Document ID: EPA-HQ-OPP-2008-0657-0013
Agency: epa
Document Type: Notice
Title: Registration Reviews: Draft Human Health and Ecological Risk Assessment
Posted Date: 2013-09-27T04:00Z

[Federal Register Volume 78, Number 188 (Friday, September 27, 2013)]
[Notices]
[Pages 59685-59688]
From the Federal Register Online via the Government Printing 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: 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 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
------------------------------------------------------------------------
                                                      Chemical review
 Registration review case name   Pesticide docket    manager, telephone
            and No.               identification     number, and email
                                     (ID) No.             address
------------------------------------------------------------------------
2-(Decylthio) ethanamine        EPA-HQ-OPP-2009-0  Seiichi Murasaki,
 hydrochloride (DTEA-HCl),       336.               (703) 347-0163,
 Case No. 5029.                                     murasaki.
                                                    seiichi@epa.gov.
Flumetsulam, Case No. 7229....  EPA-HQ-2008-0625.  Katherine St. Clair,
                                                    (703) 347-8778,
                                                    Katherine.
                                                    StClair@epa.gov.
Paclobutrazol, Case No. 7002..  EPA-HQ-OPP-2006-0  Khue Nguyen, (703)
                                 109.               347-0248, Nguyen.
                                                    khue@epa.gov.
Trinexapac-ethyl, Case No.      EPA-HQ-OPP-2008-0  Kaitlin Keller, (703)
 7228.                           657.               308-8172,
                                                    Keller.kaitlin@epa.gov.
------------------------------------------------------------------------

     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]
BILLING CODE 6560-50-P