Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Rules and Regulations 12829 

purpose of this notice is to relieve a 

restriction (5 U.S.C. 553(d)(1)). 

III. Statutory and Executive Order 

Reviews 

This action defers sanctions and 

imposes no additional requirements. For 

that reason, this action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Orders 12866 (58 FR 51735, 

October 4, 1993) and 13563 (76 FR 3821, 

January 21, 2011); 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• Does not provide the EPA with the 

discretionary authority to address 

disproportionate human health or 

environmental effects with practical, 

appropriate, and legally permissible 

methods under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

• Is not approved to apply on any 

Indian reservation land or in any other 

area where the EPA or an Indian tribe 

has demonstrated that a tribe has 

jurisdiction. In those areas of Indian 

country, the rule does not have tribal 

implications and will not impose 

substantial direct costs on tribal 

governments or preempt tribal law as 

specified by Executive Order 13175 (65 

FR 67249, November 9, 2000). 

• Is subject to the CRA, and the EPA 

will submit a rule report to each House 

of the Congress and to the Comptroller 

General of the United States. The CRA 

allows the issuing agency to make a rule 

effective sooner than otherwise 

provided by the CRA if the agency 

makes a good cause finding that notice 

and comment rulemaking procedures 

are impracticable, unnecessary or 

contrary to the public interest (5 U.S.C. 

808(2)). The EPA has made a good cause 

finding for this rule as discussed in 

section II of this preamble, including the 

basis for that finding. 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by May 4, 2021. Filing a petition 

for reconsideration by the EPA 

Administrator of this final rule does not 

affect the finality of this rule for the 

purpose of judicial review nor does it 

extend the time within which petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. This action may not 

be challenged later in proceedings to 

enforce its requirements (see CAA 

section 307(b)(2)). 

List of Subjects in 40 CFR Part 52 

Environmental protection, 

Administrative practice and procedure, 

Air pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen dioxide, Ozone, Reporting and 

recordkeeping requirements, Volatile 

organic compounds. 

Authority: 42 U.S.C. 7401 et seq. 

Dated: February 23, 2021. 

Deborah Jordan, 

Acting Regional Administrator, Region IX. 

[FR Doc. 2021–04388 Filed 3–4–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0653; FRL–10019–99] 

Picarbutrazox; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of picarbutrazox 

in or on multiple commodities which 

are identified and discussed later in this 

document. Nippon Soda Co., Ltd c/o 

Nisso America, Inc. requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 5, 2021. Objections and requests 

for hearings must be received on or 

before May 4, 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–2017–0653, 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 

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/ 


jbell on DSKJLSW7X2PROD with RULES
12830 Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Rules and Regulations 

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–2017–0653 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 

4, 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– 

2017–0653, 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 March 6, 

2018 (83 FR 9471) (FRL–9973–27), 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 7F8623) by Nippon Soda 

Co., Ltd c/o Nisso America, Inc., 88 Pine 

Street, 14th Floor, New York, NY 10005. 

The petition requested that 40 CFR part 

180 be amended by establishing 

tolerances for residues of the fungicide 

picarbutrazox, 1,1-Dimethylethyl N-(6- 

((((Z)-((1-methyl-1H-tetrazol-5-yl) 

phenylmethylene) amino)oxy)methyl)-2- 

pyridinyl)carbamate, in or on corn, 

forage at 0.01 parts per million (ppm); 

corn, grain at 0.01 ppm; corn, stover at 

0.01 ppm; corn, sweet, forage at 0.01 

ppm; corn, sweet, kernel plus cob with 

husks removed at 0.01 ppm; corn, 

sweet, stover at 0.01 ppm; crop group 9, 

cucurbit vegetables at 0.20 ppm, crop 

subgroup 4–16A, leafy greens at 10 

ppm; popcorn, grain at 0.01 ppm; 

soybean, forage at 0.01 ppm; soybean, 

hay at 0.01 ppm and soybean, seed at 

0.01 ppm. That document referenced a 

summary of the petition prepared by 

Nippon Soda Co., Ltd c/o Nisso 

America, the registrant, which is 

available in the docket, http://

www.regulations.gov. Nine comments 

were received on the notice of filing. 

