan 1215 (Nalco’s Petition

at 12-15). Nalco’s reasoning is flawed and misleading, however, because ammonia is a 
-10-

precursor of MCA – specifically, a reactant in its formation – not an adjuvant. Ammonia reacts 

with sodium hypochlorite in water to form a different chemical compound, MCA, and both the 

ammonia and the sodium hypochlorite are consumed in the reaction. Conversely, the chemical 

substances and products that Nalco identifies do not react to form a different chemical compound 

or compounds and remain chemically unchanged. 

Nalco perpetuates a self-serving fiction that ammonia merely “sequesters” and, later, 

releases “chlorine” (hypochlorous acid) (Nalco’s Petition at 4, 6-7, 11-12; Ex. C at 7; Ex. D at 7). 

This characterization is false for several reasons. First, the use of Nalco’s OxiPRO Feed System 

unmistakably produces MCA, which EPA recognizes as a separate and distinct active ingredient 

from chlorine (Oxidants Manual at 2-30, 6-1). Second, a chemical reaction takes place when 

Nalco’s ammonia product is used. The reaction produces MCA and possibly other chloramines. 

Third, the chemical reaction that produces MCA is not considered reversible. In other words, 

once the chloramine (or -amines) have formed through chemical reaction, they cannot break 

down readily into, or otherwise produce, ammonia and hypochlorous acid/hypochlorite ions.3

Furthermore, MCA and chlorine have different chemical and antimicrobial properties, 

and such differences favor MCA over chlorine in certain applications. For example, MCA is 

increasingly used as a secondary disinfectant in drinking water distribution systems, because it 

decays more slowly and produces substantially fewer disinfection byproducts than chlorine 

(Oxidants Manual at 6-10, 6-27 to 6-29).

MCA and chlorine also have different mechanisms by which they inactivate 

microorganisms. MCA reacts with four amino acids (cysteine, cystine, methionine, and 

3 MCA can hydrolyze very slowly in a process that can form chlorine. Also, making a solution of MCA strongly 

acidic (pH < 1-2) can cause the MCA to decompose and generate some chlorine. Under the conditions under which 

MCA is used for water treatment, no such hydrolysis or decomposition should occur. 
-11-

tryptophan), and the mechanism of inactivation is thought to involve inhibition of proteins or 

protein mediated processes, such as respiration (Oxidants Manual at 6-12). Also, MCA typically 

requires “multiple hits” upon bacterial cells before cell death (Oxidants Manual at 6-12). By 

contrast, chlorine is capable of producing lethal events at or near the cell membrane and of 

affecting DNA (Oxidants Manual at 2-35). In bacteria, chlorine adversely affects cell 

respiration, transport, and possibly DNA activity (Oxidants Manual at 2-35). Accordingly, MCA

does not kill microorganisms by “releasing” chlorine, or MCA would have the same 

antimicrobial properties as chlorine, and it does not.

Furthermore, EPA has determined that MCA does not control as many different 

microorganisms as chlorine and hypochlorous acid (Oxidant Manual at 2-36 to 2-39, 6-13 to 

6-15). Accordingly, Nalco’s unqualified antimicrobial claims for its OxiPRO Feed System 

(Ex. C; Ex. D) imply a level of microbial control that is not provided by MCA. The only way to 

clearly separate appropriate claims for MCA from those for chlorine and hypochlorous acid is to 

register Nalco’s ammonia and all other ammonia for water treatment and to properly attribute the 

antimicrobial claims for MCA to such ammonia registrations.

V. EPA should promptly deny Nalco’s Petition to revoke Buckman’s ammonia 

registrations, because the Agency has properly registered Buckman’s ammonia as a 

precursor of MCA for water treatment.

