Document ID: EPA-HQ-OPP-2008-0850-0856
Agency: epa
Document Type: Notice
Title: Draft Biological Evaluations: Chlorpyrifos, Diazinon, and Malathion Registration Review
Posted Date: 2016-04-22T04:00Z

[Federal Register Volume 81, Number 69 (Monday, April 11, 2016)]
[Notices]
[Pages 21341-21343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08279]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2016-0167; FRL-9944-32]

Chlorpyrifos, Diazinon, and Malathion Registration Review; Draft 
Biological Evaluations; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing the availability of the draft biological 
evaluations for the registration reviews of all uses of chlorpyrifos, 
diazinon, and malathion for public review and comment. 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. Through the registration review 
program, EPA is ensuring that each pesticide's registration is based on 
the most current scientific methods. Furthermore, EPA is meeting its 
obligation under section 7 of the Endangered Species Act by ensuring 
that each pesticide's registration is not likely to jeopardize the 
continued existence of any listed species or result in the destruction 
or adverse modification of designated critical habitat.

DATES: Comments must be received on or before June 10, 2016.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2016-0167, 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 for the pesticide of interest 
identified in the following table.

------------------------------------------------------------------------
                                                      Chemical review
 Registration review case name   Pesticide docket    manager, telephone
            and No.                   ID No.       number, email address
------------------------------------------------------------------------
Chlorpyrifos, 100.............  EPA-HQ-OPP-2008-0  Dana Friedman, 703-
                                 850.               347-8827,
                                                    friedman.dana@epa.gov.
Diazinon, 238.................  EPA-HQ-OPP-2008-0  Khue Nguyen, 703-347-
                                 351.               0248,
                                                    nguyen.khue@epa.gov.
Malathion, 248................  EPA-HQ-OPP-2009-0  Steven Snyderman, 703-
                                 317.               347-0249,
                                                    Snyderman.steven@epa.gov.
------------------------------------------------------------------------

    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, farm 
worker, and agricultural advocates; the chemical industry; pesticide 
users; and members of the public interested in the sale, distribution, 
or use of pesticides and/or the potential impacts of pesticide use on 
listed species and designated critical habitat. 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 for the pesticide of 
interest identified 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 preparing and submitting 
your comments, see the commenting tips at

[[Page 21342]]

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. Executive Summary

A. What action is the agency taking?

    EPA is providing an opportunity for public review of its draft 
biological evaluations for the registration reviews of chlorpyrifos, 
diazinon, and malathion. 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. 
As part of the registration review process, the Agency has completed 
comprehensive draft biological evaluations for all chlorpyrifos, 
diazinon, and malathion uses.
    These draft biological evaluations represent the first ever 
nationwide assessments of these pesticides to federally endangered and 
threatened species (i.e., listed species) and designated critical 
habitat. The interim scientific methods used in these draft biological 
evaluations were developed collaboratively with the U.S. Fish and 
Wildlife Service (USFWS) and the National Marine Fisheries Service 
(NMFS), hereafter referred to as the Services, based on recommendations 
from the April 2013 National Academy of Sciences (NAS) report 
``Assessing Risks to Endangered and Threatened Species from 
Pesticides.'' As part of this effort, the U.S. Department of 
Agriculture has provided expertise on crop production and pesticide 
uses and assistance with the use of the National Agricultural 
Statistics Service Cropland Data Layer to help define the footprint of 
agricultural use patterns.
    After reviewing comments received during the public comment period, 
EPA will issue revised final biological evaluations, explain any 
changes, respond to comments, and may request public input on risk 
mitigation before completing proposed registration review decisions for 
chlorpyrifos, diazinon, and malathion. For those species and designated 
critical habitats where registered uses of the pesticides are ``likely 
to adversely affect'' species and/or habitat, USFWS and NMFS will 
utilize the analyses and data from the biological evaluations in their 
final Biological Opinions for each of the three chemicals.

B. What is the agency's authority for taking this action?

    EPA is conducting its registration review of chlorpyrifos, 
diazinon, and malathion pursuant to section 3(g) of the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
seq., 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.
    EPA develops endangered species biological evaluations and consults 
with the Services pursuant to section 7(a)(2) of the Endangered Species 
Act (ESA), 16 U.S.C. 1531 et seq., and the implementing regulations at 
50 CFR part 402.

