Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Rules and Regulations 52083 

I. Does this action apply to me? 

The Agency included in the April 7, 

2021 final rule a list of those who may 

be potentially affected by this action. 

II. What do these corrections do? 

EPA issued a final rule in the Federal 

Register of April 7, 2021 (86 FR 17907) 

(FRL–10020–24) that established 

tolerances for residues of spinetoram in 

or on multiple commodities and 

removed some tolerances in response to 

a petition filed by IR–4. EPA 

inadvertently reversed the instructions 

to the Federal Register regarding the 

entries for ‘‘vegetable, leafy, except 

Brassica, group 4’’ and ‘‘vegetable, leafy, 

group 4–16’’ in the tolerance table in 

paragraph (a) of 40 CFR 180.635. The 

instructions inadvertently directed the 

Federal Register to add an entry in the 

table for ‘‘vegetable, leafy, except 

Brassica, group 4’’. The instructions 

should have directed the Federal 

Register to remove that entry from the 

table, as described in Unit V. of the 

April 7, 2021 final rule and as reflected 

in the amended table in the regulatory 

text of the final rule. Additionally, the 

instructions inadvertently directed the 

Federal Register to remove the entry in 

the table for ‘‘vegetable, leafy, group 4– 

16’’. The instructions should have 

directed the Federal Register to add that 

entry to the table, as described in Unit 

V. of the April 7, 2021 final rule and as 

reflected in the amended table in the 

regulatory text of the final rule. 

EPA’s instructions in the April 7, 

2021 final rule regarding tolerances for 

‘‘vegetable, leafy, except Brassica, group 

4’’ and ‘‘vegetable, leafy, group 4–16’’ 

were not consistent with its authority 

under FFDCA section 408(d)(4)(A) or 

with the preamble or regulatory text of 

the April 7, 2021 final rule. Therefore, 

EPA is rescinding those instructions and 

directing the Federal Register to remove 

the entry for ‘‘vegetable, leafy, except 

Brassica, group 4’’ and add an entry for 

‘‘vegetable, leafy, group 4–16’’ in the 

tolerance table in paragraph (a) of 40 

CFR 180.635. 

III. Why are these corrections issued as 

a final rule? 

Section 553 of the Administrative 

Procedure Act (APA) (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 final 

rule without providing notice and an 

opportunity for public comment. EPA 

has determined that there is good cause 

for making these correcting amendments 

final without prior proposal and 

opportunity for comment, because EPA 

inadvertently reversed the instructions 

to the Federal Register so that the new 

tolerance for ‘‘vegetable, leafy, group 4– 

16’’ was not established and the existing 

tolerance for ‘‘vegetable, leafy, except 

Brassica, group 4’’ was not removed. 

EPA finds that this constitutes good 

cause under 5 U.S.C. 553(b)(3)(B). 

IV. Do any of the statutory and 

executive order reviews apply to this 

action? 

No. For a detailed discussion 

concerning the statutory and Executive 

order review refer to Unit VI. of the 

April 7, 2021 final rule. 

V. 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: September 13, 2021. 

Marietta Echeverria, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, EPA corrects 40 CFR part 180 

by making the following correcting 

amendments: 

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. In § 180.635, amend Table 1 to 

Paragraph (a) as follows: 

■ a. Remove the entry for ‘‘Vegetable, 

leafy, except Brassica, group 4’’; and 

■ b. Add alphabetically an entry for 

‘‘Vegetable, leafy, group 4–16’’. 

The addition reads as follows: 

§ 180.635 Spinetoram; tolerances for 

residues. 

(a) * * * 

TABLE 1 TO PARAGRAPH (a) 

Commodity Parts per 

million 

* * * * * 

Vegetable, leafy, group 4–16 ..... 10 

* * * * * 

* * * * * 

[FR Doc. 2021–20248 Filed 9–17–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0227; FRL–8857–01– 

OCSPP] 

Pyraclostrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyraclostrobin 

in or on pomegranate. Interregional 

Research Project Number 4 (IR–4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

September 20, 2021. Objections and 

requests for hearings must be received 

on or before November 19, 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–2020–0227, 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 emergency, 

the EPA Docket Center (EPA/DC) and 

Reading Room was closed to public 

visitors on March 31, 2020. Our EPA/DC 

staff will continue to provide customer 

service via email, phone, and webform. 

