[Federal Register Volume 85, Number 48 (Wednesday, March 11, 2020)]
[Rules and Regulations]
[Pages 14143-14145]
[FR Doc No: 2020-04999]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 85, No. 48 / Wednesday, March 11, 2020 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0198; Product Identifier 2020-NM-018-AD; Amendment
39-19859; AD 2020-05-10]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Dassault Aviation Model FALCON 7X airplanes. This AD was
prompted by a report of an incorrect version of EASy ``Top-Level
System'' operational software installed in the avionics system due to
use of an improper CD-ROM. This AD requires ensuring that the correct
versions of the operational software and CD-ROM are installed, and
doing corrective action if necessary, as specified in a European Union
Aviation Safety Agency (EASA) AD, which is incorporated by reference.
The FAA is issuing this AD to address the unsafe condition on these
products.

DATES: This AD becomes effective March 26, 2020.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of March 26,
2020.
    The FAA must receive comments on this AD by April 27, 2020.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For the material incorporated by reference (IBR) in this AD,
contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 89990 1000; email<EMAIL_ADDRESS>internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. You may view this IBR material at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195. It is also available in the AD docket on the internet at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2020-0198.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0198; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations is listed above.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0014, dated January 29, 2020
(``EASA AD 2020-0014'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for certain Dassault Aviation Model FALCON 7X airplanes.
    This AD was prompted by a report of an incorrect version of EASy
``Top-Level System'' operational software loaded into the avionics
system due to the use of an improper CD-ROM. The FAA is issuing this AD
to address misleading information and erroneous guidance affecting the
functional capabilities of the avionics system, which could result in
reduced control of the airplane. See the MCAI for additional background
information.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2020-0014 describes procedures for ensuring that correct
versions of EASy ``Top-Level System'' operational software and CD-ROM
are installed. EASA AD 2020-0014 also describes procedures for
applicable corrective actions, which include amending the applicable
airplane flight manual (AFM) to limit the use of the software during
descent, and installing the correct version of the operational software
and CD-ROM, which eliminates the need for the AFM revision.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to a bilateral agreement with the State of Design Authority, the FAA
has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is issuing this AD because the agency
evaluated all pertinent information and determined the unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Requirements of This AD

    This AD requires accomplishing the actions specified in the service
information described previously, as incorporated by reference, except
for any differences identified as exceptions in the regulatory text of
this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2020-0014
is incorporated by reference in this final rule. This AD, therefore,
requires compliance with EASA AD 2020-0014 in its entirety, through
that incorporation, except for any differences identified as exceptions
in the regulatory text of this AD. Using common terms that are the same
as the heading of a particular section in the EASA AD does not mean
that operators need comply only with that section. For example, where
the AD requirement refers to ``all required actions and compliance
times,'' compliance with this AD requirement is not limited to the
section titled ``Required Action(s) and Compliance Time(s)'' in the
EASA AD. Service information specified in EASA AD 2020-0014 that is
required for compliance with EASA AD 2020-0014 is available on the
internet at https://www.regulations.gov by searching for and locating
Docket No. FAA-2020-0198.

FAA's Justification and Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies waiving notice and comment prior to adoption of this rule
because misleading information and erroneous guidance affecting the
functional capabilities of the avionics system could result in reduced
control of the airplane. Therefore, the FAA finds good cause that
notice and opportunity for prior public comment are impracticable. In
addition, for the reasons stated above, the FAA finds that good cause
exists for making this amendment effective in less than 30 days.

Regulatory Flexibility Act (RFA)

    The requirements of the RFA do not apply when an agency finds good
cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and
comment. Because the FAA has determined that it has good cause to adopt
this rule without notice and comment, RFA analysis is not required.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and the FAA did not precede it by notice and opportunity for
public comment. The FAA invites you to send any written relevant data,
views, or arguments about this AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2020-0198;
Product Identifier 2020-NM-018-AD'' at the beginning of your comments.
The FAA specifically invites comments on the overall regulatory,
economic, environmental, and energy aspects of this AD. The FAA will
consider all comments received by the closing date and may amend this
AD based on those comments.
    The FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide.
The FAA will also post a report summarizing each substantive verbal
contact received about this AD.

Costs of Compliance

    The FAA estimates that this AD affects 59 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
1 work-hour x $85 per hour = $85.............................              $0              $85           $5,015
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition actions that would be required based on the results of any
required actions. The FAA has no way of determining the number of
aircraft that might need these on-condition actions:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
Up to 7 work-hours x $85 per hour =                 $0             $595
 $595.................................
------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    The FAA has determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government. For the
reasons discussed above, I certify that this AD:

    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2020-05-10 Dassault Aviation: Amendment 39-19859; Docket No. FAA-
2020-0198; Product Identifier 2020-NM-018-AD.

(a) Effective Date

    This AD becomes effective March 26, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Dassault Aviation Model FALCON 7X airplanes,
certificated in any category, as identified in European Union
Aviation Safety Agency (EASA) AD 2020-0014, dated January 29, 2020
(``EASA AD 2020-0014'').

