UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

Mr. Michael Boucher McKenna Long & Aldridge Counsel for BuckmanLaboratories 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** 

### 1 201 0
OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

The U
.S
. Environmental Protection Agencyhas reached a decision regarding the applicability ofFIFRA registration requirement to both ammonia (and its salts) and urea products when sold or distributed for use inbiocidal control systems in the pulp and paperboard industry along with a chlorine source. This letter provides official notice ofthat decision and also outlines the actions necessary for Nalco, Inc
. to bring its products into compliance with the requirements ofthe 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 ofa system to control microorganisms
. The petitions were submitted by three companies

- Nalco, Inc
. ("Nalco"), Buckman Laboratories ("Buckman"), and Ashland

-Hercules ("Ashland")

- all ofwhich compete against each other in the marketing ofproducts and services for the control ofmicroorganisms in pulp and paperboard industry manufacturing. Buckman currently holds registrations for ammonia products, BCMW and Busan 1215, and Ashland is a distributor ofa 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 sodiumhypochlorite 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 2801 4) 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 bythe petitioners, as well as public comments. Issue Presented The petitions submitted by the various parties present the central issue ofwhether ammonia and urea products should beregistered as biocides when sold or distributed for use in combination with sodiumhypochlorite or other chlorine sources as part ofbiocidal control systems in the pulp and paperboard industry. In terms ofthe regulatory status ofparticular 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 Agencyreconsider 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 ofammonia. Buckman's petition further requested that the Agency immediately prohibit further sale and distribution ofunregistered 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 ofunregistered urea when used as part ofa biocidal system in the pulp and paperboard industry. Decision The Agency has determined, based on the activity and fundamental purpose ofadding ammonia and/or urea to chlorinated water to facilitate the production ofchloramine for biocidal purposes, that Nalcon 60615 and Nalcon 60620 are required to beregistered 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 beposted to the public docket (EPA

HQ

-OPP

- 2009-1005). This decision is effective immediately. Instructions for Nalco to achieve compliance with this decision are set forth in the final section ofthis letter.

Page 

# 12

### Rationale For the reasons explained below, the Agency concludes thatboth 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 ofbiocidal 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 norurea, 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 def inition 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 ofa 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, itreacts 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 waterhas 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, EPArelies 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 itselfor in combination with any other substance) can or should be used as a pesticide; or ... (c) The person who distributes or sells the substancehas actual or constructive knowledge that the substance will be used, or is intended to be used, for a pesticidal purpose.

Page 13Finally, 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 ifit:

... has the ability to elicit or enhance a pesticidal effect in another compound whose pesticidal activity is substantially increased due to the interaction ofthe compounds. Compounds which function simplyto enhance or prolong the activity ofan active ingredient byphysical action, such as stickers or other adjuvants, are not generally considered to be active ingredients. Chloramine and chlorine, as part ofa 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 ofa 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 ofthe chlorine in the system. Although not specifically stated in the use directions, this occurs as a result ofthe chemical reaction between the chlorine and either the ammonia or urea and not as a result ofphysical 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 beused as part ofa biocidal control system to control microbial pests in pulp and paperboard industry manufacturing. Under40 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 ofan 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 itselfis 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 norurea 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 ofcitric acid, acetic acid, and cyanuric acid as halogen stabilizers does not result in the formation ofa new chemical which has a different spectrum ofpesticidal activity. Ammonia does not have the same activity when combined with sodiumhypochlorite 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.

Page 

## 14Further, EPA finds that the interaction ofammonia orurea with chlorine prolongs and therefore substantially increases the pesticidal activity ofchlorine. 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 ofall ofthe 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 mustberegistered (or remain registered) under FIFRA. 

### Required Actions In light ofthe foregoing, and within 30 days ofNalco's counsel's receipt ofthis letter, Nalco must submit full application packages for new active ingredients for Nalcon 60615 and Nalcon 60620 to satisfy this determination that FIFRAregistrations are required for these products. The Application for Pesticide Registration must include the following: Application for registration (Form 8570

- 1) Confidential Statement ofFormula (Form 8570

-4) Certification with Respect to Citation ofData form (Form 8570-34) Data Matrix (Form 8570

-35) Copies ofproposed label Data

- The following data mustbe 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
.

Page 15

### 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 ofthose products constitutes a violation ofFIFRA. 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 contactJoan Harrigan

-Farrelly, Director ofthe Antimicrobials Division, at HarriganFarrellyJoan@epa.gov or call 703

-308-=6468.
Sincerely,

# ~~-- StevenP. Bradbury, Ph.D., Director Office ofPesticide Programs

cc: Rosemarie Kelly, EPA Office ofEnforcement and Compliance Assurance Philip J. Ross, EPA Office ofGeneral Counsel Joan Harrigan

-Farrelly, Antimicrobials Division Director

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