Rule2023-00017
Extract of Caesalpinia Spinosa; 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
January 6, 2023
Effective
January 6, 2023
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of extract of Caesalpinia spinosa in or on all food commodities when used in accordance with good agricultural practices. Exponent, on behalf of Ag Chem Resources, LLC, 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 extract of Caesalpinia spinosa when used in accordance with this exemption.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 4 (Friday, January 6, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 4 (Friday, January 6, 2023)]
[Rules and Regulations]
[Pages 990-993]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-00017]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0209; FRL-10495-01-OCSPP]
Extract of Caesalpinia Spinosa; Exemption From the Requirement of
a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of extract of Caesalpinia spinosa in or on
all food commodities when used in accordance with good agricultural
practices. Exponent, on behalf of Ag Chem Resources, LLC, 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 extract of Caesalpinia spinosa when used in accordance
with this exemption.
DATES: This regulation is effective January 6, 2023. Objections and
requests for hearings must be received on or before March 7, 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-2021-0209, 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#cd8f9d9d898b9f83a2b9a4aea8be8da8bdace3aaa2bb"><span class="__cf_email__" data-cfemail="7e3c2e2e3a382c30110a171d1b0d3e1b0e1f50191108">[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, 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-2021-0209 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 7, 2023. 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-2021-0209 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>.
[[Page 991]]
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 (PP0F8893) by Ag Chem Resources, LLC, 10120 Dutch Iris Drive,
Bakersfield, CA 93311. The petition requested that 40 CFR part 180 be
amended by establishing an exemption from the requirement of a
tolerance for residues of extract of Caesalpinia spinosa in or on raw
agricultural commodities and processed foods when used in accordance
with good agricultural practices. That document referenced a summary of
the petition prepared by the petitioner Ag Chem Resources, c/o
Exponent, which is available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>
(EPA-HQ-OPP-2021-0209). There were no comments received in response to
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 for extract of Caesalpinia spinosa
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with extract
of Caesalpinia spinosa follows.
IV. Toxicological Profile
Extract of Caesalpinia spinosa is a tannin-rich extract from the
seed pods of Peruvian tara trees (Caesalpinia spinosa). There is a long
history of safe exposure to tannins as these compounds are a part of
the human diet and are naturally present in coffee and tea and nearly
all vegetation, including in leaves, twigs, bark, wood, or fruit (U.S.
EPA, 2006). Tannin compounds are found throughout the plant kingdom in
forms ranging from simple phenols to macromolecules. Tannic acid is the
macromolecule tannin compound found in Caesalpinia spinosa extract.
In conducting its hazard assessment for extract of Caesalpinia
spinosa, EPA relied on the following data/information to satisfy the
data requirements: (1) guideline acute toxicity studies; (2) guideline
for the 90-day oral toxicity, prenatal developmental toxicity, and
genetic toxicity studies; and (3) data waivers supported by information
from open scientific literature in lieu of guideline studies for the
90-day dermal and 90-day inhalation data requirements. No adverse
effects have been identified in the available data.
Extract of Caesalpinia spinosa has a low acute toxicity profile as
evident by its toxicity Category IV classification for acute
inhalation, acute dermal, acute oral toxicity, primary eye irritation,
and primary dermal irritation. extract of Caesalpinia spinosa is not a
dermal sensitizer.
To address the subchronic 90-day dermal data requirement, EPA
granted a waiver based upon a weight of the evidence (WOE) approach as
follows: (1) Extract of Caesalpinia spinosa is considered non-
irritating to the skin, is not a dermal sensitizer, and is classified
as Toxicity Category IV for acute dermal toxicity; (2) tannic acid is
naturally occuring with a long history of exposure without adverse
reactions seen in cosmetics and foods approved for use by the FDA; (3)
the non-water component of the extract, tannin acid, has physiochemical
properties that suggest a low probability for dermal penetration.
In terms of the 90 day-inhalation toxicity data requirement, EPA
also granted a waiver based on the following: (1) tannic acid is
naturally occurring with a long history of exposure with no adverse
reactions reported; (2) tannic acid is approved for use in food by the
FDA; (3) the physical and chemical properties of tannic acid (e.g., the
vapor pressure was too low to be reliably quantified for extract of
Caesalpinia spinosa or tannic acid); (4) tannic acid is approved for
inert ingredient (dispersing agent) use in pesticide products.
To address subchronic 90-day oral toxicity, data from a 90-day oral
gavage study and a 4-week oral gavage study on rats with extract of
Caesalpinia spinosa were conducted and found there were no adverse
effects. The no-observed-effect-level (NOAEL) for both sexes was 3,500
mg/kg-bw/day and 3,000 mg/kg-bw/day, respectively, which were the
highest doses tested in the studies. In addition, a 12-week dietary
study on rats was provided using up to 800 mg/kg/day of tannic acid. In
this study there were no significant changes in body weight, food
intake, liver and kidney weights, gross pathology and histopathology
observed.
For prenatal developmental and genetic toxicity, no maternal or
developmental adverse treatment-related effects were observed. The
NOAEL was greater than 3,500 mg/kg-bw/day, the highest dose level
tested. In terms of mutagenicity, the active ingredient was determined
to be non-mutagenic, and not genotoxic.
