82_FR_11549 82 FR 11513 - VNT1 Protein in Potato; Exemption From the Requirement of a Tolerance

82 FR 11513 - VNT1 Protein in Potato; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 36 (February 24, 2017)

Page Range11513-11515
FR Document2017-03580

This regulation establishes an exemption from the requirement of a tolerance for residues of VNT1 protein in potato when used as a plant-incorporated protectant. J.R. Simplot Company submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting a permanent exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of VNT1 protein in potato under FFDCA.

Federal Register, Volume 82 Issue 36 (Friday, February 24, 2017)
[Federal Register Volume 82, Number 36 (Friday, February 24, 2017)]
[Rules and Regulations]
[Pages 11513-11515]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-03580]


=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2014-0457; FRL-9957-97]


VNT1 Protein in Potato; 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 VNT1 protein in potato when used as a 
plant-incorporated protectant. J.R. Simplot Company submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
requesting a permanent exemption from the requirement of a tolerance. 
This regulation eliminates the need to establish a maximum permissible 
level for residues of VNT1 protein in potato under FFDCA.

DATES: This regulation is effective February 24, 2017. Objections and 
requests for hearings must be received on or before April 25, 2017 and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also

[[Page 11514]]

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 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: [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?&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-2014-0457 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 
April 25, 2017. 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://www.epa.gov/dockets.

II. Background

    In the Federal Register of April 25, 2016 (81 FR 24047) (FRL-9944-
86), 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 5F8425) by J.R. Simplot Co., 5369 W. Irving St., Boise, ID 
83706. The petition requested that 40 CFR part 174 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of VNT1 protein in potato. That document referenced a summary 
of the petition prepared by the petitioner J.R. Simplot Company, which 
is available in the docket via http://www.regulations.gov. There were 
no comments received in response to the notice of filing.
    EPA previously established a temporary exemption from tolerance for 
VNT1 protein in potato (40 CFR 174.534; 80 FR 9387) in conjunction with 
an Experimental Use Permit (8917-EUP-2) in 2015. This temporary 
exemption was subsequently amended (extended) on December 17, 2015 and 
expires on April 1, 2017.

III. Final Rule

A. EPA's Safety Determination

    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 or tolerance exemption, 
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 EPA consider ``available information concerning the 
cumulative effects of [a particular pesticide's] . . . residues and 
other substances that have a common mechanism of toxicity.''
    EPA evaluated the available toxicity and exposure data on VNT1 
protein and considered its validity, completeness, and reliability, as 
well as the relationship of this information to human risk. A full 
explanation of the data upon which EPA relied and its risk assessment 
based on that data can be found within the December 6, 2016, document 
entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations 
for VNT1 protein.'' This document, as well as other relevant 
information, is available in the docket

[[Page 11515]]

for this action as described under ADDRESSES. Based upon its 
evaluation, 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 residues of VNT1 protein. 
Therefore, an exemption from the requirement of a tolerance is 
established for residues of VNT1 protein in potato when used as a 
plant-incorporated protectant in accordance with the terms of 
registration.

B. Analytical Enforcement Methodology

    EPA has determined that an analytical method is not required for 
enforcement purposes since the Agency is establishing an exemption from 
the requirement of a tolerance without any numerical limitation. 
Nonetheless, an analytical method was provided by J.R. Simplot for the 
detection of VNT1 protein in potato. This method utilizes a 
quantitative polymerase chain reaction (qPCR) to detect the presence of 
the Rpi-vntl gene in pSIM1678 transformed plants (pSIM1678 is the 
transformation vector used by the registrant to incorporate the Rpi-
vntl gene into potato varieties). There are numerous homologs of Rpi-
vnt1 present in potato and tomato varieties and other wild Solanum 
species that may result in non-specific amplification when using 
primers designed to amplify Rpi-vnt1. To distinguish between plants 
that naturally contain homologous sequences and those transformed with 
pSIM1678, a second method amplifies a unique junction between the Rpi-
vnt1 terminator and the AGP promoter present in the pSIM1678 T-DNA. 
This second method is intended to confirm the presence or absence of 
pSIM1678 if there are false positive detection of Rpi-vnt1 homologs.

C. Revisions to Requested Tolerance Exemption

    The current temporary tolerance exemption for VNT1 protein in 
potato (40 CFR 174.534) approved by EPA on December 17, 2015, will be 
changed to a permanent tolerance exemption.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section 
408(d) in response to a petition submitted to EPA. 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 tolerance 
exemption in this action, 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. As a result, this 
action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 EPA's 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).

