83_FR_25047 83 FR 24942 - Defensin Proteins Derived From Spinach in Citrus Plants; Temporary Exemption From the Requirement of a Tolerance

83 FR 24942 - Defensin Proteins Derived From Spinach in Citrus Plants; Temporary Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 105 (May 31, 2018)

Page Range24942-24944
FR Document2018-11750

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.

Federal Register, Volume 83 Issue 105 (Thursday, May 31, 2018)
[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)]
[Rules and Regulations]
[Pages 24942-24944]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-11750]



[[Page 24942]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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



                                             24942              Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Rules and Regulations

                                             ENVIRONMENTAL PROTECTION                                20460–0001; main telephone number:                    by docket ID number EPA–HQ–OPP–
                                             AGENCY                                                  (703) 305–7090; email address:                        2018–0040, by one of the following
                                                                                                     BPPDFRNotices@epa.gov.                                methods:
                                             40 CFR Part 174                                         SUPPLEMENTARY INFORMATION:                              • Federal eRulemaking Portal: http://
                                             [EPA–HQ–OPP–2018–0040; FRL–9977–62]                                                                           www.regulations.gov. Follow the online
                                                                                                     I. General Information                                instructions for submitting comments.
                                             Defensin Proteins Derived From                          A. Does this action apply to me?                      Do not submit electronically any
                                             Spinach in Citrus Plants; Temporary                                                                           information you consider to be CBI or
                                                                                                        You may be potentially affected by                 other information whose disclosure is
                                             Exemption From the Requirement of a                     this action if you are an agricultural
                                             Tolerance                                                                                                     restricted by statute.
                                                                                                     producer, food manufacturer, or                         • Mail: OPP Docket, Environmental
                                             AGENCY:  Environmental Protection                       pesticide manufacturer. The following                 Protection Agency Docket Center (EPA/
                                             Agency (EPA).                                           list of North American Industrial                     DC), (28221T), 1200 Pennsylvania Ave.
                                             ACTION: Final rule.                                     Classification System (NAICS) codes is                NW, Washington, DC 20460–0001.
                                                                                                     not intended to be exhaustive, but rather               • Hand Delivery: To make special
                                             SUMMARY:   This regulation establishes a                provides a guide to help readers                      arrangements for hand delivery or
                                             temporary exemption from the                            determine whether this document                       delivery of boxed information, please
                                             requirement of a tolerance for residues                 applies to them. Potentially affected                 follow the instructions at http://
                                             of the spinach defensin proteins SoD2,                  entities may include:                                 www.epa.gov/dockets/contacts.html.
                                             SoD2*, SoD7, and SoD8 in or on citrus                      • Crop production (NAICS code 111).                  Additional instructions on
                                             when used as plant-incorporated-                           • Animal production (NAICS code                    commenting or visiting the docket,
                                             protectants in accordance with the                      112).                                                 along with more information about
                                             terms of Experimental Use Permit (EUP)                     • Food manufacturing (NAICS code                   dockets generally, is available at http://
                                             No. 88232–EUP–1. Southern Gardens                       311).                                                 www.epa.gov/dockets.
                                             Citrus Nursery, LLC, submitted a                           • Pesticide manufacturing (NAICS
                                             petition to EPA under the Federal Food,                 code 32532).                                          II. Background
                                             Drug, and Cosmetic Act (FFDCA),                         B. How can I get electronic access to                    In the Federal Register of May 6, 2015
                                             requesting the temporary tolerance                      other related information?                            (80 FR 25943) (FRL–9926–99), EPA
                                             exemption. This regulation eliminates                                                                         previously established a temporary
                                             the need to establish a maximum                           You may access a frequently updated
                                                                                                                                                           exemption from the requirement of a
                                             permissible level for residues of spinach               electronic version of 40 CFR part 174
                                                                                                                                                           tolerance in 40 CFR part 174.535 for
