[Federal Register Volume 86, Number 99 (Tuesday, May 25, 2021)]
[Notices]
[Pages 28097-28099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10519]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0136; FRL-10023-41]


Pesticide Registration Review; Sulfuryl Fluoride Draft Interim 
Re-Entry Mitigation Measures and Registration Review Draft Risk 
Assessments for Sulfuryl Fluoride; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's Sulfuryl 
Fluoride Draft Interim Re-Entry Mitigation Measures and several 
registration review draft risk assessments for sulfuryl fluoride. 
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, that the pesticide can perform its 
intended function without causing unreasonable adverse effects on human 
health or the environment. 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. 
EPA may pursue mitigation at any time during the registration review 
process if it finds that a pesticide poses unreasonable adverse effects 
to human health or the environment. To address human health incidents 
and in response to EPA's Office of Inspector General 2016 (OIG) Report, 
Additional Measures Can Be Taken to Prevent Deaths and Serious Injuries 
From Residential Fumigations (No. 17-P-0053), the EPA believes that the 
mitigation measures outlined in this Sulfuryl Fluoride Draft Interim 
Re-Entry Mitigation Measures are necessary to address identified human 
health risk concerns. The scope of this interim mitigation is focused 
on the use of sulfuryl fluoride as a structural fumigant in residential 
use sites. The Agency is also publishing several registration review 
risk assessments on sulfuryl fluoride for public comment.

DATES: Comments must be received on or before July 26, 2021.

ADDRESSES: Submit your comments 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.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, are available at http://www.epa.gov/dockets.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Public Reading Room are closed to visitors 
with limited exceptions. The EPA/DC staff continue to provide remote 
customer service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For pesticide specific information 
contact: Moana Appleyard, Pesticide Re-Evaluation Division (7508P), 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(703) 308-8175; email address: [email protected].
    For general questions on the registration review program, contact: 
Melanie Biscoe, Pesticide Re-Evaluation Division (7508P), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave. NW, Washington, DC 20460-0001; telephone number: (703) 305-7106; 
email address: [email protected].

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 and 
human health 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.

[[Page 28098]]

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. Background

    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 the Sulfuryl Fluoride Draft Interim Re-Entry 
Mitigation Measures. This decision document is in response to the EPA 
Office of the Inspector General's (OIG) 2016 report entitled Additional 
Measures Can Be Taken to Prevent Deaths and Serious Injuries From 
Residential Fumigations (available at: https://www.epa.gov/sites/production/files/2016-12/documents/_epaoig_20161212-17-p-0053.pdf). The 
OIG conducted this report to determine the extent and nature of adverse 
impacts caused by structural fumigation, after two incidents in 2015, 
including one with the chemical sulfuryl fluoride. The OIG report 
sought to determine whether regulatory, program execution (e.g., 
training, funding, inspections, enforcement, etc.), or other factors 
were associated with adverse impacts. The focus of the audit with 
regards to the chemical sulfuryl fluoride, is residential fumigation 
use. The OIG report detailed several recommendations that fall under 
the purview of the Office of Pesticide Programs (OPP), including:
     Implement a process to evaluate label changes for all 
three brands of sulfuryl fluoride to require secured tenting and 
fumigation management plans.
     Clearly define the criteria for meeting the applicator 
stewardship training requirement.
     Conduct an assessment of clearance devices to validate 
their effectiveness.
    The purpose of the Sulfuryl Fluoride Draft Interim Re-Entry 
Mitigation Measures is to propose risk mitigation measures to address 
these recommendations from the OIG report ahead of the typical 
mitigation phase of Registration Review. EPA expects that the 
implementation of the mitigation measures described in this risk 
mitigation document will allow sulfuryl fluoride products to remain 
available to users while addressing the recommendations from the OIG 
report.
    The Agency has also completed several registration review draft 
human health and ecological risk assessments for sulfuryl fluoride. 
After reviewing comments received during the public comment period, EPA 
may then issue the Sulfuryl Fluoride Final Interim Re-Entry Mitigation 
Measures, revised risk assessments, explain any changes to the 
mitigation measures and draft risk assessments, and respond to 
comments. The Agency is only proposing mitigation to address the OIG 
audit at this time. Once all the risk assessments are completed for all 
the uses of sulfuryl fluoride, EPA may propose additional mitigation to 
address potential risks, as part of the normal registration review 
process. At that time, EPA may request public input on additional risk 
mitigation before completing a Proposed Interim Decision (PID). 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.

