[Federal Register Volume 80, Number 35 (Monday, February 23, 2015)]
[Rules and Regulations]
[Pages 9387-9390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03570]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2014-0457; FRL-9922-53]


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 potato 
when used as a plant-incorporated protectant in accordance with the 
terms of Experimental Use Permit (EUP) No. 8917-EUP-2. J.R. Simplot 
Company submitted a petition to EPA under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), requesting 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 December 31, 2015.

DATES: This regulation is effective February 23, 2015. Objections and 
requests for hearings must be received on or before April 24, 2015, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2014-0457, 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 174 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, 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 24, 2015. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2014-0457, 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 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 tolerance 
petition (PP 4F8251) by J.R. Simplot Company, 5369 W. Irving St., 
Boise, ID 83706. In the Federal Register of December 17, 2014 (79 FR 
75107) (FRL-9918-90), EPA inadvertently reannounced 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 VTN1 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, http://www.regulations.gov. Comments were received, and 
EPA's response to these comments is discussed in Unit VII.B.
    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.''

[[Page 9388]]

Section 408(c)(2)(A)(ii) of FFDCA defines ``safe '' to mean that 
``there is a reasonable certainty that no harm will result from 
aggregate exposure to the pesticide chemical residue, including all 
anticipated dietary exposures and all other exposures for which there 
is reliable information.'' This includes exposure through drinking 
water and in residential settings, but does not include occupational 
exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or 
maintaining in effect an exemption from the requirement of a tolerance, 
EPA must take into account the factors set forth in FFDCA section 
408(b)(2)(C), which require EPA to give special consideration to 
exposure of infants and children to the pesticide chemical residue in 
establishing a tolerance and to ``ensure that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue. . . .'' 
Additionally, FFDCA section 408(b)(2)(D) requires that the Agency 
consider ``available information concerning the cumulative effects of a 
particular pesticide's residues'' and ``other substances that have a 
common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability, 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children.

A. Product Characterization Overview

    The gene that confers Potato Late Blight Resistance (Rpi-vnt1) is 
found naturally in wild potato varieties. When Rpi-vnt1 is expressed in 
potato, the VNT1 protein it encodes confers broad-spectrum resistance 
to Phytophthora infestans, late blight of potato. VNT1 activates a 
signal transduction pathway that leads to localized plant cell death or 
the hypersensitive response. Death is restricted to a few plant cells 
and limits the growth and spread of Phytophthora infestans throughout 
the rest of the plant.
    Although people have not been exposed to the VNT1 protein in 
potatoes (because it is currently only found in wild potato varieties), 
humans have been exposed to the VNT1 protein in tomatoes. In addition 
to conferring resistance to late blight in potato, the VNT1 protein 
also confers resistance to late blight in tomatoes. Both potato and 
tomato, which both belong to the Solanum genus, are affected by late 
blight and have developed resistance through the same VNT1 protein.
    In addition, the VNT1 protein found in wild potatoes and tomatoes 
is similar to several other protein sequences in tomatoes. The protein 
in tomato species most closely related to the VNT1 protein (over 90% 
similarity) introduced into potato is called Tm-2 or Tm2\2\, which is a 
protein bred into tomato for resistance to the tomato mosaic virus.

B. Mammalian Toxicity and Allergenicity Assessment

    Since the VNT1 protein is not detectable by current methodologies 
and attempts to isolate or produce the VNT1 protein were not 
successful, no toxicity testing was performed with either plant 
purified protein or protein produced in a surrogate organism. Rather, 
the Agency has reviewed a bioinformatics analysis of the allergenic and 
toxic potential of the VNT1 protein and on similar proteins to which 
humans are currently and regularly exposed through ingestion of edible 
plants. The Agency has identified known allergens found in potatoes and 
tomatoes, and the analysis shows that VNT1 protein does not have any 
similarity to any known allergens.
    The Agency has not identified any other potential toxicity with the 
VNT1 protein. Although some proteins may have toxic properties, those 
proteins are not found in tomato or potato, and the VNT1 protein does 
not have any similarity to those proteins. Furthermore, consumers have 
been exposed previously to the VNT1 protein in tomatoes. Also, 
consumers have been exposed to the very similar Tm-2 protein in tomato. 
Many tomato mosaic virus resistant tomato varieties are readily 
available and grown in the U.S. for fresh market tomato production and 
are widely consumed. Since no health or toxicity issues have been 
raised in tomato containing the Tm-2 protein, the Agency does not 
expect any toxicity to be associated with the VNT1 protein in potato.
    Therefore, EPA concludes that VNT1 protein is not likely to pose 
any toxicity or cause any allergenicity based on the following:
    1. The VNT1 protein has been a component of the human diet from 
ingestion of tomatoes for a long time.
    2. The VNT1 protein is similar to other proteins to which people 
are regularly exposed in their diet without adverse effect.
    3. The VNT1 protein is not similar to any known allergens.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).
    The Agency has considered available information on the aggregate 
exposure levels of consumers (and major identifiable subgroups of 
consumers) to the pesticide chemical residue and to other related 
substances. These considerations include dietary exposure under the 
tolerance exemption and all other tolerances or exemptions in effect 
for the residues of plant-incorporated protectant, and exposure from 
non-occupational sources.
    The Agency expects consumers to be exposed to the VNT1 protein 
through potatoes containing the plant-incorporated protectant derived 
from the Rpi-vnt1 gene and to other potatoes and tomatoes containing 
the gene naturally. Since this protein will be directly incorporated 
into the potato in a plant-incorporated protectant, the Agency does not 
expect any exposure through drinking water or through inhalation or 
dermal routes of exposure. The Agency also does not expect any non-
occupational (i.e., other residential) exposure to the VNT1 protein 
since there are no residential uses for this plant-incorporated 
protectant.

