Document ID: EPA-HQ-OPP-2018-0278-0001
Agency: epa
Document Type: Notice
Title: Emergency Exemptions; Applications: Ortho-Phthalaldehyde
Posted Date: 2018-06-14T04:00Z

[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Notices]
[Pages 27766-27768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12803]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2018-0278; FRL-9978-55]

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 chemical 
which is not registered by EPA. Accordingly, as required by the Code of 
Federal Regulations, EPA is publishing this notice of receipt to allow 
public comment.

DATES: Because of the long lead time required for acquiring and sending 
products to the International Space Station (ISS), and because this is 
a

[[Page 27767]]

repeat of a previously-approved emergency exemption request, EPA has 
approved NASA's request in advance of publication of this Notice in 
accordance with 40 CFR 166.24(c). Accordingly, there is no prescribed 
period for submitting comments. EPA still welcomes public comment on 
the request, and notes that EPA's regulations provide that an emergency 
exemption may be modified or revoked if, among other things, additional 
information indicates that the product may cause unreasonable adverse 
effects or may not be effective at controlling the target pests. 
Accordingly, the Agency will review all comments received in response 
to this Notice, and consider whether any such comments identify a need 
for modification or revocation of the specific exemption.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2018-0278, 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/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, 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: 
[email protected].

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 (NAICS code 32532) or involved with the 
International Space Station. This listing is not intended to be 
exhaustive, but rather provides a guide for readers regarding entities 
likely to be affected by this action. 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 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 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.
    Previous notices of applications for emergency exemptions for this 
same use of OPA in the ISS IATCS have not elicited significant 
substantive comment. Owing to NASA's need for an expedited decision, 
the negligible human and environmental exposures expected from the 
proposed emergency use, and the absence of registered alternatives that 
meet the ISS IATCS criteria, EPA has approved this emergency exemption 
request prior to receipt of public comments, consistent with 40 CFR 
166.24(c). EPA's regulations provide that an emergency exemption may be 
modified or revoked if, among other things, additional information 
indicates that the product

[[Page 27768]]

may cause unreasonable adverse effects or may not be effective at 
controlling the target pests. Accordingly, EPA still welcomes comments 
on this request and will review all comments received in response to 
this Notice, and consider whether any such comments identify a need for 
modification or revocation of the specific exemption.

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

    Dated: June 6, 2018.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2018-12803 Filed 6-13-18; 8:45 am]
 BILLING CODE 6560-50-P