(d) Subject

    Air Transport Association (ATA) of America Code 34, Navigation.

(e) Reason

    This AD was prompted by a report of an incorrect version of EASy
``Top-Level System'' operational software installed in the avionics
system due to use of an improper CD-ROM. The FAA is issuing this AD
to address misleading information and erroneous guidance affecting
the functional capabilities of the avionics system, which could
result in reduced control of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2020-0014.

(h) Exceptions to EASA AD 2020-0014

    (1) Where EASA AD 2020-0014 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2020-0014 does not apply
to this AD.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2020-0014
specifies to submit certain information and send a ``wrong CD-ROM''
to the manufacturer, this AD does not include that requirement.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (k) of this AD. Information may
be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or EASA; or Dassault
Aviation's EASA Design Organization Approval (DOA). If approved by
the DOA, the approval must include the DOA-authorized signature.

(k) Related Information

    For more information about this AD, contact Tom Rodriguez,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2020-0014,
dated January 29, 2020.
    (ii) [Reserved]
    (3) For information about EASA AD 2020-0014, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
89990 6017; email<EMAIL_ADDRESS>internet www.easa.europa.eu.
You may find this EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this material at the FAA, Transport Standards
Branch, 2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. This
material may be found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2020-0198.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on March 2, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-04999 Filed 3-6-20; 4:15 pm]
 BILLING CODE 4910-13-P


[Federal Register: June 16, 2009 (Volume 74, Number 114)]
[Proposed Rules]
[Page 28467-28468]
[DOCID:fr16jn09-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2009-0350; FRL-8918-3]

Revisions to the California State Implementation Plan, San
Joaquin Valley Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve revisions to the San Joaquin
Valley Air Pollution Control District portion of the California State
Implementation Plan (SIP). These revisions concern volatile organic
compound (VOC) emissions from coating of metal parts, large appliances,
metal furniture, motor vehicles, mobile equipment, cans, coils, and
organic solvent cleaning, storage, and disposal related to such
operations. We are approving three local rules that regulate these
emission sources under the Clean Air Act as amended in 1990 (CAA or the
Act). We are taking comments on this proposal and plan to follow with a
final action.

DATES: Any comments must arrive by July 16, 2009.

ADDRESSES: Submit comments, identified by docket number [EPA-R09-OAR-
2009-0350], by one of the following methods:
    1. Federal eRulemaking Portal: www.regulations.gov. Follow the on-
line instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or e-mail.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send e-mail directly to EPA, your e-mail
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at EPA Region
IX, 75 Hawthorne Street, San Francisco, California. While all documents
in the docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available in either location (e.g., CBI).
To inspect the hard copy materials, please schedule an appointment
during normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Nicole Law, EPA Region IX, (415) 947-
4126<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rule revisions?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. EPA recommendations to further improve the rules.
    D. Public comment and final action.
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules addressed by this proposal with the dates
that they were adopted by the local air agency and submitted by the
California Air Resources Board.

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
           Local agency             Rule            Rule title               Adopted        Submitted
----------------------------------------------------------------------------------------------------------------
SJVAPCD...........................            4603  Surface Coating of Metal            10/16/08        12/23/08
                                                     Parts and Products.
SJVAPCD...........................            4604  Can and Coil Coating                09/20/07        03/07/08
                                                     Operations.
SJVAPCD...........................            4612  Motor Vehicle and Mobile            09/20/07        03/07/08
                                                     Equipment Coating
                                                     Operations.
----------------------------------------------------------------------------------------------------------------

    On April 20, 2009 and April 17, 2008, these rule submittals were
found to meet the completeness criteria in 40 CFR Part 51, Appendix V,
which must be met before formal EPA review.

B. Are there other versions of these rules?

    We approved versions of Rules 4603 and 4604 into the SIP on June
25, 2002 and May 19, 2002. Rule 4612 is replacing Rule 4602 which was
approved into the SIP on June 26, 2002. The San Joaquin Valley Air
Pollution Control District adopted revisions to the SIP-approved
version of Rule 4603 on May 18, 2006, September 20, 2007, and October
16, 2008 and CARB submitted them to us on October 5, 2006, March 7,
2008, and December 23, 2008. While we can act on only the most recently
submitted version, we have reviewed materials provided with previous
submittals. No other versions of Rule 4604 and 4602/4612 have been
adopted by the district after 2002.

C. What is the purpose of the submitted rule revisions?

    VOCs help produce ground-level ozone and smog, which harm human
health and the environment. Section 110(a) of the CAA requires States
to submit regulations that control VOC emissions. The rules control VOC
emissions by limiting VOC content in the coatings used for metal parts,
large appliances, metal furniture, motor vehicles, mobile equipment,
cans, and coils. In addition, the rules also limit emission of VOCs by
regulating organic solvent cleaning, storage, and disposal relating to
the coating operations. The most significant changes in the rules are
reductions of the VOC limits on organic solvents to 25 grams of VOC per
liter solvent. EPA's technical support documents (TSDs) have more
information about these rules.