                                             defensin proteins SoD2, SoD2*, SoD7,                    through the Government Printing
                                                                                                                                                           residues of spinach defensin proteins
                                             and SoD8. The temporary tolerance                       Office’s e-CFR site at http://
                                                                                                                                                           SoD2 and SoD7 in citrus. This
                                             exemption expires on May 31, 2021.                      www.ecfr.gov/cgi-bin/text-
                                                                                                                                                           exemption was established concurrently
                                             DATES: This regulation is effective May                 idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                                                                                                                                           with an Experimental Use Permit
                                             31, 2018. Objections and requests for                   40tab_02.tpl.
                                                                                                                                                           (88232–EUP–1). Both the temporary
                                             hearings must be received on or before                  C. How can I file an objection or hearing             tolerance exemption and EUP have
                                             July 30, 2018, and must be filed in                     request?                                              expiration dates of April 18, 2018.
                                             accordance with the instructions                                                                                 In the Federal Register of March 1,
                                                                                                       Under FFDCA section 408(g), 21
                                             provided in 40 CFR part 178 (see also                                                                         2018 (83 FR 8827) (FRL–9973–57), EPA
                                                                                                     U.S.C. 346a, any person may file an
                                             Unit I.C. of the SUPPLEMENTARY                                                                                issued a document pursuant to FFDCA
                                                                                                     objection to any aspect of this regulation
                                             INFORMATION).                                                                                                 section 408(d)(3), 21 U.S.C. 346a(d)(3),
                                                                                                     and may also request a hearing on those
                                             ADDRESSES:    The docket for this action,               objections. You must file your objection              announcing the filing of a pesticide
                                             identified by docket identification (ID)                or request a hearing on this regulation               tolerance petition (PP 7G8630) by
                                             number EPA–HQ–OPP–2018–0040, is                         in accordance with the instructions                   Southern Gardens Citrus Nursery, LLC,
                                             available at http://www.regulations.gov                 provided in 40 CFR part 178. To ensure                1820 Country Road 833, Clewiston, FL
                                             or at the Office of Pesticide Programs                  proper receipt by EPA, you must                       33440. The petition requested that the
                                             Regulatory Public Docket (OPP Docket)                   identify docket ID number EPA–HQ–                     temporary tolerance exemption
                                             in the Environmental Protection Agency                  OPP–2018–0040 in the subject line on                  established in 40 CFR part 174.535 be
                                             Docket Center (EPA/DC), West William                    the first page of your submission. All                amended and extended for residues of
                                             Jefferson Clinton Bldg., Rm. 3334, 1301                 objections and requests for a hearing                 Spinach Defensin Proteins. Because the
                                             Constitution Ave. NW, Washington, DC                    must be in writing, and must be                       temporary tolerance exemption expired
                                             20460–0001. The Public Reading Room                     received by the Hearing Clerk on or                   before we could complete this action,
                                             is open from 8:30 a.m. to 4:30 p.m.,                    before July 30, 2018. Addresses for mail              we are treating this as a petition to
                                             Monday through Friday, excluding legal                  and hand delivery of objections and                   reestablish a temporary tolerance
                                             holidays. The telephone number for the                  hearing requests are provided in 40 CFR               exemption. The petition referenced a
                                             Public Reading Room is (202) 566–1744,                  178.25(b).                                            summary of the petition prepared by the
                                             and the telephone number for the OPP                      In addition to filing an objection or               petitioner Southern Gardens Citrus
                                             Docket is (703) 305–5805. Please review                 hearing request with the Hearing Clerk                Nursery, LLC, which is available in the
                                             the visitor instructions and additional                 as described in 40 CFR part 178, please               docket, http://www.regulations.gov.
                                             information about the docket available                  submit a copy of the filing (excluding                Comments were received on the notice
pmangrum on DSK30RV082PROD with RULES