For further information on EPA/DC 

services, docket contact information and 

the current status of the EPA/DC and 

52084 Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Rules and Regulations 

Reading Room, please visit http://

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Marietta Echeverria, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; main 

telephone number: (703) 305–7090; 

email address: 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 

e-CFR site at http://www.ecfr.gov/cgibin/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–2020–0227 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 

November 19, 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– 

2020–0227, 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 September 

30, 2020 (85 FR 61681) (FRL–10014–74), 

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 0E8826) by IR–4, 

IR–4 Project Headquarters, Rutgers, The 

State University of New Jersey, 500 

College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested to establish tolerances in 40 

CFR 180.582 for residues of the sum of 

pyraclostrobin, (carbamic acid, [2-[[[1- 

(4-chlorophenyl)-1H-pyrazol-3- 

yl]oxy]methyl]phenyl]methoxy-, methyl 

ester) and its desmethoxy metabolite 

(methyl-N-[[[1-(4-chlorophenyl)-1Hpyrazol-3-yl]oxy]methyl] 

phenylcarbamate), calculated as the 

stoichiometric equivalent of 

pyraclostrobin, in or on the raw 

agricultural commodity pomegranate at 

0.3 ppm. That document referenced a 

summary of the petition prepared by 

BASF, the registrant, which is available 

in the docket, http://

www.regulations.gov. No comments 

were received in response to the notice 

of filing. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for pyraclostrobin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with pyraclostrobin follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The primary target tissues following 

repeated pyraclostrobin exposure 

appear to be mucosal membranes, with 

histopathology or secondary effects (e.g., 

diarrhea) observed in different species. 

The primary effects were decreased 

body weight and food consumption in 

addition to diarrhea. There was no 

observed neurotoxicity, mutagenicity, 

genotoxicity, or immunotoxicity in the 

database. Also, there was no evidence of 

increased susceptibility following prenatal exposure to rats and rabbits in the 

developmental toxicity studies, nor 

following pre- and post-natal exposure 

to rats in the multi-generation 

reproduction study. Pyraclostrobin is 

classified as ‘‘not likely to be 

carcinogenic to humans.’’ 

Additional information on the 

toxicological profile can be found at 

http://www.regulations.gov in the 

Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Rules and Regulations 52085 

document titled ‘‘Pyraclostrobin; 

Human Health Risk Assessment for a 

New Use on Pomegranate’’ (hereinafter 

‘‘Pyraclostrobin Human Health Risk 

Assessment’’) in docket ID number 

EPA–HQ–OPP–2020–0227. 

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 pyraclostrobin used for 

human risk assessment can be found on 

pages 10–11 in the Pyraclostrobin 

Human Health Risk Assessment. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to pyraclostrobin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing pyraclostrobin tolerances in 40 

CFR 180.582. EPA assessed dietary 

exposures from pyraclostrobin 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 pyraclostrobin. 

In conducting the acute dietary 

exposure assessment, EPA used the 

2003–2008 food consumption data from 

the U.S. Department of Agriculture’s 

National Health and Nutrition 

Examination Survey, What We Eat in 

America (NHANES/WWEIA). A 

partially refined acute dietary exposure 

assessment was conducted for 

pyraclostrobin. The analysis used 

tolerance-level residues or highest 

average field trial residues (HAFT) and 

100 percent crop treated (PCT). 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the 2003–2008 

food consumption data from the USDA’s 

NHANES/WWEIA. A partially refined 

chronic dietary analysis was conducted 

for pyraclostrobin. The chronic dietary 

analysis included tolerance-level or 

average field trial residues and average 

PCT estimates when available. 

iii. Cancer. Pyraclostrobin is classified 

as ‘‘Not Likely to Be Carcinogenic to 

Humans’’ therefore, a cancer assessment 

is not needed. 

iv. Anticipated residue and PCT 

information. Section 408(b)(2)(F) of 

FFDCA states that the Agency may use 

data on the actual percent of food 

treated for assessing chronic dietary risk 

only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, and the exposure 

estimate does not understate exposure 

for the population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

The following average PCT estimates 

were used in the chronic dietary risk 

assessments for the crops that are 

currently registered for pyraclostrobin: 

