Lysate of Willaertia magna C2c Maky; Exemption From the Requirement of a Tolerance, 61534-61537 [2022-22045]
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61534
Federal Register / Vol. 87, No. 196 / Wednesday, October 12, 2022 / Rules and Regulations
Dated: October 5, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office
of Pesticide Programs.
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.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR part
180 as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.920, amend table 1 by:
■ a. Removing the entry for ‘‘Dimethyl
sulfoxide’’; and
■ b. Revising the entry ‘‘Dimethyl
sulfoxide (CAS Reg. No. 67–68–5)’’.
The revision reads as follows:
■
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
1. The authority citation for part 180
continues to read as follows:
■
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*
TABLE 1 TO 180.920
Inert ingredients
Limits
*
*
*
*
Dimethyl sulfoxide (CAS Reg. No. 67–68–5) ...............................................................
*
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178 (see also Unit I.C. of the
BILLING CODE 6560–50–P
SUPPLEMENTARY INFORMATION).
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2021–0422, 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 (202) 566–1744. For the latest
status information on EPA/DC services,
docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Charles Smith, Biopesticides and
Pollution Prevention Division (7511M),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(202) 566–1400; email address:
BPPDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
40 CFR Part 180
[EPA–HQ–OPP–2021–0422; FRL–9994–01–
OCSPP]
Lysate of Willaertia magna C2c Maky;
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of Lysate of
Willaertia magna C2c Maky in or on raw
agricultural commodities and processed
food, when used in accordance with
label directions and good agricultural
practices. The Amoe´ba SA, 38 ave des
Fre`res Montgolfier, F–69680 Chassieu,
France, submitted a petition to EPA
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting an
exemption from the requirement of a
tolerance. This regulation eliminates the
need to establish a maximum
permissible level for residues of Lysate
of Willaertia magna C2c Maky when
used in accordance with this exemption.
DATES: This regulation is effective
October 12, 2022. Objections and
requests for hearings must be received
on or before December 12, 2022, and
must be filed in accordance with the
instructions provided in 40 CFR part
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SUMMARY:
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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,
greenhouse owner, or pesticide
manufacturer. The following list of
North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
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Solvent/co-solvent.
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[FR Doc. 2022–22129 Filed 10–11–22; 8:45 am]
ENVIRONMENTAL PROTECTION
AGENCY
Uses
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*
*
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–2021–0422 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
December 12, 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
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submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2021–0422, 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.
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II. Background and Statutory Findings
In the Federal Register of April 28,
2022 (87 FR 25178 (FRL–8792–03–
OCSPP), EPA issued a document
pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing
of a pesticide tolerance petition (PP
0F8873) by Amoe´ba SA, 38 ave des
Fre`res Montgolfier, F–69680 Chassieu,
France. The petition requested that 40
CFR part 180 be amended to establish
an exemption from the requirement of a
tolerance for residues of the pesticide,
when used as a fungicide and systemic
resistance inducer for various food
crops in fields and greenhouses, in
accordance with label directions and
good agricultural practices. That
document referenced a summary of the
petition prepared by the petitioner,
Amoe´ba SA, which is available in the
docket, https://www.regulations.gov.
There were no relevant comments
received in response to the notice of
filing.
Based upon review of the data
supporting the petition and in
accordance with its authority under
FFDCA section 408(d)(4)(A)(i), EPA is
establishing a tolerance exemption that
varies from what the petitioner sought.
The reason for the change is explained
in full detail in Unit V.B.
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61535
III. Aggregate Risk Assessment and
Determination of Safety
associated with Lysate of Willaertia
magna C2c Maky follows.
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the exemption is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings but does not include
occupational exposure. Pursuant to
FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an
exemption from the requirement of a
tolerance, EPA must take into account
the factors set forth in FFDCA section
408(b)(2)(C), which require 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. . . .’’ Additionally,
FFDCA section 408(b)(2)(D) requires
that 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 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. If EPA is able to
determine that a tolerance is not
necessary to ensure that there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, 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 Lysate of
Willaertia magna C2c Maky including
exposure resulting from the exemption
established by this action. EPA’s
assessment of exposures and risks
A. Toxicological Profile
Willaertia magna C2c Maky is a nongenetically modified microorganism
isolated from the thermal baths of Aixles-Bains (France). It is a thermophilic
free-living amoeba strain that belongs to
the protozoan order, among eukaryotic
unicellular mobile microorganisms
(with flagella). It is a natural predator of
bacteria, including Legionella, and other
smaller amoebas. The lack of
pathogenicity of this amoeba in human
endothelial cells was demonstrated by
cell culture.
With regard to the overall
toxicological profile, Willaertia magna
C2c Maky is of low toxicity. Based on
acute studies, Willaertia magna C2c
Maky is of low acute oral toxicity and
acute inhalation toxicity (Toxicity
Category III), low acute dermal toxicity
(Toxicity Category III) and is nonirritating to the skin and eye (Toxicity
Category IV). The chemical is not a skin
sensitizer. Subchronic 90-day oral
toxicity, developmental toxicity,
reproductive toxicity and mutagenicity
data requirements were satisfied by
guideline studies. There were no
adverse subchronic effects for any oral
routes of exposure. The active
ingredient was determined to be nonmutagenic, and no adverse effects were
identified relative to either
developmental toxicity or reproductive
toxicity. EPA granted waivers for the 90day dermal and 90-day inhalation data
requirements based on a weight of the
evidence approach (WOE) due to: (1)
significant volatilization not being
expected, (2) low overall acute toxicity
(Toxicity Category III for inhalation), (3)
its components are naturally-occurring
and are similar to substances already
present in mammalian cells, (4) the
lysate of Willaertia magna C2c Maky
being non-irritating to the skin and nonsensitizing to the skin and its physical/
chemical properties indicate it is
unlikely to be dermally absorbed, and
(5) no adverse effects were seen in
neither the 90-day oral toxicity study up
to the limit dose nor the prenatal
developmental toxicity study up to the
limit dose.
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B. Toxicological Points of Departure/
Levels of Concern
EPA did not identify any toxicological
endpoints of concern for Willaertia
magna C2c Maky.
C. Exposure Assessment
1. Dietary exposure from food, feed
uses, and drinking water. As part of its
qualitative risk assessment for lysate of
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Willaertia magna C2c Maky, the Agency
considered the potential for dietary
exposure to residues of lysate of
Willaertia magna C2c Maky. EPA
concludes that dietary (food and
drinking water) exposures are possible.
However, no toxicological endpoint of
concern was identified for lysate of
Willaertia magna C2c Maky, and
therefore, a quantitative assessment of
dietary exposure is not necessary.
2. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables). There are currently no proposed
residential uses for this active
ingredient; therefore, a residential
exposure assessment is not necessary.
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 that lysate of Willaertia magna
C2c Maky shares a common mechanism
of toxicity with any other substances,
and it does not appear to produce a
toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed lysate of Willaertia magna C2c
Maky does not have a common
mechanism of toxicity with other
substances. For information regarding
EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see EPA’s website at https://
www.epa.gov/pesticides/cumulative.
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
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data available to EPA support the choice
of a different factor. An FQPA safety
factor is not required at this time for
lysate of Willaertia magna C2c Maky
because no dietary endpoints have been
selected based on the lack of humanrelevant adverse effects at limit doses in
the 90-day oral toxicity study and
prenatal developmental toxicity study.
E. Aggregate Risk
Based on the available data and
information, the EPA has concluded
that a qualitative aggregate risk
assessment is appropriate to support the
pesticidal use of lysate of Willaertia
magna C2c Maky, and that risks of
concern are not anticipated from
aggregate exposure to the substance.
This conclusion is based on the low
toxicity of the active ingredient.
A full explanation of the data upon
which EPA relied and its risk
assessment based on those data can be
found within the January 13, 2022,
document entitled ‘‘BPPD Risk
Assessment 91283–I, 91283–O and
Tolerance Petition.’’ This document, as
well as other relevant information, is
available in the docket for this action as
described under ADDRESSES.
IV. Determination of Safety for U.S.
Population, Infants and Children
Based on the Agency’s assessment,
EPA concludes that there is reasonable
certainty that no harm will result to the
U.S. population, including infants and
children, from aggregate exposure to
residues of lysate of Willaertia magna
C2c Maky.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is establishing an exemption
from the requirement of a tolerance
without any numerical limitation.
B. Revisions to Petitioned-For Tolerance
Exemption
The petitioned-for tolerance
exemption for lysate of Willaertia
magna C2c Maky is different from that
being established by EPA. EPA
determined that based on the low
toxicity of lysate of Willaertia magna
C2c Maky, any possible residues from
the use of this active ingredient as a
pesticide are not expected to result in
any risks of concern to humans.
Therefore, EPA has determined that the
broad exemption for all food
commodities, when used in accordance
with label directions, is appropriate.
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VI. Conclusions
Therefore, EPA is establishing an
exemption for residues of lysate of
Willaertia magna C2c Maky in or on all
food commodities, when used in
accordance with label directions and
good agricultural practices.
VII. Statutory and Executive Order
Reviews
This action amends an exemption
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 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
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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: October 5, 2022.
Edward Messina,
Director, 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
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.1394 to subpart D to read
as follows:
■
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§ 180.1394 Lysate of Willaertia magna C2c
Maky; Exemption from the Requirement of
a Tolerance.
An exemption from the requirement
of a tolerance is established for residues
of the pesticide, lysate of Willaertia
magna C2c Maky, in or on all food
commodities, when used in accordance
with label directions.
[FR Doc. 2022–22045 Filed 10–11–22; 8:45 am]
BILLING CODE 6560–50–P
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61537
SUPPLEMENTARY INFORMATION:
ENVIRONMENTAL PROTECTION
AGENCY
I. General Information
40 CFR Part 180
A. Does this action apply to me?
[EPA–HQ–OPP–2022–0507; FRL–10196–01–
OCSPP]
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).
Siloxanes and Silicones, di-Me, Me
Hydrogen; Tolerance Exemption
Environmental Protection
Agency (EPA)
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of siloxanes and
silicones, di-Me, Me hydrogen, reaction
products with vinyl group-terminated
di-Me siloxanes (CAS Reg. No. 156065–
02–0), when used as an inert ingredient
in a pesticide chemical formulation. The
Dow Chemical Company submitted a
petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA),
requesting an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of siloxanes and silicones,
di-Me, Me hydrogen, reaction products
with vinyl group-terminated di-Me
siloxanes on food or feed commodities.
DATES: This regulation is effective
October 12, 2022. Objections and
requests for hearings must be received
on or before December 12, 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–2022–0507, 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 (202) 566–1744. 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 (7505T), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; main
telephone number: (202) 566–1030;
email address: RDFRNotices@epa.gov.
SUMMARY:
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Office of the Federal
Register’s e-CFR site at https://
www.ecfr.gov/current/title-40.
C. Can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2022–0507 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
December 12, 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–
2022–0507, by one of the following
methods.
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
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Agencies
[Federal Register Volume 87, Number 196 (Wednesday, October 12, 2022)]
[Rules and Regulations]
[Pages 61534-61537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22045]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0422; FRL-9994-01-OCSPP]
Lysate of Willaertia magna C2c Maky; Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Lysate of Willaertia magna C2c Maky in
or on raw agricultural commodities and processed food, when used in
accordance with label directions and good agricultural practices. The
Amo[eacute]ba SA, 38 ave des Fr[egrave]res Montgolfier, F-69680
Chassieu, France, submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of Lysate of
Willaertia magna C2c Maky when used in accordance with this exemption.
DATES: This regulation is effective October 12, 2022. Objections and
requests for hearings must be received on or before December 12, 2022,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0422, 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 (202) 566-1744. For the latest
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and
Pollution Prevention Division (7511M), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (202) 566-1400; 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, greenhouse owner, 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-2021-0422 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
December 12, 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
[[Page 61535]]
submit a copy of the filing (excluding any Confidential Business
Information (CBI)) for inclusion in the public docket. Information not
marked confidential pursuant to 40 CFR part 2 may be disclosed publicly
by EPA without prior notice. Submit the non-CBI copy of your objection
or hearing request, identified by docket ID number EPA-HQ-OPP-2021-
0422, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Background and Statutory Findings
In the Federal Register of April 28, 2022 (87 FR 25178 (FRL-8792-
03-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 0F8873) by Amo[eacute]ba SA, 38 ave des Fr[egrave]res
Montgolfier, F-69680 Chassieu, France. The petition requested that 40
CFR part 180 be amended to establish an exemption from the requirement
of a tolerance for residues of the pesticide, when used as a fungicide
and systemic resistance inducer for various food crops in fields and
greenhouses, in accordance with label directions and good agricultural
practices. That document referenced a summary of the petition prepared
by the petitioner, Amo[eacute]ba SA, which is available in the docket,
https://www.regulations.gov. There were no relevant comments received
in response to the notice of filing.
Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
is establishing a tolerance exemption that varies from what the
petitioner sought. The reason for the change is explained in full
detail in Unit V.B.
III. 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 exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require 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. . .
.'' Additionally, FFDCA section 408(b)(2)(D) requires that 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 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. If EPA is
able to determine that a tolerance is not necessary to ensure that
there is a reasonable certainty that no harm will result from aggregate
exposure to the pesticide chemical residue, 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 Lysate of Willaertia magna C2c
Maky including exposure resulting from the exemption established by
this action. EPA's assessment of exposures and risks associated with
Lysate of Willaertia magna C2c Maky follows.
A. Toxicological Profile
Willaertia magna C2c Maky is a non-genetically modified
microorganism isolated from the thermal baths of Aix-les-Bains
(France). It is a thermophilic free-living amoeba strain that belongs
to the protozoan order, among eukaryotic unicellular mobile
microorganisms (with flagella). It is a natural predator of bacteria,
including Legionella, and other smaller amoebas. The lack of
pathogenicity of this amoeba in human endothelial cells was
demonstrated by cell culture.
