# From Edwards.Dennis@epamail.epa.gov 

## Sent Saturday July

## 26 2008 

## 1049

# AM

# GMT To Boucher Michael 

## mbouchermckennalong corn Subject 

# RE Petition to 

### Cancel Registration of

## BusanR 1215 

# EPAReg

# No 1448-433 

## Attach 

## AmmoniaCompound Briefing 

### Paper

## REDACTED.PDF

Michael

have asked Velma Noble to get back toyou with this information Her number is 703-308-6233 

## We are working on arranging meeting have set up an internal meeting and will getback toyou shortly

Dennis Edwards Chief Regulatory Management Branch Antimicrobials Division 703 -308-8087



### Boucher Michael 

### mboucher@mckenn To along.com Dennis 

### Edwards/DC/USEPA/US@EPA cc 07/25/2008 

### 0628 Frank 

### Sanders/DC/USEPA/US@EPA 

## PM Betty 

### Shackleford/DC/USEPA/US@EPA Velma 

### Noble/DC/USEPA/US@EPA Philip 

### Ross/DC/USEPA/US@EPA Boucher Michael 

### mbouchermckennalong 

## com Subject 

## RE Petition to Cancel Registration of BusanR 1215 

## EPA Reg 

## No 1448-433

Dear Dennis
At the bottom of the firstpage of Nalcos October 

### 30 2007 

## Ammonia Compound Briefing Paper 

### copy attached and carlying over to the second page Nalco refers to guidance an

## AD representative provided our office via email in

### 2005 which was and is being relied 

## upon Wouldyou kindly also produce this 2005

## AD guidance that was provided to 

### NalcoThank you foryour help with this further request 

## We also look forward toyour response with respect to ourpending meeting request Sincerely
Michael Boucher Counsel to

### Buckman Laboratories Inc and 

### Buckman Laboratories International Inc

Michael Boucher 

### McKenna Long Aldridge 

### LLP 1900 Street 

# NW Suite 100 Washington 

## DC 20006-1110 

## 202 496-7729 -7756 

## fax e-mail 

### mbouchermckennalong.com

Original Message 

### From Edwards.Dennisepamail.epa.gov 

### gov Sent Thursday July 10 2008 

### 510

## PM To Boucher Michael 

## Cc Sanders.Frankepamail.epa.gov Shackleford.Bettyepamail.epa 

### gov Noble 

### Velmaepa.gov Ross.Philipepamail.epa.gov SGoldbergsteptoe 

### com Subject Petition to Cancel Registration ofBusanR 1215 

## EPAReg 

## No 1448-43

Dear

## Mr Boucher 

### On June 

### 25 2008 you sent letter to theAgency concerning petition filed on behalf of

## NALCOconcerning theAgencys approval ofyour client 

### Buckman Laboratories Inc.s applications for registration oftwo ammonia products as pesticides 

## NALCO in its petition has asked the Agency to reconsider its approval of those registrations and has raised questions about the status of ammonia products as pesticides 

### when used in combination with chlorine treated water In your letter 

### among other things you have asked for copy of the petition as well as any correspondence between theAgency and 

## NALCOconcerning its petition 

### You also asked for copy of an interim response that theAgency sent to 

## NALCO after receiving its petition This email responds to those requests fordocuments only and is not addressing at this time any other statements or requests that you have included inyour letter

In filling your request 

### we are providing you with thedocuments which constitute the petition and support documents as well as subsequent correspondence between theAgency and 

## NALCOconcerning some questions theAgency has had as of this point about 

## NALCOs petition and support documents 

## We are also providing you with copy of theAgencys interim response to

## NALCOwhich you specifically asked about inyour letter Additionally since

### we are sending copy of this email and the attachments to counsel for

## NALCO we are including your letter to Frank Sanders dated June 

### 25 2008 as well as some email exchanges between you and Agency counsel on this matter Please note that 

### we are notincluding email exchanges that Agency staff had with 

## NALCOcounsels firmwhich pertained only to theneed forreview of various documents for confidential business information and subsequent redactions The documents you are being provided have been reviewed and redacted as appropriate to remove any confidential business information The following documents are being provided to

