Document ID: EPA-HQ-OPP-2011-0094-0014
Agency: epa
Document Type: Notice
Title: Draft Human Health and Ecological Risk Assessments: Aldicarb, Bensulide, Coumaphos, Ethalfluralin, and Pirimiphos-methyl  Registration Review
Posted Date: 2016-04-26T04:00Z

[Federal Register Volume 81, Number 80 (Tuesday, April 26, 2016)]
[Notices]
[Pages 24610-24613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09732]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0794; FRL-9943-82]

Aldicarb, Bensulide, Coumaphos, Ethalfluralin, and Pirimiphos-
methyl 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 risk and draft ecological risk assessments for aldicarb, 
bensulide, coumaphos, ethalfluralin, and pirimiphos-methyl 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 a 
comprehensive draft human health and ecological risk assessments for 
all aldicarb, bensulide, coumaphos, ethalfluralin, and pirimiphos-
methyl uses. After reviewing comments received during the public 
comment period, EPA will issue a revised risk assessment, explain any 
changes to the draft risk assessment, and respond to comments and may 
request public input on risk mitigation before completing a proposed 
registration review decision for aldicarb, bensulide, coumaphos, 
ethalfluralin, and pirimiphos-methyl. Through this program, EPA is 
ensuring that each pesticide's registration is based on

[[Page 24611]]

current scientific and other knowledge, including its effects on human 
health and the environment.

DATES: Comments must be received on or before June 27, 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 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 1of 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 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 of 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/comments.html.
    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 aldicarb, bensulide, 
coumaphos, ethalfluralin, and pirimiphos-methyl 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 
registration for aldicarb, bensulide, coumaphos, ethalfluralin, and 
pirimiphos-methyl to ensure that it continues to satisfy the FIFRA 
standard for registration--that is, that aldicarb, bensulide, 
coumaphos, ethalfluralin, and pirimiphos-methyl can still be used 
without unreasonable adverse effects on human health or the 
environment.

                     Table 1--Draft Risk Assessments Being Made Available for Public Comment
----------------------------------------------------------------------------------------------------------------
 Registration review case name  and                                                Chemical review manager and
               number                             Docket ID number                     contact information
----------------------------------------------------------------------------------------------------------------
Aldicarb............................  EPA-HQ-OPP-2012-0161                      Susan Bartow,
0140................................                                             bartow.susan@epa.gov, (703) 603-
                                                                                 0065.
Bensulide...........................  EPA-HQ-OPP-2008-0022                      Margaret Hathaway,
2035................................                                             hathaway.margaret@epa.gov,
                                                                                 (703) 305-5076.
Coumaphos...........................  EPA-HQ-OPP-2008-0023                      Brian Kettl,
0018................................                                             kettl.brian@epa.gov, (703) 347-
                                                                                 0535.
Ethalfluralin.......................  EPA-HQ-OPP-2011-0094                      Kelly Ballard,
2260................................                                             ballard.kelly@epa.gov, (703)
                                                                                 305-8126.
Pirimiphos-methyl...................  EPA-HQ-OPP-2009-0056                      Caitlin Newcamp,
2535................................                                             newcamp.caitlin@epa.gov, (703)
                                                                                 347-0397.
----------------------------------------------------------------------------------------------------------------

[[Page 24612]]

