From Boucher Michael

Sent Friday July 25 2008 1029 PM GMT

To Edwards.Denniseparnail.epa.gov

Cc Sanders.Frank@eparnail.epa.gov Shackleford.Betty@eparnail.epa.gov

Noble.Velrnaepa.gov Ross.Philipeparnail.epa.gov Boucher Michael

rnboucherrnckennalong corn

Subject RE Petition to Cancel Registration of BusanR 1215 EPA Reg No 1448-433

Attach Arnrnonia Cornpound Briefing Paper REDACTED.PDF

Dear Dennis

At the bottom of the first page of Nalcos October 30 2007 Ammonia Compound Briefing Paper copy attached and carrying 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 Would you kindly also produce this 2005 AD guidance that was provided to Nalco

Thank you for your help with this further request We also look forward to your response with respect to our pending 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 mboucher@mckennalong.com

Original Message

From Edwards.Dennisepamail.epa.gov Edwards.Dennis@epamail epa gov

Sent Thursday July 10 2008 510 PM

To Boucher Michael

Cc Sanders.Frank@epamail.epa.gov Shackleford.Betty@epamail.epa.gov Noble Velma@epa.gov Ross.Philip@epamail.epa.gov

SGoldberg@steptoe.com

Subject Petition to Cancel Registration of BusanR 1215 EPA Reg No 1448-433

Dear Mr Boucher

On June 25 2008 you sent letter to the Agency concerning petition filed on behalf of NALCO concerning the Agencys approval

of your client Buckman Laboratories Inc.s applications for registration of two 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 the Agency and NALCO concerning its petition

You also asked for copy of an interim response that the Agency sent to NALCO after receiving its petition This email responds to

those requests for documents only and is not addressing at this time any other statements or requests that you have included in your

letter
In filling your request we are providing you with the documents which constitute the petition and support documents as well as

subsequent correspondence between the Agency and NALCO concerning some questions the Agency has had as of this point about

NALCOs petition and support documents We are also providing you with copy of the Agencys interim response to NALCO which

you specifically asked about in your 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 not

including email exchanges that Agency staff had with NALCO counsels firm which pertained only to the need for review 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 NALCO to 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 Ammonia Compound 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 NALCO dated February 2008

concerning its petition It is contained in the file named NALCO resp

ltr 2.7.08

See attached file Nalco resp ltr 2.7.08.pdf
Email 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 the Agency 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 Email exchanges between Ross Agency counsel in this matter 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 EPA repetition 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
REQUEST FOR IMMEDIATE INTERIM STATEMENT BY EPA THAT SALE

AND USE OF AMMONTUMBASED COMPOUNDS FOR USE WITH

CHLORINE TO GENERATE CHLORAMINES AT INDUSTRIAL FACILITIES

AND MUNICIPAL DRINKING WATER TREATMENT PLANTS WILL NOT

RESULT IN ENFORCEMENT ACTION

AND

REQUEST FoR EPA TO REVISIT THE NEED FOR REGISTRATRN OF

THESE COMPOUNDS IN TRANSPARENT PUBLIC FORUM

October 30 20C7

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 must be registered as pesticide This

registration is in addition to the registration of the chlorine-based precursor The end use

product label states that the product cis applied in conjunction with sodium hypochlorite

12.S/u ai to form monochloranrine less aggressive oxidizing nricrohiocide Tihe

monochlorainne solution must be genera ted and fed into the treatment water system

only by trained Bucknan representative Use of this product 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 some of 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 must be 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 mills and 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 or opportunity 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 urn ty 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 is both procedurally and substantively deficient

Impact There is currently only one registered source of ammonia Buckmans and that

registration is limited to use by Buckrnantrained personnel in water disinfection in paper

mills only Effectively EPA therefore is requiring all users to purchase from one vendor

This is rnanifestl unfair to 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 or in the drinking water treatment p1 ants that supply clii oramnine

treated water to over 68 million Americans in the paper industry the registrant of the

ammonia product is aggressively marketing its product and stating that enforcement is the

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 other than 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 EPA provides

guidance on path fOrward

Request for Immediate ReheF To minimize further disniption in the market place

EPA should immediately issue puhliclyavaiiahl written statement providing assurance

that no enforcement action will be taken against suppliers of unregistered ammonia

compounds for use with chlorine to generate chloramines in water disinfection markets

The notice al so could state that EPA is reviewing the situation and will solicit input on

the issue of the 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 EPA provides

guidance on path torward
the event its reevaluation concludes that ammonia used under these 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 must be registered in order to comply with FIFRA As mentioned

above

This decision was made without public notice of receipt of an application for new

active ingredi erit and tile opportunity tor pub hc 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 was made 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 history of 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 ad hoc 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 EPA Reg 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 rn ul ti pie 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 clii orarnines Al though ammonia compounds are discussed

no mention is made of any registration requirement

eedt1ra1Aseets

Ammonia was 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 prior notice that

the i-\gency was considering change in policy

No notice of issuance of the registration of new active ingredient was published by

EPA

To date we have not been able to locate or obtain 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 for over 70 years The

city of Denver hasused chloramines fbr municipal drinking water disinfection since

i9I7 chloramines currently are used in large number of US drinking water systems

including those in Arlington VA

Ii

ttp i/ivwiv.arlingtonva us1 dcpac 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 oilier locations

h.ttp//wrvw.ccwa.com/chloramin.es.htni
http //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 ecti on/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 maximum contaminant 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 dI 904

sttbrlelief

The foregoing brief summary demonstrates that the current situation is untenable and most likely

the result of decision made without comp etc inforrnati on Nal co requests EPA take the

following actions to address these issues

Immediately issue guidance indicating that no enforcement action will be taken against

suppliers or users while the Agency re-evaluates this issue

Engage in public process to reyiew the 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

If the decision is that ammonia riced not he registered cancel the current registrations as

improvidently granted If the decision is that ammonia should be registered develop

thoughtfiul implementation scheme that will provide adequate time for suppliers and users of

ammonia compounds to come into compliance