Federal Register / Vol. 86, No. 44 / Tuesday, March 9, 2021 / Rules and Regulations 13459 

(3) Employees and officers may ask 

questions, raise concerns, or report instances 

of non-compliance with this policy and/or 

any of the existing underlying relevant 

policies by contacting the following: 

[COMPLIANCE HELP LINE OR E–MAIL]. 

G. Certification 

On an annual basis, the ECIP recipient will 

deliver to the Department of the Treasury a 

certification, executed by two senior 

executive officers (one of which must be 

either the ECIP recipient’s principal 

executive officer or principal financial 

officer) certifying that (i) the Organization is 

in compliance with this policy and (ii) the 

approval of any expenditure requiring the 

prior approval of any senior executive officer, 

any executive officer of a substantially 

similar level of responsibility, or the board of 

directors (or a committee of such board), was 

properly obtained with respect to each such 

expenditure. 

David Lebryk, 

Fiscal Assistant Secretary. 

[FR Doc. 2021–04900 Filed 3–5–21; 11:15 am] 

BILLING CODE 4810–AK–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 62 

[EPA–R03–OAR–2019–0527.; FRL–10020– 

90–Region 3] 

Approval and Promulgation of State 

Air Quality Plans for Designated 

Facilities and Pollutants; State of 

Maryland; Control of Emissions From 

Existing Sewage Sludge Incineration 

Units; Correction 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; correction. 

SUMMARY: The Environmental Protection 

Agency (EPA) issued a final rule on 

February 9, 2021 entitled ‘‘Approval 

and Promulgation of State Air Quality 

Plans for Designated Facilities and 

Pollutants; State of Maryland; Control of 

Emissions from Existing Sewage Sludge 

Incineration Units.’’ This document 

corrects an error in the rule language of 

the final rule pertaining to EPA’s 

approval of Maryland’s negative 

declaration regarding the existence of 

Sewage Sludge Incineration (SSI) units 

in the state submitted by the State of 

Maryland. 

DATES: Effective on March 11, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Matthew Willson, Permits Branch 

(3AD10), Air & Radiation Division, U.S. 

Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. The 

telephone number is (215) 814–5795. 

Mr. Willson can also be reached via 

electronic mail at Willson.Matthew@

epa.gov. 

SUPPLEMENTARY INFORMATION: On 

February 9, 2021, (86 FR 8699), EPA 

published a final rule action 

announcing our approval of Maryland’s 

negative declaration regarding the 

existence of SSI units in the state. In the 

document, we inadvertently indicated 

that a section should be added to the 

Code of Federal Regulations (CFR) at 40 

CFR 62.4690 for air emissions from 

existing SSI units. The intent of the rule 

was to add a section for air emissions 

from existing SSI units at 40 CFR 

62.5170. This document corrects the 

erroneous language. 

Need for Correction 

As published, the final rule would 

amend subpart T, which is for the 

approval of state plans for designated 

facilities and pollutants for the state of 

Louisiana. The intent of the final rule 

was to change the approval of state 

plans for designated facilities and 

pollutants for the State of Maryland. 

This correction will ensure that the 

correct section of the CFR, which for 

Maryland is subpart V, is amended. 

Section 553 of the Administrative 

Procedure Act, 5 U.S.C. 553(b)(3)(B), 

provides that, when an agency for good 

cause finds that notice and public 

procedure are impracticable, 

unnecessary or contrary to the public 

interest, the agency may issue a rule 

without providing notice and an 

opportunity for public comment. We 

have determined that there is good 

cause for making this rule final without 

prior proposal and opportunity for 

comment because we are merely 

correcting an incorrect citation in a 

previous action. Thus, notice and public 

procedure are unnecessary. We find that 

this constitutes good cause under 5 

U.S.C. 553(b)(3)(B). 

