[Federal Register Volume 85, Number 187 (Friday, September 25, 2020)]
[Notices]
[Pages 60458-60459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21185]


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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2020-0390; FRL-10014-21]


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

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 (CFR), EPA is soliciting public 
comment before making the decision whether to grant the exemption.

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

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2020-0390, 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.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues 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: Marietta Echeverria, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: In accordance with the regulations at 40 CFR 
166.24(a)(1), EPA is soliciting public comment before making the 
decision whether to grant the exemption.

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

[[Page 60459]]

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 
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 stated that it has 
considered the registered biocide alternatives and has concluded that 
OPA is the most effective biocide which 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 canister, 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 500 milligrams 
(mg) of OPA per liter of coolant fluid. A total of 414,500 mg of OPA 
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 1,974 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 2024, the need for this use is expected to 
continue for the duration.
    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 NASA.

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

    Dated: September 11, 2020.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2020-21185 Filed 9-24-20; 8:45 am]
BILLING CODE 6560-50-P