It is also relevant to the toxicological profile that ``tannin'' is
approved for use as a direct human food additive as a boiler water
additive under 21 CFR 173.310 and ``tannic acid'' is considered
Generally Recognized as Safe (GRAS) when used as a flavoring agent,
adjuvant, and pH control agent in baked goods, alcoholic beverages,
beverage bases, gelatins, and frozen dairy desserts
[[Page 992]]
per 21 CFR 184.1097. In terms of its use in pesticide formulations,
tannin (including tannic acid) is exempt from the requirement of a
tolerance as an inert ingredient in pesticide products when used as a
dispersing agent applied to growing crops under 40 CFR 180.920. In
addition to its widespread natural presence in foods, tannic acid is
widely used in various cosmetic products such as soap, facial
cleansers, masks, moisturizers, and serums. Further, tannic acid
derived from plants is recognized as an animal feed additive for all
species by the European Union of Feed Additives pursuant to Regulation
EC No. 1831/2003.
A. Toxicological Points of Departure/Levels of Concern
Based on the toxicological profile, EPA did not identify any
toxicological endpoints of concern for assessing risk for this
chemical.
B. Exposure Assessment
1. Dietary exposure from food, feed uses, and drinking water.
Extract of Caesalpinia spinosa is a naturally occurring, tannin rich
extract found in plants to which humans have been exposed through
fruit, tea, coffee, feed grains, and vegetable consumption. As part of
its qualitative risk assessment for extract of Caesalpinia spinosa, the
Agency considered the potential for any additional dietary exposure to
residues of extract of Caesalpinia spinosa from its proposed use as a
nematicide on agricultural use sites. EPA concludes that such dietary
(food and drinking water) exposures are likely to be negligible, as
extract of Caesalpinia spinosa is readily biodegradable in the
environment, potential residues of the substance are not anticipated on
treated commodities at the time of consumption based on its physical
chemical properties. Furthermore, residue data available for carrots
and tomatoes show that when the proposed end-use product was applied
according to labeled rates and methods, pesticide residues were
indistinguishable from background levels. A quantitative dietary
exposure assessment was not conducted because a toxicological endpoint
for risk assessment was not identified.
2. Residential exposure. The term ``residential exposure'' is used
in this document to refer to non-occupational, non-dietary exposure.
There are no anticipated residential uses and significant residential
exposure is not expected; therefore, residential handler and post-
application risks of concern are not expected. Residential exposure may
occur from non-pesticidal uses such as use in food commodities.
However, inhalation exposure is not expected since tannins do not
easily volatize because of their physical and chemical properties. A
quantitative dietary 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 a tolerance exemption, 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.'' Unlike other pesticides for which EPA
has followed a cumulative risk approach based on a common mechanism of
toxicity, EPA has not made a common mechanism of toxicity finding as to
extract of Caesalpinia spinosa and any other substances, and this
biopesticide does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this action, EPA has not assumed
that this active ingredient has 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>.
C. 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 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 extract
of Caesalpinia spinosa because EPA is performing a qualitative dietary
assessment based on negligible toxicological and exposure concerns.
D. Aggregate Risks
Based on the available data and information, the Agency has
concluded that a qualitative aggregate risk assessment is appropriate
to support this action, and that risks of concern are not anticipated
from aggregate exposure to the extract of Caesalpinia spinosa. This
conclusion is based on the low toxicity of the active ingredient,
expected ready biodegradation in the environment, and existing natural
levels present in foodstuffs. Anticipated dietary (food and drinking
water) and bystander exposures are expected to be negligible, and there
are no residential uses for the active ingredient. A full explanation
of the data upon which EPA relied and its risk assessment based on
those data can be found in the Memorandum entitled ``Product Chemistry
Review and Human Health Risk Assessment for FIFRA Section 3
Registrations of the Manufacturing-Use Product, AgChem1, and the End-
Use Product AgChem1-EP1, Containing extract of Caesalpinia spinosa
(99.9%) as a New Active Ingredient''. This document, as well as other
relevant information, is available in the docket for this action as
described under ADDRESSES.
V. 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
extract of Caesalpinia spinosa. Therefore, the establishment of an
exemption from the requirement of a tolerance for residues of extract
of Caesalpinia spinosa in or on all food commodities when used in
accordance with good agricultural practices is safe under FFDCA section
408.
VI. 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.
VII. Conclusion
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR part 180 for residues of extract of
Caesalpinia spinosa in or on all food commodities when used in
accordance with good agricultural practices.
VIII. 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
[[Page 993]]
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
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).
IX. 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: December 21, 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. 180.1396 to subpart D to read as follows:
Sec. 180.1396 Extract of Caesalpinia spinosa; exemption from the
requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
extract of Caesalpinia spinosa in or on all food commodities when used
in accordance with good agricultural practices.
[FR Doc. 2023-00017 Filed 1-5-23; 8:45 am]
BILLING CODE 6560-50-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on January 6, 2023.
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.