In FR doc. 2021–02617 appearing on 

page 8699 in the Federal Register of 

Tuesday, February 9, 2021 the following 

corrections are made: 

Subpart V—[Corrected] 

■ 1. On page 8700, in the third column, 

in part 62, in amendment 2, the 

instruction ‘‘Add an undesignated 

center heading and § 62.4690 to read as 

follows:’’ is corrected to read ‘‘Add an 

undesignated center heading and 

§ 62.5170 to read as follows:’’ 

■ 2. On page 8700, in the third column, 

the section heading ‘‘§ 62.4690 

Identification of plan—negative 

declaration.’’ is corrected to read 

‘‘§ 62.5170 Identification of plan— 

negative declaration.’’ 

Dated: March 3, 2021. 

Diana Esher, 

Acting Regional Administrator EPA Region 

III. 

[FR Doc. 2021–04827 Filed 3–8–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2018–0551; FRL–10019–19] 

Fluindapyr; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluindapyr in 

or on multiple commodities which are 

identified and discussed later in this 

document. FMC Corporation requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 9, 2021. Objections and requests 

for hearings must be received on or 

before May 10, 2021, 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–2018–0551, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW, Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. 

Due to the public health concerns 

related to COVID–19, the EPA Docket 

Center (EPA/DC) and Reading Room is 

closed to visitors with limited 

exceptions. The staff continues to 

provide remote customer service via 

email, phone, and webform. For the 

latest status information on EPA/DC 

services and docket access, visit https:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Marietta Echeverria, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; main 


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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 Government Publishing Office’s eCFR site at http://www.ecfr.gov/cgi-bin/ 

text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

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–2018–0551 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 

10, 2021. 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– 

2018–0551, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

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 http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of May 9, 2019 

(84 FR 20320) (FRL–9992–36), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 8F8685) by FMC 

Corporation, 2929 Walnut Street, 

Philadelphia, PA 19104. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the fungicide, fluindapyr, 3- 

(difluoromethyl)-N-(7-fluoro-2,3- 

dihydro-1,1,3-trimethyl-1H-inden-4-yl)- 

1-methyl-1H-pyrazole-4-carboxamide, in 

or on almond, hulls at 15 parts per 

million (ppm); aspirated grain fractions 

at 60 ppm; cattle, fat at 0.15 ppm; cattle, 

meat byproducts at 0.6 ppm; field corn, 

grain at 0.01 ppm; field corn, oil at 0.03 

ppm; fruit, small vine-climbing except 

fuzzy kiwifruit, crop subgroup 13–07F 

at 3 ppm; grain, cereal, crop group 15, 

except rice and corn at 0.9 ppm; grain, 

cereal, forage, crop group 16, except 

rice, forage at 15 ppm; grain, cereal, hay, 

crop group 16 except rice, hay at 8 ppm; 

grain, cereal, stover, crop group 16 

except rice, stover, and sweet corn 

stover at 4 ppm; grain, cereal, straw, 

crop group 16, except rice, straw at 20 

ppm; poultry, meat byproducts at 0.03 

ppm; soybean, forage at 15 ppm; 

soybean, hay at 30 ppm; soybean, hulls 

at 0.6 ppm; soybean, seed at 0.2 ppm; 

sweet corn, K+CWHR at 0.01 ppm; 

sweet corn, stover at 20 ppm; swine, 

meat byproducts at 0.02 ppm; and tree 

nuts, crop group 14–12 at 0.04 ppm. 

That document referenced a summary of 

the petition prepared by FMC 

Corporation, the registrant, which is 

available in the docket, http://

www.regulations.gov. One comment was 

received on the notice of filing. EPA’s 

response to this comment is discussed 

in Unit IV.C. 

Based upon review of the data 

supporting the petition and in 

accordance with its authority under 

FFDCA section 408(d)(4)(A)(i) to 

establish tolerances that vary from what 

was requested, EPA is establishing 

several tolerances at different levels 

than were requested, including 

additional livestock commodities as 

necessary. In addition, tolerances for 

fruit, small vine-climbing except fuzzy 

kiwifruit crop group 13–07F and 

soybeans were removed. The reasons for 

these changes are explained in Unit 

IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for fluindapyr 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fluindapyr 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 


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subgroups of consumers, including 

infants and children. 

