UNITED ST ATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Mr. Michael Boucher 

McKenna Long & Aldridge 

Counsel for Buckman Laboratories 

1900 K. Street, NW 

Washington, DC 20006 

Ms. Karen M. Hansen 

Beveridge & Diamond 

Counsel for Ashland-Hercules 

1350 I Street, NW, Suite 700 

Washington, DC 20005-3311 

Mr. Seth Goldberg 

Steptoe & Johnson LLP 

Counsel for Nalco, Inc. 

1330 Connecticut Avenue, NW 

Washington, DC 20036 

Dear Counselors, 

J ~C 1 2010 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

The U.S. Environmental Protection Agency has reached a decision regarding the 

applicability of FIFRA registration requirement to both ammonia (and its salts) and urea 

products when sold or distributed for use in biocidal control systems in the pulp and paperboard 

industry along with a chlorine source. This letter provides official notice of that decision and 

also outlines the actions necessary for Nalco, Inc. to bring its products into compliance with the 

requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 

Background 

Between 2007 and 2009, EPA received three petitions concerning whether certain 

products containing ammonia and urea met the definition of "pesticide" when the products were 

intended for use in the pulp and paperboard industry as part of a system to control microorganisms. The petitions were submitted by three companies - Nalco, Inc. ("Nalco"), Buckman 

Laboratories ("Buckman"), and Ashland-Hercules ("Ashland") - all of which compete against 

each other in the marketing of products and services for the control of microorganisms in pulp 

and paperboard industry manufacturing. Buckman currently holds registrations for ammonia 

products, BCMW and Busan 1215, and Ashland is a distributor of a registered ammonia product, 

Spectrum XD3899 Ammonium Bromide Technology, that is manufactured by Ameribrom, Inc. 
Nalco does not hold a registration for ammonia, but distributes ammonia and urea products, 

identified as Nalcon 60620 and Nalcon 60615, .respectively, that are so used in the pulp and 

paperboard industry. These petitions provided differing opinions on whether ammonia or urea 

products, when sold or distributed for use with sodium hypochlorite or other chlorine sources, as 

water treatments in the pulp and paperboard industry, should be registered as pesticides. 

On May 19,2010, the Agency published a Federal Register notice (75 FR 28014) and 

initiated a public comment period relative to these petitions. The Federal Register notice 

includes a more comprehensive history and other information about this matter. The docket 

number is EPA-HQ-OPP- 2009-1005. The docket contains documents submitted by the 

petitioners, as well as public comments. 

Issue Presented 

The petitions submitted by the various parties present the central issue of whether 

ammonia and urea products should be registered as biocides when sold or distributed for use in 

combination with sodium hypochlorite or other chlorine sources as part of biocidal control 

systems in the pulp and paperboard industry. In terms of the regulatory status of particular 

products, the petitions question whether NALCO products sold or distributed for such purposes 

should be required to be registered under FIFRA and whether products registered by Buckman 

and associated with Ashland (as a distributor) should be required to remain registered under 

FIFRA when sold or distributed for such purposes. 

Specifically, Nalco's petition requested that the Agency reconsider its registration of 

ammonia products as precursors to chloramine and provide assurance that there is no risk of 

enforcement during the reconsideration and any transition period. Buckman's petition was filed 

in response to Nalco's request that the Agency reconsider the registration of ammonia. 

Buckman's petition further requested that the Agency immediately prohibit further sale and 

distribution of unregistered ammonia. Ashland's petition presented the same arguments as 

Buckman for ammonia and further recommended that the Agency take action against the sale 

and distribution of unregistered urea when used as part of a biocidal system in the pulp and 

paperboard industry. 

Decision 

The Agency has determined, based on the activity and fundamental purpose of adding 

ammonia and/or urea to chlorinated water to facilitate the production of chloramine for biocidal 

purposes, that Nalcon 60615 and Nalcon 60620 are required to be registered under FIFRA and 

that Buckman's BCMW and Busan 1215 and Ashland's Spectrum XD3899 Ammonium 

Bromide Technology must remain registered when sold or distributed for such purposes. This 

decision letter as well as responses to comments will all be posted to the public docket (EPAHQ-OPP- 2009-1005). This decision is effective immediately. Instructions for Nalco to achieve 

compliance with this decision are set forth in the final section of this letter. 