II. EPA's Evaluation and Action

A. How is EPA evaluating the rules?

    Generally, SIP rules must be enforceable (see section 110(a) of the
Act), must require Reasonably Available Control Technology (RACT) for
each category of sources covered by a Control Techniques Guidelines
(CTG) document as well as each major source in nonattainment areas (see
section

182(a)(2)), and must not relax existing requirements (see sections
110(l) and 193). The San Joaquin Valley Air Pollution Control District
regulates an ozone nonattainment area (see 40 CFR part 81), so Rules
4603, 4604, and 4612 must fulfill RACT.
    Guidance and policy documents that we use to help evaluate specific
enforceability and RACT requirements consistently include the
following:
    1. Portions of the proposed post-1987 ozone and carbon monoxide
policy that concern RACT, 52 FR 45044, November 24, 1987.
    2. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies, and
Deviations,'' EPA, May 25, 1988 (the Bluebook).
    3. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001 (the Little Bluebook).
    4. ``Control Techniques Guidelines for Miscellaneous Metal and
Plastic Parts Coatings,'' EPA-453/R-08-003, September 2008.
    5. ``Control Techniques Guidelines for Large Appliance Coatings,''
EPA-453/R-07-004, September 2007.
    6. ``Control Techniques Guidelines for Metal Furniture Coatings,''
EPA-453/R-07-005, September 2007.
    7. ``Control of Volatile Organic Emissions From Existing Stationary
Sources Volume II: Surface Coating of Cans, Coils, Paper, Fabrics,
Automobiles, and Light-Duty Trucks,'' EPA-450/2-77-008, May 1977.
    8. ``Reasonably Available Control Technology (RACT) Demonstration
for Ozone State Implementation Plans (SIP)'' SJVAPCD, April 16, 2009.
    9. ``Suggested Control Measure for Automotive Coatings,'' CARB,
October 2005.
    10. Portions of the proposed post-1987 ozone and carbon monoxide
policy that concern RACT, 52 FR 45044, November 24, 1987.
    11. ``State Implementation Plans, General Preamble for the
Implementation of Title I of the Clean Air Amendments of 1990'' 57 FR
13498, April 16, 1992.
    12. ``Preamble, Final Rule to Implement the 8-hour Ozone National
Ambient Air Quality Standard'' 70 FR 71612; Nov. 29, 2005.
    13. Letter from William T. Hartnett to Regional Air Division
Directors, ``RACT Qs & As--Reasonable Available Control Technology
(RACT) Questions and Answers,'' May 18, 2006.

B. Do the rules meet the evaluation criteria?

    We believe these rules are generally consistent with the relevant
policy and guidance regarding enforceability, RACT, and SIP
relaxations. The TSDs have more information on our evaluation.

C. EPA recommendations to further improve the rule

    The TSDs describe additional rule revisions that do not affect
EPA's current action but are recommended for the next time the local
agency modifies the rule.

D. Public comment and final action

    Because EPA believes the submitted rules fulfill all relevant
requirements, we are proposing to fully approve them as described in
section 110(k)(3) of the Act. We will accept comments from the public
on this proposal for the next 30 days. Unless we receive convincing new
information during the comment period, we intend to publish a final
approval action that will incorporate these rules into the federally
enforceable SIP.

III. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Ozone, Reporting and recordkeeping requirements, Volatile
organic compounds.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: June 2, 2009.
Keith Takata,
Acting Regional Administrator, Region IX.
[FR Doc. E9-14020 Filed 6-15-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 139 (Thursday, July 21, 2022)]
[Rules and Regulations]
[Pages 43420-43427]
[FR Doc No: 2022-15017]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0296; FRL-9924-01-OCSPP]

Various Fragrance Components; Exemptions From the Requirement of
a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of various fragrance components listed in unit
II of this document when they are used as inert ingredients in
antimicrobial pesticide formulations for use on food contact surfaces
in public eating places, dairy processing equipment, and food
processing equipment and utensils with end-use concentration not to
exceed 100 parts per million (ppm). Verto Solutions on behalf of The
Clorox Company submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting the establishment of such
exemptions from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of various fragrance components.