                                             at http://www.epa.gov/dockets.                          any Confidential Business Information                 of filing. EPA’s response to these
                                             FOR FURTHER INFORMATION CONTACT:                        (CBI)) for inclusion in the public docket.            comments is discussed in Unit III.C.
                                             Robert McNally, Biopesticides and                       Information not marked confidential                   III. Final Rule
                                             Pollution Prevention Division (7511P),                  pursuant to 40 CFR part 2 may be
                                             Office of Pesticide Programs,                           disclosed publicly by EPA without prior               A. EPA’s Safety Determination
                                             Environmental Protection Agency, 1200                   notice. Submit the non-CBI copy of your                  Section 408(c)(2)(A)(i) of FFDCA
                                             Pennsylvania Ave. NW, Washington, DC                    objection or hearing request, identified              allows EPA to establish an exemption


                                        VerDate Sep<11>2014   14:57 May 30, 2018   Jkt 244001   PO 00000   Frm 00038   Fmt 4700   Sfmt 4700   E:\FR\FM\31MYR1.SGM   31MYR1


                                                                Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Rules and Regulations                                         24943

                                             from the requirement for a tolerance (the               the defensin proteins, spinach, has long              temporary exemption is established for
                                             legal limit for a pesticide chemical                    been part of the human diet and there                 residues of spinach defensin SoD2,
                                             residue in or on a food) only if EPA                    have been no findings that indicate                   SoD2*, SoD7, and SoD8 proteins in or
                                             determines that the exemption is ‘‘safe.’’              toxicity or allergenicity of spinach                  on citrus when the proteins are used as
                                             Section 408(c)(2)(A)(ii) of FFDCA                       proteins.                                             plant-incorporated protectants in citrus
                                             defines ‘‘safe’’ to mean that ‘‘there is a                 Given the lack of toxicity or                      plants. This exemption is being
                                             reasonable certainty that no harm will                  allergenicity of the spinach defensin                 established concurrently with an
                                             result from aggregate exposure to the                   proteins SoD2, SoD2*, SoD7, and SoD8,                 extension to the Experimental Use
                                             pesticide chemical residue, including                   the Agency has not identified any                     Permit (EUP) No. 88232–EUP–1, and is
                                             all anticipated dietary exposures and all               toxicological endpoints for assessing                 therefore being established on a
                                             other exposures for which there is                      risk. Due to the lack of any threshold                temporary basis. Both the EUP and
                                             reliable information.’’ This includes                   effects, EPA has determined that the                  temporary tolerance exemption will
                                             exposure through drinking water and in                  provision under FFDCA section                         expire on May 31, 2021.
                                             residential settings, but does not include              408(b)(2)(C) to retain a 10X safety factor
                                                                                                     for the protection of infants and                     B. Analytical Enforcement Methodology
                                             occupational exposure. Pursuant to
                                             FFDCA section 408(c)(2)(B), in                          children does not apply. Similarly, the                 An analytical method is not required
                                             establishing or maintaining in effect an                lack of any toxic mode of action or toxic             for enforcement purposes since the
                                             exemption from the requirement of a                     metabolites means that there is no                    Agency is establishing a temporary
                                             tolerance, EPA must take into account                   available information concerning the                  exemption from the requirement of a
                                             the factors set forth in FFDCA section                  cumulative effects of such residues and               tolerance without any numerical
                                             408(b)(2)(C), which require EPA to give                 other substances that have a common                   limitation.
                                             special consideration to exposure of                    mechanism of toxicity to be considered.               C. Response to Comments
                                             infants and children to the pesticide                      Oral exposure to spinach defensin
                                             chemical residue in establishing a                      proteins SoD2, SoD2*, SoD7, and SoD8                    Two comments were received in
                                             tolerance and to ‘‘ensure that there is a               may occur from ingestion of citrus                    response to the Notice of Filing (83 FR
                                             reasonable certainty that no harm will                  products, such as fruit and juice. In                 8827). Neither of these anonymous
                                             result to infants and children from                     addition, people have had a long history              comments were relevant to the proposed
