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
M C K ENNA L ONG & A LDRIDGE LLP 1900 K Street , NW Washington, D.C. 20006 (202) 496

- 7729
C ounsel to Buckman Laboratories, Inc.

September 2 , 2008TABLE OF CONTENTS Page

- i

I. Overview

................................ ................................ ................................ ....................... 1 II. Both Nal co and Buckman sell ammo nia for use in proprietary systems in which ammo nia and sodium hypochlorite react to form MCA, which is the act ive ingredient supplied by each system for water treatment.

................................ ................. 4 III. Registration o f a mmo nia is necessary, because MCA is too unstable to exist as a marketable co mmo di

ty , no EPA

- approved sodium hypochlorite label has instructi ons for use with ammo nia to safely produce MCA, and the continued use of unregistered ammo nia to produce MCA presents unnecessary and potentially unr easonable ri sks to human healt h and the environment.

................................ ............... 7 IV. Ammo nia does not sequester or release “chlorine” and is not an adjuvant; ammo nia does react with sodium hypochlorite to produce an entirely new active ingredient, MCA, which has distinct properties from hypochlorous acid.

....................... 9 V. EPA should prompt ly deny Nalco’s Petit io n to revoke Buckman’s ammo nia regi strati ons, because the Agency has properly registered Buckman’s ammo nia as a precursor of MCA for water treatment.

................................ ................................ ...... 11 VI. EPA should immediately prohibi t f urther distribut ion and sale of unregistered ammo nia for water treatment, because the continued sale of unregistered ammo nia to the same customers for, and for the same uses as, Buckman’s regi stered ammo nia presents unnecessary and potent ia lly unreasona ble risks to human healt h and the environment, contradicts and undermines the Agency’s proper registration of Buckman’s ammo nia, and unfairly damages the commercial value of Buckman’s registrations.

................................ ................................ ................ 12 VII. Concl

usi on
................................ ................................ ................................ ................... 14
EXHIB IT A Food addit ive pet it io n o f t he Zentox Corporation to provide for the safe

use of MCA as an antimicrobial agent i n poul try process chiller water
EXHIBIT B Label o f Nalcon 60620 EXHIBIT C Nal co Com p any proposal fo r OxiPRO microbio lo gical control program
EXHIBIT D Nal co Com pany slide prese nt ati on, “ PM ■ Bi oci de Tri al Operator Overview”
EXHIBIT E EPA

- regi stered label o f Busan 1215
EXHIBIT F Photograph of Busan 1215 Feed System EXHIBIT G Line drawing of Busan 1215 Feed SystemTABLE OF CONTENTS (continued)

- ii

EXHIBIT 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

- regi stered label s of Nalco Com pany’s sodi

um hypochl ori

te products
EXHIBIT K EPA

- regi stered label o f Sunny Sol 150
EXHIBIT L February 2, 2008 letter from Frank Sanders to Seth Goldberg- 1

-

I. O ve rview Nal co Com

pany’s ( hereinafter, “Nalco’s”) December 4, 2007 “Request T hat EPA
Reconsider Its Registration for Ammo nia Produc ts as Precursors to Chloramine U sed in Water
T reatment and Provide Assurance T hat T here Is No Risk of Enforcement d uring the
Rec onsiderat io n and Any Necessary Transit io n Period” (hereinafter, “Nalco’s Pet it io n”) is a
ti rade against EPA’s registrati on s of BCMW (EPA Reg. No. 1448

- 432) and Busan 1215 (EPA Reg. No. 1448

- 43 3) , Buckman Laboratories, Inc.’s (hereinafter, “Buckman’s”) ma nu facturing

use and end

- use ammo nia product s, respectively . T he vio lence of Nalco’s protest taci tl y acknowledges Nalco’s need to regi ster it s own c urrent end

- use ammo nia product, Nalcon 60620,
because Nalcon 60620 and Busan 1215 essent ia lly have th e same co mposit io n, are used by the

same industrial users in th e same manner for water disinfect io n , and are considered
int erchangeable products in the market place

. Nalco ’s Petit io n ignores the unknown and potenti ally unreasonable risks presented by th e ongoing us e of unregistered ammo nia to produce

mo nochloramine ( hereinafter, “MCA”) , including human healt h r isk s from unapproved residues
of MCA in paper used for food packaging and toxicit y to aquati c organisms fro m MCA residues
in industrial waste water. 1 Not sur pri singly , Nalco also ig nores the si gnificant and ongoing
dam age being done unfairly to the commercial value of Buckman ’s ammo nia registrati on s

– and
to Buckman’s abilit y t o recoup its invest me nt in such registrati on s

– by Nalco ’s ongoing sale of unregiste red ammo nia wi th EPA’s “t em

porary ” permissio n , which has lengthened to seven

mo nt hs wit h no end in sight

.

