Document ID: EPA-HQ-OPP-2010-0434-0001
Agency: epa
Document Type: Notice
Title: Draft Ecological Risk Assessment and Endangered Species Effects Determination; Availability: Inorganic Nitrates-Nitrite, Carbon and Carbon Dioxide, and Sulfur Registration Review
Posted Date: 2010-05-26T04:00Z

[Federal Register: May 26, 2010 (Volume 75, Number 101)]
[Notices]               
[Page 29534-29536]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26my10-45]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0434; FRL-8826-6]

 
Inorganic Nitrates-Nitrite, Carbon and Carbon Dioxide, and Sulfur 
Registration Review; Draft Ecological Risk Assessment and Endangered 
Species Effects Determination; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY:  This notice announces the availability of EPA's draft 
ecological risk assessment for the registration review of inorganic 
nitrates - nitrites, carbon and carbon dioxide, and gas cartridge uses 
of sulfur, and opens a public comment period on this document. Comments 
and input may address, among other things, the Agency's risk assessment 
methodologies and assumptions, as applied to this draft risk 
assessment. Interested parties may also provide suggestions for 
mitigation of the risk identified in the draft ecological risk 
assessment. As part of the registration review process, the Agency has 
completed a comprehensive draft ecological risk assessment, including 
an endangered species assessment that identifies those species for 
which exposure and effects may occur for all inorganic nitrates-
nitrites, carbon and carbon dioxide uses, as well as gas cartridge uses 
of sulfur. The risk assessment includes a species specific analysis and 
effects determination on 3 of 11 species found in the San Francisco Bay 
area that are listed as endangered or threatened under the Endangered 
Species Act (ESA). Concurrent with this public comment opportunity, EPA 
is initiating informal consultation with the U.S. Fish and Wildlife 
Service. After reviewing comments received during this public comment 
period, EPA will issue a revised risk assessment, explain any changes 
to the draft risk assessment, and respond to comments. The Agency may 
request further public input on risk mitigation before developing a 
proposed registration review decision for inorganic nitrates - 
nitrites, carbon and carbon dioxide, and sulfur. After a revised risk 
assessment is completed, EPA will also initiate further consultation, 
as needed, when appropriate, with the U.S. Fish and Wildlife Service 
regarding potential risks to federally listed threatened or endangered 
species and their designated critical habitat.

DATES: Comments must be received on or before July 26, 2010.

ADDRESSES: The mailing address for each Chemical Review Manager listed 
in the table in Unit II. is: Pesticide Re-evaluation Division (7508P), 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001. Submit your comments 
identified by the docket identification (ID) number for the specific 
pesticide of interest provided in the table in Unit II. by one of the 
methods listed below:
     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 numbers listed 
in the table in Unit II. for the pesticides you are commenting on. 
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.
    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 pesticide specific information 
contact: The Chemical Review Manager identified in the table in Unit 
II. for the pesticide of interest.
    For general questions on the registration review program, contact: 
Kevin Costello, Pesticide Re-evaluation Division (7508P), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-5026; 
fax number: (703) 308-8090; e-mail address: costello.kevin@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

 A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of 
interest to a wide range of stakeholders including environmental, human 
health, farm worker, and agricultural advocates; the

[[Page 29535]]

chemical industry; pesticide users; and members of the public 
interested in the sale, distribution, or use of pesticides. Since 
others also may be interested, the Agency has not attempted to describe 
all the specific entities that may be affected by this action. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the appropriate Chemical Review Manager 
listed 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; suggest alternatives and 
substitute language for your requested changes.
    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 detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    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 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. Authority

    EPA is conducting its registration review of inorganic nitrates - 
nitrites, carbon and carbon dioxide, and sulfur pursuant to section 
3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
and the Procedural Regulations for Registration Review at 40 CFR part 
155, subpart C. Section 3(g) of FIFRA provides, among other things, 
that the registrations of pesticides are to be reviewed every 15 years. 
Under FIFRA, a pesticide product may be registered or remain registered 
only if it meets the statutory standard for registration given in FIFRA 
section 3(c)(5). When used in accordance with widespread and commonly 
recognized practice, the pesticide product must perform its intended 
function without unreasonable adverse effects on the environment; that 
is, without any unreasonable risk to man or the environment, or a human 
dietary risk from residues that result from the use of a pesticide in 
or on food.
    The pesticides that are the subject of this notice and the Chemical 
Review Managers are listed in the following table:

           Table--Pesticides Available for Registration Review
------------------------------------------------------------------------
                                                        Chemical Review
                                                      Manager, Telephone
        Docket ID Number            Pesticide name        Number, fax
                                                        number, E-mail
                                                            Address
------------------------------------------------------------------------
EPA-HQ-OPP-2007-1118              Inorganic           Eric Miederhoff
                                   nitrates--nitrite  (703) 347-8028
                                   s                  (703) 308-7070
                                                      miederhoff.eric@ep
                                                       a.gov.
------------------------------------------------------------------------
EPA-HQ-OPP-2007-0705              Carbon and carbon   Carissa Cyran
                                   dioxide            (703) 347-8781
                                                      (703) 308-7070
                                                      cyran.carissa@epa.
                                                       gov
------------------------------------------------------------------------
EPA-HQ-OPP-2008-0176              Sulfur              Jose Gayoso
                                                      (703) 347-8652
                                                      (703) 308-7070
                                                      gayoso.jose@epa.go
                                                       v
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III. Registration Reviews

 A. What Action is the Agency Taking?

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide 
registrations for inorganic nitrates - nitrites, carbon and carbon 
dioxide, and sulfur to ensure they continue to satisfy the FIFRA 
standard for registration--that is, that inorganic nitrates - nitrites, 
carbon and carbon dioxide, and sulfur can still be used without 
unreasonable adverse effects on human health or the environment. 
Inorganic nitrates - nitrites, carbon and carbon dioxide are active 
ingredients and are mixed in some cases with sulfur, to create fumigant 
gas cartridges which release toxic fumes after ignition. These gas 
producing cartridges are placed in animal burrows to control small 
mammal pests. EPA has completed a comprehensive draft ecological risk 
assessment, including an endangered species assessment, for all 
inorganic nitrate - nitrite, carbon and carbon dioxide uses, as well as 
gas cartridge

[[Page 29536]]

uses of sulfur. All other uses of sulfur will be included in the 
upcoming ecological risk assessment for the registration review of 
sulfur, docket EPA-HQ-OPP-2008-0176. The risk assessment includes a 
species specific analysis and effects determination of the cartridges 
on 3 of 11 species found in the San Francisco Bay area that are listed 
as endangered or threatened under the Endangered Species Act (ESA). 
These species specific effects determinations were conducted in 
response to litigation brought against EPA by the Center for Biological 
Diversity in the United States District Court for the Northern District 
of California (Civ. No. 07-2794-JSC) where sodium nitrate and potassium 
nitrate were alleged to be of concern.
    Pursuant to 40 CFR 155.53(c), EPA is providing an opportunity, 
through this notice of availability, for interested parties to provide 
comments and input concerning the Agency's draft ecological risk 
assessment for inorganic nitrates - nitrites, carbon and carbon 
dioxide, and gas cartridge uses of sulfur. Such comments and input 
could address, among other things, the Agency's risk assessment 
methodologies and assumptions, as applied to this draft risk 
assessment. Interested parties may also provide suggestions for 
mitigation of the risk identified in the draft ecological risk 
assessment.
    Concurrent with this public comment opportunity, EPA is initiating 
informal consultation with the U.S. Fish and Wildlife Service for 
purposes of validating the list of potentially affected species, to 
identify the geographic areas in which each species may reside, and to 
assist EPA in determining how best to assemble information on the 
baseline status of each species. The ESA regulations provide for two 
types of consultation; formal and informal. Informal consultation is an 
optional process that includes discussions, correspondence, etc. 
between the Services and a Federal agency or a designated non-Federal 
representative (NFR) to determine whether a Federal action is likely to 
have an adverse effect on listed species or critical habitat. During 
informal consultation the Services may suggest modifications to the 
action that a Federal agency, permit applicant or non-Federal 
representative could implement to avoid likely adverse effects to 
listed species or critical habitat. If adverse effects are likely and 
those effects cannot be addressed through informal consultation, then 
formal consultation generally occurs. The Agency will consider all 
comments received during the public comment period and make changes, as 
appropriate, to the draft ecological risk assessment. EPA will then 
issue a revised risk assessment, explain any changes to the draft risk 
assessment, and respond to comments. EPA will also, at that time, 
initiate further consultation, as needed, when appropriate, with the 
U.S. Fish and Wildlife Service regarding potential risks to federally 
listed threatened or endangered species and their designated critical 
habitat. In the Federal Register notice announcing the availability of 
the revised risk assessment, if the revised risk assessment indicates 
risks of concern, the Agency may provide an additional comment period 
for the public to submit suggestions for mitigating the risk identified 
in the revised risk assessment before developing proposed registration 
review decisions on inorganic nitrates - nitrites, carbon and carbon 
dioxide, and sulfur.