DATES: This regulation is effective July 21, 2022. Objections and
requests for hearings must be received on or before September 19, 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-2020-0296, 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 and the OPP Docket is<PHONE_NUMBER>. For the latest
status information on EPA/DC services, 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:
     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. How 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-2020-0296 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
September 19, 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-2020-0296, 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. Petition for Exemption

    In the Federal Register of June 24, 2020 (85 FR 37807) (FRL-10010-
82), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11018) by
Verto Solutions on behalf of The Clorox Company, 4900 Johnson Dr.,
Pleasanton, CA 94588. The petition requested that 40 CFR 180.940(a) be
amended by

establishing an exemption from the requirement of a tolerance for
residues of acetaldehyde ethyl cis- 3-hexenyl acetal (CAS Reg. No.
28069-74-1), (tri-)acetin (CAS Reg. No. 102-76-1), acetophenone (CAS
Reg. No. 98-86-2), allyl alpha-ionone (CAS Reg. No. 79-78-7),
benzaldehyde (CAS Reg. No. 100-52-7), benzyl alcohol (CAS Reg. No. 100-
51-6), benzyl butyrate (CAS Reg. No. 103-37-7), benzyl isobutyrate (CAS
Reg. No. 103-28-6), benzyl propionate (CAS Reg. No. 122-63-4),
carvacrol (CAS Reg. No. 499-75-2), cinnamaldehyde (CAS Reg. No. 104-55-
2), cinnamyl alcohol (CAS Reg. No. 104-54-1), cuminaldehyde (CAS Reg.
No. 122-03-2), diethyl malonate (CAS Reg. No. 105-53-3), 1,1-diethoxy-
3,7- dimethylocta-2,6-diene (CAS Reg. No. 7492-66-2), dihydro-beta-
ionone (CAS Reg. No. 17283-81-7), dihydrocarvyl acetate (CAS Reg. No.
20777-49-5), ethyl acetoacetate (CAS Reg. No. 141-97-9), ethyl benzoate
(CAS Reg. No. 93-89-0), ethylene brassylate (CAS Reg. No. 105-95-3),
ethyl salicylate (CAS Reg. No. 118-61-6), 4-formy-l-2- methoxyphenyl 2-
methylpropanoate; vanillin isobutyrate (CAS Reg. No. 20665-85-4),
hydroxycitronellal (CAS Reg. No. 107-75-5), hydroxycitronellol (CAS
Reg. No. 107-74-4), 4-(p-hydroxyphenyl)-2- butanone (CAS Reg. No. 5471-
51-2), p-methoxybenzaldehyde (CAS Reg. No. 123-11-5), 2-methoxy-4-
propylphenol (CAS Reg. No. 2785-87-7), 4'-methylacetophenone (CAS Reg.
No. 122-00-9), alpha-methylbenzyl acetate (CAS Reg. No. 93-92-5),
alpha-methylbenzyl alcohol (CAS Reg. No. 98-85-1), methyl benzoate (CAS
Reg. No. 93-58-3), alpha- methylcinnamaldehyde (CAS Reg. No. 101-39-3),
methyl cinnamate (CAS Reg. No. 103-26-4), 5-methyl-2-hepten-4- one (CAS
Reg. No. 81925-81-7), alpha-iso-methylionone (CAS Reg. No. 127-51-5),
methyl salicylate (CAS Reg. No. 119-36-8), cis-6-nonenal (CAS Reg. No.
2277-19-2), cis-6-nonen-1-ol (CAS Reg. No. 35854-86-5), octanal
dimethyl acetal (CAS Reg. No. 10022-28-3), phenethyl acetate (CAS Reg.
No. 103-45-7), phenethyl alcohol (CAS Reg. No. 60-12-8), phenethyl
isobutyrate (CAS Reg. No. 103-48-0), phenethyl phenylacetate (CAS Reg.
No. 102-20-5), phenylacetaldehyde dimethyl acetal (CAS Reg. No. 101-48-
4), 3-phenyl-1-propanol (CAS Reg. No. 122-97-4), 1-(2,6,6-
trimethylcyclohexa-1,3- dienyl)-2-buten-1-one (CAS Reg. No. 23696-85-
7), delta-1-(2,6,6-trimethyl- 3-cyclohexen-1-yl)-2- buten-1-one (CAS
Reg. No. 57378-68-4), triethyl citrate (CAS Reg. No. 77-93-0),
thiogeraniol (CAS Reg. No. 39067-80-6), thymol (CAS Reg. No. 89-83-8),
vanillin (CAS Reg. No. 121-33-5), veratraldehyde (CAS Reg. No. 120-14-
9) when used as an inert ingredient fragrance component in pesticide
formulations applied to food contact surfaces in public eating places,
dairy processing equipment, and food processing equipment with end-use
concentrations not to exceed 100 ppm. That document referenced a
summary of the petition prepared by Verto Solutions on behalf of The
Clorox Company, the petitioner, which is available in the docket,
https://www.regulations.gov/docket/EPA-HQ-OPP-2020-0296. There were no
comments received in response to the notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    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 tolerance is ``safe.'' Section 408(b)(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 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 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. . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm to human health. In order
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(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for various fragrance components
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with various
fragrance components follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies 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. Specific information on the studies received for the various
fragrance components are discussed in this unit.
    The Agency assessed these fragrance components via the Threshold of
Toxicological Concern (TTC) approach as outlined by the European Food
Safety Authority (EFSA) in their 2019 guidance document on the use of
TTC in food safety assessment. Information regarding the database of
studies and chemicals used to derive TTCs are reviewed therein. The TTC
approach has been used by the Joint Expert Committee on