1 Coincidentally, we have obt ained 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 proces s 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 processi ng.- 2

-

To just ify th e status quo, Nalco offers a series of increasingly erratic and unf ocused
argum ents. Ini

ti ally, Nal co alleges that ammo nia cannot be re gistered , because it is not an active ingredient (Nalco’s Pet it io n at 6

- 7 ), but lat er flip

- flops and acknowledg es th at , in fact, EPA can regi ster a precursor of an active ingredient , where registration of the active ingredient itself is not practi cal (Nalc o’s Peti

ti on at 9 )

– exact ly as EPA has d one wi th BCMW and Busan 1215 , because the registration of MCA it self for water treatment is impract ic al

. Then, Nal co agrees th at combining ammo nia and sodium hypochlorite produces MCA (Nal co’s Pet it io n at 4) , in a chemical react io n know n since the early 1900s, but alleges th at MCA is not a n active ingredient
th at is separate fro m “chlorine” (hypochl orous acid) ( Nalco’s Pet it io n at 8

- 9, 11 ), even though
th e production of MCA is a reaction th at i s not considered rever sible ( i.e. , once formed, MCA does not readily break down into , or otherwi se produce , ammo nia and hypochlorous
aci d/ hypochlorite io ns ) , and despite that EPA and industry recognize MCA as a dist inct active ingredient with valuable properti es th at are differ ent fro m th ose of hypochlorous acid

. Nal co also plays variat io n s o n th e fo regoing th eme , specifically , th at ammo nia “sequesters” and
rel eases “ chl ori ne ” by a novel chemical process that Nalco never explains (Nalco’s Petit io n at 4,
6

- 7, 11

- 12 ) , and th at am

mo nia is only an adjuvant used with “ chl ori ne ” and , thus, requir es no regi strati on (Nal co’s Pet it io n at 15 ) , even though ammo nia reacts com pletely wi th sodi um hypochlorite to f

orm a new act ive ingredient , MCA , and, th us , does not hold or release hypochloro us acid and does not resemble any adjuvant

. For the foregoing reasons, as articulated and explained in t his pet it io n , we respectfully request pursuant to section 553(e) of the Administrative Procedures Act ( 5 U.S.C. § 553(e) ) that
EPA deny Nalco’s Petit io n and immediately prohibit further distribution and sale of unregistered

ammo nia for water treatment

. Nalco has asked fo r time to register ammo nia but neit her needs- 3

-

nor deser ves any addit io nal t ime . Nalco has had notice of EPA’s po licy on th e registratio n of

ammo nia for water treatment since th e Agency’s registrati on of Buckman’s ammo nia products on March 6, 2007

. S ince then

– a period of 18 months

– Nalco has fo und ample time to make
tw o lengthy and duplicat ive submissio ns and one responsive submissi on to EPA in order to
subvert th e Agency’s registration of Buckman’s amm onia products . Neither of Nalco’s ori ginal filings ever had a likelihood, much less a certainty , of persuading EPA to revok e it s considered regi strati ons of amm onia , which Nalco knew at th e time of its filings

. Indeed, as recent ly as July 15, 2008 , th e A gency amended Buckman’s registration of Busan 1215 to add a new use (i ndustrial water systems) , which suggest s no int ent by EPA to grant eit her of Nal co’s ori ginal request s to revoke Buck ma n’s ammo nia registrati on s . Accordingly , in addit io n to filing pet it io ns wi th EPA , Nal co al so shoul d have filed or , at a minimum, prepared it self fully to file an applicat io n to regi ster ammo nia so met ime during th e past 18 months. If , as it appears, Nal co has
chose n instead to focus who lly on a speculat ive peti ti on effort int ended to ma nipulate EPA into
allow ing Nalco to remain on the market without a n ammonia registrati on and, thereby, to continue to co mpet e wi

th Buckman unfairly and , specifically , to e rod e it s customer base, t he Agency shoul d not now reward Nalco fo r i ts gamesmanship wi

th any addi

ti onal t ime to register

ammo nia

. In preparing thi s pet it io n on behalf o f Buckman , we co nsulted with scient ist s and regul atory consul

tants at Technol ogy Sci enc es Group Inc., namely, Dr. Robert Stewart, Vice
Presi dent and Managing Director, and Dr. David Brookman, Direct or of Environmental Chemistry . Drs. Stewart and Brookman have reviewed and concur in our technical representations in t his petit io n
.- 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 ei ther Nal co’s or Buckman’s end

- use ammoni a product , as la beled, generates the
same main act ive ingredient, MCA (monochloramine) , which is fo rm ed by a chemical reaction
th at occurs at the time o f use. The general react io n is as fo llo ws: Figure 1

H O C l / O C l - + N H 3 / N H 4 + N H 2 C l N H C l 2 N C l 3 H y p o c l o r o u s a c i d / h y p o c h l o r i t e i o n A m m o n i a /

a m m o n i u m i o n b a s e

M o n o c h l o r a m i n e D i c h l o r a m i n e N i t r o g e n t r i c h l o r i d e
The reaction is normally ter minated at the stage where MCA is formed, but dichloramine and
nit rogen tri ch l ori de also ma y o ccur.

