[Federal Register Volume 87, Number 205 (Tuesday, October 25, 2022)]
[Notices]
[Page 64499]
[FR Doc No: 2022-23121]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3586-EM; Docket ID FEMA-2022-0001]

North Carolina; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of North Carolina (FEMA-3586-EM), dated October
1, 2022, and related determinations.

DATES: The declaration was issued October 1, 2022.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated September 29, 2022, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in certain areas
of the State of North Carolina resulting from Hurricane Ian
beginning on September 28, 2022, and continuing, are of sufficient
severity and magnitude to warrant an emergency declaration under the
Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42
U.S.C. 5121 et seq. (``the Stafford Act''). Therefore, I declare
that such an emergency exists in the State of North Carolina.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), including direct Federal assistance, under the Public
Assistance program.
    Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, John F.
Boyle, of FEMA is appointed to act as the Federal Coordinating Officer
for this declared emergency.
    The following areas of the State of North Carolina have been
designated as adversely affected by this declared emergency:

    Emergency protective measures (Category B), including direct
federal assistance, under the Public Assistance program for all 100
North Carolina counties and the Eastern Band of Cherokee Indians.
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-23121 Filed 10-24-22; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 88, Number 97 (Friday, May 19, 2023)]
[Rules and Regulations]
[Pages 32125-32132]
[FR Doc No: 2023-10550]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0594; FRL-10970-01-OCSPP]

Various Fragrance Components in Pesticide Formulations; Tolerance
Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

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 applied to food-contact surfaces
in public eating places, dairy-processing equipment, and food-
processing equipment and utensils when the end-use concentration does
not 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
exemptions from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of these various fragrance components, when used in accordance
with the terms of the exemptions.

