[Federal Register Volume 87, Number 47 (Thursday, March 10, 2022)]
[Rules and Regulations]
[Pages 13636-13640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05060]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0355; FRL-9565-01-OCSPP]
Novaluron; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
novaluron in or on Almond, hulls and the Tree nut group 14-12.
Makhteshim Agan of North America (ADAMA) requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective March 10, 2022. Objections and
requests for hearings must be received on or before May 9, 2022, 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-2021-0355, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP Docket is (202) 566-1744.
Due to the public health concerns relating to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide customer service via
email, phone, and webform. For the latest status information on EPA/DC
services, docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director,
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 Office of the
Federal Register's e-
[[Page 13637]]
CFR site at https://www.ecfr.gov/current/title-40.
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-2021-0355 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
May 9, 2022. 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-2021-0355, 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/where-send-comments-epa-dockets.
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 June 28, 2021 (86 FR 33922) (FRL-10025-
08) 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
0F8872) by Makhteshim Agan of North America, Inc. (d/b/a ADAMA), 3120
Highwoods Boulevard, Suite 100, Raleigh, NC 27604. The petition
requested to establish tolerances for residues of the insecticide
novaluron in or on Tree nuts, nutmeat (Crop Group 14-12) at 0.07 parts
per million (ppm) and Almond, hulls at 15.0 ppm. That document
referenced a summary of the petition, which is available in the docket,
https://www.regulations.gov. There were no comments received in
response to the notice of filing.
Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
is establishing the tolerances at different levels than petitioned for
and is modifying the crop group definition to be consistent with Agency
terminology. A discussion of these modifications can be found in
section IV.C.
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 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 by this action. EPA's assessment of exposures
and risks associated with novaluron follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemaking of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemaking, and EPA considers referral back to those sections
as sufficient to provide an explanation of the information EPA
considered in making its safety determination for the new rulemaking.
EPA has previously published tolerance rulemakings as well as an
interim decision to support registration review for novaluron in which
EPA concluded, based on the available information, that there is a
reasonable certainty that no harm would result from aggregate exposure
to novaluron and established tolerances for residues of that chemical.
EPA is incorporating previously published sections from these
rulemakings as described further in this rulemaking, as they remain
unchanged.
Toxicological profile. For a discussion of the Toxicological
Profile of novaluron, see Unit III.A. of the novaluron tolerance
rulemaking published in the Federal Register of July 22, 2015 (80 FR
43329) (FRL-9929-57), which was not modified by the Novaluron Interim
Registration Review Decision (https://www.regulations.gov/document/EPA-HQ-OPP-2015-0171-0063).
Toxicological Points of Departure/Levels of Concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for
novaluron used for human risk assessment, please reference Unit III.B.
of the July 22, 2015, rulemaking as well as the Novaluron Interim
Registration Review Decision.
Exposure assessment. EPA's dietary exposure assessments have been
updated to include the additional exposure from the new uses of
novaluron on the tree nut group 14-12 and almond hulls. 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. The chronic dietary exposure
and risk assessment 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.''
[[Page 13638]]
Anticipated residue and PCT information. Section 408(b)(2)(E) of
FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
Updated average percent crop treated values were used for the
following crops that are currently registered for novaluron: Apples
(10%), broccoli (<1%), cabbage (5%), cantaloupe (<1%), cauliflower
(<1%), cherries (<1%), cotton (5%), dry beans/peas (<1%), peaches
(<1%), peanuts (5%), pears (25%), peppers (5%), plums/prunes (<1%),
potatoes (5%), pumpkins (<1%), sorghum (<1%), squash (<1%),
strawberries (45%), sugarcane (<1%), sweet corn (<1%), tomatoes
(<2.5%), and watermelons (<1%).
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figure for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding to
the nearest 5%, except for those situations in which the average PCT is
less than 1% or less than 2.5%. In those cases, the Agency would use
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
The Agency believes that Conditions a, b, and c discussed above
have been met. With respect to Condition a, PCT estimates are derived
from Federal and private market survey data, which are reliable and
have a valid basis. The Agency is reasonably certain that the
percentage of the food treated is not likely to be an underestimation.
As to Conditions b and c, regional consumption information and
consumption information for significant subpopulations is taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
reliable information on the regional consumption of food to which
novaluron may be applied in a particular area.