The no minal act ive ingredient in Nalco’s end

- use ammo nia product (Nalcon 60620) is

“ amm oni um sulfate ” and in Buckman’s end

- use ammo nia product ( Busan 1215 ) is “ amm onia (total ), ” which derives fro m a n aqueous mixture of ammonia and ammo nium sulfate . Therefore,
b oth products provide ammo nia or ammo nium io ns in the reaction shown in Figure 1 above, and
both lead to the in

- si

tu generati on of one or more chloram ines.
According to its label, attached hereto as Exhibit “ B , ” Nal con 60620 is an unregistered
fo rm ulat io n consist ing of 20% ammo nium su lfate and 80% “constituents ineffect ive as spray adj uvants,” presumably water. Nalco sells Nalcon 60620 as part of its “ OxiPRO TM Deposi t Control Techno lo gy

” and, specifically, for use in Nalco’s “OxiPRO Feed System,” which is
illustrated and described in a Nalco proposal and a Nal co slide presentation attached hereto as
Exhibit s “ C ” and “ D ,” respect ively. Nal co’s label fo r Nal con 60620 and Nalco’s materials on
th e OxiPRO Feed System describe a process in which a Nalco technician adds Nalcon 60620 to- 5

-

sodi um hypochlorite in a mo lar ratio between 1:1 and 2:1 , at a controlled tem perature , under
al kaline condit io ns to produce a “stabilized oxidant,” which Nalco does not ident ify but which is
MCA , upon examination

. Based upon the available informat io n, use of Nalco’s OxiPRO Feed System invo lves the
fo llo wing preparat ive steps : (1) Aqueous sodium hypochlorite (12.5%) is added to aqueous sodium hydroxide (50%) to produce an init ial mixture of sodium hypochlorite, sodium hydroxide, and water (pH 3 7). (2) To this init ial mixture, aqueous ammo nium sulfate (20%) is added in a mo lar ratio between 1:1 and 2:1 to produce a second mixtu re containing chloramines, sodium sulfate,
sodi um chl ori de, and water

. 2 (3) The second mixture is diluted with addit io nal water to produce a lower concentration
of MCA , presum ably 10

- 12 parts per millio n ( hereinafter, “ppm”) measured as total chlorine ,

w hich is the target stated in Nalco’s June 23, 2008 slide presentation (Ex. D at 9 ). The diluted mixture is prompt ly added to the customer’s process water at th e desired point (s)

. According to its label, attached hereto as Exhibit “ E ,” Busan 1215 is an EP A

- regi stered
fo rm ulat io n (EPA Reg. No. 1448

- 433) consist ing of 7.59% ammo nia and 92.41 % “inert ingredients

. ” Buckman sells Busan 1215 as part of a proprietary water disinfection system for pul p and paper mills and industrial cooling systems mill , specific ally , Buckman’s “ Busan 1215 Feed Sy stem

. ” 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, ” respect ively.

2 Nalco’s process description does not permit estimation of the exact composition of the second mixture, w hic h may contain dichloramine and possibly even nitrogen trichloride in addition to MCA.- 6

-

In the Busan 1215 Feed System, a Buckman technician ad ds 0.5 oz. of Busan 1215 to
1 oz. of sodi

um hypochlorite ( ≤ 15% wt/wt) to produce MCA under condit io ns of controlled
tem perature and pH. Specifically, use of th e Busan 1215 Feed System invo lves the fo llo wing preparative steps : (1) Aqueous ammonia (pH > 9) is diluted with water. Unlike th e OxiPRO Feed System,
th e Busan 1215 Feed System does not require the addit io n of a base, such as sodium hydroxide , because basic condit io ns are maintained by the ammo nia

. (2) The init ial mixture is added to aqueous sodium hypochlorite (12.5%) at a minim um 3:2 mo lar ratio of sodium hypochlorite to ammo nia to produce a second mixture of MCA , sodi um chl ori de, and water. (3) The second mixture is diluted with addit io nal water to achieve a concentration of 0.5 to 1 ppm of MCA in excess of the system oxidant dem and (m aximum of 5 ppm measured as total
chlorine ), and the diluted mixture is prompt ly added to the customer’s process or cooling water at the desi

red point(s).
When Busan 1215 is used as directed in the Busan 1215 Feed Process , th e sodi um hypochlorit e/ hypochlorous acid is co mp letely consumed , and chl oramines other than MCA do
not fo rm readily . For this reason, MCA is the so le o xidant ( i.e. , active ingredient) in so lut io ns prepared fro m Busan 1215. In sum, a careful examinat io n of Nalco’s OxiPRO Feed Sy stem and Buckman’s Busan 1215 Feed System shows that in both systems, ammo nia and sodium hypochlorite react to produce chloramines. The Buckman system generates MCA , and the Nalco sy stem generate s MCA and possibly also other chloramines. The basic che mistry underlying both processes is familiar and has been known since the early 1900s (U.S. Envtl. Protection Agency, Office o f- 7