V. 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: January 18, 2017.
Jack Housenger,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 174--[AMENDED]

0
1. The authority citation for part 174 continues to read as follows:

    Authority: 7. U.S.C. 136-136y; 21 U.S.C. 321(q), 346a and 371.


0
2. Revise Sec.  174.534 to read as follows:


Sec.  174.534   VNT1 protein; 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 express the VNT1 protein is 
used as a plant-incorporated protectant in potato.

[FR Doc. 2017-03580 Filed 2-23-17; 8:45 am]
BILLING CODE 6560-50-P



                                                                      Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations                                                                                    11513

                                                  Virginiamycin grams/ton                            Combination in grams/ton                                Indications for use                          Limitations                          Sponsor

                                             (ix) 20 .......................................     Semduramicin, 22.7 ................                  Broiler chickens: For preven-       Feed continuously as the sole                         066104
                                                                                                                                                        tion of necrotic enteritis          ration. Do not feed to laying
                                                                                                                                                        caused by Clostridium spp.          hens. Semduramicin as pro-
                                                                                                                                                        susceptible to virginiamycin;       vided by No. 066104 in
                                                                                                                                                        for the prevention of coccidi-      § 510.600(c) of this chapter.
                                                                                                                                                        osis caused by Eimeria
                                                                                                                                                        acervulina, E. brunetti, E.
                                                                                                                                                        maxima, E mivati/mitis, E.
                                                                                                                                                        necatrix, and E. tenella.
                                             (x) 20 ........................................     Semduramicin (biomass), 22.7                         Broiler chickens: For preven-       Feed continuously as the sole                         066104
                                                                                                                                                        tion of necrotic enteritis          ration. Withdraw 1 day be-
                                                                                                                                                        caused by Clostridium spp.          fore slaughter. Do not feed
                                                                                                                                                        susceptible to virginiamycin;       to laying hens.
                                                                                                                                                        for the prevention of coccidi-      Semduramicin as provided
                                                                                                                                                        osis caused by Eimeria              by No. 066104 in
                                                                                                                                                        acervulina, E. brunetti, E.         § 510.600(c) of this chapter.
                                                                                                                                                        maxima, E mivati/mitis, E.
                                                                                                                                                        necatrix, and E. tenella.



                                                (2) Swine—

                                                  Virginiamycin grams/ton                            Combination in grams/ton                                Indications for use                          Limitations                          Sponsor

                                             (i) 25 .........................................    ..................................................   Growing-finishing swine: As an      ..................................................    066104
                                                                                                                                                        aid in control of dysentery in
                                                                                                                                                        swine up to 120 pounds in
                                                                                                                                                        animals or on premises with
                                                                                                                                                        a history of swine dysentery
                                                                                                                                                        but where symptoms have
                                                                                                                                                        not yet occurred.
                                             (ii) 50 or 100 .............................        ..................................................   Growing-finishing swine: For        Feed 100 grams per ton for 2                          066104
                                                                                                                                                        treatment and control of            weeks, 50 grams per ton
                                                                                                                                                        swine dysentery in swine up         thereafter.
                                                                                                                                                        to 120 pounds.
                                             (iii) 100 .....................................     ..................................................   Growing-finishing swine: For        Feed for 2 weeks ....................                 066104
                                                                                                                                                        treatment of swine dys-
                                                                                                                                                        entery in nonbreeding swine
                                                                                                                                                        over 120 pounds.



                                                (3) Cattle—

                                                  Virginiamycin grams/ton                            Combination in grams/ton                                Indications for use                          Limitations                          Sponsor

                                             (i) 13.5 to 16.0 ..........................         ..................................................   Cattle fed in confinement for       Feed continuously as the sole                         066104
                                                                                                                                                        slaughter: For reduction of         ration to provide 85 to 240
                                                                                                                                                        incidence of liver abscesses.       milligrams per head per day.
                                                                                                                                                                                            Not for use in animals in-
                                                                                                                                                                                            tended for breeding.
                                             (ii) [Reserved]



