2015-25435. Registration Review Proposed Interim Decisions; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of EPA's proposed interim registration review decisions for the pesticides listed in the table in Unit II of this notice, and opens a public comment period on the proposed interim decisions. This notice also opens the dockets and announces the availability of EPA's Preliminary Work Plan and proposed interim registration review decisions for 2H-Cyclopent(d)isothiazol-3(4H)-one, 5,6-dihydro-2-methyl- and Bacillus thuringiensis, Plant-incorporated Protectants in Corn, and a Preliminary Work Plan, draft risk assessments and proposed interim decision for Aquashade. 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.

DATES:

Comments must be received on or before December 7, 2015.

ADDRESSES:

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: 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.
• 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.

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: [phone]; email address: [e-mail].

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.

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.

Table—Registration Review Proposed Interim Decisions

Registration review case name and No.	Pesticide Docket ID No.	Chemical review manager, email address, and telephone No.
D-Limonene (Case 3083)	EPA-HQ-OPP-2010-0673	Caitlin Newcamp, [e-mail], 703-347-0325.
Hydrogen cyanamide (Case 7005)	EPA-HQ-OPP-2007-1014	Dana Friedman, [e-mail], 703-347-8827.
2H-Cyclopent(d)isothiazol-3(4H)-one, 5,6-dihydro-2-methyl- (Case 5018)	EPA-HQ-OPP-2015-0266	Donna Kamarei, [e-mail], 703-347-0443.
Aquashade (Case 4010)	EPA-HQ-OPP-2015-0639	Christina Motilall, [e-mail], 703-603-0522.
Bacillus thuringiensis Plant-incorporated Protectants in Corn (Cases 6501 and 6502)	EPA-HQ-OPP-2015-0584	Alan Reynolds, [e-mail], 703-605-0515.

The registration review final decisions for these cases are dependent on the assessments of listed species under the Endangered Species Act (ESA), determinations on the potential for endocrine disruption, and/or assessments of exposure and risk to pollinators.

D-Limonene (Proposed Interim Decision). D-limonene is a naturally occurring chemical obtained from the rind of citrus fruits. It is registered as an active ingredient for use as an acaricide, insecticide, herbicide, and insect repellent, and is an inert ingredient in other products providing scent and flavoring. D-limonene is currently registered for use in/on terrestrial food (citrus, pome fruits, grapes), feed crops, non-food crops (ornamentals, Christmas trees, fencerows, recreational areas, wood protection) and for residential uses. EPA published draft registration review human health and ecological risk assessments in December 2014. For the human health assessment, no data deficiencies were identified in either the toxicity or exposure databases and the Agency concluded that d-limonene does not pose human health risks. For the ecological risk assessment, the Agency found that, due to its high volatility, low usage, and low toxicity to most taxa, d-limonene is expected to have negligible effects to most taxa. The Agency is proposing modifications to several labels to reduce potential risks to d-limonene for terrestrial plants and mammals.

Hydrogen cyanamide (Proposed Interim Decision). Hydrogen cyanamide is a plant growth regulator used to promote uniform bud break in orchard fruit trees and vines, and does not have any residential uses. It is the only registered plant growth regulator available to induce uniform bud break in U.S. fruit production, and there are significant economic benefits associated with its use in areas where the critical number of chilling hours needed for bud break does not occur or is not consistent. The Agency conducted a comprehensive human health risk assessment and determined that there are potential risks of concern for occupational handlers, as well as spray drift concerns for bystanders. However, the occupational risks identified can be mitigated through modifications to product labels, and spray drift concerns are already addressed by current labels. The Agency also conducted an ecological risk assessment and determined that there are potential risks of concern for terrestrial animals, but current use practices and label mitigation addresses many of these concerns.

2H-Cyclopent(d)isothiazol- 3(4H)-one, 5,6-dihydro-2- methyl- (Combined Preliminary Work Plan and Proposed Interim Decision). There is one EPA-registered product containing 2H-Cyclopent(d)isothiazol-3(4H)-one, 5,6-dihydro-2- methyl-, also known as MTI, as an active ingredient for material preservation of imaging products. The Agency does not anticipate the need to call-in any data in support of MTI's registration review. Additionally, the Agency does not anticipate conducting human health or environmental risk assessments due to the lack of exposure concerns for MTI's registered use. Based on the lack of potential exposure, the Agency is proposing to make a No Effects determination for listed species under the ESA. EPA is announcing the availability for public comment on the combined preliminary work plan and proposed interim registration review decision for MTI. This proposed interim decision does not cover the EDSP component of this registration review case. The Agency's final registration review decision is dependent upon the evaluation of potential endocrine disruptor risk.

Aquashade (Combined Preliminary Work Plan, Draft Risk Assessments and Proposed Interim Decision). Aquashade is as an aquatic herbicide for which the mode of action is light filtration. It is primarily used in small water bodies such as ornamental ponds and small lakes, fountains and other landscaping water features, swimming holes, aquaculture ponds, and animal watering holes. The Agency conducted an ecological risk assessment and determined there are no risks of concern for any assessed taxa. The Agency also conducted a human health risk assessment and there were no dietary, residential, or occupational risks of concern. The Agency is not proposing any risk mitigation or additional data requirements for Aquashade at this time.

Bacillus thuringiensis Plant-incorporated Protectants in Corn (Combined Preliminary Work Plan and Proposed Interim Decision). Plant-incorporated protectants (PIPs) derived from Bacillus thuringiensis (Bt) have been genetically engineered into corn hybrids to provide insecticidal protection against certain pests. One class (case 6501) of Bt corn PIPs targets lepidopteran stalk-boring and ear-feeding insects (e.g., European corn borer, corn earworm, and southwestern corn borer); a second class (case 6502) targets coleopteran root-feeding insects (corn rootworm). EPA has conducted extensive risk assessments addressing human health (including food safety), non-target wildlife, environmental fate, gene flow, and insect resistance management for all registered products. No human health risks of concern or risks of concern to non-listed species (including honey bees and Monarch butterflies) have been identified. In addition, the Agency is proposing to make No Effects determinations under the ESA for all listed species. EPA will update these assessments for the final registration review. No risk mitigation measures for human health or ecological effects are included in the proposed interim decision.

The registration review docket for a pesticide includes earlier documents related to the registration review of the case. For example, the review typically opens with the availability of a Summary Document, containing a Preliminary Work Plan, for public comment. A Final Work Plan typically is placed in the docket following public comment on the initial docket. Following a period for public comment on the proposed interim registration review decisions for products containing the affected active ingredients, the Agency will issue interim registration review decisions for products containing the affected active ingredients.

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 the Federal Register of August 9, 2006 (71 FR 45720) (FRL-8080-4) 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 decisions. 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 for each of the pesticides included in the table in Unit II. The interim registration review decision will explain the effect that any comments had on the decision and provide the Agency's response to significant comments, as needed.

Background on the registration review program is provided at: http://www2.epa.gov/​pesticide-reevaluation. Links to earlier documents related to the registration review of the pesticide cases identified in this notice are provided on the Pesticide Chemical Search data base accessible at: http://iaspub.epa.gov/​apex/​pesticides/​f?​p=​chemicalsearch:1.

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

Dated: September 25, 2015.

Richard P. Keigwin, Jr.,

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