Document ID: EPA-HQ-OPP-2009-1005-0001
Agency: epa
Document Type: Notice
Title: Petitions Concerning Whether Ammonia or Urea Sold or Distributed, etc. Should Be Regulated as Pesticides
Posted Date: 2010-05-19T04:00Z

[Federal Register: May 19, 2010 (Volume 75, Number 96)]
[Notices]               
[Page 28014-28018]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19my10-55]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-1005; FRL-8824-4]

 
Petitions Concerning Whether Ammonia or Urea Sold or Distributed 
and Used for Certain Purposes Should Be Regulated as Pesticides

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice makes available for review and public comment 
three petitions concerning the regulatory status under the Federal 
Insecticide Fungicide and Rodenticide Act (FIFRA) of products 
containing ammonia or urea sold or distributed for use in the presence 
of sodium hypochlorite as a biocide or as part of a biocidal system in 
the production of pulp and paperboard products. The notice also makes 
available for review and public comment documents associated with the 
petitions which have also been placed in a docket created for this 
matter. That docket may be accessed as described in this Notice. The 
Agency registered as ``pesticides'' two products containing ammonia as 
the active ingredient based on applications for registration and 
supporting data submitted by Buckman Laboratories, Inc. (Buckman). The 
Agency has also registered an ammonium bromide product for a similar 
use in the pulp and paperboard industry. Another company, Nalco, Inc. 
(Nalco) is currently selling unregistered ammonia and urea products to 
the pulp and paperboard industry for use in a manner similar to those 
of the three registered products. Nalco informed EPA of its view that 
Buckman's ammonia products were not ``pesticides'' and argued therefore 
that EPA should not have registered them under FIFRA. Nalco petitioned 
the Agency to cancel Buckman's registrations for the two ammonia 
products. Subsequently, the Agency received two other petitions from 
Buckman and Ashland Hercules Water Technologies (Ashland-Hercules), 
which would also be affected by any Agency decision relative to the 
contested uses of ammonia and urea, supporting the decision to register 
ammonia and further requesting that the Agency find Nalco's sale and 
distribution of its unregistered ammonia product to be contrary to law. 
Ashland-Hercules also raised issues relative to the safe use and risks 
associated with the unregistered use of urea in chlorinated water in 
pulp and paper mill use scenarios and asked that the Agency find that 
Nalco's sale and distribution of its urea product was unlawful.

DATES: Comments must be received on or before July 19, 2010.

ADDRESSES: Submit your comments identified by the docket identification 
(ID) number EPA-HQ-2009-1005, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to the docket ID number EPA-HQ-
2009-1005. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.

[[Page 28015]]

    Docket: All documents in the docket are listed in the docket index 
available at http://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of 
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The Docket Facility telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: For general information contact: Melba 
S. Morrow, Antimicrobials Division (7510P), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-2716; fax 
number: (703) 308-6467; e-mail address: morrow.melba@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

 A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are a 
business engaged in the manufacturing of pesticides and other 
agricultural chemicals. Potentially affected entities may include, but 
are not limited to:
      Pesticide and other agricultural and chemical 
manufacturing (NAICS code 325320) e.g. businesses engaged in the 
manufacture of pesticides.
     Pulp and paperboard industries (NAICS code 322110, 
322130).
     Antimicrobial pesticides (NAICS code 32561).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected. The North 
American Industrial Classification System codes have been provided to 
assist you and others in determining whether this action might apply to 
certain entities. If you have any questions regarding the applicability 
of this action to a particular entity please contact the person list 
under FOR FURTHER INFORMATION CONTACT.

 B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree with any of positions taken 
in the petitions; suggest alternatives and substitute language for your 
requested changes. Carefully consider the merits of what you are 
proposing.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient details to allow it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest appropriate alternative measures when possible.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline that has been identified.
    3. Environmental justice. EPA seeks to achieve environmental 
justice, the fair treatment and meaningful involvement of any group, 
including minority and/or low income populations, in the development, 
implementation, and enforcement of environmental laws, regulations, and 
policies. To help address potential environmental justice issues, the 
Agency seeks information on any groups or segments of the population 
who, as a result of their location, cultural practices, or other 
factors, may have atypical or disproportionately high and adverse human 
health impacts or environmental effects from exposure to the 
pesticide(s) discussed in this document, compared to the general 
population.