                                               Dated: February 17, 2017.                                                 ENVIRONMENTAL PROTECTION                                        incorporated protectant. J.R. Simplot
                                             Leslie Kux,                                                                 AGENCY                                                          Company submitted a petition to EPA
                                             Associate Commissioner for Policy.                                                                                                          under the Federal Food, Drug, and
                                                                                                                         40 CFR Part 174                                                 Cosmetic Act (FFDCA), requesting a
                                             [FR Doc. 2017–03596 Filed 2–23–17; 8:45 am]
                                                                                                                         [EPA–HQ–OPP–2014–0457; FRL–9957–97]                             permanent exemption from the
                                             BILLING CODE 4164–01–P
                                                                                                                                                                                         requirement of a tolerance. This
                                                                                                                         VNT1 Protein in Potato; Exemption                               regulation eliminates the need to
                                                                                                                         From the Requirement of a Tolerance                             establish a maximum permissible level
                                                                                                                                                                                         for residues of VNT1 protein in potato
                                                                                                                         AGENCY:  Environmental Protection
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                                                                                                                                                                                         under FFDCA.
                                                                                                                         Agency (EPA).
                                                                                                                         ACTION: Final rule.                                             DATES:  This regulation is effective
                                                                                                                                                                                         February 24, 2017. Objections and
                                                                                                                         SUMMARY:   This regulation establishes an                       requests for hearings must be received
                                                                                                                         exemption from the requirement of a                             on or before April 25, 2017 and must be
                                                                                                                         tolerance for residues of VNT1 protein                          filed in accordance with the instructions
                                                                                                                         in potato when used as a plant-                                 provided in 40 CFR part 178 (see also


                                        VerDate Sep<11>2014         14:13 Feb 23, 2017          Jkt 241001      PO 00000         Frm 00013        Fmt 4700   Sfmt 4700   E:\FR\FM\24FER1.SGM      24FER1


