Document ID: EPA-HQ-OPP-2010-0127-0011
Agency: epa
Document Type: Notice
Title: Human Health and Ecological Risk Assessments Draft; Registration Review
Posted Date: 2016-01-06T05:00Z

[Federal Register Volume 81, Number 3 (Wednesday, January 6, 2016)]
[Notices]
[Pages 478-481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-33298]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0794; FRL-9940-41]

Registration Review; Draft Human Health and Ecological Risk 
Assessments; 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 a 
group of pesticides identified individually in this document in the 
table in Unit III, and opens a public comment period. 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 draft human health and ecological risk 
assessment for the identified pesticides. After reviewing comments 
received during the public comment period on each assessment, EPA may 
issue revised risk assessments and explain any changes to the draft 
risk assessments, and respond to substantive comments on the risk 
assessments. EPA may also request public input on risk mitigation 
before completing a proposed registration review decision for the 
identified pesticides. 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 March 7, 2016.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2015-0794, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online

[[Page 479]]

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/where-send-comments-epa-dockets.
    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 (CRM) identified in the table in 
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: 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 may also 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 the table in 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/commenting-epa-dockets#tips.
    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 these pesticides 
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) (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 pesticide 
registrations for the pesticides listed in the table 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.

  Table--Draft Risk Assessments Being Made Available for Public Comment
------------------------------------------------------------------------
                                                       Chemical review
 Registration review case name      Docket ID No.    manager and contact
            and No.                                      information
------------------------------------------------------------------------
Azoxystrobin, 7020.............  EPA-HQ-OPP-2009-08  Veronica Dutch,
                                  35.                 dutch.veronica@epa.gov, (703) 308-
                                                      8585.
Bensulfuron-methyl, 7216.......  EPA-HQ-OPP-2011-06  Moana Appleyard,
                                  63.                 appleyard.moana@epa.gov, (703) 308-
                                                      8175.
Bifenazate, 7609...............  EPA-HQ-OPP-2012-06  Garland Waleko,
                                  33.                 waleko.garland@epa.gov, (703) 308-
                                                      8049.
Boric Acid and Sodium Borate     EPA-HQ-OPP-2009-03  Moana Appleyard,
 Salts, 0024.                     06.                 appleyard.moana@epa.gov, (703) 308-
                                                      8175.
Ethephon, 0382.................  EPA-HQ-OPP-2010-00  Marquea D. King,
                                  98.                 king.marquea@epa.gov, (703) 305-
                                                      7432.
Hymexazol, 7016................  EPA-HQ-OPP-2010-01  Caitlin Newcamp,
                                  27.                 newcamp.caitlin@epa.gov, (703) 347-
                                                      0325.
Lithium hypochlorite, 3084.....  EPA-HQ-OPP-2013-06  Donna Kamarei,
                                  06.                 kamarei.donna@epa.gov, (703) 347-
                                                      0443.
Pronamide, 0082................  EPA-HQ-OPP-2009-03  Wilhelmena
                                  26.                 Livingston,
                                                      livingston.wilhelmena@epa.gov, (703)
                                                      308-8025.
------------------------------------------------------------------------

    Azoxystrobin. Draft Human Health and Ecological Risk Assessments 
(EPA-HQ-OPP-2009-0835). Azoxystrobin is a systemic fungicide and 
antimicrobial registered for use on a variety of terrestrial food and 
feed crops, including vegetables, fruits and nuts; terrestrial non-food 
crops, including turf and ornamentals; and non-crop sites including 
additives for the manufacture of paint, rubber, paper products, 
textiles, and adhesives. The Agency has conducted draft human health 
and ecological risk assessments for the conventional and antimicrobial 
uses of azoxystrobin. A full endangered species assessment has not been 
completed for azoxystrobin at this time. For foliar