DATES: This regulation is effective May 19, 2023. Objections and
requests for hearings must be received on or before July 18, 2023 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-2019-0594, 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: Charles Smith, Director, Registration
Division (7505T), 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. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2019-0594 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
July 18, 2023. 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-2019-0594, 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/where-send-comments-epa-dockets#express.
    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 February 11, 2020 (85 FR 7708) (FRL-
10005-02), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11316) 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 exemptions from the requirement
of a tolerance for residues of 1,3,3-trimethyl-2-norbornanyl acetate
(CAS Reg. No. 13851-11-1); 1H-Indole (CAS Reg. No. 120-72-9); 2,6-
Octadien-1-ol, 3,7-dimethyl-,(Z)- (CAS Reg. No. 106-25-2); 2-Decenal
(CAS Reg. No. 3913-71-1); 2-Hexenal, (2E)- (CAS Reg. No. 6728-26-3); 2-
Methyl-3-(p-isopropylphenyl)propionaldehyde (CAS Reg. No. 103-95-7); 2-
Methyl-4-phenyl-2-butanol (CAS Reg. No. 103-05-9); 2-
Phenylpropionaldehyde (CAS Reg. No. 93-53-8); 2-Phenylpropionaldehyde
dimethyl acetal (CAS Reg. No. 90-87-9); [alpha]-Pinene (CAS Reg. No.
80-56-8); [beta]-Caryophyllene (CAS Reg. No. 87-44-5);
Bicyclo(2.2.1)heptan-2-ol, 1,3,3-trimethyl- (CAS Reg. No. 1632-73-1);
Bicyclo(2.2.1)heptan-2-ol, 1,7,7-trimethyl-,propanoate, exo- (CAS Reg.
No. 2756-56-1); Bicyclo[3.1.1]heptane, 6,6-dimethyl-2-methylene- (CAS
Reg. No. 127-91-3); Butanoic acid, 1,1-dimethyl-2-phenylethyl ester
(CAS Reg. No. 10094-34-5); Celery seed oil (CAS Reg. No. 8015-90-5);
Citronellal (CAS Reg. No. 106-23-0);Cyclohexene, 1-methyl-4-(1-
methylethylidene)- (CAS Reg. No. 586-62-9); Dimethylbenzylcarbinyl
acetate (CAS Reg. No. 151-05-3); Elemi oil (Canarium spp.) (CAS Reg.
No. 8023-89-0); Ethyl (2E,4Z)-2,4-decadienoate (CAS Reg. No. 3025-30-
7); Galbanum oil (Ferula spp.) (CAS Reg. No. 8023-91-4); [gamma] -
Terpinene (CAS Reg. No. 99-85-4); Isoborneol (CAS Reg. No. 124-76-5);
Isobornyl acetate (CAS Reg. No. 125-12-2); Labdanum oil (Cistus spp.)
(CAS Reg. No. 8016-26-0); laevo-Bornyl acetate (CAS Reg. No. 5655-61-
8); Mace oil (Myristica fragrans Houtt.) (CAS Reg. No. 8007-12-3);
Methyl 2-nonenoate (CAS Reg. No. 111-79-5); Methyl 2-nonynoate (CAS
Reg. No. 111-80-8); Methyl anthranilate (CAS Reg. No. 134-20-3); Methyl
heptine carbonate (CAS Reg. No. 111-12-6); Methyl N-methylanthranilate
(CAS Reg. No. 85-91-6); Nerolidol (isomer unspecified) (CAS Reg. No.
7212-44-4); Nona-2-trans-6-cis-dienal (CAS Reg. No. 557-48-2); Oil of
lemon (CAS Reg. No. 8008-56-8); Oil of lemongrass (CAS Reg. No. 8007-
02-1); Oils, clove (CAS Reg. No. 8000-34-8); Oils, ginger (CAS Reg. No.
8007-08-7); Oils, grapefruit (CAS Reg. No. 8016-20-4); Oils, lime (CAS
Reg. No. 8008-26-2); Oils, orange, sweet, terpene-free (CAS Reg. No.
68606-94-0); Olibanum oil (Boswellia spp.) (CAS Reg. No. 8016-36-2);
Oxacycloheptadec-10-ene-2-one (CAS Reg. No. 28645-51-4); p-Cymene (CAS
Reg. No. 99-87-6); Phenol, 2-methoxy-4-(2-propenyl)- (CAS Reg. No. 97-
53-0); p-Methylanisole (CAS Reg. No. 104-93-8); Tangerine oil (Citrus
reticulata blanco) (CAS Reg. No. 8008-31-9); Ylang-ylang oils (CAS Reg.
No. 8006-81-3); when used as inert ingredients (fragrance components)
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, which is available in the
docket, https://www.regulations.gov. 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(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 in residential settings but does not include
occupational exposure. When making a safety determination for an
exemption for the requirement of a tolerance, FFDCA section
408(c)(2)(B) directs EPA to consider the considerations in section
408(b)(2)(C) and (D). 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. . . .'' Section 408(b)(2)(D) lists other factors for EPA's
consideration in making safety determinations, e.g., the validity,
completeness, and reliability of available data, nature of toxic
effects, available information concerning the cumulative effects of the
pesticide chemical and other substances with a common mechanism of
toxicity, and available information concerning aggregate exposure
levels to the pesticide chemical and other related substances, among
other factors.
    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 the various fragrance
components identified in Unit II of this document, including exposure
resulting from the exemptions established by this action. EPA's
assessment of exposures and risks associated with these 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 and the nature
of the adverse effects caused by the various fragrance components
identified in Unit II, as well as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the
toxicity studies, 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 United Nations' (U.N.) Food and Agriculture Organization and the
World Health Organization (JECFA), 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 Organisation for Economic Co-operation and Development (OECD)
Quantitative Structure-Activity Relationships (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 27 chemicals had in silico 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 on the chemical or structurally related
chemicals. Therefore, the TTC method can be applied to these
fragrances.
    TTCs are derived from a conservative and rigorous approach 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 which correspond to
the probability of low, moderate and high toxicity) 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. All of the fragrance
components listed in Unit II are in Cramer Class I, 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. In evaluating dietary exposure to each of the
fragrance components listed in Unit II (e.g., ingesting foods that come
in contact with surfaces treated with pesticide formulations containing
these fragrance components, and drinking water exposures), EPA
considered exposure under the proposed exemptions at a concentration
not to exceed 100 ppm for each of the listed fragrance components as
well as any other sources of dietary exposure. EPA assessed dietary
exposures from the fragrance components listed in Unit II 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 U.S. Food and Drug
Administration guidelines.
    2. From non-dietary 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
uses. The Agency's assessment of children's residential exposure
includes total post-application exposures associated with contact with
treated indoor surfaces (dermal and hand-to-mouth exposures).
    3. 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 the fragrance components listed in Unit II to
share a common mechanism of toxicity with any other substances, nor do
they appear to produce a toxic metabolite produced by other substances.
For the purposes of the tolerance exemptions established in this rule,
therefore, EPA has assumed that the fragrance components listed in Unit
II do not have common mechanisms 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/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. 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 (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 Food Quality Protection Act
(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 used to derive
the endpoints (which included developmental and reproductive toxicity
studies), maternal and developmental-specific 5th percentile NOELs
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 was selected for
any of the fragrance components listed in Unit II. Therefore, these
fragrance components 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 for residential post-application exposure scenarios,
MOEs ranged from 380 to 7,400. These MOEs are greater than the level of
concern (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.
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 these 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 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
these fragrance components 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 cPAD).
    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

Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
the fragrance components listed in Unit II of this document in or on
any food commodities. EPA is, however, establishing limitations on the
amount of these fragrance components that may be used in antimicrobial
pesticide formulations. These 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 contains
these fragrance components in excess of 100 ppm in the final pesticide
formulation.

VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance are
established for residues of the various fragrance components listed in
Unit II of this document when used as inert ingredients (fragrance
components) in pesticide formulations applied to food-contact surfaces
in public eating places, dairy-processing equipment, and food-
processing equipment and utensils with an end-use concentration not to
exceed 100 ppm under 40 CFR 180.940(a).

VII. Statutory and Executive Order Reviews

    This action establishes exemptions from the requirement of 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 exemptions 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: May 12, 2023.
Charles Smith,
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. Section 180.940 is amended by adding in alphabetical order the
following inert ingredients to table 1 to paragraph (a):
0
a. Bicyclo(2.2.1)heptan-2-ol, 1,3,3-trimethyl-
0
b. Bicyclo(2.2.1)heptan-2-ol, 1,7,7-trimethyl-,propanoate, exo-
0
c. Bicyclo[3.1.1]heptane, 6,6-dimethyl-2-methylene-
0
d. Butanoic acid, 1,1-dimethyl-2-phenylethyl ester
0
e. [beta]-Caryophyllene
0
f. Celery seed oil
0
g. Citronellal
0
h. Cyclohexene, 1-methyl-4-(1-methylethylidene)-
0
i. p-Cymene
0
j. 2-Decenal

0
k. Dimethylbenzylcarbinyl acetate
0
l. Elemi oil (Canarium spp.)
0
m. Ethyl (2E,4Z)-2,4-decadienoate
0
n. Galbanum oil (Ferula spp.)
0
o. 2-Hexenal, (2E)-
0
p. 1H-Indole
0
q. Isoborneol
0
r. Isobornyl acetate
0
s. Labdanum oil (Cistus spp.)
0
t. laevo-Bornyl acetate
0
u. Mace oil (Myristica fragrans Houtt.)
0
v. Methyl anthranilate
0
w. Methyl heptine carbonate
0
x. 2-Methyl-3-(p-isopropylphenyl)propionaldehyde
0
y. Methyl N-methylanthranilate
0
z. Methyl 2-nonenoate
0
aa. Methyl 2-nonynoate
0
bb. 2-Methyl-4-phenyl-2-butanol
0
cc. p-Methylanisole
0
dd. Nerolidol (isomer unspecified)
0
ee. Nona-2-trans-6-cis-dienal
0
ff. 2,6-Octadien-1-ol, 3,7-dimethyl-,(Z)-
0
gg. Oil of lemon
0
hh. Oil of lemongrass
0
ii. Oils, clove
0
jj. Oils, ginger
0
kk. Oils, grapefruit
0
ll. Oils, lime
0
mm. Oils, orange, sweet, terpene-free
0
nn. Olibanum oil (Boswellia spp.)
0
oo. Oxacycloheptadec-10-ene-2-one
0
pp. Phenol, 2-methoxy-4-(2-propenyl)-
0
qq. 2-Phenylpropionaldehyde
0
rr. 2-Phenylpropionaldehyde dimethyl acetal
0
ss. [alpha]-Pinene
0
tt. Tangerine oil (Citrus reticulata blanco)
0
uu. [gamma]-Terpinene
0
vv. 1,3,3-trimethyl-2-norbornanyl acetate
0
ww. Ylang-ylang oils.
    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
------------------------------------------------------------------------