The target organs of fluindapyr are the 

liver and thyroid. Liver effects include 

hepatocellular hypertrophy, increased 

liver weights, and bile duct hyperplasia 

with correlated increases in alkaline 

phosphatase (ALP), alanine 

aminotransferase (ALT), and gamma 

glutamyl transferase (GGT) at the 

highest dose tested. Liver effects 

progress with time in treated dogs, 

while similar effects are not seen in rats 

and mice at high dose levels. Liver 

effects are seen in the mouse 

carcinogenicity study at a higher dose 

level than the liver effects observed in 

dogs; the effects consisted of increased 

incidence of hepatocellular alterations 

(basophilic, eosinophilic, vacuolated), 

necrosis, and pigmented macrophages. 

Thyroid effects include increased 

instances of follicular hypertrophy/ 

hyperplasia. 

In the acute neurotoxicity study, 

potential evidence of neurotoxicity in 

the form of decreases in total and 

ambulatory motor activities and in 

rearing were seen in the rat. However, 

no additional functional observation 

(FOB) parameters were affected, and no 

neuropathological findings of both 

central and peripheral nerves were 

observed. 

There is no evidence of increased 

quantitative or qualitative susceptibility 

in the developmental toxicity studies in 

rabbits or rats; or the reproductive 

toxicity study in rats. With in-utero 

exposure in the developmental toxicity 

studies, fluindapyr did not produce any 

adverse effects in either rat or rabbit 

parental animals or fetuses at or 

approaching the limit dose. In the 

reproduction study, in parental animals 

(P and F1 males and females), 

fluindapyr induced an increase in 

thyroid follicular hypertrophy/ 

hyperplasia. It also induced adverse 

effects on a host of reproductive 

parameters. It also produced adverse 

offspring effects as indicated by 

decreases in F1 and F2 pup body 

weights in both sexes; thymus and 

spleen weights were also decreased. The 

parental, reproductive, and offspring 

effects all occurred at the same dose 

levels. The increased incidence of 

thyroid follicular hypertrophy/ 

hyperplasia raised concerns for the 

potential of thyroid effects on the 

developing animals. EPA applied a 10X 

safety factor to the appropriate exposure 

scenarios to account for the 

uncertainties associated with the life 

stage susceptibility. 

In the chronic toxicity/carcinogenicity 

studies in rats and mice, there was no 

evidence of carcinogenicity. The 

mutagenicity battery was negative. 

Fluindapyr is classified as ‘‘Not Likely 

to be Carcinogenic to Humans’’. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fluindapyr as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Fluindapyr: Human Health Risk 

Assessment for Section 3 Registration 

and Tolerance Requests for a New 

Active Ingredient Proposed for Use on 

Cereal Grains Crop Group 15 except 

Rice; Forage, Fodder and Straw of 

Cereal Grains Crop Group 16; and 

Soybean’’ (hereinafter ‘‘Fluindapyr 

Human Health Risk Assessment’’) on 

pages 14–20 in docket ID number EPA– 

HQ–OPP–2018–0551. 

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 http://

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticide. 

A summary of the toxicological 

endpoints for fluindapyr used for 

human risk assessment can be found in 

the Fluindapyr Human Health Risk 

Assessment. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluindapyr, EPA considered 

exposure under the petitioned-for 

tolerances. EPA assessed dietary 

exposures from fluindapyr in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. Such effects were identified 

for fluindapyr. In estimating acute 

dietary exposure, EPA used 2003–2008 

food consumption information from the 

United States Department of Agriculture 

(USDA) Nationwide Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, the acute 

analysis assumed 100% crop treated 

(PCT) for all commodities, highest 

average field trial (HAFT) residue 

values, empirical and default processing 

factors, and anticipated livestock 

residues based on calculated livestock 

dietary burden and tissue transfer rates 

from the livestock feeding studies. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used 2003–2008 food consumption 

data from the USDA’s NHANES/ 

WWEIA. As to residue levels in food, 

chronic analysis assumed 100 PCT for 

all commodities, field trial mean residue 

values, empirical and default processing 

factors, and anticipated livestock 

residues based on calculated livestock 

dietary burden and tissue transfer rates 

from the livestock feeding studies and 

metabolite ratios from the metabolism 

studies. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fluindapyr does not pose 

a cancer risk to humans. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue. 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) 


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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. 

