Federal Register / Vol. 86, No. 30 / Wednesday, February 17, 2021 / Rules and Regulations 9869 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2019–0580; FRL–10018–53] 

Orthosulfamuron; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

orthosulfamuron (1-(4,6- 

dimethoxypyrimidin-2-yl)-3-{[2- 

(dimethylcarbamoyl)phenyl]

csulfamoyl}urea) in or on Almond, 

hulls; Fruit, small, vine climbing, except 

fuzzy kiwifruit, subgroup 13–07F; Nut, 

tree, group 14–12. Nichino America, 

Inc. requested tolerances for these 

commodities under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 17, 2021. Objections and 

requests for hearings must be received 

on or before April 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–2019–0580, 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/ 

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–2019–0580 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 April 

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– 

2019–0580, 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 3, 

2020 (85 FR 12454) (FRL–10005–58), 

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 9F8776) by 

Nichino America, Inc., 4550 Linden Hill 

Road, Suite 501, Wilmington, DE 19808. 

The petition requested that 40 CFR 

180.625 be amended by establishing 

tolerances for residues of the herbicide 

orthosulfamuron in or on almond hulls 

at 0.03 parts per million (ppm), small 

fruit vine climbing subgroup, except 

fuzzy kiwifruit (crop subgroup 13–07F) 

at 0.01 ppm, and tree nuts (crop group 

14–12) at 0.01 ppm. That document 

referenced a summary of the petition 

prepared by Nichino America, Inc., the 

registrant, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. Based 

upon review of the data supporting the 

petition, EPA has corrected the 

commodity definitions to reflect current 

Agency terminology. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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


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occupational exposure. Section 

408(b)(2)(C) of the 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 

therein, 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 

orthosulfamuron including exposure 

resulting from the tolerances established 

by this action. EPA’s assessment of 

exposures and risks associated with 

orthosulfamuron 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. 

Orthosulfamuron is included in a 

group of herbicides referred to as 

sulfonylureas that control weeds 

through inhibition of the enzyme 

acetolactate synthase (ALS). The 

toxicological database for 

orthosulfamuron is complete and no 

additional data are required. 

Orthosulfamuron showed low acute 

toxicity by all routes and no dermal 

irritation or sensitization (Category IV) 

and was a mild eye irritant (Category 

III). The major target organs of 

orthosulfamuron are the liver, kidneys 

and thyroid gland, with effects generally 

observed at high doses following 

chronic oral exposure. No evidence of 

pre- and/or post-natal quantitative or 

qualitative susceptibility was observed, 

and the database overall did not show 

evidence of neurotoxicity. 

Thyroid follicular cell tumors were 

observed at high doses in only one sex 

and one species, and there was no 

evidence of genotoxicity. Therefore, in 

accordance with the EPA Final 

Guidelines for Carcinogen Risk 

Assessment (March 2005), 

orthosulfamuron is classified as 

‘‘Suggestive Evidence of 

Carcinogenicity.’’ 

Specific information on the studies 

received and the nature of the adverse 

effects caused by orthosulfamuron as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Orthosulfamuron. Human Health Risk 

Assessment for Proposed New Uses on 

Small Fruit Vine Climbing Subgroup, 

Except Fuzzy Kiwifruit (13–07F), Tree 

Nuts (14–12), Non-Bearing Citrus Fruit 

(10–10), and Non-Bearing Stone Fruit 

(12–12)’’ (hereinafter ‘‘Orthosulfamuron 

Human Health Risk Assessment’’) on 

page numbers 25–35 in docket ID 

number EPA–HQ–OPP–2019–0580. 

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-pesticides. 

A summary of the toxicological 

endpoints for orthosulfamuron used for 

human risk assessment can be found on 

page 13 in the Orthosulfamuron Human 

Health Risk Assessment. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to orthosulfamuron, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing orthosulfamuron tolerances in 

40 CFR 180.625. EPA assessed dietary 

exposures from orthosulfamuron 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 

orthosulfamuron; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used 2003–2008 food 

consumption data from the U.S. 

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 assumed 

tolerance-level residues and 100 percent 

crop treated (PCT). 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or nonlinear approach. 

Based on the available data for 

orthosulfamuron, which is summarized 

in Unit III.A., EPA has concluded that 

a nonlinear approach is appropriate for 

assessing cancer risk to 

orthosulfamuron. The chronic dietary 

reference dose (cRfD) is significantly 

lower than the dose that caused thyroid 

tumors in male rats, and therefore is 

protective of potential carcinogenicity. 

Cancer risk was assessed using the same 

exposure estimates as discussed in Unit 

III.C.1.ii., chronic exposure. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue or PCT 

information in the dietary assessment 

for orthosulfamuron. Tolerance-level 

residues and 100 PCT were assumed for 

all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for orthosulfamuron in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

orthosulfamuron. 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. 

Screening groundwater-sourced 

drinking water exposure estimates were 


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generated with the Pesticide Root Zone 

Model for GroundWater (PRZM–GW, 

version 1.07) for use in sulfonylurea 

dietary risk assessments. Rather than 

using chemical-specific estimated 

drinking water concentrations (EDWCs) 

following the usual assessment 

procedures, these coarse-screen 

estimates should exceed upper-bound, 

chemical-specific EDWCs for any 

sulfonylurea (SU). This was achieved by 

using model inputs that represent the 

use pattern of highest exposure from 

any SU, the highest soil mobility of any 

SU residue of concern, and the highest 

persistence to any route of degradation 

over time. The resulting coarse-screen 

EDWC from PRZM–GW was used as the 

conservative estimate of exposure. The 

chronic dietary assessment for 

orthosulfamuron used the coarse-screen 

maximum daily concentration of 0.751 

ppm. 

