80_FR_26030 80 FR 25943 - Defensin Proteins (SoD2 and SoD7) Derived From Spinach (Spinacia oleracea L.) in Citrus Plants; Temporary Exemption From the Requirement of a Tolerance

80 FR 25943 - Defensin Proteins (SoD2 and SoD7) Derived From Spinach (Spinacia oleracea L.) in Citrus Plants; Temporary Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 87 (May 6, 2015)

Page Range25943-25946
FR Document2015-10486

This regulation establishes a temporary exemption from the requirement of a tolerance for residues of SoD2 and SoD7, two defensin proteins derived from spinach (Spinacia oleracea L.), in or on citrus when used as plant-incorporated protectants (PIPs) in accordance with the terms of Experimental Use Permit (EUP) No. 88232-EUP-1. Southern Gardens Citrus 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 SoD2 and SoD7 in or on citrus. The temporary tolerance exemption expires on April 18, 2018.

Federal Register, Volume 80 Issue 87 (Wednesday, May 6, 2015)
[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Rules and Regulations]
[Pages 25943-25946]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10486]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2014-0834; FRL-9926-99]


Defensin Proteins (SoD2 and SoD7) Derived From Spinach (Spinacia 
oleracea L.) 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 SoD2 and SoD7, two defensin 
proteins derived from spinach (Spinacia oleracea L.), in or on citrus 
when used as plant-incorporated protectants (PIPs) in accordance with 
the terms of Experimental Use Permit (EUP) No. 88232-EUP-1. Southern 
Gardens Citrus 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 SoD2 and SoD7 in or on citrus. The 
temporary tolerance exemption expires on April 18, 2018.

DATES: This regulation is effective May 6, 2015. Objections and 
requests for hearings must be received on or before July 6, 2015, 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-2014-0834, 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

[[Page 25944]]

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 180 through the Government Publishing 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-2014-0834 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 6, 2015. 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-2014-0834, 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 and Statutory Framework

    In the Federal Register of January 28, 2015 (80 FR 4525) (FRL-9921-
55), 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 4F8289) by Southern Gardens Citrus, 1820 Country Road 833, 
Clewiston, FL 33440. The petition requested that 40 CFR part 174 be 
amended by establishing a temporary exemption from the requirement of a 
tolerance for residues of spinach defensin (SoD2 and SoD7) proteins in 
or on citrus. That document referenced a summary of the petition 
prepared by the petitioner Southern Gardens Citrus, which is available 
in the docket, http://www.regulations.gov. A comment was received on 
the notice of filing. EPA's response to this comment is discussed in 
Unit VII.C.
    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 performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability, 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children.
    Diverse defensin proteins are expressed by most eukaryotic species 
to combat various bacterial and fungal organisms. Homologous proteins 
have also diverged in evolution to provide functions related to plant 
stresses such as heat and drought.
    There is a long history of mammalian consumption of the entire 
spinach plant (both raw and cooked) as food, without causing any known 
deleterious human health effects or any evidence of toxicity. Spinach 
plant leaves have long been part of the human diet and there have been 
no findings that indicate toxicity or allergenicity of spinach 
proteins. Spinach is commonly regarded as a ``super food'' that serves 
as an excellent source of vitamins, minerals, and antioxidants. Recent 
U.S. consumption statistics indicate that, on average, 2 lbs. of 
spinach are consumed per person per year in the United States. 
``Spinach Profile,'' Agricultural Marketing Resource Center (June 2013) 
(http://www.agmrc.org/commodities_products/vegetables/spinach-profile/
). Similarly, citrus whole fruits and juices have been an important 
part of the

[[Page 25945]]