Almonds 45%; apples 20%; apricots 

30%; barley 10%; green beans 5%; 

blueberries 40%; broccoli 5%; Brussels 

sprouts 15%; cabbage 10%; caneberries 

50%; cantaloupes 15%; carrots 35%; 

cauliflower 5%; celery 2.5%; cherries 

55%; chicory 5%; corn 10%; cotton 

(seed treatment) 10%; cucumber 5%; 

dry beans/peas 10%; garlic 10%; 

grapefruit 35%; grapes 30%; hazelnuts 

20%; lemons 5%; lettuce 5%; nectarines 

15%; oats 5%; onions 30%; oranges 5%; 

peaches 25%; peanuts 20%; pears 20%; 

green peas 5%; pecans 5%; peppers 

15%; pistachios 30%; potatoes 20%; 

pumpkins 15%; soybeans (seed 

treatment) 10%; spinach 5%; squash 

15%; strawberries 65%; sugar beets 

50%; sugarcane 5%; sweet corn 5%; 

tangerines 10%; tomatoes 25%; walnuts 

10%; watermelons 25%; wheat 5%. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and 

California Department of Pesticide 

Regulation (CalDPR) Pesticide Use 

Reporting (PUR) for the chemical/crop 

combination for the most recent 10 

years. EPA uses an average PCT for 

chronic dietary risk analysis and a 

maximum PCT for acute dietary risk 

analysis. The average PCT figure for 

each existing use is derived by 

combining available public and private 

market survey data for that use, 

averaging across all observations, and 

rounding to the nearest 5%, except for 

those situations in which the average 

PCT is less than 1% or less than 2.5%. 

In those cases, the Agency would use 

less than 1% or less than 2.5% as the 

average PCT value, respectively. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the most recent 10 years of 

available public and private market 

survey data for the existing use and 

rounded up to the nearest multiple of 

5%, except where the maximum PCT is 

less than 2.5%, in which case the 

Agency uses less than 2.5% as the 

maximum PCT. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

52086 Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Rules and Regulations 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which pyraclostrobin may be applied in 

a particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for pyraclostrobin in drinking water. 

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. 

Based on the Pesticide in Water 

Calculator (PWC), for the acute dietary 

risk assessment, EPA used an estimated 

drinking water concentration (EDWC) of 

22 ppb into the DEEM–FCID Model. For 

the chronic exposure assessment, EPA 

used a value of 0.99 ppb. 

3. Non-dietary exposure. The term 

‘‘residential exposure’’ is used in this 

document to refer to non-occupational, 

non-dietary exposure (e.g., for lawn and 

garden pest control, indoor pest control, 

termiticides, and flea and tick control 

on pets). 

Pyraclostrobin is currently registered 

for uses that may result in residential 

handler and post-application exposures, 

including commercial and residential 

use on lawns, as well as commercial use 

on ornamental turf and trees, golf 

courses, and parks. 

Based upon the hazard analysis for 

pyraclostrobin, short-term residential 

exposure that is available to be 

aggregated include incidental oral 

exposure (e.g., hand-to-mouth or objectto-mouth). Hand-to-mouth and objectto-mouth scenarios are considered interrelated, and it is likely that they occur 

interspersed amongst each other across 

time; combining these scenarios would 

be overly conservative. Residential short 

and intermediate-term dermal exposures 

(from children, youth, or adult 

scenarios) are not being combined with 

incidental oral exposure due to differing 

endpoints selected. Based upon the 

available scenarios, incidental oral 

(hand-to-mouth) exposures were used in 

the pyraclostrobin short-term aggregate 

assessment. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/ 

standard-operating-proceduresresidential-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.’’ 

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 

pyraclostrobin and any other substances 

and pyraclostrobin does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

not assumed that pyraclostrobin 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 rat developmental toxicity study, 

skeletal variations occurred at doses 

greater than or equal to those doses 

causing maternal toxicity (i.e., diarrhea, 

decreased body weight, food 

consumption, and clinical signs of 

toxicity). In the rabbit developmental 

study, increased resorptions per litter, 

increased post-implantation loss, and 

dams with total resorptions were 

observed. Since the cause of fetal death 

is undetermined and may be attributed 

to either maternal or direct embryo fetal 

toxicity, the effect is part of both the 

maternal and developmental LOAEL. In 

one rat reproduction study, systemic 

toxicity manifested as decreased body 

weights in both the parents and 

offspring, with offspring effects 

occurring at a higher dose level than 

parental toxicity. In the second rat 

reproduction study, no toxicity was 

observed in both parents and offspring. 

