[Federal Register Volume 85, Number 157 (Thursday, August 13, 2020)]
[Rules and Regulations]
[Pages 49261-49264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16457]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0249; FRL-10011-78]
Novaluron; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes and modifies tolerances for
residues of novaluron in or on multiple commodities which are
identified and discussed later in this document. Interregional Research
Project Number 4 (IR-4) requested these tolerances and modifications
under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective August 13, 2020. Objections and
requests for hearings must be received on or before October 13, 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-2019-0249, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805.
Please note that due to the public health emergency, the EPA Docket
Center (EPA/DC) and Reading Room was closed to public visitors on March
31, 2020. Our EPA/DC staff will continue to provide customer service
via email, phone, and webform. For further information on EPA/DC
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), 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 EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2019-0249 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
October 13, 2020. 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-2019-0249, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of August 30, 2019 (84 FR 45702) (FRL-9998-
15), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
9E8746) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition requested to amend 40 CFR 180.598 by
establishing tolerances for residues of the insecticide novaluron,
including its metabolites and degradates, in or on the following
commodities: Brassica, leafy greens, subgroup 4-16B at 25 parts per
million (ppm); cottonseed subgroup 20C at 0.6 ppm; kohlrabi at 0.7 ppm;
sunflower subgroup 20B at 0.07 ppm; tropical and subtropical, small
fruit, inedible peel, subgroup 24A at 9 ppm;
[[Page 49262]]
and vegetable, brassica, head and stem, group 5-16 at 0.7 ppm; and by
modifying the existing tolerance on vegetable, fruiting, group 8-10
from 1.0 ppm to 1.5 ppm due to the proposed use on greenhouse grown
peppers. The document also requested to remove the established
tolerances in or on the following commodities: Brassica, head and stem,
subgroup 5A at 0.50 ppm; brassica, leafy greens, subgroup 5B at 25 ppm;
cotton, undelinted seed at 0.60 ppm; and turnip, greens at 25 ppm
because these commodities would be covered by the new tolerances
established for the crop group expansions and conversions above.
That document referenced a summary of the petition prepared by
Makhteshim (d/b/a ADAMA), the registrant, which is available in the
docket, http://www.regulations.gov. A comment was received in response
to the notice of filing. EPA's response to this comment is discussed in
Unit IV.C.
Based upon review of the data supporting the petition, EPA is
establishing and modifying tolerances that vary from what was
requested. The reason for these changes is explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of the 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 the 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 the 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 therein, 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 novaluron, including exposure resulting from the
tolerances established or modified by this action. EPA's assessment of
exposures and risks associated with novaluron follows.
On July 22, 2015, EPA published in the Federal Register a final
rule establishing tolerances for residues of novaluron in or on
multiple agricultural commodities based on the Agency's conclusion that
aggregate exposure to novaluron is safe for the general population,
including infants and children. See 80 FR 43329 (FRL-9929-57). EPA is
incorporating the following portions of that document by reference
here, as they have not changed in the Agency's current assessment of
exposures and risks associated with novaluron: The toxicological
profile and points of departure, certain assumptions for exposure
assessment, cumulative effects from substances with a common mechanism
of toxicity, and the Agency's determination regarding the children's
safety factor.
EPA's dietary exposure assessments have been updated to include the
additional exposure from the new uses of novaluron on the tropical and
subtropical, small fruit, inedible peel, subgroup 24A, the sunflower
subgroup 20B, and greenhouse-grown peppers; the crop group expansion
for the cottonseed subgroup 20C; and the crop group conversions for
Brassica, leafy greens, subgroup 4-16B, the vegetable, Brassica, head
and stem, group 5-16, and kohlrabi. An acute dietary exposure
assessment was not performed as there are no appropriate toxicological
effects attributable to a single exposure (dose). A partially refined
chronic dietary (food and drinking water) exposure and risk assessment
was conducted that incorporated tolerance-level residues for the
proposed new uses, crop group expansions, and crop group conversions.
The chronic analysis also incorporated average percent crop treated
(PCT) data for several registered commodities. For the remaining
commodities, 100 PCT was assumed. Anticipated residues for meat, milk,
hog, and poultry commodities were incorporated as well. A cancer
dietary assessment was not conducted because novaluron is classified as
``not likely to be carcinogenic to humans.'' In addition, the chronic
dietary exposure and risk assessment incorporated the highest total
estimated drinking water concentration of 8.4 parts per billion into
this dietary assessment. EPA's aggregate exposure assessment
incorporated this additional assumed dietary exposure in food and
drinking water and residential exposure for existing uses; the
residential exposure assessment has not changed since the 2015 final
rule because no new residential uses are being added by this action.
Chronic dietary risks are below the Agency's level of concern of
100% of the chronic population adjusted dose (cPAD); they are estimated
to be 50% of the cPAD for children 1 to 2 years old, the population
subgroup with the highest exposure estimate. Short- and intermediate-
term aggregate (dietary and residential) margins of exposure (MOEs) are
3,400 for adults and 420 for children 1-2 years old, which are not of
concern because they are greater than EPA's levels of concern (MOEs
less than or equal to 100). There are no anticipated long-term
exposures because the pet spot-on use of novaluron was voluntarily
cancelled in 2017, so the long-term aggregate assessment is equivalent
to the chronic dietary.
Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to novaluron residues. Further information about
EPA's risk assessment and determination of safety supporting the
tolerances established and modified in this regulation can be found at
http://www.regulations.gov in the document titled, ``Novaluron. Human
Health Risk Assessment for Proposed New Uses on Tropical and
Subtropical, Small Fruit, Inedible Peel, Subgroup 24A; Sunflower
Subgroup 20B; and Greenhouse-Grown Peppers; and Crop Group Expansion
for Cottonseed Subgroup 20C, and Crop Group Conversions for Brassica,
Leafy Greens, Subgroup 4-16B, Vegetable, Brassica, Head and Stem, Group
5-16, and Kohlrabi'' dated June 30, 2020 in docket ID number EPA-HQ-
OPP-2019-0249.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography/electron-
capture detection (GC/ECD) and high-performance liquid chromatography/
ultraviolet (HPLC/UV)) is available to enforce the tolerance
expression.
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
[[Page 49263]]
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 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.
Codex MRLs are established for residues of novaluron in mustard
greens (part of the Brassica, leafy greens, subgroup 4-16B), the group
of Brassica vegetables (which includes the commodities in the
vegetable, Brassica, head and stem, group 5-16 and kohlrabi), and
cotton seed (part of the cottonseed subgroup 20C) at the same levels as
the U.S. tolerances and are thus harmonized. There are no Codex MRLs
for any of the commodities in the tropical and subtropical, small
fruit, inedible peel, subgroup 24A or sunflower subgroup 20B and
therefore harmonization is not an issue. There are Canadian MRLs at 1
ppm and Codex MRLs at 0.7 ppm for pepper, bell; pepper, non-bell; and
tomato, which are the representative commodities in the vegetable,
fruiting, group 8-10. Based on the data submitted with this petition,
EPA is revising the existing tolerance in/on the vegetable, fruiting,
group 8-10 to be 2 ppm. Harmonization with the Canada or Codex MRLs is
not possible because lowering the tolerance could cause U.S. growers to
have violative residues despite using the pesticide according to the
label.
C. Response to Comments
One comment was received in response to the notice of filing that
stated in part that ``increasing the tolerance so that more pesticide
junk can be on brassica and turnips--that is a very bad idea.''
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 authorizes EPA to
establish tolerances when it determines that the tolerance is safe.
Upon consideration of the validity, completeness, and reliability of
the available data as well as other factors the FFDCA requires EPA to
consider, EPA has determined that the novaluron residue tolerances
established and modified by this action are safe. The commenter has
provided no information supporting a contrary conclusion.
D. Revisions to Petitioned-For Tolerances
The Agency is modifying the tolerance for vegetable, fruiting,
group 8-10 to 2 ppm, rather than 1.5 ppm as proposed by the petitioner.
The petitioner did not use the Organization for Economic Cooperation
and Development (OECD) tolerance calculator and instead estimated the
proposed tolerance level. To be conservative, EPA utilized all of the
submitted field trial data for greenhouse pepper (which is a
representative commodity in the vegetable, fruiting, group 8-10) at the
pre-harvest interval (PHI) which gave the highest residue levels,
because data showed that residues increased with increasing PHI. These
values were input into the OECD calculator.
Also, although the petitioner proposed a 0.6 ppm tolerance for the
cottonseed subgroup 20C, the Agency is establishing the tolerance at
0.5 ppm for harmonization with Codex. While the OECD calculator
determined a rounded tolerance of 0.6 ppm based on previously submitted
cotton field trial data, EPA concludes that a 0.5 ppm tolerance is
appropriate because it is based on the following conservative
tolerance-setting assumptions: Cottonseed is a blended commodity
(therefore, residues are likely to be lower), and field trials are
based on maximum application rates (which provides a ``worst-case''
residue level). Furthermore, the OECD calculator provided an unrounded
maximum residue limit (MRL) of 0.52 ppm, which is close to 0.5 ppm.
V. Conclusion
Therefore, tolerances are established for residues of novaluron in
or on Brassica, leafy greens, subgroup 4-16B at 25 ppm; cottonseed
subgroup 20C at 0.5 ppm; kohlrabi at 0.7 ppm; sunflower subgroup 20B at
0.07 ppm; tropical and subtropical, small fruit, inedible peel,
subgroup 24A at 9 ppm; and vegetable, Brassica, head and stem, Group 5-
16 at 0.7 ppm. Furthermore, the existing tolerance for vegetable,
fruiting, group 8-10 is modified from 1.0 ppm to 2 ppm. Lastly, the
following tolerances are removed as unnecessary due to the
establishment of the above tolerances: Brassica, head and stem,
subgroup 5A; Brassica, leafy greens, subgroup 5B; cotton, undelinted
seed; and turnip greens.
VI. Statutory and Executive Order Reviews
This action establishes and modifies 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 tolerances and
modifications 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
[[Page 49264]]
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: July 16, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons states in the preamble, the EPA amend 40
CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
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. 180.598, amend the table in paragraph (a) by:
0
a. Removing the entry for ``Brassica, head and stem, subgroup 5A'';
0
b. Adding in alphabetical order an entry for ``Brassica, leafy greens,
subgroup 4-16B'';
0
c. Removing the entries for ``Brassica, leafy greens, subgroup 5B'' and
``Cotton, undelinted seed'';
0
d. Adding in alphabetical order entries for ``Cottonseed subgroup
20C,'' ``Kohlrabi,'' ``Sunflower subgroup 20B,'' ``Tropical and
subtropical, small fruit, inedible peel, subgroup 24A'';
0
e. Removing the entry for ``Turnip greens'';
0
f. Adding in alphabetical order an entry for ``Vegetable, Brassica,
head and stem, Group 5-16''; and
0
g. Revising the entry for ``Vegetable, fruiting, group 8-10''.
The additions and revision read as follows:
Sec. 180.598 Novaluron; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
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* * * * * * *
Brassica, leafy greens, subgroup 4-16B.................. 25
* * * * * * *
Cottonseed subgroup 20C................................. 0.5
* * * * * * *
Kohlrabi................................................ 0.7
* * * * * * *
Sunflower subgroup 20B.................................. 0.07
* * * * * * *
Tropical and subtropical, small fruit, inedible peel, 9
subgroup 24A...........................................
Vegetable, Brassica, head and stem, Group 5-16.......... 0.7
* * * * * * *
Vegetable, fruiting, group 8-10......................... 2
* * * * * * *
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[FR Doc. 2020-16457 Filed 8-12-20; 8:45 am]
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