                              * * * * * * *
Bicyclo(2.2.1)heptan-2-ol,            1632-73-1  When ready for use, the
 1,3,3-trimethyl-.                                end-use concentration
                                                  is not to exceed 100
                                                  ppm.
Bicyclo(2.2.1)heptan-2-ol,            2756-56-1  When ready for use, the
 1,7,7-trimethyl-,propanoate,                     end-use concentration
 exo-.                                            is not to exceed 100
                                                  ppm.
Bicyclo[3.1.1]heptane, 6,6-            127-91-3  When ready for use, the
 dimethyl-2-methylene-.                           end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Butanoic acid, 1,1-dimethyl-2-       10094-34-5  When ready for use, the
 phenylethyl ester.                               end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
[beta]-Caryophyllene...........         87-44-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
Celery seed oil................       8015-90-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Citronellal....................        106-23-0  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Cyclohexene, 1-methyl-4-(1-            586-62-9  When ready for use, the
 methylethylidene)-.                              end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
p-Cymene.......................         99-87-6  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
2-Decenal......................       3913-71-1  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Dimethylbenzylcarbinyl acetate.        151-05-3  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Elemi oil (Canarium spp.)......       8023-89-0  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Ethyl (2E,4Z)-2,4-decadienoate.       3025-30-7  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Galbanum oil (Ferula spp.).....       8023-91-4  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
2-Hexenal, (2E)-...............       6728-26-3  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
1H-Indole......................        120-72-9  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Isoborneol.....................        124-76-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
Isobornyl acetate..............        125-12-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Labdanum oil (Cistus spp.).....       8016-26-0  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
laevo-Bornyl acetate...........       5655-61-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Mace oil (Myristica fragrans          8007-12-3  When ready for use, the
 Houtt.).                                         end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Methyl anthranilate............        134-20-3  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Methyl heptine carbonate.......        111-12-6  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
2-Methyl-3-(p-                         103-95-7  When ready for use, the
 isopropylphenyl)propionaldehyd                   end-use concentration
 e.                                               is not to exceed 100
                                                  ppm.
Methyl N-methylanthranilate....         85-91-6  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Methyl 2-nonenoate.............        111-79-5  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Methyl 2-nonynoate.............        111-80-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
2-Methyl-4-phenyl-2-butanol....        103-05-9  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
p-Methylanisole................        104-93-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Nerolidol (isomer unspecified).       7212-44-4  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Nona-2-trans-6-cis-dienal......        557-48-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
2,6-Octadien-1-ol, 3,7-dimethyl-       106-25-2  When ready for use, the
 ,(Z)-.                                           end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Oil of lemon...................       8008-56-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

