Rule2023-17019
Flg22-Bt Peptide; 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
August 9, 2023
Effective
August 9, 2023
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of Flg22-Bt Peptide in or on all food commodities when used as a plant regulator and inducer of local and systemic resistance in accordance with label directions and good agricultural practices. Elemental Enzymes Ag & Turf, LLC submitted a petition, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), requesting an exemption from the requirement of a tolerance for the biochemical pesticide Flg22-Bt Peptide. This regulation eliminates the need to establish a maximum permissible level for residues of Flg22-Bt Peptide under FFDCA when used in accordance with this exemption.
Full Text
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<title>Federal Register, Volume 88 Issue 152 (Wednesday, August 9, 2023)</title>
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[Federal Register Volume 88, Number 152 (Wednesday, August 9, 2023)]
[Rules and Regulations]
[Pages 53806-53809]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17019]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0226; FRL-11264-01-OCSPP]
Flg22-Bt Peptide; 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 Flg22-Bt Peptide in or on all food
commodities when used as a plant regulator and inducer of local and
systemic resistance in accordance with label directions and good
agricultural practices. Elemental Enzymes Ag & Turf, LLC submitted a
petition, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), requesting an exemption from
the requirement of a tolerance for the biochemical pesticide Flg22-Bt
Peptide. This regulation eliminates the need to establish a maximum
permissible level for residues of Flg22-Bt Peptide under FFDCA when
used in accordance with this exemption.
DATES: This regulation is effective August 9, 2023. Objections and
requests for hearings must be received on or before October 10, 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-2021-0226, 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. Please review the
visitor instructions and additional information about the docket
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Chris Pfeifer, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (202) 566-1599; email address:
<a href="/cdn-cgi/l/email-protection#440614140002160a2b302d272137042134256a232b32"><span class="__cf_email__" data-cfemail="f7b5a7a7b3b1a5b998839e949284b7928796d9909881">[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-2021-0226 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
October 10, 2023. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
[[Page 53807]]
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-2021-0226 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/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</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 22, 2021 (86 FR 21317) (FRL-10022-
59), 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 0F8889) by Elemental Enzymes Ag & Turf, LLC, 1685 Galt
Industrial Blvd. Saint Louis, MO 63132. The petition requested that 40
CFR part 180 be amended to establish an exemption from the requirement
of a tolerance for residues of Flg22-Bt Peptide, when used as a plant
regulator and an inducer of local and systemic resistance in accordance
with label directions and good agricultural practices. That document
referenced a summary of the petition prepared by Elemental Enzymes Ag &
Turf, LLC, which is available in the docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. No comments were received on the notice of filing.
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 to Flg22-Bt Peptide, including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with Flg22-Bt Peptide
follows.
A. Toxicological Profile
Flg22-Bt Peptide is a synthetically produced and purified peptide
containing 22 amino acids. The amino acid sequence is naturally
occurring and is derived from the Bacillus thuringiensis flagellin
protein. Bacillus thuringiensis is a ubiquitous soil-dwelling bacterium
and is a common active ingredient in microbial pesticide products.
Mode-of-action claims for the active ingredient include activation of
multiple plant defense mechanisms, promotion of plant growth and
increased vigor. With regard to activation of plant defenses, it is
proposed that the active ingredient activates plant cell-surface
receptor Flagellin-Sensing 2, which results in the initiation of
various intra- and extra-cellular responses that ultimately inhibit
pathogen growth.