### you December 2007 email from Seth Goldberg to Debbie Edwards It is contained in the file named 12-4-07 email to

### EPA.Redacted See attached file 12-4-2008 email to EPA.Redacted.pdf
December 2007 request from

## NALCOto reconsider It is contained in the file named Redacted Request to Reconsider 

### Ammonia Registration 

### See attached file Redacted Request to Reconsider 

### Ammonia Registration.pdf

October 

### 31 2007 email from Seth Goldberg to Debbie Edwards It is contained in the file named 10-31-07 email redacted 

### See attached file 10-31-07 email redacted.PDF


## An attachment to the October 

### 31 2007 email from Seth Goldberg concerning 

### ammonia It is contained in the file named 

## AmmoniaCompound Briefing Paper 

## REDACTED See attached file 

### Ammonia Compound Briefing Paper 

## REDACTED.PDF

product label for 1448-432 

# MUP that was attached to the October 

### 31 2007 Goldberg email It is contained in the file named 1448-432 

# MUP
See attached file 1448-432 

### MUP.pdf

product label for 1448-43 

# EP that was attached to the October 

### 31 2007 Goldberg email It is contained in the file named 1448-433 

# EP
See attached file 1448-43 EP.pdf

The Agencys interim response to

## NALCOdated February 

### 2008 concerning its petition It is contained in the file named 

# NALCOresp ltr2.7.08 

### See attached file Nalco resp ltr 2.7.08.pdfEmail correspondence from

### Brown with Steptoe which is

## NALCOs counsel dated June 

### 26 2008 It is contained in the file named 

## Brown Steptoe to Holmes email 6-26-2008 

### See attached file 

### Brown Steptoe to Holmes email 6-26-2008.pdf

Email exchanges involving 

### Brown Steptoe and 

### Holmes They are contained in the file named 

### Email to

### Brown and 7-7-2008 reply 

### See attached file Email to

### Brown and 7-7-2008 reply.pdf
10 July 2008 

### Ammonia Supplemental Information provided to theAgency by 

### Brown Steptoe It is contained in the file named 7-7-2008 

### Ammonia

supplemental information 

### See attached file 7-7-2008 

### Ammonia supplemental information.pdf
11 Emailexchanges between Ross 

### Agency counsel in thismatter and Boucher counsel for

### Buckman Laboratories Inc. They are contained in the file named Ross-Boucher-email-exchanges-ammonia 

### See attached file Ross-Boucher-email-exchanges-ammonia.pdf
12 Boucher letter to Frank Sanders dated June 

### 25 2008 It is contained in the file named Letter to

## EPA re petition to cancel Busan 

### 1215 See attached file Letter to

## EPArepetition to cancel Busan 1215.pdf
Should you have any questions please direct them in writing to

### me with

copy to Philip Ross in our Office of General Counsel 

### You should also provide copy of any correspondence pertaining to this matter to counsel for

## NALCO
Sincerely

Dennis Edwards Chief Regulatory Management Branch Antimicrobials Division 703 -308-8087 

### CONFIDENTIALITY 

## NOTICE This e-mail and any attachments contain information from the lawfirm of

### McKenna Long Aldridge 

## LLP and are intended solely forthe use of thenamed recipient or recipients This e-mail 

### may contain privileged attorney/client communications orwork product 

### Any dissemination of this e-mail by anyone other than an intended recipient is strictly prohibited Ifyou are not named recipient you are prohibited from any furtherviewing of the e-mail or any attachments orfrom making any use of the e-mail or attachments Ifyou believe you have received this e-mail in error notify the sender immediately and permanently delete the e-mail any attachments and all copies thereof from any drives or storage media and destroy any printouts of the e-mail or attachments 

### See attached file 

### Ammonia Compound Briefing Paper 

## REDACTED.PDF

# REQUESTFORIMMEDIATEINTERIM 

# STATEMENT BY EPA

# THATSALE 

# ANDUSE 

# OF

# AMMONTUMBASED COMPOUNDS FORUSE

# WITH CHLORINETO GENERATE CHLORAMINES ATINDUSTRIAL FACILITIES 

# ANDMUNICIPAL DRINKING

# WATER TREATMENT PLANTS

# WILLNOT RESULT IN

# ENFORCEMENT ACTION 

# AND REQUEST FoREPA

# TOREVISIT 

# THE NEED FORREGISTRATRN OF THESE

# COMPOUNDS IN 

# TRANSPARENT PUBLIC 

# FORUM October

## 3020C7 Stmim7ary of the 

### ProNein 

## and Necessary Relief 

### Issoe The Antinicrohlals Division in

## March 2007 for the first time registered 

## ammonia
as 

## new active ingredient fOr use in water disinfection in pulp 

### and paper mills

# EPA R.eg hJo 

### 1448-432 and 148-433 attached based on the decision that aninionia 

## when used in conjunction with chlorine-based 

### water disinfectant is precursor to chlorarnines 

# AD has 

### determined that chlorairiines are the 

### acuve 

## compound in such systems and that the

## ammonia compound mustbe registered as pesticide This registration is in addition to the registration ofthe chlorine-based precursor 