II. Legal Authority

    Under FIFRA and its regulations, no person may distribute or sell 
any pesticide product that is not registered under the Act except as 
provided under 40 CFR 152.20, 152.25 and 152.30. A pesticide is any 
substance (or mixture of substances) intended for a pesticidal purpose 
i.e., use for the purpose of preventing, destroying, repelling, or 
mitigating any pest, among other things. The regulations in 40 CFR 
152.15 contain provisions that guide the Agency's determination of 
whether a particular product is a ``pesticide'' under FIFRA.
    FIFRA also provides the Agency with authority to cancel or suspend 
pesticides which do not comply with the Act or no longer meet the 
statutory standard for registration. FIFRA further authorizes the 
Agency to initiate enforcement action against persons who are not in 
compliance with the Act. Enforcement actions may, among other things, 
be initiated on the basis of sale or distribution of unregistered 
pesticide products or unlawful use of a registered pesticide product. 
See generally, FIFRA Sections 3, 6, 12, and 13.

III. History of Registrations for Ammonia and Urea Products for Use in 
the Pulp and Paper Industry

    Buckman is the registrant of BCMW (EPA Reg. No. 1448-432) and Busan 
1215 (EPA Reg. No.1442-433). Both products were registered in 2007, and 
both products contain ammonia as the active ingredient. Buckman's 
ammonia products are registered for use as a water treatment in 
combination with sodium hypochlorite to inhibit the growth of bacteria 
in pulp and paper mills. Ashland-Hercules is the authorized distributor 
of Spectrum XD3899 Ammonium Bromide Technology (EPA Reg. No. 8622-64-
74655), an ammonium bromide solution sold as a FIFRA Section 3(e) 
supplemental distributor product under Ameribrom, Inc.'s Fuzzicide 
Solution (EPA Reg. No. 8622-64) that was registered in 2003. Nalco does 
not hold any registrations for ammonia or urea products for use in pulp 
and paper mills. Nalco is currently marketing and distributing their 
ammonia product, Nalcon 60620, that is used in combination with sodium 
hypochlorite. Nalco is also marketing and distributing a urea-based 
product, Nalcon 60615, which is also used as a water treatment for the 
production of biocides in pulp and paper mill settings.

[[Page 28016]]

IV. Summary of the Petitions and Other Documents

    The Agency has received petitions and multiple related submissions 
from Ashland-Hercules, Buckman, and Nalco regarding the regulatory 
status of products containing ammonia or urea when intended for use in 
the presence of sodium hypochlorite as a biocide or as part of a 
biocidal system in the production of pulp and paperboard products. The 
submissions from Nalco generally argue that under FIFRA, those products 
are not ``pesticides'' when used under that circumstance. The 
submissions provided by Ashland-Hercules and Buckman argue that these 
products when intended or used for such purpose are ``pesticides'' 
requiring registration under FIFRA. The history of each petition and 
the principal arguments are summarized below.

