Bacteriophage Active Against Xylella fastidiosa; Exemption From the Requirement of a Tolerance, 16789-16791 [2019-08111]
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16789
Federal Register / Vol. 84, No. 78 / Tuesday, April 23, 2019 / Rules and Regulations
EPA-APPROVED GEORGIA NON-REGULATORY PROVISIONS
Name of non-regulatory SIP provision
Applicable geographic or
nonattainment area
*
*
Non-Interference Demonstration and
Maintenance Plan Revision for Federal Low-Reid Vapor Pressure Requirement in the Atlanta Area.
*
*
Cherokee, Clayton, Cobb, Coweta,
DeKalb, Douglas, Fayette, Forsyth,
Fulton, Gwinnett, Henry, Paulding,
and Rockdale counties.
[FR Doc. 2019–08062 Filed 4–22–19; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2017–0593; FRL–9991–86]
Bacteriophage Active Against Xylella
fastidiosa; Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of lytic
bacteriophage active against Xylella
fastidiosa in or on all food commodities
when the bacteriophage are sequenced
and have sequences free of toxins and
lysogenic genes and are used in
accordance with label directions and
good agricultural practices. Otsuka
Pharmaceutical Co., Ltd. (c/o
Technology Sciences Group Inc.)
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting an exemption from
the requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of bacteriophage active
against Xylella fastidiosa in or on all
food commodities under FFDCA.
DATES: This regulation is effective April
23, 2019. Objections and requests for
hearings must be received on or before
June 24, 2019, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2017–0593, is
available at https://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
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ADDRESSES:
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State
submittal date/
effective date
*
8/15/2018
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 https://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:
BPPDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Publishing
Office’s e-CFR site at https://
www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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EPA
approval
date
*
4/23/2019, [Insert
Federal Register citation].
Explanation
*
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–2017–0593 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 June 24, 2019. 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–
2017–0593, by one of the following
methods:
• Federal eRulemaking Portal: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
E:\FR\FM\23APR1.SGM
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16790
Federal Register / Vol. 84, No. 78 / Tuesday, April 23, 2019 / Rules and Regulations
available at https://www.epa.gov/
dockets.
II. Background
In the Federal Register of March 6,
2018 (83 FR 9471) (FRL–9973–27), EPA
issued a document pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
tolerance petition (PP 7F8562) by
Otsuka Pharmaceutical Co., Ltd.
(Otsuka), 2–9 Kanda-Tsukasamachi,
Chiyoda-ku, Tokyo, 101–8535, Japan
(c/o Technology Sciences Group Inc.,
712 Fifth St., Suite A, Davis, CA 95616).
The petition requested that 40 CFR part
180 be amended by establishing an
exemption from the requirement of a
tolerance for residues of the bactericide
bacteriophages active against Xylella
fastidiosa in or on all food commodities.
That document referenced a summary of
the petition prepared by the petitioner
Otsuka (c/o Technology Sciences Group
Inc.) and available in the docket via
https://www.regulations.gov. Comments
were received on the notice of filing.
EPA’s response to these comments is
discussed in Unit III.C.
Based upon review of data and other
information supporting the petition,
EPA is granting a tolerance exemption
that differs slightly from what the
petition requested. The reason for this
difference is explained in Unit III.D.
III. Final Rule
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A. EPA’s Safety Determination
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement of a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the exemption is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings but does not include
occupational exposure. Pursuant to
FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an
exemption from the requirement of a
tolerance, EPA must take into account
the factors set forth in FFDCA section
408(b)(2)(C), which require EPA to give
special consideration to exposure of
infants and children to the pesticide
chemical residue in establishing a
tolerance or tolerance exemption and to
‘‘ensure that there is a reasonable
certainty that no harm will result to
infants and children from aggregate
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exposure to the pesticide chemical
residue. . . .’’ Additionally, FFDCA
section 408(b)(2)(D) requires that EPA
consider ‘‘available information
concerning the cumulative effects of [a
particular pesticide’s] . . . residues and
other substances that have a common
mechanism of toxicity.’’