However, they were not germane to this 

submission. 

Based upon review of the data 

supporting the petition, EPA is 

establishing, in accordance with section 

408(d)(4)(a)(i), tolerances that vary in 

some respects from what the petitioner 

requested. Also, EPA is not establishing 

tolerances for Crop Group 9, Cucurbit 

Vegetables and Crop Subgroup 4–16A, 

Leafy Greens, as the petitioner withdrew 

the request for those tolerances after 

submitting the petition. The Agency’s 

underlying rationale for those variations 

are explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

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 picarbutrazox 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with picarbutrazox 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 organs for 

picarbutrazox are the liver and the 

thyroid gland across species and 

durations (except acute). The rat was the 

most sensitive species, followed by the 

mouse and the dog. Both the liver and 

the thyroid showed increases in organ 

weights and histopathological changes. 

In the liver, changes included 

hepatocyte hypertrophy, periportal 

vacuolation, cytoplasmic inclusions, 

and portal inflammatory cell 

infiltration. In the thyroid, there were 

increased incidences of thyroid 

hypertrophy which corresponded with 

increased thyroid weights in both 

parental animals and neonates. 

Disruption of thyroid hormones was 

also observed across the guideline 

studies, for the short-term and long-term 

durations in rats (alterations in 

triiodothyronine (T3), thyroxine (T4), 

and thyroid stimulating hormone 

(TSH)). Thyroid follicular tumors were 

observed in rats following 2 years of oral 

exposure. No treatment-related effects 

were observed in mice following 78 

weeks of exposure. There is no evidence 

of genotoxicity or mutagenicity in the 

picarbutrazox hazard database. 

There is no evidence of increased 

prenatal susceptibility in rats or rabbits 

or postnatal susceptibility in rats. There 

were no adverse fetal or maternal effects 

in the available developmental toxicity 

studies in rats or rabbits. Both studies 

tested up to the limit dose. In the multigeneration reproductive study, adverse 

thyroid effects were observed in the 

parental animals and occurred at doses 

lower than offspring effects. There were 

no adverse reproductive effects up to 

the highest dose tested (46/63 mg/kg/ 

day). 


jbell on DSKJLSW7X2PROD with RULES
Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Rules and Regulations 12831 

Subchronic studies in rats were 

performed for the numerous plant 

metabolites generated from parent 

picarbutrazox. All were less toxic than 

the parent molecule. No signs of 

neurotoxicity were observed in the 

acute neurotoxicity study up to the limit 

dose (2,000 mg/kg/day). No dermal 

toxicity was observed in rats up to the 

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

Picarbutrazox is categorized as having 

low acute lethality through the oral, 

dermal, and inhalation routes. It is 

minimally irritating to the eye and is 

neither a dermal irritant nor sensitizer. 

In accordance with the EPA’s Final 

Guidelines for Carcinogen Risk 

Assessment (March 2005), the Agency 

classified picarbutrazox as ‘‘Suggestive 

Evidence of Carcinogenic Potential’’ 

based on an increase in the incidence of 

thyroid follicular cell tumors, driven by 

adenomas in male and female rats and 

combined thyroid follicular adenomas/ 

carcinomas in male rats. There is no 

concern for genotoxicity or mutagenicity 

and no treatment-related tumors were 

observed in mice. Based on its weightof-evidence analysis, the Agency has 

determined that quantification of risk 

using a non-linear approach (i.e., 

chronic reference dose (cRfD)) will 

adequately account for all chronic 

toxicity, including potential 

carcinogenicity, that could result from 

exposure to picarbutrazox. The chronic 

reference dose is several times lower 

than the dose at which tumors were 

observed. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by picarbutrazox 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 

‘‘Picarbutrazox. Human Health Risk 

Assessment in Support of a New Active 

Ingredient for Use on Corn and Soybean 

Seed and Turf’’, dated December 18, 

2020, hereinafter ‘‘Picarbutrazox Human 

Health Risk Assessment’’ in docket ID 

number EPA–HQ–OPP–2017–0653. 