EPA did not use information on the 

percent of food actually treated in the 

dietary assessment for fluindapyr; 100 

PCT was 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 fluindapyr in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of fluindapyr. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

Using the Pesticide Water Calculator 

(PWC, version 1.52), the estimated 

drinking water concentrations (EDWCs) 

of fluindapyr were determined to be 

higher in groundwater than in surface 

water for both acute and chronic 

exposure durations. The following 

groundwater EDWCs were used directly 

in the dietary exposure model to 

account for the contribution of 

fluindapyr and relevant transformation 

products (3–OH–F9990 and 1–COOH– 

F9990) residues in drinking water as 

follows: 254.1 ppb was used in the acute 

assessment and 217.8 ppb was used in 

the chronic assessment. 

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). 

Fluindapyr is currently registered for 

the following use that could result in 

residential exposures: Golf course turf. 

The currently registered use on golf 

courses will result in short-term (1 to 30 

days) residential post-application 

dermal exposures to adult, youth 11 to 

less than 16 years old, and children 6 

to less than 11 years old. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 

http://www.epa.gov/pesticides/trac/ 

science/trac6a05.pdf. 

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.’’ 

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

fluindapyr and any other substances 

and fluindapyr does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this action, therefore, EPA has not 

assumed that fluindapyr has a common 

mechanism of toxicity with other 

substances. 

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. 

In the developmental toxicity studies 

(rat and rabbit), fluindapyr did not 

produce any adverse effects in parental 

animals or fetuses at or approaching the 

limit dose (1,000 mg/kg/day). In the 

reproduction study, in parental animals 

(P and F1 males and females), 

fluindapyr induced an increase in 

thyroid follicular hypertrophy/ 

hyperplasia. It also induced adverse 

effects on a host of reproductive 

parameters. There is no evidence of 

increased quantitative or qualitative 

susceptibility in the developmental 

toxicity studies in rabbits or rats or the 

reproductive toxicity study in rats. In 

the 2-generation reproduction study in 

rats, reproductive effects were observed, 

and offspring toxicity (decreased pup 

weights in F1 and F2 generation; 

thymus and spleen weights were 

decreased) was observed in the presence 

(same dosage) of parental toxicity 

(increase in thyroid follicular 

hypertrophy/hyperplasia and 

reproductive effects). 

3. Conclusion. Due to the 

uncertainties concerning the potential 

life stage susceptibility related to 

adverse thyroid effects seen in parental 

animals of the reproductive study, EPA 

is retaining the FQPA 10X SF for 

exposure scenarios that rely on the 

reproductive study in which such 

effects were seen. For purposes of this 

safety assessment, those scenarios are 

the post-application short-term dermal 

exposures and the short-term aggregate 

risk assessment. For the acute and 

chronic dietary assessments, 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. That decision is 

based on the following findings: 

i. The toxicity database for fluindapyr 

is complete. Fluindapyr caused an 

increased in the thyroid follicular 

hypertrophy/hyperplasia in the 2- 

generation reproduction study. The 

results of these findings raised concerns 

about the potential impact to the 

developing brain in response to 

changing thyroid levels brought on by 

thyroid effect in the parents. A database 

uncertainty factor of 10X is placed on 

fluindapyr to address this concern. 

ii. In the acute neurotoxicity study 

(ACN), decreases in total and 

ambulatory motor activities and in 

rearing were seen and could be 

considered as potential evidence for 

neurotoxicity. However, concern with 

fluindapyr is low because (1) no other 

effects were observed in database 

including in the subchronic 

neurotoxicity study (SCN); (2) no 

neurohistopathology was found in the 

ACN, SCN or any toxicity study in the 

fluindapyr database; and (3) the toxicity 

endpoints and PoD selected for risk 

assessment are protective of the effects 

seen in the ACN. 