Therefore, there was no evidence of 

increased susceptibility (quantitatively) 

following pre-natal exposure to rats and 

rabbits in the developmental studies nor 

following pre- and post-natal exposure 

to rats in the multi-generation 

reproduction studies. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for pyraclostrobin 

is complete. 

ii. There are no indications in any of the 

studies available that the nervous system is 

a target for pyraclostrobin. In the absence of 

definitive neurotoxicity or neuropathology 

findings in the neurotoxicity battery or 

elsewhere in the database, a developmental 

neurotoxicity study is not required. 

iii. For the reasons summarized in section 

III.D.2, the degree of concern for prenatal and 

postnatal toxicity is low. 

iv. There are no residual uncertainties 

identified in the exposure databases. The 

acute dietary exposure assessments were 

performed assuming 100 percent of the crops 

were treated with pyraclostrobin and 

incorporating tolerance-level or highest field 

trial residues. The chronic dietary exposure 

assessments were performed using average 

PCT estimates and tolerance-level or average 

field trial residues for crops in the screening 

level use analysis (SLUA), while 100 PCT 

was used for crops not included in the SLUA. 

EPA made conservative (protective) 

assumptions in the ground and surface water 

modeling used to assess exposure to 

pyraclostrobin in drinking water. Although 

the acute and chronic assessments included 

minor refinements, the use of field trial and 

PCT estimates ensures that actual exposures/ 

risks from residues in food will not be 

underestimated. Although some of the 

residue values used in the dietary exposure 

assessment were refined, these assessments 

will not underestimate the dietary exposure 

to pyraclostrobin. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

described in this unit for acute 

exposure, EPA has concluded that acute 

exposure to pyraclostrobin from food 

and water will utilize 86% of the aPAD 

for females 13 to 49 years old, the only 

Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Rules and Regulations 52087 

population group of concern because no 

appropriate toxicological effect 

attributable to a single dose was 

observed for the general US population 

or any other population subgroup. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to pyraclostrobin 

from food and water will utilize 28% of 

the cPAD for all children 1 to 2 years 

old, the population group receiving the 

greatest exposure. Chronic residential 

exposure to residues of pyraclostrobin is 

not expected. 

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). 

Pyraclostrobin is currently registered 

for uses that could result in short-term 

residential exposure, and the Agency 

has determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to pyraclostrobin. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in an 

aggregate MOE of 430 for children 1 to 

2 years old. Because EPA’s level of 

concern for pyraclostrobin is a MOE of 

100 or below, this MOE is not of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

A separate intermediate-term adverse 

effect was identified for pyraclostrobin. 

However, pyraclostrobin is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposures that can be 

combined with background dietary 

exposures. Because there is no 

intermediate-term residential aggregate 

exposures and chronic dietary exposure 

has already been assessed under the 

appropriately protective cPAD, no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

pyraclostrobin. 

5. Aggregate cancer risk for U.S. 

population. Pyraclostrobin is classified 

as ‘‘Not Likely to Be Carcinogenic to 

Humans’’; therefore, EPA does not 

expect pyraclostrobin exposures to pose 

an aggregate cancer risk. 

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 

pyraclostrobin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Two adequate methods are available 

for enforcement purposes for residues of 

pyraclostrobin and its metabolites in/on 

plant commodities: a liquid 

chromatography with tandem mass 

spectroscopy (LC/MS/MS) method 

(BASF Method D9908) and a highperformance liquid chromatography/ 

ultraviolet (HPLC/UV) method (Method 

D9904). 

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). 

There is no Codex MRL for 

pyraclostrobin in or on pomegranate. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of pyraclostrobin in or on 

pomegranate at 0.3 ppm. Additionally, 

the Agency is putting back a footnote 

that states ‘‘There is no U.S. registration 

on coffee, bean, green as of September 

30, 2009’’ to the table in paragraph (a)(1) 

that was inadvertently removed in 2013. 

VI. Statutory and Executive Order 

Reviews 

This action establishes a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

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

has determined that this action will not 

have a substantial direct effect on States 

or Tribal Governments, on the 

relationship between the National 

Government and the States or Tribal 

Governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

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

addition, this action does not impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

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

seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

VII. Congressional Review Act (CRA) 

Pursuant to the CRA (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, 

52088 Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Rules and Regulations 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 13, 2021. 

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. In § 180.582, amend the table in 

paragraph (a)(1) by adding in 

alphabetical order the commodity 

‘‘Pomegranate’’ and a footnote 1 at the 

end of the table to read as follows: 

§ 180.582 Pyraclostrobin; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

*****

Pomegranate .............................. 0.3 

*****

1There is no U.S. registration on coffee, 

bean, green as of September 30, 2009. 

