82_FR_57368 82 FR 57137 - Pseudomonas fluorescens 4-hydroxyphenylpyruvate dioxygenase (HPPD-4); Exemption From the Requirement of a Tolerance

82 FR 57137 - Pseudomonas fluorescens 4-hydroxyphenylpyruvate dioxygenase (HPPD-4); Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 231 (December 4, 2017)

Page Range57137-57140
FR Document2017-26086

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.

Federal Register, Volume 82 Issue 231 (Monday, December 4, 2017)
[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Rules and Regulations]
[Pages 57137-57140]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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



                                                              Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations                                               57137

                                             effects due to the lack of toxicity and                 and Controlling Regulatory Costs’’ (82                Register. This action is not a ‘‘major
                                             allergenicity for this PIP. As a result, an             FR 9339, February 3, 2017). This action               rule’’ as defined by 5 U.S.C. 804(2).
                                             additional margin of safety for the                     does not contain any information
                                                                                                                                                           List of Subjects in 40 CFR Part 174
                                             protection of infants and children is                   collections subject to OMB approval
                                             unnecessary.                                            under the Paperwork Reduction Act                       Environmental protection,
                                                Based upon its evaluation, EPA                       (PRA) (44 U.S.C. 3501 et seq.) nor does               Administrative practice and procedure,
                                             concludes that there is reasonable                      it require any special considerations                 Agricultural commodities, Pesticides
                                             certainty that no harm will result to the               under Executive Order 12898, entitled                 and pests, Reporting and recordkeeping
                                             U.S. population, including infants and                  ‘‘Federal Actions to Address                          requirements.
                                             children, from aggregate exposure to                    Environmental Justice in Minority                       Dated: November 13, 2017.
                                             residues of the Cry14Ab–1 protein in or                 Populations and Low-Income                            Richard P. Keigwin, Jr.,
                                             on soybean. This includes all                           Populations’’ (59 FR 7629, February 16,
                                                                                                                                                           Director, Office of Pesticide Programs.
                                             anticipated dietary exposures and all                   1994).
                                             other exposures for which there is                         Since tolerances and exemptions that                 Therefore, 40 CFR chapter I is
                                             reliable information. The Agency has                    are established on the basis of a petition            amended as follows:
                                             arrived at this conclusion based on the                 under FFDCA section 408(d), such as
                                             lack of toxicity and allergenicity for the              the tolerance exemption in this action,               PART 174—[AMENDED]
                                             Bacillus thuringiensis Cry14Ab–1                        do not require the issuance of a
                                             protein. Therefore, a temporary                         proposed rule, the requirements of the                ■ 1. The authority citation for part 174
                                             exemption is established for residues of                Regulatory Flexibility Act (RFA) (5                   continues to read as follows:
                                             this plant-incorporated protectant                      U.S.C. 601 et seq.) do not apply.                       Authority: 7 U.S.C. 136–136y; 21 U.S.C.
                                             Bacillus thuringiensis Cry14Ab–1                           This action directly regulates growers,            321(q), 346a and 371.
                                             protein in or on soybean.                               food processors, food handlers, and food              ■ 2. Add § 174.538 to subpart W to read
                                                                                                     retailers, not States or tribes. As a result,         as follows:
                                             B. Analytical Enforcement Methodology                   this action does not alter the
                                                An analytical method is not required                 relationships or distribution of power                § 174.538 Bacillus thuringiensis Cry14Ab–
                                             for enforcement purposes because EPA                    and responsibilities established by                   1 protein in soybean; temporary exemption
                                             is establishing a temporary exemption                   Congress in the preemption provisions                 from the requirement of a tolerance.
                                             from the requirement of a tolerance                     of FFDCA section 408(n)(4). As such,                     Residues of the protein Cry14Ab–1 in
