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Registration Review Proposed Interim Decisions; Notice of Availability

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Environmental Protection Agency (EPA).




This notice announces the availability of EPA's proposed interim registration review decisions on certain pesticides and opens a public comment period on the proposed interim decisions. 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, that the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. 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.March 25, 2015


Comments must be received on or before May 26, 2015.


Submit your comments, identified by the docket identification (ID) number for the specific pesticide of interest provided in the table in Unit II., 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 the table in Unit II.

For general information 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) 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. Start Printed Page 15786Since 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 for the pesticide of interest identified in the table in Unit II.

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.

II. What action is the Agency taking?

Pursuant to 40 CFR 155.58, this notice announces the availability of EPA's proposed interim registration review decisions for the pesticides shown in the following table, and opens a 60-day public comment period on the proposed interim decisions.

Table—Registration Review Proposed Interim Decisions

Registration review case name and No.Pesticide Docket ID No.Chemical review manager, telephone No., email address
Debacarb (2-EEEBC) (Case 4031)EPA-HQ-OPP-2008-0802Roy Johnson, 703-347-0492,
Maleic Hydrazide (Case 0381)EPA-HQ-OPP-2009-0387Ricardo Jones, 703-347-0493,
Soap Salts (Case 4083)EPA-HQ-OPP-2008-0519Eric Miederhoff, 703-347-8028

Debacarb (2-EEEBC) (Proposed Interim Decision). 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. Direct adverse effects are not expected for birds, reptiles, terrestrial-phase amphibians, mammals, and terrestrial plants. The Agency has made a No Effects (NE) determination for all federally-listed species within these groups and a No Habitat Modification determination for all designated critical habitats associated with these species for the currently registered uses of debacarb. Risks currently cannot be precluded for aquatic receptors and terrestrial invertebrates. At this time, to eliminate uncertainty and reduce potential risks to non-listed aquatic species, the Agency is proposing restrictions on application to trees near waterbodies. To reduce uncertainty and potential risks to insect pollinators, the Agency is proposing that applications to trees be limited to the post-bloom period. This proposed interim decision does not cover the Endocrine Disruptor Screening program (EDSP) component of this registration review case, nor does it provide a complete Endangered Species assessment (ESA) for debacarb. However, pending the outcome of this action, the EPA is planning to issue an interim registration review decision for debacarb.

Maleic Hydrazide (Proposed Interim Decision). The registration review docket for maleic hydrazide (EPA-HQ-OPP-2009-0387) opened in September 2009. Maleic hydrazide is a systemic plant growth regulator registered for use on tobacco, potato, onions, non-bearing citrus, turf, utility and highway rights-of-way, airports, industrial land, lawns, recreational areas, ornamental/shade trees and ornamental plants. Uses include residential use on turf and lawns as a perimeter or spot treatment. EPA published draft human health and ecological risk assessments in July 2014. No human health risks of concern were identified. The Agency also completed an ecological risk assessment. The results of this quantitative risk assessment indicates that the currently labeled rates of maleic hydrazide pose a potential for risk to non-target terrestrial birds and terrestrial invertebrates. In addition, applications may impact sensitive species of semi-aquatic and terrestrial monocotyledonous plants (monocots). The Agency completed a screening-level ESA and made a “no effects” determination for the following taxa: Aquatic plants and aquatic freshwater and estuarine/marine organisms. For all other species applications “may affect” or are uncertain. Maleic hydrazide has not been evaluated under the EDSP nor has it completed ESA section 7 consultation with the U.S. Fish and Wildlife Service and the National Marine and Fisheries Service (Services). Therefore, the Agency's final registration review decision is dependent upon the result of the evaluation of potential endocrine disruptor risk and consultation with the Services for endangered species. Pending the outcome of this action, the EPA is planning to issue an interim registration review decision for maleic hydrazide.

Soap Salts (Proposed Interim Decision). The registration review docket for soap salts (EPA-HQ-OPP-2008-0519) opened in September 2008. Soap Salts are used as acaricides, 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 repellants. EPA published draft human health and ecological risk assessments in March 2013. EPA conducted a human health risk assessment and did not identify any risks of concern. No human health mitigation is being proposed by the Agency for the soap salts at this time. The Agency also conducted an ecological risk assessment for the current uses of the soap salts. The screening-level risk assessment did find the potential for minor risk to terrestrial plants and aquatic organisms from the use of potassium and ammonium salts. However, the Agency believes there is little actual risk to non-target plants exposed to soap salts due to the rapid degradation of soap salts in surface water runoff, which was not accounted for in the risk assessment model, and the inherent insolubility and low toxicity of the soap salts. Therefore, the Agency has no risk concerns from the terrestrial or aquatic assessments and is Start Printed Page 15787not proposing ecological risk mitigation at this time. The Agency also completed a screening-level endangered and threatened (listed) species assessment for soap salts and identified potential risks to several taxa: Freshwater invertebrates, estuarine/marine invertebrates, and terrestrial plants. However, at this time in registration review, it is premature to make an endangered species effects determination for federally listed species and their designated critical habitats under ESA. Also, the soap salts have not yet been evaluated under the EDSP. Therefore, the Agency's final registration review decision is dependent upon the results of the evaluation of risks to threatened and endangered species and of potential endocrine disruptor risk. Pending the outcome of this action, the EPA is planning to issue an interim registration review decision for the soap salts.

The registration review docket for a pesticide includes earlier documents related to the registration review of the case. For example, the review opened with a Summary Document, containing a Preliminary Work Plan, for public comment. A Final Work Plan was placed in the docket following public comment on the initial docket. The documents in the docket describe EPA's rationales for conducting additional risk assessments, as well as the Agency's subsequent risk findings and consideration of possible risk mitigation measures. A proposed interim registration review decision is supported by the rationales included in those documents. Following public comment on a proposed decision, the Agency will issue interim registration review decisions for products containing the pesticides listed in the table in Unit II.

The registration review program is being conducted under congressionally mandated time frames, and EPA recognizes the need both to make timely decisions and to involve the public. Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136a(g)) required EPA to establish by regulation procedures for reviewing pesticide registrations, originally with a goal of reviewing each pesticide's registration every 15 years to ensure that a pesticide continues to meet the FIFRA standard for registration. The Agency's final rule to implement this program was issued in August 2006 and became effective in October 2006, and appears at 40 CFR part 155, subpart C. The Pesticide Registration Improvement Act of 2003 (PRIA) was amended and extended in September 2007. FIFRA, as amended by PRIA in 2007, requires EPA to complete registration review decisions by October 1, 2022, for all pesticides registered as of October 1, 2007.

The registration review final rule at 40 CFR 155.58(a) provides for a minimum 60-day public comment period on all proposed interim registration review decisions. This comment period is intended to provide an opportunity for public input and a mechanism for initiating any necessary amendments to the proposed interim decision. All comments should be submitted using the methods in ADDRESSES, and must be received by EPA on or before the closing date. These comments will become part of the docket for the pesticides included in the table in Unit II. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.

The Agency will carefully consider all comments received by the closing date and will provide a “Response to Comments Memorandum” in the docket as appropriate. The final registration review decision will explain the effect that any comments had on the decision.

Background on the registration review program is provided at:​pesticide-reevaluation. Links to earlier documents related to the registration review of these pesticides are provided at:​oppsrrd1/​registration_​review/​reg_​review_​status.htm.

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

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Dated: March 17, 2015.

Richard P. Keigwin, Jr.,

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

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[FR Doc. 2015-06860 Filed 3-24-15; 8:45 am]