-

Water, “Alternat ive Disinfectants and Oxidants Guidance Manual” (April 1999) at 6

- 1 , available

at http://www.epa.gov/OGWDW/mdbp/alternative_disinfectants_guidance.pdf ; hereinafter,
“O xidants Manual”)

. In its December 4, 2007 peti ti on , Nal co does every

thing but explain in
accurate chemical terms h ow ammo nia is used in Nalco’s and Buckman’s water treatm ent system s . Accordingly , Nalco’s avo idance of chemistry obscures the fact th at MCA is the pesticidal act ive ingredient that results fro m both Nal co’s and Buckman’s use o f a mmo nia for
water treatm ent

. 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 pr oduce MCA , and the continued use of unreg istered 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 Cl 2 :N rati o, MCA will degrade slowly to dichloramine, specifically, to a ratio of 43% MCA to 57% dichloramine , which is it self unstable and also has an unpleasant taste and odor to humans ( Oxidants Manual at 6

- 2 to 6

- 3). For thi s reason , i t i s impract ic al to bottle and sell MCA as a commercial pest ic ide 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)
fo r use as a water disinfectant ( Oxidants Manual at 6

- 1).
In 1986 , EPA’s Environmental Appeal s Board affirm ed th e Agency’s authorit y t o register a “parent chemical” or “immediate precursor” that “does not itself have pesticidal properties” but “produces pest ic idal action at the site of applicat io n , ” when “the actual pest ic ide required to be regul a ted under the Federal Insect ic ide, Fungicide... cannot exist as a marketable co mmo di ty , ” and when th e parent chemical / immediate precursor is “the only logical chemical through which
th e use of the [actual] pest ic ide can be regulated” ( In the Matter of: South Coast Chemical, Inc. , 2 E.A.D. 139, 145 ( 1986) ; included as Exhibit “ I ” hereto)

. Under t he foregoing rat io nale ,- 8

-

ammo nia should be registered, despite it s lack of pesticidal properties, because ammo nia produce s pesticidal act io n at the site of applicat io n , i.e. , produces MCA at the use site ; because
MCA cannot exist as a marketable co mmo di ty , due to its instabilit y; and because ammo nia is the only lo gical chemical through which the use of MCA can be regulated.
Nal co proposes , i

n effect , that th e registrat io n of sodi um hypochlorite al on e is sufficient to regulate the use of MCA , but there is no EPA registration of sodi um hypochlorite th at addresses use with ammo nia to produce MCA . Nalco’s five sodi um hypochlorite regi strati ons ( EPA Reg. Nos. 1706

- 17 1,

- 179 , - 238,

- 20001,

- 20002), attached hereto as Exhibit “ J ,” are silent
about any use with ammo nia, as is the registration of “Sunny Sol ® 150” (EPA Reg. No. 1744

- 20001) , attached hereto as Exhibit “K , ” a regi stered sodi um hypochlorite product th at Nalco

recomm ends fo r use wi

th ammo nia in Nalco’s OxiPRO Feed System

. Thus, maintaining the status quo

– Nal co’s pl an

– will not ensure that users of ammo nia and sodi um hypochlorite to produce MCA will have appropriate labeling, including warnings, precautions, and di recti ons for

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

. A t heoretical al

ternative to the status quo is to am end all exist ing sodi um hypochl ori

te regi strati ons eit her to prohibit use with ammo nia or to specificall y address suc h use to produce
MCA , but this is an impract ical so lut io n, because there are 211 registrants wit h 379 registrations
of sodi um hypochlorite. On the other hand , amm onia has only one registrant, Buckman, and only one end

- use regi strati on, fo r Bu san 1215, which is registered specifically fo r use wi th
sodi um hypochlorite to produce MCA ; i ndeed, ammo nia current ly has no other “ pest ic idal ” use
. Accordingly , to regul ate the use of MCA , EPA’s best and only pract ical opti on is t o register

ammo nia as a precursor of MCA , as the Agency has done in Buc kman’s case and now needs to
do in the case o f Nalcon 60620 and all other unregistered ammo nia fo r water treatment

.- 9

-

EPA al so need s to register ammo nia to ensure that the use of MCA does not present
unreasonab le adverse effects on the environment. In the case of Busan 1215, for example, EPA requi red Buckman, as a condition of registration, to obtain a letter from the Food and Drug
Ad ministrati on regarding whether MCA requi re s a food additive tolerance under se ct io n 409 of
th e Federal Food, Drug, and Cosmet ic Act for any residues of MCA in paper used for food packaging. In addit io n, MCA is toxic to aquatic organisms , and Buckman’s label includes
di rect io ns fo r use that limit th e quantit y o f MCA added to the cus tom er’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
th at the MCA produced with Busan 1215 w as used safely, specifically, so as to prevent unapproved residues in food packaging and aquat ic toxic it y fr om residues in effluent. Conversely , EPA has not evaluated the use of any unregistered ammo nia product to produce MCA , and has no assurances wit h r espect to any residues of MCA in fo od packaging or
waste water . Thus, unnecessary and potenti al ly adverse ri sks to human healt h and the
environment remain. For example, Nalco’s OxiPRO Feed System releases 10