### The end use product label states that the product cis applied in conjunction with 

### sodium hypochlorite 

### 12.S/u ai to 

### formmonochloranrine less aggressive oxidizing nricrohiocide 

### Tihe monochlorainne solution 

### mustbe genera ted

### and fed into the treatment water 

### system only 

### by trained 

## Bucknan representative 

## Use of thisproduct for 

### any other purposes is 

### prohibited Prior to this registration the use of registered chlorine-based products 

### combined with non-registered 

### ammonia-based products to generate chloramines 

### was well 

## known and frequently 

### used This practice is 

### coimnon in industrial facilities such as pulp and paper mills

### where high organic loads are present as 

### means to reduce chlorines reactivity and extend the period ot time betore additional chlorine inputs are 

### needed This practice also is

### well-known and widely 

### used in niunicipal 

### water ueatnient facilities 

### Use of chloramines as substitute for

## someof the required direct chlorine input is

### one method advanced by

# EPAs Office of

### Water to assist municipal water treaters to 

### meet the requirements of

# EPAs Stage Disinfectant 

## By Products regulation 

### As result of the recent aninmonia registration

# AD is taking the position that all 

## ammonia used along with chlorine to generate chloranmines 

### mustbe registered This 

### means that all coiripanies that provide unregistered 

## ammonia compounds for use with chlorine in water treatment including industrial facilities 

### e.g. pulp 

### and paper 

### millsand municipal drinking water treatnent plants are in violation of

## FIFRA as are the facilities themselves
This situation is particularly serious 

### The change in policy took place with 

### no public notice oropportunity for 

### input as required for 

## new active ingredient or

## new use 

### under FIFR.A It is contrary to 

### guidance

# AD representative provided our office via email in

## 2005 which was and is

### being relied 

## upon 

## OPP performed no assessment of

### impact on the regulated 

## comm urnty 

### no coordination with

# EPA Office of 

### Drinking Water and no visible effort to thoroughly 

### review the science underlying the use of

## ammonia and chlorine or

### even to 

### review jntommation that 

## OPP and

# ODW already 

### have on this topic 

### The dcci sion therefbre isboth procedurally 

### and substantively deficient 

## Impact There is currently only 

### one registered source of

## ammonia 

# Buckmans and that registration is limited to use 

### byBuckrnantrained personnel in 

### water disinfection in paper mills

### only Effectively 

## EPA therefore is requiring all users to purchase 

### fromonevendor This is rnanifestl unfairto others including our client Nal

## co which relies 

### upon the written 

### guidance

## we received in

### 2005 to provIde unregistered 

## ammonia compounds into this

### market Further there are 

### no registered 

## ammoniahased products for

### usein other industrial facilities orin the drinking water treatment p1 ants that supply cliioramnine treated 

### water to over 

### 68 million

### Americans inthe paper industry the registrant of the 

## ammonia product is aggressively 

### marketing its product 

### and stating that 

### enforcement isthe likely 

### outcome for

### any facility that uses unregistered 

## ammonia compounds The market place is 

### growing increasingly uncertain 

### and verging 

### on chaotic Sonic pulp 

### and paper mill facilities already 

### have chosen to convert from system that rely 

### on chi 

### oramines to systems that rely 

### on straight chl

### orine4ased product 

### feeds Such conversions are expected to continue 

### and

## mean that literally niil lions ot dollars in canital



### Other industrial facilities are out of

### compliance today assuming

# ADs interpretation continues 

### They have no choice otherthan to convert or to purchase product not in 

### compliance with 

## FIFRA Again the costs of conversion will 

### be

## enormous Drinking water treatment facilities are faced with the choice of continuing to purchase unregistered 

## ammonia compounds in violation of

## FIERA or to convert to straight chlorine product 

### feeds and liii out of corn ph ance with the

# IBP regulation issued under the Safe 

### Drinking Water 