V. Cumulative Effects From Substances With a Common Mechanism of 
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA has concluded that the VNT1 protein in potato does not have a 
toxic mode of action and thus does not share a common mechanism of 
toxicity with other substances; therefore, section 408(b)(2)(D)(v)) 
does not apply.

[[Page 9389]]

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C) provides that, in considering the 
establishment of a tolerance or tolerance exemption for a pesticide 
chemical residue, EPA shall assess the available information about 
consumption patterns among infants and children, special susceptibility 
of infants and children to pesticide chemical residues, and the 
cumulative effects on infants and children of the residues and other 
substances with a common mechanism of toxicity. In addition, FFDCA 
section 408(b)(2)(C) provides that EPA shall apply an additional 
tenfold (10X) margin of exposure (safety) for infants and children in 
the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines that a different margin of exposure (safety) will 
be safe for infants and children. This additional margin of exposure 
(safety) is commonly referred to as the Food Quality Protection Act 
Safety Factor (FQPA SF). In applying this provision, EPA either retains 
the default value of 10X or uses a different additional safety factor 
when reliable data available to EPA support the choice of a different 
factor.
    Based on the information discussed in Unit III., EPA concludes that 
there are no threshold effects of concern to infants, children, or 
adults from exposure to the VNT1 protein. As a result, EPA concludes 
that no additional margin of exposure (safety) is necessary to protect 
infants and children and that not adding any additional margin of 
exposure (safety) will be safe for infants and children.
    Therefore, based on the discussion in Unit III and the supporting 
documentation, EPA concludes that there is a reasonable certainty that 
no harm will result to the U.S. population, including infants and 
children, from aggregate exposure to the residues of 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.

VII. Other Considerations

A. 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.

B. Response to Comments

    EPA received two comments relevant to this petition.
    It is unclear whether one commenter, which urged ``no 
deregulation'', had a general comment related to the Agency's tolerance 
action for the VNT1 protein. EPA's action is establishing a regulation 
that would exempt residues of the VNT1 protein in potato from the 
requirement of a tolerance; the Agency does not consider such action to 
be a ``deregulation''. EPA continues to regulate this pesticidal active 
ingredient through the FFDCA and the Federal Insecticide Fungicide and 
Rodenticide Act (FIFRA). To the extent the commenter is arguing 
generally that that pesticides, including plant-incorporated 
protectants, should be banned on agricultural crop, the comment appears 
to be directed at the underlying statute and not EPA's implementation 
of it. However, the existing legal framework provided by section 408 of 
the FFDCA states that tolerances or exemptions may be set when the 
Agency determines that the pesticide meets the safety standard imposed 
by that statute.
    Another commenter raised issues in regards to pollen drift, soil 
health, and mammalian health for plant-incorporated protectants. In 
this FFDCA action, the Agency has reviewed the food safety issues for 
this product and has concluded the product is safe for human/animal 
consumption. The potatoes with the VNT1 protein are safe for human 
consumption at levels likely to be found in these sources. The other 
issues raised by the commenter, pollen drift and soil health, are not 
relevant to this food safety determination made under FFDCA. However, 
EPA has considered these issues as part of its review of the EUP 
regulated under FIFRA.

VIII. Conclusion

    The Agency concludes that there is a reasonable certainty that no 
harm will result to the U.S. population, including infants and 
children, from aggregate exposure to residues of VNT1 protein in 
potato. Therefore, a temporary exemption is established for residues 
the VNT1 protein in potato. The experimental use permit (EUP No. 8917-
EUP-2) expires on December 31, 2015, so EPA is establishing an 
expiration for this temporary tolerance of the same date.

IX. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a 
tolerance under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993). Because this action has been exempted from review 
under Executive Order 12866, this action is not subject to Executive 
Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This action does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special 
considerations under Executive Order 12898, entitled ``Federal Actions 
to Address Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the exemption in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require

[[Page 9390]]

Agency consideration of voluntary consensus standards pursuant to 
section 12(d) of the National Technology Transfer and Advancement Act 
(NTTAA) (15 U.S.C. 272 note).

X. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 174

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 4, 2015.
Kimberly Nesci,
Chief, Microbial Pesticides Branch, 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 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. Add Sec.  174.534 to subpart W 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 December 31, 
2015.

[FR Doc. 2015-03570 Filed 2-20-15; 8:45 am]
BILLING CODE 6560-50-P