- 12 ppm of MCA measured as total chlorine to th e customer’s process water, which is more than tw ice th e concentration of MCA permi tted by EPA on Buckman’s end

- use ammo nia label (Ex. D at 9)

. IV. Ammonia does not sequester or release “ chlorine ” and is not an adjuvant ; ammonia does react with sodium hypochl orite to produce a n entirely new active ingredient, MCA , which has distinct properties from hypoch lorous acid
. Nal co i dent ifies chemical substances (cyanuric acid, diethano la mine, disodium zinc ethylene diamine tetracetate dehydrate, ammo nium carbamate) a nd product ty pes (stabilizers, sequestrants, synergists) that allegedly “perform similar funct io ns” as ammo nia but are not regi stered, implying that EPA has acted irrationally in registering Busan 1215 (Nalco ’s Pet it io n
at 12

- 15 ). Nal co’s reasoning is fla wed and misleading, however, because ammo nia is a- 10

-

precursor of MCA

– specifically , a reactant in its formation

– not an adjuvant. Ammo nia reacts
wi th sodi um hypochlorite in water to form a different chemical co mpound, MCA , and both the

ammo nia and the sod iu m hypochlorite are consumed in the reaction. Conversely, the chemical substances and products that Nalco ident ifies do not react to form a different chemical co mpound or compounds and remain chemically unchanged.
Nal co perpetuates a self

- serving fict io n t hat ammo nia merely “sequesters” and, later,
rel eases “chlor ine” (hypochlorous acid) (Nalco’s Petit io n at 4, 6

- 7, 11

- 12 ; Ex. C at 7; Ex. D at 7 ).
This characterizat io n is false for several reasons. First, the use of Nalco’s OxiPRO Feed System
unmistaka

bly produces MCA , which EPA recognizes as a separate and dist inct active ingredient
fro m c hlorine ( Oxidants Manual at 2

- 30, 6

- 1 ). Second, a chemical react io n t akes place when
Nal co’s amm onia product i s used. The reaction produces MCA and possibly other c hloramines.
Thi rd, the chemical react io n t hat produces MCA is not co nsidered reversible. In other words,

o nce the chloramine (or

- amines) have formed through chemical reaction, they cannot break
down readily int o , or otherwi se produce , ammo nia and hypoch lo rous aci d / hypochl ori

te i ons. 3
Furtherm ore, MCA and chlorine have different chemical and ant imicrobial 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 substant ia lly 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 inact ivate
mi croorga n isms. MCA reacts with four amino acids ( cy steine, cyst ine, methio nine, and

3 MCA can hydrolyze ver y slowly in a process that can f or m 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

-

try ptophan), and the mechanism of inact ivat io n is thought to invo lve inhibit io n of proteins or protein mediated processes, such as respiration ( Oxidants Manual at 6

- 12 ). A lso, MCA ty pically requi res “mult ip le hits” upon bacterial cells before cell death ( Oxidants Manual at 6

- 12 ). B y contrast, c hlorine is capable of producing lethal events at or near the cell membrane and of
affect ing DNA ( Oxidants Manual at 2

- 35 )

. In bact eri a, chlorine adversely affect s cell respi rat io n, transport, and possibly DNA activit y ( Oxidants Manual at 2

- 35 )

. Accordingly, MCA does not kill microorganisms by “releasing” chlorine, or MCA woul d have the same

ant imicrobial properties as chlorine, and it does not.
Furtherm ore, EPA has determined that MCA does not con trol as many different microorganisms as chl ori ne and hypochlorous acid (Oxidant Manual at 2

- 36 to 2

- 39 , 6

- 13 to
6

- 15 )

. Accordingly, Nalco ’s unqualified ant imicrobial claims for its OxiPRO Feed System ( Ex. C ; Ex. D ) imply a level o f microbial control that is not provided by MCA. The only way to
cl early separate appropriate cl aims for MCA from those for chlorine and hypochlorous acid is to regi ster Nal co’s ammo nia and all other ammo nia for water treatment and to properly attribute the

ant imicrobial claims for MCA to such ammo nia registrations.
V. EPA should pr ompt ly deny Nalco ’ s Petition to revoke Buckman ’ s ammonia registration s , because the Agency has properly registered Buckman ’ s ammonia as a precursor of MCA for water treatment
. As explained in sect io n II above , a sci ent ific analysis of how ammo nia is used in Nalco’s and Buckman’s proprietary water treatment systems shows unambiguously th at MCA is t he active ingredient released by these sys tems fo r water treatm ent . As explained in section III above, MCA is too unstable to be bottled and so ld as a marketable commodit y and, th erefore , is universally produced in situ

