[Federal Register Volume 88, Number 164 (Friday, August 25, 2023)]
[Notices]
[Pages 58265-58266]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18389]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2023-0404; FRL-11284-01-OCSPP]


Ortho-Phthalaldehyde; Receipt of Application for Emergency 
Exemption, Solicitation of Public Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has received a specific exemption request from the 
National Aeronautics and Space Administration (NASA) to use the 
pesticide ortho-phthalaldehyde (OPA, CAS No. 643-79-8) to treat the 
coolant fluid of the internal active thermal control system of the 
International Space Station to control aerobic/microaerophilic bacteria 
in the aqueous coolant. The applicant proposes the use of a new 
chemical which has not been registered by EPA. Therefore, in accordance 
with the Code of Federal Regulations, EPA is soliciting public comment 
before making the

[[Page 58266]]

decision whether to grant the exemption.

DATES: Comments must be received on or before September 11, 2023.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2023-0404, through the Federal eRulemaking 
Portal at 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. Additional 
instructions on commenting and visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Director Registration 
Division (7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address: 
<a href="/cdn-cgi/l/email-protection#d2809694809cbda6bbb1b7a192b7a2b3fcb5bda4"><span class="__cf_email__" data-cfemail="74263032263a1b001d171107341104155a131b02">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are a 
pesticide manufacturer, North American Industrial Classification System 
(NAICS) (Code 32532) or involved with the International Space Station. 
This listing is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Other types of entities not listed could also be affected.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
www.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/commenting-epa-dockets.
    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 
pesticide(s) discussed in this document, compared to the general 
population.

II. What action is the Agency taking?

    Under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) (7 U.S.C. 136p), at the discretion of the EPA 
Administrator, a Federal or State agency may be exempted from any 
provision of FIFRA if the EPA Administrator determines that emergency 
conditions exist which require the exemption. NASA has requested the 
EPA Administrator to issue a specific exemption for the use of ortho-
phthalaldehyde (OPA) in the coolant of the internal active thermal 
control system (IATCS) of the International Space Station (ISS) to 
control aerobic/microaerophilic bacteria in the aqueous coolant. 
Information in accordance with 40 CFR part 166 was submitted as part of 
this request.
    As part of this request, the applicant asserted that it has 
considered the registered biocide alternatives and has concluded that 
OPA is the most effective biocide that meets the requisite criteria 
including: The need for safe, non-intrusive implementation and 
operation in a functioning system; the ability to control existing 
planktonic and biofilm-residing micro-organisms; a negligible impact on 
system wetted materials of construction; and a negligible reactivity 
with existing coolant additives. The ISS would not have an adequate 
long-term solution for controlling the micro-organisms in the IATCS 
coolant without the use of OPA. The OPA is incorporated into a porous 
resin material contained in a stainless-steel canister. The canister 
containing the OPA-incorporated resin is inserted into a coolant system 
loop, using flexible hose and quick disconnects and is placed in line 
for 8 hours to deliver the OPA into the fluid. As the coolant fluid 
flows through the cannister, the OPA elutes from the resin material 
into the coolant fluid. The total volume of the circulatory loops of 
the IATCS is 829 liters. The maximum concentration would be 350 
milligrams (mg) of OPA per liter of coolant fluid. A total of 290,150 
mg would be needed for the entire system. The OPA is incorporated into 
the resin at 210 mg OPA per cm\3\ resin, resulting in a potential total 
use of 1,382 cm\3\ of the OPA-containing resin. The level of OPA in the 
coolant is monitored periodically, and because OPA degrades over time, 
the concentration decreases to a level that is no longer effective in 
about 1 to 2 years. At this point, replenishment with new OPA-
containing canisters is required. EPA has authorized similar emergency 
exemptions for this use since 2011. With the decision to extend the 
mission of the ISS to 2030, the need for this use is expected to 
continue for the duration of the program.
    This notice does not constitute a decision by EPA on the 
application itself. The regulations governing FIFRA section 18 require 
publication of a notice of receipt of an application for a specific 
exemption proposing the use of a new chemical (i.e., an active 
ingredient) which has not been registered by EPA.
    The notice provides an opportunity for public comment on the 
application. The Agency will review and consider all comments received 
during the comment period in determining whether to issue the specific 
exemption requested by the NASA.
    Authority: 7 U.S.C. 136 et seq.

    Dated: August 21, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2023-18389 Filed 8-24-23; 8:45 am]
BILLING CODE 6560-50-P


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