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
Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 25947 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of B.t. Cry1A.105 protein in 

or on soybean. 

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–2014–0454, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Robert McNally, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

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

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 174 

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(g), any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2014–0454 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– 

2014–0454, 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 Findings 

In the Federal Register initially on 

October 24, 2014 (79 FR 63596) (FRL– 

9916–03) and then again on December 

17, 2014 (79 FR 75111) (FRL–9918–90), 

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 4F8275) 

by Monsanto Company, 800 North 

Lindbergh Blvd., St. Louis, MO 63167. 

The petition requested that 40 CFR part 

174 be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of the B.t. 

Cry1A.105 protein in or on all food 

commodities. That document referenced 

a summary of the petition prepared by 

the petitioner Monsanto Company, 

which is available in the docket, 

http://www.regulations.gov. A comment 

was received on the October 24, 2014, 

notice of filing. EPA’s response to this 

comment is discussed in Unit VII.C. 

Based on available data, EPA is 

amending the existing exemption for 

residues of B.t. Cry1A.105 protein to 

include residues in soybean rather than 

all food commodities as requested. The 

reasons for this change are discussed in 

Unit VII.D. 

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 


tkelley on DSK3SPTVN1PROD with RULES
25948 Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 

‘‘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. 

The acute oral toxicity data 

demonstrates the lack of mammalian 

toxicity at high levels of exposure to the 

pure B.t. Cry1A.105 protein. Further, 

amino acid sequence comparisons 

showed no similarities between the B.t. 

Cry1A.105 protein and known toxic 

proteins in protein databases. In 

addition, the B.t. Cry1A.105 protein was 

shown to be substantially degraded by 

heat when examined by immunoassay. 

This instability to heat would also 

lessen the potential dietary exposure to 

intact B.t. Cry1A.105 protein in cooked 

or processed foods. These biochemical 

features along with the lack of adverse 

results in the acute oral toxicity test 

support the conclusion that there is a 

reasonable certainty no harm from 

toxicity will result from dietary 

exposure to residues of the B.t. 

Cry1A.105 protein in the identified 

soybean commodities. 

Since the PIP is a protein, allergenic 

potential was also considered. 

Currently, no definitive tests for 

determining the allergenic potential of 

novel proteins exist. Therefore, EPA 

uses a weight-of-evidence approach 

where the following factors are 

considered: Source of the trait; amino 

acid sequence comparison with known 

allergens; and biochemical properties of 

the protein, including in-vitro 

digestibility in simulated gastric fluid 

(SGF) and glycosylation. This approach 

is consistent with the approach outlined 

in the Annex to the Codex Alimentarius, 

‘‘Guideline for the Conduct of Food 

Safety Assessment of Foods Derived 

from Recombinant-DNA Plants.’’ The 

allergenicity assessment for the B.t. 

Cry1A.105 protein follows: 

1. Source of the trait. Bacillus 

thuringiensis is not considered to be a 

source of allergenic proteins. 

2. Amino acid sequence. A 

comparison of the amino acid sequence 

of the B.t. Cry1A.105 protein with 

known allergens showed no significant 

overall sequence similarity or identity at 

the level of eight contiguous amino acid 

residues. 

3. Digestibility. The B.t. Cry1A.105 

protein was rapidly digested in less than 

30 seconds in simulated mammalian 

gastric fluid containing pepsin. 

4. Glycosylation. The B.t. Cry1A.105 

protein expressed in soybean was 

shown not to be glycosylated. 

5. Conclusion. Considering all of the 

available information, EPA has 

concluded that the potential for the B.t. 

Cry1A.105 protein to be a food allergen 

is minimal. 

The information on the safety of the 

pure B.t. Cry1A.105 protein provides 

adequate justification to address 

possible exposures in all soybean crops. 

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 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 exemptions in effect for the B.t. 

Cry1A.105 protein residue, and 

exposure from non-occupational 

sources. Oral exposure may occur at 

very low levels from ingestion of corn 

and soybean products. With respect to 

drinking water, since the PIP is 

integrated into the plant genome and 

based upon EPA’s human health and 

environmental assessments for B.t. 

Cry1A.105 protein (Refs. 1 and 2), the 

Agency expects residues in drinking 

water to be extremely low or nonexistent. 

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 exposure by 

these routes to negligible. Exposure to 

infants and children via residential or 

lawn use is also not expected because 

the use sites for the B.t. Cry1A.105 

protein is agricultural. 

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 the B.t. Cry1A.105 protein does 

not act through a toxic mode of action, 

nor does the B.t. Cry1A.105 protein 

appear to produce a toxic metabolite 

produced by other substances, the 

protein does 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 B.t. Cry1A.105 protein. 

