[Federal Register Volume 79, Number 164 (Monday, August 25, 2014)]
[Notices]
[Pages 50660-50661]
[FR Doc No: 2014-20016]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Cellular, Tissue and Gene Therapies Advisory
Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on November 6, 2014, from 9
a.m. to approximately 4:30 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD
20993. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Gail Dapolito or Rosanna Harvey, Food and Drug
Administration, Center for Biologics Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 71, Silver Spring, MD 20993,<PHONE_NUMBER> or 240-
402-8072, email<EMAIL_ADDRESS>or
<EMAIL_ADDRESS>or FDA Advisory Committee Information Line,
1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A notice in
the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The committee will discuss the draft guidance for industry
entitled ``Design and Analysis of Shedding Studies for Virus or
Bacteria-Based Gene Therapy and Oncolytic Products'' and the Dear Gene
Therapy IND or Master File Sponsor Letter.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
October 23, 2014. Oral presentations from the public will be scheduled
between approximately 11:05 a.m. and 12:05 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before October 15, 2014.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by October 16, 2014.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Gail Dapolito at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/

AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct
during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: August 19, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-20016 Filed 8-22-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 17 (Thursday, January 26, 2023)]
[Notices]
[Page 4992]
[FR Doc No: 2023-01489]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 15271-000]

Premium Energy Holdings, LLC; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

    On March 31, 2022, Premium Energy Holdings, LLC filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act (FPA), proposing to study the feasibility of the
Twitchell Pumped Storage Hydro Project to be located approximately 6
miles northeast of Santa Maria, California in the limits between San
Luis Obispo and Santa Barbara Counties. The sole purpose of a
preliminary permit, if issued, is to grant the permit holder priority
to file a license application during the permit term. A preliminary
permit does not authorize the permit holder to perform any land-
disturbing activities or otherwise enter upon lands or waters owned by
others without the owners' express permission.
    The proposed project would consist of the following: (1) a new
upper reservoir located either, on the western side of the Sierra Madre
Mountains in Santa Barbara County, California, with a maximum elevation
of 1,788 feet average mean sea level, with a surface area of 72 acres
and a storage capacity of 7,150 acre-feet (alternative 1), or a new
reservoir 0.5 mile west of Twitchell Lake with a maximum elevation of
1,296 feet average mean sea level, with a surface area of 83 acres and
a storage capacity of 11,400 acre-feet (alternative 2); (2) an existing
lower reservoir (Twitchell Reservoir), with an elevation of 592 feet
average mean sea level, a surface area of approximately 400 acres and a
storage capacity of 197,756 acre-feet; (3) either a 0.32-mile-long
headrace tunnel, 0.07-mile-long vertical shaft, 2.20-mile-long
horizontal tunnel, 0.03-mile-long penstock, and 0.46-mile-long tailrace
tunnel (alternative A), or a 0.16-mile-long headrace tunnel, 0.04-mile-
long vertical shaft, 1.10-mile-long horizontal tunnel, 0.02-mile-long
penstock, and 0.23-mile long tailrace tunnel (alternative B) connecting
the reservoirs to the powerhouse, with a maximum head of 704 or 1,196
feet depending on the selected upper reservoir; (4) either a new 9-
mile-long 230-kilovolt (kV) line and 2.5 miles of SCE's existing right
of way that will interconnect the project with the existing PG&E
transmission system at the Mesa Substation (alternative 1), or a 230-kV
line that would be installed that would interconnect at a future
substation that would be a part of the Central California Power Connect
project (alternative 2); (5) a new powerhouse that would house 4 new
pump-turbines rated at 150 megawatts each; (6) a new substation
installed on the northern or southern side of the Twitchell Reservoir
depending on the upper reservoir alternatives, close to the powerhouse;
and (7) appurtenant facilities. The estimated annual power generation
at the Twitchell Pumped Storage Project would be 1,200,000 megawatt-
hours.
    Applicant Contact: Victor M. Rojas, Managing Director, Premium
Energy Holdings, LLC. 355 South Lemon Ave., Suite A, Walnut, California
91789; phone:<PHONE_NUMBER>; [email protected].
    FERC Contact: Benjamin Mann; email: [email protected]; phone:
(202) 502-8127.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, notices of intent, and competing
applications using the Commission's eFiling system at https://ferconline.ferc.gov/eFiling.aspx. Commenters can submit brief comments
up to 6,000 characters, without prior registration, using the eComment
system at https://ferconline.ferc.gov/QuickComment.aspx. You must
include your name and contact information at the end of your comments.
For assistance, please contact FERC Online Support. In lieu of
electronic filing, you may submit a paper copy. Submissions sent via
the U.S. Postal Service must be addressed to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Room 1A, Washington, DC 20426. Submissions sent via any other carrier
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852.
The first page of any filing should include docket number P-15271.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-15271) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: January 19, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-01489 Filed 1-25-23; 8:45 am]
BILLING CODE 6717-01-P