Oil of lemongrass..............       8007-02-1  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Oils, clove....................       8000-34-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Oils, ginger...................       8007-08-7  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
Oils, grapefruit...............       8016-20-4  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Oils, lime.....................       8008-26-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
Oils, orange, sweet, terpene-        68606-94-0  When ready for use, the
 free.                                            end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Olibanum oil (Boswellia spp.)..       8016-36-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Oxacycloheptadec-10-ene-2-one..      28645-51-4  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Phenol, 2-methoxy-4-(2-                 97-53-0  When ready for use, the
 propenyl)-.                                      end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
2-Phenylpropionaldehyde........         93-53-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.
2-Phenylpropionaldehyde                 90-87-9  When ready for use, the
 dimethyl acetal.                                 end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
[alpha]-Pinene.................         80-56-8  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Tangerine oil (Citrus                 8008-31-9  When ready for use, the
 reticulata blanco).                              end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
[gamma]-Terpinene..............         99-85-4  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
1,3,3-trimethyl-2-norbornanyl        13851-11-1  When ready for use, the
 acetate.                                         end-use concentration
                                                  is not to exceed 100
                                                  ppm.

                              * * * * * * *
Ylang-ylang oils...............       8006-81-3  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 100
                                                  ppm.

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

* * * * *
[FR Doc. 2023-10550 Filed 5-18-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 224 (Wednesday, November 20, 2019)]
[Notices]
[Pages 64128-64129]
[FR Doc No: 2019-24971]

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

SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

    Upon Written Request, Copies Available From: Securities and
Exchange Commission, Office of FOIA Services, 100 F Street NE,
Washington, DC 20549-2736

New Collection:
    Rule 139b; OMB Control No. New Collection, SEC File No. 270-815

    Notice is hereby given that the Securities and Exchange Commission
(the ``Commission'') has, in accordance with the Paperwork Reduction
Act of 1995 (Pub. L. 104-13, 44 U.S.C. 3501 et seq.) (``PRA''),
submitted a sponsored information collection request (``ICR'') to the
Office of Management and Budget (``OMB'') for review and clearance for
the collection of information associated with the new Rule 139b (17 CFR
230.139b) under the Securities Act of 1933 (15 U.S.C. 77a et seq.)
(``Securities Act'') that was adopted by the Commission on November 30,
2018.\1\ The title for this collection of information is: ``Rule 139b
Disclosure of Standardized Performance.''
---------------------------------------------------------------------------

    \1\ See Release No. 33-10580 (Nov. 30, 2018) [83 FR 64180 (Dec.
13, 2018)] (``Adopting Release''). New rule 139b will be effective
on January 14, 2019.
---------------------------------------------------------------------------

    As directed by the Fair Access to Investment Research Act of 2017
(Pub. L. 115-66, 131 Stat. 1196 (2017) (the ``FAIR Act''), the
Commission adopted new rule 139b under the Securities Act to extend the
safe harbor under rule 139 to a ``covered investment fund research
report.'' Specifically, new rule 139b provides a safe harbor to a
broker-dealer who publishes or distributes in the regular course of its
business research reports concerning one or more ``covered investment
fund(s)'' while participating in the distribution of a covered
investment fund's securities.
    In the Proposing Release, we solicited comment on whether rule 139b
should include a standardized performance disclosure requirement.\2\ In
response to comments received, we have decided to adopt such a
requirement.\3\ We believe that standardized performance presentation
is an appropriate requirement because investors tend to consider fund
performance a significant factor in evaluating or comparing investment
companies, and the requirement addresses potential investor confusion
if a communication were not easily recognizable as research as opposed
to an advertising prospectus or supplemental sales literature. Rule
139b requires that research reports about open-end funds that include
performance information must present it in accordance with paragraphs
(d), (e), and (g) of rule 482. Rule 139b also requires that research
reports about closed-end funds that include performance information
must present it in accordance with instructions to item 4.1(g) of Form
N-2. Performance measures calculated by broker-dealers are not required
to be kept confidential and there is no mandatory retention period. We
anticipate that compliance with these performance measures for each
fund discussed in a research report, and for which the performance
measures apply, would increase compliance costs for broker-dealers
seeking to publish or distribute a covered investment fund research
report.
---------------------------------------------------------------------------

    \2\ See Covered Investment Fund Research Reports, Securities Act
Release No. 10498 (May 23, 2018) [83 FR 26788 (June 8, 2018)]
(``Proposing Release'') at 26803-04.
    \3\ See Adopting Release, supra note I, at Section II.C.
---------------------------------------------------------------------------

