Federal Register / Vol. 81, No. 12 / Wednesday, January 20, 2016 / Rules and Regulations 3001 

CALIFORNIA—2006 24-HOUR PM2.5 NAAQS—Continued 

[Primary and secondary] 

Designated area 

Designation a Classification 

Date 1 Type Date 2 Type 

That portion of Kern County which lies west and north 

of a line described as follows: Beginning at the KernLos Angeles County boundary and running north and 

east along the northwest boundary of the Rancho La 

Libre Land Grant to the point of intersection with the 

range line common to R. 16 W. and R. 17 W., San 

Bernardino Base and Meridian; north along the range 

line to the point of intersection with the Rancho El 

Tejon Land Grant boundary; then southeast, northeast, and northwest along the boundary of the Rancho El Tejon Land Grant to the northwest corner of S. 

3, T. 11 N., R. 17 W.; then west 1.2 miles; then north 

to the Rancho El Tejon Land Grant boundary; then 

northwest along the Rancho El Tejon line to the 

southeast corner of S. 34, T. 32 S., R. 30 E., Mount 

Diablo Base and Meridian; then north to the northwest corner of S. 35, T. 31 S., R. 30 E.; then northeast along the boundary of the Rancho El Tejon Land 

Grant to the southwest corner of S. 18, T. 31 S., R. 

31 E.; then east to the southeast corner of S. 13, T. 

31 S., R. 31 E.; then north along the range line common to R. 31 E. and R. 32 E., Mount Diablo Base 

and Meridian, to the northwest corner of S. 6, T. 29 

S., R. 32 E.; then east to the southwest corner of S. 

31, T. 28 S., R. 32 E.; then north along the range line 

common to R. 31 E. and R. 32 E. to the northwest 

corner of S. 6, T. 28 S., R. 32 E., then west to the 

southeast corner of S. 36, T. 27 S., R. 31 E., then 

north along the range line common to R. 31 E. and 

R. 32 E. to the Kern-Tulare County boundary.

Kings County ........................................................................... Nonattainment .......... February 19, 

2016.

Serious. 

Madera County ....................................................................... Nonattainment .......... February 19, 

2016.

Serious. 

Merced County ........................................................................ Nonattainment .......... February 19, 

2016.

Serious. 

San Joaquin County ............................................................... Nonattainment .......... February 19, 

2016.

Serious. 

Stanislaus County ................................................................... Nonattainment .......... February 19, 

2016.

Serious. 

Tulare County ......................................................................... Nonattainment .......... February 19, 

2016.

Serious. 

* * * * * * * 

* * * * * 

[FR Doc. 2016–00739 Filed 1–19–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 174 

[EPA–HQ–OPP–2014–0457; FRL–9939–49] 

VNT1 Protein in Potato; Amendment to 

a Temporary Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

temporary exemption from the 

requirement of a tolerance for residues 

of the VNT1 protein in or on potatoes 

when used as a plant-incorporated 

protectant in accordance with the terms 

of Experimental Use Permit (EUP) 

(8917–EUP–2). J.R. Simplot Company 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an amendment of 

the temporary tolerance exemption. 

This regulation eliminates the need to 

establish a maximum permissible level 

for residues of VNT1 protein in potato. 

The temporary tolerance exemption 

expires on April 1, 2017, concurrent 

with the EUP (8917–EUP–2). 

DATES: This regulation is effective 

January 20, 2016. Objections and 

requests for hearings must be received 

on or before March 21, 2016, 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–2014–0457, 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 


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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://www2.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 Printing 

Office’s e-CFR site at http://

www.ecfr.gov/cgi-bin/text-idx?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–2014–0457 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 March 21, 2016. 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– 

2014–0457, 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:// 

www2.epa.gov/dockets. 

II. Background and Statutory Findings 

In the Federal Register of October 24, 

2014 (79 FR 63594) (FRL–9916–03), 

EPA issued a document pursuant to 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition ((PP) 4F8251) by J.R. 

