81_FR_3013 81 FR 3001 - VNT1 Protein in Potato; Amendment to a Temporary Exemption From the Requirement of a Tolerance

81 FR 3001 - VNT1 Protein in Potato; Amendment to a Temporary Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 12 (January 20, 2016)

Page Range3001-3003
FR Document2016-00419

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).

Federal Register, Volume 81 Issue 12 (Wednesday, January 20, 2016)
[Federal Register Volume 81, Number 12 (Wednesday, January 20, 2016)]
[Rules and Regulations]
[Pages 3001-3003]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-00419]


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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

[[Page 3002]]

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: [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 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

[[Page 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]

0
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.


0
2. Section 174.534 is revised to read as follows:


Sec.  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



                                                                 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]

                                                                                                                                                                   Designation a                                Classification
                                                                              Designated area
                                                                                                                                                        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 Kern-
                                                        Los 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, north-
                                                        east, and northwest along the boundary of the Ran-
                                                        cho 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 north-
                                                        west corner of S. 35, T. 31 S., R. 30 E.; then north-
                                                        east 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 com-
                                                        mon 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,   Serious.
                                                                                                                                                                                                           2016.
                                                  Madera County .......................................................................                                   Nonattainment ..........       February   19,   Serious.
                                                                                                                                                                                                           2016.
                                                  Merced County ........................................................................                                  Nonattainment ..........       February   19,   Serious.
                                                                                                                                                                                                           2016.
                                                  San Joaquin County ...............................................................                                      Nonattainment ..........       February   19,   Serious.
                                                                                                                                                                                                           2016.
                                                  Stanislaus County ...................................................................                                   Nonattainment ..........       February   19,   Serious.
                                                                                                                                                                                                           2016.
                                                  Tulare County .........................................................................                                 Nonattainment ..........       February   19,   Serious.
                                                                                                                                                                                                           2016.

                                                         *                             *                             *                             *                        *                        *                       *



                                             *      *        *         *        *                                 SUMMARY:   This regulation establishes a                         DATES:  This regulation is effective
                                             [FR Doc. 2016–00739 Filed 1–19–16; 8:45 am]                          temporary exemption from the                                     January 20, 2016. Objections and
                                             BILLING CODE 6560–50–P                                               requirement of a tolerance for residues                          requests for hearings must be received
                                                                                                                  of the VNT1 protein in or on potatoes                            on or before March 21, 2016, and must
                                                                                                                  when used as a plant-incorporated                                be filed in accordance with the
                                             ENVIRONMENTAL PROTECTION                                             protectant in accordance with the terms                          instructions provided in 40 CFR part
                                             AGENCY                                                               of Experimental Use Permit (EUP)                                 178 (see also Unit I.C. of the
                                                                                                                  (8917–EUP–2). J.R. Simplot Company                               SUPPLEMENTARY INFORMATION).
                                             40 CFR Part 174
                                                                                                                  submitted a petition to EPA under the                            ADDRESSES:   The docket for this action,
                                                                                                                  Federal Food, Drug, and Cosmetic Act                             identified by docket identification (ID)
                                             [EPA–HQ–OPP–2014–0457; FRL–9939–49]
                                                                                                                  (FFDCA), requesting an amendment of                              number EPA–HQ–OPP–2014–0457, is
                                             VNT1 Protein in Potato; Amendment to                                 the temporary tolerance exemption.                               available at http://www.regulations.gov
                                                                                                                  This regulation eliminates the need to                           or at the Office of Pesticide Programs
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                                             a Temporary Exemption From the
                                             Requirement of a Tolerance                                           establish a maximum permissible level                            Regulatory Public Docket (OPP Docket)
                                                                                                                  for residues of VNT1 protein in potato.                          in the Environmental Protection Agency
                                             AGENCY: Environmental Protection                                     The temporary tolerance exemption                                Docket Center (EPA/DC), West William
                                             Agency (EPA).                                                        expires on April 1, 2017, concurrent                             Jefferson Clinton Bldg., Rm. 3334, 1301
                                                                                                                  with the EUP (8917–EUP–2).                                       Constitution Ave. NW., Washington, DC
                                             ACTION:    Final rule.
                                                                                                                                                                                   20460–0001. The Public Reading Room


