[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)]
[Notices]
[Pages 57812-57816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24452]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2015-0386; FRL-9933-68]
Pesticide Registration Review; Draft Human Health and Ecological
Risk Assessments for Sulfonylureas and Certain Other Pesticides; Notice
of Availability and Request for Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of and opens a public
comment period on EPA's draft human health and ecological risk
assessments for the registration review of a group of pesticides known
collectively as sulfonylureas (SUs) that are identified individually in
this document in Table 1 of Unit III, as well as additional chemicals
identified in Table 2 of Unit III. This notice also announces both the
opening of the registration review docket and the availability of the
registration review human health and ecological risk assessments for
antimycin A and imazosulfuron. 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 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 a comprehensive
preliminary human health and ecological risk assessment for the
pesticide uses of the identified pesticides. After reviewing comments
received during the public comment period, EPA may issue a revised risk
assessment, explain any changes to the draft risk assessment, and
respond to comments and may request public input on risk mitigation
before completing a proposed registration review decision for the
identified pesticides. Through this program, EPA is ensuring that the
registration of each pesticide 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 24, 2015.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2015-0386, 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 and Table 2 of
Unit III.
For general questions 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].
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 and Table 2 of
Unit III.
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.
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 atypical 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 the registration review of the pesticides
identified in this document pursuant to section 3(g) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq., and the Procedural Regulations for Registration Review at 40 CFR
part 155, subpart C. FIFRA section 3(g) 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) (7 U.S.C. 136a(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
As directed by FIFRA section 3(g), EPA is reviewing the
registrations for the pesticides listed in Tables 1 and 2 to ensure
that each pesticide on the list
[[Page 57813]]
continues 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.
Table 1--Draft Risk Assessments Being Made Available for Public Comment--
Sulfonylureas
------------------------------------------------------------------------
Chemical review
Registration review case Docket ID No. manager and contact
name and No. information
------------------------------------------------------------------------
Bensulfuron-methyl.......... EPA-HQ-OPP-2011-0663 Moana Appleyard,
7216........................ [email protected], (703) 308-
8175.
Chlorimuron-ethyl........... EPA-HQ-OPP-2010-0478 Wilhelmena
7403........................ Livingston,
[email protected], (703)
308-8025.
Chlorsulfuron............... EPA-HQ-OPP-2012-0878 Miguel Zavala,
0631........................ [email protected], (703) 347-0504.
Flazasulfuron............... EPA-HQ-OPP-2011-0994 Ricardo Jones,
7271........................ [email protected], (703) 347-0493.
Foramsulfuron............... EPA-HQ-OPP-2012-0387 Jose Gayoso,
7252........................ [email protected]
, (703) 347-8652.
Halosulfuron-methyl......... EPA-HQ-OPP-2011-0745 Brittany Pruitt,
7233........................ [email protected], (703) 347-
0289.
Imazosulfuron............... EPA-HQ-OPP-2015-0625 Caitlin Newcamp,
7285-1...................... [email protected], (703) 347-
0325.
Iodosulfuron-methyl-sodium.. EPA-HQ-OPP-2012-0717 Katherine St. Clair,
7253........................ [email protected], (703) 347-
8778.
Mesosulfuron-methyl......... EPA-HQ-OPP-2012-0833 Jolene Trujillo,
7277........................ [email protected], (303) 312-
6579.
Metsulfuron-methyl.......... EPA-HQ-OPP-2011-0375 Katherine St. Clair,
7205........................ [email protected], (703) 347-
8778.
Nicosulfuron................ EPA-HQ-OPP-2012-0372 Miguel Zavala,
7227........................ [email protected], (703) 347-0504.
Orthosulfamuron............. EPA-HQ-OPP-2011-0438 Khue Nguyen,
7270........................ [email protected]
, (703) 347-0248.
Primisulfuron-methyl........ EPA-HQ-OPP-2011-0844 Christina Scheltema,
7220........................ [email protected], (703) 308-
2201.
Prosulfuron................. EPA-HQ-OPP-2011-1010 Wilhelmena
7235........................ Livingston,
[email protected], (703)
308-8025.
Rimsulfuron................. EPA-HQ-OPP-2012-0178 Jose Gayoso,
7218........................ [email protected]
, (703) 347-8652.
Sulfometuron-methyl......... EPA-HQ-OPP-2012-0433 Caitlin Newcamp,
3136........................ [email protected], (703) 347-
0325.
Sulfosulfuron............... EPA-HQ-OPP-2011-0434 Kelly Ballard,
7247........................ [email protected], (703) 305-8126.
Thifensulfuron-methyl....... EPA-HQ-OPP-2011-0171 Brittany Pruitt,
7206........................ [email protected], (703) 347-
0289.