                                             aggregate exposure to the pesticide                     of consumption of spinach and will                    temporary tolerance exemption for
                                             chemical residue. . . .’’ Additionally,                 continue to be exposed to defensin                    spinach defensin proteins in citrus. One
                                             FFDCA section 408(b)(2)(D) requires                     proteins through consumption of                       comment pertained to wind turbines
                                             that the Agency consider ‘‘available                    spinach. Based on the lack of adverse                 and the other pertained to Chinese air
                                             information concerning the cumulative                   effects and the rapid digestibility of the            quality.
                                             effects of a particular pesticide’s                     proteins, however, the Agency does not                IV. Statutory and Executive Order
                                             residues’’ and ‘‘other substances that                  anticipate any risk from reasonably                   Reviews
                                             have a common mechanism of toxicity.’’                  foreseeable levels of exposure. Since the
                                                EPA has reviewed the available                       plant-incorporated protectant is                         This action establishes a temporary
                                             toxicity and exposure data on spinach                   integrated into the plant’s genome, the               exemption from the requirement for a
                                             defensin proteins SoD2, SoD2*, SoD7,                    Agency has concluded, based upon                      tolerance under FFDCA section 408(d)
                                             and SoD8 and considered its validity,                   previous science reviews, that the plant-             in response to a petition submitted to
                                             completeness and reliability, and the                   incorporated protectant will not likely               the Agency. The Office of Management
                                             relationship of this information to                     be found in ground or surface water and               and Budget (OMB) has exempted these
                                             human risk. A full explanation of the                   that residues in drinking water will be               types of actions from review under
                                             data upon which EPA relied and its risk                 extremely low or non-existent. Non-                   Executive Order 12866, entitled
                                             assessment based on that data can be                    occupational exposure via the skin or                 ‘‘Regulatory Planning and Review’’ (58
                                             found within the document entitled                      inhalation is not likely since the plant-             FR 51735, October 4, 1993). Because
                                             ‘‘Federal Food, Drug, and Cosmetic Act                  incorporated protectant is contained                  this action has been exempted from
                                             (FFDCA) Assessment of Defensin                          within plant cells, which essentially                 review under Executive Order 12866,
                                             Proteins Derived from Spinach in Citrus                 eliminates these exposure routes or                   this action is not subject to Executive
                                             Plants’’ dated April 27, 2018. This                     reduces these exposure routes to                      Order 13211, entitled ‘‘Actions
                                             document, as well as other relevant                     negligible levels of exposure. In any                 Concerning Regulations That
                                             information, is available in the docket                 event, there are no non-dietary non-                  Significantly Affect Energy Supply,
                                             for this action as described under                      occupational uses of SoD2, SoD2*,                     Distribution, or Use’’ (66 FR 28355, May
                                             ADDRESSES.                                              SoD7, and SoD8 as they are only used                  22, 2001) or Executive Order 13045,
                                                Based upon available data, EPA                       in agricultural settings.                             entitled ‘‘Protection of Children from
                                             concludes that spinach defensin                            Based on its evaluation, EPA                       Environmental Health Risks and Safety
                                             proteins SoD2, SoD2*, SoD7, and SoD8,                   concludes that there is a reasonable                  Risks’’ (62 FR 19885, April 23, 1997).
                                             do not show evidence of toxicity.                       certainty that no harm will result from               This action does not contain any
                                             Moreover, there is no significant                       aggregate exposure to the U.S.                        information collections subject to OMB
                                             similarity between spinach defensin                     population, including infants and                     approval under the Paperwork
                                             proteins SoD2, SoD2*, SoD7, and SoD8                    children, to the spinach defensin                     Reduction Act (PRA) (44 U.S.C. 3501 et
                                             and known toxins and allergens. In                      proteins SoD2, SoD2*, SoD7, and SoD8.                 seq.), nor does it require any special
                                             addition, as discussed in the                           This includes all anticipated dietary                 considerations under Executive Order
pmangrum on DSK30RV082PROD with RULES




