79 FR 247 pgs. 77480-77483 - Registration Review Proposed Interim Decisions; Notice of Availability
Type: NOTICEVolume: 79Number: 247Pages: 77480 - 77483
Pages: 77480, 77481, 77482, 77483Docket number: [EPA-HQ-OPP-2014-0814; FRL-9919-24]
FR document: [FR Doc. 2014-30088 Filed 12-23-14; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2014-0814; FRL-9919-24]
Registration Review Proposed Interim Decisions; Notice of Availability
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Notice.
SUMMARY:
[top] This notice announces the availability of EPA's proposed interim registration review decisions and opens a public comment. 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,
DATES:
Comments must be received on or before February 23, 2015.
ADDRESSES:
Submit your comments, identified by docket identification (ID) number for the specific pesticide of interest provided in the table in Unit II.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.
• 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.
• 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.html. 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, contact: The Chemical Review Manager for the pesticide of interest identified in the table in Unit II.A.
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) 305-8015; 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 for the pesticide of interest identified in the table in Unit II.A.
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 preparing and submitting your comments, see the commenting tips at http://www.epa.gov/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.
| Registration review case name and No. | Pesticide docket ID No. | Chemical review manager, telephone number, email address |
|---|---|---|
| Acetic acid and sodium diacetate (Case 4001) | EPA-HQ-OPP-2008-0016 | Carolyn Schroeder, (703) 308-2961, schroeder.carolyn@epa.gov. |
| Fosetyl-Al (Case 0646) | EPA-HQ-OPP-2007-0379 | Ricardo Jones, (703) 347-0493, jones.ricardo@epa.gov. |
| Picaridin (Case 7433) | EPA HQ-OPP-2014-0341 | Ricardo Jones, (703) 347-0493, jones.ricardo@epa.gov. |
| Sodium fluoride (NaF) (Case 3132) | EPA-HQ-OPP-2014-0655 | SanYvette Williams, (703) 305-7702, williams.sanyvette@epa.gov. |
| Yellow mustard seed (Case 7618) and Sulfonic acid salts (Case 7619) | EPA-HQ-OPP-2014-0762 | Roy Johnson, (703) 347-0492, johnson.roy@epa.gov. |
[top] 1. Acetic acid and sodium diacetate. Acetic acid (Proposed Interim Decision). The registration review docket for acetic acid and sodium diacetate (EPA-HQ-OPP-2008-0016) opened in March 2008. Acetic acid and sodium diacetate are two different active ingredients: Sodium diacetate is a salt of acetic acid. Acetic acid is used as a preservative for post harvest stored grains and hay intended for livestock feed. Additionally, it is also applied as a non-selective herbicide for control of broadleaf weeds and weed grasses. Sodium diacetate is a fungicide and bactericide registered to control molds and bacteria. It is applied to hay to prevent spoilage and to silage as an aid in fermentation. EPA published the Final Work Plan in August 2008. The Agency determined that previous human health assessments for acetic acid and sodium diacetate were sufficient for registration review and no human health risks of concern were identified. The Agency completed a comprehensive ecological risk assessment for the nonselective herbicide use of acetic acid, including an endangered species assessment, and a qualitative ecological risk assessment for sodium diacetate. The Agency concludes a "no effect" determination for acetic acid used as a nonselective herbicide and all currently registered uses of sodium diacetate for all non-target organisms; no mitigation measures regarding ecological effects are included in the proposed interim decision. The risk assessments and proposed interim decision for acetic acid and sodium diacetate are currently available in the docket for public comment. Acetic acid and sodium diacetate have not been evaluated under the EDSP. Therefore, the Agency's final registration review decision is dependent upon the results of the evaluation of acetic acid and sodium diacetate as potential endocrine disruptor risks. Pending the outcome of
2. Fosetyl-Al. Fosetyl-Al (Proposed Interim Decision). The registration review docket for fosetyl-Al (EPA-HQ-OPP-2007-0379) opened in December 2007. Fosetyl-Al is systemic fungicide used to control diseases caused by oomycetes such as downy mildews. It is registered for use on agricultural crops as well as residential and commercial areas. EPA published draft human health and ecological risk assessments in March 2014. There are no human health risks of concern. The Agency also completed an ecological risk assessment. The results of this quantitative risk assessment indicates that the currently labeled rates of fosestyl-Al pose a potential for adverse effects, i.e., risk, to non-target terrestrial animals, including insects, birds, reptiles, terrestrial-phase amphibians and mammals. In addition, applications may impact sensitive species of dicotyledenous plants (dicots) in terrestrial habitats. In order to address potential ecological risks, the Agency is proposing changes to product labels which incorporate certain risk mitigation measures meant to reduce these risks. These measures include restricting aerial application of fosetyl-Al for certain uses, reducing the total number of applications that can be made annually for certain uses, and clarifying labels to better define how fosetyl-Al may be applied. The Agency completed a screening-level endangered species assessment and made a "no effects" determination for the following taxa: Fish, aquatic-phase amphibians, aquatic invertebrates, aquatic plants, and monocot plants. For all other species the effects determinations are uncertain. Fosetyl-Al has not been evaluated under the Endocrine Disruptor Screening Program (EDSP) nor has it completed the Endangered Species Act (ESA) Section 7 consultation with the U.S. Fish and Wildlife Service (Service). 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 Service for endangered species. Pending the outcome of these actions, EPA is planning to issue an interim registration review decision for fosetyl-Al.