                                             11514             Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations

                                             Unit I.C. of the SUPPLEMENTARY                          objection to any aspect of this regulation            the docket via http://
                                             INFORMATION).                                           and may also request a hearing on those               www.regulations.gov. There were no
                                             ADDRESSES: The docket for this action,                  objections. You must file your objection              comments received in response to the
                                             identified by docket identification (ID)                or request a hearing on this regulation               notice of filing.
                                             number EPA–HQ–OPP–2014–0457, is                         in accordance with the instructions                     EPA previously established a
                                             available at http://www.regulations.gov                 provided in 40 CFR part 178. To ensure                temporary exemption from tolerance for
                                             or at the Office of Pesticide Programs                  proper receipt by EPA, you must                       VNT1 protein in potato (40 CFR
                                             Regulatory Public Docket (OPP Docket)                   identify docket ID number EPA–HQ–                     174.534; 80 FR 9387) in conjunction
                                             in the Environmental Protection Agency                  OPP–2014–0457 in the subject line on                  with an Experimental Use Permit (8917–
                                             Docket Center (EPA/DC), West William                    the first page of your submission. All                EUP–2) in 2015. This temporary
                                             Jefferson Clinton Bldg., Rm. 3334, 1301                 objections and requests for a hearing                 exemption was subsequently amended
                                             Constitution Ave. NW., Washington, DC                   must be in writing, and must be                       (extended) on December 17, 2015 and
                                             20460–0001. The Public Reading Room                     received by the Hearing Clerk on or                   expires on April 1, 2017.
                                                                                                     before April 25, 2017. Addresses for
                                             is open from 8:30 a.m. to 4:30 p.m.,                                                                          III. Final Rule
                                                                                                     mail and hand delivery of objections
                                             Monday through Friday, excluding legal
                                                                                                     and hearing requests are provided in 40               A. EPA’s Safety Determination
                                             holidays. The telephone number for the
                                                                                                     CFR 178.25(b).                                           Section 408(c)(2)(A)(i) of FFDCA
                                             Public Reading Room is (202) 566–1744,                    In addition to filing an objection or
                                             and the telephone number for the OPP                                                                          allows EPA to establish an exemption
                                                                                                     hearing request with the Hearing Clerk
                                             Docket is (703) 305–5805. Please review                                                                       from the requirement for a tolerance (the
                                                                                                     as described in 40 CFR part 178, please
                                             the visitor instructions and additional                                                                       legal limit for a pesticide chemical
                                                                                                     submit a copy of the filing (excluding
                                             information about the docket available                                                                        residue in or on a food) only if EPA
                                                                                                     any Confidential Business Information
                                             at http://www.epa.gov/dockets.                                                                                determines that the exemption is ‘‘safe.’’
                                                                                                     (CBI)) for inclusion in the public docket.
                                             FOR FURTHER INFORMATION CONTACT:                        Information not marked confidential                   Section 408(c)(2)(A)(ii) of FFDCA
                                             Robert McNally, Biopesticides and                       pursuant to 40 CFR part 2 may be                      defines ‘‘safe’’ to mean that ‘‘there is a
                                             Pollution Prevention Division (7511P),                  disclosed publicly by EPA without prior               reasonable certainty that no harm will
                                             Office of Pesticide Programs,                           notice. Submit the non-CBI copy of your               result from aggregate exposure to the
                                             Environmental Protection Agency, 1200                   objection or hearing request, identified              pesticide chemical residue, including
                                             Pennsylvania Ave. NW., Washington,                      by docket ID number EPA–HQ–OPP–                       all anticipated dietary exposures and all
                                             DC 20460–0001; main telephone                           2014–0457, by one of the following                    other exposures for which there is
                                             number: (703) 305–7090; email address:                  methods:                                              reliable information.’’ This includes
                                             BPPDFRNotices@epa.gov.                                    • Federal eRulemaking Portal: http://               exposure through drinking water and in
                                             SUPPLEMENTARY INFORMATION:                              www.regulations.gov. Follow the online                residential settings but does not include
                                                                                                     instructions for submitting comments.                 occupational exposure. Pursuant to
                                             I. General Information                                                                                        FFDCA section 408(c)(2)(B), in
                                                                                                     Do not submit electronically any
                                             A. Does this action apply to me?                        information you consider to be CBI or                 establishing or maintaining in effect an
                                                                                                     other information whose disclosure is                 exemption from the requirement of a
                                                You may be potentially affected by                                                                         tolerance, EPA must take into account
                                             this action if you are an agricultural                  restricted by statute.
                                             producer, food manufacturer, or                           • Mail: OPP Docket, Environmental                   the factors set forth in FFDCA section
                                                                                                     Protection Agency Docket Center (EPA/                 408(b)(2)(C), which require EPA to give
                                             pesticide manufacturer. The following                                                                         special consideration to exposure of
                                             list of North American Industrial                       DC), (28221T), 1200 Pennsylvania Ave.
                                                                                                     NW., Washington, DC 20460–0001.                       infants and children to the pesticide
                                             Classification System (NAICS) codes is
                                                                                                       • Hand Delivery: To make special                    chemical residue in establishing a
                                             not intended to be exhaustive, but rather                                                                     tolerance or tolerance exemption, and to
                                                                                                     arrangements for hand delivery or
                                             provides a guide to help readers                                                                              ‘‘ensure that there is a reasonable
                                                                                                     delivery of boxed information, please
                                             determine whether this document                                                                               certainty that no harm will result to
                                                                                                     follow the instructions at http://
                                             applies to them. Potentially affected                                                                         infants and children from aggregate
                                                                                                     www.epa.gov/dockets/contacts.html.
                                             entities may include:                                                                                         exposure to the pesticide chemical
                                                • Crop production (NAICS code 111).                  Additional instructions on commenting
                                                                                                     or visiting the docket, along with more               residue . . . .’’ Additionally, FFDCA
                                                • Animal production (NAICS code
                                                                                                     information about dockets generally, is               section 408(b)(2)(D) requires that EPA
                                             112).
                                                • Food manufacturing (NAICS code                     available at http://www.epa.gov/                      consider ‘‘available information
                                             311).                                                   dockets.                                              concerning the cumulative effects of [a
                                                • Pesticide manufacturing (NAICS                                                                           particular pesticide’s] . . . residues and
                                                                                                     II. Background                                        other substances that have a common
                                             code 32532).
                                                                                                        In the Federal Register of April 25,               mechanism of toxicity.’’
                                             B. How can I get electronic access to                   2016 (81 FR 24047) (FRL–9944–86),                        EPA evaluated the available toxicity
                                             other related information?                              EPA issued a document pursuant to                     and exposure data on VNT1 protein and
                                               You may access a frequently updated                   FFDCA section 408(d)(3), 21 U.S.C.                    considered its validity, completeness,
                                             electronic version of 40 CFR part 180                   346a(d)(3), announcing the filing of a                and reliability, as well as the
                                             through the Government Printing                         pesticide tolerance petition (PP 5F8425)              relationship of this information to
                                             Office’s e-CFR site at http://                          by J.R. Simplot Co., 5369 W. Irving St.,              human risk. A full explanation of the
                                             www.ecfr.gov/cgi-bin/text-                              Boise, ID 83706. The petition requested               data upon which EPA relied and its risk
pmangrum on DSK3GDR082PROD with RULES