With regard to the overall toxicological profile, Willaertia magna
C2c Maky is of low toxicity. Based on acute studies, Willaertia magna
C2c Maky is of low acute oral toxicity and acute inhalation toxicity
(Toxicity Category III), low acute dermal toxicity (Toxicity Category
III) and is non-irritating to the skin and eye (Toxicity Category IV).
The chemical is not a skin sensitizer. Subchronic 90-day oral toxicity,
developmental toxicity, reproductive toxicity and mutagenicity data
requirements were satisfied by guideline studies. There were no adverse
subchronic effects for any oral routes of exposure. The active
ingredient was determined to be non-mutagenic, and no adverse effects
were identified relative to either developmental toxicity or
reproductive toxicity. EPA granted waivers for the 90-day dermal and
90-day inhalation data requirements based on a weight of the evidence
approach (WOE) due to: (1) significant volatilization not being
expected, (2) low overall acute toxicity (Toxicity Category III for
inhalation), (3) its components are naturally-occurring and are similar
to substances already present in mammalian cells, (4) the lysate of
Willaertia magna C2c Maky being non-irritating to the skin and non-
sensitizing to the skin and its physical/chemical properties indicate
it is unlikely to be dermally absorbed, and (5) no adverse effects were
seen in neither the 90-day oral toxicity study up to the limit dose nor
the prenatal developmental toxicity study up to the limit dose.
B. Toxicological Points of Departure/Levels of Concern
EPA did not identify any toxicological endpoints of concern for
Willaertia magna C2c Maky.
C. Exposure Assessment
1. Dietary exposure from food, feed uses, and drinking water. As
part of its qualitative risk assessment for lysate of
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Willaertia magna C2c Maky, the Agency considered the potential for
dietary exposure to residues of lysate of Willaertia magna C2c Maky.
EPA concludes that dietary (food and drinking water) exposures are
possible. However, no toxicological endpoint of concern was identified
for lysate of Willaertia magna C2c Maky, and therefore, a quantitative
assessment of dietary exposure is not necessary.
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). There
are currently no proposed residential uses for this active ingredient;
therefore, a residential exposure assessment is not necessary.
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 that
lysate of Willaertia magna C2c Maky shares a common mechanism of
toxicity with any other substances, and it does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed lysate of Willaertia magna
C2c Maky does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticides/cumulative.
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. An FQPA
safety factor is not required at this time for lysate of Willaertia
magna C2c Maky because no dietary endpoints have been selected based on
the lack of human-relevant adverse effects at limit doses in the 90-day
oral toxicity study and prenatal developmental toxicity study.
E. Aggregate Risk
Based on the available data and information, the EPA has concluded
that a qualitative aggregate risk assessment is appropriate to support
the pesticidal use of lysate of Willaertia magna C2c Maky, and that
risks of concern are not anticipated from aggregate exposure to the
substance. This conclusion is based on the low toxicity of the active
ingredient.
A full explanation of the data upon which EPA relied and its risk
assessment based on those data can be found within the January 13,
2022, document entitled ``BPPD Risk Assessment 91283-I, 91283-O and
Tolerance Petition.'' This document, as well as other relevant
information, is available in the docket for this action as described
under ADDRESSES.
IV. Determination of Safety for U.S. Population, Infants and Children
Based on the Agency's assessment, EPA concludes that there is
reasonable certainty that no harm will result to the U.S. population,
including infants and children, from aggregate exposure to residues of
lysate of Willaertia magna C2c Maky.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. Revisions to Petitioned-For Tolerance Exemption
The petitioned-for tolerance exemption for lysate of Willaertia
magna C2c Maky is different from that being established by EPA. EPA
determined that based on the low toxicity of lysate of Willaertia magna
C2c Maky, any possible residues from the use of this active ingredient
as a pesticide are not expected to result in any risks of concern to
humans. Therefore, EPA has determined that the broad exemption for all
food commodities, when used in accordance with label directions, is
appropriate.
VI. Conclusions
Therefore, EPA is establishing an exemption for residues of lysate
of Willaertia magna C2c Maky in or on all food commodities, when used
in accordance with label directions and good agricultural practices.
VII. Statutory and Executive Order Reviews
This action amends an exemption 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 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
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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: October 5, 2022.
Edward Messina,
Director, 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. Add Sec. 180.1394 to subpart D to read as follows:
Sec. 180.1394 Lysate of Willaertia magna C2c Maky; Exemption from
the Requirement of a Tolerance.
An exemption from the requirement of a tolerance is established for
residues of the pesticide, lysate of Willaertia magna C2c Maky, in or
on all food commodities, when used in accordance with label directions.
[FR Doc. 2022-22045 Filed 10-11-22; 8:45 am]
BILLING CODE 6560-50-P