UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D

.C. 20460



## DEC 16 2010

MEMORANDUM OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

SUBJECT: Transmittal ofResponse to Comments Received for docket #EPA

-H 2009

- 1005 (Ammonia and Urea) 

### FROM: Joan Harrigan

-Farrelly, Director

# ~ Antimicrobials Division, Office f esticide Programs TO: Steven P. Bradbury, Ph.D., Director Office ofPesticide Programs

The Antimicrobials Divisionhas completed its review ofcomments received to docket #EPA

-HQ-OPP

- 2009

-1005, concerning the registration ofammonia and urea, and have responded accordingly. After review ofthe comments, scientific analysis and deliberation ofthe issues raised, the Agencyhas made a determination that Nalco, Inc. products Nalcon 60615 and Nalcon 60620 are required to be registered under FIFRA. Eleven comments were received relative to the petitions that were made available inthe docket. Comments providing opinions regarding the registration ofammonia and or urea were received from one private citizen; Beveridge and Diamond (the law firm that represents Ashland

Hercules); three members ofthe regulated community; and Steptoe and Johnson (the law firm representing Nalco). To facilitate the Agency's response to the comments received, some comments with similar concerns have been grouped together and summarized. For example, comments from the water and fertilizer interests are grouped together.
Background Between 2007 and 2009, EPAreceived 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 con,trol micro

organIsms.

### On February 16,2010, the Agency met with the three companies to allow the parties to present their views and discuss relevant issues before the Agency. On May 19,2010, we published a Federal Register notice soliciting public comments on the petitions and supporting information. The comment period ended September 2,2010. With this transmittal, the response to comments will be posted, along with the Agency's decision.

# Response To Comments 

# Docket ID # 

# EPA-HQ-OPP- 2009-1005 Registration ofAmmonia and Urea-Based Biocide

Products Used in Pulp and Paperboard Industry
December 16,2010

Environmental Protection Agency Office ofPesticide Programs Antimicrobials Division
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### Response to Comments Received Relative to the Registration ofAmmonia and Urea A. 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 pulp and paperboard manufacturing as part of a system to control microorganisms. The petitions were submitted bythree companies

- Na1co, Inc. ("Na1co"), 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 manufacturing Buckman currently holds registrations for ammonia and Ashland is a distributor ofa registered ammonia product that is manufactured byAmeribrom, Inc. Na1co does nothold a registration for ammonia, but distributes ammonia and urea products that are so used in the pulp and paperboard industry. These petitions provided differing opinions on whether ammonia orurea products, when sold or distributed for use with sodium hypochlorite or other sources ofchlorine, as water treatments in the pulp and paperboard industry, should beregistered as pesticides. Specifically, Na1co'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 Na1co's request that the Agency reconsider the registration ofammonia. Buckman's petition further requested that the Agency immediately prohibit further sale and distribution ofumegistered 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 ofumegistered urea when used as part ofa biocidal system in the pulp and paperboard industry. EPA established a public docket for these petitions; it is available at: EPA

-HQ

-OPP

2009

-1005. OnMay 19,2010, the Agency initiated a public comment period relative to these petitions. (75 FR 28014). ThatFederal Register notice includes a more comprehensive history and other information about this matter. The docket contains documents submitted by the petitioners, as well as public comments. Eleven comments were received relative to the petitions. Comments providing opinions regarding the registration ofammonia and orurea were received from one private citizen; Beveridge and Diamond (the law firm that represents AshlandHercules); three members ofthe regulated community; and Steptoe and Johnson (the law firm representing Na1co). Comments were also received from associations that are responsible for maintaining the quality ofdrinking water and for the agricultural uses ofammonia and urea. These associations include the Association ofMetropolitan WaterAgencies (AMW A), the American Water Works Association (AWW A), the Association ofState Drinking Water Administrators (ASDW A), The Fertilizer Institute (TFI) and the Agricultural Retailers Association (ARA). In addition, other documents were submitted during the comment period, but were not comments on the petition. These submissions included pieces ofinformation and correspondence between the Agency and specific petitioners, which were not captured in the
Page 2 of8initial information that was made a part ofthe docket, as well as letters from petitioners requesting meetings with members ofthe Office ofPesticide Programs. EPA has reviewed the comments received, grouped similar comments together, and summarized them. To facilitate the Agency's response to the comments received, some comments raising common concerns, such as the comments from the water and fertilizer interests, are grouped together. 