                                        VerDate Sep<11>2014      16:38 Jan 19, 2016        Jkt 238001     PO 00000       Frm 00035      Fmt 4700       Sfmt 4700   E:\FR\FM\20JAR1.SGM    20JAR1


                                             3002             Federal Register / Vol. 81, No. 12 / Wednesday, January 20, 2016 / Rules and Regulations

                                             is open from 8:30 a.m. to 4:30 p.m.,                    mail and hand delivery of objections                   accordance with the terms of EUP 8917–
                                             Monday through Friday, excluding legal                  and hearing requests are provided in 40                EUP–2, with an expiration date of
                                             holidays. The telephone number for the                  CFR 178.25(b).                                         December 31, 2015, in the Federal
                                             Public Reading Room is (202) 566–1744,                    In addition to filing an objection or                Register of February 23, 2015 (80 FR
                                             and the telephone number for the OPP                    hearing request with the Hearing Clerk                 9387) (FRL–9922–53).
                                             Docket is (703) 305–5805. Please review                 as described in 40 CFR part 178, please                   In the Federal Register of September
                                             the visitor instructions and additional                 submit a copy of the filing (excluding                 9, 2015 (80 FR 54257) (FRL–9933–26)
                                             information about the docket available                  any Confidential Business Information                  EPA issued a document pursuant to
                                             at http://www2.epa.gov/dockets.                         (CBI)) for inclusion in the public docket.             FFDCA section 408(d)(3), 21 U.S.C.
                                             FOR FURTHER INFORMATION CONTACT:                        Information not marked confidential                    346a(d)(3), announcing the filing of a
                                             Robert McNally, Biopesticides and                       pursuant to 40 CFR part 2 may be                       pesticide petition ((PP) 5G8375) by J.R.
                                             Pollution Prevention Division (7511P),                  disclosed publicly by EPA without prior                Simplot Company, 5369 W. Irving St.,
                                             Office of Pesticide Programs,                           notice. Submit the non-CBI copy of your                Boise, ID 83706. The petition requested
                                             Environmental Protection Agency, 1200                   objection or hearing request, identified               that 40 CFR 174.534 be amended. That
                                             Pennsylvania Ave. NW., Washington,                      by docket ID number EPA–HQ–OPP–                        document referenced a summary of the
                                             DC 20460–0001; main telephone                           2014–0457, by one of the following                     petition prepared by the petitioner J.R.
                                             number: (703) 305–7090; email address:                  methods:                                               Simplot Company, which is available in
                                                                                                       • Federal eRulemaking Portal: http://                the docket EPA–HQ–OPP–2014–0457,
                                             BPPDFRNotices@epa.gov.
                                                                                                     www.regulations.gov. Follow the online                 http://www.regulations.gov. No
                                             SUPPLEMENTARY INFORMATION:                              instructions for submitting comments.                  comments were received on this FR
                                             I. General Information                                  Do not submit electronically any                       notice.
                                                                                                     information you consider to be CBI or                     Because the pesticide petition ((PP)
                                             A. Does this action apply to me?                        other information whose disclosure is                  5G8375) was submitted concurrently
                                                You may be potentially affected by                   restricted by statute.                                 with a request to amend the EUP linked
                                             this action if you are an agricultural                    • Mail: OPP Docket, Environmental                    to this tolerance exemption, EPA only
                                             producer, food manufacturer, or                         Protection Agency Docket Center (EPA/                  considered amendments to the tolerance
                                             pesticide manufacturer. The following                   DC), (28221T), 1200 Pennsylvania Ave.                  exemption relevant to the pending
                                             list of North American Industrial                       NW., Washington, DC 20460–0001.                        request to extend the associated EUP.
                                             Classification System (NAICS) codes is                    • Hand Delivery: To make special                     The request to amend the EUP involved
                                             not intended to be exhaustive, but rather               arrangements for hand delivery or                      increased acreage, locations and
                                             provides a guide to help readers                        delivery of boxed information, please                  extending the expiration date of EUP
                                             determine whether this document                         follow the instructions at http://                     No. 8917–EUP–2 to April 1, 2017.
                                             applies to them. Potentially affected                   www.epa.gov/dockets/contacts.html.                     Because EPA is extending the EUP until
                                             entities may include:                                     Additional instructions on                           April 1, 2017, EPA is revising the
                                                • Crop production (NAICS code 111).                  commenting or visiting the docket,                     expiration date of the existing tolerance