* * * * * 

[FR Doc. 2021–20251 Filed 9–17–21; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 2 and 95 

[ET Docket No. 20–382; FCC 21–72; FR ID 

43219] 

Allowing Earlier Equipment Marketing 

and Importation Opportunities 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: The Federal Communications 

Commission (Commission) adopts 

targeted enhancements that will 

modernize the Commission’s marketing 

and importation rules to allow 

radiofrequency (RF) equipment 

manufacturers to better gauge consumer 

interest and prepare for new product 

launches. These steps will further the 

communications sector’s ability to drive 

innovation that will advance America’s 

global competitiveness and promote 

economic growth. As product 

development cycles have accelerated, 

new marketplace models and 

assessment tools have emerged that rely 

on individual interest to fund products, 

optimize production, and match imports 

to anticipated sales. The rules the 

Commission is adopting will allow 

manufacturers to better use these tools 

to quickly deploy new technologies and 

devices to consumers while ensuring 

that communications equipment subject 

to equipment authorization continues to 

meet the Commission’s stringent 

program requirements. 

DATES: Effective October 20, 2021, 

except for §§ 2.803(c)(2)(i) and 

2.1204(a)(11), which contain 

information collection requirements that 

are not effective until approved by the 

Office of Management and Budget. The 

Federal Communications Commission 

will publish a document in the Federal 

Register announcing the effective date 

for those sections. 

FOR FURTHER INFORMATION CONTACT: 

Jamie Coleman, Spectrum Policy Branch 

Chief, Policy and Rules Division, Office 

of Engineering and Technology, at (202) 

418–2705 or Jamie.Coleman@FCC.gov. 

For additional information concerning 

the Paperwork Reduction Act 

information collection requirements 

contained in this document, contact 

Nicole Ongele, Office of Managing 

Director, at (202) 418–2991 or 

Nicole.Ongele@fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Report 

and Order, ET Docket No. 20–382, FCC 

21–72, adopted and released June 17, 

2021. The complete text of this 

document is available by downloading 

the text from the Commission’s website 

at https://www.fcc.gov/document/ 

allowing-earlier-equipment-marketingand-importation-opportunities-1. When 

the FCC Headquarters reopens to the 

public, the full text of this document 

also will be available for public 

inspection and copying during regular 

business hours in the FCC Reference 

Center, 45 L Street NE, Washington, DC 

20554. Alternative formats are available 

for people with disabilities (Braille, 

large print, electronic files, audio 

format) by sending an email to FCC504@

fcc.gov or calling the Commission’s 

Consumer and Governmental Affairs 

Bureau at (202) 418–0530 (voice), (202) 

418–0432 (TTY). 

Final Regulatory Flexibility Analyses 

The Regulatory Flexibility Act of 

1980, as amended (RFA) requires that an 

agency prepare a regulatory flexibility 

analysis for notice and comment 

rulemakings, unless the agency certifies 

that ‘‘the rule will not, if promulgated, 

have a significant economic impact on 

a substantial number of small entities.’’ 

As required by the RFA, an Initial 

Regulatory Flexibility Analysis (IRFA) 

was incorporated in the Notice of 

Proposed Rulemaking (NPRM) (86 FR 

2337, Jan. 12, 2021). The Commission 

sought written public comment on the 

proposals in the NPRM, including 

comments on the IRFA. No comments 

were filed addressing the IRFA. 

Accordingly, the Commission has 

prepared a Final Regulatory Flexibility 

Analysis (FRFA) concerning the 

possible impact of the rule changes 

contained in this document on small 

entities. This present FRFA conforms to 

the RFA. 

Paperwork Reduction Act 

This document contains modified 

information collection requirements. 

The Commission, as part of its 

continuing effort to reduce paperwork 

burdens will invite the general public to 

comment on the information collection 

requirements contained in this 

document as required by the Paperwork 

Reduction Act of 1995, Public Law 104– 

13. In addition, the Commission notes 

that pursuant to the Small Business 

Paperwork Relief Act of 2002, Public 

Law 107–198, see 44 U.S.C. 3506(c)(4), 

we previously sought specific comment 

on how the Commission might further 

reduce the information collection 

burden for small business concerns with 

fewer than 25 employees. 

In this present document, we have 

assessed the effects of requiring 

marketing disclosures on RF equipment 

manufacturers, some of which may be 

small entities, to market and import RF 

equipment, and find that the 

Commission’s rules are not unduly 

burdensome. We believe the regulatory 

burdens the Commission is 

implementing are necessary to ensure 

that the public receives the benefits of 

innovative products and technologies in 

a prompt and efficient manner, and 

those burdens apply equally to large and 

small entities without differential 

impact. 

Congressional Review Act 

The Commission has determined, and 

Administrator of the Office of 

Information and Regulatory Affairs, 

Office of Management and Budget, 

concurs, that this rule is ‘‘non-major’’