American and international diets for centuries. ``History of Citrus,'' 
All Foods Natural (2013) (available online at: http://www.allfoodnatural.com/article/history-of-citrus.html). Available 
studies demonstrate that spinach defensin 2 (SoD2) and spinach defensin 
7 (SoD7) proteins have very low oral toxicity. In an acute oral 
toxicity study conducted with a single dose of 5,000 milligram/kilogram 
(mg/kg) of microbial-produced SoD2 protein, no evidence of toxic or 
adverse effects was observed. Due to the high similarity between SoD2 
and SoD7, the toxicity assessment is applicable to both proteins.
    In an in vitro study, microbial-produced SoD2 and SoD7 proteins 
were rapidly and extensively hydrolyzed in stimulated gastric and 
intestinal conditions in the presence of pepsin (at pH 1.2) and 
pancreatin, respectively. Both microbial-produced SoD2 and SoD7 
proteins demonstrated half-lives of approximately five minutes when 
subjected to pepsin digest, and both proteins were completely 
proteolyzed to amino acids and small peptide fragments in less than one 
minute in the presence of 0.15 milligram/liter (mg/ml) pancreatin. 
These results indicate that both the SoD2 and SoD7 proteins are highly 
susceptible to degradation in conditions similar to the human digestive 
tract.
    A literature search was performed to identify any published studies 
that might implicate these spinach proteins as allergens. No scientific 
references were found to suggest possible allergenicity associated with 
these spinach proteins. Sequence comparisons were made between the 
novel proteins from spinach, SoD2 and SoD7, against those of known and 
putative allergens using FASTA3 to search the AllergenOnline.org 
database using full-length matches, sliding window of 80 amino acids 
and finally 8-mer identity searches. In addition, the sequences were 
searched against the National Center for Biotechnology Information 
(NCBI) Protein database without keyword limits to identify highly 
related proteins and with the keyword limit of allergen, to find any 
high scoring identity matches to proteins annotated as allergens, as a 
check on the AllergenOnline.org data. No significant sequence matches 
were found between either SoD2 or SoD7 and any allergens. Thus there 
are no potential safety concerns related to allergenicity that would 
require further testing.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).
    The Agency has considered available information on the aggregate 
exposure levels of consumers (and major identifiable subgroups of 
consumers) to the pesticide chemical residue and to other related 
substances. These considerations include dietary exposure under the 
tolerance exemption and all other tolerances or exemptions in effect 
for the plant-incorporated protectant chemical residue, and exposure 
from non-occupational sources. The Agency anticipates that there may be 
dietary exposure to the pesticide from the consumption of citrus 
products. In addition, people have a long history of consumption of 
spinach and will continue to be exposed to defensin proteins through 
consumption of spinach. Since the PIP is integrated into the plants 
genome, the Agency has concluded, based upon previous science reviews, 
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. In any event, there are no non-
dietary non-occupational uses of SoD2 and SoD7 as it is only used in 
agricultural settings.

V. Cumulative Effects From Substances With a Common Mechanism of 
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    Since SoD2 and SoD7 proteins do not act through a toxic mode of 
action nor do the SoD2 and SoD7 proteins appear to produce a toxic 
metabolite produced by other substances, the proteins do not have a 
common mechanism of toxicity with other substances; therefore, the 
requirements of section 408(b)(2)(D)(v) do not apply.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C) provides that, in considering the 
establishment of a tolerance or tolerance exemption for a pesticide 
chemical residue, EPA shall assess the available information about 
consumption patterns among infants and children, special susceptibility 
of infants and children to pesticide chemical residues, and the 
cumulative effects on infants and children of the residues and other 
substances with a common mechanism of toxicity. In addition, FFDCA 
section 408(b)(2)(C) provides that EPA shall apply an additional 
tenfold (10X) margin of exposure (safety) for infants and children in 
the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines that a different margin of exposure (safety) will 
be safe for infants and children. This additional margin of exposure 
(safety) is commonly referred to as the Food Quality Protection Act 
Safety Factor (FQPA SF). In applying this provision, EPA either retains 
the default value of 10X or uses a different additional safety factor 
when reliable data available to EPA support the choice of a different 
factor.
    Based on the information discussed in Unit III., EPA concludes that 
there are no threshold effects of concern to infants, children, or 
adults from exposure to the spinach defensin proteins SoD2 and SoD7. As 
a result, EPA concludes that no additional margin of exposure (safety) 
is necessary to protect infants and children and that not adding any 
additional margin of exposure (safety) will be safe for infants and 
children.
    Therefore, based on the discussion in Units III and IV, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the U.S. population, including infants and children, from aggregate 
exposure to the residues of spinach defensin proteins SoD2 and SoD7 in 
citrus, when it is used as a plant-incorporated protectant. Such 
exposure includes all anticipated dietary exposures and all other 
exposures for which there is reliable information. The Agency has 
arrived at this conclusion based on a lack of toxicity and 
allergenicity of the SoD2 and SoD7 proteins.

VII. Other Considerations

A. Endocrine Disruptors

    The pesticidal active ingredient is a protein, derived from a 
source that is not known to exert an influence on the endocrine system. 
Therefore, the Agency is not requiring information on the endocrine 
effects of the plant-incorporated protectant at this time.

[[Page 25946]]

B. Analytical Enforcement Methodology

    A standard operating procedure for an enzyme-linked immunosorbent 
assay for the detection and quantification of spinach defensin proteins 
SoD2 and SoD7 in citrus plant tissue has been judged useful for its 
intended purpose.

C. Response to Comments

    EPA received one comment relevant to this petition. The comment 
supports this tolerance exemption and therefore warrants no response.

VIII. Conclusion

    The Agency concludes that there is a reasonable certainty that no 
harm will result to the U.S. population, including infants and 
children, from aggregate exposure residues of spinach defensin SoD2 and 
SoD7 proteins in or on citrus. 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 
discussed previously no toxicity to mammals has been observed, nor is 
there any indication of allergenicity potential for the plant-
incorporated protectant.
    Therefore, an exemption is established for residues of spinach 
defensin SoD2 and SoD7 proteins in or on citrus when the protein is 
used as a PIP in citrus plants.

IX. 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 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).

X. 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: April 28, 2015.
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. Add Sec.  174.535 to subpart W to read as follows:


Sec.  174.535  Spinach Defensin proteins; temporary exemption from the 
requirement of a tolerance.