                                                • Animal production (NAICS code                      along with more information about                      exemption to April 1, 2017.
                                             112).                                                   dockets generally, is available at http://                Section 408(c)(2)(A)(i) of FFDCA
                                                • Food manufacturing (NAICS code                     www2.epa.gov/dockets.                                  allows EPA to establish an exemption
                                             311).                                                                                                          from the requirement for a tolerance (the
                                                                                                     II. Background and Statutory Findings
                                                • Pesticide manufacturing (NAICS                                                                            legal limit for a pesticide chemical
                                             code 32532).                                               In the Federal Register of October 24,              residue in or on a food) only if EPA
                                                                                                     2014 (79 FR 63594) (FRL–9916–03),                      determines that the exemption is ‘‘safe.’’
                                             B. How can I get electronic access to                   EPA issued a document pursuant to                      Section 408(c)(2)(A)(ii) of FFDCA
                                             other related information?                              FFDCA section 408(d)(3), 21 U.S.C.                     defines ‘‘safe ’’ to mean that ‘‘there is a
                                               You may access a frequently updated                   346a(d)(3), announcing the filing of a                 reasonable certainty that no harm will
                                             electronic version of 40 CFR part 180                   pesticide petition ((PP) 4F8251) by J.R.               result from aggregate exposure to the
                                             through the Government Printing                         Simplot Company, 5369 W. Irving St.,                   pesticide chemical residue, including
                                             Office’s e-CFR site at http://                          Boise, ID 83706. Also, in the Federal                  all anticipated dietary exposures and all
                                             www.ecfr.gov/cgi-bin/text-idx?tpl=/                     Register of December 17, 2014 (79 FR                   other exposures for which there is
                                             ecfrbrowse/Title40/40tab_02.tpl.                        75107) (FRL–9918–90), EPA                              reliable information.’’ This includes
                                                                                                     inadvertently re-announced the filing of               exposure through drinking water and in
                                             C. How can I file an objection or hearing               this same petition. The petition                       residential settings, but does not include
                                             request?                                                requested that 40 CFR part 174 be                      occupational exposure. Pursuant to
                                               Under FFDCA section 408(g), 21                        amended by establishing a temporary                    FFDCA section 408(c)(2)(B), in
                                             U.S.C. 346a, any person may file an                     exemption from the requirement of a                    establishing or maintaining in effect an
                                             objection to any aspect of this regulation              tolerance for residues of Potato Late                  exemption from the requirement of a
                                             and may also request a hearing on those                 Blight Resistance protein VNT1 in or on                tolerance, EPA must take into account
                                             objections. You must file your objection                potato. Those documents referenced a                   the factors set forth in FFDCA section
                                             or request a hearing on this regulation                 summary of the petition prepared by the                408(b)(2)(C), which require EPA to give
                                             in accordance with the instructions                     petitioner J.R. Simplot Company, which                 special consideration to exposure of
                                             provided in 40 CFR part 178. To ensure                  is available in the docket EPA–HQ–                     infants and children to the pesticide
                                             proper receipt by EPA, you must                         OPP–2014–0457, http://                                 chemical residue in establishing a
                                             identify docket ID number EPA–HQ–                       www.regulations.gov. Upon determining                  tolerance and to ‘‘ensure that there is a
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                                             OPP–2014–0457 in the subject line on                    that such exemption meets the FFDCA                    reasonable certainty that no harm will
                                             the first page of your submission. All                  safety standard, EPA established a                     result to infants and children from
                                             objections and requests for a hearing                   temporary exemption from the                           aggregate exposure to the pesticide
                                             must be in writing, and must be                         requirement of a tolerance for residues                chemical residue. . . .’’ Additionally,
                                             received by the Hearing Clerk on or                     of Potato Late Blight Resistance protein               FFDCA section 408(b)(2)(D) requires
                                             before March 21, 2016. Addresses for                    VNT1 in or on potato when used in                      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                   concurrent EUP for VNT1 protein                        to this action. In addition, this action
                                             effects of a particular pesticide’s                     (8917–EUP–2).                                          does not impose any enforceable duty or
                                             residues’’ and ‘‘other substances that                                                                         contain any unfunded mandate as
