SUMMARY: This regulation establishes time-limited tolerances for

residues of the insecticide flupyradifurone including its degradates

and metabolites in or on sugarcane, cane and sugarcane, molasses. This

action is associated with the utilization of a crisis exemption under

the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

authorizing use of the pesticide on sugarcane. This regulation

establishes a maximum permissible level for residues of flupyradifurone

in or on these commodities. The time-limited tolerances expire on

December 31, 2023.

Sugarcane, cane…………………….               3  ppm

Sugarcane, molasses…………………           90 ppm

---

*Online at https://www.govinfo.gov/content/pkg/FR-2021-04-26/html/2021-08598.htm

---

DATES: This regulation is effective April 26, 2021. Objections and

requests for hearings must be received on or before June 25, 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-2020-0478, 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, Acting Director,

Registration Division (7505P), Office of Pesticide Programs,

Environmental Protection Agency, 1200 Pennsylvania Avenue NW,

Washington, DC 20460-0001; main telephone number: (703) 305-7090; email

address: RDFRNotices@epa.gov.

 

SUPPLEMENTARY INFORMATION:

 

1. General Information

 

1. 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).

 

1. How can I get electronic access to other related information?

 

You may access a frequently updated electronic version of 40 CFR

part 180 through the Government Publishing Office’s e-CFR site at

http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

 

[[Page 21945]]

 

1. How can I file an objection or hearing request?

 

Under section 408(g) of the Federal Food, Drug, and Cosmetic Act

(FFDCA), 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-

2020-0478 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 June 25, 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-2020-0478, 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.

 

1. Background and Statutory Findings

 

EPA, on its own initiative, in accordance with FFDCA sections

408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is

establishing time-limited tolerances for residues of flupyradifurone in

or on sugarcane, cane at 3 parts per million (ppm) and sugarcane,

molasses at 90 ppm. These time-limited tolerances expire on December

31, 2023.

Section 408(l)(6) of FFDCA requires EPA to establish a time-limited

tolerance or exemption from the requirement for a tolerance for

pesticide chemical residues in food that will result from the use of a

pesticide under an emergency exemption granted by EPA under FIFRA

section 18. Such tolerances can be established without providing notice

or period for public comment. EPA does not intend for its actions on

FIFRA section 18 related time-limited tolerances to set binding

precedents for the application of FFDCA section 408 and the safety

standard to other tolerances and exemptions. Section 408(e) of FFDCA

allows EPA to establish a tolerance or an exemption from the

requirement of a tolerance on its own initiative, i.e., without having

received any petition from an outside party.

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. . .

.”

Section 18 of FIFRA authorizes EPA to exempt any Federal or State

agency from any provision of FIFRA, if EPA determines that “emergency

conditions exist which require such exemption.” EPA has established

regulations governing such emergency exemptions in 40 CFR part 166.

 

III. Emergency Exemption for Flupyradifurone on Sugarcane, Cane and

Sugarcane, Molasses and FFDCA Tolerances

 

The Louisiana Department of Agriculture and Forestry (LDAF) asserts

that an emergency condition exists in accordance with the criteria for

approval of an emergency exemption and has utilized a crisis exemption

under FIFRA section 18 to allow the use of flupyradifurone for control

of sugarcane aphid infestations in Louisiana sugarcane. According to

LDAF, the sugar industry is vital to Louisiana’s economy and sugarcane

aphids which were once sporadic in the state are now widespread as

outbreaks have become more frequent in recent years. After having

reviewed the crisis exemption, EPA concurred on the 15-day stand-alone

emergency action, which expired on August 5, 2020.

As part of its evaluation of the crisis exemption, EPA assessed the

potential risks presented by residues of flupyradifurone in or on

sugarcane, cane at 3 ppm and sugarcane, molasses at 90 ppm. In doing

so, EPA considered the safety standard in FFDCA section 408(b)(2), and

EPA decided that the necessary tolerance under FFDCA section 408(l)(6)

would be consistent with the safety standard and with FIFRA section 18.

Consistent with the need to move quickly on the emergency exemption in

order to address an urgent non-routine situation and to ensure that the

resulting food is safe and lawful, EPA is issuing this tolerance

without notice and opportunity for public comment as provided in FFDCA

section 408(l)(6). Although these time-limited tolerances expire on

December 31, 2023, under FFDCA section 408(l)(5), residues of the

pesticide not in excess of the amounts specified in the tolerance

remaining in or on sugarcane after that date will not be unlawful,

provided the pesticide was applied in a manner that was lawful under

FIFRA, and the residues do not exceed a level that was authorized by

these time-limited tolerances at the time of that application. EPA will

take action to revoke these time-limited tolerances earlier if any

experience with, scientific data on, or other relevant information on

this pesticide indicate that the residues are not safe.

