Federal Register / Vol. 87, No. 62 / Thursday, March 31, 2022 / Rules and Regulations 18717 

TABLE 9 TO PARAGRAPH (d)(2)(vii)—DELEGATION STATUS FOR NEW SOURCE PERFORMANCE STANDARDS FOR SAN

DIEGO COUNTY APCD, SAN JOAQUIN VALLEY UNIFIED APCD, SAN LUIS OBISPO COUNTY APCD, AND SANTA BARBARA COUNTY APCD—Continued 

Subpart 

Air pollution control agency 

San Diego 

County APCD 

San Joaquin 

Valley Unified 

APCD 

San Luis 

Obispo County 

APCD 

Santa Barbara 

County APCD 

QQQQ ........... Standards of Performance for New Residential Hydronic 

Heaters and Forced-Air Furnaces.

X ........................ ........................ ........................

TTTT .............. Standards of Performance for Greenhouse Gas Emissions 

for Electric Generating Units.

X ........................ ........................ ........................

* * * * * 

[FR Doc. 2022–06279 Filed 3–30–22; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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: RDFRNotices@

epa.gov. 

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 eCFR 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-sendcomments-epa-dockets. 


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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 timelimited 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 glyphosateresistant 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 


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Federal Register / Vol. 87, No. 62 / Thursday, March 31, 2022 / Rules and Regulations 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-andassessing-pesticide-risks/assessinghuman-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

Exposure/scenario 

Point of departure 

and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (Females 13–50 

years of age).

NOAEL = 20 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = aPAD = 

0.20 mg/kg/day.

Rat Developmental Study: LOAEL = 90 mg/kg/day based on increased incidence of slightly dilated lateral ventricles of the 

brain. 

Acute dietary (General population including infants and 

children).

NOAEL = 293 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = aPAD = 

2.9 mg/kg/day.

Acute Neurotoxicity Study: LOAEL = 440 mg/kg/day based on 

decreased motor activity in females. 

Chronic dietary (All populations) NOAEL = 1.25 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = cPAD 

= 0.013 mg/kg/day.

Rat Parental Reproduction Study: LOAEL = 25 mg/kg/day 

based on dilatation of tubules in the outer medulla of kidneys 

in 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 

30 days).

NOAEL = 25 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x .........

Residential LOC for 

MOE = 100.

No residential uses. 

Accounts for spray 

drift 

Rat Offspring Reproduction Study: LOAEL = 125 mg/kg/day 

based on decreased body weight (both generations; ↓6– 

26%) and increased incidence of dilatation of the renal pelvis 

in the F2 generation. 

Dermal short-term (1 to 30 

days).

NOAEL = 25 mg/kg/ 

day.

DAF = 18% 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for 

MOE = 100.

No residential uses. 

Accounts for spray 

drift 

Rat Offspring Reproduction Study: LOAEL = 125 mg/kg/day 

based on decreased body weight (both generations; ↓6– 

26%) and 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, 


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18720 Federal Register / Vol. 87, No. 62 / Thursday, March 31, 2022 / Rules and Regulations 

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 fooduse 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-assessingpesticide-risks/about-water-exposuremodels-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 nonoccupational, 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 -assessingpesticide-risks/standard-operatingprocedures-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 timelimited 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-andassessing-pesticide-risks/cumulativeassessment-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. 


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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, intermediateterm 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 nonlinear 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 noncancer 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: residuemethods@

epa.gov. 

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 standardssetting 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 


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18722 Federal Register / Vol. 87, No. 62 / Thursday, March 31, 2022 / Rules and Regulations 

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 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.383(b) is added to read 

as follows: 

§ 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-chloro4(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) 

Commodity 

Parts 

per 

million 

Expiration 

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 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 17 

[Docket No. FWS–R8–ES–2018–0042; 

FXES1113090FEDR–223–FF09E42000] 

RIN 1018–BD00 

Endangered and Threatened Wildlife 

and Plants; Reclassification of the 

Endangered Layia carnosa (Beach 

Layia) to Threatened With Section 4(d) 

Rule 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Final rule. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service (Service), are 

reclassifying the plant beach layia 

(Layia carnosa) from an endangered to 

a threatened species under the 

Endangered Species Act of 1973, as 

amended (Act), due to substantial 

improvements in the species’ overall 

status since its original listing as 

endangered in 1992. This action is 

based on a thorough review of the best 

scientific and commercial data 

available, which indicates that beach 

layia no longer meets the definition of 

an endangered species under the Act. 

Beach layia will remain protected as a 

threatened species under the Act. We 

are also finalizing a rule under section 

4(d) of the Act that provides for the 

conservation of beach layia. 

DATES: This rule is effective May 2, 

2022. 

ADDRESSES: This final rule, supporting 

documents we used in preparing this 

rule, and public comments we received 

are available on the internet at https:// 

www.regulations.gov at Docket No. 

FWS–R8–ES–2018–0042. 

FOR FURTHER INFORMATION CONTACT: 

Tanya Sommer, Field Supervisor, 

Arcata Fish and Wildlife Office, 1655 

Heindon Rd., Arcata, CA 95521; 

telephone 707–822–7201. 

Individuals in the United States who 

are deaf, deafblind, hard of hearing, or 

have a speech disability may dial 711 

(TTY, TDD, or TeleBraille) to access 

telecommunications relay services. 

Individuals outside the United States 

should use the relay services offered 

within their country to make 

international calls to the point-ofcontact in the United States. 

SUPPLEMENTARY INFORMATION: 

Previous Federal Actions 

On June 22, 1992, we listed the beach 

layia as an endangered species (57 FR 

27848). On September 29, 1998, we 

finalized a recovery plan for this and six 

other coastal species (Service 1998, 

entire). In 2011, we completed a 5-year 

review (Service 2011, entire) and 

concluded that there was evidence to 

support a decision to reclassify beach 

layia from an endangered species to a 

threatened species under the Act. We 

announced the availability of this 

review on April 27, 2012 (77 FR 25112). 

On September 30, 2020, we proposed 

to reclassify beach layia from an 

endangered species to a threatened 

species with a rule issued under section 

4(d) of the Act (‘‘4(d) rule’’) to provide 

for the conservation of beach layia (85 

FR 61684). On April 13, 2021, we 

reopened the public comment period for 

the proposed rule and announced a 

public informational meeting and public 

hearing (86 FR 19184), which we held 

on April 29, 2021. 

Summary of Changes From the 

Proposed Rule 

In this rule, we make certain 

nonsubstantive, editorial changes to 

some text that we presented in the 

proposed rule, and we include a minor 

amount of new information (e.g., some 

updated abundance information and 

new references) that we received or that 

became available since the proposed 

rule published. However, this new 

information did not change our analysis, 

rationales, or determination for either 


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