As an active ingredient in pesticidal end-use products (EPs),
Flg22-Bt Peptide is intended to be applied as part of a solution,
primarily as a spray applied to crops, but also as a commercial seed
treatment and an injection for trees. Potential exposures to the
biochemical active ingredient Flg22-Bt Peptide are not expected to
result in any risks of toxicological concern. The active ingredient is
naturally occurring and is derived from the Bacillus thuringiensis
flagellin Deleprotein to which humans are already exposed. (Flagellin
is the major structural protein of the flagella of Gram-negative
bacteria, including Bacillus thuringiensis, and these microbes are
ubiquitous in the environment.) Flg22-Bt Peptide is not expected to
pose a risk through any pathways for the following reasons. (1) Flg22-
Bt Peptide degrades in the gastrointestinal tract as it is digested by
the common digestive enzyme Pepsin. (2) This peptide sequence is
dissimilar to any allergenic peptide sequences. As such, the potential
for any allergenicity is negligible. (3) Negligible potential for
allergenicity notwithstanding, Flg22-Bt Peptide is rapidly degraded
under simulated mammalian gastric conditions and will not persist long
enough under these conditions to induce an allergic response. (4)
Flg22-Bt Peptide degrades rapidly in the environment and is not
anticipated to be present in any concentration outside potential
naturally occurring background levels. (5) No toxicological endpoints
have been identified for Flg22-Bt Peptide. All the data submitted in
support of the registration of this peptide confirm its low toxicity
profile.
With regard to the overall toxicological profile, Flg22-Bt Peptide
is of low toxicity. Acute toxicity data indicate that Flg22-Bt Peptide
is Toxicity Category IV for acute oral toxicity, acute dermal toxicity,
dermal irritation, and eye irritation, and Toxicity Category III for
acute inhalation toxicity. The available data also suggest it is not a
skin sensitizer. Guideline
[[Page 53808]]
studies were submitted for all the acute toxicity data requirements.
All subchronic data requirements for the active ingredient Flg22-Bt
Peptide (90-day oral toxicity, 90-day dermal toxicity and 90-day
inhalation toxicity) were satisfied with acceptable waiver rationales,
based on low toxicity and low exposure. The 90-day oral toxicity
rationale provided the following points of support: (1) Flg22-Bt
Peptide is of low acute oral toxicity (Toxicity Category IV); (2) based
on an acceptable in vitro digestion study using simulated gastric
fluid, Flg22-Bt Peptide is anticipated to be rapidly and completely
degraded in the gastrointestinal tract; (3) a search of in silico
databases revealed no similarity in sequence between the Flg22-Bt
Peptide and any known protein toxins, indicating low toxicity through
its structural relationships; (4) Flg22-Bt Peptide is naturally
occurring and is derived from the Bacillus thuringiensis flagellin
protein to which humans are regularly exposed.; and (5) dietary
exposure is expected to be negligible based on low application rates
(e.g., maximum rate of 0.00052 lb AI/acre for foliar applications) and
rapid degradation in the environment. The 90-day dermal toxicity data
requirement was also addressed with an acceptable rationale that
contained the same information provided to address the 90-day oral
toxicity requirement combined with the following additional
information: (1) the active ingredient is of low acute dermal toxicity
(Toxicity Category IV), is only slightly irritating to the skin
(Toxicity Category IV), and is not a skin sensitizer; and (2)
significant repeat dermal exposure is not anticipated as the proposed
end-use products containing this peptide will not be directly applied
to the skin and will be applied in low concentrations (0.002-0.012%, by
weight) at low application rates. As a final limitation to dermal
exposure, personal protective equipment (PPE) required for pesticides
using Flg22-Bt Peptide (i.e., long-sleeved shirt and long pants, shoes
plus socks, and waterproof gloves) will mitigate dermal exposure to
pesticide applicators and other handlers. The 90-day inhalation
toxicity data requirement was also addressed with an acceptable
rationale that contained the same information used to address the 90-
day oral toxicity requirement combined with the following additional
information: (1) Flg22-Bt Peptide is of low acute inhalation toxicity;
(2) because Flg22-Bt Peptide is of low acute toxicity for all paths of
exposure, there is minimal concern for localized or portal-of-entry
inhalation effects; (3) significant repeat inhalation exposure is not
anticipated as the proposed end-use products will be applied at low
concentrations of active ingredient (0.002-0.012%, by weight) and at
low application rates; and (4) based on its physical and chemical
properties, such as low vapor pressure and high water solubility,
inhalation exposure due to volatilization is not expected for Flg22-Bt
Peptide.
The data requirements for developmental toxicity were also
satisfied with the submission of an acceptable rationale, which was
nearly identical to that submitted to satisfy the subchronic toxicity
data requirements. For details of that rationale, refer to the points
of support in the preceding paragraph. In short, Flg-22 Bt Peptide is
of low toxicity and significant exposure from use as a pesticide is not
anticipated and, as such, is not expected to pose any risks with regard
to developmental toxicity.
