46156 Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

§ 721.11442 Halogenated alkylbenzoic 

acid, ethyl ester (generic) (P–19–108). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated alkylbenzoic 

acid, ethyl ester (PMN P–19–108) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), (g)(2)(i) through (iii), 

(g)(3)(i) and (ii), and (g)(5). For purposes 

of § 721.72(e), the concentration is set at 

1.0%. For purposes of § 721.72(g)(1), 

this substance may cause: Skin 

irritation; respiratory complications; 

central nervous system effects; internal 

organ effects; reproductive effects; 

developmental effects; eye irritation. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) and (q). It is a 

significant new use to manufacture or 

process the substance without including 

the engineering controls/processes 

described in the premanufacture notice. 

(iii) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4) where N=14. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

§ 721.11443 Halogenated benzoic acid, 

ethyl ester (generic) (P–19–110). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated benzoic acid, 

ethyl ester (PMN P–19–110) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), (g)(2)(i) through (iii), 

(g)(3)(i) and (ii), and (g)(5). For purposes 

of § 721.72(e), the concentration is set at 

1.0%. For purposes of § 721.72(g)(1), 

this substance may cause: Skin 

irritation; respiratory complications; 

central nervous system effects; internal 

organ effects; reproductive effects; 

developmental effects; eye irritation. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) and (q). It is a 

significant new use to manufacture or 

process the substance without including 

the engineering controls/processes 

described in the premanufacture notice. 

(iii) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4) where N=14. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

[FR Doc. 2021–17392 Filed 8–17–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0118; FRL–8653–01– 

OCSPP] 

Fluensulfone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerance for residues of fluensulfone in 

or on soybean, seed. Makhteshim Agan 

of North America (d/b/a ADAMA) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

August 18, 2021. Objections and 

requests for hearings must be received 

on or before October 18, 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–2020–0118, 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). 


jbell on DSKJLSW7X2PROD with RULES
Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations 46157 

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(g), any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2020–0118 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 

October 18, 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– 

2020–0118, 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 April 15, 

2020 (85 FR 20910) (FRL–10006–54), 

EPA issued a document pursuant to 

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

346a(d)(3), announcing the filing of 

pesticide petition (PP 9F8799) by 

Makhteshim Agan of North America (d/ 

b/a ADAMA), 3120 Highwoods Blvd., 

Suite 100, Raleigh, NC 27604. The 

petition requested that 40 CFR 180.680 

be amended by establishing tolerances 

for residues of the nematicide 

fluensulfone, in or on soybean, seed at 

0.1 parts per million (ppm); soybean, 

forage at 7.0 ppm; and soybean, hay at 

20 ppm. That document referenced a 

summary of the petition prepared by 

Makhteshim Agan of North America, the 

petitioner, which is available in the 

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

Two comments were received on the 

notice of filing. EPA’s response to these 

comments is discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA is 

establishing a tolerance that varies from 

what is requested. The reason for these 

changes is explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue . . . .’’ 

Consistent with FFDCA section 

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

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 fluensulfone, 

including exposure resulting from the 

tolerance established by this action. 

EPA’s assessment of exposures and risks 

associated with fluensulfone follows. 

In an effort to streamline Federal 

Register publications, EPA is not 

reprinting here summaries of its 

analyses that have previously appeared 

in the Federal Register in previous 

tolerance rulemakings for the same 

pesticide. To that end, this rulemaking 

refers the reader to several sections from 

the April 13, 2018 tolerance rulemaking 

for residues of fluensulfone that remain 

unchanged for an understanding of the 

Agency’s rationale in support of this 

rulemaking. See 83 FR 15971 (FRL– 

9975–76). Those sections are: Units III.A 

(Toxicological Profile); III.B. 

(Toxicological Points of Departure/ 

Levels of Concern); and III.C. (Exposure 

Assessment), except as explained in the 

next paragraphs; III.D. (Safety Factor for 

Infants and Children). 

Exposure assessment updates. EPA’s 

exposure assessments have been 

updated to include the additional 

exposure from use of fluensulfone on 

soybeans. EPA’s aggregate exposure 

assessment incorporated this additional 

dietary exposure, as well as exposure 

from drinking water and from 

residential sources. The new use does 

not result in an increase in the 

estimated residue levels in drinking 

water or in exposure from residential 

sources relative to those used in the last 

assessment. 

Further information about EPA’s risk 

assessment and determination of safety 

supporting the new fluensulfone 

tolerance can be found at http://

www.regulations.gov in the document 

titled ‘‘Fluensulfone. Human Health 

Risk Assessment for a New Use on 

Soybean.’’ in docket ID EPA–HQ–OPP– 

2020–0118. 

Assessment of aggregate risks. EPA 

determines whether acute and chronic 

dietary pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the acute population adjusted dose 

(aPAD) and chronic population adjusted 

dose (cPAD). Short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing the estimated aggregate food, 

water, and residential exposure to the 

appropriate points of departure (PODs) 

to ensure that an adequate margin of 

exposure (MOE) exists. For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. 

Acute dietary risks are below the 

Agency’s level of concern: The acute 

dietary risk estimate is 21% of the aPAD 

for infants (<1 year old), the group with 

the highest exposure. Chronic dietary 

risks are below the Agency’s level of 

concern: 4.8% of the cPAD for infants 

(<1 year old), the group with the highest 


jbell on DSKJLSW7X2PROD with RULES
46158 Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations 

exposure. EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

margins of exposure above the level of 

concern of 100 for all scenarios assessed 

and are not of concern. EPA has 

determined that quantification of cancer 

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

reference dose) will adequately account 

for all chronic toxicity, including 

carcinogenicity, that could result from 

exposure to fluensulfone; the chronic 

aggregate assessment did not result in 

risk estimates of concern. 

Determination of safety. Therefore, 

based on the risk assessments and 

information described above, EPA 

concludes there is a reasonable certainty 

that no harm will result to the general 

population, or to infants and children, 

from aggregate exposure to fluensulfone 

residues. More detailed information on 

this action to establish a tolerance on 

soybean can be found in the document 

entitled, ‘‘Fluensulfone. Human Health 

Risk Assessment for a new use on 

Soybean’’ by going to the docket 

established by this action, which is 

described under ADDRESSES. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

There are adequate residue analytical 

methods for enforcing tolerances for 

fluensulfone residues of concern in/on 

the registered plant and livestock 

commodities. These methods include 

two high-performance liquid 

chromatography methods with tandem 

mass-spectroscopy detection (HPLC/ 

MS/MS) for determining residues in/on 

plant and livestock matrices. 

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). 

EPA may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for fluensulfone on soybean. 

C. Response to Comments 

EPA received two comments from 

anonymous sources. One comment cited 

concern regarding fluoride; this 

comment is not relevant to the Agency’s 

evaluation of a tolerance for the 

proposed new use of fluensulfone on 

soybean. The other comment expresses 

concern about pesticides in general, and 

requests that the Agency deny use of 

fluensulfone without specifically 

mentioning the new use on soybean. 

While the agency recognizes that some 

people do not like pesticides, the 

Agency has evaluated the aggregate risk 

of fluensulfone and has determined that 

there is a reasonable certainty that no 

harm will result to the general 

population, or to infants and children, 

from aggregate exposure to fluensulfone 

residues. 

D. Revisions to Petitioned-For 

Tolerances 

The agency has determined that 

tolerances are not needed for soybean, 

forage and soybean, hay, as the label 

contains a feeding restriction for those 

commodities, and the commodities will 

not be in the channels of trade. Further, 

the agency has recommended amending 

the proposed tolerance for soybean, seed 

from 0.1 ppm to 0.07 ppm based upon 

the OECD MRL/Tolerance Calculation 

Procedures. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of fluensulfone on soybean, 

seed at 0.07 ppm. 

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 

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. 


jbell on DSKJLSW7X2PROD with RULES
Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations 46159 

Dated: August 6, 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 § 180.680, amend the table 1 to 

§ 180.680 by adding in alphabetical 

order in paragraph (a) the entry 

‘‘Soybean, seed’’ to read as follows: 

§ 180.680 Fluensulfone; tolerances for 

residues. 

(a) * * * 

TABLE 1 TO § 180.680 

Commodity Parts per 

million 

*******

Soybean, seed ....................................................................................................................................................................................... 0.07 

* * * * * * * 

* * * * * 

[FR Doc. 2021–17682 Filed 8–17–21; 8:45 am] 

BILLING CODE 6560–50–P 


jbell on DSKJLSW7X2PROD with RULES