2015-19590. 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 decisions. This notice also opens the dockets and announces the availability of EPA's proposed interim registration review decisions for 2-propen-1-aminium, N,N-dimethyl-N-2-propenyl-, chloride, homopolymer (or homopolymer) and tributyltin oxide (or TBTO); and also opens the docket, announces the availability of the draft human health and ecological risk assessments, and announces the proposed interim registration review decision for dipropyl isocinchomeronate. 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 October 9, 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.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.
• 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 number	Docket ID number	Chemical review manager and contact information
Chlorfenapyr 7419	EPA-HQ-OPP-2010-0467	Margaret Hathaway, [e-mail], 703-305-5076.
Daminozide 0032	EPA-HQ-OPP-2009-0242	Margaret Hathaway, [e-mail], 703-305-5076.
Dipropyl isocinchomeronate 2215	EPA-HQ-OPP-2014-0578	Marianne Mannix, [e-mail], 703-347-0275.
Fenoxaprop p-ethyl 7209	EPA-HQ-OPP-2007-0437	Miguel Zavala, [e-mail], 703-347-0504.
Imazapyr 3078	EPA-HQ-OPP-2014-0200	Joel Wolf, [e-mail], 703-347-0228.
Isoxaben 7219	EPA-HQ-OPP-2007-1038	Christina Scheltema, [e-mail], 703-308-2201.
Paclobutrazol 7002	EPA-HQ-OPP-2006-0109	Khue Nguyen [e-mail] 703-347-0248.
2-Propen-1-aminium, N,N-dimethyl-N-2-propenyl-, chloride, homopolymer (or homopolymer) 5024	EPA-HQ-OPP-2015-0255	Donna Kamarei, [e-mail], 703-347-0443.
Silicon dioxide and silica gel 4081	EPA-HQ-OPP-2007-1140	James Parker [e-mail] 703-306-0469.
Sulfentrazone 7231	EPA-HQ-OPP-2009-0624	Christina Scheltema, [e-mail], 703-308-2201.
Tributyltin Oxide (or TBTO) 2620	EPA-HQ-OPP-2014-0801	Sandra O'Neill, [e-mail], 703-347-0141.

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.

Chlorfenapyr (Proposed Interim Decision). Chlorfenapyr is a member of the pyrroles class of insecticide/miticides, which works by disrupting adenosine triphosphate (ATP) production, leading to cell dysfunction. Chlorfenapyr is registered only for application to fruiting vegetables and ornamentals in greenhouses; and as a crack/crevice/spot treatment on indoor and outdoor residential sites (including treatment for bed bugs), food/feed handling areas, indoor and outdoor commercial sites, and indoor medical sites. EPA conducted assessments for both human health and ecological risks. Possible human health risks of concern were identified for chlorfenapyr, including occupational risks and risks to young children for certain residential uses. Several risk mitigation measures, including the termination of the use of chlorfenapyr on mattresses, are proposed to address human health risk concerns. No risks of concern were identified in the ecological risk assessment for non-listed species. The Agency has made a No Effect determination for chlorfenapyr under ESA section 7 for all listed species and a No Habitat Modification determination for all designated critical habitats for the currently registered uses.

Daminozide (Proposed Interim Decision). Daminozide is a systemic plant growth regulator registered to control the development of commercially grown container plants. It is used in nurseries, shadehouses, and greenhouses, and is applied as a foliar spray, a use pattern resulting in little or no potential for off-site drift. Daminozide has no registered food or residential uses. EPA conducted ecological and human health risk assessments for daminozide, and concluded that there were no significant risks of concern. Other than clarifying application rate information, the Agency is not calling for changes to daminozide registrations or labels at this time.

Dipropyl isocinchomeronate (Combined Docket Opening, Release of Draft Human Health and Ecological Risk Assessments, and Proposed Interim Decision). Dipropyl isocinchomeronate is registered for use as an insect repellent for use on humans and companion animals to repel flies, gnats, and other flying and biting insects. The Agency has concluded that there are no human health risk concerns associated with the use of dipropyl isocinchomeronate. Based on the limited usage, diffusion over a large treatment area, and the low probability of non-target organism exposure, the Agency has not found any ecological risks of concern associated with dipropyl isocinchomeronate, and anticipates making a No Effect determination for all listed species and a No Habitat Modification determination for all designated critical habitats for listed species. At this time, the Agency is proposing that no additional data are needed, and is not proposing any risk reduction measures for this case.

Fenoxaprop p-ethyl (Proposed Interim Decision). FPE is a selective aryloxy phenoxy-propionate herbicide registered for use on barley, cotton, rice, soybeans, and wheat for post-emergence control of grassy weeds. Additional non-agricultural use sites include conservation reserves, ornamentals, rights-of-way, and turf. EPA's Registration Review Proposed Interim Decision for FPE is: First; no additional data are required at this time; and second, certain risk reduction measures are needed at this time. To address potential risk to non-target terrestrial monocots, spray drift management language is proposed for all FPE product registrations used on agricultural, wide area, or rights-of-way use sites. The Agency also is proposing the implementation of label language clarifying use rates, to which the registrants have already agreed. In addition, EPA proposes label language to include recommended herbicide-resistance management measures.