As explained in section II above, a scientific analysis of how ammonia is used in Nalco’s 

and Buckman’s proprietary water treatment systems shows unambiguously that MCA is the 

active ingredient released by these systems for water treatment. As explained in section III 

above, MCA is too unstable to be bottled and sold as a marketable commodity and, therefore, is 

universally produced in situ. Accordingly, there are no active or inactive EPA registrations of 

MCA by which EPA can control the potential risks from using MCA, which include unapproved 

residues in food packaging and aquatic toxicity. To address these potential risks, EPA must 
-12-

register one or both of the immediate precursors of MCA, sodium hypochlorite or ammonia. 

With one registrant (Buckman), one end-use registration (Busan 1215), and no other pesticidal 

uses, ammonia is the best and only practical candidate for registration, which EPA has 

recognized by registering Buckman’s ammonia products after careful consideration. 

Furthermore, as explained in section IV above, ammonia is a precursor of MCA, not an adjuvant: 

Ammonia reacts with sodium hypochlorite to produce a new active ingredient, MCA, which has 

distinct properties from hypochlorous acid, this reaction is not reversible, and ammonia does not 

sequester or release hypochlorous acid. Thus, EPA’s decision to register ammonia as a precursor 

of MCA has no relationship to the Agency’s past or present regulatory handling of the adjuvants 

identified by Nalco. For all of the foregoing reasons, EPA properly granted registrations to 

Buckman’s ammonia products, and Buckman respectfully requests that the Agency deny Nalco’s 

Petition request to revoke Buckman’s registrations.

VI. EPA should immediately prohibit further distribution and sale of unregistered 

ammonia for water treatment, because the continued sale of unregistered ammonia 

to the same customers for, and for the same uses as, Buckman’s registered ammonia 

presents unnecessary and potentially unreasonable risks to human health and the 

environment, contradicts and undermines the Agency’s proper registration of 

Buckman’s ammonia, and unfairly damages the commercial value of Buckman’s 

registrations. 

If EPA has properly registered Buckman’s ammonia as a precursor of MCA for water 

treatment, then Nalco’s ammonia also must be registered, which Nalco has acknowledged by its 

violent reaction to the registration of BCMW and Busan 1215. As demonstrated in section II 

above, Nalcon 60620 and Busan 1215 are commercially interchangeable: Both products are used 

by the same people for the same purpose, namely, as a source of ammonia to produce MCA in 

situ for the disinfection of industrial water. Nalco’s label description of Nalcon 60620 as a 

“stabilizer for active chlorine sources” is dishonest in scientific terms, because it does not match 

the chemical reactions that actually occur in the OxiPRO Feed System.
-13-

By letter dated February 7, 2008, attached hereto as Exhibit “L,” however, EPA has 

“temporarily” accepted Nalco’s erroneous description of Nalcon 60620 as a chlorine stabilizer,

pending further investigation. Since then – seven months and counting – Nalco has aggressively 

marketed and sold unregistered ammonia to commercial users, who continue to produce and use 

MCA without any EPA oversight, specifically, while Nalco has not had to demonstrate, and EPA 

has not had the opportunity to confirm, that the use of Nalcon 60620 to produce MCA

adequately addresses the potential human health and environmental risks from the use of MCA.

Meanwhile, Buckman cannot explain EPA’s differential treatment of Nalcon 60620 and 

Busan 1215 to customers, and because these products are interchangeable in the marketplace, 

many customers now perceive EPA’s registration of Busan 1215 as pointless and unnecessary –

an impression that has been reinforced by EPA’s failure to date to require the registration of any

ammonia products for water treatment other than Buckman’s. EPA’s inaction not only

contradicts Buckman’s ammonia registrations, it unfairly damages their commercial value. 

Accordingly, the longer that EPA discriminates against Buckman by requiring the registration of 

Buckman’s ammonia while allowing all competitive ammonia products for water treatment to be 

sold without registration, the better it serves Nalco’s desire to delay registration, the harder it is 

for Buckman to salvage its considerable investment to register ammonia, and the longer the 

public goes without assurance that MCA is being used safely, which is provided only by EPA’s 

registering all ammonia for water treatment. Furthermore, Nalco has had more than enough time 

to register ammonia and has chosen instead to focus solely on a petition process to delay 

registration for as long as possible while it continues to compete unfairly against Buckman in the 

marketplace with unregistered ammonia that reflects no regulatory costs. Thus, EPA should not 

reward Nalco’s delaying tactics and opportunism with any additional time to register. For all of 
-14-

these reasons, Buckman respectfully requests that EPA immediately prohibit further distribution 

and sale of unregistered ammonia for use in water treatment. 