As for the mutagenicity data requirements, those were satisfied
through the submission of guideline studies. There were no indications
of genotoxicity or mutagenicity in the submitted guideline in vitro
studies. Specifically, there was no evidence of induced mutant colonies
over background with or without metabolic activation in the reverse
gene mutation assay in bacteria; and there was no evidence of inducted
mutant colonies over background with or without metabolic activation in
the mammalian forward gene mutation assay in Chinese hamster ovary
cells. All submitted data indicate that Flg22-Bt Peptide is non-
genotoxic and non-mutagenic.
B. Toxicological Points of Departure/Levels of Concern
No toxicological endpoints have been identified for Flg22-Bt
Peptide. The active ingredient is of low toxicity, and significant
exposure is not expected based on the low application rates and rapid
degradation in the environment.
C. Exposure Assessment
1. Dietary exposure from food, feed uses, and drinking water. As
part of its qualitative risk assessment for Flg22-Bt Peptide, the
Agency considered the potential for dietary exposure to residues of the
chemical. EPA concludes that dietary (food and drinking water)
exposures are possible, but they are expected to be negligible based on
low application rates and rapid degradation in the environment and are
not anticipated in any concentration outside potential naturally
occurring background levels. Moreover, no toxicological endpoint of
concern was identified for Flg22-Bt Peptide; and therefore, a
quantitative assessment of dietary exposure is not necessary. Dietary
risk is not of a concern.
2. 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,
although there is a potential for residential post-application exposure
from pesticide applications to turf. However, no risks of concern have
been identified for this turf application due to the low toxicity of
the Flg22-Bt Peptide and negligible exposure based on low application
rates and rapid degradation in the environment. Therefore, a
quantitative assessment of residential exposure 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
Flg22-Bt Peptide 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 Flg22-Bt Peptide 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/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</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 Food Quality Protection Act
(FQPA) safety factor. In applying this provision, EPA
[[Page 53809]]
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 Flg22-Bt Peptide because no toxicological endpoints have been
established and the qualitative risk assessment has concluded that
Flg22-BT Peptide is of low toxicity and that no significant exposures
are expected.
E. Aggregate Risk
In accordance with the FFDCA, OPP must consider and aggregate (add)
pesticide exposures and risks from three major sources: food, drinking
water, and residential exposures. In an aggregate assessment, exposures
from relevant sources that have the same toxicological endpoints are
added together and compared to quantitative estimates of hazard, or the
risks themselves can be aggregated. When aggregating exposures and
risks from various sources, EPA considers both the route and duration
of exposure. A qualitative aggregate risk assessment has been conducted
for the proposed use of Flg22-Bt Peptide based on the lack of
identified endpoints in the toxicological database and minimal exposure
to the active ingredient. No risks of concern have been identified.
A full explanation of the data upon which EPA relied and its risk
assessment based on those data can be found within the April 7, 2023,
document entitled ``Product Chemistry Review and Human Health
Assessment for a FIFRA Section 3 Registration of Flg22-BtPeptide
Technical, Containing 70% Flg22-Bt Peptide as the Active Ingredient.''
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
Flg22-Bt Peptide.
V. Other Considerations
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.
VI. Conclusion
Therefore, EPA is establishing an exemption from the requirement of
a tolerance for residues of Flg22-BtPeptide in or on all food
commodities when used as a plant regulator and inducer of local and
systemic resistance in accordance with label directions and good
agricultural practices.
VII. Statutory and Executive Order Reviews
This action establishes 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 exemption 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: August 3, 2023.
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. 180.1405 to subpart D to read as follows:
Sec. 180.1405 Flg22-Bt Peptide; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of Flg22-Bt Peptide in or on all food commodities when used as
a plant regulator and inducer of local and systemic resistance in
accordance with label directions and good agricultural practices.
[FR Doc. 2023-17019 Filed 8-8-23; 8:45 am]
BILLING CODE 6560-50-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.