Pesticide Registration Review; Draft Human Health and Ecological Risk Assessments for Several Pesticides for Several Isothiazolinones; Notice of Availability, 28944-28946 [2020-10376]

Download as PDF 28944 Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices recommendations to the EPA Administrator on the technical basis for EPA actions. As a Federal Advisory Committee, the SAB conducts business in accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2) and related regulations. The SAB Radiation Advisory Committee (RAC) is a subcommittee of the SAB that provides strategic advice through the chartered SAB on radiation protection, radiation science, and radiation science applications. The SAB and the RAC, augmented with additional experts, will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies. MARSSIM provides information on planning, conducting, evaluating, and documenting environmental radiological surveys of surface soil and building surfaces for demonstrating compliance with regulations. MARSSIM, when finalized as Revision 2, will update this multi-agency consensus document. MARSSIM was originally developed by the technical staffs of the four Federal agencies having authority for control of radioactive materials: DoD, DOE, EPA, and NRC (60 FR 12555; March 7, 1995). The four agencies issued Revision 1 to MARSSIM in August 2000, and additional edits to Revision 1 in June 2001. MARSSIM has not been updated since 2001; updates prior to 2001 primarily consisted of minor non-technical edits. Revision 2 updates the science, clarifies methods, and implements lessons learned from over 20 years of the document’s use in industry. Request for Nominations The SAB Staff Office is seeking nominations of nationally and internationally recognized scientists and engineers with demonstrated expertise and experience to augment the RAC for the peer review of MARSSIM, Revision 2. The SAB Staff Office is looking for experts in one or more of the following disciplinary areas: Environmental monitoring and sampling, geology, hydrogeology, measurement protocols and statistics. Expertise should include a focus on radionuclides. jbell on DSKJLSW7X2PROD with NOTICES Additional Information For questions concerning ‘‘MARSSIM, Rev. 2 (2020) please contact Kathryn Snead of the U.S. EPA, Office of Radiation and Indoor Air, by telephone at (202) 343–9228, or email at snead.kathryn@epa.gov. VerDate Sep<11>2014 18:29 May 13, 2020 Jkt 250001 Process and Deadline for Submitting Nominations Any interested person or organization may nominate qualified individuals with relevant experience for possible service on the SAB MARSSIM Review Panel identified in this notice. Nominations should be submitted in electronic format (preferred) following the instructions for ‘‘Nominating Experts to Advisory Panels and Ad hoc Committees Being Formed,’’ provided on the SAB website (see the ‘‘Nomination of Experts’’ link under ‘‘Current Activities’’) at https:// www.epa.gov.sab. To receive full consideration, EPA’s SAB Staff Office requests contact information about the person making the nomination; contact information about the nominee; the disciplinary and specific areas of expertise of the nominee; the nominee’s resume or curriculum vitae; sources of recent grant and/or contract support; and a biographical sketch of the nominee indicating current position, educational background, research activities, and recent service on other national advisory committees or national professional organizations. Persons having questions about the nomination procedures, or who are unable to submit nominations through the SAB website, should contact Dr. Diana Wong as indicated above in this notice. Nominations should be submitted in time to arrive no later than June 4, 2020. EPA values and welcomes diversity. All qualified candidates are encouraged to apply regardless of sex, race, disability, or ethnicity. The EPA SAB Staff Office will acknowledge receipt of nominations. The names and biosketches of qualified nominees identified by respondents to this Federal Register notice, and additional experts identified by the SAB Staff, will be posted in a List of Candidates on the SAB website at https://www.epa.gov/sab. Public comments on the List of Candidates will be accepted for 21 days. The public will be requested to provide relevant information or other documentation on nominees that the SAB Staff Office should consider in evaluating candidates. For the EPA SAB Staff Office, a balanced review panel includes candidates who possess the necessary domains of knowledge, the relevant scientific perspectives (which, among other factors, can be influenced by work history and affiliation), and the collective breadth of experience. The SAB Staff Office will consider public comments on the List of Candidates, PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 