[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Notices]
[Pages 28944-28946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10376]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0720; FRL-10008-07]


Pesticide Registration Review; Draft Human Health and Ecological 
Risk Assessments for Several Pesticides for Several Isothiazolinones; 
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 and ecological risk assessments for the registration review of 
Methylisothiazolinone/Chloromethylisothiazolinone (MIT/CMIT), 
Octhilinone (OIT), Benzisothiazolin-3-one, 3(2H)-Isothiazolone (BIT), 
1,2-Benzisothiazol-3(2H)-one,2-butyl (BBIT), and 3(2H)-isothiazolone, 
4,5-dichloro-2-octyl- (DCOIT).

[[Page 28945]]


DATES: Comments must be received on or before July 13, 2020.

ADDRESSES: Submit your comments, to the docket identification (ID) 
number for the specific pesticide of interest provided in the Table in 
Unit IV, 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, are 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 Table in Unit IV.
    For general questions on the registration review program, contact: 
Richard Fehir, Antimicrobials Division (7510P), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, 
Washington, DC 20460-0001; telephone number: (703) 347-8101; 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, 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 identified in the Table in Unit IV.

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 comprehensive draft human health and/or 
ecological risk assessments for all pesticides listed in the Table in 
Unit IV. After reviewing comments received during the public comment 
period, EPA may 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 the pesticides listed in the Table in 
Unit IV. 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 chemicals listed 
in the Table 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 human health and ecological risk assessments for the 
pesticides shown in the following table and opens a 60-day public 
comment period on the risk assessments.

  Table--Draft Risk Assessments Being Made Available for Public Comment
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                                                      Chemical review
 Registration review case name    Docket ID No.     manager and contact
            and No.                                     information
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MIT/CMIT Case 3092............  EPA-HQ-OPP-2013-0  Stephen Savage,
                                 605.               [email protected], (703) 347-0345.
OIT Case 2475.................  EPA-HQ-OPP-2014-0  Stephen Savage,
                                 160.               [email protected], (703) 347-0345.
BIT Case 3026.................  EPA-HQ-OPP-2014-0  Stephen Savage,
                                 159.               [email protected], (703) 347-0345.
BBIT Case 5017................  EPA-HQ-OPP-2015-0  Stephen Savage,
                                 736.               [email protected], (703) 347-0345.

[[Page 28946]]

 
DCOIT Case 5023...............  EPA-HQ-OPP-2014-0  Stephen Savage,
                                 403.               [email protected], (703) 347-0345.
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    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/or 
ecological risk assessments for the pesticides listed in the Table in 
Unit IV. The Agency will consider all comments received during the 
public comment period and make changes, as appropriate, to a draft 
human health and/or ecological risk assessment. For specific comments 
the Agency is soliciting, see Unit V of this notice. EPA may then issue 
a revised risk assessment as part of the proposed interim decision 
(PID), explain any changes to the draft risk assessment, 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 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.

V. Request for Comment

    The EPA specifically requests comment concerning the draft risk 
assessments in the following areas:
     The use of in vitro and the artificial neural network-
based defined approach (DA) to determine points of departure used in 
the isothiazolinone draft risk assessments instead of using laboratory 
animal data to evaluate risks for dermal sensitization.
     The use of a 100-fold uncertainty factor (UF) for the in 
vitro points of departure and use of a 10-fold UF for the human study 
point of departure selected for the human health dermal assessment.
    Additionally, EPA requests information that may help the Agency 
refine the draft risk assessments. For the human health risk 
assessment, EPA welcomes the following information:
     For the assessment of inhalation risk, the inhalation 
toxicity study for DCOIT has been bridged to assess hazard of both BIT 
and BBIT, which do not have inhalation toxicity data. While the no 
observed adverse effect level (NOAEC) value from the DCOIT study is 
conservative, refinement of the NOAEC through benchmark dosing is not 
possible. Due to the 32-fold difference between the NOAEC and lowest 
observed adverse effect level (LOAEC) values in the DCOIT study, the 
inhalation risks may be overestimated using the conservative, unrefined 
endpoint from DCOIT. Additional chemical-specific inhalation toxicity 
data using proper dose spacing to conduct benchmark dose analysis would 
help to refine the inhalation risk assessments for the 
isothiazolinones.
     Residue transfer data are not available at this time for 
textiles/clothing, plastics, and carpets and 100% of the application 
rate was assumed to transfer to children. Data currently being 
collected by the Antimicrobial Exposure Assessment Task Force (AEATF 
II) will potentially help to refine the human incidental oral and 
dermal exposures.
    For the environmental risk assessments, EPA requests the following 
information:
     Degradation studies to show potential degradation in 
wastewater treatment facilities.
     More robust usage data on paper production, including 
information on how the compounds are used in paper production.

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

    Dated: April 9, 2020.
Anita Pease,
Director, Antimicrobials Division, Office of Pesticide Programs.
[FR Doc. 2020-10376 Filed 5-13-20; 8:45 am]
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