iii. There is no evidence that 

fluindapyr results in increased 

quantitative or qualitative susceptibility 

in the developmental toxicity studies in 

rabbits or rats or the reproductive 

toxicity study in rats. In the 2- 

generation reproduction study in rats, 

reproductive effects were observed, and 

offspring toxicity (decreased pup 

weights in F1 and F2 generation; 

thymus and spleen weights were 

decreased) was observed in the presence 

(same dosage) of parental toxicity. Based 

on the effects in the 2-generation 

reproduction study, there is some 

uncertainty about the potential thyroidrelated effects on the developing fetus or 

child. While EPA is retaining the 10X 

FQPA SF for short-term aggregate risk 

assessment, there is no concern for this 

uncertainty for the acute dietary 

exposure assessment because 

perturbation of thyroid after a single 

dose is not anticipated to impact the 

developing fetus or offspring. Nor is 

there a concern for this uncertainty in 

the chronic dietary assessment because 

the chronic dietary endpoint, based on 


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Federal Register / Vol. 86, No. 44 / Tuesday, March 9, 2021 / Rules and Regulations 13463 

effects in dogs, is protective of potential 

thyroid-related effects observed in 

developing rats or offspring. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary risk assessments are based 

on high-end assumptions such as 100 

PCT assumptions, HAFT and field trial 

mean residue values, empirical and 

default processing factors, anticipated 

livestock residues based on calculated 

livestock dietary burden and tissue 

transfer rates from the livestock feeding 

studies and modeled, high-end 

estimates of residues in drinking water. 

All of the exposure estimates are based 

on high-end assumptions and are not 

likely to underestimate risk. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to fluindapyr in 

drinking water. EPA used similarly 

conservative assumptions to assess 

postapplication exposure of children. 

These assessments will not 

underestimate the exposure and risks 

posed by fluindapyr. 

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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

fluindapyr will occupy 8.9% of the 

aPAD for all infants (<1 year old), the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fluindapyr 

from food and water will utilize 33% of 

the cPAD for infants <1 year old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of fluindapyr is not expected. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Short-term and 

intermediate-term endpoints and 

residential exposure estimates are 

identical, and so short-term aggregate 

exposure is considered protective of 

intermediate-term aggregate exposures. 

The three population subgroups 

assessed for residential post-application 

exposures are: Adults, youth 11 to <16 

years old, and children 6 to <11 years 

old. Of the three population subgroups, 

the children 6 to <11 years old represent 

the highest dermal exposure from postapplication exposures and the highest 

background dietary exposure. Therefore, 

this population subgroup is considered 

protective of the other two population 

subgroups. 

For adults, intermediate-term 

exposure is not expected for the 

residential exposure pathway. 

Therefore, the intermediate-term 

aggregate risk would be equivalent to 

the chronic dietary exposure estimate. 

For children, all intermediate-term 

aggregate risks are equivalent to shortterm aggregate risks. 

Using the exposure assumptions 

described in this unit for short-term and 

intermediate-term exposures, EPA has 

concluded the combined short- and 

intermediate term food, water, and 

residential exposures result in aggregate 

MOEs of 720 for youth (6 to <11 yrs. 

old) with dermal exposure from postapplication exposure to residue from 

treated golf course. Because EPA’s level 

of concern for fluindapyr is a MOE of 

100 or below, these MOEs are not of 

concern. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

fluindapyr is not expected to pose a 

cancer risk to humans. 

5. 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 fluindapyr 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

The petitioner has proposed a liquid 

chromatography with tandem mass 

spectrometer (LC/MS/MS) for 

determination of fluindapyr and 

metabolites 3–OH–F9990, F9990–DMglucoside, 1–OH-Me-F9990, 1–OH-MeDM–F9990, and 1–COOH–F9990 in 

plant commodities. For livestock 

commodities, adequate enforcement 

methodology using LC/MS/MS is 

available for determination of residues 

of fluindapyr and its metabolites. 

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). 

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 an 

MRL for fluindapyr. 