VII. Conclusion

Buckman has demonstrated that its and Nalco’s ammonia products are used in the same 

way (as precursors to produce MCA) by the same industrial users (primarily, pulp and paper 

mills, but also facilities with industrial cooling systems), who perceive the two products as 

interchangeable for water treatment applications (disinfection of mill and industrial cooling 

water). Buckman has shown that its and Nalco’s ammonia products do not “sequester” or release 

hypochlorous acid and are not adjuvants, and that EPA has the authority to register ammonia 

products as precursors of MCA, since the registration of MCA itself for water treatment is 

impractical. Buckman also has shown that only the registration of all ammonia products for 

water treatment will ensure that EPA has evaluated any potential risks from the use of MCA and 

restore a level playing field in the marketplace for industrial water disinfection. For these

reasons, as explained in this petition, we renew our request that EPA deny Nalco’s Petition and

immediately prohibit further distribution and sale of unregistered ammonia for water treatment. 

We welcome an opportunity to discuss our petition with EPA.
-15-

Respectfully submitted,

Michael Boucher

MCKENNA LONG & ALDRIDGE LLP

1900 K Street, NW

Washington, D.C. 20006

(202) 496-7729

Counsel to

Buckman Laboratories, Inc.

Dated: September 2, 2008
EXHIBIT A
DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA2008F0462] 

Zentox Corp.; Filing of Food Additive Petition 

AGENCY: 

 Food and Drug Administration, HHS. 

ACTION: 

 Notice. 

SUMMARY: 

 The Food and Drug Administration (FDA) is announcing that Zentox Corp. has 

filed a petition proposing that the food additive regulations be amended to 

provide for the safe use of monochloramine as an antimicrobial agent in poultry 

process chiller water. 

DATES: 

Submit written or electronic comments on the petitioner's environmental 

assessment by [insert date 30 days after date of publication in the Federal 

Register]. 

ADDRESSES: 

 Submit written comments to the Division of Dockets Management (HFA305), Food 

and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

 Judith Kidwell, Center for Food Safety and Applied Nutrition (HFS265), Food and 

Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 207403835, 

3014361071. 

SUPPLEMENTARY INFORMATION: 

Under the Federal Food, Drug, and Cosmetic Act (sec. 409(b)(5) (21 U.S.C. 

348(b)(5))), notice is given that a food additive petition (FAP 8A4775) has been 

filed by Zentox Corp., c/o Burdock Group, 801 North Orange Ave., suite 710, 

Orlando, FL 32801. The petition proposes to amend the food additive regulations 

in part 173Secondary Direct Food Additives Permitted in Food for Human 

Consumption (21 CFR part 173) to provide for the safe use of monochloramine as 

an antimicrobial agent in poultry process chiller water. 

The potential environmental impact of this petition is being reviewed. To 

encourage public participation consistent with regulation issued under the 
National Environmental Policy Act (40 CFR 1501.4(b)), the agency is placing the 

environmental assessment submitted with the petition that is the subject of this 

notice on public display at the Division of Dockets Management (see DATES and 

ADDRESSES) for public review and comment. 

Interested persons may submit to the Division of Dockets Management (see 

ADDRESSES) written or electronic comments regarding this document. Submit a 

single copy of electronic comments or two paper copies of any mailed comments, 

except that individuals may submit one paper copy. Comments are to be identified 

with the docket number found in brackets in the heading of this document. 