                                             without any numerical limitation for                    EPA has determined that this action will              or on soybean are temporarily exempt
                                             which enforcement is unnecessary.                       not have a substantial direct effect on               from the requirement of a tolerance
                                                                                                     States or tribal governments, on the                  when used as a plant-incorporated
                                             C. Revisions to the Requested Tolerance
                                                                                                     relationship between the national                     protectant in soybean plants in
                                             Exemption                                               government and the States or tribal                   accordance with the terms of
                                                EPA’s final rule revises the request                 governments, or on the distribution of                Experimental Use Permit No. 264–EUP–
                                             from ‘‘plant-pesticide’’ to ‘‘plant-                    power and responsibilities among the                  151. This temporary exemption from the
                                             incorporated protectant’’ to align with                 various levels of government or between               requirement of a tolerance expires on
                                             the Agency’s language published in 40                   the Federal Government and Indian                     April 1, 2020.
                                             CFR 174.3; adds the term ‘‘temporary’’                  tribes. Thus, EPA has determined that                 [FR Doc. 2017–26080 Filed 12–1–17; 8:45 am]
                                             to reflect that this exemption is linked                Executive Order 13132, entitled                       BILLING CODE 6560–50–P
                                             to the pending experimental use permit                  ‘‘Federalism’’ (64 FR 43255, August 10,
                                             action, and is published in part 174                    1999), and Executive Order 13175,
                                             rather than part 180, since PIP tolerance               entitled ‘‘Consultation and                           ENVIRONMENTAL PROTECTION
                                             exemptions are published in part 174.                   Coordination with Indian Tribal                       AGENCY
                                             IV. Statutory and Executive Order                       Governments’’ (65 FR 67249, November
                                             Reviews                                                 9, 2000), do not apply to this action. In             40 CFR Part 174
                                                                                                     addition, this action does not impose                 [EPA–HQ–OPP–2017–0115; FRL–9969–94]
                                                This action establishes an exemption                 any enforceable duty or contain any
                                             from the requirement of a tolerance                     unfunded mandate as described under                   Pseudomonas fluorescens 4-
                                             under FFDCA section 408(d) in                           Title II of the Unfunded Mandates                     hydroxyphenylpyruvate dioxygenase
                                             response to a petition submitted to EPA.                Reform Act (UMRA) (2 U.S.C. 1501 et                   (HPPD–4); Exemption From the
                                             The Office of Management and Budget                     seq.).                                                Requirement of a Tolerance
                                             (OMB) has exempted these types of                          This action does not involve any
                                             actions from review under Executive                     technical standards that would require                AGENCY:  Environmental Protection
                                             Order 12866, entitled ‘‘Regulatory                      EPA’s consideration of voluntary                      Agency (EPA).
                                             Planning and Review’’ (58 FR 51735,                     consensus standards pursuant to section               ACTION: Final rule.
                                             October 4, 1993). Because this action                   12(d) of the National Technology
                                             has been exempted from review under                     Transfer and Advancement Act                          SUMMARY:    This regulation establishes an
                                             Executive Order 12866, this action is                   (NTTAA) (15 U.S.C. 272 note).                         exemption from the requirement of a
                                             not subject to Executive Order 13211,                                                                         tolerance for residues of the HPPD–4
                                             entitled ‘‘Actions Concerning                           V. Congressional Review Act                           protein derived from the 4-
                                             Regulations That Significantly Affect                     Pursuant to the Congressional Review                hydroxyphenylpyruvate dioxygenase
                                             Energy Supply, Distribution, or Use’’ (66               Act (5 U.S.C. 801 et seq.), EPA will                  enzyme of Pseudomonas fluorescens in
ethrower on DSK3G9T082PROD with RULES




