[Federal Register Volume 89, Number 16 (Wednesday, January 24, 2024)]
[Rules and Regulations]
[Pages 4559-4562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01321]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2023-0065; FRL-11656-01-OCSPP]


Baicalin in Pesticide Formulations; Tolerance Exemption

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 Baicalin anhydrous and Baicalin hydrate 
when used as inert ingredients (stabilizer) on growing crops pre-
harvest, limited to a maximum concentration of 10% of the end-use 
formulation. Exponent, Inc. on behalf of UPL NA Inc. submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
requesting establishment of an exemption from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of baicalin anhydrous and baicalin 
hydrate, when used in accordance with the terms of those exemptions.

DATES: This regulation is effective January 24, 2024. Objections and 
requests for hearings must be received on or before March 25, 2024 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-2023-0065, 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. Please review the 
visitor instructions and additional information about the docket 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, 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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Office of the Federal Register's e-CFR site at 
https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2023-0065 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 
March 25, 2024. 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-2023-0065, 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/.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/.

II. Petition for Exemption

    In the Federal Register of March 24, 2023 (88 FR 17778) (FRL-10579-
02), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-11658) by 
Exponent, Inc., 1150 Connecticut Ave., Suite 1100, Washington, DC 
20036, on behalf of UPL NA Inc., 630 Freedom Business Center, Suite 
402, King of Prussia, PA 19406. The petition requested that 40 CFR 
180.920 be amended by establishing an exemption from the requirement of 
a tolerance for residues of baicalin anhydrous (CAS Reg. No.

[[Page 4560]]

21967-41-9) and baicalin hydrate (CAS Reg. No. 206752-33-2) when used 
as inert ingredients (stabilizer) in pesticide formulations applied to 
growing crops pre-harvest limited to a maximum concentration of 10% of 
the end-use formulation. That document referenced a summary of the 
petition prepared by Exponent, Inc. on behalf of UPL NA Inc., the 
petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the 
notice of filing. For ease of reading, baicalin is used throughout this 
document and refers to both baicalin anhydrous and hydrate forms.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings but does not include 
occupational exposure. When making a safety determination for an 
exemption for the requirement of a tolerance FFDCA section 408(c)(2)(B) 
directs EPA to consider the considerations in section 408(b)(2)(C) and 
(D). Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue . . 
. .'' Section 408(b)(2)(D) lists other factors for EPA consideration 
making safety determinations, e.g., the validity, completeness, and 
reliability of available data, nature of toxic effects, available 
information concerning the cumulative effects of the pesticide chemical 
and other substances with a common mechanism of toxicity, and available 
information concerning aggregate exposure levels to the pesticide 
chemical and other related substances, among others.
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no harm to human health. In order 
to determine the risks from aggregate exposure to pesticide inert 
ingredients, the Agency considers the toxicity of the inert in 
conjunction with possible exposure to residues of the inert ingredient 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings. If EPA is able to 
determine that a finite tolerance is not necessary to ensure that there 
is a reasonable certainty that no harm will result from aggregate 
exposure to the inert ingredient, an exemption from the requirement of 
a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for baicalin including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with baicalin follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the adverse effects caused by baicalin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in this unit.
    Baicalin exhibits low levels of acute toxicity via the oral route 
of exposure. Acute dermal toxicity is expected to be low based on low 
oral acute toxicity and the absence of clinical signs in a skin 
irritation study in rabbits. Acute inhalation toxicity is expected to 
be low based on its low vapor pressure. Baicalin is not a skin 
sensitizer. Special studies reported no acute adverse effects on 
respiratory function and the central nervous system (CNS) in rats up to 
5,000 mg/kg (equivalent to 3,000 mg/kg baicalin) or on cardiovascular 
function in dogs up to 1,000 mg/kg (equivalent to 600 mg/kg baicalin).
    No effects were seen in subchronic oral toxicity studies in rats up 
to 2,000 mg/kg/day (~1,200 mg/kg/day baicalin), in mice up to 500 mg/
kg/day (~300 mg/kg/day baicalin) and in dogs up to 1,000 mg/kg/day 
(~630 mg/kg/day baicalin). No increased offspring susceptibility was 
observed in the available studies as no offspring or maternal effects 
were observed. Concern for carcinogenicity is low based on a negative 
result in a mutagenicity study, lack of effects in subchronic studies, 
and the lack of relevant structural alerts for carcinogenicity.
    No evidence of neurotoxicity or immunotoxicity was observed in the 
available studies. Also, no neurotoxicity was observed in an acute 
toxicity study evaluating central nervous system effects in rats.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold

[[Page 4561]]

risks, the Agency assumes that any amount of exposure will lead to some 
degree of risk. Thus, the Agency estimates risk in terms of the 
probability of an occurrence of the adverse effect expected in a 
lifetime. For more information on the general principles EPA uses in 
risk characterization and a complete description of the risk assessment 
process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.
    The hazard profile of baicalin is adequately defined. Overall, 
baicalin is of low acute, subchronic, and developmental toxicity. No 
systemic toxicity is observed up to 2,000 mg/kg/day (~1,200 mg/kg/day 
baicalin), in mice up to 500 mg/kg/day (~300 mg/kg/day baicalin) and in 
dogs up to 1,000 mg/kg/day (~630 mg/kg/day baicalin). Since signs of 
toxicity were not observed, no toxicological endpoints of concern or 
PODs were identified. Therefore, a qualitative risk assessment for 
baicalin can be performed.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to baicalin, EPA considered exposure under the proposed 
exemption from the requirement of a tolerance. EPA assessed dietary 
exposures from baicalin in food as follows:
    Dietary exposure (food and drinking water) to baicalin may occur 
following ingestion of foods with residues from their use in accordance 
with this exemption and use as an herbal supplement. However, a 
quantitative dietary exposure assessment was not conducted since a 
toxicological endpoint for risk assessment was not identified.
    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).
    Baicalin may be present in pesticide and non-pesticide products 
that may be used in and around the home and in cosmetic products. 
However, a quantitative residential exposure assessment was not 
conducted since a toxicological endpoint for risk assessment was not 
identified.
    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.''
    Based on the lack of toxicity in the available database, EPA has 
not found baicalin to share a common mechanism of toxicity with any 
other substances, and baicalin does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance exemption, therefore, EPA has assumed that baicalin 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/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an 
additional tenfold (10X) margin of safety for infants and children in 
the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the Food Quality Protection Act 
(FQPA) Safety Factor (SF). In applying this provision, EPA either 
retains the default value of 10X, or uses a different additional safety 
factor when reliable data available to EPA support the choice of a 
different factor.
    Based on an assessment of baicalin, EPA has concluded that there 
are no toxicological endpoints of concern for the U.S. population, 
including infants and children. Because there are no threshold effects 
associated with baicalin, EPA conducted a qualitative assessment. As 
part of that assessment, the Agency did not use safety factors for 
assessing risk, and no additional safety factor is needed for assessing 
risk to infants and children.

E. Aggregate Risks and Determination of Safety

    Because no toxicological endpoints of concern were identified, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to baicalin residues.

V. Other Considerations

Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is not establishing a numerical tolerance for residues of 
baicalin in or on any food commodities. EPA is establishing a 
limitation on the amount of baicalin that may be used in pesticide 
formulations applied pre-harvest. This limitation will be enforced 
through the pesticide registration process under the Federal 
Insecticide, Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136 
et seq. EPA will not register any pesticide formulation for food use 
that exceeds 10% by weight of baicalin in the final pesticide 
formulation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established for residues of baicalin anhydrous (CAS Reg. No. 21967-41-
9) and baicalin hydrate (CAS Reg. No. 206752-33-2) when used as inert 
ingredients (stabilizer) in pesticide formulations on growing crops 
pre-harvest under 40 CFR 180.920 limited to a maximum concentration of 
10% of the end-use formulation.

VII. Statutory and Executive Order Reviews

    This action establishes exemptions from the requirement of a 
tolerance under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993). Because this action has been exempted from review 
under Executive Order 12866, this action is not subject to Executive 
Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This action does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special 
considerations under Executive Order 12898, entitled ``Federal Actions 
to Address Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition

[[Page 4562]]

under FFDCA section 408(d), such as the exemptions in this final rule, 
do not require the issuance of a proposed rule, the requirements of the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal Governments, on the relationship between the National Government 
and the States or Tribal Governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: January 18, 2024.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.920, amend table 1 to 180.920 by revising its heading 
and adding in alphabetical order entries for ``Baicalin anhydrous'' and 
``Baicalin hydrate'' to read as follows:


Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

                                            Table 1 to Sec.   180.920
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           Inert ingredients                       Limits                                Uses
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Baicalin anhydrous (CAS Reg. No. 21967-  10% by weight.............  Stabilizer.
 41-9).
Baicalin hydrate (CAS Reg. No. 206752-   10% by weight.............  Stabilizer.
 33-2).
 
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[FR Doc. 2024-01321 Filed 1-23-24; 8:45 am]
BILLING CODE 6560-50-P