Document ID: EPA-HQ-OPP-2013-0152-0002
Agency: epa
Document Type: Notice
Title: Draft Human Health and Ecological Risk Assessments; Availability: Registration Review
Posted Date: 2013-06-26T04:00Z

[Federal Register Volume 78, Number 123 (Wednesday, June 26, 2013)]
[Notices]
[Pages 38315-38318]
From the Federal Register Online via the Government Printing 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: robbins.jane@epa.gov.

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
------------------------------------------------------------------------
                                                      Chemical review
 Registration review case name   Pesticide docket    manager, telephone
            and No.               identification     number, and email
                                     (ID) No.             address
------------------------------------------------------------------------
Acetaminophen, Case No. 7610..  EPA-HQ-OPP-2012-0  Bonnie Adler, (703)
                                 145.               308-8523,
                                                    adler.bonnie@epa.gov
                                                    .
Clofentezine, Case No. 7602...  EPA-HQ-OPP-2006-0  Wilhelmena
                                 240.               Livingston, (703)
                                                    308-8025,
                                                    livingston.wilhelmena@epa.gov.
Fluazinam, Case No. 7013......  EPA-HQ-OPP-2009-0  Steven Snyderman,
                                 039.               (703) 347-0249,
                                                    snyderman.steven@epa.gov.
Hexythiazox, Case No. 7404....  EPA-HQ-OPP-2006-0  Molly Clayton, (703)
                                 114.               603-0522,
                                                    clayton.molly@epa.gov.
Quinclorac, Case No. 7222.....  EPA-HQ-OPP-2007-1  Wilhelmena
                                 135.               Livingston, (703)
                                                    308-8025,
                                                    livingston.wilhelmena@epa.gov.
Sulfur, Case No. 0031.........  EPA-HQ-OPP-2008-0  Jose Gayoso, (703)
                                 176.               347-8652,
                                                    gayoso.jose@epa.gov.

[[Page 38317]]

 
Triflumizole, Case No. 7003...  EPA-HQ-OPP-2006-0  Steven Snyderman,
                                 115.               (703) 347-0249,
                                                    snyderman.steven@epa.gov.
------------------------------------------------------------------------

     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

[[Page 38318]]

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]
BILLING CODE 6560-50-P