UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

DEC 1 6 2010 

MEMORANDUM 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

SUBJECT: Transmittal of Response to Comments Received for docket #EPA-H 

2009-1005 (Ammonia and Urea) 

FROM: Joan 

Antimicrobials Division, 

Harrigan-Farrelly, Director 

Office f esticide 

~ Programs 

TO: Steven P. Bradbury, Ph.D., Director 

Office of Pesticide Programs 

The Antimicrobials Division has completed its review of comments received to docket 

#EPA-HQ-OPP- 2009-1005, concerning the registration of ammonia and urea, and have responded 

accordingly. After review of the comments, scientific analysis and deliberation of the issues 

raised, the Agency has 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 in the 

docket. Comments providing opinions regarding the registration of ammonia and or urea were 

received from one private citizen; Beveridge and Diamond (the law firm that represents AshlandHercules); three members of the 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, 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 con,trol microorganIsms. 
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 of Ammonia and Urea-Based Biocide 

Products Used in Pulp and Paperboard Industry 

December 16,2010 

Environmental Protection Agency 

Office of Pesticide Programs 

Antimicrobials Division 

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Response to Comments Received Relative to the Registration of Ammonia 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 by three companies - Na1co, Inc. ("Na1co"), 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 manufacturing Buckman currently holds registrations for ammonia and Ashland 

is a distributor of a registered ammonia product that is manufactured by Ameribrom, Inc. Na1co 

does not hold 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 or urea products, when sold or distributed for use with sodium hypochlorite or other 

sources of chlorine, as water treatments in the pulp and paperboard industry, should be registered 

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 of ammonia. 

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

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

paperboard industry. 

EPA established a public docket for these petitions; it is available at: EPA-HQ-OPP2009-1005. On May 19,2010, the Agency initiated a public comment period relative to these 

petitions. (75 FR 28014). That Federal 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 of ammonia and or urea were 

received from one private citizen; Beveridge and Diamond (the law firm that represents AshlandHercules); three members of the regulated community; and Steptoe and Johnson (the law firm 

representing Na1co). Comments were also received from associations that are responsible for 

maintaining the quality of drinking water and for the agricultural uses of ammonia and urea. 

These associations include the Association of Metropolitan Water Agencies (AMW A), the 

American Water Works Association (A WW A), the Association of State 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 of information and 

correspondence between the Agency and specific petitioners, which were not captured in the 

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initial information that was made a part of the docket, as well as letters from petitioners 

requesting meetings with members of the Office of Pesticide 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 be registered as biocides when sold or distributed for use in combination with sodium 

hypochlorite or another chlorine source as part of biocidal control systems in the pulp and 

paperboard industry. 

Agency Response. For the 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 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 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 of a 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 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 state: 

Page 3 of 8 
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. 

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 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 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 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 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 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 

Page 4 of 8 
microbial pests in water systems are-pesticides and must be registered (or remain registered) 

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 of stabilizers 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 sodium hypochlorite is not a stabilizer 

since a stabilizer does not change the characteristics of the active ingredient when mixed with 

other substances. These commenters further stated that the Agency should continue to apply 

standards for registration of pesticides as set forth under FIFRA to products that create in-situ 

generated pesticides and that there is no justifiable 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 of ammonia as a 

stabilizer. Rather, EPA agrees with the comments which stated that 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. 

EPA also disagrees that ammonia performs 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. Further, the Agency disagrees that ammonia has the same activity when 

combined with sodium hypochlorite or a chlorine source that is ascribed to chemicals that are 

used to stabilize other pesticides to prevent their degradation in the presence of sunlight. 

In sum, the Agency has 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 of both ammonia and urea, 

stating environmental and ecological concerns (water eutrophication, soil acidification, danger of 

species annihilation, liver damage to juvenile trout, and reproductive effects on fish) that may 

occur if the use of ammonia and urea is not regulated. Both ammonia and urea have proven 

environmental and human effects and should be regulated by the government to ensure no 

mIsuse. 

Agency Response. The Agency agrees that both ammonia and urea should be regulated under 

FIFRA as pesticides, when they are used along with a chlorine source to control microbial pests 

Page 5 of 8 
in water systems in the pulp and paperboard industry. Based on its review of the 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 be used, EPA does not think that these uses of ammonia and urea are posing risks of 

concern. The Agency conducted risk assessments on the chloramine prior to granting 

registrations for the Buckman and Ameribrom ammonia products. Nonetheless, EPA thinks that 

regulatory controls on the use of pesticides are not only legally required but also appropriate to 

ensure that EPA retains the ability to address newly discovered risks and instances of misuse, 

should they appear. 

FIFRA establishes a comprehensive framework for the regulation of pesticides. Section 

3 of FIFRA establishes requirements for registration of pesticides. Prior to granting a registration 

of any new pesticide, EPA has to conclude, among other things, that the pesticide, when used in 

accordance with widespread and commonly recognized practices, will not cause unreasonable 

adverse effects on the environment. In making that statutory determination under FIFRA, EPA 

considers both effects on human health, including the health of infants 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 of a pesticide. Once EPA 

registers a product, a person may sell or distribute the pesticide with the labeling approved by 

EPA. It becomes a violation of federal law to use the pesticide in a manner inconsistent with its 

labeling. 

Comment 4. Several comments shared the belief that the registration of ammonia, when used 

as part of biocide control systems in the pulp and paperboard industry, would necessitate the 

registration of ammonia 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 not be 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 of ammonia 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 of Pesticide Programs is only addressing the 

applicability of FIFRA to the ammonia and urea products being sold to the pulp and paperboard 

industry by Ashland, Buckman, and Na1co. Nonetheless, EPA recognizes that this decision may 

possibly be cited as a precedent if EPA is asked whether the sale of ammonia for use in drinking 

water treatment requires registration. Although public comments have offered views on the 

applicability of FIFRA 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. If the issue arises, EPA may also need to consider 

additional factors such as the existing regulatory requirements imposed under the Safe Drinking 

Water Act (SDW A) on the operation of public water supply systems. 

Comment 5. Organizations representing agricultural constituents stated that the regulation of 

ammonia and urea would have a significant impact on the entire agricultural input supply chain 

Page 6 of 8 
from the manufacturer to the farmer. These organizations believe this would limit the farmer's 

choice of fertilizers. 

Agency Response. The commenters appear to think that, if EPA 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 of the 

intended or actual use to be registered. If so, 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 "custom blending" of pesticides and fertilizers). EPA does not consider its decision 

regarding the sale or distribution of ammonia 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 be registered. 

Comment 6. One of the 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 of confidentiality. 

Agency Response. This comment concerns aspects of the process by which the Agency has 

reached its decision regarding the applicability of FIFRA to the sale of the 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 of the 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. 

Comment 7. One commenter expressed concern that no matter what the outcome of the 

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 8 
Agency Response. 

Within 30 days ofNalco'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. 

Petitioners Ashland and Buckman have asked EPA to take enforcement action against 

Nalco for selling unregistered pesticides. The Office of Enforcement and Compliance 

Assistance (OECA) within EPA will respond separately to this request. 

. an-F"/tY 

nVlfonmenta . IP7~rotectlOn A gency 

i ctor, Antimicrobials Division 

Office of Pesticide Programs 

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