A. Nalco, Inc.

    Nalco filed a petition on October 30, 2007 and requested that EPA 
revisit the requirement to register ammonia as a pesticide under FIFRA. 
The petitioner acknowledged the Agency had issued registrations for 
products containing ammonia to be used to inhibit the growth of 
bacteria in water used in pulp and paper mills. In its discussion of 
current biocidal control practices in the manufacture of pulp and 
paperboard products, the petitioner explained that it is common 
practice to add ammonia-based products to water which has been treated 
with chlorine in order to generate chloramines. Nalco further contended 
that, by requiring registration of ammonia, all companies that 
currently provide unregistered ammonia products for use with chlorine 
in water treatment are in violation of FIFRA. The Nalco petition stated 
that, in requiring the registration of ammonia, the Agency had failed 
to assess the impact that such a requirement would have on the 
regulated community. According to Nalco, EPA's decision to register 
ammonia products intended for use as part of a biocidal system in the 
production of pulp and paperboard products represented a change in 
EPA's policy that was undertaken without an opportunity for public 
input. The Nalco petition further stated that requiring registration of 
ammonia would in essence require that all users purchase ammonia from 
the only EPA-registered source. The Nalco petition requested that the 
Agency issue an interim statement that the sale of ammonia-based 
compounds for use with chlorine in water systems would not result in 
enforcement action and that the Agency would reconsider whether 
companies need to register ammonia when intended for use as part of a 
biocidal system in the production of pulp and paperboard products. The 
petition also argued that the decision to require the registration of 
ammonia products would also have an impact on municipal water treatment 
facilities, as the practice of adding ammonia is necessary to produce 
chloramines for municipal water disinfection.
    On December 4, 2007, Nalco wrote the Agency asking EPA to 
reconsider earlier actions requiring the registration of ammonia, which 
Nalco described as a ``precursor'' to chloramine in water treatment 
processes, and to assure Nalco that there would be no enforcement 
action taken during the transition period. The December 4 Nalco 
submission made the following assertions and arguments:
     As shown in the background information on the chemistry of 
chlorine in antimicrobial water treatment, chloramines are weak 
biocides. Because they are more stable than chlorine, chloramines are 
used in water systems to extend the period of antimicrobial activity 
and to minimize the production of other by-products of water 
disinfection by reducing the reactivity of chlorine.
     Ammonia is not a pesticide and does not contribute to the 
pesticidal activity of sodium hypochlorite or other chlorine-based 
water disinfectants. In industrial water systems such as those used by 
pulp and paper mills, there is high organic content in the water 
systems which can be controlled through the generation of chloramines. 
Chloramines reduce disinfection demands. The pesticidal activity of 
chloramine is a result of the residual activity of chlorine.
     Chlorine is the active ingredient in water treatment and 
the reaction with ammonia only stabilizes or sequesters ammonia. Thus, 
ammonia is not a precursor for in situ generation of a pesticide. 
Moreover, even if ammonia were a precursor, the Agency's decision to 
register ammonia is inappropriate because in the past, EPA has 
registered precursors when they are the only logical chemical through 
which the use of a pesticide can be regulated. Prior to the 
registration of ammonia for use as part of a biocidal system in the 
production of pulp and paperboard products, the Agency never required 
registration of ammonia compounds.
     Rather than designating ammonia as a ``precursor,'' EPA 
should consider it a ``stabilizer'' or an ``activator.'' The Agency's 
historical position has been that activators need not be registered. 
The Agency's decision to require the registration of ammonia is also 
inconsistent with the Agency's position on other chemicals, such as 
cyanuric acid used to stabilize chlorine in swimming pools, which 
performs similar functions. The submission contained an Appendix 
listing inert ingredients found in other pesticides that allegedly play 
a role similar to ammonia.
     The Agency should articulate a rule of decision regarding 
when registration is required and assess the impact of that rule before 
it is implemented. The rationale for a decision to require registration 
of ammonia should also be articulated. The current situation, in which 
one registrant of ammonia is threatening enforcement against users of 
similar systems in pulp and paper mills using unregistered ammonia 
compound, is causing confusion in the marketplace.
    In follow-up to the December submission, on February 7, 2008, EPA 
sent Nalco a letter indicating that the December 4th communication 
would be treated as a petition. The letter further stated ``...the 
Office of Pesticide Programs would regard Nalco's sale and distribution 
of ammonia and ammonia products for use in connection with chlorine to 
treat water to require registration under FIFRA Section 3 only if Nalco 
makes a pesticidal claim for such products.'' In July 2008, the Agency 
asked Nalco to define the term ``activator'' and to provide further 
explanation of the relationship between ammonia and the inert 
ingredients listed in the appendix to the December submission.
    In July 2008, Nalco filed a supplement to its December 2007 
submission. Nalco acknowledged that there is no regulatory definition 
of an activator and stated its opinion that ammonia is merely a 
``stabilizer'' which acts to prolong the availability of chlorine, and 
would therefore not meet the definition of a pesticide. Nalco further 
characterized ammonia as a ``sequestrant'', and defined that term as a 
substance which acts by preventing or inhibiting normal ion behavior by 
combination with added materials. In reference to the compounds 
identified in an appendix to Nalco's December 2007 submission, Nalco 
stated that they were included as examples of available compounds that 
have been determined by the Agency to be inert compounds. The 
description of the purpose of the inert component indicates that it 
will modify the activity of or interact with the pesticidally active 
ingredient in the formulation. Nalco compared the role of the inert 
compounds to that of ammonia by stating that the description of the 
inert compounds suggests a chemical

[[Page 28017]]

reaction but not one that is needed to produce a pesticidally active 
ingredient.

B. Buckman Laboratories, Inc.

    Buckman filed its petition on September 2, 2008, and responded to 
the concerns raised by Nalco's petition. Buckman defended the status of 
its ammonia products as registered pesticides and requested that the 
Agency immediately prohibit further distribution and sale of 
unregistered ammonia for water treatment. In addition, Buckman provided 
information on the chemical reaction which results in the formation of 
chloramines following the addition of ammonia to chlorinated water. 
Buckman stated in its petition that ammonia does not sequester or 
release chlorine and is not an adjuvant. Buckman further contended that 
ammonia reacts with sodium hypochlorite to produce an entirely new 
active ingredient, monochloramine (MCA), which has distinct biocidal 
properties. Buckman stated its opinion that the MCA, which is created 
by the chemical reaction, ``is the main active ingredient'' for 
biocidal water treatment in the pulp and paper process.
    Buckman provided the following rationale to support its request 
that the Agency maintain the status quo, i.e., its position that 
products containing ammonia intended for use in the presence of sodium 
hypochlorite as a biocide or as part of a biocidal system in the 
production of pulp and paperboard products are pesticides requiring 
registration under FIFRA. Buckman repeated its request that EPA 
prohibit further distribution and sale of unregistered ammonia 
products. Buckman's main points were:
     Both Nalco and Buckman sell ammonia for use in proprietary 
systems in which ammonia and sodium hypochlorite react to form 
monochloramine, which is the active ingredient supplied by each system 
for water treatment. The basic chemistry involving both the Nalco and 
Buckman products and the production of MCA is the same.
     The registration of ammonia is necessary because 
monochloramine is too unstable to exist as a marketable commodity, and 
no EPA-approved sodium hypochlorite label has instructions for use with 
ammonia to result in the safe production of MCA. In addition, the 
continued use of unregistered ammonia to produce MCA poses a 
potentially unreasonable risk to human health and the environment. 
There is no way to ensure that the MCA produced with an unapproved 
product will result in acceptable residues in food packaging or not 
pose a risk of toxicity to aquatic organisms from the residues in the 
effluent.
     Ammonia does not sequester or release chlorine and is not 
an adjuvant. Ammonia reacts with sodium hypochlorite to produce MCA 
which has distinct properties (the mechanism by which it inactivates 
microorganisms by adversely affecting cell respiration, transport and 
DNA activity; a different spectrum of antimicrobial activity) from 
hypochlorous acid.
     The Agency should deny Nalco's petition to revoke 
Buckman's ammonia registrations because the Agency has acted properly 
in its registration of ammonia as a precursor to the formation of MCA 
for water treatment. As a precursor of MCA, ammonia reacts with sodium 
hypochlorite to produce a new active ingredient, which has distinct 
properties as described above.
     The Agency should prohibit further distribution and sale 
of unregistered ammonia for water treatment because the continued sale 
of unregistered ammonia presents an unreasonable risk to public health 
and unfairly damages the commercial value of Buckman's registrations.