                                             ‘‘Toxicological Profile’’ in the April 27,              exposures and all other exposures for                 12898, entitled ‘‘Federal Actions to
                                             2018 FFDCA Assessment document, the                     which there is reliable information. The              Address Environmental Justice in
                                             spinach defensin proteins SoD2, SoD2*,                  Agency has arrived at this conclusion                 Minority Populations and Low-Income
                                             SoD7, and SoD8 readily digest in                        because, as previously discussed, there               Populations’’ (59 FR 7629, February 16,
                                             simulated gastric fluids. Therefore,                    is no indication of toxicity or                       1994).
                                             cumulative, chronic, and acute effects                  allergenicity potential for the plant-                   Since tolerances and exemptions that
                                             are unlikely. Furthermore, the source of                incorporated protectant. Therefore, a                 are established on the basis of a petition


                                        VerDate Sep<11>2014   14:57 May 30, 2018   Jkt 244001   PO 00000   Frm 00039   Fmt 4700   Sfmt 4700   E:\FR\FM\31MYR1.SGM   31MYR1


                                             24944              Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Rules and Regulations

                                             under FFDCA section 408(d), such as                       Dated: May 22, 2018.                                August 2018 through July 2019 fishing
                                             the temporary tolerance exemption in                    Robert McNally,                                       year. This closure is necessary to protect
                                             this final rule, do not require the                     Director, Biopesticides and Pollution                 the South Atlantic yellowtail snapper
                                             issuance of a proposed rule, the                        Prevention Division, Office of Pesticide              resource.
                                             requirements of the Regulatory                          Programs.
                                                                                                                                                           DATES:  This rule is effective at 12:01
                                             Flexibility Act (RFA) (5 U.S.C. 601 et                    Therefore, 40 CFR chapter I is                      a.m., local time, June 5, 2018, until
                                             seq.), do not apply.                                    amended as follows:                                   12:01 a.m., local time, August 1, 2018.
                                                This action directly regulates growers,              PART 174—[AMENDED]                                    FOR FURTHER INFORMATION CONTACT:
                                             food processors, food handlers, and food                                                                      Mary Vara, NMFS Southeast Regional
                                             retailers, not States or tribes, nor does               ■ 1. The authority citation for part 174              Office, telephone: 727–824–5305, email:
                                             this action alter the relationships or                  continues to read as follows:                         mary.vara@noaa.gov.
                                             distribution of power and                                   Authority: 21 U.S.C. 321(q), 346a and 371.        SUPPLEMENTARY INFORMATION: The
                                             responsibilities established by Congress                                                                      snapper-grouper fishery of the South
                                             in the preemption provisions of FFDCA                   ■   2. Revise § 174.535 to read as follows:
                                                                                                                                                           Atlantic includes yellowtail snapper
                                             section 408(n)(4). As such, the Agency                  § 174.535 Spinach Defensin proteins;                  and is managed under the Fishery
                                             has determined that this action will not                temporary exemption from the requirement              Management Plan for the Snapper-
                                             have a substantial direct effect on States              of a tolerance.                                       Grouper Fishery of the South Atlantic
                                             or tribal governments, on the                              Residues of the defensin proteins                  Region (FMP). The FMP was prepared
                                             relationship between the national                       SoD2, SoD2*, SoD7, and SoD8 derived                   by the South Atlantic Fishery
                                             government and the States or tribal                     from spinach (Spinacia oleracea L.) in                Management Council and is
                                             governments, or on the distribution of                  or on citrus food commodities are                     implemented by NMFS under the
                                             power and responsibilities among the                    temporarily exempt from the                           authority of the Magnuson-Stevens
                                             various levels of government or between                 requirement of a tolerance when used as               Fishery Conservation and Management
                                             the Federal Government and Indian                       a plant-incorporated protectant in citrus             Act (Magnuson-Stevens Act) by
                                             tribes. Thus, the Agency has determined                 plants in accordance with the terms of                regulations at 50 CFR part 622.
                                             that Executive Order 13132, entitled                    Experimental Use Permit No. 88232–                       The yellowtail snapper commercial
                                             ‘‘Federalism’’ (64 FR 43255, August 10,                 EUP–1. This temporary exemption from                  ACL is 1,596,510 lb (724,165 kg), round
                                                                                                     the requirement of a tolerance expires                weight, as specified in 50 CFR
                                             1999) and Executive Order 13175,
                                                                                                     on May 31, 2021.                                      622.193(n)(1)(i). The yellowtail snapper
                                             entitled ‘‘Consultation and Coordination
                                             with Indian Tribal Governments’’ (65 FR                 [FR Doc. 2018–11750 Filed 5–30–18; 8:45 am]           fishing year is August 1 through July 31,
                                             67249, November 9, 2000) do not apply                   BILLING CODE 6560–50–P                                as specified in 50 CFR 622.7(f). Under
