[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Rules and Regulations]
[Pages 57137-57140]
[FR Doc No: 2017-26086]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2017-0115; FRL-9969-94]

Pseudomonas fluorescens 4-hydroxyphenylpyruvate dioxygenase
(HPPD-4); Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the HPPD-4 protein derived from the 4-
hydroxyphenylpyruvate dioxygenase enzyme of Pseudomonas fluorescens in
or on all food commodities, when used as a plant-incorporated
protectant inert ingredient. Bayer CropScience LP submitted a petition
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting this exemption

from the requirement of a tolerance. This regulation eliminates the
need under FFDCA to establish a maximum permissible level for such
residues.

DATES: This regulation is effective December 4, 2017. Objections and
requests for hearings must be received on or before February 2, 2018,
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-2017-0115, 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. 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:<PHONE_NUMBER>; 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(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-2017-0115 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
February 2, 2018. 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-2017-0115, 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 June 8, 2017 (82 FR 26639 (FRL-9961-90)
and 82 FR 26641 (FRL-9961-14)), EPA issued notice pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a
pesticide tolerance petition (IN-11022) by Bayer CropScience LP 2 T.W.
Alexander Dr., Research Triangle Park, NC 27709. The petition requested
that 40 CFR part 180 be amended by establishing an exemption from the
requirement of a tolerance for plant-pesticide inert HPPD-4 in or on
all food commodities. A summary of the petition prepared by the
petitioner Bayer CropScience LP, is available in the docket via http://www.regulations.gov. There were no comments received in response to
either notice.
    Two modifications have been made to the original request for a
tolerance exemption. EPA changed ``plant-pesticide inert'' to ``plant-
incorporated protectant inert'' to align with the Agency's vocabulary,
which is published in 40 CFR part 174.3. Also, because EPA publishes
all tolerances or exemptions for plant-incorporated protectants in part
174, EPA's rule is being issued in part 174, rather than part 180 as
requested.

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 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 HPPD-4
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 October 2, 2017, document entitled
``Federal Food, Drug, and Cosmetic Act (FFDCA) Assessment of the plant-
incorporated protectant inert Pseudomonas fluorescens 4-
hydroxyphenylpyruvate dioxygenase (HPPD-4).'' This document, as well as
other relevant information, is available in the docket for this action
as described under ADDRESSES.
    The HPPD-4 protein is derived from the 4-hydroxyphenylpyruvate
dioxygenase (HPPD) enzyme of the bacterium Pseudomonas fluorescens.
Four amino acid changes were made to the original bacterial protein
sequence in order to decrease the binding efficacy of the HPPD-
inhibitor herbicide. The resulting modified protein (the HPPD-4
protein) is the PIP inert ingredient. As a PIP inert, the HPPD-4
protein functions as a selectable marker in a PIP.
    Based upon available data, EPA concludes that the HPPD-4 protein
derived from the Pseudomonas fluorescens HPPD enzyme does not show
evidence of toxicity. Moreover, the source is not allergenic, nor is
there any significant similarity between the HPPD-4 protein and known
toxins and allergens. In addition, the HPPD-4 protein readily digests
in gastric fluids and therefore cumulative, chronic, and acute effects
are unlikely.
    Given the lack of toxicity or allergenicity of the HPPD-4 protein,
the Agency has not identified any toxicological endpoints for assessing
risk. Consequently, the Agency's assessment of exposure is qualitative.
In addition, due to the lack of any threshold effects, EPA has
determined that the provision to retain a 10X safety factor for the
protection of infants and children does not apply. Similarly, the lack
of any toxic mode of action or toxic metabolites means that the
provision requiring an assessment of cumulative effects does not apply.
    Oral exposure may occur from ingestion of the raw crops containing
HPPD-4, as well as their processed derivatives. Currently, HPPD-4 is
only proposed to be used as a PIP inert ingredient in soybean, although
it could be used in other crops in the future. The current proposed use
results in the presence of HPPD-4 protein at low levels within the
plant, although future uses could be higher. Based on the lack of
adverse effects and the rapid digestibility of the protein, however,
the Agency does not anticipate any risk from reasonably foreseeable
levels of exposure. Residues in drinking water may theoretically be
present because plant stubble may release modified HPPD-4 protein into
ground water upon decay. However, the protein would not be expected to
survive in the soil due to microbial degradation, adherence to soil
components, and removal upon drinking water treatment procedures. In
addition, oral toxicity testing showed no adverse effects. Moreover,
because the PIP inert ingredient is currently only proposed to be used
only in plants grown for commercial use, the Agency does not anticipate
residential exposures. In the event that future uses are sold for
residential use, the Agency does not expect there to be residential,
non-occupational dermal or inhalation exposures, due to containment of
the HPPD-4 protein within the plant.
    Based on the lack of any evidence of adverse effects in the
toxicological database, dietary exposure to the HPPD-4 protein is not
anticipated to pose any harm to the U.S. population. 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 the HPPD-4 protein derived from the Pseudomonas fluorescens
HPPD enzyme. Therefore, an exemption from the requirement of a
tolerance is established for residues of the plant-incorporated
protectant inert ingredient Pseudomonas fluorescens HPPD-4 protein in
or on all food commodities.

B. Analytical Enforcement Methodology

    An analytical method is not required because the lack of adverse
effects makes enforcement and monitoring of residues unnecessary to
ensure food safety.

IV. 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 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: November 13, 2017.
Richard P. Keigwin, Jr.,
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:  21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  174.537 to subpart W to read as follows:

Sec.  174.537   HPPD-4 protein; exemption from the requirement of a
tolerance.

    Residues of the HPPD-4 protein, which is a modified protein derived
from the 4-hydroxyphenylpyruvate dioxygenase enzyme of Pseudomonas
fluorescens, in or on all food commodities are exempt from the
requirement of a tolerance, when the HPPD-4 protein is used as a plant-
incorporated protectant inert ingredient.

[FR Doc. 2017-26086 Filed 12-1-17; 8:45 am]
 BILLING CODE 6560-50-P