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Registration Review; Neonicotinoid Risk Assessments; Neonicotinoid Benefits Assessments; Notice of Availability

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Environmental Protection Agency (EPA).




This notice announces the availability of EPA's (or Agency) draft ecological non-pollinator risk assessment for the registration review of imidacloprid, along with draft human health and non-pollinator ecological risk assessments for the registration review of clothianidin, thiamethoxam, and dinotefuran, and opens a public comment period on these assessments. This notice also announces the availability of assessments of benefits of neonicotinoid insecticide use in cotton and citrus. While EPA typically releases benefits assessments along with the proposed interim decisions, EPA is releasing and obtaining public comment on these two benefits assessments at an earlier stage of the registration review process. These benefits assessments will help EPA evaluate the impacts of potential measures to reduce certain risks to pollinators identified in previously issued preliminary pollinator risk assessments. EPA is not proposing any mitigation at this stage, and anticipates that early input and information from the public on the benefits of these compounds will be helpful as EPA evaluates and considers the risks and the benefits of the neonicotinoid insecticides. Finally, EPA is releasing a response to public comments on the Agency's 2014 assessment of the benefits of neonicotinoid seed treatments to soybean production. This assessment and associated comments are available in docket EPA-HQ-OPP-2014-0737. Copies of all of the benefits assessments will be placed in the individual chemical dockets for each of the four neonicotinoid insecticides listed in Table 1 of Unit III.


Comments must be received on or before February 20, 2018.


Submit your comments, identified by the docket identification (ID) number for the specific pesticide of interest provided in Table 1 of Unit III, 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: The Chemical Review Manager for the pesticide of interest identified in Table 1 of Unit III.

For general questions on the registration review program, contact: Dana Friedman, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Start Printed Page 60600Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (703) 308-8015; 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 identified in Table 1 of Unit III.

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 preparing and submitting your comments, see the commenting tips at​dockets/​comments.html.

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 the chemicals listed in Table 1 of Unit III 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) (7 U.S.C. 136a(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

As directed by FIFRA section 3(g), EPA is reviewing the pesticide registration for the pesticides listed in Table 1 to ensure that they continue to satisfy the FIFRA standard for registration.

Table 1—Assessments Being Made Available for Public Comment

Registration review case name and No.Docket ID No.Chemical review manager and contact information
Clothianidin, 7620EPA-HQ-OPP-2011-0865Thomas Harty,, 703-347-0338.
Dinotefuran, 7441EPA-HQ-OPP-2011-0920Steven Snyderman,, 703-347-0249.
Imidacloprid, 7605EPA-HQ-OPP-2008-0844Steven Snyderman,, 703-347-0249.
Thiamethoxam, 7614EPA-HQ-OPP-2011-0581Thomas Harty,, 703-347-0338.

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/or ecological risk assessments for the pesticides listed in the Table 1 in Unit III. This Notice is announcing the availability of the human health risk assessments and the ecological risk assessments for non-pollinator species for clothianidin, thiamethoxam and dinotefuran. Preliminary pollinator-only ecological risk assessments for these chemicals were previously issued in May 2017, and are available in the individual chemical dockets. For imidacloprid, this Notice is announcing the availability of the terrestrial non-pollinator ecological assessment. A preliminary pollinator-only risk assessment was issued in January 2016, an aquatic species-only ecological risk assessment was issued in January 2017, and a human health risk assessment was issued in September 2017. All of these assessments were previously made available for comment and are available in the imidacloprid docket.

1. Other related information. Additional information on the registration review status of the chemicals listed in Table 1, as well as information on the Agency's registration review program and on its implementing regulation is available at​pesticide-reevaluation.

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.Start Printed Page 60601
  • 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: November 30, 2017.

Charles Smith,

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

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[FR Doc. 2017-27520 Filed 12-20-17; 8:45 am]