                                             FR 28355, May 22, 2001); Executive                      submit a report containing this rule and              or on all food commodities, when used
                                             Order 13045, entitled ‘‘Protection of                   other required information to the U.S.                as a plant-incorporated protectant inert
                                             Children from Environmental Health                      Senate, the U.S. House of                             ingredient. Bayer CropScience LP
                                             Risks and Safety Risks’’ (62 FR 19885,                  Representatives, and the Comptroller                  submitted a petition to EPA under the
                                             April 23, 1997); or Executive Order                     General of the United States prior to                 Federal Food, Drug, and Cosmetic Act
                                             13771, entitled ‘‘Reducing Regulations                  publication of the rule in the Federal                (FFDCA), requesting this exemption


                                        VerDate Sep<11>2014   17:52 Dec 01, 2017   Jkt 244001   PO 00000   Frm 00033   Fmt 4700   Sfmt 4700   E:\FR\FM\04DER1.SGM   04DER1


                                             57138            Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations

                                             from the requirement of a tolerance.                    through the Government Printing                       tolerance petition (IN–11022) by Bayer
                                             This regulation eliminates the need                     Office’s e-CFR site at http://                        CropScience LP 2 T.W. Alexander Dr.,
                                             under FFDCA to establish a maximum                      www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&                Research Triangle Park, NC 27709. The
                                             permissible level for such residues.                    tpl=/ecfrbrowse/Title40/40tab_02.tpl.                 petition requested that 40 CFR part 180
                                             DATES: This regulation is effective                                                                           be amended by establishing an
                                                                                                     C. How can I file an objection or hearing
                                             December 4, 2017. Objections and                        request?                                              exemption from the requirement of a
                                             requests for hearings must be received                                                                        tolerance for plant-pesticide inert
                                             on or before February 2, 2018, and must                   Under FFDCA section 408(g), 21                      HPPD–4 in or on all food commodities.
                                             be filed in accordance with the                         U.S.C. 346a(g), any person may file an                A summary of the petition prepared by
                                             instructions provided in 40 CFR part                    objection to any aspect of this regulation            the petitioner Bayer CropScience LP, is
                                             178 (see also Unit I.C. of the                          and may also request a hearing on those               available in the docket via http://
                                             SUPPLEMENTARY INFORMATION).                             objections. You must file your objection              www.regulations.gov. There were no
                                                                                                     or request a hearing on this regulation               comments received in response to either
                                             ADDRESSES: The docket for this action,
                                                                                                     in accordance with the instructions                   notice.
                                             identified by docket identification (ID)
                                                                                                     provided in 40 CFR part 178. To ensure
                                             number EPA–HQ–OPP–2017–0115, is                                                                                 Two modifications have been made to
                                                                                                     proper receipt by EPA, you must
                                             available at http://www.regulations.gov                                                                       the original request for a tolerance
                                                                                                     identify docket ID number EPA–HQ–
                                             or at the Office of Pesticide Programs                                                                        exemption. EPA changed ‘‘plant-
                                                                                                     OPP–2017–0115 in the subject line on
                                             Regulatory Public Docket (OPP Docket)                                                                         pesticide inert’’ to ‘‘plant-incorporated
                                                                                                     the first page of your submission. All
                                             in the Environmental Protection Agency                                                                        protectant inert’’ to align with the
                                                                                                     objections and requests for a hearing
                                             Docket Center (EPA/DC), West William                                                                          Agency’s vocabulary, which is
                                                                                                     must be in writing, and must be
                                             Jefferson Clinton Bldg., Rm. 3334, 1301                                                                       published in 40 CFR part 174.3. Also,
                                                                                                     received by the Hearing Clerk on or
                                             Constitution Ave. NW., Washington, DC                                                                         because EPA publishes all tolerances or
                                                                                                     before February 2, 2018. Addresses for
                                             20460–0001. The Public Reading Room                                                                           exemptions for plant-incorporated
                                                                                                     mail and hand delivery of objections
                                             is open from 8:30 a.m. to 4:30 p.m.,                                                                          protectants in part 174, EPA’s rule is
                                                                                                     and hearing requests are provided in 40
                                             Monday through Friday, excluding legal                                                                        being issued in part 174, rather than
                                                                                                     CFR 178.25(b).
                                             holidays. The telephone number for the                    In addition to filing an objection or               part 180 as requested.
                                             Public Reading Room is (202) 566–1744,                  hearing request with the Hearing Clerk
                                             and the telephone number for the OPP                                                                          III. Final Rule
                                                                                                     as described in 40 CFR part 178, please