## Act Again this situation will continue until 

# EPAprovides guidance 

### on path 

### fOrward Request for

## ImmediateReheF To minimize furtherdisniption in the 

### market place 

## EPA should 

### immediately issue puhliclyavaiiahl written statement providing assurance that 

### no enforcement action will 

### betaken against suppliers ofunregistered 

## ammonia compounds for use with chlorine to generate chloramines in water disinfection 

### markets The notice also could state that 

## EPA is reviewing the situation 

### and will solicit input on the issue ofthe registration of

### chloramine precursors Facilities that rely 

### upon combining 

## ammonia with chlorine to 

### form chioramines 

### need similarassurance that they will not 

### be subject to 

### enforcement before 

## EPA has issued formal written clarification 

### on the regulatory status of

## compounds used to generate chioramines for

### water disinfection It

## aho portent ihet 

## PA inikc ear that it \Smll prortcc 

### adequeL trmnc for trdn itmon n.m 

### Such losses will continue 

### and be rnultiphed 

## many times until 

# EPAprovides 

### guidance on path 

### torwardthe event its reevaluation concludes that 

## ammonia used underthese conditions 

### must he registered 

### immediate relief is appropriate because the 

### cunent impact of the underlying decision to register 

## ammonia is being used to support position that all 

## ammonia compounds used to generate chloramines 

### mustbe registered in orderto 

### comply with 

## FIFRA Asmentioned 

## above
This decision 

## wasmade without public notice of receipt ofan application for 

## new active ingredi erit

### and tile opportunity tor 

### pubhc

## comment as required 

### by

## FTFRA section

# 3c4
This decision 

### was 

## made despite

# AD having provided written 

### guidance to the contrary This decision 

### was 

## made without 

### any consideration of the 

### lmpact on existing 

### markets for

### water disinfection products2 including both producers of the 

## compounds and the fhcilities that rely 

### on

## them
This decision 

## wasmade without 

### consutaton with other

## EPA offices including the Office of

## Water the Office ot 

### Enforcement and Compliance Assurance and the Office of General 

### Counsel
This decision 

### was 

## made without detailed consideration of the science of chloramine-based 

### water treatment 

### systems the historyof use 

### and regulation and an evaiuation of 

## how such chemistry shouid he reguiated in 

### view of 

## EPA regulation of other 

### complex disinfection chemistries 

## Any decision in these areas should 

### be part of consistent 

### and science 

### based approach The 

## Agencys adhoc decision to register single product for single 

## company should 

### he reconsidered in light of these scientific 

### policy process 

### and impact considerations 

# PERTINENT DETAILS 

# kround
in early 

### 2007 

## OPP issued 

### one manufacturing and one end use pesticide registration for

## ammonia when intended to 

### be used in

### water treatment in conjunction with source of chlorine to 

### form chloramines 

# EPAReg 

# No i448432 and 141C433 attached These were the first registrations for

### any ainmoniunubased 

## compound for such use 

### and the first registration of the active ingredient 

## ammonia Chioramines an intermediate stabilized 

### form of

### chiorinebased disinfectants 

### produced in the presence of either naturally- occurring or introduced 

## ammonium have been used in water treatment since the early in the 20th 

### Century

iJnti 

# EPAs decision that arnrn orri 

### must he registered the water treaters 

### were required to use registered chlorine in systems utilizing chloramin.es 

### The 

## ammonia
-3-

## compounds did not contribute an active ingredient 

### and therefore 

### were not subject to registration 

## EPA confirmed this in an email to our office in

## 2005 copy of 

### which prevlousiy has 

### been provided 

## Ammonia or

## ammoniuinbased compounds alone 

### do not 

### have antimicrobial efficacy 

### and can serve as nutrient source for

### microbes EPAJOPIP previously 

### concluded that 

### chioramine generation 

### by adding an 

## ammonia source to chlorine--based disinfectant did not rise to the level of separate active ingredient concluding in the 1995 chlorine gas 