EPA evaluated the available toxicity
and exposure data on bacteriophage
active against Xylella fastidiosa and
considered their 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 those data can be
found within the document entitled
‘‘Federal Food, Drug, and Cosmetic Act
(FFDCA) Safety Determination for
Bacteriophage Active Against Xylella
fastidiosa’’ (Safety Determination). This
document, as well as other relevant
information, is available in the docket
for this action as described under
ADDRESSES.
The available data demonstrated that,
with regard to humans, bacteriophage
active against Xylella fastidiosa are not
anticipated to be toxic, pathogenic, or
infective via any route of exposure.
Furthermore, humans, including infants
and children, have been exposed to
bacteriophage through food and water,
where they are commonly found, with
no known adverse effects. Although
there may be some exposure to residues
when bacteriophage active against
Xylella fastidiosa is used on food
commodities in accordance with label
directions and good agricultural
practices (only grape for now), there is
a lack of concern due to the lack of
potential for adverse effects. EPA also
determined in the Safety Determination
that retention of the Food Quality
Protection Act (FQPA) safety factor was
not necessary as part of the qualitative
assessment conducted for bacteriophage
active against Xylella fastidiosa.
Based upon its evaluation in the
Safety Determination, 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 bacteriophage active against
Xylella fastidiosa. Therefore, an
exemption from the requirement of a
tolerance is established for residues of
lytic bacteriophage active against
Xylella fastidiosa in or on all food
commodities when the bacteriophage
are sequenced and have sequences free
of toxins and lysogenic genes and are
used in accordance with label directions
and good agricultural practices.
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B. Analytical Enforcement Methodology
An analytical method is not required
because EPA is establishing an
exemption from the requirement of a
tolerance without any numerical
limitation.
C. Response to Comments
Nine comments were received in
response to the notice of filing. EPA
reviewed the comments and determined
that they are irrelevant to the tolerance
exemption in this action.
D. Differences Between Petition and
Tolerance Exemption Rule
In its petition, the petitioner
requested generally that EPA issue an
exemption from the requirement of a
tolerance for residues of bacteriophage
active against Xylella fastidiosa in or on
all food commodities. The petitioner’s
supporting materials indicated that the
actual pesticide that would be used
would be safe because the bacteriophage
were lytic and were sequenced and have
sequences free of toxins and lysogenic
genes. EPA believes that only
bacteriophage that have these same
characteristics as the organism tested
would be safe and should be exempt
from the requirement of a tolerance.
Therefore, EPA is issuing a tolerance
exemption that differs slightly from the
petition by limiting the exemption to
residues of the bacteriophage that
possess the same characteristics as the
bacteriophage that were tested to
support this exemption.
IV. Statutory and Executive Order
Reviews
This action establishes a tolerance
exemption 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), nor is it considered a
regulatory action under Executive Order
13771, entitled ‘‘Reducing Regulations
and Controlling Regulatory Costs’’ (82
FR 9339, February 3, 2017). This action
does not contain any information
collections subject to OMB approval
under the Paperwork Reduction Act, 44
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Federal Register / Vol. 84, No. 78 / Tuesday, April 23, 2019 / Rules and Regulations
jbell on DSK3GLQ082PROD with RULES
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 (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 (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 (15
U.S.C. 272 note).
V. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
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Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: April 12, 2019.
Richard P. Keigwin, Jr.,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.1365 to subpart D to read
as follows:
■
§ 180.1365 Bacteriophage active against
Xylella fastidiosa; exemption from the
requirement of a tolerance.
An exemption from the requirement
of a tolerance is established for residues
of lytic bacteriophage active against
Xylella fastidiosa in or on all food
commodities when the bacteriophage
are sequenced and have sequences free
of toxins and lysogenic genes and are
used in accordance with label directions
and good agricultural practices.
[FR Doc. 2019–08111 Filed 4–22–19; 8:45 am]
BILLING CODE 6560–50–P
NATIONAL SCIENCE FOUNDATION
45 CFR Part 670
RIN 3145–AA59
Conservation of Antarctic Animals and
Plants
National Science Foundation.
Direct final rule.
AGENCY:
ACTION:
Pursuant to the Antarctic
Conservation Act of 1978, as amended,
the National Science Foundation (NSF)
is amending its regulations to reflect
changes to designated Antarctic
specially protected areas (ASPA),
Antarctic specially managed areas
(ASMA) and historic sites or
monuments (HSM). These changes
reflect decisions already adopted by the
Antarctic Treaty Parties at recent
Antarctic Treaty Consultative Meetings
(ATCM). The United States Department
of State heads the United States
delegation to these annual Antarctic
Treaty meetings.