                                             Docket is (703) 305–5805. Please review                 submit a copy of the filing (excluding                A. EPA’s Safety Determination
                                             the visitor instructions and additional                 any Confidential Business Information
                                             information about the docket available                  (CBI)) for inclusion in the public docket.               Section 408(c)(2)(A)(i) of FFDCA
                                             at http://www.epa.gov/dockets.                          Information not marked confidential                   allows EPA to establish an exemption
                                             FOR FURTHER INFORMATION CONTACT:                        pursuant to 40 CFR part 2 may be                      from the requirement for a tolerance (the
                                             Robert McNally, Biopesticides and                       disclosed publicly by EPA without prior               legal limit for a pesticide chemical
                                             Pollution Prevention Division (7511P),                  notice. Submit the non-CBI copy of your               residue in or on food) only if EPA
                                             Office of Pesticide Programs,                           objection or hearing request, identified              determines that the exemption is ‘‘safe.’’
                                             Environmental Protection Agency, 1200                   by docket ID number EPA–HQ–OPP–                       Section 408(c)(2)(A)(ii) of FFDCA
                                             Pennsylvania Ave. NW., Washington,                      2017–0115, by one of the following                    defines ‘‘safe’’ to mean that ‘‘there is a
                                             DC 20460–0001; main telephone                           methods:                                              reasonable certainty that no harm will
                                             number: (703) 305–7090; email address:                    • Federal eRulemaking Portal: http://               result from aggregate exposure to the
                                             BPPDFRNotices@epa.gov.                                  www.regulations.gov. Follow the online                pesticide chemical residue, including
                                             SUPPLEMENTARY INFORMATION:                              instructions for submitting comments.                 all anticipated dietary exposures and all
                                                                                                     Do not submit electronically any                      other exposures for which there is
                                             I. General Information                                                                                        reliable information.’’ This includes
                                                                                                     information you consider to be CBI or
                                             A. Does this action apply to me?                        other information whose disclosure is                 exposure through drinking water and in
                                                                                                     restricted by statute.                                residential settings but does not include
                                                You may be potentially affected by
                                                                                                       • Mail: OPP Docket, Environmental                   occupational exposure. Pursuant to
                                             this action if you are an agricultural
                                                                                                     Protection Agency Docket Center (EPA/                 FFDCA section 408(c)(2)(B), in
                                             producer, food manufacturer, or
                                                                                                     DC), (28221T), 1200 Pennsylvania Ave.                 establishing or maintaining in effect an
                                             pesticide manufacturer. The following
                                                                                                     NW., Washington, DC 20460–0001.                       exemption from the requirement of a
                                             list of North American Industrial
                                             Classification System (NAICS) codes is                    • Hand Delivery: To make special                    tolerance, EPA must take into account
                                                                                                     arrangements for hand delivery or                     the factors set forth in FFDCA section
                                             not intended to be exhaustive, but rather
                                                                                                     delivery of boxed information, please                 408(b)(2)(C), which require EPA to give
                                             provides a guide to help readers
                                                                                                     follow the instructions at http://                    special consideration to exposure of
                                             determine whether this document
                                                                                                     www.epa.gov/dockets/contacts.html.                    infants and children to the pesticide
                                             applies to them. Potentially affected
                                                                                                     Additional instructions on commenting                 chemical residue in establishing a
                                             entities may include:
                                                                                                     or visiting the docket, along with more               tolerance or tolerance exemption and to
                                                • Crop production (NAICS code 111).
                                                • Animal production (NAICS code                      information about dockets generally, is               ‘‘ensure that there is a reasonable
                                             112).                                                   available at http://www.epa.gov/                      certainty that no harm will result to
                                                • Food manufacturing (NAICS code                     dockets.                                              infants and children from aggregate
                                             311).                                                                                                         exposure to the pesticide chemical
                                                                                                     II. Background
                                                • Pesticide manufacturing (NAICS                                                                           residue. . . .’’ Additionally, FFDCA
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                                             code 32532).                                               In the Federal Register of June 8, 2017            section 408(b)(2)(D) requires that EPA
                                                                                                     (82 FR 26639 (FRL–9961–90) and 82 FR                  consider ‘‘available information
                                             B. How can I get electronic access to                   26641 (FRL–9961–14)), EPA issued                      concerning the cumulative effects of [a
                                             other related information?                              notice pursuant to FFDCA section                      particular pesticide’s] . . . residues and
                                               You may access a frequently updated                   408(d)(3), 21 U.S.C. 346a(d)(3),                      other substances that have a common
                                             electronic version of 40 CFR part 174                   announcing the filing of a pesticide                  mechanism of toxicity.’’


