[Federal Register Volume 78, Number 123 (Wednesday, June 26, 2013)]
[Notices]
[Pages 38315-38318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-15304]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2013-0152; FRL-9390-8]
Registration Review; Draft Human Health and Ecological Risk
Assessments; 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 of
acetaminophen, clofentezine, fluazinam, hexythiazox, quinclorac,
sulfur, and triflumizole 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 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
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 August 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., 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 information about a particular
pesticide included in this document, contact: The Chemical Review
Manager identified in Table 1. in Unit III. 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 identified in Table 1. in Unit III.
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 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 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
[[Page 38316]]
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 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
As directed by FIFRA section 3(g), EPA is reviewing the pesticide
registrations for acetaminophen, clofentezine, fluazinam, hexythiazox,
quinclorac, sulfur, and triflumizole to ensure that 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 final paper, announced in the Federal Register issue of March 27,
2013 (78 FR 18585) (FRL-9382-5), jointly developed with the U.S.
Department of Agriculture (USDA), 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 a refined
assessment 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 was
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 acetaminophen, clofentezine, fluazinam,
hexythiazox, quinclorac, sulfur, and triflumizole. 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
acetaminophen, clofentezine, fluazinam, hexythiazox, quinclorac,
sulfur, and triflumizole. 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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Acetaminophen, Case No. 7610.. EPA-HQ-OPP-2012-0 Bonnie Adler, (703)
145. 308-8523,
[email protected]
.
Clofentezine, Case No. 7602... EPA-HQ-OPP-2006-0 Wilhelmena
240. Livingston, (703)
308-8025,
[email protected].
Fluazinam, Case No. 7013...... EPA-HQ-OPP-2009-0 Steven Snyderman,
039. (703) 347-0249,
[email protected].
Hexythiazox, Case No. 7404.... EPA-HQ-OPP-2006-0 Molly Clayton, (703)
114. 603-0522,
[email protected].
Quinclorac, Case No. 7222..... EPA-HQ-OPP-2007-1 Wilhelmena
135. Livingston, (703)
308-8025,
[email protected].
Sulfur, Case No. 0031......... EPA-HQ-OPP-2008-0 Jose Gayoso, (703)
176. 347-8652,
[email protected].
[[Page 38317]]
Triflumizole, Case No. 7003... EPA-HQ-OPP-2006-0 Steven Snyderman,
115. (703) 347-0249,
[email protected].
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Acetaminophen. The registration review docket for
acetaminophen (EPA-HQ-OPP-2012-0145) opened in the Federal Register
issue of March 28, 2012 (77 FR 18810) (FRL-9342-1). Acetaminophen (also
known by the brand name Tylenol) is registered for use as a vertebrate
pesticide to control the invasive brown tree snake in Guam. The snakes
ingest baited mice, which are lethal to the snake. One FIFRA section 3
product is registered, and two FIFRA section 18 registrations are held
by USDA Animal Plant Health Inspection Service. The Agency has
conducted a quantitative ecological risk and endangered species
assessment for acetaminophen based on the available information and on
the limited use of this pesticide active ingredient. There was no need
for a human health risk assessment due to acetaminophen's well-studied
pharmaceutical use and extremely limited opportunities for exposure
from its pesticidal use on Guam. In addition, EPA has determined that
no new data are needed to support the registration review decision for
acetaminophen.
Clofentezine. The registration review docket for
clofentezine (EPA-HQ-OPP-2006-0240) opened in the Federal Register
issue of March 28, 2007 (72 FR 14548) (FRL-8118-3). Clofentezine is an
acaricide that is currently registered as a liquid formulation for use
on almonds, apples, apricots, cherries, Christmas trees, grapes,
nectarines, ornamentals (greenhouse and outdoor), peaches, pears,
persimmons, and walnuts. There are currently no residential uses
associated with clofentezine. The Agency has conducted a human health
risk assessment for both dietary (food and drinking water) and
occupational exposure pathways. The Agency has also 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.
Fluazinam. The registration review docket for fluazinam
(EPA-HQ-OPP-2009-0039) opened in the Federal Register issue of
September 23, 2009 (74 FR 48559) (FRL-8434-6). Fluazinam is a pyridine
fungicide registered for agricultural use on a variety of crops,
including but not limited to melons, peanuts, peppers/eggplants,
potatoes, and soybeans. Fluazinam is also registered for non-
agricultural use on golf course turf. The Agency has conducted a human
health risk assessment for dietary (food and drinking water),
residential and occupational exposure pathways. An addendum to the most
recent human health risk assessment was completed to incorporate
information received shortly after the completion of the risk
assessment. The addendum and risk assessment are available in the
registration review docket. The Agency has also 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.
Hexythiazox. The registration review docket for
hexythiazox (EPA-HQ-OPP-2006-0114) opened in the Federal Register issue
of February 2, 2007 (72 FR 5050) (FRL-8113-1). Hexythiazox is an
acaricide that acts primarily as a mite growth inhibitor/ovicide and is
used to control mites. It is registered for use on a variety of
agricultural crops, turf, and various residential plants. The Agency
has conducted a human health risk assessment for dietary (food and
drinking water), 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.
Quinclorac. The registration review docket for quinclorac
(EPA-HQ-OPP-2007-1135) opened in the Federal Register issue of December
19, 2007 (72 FR 71893) (FRL-8342-9). Quinclorac is an herbicide for the
selective post-emergent control of various annual grasses and broadleaf
weeds. The variety of end-use products containing quinclorac are
currently registered on rice, sorghum, and wheat. Additionally,
quinclorac is registered for use by commercial applicators and
homeowners on lawns, parks, in and around ornamentals, and golf
courses. The Agency has conducted a human health risk assessment for
dietary (food and drinking water), residential, and occupational
exposure pathways in support of registration review, and for new
proposed use on rhubarb, and low growing berry (except for strawberry),
subgroup 13-07H. 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.
Sulfur. The registration review docket for sulfur (EPA-HQ-
OPP-2008-0176) opened in the Federal Register issue of March 26, 2008
(73 FR 16011) (FRL-8356-4). Elemental sulfur is a naturally occurring
component of the earth's core and crust and is ubiquitous in the
environment. Sulfur has been used as a pesticide in the United States
since the 1920s, and is currently registered for use as an insecticide
and fungicide on a wide range of field and greenhouse-grown food and
feed crops, livestock (and livestock quarters), and indoor and outdoor
residential sites. Use sites include berries, field crops, ornamentals,
pets (dogs), root crops, tree fruit, vegetables, and turf (including
residential lawns and golf courses). Sulfur is also registered for use
in gas cartridge products, which are used for vertebrate pest control
in a variety of sites. The Agency has conducted a qualitative human
health risk assessment. The Agency has also conducted a quantitative
ecological risk assessment, which includes a screening-level listed
species assessment. EPA
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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. The human health risk assessment includes all uses of
sulfur, including gas cartridges. The most recent ecological risk
assessment includes all uses except gas cartridges. A separate
ecological risk assessment for gas cartridge uses was conducted in 2010
and can be found in the sulfur registration review docket.
Triflumizole. The registration review docket for
triflumizole (EPA-HQ-OPP-2006-0115) opened in the Federal Register
issue of March 28, 2007 (72 FR 14548) (FRL-8118-3). Triflumizole is a
broad spectrum, imidazole fungicide (group 3) that inhibits ergosterol
biosynthesis in fungi. It is registered for use on a variety of
agricultural crops, ornamentals in greenhouses/shade houses, interior
scapes, and Christmas trees/conifers on nurseries and plantations. It
is also registered for use as a pre-plant pineapple seed treatment. The
Agency has conducted a human health risk assessment for dietary (food
and drinking water), residential and occupational exposure pathways.
The Agency has also 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 on these
pesticides is 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.
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.
List of Subjects
Environmental protection, Acetaminophen, Clofentezine, Fluazinam,
Hexythiazox, Pesticides and pests, Quinclorac, Sulfur, Triflumizole.
Dated: June 19, 2013.
Michael Goodis,
Acting Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2013-15304 Filed 6-25-13; 8:45 am]
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