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 picarbutrazox used for 

human risk assessment can be found on 

pages 19–20 in the Picarbutrazox 

Human Health Risk Assessment. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to picarbutrazox, EPA 

considered exposure under the 

petitioned-for tolerances. EPA assessed 

dietary exposures from picarbutrazox 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. No such effects were 

identified in the toxicological studies 

for picarbutrazox; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the United States Department of 

Agriculture’s (USDA’s) National Health 

and Nutrition Examination Survey, 

What We Eat in America, (NHANES/ 

WWEIA). As to residue levels in food, 

EPA conducted an unrefined chronic 

dietary exposure assessment using 

tolerance-level residues, 100 percent 

crop treated (PCT), and default 

processing factors. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to picarbutrazox. 

Quantification of risk using a non-linear 

approach (i.e., cRfD) will adequately 

account for all chronic toxicity, 

including potential carcinogenicity, that 

could result from exposure to 

picarbutrazox. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for picarbutrazox. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for picarbutrazox in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

picarbutrazox. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www2.epa.gov/ 

pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide. 

Using the Pesticides in Water 

Calculator (PWC) ver. 1.52, EPA 

calculated the estimated drinking water 

concentrations (EDWCs) of 

picarbutrazox for chronic exposures in 

surface and ground water. The 

groundwater estimates were 

significantly lower. EPA used the 

modeled EDWC of 2.56 ppb directly in 

dietary exposure model to account for 

the contribution of picarbutrazox 

residues in drinking water for the 

chronic dietary risk 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). 

Picarbutrazox is currently proposed for 

turf uses that could result in residential 

exposures. EPA assessed residential 

exposure using the following 

assumptions: There is the potential for 

post-application exposure for adults and 

children following turf treatments made 

by professional applicators with 

picarbutrazox. A dermal exposure 

assessment was not quantitatively 

conducted because a dermal POD was 

not selected. The quantitative exposure/ 

risk assessment for residential postapplication exposures is based only on 

incidental oral scenarios for children 1 

to <2 years old from hand to mouth 

activities on treated turf. Postapplication exposure and risk estimates 

indicate that the short-term incidental 

oral MOEs, ranging from 970 to 360,000, 

are not of concern (i.e., MOEs ≥30). 

Further information regarding EPA 

standard assumptions and generic 


jbell on DSKJLSW7X2PROD with RULES
12832 Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Rules and Regulations 

inputs for residential exposures may be 

found at https://www.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.’’ 

EPA has not found picarbutrazox to 

share a common mechanism of toxicity 

with any other substances, and 

picarbutrazox does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that picarbutrazox does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. 

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. 

There is no evidence of increased 

prenatal susceptibility in rats or rabbits 

or postnatal susceptibility in rats, with 

no adverse effects observed in the 

developmental toxicity 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 

picarbutrazox is complete. 

ii. There is no indication that 

picarbutrazox is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

picarbutrazox results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT, 

tolerance-level residues, default 

processing factors, and modeled 

drinking water estimates. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to picarbutrazox 

in drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children as well 

as incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by picarbutrazox. 

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). 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. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, picarbutrazox is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to picarbutrazox 

from food and water will utilize <1% of 

the cPAD for all 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 

picarbutrazox is not expected. 

3. Short-term and Intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure takes into account 

short-term or intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Picarbutrazox is currently proposed for 

uses that could result in short-term and 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

short-term or intermediate-term 

residential exposures to picarbutrazox. 

Using the exposure assumptions 

described in this unit for short-term and 

intermediate-term exposures, EPA has 

concluded the combined short-term or 

intermediate-term food, water, and 

residential exposures result in aggregate 

MOE of 950 for children 1 to <2 years 

old from dietary (food and drinking 

water) and incidental oral exposure 

from hand-to-mouth activities from 

post-application exposure to turf 

applications. Because EPA’s level of 

concern for picarbutrazox is an MOE of 

30 or below, these MOEs are not of 

concern. 