. Accordingly , there are no active or inact ive EPA registrati ons of
MCA by wh ich EPA can control th e potenti al ri sks f rom using MCA , which include unapproved
resi dues in food packaging and aquat ic toxi ci ty . To address these potential risks, EPA must- 12

-

regi ster one or both of the immediate precursors of MCA , sodi um hypochlorite or am

mo nia

. W it h one registrant (Buckman) , one end

- use registrati on (Busan 1215) , and no other pesticidal

uses, ammo nia is the best and only pract ical candidate for registration , which EPA has recogni zed by registering Buckman’s ammo nia products after careful considerat io n
. Furtherm ore, as explained in sect io n IV above, ammo nia is a precursor of MCA , not an adjuvant : Ammo nia reacts with sodium hypochlorite to produce a new act ive ingredient, MCA , which has
di st inct properties from hypochlorous acid , th is reac ti on is not reversible, and ammo nia does not sequester or release hypochlor ous aci d

. Th us, EPA’s decisio n t o register ammo nia as a precursor of MCA has no relat io n ship to the Agency’s past or present regulatory handling of th e adj uvants ident ified by Nalc o. For all of the foregoing reasons, EPA properly granted registration s to Buckman’s ammo nia products, and Buckman respectfully requests that th e Agency deny Nalco’s
Peti ti on request to revoke Buckma n’s registration s
. VI. EPA should immediately prohibit furt her distribution and sale of unregistered ammonia for water treatment , b ecause the continued sale of unregistered ammonia to the same customers for, and for the same use s as, Buckman ’ s registered ammonia presents unnecessary and potentially unreasonable ri sks 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 registration s . If EPA has properly regist ered B uckm an’s ammo nia as a precurso r of MCA fo r water
treatm ent , th en Nalco’s ammo nia also m ust be registered , which Nalco has acknowledged by its
vio lent reaction to the registration of BCMW and Busan 1215 . As demonstrated in sect io n II above, Nalcon 60620 and Busan 1215 are commerci ally int erchangeable : Both products are used by t he same people fo r the same purpose, namely, as a source of ammo nia to produce MCA in
si tu f or th e di sinfect io n of industri al water

. Nalco’s label descript io n of Nalcon 60620 as a
“stabilizer for active chlorin e sources” is dishonest in scientific terms, because it does not mat ch
th e 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
“t em porarily” accepted Nal co’s erroneous descriptio n of Nalcon 60620 as a chlorine stabilizer , pending further investigation . Since then

– seven mo nt hs and counting

– Nalco has aggressively
marketed and sold unregistered ammo nia to commercial users, who continue to produce and use
MCA wi th out any EPA oversight, specifically, while Nalco has not had to demonstrate, and EPA
has no t h ad the opportunit y t o c onfi rm , that the use of Nalcon 60620 to produce MCA adequately addresses the potential human healt h and environmental ri sks fro m t he us e of MCA

. Meanwhile, Buckman cannot explain EPA’s different ia l treatment of Nalcon 60620 and
Busan 1215 to customers , and because these products are interchangeable in t he marketplace, many customers now perceive EPA’s registration of Busan 1215 as point l ess and unnecessary

– an impressio n t hat has been reinforced by EPA’s failure to date to requi re the registration of any

ammo nia products fo r water treatment other than Buckman’s

. EPA’s inaction not only
contradi ct s Buckm an’s ammo nia registrati on s , it unf ai rly damages th ei

r commercial value. Accordingly , the longer that EPA di scriminates against Buckman by requiring the registration of
Buckman’s ammo nia while allowing all co mpet it ive ammo nia products for water treatment to be
sol d wi th out regi strati on, th e better it serves Nalco’s desire to delay registrati on, th e harder it is
fo r Buckm an to salvage it s considerable invest me nt to register ammo nia , and the longer the public goes without assurance that MCA is being used safely, which is provided only by EPA’ s regi stering all amm onia fo r water treatment

. Furthermore, Nalco has had mo re than enough time to register ammo nia and has chosen instead to fo cus solely on a peti ti on process to delay regi strati on for as long as possible while it continues to co mpete un fa ir ly agains t Buckman in the marketpl ace wit h unregistered ammo nia that reflects no regulatory costs

. Thus, EPA should not reward Nalco’s delaying tactics and opportunism wi th any addi

ti on al ti me to register. Fo r all o f- 14

-

th ese reasons, Buckman respectful ly requests that EPA immediate ly prohibi t f urther di stribut io n and sale o f unregistered ammo nia for use in water treatment

. VII. C onclusion Buckman has demonstrated that it s and Nalco’s ammo nia products are used in the same
way ( as precursors to produce MCA ) b y t he same industrial users (primarily, pulp and paper mills, but also facilit ies with industrial cooling systems) , who perceive the tw o products as int erchangeable fo r water treatm ent applicat io ns (disinfect io n of mill and industrial cooling water)