Because these time-limited tolerances are being approved under

emergency conditions, EPA has not made any decisions about whether

flupyradifurone meets FIFRA’s registration requirements for use on

sugarcane or whether permanent tolerances for this use would be

appropriate. Under these circumstances, EPA does not believe that this

time-limited tolerance decision serves as a basis for registration of

flupyradifurone by a State for special local needs under FIFRA section

24(c). Nor does this tolerance by itself serve as the authority for

persons in any State other than Louisiana to use this pesticide on the

applicable crops under FIFRA section 18 absent the issuance of an

emergency exemption applicable within that State. For additional

information regarding the emergency exemption for

 

[[Page 21946]]

 

flupyradifurone, contact the Agency’s Registration Division at the

address provided under FOR FURTHER INFORMATION CONTACT.

 

1. 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 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 expected as a result of this emergency exemption

request and the time-limited tolerances for residues of flupyradifurone

on sugarcane, cane at 3 ppm and sugarcane, molasses at 90 ppm.

On September 23, 2016 (81 FR 65552) (FRL-9951-68) and August 21,

2020 (85 FR 51668-51672) (FRL-10010-98), EPA published final rules that

established tolerances for residues of flupyradifurone in or on

multiple commodities based on the Agency’s determination that aggregate

exposure to flupyradifurone resulting from the residues subject to

those tolerances is safe for the U.S. general population, including

infants and children. The toxicity profile for flupyradifurone has not

changed since the September 23, 2016 (81 FR 65552) (FRL-9951-68) rule

was published, therefore EPA is relying upon the discussion of that

profile (Unit III.A.) and the identified toxicological endpoints (Unit

III.A.) and the identified toxicological endpoints (Unit III B.), as

part of this rulemaking.

EPA’s most recent exposure assessment for flupyradifurone appears

in the comprehensive risk assessment dated June 30, 2020 and entitled:

“Flupyradifurone: Human Health Risk Assessment for Uses on Grass

Forage Fodder and Hay Group 17, Pineapple, Rapeseed Subgroup 20A,

Sesame Seed, Stalk and Stem Vegetable Subgroup 22A (except Prickly Pear

Pads and Prickly Pear Texas Pads), Sunflower Subgroup 20B, Sweet

Sorghum, Tropical and Subtropical Palm Fruit Edible Peel Subgroup 23C,

Crop Group Expansions/Conversions of Tolerances to Brassica Leafy

Greens Subgroup 4-16B, Leafy Greens Subgroup 4-16A, Leaf Petiole

Vegetable Subgroup 22B, Tropical and Subtropical Inedible Peel Cactus

Subgroup 24D, Vegetable Brassica Head and Stem Group 5-16 and Establish

Individual Tolerances on Lettuce, Fennel Florence, Kohlrabi; and

Coffee,” as that assessment included dietary and aggregate exposures

to flupyradifurone in or on multiple agricultural and non-agricultural

commodities that are complete except for exposures due to the emergency

use addressed in this document.

For aggregate risk assessment, risk estimates resulting from food,

drinking water, and residential uses are combined. Acute, short-and

intermediate-term, and long-term (chronic) aggregate assessments were

performed for flupyradifurone. Further information about EPA’s risk

assessment and determination of safety supporting the tolerances

established in the August 21, 2020 final rule can be found
at http://www.regulations.gov in the document entitled “Flupyradifurone: Human

Health Risk Assessment for Uses on Grass Forage Fodder and Hay Group

17, Pineapple, Rapeseed Subgroup 20A, Sesame Seed, Stalk and Stem

Vegetable Subgroup 22A (except Prickly Pear Pads and Prickly Pear Texas

Pads), Sunflower Subgroup 20B, Sweet Sorghum, Tropical and Subtropical

Palm Fruit Edible Peel Subgroup 23C, Crop Group Expansions/Conversions

of Tolerances to Brassica Leafy Greens Subgroup 4-16B, Leafy Greens

Subgroup 4-16A, Leaf Petiole Vegetable Subgroup 22B, Tropical and

Subtropical Inedible Peel Cactus Subgroup 24D, Vegetable Brassica Head

and Stem Group 5-16 and Establish Individual Tolerances on Lettuce,

Fennel Florence, Kohlrabi; and Coffee,” dated June 30, 2020 (docket ID

EPA-HQ-OPP-2019-0460).

