Indoxacarb; Pesticide Tolerances, 31386-31389 [2020-10483]
Download as PDF
<![CDATA[
31386
Federal Register / Vol. 85, No. 101 / Tuesday, May 26, 2020 / Rules and Regulations
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 final rule, 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, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
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, the Agency 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
Agency 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).
VerDate Sep<11>2014
16:12 May 22, 2020
Jkt 250001
VII. 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: May 6, 2020.
Michael Goodis,
Director, Registration Division, 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. In § 180.698, revise the entry for
‘‘Oat, grain’’ and the footnote in
paragraph (a) to read as follows:
■
§ 180.698 Chlormequat chloride;
tolerances for residues.
*
*
*
*
*
*
Parts per
million
*
*
*
Oat, grain 2 ............................
*
*
*
40
*
This regulation is effective May
26, 2020. Objections and requests for
hearings must be received on or before
July 27, 2020, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
DATES:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2019–0384 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. 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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
*
Commodity
indoxacarb in or on corn, pop, grain at
0.02 parts per million (ppm) and corn,
pop, stover at 15 ppm. FMC Corporation
requested this tolerance under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
*
Michael L. Goodis, Director,
Registration Division (7505P), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Avenue NW, Washington, DC 20460–
0001; main telephone number: (703)
305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
2 There are no U.S. registrations for this
commodity.
*
*
*
*
*
[FR Doc. 2020–10331 Filed 5–22–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2019–0384; FRL–9995–89]
Indoxacarb; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
tolerance for residues of the insecticide
SUMMARY:
PO 00000
Frm 00030
Fmt 4700
Sfmt 4700
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).
E:\FR\FM\26MYR1.SGM
26MYR1
Federal Register / Vol. 85, No. 101 / Tuesday, May 26, 2020 / Rules and Regulations
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Publishing Office’s eCFR 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, 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–2019–0384 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 July
27, 2020. Addresses for mail and hand
delivery of objections and hearing
requests are provided in 40 CFR
178.25(b). 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–
2019–0384, 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.
VerDate Sep<11>2014
16:12 May 22, 2020
Jkt 250001
II. Summary of Petitioned-For
Tolerance
In the Federal Register of February
25, 2020 (85 FR 10642) (FRL–10000–85),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
revised pesticide petition (PP 8F8708)
by FMC Corporation, 2929 Walnut
Street, Philadelphia, PA 19104. The
petition requested that 40 CFR 180.564
be amended by establishing tolerances
for residues of the insecticide
indoxacarb, [(S)-methyl 7-chloro-2,5dihydro-2-[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]amino]carbonyl]indeno
[1,2e][1,3,4]oxadiazine-4a(3H)carboxylate], and its R-enantiomer [(R)methyl 7 chloro-2,5-dihydro2[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno [1,2e][1,3,4]oxadiazine-4a(3H)-carboxylate],
in or on corn, pop, grain at 0.02 parts
per million (ppm) and corn, pop, stover
at 15 ppm. That document referenced a
corrected summary of the petition
prepared by FMC Corporation, the
registrant, which is available in the
docket, https://www.regulations.gov.
EPA published this document in
response to a comment received from
FMC Corporation in response to a
previously published notice of filing of
August 2, 2019. In a comment submitted
in response to that August 2, 2019
document, FMC Corporation noted that
the August 2, 2019 notice indicated that
E.I. du Pont de Nemours had filed the
petition and that the incorrect petition
summary was contained in the docket.
EPA also noticed that the originally
submitted petition did not actually
request tolerances for residues of
indoxacarb in or on popcorn
commodities, despite the intent to do
so. As a result, FMC Corporation
submitted a revised petition, including
a corrected summary of the petition, to
correct the original notice error. One
public comment was received in
response to the corrected notice of
filing. EPA’s response to this comment
is discussed in Unit IV.C.
Based upon review of the data
supporting the referenced petition, EPA
is establishing a tolerance for residues of
indoxacarb in or on corn, pop, grain and
corn, pop, stover.
III. Aggregate Risk Assessment and
Determination of Safety
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.’’
PO 00000
Frm 00031
Fmt 4700
Sfmt 4700
31387
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. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance 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. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for indoxacarb in or
on corn, pop, grain and corn, pop,
stover.
In the Federal Register on December
8, 2017 (82 FR 57860) (FRL–9970–39),
EPA published a final rule establishing
a tolerance for residues of the
insecticide indoxacarb in or on corn,
field, forage; corn, field, grain; and corn,
field, stover based on the Agency’s
determination that aggregate exposure to
indoxacarb is safe for the U.S. general
population, including infants and
children. Because the toxicity profile for
indoxacarb has not changed since that
last rule was published, EPA is
incorporating the discussion of that
profile (Unit III.A.) and the identified
toxicological endpoints (Unit III.B.) as
part of this rulemaking.
EPA’s 2017 exposure assessment
remains current in providing an up-todate assessment of indoxacarb, as that
assessment included exposures to
indoxacarb in or on popcorn
commodities as reflected in this
document. Based on the current and
newly proposed uses of indoxacarb in or
on corn, pop, grain and corn, pop,
stover, exposures can occur both from
dietary sources (food + water) and in
residential settings. For aggregate risk
assessment, risk estimates resulting
from food, drinking water, and
residential uses are combined. Acute,
short-and intermediate-term, and longterm (chronic) aggregate assessments
were performed for indoxacarb. Further
information about EPA’s risk assessment
and determination of safety supporting
the tolerances established in the
E:\FR\FM\26MYR1.SGM
26MYR1
31388
Federal Register / Vol. 85, No. 101 / Tuesday, May 26, 2020 / Rules and Regulations
December 8, 2017 Federal Register
action, as well as the new indoxacarb
tolerances can be found at https://
www.regulations.gov in the documents
entitled ‘‘Indoxacarb: Human Health
Risk Assessment for Indoxacarb to
Support the Proposed New Uses on
Corn (Field, Pop, and Grown for Seed),’’
dated October 24, 2017 (docket ID EPA–
HQ–OPP–2017–0095), and ‘‘Indoxacarb.
Section 3 Registration for the New Use
of Indoxacarb on Popcorn. Abbreviated
Residue Chemistry Review,’’ dated
September 16, 2019 (docket ID EPA–
HQ–OPP–2019–0384), respectively.
The acute dietary risk estimates
determined for indoxacarb (food +
water) were found not to be of concern
at the 99.9th exposure percentile for the
U.S. general population and all
population subgroups and are below the
Agency’s LOC (<100% of the acute
population adjusted dose (aPAD)). In
addition, the chronic dietary risk
estimates determined for indoxacarb
(food + water) were found not to be of
concern for the U.S. general population
and all population subgroups and are
below the Agency’s LOC (<100% of the
chronic population adjusted dose
(cPAD)). As indicated in the supporting
documents, the acute and chronic
dietary risks are below the Agency’s
level of concern: 56% of the aPAD for
children 1–2 years old, the group with
the highest exposure level; 35% of the
cPAD for all infants (less than 1 year
old), the group with the highest
exposure level.
The acute aggregate assessment is
based on food + drinking water
exposures only, because there are no
acute residential exposures expected.
For the short-, intermediate- and longterm (chronic) aggregates, the highest
non-dietary exposure scenarios were
selected as being protective of all other
potential exposure scenarios—these
were from spot treatments to carpets
[coarse and pin stream] for short-term
exposures, and from spot-on treatments
of dogs for intermediate- and long-term
exposures. There are no acute, shortterm, intermediate-term, or long-term
(chronic) aggregate risk estimates of
concern for adult or child aggregate
exposure to indoxacarb as a result of the
current and proposed uses (short-term
aggregate margin of exposure (MOE) =
120; intermediate-/long-term aggregate
MOE = 260) because EPA considers
MOEs of less than 100 to be of concern
for aggregate risk.
Therefore, based on the risk
assessments and information described
above, EPA concludes there is a
reasonable certainty that no harm will
result to the U.S. general population, or
to infants and children, from aggregate
VerDate Sep<11>2014
16:12 May 22, 2020
Jkt 250001
exposure to indoxacarb residues. More
detailed information on the subject
action to establish tolerances in or on
corn, pop, grain and corn, pop, stover
can be found at https://
www.regulations.gov in the document
entitled ‘‘Indoxacarb. Section 3
Registration for the New Use of
Indoxacarb on Popcorn. Abbreviated
Residue Chemistry Review.’’ This
document can be found in docket ID
number EPA–HQ–OPP–2019–0384.
IV. Other Considerations
A. Analytical Enforcement Methodology
For the enforcement of tolerances
established on crops, two High
Performance Liquid Chromatograph/
Ultraviolet Detection (HPLC/UV)
methods, DuPont protocols AMR 2712–
93 and DuPont–11978, are available for
use. The limits of quantitation (LOQs)
for these methods range from 0.01 to
0.05 ppm for a variety of plant
commodities. A third procedure, Gas
Chromatograph/Mass-Selective
Detection (GC/MSD), DuPont method
AMR 3493–95 Supplement No. 4, is also
available for the confirmation of
residues in plants.
The method 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.
B. 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 MRLs in corn, pop, grain
and corn, pop, stover for indoxacarb.
C. Response to Comments
EPA received one public comment in
response to the corrected notice of
PO 00000
Frm 00032
Fmt 4700
Sfmt 4700
filing, generally opposed to any
indoxacarb residues in or on corn, pop,
grain and corn, pop, stover. Although
the Agency recognizes that some
individuals believe that pesticides
should be banned on agricultural crops,
the existing legal framework provided
by section 408 of the FFDCA states that
tolerances may be set when persons
seeking such tolerances or exemptions
have demonstrated that the pesticide
meets the safety standard imposed by
that statute. This comment appears to be
directed at the underlying statute and
not EPA’s implementation of it; the
comment provides no information
relevant to the Agency’s safety
determination.
V. Conclusion
Therefore, tolerances are established
for residues of the insecticide
indoxacarb in or on corn, pop, grain at
0.02 parts per million (ppm) and corn,
pop, stover at 15 ppm.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. 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 final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
E:\FR\FM\26MYR1.SGM
26MYR1
Federal Register / Vol. 85, No. 101 / Tuesday, May 26, 2020 / Rules and Regulations
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, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
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, the Agency 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
Agency 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).
VII. 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: May 7, 2020.
Michael L. Goodis,
Director, Registration Division, 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:
■
VerDate Sep<11>2014
16:12 May 22, 2020
Jkt 250001
Authority: 21 U.S.C. 321(q), 346a and 371.
31389
and will remain on the NPL. The EPA
and the State of Montana, through the
Montana Department of Environmental
Quality, have determined that all
appropriate response actions under
CERCLA, other than operation and
§ 180.564 Indoxacarb; tolerances for
maintenance, monitoring and five-year
residues.
reviews, have been completed.
However, the deletion of these parcels
(a) * * *
does not preclude future actions under
(1) * * *
Superfund.
Parts per
DATES: This action is effective May 26,
Commodity
million
2020.
ADDRESSES: EPA has established a
docket for this action under Docket
*
*
*
*
*
Corn, pop, grain ....................
0.02 Identification No. EPA–HQ–SFUND–
Corn, pop, stover ..................
15 2002–0008. All documents in the docket
are listed on the https://
*
*
*
*
*
www.regulations.gov website. Although
listed in the index, some information is
*
*
*
*
*
not publicly available, i.e., Confidential
[FR Doc. 2020–10483 Filed 5–22–20; 8:45 am]
Business Information or other
BILLING CODE 6560–50–P
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
ENVIRONMENTAL PROTECTION
is not placed on the internet and will be
AGENCY
publicly available only in hard copy
form. Publicly available docket
40 CFR Part 300
materials are available electronically in
[EPA–HQ–SFUND–2002–0008; FRL–10008–
https://www.regulations.gov; by calling
19–Region 8]
EPA Region 8 at (303) 312–7279 and
leaving a message; and at the EPA Info
National Oil and Hazardous
Center, 108 E 9th Street, Libby, MT
Substances Pollution Contingency
59923, (406) 293–6194, Monday through
Plan; National Priorities List: Partial
Thursday from 8:00 a.m.–4:00 p.m.
Deletion of the Libby Asbestos
FOR FURTHER INFORMATION CONTACT:
Superfund Site
Dania Zinner, Remedial Project
Manager, U.S. Environmental Protection
AGENCY: Environmental Protection
Agency, Region 8, 1595 Wynkoop
Agency.
Street, Mailcode: 8SEM–RB, Denver, CO
ACTION: Final rule; partial deletion.
80202–1129, email: zinner.dania@
SUMMARY: The Environmental Protection epa.gov.
Agency (EPA) Region 8 announces the
SUPPLEMENTARY INFORMATION: The
deletion of the Operable Unit 1 (OU1),
portion of the site to be deleted from the
Former Export Plant of the Libby
NPL is: OU1, Lincoln County, MT. A
Asbestos Superfund Site (Site) located
Notice of Intent for Partial Deletion for
in Lincoln County, Montana, from the
this Site was published in the Federal
National Priorities List (NPL). The NPL, Register (85 FR 4249) on January 24,
promulgated pursuant to section 105 of
2020.
the Comprehensive Environmental
The closing date for comments on the
Response, Compensation, and Liability
Notice of Intent for Partial Deletion was
Act (CERCLA) of 1980, as amended, is
February 24, 2020. Two public
an appendix of the National Oil and
comments were received. The
Hazardous Substances Pollution
comments did not object to the deletion;
Contingency Plan (NCP). This partial
they highlighted management of
deletion pertains to OU1. Operable Unit institutional controls and updating the
2 (OU2), Former Screening Plant, was
operations and maintenance plan as
deleted from the NPL on April 10, 2019. appropriate in the future. EPA believes
Operable Unit 3 (OU3), Former
the partial deletion action is
Vermiculite Mine; Operable Unit 4 and
appropriate. A responsiveness summary
Operable Unit 7 (OU4/OU7),
was prepared and placed in both the
Residential/Commercial Properties of
docket, EPA–HQ–SFUND–2002–0008,
Libby and Troy; Operable Unit 5 (OU5), on www.regulations.gov, and in the
Former Stimson Lumber Mill; Operable
local repositories listed above.
Unit 6 (OU6), BNSF Rail Corridor; and
EPA maintains the NPL as the list of
Operable Unit 8 (OU8), Highways and
sites that appear to present a significant
Roadways, are not being considered for
risk to public health, welfare, or the
deletion as part of this proposed action
environment. Deletion of a site from the
2. In § 180.564, add alphabetically the
entries ‘‘Corn, pop, grain’’ and ‘‘Corn,
pop, stover’’ to the table in paragraph (a)
to read as follows:
■
PO 00000
Frm 00033
Fmt 4700
Sfmt 4700
E:\FR\FM\26MYR1.SGM
26MYR1
]]>Agencies
[Federal Register Volume 85, Number 101 (Tuesday, May 26, 2020)]
[Rules and Regulations]
[Pages 31386-31389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10483]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0384; FRL-9995-89]
Indoxacarb; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of the
insecticide indoxacarb in or on corn, pop, grain at 0.02 parts per
million (ppm) and corn, pop, stover at 15 ppm. FMC Corporation
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective May 26, 2020. Objections and
requests for hearings must be received on or before July 27, 2020, 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-2019-0384 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. 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: Michael L. Goodis, Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Avenue 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).