C. Response to Comments 

One comment was received in 

response to the notice of filing that 

argued against the use fluindapyr on 

several commodities and the overall 

toxicity of pesticides. In addition, the 

commenter raised three additional 

concerns: The lack of tests involving the 

combination of fluindapyr and other 

chemicals; fluindapyr a potential 

cancer-causing agent; and fluindapyr is 

a fluoride compound. Although the 

Agency recognizes that some 

individuals believe that pesticides 

should be banned on agricultural crops, 

the existing legal framework provided 

by section 408 of the Federal Food, 

Drug, and Cosmetic Act (FFDCA) 

authorized EPA to establish tolerances 

when it determines that the tolerance is 

safe. Upon consideration of the validity, 

completeness, and reliability of the 

available data as well as other factors 

the FFDCA requires EPA to consider, 

EPA has determined that these 

fluindapyr tolerances are safe. The 

commenter has provided no information 

supporting a contrary conclusion. 

In its assessment of safety under the 

FFDCA, EPA considers combinations of 

pesticides by evaluating the cumulative 

effects of pesticides that have a common 

mechanism of toxicity. At this time, 

EPA has not identified a common 


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mechanism of toxicity between 

fluindapyr and other pesticides and 

thus there are no combinations of 

pesticides to consider at this time. 

EPA has evaluated available data 

concerning carcinogenicity and 

determined that fluindapyr is not likely 

to be carcinogenic to humans. This 

conclusion is based on a lack of 

treatment-related tumors seen in male or 

female rats or mice and no concern for 

mutagenicity. The commenter has 

provided no additional information 

about potential carcinogenicity. 

Fluindapyr contains a difluoromethyl 

group and a fluorine-substituted phenyl 

group. The difluoromethyl group 

remains intact on the compounds 

identified in crop (primary and 

rotational), livestock, and 

environmental fate studies, including 

the compounds identified as the 

residues of concern for tolerance 

enforcement and risk assessment 

purposes for crop and livestock 

commodities. While the metabolism 

studies show the phenyl group does 

degrade, it is extremely unlikely for the 

fluorine to form a free fluorine because 

the stability of the bond between the 

fluorine and carbon atom. Therefore, 

applications of fluindapyr are not 

expected to result in dietary exposure to 

fluoride. 

D. Revisions to Petitioned-For 

Tolerances 

Based on EPA’s review of the data 

supporting the petition, EPA is 

establishing tolerances that vary from 

what the petitioner requested under its 

authority in FFDCA section 

408(d)(4)(A)(i). Some commodity terms 

are altered to be consistent with Agency 

nomenclature. EPA is not establishing 

tolerances for corn oil since EPA 

determined that residues on this 

commodity will be adequately covered 

under corn, field, grain due to the lack 

of concentration during processing. EPA 

is also not establishing tolerances for 

fruit, small vine-climbing except fuzzy 

kiwifruit, crop subgroup 13–07F and the 

soybean commodities as initially 

requested since they are not necessary at 

this time, due to the withdrawal of the 

proposed uses by the petitioner. 

EPA is establishing tolerance levels 

lower than what the petitioner 

requested for grain, aspirated fractions; 

grain, cereal, group 15, except rice and 

corn from 0.9 ppm; and cattle, fat based 

on the submitted field trial data for 

those commodities using the OEDC 

MRL (Maximum Residue Limit) 

calculator. 

Because of potential increase of 

fluindapyr (including metabolites and 

degradates) in livestock diet, largely due 

to cereal grain crop group 15 and 16 use, 

and based on updated maximum 

reasonably balanced diet (MRBD) 

calculations for livestock, the Agency 

has determined that finite residues will 

be incurred in poultry (egg, fat, meat, 

and meat byproducts), ruminants (fat, 

milk, meat, and meat byproducts), hog 

(fat, meat, and meat byproducts), and 

horse (fat, meat, and meat byproducts); 

therefore, under 40 CFR 180.6, EPA is 

establishing tolerances for those 

commodities. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluindapyr, 3- 

(difluoromethyl)-N-(7-fluoro-2,3- 

dihydro-1,1,3-trimethyl-1H-inden-4-yl)- 

1-methyl-1H-pyrazole-4-carboxamide, in 

or on almond, hulls at 15 ppm ; corn, 

field, grain at 0.01 ppm; corn, sweet, 

kernel plus cob with husks removed at 

0.01 ppm; corn, sweet, stover at 20 ppm; 

grain, aspirated fractions at 20 ppm; 

grain, cereal, forage, fodder, and straw, 

group 16 forage, except rice at 15 ppm; 