Imazapyr (Proposed Interim Decision). Imazapyr is a non-selective systemic herbicide registered for use in pre- and post-emergent treatments to control terrestrial and aquatic weeds, including grasses, broadleaf weeds, and woody species. The registration review case includes both the acid (imazapyr) and the isopropylamine salt (imazapyr IPA). EPA's Registration Review Proposed Interim Decision for the case is that first, no additional data are required at this time, and second, no changes to the registrations or their labeling are needed at this time.

Isoxaben (Proposed Interim Decision). Isoxaben is a pre-emergent, soil-directed benzamide herbicide registered for use in controlling a variety of broad-leaf weeds. Agricultural uses include grapes and bearing fruit and nut trees. Non-agricultural uses include turf, lawns, ornamentals, and landscape mulch. Quantitative human health and ecological risk assessments were completed for isoxaben. There are no occupational or residential risks of concern. There are potential ecological risks to listed and non-listed aquatic vascular and terrestrial plants, and risks to mammals from foliar applications of isoxaben. The Agency has made the following Registration Review Proposed Interim Decision for isoxaben: First, no additional data are required at this time, and second, certain risk reduction measures are needed at this time, including uniform spray drift management label language for products applied by spraying, and recommended herbicide resistance management language on all product labels.

Paclobutrazol (Proposed Interim Decision). Paclobutrazol is a systemic triazole plant growth regulator registered for use on nonresidential turf, on ornamentals in greenhouses and nurseries, as a tree injection, and as a seed treatment for certain vegetable crops. There are no residential uses of paclobutrazol. EPA conducted risk assessments for both human health and ecological risk, and a screening level endangered species assessment. No human health risks were identified. The ecological risk assessment indicated potential risks to birds, mammals, terrestrial and aquatic plants, freshwater and estuarine/marine fish, and freshwater and estuarine/marine invertebrates. The Agency is proposing to modify the application directions for paclobutrazol to reduce risks to non-target organisms from runoff. The screening-level endangered species assessment did not come to a conclusion of No Effect to listed species, therefore, consultation with the Fish and Wildlife Service and the National Marine Fisheries Service (“the Services”) on the potential risk of paclobutrazol to listed species will be necessary.

2-Propen-1-aminium, N,N-dimethyl-N-2-propenyl-, chloride, homopolymer (Combined Preliminary Work Plan and Proposed Interim Decision). There is one product containing this active ingredient; it is registered to control mollusks in potable water supplies. The Agency did not call-in any data in support of this registration review case. Additionally, the Agency did not conduct a human health or an environmental risk assessment due to the lack of exposure concern for the product's registered use. Based on the lack of potential exposure, the Agency is proposing a No Effect determination for listed species.

Silicon dioxide and silica gel (Proposed Interim Decision). Products containing these two naturally occurring active ingredients are registered for use as insecticides on a variety of agricultural and residential use sites to control pests such as ants, cockroaches, flies, fleas, and ticks. EPA conducted an ecological risk assessment that included a screening-level endangered species assessment. The Agency engaged in informal consultation with FWS to reach a “may affect, but not likely to adversely affect” determination for direct effects to terrestrial invertebrates and a No Effect determination for all other listed taxa. No human health risk assessment was conducted because no toxicological endpoints are identified for the two active ingredients. No risk mitigation measures for human health or ecological effects are included in the silica gel and silicon dioxide Proposed Interim Decision.

Sulfentrazone (Proposed Interim Decision). Sulfentrazone is a broad spectrum, pre-emergence, soil-directed proto porphyrinogen herbicide used to control a variety of weeds. It is registered for use on field crops, specialty vegetable crops, fruit trees, ornamentals, and turf grass. EPA completed quantitative human health and ecological risk assessments for sulfentrazone in 2014, and amended the ecological risk assessment in 2015. There are no residential risks of concern; however, there is a risk concern for pesticide handlers that can be adequately mitigated by wearing chemical-resistant gloves. In addition, there are potential risk concerns for terrestrial plants. The Agency has made the following Registration Review Proposed Interim Decision for sulfentrazone: First, no additional data are required at this time; and second, certain risk reduction measures are needed at this time. These measures include uniform spray drift management language on sulfentrazone labels for products applied by spraying and recommended herbicide resistance management language on all product labels.

Tributyltin oxide (Combined Preliminary Work Plan and Proposed Interim Decision). There are two EPA registrations for TBTO for rubber coatings on the sonar domes of nuclear submarines and for oceanographic conductivity sensors. Based on the lack of potential for dietary exposure and no residential uses, the Agency did not conduct a human health risk assessment. Exposure to aquatic organisms would occur only from the small amount of TBTO potentially leaching from sonar domes, and the Agency believes that risks to non-target, non-listed species are minimal. TBTO use as an antifoulant on sonar domes is undergoing ESA consultation with the Department of Defense, EPA, and the Services for compounds covered under EPA's Uniform National Discharge Standards. At this time, the Agency is proposing that no additional data are needed, and is not proposing any risk reduction measures for this case.

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 decisions announced in this notice, 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, as appropriate, 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 such 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.

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

Dated: July 30, 2015.

Richard P. Keigwin, Jr.,

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