Document ID: EPA-HQ-OPP-2007-1089-0029
Agency: epa
Document Type: Notice
Title: Draft Human Health and Ecological Risk Assessments; Availability: Pesticide Chemicals; Registration Review
Posted Date: 2013-03-20T04:00Z

[Federal Register Volume 78, Number 54 (Wednesday, March 20, 2013)]
[Notices]
[Pages 17201-17204]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06406]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2013-0152; FRL-9381-3]

Pesticide Chemicals; 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 
ancymidol, fosthiazate, lactofen, polybutene resins, quizalofop, and 
soap salts 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

[[Page 17202]]

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 20, 2013.

ADDRESSES: Submit your comments, identified by the docket 
identification (ID) number for the specific pesticide of interest 
provided in Table 1. in Unit III.A., by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. 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 Table 1. in Unit III.A. for the pesticide of 
interest.
    For general questions on the registration review program, contact: 
Jane Robbins, 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: robbins.jane@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 Table 1. in Unit 
III.A. 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

 A. What action is the Agency taking?

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide 
registrations for ancymidol, fosthiazate, lactofen, polybutene resins, 
quizalofop, and soap salts 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 proposed notice, published in the Federal Register issue of August 
17, 2012 (77 FR 49792) (FRL-9356-5), jointly developed with the U.S. 
Department of Agriculture, the National Marine Fisheries Service, and 
the U.S. Fish and Wildlife Service (``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 listed endangered and threatened species (hereafter 
referred to as ``listed species''). EPA intends to complete a refined 
assessment of potential risks to individual listed

[[Page 17203]]

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: http://www8.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:
     More detailed, species-specific ecological and biological 
data.
     More detailed and accurate information on chemical use 
patterns.
     Sub-county level spatial proximity data depicting the co-
occurrence of potential effects areas and listed species and any 
designated critical habitat.
    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 ancymidol, fosthiazate, lactofen, 
polybutene resins, quizalofop, and soap salts. 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 in this unit.

           Table 1--Registration Review Draft Risk Assessments
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                                                      Chemical review
 Registration review case name   Pesticide docket    manager, telephone
            and No.               identification       No., and email
                                       No.                address
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Ancymidol, Case No. 3017......  EPA-HQ-OPP-2011-0  Christina Scheltema,
                                 482.               (703) 308-2201,
                                                    scheltema.christina@epa.gov.
Fosthiazate, Case No. 7604....  EPA-HQ-OPP-2009-0  Khue Nguyen, (703)
                                 267.               347-0248,
                                                    nguyen.khue@epa.gov.
Lactofen, Case No. 7210.......  EPA-HQ-OPP-2005-0  Kelly Ballard, (703)
                                 287.               305-8126,
                                                    ballard.kelly@epa.gov.
Polybutene resins, Case No.     EPA-HQ-OPP-2009-0  Joel Wolf, (703) 347-
 4076.                           649.               0228,
                                                    wolf.joel@epa.gov.
Quizalofop, Case No. 7215.....  EPA-HQ-OPP-2007-1  Khue Nguyen, (703)
                                 089.               347-0248,
                                                    nguyen.khue@epa.gov.
Soap salts, Case No. 4083.....  EPA-HQ-OPP-2008-0  Monica Wait, (703)
                                 519.               347-8019,
                                                    wait.monica@epa.gov.
------------------------------------------------------------------------