Food Additives of the U.N.'s Food and Agriculture Organization and the
World Health Organization, the former Scientific Committee on Food of
the European Commission, the European Medicines Agency, and EFSA.
    Information from JECFA reports as well as predictive toxicology
using the OECD QSAR Toolbox was used to confirm that the fragrances
listed in Unit II have low carcinogenic potential and are thus good
candidates for the application of the TTC method. Although 13 chemicals
had carcinogenicity alerts, JECFA concluded and EPA concurs that all
fragrances listed in unit II have low carcinogenic potential, based on
in vitro and/or in vivo genotoxicity studies available. Therefore, the
TTC method can be applied to these fragrances.
    TTCs are derived from a conservative and rigorous approach
developed by Munro and Kroes to establish generic threshold values for
human exposure at which a very low probability of adverse effects is
likely. By comparing a range of compounds by Cramer Class (classes I,
II, and III) and NOEL (no-observed-effect-level), fifth percentile
NOELs were established for each Cramer Class as ``Human Exposure
Thresholds''. These values were 3, 0.91 and 0.15 mg/kg/day for classes
I, II, and III, respectively.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.
    The human exposure threshold value for threshold (i.e., non-cancer)
risks is based upon Cramer structural class. In the case of the
fragrance components listed above, all the substances included are in
the Cramer Class I category, which is defined as chemicals of simple
structure and efficient modes of metabolism, suggesting low oral
toxicity.
    Therefore, the NOEL of 3 mg/kg/day is selected as the point of
departure for all exposure scenarios assessed (chronic dietary,
incidental oral, dermal and inhalation exposures).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Dietary exposure (food
and drinking water) may occur from the existing (non-food) and proposed
uses of fragrance components listed in unit II (e.g., eating foods
treated with pesticide formulations containing these fragrances, and
drinking water exposures). In evaluating dietary exposure to each of
the fragrance components listed in Unit II, EPA considered exposure
under the proposed tolerance exemptions at a concentration not to
exceed 100 ppm for each of the fragrance components listed in Unit II.
as well as any other sources of dietary exposure. EPA assessed dietary
exposures from various fragrance components in food as follows:
    The dietary assessment for food contact sanitizer solutions
calculated the Daily Dietary Dose (DDD) and the Estimated Daily Intake
(EDI). The assessment considered: Application rates, residual solution
or quantity of solution remaining on the treated surface without
rinsing with potable water, surface area of the treated surface which
comes into contact with food, pesticide migration fraction, and body
weight. These assumptions are based on Food and Drug Administration
(FDA) guidelines.
    2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for various fragrance
components a conservative drinking water concentration value of 100 ppb
based on screening level modeling was used to assess the contribution
to drinking water for the chronic dietary risk assessments for parent
compound. These values were directly entered into the dietary exposure
model.
    3. Residential exposure. The term ``residential exposure'' is used
in this document to refer to non-occupational, non-dietary exposure
(e.g., textiles (clothing and diapers), carpets, swimming pools, and
hard surface disinfection on walls, floors, tables). The fragrance
components listed in Unit II may be used as inert ingredients in
products that are registered for specific uses that may result in
residential exposure, such as pesticides used in and around the home.
The Agency conducted a conservative assessment of potential residential
exposure by assessing various fragrance components in disinfectant-type
uses (indoor scenarios). The Agency's assessment of adult residential
exposure combines high-end dermal and inhalation handler exposure from
indoor hard surface, wiping and aerosol spray. The Agency's assessment
of children's residential exposure includes total post-application
exposures associated with total exposures associated with contact with
treated indoor surfaces (dermal and hand-to-mouth exposures).
    4. 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 made a common mechanism of toxicity finding as to these
fragrance chemicals listed in unit II and any other substances, and
these fragrance chemicals do not appear to produce toxic metabolites
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that these fragrance chemicals
listed in unit II 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.

D. Safety Factor for Infants and Children

    FFDCA Section 408(b)(2)(C) provides that EPA shall retain an
additional tenfold (10X) 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 database on toxicity and exposure

unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA safety factor (SF). In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor. The FQPA SF
has been reduced to 1X in this risk assessment because clear NOELs and
LOELs were established in the studies analyzed by Munro et al 1996
(which included developmental and reproductive toxicity studies),
maternal and developmental-specific 5th percentile NOAELs calculated by
van Ravenzwaay et al 2011 indicate low potential for offspring
susceptibility, and the conservative assumptions made in the exposure
assessment are unlikely to underestimate risk.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute aggregate risk. An acute aggregate risk assessment takes
into account acute exposure estimates from dietary consumption of food
and drinking water. No adverse effects resulting from a single oral
exposure were identified and no acute dietary endpoint were selected
for any of the fragrance components. Therefore, the fragrance
components listed in Unit II are not expected to pose an acute risk.
    2. Short-term aggregate risk. Short-term aggregate exposure takes
into account short-term residential exposure plus chronic exposure to
food and water (considered to be a background exposure level). For
residential handler short-term exposure scenarios, MOEs ranged from 140
to 2,500, while residential post-application exposure scenarios MOEs
ranged from 380 to 7,400. These MOEs are greater than the LOC of 100
and therefore are not of concern. The short-term aggregate MOE is 109
for adults and 135 for children, which are greater than the LOC of 100
and therefore are not of concern.
    3. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
the fragrance components listed in Unit II are not currently used as an
inert ingredient in pesticide products that are registered for any use
patterns that would result in intermediate-term residential exposure.
Intermediate-term risk is assessed based on intermediate-term
residential exposure plus chronic dietary exposure. Because there is no
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess intermediate-term
risk), no further assessment of intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for various fragrance components.
    4. Chronic aggregate risk. Using the exposure assumptions described
in this unit for chronic exposure, EPA has concluded that chronic
exposure to the fragrance components listed in Unit II from food and
water will utilize 19% of the chronic PAD (cPAD) for the U.S.
population and 48% of the cPAD for children 1 to 2 years old, the
population group receiving the greatest exposure. Chronic residential
exposure to residues of benoxacor is not expected. Therefore, the
chronic aggregate risk is equal to the chronic dietary exposure for
children 1 to 2 years old (48% of the PAD).
    5. Aggregate cancer risk for U.S. population. There is low concern
for genotoxicity/carcinogenicity in humans for the fragrance components
listed in Unit II of this document. Therefore, the assessment under the
TTC value for non-cancer risks is protective for all risks, including
carcinogenicity.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to residues of the fragrance components listed in Unit II.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for fragrances
listed in unit II of this document in or on any food commodities. EPA
is establishing a limitation on the amount of the fragrances listed in
unit II that may be used in antimicrobial pesticide formulations. This
limitations will be enforced through the pesticide registration process
under the Federal Insecticide, Fungicide, and Rodenticide Act
(``FIFRA''), 7 U.S.C. 136 et seq. EPA will not register any pesticide
formulation for food use that exceeds 100ppm of fragrances listed in
unit II in the final pesticide formulation.

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 Nation 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 the fragrance components
listed in Unit II.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.940(a) for acetaldehyde ethyl cis- 3-
hexenyl acetal (CAS Reg. No. 28069-74-1), (tri-)acetin (CAS Reg. No.
102-76-1), acetophenone (CAS Reg. No. 98-86-2), allyl alpha-ionone (CAS
Reg. No. 79-78-7), benzaldehyde (CAS Reg. No. 100-52-7), benzyl alcohol
(CAS Reg. No. 100-51-6), benzyl butyrate (CAS Reg. No. 103-37-7),
benzyl isobutyrate (CAS Reg. No. 103-28-6), benzyl propionate (CAS Reg.
No. 122-63-4), carvacrol (CAS Reg. No. 499-75-2), cinnamic aldehyde
(cinnamaldehyde) (CAS Reg. No. 104-55-2), cinnamic alcohol (cinnamyl
alcohol) (CAS Reg. No. 104-54-1), cuminaldehyde (CAS Reg. No. 122-03-
2), diethyl malonate (CAS Reg. No. 105-53-3), 1,1-diethoxy-3,7-
dimethylocta-2,6-diene (CAS Reg. No. 7492-66-2), dihydro-beta-ionone
(CAS Reg. No. 17283-81-7), dihydrocarvyl acetate (CAS Reg. No. 20777-
49-5), butanoic acid, 3-oxo-, ethyl ester (ethyl acetoacetate) (CAS
Reg. No. 141-97-9),