                                             to this action. In addition, this action                                                                      50 CFR 622.193(n)(1)(i), NMFS is
                                                                                                                                                           required to close the yellowtail snapper
                                             does not impose any enforceable duty or
                                                                                                     DEPARTMENT OF COMMERCE                                commercial sector when the commercial
                                             contain any unfunded mandate as
                                                                                                                                                           ACL has been reached, or is projected to
                                             described under Title II of the Unfunded
                                                                                                     National Oceanic and Atmospheric                      be reached, by filing a notification to
                                             Mandates Reform Act (UMRA) (2 U.S.C.                    Administration                                        that effect with the Office of the Federal
                                             1501 et seq.).                                                                                                Register. NMFS has projected that the
                                                This action does not involve any                     50 CFR Part 622                                       yellowtail snapper commercial sector
                                             technical standards that would require                                                                        will reach its ACL on June 5, 2018.
                                                                                                     [Docket No. 100812345–2142–03]
                                             Agency consideration of voluntary                                                                             Therefore, this temporary rule
                                             consensus standards pursuant to section                 RIN 0648–XG253                                        implements an AM to close the
                                             12(d) of the National Technology                                                                              yellowtail snapper commercial sector in
                                                                                                     Snapper-Grouper Fishery of the South                  the South Atlantic EEZ, effective from
                                             Transfer and Advancement Act
                                                                                                     Atlantic; 2018 Commercial                             12:01 a.m., local time, June 5, 2018,
                                             (NTTAA) (15 U.S.C. 272 note).
                                                                                                     Accountability Measure and Closure                    until August 1, 2018, the start of the
                                             V. Congressional Review Act                             for South Atlantic Yellowtail Snapper                 2018–2019 fishing year.
                                               Pursuant to the Congressional Review                  AGENCY:  National Marine Fisheries                       The operator of a vessel with a valid
                                             Act (5 U.S.C. 801 et seq.), EPA will                    Service (NMFS), National Oceanic and                  commercial vessel permit for South
                                                                                                     Atmospheric Administration (NOAA),                    Atlantic snapper-grouper having
                                             submit a report containing this rule and
                                                                                                     Commerce.                                             yellowtail snapper on board must have
                                             other required information to the U.S.
                                                                                                     ACTION: Temporary rule; closure.                      landed and bartered, traded, or sold
                                             Senate, the U.S. House of                                                                                     such species prior to June 5, 2018.
                                             Representatives, and the Comptroller                    SUMMARY:  NMFS implements an                          During the commercial closure, all sale
                                             General of the United States prior to                   accountability measure (AM) for the                   or purchase of yellowtail snapper from
                                             publication of the rule in the Federal                  commercial sector for yellowtail                      the South Atlantic EEZ is prohibited.
                                             Register. This action is not a ‘‘major                  snapper in the South Atlantic exclusive               The harvest or possession of yellowtail
                                             rule’’ as defined by 5 U.S.C. 804(2).                   economic zone (EEZ). NMFS projects                    snapper in of from the South Atlantic
                                             List of Subjects in 40 CFR Part 174                     that commercial landings of yellowtail                EEZ is limited to the bag limit specified
                                                                                                     snapper will reach the commercial                     in 50 CFR 622.187(b)(4) and the
pmangrum on DSK30RV082PROD with RULES




                                               Environmental protection,                             annual catch limit (ACL) for the August               possession limits specified in 50 CFR
                                             Administrative practice and procedure,                  2017 through July 2018 fishing year by                622.187(c). These bag and possession
                                             Agricultural commodities, Pesticides                    June 5, 2018. Therefore, NMFS closes                  limits apply on board a vessel for which
                                             and pests, Reporting and recordkeeping                  the commercial sector for yellowtail                  a valid Federal commercial or charter
                                             requirements.                                           snapper in the South Atlantic EEZ on                  vessel/headboat permit for South
                                                                                                     June 5, 2018, and it will remain closed               Atlantic snapper-grouper has been
                                                                                                     until August 1, 2018, the start of the                issued, regardless of whether such


                                        VerDate Sep<11>2014   14:57 May 30, 2018   Jkt 244001   PO 00000   Frm 00040   Fmt 4700   Sfmt 4700   E:\FR\FM\31MYR1.SGM   31MYR1



Document Created: 2018-05-31 00:48:49
Document Modified: 2018-05-31 00:48:49
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactRobert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
FR Citation83 FR 24942 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR