[EPA-HQ-OPP-2017-0288 and EPA-HQ-OPP-2017-0283; FRL-9986-73] HEAD6-Benzyladenine; Pesticide Tolerances, 64027-64030 [2018-27047]
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Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Rules and Regulations
authorized in section 110(k)(3) of the
Act, the EPA is approving these
certifications into the California SIP as
proposed.
amozie on DSK3GDR082PROD with RULES
IV. Statutory and Executive Order
Reviews
Under the CAA, the Administrator is
required to approve a SIP submission
that complies with the provisions of the
Act and applicable Federal regulations.
42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the
EPA’s role is to approve state choices,
provided that they meet the criteria of
the CAA. Accordingly, this action
merely approves state law as meeting
Federal requirements and does not
impose additional requirements beyond
those imposed by state law. For that
reason, this action:
• Is not a significant regulatory action
subject to review by the Office of
Management and Budget under
Executive Orders 12866 (58 FR 51735,
October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011);
• Is not an Executive Order 13771 (82
FR 9339, February 2, 2017) regulatory
action because SIP approvals are
exempted under Executive Order 12866;
• Does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
• Is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act (5
U.S.C. 601 et seq.);
• Does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• Does not have Federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the Clean Air Act;
and
• Does not provide the EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
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methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, the SIP is not approved
to apply on any Indian reservation land
or in any other area where the EPA or
an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of
Indian country, the rule does not have
tribal implications and will not impose
substantial direct costs on tribal
governments or preempt tribal law as
specified by Executive Order 13175 (65
FR 67249, November 9, 2000).
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. The EPA will
submit a report containing this action
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. A major rule cannot take effect
until 60 days after it is published in the
Federal Register. This action is not a
‘‘major rule’’ as defined by 5 U.S.C.
804(2).
64027
November 16, 2017 by the Governor’s
designee.
(i) [Reserved]
(ii) Additional materials. (A) South
Coast Air Quality Management District.
(1) ‘‘Nonattainment New Source
Review (NSR) Compliance
Demonstration for the 2008 Ozone
National Ambient Air Quality Standard
(NAAQS),’’ adopted July 7, 2017.
(2) [Reserved]
(511) New additional materials for the
following APCD’s were submitted on
June 19, 2018 by the Governor’s
designee.
(i) [Reserved]
(ii) Additional materials. (A) San
Joaquin Valley Air Pollution Control
District.
(1) ‘‘Certification that the San Joaquin
Valley Unified Air Pollution Control
District’s Current NNSR Program
Addresses the 2008 Ozone NAAQS SIP
Requirements Rule,’’ adopted April 19,
2018.
(2) [Reserved]
(B) Yolo-Solano Air Quality
Management District.
(1) ‘‘Certification that Yolo-Solano’s
Existing NNSR Program meets the 2008
Ozone NAAQS SIP Requirements Rule,’’
adopted March 14, 2018.
(2) [Reserved]
[FR Doc. 2018–26921 Filed 12–12–18; 8:45 am]
BILLING CODE 6560–50–P
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Nitrogen dioxide, Ozone, Reporting and
recordkeeping requirements, Volatile
organic compounds.
Dated: October 24, 2018.
Michael Stoker,
Regional Administrator, Region IX.
Part 52, Chapter I, Title 40 of the Code
of Federal Regulations is amended as
follows:
1. The authority citation for Part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
Subpart F—California
2. Section 52.220 is amended by
adding paragraphs (c)(510) and (511) to
read as follows:
■
Identification of plan—in part.
*
*
*
*
*
(c) * * *
(510) New additional materials for the
following APCD was submitted on
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40 CFR Part 180
[EPA–HQ–OPP–2017–0288 and EPA–
HQ–OPP–2017–0283; FRL–9986–73]
6-Benzyladenine; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of 6benzyladenine in or on avocados,
peppers, tomatoes, cucumbers, melons,
and squash. Interregional Research
Project Number 4 and Valent
BioSciences LLC have requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
December 13, 2018. Objections and
requests for hearings must be received
on or before February 11, 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 dockets for this action,
identified by docket identification (ID)
SUMMARY:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
§ 52.220
ENVIRONMENTAL PROTECTION
AGENCY
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Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Rules and Regulations
numbers EPA–HQ–OPP–2017–0288 and
EPA–HQ–OPP–2017–0283, are 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:
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?