Drinking water and non-occupational exposures. An updated drinking
water assessment (DWA) for the proposed use of novaluron on tree nuts
(Crop Group 14-12) was conducted. The maximum screening-level estimated
drinking water concentrations (EDWCs) for uses on tree nuts are 9.6 ppb
(acute) and 0.89 ppb (chronic) from surface water sources. The
calculated EDWCs for these commodities do not supersede the previously
used EDWCs of 31 ppb (acute) and 8.4 ppb (chronic). Therefore, the
previously recommended EDWCs remain current and are considered
protective potential drinking water residue levels anticipated from the
proposed tolerance updates to tree nuts. As stated in the August 13,
2020, rulemaking (85 FR 49261) (FRL-10011-78), the chronic dietary
exposure and risk assessment incorporate the highest total EDWC of 8.4
parts per billion directly into this dietary assessment. The
residential exposure assessment has not changed since the 2015 final
rule because there are no proposed new residential uses. For a summary
of the residential exposure analysis for novaluron used for the human
risk assessment, please reference Unit III.C.3. of the July 22, 2015,
rulemaking.
Cumulative exposure. Section 408(b)(2)(D)(v) of FFDCA requires
that, when considering whether to establish, modify, or revoke a
tolerance, the Agency consider ``available information'' concerning the
cumulative effects of a particular pesticide's residues and ``other
substances that have a common mechanism of toxicity.'' Unlike other
pesticides for which EPA has followed a cumulative risk approach based
on a common mechanism of toxicity, EPA has not made a common mechanism
of toxicity finding as to novaluron and any other substances and
novaluron does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this action, therefore, EPA has
not assumed that novaluron has a common mechanism of toxicity with
other substances.
Safety Factor for Infants and Children. EPA continues to conclude
that there are reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit
III.D. of the July 22, 2015, rulemaking for a discussion of the
Agency's rationale for that determination.
Aggregate risks and determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
aggregate exposure estimates to the acute population-adjusted dose
(aPAD) and chronic population-adjusted dose (cPAD). Short-,
intermediate-, and chronic-term risks are evaluated by comparing the
estimated aggregate food, water, and residential exposure to the
appropriate points of departure to ensure that an adequate margin of
exposure (MOE) exists. For linear cancer risks, EPA calculates the
lifetime probability of acquiring cancer given the estimated aggregate
exposure.
An acute dietary exposure assessment was not performed as there
were no
[[Page 13639]]
appropriate toxicological effects attributable to a single exposure
(dose) observed in available oral toxicity studies, including maternal
toxicity in the developmental toxicity studies. Chronic dietary risks
are below the Agency's level of concern of 100% of the cPAD; they are
47% of the cPAD for children 1 to 2 years old, the group with the
highest exposure. The combined short- and intermediate-term food,
water, and residential exposures result in aggregate MOEs of 3,500 for
adults and 250 for children 1 to 2 years old. These MOEs are greater
than the level of concern of 100 and are therefore not of concern.
Novaluron is classified as ``Not Likely to Be Carcinogenic to Humans'';
therefore, EPA does not expect novaluron exposures to pose an aggregate
cancer 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 general population, or to infants and children, from
aggregate exposure to novaluron residues. More detailed information on
this action can be found in the document titled ``Novaluron. Human
Health Risk Assessment for Proposed New Uses on Nut, Tree, Group 14-
12'' in docket ID EPA-HQ-OPP-2021-0355.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the July 22, 2015, rulemaking.
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).
There are no Codex MRLs for either Almond, hulls or the Nut, tree,
group 14-12 crop group; therefore, harmonization is not an issue.
C. Revisions to Petitioned-For Tolerances
The Agency is establishing a 0.08 ppm tolerance level for Nut,
tree, group 14-12, rather than at 0.07 ppm as proposed by the
petitioner. The petitioner used the Organization for Economic Co-
operation and Development (OECD) tolerance calculator but combined the
almond and pecan data sets. EPA separately input the almond and pecan
nutmeat data, which resulted in the higher residue. EPA is therefore
using a tolerance level of 0.08 ppm (from almond data) as it is the
higher of the two results. The commodity definition for ``Tree nuts,
nutmeat (Crop Group 14-12)'' is also being modified to ``Nut, tree,
group 14-12'' to be consistent with Agency nomenclature. EPA also
revised the tolerance level for Almond, hulls to be consistent with the
OECD rounding class practice.
V. Conclusion
Therefore, tolerances are established for residues of novaluron in
or on Almond, hulls at 15 ppm and the Nut, tree, group 14-12 at 0.08
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 to Executive Order 13045,
entitled ``Protection of Children from Environmental Health Risks and
Safety Risks'' (62 FR 19885, April 23, 1997). This action does not
contain any information collections subject to OMB approval under the
Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it
require any special considerations under Executive Order 12898,
entitled ``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances 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).
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: March 4, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
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. Section 180.598(a) is amended by:
0
a. Adding a table heading; and
[[Page 13640]]
0
b. Adding the commodities ``Almond, hulls'' and ``Nut, tree, group 14-
12'' to the table in alphabetical order.
The additions read as follows:
Sec. 180.598 Novaluron; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
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Almond, hulls............................................... 15
* * * * *
Nut, tree, group 14-12...................................... 0.08
* * * * *
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[FR Doc. 2022-05060 Filed 3-9-22; 8:45 am]
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