[Federal Register Volume 78, Number 188 (Friday, September 27, 2013)]
[Notices]
[Pages 59685-59688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23689]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2013-0152; FRL-9399-2]
Registration Review; Draft Human Health and Ecological Risk
Assessment; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's draft human
health and ecological risk assessments for the registration review for
2-(decylthio) ethanamine hydrochloride (DTEA-HCl), flumetsulam,
paclobutrazol, and trinexapac-ethyl, and opens a public comment period
on these documents. 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, the pesticide
can
[[Page 59686]]
perform its intended function without unreasonable adverse effects on
human health or the environment. As part of the registration review
process, the Agency has completed comprehensive draft risk assessments
for each of the subject chemicals and is making them available for
public comment. After reviewing comments received during the public
comment period, EPA will issue revised risk assessments, if
appropriate, explain any changes to the draft risk assessments, and
respond to comments and may request public input on risk mitigation
before completing a proposed registration review decision for each of
the subject chemicals. 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 November 26, 2013.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number for the specific pesticide of interest provided in Table 1
in Unit III.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 listed in Table 1 in Unit III.A.
for the pesticide of interest.
For general questions on the registration review program, contact:
Jane Robbins, Pesticide Re-evaluation Division (7508P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-0048;
fax number: (703) 305-8005; email address: [email protected].
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 listed in Table 1 in Unit III.A.
for the pesticide of interest.
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 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 submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have a typical or disproportionately high and adverse
human health impacts or environmental effects from exposure to the
pesticides discussed in this document, compared to the general
population.
II. Authority
EPA is conducting its registration review of the pesticides
identified in this document pursuant to section 3(g) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural
Regulations for Registration Review at 40 CFR part 155, subpart C.
Section 3(g) of FIFRA provides, among other things, that the
registrations of pesticides are to be reviewed every 15 years. Under
FIFRA, a pesticide product may be registered or remain registered only
if it meets the statutory standard for registration given in FIFRA
section 3(c)(5). When used in accordance with widespread and commonly
recognized practice, the pesticide product must perform its intended
function without unreasonable adverse effects on the environment; that
is, without any unreasonable risk to man or the environment, or a human
dietary risk from residues that result from the use of a pesticide in
or on food.
III. Registration Reviews
A. What action is the agency taking?
As directed by FIFRA section 3(g), EPA is reviewing the pesticide
registrations for 2-(decylthio) ethanamine hydrochloride (DTEA-HCl),
flumetsulam, paclobutrazol, and trinexapac-ethyl to ensure they
continue to satisfy the FIFRA standard for registration--that is, that
these pesticides can still be used without unreasonable adverse effects
on human health or the environment.
At this stage in the registration review process, consistent with
the changes to the registration review process
[[Page 59687]]
announced on March 27, 2013, jointly developed with the U.S. Department
of Agriculture, the National Marine Fisheries Service, and the U.S.
Fish and Wildlife Service (``the Services'') to enhance opportunities
for stakeholder input during pesticide registration reviews and
endangered species consultations, draft environmental risk assessments
include an evaluation of the potential risks to federally listed
endangered and threatened species (hereafter referred to as ``listed
species''). EPA intends to complete refined assessments of potential
risks to individual listed species, as needed. The refined listed
species assessments will be based on the recommendations of the
National Research Council (NRC), which has been tasked with providing
advice on ecological risk assessment tools and scientific approaches in
developing listed species risk assessments that are compliant with both
FIFRA and the Endangered Species Act (ESA). The NRC report, issued
April 30, 2013, provides recommendations to ensure scientific soundness
and maximize the utility of risk assessment refinements for listed
species. Additional information can be found at the following Web site:
http://www8.nationalacademies.org/cp/projectview.aspx?key=49396.
Revisions to risk assessments will likely reflect Agency review of
the report and any associated methodology and science policy based on
the report's recommendations. Refinements to the listed species
assessments may include, but not be limited to, the following:
More detailed, species-specific ecological and biological
data.
More detailed and accurate information on chemical use
patterns.
Sub-county level spatial proximity data depicting the co-
occurrence of potential effects areas and listed species and any
designated critical habitat.
