Document ID: EPA-HQ-OPP-2006-0108-0031
Agency: epa
Document Type: Notice
Title: Registration Reviews; Draft Human Health and Ecological Risk Assessments: Cyromazine, Silica Silicates, Glufosinate Ammonium, Dioctyl Sodium Sulfosuccinate and Undecylenic Acid
Posted Date: 2013-03-07T05:00Z

[Federal Register Volume 78, Number 44 (Wednesday, March 6, 2013)]
[Notices]
[Pages 14540-14543]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05246]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2012-0907; FRL-9379-5]

Cyromazine, Silica Silicates (Silica Dioxide and Silica Gel), 
Glufosinate Ammonium, Dioctyl Sodium Sulfosuccinate (DSS) and 
Undecylenic Acid (UDA) Registration Review; Draft Human Health and 
Ecological Risk Assessments; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's draft human 
health and ecological risk assessments for the registration review of 
cyromazine, silica silicates (silica dioxide and silica gel), 
glufosinate ammonium, dioctyl sodium sulfosuccinate (DSS) and 
undecylenic acid (UDA) and opens a public comment period on these 
documents. Registration review is EPA's periodic review of pesticide 
registrations to ensure that each pesticide continues to satisfy the 
statutory standard for registration, that is, the pesticide can perform 
its intended function without unreasonable adverse effects on human 
health or the environment. As part of the registration review process, 
the Agency has completed draft risk assessments for each of the subject 
chemicals and is making them available for public comment. After 
reviewing comments received during the public comment period, EPA will 
issue a revised risk assessment, if appropriate, explain any changes to 
the draft risk assessment, and respond to comments and may request 
public input on risk mitigation. Through this program, EPA is ensuring 
that each pesticide's registration is based on current scientific and 
other knowledge, including its effects on human health and the 
environment.

DATES: Comments must be received on or before May 6, 2013.

ADDRESSES: Submit your comments, identified by the docket 
identification (ID) number for the specific pesticide of interest 
provided in the table in Unit III., by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments.

[[Page 14541]]

Do not submit electronically any information you consider to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For information about a particular 
pesticide included in this document, contact the Chemical Review 
Manager identified in the table in Unit III. for the pesticide of 
interest.
    For general questions on the registration review program, contact:
    Jane Scott-Smith, Pesticide Re-evaluation Division (7508P), Office 
of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(703) 308-0048; fax number: (703) 305-8005; email address: smith.jane-scott@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 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 Chemical Review Manager identified in the table in Unit 
III. for the pesticide of interest.

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 email. 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 and/or environmental effects from exposure to the 
pesticides discussed in this document, compared to the general 
population.

II. Authority

    EPA is conducting its registration review of the pesticides 
identified in this document 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.

III. Registration Reviews

What action is the agency taking?

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide 
registrations for cyromazine, silica silicates, glufosinate ammonium, 
DSS, and UDA to ensure that they continue to satisfy the FIFRA standard 
for registration--that is, that these pesticides can still be used 
without unreasonable adverse effects on human health or the 
environment.
    At this stage in the registration review process, consistent with 
the notice published in the Federal Register of August 17, 2012, (77 FR 
49792) (FRL-9356-5), jointly developed with the U.S. Department of 
Agriculture (USDA), the National Marine Fisheries Service (NMFS) and 
the U.S. Fish and Wildlife Service (USFWS) (``the Services'') to 
enhance opportunities for stakeholder input during pesticide 
registration reviews and endangered species consultations, draft 
environmental risk assessments include a screening-level evaluation of 
the potential risks to Federally endangered and threatened species 
(hereafter referred to as ``listed species''). EPA intends to complete 
a refined assessment of potential risks to individual listed species, 
as needed. The refined listed species assessments will be based on the 
recommendations of the National Research Council (NRC), which has been 
tasked with providing advice on ecological risk assessment tools and 
scientific approaches in developing listed species risk assessments 
that are compliant with both FIFRA and the Endangered Species Act 
(ESA). EPA anticipates that the NRC report, expected in spring 2013, 
will provide recommendations to ensure scientific soundness and 
maximize the utility of risk assessment refinements for listed species. 
Additional information can be found at the following Web site:

[[Page 14542]]

http://www.nationalacademies.org/cp/projectview.aspx?key=49396. Useful 
refinements to the listed species assessments are expected to include, 
but not be limited to, the following: (1) More detailed, species-
specific ecological and biological data; (2) more detailed and accurate 
information on chemical use patterns; and (3) sub-county level spatial 
proximity data depicting the co-occurrence of potential effects and 
listed species and any designated critical habitat.
    If, in the event that a draft risk assessment shows risks of 
concern to human health or the environment for a specific chemical, EPA 
reserves the right to initiate mitigation at this stage of registration 
review. This effort to mitigate a chemical's risks early in the 
registration review process is consistent with the Agency's approach 
for registration review. Where risks are identified early in the 
registration review process and opportunities for early mitigation 
exist, the Agency may pursue those opportunities as they arise, rather 
then waiting for completion of a chemical's registration review in 
order to mitigate risks. The public comment period for the draft risk 
assessments allows members of the public to provide comments and 
suggestions for revising the draft risk assessments and for reducing 
risks.
    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 human health and 
ecological risk assessments for cyromazine, silica silicates, 
glufosinate ammonium, DSS, and UDA. Such comments and input could 
address, among other things, the Agency's risk assessment methodologies 
and assumptions, as applied in these draft risk assessments.
    The Agency will consider all comments received during the public 
comment period and make changes, as appropriate, to the draft human 
health and ecological risk assessments. EPA will then issue revised 
risk assessments, if appropriate, and explain any changes to the draft 
risk assessments, and respond to comments. In the Federal Register 
notice announcing the availability of the revised risk assessments, if 
any of the revised risk assessments indicate risks of concern, the 
Agency may provide a comment period for the public to submit 
suggestions for mitigating the risks identified in those revised risk 
assessments. At present, EPA is releasing registration review draft 
risk assessments for the pesticide cases identified in the following 
table and further described after the table.

                                Table--Registration Review Draft Risk Assessments
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  Registration review case name and                              Chemical review manager, telephone number, and
               number                 Pesticide docket ID No.                    Email address
----------------------------------------------------------------------------------------------------------------
Cyromazine, Case  7439.....  EPA-HQ-OPP-2006-0108...  Kelly Ballard,
                                                               (703) 305-8126,
                                                               Ballard.kelly@epa.gov.
Dioctyl sodium sulfosuccinate,        EPA-HQ-OPP-2010-1006...  Garland Waleko,
 Case 4029.                                           (703) 308-8049,
                                                               Waleko.garland@epa.gov.
Glufosinate Ammonium,...............  EPA-HQ-OPP-2008-0190...  Katie Weyrauch,
Case 7224..................                           (703) 308-0166,
                                                               Weyrauch.katie@epa.gov.
Silica Silicates, Case 4081  EPA-HQ-OPP-2007-1140...  Laura Parsons,
                                                               (703) 305-5776,
                                                               Parsons.laura@epa.gov.
Undecylenic acid, Case 4095  EPA-HQ-OPP-2011-0910...  Garland Waleko,
                                                               (703) 308-8049,
                                                               Waleko.garland@epa.gov.
----------------------------------------------------------------------------------------------------------------

Cyromazine

    The registration review docket for cyromazine (EPA-HQ-OPP-2006-
0108) opened in a notice published in the Federal Register of March 28, 
2007 (72 FR 14548) (FRL-8118-3). Cyromazine, an insecticide/larvicide, 
is a member of the triazine class of chemicals registered for use on a 
variety of agricultural food crop as well as non-food uses such as 
landscape and greenhouse ornamentals. For cyromazine, the Agency has 
conducted a human health risk assessment for both dietary (food and 
drinking water) and occupational exposure pathways. The Agency has also 
conducted an ecological risk assessment, which includes a screening-
level listed species assessment. EPA acknowledges that further 
refinements to the listed species assessment will be completed in 
future revisions and requests public comment on specific areas that 
will reduce the uncertainties associated with the characterization of 
risk to listed species identified in the current assessment.

Dioctyl Sodium Sulfosuccinate (DSS)

    The registration review docket for DSS (EPA-HQ-OPP-2010-1006) 
opened in a notice published in the Federal Register of December 22, 
2010 (75 FR 80496) (FRL-8857-6). DSS is registered as an insecticide in 
pet shampoos and spray products in combination with undecylenic acid. 
There are no food uses and, thus, no tolerances are established. DSS is 
also used as an inert ingredient in several end-use pesticide products, 
disinfectants and sanitizers, and as a wetting agent in industrial, 
drug, cosmetic, and food products. The Agency has conducted a 
qualitative assessment of both human health and ecological risks, 
including listed species for DSS.

