[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Rules and Regulations]
[Pages 78562-78568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27715]



[[Page 78562]]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0301; FRL-9321-01-OCSPP]


Simazine; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
simazine in or on citrus fruits (crop group 10-10), pome fruits (crop 
group 11-10), stone fruits (crop group 12-12), and tree nuts (crop 
group 14-12) and amends the tolerance for residues in or on almond 
hulls. Syngenta Crop Protection, LLC requested these tolerances under 
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 22, 2022. Objections and 
requests for hearings must be received on or before February 21, 2023, 
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-2012-0301, 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 the 
Public Reading Room and the OPP Docket is (202) 566-1744. For the 
latest status information on EPA/DC services and docket access, visit 
https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Registration 
Division (Mail Code 7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; 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-2012-0301 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 21, 2023. 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-2012-0301, 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/.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 25, 2012 (77 FR 43562) (FRL-9353-
6), 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 
(PP2F8006) by Syngenta Crop Protection, LLC, P.O. Box 18300, 
Greensboro, NC 27419-8300. The petition requested that 40 CFR 180.213 
be amended by establishing tolerances for residues of the herbicide 
simazine, in or on citrus fruits (crop group 10), pome fruits (crop 
group 11), stone fruits (crop group 12), and tree nuts (crop group 14, 
except almond hull) at 0.05, 0.03, 0.1, and 0.07 parts per million 
(ppm), respectively, and amending the tolerance for residues in or on 
almond hulls to 3 ppm. In addition, the petition requested the removal 
of tolerances for apple, hazelnut, peach, pecan, plum, and walnut at 
0.20 ppm, and for almond, cherry, grapefruit, lemon, macadamia nut, 
orange, and pear at 0.25 ppm, upon establishment of the new tolerances. 
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.
    Based upon review of the data supporting the petition, EPA 
determined that the residue data for the citrus fruit crop group 
support a tolerance level of 0.04 ppm, not 0.05 ppm as proposed by the 
registrant, and a level of 0.05 ppm not 0.07 ppm is being established 
for crop group 14-12. The reasons for these changes are explained in 
Unit 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

[[Page 78563]]

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 simazine including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with simazine follows.

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.
Simazine and Its Chlorinated Metabolites
    Simazine is a chlorotriazine herbicide that is similar in structure 
to atrazine and propazine. These chlorotriazine herbicides, along with 
their common chlorinated metabolites, have been determined by the EPA 
to share a common neuroendocrine mechanism of toxicity and constitute 
the triazine common mechanism group (CMG). Because of the similar 
structures and metabolites among these three pesticides, they are also 
assumed to be of equal potency for neuroendocrine effects. Therefore, 
the more robust toxicological database for atrazine has been used to 
characterize neuroendocrine toxicity, and for endpoint selection, for 
all of these compounds. The neuroendocrine endpoint chosen for these 
chemicals is attenuation of the luteinizing hormone (LH) surge after 4 
days of exposure, the most sensitive effect which protects for other 
downstream adverse endocrine related toxicological effects and 
potential effects on non-endocrine systems.
    EPA has concluded that the available data do not identify a unique 
quantitative susceptibility in the developing organism. None of the 
available studies with atrazine evaluating rats exposed during 
gestation, lactation, or in the peri-pubertal periods have shown 
effects at doses lower than those eliciting the LH surge attenuation in 
adult female rats after 4 days of exposure. Additionally, the POD, 
based upon attenuation of the LH surge, is protective against adverse 
reproductive/developmental outcomes such as delays in onset of puberty, 
disruption of ovarian cyclicity and inhibition of prolactin release. 
For other potential adverse outcomes, the effects occurred at dose 
levels approximately one order of magnitude or higher than the no 
observed adverse effect level (NOAEL)/lowest observed adverse effect 
level (LOAEL) for LH surge attenuation. As simazine has been classified 
as ``Not likely to be carcinogenic to humans,'' cancer risk is not a 
concern and a quantitative cancer risk assessment was not conducted.
Hydroxysimazine and Its Hydroxylated Metabolites
    In addition to the chlorotriazine metabolites, simazine also has an 
analogous series of metabolites, known as the hydroxy metabolites, in 
which the chlorine is replaced by a hydroxy moiety. While the hydroxy 
metabolites are all considered to be of equal toxicity to each other, 
these compounds exhibit different toxicological properties than the 
chlorinated metabolites, and risk estimates are therefore quantified 
separately using an endpoint and POD based on hydroxyatrazine. The 
available data indicate that the kidney is the primary target organ for 
hydroxysimazine and its metabolites.
    There is no evidence for increased susceptibility in the young 
following in utero exposure or carcinogenicity in the available data 
for hydroxysimazine and its metabolites.
    A complete discussion of the toxicological profile for simazine and 
specific information on the studies received and the nature of the 
adverse effects caused by simazine 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 at https://www.regulations.gov in document titled Simazine. ``Human Health Risk 
Assessment for Registration Review and to Support the Registration of 
Proposed Uses on Citrus Fruit (Crop Group 10-10), Pome Fruit (Crop 
Group 11-10), Stone Fruit (Crop Group 12-12), Tree Nuts (Crop Group 14-
12), and Tolerance Amendment for Almond Hulls'' in docket ID number 
EPA-HQ-OPP-2013-0251.