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You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
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
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16:00 Dec 12, 2018
Jkt 247001
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–2017–0288 and EPA–HQ–OPP–
2017–0283 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 11, 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 numbers EPA–HQ–OPP–
2017–0288 and EPA–HQ–OPP–2017–
0283, 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
available at https://www.epa.gov/
dockets.
II. Background
In the Federal Register of September
15, 2017 (82 FR 43352) (FRL–9965–43),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of two
pesticide petitions: PP 6E8526 by
Interregional Research Project Number 4
(IR–4), Rutgers, State University of New
Jersey, 681 U.S. Highway No. 1, S. North
New Brunswick, NJ 08902; and PP
7F8548 by Valent BioSciences LLC
(Valent), 870 Technology Way,
Libertyville, IL 60048. Petition 6E8526
requested that 40 CFR part 180 be
amended by establishing a tolerance for
residues of the plant growth regulator 6benzyladenine, in or on avocados at
0.05 parts per million (ppm). Petition
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7F8548 requested amendment of the
current exemption from the requirement
of tolerance for residues of 6benzyladenine, 40 CFR 180.1150, to add
fruiting vegetables (tomatoes and
peppers) and cucurbit vegetables
(cucumbers, melons, and squash). That
document referenced summaries of the
petitions prepared by Valent, the
registrant, which are available in the
respective dockets via,
www.regulations.gov. Comments were
received on the notice of filing, and the
Agency’s response can be found in Unit
III.D.
Based upon review of the data
supporting each petition, EPA is
establishing tolerance levels for 6benzyladenine on avocados, tomatoes,
peppers, cucumbers, melons and squash
in one final rule. The reasons for these
changes are explained in Part III.E. of
this document.
III. Final Rule
A. EPA’s Safety Determination
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(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. 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
toxicological and exposure data on 6benzyladenine and considered their
validity, completeness, and reliability,
as well as the relationship of this
information to human risk. A summary
of the data upon which EPA relied and
its risk assessment based on those data
can be found within the document
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Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Rules and Regulations
entitled ‘‘Federal Food, Drug, and
Cosmetic Act (FFDCA) Safety
Assessment for Tolerances for Residues
of 6-benzyladenine.’’ 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
the predominant adverse effect from
exposure to 6-benzyladenine was a
significant reduction in body weight,
including an increased susceptibility of
body weight effects in fetuses and
offspring. Despite these effects, EPA
determined that reliable data show the
safety of infants and children would be
adequately protected if the Food Quality
Protection Act (FQPA) safety factor was
reduced to 1X. EPA conducted a
quantitative aggregate risk assessment,
taking into account chronic exposures to
residues of 6-benzyladenine in food and
drinking water (no residential exposures
are anticipated) and concluded that
risks do not exceed EPA’s level of
concern.
Based upon its evaluation, 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 6-benzyladenine. Therefore,
tolerances are established for residues of
6-benzyladenine, in or on tomato,
pepper, cucumber, melon, and squash at
0.01 ppm and in or on avocado at 0.02
ppm.
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B. Analytical Enforcement Methodology
Adequate enforcement methodologies
to quantitatively determine 6benzyladenine residues by liquid
chromatography/mass spectrometer/
mass spectrometer (LC/MS/MS) (Meth209, Determination of 6-Benzyladenine
(6–BA) in Selected Fruiting Vegetable
and Cucurbit Vegetable Raw
Agricultural and Processed
Commodities and Meth-210,
Determination of 6-Benzyladenine (6–
BA) in Selected Oily Crop Raw
Agricultural Commodities) are available
to enforce the tolerance expression. The
methods may be requested from: Chief,
Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
C. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
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(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level. The Codex has not
established an MRL for 6benzyladenine; however, Canada and
the European Union (EU) have set
default MRLs at 0.1 ppm (Canada) and
0.01 ppm (EU), respectively.
D. Response to Comments
One comment was received in
response to each of the petitions. Each
comment generally opposed pesticide
residues on food; only one mentioned 6benzyladenine by name. Neither
comment was accompanied by any
substantiation or data supporting a
conclusion that the tolerances being
established in this action do not meet
the FFDCA safety standard. Although
EPA recognizes that some individuals
would oppose any use of pesticides on
food, section 408 of the FFDCA
authorizes EPA to set tolerances for
residues of pesticide chemicals in or on
food when it determines that the
tolerance meets the safety standard
imposed by that statute. EPA has made
that determination for the 6benzyladenine tolerances established by
this final rule.