Glufosinate Ammonium

    The registration review docket for glufosinate ammonium (EPA-HQ-
OPP-2008-0190) opened in a notice published in the Federal Register of 
March 26, 2008 (73 FR 16011) (FRL-8356-4). Glufosinate ammonium is an 
herbicide that acts by inhibiting glutamine synthetase, which leads to 
poisoning in plants via the overproduction of ammonia. Glufosinate 
ammonium is registered for use on a variety of food crops, and is 
registered for use on non-crop areas such as golf course turf and spot 
treatments on residential lawns. To support the registration review of 
glufosinate ammonium, the Agency has conducted a human health risk 
assessment via a new use risk assessment for citrus,

[[Page 14543]]

pome, and stone fruits completed July 25, 2012, and an addendum 
completed on January 24, 2013, that addresses other scenarios not 
covered in the July 25, 2012 new use assessment. The Agency has also 
conducted an ecological risk assessment, which includes a screening-
level listed species assessment. EPA acknowledges that further 
refinements to the listed species assessment will be completed in 
future revisions and requests public comment on specific areas that 
will reduce the uncertainties associated with the characterization of 
risk to listed species identified in the current assessment.

Silica Silicates

    The registration review docket for silica silicates (EPA-HQ-OPP-
2007-1140) opened in a notice published in the Federal Register of 
March 26, 2008 (73 FR 16011) (FRL-8356-4). Silica silicates, silicon 
dioxide and silica gel, are insecticides and acaracides used in 
controlling insects at indoor and outdoor sites including a variety of 
crops. Silicon dioxide is diatomaceous earth, a naturally-occurring 
material composed of the shells of minute, single-celled algae. Silica 
gel is an amorphous form of silicon dioxide. Because of their abrasive 
characteristics, both active ingredients affect insects by removing the 
oily protective film covering their bodies which normally prevents the 
loss of water, leading to death by desiccation. The qualitative human 
health risk assessment conducted for the 1991 reregistration 
eligibility decision (RED) is still considered to be an adequate 
analysis of potential risks to humans. No new human health toxicology 
or exposure data were required or are available for silica silicates; 
therefore, a new human health risk assessment was not necessary to be 
completed for registration review nor is one being made available for 
comment at this time. Further, due to low toxicity, and the fact that 
silica silicates naturally occur in the environment, the Agency has 
conducted a qualitative ecological risk assessment for non-target 
terrestrial species. EPA acknowledges that further refinements to the 
listed species assessment will be completed in future revisions and 
requests public comment on specific areas that will reduce the 
uncertainties associated with the characterization of risk to listed 
species identified in the current assessment.

Undecylenic Acid (UDA)

    The registration review docket for UDA (EPA-HQ-OPP-2011-0910) 
opened in a notice published in the Federal Register of December 21, 
2011 (76 FR 79173) (FRL-9329-7). UDA is registered as an insecticide in 
pet shampoos and spray products in combination with dioctyl sodium 
sulfosuccinate (DSS). There are no food uses and, thus, no tolerances 
are established. UDA is approved by the U.S. Food and Drug 
Administration (FDA) as an active ingredient in over the counter anti-
fungal products, and it is also used as a flavoring agent. EPA has 
conducted a qualitative assessment for both human health and ecological 
risks, including listed species for UDA.
    1. Other related information. Additional information on cyromazine, 
silica silicates, glufosinate ammonium, DSS, and UDA is available on 
the chemical pages for these pesticides in Chemical Search, http://www.epa.gov/pesticides/chemicalsearch/, and in each chemical's 
individual docket listed in Table in Unit III. 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, cyromazine, silica 
silicates (silica dioxide and silica gel), glufosinate ammonium 
(glufosinate), dioctyl sodium sulfosuccinate (DSS), and undecylenic 
acid (UDA), draft risk assessments.

    Dated: Feburary 26, 2013.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2013-05246 Filed 3-5-13; 8:45 am]
BILLING CODE 6560-50-P