4. Aggregate cancer risk for U.S. 

population. As stated in Unit III.A., a 

separate cancer analysis was not 

conducted as the chronic assessment 

adequately accounts for all chronic 

toxicity, including potential 

carcinogenicity. Based on the lack of 

chronic risk, EPA concludes that 

aggregate exposure to picarbutrazox will 

not pose a cancer risk. 

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 

picarbutrazox residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography with tandem 

mass spectroscopy (LC/MS/MS) and 

high-performance liquid 

chromatography (HPLC/MS/MS)) is 

available to enforce the tolerance 

expression. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 


jbell on DSKJLSW7X2PROD with RULES
Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Rules and Regulations 12833 

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. 

Picarbutrazox is a new active 

ingredient, and no maximum residue 

limits (MRLs) have yet been established 

by Codex. 

C. Revisions to Petitioned-For 

Tolerances 

The Agency is establishing tolerances 

for picarbutrazox using tolerance 

expression and commodity definitions 

that conform to current practices. 

Additionally, the Agency is establishing 

a tolerance on corn, pop, stover and 

corn, field, stover; the petitioner 

requested a tolerance on ‘‘corn, stover’’, 

but the correct terminology is ‘‘corn, 

pop, stover’’ and ‘‘corn, field, stover’’. 

V. Conclusion 

Therefore, tolerances are established 

for residues of picarbutrazox, 1,1- 

Dimethylethyl N-(6-((((Z)-((1-methyl-1Htetrazol-5-yl) phenylmethylene) 

amino)oxy)methyl)-2- 

pyridinyl)carbamate, in or on corn, 

field, forage at 0.01 ppm; corn, field, 

grain at 0.01 ppm; corn, field, stover at 

0.01 ppm; corn, pop, grain at 0.01 ppm; 

corn, pop, stover at 0.01 ppm; corn, 

sweet, forage at 0.01 ppm; corn, sweet, 

kernel plus cob with husks removed at 

0.01 ppm; corn, sweet, stover at 0.01 

ppm; soybean, forage at 0.01 ppm; 

soybean, hay at 0.01 ppm and soybean, 

seed at 0.01 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), nor is it considered a 

regulatory action under Executive Order 

13771, entitled ‘‘Reducing Regulations 

and Controlling Regulatory Costs’’ (82 

FR 9339, February 3, 2017). 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 tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or Tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

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

has determined that this action will not 

have a substantial direct effect on States 

or Tribal Governments, on the 

relationship between the National 

Government and the States or Tribal 

Governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

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

addition, this action does not impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

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

seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Edward Messina, 

Acting Director, 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. Add § 180.718 to subpart C to read 

as follows: 

§ 180.718 Picarbutrazox; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

picarbutrazox, including its metabolites 

and degradates, in or on the 

commodities to Table 1 of this section. 

Compliance with the tolerance levels 

specified in Table 1 is to be determined 

by measuring only picarbutrazox (1,1- 

dimethylethyl N-[6-[[[(Z)-[(1-methyl-1Htetrazol-5-yl)phenylmethylene]

amino]oxy]methyl]-2-pyridinyl]

carbamate in or on the commodity. 

TABLE 1 TO PARAGRAPH (a) 

Commodity Parts per 

million 

Corn, field, forage ....................... 0.01 

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

Corn, field, stover ....................... 0.01 

Corn, pop, grain .......................... 0.01 

Corn, pop, stover ........................ 0.01 

Corn, sweet, forage .................... 0.01 

Corn, sweet, kernel plus cob 

with husks removed ................ 0.01 

Corn, sweet, stover .................... 0.01 

Soybean, forage ......................... 0.01 

Soybean, hay .............................. 0.01 

Soybean, seed ............................ 0.01 

(b)–(d) [Reserved] 

[FR Doc. 2021–04251 Filed 3–4–21; 8:45 am] 

BILLING CODE 6560–50–P 


jbell on DSKJLSW7X2PROD with RULES