Triasulfuron................ EPA-HQ-OPP-2012-0115 Margaret Hathaway,
7221........................ [email protected], (703) 305-
5076.
Tribenuron-methyl........... EPA-HQ-OPP-2010-0626 Brittany Pruitt,
7217........................ [email protected], (703) 347-
0289.
Trifloxysulfuron-Sodium..... EPA-HQ-OPP-2013-0409 Kelly Ballard,
7208........................ [email protected], (703) 305-8126.
Triflusulfuron-methyl....... EPA-HQ-OPP-2012-0605 Matthew Manupella,
7236........................ [email protected]v, (703) 347-
0411.
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A single, streamlined ecological risk assessment document covering
the 22 sulfonylurea chemicals listed in Table 1, as well as 22
chemical-specific human health risk assessments separately addressing
the same 22 active ingredients are being made available for public
review and comment. The sulfonylureas (SUs) are an established and
widely used class of agricultural pesticides in the United States. They
are used to control broadleaf and grassy weeds and are registered for
many agricultural and non-agricultural uses. The ecological risk
assessment examines risks from the SUs simultaneously but not
cumulatively. The streamlined assessment for SUs will focus on the
risks to plants. This single document approach is intended to increase
efficiency and consistency in assessing potential risks from this class
of compounds. Separate human health risk assessment documents have been
generated for each of the SUs because of differences in toxicity
endpoints and points of departure.
Table 2--Draft Risk Assessments Being Made Available for Public Comment--
Additional Chemicals
------------------------------------------------------------------------
Chemical review
Registration review case Docket ID No. manager and contact
name and No. information
------------------------------------------------------------------------
Antimycin A................. EPA-HQ-OPP-2015-0480 Christina Scheltema,
4121........................ [email protected], (703) 308-
2201.
Chlorpyrifos-methyl......... EPA-HQ-OPP-2010-0119 Joel Wolf,
8011........................ [email protected],
(703) 347-0228.
[[Page 57814]]
Dicrotophos................. EPA-HQ-OPP-2008-0440 Khue Nguyen,
Case 0145................... [email protected]
, (703) 347-0248.
Dimethoate.................. EPA-HQ-OPP-2009-0059 Kelly Ballard,
0088........................ [email protected], (703) 305-8126.
Diquat Dibromide............ EPA-HQ-OPP-2009-0846 Bonnie Adler,
0288........................ [email protected], (703) 308-8523.
Ethoprop.................... EPA-HQ-OPP-2008-0560 Tracy Perry,
0106........................ [email protected]
, (703) 308-0128.
Fosamine ammonium........... EPA-HQ-OPP-2010-0215 James Parker,
2355........................ [email protected], (703) 306-0469.
Hexazinone.................. EPA-HQ-OPP-2009-0755 Dana L. Friedman,
0266........................ [email protected], (703) 347-8827.
Methoxyfenozide............. EPA-HQ-OPP-2012-0663 Bonnie Adler,
7431........................ [email protected], (703) 308-8523.
Profenofos.................. EPA-HQ-OPP-2008-0345 Christina Scheltema,
2540........................ [email protected], (703) 308-
2201.
Tebufenozide................ EPA-HQ-OPP-2008-0824 Christina Scheltema,
7416........................ [email protected], (703) 308-
2201.
Terbufos.................... EPA-HQ-OPP-2008-0119 Matthew Manupella,
0109........................ [email protected], (703) 347-
0411.
Tribufos.................... EPA-HQ-OPP-2008-0883 Marianne Mannix,
2145........................ [email protected], (703) 347-
0275.
------------------------------------------------------------------------
Antimycin A. Draft Human Health and Ecological Risk Assessments,
Preliminary Work Plan (EPA-HQ-OPP-2015-0480). Antimycin A
(Fintrol[supreg]) is a restricted use pesticide registered for limited
aquatic use by the U.S. National Park Service to control invasive
species and restore native fish populations. EPA has completed combined
scoping and preliminary human health and ecological risk assessments
for Antimycin A. These assessments are limited to the current
registered uses of Antimycin A in accordance with the Federal label and
do not consider endangered species or endocrine effects.
Chlorpyrifos-methyl. Draft Human Health and Ecological Risk
Assessments (EPA-HQ-OPP-2010-0119). Chlorpyrifos-methyl is registered
as an insecticide used to target and kill a variety of stored grain
insects including beetles, weevils, moths, and grain borers. The
registered uses of chlorpyrifos-methyl are limited to indoor
applications made to the interior of empty grain storage bins or
warehouses. EPA conducted a preliminary ecological risk assessment and
effects determination and a human health risk assessment. An endangered
species assessment was completed and a No Effect determination was made
for all listed species, as well as a No Habitat Modification
determination for all designated critical habitats for the currently
registered uses of chlorpyrifos-methyl. Chlorpyrifos-methyl was not on
either initial list of chemicals to be screened under the EDSP, and an
endangered species assessment has not been conducted at this time.