E. Revisions to Petitioned-For Tolerance
and Tolerance Exemption
The applicant requested a tolerance
for residues of 6-benzyladenine on
avocado at 0.05 ppm. Based on available
residue data and using the Organisation
for Economic Co-operation and
Development (OECD) calculator, EPA
has determined that a tolerance for
residues of 6-benzyladenine on avocado
at 0.02 ppm is appropriate. In addition,
the applicant requested to amend the
current exemption, 40 CFR 180.1150, for
residues of 6-benzyladenine by adding
fruiting vegetables (tomatoes and
peppers) and cucurbit vegetables
(cucumbers, melons, and squash) at 20
parts per million (ppm) at a maximum
of five applications (total 18.8 grams of
active ingredient per acre per season)
with a seven-day interval between
applications. Due to the toxicological
profile of the chemical and the
measurable residues, EPA has
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64029
concluded that a tolerance is the
appropriate regulatory mechanism for
covering residues of 6-benzyladenine
under the FFDCA. Based on the
available residue data and using the
OECD calculator, EPA has determined
that tolerances for residues of 6benzyladenine on tomato, pepper,
cucumber, melon, and squash at 0.01
ppm are appropriate.
IV. Statutory and Executive Order
Reviews
This action establishes tolerances
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
(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 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
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Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Rules and Regulations
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, EPA has determined that
Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999), and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000), do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
EPA’s consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
V. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: November 28, 2018.
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 § 180.703 to subpart C to read
as follows:
■
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§ 180.703 6-benzyladenine; tolerances for
residues.
(a) General. Tolerances are
established for residues of the plant
growth regulator, 6-benzyladenine in or
on the commodities listed in the table
below. Compliance with the tolerance
levels specified in this paragraph is to
be determined by measuring only 6benzyladenine in or on the commodity.
VerDate Sep<11>2014
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Parts per
million
Commodity
Avocado ......................................
Cucumber ...................................
Melon ..........................................
Pepper ........................................
Squash ........................................
Tomato ........................................
0.02
0.01
0.01
0.01
0.01
0.01
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. 2018–27047 Filed 12–12–18; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 64
[Docket ID FEMA–2018–0002; Internal
Agency Docket No. FEMA–8559]
Suspension of Community Eligibility
Federal Emergency
Management Agency, DHS.
ACTION: Final rule.
AGENCY:
This rule identifies
communities where the sale of flood
insurance has been authorized under
the National Flood Insurance Program
(NFIP) that are scheduled for
suspension on the effective dates listed
within this rule because of
noncompliance with the floodplain
management requirements of the
program. If the Federal Emergency
Management Agency (FEMA) receives
documentation that the community has
adopted the required floodplain
management measures prior to the
effective suspension date given in this
rule, the suspension will not occur and
a notice of this will be provided by
publication in the Federal Register on a
subsequent date. Also, information
identifying the current participation
status of a community can be obtained
from FEMA’s Community Status Book
(CSB). The CSB is available at https://
www.fema.gov/national-floodinsurance-program-community-statusbook.
SUMMARY:
The effective date of each
community’s scheduled suspension is
the third date (‘‘Susp.’’) listed in the
third column of the following tables.
FOR FURTHER INFORMATION CONTACT: If
you want to determine whether a
DATES:
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particular community was suspended
on the suspension date or for further
information, contact Adrienne L.
Sheldon, PE, CFM, Federal Insurance
and Mitigation Administration, Federal
Emergency Management Agency, 400 C
Street SW, Washington, DC 20472, (202)
212–3966.
SUPPLEMENTARY INFORMATION: The NFIP
enables property owners to purchase
Federal flood insurance that is not
otherwise generally available from
private insurers. In return, communities
agree to adopt and administer local
floodplain management measures aimed
at protecting lives and new construction
from future flooding. Section 1315 of
the National Flood Insurance Act of
1968, as amended, 42 U.S.C. 4022,
prohibits the sale of NFIP flood
insurance unless an appropriate public
body adopts adequate floodplain
management measures with effective
enforcement measures. The
communities listed in this document no
longer meet that statutory requirement
for compliance with program
regulations, 44 CFR part 59.