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 no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). 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://www.epa.gov/science-and-assessing-pesticide-risks.
    The toxicological endpoints for simazine used for human risk 
assessment and an explanation for how the Agency calculated those PODs 
can be found in the Simazine Human Health Risk Assessment, sections 
4.6-4.84, 5.4.2.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to simazine, EPA considered exposure under the petitioned-for 
tolerances as well as all existing simazine tolerances in 40 CFR 
180.213. EPA assessed dietary exposures from simazine and its 
chlorinated metabolites separately from exposures to hydroxysimazine 
and the hydroxylated metabolites due to the different toxicities 
observed for the compounds. The assessments of residues of these 
substances in food were conducted 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

[[Page 78564]]

possibility of an effect of concern occurring as a result of a 1-day or 
single exposure. Such effects were identified for simazine and its 
chlorinated metabolites but not for hydroxysimazine and the 
hydroxylated metabolites.
    In estimating acute dietary exposure to residues of simazine and 
its chlorinated metabolites, EPA used 2003-2008 food consumption 
information from the United States Department of Agriculture's (USDA's) 
National Health and Nutrition Examination Survey, What We Eat in 
America, (NHANES/WWEIA). As to anticipated residue levels in food, the 
acute assessment was refined using field trial data, default processing 
factors, and assumed that 100% of the proposed and registered 
commodities were treated.
    ii. Four-day/Chronic exposure. Typically, chronic exposure is 
assessed, but for simazine and its chlorinated metabolites a four-day 
exposure duration is appropriate since the toxicological effect 
(attenuation of the LH surge) occurs after four days of exposure and is 
protective of exposures of longer durations. In conducting the four-day 
dietary exposure assessment, EPA used the food consumption data from 
the United States Department of Agriculture's (USDA's) National Health 
and Nutrition Examination Survey, What We Eat in America, (NHANES/
WWEIA). As to anticipated residue levels in food, four-day dietary 
assessments were partially refined using field trial studies, default 
processing factors, and assumed that 100% of the proposed and 
registered commodities were treated.
    In conducting the chronic dietary exposure assessment for 
hydroxysimazine and its hydroxylated metabolites, EPA used the food 
consumption data from USDA's NHANES/WWEIA. As to anticipated residue 
levels in food, the chronic dietary assessment for hydroxysimazine and 
its hydroxylated metabolites was refined using residue levels from 
metabolism studies, default processing factors, and average percent 
crop treated data.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that neither simazine nor hydroxysimazine poses a cancer risk 
to humans. Therefore, a dietary exposure assessment for the purpose of 
assessing cancer risk is unnecessary.
    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, 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 acute and four-day steady state dietary assessment for simazine 
assumed 100% crop treated for all registered and requested crops. The 
chronic (background) assessments for simazine and its chlorinated 
metabolites and for hydroxysimazine and its hydroxylated metabolites 
incorporated average percent crop treated estimates as follows: almond: 
10%; apple: 10%; avocado: 5%; blueberry: 15%; caneberry: 45%; cherry: 
5%; field corn: 5%; sweet corn: 2.5%; grapefruit: 20%; grape: 25%; 
hazelnut: 35%; lemon: 10%; nectarine: 5%; olive: 15%; orange: 25%; 
peach: 15%; pear: 10%; pecan: 5%; plums/prunes: 2.5%; strawberry: 5%; 
tangerine: 5%; and walnut: 20%. 100% CT was assumed for the remaining 
commodities.
    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 figures for each existing 
use are derived by combining available public and private market survey 
data for that use, averaging across all observations, and rounding up 
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 simazine may be applied in a particular area.
    2. Dietary exposure from drinking water. Extensive and robust 
surface and groundwater monitoring data are available for triazines 
(including simazine) and were included in the drinking water 
assessment. The Agency also used screening-level water exposure models 
in the dietary exposure analysis and risk assessment for simazine in 
drinking water. These simulation models take into account data on the 
physical, chemical, and fate/transport characteristics of simazine. 
Estimated drinking water concentrations (EDWCs) are based on total 
triazine

[[Page 78565]]

residues, which include atrazine, propazine, and simazine, and all the 
related metabolites, and are not just based on simazine and its 
chlorinated and hydroxylated metabolites, these EDWCs may be considered 
high-end estimates for the simazine risk assessment. Further 
information regarding EPA drinking water models used in pesticide 
exposure assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-risk-assessment.
    Based on the Pesticide Root Zone Model Ground Water (PRZM GW), the 
surface water concentration calculator (SWCC), and FQPA Index Reservoir 
Screening Tool (FIRST) modeling, the EDWCs of simazine are estimated to 
be 265-610 parts per billion (ppb) for surface water and 92.6-100 ppb 
for groundwater for acute exposure; 265-585 ppb for surface water and 
92.6-100 ppb for groundwater for the 4-day exposures; and 76-104 ppb 
for surface water and 5.11-7.33 ppb for groundwater for chronic 
exposures for non-cancer assessments.
    A drinking water level of comparison (DWLOC) approach to aggregate 
risk was used to calculate the amount of exposure available in the 
total `risk cup' for drinking water after accounting for any exposures 
from food and/or residential use. The DWLOCs are then compared to the 
EDWCs. If the DWLOCs are greater than the EDWCs, there is no aggregate 
risk of concern. The use of a DWLOC approach facilitates determining 
aggregate risks when there are multiple EDWCs or when there are 
potential aggregate risk estimates of concern. Water ingestion rates 
are included in the acute and chronic DWLOC calculations. These values 
vary with population subgroup, the duration time of interest, and the 
exposure percentile applicable for regulation. These values were 
determined directly from the NHANES/WWEIA water consumption data, 
making use of the appropriate exposure durations and percentiles. For 
the simazine 4-day aggregate assessments, the DWLOC approach used a 
reciprocal MOE calculation method since the target MOEs (level of 
concern based on the total uncertainty factor) are the same for all 
relevant sources of exposure. For the four-day assessment, water 
consumption is accounted for in the PBPK model when deriving the 
drinking water PODs and is not included in the DWLOC calculation. 
Infants and children were assumed to consume water 6 times a day, with 
a total consumption volume of 0.688557 liters per day (L/day). Youths 
and female adults were assumed to consume water 4 times a day, with a 
total consumption volume of 1.71062 L/day.
    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). Simazine is currently 
registered for the following uses that could result in residential 
exposures: residential turf. There are no residential handler combined 
(dermal + inhalation) risk estimates of concern for simazine.
    There is potential for short-term post-application exposure for 
individuals as a result of being in an environment that has been 
previously treated with simazine. There were post-application dermal 
risk estimates of concern for adults and children 1 to <2 years old and 
combined (dermal + incidental oral) risk estimates of concern for 
children 1 to <2 years old (LOC = 30) from high contact activities on 
treated turf. These scenarios are considered worst-case and are 
protective of all other exposure scenarios.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/operating-procedures-residential-pesticide.
    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.''
    Simazine is a chlorotriazine herbicide. A cumulative risk 
assessment with the chlorotriazines atrazine, simazine, propazine, and 
their common metabolites is available at https://www.regulations.gov, 
Docket ID EPA-HQ-OPP-2013-0266.

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 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. For simazine and its 
chlorinated metabolites, there was no increased quantitative or 
qualitative susceptibility in any of the guideline studies on atrazine 
in the rat, and there was no increased quantitative susceptibility in 
the rabbit study. Although there was increased qualitative 
susceptibility in the atrazine rabbit study, increased resorptions 
(deaths) at a dose level that resulted in decreased body-weight gain 
and clinical signs in the maternal animal the observed effects occur at 
higher doses than the benchmark dose lower confidence limit (BMDL) of 
2.42 mg/kg/day used to assess risk. The BMDL of 2.42 mg/kg/day is 
protective of developmental effects in the rabbit.
    For hydroxysimazine, there was no evidence of increased qualitative 
or quantitative susceptibility in the available toxicological data on 
this metabolite including a developmental rat study and female and male 
pubertal assays.
    3. Conclusion. For simazine and its chlorinated metabolites, 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 based on lack of increased sensitivity for infants and children. 
That decision is based on the following findings:
    i. The toxicity database for the chlorotriazines (including 
simazine) and their metabolites is considered complete.
    ii. Chlorotriazines have an established neuroendocrine mode of 
action and LH attenuation is the most sensitive endpoint identified in 
the database. LH attenuation is protective of potential health outcomes 
associated with chlorotriazines.
    iii. There was no increased quantitative or qualitative 
susceptibility in any of the guideline studies on atrazine in the rat, 
and there was no increased quantitative susceptibility in the rabbit 
study. Although there was increased qualitative susceptibility in the 
atrazine rabbit study, the observed effects occur at higher doses than 
the benchmark dose lower confidence limit (BMDL) of 2.42 mg/kg/day used 
to assess risk. The BMDL of 2.42 mg/kg/day is protective of 
developmental effects in the rabbit.
    iv. There are no residual uncertainties identified in the exposure 
databases.

[[Page 78566]]

EPA made conservative (protective) assumptions in the ground and 
surface water modeling used to assess exposure to simazine in drinking 
water. These assessments will not underestimate the exposure and risks 
posed by simazine.
    For hydroxysimazine, 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 based on lack of increased sensitivity for 
infants and children. That decision is based on the following findings:
    i. The toxicity database for hydroxysimazine is complete for a 
metabolite.
    ii. Hydroxysimazine does not have a neuroendocrine mode of action 
as the parent chlorotriazines.
    iii. There was no evidence of increased qualitative or quantitative 
susceptibility in the available toxicological data on this metabolite 
including a developmental rat study and female and male pubertal 
assays.
    iv. There are no residual uncertainties identified in the exposure 
databases.

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. Simazine and its chlorinated metabolites. The acute 
aggregate assessment considers food and water exposures. The acute 
DWLOC for females 13 to 49 years old is 5,500 ppb. The acute DWLOC is 
greater than the acute EDWCs for total chlorotriazines TCTs in surface 
water or ground water (EDWC range = 100-610 ppb); there is no acute 
aggregate risk of concern.
Hydroxysimazine and its Hydroxylated Metabolites
    No toxicological effects attributable to a single dose were 
identified for hydroxysimazine; therefore, an acute endpoint has not 
been identified and no risk is expected from this exposure scenario.
    2. Four-day/Chronic risk. Simazine and its chlorinated metabolites. 
The four-day aggregate risk assessments are protective for short-term, 
intermediate-term, and chronic aggregate risks since the POD and 
endpoint used for the four-day assessment are the most sensitive for 
any duration, and are, therefore, protective of longer durations of 
exposure. The calculated four-day DWLOCs are all greater than the 4-day 
EDWCs for TCTs in surface water or ground water; there are no four-day 
aggregate risks of concern.
Hydroxysimazine and its Hydroxylated Metabolites
    The chronic aggregate risk assessment for the hydroxysimazine 
considers food and water exposures. No residential exposures to the 
hydroxysimazine metabolite are expected from the simazine uses. The 
lowest chronic DWLOC for hydroxysimazine is for all infants (<1 year 
old) at 1300 ppb. The chronic DWLOCs are greater than the chronic EDWCs 
for total hydroxytriazines (THTs) in surface water or ground water 
(EDWC range = 7.33-76 ppb); there is no chronic aggregate risk of 
concern.
    3. Aggregate cancer risk for U.S. population. Simazine has been 
classified as ``Not likely to be carcinogenic to humans.'' 
Hydroxysimazine is also not likely to pose cancer risks based on the 
lack of cancer effects seen in available studies.
    4. 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 simazine residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (LC-MS/MS) is available to enforce 
the tolerance expression.

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 for simazine.

C. Revisions to Petitioned-For Tolerances.

    The submitted residue data support a tolerance level of 0.04 ppm 
for the citrus fruit crop group. The petitioner's proposed tolerance 
level of 0.05 ppm was based on using the maximum combined residue level 
of 0.038 ppm (one grapefruit sample) in the Organisation for Economic 
Co-operation and Development (OECD) tolerance calculation procedures. 
EPA's approach to tolerance calculations uses the average field trial 
value of 0.034 ppm, which warrants a tolerance of level of 0.04 ppm 
instead. Also, although the proposed tolerance level of 0.07 ppm for 
crop group 14-12 is supported by OECD tolerance calculations, EPA is 
establishing the tolerance at 0.05 ppm to harmonize with the Canadian 
MRL. Due to the conservatisms in the OECD calculator, the tolerance 
level of 0.05 ppm will be sufficient to cover residues of simazine in 
or on food resulting from legal applications of the pesticide.

D. International Trade Considerations

    In this Final Rule, EPA is reducing the existing tolerances for the 
commodities of almond from 0.25 to 0.05 ppm as part of nut, tree, group 
14-12; apple from 0.2 to 0.03 ppm as part of fruit, pome, group 11-10; 
cherry from 0.25 to 0.1 ppm as part of fruit, stone, group 12-12; 
grapefruit, lemon, and orange from 0.25 to 0.04 ppm as part of fruit, 
citrus, group 10-10; hazelnut, nut, macadamia, pecan, and walnut from 
0.2 to 0.05 ppm as part of nut, tree, group 14-12; peach and plum from 
0.2 to 0.1 ppm as part of fruit, stone, group 12-12; and pear from 0.25 
to 0.03 as part of fruit, pome, group 11-10. The Agency is reducing 
these tolerances because available residue data demonstrates that the 
new tolerances are sufficient to cover residues on these commodities.
    In accordance with the World Trade Organization's (WTO) Sanitary 
and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the 
WTO of this revision in order to satisfy its obligation. In addition, 
the SPS Agreement requires that Members provide a ``reasonable 
interval'' between the publication of a regulation subject to the 
Agreement and its entry into force to allow time for producers in 
exporting Member countries to adapt to the new requirement. At this 
time, EPA is establishing an expiration date for the existing 
tolerances to allow those

[[Page 78567]]

tolerances to remain in effect for a period of six months after the 
effective date of this final rule, in order to address this 
requirement. After the six-month period expires, residues of simazine 
on grapefruit, lemon, and orange cannot exceed the citrus fruits (crop 
group 10-10) tolerance of 0.04 ppm; apple and pear cannot exceed the 
pome fruits (crop group 11-10) tolerance of 0.03 ppm; cherry, peach, 
and plum cannot exceed the stone fruits (crop group 12-12) tolerance of 
0.1 ppm; and almond, hazelnut, nut, macadamia, pecan, and walnut cannot 
exceed the tree nuts (crop group 14-12) tolerance of 0.05 ppm.
    This reduction in tolerance levels is not discriminatory; the same 
food safety standard contained in the FFDCA applies equally to 
domestically produced and imported foods. The new tolerance levels are 
supported by available residue data.

V. Conclusion

    Therefore, tolerances are established for residues of simazine in 
or on Fruit, citrus, group 10-10, Fruit, pome, group 11-10, Fruit, 
stone, group 12-12, and Nut, tree, group 14-12 at 0.04 ppm, 0.03 ppm, 
0.10 ppm, and 0.05 ppm, respectively, and the tolerance for Almond, 
hulls is amended to 3 ppm.

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). 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 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 16, 2022.
Daniel Rosenblatt,
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. Revise Sec.  180.213 to read as follows:


Sec.  180.213  Simazine; tolerances for residues.

    (a) General. Tolerances are established residues of the herbicide 
simazine, including its metabolites and degradates, in or on the 
commodities in table 1 to this paragraph (a). Compliance with the 
tolerance levels specified in table 1 to this paragraph (a) is to be 
determined by measuring only the sum of simazine, 6-chloro-N,N'-
diethyl-1,3,5-triazine-2,4-diamine, and its metabolites 6-chloro-N-
ethyl-1,3,5-triazine-2,4-diamine, and 6-chloro-1,3,5-triazine-2,4-
diamine, calculated as the stoichiometric equivalent of simazine, in or 
on the commodity.

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond \1\..................................................        0.25
Almond, hulls...............................................           3
Apple \1\...................................................        0.20
Avocado.....................................................        0.20
Blackberry..................................................        0.20
Blueberry...................................................        0.20
Cattle, meat................................................        0.03
Cattle, meat byproducts.....................................        0.03
Cherry \1\..................................................        0.25
Corn, field, forage.........................................        0.20
Corn, field, grain..........................................        0.20
Corn, field, stover.........................................        0.25
Corn, pop, grain............................................        0.20
Corn, pop, stover...........................................        0.25
Corn, sweet, forage.........................................        0.20
Corn, sweet, kernel plus cob with husks removed.............        0.25
Corn, sweet, stover.........................................        0.25
Cranberry...................................................        0.25
Currant.....................................................        0.25
Egg.........................................................        0.03
Fruit, citrus, group 10-10..................................        0.04
Fruit, pome, group 11-10....................................        0.03
Fruit, stone, group 12-12...................................         0.1
Goat, meat..................................................        0.03
Goat, meat byproducts.......................................        0.03
Grape.......................................................        0.20
Grapefruit \1\..............................................        0.25
Hazelnut \1\................................................        0.20
Horse, meat.................................................        0.03
Horse, meat byproducts......................................        0.03
Lemon \1\...................................................        0.25

[[Page 78568]]

 
Loganberry..................................................        0.20
Milk........................................................        0.03
Nut, macademia \1\..........................................        0.25
Nut, tree, group 14-12......................................        0.05
Olive.......................................................        0.20
Orange \1\..................................................        0.25
Peach \1\...................................................        0.20
Pear \1\....................................................        0.25
Pecan \1\...................................................        0.20
Plum \1\....................................................        0.20
Raspberry...................................................        0.20
Sheep, meat.................................................        0.03
Sheep, meat byproducts......................................        0.03
Strawberry..................................................        0.25
Walnut \1\..................................................         0.2
------------------------------------------------------------------------
\1\ This tolerance expires on June 22, 2023.

    (b) through(d) [Reserved]

[FR Doc. 2022-27715 Filed 12-21-22; 8:45 am]
BILLING CODE 6560-50-P