    (a) Residues of the defensin protein SoD2 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 April 18, 2018.
    (b) Residues of the defensin protein SoD7 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 April 18, 2018.

[FR Doc. 2015-10486 Filed 5-5-15; 8:45 am]
 BILLING CODE 6560-50-P



                                                               Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations                                         25943

                                            (including delivery by courier), by                     effected through the electronic filing                ENVIRONMENTAL PROTECTION
                                            electronic delivery in accordance with                  system;                                               AGENCY
                                            § 4.4(e), or by first-class mail to the lead               (ii) Each such party thereby agrees
                                            complaint counsel, with a copy to the                                                                         40 CFR Part 174
                                                                                                    that, for any document served through
                                            Administrative Law Judge.
                                               (ii) Upon a party other than                         the electronic filing system,                         [EPA–HQ–OPP–2014–0834; FRL–9926–99]
                                            complaint counsel or upon a third                       transmission of the notice of electronic
                                                                                                    filing provided by the electronic filing              Defensin Proteins (SoD2 and SoD7)
                                            party. A copy may be served by personal                                                                       Derived From Spinach (Spinacia
                                            delivery (including delivery by courier),               system shall satisfy the service
                                                                                                                                                          oleracea L.) in Citrus Plants;
                                            by electronic delivery in accordance                    obligations of the serving party; and
                                                                                                                                                          Temporary Exemption From the
                                            with § 4.4(e), or by first-class mail, with                (iii) A document served via the                    Requirement of a Tolerance
                                            a copy to the Administrative Law Judge.                 electronic filing system shall be deemed
                                            If the party is an individual or                        served on the date the notice of                      AGENCY:  Environmental Protection
                                            partnership, delivery shall be to such                  electronic filing is transmitted, unless              Agency (EPA).
                                            individual or a member of the                           the serving party learns that the notice              ACTION: Final rule.
                                            partnership; if a corporation or                        of electronic filing did not reach the
                                            unincorporated association, to an officer                                                                     SUMMARY:   This regulation establishes a
                                                                                                    person to be served.                                  temporary exemption from the
                                            or agent authorized to accept service of
                                            process therefor. Personal delivery                        (2) Service by other methods of                    requirement of a tolerance for residues
                                            includes handing the document to be                     electronic delivery. (i) In the following             of SoD2 and SoD7, two defensin
                                            served to the individual, partner, officer,             circumstances, service by other methods               proteins derived from spinach (Spinacia
                                            or agent; leaving it at his or her office               of electronic delivery (including service             oleracea L.), in or on citrus when used
                                            with a person in charge thereof; or, if                 by email) may be effected as the                      as plant-incorporated protectants (PIPs)
                                            there is no one in charge or if the office              Administrative Law Judge and the                      in accordance with the terms of
                                            is closed or if the party has no office,                Secretary may direct:                                 Experimental Use Permit (EUP) No.
                                            leaving it at his or her dwelling house                                                                       88232–EUP–1. Southern Gardens Citrus
                                                                                                       (A) The document to be served is
                                            or usual place of abode with some                                                                             submitted a petition to EPA under the
                                                                                                    labeled ‘‘In Camera’’ or ‘‘Confidential’’             Federal Food, Drug, and Cosmetic Act
                                            person of suitable age and discretion
                                                                                                    pursuant to § 4.2(b);                                 (FFDCA), requesting the temporary
                                            then residing therein.
                                               (2) Unless otherwise specified in                       (B) The party to be served has not                 tolerance exemption. This regulation
                                            § 4.4(e), documents served in                           elected to be served via the electronic               eliminates the need to establish a
                                            adjudicative proceedings under part 3                   filing system;                                        maximum permissible level for residues
                                            shall be deemed served on the day of                       (C) The document is to be served                   of SoD2 and SoD7 in or on citrus. The
                                            personal delivery (including delivery by                upon a third party; or                                temporary tolerance exemption expires
                                            courier), the day of electronic delivery,                                                                     on April 18, 2018.
                                            or the day of mailing.                                     (D) Service under paragraph (e)(1) of
                                                                                                                                                          DATES: This regulation is effective May
                                               (c) Service upon counsel. When                       this section is unavailable for technical             6, 2015. Objections and requests for
                                            counsel has appeared in a proceeding                    reasons.                                              hearings must be received on or before
                                            on behalf of a party, service upon such                    (ii) If documents labeled ‘‘In Camera’’            July 6, 2015, and must be filed in
                                            counsel of any document, other than a                   or ‘‘Confidential’’ are being served                  accordance with the instructions
                                            complaint, shall be deemed service                      under this paragraph (e)(2), the                      provided in 40 CFR part 178 (see also
                                            upon the party. However, service of                     documents must be encrypted prior to                  Unit I.C. of the SUPPLEMENTARY
                                            those documents specified in paragraph                  transit or must be transferred through a              INFORMATION).
                                            (a)(1) of this section shall be in                      secure file transfer protocol. Service of
                                            accordance with paragraphs (a)(1)(i),                                                                         ADDRESSES:    The docket for this action,
                                                                                                    a document under this paragraph (e)(2)                identified by docket identification (ID)
                                            (ii), and (iii) of this section.                        shall be complete upon transmission by
                                               (d) Proof of service. In an adjudicative                                                                   number EPA–HQ–OPP–2014–0834, is
                                            proceeding under part 3, documents                      the serving party, unless the serving                 available at http://www.regulations.gov
                                            presented for filing shall contain proof                party learns that the document did not                or at the Office of Pesticide Programs
                                            of service in the form of a statement of                reach the person to be served.                        Regulatory Public Docket (OPP Docket)
                                            the date and manner of service and of                      (f) Service of process upon the                    in the Environmental Protection Agency
                                            the names of the persons served,                        Commission. Documents served upon                     Docket Center (EPA/DC), West William
                                            certified by the person who made                        the Commission may be served by                       Jefferson Clinton Bldg., Rm. 3334, 1301
                                            service. Proof of service must appear on                personal delivery (including delivery by              Constitution Ave. NW., Washington, DC
                                            or be affixed to the documents filed.                   courier) or by first-class mail to the                20460–0001. The Public Reading Room
                                               (e) Service by electronic delivery in an                                                                   is open from 8:30 a.m. to 4:30 p.m.,
                                                                                                    Office of the Secretary of the
                                            adjudicative proceeding under part 3 of                                                                       Monday through Friday, excluding legal
                                                                                                    Commission.
                                            this chapter—(1) Service through the                                                                          holidays. The telephone number for the
                                            electronic filing system. A party may                     By direction of the Commission.                     Public Reading Room is (202) 566–1744,
                                            elect, for documents labeled ‘‘Public’’                 Donald S. Clark,                                      and the telephone number for the OPP
                                            pursuant to § 4.2(b), to be served via the              Secretary.                                            Docket is (703) 305–5805. Please review
                                            electronic filing system provided by the                [FR Doc. 2015–10517 Filed 5–5–15; 8:45 am]
                                                                                                                                                          the visitor instructions and additional
                                            Office of the Secretary. The electronic                                                                       information about the docket available
tkelley on DSK3SPTVN1PROD with RULES