Accordingly, the communities will be
suspended on the effective date in the
third column. As of that date, flood
insurance will no longer be available in
the community. We recognize that some
of these communities may adopt and
submit the required documentation of
legally enforceable floodplain
management measures after this rule is
published but prior to the actual
suspension date. These communities
will not be suspended and will continue
to be eligible for the sale of NFIP flood
insurance. A notice withdrawing the
suspension of such communities will be
published in the Federal Register.
In addition, FEMA publishes a Flood
Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard
Areas (SFHAs) in these communities.
The date of the FIRM, if one has been
published, is indicated in the fourth
column of the table. No direct Federal
financial assistance (except assistance
pursuant to the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act not in connection with a
flood) may be provided for construction
or acquisition of buildings in identified
SFHAs for communities not
participating in the NFIP and identified
for more than a year on FEMA’s initial
FIRM for the community as having
flood-prone areas (section 202(a) of the
Flood Disaster Protection Act of 1973,
42 U.S.C. 4106(a), as amended). This
prohibition against certain types of
Federal assistance becomes effective for
the communities listed on the date
shown in the last column. The
E:\FR\FM\13DER1.SGM
13DER1
]]>Agencies
[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)]
[Rules and Regulations]
[Pages 64027-64030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27047]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0288 and EPA-HQ-OPP-2017-0283; FRL-9986-73]
6-Benzyladenine; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of 6-
benzyladenine in or on avocados, peppers, tomatoes, cucumbers, melons,
and squash. Interregional Research Project Number 4 and Valent
BioSciences LLC have requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective December 13, 2018. Objections and
requests for hearings must be received on or before February 11, 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 dockets for this action, identified by docket
identification (ID)
[[Page 64028]]
numbers EPA-HQ-OPP-2017-0288 and EPA-HQ-OPP-2017-0283, are 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 Printing 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-2017-0288 and EPA-HQ-OPP-2017-0283 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 11, 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 numbers EPA-HQ-OPP-2017-0288 and EPA-
HQ-OPP-2017-0283, 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 available at https://www.epa.gov/dockets.
II. Background
In the Federal Register of September 15, 2017 (82 FR 43352) (FRL-
9965-43), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of two pesticide petitions: PP
6E8526 by Interregional Research Project Number 4 (IR-4), Rutgers,
State University of New Jersey, 681 U.S. Highway No. 1, S. North New
Brunswick, NJ 08902; and PP 7F8548 by Valent BioSciences LLC (Valent),
870 Technology Way, Libertyville, IL 60048. Petition 6E8526 requested
that 40 CFR part 180 be amended by establishing a tolerance for
residues of the plant growth regulator 6-benzyladenine, in or on
avocados at 0.05 parts per million (ppm). Petition 7F8548 requested
amendment of the current exemption from the requirement of tolerance
for residues of 6-benzyladenine, 40 CFR 180.1150, to add fruiting
vegetables (tomatoes and peppers) and cucurbit vegetables (cucumbers,
melons, and squash). That document referenced summaries of the
petitions prepared by Valent, the registrant, which are available in
the respective dockets via, www.regulations.gov. Comments were received
on the notice of filing, and the Agency's response can be found in Unit
III.D.
Based upon review of the data supporting each petition, EPA is
establishing tolerance levels for 6-benzyladenine on avocados,
tomatoes, peppers, cucumbers, melons and squash in one final rule. The
reasons for these changes are explained in Part III.E. of this
document.
III. Final Rule
A. EPA's Safety Determination
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(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. 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 toxicological and exposure data on 6-
benzyladenine and considered their validity, completeness, and
reliability, as well as the relationship of this information to human
risk. A summary of the data upon which EPA relied and its risk
assessment based on those data can be found within the document
[[Page 64029]]
entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Safety
Assessment for Tolerances for Residues of 6-benzyladenine.'' 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 the predominant adverse effect
from exposure to 6-benzyladenine was a significant reduction in body
weight, including an increased susceptibility of body weight effects in
fetuses and offspring. Despite these effects, EPA determined that
reliable data show the safety of infants and children would be
adequately protected if the Food Quality Protection Act (FQPA) safety
factor was reduced to 1X. EPA conducted a quantitative aggregate risk
assessment, taking into account chronic exposures to residues of 6-
benzyladenine in food and drinking water (no residential exposures are
anticipated) and concluded that risks do not exceed EPA's level of
concern.
