Document ID: EPA-HQ-OPP-2017-0115-0004
Agency: epa
Document Type: Rule
Title: Tolerance Exemptions: Pseudomonas fluorescens 4-hydroxyphenylpyruvate dioxygenase (HPPD-4)
Posted Date: 2017-12-04T05:00Z

[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Rules and Regulations]
[Pages 57137-57140]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

[[Page 57138]]

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 (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(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.''

[[Page 57139]]

    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

[[Page 57140]]

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