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Rationale 

For the reasons explained below, the Agency concludes that both ammonia and urea 

products need to be registered as pesticides when sold or distributed for use in combination with 

chlorine in biocidal control systems to address microbial pest problems in the pulp and 

paperboard industry. 

EPA has carefully reviewed the available information concerning how ammonia and urea 

function as part of biocidal control systems in the pulp and paperboard industry, as well as how 

Ashland, Buckman, and Na1co intend their ammonia and urea products to be used. Neither 

ammonia nor urea, by itself, has pesticidal activity. Nonetheless, the ways in which the three 

companies market their ammonia and urea products, as well as the known and intended uses of 

those products in the pulp and paperboard industry, bring those products within the definition of 

a pesticide. Specifically, EPA has determined that the three companies directly state or imply 

and intend that their products should be added to chlorinated water as part of a biocide control 

system in the pulp and paperboard industry where the material will interact with chlorine that is 

also added to the water. Once the ammonia or urea is added, it reacts with chlorine to ultimately 

form a new chemical substance, chloramine. (Urea in the presence of sodium hypochlorite or a 

chlorine source forms a chlorourea, which undergoes further chemical reaction to form 

chloramine.) As the three companies know, the chloramine formed following the addition of 

ammonia and urea to chlorinated water has pesticidal activity against microbial organisms. 

Moreover, compared to chlorine, chloramine exhibits extended antimicrobial activity. 

In reaching its conclusion that the products under review are pesticides, EPA relies on the 

statutory definition of "pesticide" in FIFRA 2(u), as well as its regulations in 40 CFR 

152.15(a)(1), 40 CFR 152.15(c) and 40 CFR 153.125(a)(2). FIFRA section 2(u) defines a 

"pesticide" in pertinent part as "any substance or mixture of substances intended for preventing, 

destroying, repelling, or mitigating any pest .... " EPA has interpreted this statutory term in 

regulations at 40 CFR 152.15, which states: 

No person may distribute or sell any pesticide product that is not registered under the 

Act. .. A substance is considered to be intended for a pesticidal purpose, and thus to be a 

pesticide requiring registration, if: 

(a) The person who distributes or sells the substance claims, states, or implies (by 

labeling or otherwise): 

(1) That the substance (either by itself or in combination with any other substance) can 

or should be used as a pesticide; or ... 

(c) The person who distributes or sells the substance has actual or constructive 

knowledge that the substance will be used, or is intended to be used, for a pesticidal 

purpose. 

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Finally, EPA's conclusion also takes into consideration the regulation in 40 CFR 153.125(a)(2), 

which sets forth criteria for determining whether a substance has pesticidal activity. The 

regulation states that an ingredient will be considered to be an active ingredient if it: 

... has the ability to elicit or enhance a pesticidal effect in another compound whose 

pesticidal activity is substantially increased due to the interaction of the compounds. 

Compounds which function simply to enhance or prolong the activity of an active 

ingredient by physical action, such as stickers or other adjuvants, are not generally 

considered to be active ingredients. 

Chloramine and chlorine, as part of a biocidal control system, destroy microbial pests in 

pulp and paperboard industry manufacturing; each is clearly a "pesticide" under FIFRA section 

2(u). Ashland, Buckman, and Nalco are selling their ammonia and urea products for use as part 

of a biocidal control system in the pulp and paperboard industry. The directions for use on these 

products indicate that they should be added to the water systems, which already contain chlorine, 

to prolong the antimicrobial activity of the chlorine in the system. Although not specifically 

stated in the use directions, this occurs as a result of the chemical reaction between the chlorine 

and either the ammonia or urea and not as a result of physical action. Thus, EPA finds the three 

companies are selling substances for which they state or imply that their products used in 

combination with a chlorine source in water can be used as part of a biocidal control system to 

control microbial pests in pulp and paperboard industry manufacturing. Under 40 CFR 152.15 

