Document ID: EPA-HQ-OPP-2009-0483-0027
Agency: epa
Document Type: Notice
Title: Draft Human Health and Ecological Risk Assessments; Availability: Clethodim, Hydrogen Cyanamide, Flutolanil, Fosetyl-Aluminum, Hexaflumuron, and Piperalin Registration Review
Posted Date: 2014-03-31T04:00Z

[Federal Register Volume 79, Number 60 (Friday, March 28, 2014)]
[Notices]
[Pages 17536-17538]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07096]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0216; FRL-9908-11]

Clethodim, Hydrogen Cyanamide, Flutolanil, Fosetyl-Aluminum, 
Hexaflumuron, and Piperalin 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 
clethodim, hydrogen cyanamide, flutolanil, fosetyl-aluminum, 
hexaflumuron, and piperalin, 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, 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 28, 2014.

ADDRESSES: Submit your comments, identified by the docket 
identification (ID) number for the specific pesticide of interest 
provided in the table 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 pesticide-specific information 
see: The Chemical Review Manager identified in the table in Unit III.A. 
for the pesticide of interest.
    For general information contact: Richard Dumas, Pesticide Re-
Evaluation Division (7508P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8015; fax 
number: (703) 308-8005; email address: dumas.richard@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 listed in the table 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 or environmental effects from exposure to the pesticides 
discussed in this document, compared to the general population.

[[Page 17537]]

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 
registration for clethodim, hydrogen cyanamide, flutolanil, fosetyl-
aluminum, hexaflumuron, and piperalin to ensure that they continues 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.
    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 clethodim, hydrogen cyanamide, 
flutolanil, fosetyl-aluminum, hexaflumuron, and piperalin. Such 
comments and input could address, among other things, the Agency's risk 
assessment methodologies and assumptions, as applied to the 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 a revised 
risk assessment, explain any changes to the draft risk assessment, and 
respond to comments. 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 a comment 
period for the public to submit suggestions for mitigating the risk 
identified in the revised risk assessment before developing a proposed 
registration review decision. At present, EPA is releasing registration 
review draft risk assessments for the pesticide cases identified in the 
following table and further described below.

                               Table 1--Registration Review Draft Risk Assessments
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                                                                                    Chemical review manager,
  Registration review case name and            Pesticide docket ID No.            telephone number, and e-mail
                 No.                                                                         address
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Clethodim, Case  7226......  EPA-HQ-OPP-2008-0658....................  Ricardo Jones; (703) 347-0493;
                                                                                 jones.ricardo@epa.gov.
Hydrogen cyanamide, Case     EPA-HQ-OPP-2007-1014....................  Dana Friedman; (703) 347-8827;
 7005.                                                                           friedman.dana@epa.gov.
Flutolanil, Case  7010.....  EPA-HQ-OPP-2008-0148....................  Garland Waleko; (703) 308-8049;
                                                                                 waleko.garland@epa.gov.
Fosetyl-aluminum, Case       EPA-HQ-OPP-2007-0379....................  Kelly Ballard; (703) 305-8126;
 4095.                                                                           ballard.kelly@epa.gov.
Hexaflumuron, Case  7413...  EPA-HQ-OPP-2009-0568....................  Ricardo Jones; (703) 347-0493;
                                                                                 jones.ricardo@epa.gov.
Piperalin, Case  3114......  EPA-HQ-OPP-2009-0483....................  Matthew Manupella; 703-347-0411;
                                                                                 manupella.matthew@epa.gov.
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    1. Clethodim. Clethodim is a selective post-emergence 
cyclohexanedione herbicide used to control annual and perennial grasses 
in a wide variety of broad leaf crops including soybeans, cotton, 
peanuts, dry beans, peas, potatoes and alfalfa among many others. Non-
food uses include sod farms, conifer trees, non-crop areas, and 
greenhouse/outdoor ornamentals. Tolerances have been established for 
clethodim in and on various raw agricultural commodities. EPA has 
completed a comprehensive draft human health and ecological risk 
assessment including an endangered species assessment, for all 
clethodim uses.
    2. Hydrogen cyanamide. Hydrogen cyanamide is a plant growth 
regulator used primarily on orchard crops to produce a more uniform bud 
break. EPA has completed a comprehensive draft human health and 
ecological risk assessment including an endangered species assessment, 
for all hydrogen cyanamide uses.
    3. Flutolanil. Flutolanil is a systemic benzanilide fungicide used 
to prevent and control powdery scab, Spogospora subterranean, 
Rhizoctonia solani (the causal agent of limb/pod rot in peanuts), 
sheath blight in rice, black scurf in potato, wirestem in Brassica 
(Cole) leafy vegetables and turnip greens, and black scurf, Rhizoctonia 
solani, and crown rot in ginseng. Flutolanil is also effective in 
controlling white mold in peanuts and rust diseases in several crops. 
Flutolanil is currently registered for application to Brassica (Cole) 
leafy vegetables, peanuts, potatoes, rice, and turnip greens, and as a 
seed treatment for soybean and cotton. Tolerances have been established 
for these commodities as well as tolerances for inadvertent residues 
for wheat commodities as rotational crops and tolerances for ruminant 
commodities. Non-food uses of flutolanil include turf, and greenhouse, 
nursery, and potted ornamentals. EPA has completed a comprehensive 
draft human health and ecological risk assessment including an 
endangered species assessment, for all flutolanil uses.
    4. Fosetyl-aluminum. Fosetyl-aluminum is a systemic fungicide used 
to control fungal pathogens on plants, and is registered for use on a 
wide range of agricultural crops. Fosetyl-aluminum is also registered 
for ornamental plants and turf. EPA has completed a comprehensive draft 
human health and ecological risk assessment including an endangered 
species assessment, for all fosetyl-aluminum uses.
    5. Hexaflumuron. Hexaflumuron is a benzoyl-phenylurea termiticide 
registered for use to control termites in above- and below-ground 
termite bait station systems. Treatment sites may include interior and 
exterior surfaces of buildings and crawl spaces, fences, utility poles, 
decking, landscape decorations, trees, and other features which could 
be damaged by termite foraging and feeding activity including in 
residential structures. The Agency has conducted a qualitative 
assessment of human health risks, and a comprehensive assessment of 
ecological risk including listed species for hexaflumuron.
    6. Piperalin. Piperalin is a fungicide used to control powdery 
mildew on ornamental plants, shrubs, vines, and trees grown in 
commercial greenhouses and other similar enclosed structures. There are 
no registered outdoor uses for piperalin. EPA has completed a 
qualitative draft human health and ecological risk assessment including 
an

[[Page 17538]]

endangered species assessment, for piperalin.

B. Additional Information

    1. Other related information. Additional information on clethodim, 
hydrogen cyanamide, flutolanil, fosetyl-aluminum, hexaflumuron, and 
piperalin 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, Clethodim, Flutolanil, Fosetyl-aluminum, 
Hexaflumuron, Hydrogen cyanamide, Pesticides and pests, Piperalin.

    Dated: March 24, 2014.
Michael Goodis,
Acting Director, Pesticide Re-Evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2014-07096 Filed 3-26-14; 4:15 pm]
BILLING CODE 6560-50-P