Rule2021-18786
Defensin Proteins Derived From Spinach in Citrus Plants; Temporary 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
September 14, 2021
Effective
September 14, 2021
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes a temporary exemption from the requirement of a tolerance for residues of spinach defensin proteins SoD2, SoD2*, SoD7, and SoD8 in or on citrus when used as a plant- incorporated protectant in accordance with the terms of Experimental Use Permit (EUP) No. 88232-EUP-1. Southern Gardens Citrus Nursery, LLC., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the temporary tolerance exemption. This regulation eliminates the need to establish a maximum permissible level for residues of spinach defensin proteins SoD2, SoD2*, SoD7, and SoD8. The temporary tolerance exemption expires on May 31, 2025.
Full Text
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<title>Federal Register, Volume 86 Issue 175 (Tuesday, September 14, 2021)</title>
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[Federal Register Volume 86, Number 175 (Tuesday, September 14, 2021)]
[Rules and Regulations]
[Pages 51001-51004]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18786]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 174
[EPA-HQ-OPP-2021-0170; FRL-8908-01-OCSPP]
Defensin Proteins Derived From Spinach in Citrus Plants;
Temporary Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a temporary exemption from the
requirement of a tolerance for residues of spinach defensin proteins
SoD2, SoD2*, SoD7, and SoD8 in or on citrus when used as a plant-
incorporated protectant in accordance with the terms of Experimental
Use Permit (EUP) No. 88232-EUP-1. Southern Gardens Citrus Nursery,
LLC., submitted a petition to EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting the temporary tolerance exemption.
This regulation eliminates the need to establish a maximum permissible
level for residues of spinach defensin proteins SoD2, SoD2*, SoD7, and
SoD8. The temporary tolerance exemption expires on May 31, 2025.
DATES: This regulation is effective September 14, 2021. Objections and
requests for hearings must be received on or before November 15, 2021,
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-2021-0170, is available at <a href="http://www.regulations.gov">http://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 is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and 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 (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (703) 305-7090; email address:
<a href="/cdn-cgi/l/email-protection#8bc9dbdbcfcdd9c5e4ffe2e8eef8cbeefbeaa5ece4fd"><span class="__cf_email__" data-cfemail="b0f2e0e0f4f6e2fedfc4d9d3d5c3f0d5c0d19ed7dfc6">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
[[Page 51002]]
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 174 through the Government Publishing Office's e-CFR site at
<a href="http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl">http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl</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-2021-0170 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
November 15, 2021. 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-2021-0170, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://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="http://www.epa.gov/dockets/contacts.html">http://www.epa.gov/dockets/contacts.html</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="http://www.epa.gov/dockets">http://www.epa.gov/dockets</a>.
II. Background
In the Federal Register of March 22, 2021 (86 FR 15162) (FRL-10021-
44), 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 1G8896) by Southern Gardens Citrus Nursery, LLC., 1820
Country Road 833, Clewiston, Florida 33440. The petition requested that
the temporary tolerance exemption established in 40 CFR 174.535 be
amended and extended for residues of defensin proteins SoD2, SoD2*,
SoD7, and SoD8 derived from spinach. Because the temporary tolerance
exemption expired before we could complete this action, we are treating
this as a petition to reestablish a temporary tolerance exemption. The
notice of filing referenced a summary of the petition prepared by the
petitioner Southern Gardens Citrus, LLC., which is available in the
docket for this action at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. There were no
comments received in response to the notice of filing.
III. Final Rule
A. EPA's Safety Determination
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 has reviewed the available toxicity and exposure data on
spinach defensin proteins SoD2, SoD2*, SoD7, and SoD8 and considered
its validity, completeness and reliability, and the relationship of
this information to human risk. A full explanation of the data upon
which EPA relied and its risk assessment based on those data can be
found within the document entitled ``Review of the application for
renewal and extension of experimental use permit 88232-EUP-1 and
extension of the associated temporary tolerance exemption for the
defensin proteins SoD2, SoD2*, SoD7, and SoD8 derived from spinach
(Spinacia oleracea L.) used as a plant-incorporated protectant in
citrus plants at 40 CFR part 174.535 for additional 4 years, until May
31, 2025'' dated June 24, 2021 (Ref. 1). This document, as well as
other relevant information, is available in docket for this action as
described under ADDRESSES.
Based upon available data, EPA concludes that spinach defensin
proteins SoD2, SoD2*, SoD7, and SoD8, do not show evidence of toxicity
(Ref. 2). Moreover, there is no significant similarity between spinach
defensin proteins SoD2, SoD2*, SoD7, and SoD8 and known toxins and
allergens. In addition, the spinach defensin proteins SoD2, SoD2*,
SoD7, and SoD8 readily digest in simulated gastric fluids and therefore
cumulative, chronic, and acute effects are unlikely. Furthermore, the
source of the defensin proteins, spinach, has long been part of the
human diet and there have been no findings that indicate toxicity or
allergenicity of spinach proteins (Ref. 2).