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                                                              Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations                                           57139

                                                EPA evaluated the available toxicity                 of adverse effects and the rapid                      Order 13045, entitled ‘‘Protection of
                                             and exposure data on HPPD–4 and                         digestibility of the protein, however, the            Children from Environmental Health
                                             considered its validity, completeness,                  Agency does not anticipate any risk                   Risks and Safety Risks’’ (62 FR 19885,
                                             and reliability, as well as the                         from reasonably foreseeable levels of                 April 23, 1997). This action does not
                                             relationship of this information to                     exposure. Residues in drinking water                  contain any information collections
                                             human risk. A full explanation of the                   may theoretically be present because                  subject to OMB approval under the
                                             data upon which EPA relied and its risk                 plant stubble may release modified                    Paperwork Reduction Act (PRA) (44
                                             assessment based on that data can be                    HPPD–4 protein into ground water upon                 U.S.C. 3501 et seq.) nor does it require
                                             found within the October 2, 2017,                       decay. However, the protein would not                 any special considerations under
                                             document entitled ‘‘Federal Food, Drug,                 be expected to survive in the soil due to             Executive Order 12898, entitled
                                             and Cosmetic Act (FFDCA) Assessment                     microbial degradation, adherence to soil              ‘‘Federal Actions to Address
                                             of the plant-incorporated protectant                    components, and removal upon                          Environmental Justice in Minority
                                             inert Pseudomonas fluorescens 4-                        drinking water treatment procedures. In               Populations and Low-Income
                                             hydroxyphenylpyruvate dioxygenase                       addition, oral toxicity testing showed no             Populations’’ (59 FR 7629, February 16,
                                             (HPPD–4).’’ This document, as well as                   adverse effects. Moreover, because the                1994).
                                             other relevant information, is available                PIP inert ingredient is currently only                   Since tolerances and exemptions that
                                             in the docket for this action as described              proposed to be used only in plants                    are established on the basis of a petition
                                             under ADDRESSES.                                        grown for commercial use, the Agency                  under FFDCA section 408(d), such as
                                                The HPPD–4 protein is derived from                   does not anticipate residential                       the tolerance exemption in this action,
                                             the 4-hydroxyphenylpyruvate                             exposures. In the event that future uses              do not require the issuance of a
                                             dioxygenase (HPPD) enzyme of the                        are sold for residential use, the Agency              proposed rule, the requirements of the
                                             bacterium Pseudomonas fluorescens.                      does not expect there to be residential,              Regulatory Flexibility Act (RFA) (5
                                             Four amino acid changes were made to                    non-occupational dermal or inhalation                 U.S.C. 601 et seq.) do not apply.
                                             the original bacterial protein sequence                 exposures, due to containment of the                     This action directly regulates growers,
                                             in order to decrease the binding efficacy               HPPD–4 protein within the plant.                      food processors, food handlers, and food
                                             of the HPPD-inhibitor herbicide. The                      Based on the lack of any evidence of                retailers, not States or tribes. As a result,
                                             resulting modified protein (the HPPD–4                  adverse effects in the toxicological                  this action does not alter the
                                             protein) is the PIP inert ingredient. As                database, dietary exposure to the HPPD–               relationships or distribution of power
                                             a PIP inert, the HPPD–4 protein                         4 protein is not anticipated to pose any              and responsibilities established by
                                             functions as a selectable marker in a                   harm to the U.S. population. EPA                      Congress in the preemption provisions
                                             PIP.                                                    concludes that there is a reasonable                  of FFDCA section 408(n)(4). As such,
                                                Based upon available data, EPA                       certainty that no harm will result to the             EPA has determined that this action will
                                             concludes that the HPPD–4 protein                       U.S. population, including infants and                not have a substantial direct effect on
                                             derived from the Pseudomonas                            children, from aggregate exposure to                  States or tribal governments, on the
