Document ID: EPA-HQ-OPP-2007-1038-0022
Agency: epa
Document Type: Notice
Title: Pesticide Chemicals: Draft Human Health and Ecological Risk Assessment; Registration Review
Posted Date: 2014-09-24T04:00Z

[Federal Register Volume 79, Number 185 (Wednesday, September 24, 2014)]
[Notices]
[Pages 57080-57081]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22584]

[[Page 57080]]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0594; FRL-9915-54]

Pesticide Chemicals; Registration Review; Draft Human Health and 
Ecological Risk Assessment; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces the availability of EPA's draft human 
health and ecological risk assessments for the registration review of 
2-EEEBC (debacarb) and isoxaben, 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 draft human health and ecological 
risk assessments, including an endangered species assessment, for all 
uses of the previously listed pesticide chemicals. After reviewing 
comments received during the public comment period, EPA will issue 
revised risk assessments, explain any changes to the draft risk 
assessments, and respond to comments and may request public input on 
risk mitigation before completing proposed registration review 
decisions for the previously listed pesticide 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 24, 2014.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number for the specific pesticide of interest provided in the 
table 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: Chemical Review Manager 
identified in the table in Unit III.A. for the pesticide of interest.
    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) 305-8015; 
email address: dumas.richard@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 under FOR FURTHER 
INFORMATION CONTACT.

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 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 2-EEEBC (debacarb), 
acephate, allethrins, chlorethoxyfos, coumaphos, daminozide, 
dimethoate, isoxaben, picaridin, and propoxur 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

[[Page 57081]]

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-EEEBC (debacarb) and isoxaben, 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.
    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-EEEBC (debacarb) and isoxaben. Such 
comments and input could address, among other things, the Agency's risk 
assessment methodologies and assumptions, as applied to 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, explain any changes to the draft risk 
assessments, 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 risk identified in the revised risk assessments. At 
present, EPA is releasing registration review draft risk assessments 
for the pesticide cases identified in the following table and further 
described after the table.

           Table 1--Registration Review Draft Risk Assessments
------------------------------------------------------------------------
                                                      Chemical review
 Registration review case name   Pesticide docket    manager, telephone
            and No.                   ID No.           No., and email
                                                          address
------------------------------------------------------------------------
2-EEEBC (Debacarb) (Case 4031)  EPA-HQ-OPP-2008-0  Roy Johnson (703) 347-
                                 802.               0492,
                                                    johnson.roy@epa.gov.
Isoxaben (Case 7219)..........  EPA-HQ-OPP-2007-1  Christina Scheltema,
                                 038.               (703) 308-2201,
                                                    scheltema.christina@epa.gov.
------------------------------------------------------------------------

    1. 2-EEEBC (debacarb). Debacarb is a fungicide registered for use 
to control certain diseases in ornamental trees. The fungicide is 
applied to mature trees by injection through the trunk. EPA has 
completed a draft ecological risk assessment, including a screening-
level listed species assessment. A human health risk assessment is not 
needed because the method of application limits the possibility for 
applicator or other human exposure. EPA acknowledges that further 
refinements to the listed species assessment will be completed in 
future revisions and requests public comment on any aspect of the 
ecological risk assessment, particularly any information on the 
disposition of the fungicide within the plant after application, the 
extent of use of the registered products, or any data available on 
adverse effects to potentially exposed non-target species.
    2. Isoxaben. Isoxaben is a broad spectrum pre-emergent herbicide 
used to control broadleaf weeds, grasses, and vines. Isoxaben is used 
around non-bearing food crops, ornamental trees, and shrubs in 
agriculture nurseries, rights-of-way, and urban areas. It is also used 
on bearing nut trees and grape vineyards. EPA has completed draft human 
health and ecological risk assessments, including a screening-level 
listed species assessment, for all isoxaben uses. 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.
    3. Other related information. Additional information on chemicals 
2-EEEBC (debacarb) and isoxaben, is available for each pesticide, at 
http://www.epa.gov/pesticides/chemicalsearch and in each chemical's 
individual docket listed in the table in Unit III.A. Information on the 
Agency's registration review program and its implementing regulation is 
available at http://www2.epa.gov/pesticide-reevaluation.
    4. 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 12, 2014.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2014-22584 Filed 9-23-14; 8:45 am]
BILLING CODE 6560-50-P