                                                                                                    BILLING CODE 6750–01–P
                                            filing system cannot be used to serve                                                                         at http://www.epa.gov/dockets.
                                            third parties. For parties that have                                                                          FOR FURTHER INFORMATION CONTACT:
                                            elected to be served via the electronic                                                                       Robert McNally, Biopesticides and
                                            filing system:                                                                                                Pollution Prevention Division (7511P),
                                               (i) Service of documents labeled                                                                           Office of Pesticide Programs,
                                            ‘‘Public’’ pursuant to § 4.2(b) may be                                                                        Environmental Protection Agency, 1200


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                                            25944              Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations

                                            Pennsylvania Ave. NW., Washington,                      objection or hearing request, identified              tolerance, EPA must take into account
                                            DC 20460–0001; main telephone                           by docket ID number EPA–HQ–OPP–                       the factors set forth in FFDCA section
                                            number: (703) 305–7090; email address:                  2014–0834, by one of the following                    408(b)(2)(C), which require EPA to give
                                            BPPDFRNotices@epa.gov.                                  methods:                                              special consideration to exposure of
                                            SUPPLEMENTARY INFORMATION:                                • Federal eRulemaking Portal: http://               infants and children to the pesticide
                                                                                                    www.regulations.gov. Follow the online                chemical residue in establishing a
                                            I. General Information                                  instructions for submitting comments.                 tolerance and to ‘‘ensure that there is a
                                            A. Does this action apply to me?                        Do not submit electronically any                      reasonable certainty that no harm will
                                                                                                    information you consider to be CBI or                 result to infants and children from
                                               You may be potentially affected by                   other information whose disclosure is                 aggregate exposure to the pesticide
                                            this action if you are an agricultural                  restricted by statute.                                chemical residue. . . .’’ Additionally,
                                            producer, food manufacturer, or                           • Mail: OPP Docket, Environmental                   FFDCA section 408(b)(2)(D) requires
                                            pesticide manufacturer. The following                   Protection Agency Docket Center (EPA/                 that the Agency consider ‘‘available
                                            list of North American Industrial                       DC), (28221T), 1200 Pennsylvania Ave.                 information concerning the cumulative
                                            Classification System (NAICS) codes is                  NW., Washington, DC 20460–0001.                       effects of a particular pesticide’s
                                            not intended to be exhaustive, but rather                 • Hand Delivery: To make special                    residues’’ and ‘‘other substances that
                                            provides a guide to help readers                        arrangements for hand delivery or                     have a common mechanism of toxicity.’’
                                            determine whether this document                         delivery of boxed information, please                    EPA performs a number of analyses to
                                            applies to them. Potentially affected                   follow the instructions at http://                    determine the risks from aggregate
                                            entities may include:                                   www.epa.gov/dockets/contacts.html.                    exposure to pesticide residues. First,
                                               • Crop production (NAICS code 111).                    Additional instructions on                          EPA determines the toxicity of
                                               • Animal production (NAICS code                      commenting or visiting the docket,                    pesticides. Second, EPA examines
                                            112).                                                   along with more information about                     exposure to the pesticide through food,
                                               • Food manufacturing (NAICS code                     dockets generally, is available at http://            drinking water, and through other
                                            311).                                                   www.epa.gov/dockets.                                  exposures that occur as a result of
                                               • Pesticide manufacturing (NAICS                                                                           pesticide use in residential settings.
                                                                                                    II. Background and Statutory
                                            code 32532).
                                                                                                    Framework                                             III. Toxicological Profile
                                            B. How can I get electronic access to                      In the Federal Register of January 28,                Consistent with FFDCA section
                                            other related information?                              2015 (80 FR 4525) (FRL–9921–55), EPA                  408(b)(2)(D), EPA has reviewed the
                                              You may access a frequently updated                   issued a document pursuant to FFDCA                   available scientific data and other
