[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

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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.

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

[[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 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