### B. Public Comments and Agency Responses Comment 

### 1. One petitioner and several commenters contend that ammonia and urea should not be registered while another petitioner and other commenters counter that ammonia and urea should beregistered as biocides when sold or distributed for use in combination with sodium hypochlorite or another chlorine source as part ofbiocidal control systems in the pulp and paperboard industry. Agency Response. Forthe reasons explained below, the Agency concludes that both ammonia and urea need to be registered as pesticides when sold or distributed for use in combination with a chlorine source inbiocidal control systems to address microbial pest problems in the pulp and paperboard industry

. EPAhas 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 Nalco 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 pesticide. Specifically, EPA has determined 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 pulp and paperboard manufacturing 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 form a new chemical substance, chloramine. (Urea in the presence ofsodiumhypochlorite 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 ofammonia and urea to chlorinated water has pesticidal activity against microbial organisms. Moreover, compared to chlorine, chloramine exhibits extended antimicrobial activity. Inreaching 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 ofsubstances intended for preventing, destroying, repelling, or mitigating any pest
... ." EPA has interpreted this statutory term in regulations at 40 CFR 152.15, which state:

Page 3 of 8No 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 (eitherby itselfor 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. Finally, EPA's conclusion also takes into consideration the regulation in 40 CPR 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 simply to enhance or prolong the activity ofan active ingredient by physical 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 pulp and paperboard manufacturing. 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 eitherthe ammonia orurea 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 canbe used as part ofa biocidal control system to control microbial pests in pulp and paperboard 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 CPR 152.15(c). Further, EPA finds that the interaction of ammonia or urea with chlorine prolongs and therefore substantially increases the pesticidal activity ofchlorine. EPAnotes that, unlike ingredients (such as stickers and other adjuvants) which prolong the activity ofa 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. Inlight ofall ofthe above, EPA concludes that the ammonia and ureaproducts sold by Ashland, Buckman, and Nalco to the pulp and paperboard industry for use in controlling
Page 4 of 8microbial pests in water systems are- pesticides and mustberegistered (or remainregistered) under FIFRA. Comment 2. Several comments contend that ammonia is a chlorine stabilizer and has no pesticidal activity. A change in policy that would require registration ofstabilizers would have a significant impact on companies that produce stabilizers. Implications would extend beyond pulp and paperboard industry use to include pool and spa water treatment and agricultural adjuvants. Other stabilizers such as citric and acetic acid and cyanuric acid are sold for uses similar to ammonia and do not require registration. Other commenters contend that ammonia when used with sodiumhypochlorite is not a stabilizer since a stabilizer does not change the characteristics ofthe active ingredient when mixed with other substances. These commenters further stated that the Agency should continue to apply standards for registration ofpesticides as set forth under FIFRA to products that create in-situ generated pesticides and that there is nojustifiable basis for reversing this position Agency Response. EPA agrees with the commenters who stated that ammonia, by itself, does not have any pesticidal activity, but disagrees with the characterization ofammonia as a stabilizer. Rather, EPA agrees with the comments which stated that a stabilizer is a chemical compound that does not change the characteristics ofan active ingredient with which it is mixed. Inthe presence ofsodium 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 onthe 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. 

