Rule2022-22045
Lysate of Willaertia magna C2c Maky; Exemption From the Requirement of a Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 12, 2022
Effective
October 12, 2022
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 196 (Wednesday, October 12, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#d59785859193879bbaa1bcb6b0a695b0a5b4fbb2baa3"><span class="__cf_email__" data-cfemail="1f5d4f4f5b594d51706b767c7a6c5f7a6f7e31787069">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/contacts.html">https://www.epa.gov/dockets/contacts.html</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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,
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
[[Page 61536]]
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 <a href="https://www.epa.gov/pesticides/cumulative">https://www.epa.gov/pesticides/cumulative</a>.
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
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