grain, cereal, forage, fodder, and straw, 

group 16, hay, except rice at 8 ppm; 

grain, cereal, forage, fodder, and straw, 

group 16, stover, except rice at 4 ppm; 

grain, cereal, forage, fodder, and straw, 

group 16, straw, except rice at 20 ppm; 

grain, cereal, group 15, except rice and 

corn at 0.8 ppm; nut, tree, group 14–12 

at 0.04 ppm; egg at 0.01 ppm; milk at 

0.01 ppm; cattle, fat at 0.03 ppm; cattle, 

meat at 0.01; goat, fat at 0.03 ppm; goat, 

meat at 0.01 ppm; hog, fat at 0.01 ppm; 

hog, meat at 0.01 ppm; horse, fat at 0.03 

ppm; horse, meat at 0.01 ppm; poultry, 

fat at 0.01 ppm; poultry, meat at 0.01 

ppm; sheep, fat at 0.03 ppm; and sheep, 

meat at 0.01 ppm. In addition, 

tolerances are established for residues of 

fluindapyr, 3-(difluoromethyl)-N-(7- 

fluoro-1,1,3-trimethyl-2,3-dihydro-1Hinden-4-yl)-1-methyl-1H-pyrazole-4- 

carboxamide, and 3-(difluoromethyl)-N- 

(7-fluoro-1-hydroxymethyl-1,3- 

dimethyl-2,3-dihydro-lH-inden-4-yl)-1- 

methyl-lH-pyrazole-4-carboxamide, in 

or on cattle, meat byproducts at 0.3 

ppm; goat, meat byproducts at 0.3 ppm; 

horse, meat byproducts at 0.3 ppm; hog, 

meat byproducts at 0.01 ppm; poultry, 

meat byproducts at 0.01 ppm; and 

sheep, meat byproducts at 0.3 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or Tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or Tribal Governments, on the 

relationship between the National 

Government and the States or Tribal 

Governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this action. In 

addition, this action does not impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act (UMRA) (2 U.S.C. 1501 et 

seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 


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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. 

Edward Messina, 

Acting Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended 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. Add § 180.716 to subpart C to read 

as follows: 

§ 180.716 Fluindapyr; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the fungicide 

fluindapyr, including its metabolites 

and degradates, in or on the 

commodities in Table 1 of this section. 

Compliance with the tolerance levels 

specified in Table 1 is to be determined 

by measuring only fluindapyr, 3- 

(difluoromethyl)-N-(7-fluoro-1,1,3- 

trimethyl-2,3-dihydro-1H-inden-4-yl)-1- 

methyl-1H-pyrazole-4-carboxamide, in 

or on the commodity. 

TABLE 1 TO PARAGRAPH (a)(1) 