                                            electronic version of 40 CFR part 180                   section 408(d)(3), 21 U.S.C. 346a(d)(3),              relevant information in support of this
                                            through the Government Publishing                       announcing the filing of a pesticide                  action and considered its validity,
                                            Office’s e-CFR site at http://                          tolerance petition (PP 4F8289) by                     completeness and reliability, and the
                                            www.ecfr.gov/cgi-bin/text-                              Southern Gardens Citrus, 1820 Country                 relationship of this information to
                                            idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                    Road 833, Clewiston, FL 33440. The                    human risk. EPA has also considered
                                            40tab_02.tpl.                                           petition requested that 40 CFR part 174               available information concerning the
                                                                                                    be amended by establishing a temporary                variability of the sensitivities of major
                                            C. How can I file an objection or hearing               exemption from the requirement of a                   identifiable subgroups of consumers,
                                            request?                                                tolerance for residues of spinach                     including infants and children.
                                              Under FFDCA section 408(g), 21                        defensin (SoD2 and SoD7) proteins in or                  Diverse defensin proteins are
                                            U.S.C. 346a, any person may file an                     on citrus. That document referenced a                 expressed by most eukaryotic species to
                                            objection to any aspect of this regulation              summary of the petition prepared by the               combat various bacterial and fungal
                                            and may also request a hearing on those                 petitioner Southern Gardens Citrus,                   organisms. Homologous proteins have
                                            objections. You must file your objection                which is available in the docket, http://             also diverged in evolution to provide
                                            or request a hearing on this regulation                 www.regulations.gov. A comment was                    functions related to plant stresses such
                                            in accordance with the instructions                     received on the notice of filing. EPA’s               as heat and drought.
                                            provided in 40 CFR part 178. To ensure                  response to this comment is discussed                    There is a long history of mammalian
                                            proper receipt by EPA, you must                         in Unit VII.C.                                        consumption of the entire spinach plant
                                            identify docket ID number EPA–HQ–                          Section 408(c)(2)(A)(i) of FFDCA                   (both raw and cooked) as food, without
                                            OPP–2014–0834 in the subject line on                    allows EPA to establish an exemption                  causing any known deleterious human
                                            the first page of your submission. All                  from the requirement for a tolerance (the             health effects or any evidence of
                                            objections and requests for a hearing                   legal limit for a pesticide chemical                  toxicity. Spinach plant leaves have long
                                            must be in writing, and must be                         residue in or on a food) only if EPA                  been part of the human diet and there
                                            received by the Hearing Clerk on or                     determines that the exemption is ‘‘safe.’’            have been no findings that indicate
                                            before July 6, 2015. Addresses for mail                 Section 408(c)(2)(A)(ii) of FFDCA                     toxicity or allergenicity of spinach
                                            and hand delivery of objections and                     defines ‘‘safe ’’ to mean that ‘‘there is a           proteins. Spinach is commonly regarded
                                            hearing requests are provided in 40 CFR                 reasonable certainty that no harm will                as a ‘‘super food’’ that serves as an
                                            178.25(b).                                              result from aggregate exposure to the                 excellent source of vitamins, minerals,
                                              In addition to filing an objection or                 pesticide chemical residue, including                 and antioxidants. Recent U.S.
                                            hearing request with the Hearing Clerk                  all anticipated dietary exposures and all             consumption statistics indicate that, on
                                            as described in 40 CFR part 178, please                 other exposures for which there is                    average, 2 lbs. of spinach are consumed
                                            submit a copy of the filing (excluding                  reliable information.’’ This includes                 per person per year in the United States.
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                                            any Confidential Business Information                   exposure through drinking water and in                ‘‘Spinach Profile,’’ Agricultural
                                            (CBI)) for inclusion in the public docket.              residential settings, but does not include            Marketing Resource Center (June 2013)
                                            Information not marked confidential                     occupational exposure. Pursuant to                    (http://www.agmrc.org/commodities_
                                            pursuant to 40 CFR part 2 may be                        FFDCA section 408(c)(2)(B), in                        products/vegetables/spinach-profile/).
                                            disclosed publicly by EPA without prior                 establishing or maintaining in effect an              Similarly, citrus whole fruits and juices
                                            notice. Submit the non-CBI copy of your                 exemption from the requirement of a                   have been an important part of the


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                                                               Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations                                          25945

                                            American and international diets for                    consider available information                        a tolerance or tolerance exemption for a
                                            centuries. ‘‘History of Citrus,’’ All Foods             concerning exposures from the pesticide               pesticide chemical residue, EPA shall
                                            Natural (2013) (available online at:                    residue in food and all other non-                    assess the available information about
                                            http://www.allfoodnatural.com/article/                  occupational exposures, including                     consumption patterns among infants
                                            history-of-citrus.html). Available studies              drinking water from ground water or                   and children, special susceptibility of
                                            demonstrate that spinach defensin 2                     surface water and exposure through                    infants and children to pesticide
                                            (SoD2) and spinach defensin 7 (SoD7)                    pesticide use in gardens, lawns, or                   chemical residues, and the cumulative
                                            proteins have very low oral toxicity. In                buildings (residential and other indoor               effects on infants and children of the
                                            an acute oral toxicity study conducted                  uses).                                                residues and other substances with a
                                            with a single dose of 5,000 milligram/                    The Agency has considered available                 common mechanism of toxicity. In
                                            kilogram (mg/kg) of microbial-produced                  information on the aggregate exposure                 addition, FFDCA section 408(b)(2)(C)
                                            SoD2 protein, no evidence of toxic or                   levels of consumers (and major                        provides that EPA shall apply an
                                            adverse effects was observed. Due to the                identifiable subgroups of consumers) to               additional tenfold (10X) margin of
                                            high similarity between SoD2 and SoD7,                  the pesticide chemical residue and to                 exposure (safety) for infants and
                                            the toxicity assessment is applicable to                other related substances. These                       children in the case of threshold effects
                                            both proteins.                                          considerations include dietary exposure               to account for prenatal and postnatal
                                               In an in vitro study, microbial-                     under the tolerance exemption and all                 toxicity and the completeness of the
                                            produced SoD2 and SoD7 proteins were                    other tolerances or exemptions in effect              database on toxicity and exposure
                                            rapidly and extensively hydrolyzed in                   for the plant-incorporated protectant                 unless EPA determines that a different
                                            stimulated gastric and intestinal                       chemical residue, and exposure from                   margin of exposure (safety) will be safe
                                            conditions in the presence of pepsin (at                non-occupational sources. The Agency                  for infants and children. This additional
                                            pH 1.2) and pancreatin, respectively.                   anticipates that there may be dietary                 margin of exposure (safety) is commonly
                                            Both microbial-produced SoD2 and                        exposure to the pesticide from the                    referred to as the Food Quality
                                            SoD7 proteins demonstrated half-lives                   consumption of citrus products. In                    Protection Act Safety Factor (FQPA SF).
                                            of approximately five minutes when                      addition, people have a long history of               In applying this provision, EPA either
                                            subjected to pepsin digest, and both                    consumption of spinach and will                       retains the default value of 10X or uses
                                            proteins were completely proteolyzed to                 continue to be exposed to defensin                    a different additional safety factor when
                                            amino acids and small peptide                           proteins through consumption of                       reliable data available to EPA support
                                            fragments in less than one minute in the                spinach. Since the PIP is integrated into             the choice of a different factor.
                                            presence of 0.15 milligram/liter (mg/ml)                the plants genome, the Agency has
                                            pancreatin. These results indicate that                 concluded, based upon previous science                   Based on the information discussed in
                                            both the SoD2 and SoD7 proteins are                     reviews, that residues in drinking water              Unit III., EPA concludes that there are
                                            highly susceptible to degradation in                    will be extremely low or non-existent.                no threshold effects of concern to
                                            conditions similar to the human                         Non-occupational exposure via the skin                infants, children, or adults from
                                            digestive tract.                                        or inhalation is not likely since the                 exposure to the spinach defensin
                                               A literature search was performed to                 plant-incorporated protectant is                      proteins SoD2 and SoD7. As a result,
                                            identify any published studies that                     contained within plant cells, which                   EPA concludes that no additional
                                            might implicate these spinach proteins                  essentially eliminates these exposure                 margin of exposure (safety) is necessary
                                            as allergens. No scientific references                  routes or reduces these exposure routes               to protect infants and children and that
                                            were found to suggest possible                          to negligible. In any event, there are no             not adding any additional margin of
                                            allergenicity associated with these                     non-dietary non-occupational uses of                  exposure (safety) will be safe for infants
                                            spinach proteins. Sequence                              SoD2 and SoD7 as it is only used in                   and children.
                                            comparisons were made between the                       agricultural settings.                                   Therefore, based on the discussion in
                                            novel proteins from spinach, SoD2 and                                                                         Units III and IV, EPA concludes that
                                            SoD7, against those of known and                        V. Cumulative Effects From Substances                 there is a reasonable certainty that no
                                            putative allergens using FASTA3 to                      With a Common Mechanism of Toxicity                   harm will result to the U.S. population,
                                            search the AllergenOnline.org database                     Section 408(b)(2)(D)(v) of FFDCA                   including infants and children, from
                                            using full-length matches, sliding                      requires that, when considering whether               aggregate exposure to the residues of
                                            window of 80 amino acids and finally                    to establish, modify, or revoke a                     spinach defensin proteins SoD2 and
                                            8-mer identity searches. In addition, the               tolerance, the Agency consider                        SoD7 in citrus, when it is used as a
                                            sequences were searched against the                     ‘‘available information’’ concerning the              plant-incorporated protectant. Such
                                            National Center for Biotechnology                       cumulative effects of a particular                    exposure includes all anticipated
                                            Information (NCBI) Protein database                     pesticide’s residues and ‘‘other                      dietary exposures and all other
                                            without keyword limits to identify                      substances that have a common                         exposures for which there is reliable
                                            highly related proteins and with the                    mechanism of toxicity.’’                              information. The Agency has arrived at
                                            keyword limit of allergen, to find any                     Since SoD2 and SoD7 proteins do not                this conclusion based on a lack of
                                            high scoring identity matches to                        act through a toxic mode of action nor                toxicity and allergenicity of the SoD2
                                            proteins annotated as allergens, as a                   do the SoD2 and SoD7 proteins appear                  and SoD7 proteins.
                                            check on the AllergenOnline.org data.                   to produce a toxic metabolite produced
                                            No significant sequence matches were                    by other substances, the proteins do not              VII. Other Considerations
                                            found between either SoD2 or SoD7 and                   have a common mechanism of toxicity                   A. Endocrine Disruptors
                                            any allergens. Thus there are no                        with other substances; therefore, the
                                            potential safety concerns related to                    requirements of section 408(b)(2)(D)(v)                 The pesticidal active ingredient is a
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                                            allergenicity that would require further                do not apply.                                         protein, derived from a source that is
                                            testing.                                                                                                      not known to exert an influence on the
                                                                                                    VI. Determination of Safety for U.S.                  endocrine system. Therefore, the
                                            IV. Aggregate Exposures                                 Population, Infants and Children                      Agency is not requiring information on
                                              In examining aggregate exposure,                        FFDCA section 408(b)(2)(C) provides                 the endocrine effects of the plant-
                                            FFDCA section 408 directs EPA to                        that, in considering the establishment of             incorporated protectant at this time.


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                                            25946              Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations

                                            B. Analytical Enforcement Methodology                   Populations’’ (59 FR 7629, February 16,                 Dated: April 28, 2015.
                                              A standard operating procedure for an                 1994).                                                Robert McNally,
                                            enzyme-linked immunosorbent assay for                      Since tolerances and exemptions that               Director, Biopesticides and Pollution
                                                                                                    are established on the basis of a petition            Prevention Division, Office of Pesticide
                                            the detection and quantification of                                                                           Programs.
                                            spinach defensin proteins SoD2 and                      under FFDCA section 408(d), such as
                                            SoD7 in citrus plant tissue has been                    the exemption in this final rule, do not                Therefore, 40 CFR chapter I is
                                            judged useful for its intended purpose.                 require the issuance of a proposed rule,              amended as follows:
                                                                                                    the requirements of the Regulatory
                                            C. Response to Comments                                                                                       PART 174—[AMENDED]
                                                                                                    Flexibility Act (RFA) (5 U.S.C. 601 et
                                              EPA received one comment relevant                     seq.), do not apply.                                  ■ 1. The authority citation for part 174
                                            to this petition. The comment supports                                                                        continues to read as follows:
                                                                                                       This action directly regulates growers,
                                            this tolerance exemption and therefore
                                                                                                    food processors, food handlers, and food                  Authority: 21 U.S.C. 321(q), 346a and 371.
                                            warrants no response.
                                                                                                    retailers, not States or tribes, nor does
                                                                                                    this action alter the relationships or                ■ 2. Add § 174.535 to subpart W to read
                                            VIII. Conclusion
                                                                                                                                                          as follows:
                                               The Agency concludes that there is a                 distribution of power and
                                            reasonable certainty that no harm will                  responsibilities established by Congress              § 174.535 Spinach Defensin proteins;
                                            result to the U.S. population, including                in the preemption provisions of FFDCA                 temporary exemption from the requirement
                                                                                                    section 408(n)(4). As such, the Agency                of a tolerance.
                                            infants and children, from aggregate
                                            exposure residues of spinach defensin                   has determined that this action will not                 (a) Residues of the defensin protein
                                            SoD2 and SoD7 proteins in or on citrus.                 have a substantial direct effect on States            SoD2 derived from spinach (Spinacia
                                            This includes all anticipated dietary                   or tribal governments, on the                         oleracea L.) in or on citrus food
                                            exposures and all other exposures for                   relationship between the national                     commodities are temporarily exempt
                                            which there is reliable information. The                government and the States or tribal                   from the requirement of a tolerance
                                            Agency has arrived at this conclusion                   governments, or on the distribution of                when used as a plant-incorporated
                                            because, as discussed previously no                     power and responsibilities among the                  protectant in citrus plants in accordance
                                            toxicity to mammals has been observed,                  various levels of government or between               with the terms of Experimental Use
                                            nor is there any indication of                          the Federal Government and Indian                     Permit No. 88232–EUP–1. This
                                            allergenicity potential for the plant-                  tribes. Thus, the Agency has determined               temporary exemption from the
                                            incorporated protectant.                                that Executive Order 13132, entitled                  requirement of a tolerance expires on
                                               Therefore, an exemption is                           ‘‘Federalism’’ (64 FR 43255, August 10,               April 18, 2018.
                                                                                                    1999) and Executive Order 13175,                         (b) Residues of the defensin protein
                                            established for residues of spinach
                                                                                                    entitled ‘‘Consultation and Coordination              SoD7 derived from spinach (Spinacia
                                            defensin SoD2 and SoD7 proteins in or
                                                                                                    with Indian Tribal Governments’’ (65 FR               oleracea L.) in or on citrus food
                                            on citrus when the protein is used as a
                                                                                                    67249, November 9, 2000) do not apply                 commodities are temporarily exempt
                                            PIP in citrus plants.
                                                                                                    to this action. In addition, this action              from the requirement of a tolerance
                                            IX. Statutory and Executive Order                       does not impose any enforceable duty or               when used as a plant-incorporated
                                            Reviews                                                 contain any unfunded mandate as                       protectant in citrus plants in accordance
                                               This action establishes a temporary                  described under Title II of the Unfunded              with the terms of Experimental Use
                                            exemption from the requirement of a                     Mandates Reform Act (UMRA) (2 U.S.C.                  Permit No. 88232–EUP–1. This
                                            tolerance under FFDCA section 408(d)                    1501 et seq.).                                        temporary exemption from the
                                            in response to a petition submitted to                                                                        requirement of a tolerance expires on
                                                                                                       This action does not involve any                   April 18, 2018.
                                            the Agency. The Office of Management                    technical standards that would require
                                            and Budget (OMB) has exempted these                                                                           [FR Doc. 2015–10486 Filed 5–5–15; 8:45 am]
                                                                                                    Agency consideration of voluntary
                                            types of actions from review under                      consensus standards pursuant to section               BILLING CODE 6560–50–P
                                            Executive Order 12866, entitled                         12(d) of the National Technology
                                            ‘‘Regulatory Planning and Review’’ (58                  Transfer and Advancement Act
                                            FR 51735, October 4, 1993). Because                                                                           ENVIRONMENTAL PROTECTION
                                                                                                    (NTTAA) (15 U.S.C. 272 note).                         AGENCY
                                            this action has been exempted from
                                            review under Executive Order 12866,                     X. Congressional Review Act
                                                                                                                                                          40 CFR Part 174
                                            this action is not subject to Executive
                                            Order 13211, entitled ‘‘Actions                           Pursuant to the Congressional Review                [EPA–HQ–OPP–2014–0454; FRL–9926–23]
                                            Concerning Regulations That                             Act (5 U.S.C. 801 et seq.), EPA will
                                            Significantly Affect Energy Supply,                     submit a report containing this rule and              Bacillus thuringiensis Cry1A.105
                                            Distribution, or Use’’ (66 FR 28355, May                other required information to the U.S.                Protein in Soybean; Exemption From
                                            22, 2001) or Executive Order 13045,                     Senate, the U.S. House of                             the Requirement of a Tolerance
                                            entitled ‘‘Protection of Children from                  Representatives, and the Comptroller
                                                                                                    General of the United States prior to                 AGENCY:  Environmental Protection
                                            Environmental Health Risks and Safety                                                                         Agency (EPA).
                                            Risks’’ (62 FR 19885, April 23, 1997).                  publication of the rule in the Federal
                                                                                                    Register. This action is not a ‘‘major                ACTION: Final rule.
                                            This action does not contain any
                                            information collections subject to OMB                  rule’’ as defined by 5 U.S.C. 804(2).                 SUMMARY:   This regulation establishes an
                                            approval under the Paperwork                            List of Subjects in 40 CFR Part 174                   exemption from the requirement of a
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                                            Reduction Act (PRA) (44 U.S.C. 3501 et                                                                        tolerance for residues of the Bacillus
                                            seq.), nor does it require any special                    Environmental protection,                           thuringiensis (B.t.) Cry1A.105 protein in
                                            considerations under Executive Order                    Administrative practice and procedure,                or on soybean when the protein is used
                                            12898, entitled ‘‘Federal Actions to                    Agricultural commodities, Pesticides                  as a plant-incorporated protectant (PIP)
                                            Address Environmental Justice in                        and pests, Reporting and recordkeeping                in soybean. Monsanto Company
                                            Minority Populations and Low-Income                     requirements.                                         submitted a petition to EPA under the


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Document Created: 2015-12-16 07:41:09
Document Modified: 2015-12-16 07:41:09
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 6, 2015. Objections and requests for hearings must be received on or before July 6, 2015, 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, DC 20460-0001; main telephone
FR Citation80 FR 25943 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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