B. Docket Content

    As described in detail in the Inorganic Nitrate-Nitrite Summary 
Document (see docket ID number EPA-HQ-OPP-2007-1118), Carbon and Carbon 
Dioxide Summary Document (see docket ID number EPA-HQ-OPP-2007-0705) 
the Agency believes that the human health risk assessments completed 
prior to registration review are adequate, and there are no human 
health risks that exceed the Agency's level of concern. Thus, no 
additional human health data are expected to be needed for the 
registration review of inorganic nitrates - nitrites, carbon and carbon 
dioxide. In the Sulfur Summary Document (see docket ID number EPA-HQ-
OPP-2008-0176) the Agency stated that revised occupational and 
residential exposure human health assessments for sulfur should be 
conducted in registration review. These human health assessments are 
still anticipated for all uses of sulfur, including the cartridge use, 
and will be included in the upcoming registration review risk 
assessment.
    1. Other related information. Additional information on inorganic 
nitrates - nitrites is available on the Pesticide Registration Review 
Status webpage for this pesticide, http://www.epa.gov/oppsrrd1/
registration_review/inorganic_nitrate/index.htm. Additional 
information on carbon and carbon dioxide is available on the Pesticide 
Registration Review Status webpage for this pesticide, http://
www.epa.gov/oppsrrd1/registration_review/carbon/index.htm. Additional 
information on sulfur is available on the Pesticide Registration Review 
Status webpage for this pesticide, http://www.epa.gov/oppsrrd1/
registration_review/sulfur/index.htm. Information on the Agency's 
registration review program and its implementing regulation is 
available at http://www.epa.gov/oppsrrd1/registration_review.
     2. Information submission requirements. Anyone may submit data or 
information in response to this document. To be considered during a 
pesticide's registration review, the submitted data or information must 
meet the following requirements:
     To ensure that EPA will consider data or information 
submitted, interested persons must submit the data or information 
during the comment period. The Agency may, at its discretion, consider 
data or information submitted at a later date.
     The data or information submitted must be presented in a 
legible and useable form. For example, an English translation must 
accompany any material that is not in English and a written transcript 
must accompany any information submitted as an audiographic or 
videographic record. Written material may be submitted in paper or 
electronic form.
     Submitters must clearly identify the source of any 
submitted data or information.
     Submitters may request the Agency to reconsider data or 
information that the Agency rejected in a previous review. However, 
submitters must explain why they believe the Agency should reconsider 
the data or information in the pesticide's registration review.
    As provided in 40 CFR 155.58, the registration review docket for 
each pesticide case will remain publicly accessible through the 
duration of the registration review process; that is, until all actions 
required in the final decision on the registration review case have 
been completed.

List of Subjects

    Environmental protection, Pesticides and pests, Inorganic nitrates-
-nitrites, Carbon and carbon dioxide, Sulfur.

    Dated: May 17, 2010.
 Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2010-12591 Filed 5-25-10; 8:45 am]
BILLING CODE 6560-50-S