benzoic acid, ethyl ester (ethyl benzoate) (CAS Reg. No. 93-89-0),
ethylene brassylate (CAS Reg. No. 105-95-3), ethyl salicylate (CAS Reg.
No. 118-61-6), propanoic acid, 2-methyl-, 4-formyl-2-methoxyphenyl
ester (4-formy-l-2- methoxyphenyl 2- methylpropanoate; vanillin
isobutyrate) (CAS Reg. No. 20665-85-4), hydroxycitronellal (CAS Reg.
No. 107-75-5), hydroxycitronellol (CAS Reg. No. 107-74-4), 4-(p-
hydroxyphenyl)-2- butanone (CAS Reg. No. 5471-51-2), benzaldehyde, 4-
methoxy- (p-methoxybenzaldehyde) (CAS Reg. No. 123-11-5), 2-methoxy-4-
propylphenol (CAS Reg. No. 2785-87-7), 4'-methylacetophenone (CAS Reg.
No. 122-00-9), benzenemethanol, alpha-methyl-, 1-acetate (alpha-
methylbenzyl acetate) (CAS Reg. No. 93-92-5), alpha-methylbenzyl
alcohol (CAS Reg. No. 98-85-1), methyl benzoate (CAS Reg. No. 93-58-3),
alpha- methylcinnamaldehyde (CAS Reg. No. 101-39-3), methyl cinnamate
(CAS Reg. No. 103-26-4), 2-hepten-4-one, 5-methyl- (5-methyl-2-hepten-
4- one) (CAS Reg. No. 81925-81-7), 3-buten-2-one, 3-methyl-4-(2,6,6-
trimethyl-2-cyclohexen-1-yl)- (alpha-iso-methylionone) (CAS Reg. No.
127-51-5), methyl salicylate (CAS Reg. No. 119-36-8), 6-nonenal, (6Z)-
(cis-6-nonenal) (CAS Reg. No. 2277-19-2), cis-6-nonen-1-ol (CAS Reg.
No. 35854-86-5), octanal dimethyl acetal (CAS Reg. No. 10022-28-3),
phenethyl acetate (CAS Reg. No. 103-45-7), phenyl ethyl alcohol
(phenethyl alcohol) (CAS Reg. No. 60-12-8), phenethyl isobutyrate (CAS
Reg. No. 103-48-0), phenethyl phenylacetate (CAS Reg. No. 102-20-5),
phenylacetaldehyde dimethyl acetal (CAS Reg. No. 101-48-4), 3-phenyl-1-
propanol (CAS Reg. No. 122-97-4), 2-buten-1-one, 1-(2,6,6-trimethyl-
1,3-cyclohexadien-1-yl)- (1-(2,6,6-trimethylcyclohexa-1,3- dienyl)-2-
buten-1-one (CAS Reg. No. 23696-85-7), delta-1-(2,6,6-trimethyl- 3-
cyclohexen-1-yl)-2- buten-1-one (CAS Reg. No. 57378-68-4), triethyl
citrate (CAS Reg. No. 77-93-0), thiogeraniol (CAS Reg. No. 39067-80-6),
thymol (8CA) (thymol) (CAS Reg. No. 89-83-8), vanillin (CAS Reg. No.
121-33-5), veratraldehyde (CAS Reg. No. 120-14-9) when used as an inert
ingredient (fragrance components) in pesticide formulations applied to
food contact surfaces in public eating places, dairy processing
equipment, and food processing equipment and utensils with end-use
concentration not to exceed 100 ppm.

VII. 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).

VIII. 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: July 8, 2022.
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 CHEMICALS
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. Section 180.940 is amended by adding in alphabetical order the
following inert ingredients to table 1 to paragraph (a):
0
a. acetaldehyde ethyl cis-3-hexenyl acetal
0
b. Acetophenone
0
c. allyl alpha-ionone
0
d. Benzaldehyde
0
e. benzyl alcohol
0
f. benzyl butyrate
0
g. benzyl isobutyrate
0
h. benzaldehyde, 4-methoxy-
0
i. benzenemethanol, alpha-methyl-, 1-acetate
0
j. benzoic acid, ethyl ester
0
k. butanoic acid, 3-oxo-, ethyl ester
0
l. 2-buten-1-one, 1-(2,6,6-trimethyl-1,3-cyclohexadien-1-yl)-
0
m. 3-buten-2-one, 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-
0
n. Carvacrol
0
o. cinnamic aldehyde

0
p. cinnamic alcohol
0
q. Cuminaldehyde
0
r. diethyl malonate
0
s. 1,1-diethoxy-3,7-dimethylocta-2,6-diene
0
t. dihydro-beta-ionone
0
u. dihydrocarvyl acetate
0
v. ethylene brassylate
0
w. ethyl salicylate
0
x. glyceryl triacetate
0
y. 2-hepten-4-one, 5-methyl-
0
z. Hydroxycitronellal
0
aa. Hydroxycitronellol
0
bb. 4-(p-hydroxyphenyl)-2-butanone
0
cc. 2-methoxy-4-propylphenol
0
dd. methyl benzoate
0
ee. 4'-methylacetophenone
0
ff. alpha-methylbenzyl alcohol
0
gg. alpha-methylcinnamaldehyde
0
hh. methyl cinnamate
0
ii. methyl salicylate
0
jj. 6-nonenal, (6Z)-
0
kk. cis-6-nonen-1-ol
0
ll. octanal dimethyl acetal
0
mm. phenethyl acetate
0
nn. phenyl ethyl alcohol
0
oo. phenethyl isobutyrate
0
pp. phenethyl phenylacetate
0
qq. phenylacetaldehyde dimethyl acetal
0
rr. 3-phenyl-1-propanol
0
ss. propanoic acid, 2-methyl-, 4-formyl-2-methoxyphenyl ester
0
tt. triethyl citrate
0
uu. delta-1-(2,6,6-trimethyl-3-cyclohexen-1-yl)-2-buten-1-
0
vv. Thiogeraniol
0
ww. thymol (8CA)
0
xx. Vanillin
0
yy. veratraldehyde
    The additions read as follows:

Sec.  180.940  Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).