     Ancymidol. The registration review docket for ancymidol 
(EPA-HQ-OPP-2011-0482) opened in the Federal Register issue of June 29, 
2011 (76 FR 38166) (FRL-8877-4). Ancymidol is a plant growth regulator 
that acts by inhibiting giberillin biosynthesis, resulting in plants 
with more compact growth. Ancymidol is registered for use only on 
container grown greenhouse and nursery ornamentals. It is used only on 
plants grown for commercial production and has no food, feed, or 
residential uses. The Final Work Plan for ancymidol described numerous 
data requirements for registration review, and a registration review 
timeline that included the issuance of a data call-in. However, EPA has 
revisited the timeline and data requirements for registration review 
and determined that a data call-in is not necessary for ancymidol. The 
Agency has conducted qualitative environmental and human health risk 
assessments for ancymidol based on the available information and on 
limited use of this pesticide active ingredient.
     Fosthiazate. The registration review docket for 
fosthiazate (EPA-HQ-OPP-2009-0267) opened in the Federal Register issue 
of June 24, 2009 (74 FR 30077) (FRL-8422-4). Fosthiazate is an 
organophosphate nematicide and insecticide that is currently registered 
for use on tomatoes. 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 a quantitative 
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.
     Lactofen. The registration review docket for lactofen 
(EPA-HQ-OPP-2005-0287) opened in the Federal Register issue of February 
2, 2007 (72 FR 5050) (FRL-8113-1). Lactofen is a light dependent 
peroxidizing herbicide (LDPH), and is registered for use on conifer 
seedlings, cotton, kenaf, peanuts, and soybean, with local 
registrations on fruiting vegetables, okra, snap beans, and 
strawberries. For lactofen, the Agency has conducted an occupational 
handler exposure risk assessment for the application of lactofen on 
conifer seedlings, snap beans, soybeans, and strawberries. 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

[[Page 17204]]

on specific areas that will reduce the uncertainties associated with 
the characterization of risk to listed species identified in the 
current assessment.
     Polybutene resins. The registration review docket for 
polybutene resins (EPA-HQ-OPP-2009-0649) opened in the Federal Register 
issue of June 23, 2010 (75 FR 35810) (FRL-8832-3). Polybutene is a 
sticky polymer registered for use as a bird and small mammal repellent. 
It is used to prevent house sparrows, pigeons, and starlings from 
roosting inside and outside of buildings, as well as to prevent beavers 
from attacking trees and shrubs. There are no food/feed uses and, it is 
exempt from a tolerance requirement when used as a sticker agent in 
packaging of insect control products used on food crops. Polybutene is 
approved by the Food and Drug Administration (FDA) as an indirect food 
additive and is used as an ingredient in cosmetic products that are 
applied directly to the skin such as sun block or moisturizer, and that 
may be incidentally ingested, such as lipstick. EPA has conducted a 
qualitative assessment for both human health and environmental fate and 
ecological risks.
     Quizalofop. The registration review docket for 
quizalofop ethyl and quizalofop-p-ethyl (EPA-HQ-OPP-2007-1089) opened 
in the Federal Register issue of December 19, 2007 (72 FR 71893) (FRL-
8342-9). Quizalofop ethyl is a 50/50 racemic mixture of R-and S-
enantiomers; quizalofop-p-ethyl is the purified R-enantiomer which is 
pesticidally active. Quizalofop-p-ethyl is registered for use to 
control weeds in food crops (including barley, beans, lentil, peas, 
sorghum, soybean, and sugar beets), non-food crops grown for seed 
(including alfalfa, carrots, garlic, onion, radish, and spinach), and 
non-cropland (including rights-of-way and fencerows). Quizalofop-p-
ethyl is not registered for residential use. The Agency has conducted a 
human health assessment for both dietary (food and drinking water) and 
occupational exposure pathways. The Agency has conducted a quantitative 
ecological risk assessment, including a listed species assessment, for 
quizalofop. EPA acknowledges that further refinements to the listed 
species assessment may 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.
     Soap salts. The registration review docket for soap salts 
(EPA-HQ-OPP-2008-0519) opened in the Federal Register issue of 
September 15, 2008 (73 FR 53244) (FRL-8381-3). The case consists of 
three active ingredients, the ammonium, potassium, and sodium salts of 
fatty acids, which are registered for use as acaricides, algaecides, 
herbicides, and insecticides on food and non-food crops in various 
settings, chiefly residential and agricultural. Ammonium and sodium 
soap salts are also used as animal repellents. Because the Agency has 
not identified any toxicological endpoints for human health risk 
assessment and because current product labels are adequate to protect 
for potential eye and skin irritation, a qualitative human health risk 
assessment was conducted for soap salts. The Agency has conducted a 
quantitative 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.

    1. Other related information. Additional information on 
ancymidol, fosthiazate, lactofen, polybutene resins, quizalofop, and 
soap salts 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 1. in Unit 
III.A. 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, Ancymidol, Fosthiazate, Lactofen, 
Pesticides and pests, Polybutene resins, Quizalofop, Soap salts.

    Dated: March 12, 2013.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2013-06406 Filed 3-19-13; 8:45 am]
BILLING CODE 6560-50-P