Simplot Company, 5369 W. Irving St., 

Boise, ID 83706. Also, in the Federal 

Register of December 17, 2014 (79 FR 

75107) (FRL–9918–90), EPA 

inadvertently re-announced the filing of 

this same petition. The petition 

requested that 40 CFR part 174 be 

amended by establishing a temporary 

exemption from the requirement of a 

tolerance for residues of Potato Late 

Blight Resistance protein VNT1 in or on 

potato. Those documents referenced a 

summary of the petition prepared by the 

petitioner J.R. Simplot Company, which 

is available in the docket EPA–HQ– 

OPP–2014–0457, http://

www.regulations.gov. Upon determining 

that such exemption meets the FFDCA 

safety standard, EPA established a 

temporary exemption from the 

requirement of a tolerance for residues 

of Potato Late Blight Resistance protein 

VNT1 in or on potato when used in 

accordance with the terms of EUP 8917– 

EUP–2, with an expiration date of 

December 31, 2015, in the Federal 

Register of February 23, 2015 (80 FR 

9387) (FRL–9922–53). 

In the Federal Register of September 

9, 2015 (80 FR 54257) (FRL–9933–26) 

EPA issued a document pursuant to 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition ((PP) 5G8375) by J.R. 

Simplot Company, 5369 W. Irving St., 

Boise, ID 83706. The petition requested 

that 40 CFR 174.534 be amended. That 

document referenced a summary of the 

petition prepared by the petitioner J.R. 

Simplot Company, which is available in 

the docket EPA–HQ–OPP–2014–0457, 

http://www.regulations.gov. No 

comments were received on this FR 

notice. 

Because the pesticide petition ((PP) 

5G8375) was submitted concurrently 

with a request to amend the EUP linked 

to this tolerance exemption, EPA only 

considered amendments to the tolerance 

exemption relevant to the pending 

request to extend the associated EUP. 

The request to amend the EUP involved 

increased acreage, locations and 

extending the expiration date of EUP 

No. 8917–EUP–2 to April 1, 2017. 

Because EPA is extending the EUP until 

April 1, 2017, EPA is revising the 

expiration date of the existing tolerance 

exemption to April 1, 2017. 

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 


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Federal Register / Vol. 81, No. 12 / Wednesday, January 20, 2016 / Rules and Regulations 3003 

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. Determination of Safety for U.S. 

Population, Infants and Children 

The Agency previously assessed the 

toxicological profile of the VNT1 

protein and the likely exposure from its 

use as a plant-incorporated protectant in 

or on potato in accordance with the 

terms of EUP No. 8917–EUP–2. Based 

on the Agency’s assessment, the Agency 

concluded that there is a reasonable 

certainty that no harm will result from 

aggregate exposure to VNT1 protein 

when used as a plant-incorporated 

protectant in or on potato in accordance 

with the terms of EUP No. 8917–EUP– 

2. See (80 FR 9387) (February 23, 2015). 

Because the toxicological profile has not 

changed, any additional exposure to the 

VNT1 protein as a result of the 

extension of the associated EUP will not 

affect the Agency’s previous safety 

finding. Therefore, the Agency is relying 

on its previous assessment to support 

the extension of the expiration date for 

40 CFR 174.534. Therefore, based on its 

previous assessment, 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 VNT1 protein in potato 

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. 

IV. Analytical Enforcement 

Methodology 

The Agency has determined that an 

analytical method is not required for 

enforcement purposes since the Agency 

is establishing a temporary exemption 

from the requirement of a tolerance 

without any numerical limitation in 

association with use under EUP No. 

8917–EUP–2. 

V. Conclusion 

The Agency is extending the 

expiration date of this temporary 

tolerance exemption to April 1, 2017. 

The temporary tolerance exemption will 

expire on the same date as the 

concurrent EUP for VNT1 protein 

(8917–EUP–2). 

VI. Statutory and Executive Order 

Reviews 

This action amends 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 amended 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). 

VII. 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: December 17, 2015. 

John E. Leahy, Jr., 

Acting 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 

is revised to read as follows: 

Authority: 7 U.S.C. 136–136y; 21 U.S.C. 

321(q), 346a and 371. 

■ 2. Section 174.534 is revised to read 

as follows: 

§ 174.534 VNT1 protein in potato; 

temporary exemption from the requirement 

of a tolerance. 

Residues of VNT1 protein in potato 

are exempt from the requirement of a 

tolerance when the Rpi-vnt1 gene that 

expresses the VNT1 protein is used as 

a plant-incorporated protectant in 

potato in accordance with the terms of 

Experimental Use Permit No. 8917– 

EUP–2. This temporary exemption from 

the requirement of a tolerance expires 

on April 1, 2017. 

[FR Doc. 2016–00419 Filed 1–19–16; 8:45 am] 

BILLING CODE 6560–50–P 


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