Received comments may be seen in the Division of Dockets Management between 9 

a.m. and 4 p.m., Monday through Friday. FDA will also place on public display 

any amendments to, or comments on, the petitioner's environmental assessment 

without further announcement in the Federal Register. If, based on its review, 

the agency finds that an environmental impact statement is not required, and 

this petition results in a regulation, the notice of availability of the 

agency's finding of no significant impact and the evidence supporting that 

finding will be published with the regulation in the Federal Register in 

accordance with 21 CFR 25.51(b). 

Please note that on January 15, 2008, the FDA Division of Dockets Management Web 

site transitioned to the Federal Dockets Management System (FDMS). FDMS is a 

Government-wide, electronic docket management system. Electronic comments or 

submissions will be accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: August 27, 2008. 

Laura M. Tarantino, 

Director, Office of Food Additive Safety, Center for Food Safety and Applied 

Nutrition. 

[FR Doc. 08????? Filed ????08; 8:45 am]BILLING CODE 416001S 

[FR Doc. 2008-20293 Filed 08/29/2008 at 8:45 am; Publication Date: 09/03/2008] 
EXHIBIT B


EXHIBIT C
 Production Leader 

Thank you for the opportunity to review our OxiPROm Deposit Control 

Technology. - Please Rnd enclosed our proposal outlining how OX~PRO~, can benefit the 

Nalco's OxiPROTM Deposit Control Technology offers improved paper machine 

efficiency by controlling microbial-based deposits through : 

Q Innovative chlorine stabilizing chernlstries 

0 A combination of new and unique proactive monitoring tools, n Application expertise & strategies to maximize performance 

Resulting in: 

P Improved system stability 

P Reduced treatment cost 

o Reduce sheet defects 

o - Increased uptime. 

We thank you once again for this opportunity to work with you and look forward 

to discussing this proposal with you in more detail. 

Sincerely, 

Gary deVries 

District Account Manager P18 

Nalco Company 

Confidential 
Nalco's OxiPROTM Deposit Control Technology is a stabilized oxidant program. It 

takes an oxidant that has been blended with caustic on site and stabilizes St with 

our unique chemistry. A specially designed feed system insures the oxidant is 

completely stabilized. Nalco's online microbiological monitoring unit provides 

continuous real time results for proactive control. 

Nalco's OxiPROm innovative oxidant stabilizer program can provide with 

these benefits: 

The most economical microbiological treatment program for neutral 

conditions 

Consistently meet or extend boil out target periods. 

Greater. system assurance through online monitoring 

Longer equipment life due to a less corrosive chemistry. 

Improved runnability of machine and converting due to less holesjdeposits 

creating sheet defects and breaks 

Specific Potential Benefits for the- Mill Operation: 

Innovative chlorine stabifizer 

Nalco has several stabilized oxidants that can be utilized for your system. 

Testing and Nalco experience has shown that Nalco 60620 is most effective in 

your system. 

Improved Silo treatment strategies to minimize biomass Nalco's OxiPROTM program creates stabilize oxidants that provide extended 

control even in the most demanding systems. Nalco will employ a slug feed 

to help Improve system cleanliness while minimizing adverse effects of high 

free chlorine residuals on machine performance and paper quality. 

Real-time microbial monitoring for greater system assurance and 

optimization. 

This program comes with Nalco's new patent pending online continuous 

microbiological monitoring unit for optimum proactive control. Real time MB 

monitoring allows for immediate response before a system upset can occur. 

Confidential 
$1. . ! Prooram Oblective and fuccess Criteria: 

Be safe and reliable at ail times 

Maintain a clean paper machine system with no microbiological deposits. 

Provide timely monitoring data for proactive control. 

Have no negative impacts on wet end chemistry. 

Provide service needed to maintain the program in peak performance and 

document the results 

Proaram Cost: 

The program would be billed on a pricefton basis. .@ 

Nalco 60620 and Nalco BL 409 $2.35/swt . .. .,. Bleach, 12.5% Supplied by-h totes or bulk 

This pricing also includes: 

One feed systems capable of feeding 4 addition points. 

One OX~PRO~ Monitoring unit, . '' ;.-?: 

Nalco service and support program. Nalco maintains ownership of the feed and monitoring equipment. 