Received from EMA February 9, 2005 Measurement Accuracy Margin for the Heavy Duty In Use Testing Final Rule EPA Staff Working Document Background: The settlement outline states that new measurement accuracy margins for the heavy duty in use testing ( HDIUT) program will be jointly determined by EPA, CARB, and the engine manufacturers. The purpose of these margins is to account for the uncertainty associated with portable emissions sampling systems incremental to laboratory performance. EPA maintains that the Final Rule needs to include " hard wired" accuracy margins for all pollutants. These are at a minimum needed for the " pilot programs." EPA has indicated that it would provide " liberal" values for these interim accuracy margins and manufacturers have indicated their agreement with these margins. 1 Further, in meetings on this subject, manufacturers have indicated that more data is needed to establish the accuracy margins for the 2007 fully enforceable program for gaseous emissions and a 2008 fully enforceable program for particulate matter ( PM). EPA also believes that more data would be helpful in determining the final accuracy margins and is willing to engage in a program to develop that information. This paper identifies how the data driven accuracy margins can be developed and how they would be implemented by a direct final rulemaking. It also describes the consequences of failing to complete the program to define data driven accuracy margins in time to start either of the enforceable programs.

Program Development: EPA will develop the basic scope and objectives of the program to derive the data driven margins with the participation of the engine manufacturers. It would be highly desirable for manufacturers to be objectively involved in the design of the program given the scope and importance of the project. ( EPA expects that each manufacturer would have one representative to assist in developing the program. CARB may also choose to participate [ CARB has committed to propose an in use testing program in substantial conformance with EPA's. The nature of CARB's participation needs to be conclusively established before any MOU is signed.]). The programmatic objectives, approach, and the relative roles of EPA and the engine manufacturers and other points of agreement necessary for a successful program would be reflected in a Memorandum of Understanding ( MOU) or similar document.

More specifically, the MOU would address the development of both gaseous and PM accuracy margins. For gaseous emissions, the document would explicitly detail the objectives, testing, data analysis, and commitments from each party including cost sharing, payments in kind, or other possible contributions. 2 The MOU would contain a hard funding limit, i. e., not to exceed value, for the gaseous emissions test program. For PM, the document would specify that the parties agree to develop a detailed testing and data analysis plan ( such as is now underway for the gaseous pollutants) within XX months of signing the MOU. The document would also explicitly detail for PM as many of the program objectives, scope, and commitments from each party as possible, including cost sharing, payments in kind, or other possible contributions. Furthermore, the MOU would specify a PM test plan similar in approach and level of testing as that used to develop the gaseous emission accuracy margins. The PM portion of the MOU 1 The additive interim accuracy margins ( g/ bhp hr) are as follows: NMHC = 0.17; NOx = 0.5; CO = 0.60; and PM = 0.10. 2 As currently envisioned for the gaseous test program, the primary contribution by all parties will be money. The total dollar cost would be split equally ( pro rata) between industry and government. Manufacturers will also contribute test engines, which will be valued as part of their monetary contribution. 2 would also contain a hard funding limit, i. e., not to exceed value, for the test program. Finally, the document would contain an agreement that the parties would not contest the data driven gaseous and PM results so long as they are derived from the agreed upon test program and the application of the agreed upon analytical methods.