                                             idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                    that 40 CFR part 174 be amended by                    assessment based on that data can be
                                             40tab_02.tpl.                                           establishing an exemption from the                    found within the December 6, 2016,
                                                                                                     requirement of a tolerance for residues               document entitled ‘‘Federal Food, Drug,
                                             C. How can I file an objection or hearing               of VNT1 protein in potato. That                       and Cosmetic Act (FFDCA)
                                             request?                                                document referenced a summary of the                  Considerations for VNT1 protein.’’ This
                                               Under FFDCA section 408(g), 21                        petition prepared by the petitioner J.R.              document, as well as other relevant
                                             U.S.C. 346a(g), any person may file an                  Simplot Company, which is available in                information, is available in the docket


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                                                               Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations                                              11515

                                             for this action as described under                      not subject to Executive Order 13211,                 submit a report containing this rule and
                                             ADDRESSES. Based upon its evaluation,                   entitled ‘‘Actions Concerning                         other required information to the U.S.
                                             EPA concludes that there is a reasonable                Regulations That Significantly Affect                 Senate, the U.S. House of
                                             certainty that no harm will result to the               Energy Supply, Distribution, or Use’’ (66             Representatives, and the Comptroller
                                             U.S. population, including infants and                  FR 28355, May 22, 2001), or Executive                 General of the United States prior to
                                             children, from aggregate exposure to                    Order 13045, entitled ‘‘Protection of                 publication of the rule in the Federal
                                             residues of VNT1 protein. Therefore, an                 Children from Environmental Health                    Register. This action is not a ‘‘major
                                             exemption from the requirement of a                     Risks and Safety Risks’’ (62 FR 19885,                rule’’ as defined by 5 U.S.C. 804(2).
                                             tolerance is established for residues of                April 23, 1997). This action does not
                                             VNT1 protein in potato when used as a                   contain any information collections                   List of Subjects in 40 CFR Part 174
                                             plant-incorporated protectant in                        subject to OMB approval under the                       Environmental protection,
                                             accordance with the terms of                            Paperwork Reduction Act (PRA), 44                     Administrative practice and procedure,
                                             registration.                                           U.S.C. 3501 et seq., nor does it require              Agricultural commodities, Pesticides
                                                                                                     any special considerations under                      and pests, Reporting and recordkeeping
                                             B. Analytical Enforcement Methodology
                                                                                                     Executive Order 12898, entitled                       requirements.
                                               EPA has determined that an analytical                 ‘‘Federal Actions to Address
                                             method is not required for enforcement                                                                          Dated: January 18, 2017.
                                                                                                     Environmental Justice in Minority
                                             purposes since the Agency is                            Populations and Low-Income                            Jack Housenger,
                                             establishing an exemption from the                      Populations’’ (59 FR 7629, February 16,               Director, Office of Pesticide Programs.
                                             requirement of a tolerance without any                  1994).                                                  Therefore, 40 CFR chapter I is
                                             numerical limitation. Nonetheless, an                      Since tolerances and exemptions that               amended as follows:
                                             analytical method was provided by J.R.                  are established on the basis of a petition
                                             Simplot for the detection of VNT1                       under FFDCA section 408(d), such as                   PART 174—[AMENDED]
                                             protein in potato. This method utilizes                 the tolerance exemption in this action,
                                             a quantitative polymerase chain reaction                do not require the issuance of a                      ■ 1. The authority citation for part 174
                                             (qPCR) to detect the presence of the Rpi-               proposed rule, the requirements of the                continues to read as follows:
                                             vntl gene in pSIM1678 transformed                       Regulatory Flexibility Act (RFA) (5                     Authority: 7. U.S.C. 136–136y; 21 U.S.C.
                                             plants (pSIM1678 is the transformation                  U.S.C. 601 et seq.) do not apply.                     321(q), 346a and 371.
                                             vector used by the registrant to                           This action directly regulates growers,
                                             incorporate the Rpi-vntl gene into potato               food processors, food handlers, and food              ■   2. Revise § 174.534 to read as follows:
                                             varieties). There are numerous                          retailers, not States or tribes. As a result,
                                                                                                                                                           § 174.534 VNT1 protein; exemption from