Dicrotophos. Draft Human Health and Ecological Risk Assessments
(EPA-HQ-OPP-2008-0440). Dicrotophos is an organophosphate insecticide
mainly used on cotton and ornamental trees. Dicrotophos is primarily
used to target stinkbugs and tarnished plant bugs in cotton growing
states. EPA published preliminary human health and ecological risk
assessments in 2014 for public comment. EPA has revised its human
health risk assessment by revising the Food Quality Protection Act
(FQPA) safety factor and its dietary analysis. EPA has identified
possible dietary risk for both adults and children, possible spray
drift risks, and possible occupational handler risk from both aerial
and ground application. EPA has revised its ecological risk assessment
by providing additional characterization of potential ecological risk
from typical application rates and average foliar residue (i.e.,
Kenaga) values for mammalian and bird dietary exposure. EPA identified
possible ecological risks for the following taxa: Aquatic
invertebrates, mammals, birds, and terrestrial invertebrates. An
endangered species assessment has not been completed for dicrotophos at
this time. Dicrotophos was not on the first list of chemicals for
endocrine disruption screening.
Dimethoate. Draft Human Health and Ecological Risk Assessments
(EPA-HQ-OPP-2009-0059). Dimethoate is a wide spectrum systemic
organophosphate insecticide. It is registered for use on a wide variety
of agricultural crops, tree crops, ornamentals, and non-cropland
adjacent to agricultural fields. There are no residential uses. EPA
conducted a comprehensive human health risk assessment and identified
potential risks of concern for dietary and occupational exposures. EPA
also conducted a screening level ecological risk assessment that
addressed all registered use of dimethoate. Potential risks were
identified for freshwater, estuarine/marine, and terrestrial
invertebrates, birds, and mammals. An endangered species assessment has
not been completed for dimethoate at this time. Dimethoate was
evaluated for its potential to affect endocrine systems in mammals and
wildlife and the results of the agency's review are found in the Weight
of Evidence review in this registration review docket.
Diquat Dibromide. Draft Human Health and Ecological Risk
Assessments (EPA-HQ-OPP-2009-0846). Diquat dibromide is a non-selective
contact algicide, defoliant, desiccant, and herbicide. As an herbicide/
algicide it is registered for use to control weeds in non-crop
(including residential) and aquatic areas. As a desiccant/defoliant, it
is registered for use on seed crops and potatoes. The Agency issued a
FWP for diquat dibromide in March 2011, and data were called in. The
reviews of those data are incorporated into the draft risk assessments.
The ecological risk assessment identifies risk of concern for both
terrestrial and aquatic
[[Page 57815]]
organisms. The human health risk assessment identifies risks of
concerns for residential and occupations handlers via inhalation, and
dermal concerns for workers after application. Diquat dibromide was not
on either initial list of chemicals to be screened under the Endocrine
Disruptor Screening Program (EDSP), and an endangered species
assessment has not been conducted at this time.
Ethoprop. Draft Human Health and Ecological Risk Assessments (EPA-
HQ-OPP-2008-0560). Ethoprop is an organophosphate, restricted use
insecticide-nematicide registered for use on a variety of crops,
including potatoes and sugarcane. The Agency has completed draft risk
assessments for ethoprop, which identified both human health and
ecological risks of concern. These assessments do not consider
endangered species. Ethoprop was evaluated for its potential to affect
endocrine systems in mammals and wildlife and the results of the
agency's review are found in the Weight of Evidence review in this
registration review docket.
Fosamine Ammonium. Draft Human Health and Ecological Risk
Assessments (EPA-HQ-OPP-2010-0215). Fosamine ammonium is an herbicide
which is applied to prevent growth of undesirable seedlings and
saplings of brush and vines. Fosamine ammonium is registered for use on
non-agricultural rights-of way, industrial sites, fencerows, and pine
plantations. It is used for general weed control in uncultivated
nonagricultural areas (e.g., airports, highway, railroad and utility
rights-of-way, and sewage disposal areas), uncultivated agricultural
areas (e.g., non-crop producing farmyards, fuel storage areas,
fencerows) and industrial sites (e.g., lumberyards, pipeline and tank
farms). The Agency has conducted a human health risk assessment for
fosamine ammonium. The Agency has also conducted a quantitative
ecological risk assessment, which includes a screening-level listed
species assessment. Fosamine ammonium was not on either initial list of
chemicals to be screened under the EDSP, and an endangered species
assessment has not been conducted at this time.