Objective, Approach, and Accommodations: The margins will compensate for the difference between in use emission measurement accuracy and laboratory emission measurement accuracy. Individual margins will be established for NOx, NMHC, CO, and PM. This program is not intended to determine potential accuracy allowances for laboratory testing at the levels of the 2007/ 2010 emission standards. The margins determined by this program will be established by a rigorous in field and laboratory test program that assesses, at a minimum, lab to PEMS emission differences and accounts for in use environmental effects on PEMS units. The overall scope, experimental design, and analytical methodology for determining each accuracy margin would be agreed upon well in advance of initiating the test program. The test programs for gaseous and PM pollutants would ideally be integrated and sequenced into the overall test plan to provide final results in time for the fully enforceable programs described above. Nonetheless, in no case should work on developing the gaseous accuracy margins be delayed while a work plan for the PM test program is being completed. It is imperative that the test program for gaseous emissions is initiated and completed quickly to avoid delaying the enforceable program that begins in 2007.

All testing and subsequent data analysis will be overseen by EPA and coordinated with the engine manufacturers. It is anticipated that much of the testing and data analysis will be performed under contract by an agreed upon third party or parties. Furthermore, it is anticipated that the experimental designs will be submitted to a statistician to ensure that the information generated is sufficient and appropriate for developing the accuracy margins, and to establish an algorithm for calculating the margins. This overall approach will provide assurances that the experimental designs are acceptable to all participants and is intended to prevent multiple interpretations of the data driven results so that the margins can be implemented by direct final rulemaking. It will also help ensure that the program will be completed on schedule and budget. ( Although EPA intends to implement data driven accuracy margins by direct final rule, the Agency cannot guarantee that the test program results would end up in a final rule if significant adverse comments are received.)

Finally, EPA understands that participation by manufacturers in the test programs will result in some burden to those companies, but will produce useful information. Therefore, if manufacturers agree to participate in the test programs, EPA would reduce the manufacturers' testing burden under the original pilot program ( 2005 2006 for gaseous and 2006 2007 for PM) to five vehicles per designated engine family.

Schedule: In order to provide adequate time to promulgate the data driven accuracy margins, the test programs will generally need to conform to the following schedule. First, the MOU containing the experimental design, analytical methods, and resource commitments for determining the accuracy margins should be signed by senior management of all parties no later than XX, 2005. Second, the subsequent detailed test and data analysis plan for PM should be signed by senior management of all parties no later than XX, 2005. Third, the test programs 3 should be completed and final accuracy margins available by September 30, 2006 for the gaseous emissions and by September 30, 2007 for PM.

Regulatory Provision: If it is determined that the test programs as described above are an appropriate mechanism for determining final accuracy margins, the basic programmatic objectives and approach, and the relative roles of the EPA and the engine manufacturers would be reflected in the HDIUT final rule. The key provisions of the MOU, such as the contributions and deliverables for each party, would be referenced and to the degree possible contained in the preamble of the rule. Certain key provisions would also be reflected in the regulatory language as a means to provide certainty to all parties. These provisions would include items such as the pilot program provisions and, as appropriate, the consequences of failing to complete the accuracy margin test programs as specified below. The accuracy margin algorithm may also be included in the regulatory text.

The MOU will address a test program that is designed to provide the data ( and associated data analysis) needed to derive the final data driven accuracy margins by September 30, 2006 for gaseous emissions and September 30, 2007 for PM. 3 The MOU will specify key interim deliverable milestones. It will also specify that the final data driven accuracy margins will be documented in a final report from the contractor as soon as practicable, but in no case later December 1, 2006 for gaseous and December 1, 2007 for PM. [ deleted sentence; awkward; repetitive] The data driven accuracy margins will be proposed by EPA in a direct final rule as soon as possible after the values are identified. The MOU will acknowledge that publishing and finalizing the direct final rule with the data driven margins would fulfill EPA's obligation under the settlement agreement.

If a failure to deliver the final accuracy values by the December 1 date is the fault of the manufacturers, the respective enforceable program goes into effect using the previously agreed upon interim accuracy margins. A manufacturers' failure may be demonstrated by missing one or more of the critical milestones as follows:

 Torque/ BSFC v. speed/ load and AECD maps delivered to contractor at time of contract signature  Contracts funded and signed within 60 days after MOU signature  Engines delivered to contractor within 90 days after MOU signature [ these dates are subject to further due diligence to assess their reasonableness]

A failure by any individual manufacturer that leads to missing one or more of the critical milestones described above would be regarded as a failure by all manufacturers.

If the interim accuracy margins go into effect as a result of a manufacturers' failure, EPA may pursue a separate rulemaking to establish different accuracy margins for any subsequent year after the enforceable program begins.