3. Picaridin. (Combined Work Plan, Preliminary Risk Assessments, and Proposed Interim Decision). The registration review docket for Picaridin (EPA HQ-OPP-2014-0341) is opening for public comment on a Combined Preliminary Work Plan, Final Work Plan, Preliminary Risk Assessments, and Proposed Interim Decision for registration review. Due to the lack of need for additional data to support this decision, the Agency is also issuing Preliminary Ecological and Human Health Risk Assessments for picaridin and opening them for public comment. Picaridin is a broad-spectrum insect repellant registered for use against biting flies, chiggers, fleas, mosquitos and ticks. Picaridin is labelled for use on human skin, clothing, footwear, and on horses. EPA has completed comprehensive draft human health and ecological risk assessments, including a screening-level endangered species assessment, for all picaridin uses. For human health, only residential exposure was assessed, and the Agency has not identified any risk concerns associated with the registered uses of picaridin. Due to its use on human skin and clothing, exposure to terrestrial non-target organisms and plants is expected to be inconsequential. Based on the lack of potential exposure and nontoxic effects, the ecological risk assessment has made a "no effect" determination for all federally listed species and "no habitat modification" of any designated critical habitat for listed species. Picaridin has not been evaluated under the EDSP. Therefore, the agency's final registration review decision is dependent upon the result of the evaluation of potential endocrine disruptor risk. Pending the outcome of this action, the Agency is planning to issue an interim registration review decision for picaridin.
4. Sodium fluoride. (Combined Preliminary Work Plan and Proposed Interim Decision). The registration review docket for sodium fluoride (EPA-HQ-OPP-2014-0655) is opening for public comment on a Combined Preliminary Work Plan and Proposed Interim Decision. Sodium fluoride is registered for use as a wood preservative to protect the groundline portion of existing wooden utility poles. It is formulated as an impregnated pole wrap material. This use is not expected to result in direct or indirect dietary (food) or drinking water exposure. Occupational and residential exposure is minimal by the dermal and inhalation routes so no assessment is needed. Based on the lack of potential exposure and nontoxic effects to fish, aquatic invertebrates and birds, the ecological risk assessment has made a "no effect" determination for Federally listed species and designated critical habitat. Sodium fluoride has not been evaluated under the EDSP. Therefore, the agency's final registration review decision is dependent upon the result of the evaluation of potential endocrine disruptor risk. Pending the outcome of this action, EPA is planning to issue a combined preliminary work plan and interim registration review decision for sodium fluoride.
5. Yellow mustard seed/Sulfonic acid salts (Combined Preliminary Work Plan and Proposed Interim Decision). The registration review docket for yellow mustard seed and sulfonic acid salts is opening for public comment on a Combined Preliminary Work Plan and Proposed Interim Decision. The registration review docket for Yellow Mustard Seed/Sulfonic Acid Salts (YMS/SAS) is opening for public comment on a combined Work Plan, Draft Risk Assessments, and a Proposed Interim Registration Review Decision. This product is a rodenticide for the control of the Richardson's ground squirrel and Wyoming ground squirrel. YMS/SAS is applied by injection under pressure as a foam into burrows inhabited by the pest species in rangeland, ornamental plantings, orchards, golf courses, parks, nurseries, and non-crop rights-of-way. No risks of concern were identified. YMS/SAS have not been evaluated under the EDSP, nor has an endangered species assessment been conducted. The Agency's final registration review decision is dependent upon the results of both assessments. Pending the outcome of those assessments, EPA is issuing an interim registration review decision for YMS/SAS.
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 dockets 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 registration review decision will be supported by the rationales included in those documents. Following public comment on a proposed decision, the Agency will issue an interim registration review decision.
[top] 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
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.A. 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: http://www2.epa.gov/pesticide-reevaluation. Information regarding earlier documents related to the registration review of these pesticides can be found at: http://www2.epa.gov/pesticide-reevaluation/individual-pesticides-registration-review.
Authority:
7 U.S.C. 136 et seq.
Dated: December 17, 2014.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide Programs.
[FR Doc. 2014-30088 Filed 12-23-14; 8:45 am]
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