DATES: Effective April 23, 2019.
FOR FURTHER INFORMATION CONTACT:
Bijan Gilanshah, Assistant General
Counsel, Office of the General Counsel,
at 703–292–8060, National Science
Foundation, 2415 Eisenhower Avenue,
Suite W 18200, Alexandria, VA 22314.
SUMMARY:
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16791
The
Antarctic Conservation Act of 1978, as
amended (‘‘ACA’’) (16 U.S.C. 2401, et
seq.) implements the Protocol on
Environmental Protection to the
Antarctic Treaty (‘‘the Protocol’’).
Annex V contains provisions for the
protection of specially designated areas
specially managed areas and historic
sites and monuments. Section 2405 of
title 16 of the ACA directs the Director
of the National Science Foundation to
issue such regulations as are necessary
and appropriate to implement Annex V
to the Protocol.
The Antarctic Treaty Parties, which
includes the United States, periodically
adopt measures to establish, consolidate
or revoke specially protected areas,
specially managed areas and historical
sites or monuments in Antarctica. This
rule is being revised to reflect five
added Antarctic specially protected
areas (ASPAs 171–175) and six
historical sites and monuments in
Antarctica (HSM 87–92). The rule is
also being revised to reflect the
revocation, of three Antarctic specially
protected areas (ASPAs 114, 118 and
130) and one Antarctic specially
managed area (ASMA 3) primarily due
to consolidation.
SUPPLEMENTARY INFORMATION:
Public Participation
The changes to these areas and sites
reflect decisions already made by the
Antarctic Treaty Parties at recent
international ATOM meetings. Because
these amendments directly involve a
foreign affairs function, the provisions
of Executive Order 12866, Executive
Order 13771 and the Administrative
Procedure Act (5 U.S.C. 553), requiring
notice of proposed rulemaking,
opportunity for public participation,
and delay in effective date, are
inapplicable. Further, because no notice
of proposed rulemaking is required for
this rule, the Regulatory Flexibility Act
(5 U.S.C. 601 and 612) does not apply.
Environmental Impact
This final rule makes technical
conforming changes to the National
Science Foundation’s regulations to
reflect the substantive outcomes of
recent Antarctic Treaty Consultative
Meetings. The actions taken by the
Antarctic Treaty Parties to manage and
protect these new Antarctic areas and
historic resources will result in added
protection of the Antarctic environment
and its historic resources.
Reducing Regulation and Controlling
Regulatory Costs
In implementing these international
ATOM agreed to changes, this direct
final rule relates to a foreign affairs
E:\FR\FM\23APR1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 78 (Tuesday, April 23, 2019)]
[Rules and Regulations]
[Pages 16789-16791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08111]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0593; FRL-9991-86]
Bacteriophage Active Against Xylella fastidiosa; 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 lytic bacteriophage active against
Xylella fastidiosa in or on all food commodities when the bacteriophage
are sequenced and have sequences free of toxins and lysogenic genes and
are used in accordance with label directions and good agricultural
practices. Otsuka Pharmaceutical Co., Ltd. (c/o Technology Sciences
Group Inc.) submitted a petition to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), requesting an exemption from the requirement
of a tolerance. This regulation eliminates the need to establish a
maximum permissible level for residues of bacteriophage active against
Xylella fastidiosa in or on all food commodities under FFDCA.
DATES: This regulation is effective April 23, 2019. Objections and
requests for hearings must be received on or before June 24, 2019, 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-2017-0593, is available at https://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 https://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 180 through the Government Publishing Office's e-CFR site at
https://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-2017-0593 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
June 24, 2019. 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-2017-0593, by one of
the following methods:
Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is
[[Page 16790]]
available at https://www.epa.gov/dockets.