C. Ashland-Hercules

    Ashland-Hercules contacted the Agency in February 2009 with a 
petition that also included a file of correspondence to and from the 
Agency that dated back to June 2008. Ashland-Hercules's arguments were 
basically the same as those provided by Buckman with regard to Nalco's 
distribution and sale of unregistered ammonia for use with sodium 
hypochlorite as a biocide or as part of a biocidal system in the 
production of pulp and paperboard products. Ashland-Hercules further 
discussed the need for the Agency to take action against the sale or 
distribution of unregistered urea products as biocidal agents in the 
pulp and paperboard industry. Ashland-Hercules based this on arguments 
that urea has not been subjected to review for registration as an 
antimicrobial pesticide as required under FIFRA. Ashland-Hercules 
stated that the use of an unregistered urea-based product presents 
potential risks to human health and safety that EPA has not evaluated. 
Ashland- Hercules made the following points:
     There is a distinction between the treatment of public 
potable water supplies with MCA and the application of ammonia in the 
presence of sodium hypochlorite to prevent biofouling in the paper 
industry. Although the two uses are conceptually similar, the 
concentrations at which ammonia and chlorine are used are not the same.
     The potential hazards presented by the unregulated and 
uncontrolled use of ammonia-based biocides in pulp and paper mills are 
far greater than those associated with potable water treatment because 
of higher concentrations of chemicals that are used for biocidal 
activity in pulp and paper mills, thereby exposing workers to increased 
risks.
     While ammonia-based products used in treating potable 
water may not be registered under FIFRA, EPA has regulated chloramines 
produced by the addition of ammonia to chlorine under the Safe Drinking 
Water Act (SDWA). Thus, there is a basis for assuring the safety of 
potable water using the authority of the SDWA. The same can not be said 
for Nalco's product.
     The chemical reaction that takes place when concentrated 
ammonia-based compounds are combined in situ with concentrated sodium 
hypochlorite can result in the release of hazardous gases such as 
nitrogen trichloride and raises safety concerns when using Nalco's 
product.
     An unregistered product has no upper limits for feed 
rates. The exposure to the undesirable compounds produced during the 
uncontrolled mixing of concentrated solutions of ammonium sulfate and 
sodium hypochlorite is unlimited as well.

D. Current Status

    The Agency believes that all three parties have raised matters 
which pose common issues and which therefore are being considered and 
addressed together. The Agency's Office of Pesticide Programs, which is 
leading this effort to consider these petitions, is also examining 
other issues, including any potential issues involving EPA's Office of 
Water and is obtaining information for use in making its decision on 
whether the sale and distribution of ammonia and urea products for use 
with chlorine-treated water in pulp and paper production are pesticidal 
uses that require registration under FIFRA.
    EPA held a meeting on February 16, 2010 with all of the parties who 
either hold registrations for ammonia or who had petitioned the Agency 
with concerns pertaining to the status of the ammonia or urea products 
described above. The materials from the meeting as well as a transcript 
of the meeting have been placed in the docket, along with the three 
petitions, and correspondence associated with the petitions.

[[Page 28018]]

V. What Action is the Agency Taking

    Through this notice, the Agency is making the petitions and other 
correspondence submitted by Nalco, Buckman Laboratories and Ashland 
Hercules available for public review and comment. Any public comments 
received on these petitions will be included in the electronic docket 
and reviewed by the Agency. Following review of the petitions and any 
comments received in response to this notice, EPA will issue its 
decision and response to the petitions.
    In reviewing the materials in the docket and submitting any 
comments to the Agency, the Agency requests that, in addition to 
providing comments regarding any other issues raised by the materials 
in the docket, commenters respond to the following specific questions:
     When the ingredients in a product do not provide any 
pesticidal activity unless they react with other chemicals, should the 
product be treated as a pesticide? Are there any other factors which 
could or should lead to a different outcome in different settings? If 
so, what are they and what would the different outcome be?
     When a product is marketed as an essential part of a 
system or as a co-ingredient in a treatment regime that provides a 
pesticidal function, should the product be registered as a pesticide? 
Should the system be registered as a pesticide product? Are there any 
other factors which could or should lead to a different outcome in 
different settings? If so, what are they and what would the different 
outcome be?
     If a system is registered as a pesticide, how should 
requirements governing labeling and compositions apply to the system 
and to individual products comprising the system?
     What are the implications for other products containing 
ammonia or urea that are used in conjunction with chlorine-treated 
water in settings other than the production of pulp and paperboard?
     What substances, other than ammonia or urea, are sold for 
uses similar to the Ashland, Buckman, and Nalco products, and might 
require registration or might currently be registered?

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: May 3, 2010.
Joan Harrigan-Farrelly,
Director, Antimicrobial Division, Office of Pesticide Programs.
[FR Doc. 2010-11445 Filed 5-18-10; 8:45 am]
BILLING CODE 6560-50-S