information provided by the candidates themselves, and background information independently gathered by the SAB Staff Office. Selection criteria to be used for panel membership include: (a) Scientific and/or technical expertise, knowledge, and experience (primary factors); (b) availability and willingness to serve; (c) absence of financial conflicts of interest; (d) absence of an appearance of a loss of impartiality; and (e) skills working in panels and advisory committees; and, (f) for the panel as a whole, diversity of expertise and scientific points of view. Candidates invited to serve will be asked to submit the ‘‘Confidential Financial Disclosure Form for Special Government Employees Serving on Federal Advisory Committees at the U.S. Environmental Protection Agency’’ (EPA Form 3110–48). This confidential form allows EPA to determine whether there is a statutory conflict between that person’s public responsibilities as a Special Government Employee and private interests and activities, or the appearance of a loss of impartiality, as defined by Federal regulation.. The form may be viewed and downloaded from the following URL address https:// yosemite.epa.gov/sab/sabproduct.nsf/ Web/ethics?OpenDocument. Dated: May 11, 2020. V. Khanna Johnston, Deputy Director, EPA Science Advisory Board Staff Office. [FR Doc. 2020–10414 Filed 5–13–20; 8:45 am] BILLING CODE 6560–50–P 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 Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: 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-Benzisothiazol3(2H)-one,2-butyl (BBIT), and 3(2H)isothiazolone, 4,5-dichloro-2-octyl(DCOIT). SUMMARY: E:\FR\FM\14MYN1.SGM 14MYN1 28945 Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices 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: https:// 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 https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, are available at https:// 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: fehir.richard@epa.gov. SUPPLEMENTARY INFORMATION: DATES: 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 https://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. jbell on DSKJLSW7X2PROD with NOTICES TABLE—DRAFT RISK ASSESSMENTS BEING MADE AVAILABLE FOR PUBLIC COMMENT Registration review case name and No. MIT/CMIT Case 3092 ...................... OIT Case 2475 ................................ BIT Case 3026 ................................ BBIT Case 5017 .............................. VerDate Sep<11>2014 18:29 May 13, 2020 Docket ID No. Chemical review manager and contact information EPA–HQ–OPP–2013–0605 EPA–HQ–OPP–2014–0160 EPA–HQ–OPP–2014–0159 EPA–HQ–OPP–2015–0736 Jkt 250001 PO 00000 Frm 00019 ........... ........... ........... ........... Fmt 4703 Stephen Stephen Stephen Stephen Sfmt 4703 Savage, Savage, Savage, Savage, savage.stephen@epa.gov, savage.stephen@epa.gov, savage.stephen@epa.gov, savage.stephen@epa.gov, E:\FR\FM\14MYN1.SGM 14MYN1 (703) (703) (703) (703) 347–0345. 347–0345. 347–0345. 347–0345. 28946 Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES TABLE—DRAFT RISK ASSESSMENTS BEING MADE AVAILABLE FOR PUBLIC COMMENT—Continued Registration review case name and No. Docket ID No. DCOIT Case 5023 .......................... EPA–HQ–OPP–2014–0403 ........... 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 VerDate Sep<11>2014 18:29 May 13, 2020 Jkt 250001 Chemical review manager and contact information Stephen Savage, savage.stephen@epa.gov, (703) 347–0345. 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: PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 • 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] BILLING CODE 6560–50–P FEDERAL COMMUNICATIONS COMMISSION [OMB 3060–0912; FRS 16752] Information Collection Being Reviewed by the Federal Communications Commission Federal Communications Commission. ACTION: Notice and request for comments. AGENCY: As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission’s burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control SUMMARY: E:\FR\FM\14MYN1.SGM 14MYN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: https://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 https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, are available at https://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 https://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
------------------------------------------------------------------------
                                                      Chemical review
 Registration review case name    Docket ID No.     manager and contact
            and No.                                     information
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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]
BILLING CODE 6560-50-P
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