Document ID: EPA-HQ-OPP-2018-0040-0005
Agency: epa
Document Type: Rule
Title: Tolerance Requirement Exemptions: Defensin Proteins Derived From Spinach in Citrus Plants
Posted Date: 2018-05-31T04:00Z

[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)]
[Rules and Regulations]
[Pages 24942-24944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11750]

[[Page 24942]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2018-0040; FRL-9977-62]

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 the spinach defensin 
proteins SoD2, SoD2*, SoD7, and SoD8 in or on citrus when used as 
plant-incorporated-protectants 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, 2021.

DATES: This regulation is effective May 31, 2018. Objections and 
requests for hearings must be received on or before July 30, 2018, 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-2018-0040, is available at http://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 is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, 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: 
[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 174 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2018-0040 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 
July 30, 2018. 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-2018-0040, by one of 
the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

    In the Federal Register of May 6, 2015 (80 FR 25943) (FRL-9926-99), 
EPA previously established a temporary exemption from the requirement 
of a tolerance in 40 CFR part 174.535 for residues of spinach defensin 
proteins SoD2 and SoD7 in citrus. This exemption was established 
concurrently with an Experimental Use Permit (88232-EUP-1). Both the 
temporary tolerance exemption and EUP have expiration dates of April 
18, 2018.
    In the Federal Register of March 1, 2018 (83 FR 8827) (FRL-9973-
57), 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 7G8630) by Southern Gardens Citrus Nursery, LLC, 1820 
Country Road 833, Clewiston, FL 33440. The petition requested that the 
temporary tolerance exemption established in 40 CFR part 174.535 be 
amended and extended for residues of Spinach Defensin Proteins. 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 petition referenced a summary of the petition 
prepared by the petitioner Southern Gardens Citrus Nursery, LLC, which 
is available in the docket, http://www.regulations.gov. Comments were 
received on the notice of filing. EPA's response to these comments is 
discussed in Unit III.C.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption

[[Page 24943]]

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 that data can be 
found within the document entitled ``Federal Food, Drug, and Cosmetic 
Act (FFDCA) Assessment of Defensin Proteins Derived from Spinach in 
Citrus Plants'' dated April 27, 2018. This document, as well as other 
relevant information, is available in the 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. 
Moreover, there is no significant similarity between spinach defensin 
proteins SoD2, SoD2*, SoD7, and SoD8 and known toxins and allergens. In 
addition, as discussed in the ``Toxicological Profile'' in the April 
27, 2018 FFDCA Assessment document, the spinach defensin proteins SoD2, 
SoD2*, SoD7, and SoD8 readily digest in simulated gastric fluids. 
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.
    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 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 there is no 
available information concerning the cumulative effects of such 
residues and other substances that have a common mechanism of toxicity 
to be considered.
    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 the plant-incorporated protectant will not likely be found in 
ground or surface water and that residues in drinking water will be 
extremely low or non-existent. 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 levels 
of exposure. 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.
    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 is established for residues of spinach 
defensin SoD2, SoD2*, SoD7, and SoD8 proteins in or on citrus when the 
proteins are used as plant-incorporated protectants 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, 2021.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing a temporary exemption from the requirement 
of a tolerance without any numerical limitation.

C. Response to Comments

    Two comments were received in response to the Notice of Filing (83 
FR 8827). Neither of these anonymous comments were relevant to the 
proposed temporary tolerance exemption for spinach defensin proteins in 
citrus. One comment pertained to wind turbines and the other pertained 
to Chinese air quality.

IV. Statutory and Executive Order Reviews

    This action establishes a temporary exemption from the requirement 
for 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 24944]]

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.

    Dated: May 22, 2018.
Robert McNally,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 174--[AMENDED]

0
1. The authority citation for part 174 continues to read as follows:

    Authority: 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, 2021.

[FR Doc. 2018-11750 Filed 5-30-18; 8:45 am]
 BILLING CODE 6560-50-P