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