                                             fluorescens HPPD enzyme does not                        residues of the HPPD–4 protein derived                relationship between the national
                                             show evidence of toxicity. Moreover,                    from the Pseudomonas fluorescens                      government and the States or tribal
                                             the source is not allergenic, nor is there              HPPD enzyme. Therefore, an exemption                  governments, or on the distribution of
                                             any significant similarity between the                  from the requirement of a tolerance is                power and responsibilities among the
                                             HPPD–4 protein and known toxins and                     established for residues of the plant-                various levels of government or between
                                             allergens. In addition, the HPPD–4                      incorporated protectant inert ingredient              the Federal Government and Indian
                                             protein readily digests in gastric fluids               Pseudomonas fluorescens HPPD–4                        tribes. Thus, EPA has determined that
                                             and therefore cumulative, chronic, and                  protein in or on all food commodities.                Executive Order 13132, entitled
                                             acute effects are unlikely.                                                                                   ‘‘Federalism’’ (64 FR 43255, August 10,
                                                Given the lack of toxicity or                        B. Analytical Enforcement Methodology                 1999), and Executive Order 13175,
                                             allergenicity of the HPPD–4 protein, the                  An analytical method is not required                entitled ‘‘Consultation and Coordination
                                             Agency has not identified any                           because the lack of adverse effects                   with Indian Tribal Governments’’ (65 FR
                                             toxicological endpoints for assessing                   makes enforcement and monitoring of                   67249, November 9, 2000), do not apply
                                             risk. Consequently, the Agency’s                        residues unnecessary to ensure food                   to this action. In addition, this action
                                             assessment of exposure is qualitative. In               safety.                                               does not impose any enforceable duty or
                                             addition, due to the lack of any                                                                              contain any unfunded mandate as
                                             threshold effects, EPA has determined                   IV. Statutory and Executive Order
                                                                                                     Reviews                                               described under Title II of the Unfunded
                                             that the provision to retain a 10X safety                                                                     Mandates Reform Act (UMRA) (2 U.S.C.
                                             factor for the protection of infants and                  This action establishes an exemption                1501 et seq.).
                                             children does not apply. Similarly, the                 from the requirement of a tolerance                      This action does not involve any
                                             lack of any toxic mode of action or toxic               under FFDCA section 408(d) in                         technical standards that would require
                                             metabolites means that the provision                    response to a petition submitted to EPA.              EPA’s consideration of voluntary
                                             requiring an assessment of cumulative                   The Office of Management and Budget                   consensus standards pursuant to section
                                             effects does not apply.                                 (OMB) has exempted these types of                     12(d) of the National Technology
                                                Oral exposure may occur from                         actions from review under Executive                   Transfer and Advancement Act
                                             ingestion of the raw crops containing                   Order 12866, entitled ‘‘Regulatory                    (NTTAA) (15 U.S.C. 272 note).
                                             HPPD–4, as well as their processed                      Planning and Review’’ (58 FR 51735,
                                             derivatives. Currently, HPPD–4 is only                  October 4, 1993). Because this action                 V. Congressional Review Act
                                             proposed to be used as a PIP inert                      has been exempted from review under                     Pursuant to the Congressional Review
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                                             ingredient in soybean, although it could                Executive Order 12866, this action is                 Act (5 U.S.C. 801 et seq.), EPA will
                                             be used in other crops in the future. The               not subject to Executive Order 13211,                 submit a report containing this rule and
                                             current proposed use results in the                     entitled ‘‘Actions Concerning                         other required information to the U.S.
                                             presence of HPPD–4 protein at low                       Regulations That Significantly Affect                 Senate, the U.S. House of
                                             levels within the plant, although future                Energy Supply, Distribution, or Use’’ (66             Representatives, and the Comptroller
                                             uses could be higher. Based on the lack                 FR 28355, May 22, 2001), or Executive                 General of the United States prior to