In the event that a draft risk assessment shows risks of concern to
human health or the environment for a specific chemical, EPA reserves
the right to initiate mitigation at this stage of registration review.
This effort to mitigate a chemical's risks early in the registration
review process is consistent with the Agency's approach for
registration review. Where risks are identified early in the
registration review process and opportunities for early mitigation
exist, the Agency may pursue those opportunities as they arise, rather
then waiting for completion of a chemical's registration review in
order to mitigate risks. The public comment period for the draft risk
assessments allows members of the public to provide comments and
suggestions for revising the draft risk assessments and for reducing
risks.
Pursuant to 40 CFR 155.53(c), EPA is providing an opportunity,
through this notice of availability, for interested parties to provide
comments and input concerning the Agency's draft human health and
ecological risk assessments for 2-(decylthio) ethanamine hydrochloride
(DTEA-HCl), flumetsulam, paclobutrazol, and trinexapac-ethyl. Such
comments and input could address, among other things, the Agency's risk
assessment methodologies and assumptions, as applied in these draft
risk assessments. The Agency will consider all comments received during
the public comment period and make changes, as appropriate, to the
draft human health and ecological risk assessments. EPA will then issue
revised risk assessments, if appropriate, explain any changes to the
draft risk assessment, and respond to comments. In the Federal Register
notice announcing the availability of the revised risk assessments, if
the revised risk assessments indicate risks of concern, the Agency may
provide a comment period for the public to submit suggestions for
mitigating the risks identified in those revised risk assessments
before developing proposed registration review decisions on
flumetsulam, paclobutrazol, and 2-(decylthio) ethanamine hydrochloride
(DTEA-HCI) trinexapac-ethyl. At present, EPA is releasing registration
review draft risk assessments for the pesticide cases identified in the
following table and further described in this unit.
Table 1--Registration Review Draft Risk Assessments
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Chemical review
Registration review case name Pesticide docket manager, telephone
and No. identification number, and email
(ID) No. address
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2-(Decylthio) ethanamine EPA-HQ-OPP-2009-0 Seiichi Murasaki,
hydrochloride (DTEA-HCl), 336. (703) 347-0163,
Case No. 5029. murasaki.
[email protected].
Flumetsulam, Case No. 7229.... EPA-HQ-2008-0625. Katherine St. Clair,
(703) 347-8778,
Katherine.
[email protected].
Paclobutrazol, Case No. 7002.. EPA-HQ-OPP-2006-0 Khue Nguyen, (703)
109. 347-0248, Nguyen.
[email protected].
Trinexapac-ethyl, Case No. EPA-HQ-OPP-2008-0 Kaitlin Keller, (703)
7228. 657. 308-8172,
[email protected].
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2-(decylthio) ethanamine hydrochloride (DTEA-
HCl). The registration review docket for 2-(decylthio) ethanamine
hydrochloride (DTEA-HCl) (EPA-HQ-OPP-2009-0336) opened in the Federal
Register issue of June 24, 2009 (74 FR 30070) (FRL-8421-8). DTEA-HCl is
registered for use in recirculating cooling water systems to control
bacterial, fungal and algal slimes. Examples of DTEA-HCl use sites
include evaporative condenser water systems, heat exchange water
systems, commercial and industrial cooling towers, influent systems
such as flow-through filters and lagoons, industrial scrubbing systems,
and brewery pasteurizer water systems. The Agency has conducted a
qualitative human health risk assessment for the dietary (food and
drinking water) pathway. The residential and occupational exposure
pathways were not assessed because these exposures are not expected to
occur. The Agency has conducted a quantitative ecological risk
assessment, which includes a screening-level listed species assessment.
EPA acknowledges that further refinements to the listed species
assessment will be completed in future revisions and requests public
comment on specific areas that will reduce the uncertainties associated
with the characterization of risk to listed species identified in the
current assessment.
Flumetsulam. The registration review docket for
flumetsulam (EPA-HQ-OPP-2008-0625) opened in the Federal Register issue
of September 15, 2008 (73 FR 53244) (FRL-8381-3). Flumetsulam is a
sulfonanilide herbicide belonging to the triazolopyrimidine chemical
class. Flumetsulam is marketed in water dispersible granule (WDG),
emulsifiable concentrate (EC), and wettable powder (WP) products
intended for use in agriculture to control broadleaf weeds in field
corn and soybeans. There are no residential or public recreational uses
of
[[Page 59688]]
flumetsulam. The Agency has conducted a human health risk assessment
for both dietary (food and drinking water) and occupational exposure
pathways. The Agency also has conducted a quantitative ecological risk
assessment, which includes a screening-level listed species assessment.
