[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Rules and Regulations]
[Pages 72846-72851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27602]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0542; FRL-9199-01-OCSPP]
Bicyclopyrone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
bicyclopyrone in or on the fresh and dried forms of lemongrass,
rosemary, and wormwood. Syngenta Crop Protection, LLC., requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective December 23, 2021. Objections and
requests for hearings must be received on or before February 22, 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-2019-0542, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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-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, 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-2019-0542 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
February 22, 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-2019-0542, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting
[[Page 72847]]
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 April 22, 2021 (86 FR 21317) (FRL-10022-
59), and of June 1, 2021 (86 FR 29229) (FRL-10023-95), 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 9F8777) by Syngenta
Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419-8300. The
petition requested that 40 CFR part 180 be amended by establishing
tolerances for residues of the herbicide bicyclopyrone, 4-hydroxy-3-
{time} 2-[(2-methoxyethoxy)methyl{-6-(trifluoromethyl)
3pyridylcarbonyl{bicyclo[3.2.1]oct-3-en-2-one, in or on rosemary, fresh
at 0.03 parts per million (ppm); rosemary, dried at 0.3 ppm;
lemongrass, fresh at 0.3 ppm; lemongrass, dried at 0.5 ppm; wormwood,
fresh at 0.05 ppm and wormwood, dried at 0.09 ppm. That document
referenced a summary of the petition prepared by Syngenta Crop
Protection, LLC., the registrant, which is available in the docket,
https://www.regulations.gov. There were no comments received in
response to the notice of filing.
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 bicyclopyrone including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with bicyclopyrone
follows.[FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/
DATE][RULES][RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/
PREAMB][SUPLINF][HED]*[/HED]
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The bicyclopyrone database is considered complete for risk
assessment purposes.
Bicyclopyrone is a 4-hydroxyphenylpyruvate dioxygenase (HPPD)-
inhibiting chemical. HPPD is an enzyme involved in the catabolism of
tyrosine, an essential amino acid for mammals. Recently OPP evaluated
(HPPD Inhibiting Herbicides: State of the Science. 9/18/2020. Authors:
K. Yozzo and M. Perron) a proposed mode-of-action (MOA)/adverse-outcome
pathway (AOP) for HPPD inhibitors in mammals and determined there was
sufficient evidence to establish the MOA/AOP. The initiating event in
the MOA/AOP for HPPD-inhibiting chemicals, including bicyclopyrone,
involves binding of the chemical to the HPPD enzyme causing complete or
virtually complete enzyme inhibition, which leads to a build-up of
systemic tyrosine levels (tyrosinemia) and a spectrum of tyrosine-
mediated effects. In laboratory animals, these have been identified as
ocular and skeletal developmental effects.
Bicyclopyrone is classified as ``Suggestive Evidence of
Carcinogenic Potential'' based on the presence of rare ocular tumors in
male rats. The EPA has determined that using a non-linear approach
(i.e., chronic reference dose (cRfD)) will adequately account for all
chronic toxicity, including carcinogenicity that could result from
exposure to bicyclopyrone.
A complete discussion of the toxicological profile for
bicyclopyrone as well as specific information on the studies received
and the nature of the adverse effects caused by bicyclopyrone as well
as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies can be
found in the document titled ``Bicyclopyrone: Human Health Risk
Assessment for the Establishment of Permanent Tolerances for Residues
in/on Lemongrass, Rosemary, and Wormwood'' (hereinafter ``Bicyclopyrone
Human Health Risk Assessment'') in docket ID number EPA-HQ-OPP-2019-
0542 in regulations.gov.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which the NOAEL and the LOAEL are identified.
Uncertainty/safety factors are used in conjunction with the POD to
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of
exposure (MOE). For non-threshold risks, the Agency assumes that any
amount of exposure will lead to some degree of risk. Thus, the Agency
estimates risk in terms of the probability of an occurrence of the
adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
The ability of a species to clear excess tyrosine can impact its
sensitivity to HPPD-inhibiting chemicals and its relevance for human
health risk assessment. Therefore, during the evaluation of the MOA/AOP
for HPPD inhibitors in mammals, endpoints for human health risk
assessment of HPPD inhibitors, including bicyclopyrone, were selected
from studies available in mice and dogs. The developmental and
reproduction toxicity studies in mice
[[Page 72848]]
are not available for bicyclopyrone; however, mouse developmental and
reproduction toxicity studies for other HPPD inhibitors are available
for bridging across the chemical class. The reproduction toxicity study
for mesotrione (a HPPD inhibitor) provides the lowest point of
departure (no-observed adverse-effect level (NOAEL) = 71 mg/kg/day) for
these studies and was considered in conjunction with the bicyclopyrone
database for endpoint selection.
A summary of the toxicological endpoints for bicyclopyrone used for
human risk assessment can be found in the Bicyclopyrone Human Health
Risk Assessment in the docket.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to bicyclopyrone, EPA considered exposure under the
petitioned-for tolerances as well as all existing bicyclopyrone
tolerances in 40 CFR 180.682. EPA assessed dietary exposures from
bicyclopyrone in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
No such effects were identified in the toxicological studies for
bicyclopyrone; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the 2003-2008 food consumption data from the U.S.
Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA). As to
residue levels in food, EPA conducted a partially refined analysis that
assumed average field trial residues for registered crops, tolerance
levels for the proposed crops, average empirical processing factors for
registered crops, anticipated residues for livestock commodities, and
percent crop treated (PCT) for registered crop commodities.
iii. Cancer. Based on the data discussed in Unit III.A., EPA has
determined that a separate cancer exposure assessment does not need to
be conducted and that using a non-linear approach (i.e., reference dose
(RfD)) will adequately account for all chronic toxicity, including
carcinogenicity, that could result from exposure to bicyclopyrone.
iv. Anticipated residue and percent crop treated (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.
The chronic dietary assessment incorporated the following average
PCT estimates: Barley, 1%; field corn, 10%; sweet corn, 5%; pop corn,
10% (used the higher of the corn PCTs); and wheat, 5% (used spring
wheat PCT which was higher than winter wheat PCT). The PCT for
livestock commodities is based on the PCT value for the livestock feed
item used in the dietary burden with the highest percent crop treated
(field corn, 10%).[FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/
DATE][RULES][RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/
PREAMB][SUPLINF][HED]*[/HED]
In most cases, EPA uses available data from the United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the 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 the three conditions discussed in Unit
III.C.1.iv. 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 bicyclopyrone may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for bicyclopyrone in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of bicyclopyrone. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
The Surface Water Concentration Calculator (SWCC) computer model
was used to generate surface water Estimated
[[Page 72849]]
Drinking Water Concentrations (EDWCs), while the Pesticide Root Zone
Model for Groundwater (PRZM-GW) and the Screening Concentration in
Ground Water (SCI-GROW) models were used to generate groundwater EDWCs.
The maximum acute and chronic surface water EDWCs associated with
bicyclopyrone use were 3.43 and 1.02 parts per billion (ppb),
respectively. For groundwater sources of drinking water, the maximum
acute and chronic and cancer EDWCs of bicyclopyrone in shallow
groundwater from PRZM-GW were 4.82 and 4.2 ppb, respectively.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Bicyclopyrone is not
registered for any use patterns that would result in residential
exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. 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.''[FEDREG][VOL]*[/VOL][NO]*[/
NO][DATE]*[/DATE][RULES][RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/
SUBJECT][/PREAMB][SUPLINF][HED]*[/HED]
The Agency is required to consider the cumulative risks of
chemicals sharing a common mechanism of toxicity per OPP's Guidance For
Identifying Pesticide Chemicals and Other Substances that have a Common
Mechanism of Toxicity, which can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-identifying-pesticide-chemicals-and-other. As a result, the Agency has determined
that the (p-hydroxyphenyl-pyruvate dioxygenase) HPPD inhibitors,
including bicyclopyrone, share a common mechanism of toxicity as
discussed in the HPPD Inhibiting Herbicides: State of the Science paper
(HPPD Inhibiting Herbicides: State of the Science. 9/18/2020. Authors:
K. Yozzo and M. Perron). As explained in that document, the members of
this group share the ability to bind to and inhibit the HPPD enzyme
resulting in elevated systemic tyrosine levels and common apical
outcomes that are mediated by tyrosine, including ocular and
developmental effects. In 2021, after establishing a common mechanism
grouping for the HPPD inhibitors, the Agency conducted a cumulative
risk assessment (CRA) (J. Godshall; 30-June-2021; D462487) and
concluded that cumulative exposures to HPPD inhibitors (based on
proposed and registered pesticidal uses at the time the assessment was
conducted) did not present risks of concern.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
2. Prenatal and postnatal sensitivity. Although there is potential
evidence of neurotoxicity and increased quantitative susceptibility,
concern is low because neurotoxicity was only observed in the rat,
which is not considered a relevant model for evaluating HPPD
inhibitors, and selected endpoints are protective of the potential
sensitivity/susceptibility for animal models appropriate for evaluating
HPPD inhibitors.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X for all exposure scenarios, except for the
chronic dietary endpoint where the FQPA SF is being retained as a
database UF because of the use of a LOAEL as the point of departure
(UFL). That decision is based on the following findings:
i. The toxicity database for bicyclopyrone is complete.
ii. There is no evidence of neurotoxicity in the bicyclopyrone
database, including in the rat acute or subchronic neurotoxicity
studies; however, histopathological findings were observed in the
chronic dog study (swelling of the dorsal root ganglion and nerve fiber
degeneration). Concern is low since the chronic dietary endpoint is
based upon these effects, and these are the most sensitive effects in
the bicyclopyrone hazard database in one of them most appropriate
species for risk assessment.
iii. There was evidence of increased susceptibility in rat and
rabbit developmental studies for bicyclopyrone. Since developmental and
reproduction toxicity studies in mice are not available for
bicyclopyrone, mouse developmental and reproduction toxicity studies
for other HPPD inhibitors are available for bridging. In some
instances, increased quantitative susceptibility was also observed in
these mouse studies, including the 2-generation reproduction toxicity
study for mesotrione. Although there was evidence of increased
susceptibility, concern is low because: (1) Rat and rabbits were not
considered appropriate animal models for assessing human health risk
for HPPD inhibitors, (2) there are clear NOAEL/LOAEL values for the
observed developmental and offspring effects, (3) developmental/
offspring effects in mice for other HPPD inhibitors were seen at doses
>=600 mg/kg/day, except the mesotrione 2-generation reproduction
toxicity study, (4) the offspring LOAEL of 300 mg/kg/day in the
mesotrione reproduction toxicity study was set conservatively based on
a low incidence of opaque/cloudy eyes, and (5) selected endpoints are
protective of any potential sensitivity observed in mice.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary assessment does not underestimate exposure. In
addition, there are no currently proposed residential uses.
E. 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 PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
bicyclopyrone is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
bicyclopyrone from food and water will utilize 9.5% of the cPAD for all
infants, the population group receiving the greatest exposure.
[[Page 72850]]
3. Short-term risk. A short-term adverse effect was identified;
however, bicyclopyrone is not registered for any use patterns that
would result in short-term residential exposure. Short-term risk is
assessed based on short-term residential exposure plus chronic dietary
exposure. Because there is no short-term residential exposure and
chronic dietary exposure has already been assessed under the
appropriately protective cPAD (which is at least as protective as the
POD used to assess short-term risk), no further assessment of short-
term risk is necessary, and EPA relies on the chronic dietary risk
assessment for evaluating short-term risk for
bicyclopyrone.[FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/
DATE][RULES][RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/
PREAMB][SUPLINF][HED]*[/HED]
4. Intermediate-term risk. An intermediate-term adverse effect was
identified; however, bicyclopyrone is not registered for any use
patterns that would result in intermediate-term residential exposure.
Intermediate-term risk is assessed based on intermediate-term
residential exposure plus chronic dietary exposure. Because there is no
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess intermediate-term
risk), no further assessment of intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for bicyclopyrone.
5. Aggregate cancer risk for U.S. population. Because the Agency
has determined that the chronic RfD will be protective of any potential
cancer risk and there are no chronic risks that exceeds the Agency's
level of concern, EPA concludes that there is not a concern for cancer
risk from exposure to bicyclopyrone.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to bicyclopyrone residues.
More detailed information about the Agency's analysis can be found
in the Bicyclopyrone Human Health Risk Assessment in docket ID number
EPA-HQ-OPP-2019-0542 in regulations.gov at https://www.regulations.gov.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology liquid chromatography-mass
spectroscopy/mass spectroscopy (LCMS/MS) methods for tolerance
enforcement have been developed and independently validated. For all
matrices and analytes, the level of quantification (LOQ), defined as
the lowest spiking level where acceptable precision and accuracy data
were obtained, was determined to be 0.01 ppm for each of the common
moieties, SYN503780 and CSCD686480, for a combined LOQ of 0.02 ppm 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 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 has not established a MRL for residues of bicyclopyrone
in/on lemongrass, rosemary, or wormwood.
V. Conclusion
Therefore, tolerances are established for residues of
bicyclopyrone, 4-hydroxy-3-{2-[(2-methoxyethoxy)methyl]-6-
(trifluoromethyl)-3-pyridylcarbonyl{time} bicyclo[3.2.1]oct-3-en-2-one,
including its metabolites and degradates in or on lemongrass, dried at
0.5 ppm; lemongrass, fresh at 0.3 ppm; rosemary, dried at 0.3 ppm;
rosemary, fresh at 0.03 ppm; wormwood, dried at 0.09 ppm; and wormwood,
fresh at 0.05 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). 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).
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
[[Page 72851]]
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: December 9, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
[FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/
DATE][RULES][RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/
PREAMB][SUPLINF][HED]*[/HED]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. In Sec. 180.682, amend paragraph (a)(1) by:
0
a. In the introductory text, removing ``table below'' and ``specified
below'' and adding ``following table'' and ``specified in this
paragraph (a)(1)'' in their places, respectively; and
0
b. In the table, adding a table heading and entries in alphabetical
order for ``Lemongrass, dried''; ``Lemongrass, fresh''; ``Rosemary,
dried''; ``Rosemary, fresh''; ``Wormwood, dried''; and ``Wormwood,
fresh''.
The additions read as follows:
Sec. 180.682 Bicyclopyrone; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Lemongrass, dried.......................................... 0.5
Lemongrass, fresh.......................................... 0.3
Rosemary, dried............................................ 0.3
Rosemary, fresh............................................ 0.03
* * * * *
Wormwood, dried............................................ 0.09
Wormwood, fresh............................................ 0.05
------------------------------------------------------------------------
* * * * *
[FR Doc. 2021-27602 Filed 12-22-21; 8:45 am]
BILLING CODE 6560-50-P[FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/
DATE][RULES]