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)

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, 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.

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SUMMARY: This regulation establishes a temporary exemption from the 
requirement of a tolerance for residues of the VNT1 protein in or on 
potatoes when used as a plant-incorporated protectant in accordance 
with the terms of Experimental Use Permit (EUP) (8917-EUP-2). J.R. 
Simplot Company submitted a petition to EPA under the Federal Food, 
Drug, and Cosmetic Act (FFDCA), requesting an amendment of the 
temporary tolerance exemption. This regulation eliminates the need to 
establish a maximum permissible level for residues of VNT1 protein in 
potato. The temporary tolerance exemption expires on April 1, 2017, 
concurrent with the EUP (8917-EUP-2).

DATES: This regulation is effective January 20, 2016. Objections and 
requests for hearings must be received on or before March 21, 2016, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2014-0457, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room

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is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. The telephone number for the Public Reading Room is 
(202) 566-1744, and the telephone number for the OPP Docket is (703) 
305-5805. Please review the visitor instructions and additional 
information about the docket available at http://www2.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; main telephone number: (703) 305-7090; email 
address: [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

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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