[Federal Register Volume 84, Number 95 (Thursday, May 16, 2019)]
[Notices]
[Pages 22120-22122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10177]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2019-0185; FRL-9993-03]


Pesticides; Draft Revised Method for National Level Endangered 
Species Risk Assessment Process for Biological Evaluations of 
Pesticides; Notice of Availability and Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is seeking comment 
on a draft revised method for conducting national level threatened and 
endangered (listed) species biological evaluations (BEs) for 
pesticides. EPA is also announcing a public meeting on June 10, 2019, 
where EPA will present the draft revised method and provide an 
additional opportunity for the public to provide feedback.

DATES: Meeting: The public meeting will be held from 9:00 a.m. to 12:00 
noon, Eastern Standard Time, on June 10, 2019, and you must register to 
participate in the meeting using the instructions in Unit III. on or 
before May 30, 2019.
    Accommodations requests: To request accommodation of a disability, 
please contact the person listed under FOR FURTHER INFORMATON CONTACT, 
preferably at least 10 days prior to the meeting, to give EPA as much 
time as possible to process your request.
    Comments: Comments must be received on or before July 1, 2019.

ADDRESSES: Meeting: The meeting will be held in the Lobby-level 
Conference Center of EPA's Potomac Yard South Bldg. (One Potomac Yard), 
2777 South Crystal Drive, Arlington, VA 22202-4501. EPA's Potomac Yard 
South Bldg. is approximately 1 mile from the Crystal

[[Page 22121]]

City Metro Station. Register to participate in the meeting using the 
instructions in Unit III.
    Comments: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2019-0185, 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: Tracy Perry, Pesticide Re-Evaluation 
Division (7508P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (703) 308-0128; email address: 
perry.tracy@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This 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. Given the broad interest, the 
Agency has not attempted to identify or describe all the specific 
entities that may be affected by this action.

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.

C. How can I get copies of this document and other related information?

    A copy of the EPA Draft Revised Method for National Level 
Endangered Species Risk Assessment Process for Biological Evaluations 
of Pesticides is available in the docket. The docket, identified by 
docket ID number EPA-HQ-OPP-2019-0185, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

II. What action is the agency taking?

A. Authority

    The Endangered Species Act (ESA), 16 U.S.C. 1531 et seq., requires 
federal agencies, such as EPA, to ensure that their actions are not 
likely to jeopardize the continued existence of species listed as 
threatened or endangered under the ESA or destroy or adversely modify 
the designated critical habitat of such species. The registration of a 
pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA), 7 U.S.C. 136 et seq., constitutes an EPA ``action'' under the 
ESA. If EPA determines a pesticide may affect a listed species or its 
designated critical habitat, EPA must initiate consultation with the 
U.S. Fish and Wildlife Service and/or the National Marine Fisheries 
Service (collectively referred to as the Services), as appropriate. EPA 
initiates formal consultation with the Services through the conduct and 
transmittal of a biological evaluation (BE) with its findings.

B. Background

    On January 18, 2017, EPA released its first nationwide BEs for 
pesticides conducted using a pilot interagency method developed by EPA 
and the Services, with collaboration from the U.S. Department of 
Agriculture (USDA). The pilot method was developed following the 
recommendations of the April 2013 National Academy of Sciences' (NAS) 
report, Assessing Risks to Endangered and Threatened Species from 
Pesticides. When developing the pilot process, EPA and the Services 
intended to revisit and refine the method to address limitations 
identified through evaluation of the pilot chemicals (i.e., 
chlorpyrifos, diazinon and malathion). A full description of the pilot 
method and the NAS report recommendations are available at: https://www.epa.gov/endangered-species/implementing-nas-report-recommendations-ecological-risk-assessment-endangered-and.
    EPA believes that the pilot method had the following major 
limitations: (1) The method did not meaningfully distinguish species 
that are likely to be exposed to and affected by the assessed 
pesticides from those that are not likely; (2) The level of effort was 
too high for EPA to sustain for all pesticides; and (3) The amount of 
documentation produced was too great for the public to review and 
comment upon in a reasonable timeframe. Consistent with the pilot 
process, EPA has developed and is proposing a revised method for the 
nationwide evaluation of pesticide risks to listed species that is 
based on the experience gained through the pilot BEs and on information 
received in public comments on the draft pilot BEs and through several 
stakeholder meetings. EPA's draft revised method, which continues to 
follow NAS's recommendations, is designed to be: (1) Efficient, relying 
upon automation as much as possible; (2) Protective without being 
overly conservative; (3) Transparent; and (4) Scientifically 
defensible, relying on the best available data.