III. Authority

    EPA is conducting its registration review of the sulfuryl fluoride 
documents listed in Unit IV 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.

IV. What action is the Agency taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability 
of EPA's Sulfuryl Fluoride Draft Interim Re-Entry Mitigation Measures 
and several human health and ecological risk assessments for sulfuryl 
fluoride and opens a 60-day public comment period on the Sulfuryl 
Fluoride Draft Interim Re-Entry Mitigation Measures and the risk 
assessments. Additional support documents will be available in the 
public docket, which the Agency is not taking comment on.
    Documents to publish in response to the OIG audit and open for 
public comment:
     Sulfuryl Fluoride Draft Interim Re-Entry Mitigation 
Measures.
     Sulfuryl Fluoride: Tier I Review of Human Incidents for 
Draft Risk Assessment.
    Support documents to publish in response to the OIG audit that are 
not open for public comment:
     Memorandum: Assessment of Portable Devices for Their 
Effectiveness in Detecting Sulfuryl Fluoride (SF) at Clearance Level.
     Laboratory Testing of Portable Clearance Devices with 
Sulfuryl Fluoride Standard, Analytical Chemistry Branch (ACB), Office 
of Pesticide Programs.
    The Agency is also publishing the following documents to the 
sulfuryl fluoride docket as part of the Registration Review of sulfuryl 
fluoride. These documents will publish for a 60-day comment period. 
After the dietary risk assessment for sulfuryl fluoride is

[[Page 28099]]

completed and publishes for comment, the Agency will issue a Proposed 
Interim Decision (PID) to address all the uses of sulfuryl fluoride.
    Registration Review documents available for publication and open 
for public comment:
     Sulfuryl Fluoride. Residential Post-application Exposure 
and Risk Assessment.
     Sulfuryl Fluoride. Occupational and Residential Exposure 
Assessment in Support of Registration Review.
     Sulfuryl Fluoride--Draft Risk Assessment in Support of 
Office of Registration Review Part I: Occupational and Residential 
Exposure.
     Six Structural and Commodity Fumigants: Combined Draft 
Risk Assessment (DRA) and Drinking Water Assessment (DWA) for 
Registration Review.
     Overview of Application Methods and Factors, Use, Usage, 
and Benefits of Commodity and Structural Fumigants: Phosphine [(066500) 
including Aluminum Phosphide (066501) and Magnesium Phosphide 
(066504)], Propylene Oxide (042501), Sulfur Dioxide (077601), Sodium 
Metabisulfite (111409), Sulfuryl Fluoride, (078003), Ethylene Oxide 
(042301), and Methyl Bromide (053201).
    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 Sulfuryl Fluoride Draft 
Interim Re-Entry Mitigation Measures and the draft human health and 
ecological risk assessments for sulfuryl fluoride. The Agency will 
consider all comments received during the public comment period and 
make changes, as appropriate, to these documents. EPA may then issue 
the Sulfuryl Fluoride Final Interim Re-Entry Mitigation Measures, 
revised risk assessments, explain any changes to the mitigation 
measures and draft risk assessments, and respond to comments.
    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 audio-graphic or video-
graphic 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: May 5, 2021.
Mary Reaves,
Director, Pesticide Re-Evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2021-10519 Filed 5-24-21; 8:45 am]
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