Given the lack of toxicity or allergenicity of the spinach defensin
proteins SoD2, SoD2*, SoD7, and SoD8, the Agency has not identified any
toxicological endpoints for assessing risk. Due to the lack of any
threshold effects, EPA has determined that the
[[Page 51003]]
provision under FFDCA section 408(b)(2)(C) to retain a 10X safety
factor for the protection of infants and children does not apply.
Similarly, the lack of any toxic mode of action or toxic metabolites
means that the provision requiring an assessment of cumulative effects
does not apply.
Oral exposure to spinach defensin proteins SoD2, SoD2*, SoD7, and
SoD8 may occur from ingestion of citrus products, such as fruit and
juice. In addition, people have had a long history of consumption of
spinach and will continue to be exposed to defensin proteins through
consumption of spinach. Based on the lack of adverse effects and the
rapid digestibility of the proteins, however, the Agency does not
anticipate any risk from reasonably foreseeable levels of exposure.
Since the plant-incorporated protectant is integrated into the plant's
genome, the Agency has concluded, based upon previous science reviews,
that residues in drinking water will be extremely low or non-existent
(Ref. 2). Non-occupational exposure via the skin or inhalation is not
likely since the plant-incorporated protectant is contained within
plant cells, which essentially eliminates these exposure routes or
reduces these exposure routes to negligible. In any event, there are no
non-dietary non-occupational uses of SoD2, SoD2*, SoD7, and SoD8 as
they are only used in agricultural settings.
B. 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.
C. Conclusion
Based on its evaluation, EPA concludes that there is a reasonable
certainty that no harm will result from aggregate exposure to the U.S.
population, including infants and children, to the spinach defensin
proteins SoD2, SoD2*, SoD7, and SoD8. This includes all anticipated
dietary exposures and all other exposures for which there is reliable
information. The Agency has arrived at this conclusion because, as
previously discussed, there is no indication of toxicity or
allergenicity potential for the plant-incorporated protectant.
Therefore, a temporary exemption from the requirement of a tolerance is
established for residues of spinach defensin SoD2, SoD2*, SoD7, and
SoD8 proteins in or on citrus when the proteins are used as a plant-
incorporated protectant in citrus plants. This exemption is being
established concurrently with an extension to the experimental use
permit (EUP) No. 88232-EUP-1 and is therefore being established on a
temporary basis. Both the EUP and temporary tolerance exemption will
expire on May 31, 2025.
D. References
The following is a listing of documents that are specifically
referenced in this document. These documents are available in the
listed dockets at <a href="http://www.regulations.gov">http://www.regulations.gov</a> or at the Office of
Pesticide Programs Regulatory Public Docket (OPP Docket) via the direct
links below.
1. U.S. EPA, ``Review of the application for renewal and extension
of experimental use permit 88232-EUP-1 and extension of the
associated temporary tolerance exemption for the defensin proteins
SoD2, SoD2*, SoD7, and SoD8 derived from spinach (Spinacia oleracea
L.) used as a plant-incorporated protectant in citrus plants at 40
CFR part 174.535 for additional 4 years, until May 31, 2025.'' June
24, 2021. <a href="https://www.regulations.gov/document/EPA-HQ-OPP-2021-0170">https://www.regulations.gov/document/EPA-HQ-OPP-2021-0170</a>.
2. U.S. EPA, ``Review of Product Characterization, Toxicity Waiver
Requests, Allergenicity, and Human Health Data for Plant-
Incorporated Protectants (PIPs): Defensin proteins derived from
spinach (Spinach oleracea L.) Sod2, Sod2*, Sod7, Sod8.'' April 24,
2018. <a href="https://www.regulations.gov/document/EPA-HQ-OPP-2018-0040-0007">https://www.regulations.gov/document/EPA-HQ-OPP-2018-0040-0007</a>.
IV. Statutory and Executive Order Reviews
This action establishes a temporary 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 temporary
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).
V. 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 174
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
[[Page 51004]]
Dated: August 25, 2021.
Charles Smith,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 174--PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED
PROTECTANTS
0
1. The authority citation for part 174 continues to read as follows:
Authority: 7 U.S.C. 136-136y; 21 U.S.C. 321(q), 346a and 371.
0
2. Revise Sec. 174.535 to read as follows:
Sec. 174.535 Spinach Defensin proteins; temporary exemption from the
requirement of a tolerance.
Residues of the defensin proteins SoD2, SoD2*, SoD7, and SoD8
derived from spinach (Spinacia oleracea L.) in or on citrus food
commodities are temporarily exempt from the requirement of a tolerance
when used as a plant-incorporated protectant in citrus plants in
accordance with the terms of Experimental Use Permit No. 88232-EUP-1.
This temporary exemption from the requirement of a tolerance expires on
May 31, 2025.
[FR Doc. 2021-18786 Filed 9-13-21; 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.