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                                             57140            Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations

                                             publication of the rule in the Federal                  ADDRESSES:    The docket for this action,             or request a hearing on this regulation
                                             Register. This action is not a ‘‘major                  identified by docket identification (ID)              in accordance with the instructions
                                             rule’’ as defined by 5 U.S.C. 804(2).                   number EPA–HQ–OPP–2016–0495, is                       provided in 40 CFR part 178. To ensure
                                                                                                     available at http://www.regulations.gov               proper receipt by EPA, you must
                                             List of Subjects in 40 CFR Part 174
                                                                                                     or at the Office of Pesticide Programs                identify docket ID number EPA–HQ–
                                               Environmental protection,                             Regulatory Public Docket (OPP Docket)                 OPP–2016–0495 in the subject line on
                                             Administrative practice and procedure,                  in the Environmental Protection Agency                the first page of your submission. All
                                             Agricultural commodities, Pesticides                    Docket Center (EPA/DC), West William                  objections and requests for a hearing
                                             and pests, Reporting and recordkeeping                  Jefferson Clinton Bldg., Rm. 3334, 1301               must be in writing, and must be
                                             requirements.                                           Constitution Ave. NW., Washington, DC                 received by the Hearing Clerk on or
                                               Dated: November 13, 2017.                             20460–0001. The Public Reading Room                   before February 2, 2018. Addresses for
                                             Richard P. Keigwin, Jr.,                                is open from 8:30 a.m. to 4:30 p.m.,                  mail and hand delivery of objections
                                                                                                     Monday through Friday, excluding legal                and hearing requests are provided in 40
                                             Director, Office of Pesticide Programs.
                                                                                                     holidays. The telephone number for the                CFR 178.25(b).
                                               Therefore, 40 CFR chapter I is                        Public Reading Room is (202) 566–1744,                  In addition to filing an objection or
                                             amended as follows:                                     and the telephone number for the OPP                  hearing request with the Hearing Clerk
                                                                                                     Docket is (703) 305–5805. Please review               as described in 40 CFR part 178, please
                                             PART 174—[AMENDED]                                      the visitor instructions and additional               submit a copy of the filing (excluding
                                                                                                     information about the docket available                any Confidential Business Information
                                             ■ 1. The authority citation for part 174                                                                      (CBI)) for inclusion in the public docket.
                                             continues to read as follows:                           at http://www.epa.gov/dockets.
                                                                                                     FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                           Information not marked confidential
                                                 Authority: 21 U.S.C. 321(q), 346a and 371.
                                                                                                     Michael Goodis, Registration Division                 pursuant to 40 CFR part 2 may be
                                             ■ 2. Add § 174.537 to subpart W to read                 (7505P), Office of Pesticide Programs,                disclosed publicly by EPA without prior
                                             as follows:                                             Environmental Protection Agency, 1200                 notice. Submit the non-CBI copy of your
                                                                                                     Pennsylvania Ave. NW., Washington,                    objection or hearing request, identified
                                             § 174.537 HPPD–4 protein; exemption from
                                                                                                     DC 20460–0001; main telephone                         by docket ID number EPA–HQ–OPP–
                                             the requirement of a tolerance.                                                                               2016–0495, by one of the following
                                                                                                     number: (703) 305–7090; email address:
                                                Residues of the HPPD–4 protein,                      RDFRNotices@epa.gov.                                  methods:
                                             which is a modified protein derived                                                                             • Federal eRulemaking Portal: http://
                                                                                                     SUPPLEMENTARY INFORMATION:                            www.regulations.gov. Follow the online
                                             from the 4-hydroxyphenylpyruvate
                                             dioxygenase enzyme of Pseudomonas                       I. General Information                                instructions for submitting comments.
                                             fluorescens, in or on all food                                                                                Do not submit electronically any
                                                                                                     A. Does this action apply to me?                      information you consider to be CBI or
                                             commodities are exempt from the
                                             requirement of a tolerance, when the                       You may be potentially affected by                 other information whose disclosure is