[[Page 480]]

applications, the ecological risk assessment identifies risks of 
concern for aquatic plants, freshwater fish, aquatic invertebrates, and 
mammals. For seed treatments, risks of concern are identified for birds 
and mammals. The conventional uses of azoxystrobin are associated with 
inhalation risks of concern for residential handlers and some 
occupational post-application scenarios even with maximum personal 
protective equipment (PPE). The antimicrobial uses of azoxystrobin are 
not associated with ecological risks of concern, but the human health 
risk assessment identifies potential risks of concern for residential 
and occupational handlers. Azoxystrobin has not been assessed under the 
endocrine disruptor screening program (EDSP) or for risks to 
pollinators.
    Bensulfuron-methyl. Draft Human Health Risk Assessment (EPA-HQ-OPP-
2011-0663). Bensulfuron-methyl is a sulfonylurea herbicide that acts by 
inhibiting acetolactate synthase. Bensulfuron-methyl is registered for 
use to control broadleaf weeds and sedges in aquatic rice production. 
Tolerances have been established for crayfish, rice, and rice straw. 
There are no registered residential uses of bensulfuron-methyl. 
Bensulfuron- methyl was first registered in 1989, and a Final Work Plan 
was published in February 2012. The ecological risks of bensulfuron-
methyl were assessed together with all other sulfonylureas in the 
Preliminary Ecological Risk Assessment for Registration Review of 22 
Sulfonylurea Herbicides, published in September 2015. EPA conducted a 
human health risk assessment and did not identify any risks of concern 
for dietary, residential, occupational, or aggregate exposure. 
Bensulfuron-methyl was not on either initial list of chemicals to be 
screened under the EDSP, nor has an endangered species or pollinator 
assessment been conducted at this time.
    Bifenazate. Draft Human Health and Ecological Risk Assessments 
(EPA-HQ-OPP-2012-0633). Bifenazate is a selective carbazate miticide/
insecticide that is registered for use to control the motile stage of 
mites in agricultural and non-agricultural sites including on bearing 
and non-bearing fruit and vegetable crops, cotton, conifer plantations, 
ornamentals, and in greenhouses, as well as indoor and outdoor 
residential, commercial, institutional, and recreational areas. The 
human health non-occupational drift assessment was updated in 
registration review for bifenazate and found no risks of concern. In 
the recent June 2014, new use assessment, all dietary, residential, 
occupational, and aggregate risks were not of concern. In the 
ecological assessment, chronic risks of concern were identified for 
mammals and birds. There are acute risks identified for listed birds, 
freshwater fish, freshwater invertebrates, and estuarine and marine 
invertebrates. There is also potential acute and chronic risk to 
terrestrial invertebrates. Bifenazate was not on either initial list of 
chemicals to be screened under the EDSP, nor has an endangered species 
or pollinator assessment been conducted at this time.
    Boric Acid and Sodium Borate Salts. Draft Human Health and 
Ecological Risk Assessments (EPA-HQ-OPP-2009-0306). Boric acid and its 
sodium salts are inorganic compounds with registrations for use as 
active ingredients in insecticides, acaricides, herbicides, algaecides, 
fungicides, and wood and material preservatives. In small quantities, 
boron is an essential nutrient for aquatic vertebrates and 
invertebrates and plants. There is also evidence that boron is 
essential or, if not essential, beneficial in birds and mammals, in 
small quantities. Boric acid and its sodium salts are also present as 
inert ingredients in pesticide products and as ingredients in non-
pesticide consumer products. The Agency issued a Final Work Plan for 
boric acid in October 2009. The ecological risk assessment identifies 
potential risks to terrestrial invertebrates, birds, mammals, reptiles, 
terrestrial-phase amphibians, aquatic organisms, and terrestrial 
plants. For birds and mammals, risk is primarily associated with the 
granular formulations and bait uses. For aquatic organisms, risk is 
primarily associated with discharge of swimming pool, hot tub, and spa 
effluent directly to surface waters, to storm drains, roadways, and 
potentially from storage of treated wood. For terrestrial plants, risk 