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). Orthosulfamuron is not 

registered for any specific use patterns 

that would result in residential 

exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the 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.’’ 

The Agency has assessed 

orthosulfamuron, and its chemical class, 

sulfonylureas, and determined that the 

SUs do not share a common mechanism 

of toxicity (EPA–HQ–OPP–2011–04538– 

0024). The SUs share a core chemical 

structure with varying degrees of 

structural similarity based on individual 

substituents on either side of the 

molecule. In addition, the SUs share a 

pesticidal mode of action (MOA) 

(inhibition of acetolactate synthase 

(ALS)), although the function of ALS in 

humans is unknown and the relevance 

of this MOA in humans in unclear. 

Based on toxicity studies, the SUs do 

not share a common toxicological 

profile; instead the target organs vary 

among the class and are often nonspecific, such as changes in body weight 

or general effects on the liver. Further 

dividing the SUs into subclasses based 

on the urea substituent did not result in 

a clear association of a target organ with 

any particular substructure. 

Based on the weight of the evidence, 

which includes the lack of a common 

toxicological profile, the uncertainty in 

the human relevance of ALS inhibition, 

and the lack of mammalian MOA data, 

a testable hypothesis for a common 

mechanism of action cannot be 

identified. Therefore, the Agency 

concludes that no common mechanism 

of toxicity exists among these pesticides 

and a cumulative risk assessment 

approach is not appropriate for this 

class of pesticides. 

D. Safety Factor for Infants and 

Children 

Section 408(b)(2)(C) of the 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. 

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. The 

rationale for that decision remains the 

same as in the February 28, 2007 final 

rule establishing tolerances for a use on 

rice. See 72 FR 8928 (FRL–8113–4) for 

the full rationale in Unit III.D. 

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, orthosulfamuron 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 

orthosulfamuron from food and water 

will utilize 81% of the cPAD for all 

infants less than 1 year old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for orthosulfamuron. 

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). 

Short-term and intermediate-term 

adverse effects were identified in the 

toxicity database (e.g., kidney and liver 

effects); however, orthosulfamuron is 

not registered for any use patterns that 

would result in short-term or 

intermediate-term residential exposure. 

Short-term risk is assessed based on 

short-term residential exposure plus 

chronic dietary exposure. Intermediateterm risk is assessed based on 

intermediate-term residential exposure 

plus chronic dietary exposure. Because 

there is no short-term or intermediateterm residential exposure and chronic 

dietary exposure has already been 

assessed under the appropriately 

protective cPAD (which is at least as 

protective as the POD used to assess 

short-term or intermediate-term risk), no 

further assessment of short-term or 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating short-term 

and intermediate-term risk for 

orthosulfamuron. 

4. Aggregate cancer risk for U.S. 

population. As stated in Unit III.C.1.iii, 

EPA has concluded that the chronic 

reference dose (RfD) will adequately 

account for all repeated exposure/ 

chronic toxicity, including 

carcinogenicity, which could result 

from exposure to orthosulfamuron. As 

there is no chronic risk of concern, EPA 

concludes that exposure to 

orthosulfamuron will not pose an 

aggregate 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 

orthosulfamuron residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

utilizing high-performance liquid 

chromatography with tandem mass 

spectrometric detection (LC/MS/MS) is 

available to enforce the tolerance 

expression. 


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The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

Codex is a joint United Nations Food 

and Agriculture Organization/World 

Health Organization food standards 

program, and it is recognized as an 

international food safety standardssetting organization in trade agreements 

to which the United States is a party. 

Although EPA may establish a tolerance 

that is different from a Codex MRL, 

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 orthosulfamuron in any 

commodity. 

V. Conclusion 

Therefore, tolerances are established 

for residues of orthosulfamuron in or on 

Almond, hulls at 0.03 ppm; Fruit, small, 

vine climbing, except fuzzy kiwifruit, 

subgroup 13–07F at 0.01 ppm; and Nut, 

tree, group 14–12 at 0.01 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under the 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 the 

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. 

Dated: January 4, 2021. 

Marietta Echeverria, 

Acting Director, Registration Division, 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. In § 180.625, 

■ a. Revise paragraph (a) introductory 

text; 

■ b. Designate the table in paragraph (a) 

and add alphabetically the commodities 

‘‘Almond, hulls’’; ‘‘Fruit, small, vine 

climbing, except fuzzy kiwifruit, 

subgroup 13–07F’’; and ‘‘Nut, tree, 

group 14–12’’. 

The revision and additions read as 

follows: 

§ 180.625 Orthosulfamuron; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the herbicide 

orthosulfamuron, including its 

metabolites and degradates, in or on the 

commodities in the table, below. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only 

orthosulfamuron, 1-(4,6- 

dimethoxypyrimidin-2-yl)-3-{[2- 

(dimethylcarbamoyl)phenyl]

sulfamoyl}urea, in or on the following 

commodities: 

TABLE TO PARAGRAPH (a) 

Commodity Parts per 

million 

Almond, hulls .............................. 0.03 

Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 

13–07F .................................... 0.01 

Nut, tree, group 14–12 ............... 0.01 

* * * * * 

* * * * * 

[FR Doc. 2021–03181 Filed 2–16–21; 8:45 am] 

BILLING CODE 6560–50–P 


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