                                                                                                     VI. Statutory and Executive Order
                                             have a common mechanism of toxicity.’’                                                                         described under Title II of the Unfunded
                                                                                                     Reviews
                                                EPA performs a number of analyses to                                                                        Mandates Reform Act (UMRA) (2 U.S.C.
                                             determine the risks from aggregate                         This action amends an exemption                     1501 et seq.).
                                             exposure to pesticide residues. First,                  from the requirement of a tolerance
                                                                                                     under FFDCA section 408(d) in                            This action does not involve any
                                             EPA determines the toxicity of                                                                                 technical standards that would require
                                             pesticides. Second, EPA examines                        response to a petition submitted to the
                                                                                                     Agency. The Office of Management and                   Agency consideration of voluntary
                                             exposure to the pesticide through food,                                                                        consensus standards pursuant to section
                                             drinking water, and through other                       Budget (OMB) has exempted these types
                                                                                                     of actions from review under Executive                 12(d) of the National Technology
                                             exposures that occur as a result of                                                                            Transfer and Advancement Act
                                             pesticide use in residential settings.                  Order 12866, entitled ‘‘Regulatory
                                                                                                     Planning and Review’’ (58 FR 51735,                    (NTTAA) (15 U.S.C. 272 note).
                                             III. Determination of Safety for U.S.                   October 4, 1993). Because this action                  VII. Congressional Review Act
                                             Population, Infants and Children                        has been exempted from review under
                                                                                                     Executive Order 12866, this action is                    Pursuant to the Congressional Review
                                                The Agency previously assessed the
                                                                                                     not subject to Executive Order 13211,                  Act (5 U.S.C. 801 et seq.), EPA will
                                             toxicological profile of the VNT1
                                                                                                     entitled ‘‘Actions Concerning                          submit a report containing this rule and
                                             protein and the likely exposure from its
                                                                                                     Regulations That Significantly Affect                  other required information to the U.S.
                                             use as a plant-incorporated protectant in
                                                                                                     Energy Supply, Distribution, or Use’’ (66              Senate, the U.S. House of
                                             or on potato in accordance with the
                                                                                                     FR 28355, May 22, 2001) or Executive                   Representatives, and the Comptroller
                                             terms of EUP No. 8917–EUP–2. Based                      Order 13045, entitled ‘‘Protection of
                                             on the Agency’s assessment, the Agency                                                                         General of the United States prior to
                                                                                                     Children from Environmental Health                     publication of the rule in the Federal
                                             concluded that there is a reasonable                    Risks and Safety Risks’’ (62 FR 19885,
                                             certainty that no harm will result from                                                                        Register. This action is not a ‘‘major
                                                                                                     April 23, 1997). This action does not                  rule’’ as defined by 5 U.S.C. 804(2).
                                             aggregate exposure to VNT1 protein                      contain any information collections
                                             when used as a plant-incorporated                       subject to OMB approval under the                      List of Subjects in 40 CFR Part 174
                                             protectant in or on potato in accordance                Paperwork Reduction Act (PRA) (44
                                             with the terms of EUP No. 8917–EUP–                     U.S.C. 3501 et seq.), nor does it require                Environmental protection,
                                             2. See (80 FR 9387) (February 23, 2015).                any special considerations under                       Administrative practice and procedure,
                                             Because the toxicological profile has not               Executive Order 12898, entitled                        Agricultural commodities, Pesticides
                                             changed, any additional exposure to the                 ‘‘Federal Actions to Address                           and pests, Reporting and recordkeeping
                                             VNT1 protein as a result of the                         Environmental Justice in Minority                      requirements.
                                             extension of the associated EUP will not                Populations and Low-Income                               Dated: December 17, 2015.