[[Page 31387]]
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 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, 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-2019-0384 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
July 27, 2020. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b). 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-2019-0384, 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. Summary of Petitioned-For Tolerance
In the Federal Register of February 25, 2020 (85 FR 10642) (FRL-
10000-85), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of a revised pesticide
petition (PP 8F8708) by FMC Corporation, 2929 Walnut Street,
Philadelphia, PA 19104. The petition requested that 40 CFR 180.564 be
amended by establishing tolerances for residues of the insecticide
indoxacarb, [(S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)-phenyl]amino]carbonyl]indeno[1,2e][1,3,4]oxadiazine-
4a(3H)-carboxylate], and its R-enantiomer [(R)-methyl 7 chloro-2,5-
dihydro-2[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]
amino]carbonyl]indeno [1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate], in
or on corn, pop, grain at 0.02 parts per million (ppm) and corn, pop,
stover at 15 ppm. That document referenced a corrected summary of the
petition prepared by FMC Corporation, the registrant, which is
available in the docket, https://www.regulations.gov.
EPA published this document in response to a comment received from
FMC Corporation in response to a previously published notice of filing
of August 2, 2019. In a comment submitted in response to that August 2,
2019 document, FMC Corporation noted that the August 2, 2019 notice
indicated that E.I. du Pont de Nemours had filed the petition and that
the incorrect petition summary was contained in the docket. EPA also
noticed that the originally submitted petition did not actually request
tolerances for residues of indoxacarb in or on popcorn commodities,
despite the intent to do so. As a result, FMC Corporation submitted a
revised petition, including a corrected summary of the petition, to
correct the original notice error. One public comment was received in
response to the corrected notice of filing. EPA's response to this
comment is discussed in Unit IV.C.
Based upon review of the data supporting the referenced petition,
EPA is establishing a tolerance for residues of indoxacarb in or on
corn, pop, grain and corn, pop, stover.
III. Aggregate Risk Assessment and Determination of Safety
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.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance 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. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for indoxacarb in or on corn, pop,
grain and corn, pop, stover.
In the Federal Register on December 8, 2017 (82 FR 57860) (FRL-
9970-39), EPA published a final rule establishing a tolerance for
residues of the insecticide indoxacarb in or on corn, field, forage;
corn, field, grain; and corn, field, stover based on the Agency's
determination that aggregate exposure to indoxacarb is safe for the
U.S. general population, including infants and children. Because the
toxicity profile for indoxacarb has not changed since that last rule
was published, EPA is incorporating the discussion of that profile
(Unit III.A.) and the identified toxicological endpoints (Unit III.B.)
as part of this rulemaking.
EPA's 2017 exposure assessment remains current in providing an up-
to-date assessment of indoxacarb, as that assessment included exposures
to indoxacarb in or on popcorn commodities as reflected in this
document. Based on the current and newly proposed uses of indoxacarb in
or on corn, pop, grain and corn, pop, stover, exposures can occur both
from dietary sources (food + water) and in residential settings. For
aggregate risk assessment, risk estimates resulting from food, drinking
water, and residential uses are combined. Acute, short-and
intermediate-term, and long-term (chronic) aggregate assessments were
performed for indoxacarb. Further information about EPA's risk
assessment and determination of safety supporting the tolerances
established in the
[[Page 31388]]
December 8, 2017 Federal Register action, as well as the new indoxacarb
tolerances can be found at https://www.regulations.gov in the documents
entitled ``Indoxacarb: Human Health Risk Assessment for Indoxacarb to
Support the Proposed New Uses on Corn (Field, Pop, and Grown for
Seed),'' dated October 24, 2017 (docket ID EPA-HQ-OPP-2017-0095), and
``Indoxacarb. Section 3 Registration for the New Use of Indoxacarb on
Popcorn. Abbreviated Residue Chemistry Review,'' dated September 16,
2019 (docket ID EPA-HQ-OPP-2019-0384), respectively.