If a failure to obtain final documentation from the contractor of the final accuracy values by the December 1 date is the fault of EPA or a party other than the manufacturers, and the delay is less 3 Laboratory and environmental testing will be performed by a third party contractor. 4 than a total of 3 months, the enforceable program will be delayed by the same amount of time it takes to complete and finalize the final contractor report, i. e., a one to one correspondence. 4 If the final documentation of the final values is delayed beyond 3 months, the Phase 1 and 2 pilot programs will be implemented for that year using the interim accuracy margins. If necessary, this cycle will be repeated until the final accuracy margins are identified and documented in a final report.

If the enforceable program is delayed, however, and subject to the negotiated annual cap on the designation of engine families for in use testing, the applicable 2007 and subsequent model year engines may be selected and subject to enforcement testing ( for gaseous as well as PM emissions) once the accuracy margins are established and the enforcement program begins.

If fundamental, irresolvable technical problems are identified relative to the PM portable emission measurement systems, the PM pilot program or enforceable program goes into abeyance until such time as suitable emission measurement devices are identified or the problems otherwise resolved. If the enforceable program is delayed, however, and subject to the negotiated annual cap on the designation of engine families for in use testing; the applicable 2007 and subsequent model year engines may be selected and subject to enforcement testing ( for gaseous as well as PM emissions) once the accuracy margins are established and the enforcement program begins.

EMADOCS: 6567.2 4 The anticipated June 30 date for designating engine families, which initiates the 18 month testing/ reporting period, would be delayed.


[Federal Register Volume 86, Number 231 (Monday, December 6, 2021)]
[Rules and Regulations]
[Pages 68918-68921]
[FR Doc No: 2021-26412]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0639; FRL-9233-01-OCSPP]

2,5-Furandione, Polymer With Ethenylbenzene, Octyl Imide, Imide
With Polyethylene-Polypropylene Glycol 2-Aminopropyl Me Ether;
Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of 2,5-furandione, polymer with
ethenylbenzene, octyl imide, imide with polyethylene-polypropylene
glycol 2-aminopropyl Me ether, when used as an inert ingredient in a
pesticide chemical formulation. Spring Regulatory Sciences, on behalf
of Colorants Solutions USA LLC, submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption
from the requirement of a tolerance. This regulation eliminates the
need to establish a maximum permissible level for residues of 2,5-
furandione, polymer with ethenylbenzene, octyl imide, imide with
polyethylene-polypropylene glycol 2-aminopropyl Me ether (CAS Reg. No.
1812871-29-6) on food or feed commodities.

DATES: This regulation is effective December 6, 2021. Objections and
requests for hearings must be received on or before February 4, 2022,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0639, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    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:<PHONE_NUMBER>; 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 an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
https://www.ecfr.gov/current/title-40.

C. Can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2021-0639 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
February 4, 2022. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2021-0639, 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 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, is available at https://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of October 21, 2021 (86 FR 58239) (FRL-
8792-01-OCSPP), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-
11612) filed by Spring Regulatory Sciences, 6620 Cypresswood Dr., Suite
250, Spring, TX 77379, on behalf of Colorants Solutions USA LLC., 4000
Monroe Road, Charlotte, NC 28205. The petition requested that 40 CFR
180.960 be amended by establishing an exemption from the requirement of
a tolerance for residues of 2,5-furandione, polymer with
ethenylbenzene, octyl imide, imide with polyethylene-polypropylene
glycol 2-aminopropyl Me ether (CAS Reg. No. 1812871-29-6). That
document included a summary of the petition prepared by the petitioner
and solicited comments on the petitioner's request. The Agency did not
receive any substantive public comments.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and use in residential settings but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing an exemption from the
requirement of a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue . . .'' and
specifies factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks to human health. To
determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers expected to present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d). 2,5-Furandione, polymer with
ethenylbenzene, octyl imide, imide with polyethylene-polypropylene
glycol 2-aminopropyl Me ether (CAS Reg. No.1812871-29-6) conforms to
the definition of a polymer given in 40 CFR 723.250(b) and meets the
following criteria that are used to identify low-risk polymers.
    1. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
    2. The polymer does contain as an integral part of its composition
at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen,
silicon, and sulfur.
    3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize: An
adequate biodegradation study (MRID 51632702) was submitted for 2,5-
furandione, polymer with ethenylbenzene, octyl imide, imide with
polyethylene-polypropylene glycol 2-aminopropyl Me ether showing lack
of biodegradation (0% >28 days).
    5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.