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. 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 25949 

Therefore, based on the discussion in 

Unit III. and the supporting 

documentation, 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 the 

B.t. Cry1A.105 protein in soybean, 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. 

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. 

B. Analytical Enforcement Methodology 

A standard operating procedure for an 

enzyme-linked Immunosorbent assay for 

the detection and quantification of the 

B.t. Cry1A.105 protein in soybean tissue 

has been submitted. 

C. Response to Comments 

EPA received one comment that is 

potentially relevant to this petition. The 

commenter generally opposed approval 

of the use of a Monsanto ‘‘B.t. pip,’’ but 

did not specify any particular PIP or any 

particular safety concern. As no specific 

basis for denying the petition was 

provided, the comment is not being 

further considered. 

D. Revisions to Petition for Tolerance 

Monsanto’s petition requested an 

exemption for residues of the B.t. 

Cry1A.105 protein in or on all food and 

feed commodities. However, based on 

the data provided, the Agency can only 

support a safety finding for residues in 

or on soybean at this time. Currently, 

the Agency does not have adequate 

information for a full range of crops for 

an exemption for the B.t. Cry1A.105 

protein in or on all food and feed 

commodities. 

VIII. Conclusions 

There is a reasonable certainty that no 

harm will result from aggregate 

exposure to the U.S. population, 

including infants and children, to 

residues of the B.t. Cry1A.105 protein in 

all food and feed commodities of 

soybean. 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 in 

this unit, 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 the B.t. 

Cry1A.105 protein in or on soybean 

when the protein is used as a PIP in 

soybean. In addition, the Agency is 

removing the existing paragraph (b) 

contained in section 174.502 because 

that tolerance has expired. 

IX. References 

1. U.S. EPA. 2014a. Review of Product 

Characterization and Human Health Data 

for Plant-Incorporated Protectant 

Bacillus thuringiensis (Bt) Cry2Ab2 and 

Cry1A.105 Insect Control Protein and the 

Genetic Material Necessary for Its 

Production in MON 87751 and the 

Combined-Trait Insect Protected 

Soybeans in Support for an Experimental 

Use Permit, Sec. 3 Registration and 

Exemptions from the Requirement of a 

Tolerance. Memorandum from J. Facey, 

Ph.D. through J. Kough, Ph.D. to K. 

Haymes, Ph.D., dated December 23, 

2014. 

2. U.S. EPA. 2014b. Environmental Risk 

Assessment for the FIFRA Section 3 Seed 

Increase Registration of the PlantIncorporated Protectant (PIP), Bacillus 

thuringiensis (Bt) Cry1A.105 and 

Cry2Ab2 Insect Control Proteins and the 

Genetic Material (PV–GMIR13196) 

Necessary for Their Production in Event 

MON 87751 Soybean. Memorandum 

from I. You, Ph.D. through S. Borges to 

K. Haymes, Ph.D., dated December 16, 

2014. 

X. Statutory and Executive Order 

Reviews 

This action establishes an 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). 

XI. 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. 


tkelley on DSK3SPTVN1PROD with RULES
25950 Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 

Dated: April 22, 2015. 

Jack Housenger, 

Director, 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: 7 U.S.C. 136–136y; 21 U.S.C. 

346a and 371. 

■ 2. In § 174.502, revise paragraph (b) to 

read as follows: 

§ 174.502 Bacillus thuringiensis Cry1A.105 

protein; exemption from the requirement of 

a tolerance. 

* * * * * 

(b) Residues of Bacillus thuringiensis 

Cry1A.105 protein in or on soybean are 

exempt from the requirement of a 

tolerance when used as a plantincorporated protectant in the food and 

feed commodities of soybean. 

[FR Doc. 2015–10624 Filed 5–5–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0353; FRL–9924–81] 

1-Octanol; 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 biochemical 

pesticide 1-octanol in or on root and 

tuber vegetables. D–I–1–4, Inc., a 

division of 1,4-Group, Inc., submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting an amendment to the 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 1- 

octanol in or on root and tuber 

vegetables. 

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–2014–0353, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Robert McNally, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

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

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. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2014–0353 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– 

2014–0353, 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 Findings 

In the Federal Register of August 1, 

2014 (79 FR 44729) (FRL–9911–67), 

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 3F8195) 

by D–I–1–4, Inc., a division of 1,4- 

Group, Inc. (the Petitioner), P.O. Box 

860, Meridian, ID 83360. The petition 

requested that 40 CFR part 180 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of 1-octanol, applied postharvest to stored potatoes and other 

sprouting root and tuber crops. That 

document referenced a summary of the 


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