# RED http/www.epa.gov/pesti cides/reregisiration/REDs4022red.pdf that these intenuediate stabilized 

### form of hypochiorite are addressed within total chlorine 1k that 

## document 

## OPP recognized that rnul tipie

### amrn oni

### abased 

## compounds are used to create 

### chioramines including 

### aqueous 

## ammonia and anhydrous 

## ammonia and 

## ammonium sulfate 

## among others 

### The document addresses reregistration of chlorine

the active mrmgredi en in cliiorarnines Al

### though 

## ammonia compounds are discussed 

### no mention is

## made of

### any registration 

### requirement 

## eedt1ra1Aseets Ammoniawas never previously registered as an active ingredient in pesticide 

### product 

# HERA section

# 3c4 and 

### 40

## CFR 52.102 requires Federal Register notice of application for the registration of 

## new active 

### ingredient 

## No notice 

### was published 

### by

## EPA so the regulated cornrnurntv arid public 

### had no priornotice that the i-\gency 

## was considering 

### change in policy 

## No notice of issuance ofthe registration of 

## new active ingredient 

### was published 

### by 

# EPA To date

## we have not 

### been able to locate orobtain 

## new active ingredient fact sheet 

### and decision 

## memorandum although 

## we have had an 

## FOl request 

### pending for several 11100 ths



### Chioramines have been recognized 

### and used as disinfectants forover 

### 70years The city of 

### Denver hasused chloramines fbr municipal drinking water disinfection since 

## i9I7chloramines currently are

### used in large

## number of

## US drinking 

### water systems including those in Arlington 

# VA

Ii ttp i/ivwiv.arlingtonva us1dcpac tmentsLLnironri1 en tal

### Seni ces/uepd/wqual ty/Envi ro 

### nmental ServicesClmnf aq 

### aspx Fairfax 

### county

# VA http//www.fcwa.org/water/faq.htm and Washington 

## DC http//wrvw.dcwasa.com/news/publications/waterquality report2002 .pdf Chiorarnines are

### used extensively in California 

### and in

## many oilierlocations h.ttp//wrvw.ccwa.com/chloramin.es.htnihttp //healthvermont.gov/enviro/water/chloramine 

### aspx ttp

### /waterquali ty

### ccc cornell

### .eduFspdfFactsh eet 

# 7R pdtl 

# EPAs

# ODW estimates that at least 

### 68 million people in the

## US are served 

### by municipal water treaunent systems that utilize ch loramines http 

### //www.epa.gov/safewaterdisinf ection/chloramine/ 

## EPA specifically addressed 

### and 

## recommended the use of chioramines in its 

### 1999 Alternative Disinfectants 

### and Oxidants Guidance Manual http 

### //wsvw.epa.gov/safewatermdbpalternative di sinfectants gui

### dance.pdf has established secondary 

## maximumcontaminant levels http//www.epa.gouncea/pdfs/water/chloramincdsvchlorarnine.pdf 

### and specifically 

## recommends chiorami nes as secondary di sintecti 

### on method to help reduce the levels of certain disinfectant by-products http //wsvw.epa.gov/safewaterdisinfecti 

### on/chloramine/ http//www.epagov/regionO9/waterchloramine.huni Chioramines have been addressed in the IRIS 

### system as long 

### ago as1994 hitp/www.epa.gov/iri 

### s/suhstiO644htmhib Significantly 

### none of these references discuss the 

### need to register the

## ammonia used to gen crate 

### chloramines Chioramines also

### were extensively evaluated 

### by the National 

### Research Council in



### 997 httpbooks.nap.eduicatal og.php9record 

## id 008 in 

### 1989 httpI/hooks.napedu/catalog..phprecordid 

# 773 and in 

### 1980 http//hooksnap.edu/catalogphprecordi 

# dI904

sttbrlelief The foregoing brief

## summary demonstrates that the current situation isuntenable 

### and most likely the result of decision 

## made without 

## competc inforrnati 

## on Nalco requests 

## EPA take the following actions to address these issues 

### Immediatelyissue

### guidance indicating that 

### no enforcement action will 

### be taken against suppliers orusers while the

## Agency re-evaluates this issue 

### Engage in public process to 

### reyiewthe science and current use of chloramines to determine 

### whether registrati orm of the

## ammonia component is appropriate Corisi deration of the regulatory status of other chemical systems should 

### he part of this

### process
Ifthe decision is that 

## ammonia riced not 

### he registered cancel the current registrations as improvidently 

### granted Ifthe decision is that 

## ammonia should 

### be registered develop thoughtfiul 

### implementationscheme that will provide adequate time for suppliers 

### and users of 

## ammonia compounds to

## come into 

### compliance