                                             affect the Agency’s previous safety                     Populations’’ (59 FR 7629, February 16,                John E. Leahy, Jr.,
                                             finding. Therefore, the Agency is relying               1994).
                                             on its previous assessment to support                                                                          Acting Director, Biopesticides and Pollution
                                                                                                        Since tolerances and exemptions that                Prevention Division, Office of Pesticide
                                             the extension of the expiration date for                are amended on the basis of a petition                 Programs.
                                             40 CFR 174.534. Therefore, based on its                 under FFDCA section 408(d), such as
                                             previous assessment, EPA concludes                      the exemption in this final rule, do not                 Therefore, 40 CFR chapter I is
                                             that there is a reasonable certainty that               require the issuance of a proposed rule,               amended as follows:
                                             no harm will result to the U.S.                         the requirements of the Regulatory
                                             population, including infants and                       Flexibility Act (RFA) (5 U.S.C. 601 et                 PART 174—[AMENDED]
                                             children, from aggregate exposure to the                seq.), do not apply.
                                             residues of VNT1 protein in potato                         This action directly regulates growers,             ■  1. The authority citation for part 174
                                             when it is used as a plant-incorporated                 food processors, food handlers, and food               is revised to read as follows:
                                             protectant. Such exposure includes all                  retailers, not States or tribes, nor does
                                             anticipated dietary exposures and all                   this action alter the relationships or                   Authority: 7 U.S.C. 136–136y; 21 U.S.C.
                                             other exposures for which there is                      distribution of power and                              321(q), 346a and 371.
                                             reliable information.                                   responsibilities established by Congress
                                                                                                                                                            ■ 2. Section 174.534 is revised to read
                                                                                                     in the preemption provisions of FFDCA
                                             IV. Analytical Enforcement                                                                                     as follows:
                                                                                                     section 408(n)(4). As such, the Agency
                                             Methodology
                                                                                                     has determined that this action will not               § 174.534 VNT1 protein in potato;
                                                The Agency has determined that an                    have a substantial direct effect on States             temporary exemption from the requirement
                                             analytical method is not required for                   or tribal governments, on the                          of a tolerance.
                                             enforcement purposes since the Agency                   relationship between the national
                                             is establishing a temporary exemption                   government and the States or tribal                      Residues of VNT1 protein in potato
                                             from the requirement of a tolerance                     governments, or on the distribution of                 are exempt from the requirement of a
                                             without any numerical limitation in                     power and responsibilities among the                   tolerance when the Rpi-vnt1 gene that
                                             association with use under EUP No.                      various levels of government or between                expresses the VNT1 protein is used as
                                             8917–EUP–2.                                             the Federal Government and Indian                      a plant-incorporated protectant in
                                                                                                     tribes. Thus, the Agency has determined                potato in accordance with the terms of
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                                             V. Conclusion                                                                                                  Experimental Use Permit No. 8917–
                                                                                                     that Executive Order 13132, entitled
                                               The Agency is extending the                           ‘‘Federalism’’ (64 FR 43255, August 10,                EUP–2. This temporary exemption from
                                             expiration date of this temporary                       1999) and Executive Order 13175,                       the requirement of a tolerance expires
                                             tolerance exemption to April 1, 2017.                   entitled ‘‘Consultation and Coordination               on April 1, 2017.
                                             The temporary tolerance exemption will                  with Indian Tribal Governments’’ (65 FR                [FR Doc. 2016–00419 Filed 1–19–16; 8:45 am]
                                             expire on the same date as the                          67249, November 9, 2000) do not apply                  BILLING CODE 6560–50–P




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Document Created: 2016-01-19 23:43:40
Document Modified: 2016-01-19 23:43:40
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 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).
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 number: (703) 305-7090; email
FR Citation81 FR 3001 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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