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

(including delivery by courier), by 

electronic delivery in accordance with 

§ 4.4(e), or by first-class mail to the lead 

complaint counsel, with a copy to the 

Administrative Law Judge. 

(ii) Upon a party other than 

complaint counsel or upon a third 

party. A copy may be served by personal 

delivery (including delivery by courier), 

by electronic delivery in accordance 

with § 4.4(e), or by first-class mail, with 

a copy to the Administrative Law Judge. 

If the party is an individual or 

partnership, delivery shall be to such 

individual or a member of the 

partnership; if a corporation or 

unincorporated association, to an officer 

or agent authorized to accept service of 

process therefor. Personal delivery 

includes handing the document to be 

served to the individual, partner, officer, 

or agent; leaving it at his or her office 

with a person in charge thereof; or, if 

there is no one in charge or if the office 

is closed or if the party has no office, 

leaving it at his or her dwelling house 

or usual place of abode with some 

person of suitable age and discretion 

then residing therein. 

(2) Unless otherwise specified in 

§ 4.4(e), documents served in 

adjudicative proceedings under part 3 

shall be deemed served on the day of 

personal delivery (including delivery by 

courier), the day of electronic delivery, 

or the day of mailing. 

(c) Service upon counsel. When 

counsel has appeared in a proceeding 

on behalf of a party, service upon such 

counsel of any document, other than a 

complaint, shall be deemed service 

upon the party. However, service of 

those documents specified in paragraph 

(a)(1) of this section shall be in 

accordance with paragraphs (a)(1)(i), 

(ii), and (iii) of this section. 

(d) Proof of service. In an adjudicative 

proceeding under part 3, documents 

presented for filing shall contain proof 

of service in the form of a statement of 

the date and manner of service and of 

the names of the persons served, 

certified by the person who made 

service. Proof of service must appear on 

or be affixed to the documents filed. 

(e) Service by electronic delivery in an 

adjudicative proceeding under part 3 of 

this chapter—(1) Service through the 

electronic filing system. A party may 

elect, for documents labeled ‘‘Public’’ 

pursuant to § 4.2(b), to be served via the 

electronic filing system provided by the 

Office of the Secretary. The electronic 

filing system cannot be used to serve 

third parties. For parties that have 

elected to be served via the electronic 

filing system: 

(i) Service of documents labeled 

‘‘Public’’ pursuant to § 4.2(b) may be 

effected through the electronic filing 

system; 

(ii) Each such party thereby agrees 

that, for any document served through 

the electronic filing system, 

transmission of the notice of electronic 

filing provided by the electronic filing 

system shall satisfy the service 

obligations of the serving party; and 

(iii) A document served via the 

electronic filing system shall be deemed 

served on the date the notice of 

electronic filing is transmitted, unless 

the serving party learns that the notice 

of electronic filing did not reach the 

person to be served. 

(2) Service by other methods of 

electronic delivery. (i) In the following 

circumstances, service by other methods 

of electronic delivery (including service 

by email) may be effected as the 

Administrative Law Judge and the 

Secretary may direct: 

(A) The document to be served is 

labeled ‘‘In Camera’’ or ‘‘Confidential’’ 

pursuant to § 4.2(b); 

(B) The party to be served has not 

elected to be served via the electronic 

filing system; 

(C) The document is to be served 

upon a third party; or 

(D) Service under paragraph (e)(1) of 

this section is unavailable for technical 

reasons. 

(ii) If documents labeled ‘‘In Camera’’ 

or ‘‘Confidential’’ are being served 

under this paragraph (e)(2), the 

documents must be encrypted prior to 

transit or must be transferred through a 

secure file transfer protocol. Service of 

a document under this paragraph (e)(2) 

shall be complete upon transmission by 

the serving party, unless the serving 

party learns that the document did not 

reach the person to be served. 

(f) Service of process upon the 

Commission. Documents served upon 

the Commission may be served by 

personal delivery (including delivery by 

courier) or by first-class mail to the 

Office of the Secretary of the 

Commission. 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. 2015–10517 Filed 5–5–15; 8:45 am] 

BILLING CODE 6750–01–P 

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 


tkelley on DSK3SPTVN1PROD with RULES
25944 Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

BPPDFRNotices@epa.gov. 

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/textidx?&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 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 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, microbialproduced 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 nonoccupational 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 plantincorporated protectant at this time. 


tkelley on DSK3SPTVN1PROD with RULES
25946 Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 

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 plantincorporated 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] 

■ 1. The authority citation for part 174 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Add § 174.535 to subpart W to read 

as follows: 

§ 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 174 

[EPA–HQ–OPP–2014–0454; FRL–9926–23] 

Bacillus thuringiensis Cry1A.105 

Protein in Soybean; Exemption From 

the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the Bacillus 

thuringiensis (B.t.) Cry1A.105 protein in 

or on soybean when the protein is used 

as a plant-incorporated protectant (PIP) 

in soybean. Monsanto Company 

submitted a petition to EPA under the 


tkelley on DSK3SPTVN1PROD with RULES