. Buck ma n has shown that it s and Nalco’s ammo nia products do not “ sequester ” or release hypochlorous acid and are not adjuvants , and th at EPA has the authorit y to regi ster ammo nia products as precursors of MCA , since th e registration of MCA it self fo r water trea tm ent is impract ical . Buckman also has shown that only the registration of all ammo nia products fo r
water treatm ent will ensure that EPA has evaluated any potential ri sks fro m t he use of MCA and
restore a le vel playing field in t he marketplace for industr ia l w ater di sinfect io n
. For the se reasons, as explained in t his pet it io n , we renew our request th at EPA deny Nalco’s Petit io n and immediately prohibi

t f urther di stribut io n and sale of unregistered ammo nia for water treatment

. We welco me an opportunit y t o discuss our petition wit h EPA

.- 15

- Respect fu lly submitted,

Michael Boucher
M C K ENNA L ONG & A LDRIDGE LLP 1900 K Street, NW Washington, D.C. 20006 (202) 496

- 7729 Counsel to Buckman Laboratories, Inc. Dated: September 2 , 2008

# EX HIBIT ADEPARTMENT 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 theNational 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]

# EX HIBIT B

# EX HIBIT COxiPROwDepositControlTechnologyPROPOSALMay5,2008-ProductionLeader-Thankyoufor the opportunitytoreviewourOxiPROmDepositControlTechnology.PleaseRndenclosedour proposaloutlininghowOX~PRO~,canbenefitthe-Nalco'sOxiPROTMDeposit ControlTechnologyoffersimprovedpapermachineefficiencybycontrollingmicrobial-baseddepositsthrough:QInnovative chlorinestabilizingchernlstries0Acombinationofnewanduniqueproactivemonitoringtools,nApplicationexpertise&strategiestomaximizeperformanceResultingin:PImprovedsystemstabilityPReducedtreatmentcostoReducesheetdefectso-Increaseduptime.Wethankyouonceagainforthisopportunitytoworkwithyouandlookforwardtodiscussingthisproposalwithyouinmoredetail.Sincerely,GarydeVriesDistrictAccountManagerP18NalcoCompanyConfidentialontrolTechnologyPROPOSALIntroduction;rOxiPROmmicrobiologicalcontrolprogramforNalco'sOxiPROTMDepositControlTechnologyisastabilizedoxidantprogram.Ittakesan oxidantthathas beenblendedwithcausticonsite andstabilizesStwithour unique chemistry.Aspeciallydesigned feedsysteminsurestheoxidant iscompletelystabilized.Nalco'sonlinemicrobiologicalmonitoringunitprovidescontinuousrealtimeresultsforproactive control.Nalco'sOxiPROminnovative oxidantstabilizerprogramcanprovidewiththesebenefits:The mosteconomical microbiologicaltreatmentprogramforneutralconditionsConsistentlymeetorextendboil out targetperiods.Greater.systemassurancethroughonlinemonitoringLongerequipmentlifeduetoalesscorrosive chemistry.Improvedrunnabilityofmachine andconvertingduetolessholesjdepositscreatingsheetdefectsandbreaksSpecificPotential Benefitsforthe-MillOperation:InnovativechlorinestabifizerNalcohasseveralstabilized oxidantsthatcanbeutilizedforyoursystem.TestingandNalco experiencehasshownthatNalco60620is mosteffectiveinyour system.ImprovedSilotreatmentstrategiestominimizebiomassNalco'sOxiPROTMprogram createsstabilizeoxidantsthatprovideextendedcontroleveninthemostdemandingsystems. NalcowillemployaslugfeedtohelpImprovesystem cleanliness whileminimizingadverseeffectsofhighfreechlorineresidualsonmachineperformanceandpaperquality.Real-timemicrobialmonitoringforgreatersystemassuranceandoptimization.ThisprogramcomeswithNalco'snewpatentpendingonlinecontinuousmicrobiologicalmonitoringunitforoptimumproactivecontrol.RealtimeMBmonitoringallows forimmediateresponsebeforeasystemupsetcanoccur.ConfidentialOxiPROTMDepositControlTechnologyPROPOSAL-w..'-Irhprovett:MachineEfficiency.Eliminatingbiologicalupsetswillhelpimprovewet endstability. Improvedmachineand convertingrunnabilityduetolessmicrobiologicalholes/deposits.$1..!ProoramOblectiveandfuccessCriteria:BesafeandreliableatailtimesMaintainacleanpapermachine systemwithnomicrobiologicaldeposits.Providetimely monitoringdataforproactivecontrol.Havenonegative impactsonwetendchemistry.Provideservice neededtomaintaintheprograminpeakperformanceanddocumenttheresultsProaramCost:Theprogramwouldbebilled onapriceftonbasis..