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Pesticide Chemicals; Registration Review; Draft Human Health and Ecological Risk Assessment; 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 2-EEEBC (debacarb) and isoxaben, 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 human health and ecological risk assessments, including an endangered species assessment, for all uses of the previously listed pesticide chemicals. After reviewing comments received during the public comment period, EPA will issue revised risk assessments, explain any changes to the draft risk assessments, and respond to comments and may request public input on risk mitigation before completing proposed registration review decisions for the previously listed pesticide chemicals. 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 November 24, 2014.


Submit your comments, identified by 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.html. 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 contact: Chemical Review Manager identified in the table in Unit III.A. for the pesticide of interest.

For general questions on the registration review program, 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) 305-8015; 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 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 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.

II. Authority

EPA is conducting its registration review of 2-EEEBC (debacarb), acephate, allethrins, chlorethoxyfos, coumaphos, daminozide, dimethoate, isoxaben, picaridin, and propoxur 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 Start Printed Page 57081perform 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 2-EEEBC (debacarb) and isoxaben, 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.

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 2-EEEBC (debacarb) and isoxaben. Such comments and input could address, among other things, the Agency's risk assessment methodologies and assumptions, as applied to 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, 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 the revised risk assessments indicate 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 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 1—Registration Review Draft Risk Assessments

Registration review case name and No.Pesticide docket ID No.Chemical review manager, telephone No., and email address
2-EEEBC (Debacarb) (Case 4031)EPA-HQ-OPP-2008-0802Roy Johnson (703) 347-0492,
Isoxaben (Case 7219)EPA-HQ-OPP-2007-1038Christina Scheltema, (703) 308-2201,

1. 2-EEEBC (debacarb). Debacarb is a fungicide registered for use to control certain diseases in ornamental trees. The fungicide is applied to mature trees by injection through the trunk. EPA has completed a draft ecological risk assessment, including a screening-level listed species assessment. A human health risk assessment is not needed because the method of application limits the possibility for applicator or other human exposure. EPA acknowledges that further refinements to the listed species assessment will be completed in future revisions and requests public comment on any aspect of the ecological risk assessment, particularly any information on the disposition of the fungicide within the plant after application, the extent of use of the registered products, or any data available on adverse effects to potentially exposed non-target species.

2. Isoxaben. Isoxaben is a broad spectrum pre-emergent herbicide used to control broadleaf weeds, grasses, and vines. Isoxaben is used around non-bearing food crops, ornamental trees, and shrubs in agriculture nurseries, rights-of-way, and urban areas. It is also used on bearing nut trees and grape vineyards. EPA has completed draft human health and ecological risk assessments, including a screening-level listed species assessment, for all isoxaben uses. 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.

3. Other related information. Additional information on chemicals 2-EEEBC (debacarb) and isoxaben, is available for each pesticide, at​pesticides/​chemicalsearch and in each chemical's individual docket listed in the table in Unit III.A. Information on the Agency's registration review program and its implementing regulation is available at​pesticide-reevaluation.

4. 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.

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Authority: 7 U.S.C. 136 et seq.

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Dated: September 12, 2014.

Richard P. Keigwin, Jr.,

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

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[FR Doc. 2014-22584 Filed 9-23-14; 8:45 am]