    6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
    7. The polymer does not contain certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length as listed in 40 CFR
723.250(d)(6).
    Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
    The polymer's number average molecular weight (MW) of 11,239
daltons is greater than 10,000 daltons. However, the polymer contains
less than 2% oligomeric material below MW 500 (<0.1%) and less than 5%
oligomeric material below MW 1,000 (<0.1%).
    Thus, 2,5-furandione, polymer with ethenylbenzene, octyl imide,
imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether
meets the criteria for a polymer to be considered low risk under 40 CFR
723.250. Based on its conformance to the criteria in this unit, no
mammalian toxicity is anticipated from dietary, inhalation, or dermal
exposure to 2,5-furandione, polymer with ethenylbenzene, octyl imide,
imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this
exemption, EPA considered that 2,5-furandione, polymer with
ethenylbenzene, octyl imide, imide with polyethylene-polypropylene
glycol 2-aminopropyl Me ether could be present in all raw and processed
agricultural commodities and drinking water, and that non-occupational
non-dietary exposure was possible. The minimum number average MW of
2,5-furandione, polymer with ethenylbenzene, octyl imide, imide with
polyethylene-polypropylene glycol 2-aminopropyl Me ether is 11,000
daltons. Generally, a polymer of this size would be poorly absorbed
through the intact gastrointestinal tract or through intact human skin.
Since 2,5-furandione, polymer with ethenylbenzene, octyl imide, imide
with polyethylene-polypropylene glycol 2-aminopropyl Me ether conforms
to the criteria that identify a low-risk polymer, there are no concerns
for risks associated with any potential exposure scenarios that are
reasonably foreseeable. The Agency has determined that a tolerance is
not necessary to protect the public health.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has not found 2,5-furandione, polymer with ethenylbenzene,
octyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl
Me ether to share a common mechanism of toxicity with any other
substances, and 2,5-furandione, polymer with ethenylbenzene, octyl
imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me
ether does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed that 2,5-furandione, polymer with ethenylbenzene, octyl
imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me
ether does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticides/cumulative.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of 2,5-furandione, polymer
with ethenylbenzene, octyl imide, imide with polyethylene-polypropylene
glycol 2-aminopropyl Me ether, EPA has not used a safety factor
analysis to assess the risk. For the same reasons the additional
tenfold safety factor is unnecessary.

VII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of 2,5-furandione, polymer with
ethenylbenzene, octyl imide, imide with polyethylene-polypropylene
glycol 2-aminopropyl Me ether.

VIII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for 2,5-furandione, polymer
with ethenylbenzene, octyl imide, imide with polyethylene-polypropylene
glycol 2-aminopropyl Me ether.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of 2,5-furandione,
polymer with ethenylbenzene, octyl imide, imide with polyethylene-
polypropylene glycol 2-aminopropyl Me ether from the requirement of a
tolerance will be safe.

X. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885,

April 23, 1997). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

XI. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: December 1, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.960, amend the table by adding a table heading and in
alphabetical order an entry for ``2,5-Furandione, polymer with
ethenylbenzene, octyl imide, imide with polyethylene-polypropylene
glycol 2-aminopropyl Me ether, minimum number average molecular weight
(in amu), 11,000'' to read as follows:

Sec.  180.960  Polymers; exemptions from the requirement of a
tolerance.

* * * * *

                        Table 1 to Sec.   180.960
------------------------------------------------------------------------
                       Polymer                              CAS No.
------------------------------------------------------------------------

                              * * * * * * *
2,5-Furandione, polymer with ethenylbenzene, octyl          1812871-29-6
 imide, imide with polyethylene-polypropylene glycol
 2-aminopropyl Me ether, minimum number average
 molecular weight (in amu), 11,000...................

                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2021-26412 Filed 12-3-21; 8:45 am]
BILLING CODE 6560-50-P


AIPORT DEICING CBI REPLACEMENT PAGE

OW-2004-0038

DCN __AD00701______________

THE FOLLOWING HAS BEEN REMOVED BECAUSE IT CONTAINS CONFIDENTIAL BUSINESS INFORMATION (CBI) PER

40 CFR PART 2, SUBPART B.