EPA acknowledges that further refinements to the listed species
assessment will be completed in future revisions and requests public
comment on specific areas that will reduce the uncertainties associated
with the characterization of risk to listed species identified in the
current assessment.
Paclobutrazol. The registration review docket
for paclobutrazol (EPA-HQ-OPP-2006-0109) opened in the Federal Register
issue of March 28, 2007 (72 FR 14548) (FRL-8118-3). Paclobutrazol is a
plant growth regulator and is registered for use on a variety of
ornamental flowers and trees, golf course turf, ornamental turf,
outdoor residential areas, and rights-of-way. The Agency has conducted
a human health risk assessment for dietary (drinking water only),
residential, and occupational exposure pathways. The Agency has
conducted a quantitative ecological risk assessment, which includes a
screening-level listed species assessment. EPA acknowledges that
further refinements to the listed species assessment will be completed
in future revisions and requests public comment on specific areas that
will reduce the uncertainties associated with the characterization of
risk to listed species identified in the current assessment.
Trinexapac-ethyl. The registration review docket
for trinexapac-ethyl (EPA-HQ-OPP-2008-0657) opened in the Federal
Register issue of September 15, 2008 (73 FR 53244) (FRL-8381-3).
Trinexapac-ethyl is a plant growth regulator and is registered for use
by homeowners and professional applicators to manage growth of warm and
cool season turfgrass on golf courses, sod farms, residential lawns,
and other areas. It is also registered for use on cereals grains
(barley, oats, triticale, and wheat), and grasses grown for seed
(forage and hay) for yield protection and lodging prevention, and on
sugarcane for internode shortening and harvest extension. The Agency
has conducted a human health risk assessment for dietary (drinking
water only), residential, and occupational exposure pathways. The
Agency has conducted a quantitative ecological risk assessment, which
includes a screening-level listed species assessment.
EPA acknowledges that further refinements to the listed species
assessment will be completed in future revisions and requests public
comment on specific areas that will reduce the uncertainties associated
with the characterization of risk to listed species identified in the
current assessment.
1. Other related information. Additional information for 2-
(decylthio) ethanamine hydrochloride (DTEA-HCl), flumetsulam,
paclobutrazol, and trinexapac-ethyl are available on the chemical pages
for these pesticides in Chemical Search, http://www.epa.gov/pesticides/chemicalsearch, and in each chemical's individual docket listed in
Table 1 in Unit III.A. Information on the Agency's registration review
program and its implementing regulation is available at http://www.epa.gov/oppsrrd1/registration_review.
2. Information submission requirements. Anyone may submit data or
information in response to this document. To be considered during a
pesticide's registration review, the submitted data or information must
meet the following requirements:
i. To ensure that EPA will consider data or information submitted,
interested persons must submit the data or information during the
comment period. The Agency may, at its discretion, consider data or
information submitted at a later date.
ii. The data or information submitted must be presented in a
legible and useable form. For example, an English translation must
accompany any material that is not in English and a written transcript
must accompany any information submitted as an audiographic or
videographic record. Written material may be submitted in paper or
electronic form.
iii. Submitters must clearly identify the source of any submitted
data or information.
iv. Submitters may request the Agency to reconsider data or
information that the Agency rejected in a previous review. However,
submitters must explain why they believe the Agency should reconsider
the data or information in the pesticide's registration review.
As provided in 40 CFR 155.58, the registration review docket for
each pesticide case will remain publicly accessible through the
duration of the registration review process; that is, until all actions
required in the final decision on the registration review case have
been completed.
List of Subjects
Environmental protection, 2-(decylthio) ethanamine hydrochloride
(DTEA-HCl), Flumetsulam, Paclobutrazol, Pesticides and pest, and
Trinexapac-ethyl.
Dated: September 19, 2013.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2013-23689 Filed 9-26-13; 8:45 am]
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