is primarily associated with discharge of effluent from swimming pools, 
hot tubs, and spas. The human health risk assessment did not identify 
risks of concern. Boric acid was not on either initial list of 
chemicals to be screened under the EDSP, nor has an endangered species 
or pollinator assessment been conducted at this time.
    Ethephon. Draft Human Health and Ecological Risk Assessments (EPA-
HQ-OPP-2010-0098). Ethephon, 2-chloroethylphosphonic acid, is an 
organophosphonate plant growth regulator intended to promote fruit 
ripening, abscission, flower induction, breaking of apical dominance 
(inhibition of the growth of lateral buds by the terminal bud of a 
shoot), and other plant responses through the release of ethylene gas, 
a natural plant hormone. EPA conducted a human health risk assessment 
and identified aggregate risks of concern for children ages 1-2 years 
old. EPA also conducted an ecological risk assessment and identified 
potential risks to birds, mammals, and non-target plants. A full 
endangered species assessment has not been completed for ethephon at 
this time. At this time, ethephon has not been evaluated for its 
potential to affect endocrine systems in mammals and wildlife, nor has 
an assessment of risks to pollinators been conducted.
    Hymexazol. Draft Human Health and Ecological Risk Assessments (EPA-
HQ-OPP-2010-0127). Hymexazol is a systemic fungicide for control of 
foliar and soil-borne plant diseases. There is only one existing 
registration as a commercial seed treatment for sugar beets. Hymexazol 
may be applied only using commercial seed treatment equipment. A Final 
Work Plan for hymexazol was published by the Agency in September 2010, 
and data were then required in a generic data call-in, dated October 
2011. The reviews of the required data have been incorporated into the 
draft risk assessments. The Draft Human Health Risk Assessment 
identified no dietary risks of concern but identified potential risk to 
occupational workers (individuals treating/mixing seed and individuals 
doing multiple activities). The Draft Ecological Risk Assessment 
identified potential risks to mammals and birds. Hymexazol was not on 
either initial list of chemicals to be screened under the EDSP, and a 
complete endangered species assessment has not been conducted at this 
time.
    Lithium hypochlorite. Draft Ecological Risk Assessment (EPA-HQ-OPP-
2013-0606). Lithium hypochlorite is an algicide, disinfectant, and 
fungicide. Its primary pesticidal use is to control algae, bacteria, 
and mildew in swimming pool water systems, hot tubs, and spas. EPA 
conducted a qualitative ecological risk assessment on the swimming pool 
uses of lithium hypochlorite as part of registration review. EPA 
previously conducted human health and ecological risk assessments at 
the time of the Reregistration Eligibility Decision (RED) for lithium 
hypochlorite in 1993. Lithium hypochlorite 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.
    Pronamide. Draft Human Health and Ecological Risk Assessments (EPA-
HQ-OPP-2009-0326). Pronamide, also called propyzamide, 3,5-dichloro-N-
(1,1-dimethyl-2-propynyl)benzamide, is

[[Page 481]]

a selective, systemic, pre-and post-emergence herbicide registered for 
the control of grasses and broadleaf weeds in several food and feed 
crops as well as woody ornamentals, Christmas trees, grasses grown for 
seed or turf (sod), golf course turf, recreational area turf, and 
fallow land. EPA conducted a human health risk assessment and did not 
identify any risks of concern for dietary, residential, occupational, 
or aggregate exposure. EPA also conducted an ecological risk assessment 
and identified potential risks to birds, mammals, and plants. An 
endangered species and pollinator assessment has not been completed for 
pronamide at this time. Pronamide 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.
    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 assessments. 
EPA may 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 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 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/pesticide-reevaluation/registration-review-process.
    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: December 24, 2015.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2015-33298 Filed 1-5-16; 8:45 am]
BILLING CODE 6560-50-P