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Clethodim, Hydrogen Cyanamide, Flutolanil, Fosetyl-Aluminum, Hexaflumuron, and Piperalin Registration Review; Draft Human Health and Ecological Risk Assessments; Notice of Availability

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Environmental Protection Agency (EPA).




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.


Comments must be received on or before May 28, 2014.


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: 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​dockets/​contacts.htm.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at​dockets.

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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:

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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 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.Start Printed 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

Registration review case name and No.Pesticide docket ID No.Chemical review manager, telephone number, and e-mail address
Clethodim, Case # 7226EPA-HQ-OPP-2008-0658Ricardo Jones; (703) 347-0493;
Hydrogen cyanamide, Case # 7005EPA-HQ-OPP-2007-1014Dana Friedman; (703) 347-8827;
Flutolanil, Case # 7010EPA-HQ-OPP-2008-0148Garland Waleko; (703) 308-8049;
Fosetyl-aluminum, Case # 4095EPA-HQ-OPP-2007-0379Kelly Ballard; (703) 305-8126;
Hexaflumuron, Case # 7413EPA-HQ-OPP-2009-0568Ricardo Jones; (703) 347-0493;
Piperalin, Case # 3114EPA-HQ-OPP-2009-0483Matthew Manupella; 703-347-0411;

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 Start Printed Page 17538endangered 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,​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​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.

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Dated: March 24, 2014.

Michael Goodis,

Acting Director, Pesticide Re-Evaluation Division, Office of Pesticide Programs.

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[FR Doc. 2014-07096 Filed 3-26-14; 4:15 pm]