Hexazinone. Draft Human Health and Ecological Risk Assessments
(EPA-HQ-OPP-2009-0755). Hexazinone is a broad spectrum herbicide
registered for use on food and feed crops (including alfalfa,
blueberry, pineapple, sugarcane), non-food crops (including Christmas
tree plantations, industrial areas, recreational areas), drainage
systems, and in forestry (including conifer release, reforestation,
forest trees). EPA conducted a comprehensive human health risk
assessment and did not identify any risks of concern for dietary or
residential exposure. Most occupational risks identified may be
addressed with additional levels of personal protective equipment,
though some scenarios still pose concerns considering engineering
controls. EPA also conducted a preliminary ecological risk assessment
that identified potential risks, mainly to terrestrial and aquatic
plants. Hexazinone was not on either initial list of chemicals to be
screened under the EDSP, and an endangered species assessment has not
been conducted at this time.
Methoxyfenozide. Draft Human Health and Ecological Risk Assessments
(EPA-HQ-OPP-2013-0606). Methoxyfenozide is a diacylhydrazine
insecticide and insect growth regulator registered for use on a variety
of agricultural and non-agricultural sites. The ecological assessment
indicates that methoxyfenozide has the potential for direct acute and
chronic effects on listed and non-listed freshwater and estuarine/
marine invertebrates. The likelihood of direct adverse effects on
birds, terrestrial-phase amphibians, reptiles, mammals, fish, aquatic-
phase amphibians, and terrestrial and aquatic plants as a result of
registered methoxyfenozide use is expected to be low. However, taxa
that depend on aquatic invertebrate species may be indirectly affected.
The endangered species protection bulletin for methoxyfenozide can be
found by following the links at http://www.epa.gov/oppfead1/endanger/bulletins.htm). The human health risk assessment considered both
current and pending proposed uses of methoxyfenozide, and the Agency
concluded there were no risks of concern identified for any route or
duration of exposure. Methoxyfenozide was not included in either the
first or second list of chemicals to be screened for endocrine
disruptor potential.
Profenofos. Draft Human Health and Ecological Risk Assessments
(EPA-HQ-OPP-2008-0345). Profenofos (Curacron[supreg]) is an
organophosphate, restricted use insecticide registered for use on
cotton. However, use has declined significantly since 2000, and EPA has
not found any reports of use since 2011. The Agency has completed
preliminary human health and ecological risk assessments for
profenofos. Profenofos was not on either initial list of chemicals to
be screened under the EDSP, and an endangered species assessment has
not been conducted at this time.
Tebufenozide. Draft Human Health and Ecological Risk Assessments
(EPA-HQ-OPP-2008-0824). Tebufenozide (Confirm[supreg]) is an insect
growth regulator registered for use on a variety of crops, mint,
ornamentals, tree and nut fruit and in forestry. EPA has completed
preliminary human health and ecological risk assessments for
tebufenozide. Tebufenozide was not on either initial list of chemicals
to be screened under the EDSP, and an endangered species assessment has
not been conducted at this time.
Terbufos. Draft Human Health and Ecological Risk Assessments (EPA-
HQ-OPP-2008-0119). Terbufos is a systemic organophosphate insecticide-
nematicide used to control a variety of pests on corn (field and sweet
corn), grain sorghum, and sugar beets. EPA conducted a dietary and
occupational human health risk assessment. The agency identified
dietary and occupational risks. EPA also conducted a comprehensive
ecological risk assessment and found risks to both aquatic and
terrestrial animals. Endangered species, EDSP and pollinator
assessments have not been completed for terbufos at this time.
Tribufos. Draft Human Health and Ecological Risk Assessments (EPA-
HQ-OPP-2008-0883). Tribufos is an organophospate chemical used as a
pre-harvest desiccant on cotton. The Environmental Protection Agency
conducted comprehensive human health and ecological risk assessments,
which identified human health and ecological risks. Tribufos was not on
either initial list of chemicals to be screened under the EDSP, and an
endangered species assessment has not been conducted at this time.
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 the pesticides identified in this
document. Such comments and input could address, among other things,
the Agency's risk assessment methodologies and assumptions, as applied
to this draft risk assessment. 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 assessment.
EPA will then issue a revised risk assessment, explain any changes to
the draft risk assessment, and respond to comments. In the Federal
Register notice announcing the availability of the revised risk
assessment, if the revised risk assessment indicates risks of concern,
the Agency may provide a comment
[[Page 57816]]
period for the public to submit suggestions for mitigating the risk
identified in the revised risk assessment before developing a proposed
registration review decision on the pesticides identified in this
document.
1. Other related information. Additional information on the
pesticides identified in this document is available on the Pesticide
Registration Review Status Web page. 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:
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.
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.
Submitters must clearly identify the source of any
submitted data or information.
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.
Authority: 7 U.S.C. 136 et seq.
Dated: September 21, 2015.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2015-24452 Filed 9-24-15; 8:45 am]
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