                                             homologs of Rpi-vnt1 present in potato                  this action does not alter the
                                                                                                                                                           the requirement of a tolerance.
                                             and tomato varieties and other wild                     relationships or distribution of power
                                             Solanum species that may result in non-                 and responsibilities established by                     Residues of VNT1 protein in potato
                                             specific amplification when using                       Congress in the preemption provisions                 are exempt from the requirement of a
                                             primers designed to amplify Rpi-vnt1.                   of FFDCA section 408(n)(4). As such,                  tolerance when the Rpi-vnt1 gene that
                                             To distinguish between plants that                      EPA has determined that this action will              express the VNT1 protein is used as a
                                             naturally contain homologous                            not have a substantial direct effect on               plant-incorporated protectant in potato.
                                             sequences and those transformed with                    States or tribal governments, on the                  [FR Doc. 2017–03580 Filed 2–23–17; 8:45 am]
                                             pSIM1678, a second method amplifies a                   relationship between the national                     BILLING CODE 6560–50–P
                                             unique junction between the Rpi-vnt1                    government and the States or tribal
                                             terminator and the AGP promoter                         governments, or on the distribution of
                                             present in the pSIM1678 T–DNA. This                     power and responsibilities among the
                                             second method is intended to confirm                    various levels of government or between               SURFACE TRANSPORTATION BOARD
                                             the presence or absence of pSIM1678 if                  the Federal Government and Indian
                                             there are false positive detection of Rpi-              tribes. Thus, EPA has determined that                 49 CFR Part 1250
                                             vnt1 homologs.                                          Executive Order 13132, entitled
                                                                                                     ‘‘Federalism’’ (64 FR 43255, August 10,               [Docket No. EP 724 (Sub-No. 4)]
                                             C. Revisions to Requested Tolerance                     1999), and Executive Order 13175,
                                             Exemption                                               entitled ‘‘Consultation and Coordination              United States Rail Service Issues—
                                               The current temporary tolerance                       with Indian Tribal Governments’’ (65 FR               Performance Data Reporting
                                             exemption for VNT1 protein in potato                    67249, November 9, 2000), do not apply                Correction
                                             (40 CFR 174.534) approved by EPA on                     to this action. In addition, this action
                                             December 17, 2015, will be changed to                   does not impose any enforceable duty or                  In rule document 2017–02492,
                                             a permanent tolerance exemption.                        contain any unfunded mandate as                       appearing on pages 9529–9529, in the
                                             IV. Statutory and Executive Order                       described under Title II of the Unfunded              issue of Tuesday, February 7, 2017,
                                             Reviews                                                 Mandates Reform Act (UMRA) (2 U.S.C.                  make the following correction:
                                                                                                     1501 et seq.).                                           On page 9529, in the third column,
                                               This action establishes a tolerance                      This action does not involve any                   the signature block should read as
                                             exemption under FFDCA section 408(d)                    technical standards that would require                follows:
                                             in response to a petition submitted to                  EPA’s consideration of voluntary
                                             EPA. The Office of Management and                                                                               Decided: January 27, 2017.
                                                                                                     consensus standards pursuant to section
pmangrum on DSK3GDR082PROD with RULES




                                             Budget (OMB) has exempted these types                   12(d) of the National Technology                        By the Board, Acting Chairman Begeman,
                                             of actions from review under Executive                                                                        Vice Chairman Miller, and Commissioner
                                                                                                     Transfer and Advancement Act                          Elliott.
                                             Order 12866, entitled ‘‘Regulatory                      (NTTAA) (15 U.S.C. 272 note).
                                             Planning and Review’’ (58 FR 51735,                                                                           Brendetta S. Jones,
                                             October 4, 1993). Because this action                   V. Congressional Review Act                           Clearance Clerk.
                                             has been exempted from review under                       Pursuant to the Congressional Review                [FR Doc. C1–2017–02492 Filed 2–23–17; 8:45 am]
                                             Executive Order 12866, this action is                   Act (5 U.S.C. 801 et seq.), EPA will                  BILLING CODE 1301–00–D




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Document Created: 2017-02-24 01:17:10
Document Modified: 2017-02-24 01:17:10
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 February 24, 2017. Objections and requests for hearings must be received on or before April 25, 2017 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 Citation82 FR 11513 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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