II. Background
In the Federal Register of March 6, 2018 (83 FR 9471) (FRL-9973-
27), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 7F8562) by Otsuka Pharmaceutical Co., Ltd. (Otsuka), 2-9
Kanda-Tsukasamachi, Chiyoda-ku, Tokyo, 101-8535, Japan (c/o Technology
Sciences Group Inc., 712 Fifth St., Suite A, Davis, CA 95616). The
petition requested that 40 CFR part 180 be amended by establishing an
exemption from the requirement of a tolerance for residues of the
bactericide bacteriophages active against Xylella fastidiosa in or on
all food commodities. That document referenced a summary of the
petition prepared by the petitioner Otsuka (c/o Technology Sciences
Group Inc.) and available in the docket via https://www.regulations.gov.
Comments were received on the notice of filing. EPA's response to these
comments is discussed in Unit III.C.
Based upon review of data and other information supporting the
petition, EPA is granting a tolerance exemption that differs slightly
from what the petition requested. The reason for this difference is
explained in Unit III.D.
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 of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance or tolerance exemption and
to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .'' Additionally, FFDCA section 408(b)(2)(D)
requires that EPA consider ``available information concerning the
cumulative effects of [a particular pesticide's] . . . residues and
other substances that have a common mechanism of toxicity.''
EPA evaluated the available toxicity and exposure data on
bacteriophage active against Xylella fastidiosa and considered their
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 those data can be
found within the document entitled ``Federal Food, Drug, and Cosmetic
Act (FFDCA) Safety Determination for Bacteriophage Active Against
Xylella fastidiosa'' (Safety Determination). This document, as well as
other relevant information, is available in the docket for this action
as described under ADDRESSES.
The available data demonstrated that, with regard to humans,
bacteriophage active against Xylella fastidiosa are not anticipated to
be toxic, pathogenic, or infective via any route of exposure.
Furthermore, humans, including infants and children, have been exposed
to bacteriophage through food and water, where they are commonly found,
with no known adverse effects. Although there may be some exposure to
residues when bacteriophage active against Xylella fastidiosa is used
on food commodities in accordance with label directions and good
agricultural practices (only grape for now), there is a lack of concern
due to the lack of potential for adverse effects. EPA also determined
in the Safety Determination that retention of the Food Quality
Protection Act (FQPA) safety factor was not necessary as part of the
qualitative assessment conducted for bacteriophage active against
Xylella fastidiosa.
Based upon its evaluation in the Safety Determination, 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 bacteriophage active against Xylella
fastidiosa. Therefore, an exemption from the requirement of a tolerance
is established for residues of lytic bacteriophage active against
Xylella fastidiosa in or on all food commodities when the bacteriophage
are sequenced and have sequences free of toxins and lysogenic genes and
are used in accordance with label directions and good agricultural
practices.
B. Analytical Enforcement Methodology
An analytical method is not required because EPA is establishing an
exemption from the requirement of a tolerance without any numerical
limitation.
C. Response to Comments
Nine comments were received in response to the notice of filing.
EPA reviewed the comments and determined that they are irrelevant to
the tolerance exemption in this action.
D. Differences Between Petition and Tolerance Exemption Rule
In its petition, the petitioner requested generally that EPA issue
an exemption from the requirement of a tolerance for residues of
bacteriophage active against Xylella fastidiosa in or on all food
commodities. The petitioner's supporting materials indicated that the
actual pesticide that would be used would be safe because the
bacteriophage were lytic and were sequenced and have sequences free of
toxins and lysogenic genes. EPA believes that only bacteriophage that
have these same characteristics as the organism tested would be safe
and should be exempt from the requirement of a tolerance. Therefore,
EPA is issuing a tolerance exemption that differs slightly from the
petition by limiting the exemption to residues of the bacteriophage
that possess the same characteristics as the bacteriophage that were
tested to support this exemption.
IV. Statutory and Executive Order Reviews
This action establishes a tolerance exemption 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), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act, 44
[[Page 16791]]
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 (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 (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 (15 U.S.C. 272 note).
V. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 12, 2019.
Richard P. Keigwin, Jr.,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Add Sec. 180.1365 to subpart D to read as follows:
Sec. 180.1365 Bacteriophage active against Xylella fastidiosa;
exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of lytic bacteriophage active against Xylella fastidiosa in or
on all food commodities when the bacteriophage are sequenced and have
sequences free of toxins and lysogenic genes and are used in accordance
with label directions and good agricultural practices.
[FR Doc. 2019-08111 Filed 4-22-19; 8:45 am]
BILLING CODE 6560-50-P