@Nalco60620andNalcoBL409$2.35/swt....,.Bleach,12.5%Suppliedby-htotesorbulkThis pricingalsoincludes:Onefeedsystemscapableoffeeding4additionpoints.OneOX~PRO~Monitoring unit,.'';.-?:Nalcoserviceandsupportprogram.Nalcomaintains ownershipofthefeed andmonitoringequipment.Awatersoftenerifneeded.oldprovidethe following:Cleanwaterforfinaldilution.Assistanceinstallingtheequipment.Electricalandpipingconnectionstotheunitsand feed points.WirelessorEthernetconnection,for-monitor informationtransfer.Bleachintotesorbulkstorageom',---'Discussion:Nalco'sOxiPROTMDeposit ControlTechnology programforincludesfeedequipment,monitoringequipment,a stabilizedoxidantprogram,and on-siteservice.Thisdiscussionwillprovidedetails andsupportinginformationfortheproposedprogram.StabilizedOxidantChemistry:OX~PRO~~Technology combinesastabilizer(Nalco60620)blendedonsitebythefeedskidwithcommercially available12.5%sodiumhypochloriteandNaOH.3ConfidentialOxiPRONDepositControlTechnologyPROPOSALThestabilizerisdeterminedbyascreeningperformedattheNalco Technical.Facilityutiliu'ngyourfurnish.Thestabilizerofchoicefromthe testingisNalco60620.Itshowedtohavethebestlowconcentrationkillaswellasthebesthighconcentrationpersistencewhen comparedwiththeotherproducts.Thisproducthas showntobeeffectiveinsimilar environmentsbothinthelabandinmillexperience.Thisproductiscurrently being utilizedinmultipletissuesandtowelmillswithgreatsuccess..,OX~PRO~FeedSystemThefeedskidblendsthe chemistriesintheappiopriateratiosand deliversthestabilized oxidanttothepaper process.Belowisasimpleflowsheetofthefeedskid operation.Thefeedskidscan bedesignedto runinaslugconfigurationoracontinuousoperation.Forthesystemwerecommendutilizingaslugfeedoperationtoassureproper coverageandcosteffectiveness.AdditionPointsNalmrecommendsthe following additionpointsforthe3operation.Thesepointscouldchange orbereducedpendingsystemrequirementsastheprogramisoptimized.--12.5%SodiumHypochloriteI.TMSifo2.TMShower WaterTank-Stabilizer50%SodiumPaperProcessHydroxide'+F+MixingMixingTeeTeeWater-DilutionOxiPROfMDepositControlTechnologyPROPOSALOX~PRO*~On-LineMonitoringNalco'sonlinemonitorisan importantpartofthis system.ThisunitwasdevelopedbyNalcotoproviderealtimeinformationandtrueproactivecontrol.Theunitcontinuousfymonitorsfoursystemconditions:1.Microbiologicalactivitylevel2.Overallfoulingrate3.ORP4.pHTheunitmonitorsaheadboxorwhitewatersystemsidestreamandthesamplecanbereturnedbacktotheprocess.Aninternetconnectedcomputerorcellphonecanaccessthedataimmediately eitheron-site orremotely.,Targetcontrolrangescanbeset foreachparameterandthe unitwillsendalarmstoacomputerorbycellphonetextmessagealertingthelocalteamtotakeactionasrequired.Thefollowingis actualdatafromthemonitorthataNalcorepresentativeusedtopreventalosttimeupset.Similarincidentsatthismillbeforethemonitorwasinstalledcausedsixhoursoflosttime.ISeptember2006wlmBN08WSmPlgms~~WE8~9miw~enMsBlWOBBnS1PBBn4K!4.mlmI-ActivityIndex-Bbmonltor-Fouibg-0RPIAsimilarlncidentlastyearcaused6hoursofdowntimeandanunscheduledbo~/outl.5ConfidentialTraditionalMicrobiologicalMonitoringInadditiontotheonlinemonitoring,Nalcoperformsstandard microbialsurveysusingplate counts andchlorineresidualsasrequired.ATPmonitoringisalsousedtohelp calibratethemonitortarget controlrangesandtroubleshootingvariationsintheprocess.NalcoSewiceProgramOurexperiencedlocalNalco teamwillprovideregularservicefortheprogram.Ourserviceprogramwillbetailoredtoyourneedsandmayinclude:AMalcorepresentameinthe,millOncall coverage24hours,7daysaweek.Regularmaintenanceandrepairofthefeedand monitoringequipment.Bi-weeklyreportssummarizingprogramperformanceWeeklymachine inspectionforMBdepositswithmoredetailedinspectionduringoutages.Systemtroubleshootingasrequired.WelookforwardtodiscussingthevalueNaico'sOX~PRO~~DepositControlProgramcangive-WewanttothankyouforMeopportunitytoserviceyourfacilityandyourrequest forthisproposal.Confidential

# EX HIBIT D

# EX HIB IT E

# EX HIB IT F

# Busan 1215 Feed Sy stem

# EX HIB IT G

# EX HIB IT 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

13 14 15 16

17

18 19 20

Bleach

Busan 1215 Emergency flush water 12' 13 12"

Application 1 Application 4 Application 3 Application 2

# EX HIB IT I