    Aldicarb. Draft Human Health and Ecological Risk Assessments (EPA-
HQ-OPP-2012-0161). Aldicarb is a systemic carbamate insecticide, 
acaricide, and nematicide registered for use on cotton, dry beans, 
peanuts, soybeans, sugar beets, and sweet potatoes. It is not 
registered for non-agricultural/residential use. EPA conducted a 
comprehensive human health risk assessment including a highly refined 
acute dietary exposure assessment for all existing food uses of 
aldicarb. Acute dietary exposure estimates for drinking water as well 
as food and drinking water combined are of concern. A commodity 
specific analysis (CSA) was conducted to obtain estimates of acute 
exposure and risk following a single consumption of a single commodity. 
Exposure estimates were above the level of concern for children 
following consumption of sweet potatoes or potatoes. Additionally, 
there are short- and intermediate-term occupational handler risk 
estimates of concern for the registered uses of aldicarb with label-
specified personal protective equipment. EPA also conducted a screening 
level ecological risk assessment and identified potential risks to both 
aquatic and terrestrial non-target organisms. The assessments did not 
cover the EDSP component of this registration review case, nor does it 
include a full pollinator assessment or a complete endangered species 
assessment.
    Bensulide. Draft Human Health and Ecological Risk Assessments (EPA-
HQ-OPP-2008-0022). Bensulide is a systemic organophosphate herbicide 
registered to control grasses and broadleaf weeds in a variety of 
agricultural (e.g., lettuce, cantaloupe, broccoli) and non-agricultural 
(golf course, turf farm, residential lawn, rights-of-way, and 
landscaping) settings, and is usually applied to bare ground before 
crops are planted. EPA conducted a comprehensive human health risk 
assessment and identified risks of concern for dietary, residential, 
occupational, and spray drift exposures. The bensulide risk assessment 
retained the FQPA 10x safety factor due to the uncertainty in the human 
dose-response relationship for neuro-developmental effects. EPA also 
conducted an ecological risk assessment for bensulide, which identified 
risks of concern for non-listed species for birds, reptiles, and 
terrestrial-phase amphibians; mammals; freshwater fish and aquatic-
phase amphibians; marine/estuarine fish; freshwater invertebrates; and 
aquatic vascular plants. Neither an endangered species assessment nor a 
pollinator assessment been completed for bensulide at this time. 
Bensulide is on the second list of chemicals for tier one screening 
under the Endocrine Disruptor Screening Program (EDSP).
    Coumaphos. Draft Human Health and Ecological Risk Assessments (EPA-
HQ-OPP-2008-0023). Coumaphos is an organophosphate acaricide. It is 
used to control ticks and mites on livestock, as well as to control 
varroa mites and small hive beetles in beehives. The human health risk 
assessment for coumaphos found dietary risks of concern, with food 
(beef meat) being the driver in the steady state risk estimates. In 
addition, almost all of the occupational exposure scenarios show risks 
of concern for both dermal and inhalation routes of exposure at varying 
levels of personal protection equipment and all formulations with the 
exception of liquid. The coumaphos risk assessment retained the FQPA 
10x safety factor due to the uncertainty in human dose-response 
relationship for neuro-developmental effects. Coumaphos is expected to 
pose an acute risk to birds. Coumaphos is not expected to pose a risk 
to endangered or non-endangered mammals because of its limited use 
pattern. Coumaphos usage on cattle may pose a high acute risk to 
aquatic invertebrates. Coumaphos is not expected to pose chronic or 
acute risks to listed or non-listed fish. Neither a comprehensive 
endangered species assessment nor a pollinator assessment has been 
completed for coumaphos at this time. Coumaphos is on the second list 
of chemicals for Tier 1 screening under EDSP.
    Ethalfluralin. Draft Human Health and Ecological Risk Assessments 
(EPA-HQ-OPP-2011-0094). Ethalfluralin is a preemergence herbicide used 
to control a variety of annual grasses and broadleaf weeds on 
agricultural sites. Ethalfluralin has multiple end-use products that 
are registered for use on various agricultural crops. EPA conducted a 
comprehensive human health risk assessment and did not identify any 
risks of concern. EPA also conducted an ecological risk assessment. 
Potential risks to aquatic animals, aquatic and terrestrial plants, and 
mammals were identified. The assessments did not cover the EDSP 
component of this registration review case, nor does it include either 
a full pollinator assessment or a complete endangered species 
assessment.
    Pirimiphos-methyl. Draft Human Health Risk and Ecological 
Assessments (EPA-HQ-OPP-2009-0056). Pirimiphos-methyl is a member of 
the organophosphate class of pesticides. Currently, it is registered 
for use as an insecticide in cattle ear tags, and on post-harvest 
stored grain/seeds (sorghum and corn). There are two special local need 
FIFRA section 24(c) registrations: A fogger treatment on iris bulbs in 
Washington, and a fogger and drench treatment on gladiola bulbs in 
Michigan. EPA conducted a human health risk assessment, and did not 
identify any risks of concern for dietary or residential exposures. 
However, risks of concern were identified for occupational exposure and 
for all handler scenarios. The pirimiphos-methyl risk assessment 
retained the FQPA 10x safety factor due to the uncertainty in human 
dose-response relationship for neuro-developmental effects. EPA also 
conducted a quantitative ecological risk assessment and identified 
potential risks to terrestrial and aquatic invertebrates. A complete 
endangered species assessment nor a pollinator assessment has been 
completed for pirimiphos-methyl. The assessments did not cover the EDSP 
component of this registration review case.
    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 aldicarb, bensulide, coumaphos, 
ethalfluralin, and pirimiphos-methyl. 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 will 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 aldicarb, bensulide, coumaphos, 
ethalfluralin, and pirimiphos-methyl.
    1. Other related information. Additional information on aldicarb, 
bensulide, coumaphos, ethalfluralin, and pirimiphos-methyl is available 
on the Agency's registration review program and its implementing 
regulation is available at https://www.epa.gov/pesticide-reevaluation.

[[Page 24613]]

    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: March 14, 2016.
Yu-Ting Guilaran,
Director, Pesticide Re-Evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2016-09732 Filed 4-25-16; 8:45 am]
 BILLING CODE 6560-50-P