Commodity Parts per 

million 

Almond, hulls ........................................... 15 

Cattle, fat ................................................. 0.03 

Cattle, meat ............................................. 0.01 

Corn, field, grain ...................................... 0.01 

Corn, sweet, kernel plus cob with husks 

removed ............................................... 0.01 

Corn, sweet, stover ................................. 20 

Egg .......................................................... 0.01 

Goat, fat .................................................. 0.03 

Goat, meat .............................................. 0.01 

Grain, aspirated fractions ........................ 20 

Grain, cereal, forage, fodder, and straw, 

group 16, forage, except rice .............. 15 

Grain, cereal, forage, fodder, and straw, 

group 16, hay, except rice ................... 8 

Grain, cereal, forage, fodder, and straw, 

group 16, stover, except rice ............... 4 

Grain, cereal forage, fodder, and straw, 

group 16, straw, except rice ................ 20 

TABLE 1 TO PARAGRAPH (a)(1)— 

Continued 

Commodity Parts per 

million 

Grain, cereal group 15, except rice and 

corn ...................................................... 0.8 

Hog, fat .................................................... 0.01 

Hog, meat ................................................ 0.01 

Horse, fat ................................................. 0.03 

Horse, meat ............................................. 0.01 

Milk .......................................................... 0.01 

Nut, tree, group 14–12 ............................ 0.04 

Poultry, fat ............................................... 0.01 

Poultry, meat ........................................... 0.01 

Sheep, fat ................................................ 0.03 

Sheep, meat ............................................ 0.01 

(2) Tolerances are established for 

residues of the fungicide fluindapyr, 

including its metabolites and 

degradates, in or on the commodities in 

Table 2 of this section. Compliance with 

the tolerance levels specified in Table 2 

is to be determined by measuring the 

sum of fluindapyr, 3-(difluoromethyl)- 

N-(7-fluoro-1,1,3-trimethyl-2,3-dihydro1H-inden-4-yl)-1-methyl-1H-pyrazole-4- 

carboxamide, and 3-(difluoromethyl)-N- 

(7-fluoro-1-hydroxymethyl-1,3- 

dimethyl-2,3-dihydro-lH-inden-4-yl)-1- 

methyl-lH-pyrazole-4-carboxamide, 

calculated as the stoichiometric 

equivalent of fluindapyr, in or on the 

commodity. 

TABLE 2 TO PARAGRAPH (a)(2) 

Commodity Parts per 

million 

Cattle, meat byproducts .......................... 0.3 

Goat, meat byproducts ............................ 0.3 

Horse, meat byproducts .......................... 0.3 

Hog, meat byproducts ............................. 0.01 

Poultry, meat byproducts ........................ 0.01 

Sheep, meat byproducts ......................... 0.3 

(b)–(d) [Reserved] 

[FR Doc. 2021–04786 Filed 3–8–21; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 17 

[Docket No. FWS–R3–ES–2018–0056; 

FF09E21000 FXES11110900000 212] 

RIN 1018–BD26 

Endangered and Threatened Wildlife 

and Plants; Endangered Species 

Status for the Missouri Distinct 

Population Segment of Eastern 

Hellbender 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Final rule. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service (Service), determine 

endangered species status under the 

Endangered Species Act of 1973 (Act), 

as amended, for the Missouri distinct 

population segment (DPS) of eastern 

hellbender (Cryptobranchus 

alleganiensis alleganiensis), a 

salamander species. This rule adds this 

DPS of this species to the Federal List 

of Endangered and Threatened Wildlife. 

DATES: This rule is effective April 8, 

2021. 

ADDRESSES: This final rule is available 

on the internet at http://

www.regulations.gov in Docket No. 

FWS–R3–ES–2018–0056 and https://

www.fws.gov/midwest/endangered/ 

amphibians/eastern_hellbender/. 

Comments and materials we received, as 

well as supporting documentation we 

used in preparing this rule, are available 

for public inspection at http://

www.regulations.gov. Comments, 

materials, and documentation that we 

considered in this rulemaking will be 

available by appointment, during 

normal business hours, at: U.S. Fish and 

Wildlife Service, Columbia, Missouri 

Ecological Services Field Office, 101 

Park DeVille Drive, Suite A, Columbia, 

MO 65203–0057; telephone 573–234– 

2132. 

FOR FURTHER INFORMATION CONTACT: 

Karen Herrington, Field Supervisor, 

Missouri Ecological Services Field 

Office, 101 Park DeVille Drive, Suite A, 

Columbia, MO 65203; telephone 573– 

234–2132. Persons who use a 

telecommunications device for the deaf 

(TDD) may call the Federal Relay 

Service at 800–877–8339. 

SUPPLEMENTARY INFORMATION: 

Previous Federal Actions 

On April 4, 2019, we published a 

proposed rule (84 FR 13223) to add the 

Missouri DPS of the eastern hellbender 

as an endangered species to the List of 

Endangered and Threatened Wildlife in 

part 17 of title 50 of the Code of Federal 

Regulations (at 50 CFR 17.11(h)). We 

concurrently published a not warranted 

finding on the listing of the eastern 

hellbender subspecies as a whole. See 

the proposed listing rule for the 

Missouri DPS of the eastern hellbender 

for more information regarding the 

previous Federal actions on the 

hellbender species and related 

subspecies. 

Background 

The Missouri DPS of the eastern 

hellbender lies completely within the 

boundaries of the State of Missouri with 

eastern hellbenders known to occur in 

Big River, Big Piney River, Courtois 


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