Document ID: EPA-HQ-OPP-2021-0604-0001
Agency: epa
Document Type: Rule
Title: Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.: Sodium Salt of Acifluorfen
Posted Date: 2022-03-31T04:00Z

[Federal Register Volume 87, Number 62 (Thursday, March 31, 2022)]
[Rules and Regulations]
[Pages 18717-18722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06817]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0604; FRL-9657-01-OCSPP]

Sodium Salt of Acifluorfen; Pesticide Tolerances for Emergency 
Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of sodium salt of acifluorfen in or on beet, sugar, roots and 
beet, sugar, leaves. This action is in response to EPA's granting of 
emergency exemptions under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) authorizing use of the pesticide on sugarbeets. 
This regulation establishes a maximum permissible level for residues of 
sodium salt of acifluorfen in or on these commodities. These time-
limited tolerances expire on December 31, 2024.

DATES: This regulation is effective March 31, 2022. Objections and 
requests for hearings must be received on or before May 31, 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-2021-0604, 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 related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is open to visitors by 
appointment only. For the latest status information on EPA/DC services 
and 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-CFR site at https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 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-2021-0604 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 31, 
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-2021-0604, 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.

[[Page 18718]]

    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(l)(6), is 
establishing time-limited tolerances for residues of sodium salt of 
acifluorfen, in or on beet, sugar, roots at 0.1 parts per million 
(ppm), and beet, sugar, leaves at 0.1 ppm. These time-limited 
tolerances expire on December 31, 2024.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in or on food that will result from the use 
of a pesticide under an emergency exemption granted by EPA under FIFRA 
section 18. Such tolerances or exemptions can be established without 
providing notice or period for public comment. EPA does not intend for 
its actions on FIFRA section 18-related time-limited tolerances to set 
binding precedents for the application of FFDCA section 408 and the 
safety standard to other tolerances and exemptions. Section 408(e) of 
FFDCA allows EPA to establish a tolerance or an exemption from the 
requirement of a tolerance on its own initiative, i.e., without having 
received any petition from an outside party.
    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. . . 
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemptions for Sodium Salt of Acifluorfen on Sugarbeets 
and FFDCA Tolerances

    The Colorado, Michigan, Minnesota, Nebraska, and North Dakota 
Departments of Agriculture requested specific emergency exemptions for 
postemergence use of acifluorfen to control glyphosate-resistant 
pigweed species, Palmer amaranth and waterhemp, on sugarbeets. 
According to the States, glyphosate-resistant Palmer amaranth and 
waterhemp have reached population levels so high that sugarbeet 
production is severely impacted. They assert that without a viable 
alternative tool for postemergence control, growers are unable to 
contain infestations in their sugarbeet fields and are expected to 
experience significant economic loss.
    After having reviewed the applications, EPA determined that an 
emergency condition exists for these States, and that the criteria for 
approval of these emergency exemptions are met. EPA authorized specific 
exemptions under FIFRA section 18 for the use of sodium salt of 
acifluorfen on sugarbeets for postemergence control of glyphosate-
resistant pigweed species in Colorado, Michigan, Minnesota, Nebraska, 
and North Dakota.
    As part of its evaluation of the emergency exemption applications, 
EPA assessed the potential risks presented by residues of sodium salt 
of acifluorfen in or on sugarbeets. In doing so, EPA considered the 
safety standard in FFDCA section 408(b)(2), and EPA decided that the 
necessary tolerances under FFDCA section 408(l)(6) would be consistent 
with the safety standard and with FIFRA section 18. Consistent with the 
need to move quickly on the emergency exemptions in order to address 
the urgent non-routine situation in these States and to ensure that the 
resulting food is safe and lawful, EPA is issuing these tolerances 
without notice and opportunity for public comment as provided in FFDCA 
section 408(l)(6). Although these time-limited tolerances expire on 
December 31, 2024, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerances 
remaining in or on sugarbeets after that date will not be unlawful, 
provided the pesticide was applied in a manner that was lawful under 
FIFRA, and the residues do not exceed a level that was authorized by 
these time-limited tolerances at the time of that application. EPA will 
take action to revoke these time-limited tolerances earlier if any 
experience with, scientific data on, or other relevant information on 
this pesticide indicate that the residues are not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
sodium salt of acifluorfen meets FIFRA's registration requirements for 
use on sugarbeets or whether permanent tolerances for this use would be 
appropriate. Under these circumstances, EPA does not believe that these 
time-limited tolerance decisions serve as a basis for registration of 
sodium salt of acifluorfen by a State for special local needs under 
FIFRA section 24(c). Nor do these tolerances by themselves serve as the 
authority for persons in any State other than Colorado, Michigan, 
Minnesota, Nebraska, and North Dakota to use this pesticide on the 
applicable crops under FIFRA section 18 absent the issuance of an 
emergency exemption applicable within that State. For additional 
information regarding these emergency exemptions for sodium salt of 
acifluorfen, contact the Agency's Registration Division at the address 
provided under FOR FURTHER INFORMATION CONTACT.

IV. 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 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 expected as a result of these emergency exemption requests

[[Page 18719]]

and the time-limited tolerances for residues of sodium salt of 
acifluorfen on beet, sugar, roots at 0.1 parts per million (ppm), and 
beet, sugar, leaves at 0.1 ppm. EPA's assessment of exposures and risks 
associated with establishing time-limited tolerances follows.

A. 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-
risk-pesticides.
    A summary of the toxicological endpoints for sodium salt of 
acifluorfen used for human health risk assessment is shown in Table 1 
of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Sodium Salt of Acifluorfen for Use in Human Health
                                                 Risk Assessment
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                                    Point of departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50       NOAEL = 20 mg/kg/day  Acute RfD = aPAD =   Rat Developmental Study: LOAEL =
 years of age).                    UFA = 10x...........   0.20 mg/kg/day.      90 mg/kg/day based on increased
                                   UFH = 10x...........                        incidence of slightly dilated
                                   FQPA SF = 1x........                        lateral ventricles of the brain.
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 293 mg/kg/    Acute RfD = aPAD =   Acute Neurotoxicity Study: LOAEL =
 including infants and children).   day.                  2.9 mg/kg/day.       440 mg/kg/day based on decreased
                                   UFA = 10x...........                        motor activity in females.
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 1.25 mg/kg/   Chronic RfD = cPAD   Rat Parental Reproduction Study:
                                    day.                  = 0.013 mg/kg/day.   LOAEL = 25 mg/kg/day based on
                                   UFA = 10x...........                        dilatation of tubules in the
                                   UFH = 10x...........                        outer medulla of kidneys in
                                   FQPA SF = 1x........                        parental females of both
                                                                               generations (33/35 (P1) and 28/40
                                                                               (F1) treated parents vs 0/35-41
                                                                               controls); one occurrence of
                                                                               tubular epithelial necrosis was
                                                                               noted in the P1 females (compared
                                                                               to 0 controls).
Incidental oral short-term (1 to   NOAEL = 25 mg/kg/day  Residential LOC for  Rat Offspring Reproduction Study:
 30 days).                         UFA = 10x...........   MOE = 100.           LOAEL = 125 mg/kg/day based on
                                   UFH = 10x...........  No residential        decreased body weight (both
                                   FQPA SF = 1x........   uses. Accounts for   generations; [darr]6-26%) and
                                                          spray drift.         increased incidence of dilatation
                                                                               of the renal pelvis in the F2
                                                                               generation.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days).  NOAEL = 25 mg/kg/day  Residential LOC for  Rat Offspring Reproduction Study:
                                   DAF = 18%...........   MOE = 100.           LOAEL = 125 mg/kg/day based on
                                   UFA = 10x...........  No residential        decreased body weight (both
                                   UFH = 10x...........   uses. Accounts for   generations; [darr]6-26%) and
                                   FQPA SF = 1x........   spray drift.         increased incidence of dilatation
                                                                               of the renal pelvis in the F2
                                                                               generation. Rat Developmental
                                                                               Study is supportive.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: Likely to be carcinogenic to humans at high enough doses to
                                    cause the biochemical and histopathological changes in livers of rodents,
                                    but unlikely to be carcinogenic at doses below those causing these changes.
                                    The non-linear RfD approach will be protective for chronic effects,
                                    including carcinogenicity.
----------------------------------------------------------------------------------------------------------------
DAF = dermal absorption factor. FQPA SF = FQPA Safety Factor. LOAEL = lowest observed adverse effect level. LOC
  = level of concern. NOAEL = no observed adverse effect level. PAD = population adjusted dose (a = acute, c =
  chronic). Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-
  response data and used to mark the beginning of extrapolation to determine risk associated with lower
  environmentally relevant human exposures. RfD = reference dose. MOE = margin of exposure. UF = uncertainty
  factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity
  among members of the human population (intraspecies).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to sodium salt of acifluorfen, EPA considered exposure under 
the time-limited tolerances established by this action as well as all 
existing sodium salt of acifluorfen tolerances in 40 CFR 180.383. EPA 
assessed dietary exposures from sodium salt of acifluorfen in food as 
follows:
    i. Acute exposure. Such effects were identified for sodium salt of 
acifluorfen. In estimating acute dietary exposure,

[[Page 18720]]

EPA used food consumption information from the Dietary Exposure 
Evaluation and Model-Food Commodity Intake Database (DEEM-FCID). As to 
residue levels in food, EPA assumed that sodium acifluorfen residues 
were present at tolerance levels in all commodities for which 
tolerances have been established or proposed and that 100% of the crops 
were treated with sodium salt of acifluorfen.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the Dietary 
Exposure Evaluation and Model-Food Commodity Intake Database (DEEM-
FCID). As to residue levels in food, EPA assumed that acifluorfen 
residues were present at tolerance levels in all commodities for which 
tolerances have been identified or proposed and that 100% of the crops 
were treated with sodium salt of acifluorfen.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or nonlinear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or nonlinear approach is used and a cancer RfD is 
calculated based on an earlier noncancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized. Based on the data summarized in Unit 
IV.A., EPA has concluded that a nonlinear RfD approach is appropriate 
for assessing cancer risk to sodium salt of acifluorfen. Cancer risk 
was assessed using the same exposure estimates as discussed in Unit 
IV.B.1.ii., chronic exposure.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for sodium salt of acifluorfen. Tolerance level 
residues and 100% PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for sodium salt of acifluorfen in drinking water. These 
simulation models take into account data on the physical, chemical, and 
fate/transport characteristics of sodium salt of acifluorfen. 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.
    Based on the groundwater modeling results from Pesticide Root Zone 
Model Ground Water (PRZM GW), the estimated drinking water 
concentrations (EDWCs) of sodium salt of acifluorfen for acute 
exposures are estimated to be 66.8 parts per billion (ppb) for surface 
water and 146 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute and chronic (non-
cancer) dietary risk assessments, the water concentration value of 146 
ppb was used to assess the contribution to drinking water.
    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).
    Sodium salt of acifluorfen is not registered for any specific use 
patterns that would result in residential exposure.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at https://www2.epa.gov/pesticide-science-and -assessing-pesticide-risks/standard-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.''
    At this time, there is not sufficient information to determine if 
any other pesticides share a common mechanism of toxicity with sodium 
salt of acifluorfen. For purposes of this time-limited tolerance 
action, EPA has assumed that sodium salt of acifluorfen does not share 
a common mechanism of toxicity with any other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risks-pesticides.

C. 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 SF when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. There is evidence of 
increased susceptibility following in utero exposure to sodium 
acifluorfen in the Sprague Dawley rat developmental toxicity study. 
However, there is low concern because effects are well characterized 
with clear NOAEL/LOAEL values and the chosen points of departure for 
risk assessment for each scenario are protective of these effects.
    3. Conclusion. EPA has determined that reliable data show that the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for sodium salt of acifluorfen is 
complete.
    ii. There is some indication that sodium salt of acifluorfen is a 
neurotoxic chemical, however, the chosen points of departure for risk 
assessment are protective of these effects, and there is no need for a 
developmental neurotoxicity study or additional UFs to account for 
neurotoxicity.
    iii. There is evidence that sodium salt of acifluorfen results in 
increased susceptibility following exposure in utero rats in the 
Sprague Dawley rat prenatal developmental study. However, there is low 
concern because effects are well characterized with clear NOAEL/LOAEL 
values and the chosen points of departure for risk assessment for each 
scenario are protective of these effects.
    iv. There are no residual uncertainties identified in the exposure 
database. The dietary food exposure assessments were performed based on 
100% PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to sodium salt of acifluorfen in drinking water. 
These assessments will not underestimate the exposure and risks posed 
by sodium salt of acifluorfen.

[[Page 18721]]

D. 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). 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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to sodium salt of acifluorfen will occupy 4.0% of the aPAD for females 
13-49 years old, the population group receiving the greatest exposure. 
There are no registered residential uses of sodium salt of acifluorfen, 
and so acute aggregate risk is equivalent to acute dietary risk, which 
is not of concern.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
sodium salt of acifluorfen from food and water will utilize 63% of the 
cPAD for all infants <1 year old, the population group receiving the 
greatest exposure. There are no registered residential uses of sodium 
salt of acifluorfen, and so chronic aggregate risk is equivalent to 
chronic dietary risk, which is not of concern.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Sodium salt 
of acifluorfen is not currently registered for a use that could result 
in short-term (non-occupational) residential exposure. Because there 
are no registered residential uses, short-term aggregate risk is 
equivalent to chronic dietary risk, which is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term non-dietary, non-occupational 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level). Because there are no registered residential 
uses, intermediate-term risk is equivalent to chronic dietary risk, 
which is not of concern.
    5. Aggregate cancer risk for U.S. population. Sodium salt of 
acifluorfen is classified as ``likely to be carcinogenic to humans at 
doses high enough to cause the biochemical and histopathological 
changes in livers of rodents, but unlikely to be carcinogenic at doses 
below those causing these changes.'' EPA determined that non-linear 
extrapolation be used in this assessment instead of a separate Q1* 
based cancer aggregate assessment.'' A non-cancer dietary assessment 
was completed that resulted in risk levels below the LOC of 100%. These 
levels are considered protective for both non-cancer and cancer risk 
because EPA regulates at doses below those where initiation of tumor 
formation is expected.
    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 sodium salt of acifluorfen residues. More detailed 
information on the subject action to establish time-limited tolerances 
in or on beet, sugar, roots and beet, sugar, leaves can be found at 
https://www.regulations.gov in the document entitled ``Sodium 
Acifluorfen: Human Health Risk Assessment for Section 18 Emergency 
Exemptions for the Use on Sugarbeets in Nebraska and Colorado.'' This 
document can be found in docket ID number EPA-HQ-OPP-2021-0604.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, the Pesticide Analytical Manual 
(PAM) Volume II gas chromatography/electron capture detector (GC/ECD) 
method, 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). Codex is a joint United Nations Food and Agriculture 
Organization/World Health Organization food standards program, and it 
is recognized as an international food safety standards-setting 
organization in trade agreements to which the United States is a party. 
EPA may establish a tolerance that is different from a Codex MRL; 
however, FFDCA section 408(b)(4) requires that EPA explain the reasons 
for departing from the Codex level.
    Codex has not established a MRL for sodium salt of acifluorfen.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
sodium salt of acifluorfen, in or on beet, sugar, roots at 0.1 parts 
per million (ppm), and beet, sugar, leaves at 0.1 ppm. These tolerances 
expire on December 31, 2024.

VII. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA sections 408(e) and 
408(l)(6). 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 in accordance 
with FFDCA sections 408(e) and 408(l)(6), 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

[[Page 18722]]

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).

VIII. 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 25, 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 180.383(b) is added to read as follows:

Sec.  180.383  Sodium salt of acifluorfen; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the herbicide sodium salt of acifluorfen, 
including its metabolites and degradates, in or on the specified 
agricultural commodities in the following table, resulting from use of 
the pesticide pursuant to FIFRA section 18 emergency exemptions. 
Compliance with the tolerance levels specified in the following table 
is to be determined by measuring only the sum of acifluorfen acid, (5-
[2-chloro-4-(trifluoromethyl) phenoxy]-2-nitrobenzoate), acifluorfen 
amine methyl ester (methyl 5-[2-chloro-4(trifluoromethyl)phenoxy]-2-
aminobenzoate), calculated as the stoichiometric equivalent of 
acifluorfen acid in or on the commodities. The tolerances expire on the 
date specified in the table.

                        Table 2 to Paragraph (b)
------------------------------------------------------------------------
                                                     Parts
                    Commodity                         per     Expiration
                                                    million      date
------------------------------------------------------------------------
Beet, sugar, roots...............................       0.1   12/31/2024
Beet, sugar, leaves..............................       0.1   12/31/2024
------------------------------------------------------------------------

* * * * *
[FR Doc. 2022-06817 Filed 3-30-22; 8:45 am]
BILLING CODE 6560-50-P