III. Registration Reviews

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide 
registrations for chlorpyrifos, diazinon, and malathion to ensure that 
these registrations continue to satisfy the FIFRA standard for 
registration--that is, that chlorpyrifos, diazinon, and malathion can 
still be used without unreasonable adverse effects.
    EPA has been collaborating with the Services to develop interim 
scientific approaches to assess the impact of pesticides on listed 
species and designated critical habitat, as required by ESA and as 
recommended by the April 2013 NAS report. Chlorpyrifos, diazinon, and 
malathion were selected for the development and implementation of these 
interim approaches because these pesticides were included in the first 
Biological Opinion issued by NMFS in response to litigation brought by 
the Washington Toxics Coalition (WTC) with regard to salmonids in the 
Pacific Northwest. This Biological Opinion was later remanded to NMFS 
by the U.S. Court of Appeals for the 3rd Circuit. The interim 
scientific approaches used in the draft biological evaluations for 
chlorpyrifos, diazinon, and malathion were developed based on a 
collaborative effort among the agencies, and will be refined based on 
the public comments received on the draft biological evaluations as 
well as input from an ESA stakeholder workshop planned for the summer 
of 2016. More information on this process is available at https://www.epa.gov/endangered-species/implementing-nas-report-recommendations-ecological-risk-assessment-endangered-and.
    Chlorpyrifos is an organophosphate (OP) insecticide, acaricide, and 
miticide used to control a variety of insects on a variety of food and 
feed crops. Currently registered uses include a variety of fruits, 
nuts, vegetables, grains, and non-agricultural areas (such golf course 
turf, industrial sites, greenhouses and nurseries, sod farms, and wood 
products). Public health uses include aerial and ground-based fogger 
treatments to control mosquitoes. There are also residential uses of 
ant and roach bait products and fire ant mound treatments. EPA has 
completed a draft biological evaluation to assess whether all 
registered uses of chlorpyrifos may affect listed species and 
designated critical habitat. The chlorpyrifos draft biological 
evaluation is viewable at: https://www.epa.gov/endangered-species/biological-evaluation-chapters-chlorpyrifos. Comments on the draft 
biological evaluation for chlorpyrifos should be submitted to the 
chlorpyrifos registration review docket (EPA-HQ-OPP-2008-0850) at 
http://www.regulations.gov.
    Diazinon is a restricted use OP insecticide currently registered 
for use on a number of fruits, vegetables, nuts, ornamentals, and in 
cattle ear tags. All residential uses were phased out as part of risk 
mitigation during reregistration, and there are currently no 
residential uses. EPA has completed a draft biological evaluation to 
assess whether all registered uses of diazinon may affect listed 
species and designated critical habitat. The diazinon draft biological 
evaluation is viewable at: https://www.epa.gov/endangered-species/biological-evaluation-chapters-diazinon. Comments on the draft 
biological evaluation for diazinon should be submitted to the diazinon

[[Page 21343]]

registration review docket (EPA-HQ-OPP-2008-0351) at http://www.regulations.gov.
    Malathion is a non-systemic, wide spectrum OP. It is used in the 
agricultural production of a wide variety of food/feed crops to control 
insects such as aphids, leafhoppers, and Japanese beetles. Malathion is 
also used in USDA's Cotton Boll Weevil Eradication Program, Fruit Fly 
(Medfly) Control Program, and for mosquito-borne disease control. It is 
also registered for outdoor residential uses which include vegetable 
gardens, home orchards, and ornamentals. EPA has completed a draft 
biological evaluation to assess whether all registered uses of 
malathion may affect listed species and designated critical habitat. 
The draft malathion biological evaluation is viewable at: https://www.epa.gov/endangered-species/biological-evaluation-chapters-malathion. Comments on the draft biological evaluation for malathion 
should be submitted to the malathion registration review docket (EPA-
HQ-OPP-2009-0317) at http://www.regulations.gov.

IV. Public Review and Comment Opportunity

    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 biological evaluations 
for chlorpyrifos, diazinon, and malathion. Such comments and input 
could address, among other things, the Agency's risk assessment 
methodologies and assumptions, as applied to these draft biological 
evaluations. The Agency will consider all comments received during the 
public comment period and make changes, as appropriate, to the draft 
biological evaluations. EPA will then issue final biological 
evaluations, explain any changes to the draft biological evaluations, 
and respond to comments. For those species and designated critical 
habitats where registered uses of the pesticides are ``likely to 
adversely affect'' species and/or habitat, USFWS and NMFS will utilize 
the analyses and data from the biological evaluations in their final 
Biological Opinions for each of the three chemicals. The final 
Biological Opinions for the three chemicals are currently scheduled for 
December 2017. In the Federal Register notice announcing the 
availability of the final biological evaluations, if the final 
biological evaluations indicate risks of concern, the Agency may 
provide a comment period for the public to submit suggestions for 
mitigating the risk identified in the final biological evaluations 
before developing proposed registration review decisions for 
chlorpyrifos, diazinon, and malathion.
    1. Other related information. Additional information on endangered 
species risk assessment and the NAS report recommendations are 
available at https://www.epa.gov/endangered-species/implementing-nas-report-recommendations-ecological-risk-assessment-endangered-and. 
Information on the Agency's registration review program and its 
implementing regulation is available at https://www.epa.gov/pesticide-reevaluation.
    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 28, 2016.
Michael Goodis,
Acting Director, Pesticide Re-Evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2016-08279 Filed 4-8-16; 8:45 am]
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