                                             HPPD–4 protein is used as a plant-                      this action if you are an agricultural                restricted by statute.
                                             incorporated protectant inert ingredient.               producer, food manufacturer, or                         • Mail: OPP Docket, Environmental
                                             [FR Doc. 2017–26086 Filed 12–1–17; 8:45 am]             pesticide manufacturer. The following                 Protection Agency Docket Center (EPA/
                                                                                                     list of North American Industrial                     DC), (28221T), 1200 Pennsylvania Ave.
                                             BILLING CODE 6560–50–P
                                                                                                     Classification System (NAICS) codes is                NW., Washington, DC 20460–0001.
                                                                                                     not intended to be exhaustive, but rather               • Hand Delivery: To make special
                                                                                                     provides a guide to help readers                      arrangements for hand delivery or
                                             ENVIRONMENTAL PROTECTION
                                                                                                     determine whether this document                       delivery of boxed information, please
                                             AGENCY
                                                                                                     applies to them. Potentially affected                 follow the instructions at http://
                                             40 CFR Part 180                                         entities may include:                                 www.epa.gov/dockets/contacts.html.
                                                                                                        • Crop production (NAICS code 111).                  Additional instructions on
                                             [EPA–HQ–OPP–2016–0495; FRL–9970–01]                        • Animal production (NAICS code                    commenting or visiting the docket,
                                                                                                     112).                                                 along with more information about
                                             Prometryn; Pesticide Tolerances                            • Food manufacturing (NAICS code                   dockets generally, is available at http://
                                                                                                     311).                                                 www.epa.gov/dockets.
                                             AGENCY:  Environmental Protection                          • Pesticide manufacturing (NAICS
                                             Agency (EPA).                                                                                                 II. Summary of Petitioned-For
                                                                                                     code 32532).                                          Tolerance
                                             ACTION: Final rule.
                                                                                                     B. How can I get electronic access to                    In the Federal Register of November
                                             SUMMARY:   This regulation establishes                  other related information?                            30, 2016 (81 FR 86312) (FRL–9954–06),
                                             tolerances for residues of prometryn in                    You may access a frequently updated                EPA issued a document pursuant to
                                             or on multiple commodities which are                    electronic version of EPA’s tolerance                 FFDCA section 408(d)(3), 21 U.S.C.
                                             identified and discussed later in this                  regulations at 40 CFR part 180 through                346a(d)(3), announcing the filing of a
                                             document. Interregional Research                        the Government Printing Office’s e-CFR                pesticide petition (PP 6E8492) by IR–4
                                             Project Number 4 (IR–4) requested these                 site at http://www.ecfr.gov/cgi-bin/text-             Project Headquarters, Rutgers, The State
                                             tolerances under the Federal Food,                      idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                  University of NJ, 500 College Road East,
                                             Drug, and Cosmetic Act (FFDCA).                         40tab_02.tpl.                                         Suite 201 W, Princeton, NJ 08540. The
                                             DATES: This regulation is effective                                                                           petition requested that 40 CFR part 180
                                                                                                     C. How can I file an objection or hearing             be amended by establishing tolerances
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                                             December 4, 2017. Objections and
                                             requests for hearings must be received                  request?                                              for residues of prometryn in or on the
                                             on or before February 2, 2018, and must                   Under FFDCA section 408(g), 21                      raw agricultural commodity lettuce at
                                             be filed in accordance with the                         U.S.C. 346a, any person may file an                   0.5 parts per million (ppm); cottonseed
                                             instructions provided in 40 CFR part                    objection to any aspect of this regulation            subgroup 20C at 0.25 ppm; fennel,
                                             178 (see also Unit I.C. of the                          and may also request a hearing on those               Florence at 0.5 ppm; leaf petiole
                                             SUPPLEMENTARY INFORMATION).                             objections. You must file your objection              vegetable subgroup 22B at 0.5 ppm;


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Document Created: 2017-12-02 00:40:15
Document Modified: 2017-12-02 00:40:15
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 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).
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 57137 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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