### EPA also disagrees that ammonia performs 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 of pesticidal activity. Further, the Agency disagrees that ammonia has the same activity when combined with sodiumhypochlorite or a chlorine source that is ascribed to chemicals that are used to stabilize otherpesticides to prevent their degradation in the presence of sunlight. In sum, the Agencyhas determined that ammonia in this use is not a stabilizer, and thus the decision regarding these ammonia and urea products does not establish a precedent for companies that produce stabilizers and/or agricultural adjuvants. Comment 3. Some comments emphasized the need for regulation ofboth ammonia and urea, stating environmental and ecological concerns (water eutrophication, soil acidification, danger of species annihilation, liver damage tojuveniletrout, and reproductive effects onfish) that may occur ifthe use ofammonia and urea is not regulated. Both ammonia and urea have proven environmental and human effects and should beregulated by the government to ensure no mIsuse. Agency Response. The Agency agrees that both ammonia and urea should beregulated under FIFRA as pesticides, when they are used along with a chlorine source to control microbial pests
Page 5 of8in water systems in the pulp and paperboard industry. Based on its review ofthe applications to register the Ameribrom Inc. product for which Ashland is the distributor and the Buckman products, and based on the information provided about the ways in which the Na1co product is intended to beused, EPA does not think that these uses ofammonia and urea are posing risks of concern. The Agency conducted risk assessments onthe chloramine prior to granting registrations for the Buckman and Ameribrom ammonia products. Nonetheless, EPA thinks that regulatory controls onthe use ofpesticides are not only legally required but also appropriate to ensure that EPAretains the ability to address newly discovered risks and instances ofmisuse, should they appear. FIFRA establishes a comprehensive framework for the regulation ofpesticides. Section 3 ofFIFRA establishes requirements for registration ofpesticides. Prior to granting a registration ofany new pesticide, EPA has to conclude, among otherthings, that the pesticide, when used in accordance with widespread and commonly recognized practices, will not cause unreasonable adverse effects onthe environment. Inmaking that statutory determination under FIFRA, EPA considers both effects onhuman health, including the health ofinfants and children, and effects on the environment. FIFRA also establishes the Agency's authority to specify the kinds of information or data that will be required to support the registration ofa pesticide. Once EPA registers a product, a person may sell or distribute the pesticide with the labeling approved by EPA. Itbecomes a violation offederal law to use the pesticide in a manner inconsistent with its labeling. Comment 4. Several comments shared the beliefthat the registration ofammonia, when used as part of biocide control systems in the pulp and paperboard industry, would necessitate the registration ofammonia for similar uses in drinking water systems. These commenters expressed concern that requiring registration under FIFRA would encroach upon a well established framework established under the Safe Drinking Water Act that has been implemented for nearly 25 years. One comment further stated that since ammonia lacked pesticidal activity by itself, it should notbe treated or labeled as a pesticide. Several comments further requested that the Agency defer to the regulatory and risk management framework set forth by the Safe Drinking Water Act. Registration ofammonia in drinking water treatment would result in regulatory overlap because guidelines already exist for chemicals used in drinking water. Agency Response. In this decision, the Office ofPesticide Programs is only addressing the applicability ofFIFRA to the ammonia and urea products being sold to the pulp and paperboard industry byAshland, Buckman, and Na1co. Nonetheless, EPA recognizes that this decision may possiblybe cited as a precedent ifEPA is asked whether the sale ofammonia for use in drinking water treatment requires registration. Although public comments have offered views onthe applicability ofFIFRA to such ammonia products, EPA is not prepared to take a position on that issue in this decision. Nonetheless, such a decision would need to consider the same range of factors as EPA has discussed in this decision. Ifthe issue arises, EPA may also need to consider additional factors such as the existing regulatory requirements imposed under the Safe Drinking Water Act (SDWA) onthe operation ofpublic water supply systems. Comment 5. Organizations representing agricultural constituents stated that the regulation of ammonia and urea would have a significant impact onthe entire agricultural input supply chain
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### from the manufacturer to the farmer. These organizations believe this would limit the farmer's choice offertilizers. Agency Response. The commenters appear to think that, ifEPA requires registration of ammonia and urea products when Ashland, Buckman, and Nalco sell them to the pulp and paperboard industry, the Agency will require all ammonia and urea products irrespective ofthe intended or actual use to be registered. Ifso, many urea- and ammonia

-based fertilizers would need registration. The Agency agrees that FIFRA does not give EPA authority to regulate fertilizers, except to the extent a pesticide may contain fertilizer as an inert ingredient. See 40 CFR part 167 (describing among other things how the establishment registration requirements apply to "customblending" ofpesticides and fertilizers). EPA does not consider its decision regarding the sale or distribution ofammonia and urea products for use in biocidal control systems in the pulp and paperboard industry as establishing or indicating in any way that fertilizers that are used in a fundamentally different manner would need to beregistered. Comment 6. One ofthe petitioners has commented that Nalco has been aware that a biocide is produced when ammonia is added to sodium hypochlorite and that the Agency has afforded Nalco exceptional treatment. It 

### is the petitioner's contention that the Agency has also excluded files from the docket because Nalco makes claims ofconfidentiality. Agency Response. This comment concerns aspects ofthe process by which the Agency has reached its decision regarding the applicability ofFIFRA to the sale ofthe ammonia and urea products intended for use in the pulp and paperboard industry by Ashland, Buckman, and Nalco. It

### does not address the substantive issue before the Agency. Nonetheless, EPA thinks that the process it has used to air the complex legal, scientific, and policy considerations has treated all of the petitioners equitably. The Agency has published and taken comment on all three companies' petitions. EPA has held a meeting to give all ofthe companies an opportunity to present their views directly to EPA decision

-makers. The Agency has maintained a docket into which it has placed documents it has received that relate to the pending petitions and provided for a public comment period. Further, with regard to comments on data confidentiality, when one petitioner states that their material is proprietary and has so labeled the content as confidential, FIFRA sec. 10 requires the Agency to treat such material as confidential and prohibits release to the public under certain circumstances.

Comment7. One commenter expressed concern that no matter what the outcome ofthe Agency's decision, all impacted parties must be given adequate time to transition their products and customers, so as not to disrupt services and to eliminate a prolonged "down time"

. Further, the Agency must provide a reasonable transition period for affected parties to come into compliance with the Agency's decision

.

Page 7 of 8Agency Response. 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 Applica tion 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 must be submitted/addressed: Chemistry data onthe active ingredient as well as the proposed product Six acute toxicity studies onthe 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 inpulp and paperboard. Petitioners Ashland and Buckman have asked EPA to take enforcement action against Nalco for selling unregistered pesticides. The Office ofEnforcement and Compliance Assistance (OECA) within EPA will respond separately to this request.



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# IP**7~ A**  nVlfonmenta rotectlOn gency i ctor, Antimicrobials Division Office ofPesticide Programs

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