A water softener if needed. 

old provide the following: 

Clean water for final dilution. 

Assistance installing the equipment. 

Electrical and piping connections to the units and feed points. 

Wireless or Ethernet connection ,for -monitor information transfer. 

Bleach in totes or bulk storage om ' , 

---' 

Discussion: 

Nalco's OxiPROTM Deposit Control Technology program for includes 

feed equipment, monitoring equipment, a stabilized oxidant program, and on-site 

service. This discussion will provide details and supporting information for the 

proposed program. 

Stabilized Oxidant Chemistry: 

OX~PRO~~ Technology combines a stabilizer (Nalco 60620) blended on site by the 

feed skid with commercially available 12.5% sodium hypochlorite and NaOH. 

3 

Confidential 
The stabilizer of choice from the testing is Nalco 60620. It showed to have the 

best low concentration kill as well as the best high concentration persistence 

when compared with the other products. 

This product has shown to be effective in similar environments both in the lab 

and in mill experience. This product is currently being utilized in multiple tissues 

and towel mills with great success. . , OX~PRO~ Feed System 

The feed skid blends the chemistries in the appiopriate ratios and delivers the 

stabilized oxidant to the paper process. Below is a simple flow sheet of the feed 

skid operation. The feed skids can be designed to run in a slug configuration or a 

continuous operation. For the system we recommend utilizing a slug 

feed operation to assure proper coverage and cost effectiveness. 

Addition Points 

Nalm recommends the following addition points for the3 operation. These 

points could change or be reduced pending system requirements as the program 

is optimized. 

- 

-1 2.5% 

Sodium 

Hypochlorite 

I. TM Sifo 

2. TM Shower Water Tank 

- Stabilizer 

50% 

Sodium 

Paper 

Process 

Hydroxide 

' 

+ + F 

Mixing Mixing 

Tee Tee 

Water 

- 

Dilution 
The unit continuousfy monitors four system conditions: 

1. Microbiological activity level 

2. Overall fouling rate 

3. ORP 

4. pH 

The unit monitors a head box or white water system side stream and the sample 

can be returned back to the process. An internet connected computer or cell 

phone can access the data immediately either on-site or remotely., Target 

control ranges can be set for each parameter and the unit will send alarms to a 

computer or by cell phone text message alerting the local team to take action as 

required. 

The following is actual data from the monitor that a Nalco representative used to 

prevent a lost time upset. Similar incidents at this mill before the monitor was 

installed caused six hours of lost time. 

I September 2006 

wlm BN08 WSmPlgms ~~ WE8 ~9miw~enMsBlWOBBnS1PBBn4K!4.mlm I -Activity Index - Bbmonltor-Fouibg -0RP I 

A similar lnciden t last year caused 6 hours 

of downtime and an unscheduled bo~/outl . 

5 

Confidential 
used to help calibrate the monitor target control ranges and troubleshooting 

variations in the process. 

Nalco Sewice Program 

Our experienced local Nalco team will provide regular service for the program. Our service program will be tailored to your needs and may include: 

A Malco representame in the ,mill On call coverage 24 hours, 7 days a week. 

Regular maintenance and repair of the feed and monitoring equipment. 

Bi-weekly reports summarizing program performance 

Weekly machine inspection for MB deposits with more detailed inspection 

during outages. 

System trouble shooting as required. 

We look forward to discussing the value Naico's OX~PRO~~ Deposit Control 

Program can give- We want to thank you for Me opportunity to 

service your facility and your request for this proposal. 

Confidential 
 7
EXHIBIT D














EXHIBIT E


EXHIBIT F
Busan 1215 Feed System
EXHIBIT G

EXHIBIT H
Busan 1215 Feed System Diagram

Set water flow rate with valve 9

Dilution water

1

2

3

4

5

6 7

8

9

11

10

12

15

14

13

16

17

19

18

20

Emergency

flush water

12"

12'

13

Applicat

Applicat

Applicat

Applicat

EXHIBIT I