    It is difficult to provide estimates of the burdens and costs for
those broker-dealers that will include performance information in a
rule 139b research report. As discussed above, this is difficult to
estimate because current data collected does not reflect the affiliate
exclusion, does not include the entire universe of covered investment
funds, and it is uncertain what percentage of communications currently
filed as rule 482 advertising prospectuses (or rule 34b-1 supplemental
sales materials) will instead be published in reliance of rule 139b, as
covered investment fund research reports.\4\ For purposes of the PRA,
we estimate that 10% of the rule 482 and rule 34b-1 communications
currently filed by broker-dealers with FINRA (approximately 65,000)
could be considered as rule 139b covered investment fund research
reports. We estimate that broker-dealers will publish annually 6,500
(10% of 65,000) covered investment fund research reports. Moreover, we
assume for purposes of the PRA that all estimated rule 139b research
reports will include fund performance information. We further estimate
that 1,417 broker-dealers would likely be respondents to the collection
of information with a frequency of 4.6 responses per year.\5\ We
further estimate that 50% of these broker-dealers will have experience
in complying with standardized performance requirements under rule 482.
For the 50% of this subset of broker-dealers that do not have
experience with complying with rule 482, we estimate that there will be
a one-time implementation cost for each broker-dealer of 5 internal
burden hours. Additionally, we estimate that each research report will
require 3 hours of ongoing internal burden hours by a broker-dealers'
personnel to comply with the rule 139b collection of information
requirements, which for each broker-dealer is estimated to be

13.8 internal burden hours.\6\ Accordingly, we estimate that the
standardized performance presentation requirements will result in an
average annual hour burden of about 16.3 hours per broker-dealer \7\ in
the first year of compliance and about 13.8 hours per broker-dealer for
each of the next two years. Amortized over three years, the average
annual hour burden will be about 14.63 hours per broker-dealer.\8\
---------------------------------------------------------------------------

    \4\ See Adopting Release, supra note 1, n. 413 and accompanying
paragraph.
    \5\ See Adopting Release, supra note 1, n. 414 and accompanying
text. 6,500 covered investment fund research reports/1,417 broker-
dealers = 4.6 annual responses per broker-dealer.
    \6\ 4.6 annual responses per broker-dealer x 3 internal burden
hours = 13.8 annual internal burden hours per broker-dealer.
    \7\ (50% of * 13.8 hours ongoing compliance) + (50% * (13.8
hours ongoing compliance + 5 hours of initial compliance hours)).
    \8\ ((16.3 internal burden hours in year 1) + (13.8 internal
burden hours in year 2) + (13.8 internal burden hours in year 3)) /
3.
---------------------------------------------------------------------------

    In sum, we estimate that rule 139b's requirements will impose a
total annual internal hour burden of 20,731 hours on broker-dealers.\9\
We do not think there is an external cost burden associated with this
collection of information.
---------------------------------------------------------------------------

    \9\ 14.63 annualized burden hours * 1,417 broker-dealers.
---------------------------------------------------------------------------

    This information collection is subject to the PRA. If approved,
responses to the new collection of information requirement would not be
mandatory for broker-dealers seeking to rely upon rule 139b but would
be necessary for those broker-dealers that would like to provide
performance information in their covered investment fund research
reports. Responses to the information collections will not be kept
confidential.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The public may view the background
documentation for this information collection at the following website,
www.reginfo.gov. Comments should be directed to: (i) Desk Officer for
the Securities and Exchange Commission, Office of Information and
Regulatory Affairs, Office of Management and Budget, Room 10102, New
Executive Office Building, Washington, DC 20503, or by sending an email
to<EMAIL_ADDRESS>and (ii) Charles Riddle, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Cynthia Roscoe, 100 F Street NE, Washington, DC 20549 or send an
email to<EMAIL_ADDRESS>Comments must be submitted to OMB within
30 days of this notice.

    Dated: November 13, 2019.
 Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-24971 Filed 11-19-19; 8:45 am]
BILLING CODE 8011-01-M