* * * * *
    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
       Pesticide chemical         CAS Reg. No.            Limits
------------------------------------------------------------------------

                              * * * * * * *
acetaldehyde ethyl cis-3-            28069-74-1  When ready for use, the
 hexenyl acetal.                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Acetophenone...................         98-86-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
allyl alpha-ionone.............         79-78-7  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Benzaldehyde...................        100-52-7  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
benzyl alcohol.................        100-51-6  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
benzyl butyrate................        103-37-7  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
benzyl isobutyrate.............        103-28-6  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
benzyl propionate..............        122-63-4  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
benzaldehyde, 4-methoxy-.......        123-11-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
benzenemethanol, alpha-methyl-,         93-92-5  When ready for use, the
 1-acetate.                                       end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
benzoic acid, ethyl ester......         93-89-0  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
butanoic acid, 3-oxo-, ethyl           141-97-9  When ready for use, the
 ester.                                           end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
2-buten-1-one, 1-(2,6,6-             23696-85-7  When ready for use, the
 trimethyl-1,3-cyclohexadien-1-                   end-use concentration
 yl)-.                                            is not to exceed 100
                                                  ppm.

                              * * * * * * *
3-buten-2-one, 3-methyl-4-             127-51-5  When ready for use, the
 (2,6,6-trimethyl-2-cyclohexen-                   end-use concentration
 1-yl)-.                                          is not to exceed 100
                                                  ppm.

                              * * * * * * *
Carvacrol......................        499-75-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
cinnamic aldehyde..............        104-55-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
cinnamic alcohol...............        104-54-1  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Cuminaldehyde..................        122-03-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
diethyl malonate...............        105-53-3  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
1,1-diethoxy-3,7-dimethylocta-        7492-66-2  When ready for use, the
 2,6-diene.                                       end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
dihydro-beta-ionone............      17283-81-7  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
dihydrocarvyl acetate..........      20777-49-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
ethylene brassylate............        105-95-3  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
ethyl salicylate...............        118-61-6  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
glyceryl triacetate............        102-76-1  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
2-hepten-4-one, 5-methyl-......      81925-81-7  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Hydroxycitronellal.............        107-75-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Hydroxycitronellol.............        107-74-4  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
4-(p-hydroxyphenyl)-2-butanone.       5471-51-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
2-methoxy-4-propylphenol.......       2785-87-7  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
methyl benzoate................         93-58-3  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
4'-methylacetophenone..........        122-00-9  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
alpha-methylbenzyl alcohol.....         98-85-1  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
alpha-methylcinnamaldehyde.....        101-39-3  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
methyl cinnamate...............        103-26-4  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
methyl salicylate..............        119-36-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
6-nonenal, (6Z)-...............       2277-19-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
cis-6-nonen-1-ol...............      35854-86-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
octanal dimethyl acetal........      10022-28-3  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
phenethyl acetate..............        103-45-7  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
phenyl ethyl alcohol...........         60-12-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
phenethyl isobutyrate..........        103-48-0  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
phenethyl phenylacetate........        102-20-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
phenylacetaldehyde dimethyl            101-48-4  When ready for use, the
 acetal.                                          end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
3-phenyl-1-propanol............        122-97-4  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
propanoic acid, 2-methyl-, 4-        20665-85-4  When ready for use, the
 formyl-2-methoxyphenyl ester.                    end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
triethyl citrate...............         77-93-0  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
delta-1-(2,6,6-trimethyl-3-          57378-68-4  When ready for use, the
 cyclohexen-1-yl)-2-buten-1-one.                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Thiogeraniol...................      39067-80-6  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
thymol (8CA)...................         89-83-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Vanillin.......................        121-33-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
veratraldehyde.................        120-14-9  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

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

[FR Doc. 2022-15017 Filed 7-20-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: May 6, 2010 (Volume 75, Number 87)]
[Notices]
[Page 24941-24942]
[DOCID:fr06my10-53]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Project No. 13715-000]

Osprey III, LLC; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

April 29, 2010.
    On April 15, 2010, Osprey III, LLC filed an application, pursuant
to section 4(f) of the Federal Power Act, proposing to study the
feasibility of the Morgan Dam Hydroelectric Project (Morgan Dam
Project), to be located on the Sebasticook River in the Town of
Hartland, Somerset County, Maine.
    The proposed project would consist of: (1) An existing 29-foot-high
concrete dam containing three sluice gates with a 100-foot-long, 25-
foot-high spillway; (2) the existing 1,728-acre Great Moose Lake; (3) a
new powerhouse containing multiple turbine generator units with total
installed capacity of 1.0 megawatts (MW); (4) a new transmission line
connecting to an existing Central Maine Power distribution line located
in the Town of Hartland; and (5) appurtenant facilities. The project
would produce an estimated average annual generation of about 5,000
megawatt-hours, which would be sold directly to a local utility.
    Applicant Contact: Mr. Hoon Won, 275 River Road, P.O. Box 202,
Woolwich, Maine 04579,<PHONE_NUMBER>.
    FERC Contact: John Ramer,<PHONE_NUMBER>.
    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. Comments,
motions to intervene, notices of intent, and competing applications may
be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at  http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of Commission's Web site at  http://
www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
13715) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-10631 Filed 5-5-10; 8:45 am]
BILLING CODE 6717-01-P