The acute dietary risk estimates determined for indoxacarb (food +
water) were found not to be of concern at the 99.9th exposure
percentile for the U.S. general population and all population subgroups
and are below the Agency's LOC (<100% of the acute population adjusted
dose (aPAD)). In addition, the chronic dietary risk estimates
determined for indoxacarb (food + water) were found not to be of
concern for the U.S. general population and all population subgroups
and are below the Agency's LOC (<100% of the chronic population
adjusted dose (cPAD)). As indicated in the supporting documents, the
acute and chronic dietary risks are below the Agency's level of
concern: 56% of the aPAD for children 1-2 years old, the group with the
highest exposure level; 35% of the cPAD for all infants (less than 1
year old), the group with the highest exposure level.
The acute aggregate assessment is based on food + drinking water
exposures only, because there are no acute residential exposures
expected. For the short-, intermediate- and long-term (chronic)
aggregates, the highest non-dietary exposure scenarios were selected as
being protective of all other potential exposure scenarios--these were
from spot treatments to carpets [coarse and pin stream] for short-term
exposures, and from spot-on treatments of dogs for intermediate- and
long-term exposures. There are no acute, short-term, intermediate-term,
or long-term (chronic) aggregate risk estimates of concern for adult or
child aggregate exposure to indoxacarb as a result of the current and
proposed uses (short-term aggregate margin of exposure (MOE) = 120;
intermediate-/long-term aggregate MOE = 260) because EPA considers MOEs
of less than 100 to be of concern for aggregate risk.
Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the U.S. general population, or to infants and children, from
aggregate exposure to indoxacarb residues. More detailed information on
the subject action to establish tolerances in or on corn, pop, grain
and corn, pop, stover can be found at https://www.regulations.gov in the
document entitled ``Indoxacarb. Section 3 Registration for the New Use
of Indoxacarb on Popcorn. Abbreviated Residue Chemistry Review.'' This
document can be found in docket ID number EPA-HQ-OPP-2019-0384.
IV. Other Considerations
A. Analytical Enforcement Methodology
For the enforcement of tolerances established on crops, two High
Performance Liquid Chromatograph/Ultraviolet Detection (HPLC/UV)
methods, DuPont protocols AMR 2712-93 and DuPont-11978, are available
for use. The limits of quantitation (LOQs) for these methods range from
0.01 to 0.05 ppm for a variety of plant commodities. A third procedure,
Gas Chromatograph/Mass-Selective Detection (GC/MSD), DuPont method AMR
3493-95 Supplement No. 4, is also available for the confirmation of
residues in plants.
The method 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].
B. 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 MRLs in corn, pop, grain and corn, pop, stover for
indoxacarb.
C. Response to Comments
EPA received one public comment in response to the corrected notice
of filing, generally opposed to any indoxacarb residues in or on corn,
pop, grain and corn, pop, stover. Although the Agency recognizes that
some individuals believe that pesticides should be banned on
agricultural crops, the existing legal framework provided by section
408 of the FFDCA states that tolerances may be set when persons seeking
such tolerances or exemptions have demonstrated that the pesticide
meets the safety standard imposed by that statute. This comment appears
to be directed at the underlying statute and not EPA's implementation
of it; the comment provides no information relevant to the Agency's
safety determination.
V. Conclusion
Therefore, tolerances are established for residues of the
insecticide indoxacarb in or on corn, pop, grain at 0.02 parts per
million (ppm) and corn, pop, stover at 15 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. 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
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory
[[Page 31389]]
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, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency 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, the Agency 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 Agency 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).
VII. 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: May 7, 2020.
Michael L. Goodis,
Director, Registration Division, 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. In Sec. 180.564, add alphabetically the entries ``Corn, pop,
grain'' and ``Corn, pop, stover'' to the table in paragraph (a) to read
as follows:
Sec. 180.564 Indoxacarb; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Corn, pop, grain........................................ 0.02
Corn, pop, stover....................................... 15
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2020-10483 Filed 5-22-20; 8:45 am]
BILLING CODE 6560-50-P
