Document ID: EPA-HQ-OPP-2015-0584-0001
Agency: epa
Document Type: Notice
Title: Registration Review Proposed Interim Decisions
Posted Date: 2015-10-07T04:00Z

[Federal Register Volume 80, Number 194 (Wednesday, October 7, 2015)]
[Notices]
[Pages 60672-60674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25435]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0099; FRL-9934-47]

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: 
(703) 308-8015; email address: dumas.richard@epa.gov.

[[Page 60673]]

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
------------------------------------------------------------------------
                                                       Chemical review
  Registration review case     Pesticide Docket ID     manager, email
        name and No.                   No.              address, and
                                                        telephone No.
------------------------------------------------------------------------
D-Limonene (Case 3083)......  EPA-HQ-OPP-2010-0673  Caitlin Newcamp,
                                                     newcamp.caitlin@epa.gov, 703-347-0325.
Hydrogen cyanamide (Case      EPA-HQ-OPP-2007-1014  Dana Friedman,
 7005).                                              friedman.dana@epa.gov, 703-347-8827.
2H-Cyclopent(d)isothiazol-    EPA-HQ-OPP-2015-0266  Donna Kamarei,
 3(4H)-one, 5,6-dihydro-2-                           kamarei.donna@epa.g
 methyl- (Case 5018).                                ov, 703-347-0443.
Aquashade (Case 4010).......  EPA-HQ-OPP-2015-0639  Christina Motilall,
                                                     motilall.christina@epa.gov, 703-603-
                                                     0522.
Bacillus thuringiensis Plant- EPA-HQ-OPP-2015-0584  Alan Reynolds,
 incorporated Protectants in                         reynolds.alan@epa.g
 Corn (Cases 6501 and 6502).                         ov, 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

[[Page 60674]]

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.
[FR Doc. 2015-25435 Filed 10-6-15; 8:45 am]
 BILLING CODE 6560-50-P