C. Summary of Major Aspects of Draft Revised Method

    The following is a summary of the major aspects for which the EPA 
is seeking comment on the draft revised method for assessing risk to 
listed species.
    First, to more accurately represent where and to what extent a 
pesticide is likely to be applied, EPA is proposing an approach for 
incorporating pesticide-

[[Page 22122]]

specific usage data into the listed species consultation process. The 
pilot BEs relied on use assumptions from pesticide product labels to 
represent where the pilot chemicals were likely to be applied (e.g., 
applied to all labelled crops at maximum application rates 
simultaneously). The revised method proposes to incorporate usage data 
(e.g., survey data, including actual application rates) in the 
determination of where a pesticide is likely to be applied.
    Second, based on the accuracy of the spatial data utilized and the 
conservative assumptions related to the action area and potential 
drift, EPA is interpreting a <1% overlap of listed species' ranges with 
potential use sites as unreliable and not representative of real 
exposure potential.
    Third, EPA's revised method proposes the use of probabilistic 
methods to determine the likelihood of a species to be adversely 
affected by a pesticide. The goal of the probabilistic analysis is to 
more fully capture and characterize the variability in the range of 
potential exposures and toxicological effects to listed species and to 
better inform the biological opinion.
    The fourth major area of revision is to apply a weight-of-evidence 
framework to distinguish those listed species that are likely to be 
adversely affected (LAA) from those that are not likely to be adversely 
affected (NLAA), based on criteria (e.g., dietary preferences, 
migration patterns, extent of range potentially exposed) associated 
with the likelihood that an individual will be exposed and affected.

D. Public Comments Sought

    EPA is seeking comment on the draft revised method for assessing 
risk to listed species, and is specifically interested in comments 
regarding the degree to which the following aspects of its draft 
revised method are reasonable and represent advances in the pilot 
methodologies for assessing risk to listed species: (1) The proposed 
methodology for incorporating usage data in Steps 1 and 2 of the BE; 
(2) The proposed interpretation that a <1% overlap of listed species' 
ranges with potential use sites is unreliable, based on the accuracy of 
the underlying data, and does not represent real-world exposure; (3) 
The proposed approach for introducing components of probabilistic 
analyses into the BE; and (4) The proposed weight-of-evidence 
framework.

III. Public Meeting

    EPA will host a public meeting, along with representatives from the 
Services and USDA, to present the draft revised method and to provide 
an additional opportunity for the public to provide feedback. This 
meeting is an opportunity for stakeholders and agencies to continue 
their dialogue on the technical aspects of implementing the NAS 
recommendations, building on public meetings held in November 2013, 
April and October 2014, April 2015, and June 2016, and furthers the 
agencies' goal of developing a sustainable methodology and process for 
assessing pesticide impacts on listed species that is efficient, 
inclusive, and transparent.
    Date: The meeting will be held on Monday, June 10, 2019 from 9:00 
a.m. to 12:00 noon, E.S.T. Additional meeting details, including an 
agenda, teleconference and webinar information, will be available 
shortly in the docket.
    Accommodations requests: To request accommodation of a disability, 
please contact the person listed under FOR FURTHER INFORMATION CONTACT, 
preferably at least 10 days prior to the meeting to give EPA as much 
time as possible to accommodate your request.
    Requests to participate: You must register by Thursday, May 30, 
2019 to attend either in person or via teleconference/webinar. Public 
comments may be made during the oral comment session of the meeting. 
Requests to participate in the meeting and to make oral comments must 
be submitted to the person listed under FOR FURTHER INFORMATION 
CONTACT.

    Authority: 7 U.S.C. 136 et seq.

    Dated: May 10, 2019.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2019-10177 Filed 5-15-19; 8:45 am]
BILLING CODE 6560-50-P