Based upon its evaluation, 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 6-
benzyladenine. Therefore, tolerances are established for residues of 6-
benzyladenine, in or on tomato, pepper, cucumber, melon, and squash at
0.01 ppm and in or on avocado at 0.02 ppm.
B. Analytical Enforcement Methodology
Adequate enforcement methodologies to quantitatively determine 6-
benzyladenine residues by liquid chromatography/mass spectrometer/mass
spectrometer (LC/MS/MS) (Meth-209, Determination of 6-Benzyladenine (6-
BA) in Selected Fruiting Vegetable and Cucurbit Vegetable Raw
Agricultural and Processed Commodities and Meth-210, Determination of
6-Benzyladenine (6-BA) in Selected Oily Crop Raw Agricultural
Commodities) are available to enforce the tolerance expression. The
methods may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; email address:
[email protected].
C. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established an MRL for 6-benzyladenine; however, Canada and the
European Union (EU) have set default MRLs at 0.1 ppm (Canada) and 0.01
ppm (EU), respectively.
D. Response to Comments
One comment was received in response to each of the petitions. Each
comment generally opposed pesticide residues on food; only one
mentioned 6-benzyladenine by name. Neither comment was accompanied by
any substantiation or data supporting a conclusion that the tolerances
being established in this action do not meet the FFDCA safety standard.
Although EPA recognizes that some individuals would oppose any use of
pesticides on food, section 408 of the FFDCA authorizes EPA to set
tolerances for residues of pesticide chemicals in or on food when it
determines that the tolerance meets the safety standard imposed by that
statute. EPA has made that determination for the 6-benzyladenine
tolerances established by this final rule.
E. Revisions to Petitioned-For Tolerance and Tolerance Exemption
The applicant requested a tolerance for residues of 6-benzyladenine
on avocado at 0.05 ppm. Based on available residue data and using the
Organisation for Economic Co-operation and Development (OECD)
calculator, EPA has determined that a tolerance for residues of 6-
benzyladenine on avocado at 0.02 ppm is appropriate. In addition, the
applicant requested to amend the current exemption, 40 CFR 180.1150,
for residues of 6-benzyladenine by adding fruiting vegetables (tomatoes
and peppers) and cucurbit vegetables (cucumbers, melons, and squash) at
20 parts per million (ppm) at a maximum of five applications (total
18.8 grams of active ingredient per acre per season) with a seven-day
interval between applications. Due to the toxicological profile of the
chemical and the measurable residues, EPA has concluded that a
tolerance is the appropriate regulatory mechanism for covering residues
of 6-benzyladenine under the FFDCA. Based on the available residue data
and using the OECD calculator, EPA has determined that tolerances for
residues of 6-benzyladenine on tomato, pepper, cucumber, melon, and
squash at 0.01 ppm are appropriate.
IV. Statutory and Executive Order Reviews
This action establishes tolerances 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 (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 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
[[Page 64030]]
governments, or on the distribution of power and responsibilities among
the various levels of government or between the Federal Government and
Indian tribes. Thus, EPA has determined that Executive Order 13132,
entitled ``Federalism'' (64 FR 43255, August 10, 1999), and Executive
Order 13175, entitled ``Consultation and Coordination with Indian
Tribal Governments'' (65 FR 67249, November 9, 2000), do not apply to
this action. In addition, this action does not impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require EPA's consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
V. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: November 28, 2018.
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. 180.703 to subpart C to read as follows:
Sec. 180.703 6-benzyladenine; tolerances for residues.
(a) General. Tolerances are established for residues of the plant
growth regulator, 6-benzyladenine in or on the commodities listed in
the table below. Compliance with the tolerance levels specified in this
paragraph is to be determined by measuring only 6-benzyladenine in or
on the commodity.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Avocado..................................................... 0.02
Cucumber.................................................... 0.01
Melon....................................................... 0.01
Pepper...................................................... 0.01
Squash...................................................... 0.01
Tomato...................................................... 0.01
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2018-27047 Filed 12-12-18; 8:45 am]
BILLING CODE 6560-50-P