(a)(1), such products are considered pesticides. Likewise, EPA finds that the three companies 

know their products are being used in the manner described above, and by specifically marketing 

their products to customers in the pulp and paperboard industry, they fall under the provision in 

40 CFR 152.15(c). 

Ammonia, by itself, does not have any pesticidal activity, but cannot be characterized as 

a stabilizer as was suggested by some parties. A stabilizer is a chemical compound that does not 

change the characteristics of an active ingredient with which it is mixed. In the presence of 

sodium hypochlorite or a chlorine source, both ammonia and urea react to ultimately form 

chloramine, which itself is a different chemical compound from chlorine or sodium hypochlorite. 

Based on the fact that ammonia and urea are consumed in an irreversible chemical reaction and 

that a new chemical is formed, which possesses pesticidal activity; neither ammonia nor urea can 

be classified as stabilizers. 

Ammonia does not perform in a similar way to citric acid, acetic acid, and cyanuric acid. 

Unlike ammonia, the use of citric acid, acetic acid, and cyanuric acid as halogen stabilizers does 

not result in the formation of a new chemical which has a different spectrum of pesticidal 

activity. Ammonia does not have the same activity when combined with sodium hypochlorite or 

a chlorine source as that ascribed to chemicals that are used to stabilize other pesticides to 

prevent their degradation in the presence of sunlight. 

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Further, EPA finds that the interaction of ammonia or urea with chlorine prolongs and 

therefore substantially increases the pesticidal activity of chlorine. EPA notes that, unlike 

ingredients (such as stickers and other adjuvants) which prolong the activity of a pesticidally 

active chemical by physical action, the ammonia and urea act by causing a chemical reaction 

with chlorine or a chlorine source to ultimately form chloramine. Therefore, ammonia and urea 

meet the criterion in 40 CFR 153.125(a)(2) for identifying a pesticidally active substance. 

In light of all of the above, EPA concludes that the ammonia and urea products sold by 

Ashland, Buckman, and Nalco to the pulp and paperboard industry for use in controlling 

microbial pests in water systems are pesticides and must be registered (or remain registered) 

under FIFRA. 

Required Actions 

In light of the foregoing, and within 30 days of N alco' s counsel's receipt of this letter, 

Nalco must submit full application packages for new active ingredients for Nalcon 60615 and 

Nalcon 60620 to satisfy this determination that FIFRA registrations are required for these 

products. 

The Application for Pesticide Registration must include the following: 

Application for registration (Form 8570-1) 

Confidential Statement of Formula (Form 8570-4) 

Certification with Respect to Citation of Data form (Form 8570-34) 

Data Matrix (Form 8570-35) 

Copies of proposed label 

Data - The following data must be submitted/addressed: 

Chemistry data on the active ingredient as well as the proposed product 

Six acute toxicity studies on the active ingredient as well as the proposed product 

90 day subchronic study 

Developmental toxicity study 

2-generation reproductive study 

Mutagenicity battery (3 studies) 

Hydrolysis study 

Avian oral LD 50 study 

Fish Acute LC 50 study 

Aquatic invertebrate LC 50 study 

Residue studies to determine chloramine levels that may occur in pulp and paperboard. 

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This letter does not constitute permission for Na1co to continue to distribute or sell such 

products unless and until they are registered. The continued distribution or sale of those products 

constitutes a violation of FIFRA. Petitioners Ashland and Buckman have asked EPA to take 

enforcement action against Na1co for selling unregistered pesticides. EPA's Office of 

Enforcement and Compliance Assistance will respond separately to these requests. 

For further information or clarification on the registration process for the Na1co products, 

please contact Joan Harrigan-Farrelly, Director of the Antimicrobials Division, at HarriganFarrellyJoan@epa.gov or call 703-308-=6468. 

Sincerely, 

~~-- Steven P. Bradbury, Ph.D., Director 

Office of Pesticide Programs 

cc: Rosemarie Kelly, EPA Office of Enforcement and Compliance Assurance 

Philip J. Ross, EPA Office of General Counsel 

Joan Harrigan-Farrelly, Antimicrobials Division Director 

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