EPA conducted unrefined and slightly refined chronic dietary

analyses for all current uses of flupyradifurone together with the

emergency use in or on sugarcane, cane and sugarcane, molasses. The

assessments incorporated tolerance-level residues, average residues

(chronic), 2018 default or empirical processing factors, conservative

drinking water estimates, and assumed that 100% of the proposed crops

were treated. The results of the acute and chronic analyses do not

exceed the Agency’s level of concern (LOC). That is, <100% of the acute

population adjusted dose (aPAD) or <100% of the chronic population

adjusted dose (cPAD) are not of concern for the general U.S. population

and all population subgroups. At the 95th percentile of exposure, the

acute dietary (food and drinking water) risk estimates utilized 24% of

the aPAD for the general U.S. general population and utilized 39% the

aPAD for children 1 to 2 years old, the most highly exposed population

subgroup. The chronic dietary (food and drinking water) risk estimates

utilized 29% of the cPAD for the U.S. population and utilized 68% of

the cPAD for children 1 to 2 years old, the group with the highest

exposed population subgroup.

The aggregate exposure assessment for flupyradifurone is based on

food and drinking water as well as residential uses. Neither

intermediate- nor long-term (chronic) residential exposures are

expected, so only a short-term aggregate assessment was conducted.

Aggregate short-term residential exposure to adults and children

(residential exposures to handlers and post-application exposures to

adults and children) with the chronic (background) dietary exposure

yields margins of exposure MOEs of 300 for adults and 220 for

children); neither is of concern because EPA considers MOEs of less

than 100 to be of concern for aggregate risk.

Therefore, based on the risk assessments and information described

above, EPA concludes there is a reasonable certainty that no harm will

result to the U.S. general population, or to infants and children from

aggregate exposure to flupyradifurone residues. More detailed

information on the subject action to establish time-limited tolerances

in or on sugarcane, cane and sugarcane, molasses can be found
at http://www.regulations.gov in the document entitled “Flupyradifurone: Human

Health Risk Assessment for Section 18 Emergency Exemption Request for

Use on Sugarcane in Louisiana.” This document can be found in docket

ID number EPA-HQ-OPP-2020-0478.

 

1. Other Considerations

 

1. Analytical Enforcement Methodology

 

An adequate enforcement methodology (Method RV-001-P10-03) is

available to enforce the tolerance expression. This method uses high-

performance liquid chromatography

 

[[Page 21947]]

 

with tandem mass spectrometry [HPLC/MS/MS) to quantitate residues of

flupyradifurone in various crops is available for enforcement.

These methods may be requested from: Chief, Analytical Chemistry

Branch, Environmental Science Center, 701 Mapes Road, Ft. Meade, MD

20755-5350; telephone number: (410) 305-2905; email address:

residuemethods@epa.gov.

 

1. International Residue Limits

In making its tolerance decisions, EPA seeks to harmonize U.S.

tolerances with international standards whenever possible, consistent

with U.S. food safety standards and agricultural practices. EPA

considers the international maximum residue limits (MRLs) established

by the Codex Alimentarius Commission (Codex), as required by FFDCA

section 408(b)(4). The Codex Alimentarius is a joint United Nations

Food and Agriculture Organization/World Health Organization food

standards program, and it is recognized as an international food safety

standards-setting organization in trade agreements to which the United

States is a party. EPA may establish a tolerance that is different from

a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain

the reasons for departing from the Codex level.

There are no Codex and Canadian MRLs established on sugarcane.

 

1. Conclusion

 

Therefore, time-limited tolerances are established for residues of

flupyradifurone in or on sugarcane, cane at 3 ppm and sugarcane,

molasses at 90 ppm. These tolerances expire on December 31, 2023.

 

VII. Statutory and Executive Order Reviews

 

This action establishes tolerances under FFDCA sections 408(e) and

408(l)(6). 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,

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 in accordance

with FFDCA sections 408(e) and 408(l)(6), 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, but does not directly regulate 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).

 

VIII. 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: April 20, 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

 

0

1. The authority citation for part 180 continues to read as follows:

 

Authority: 21 U.S.C. 321(q), 346a and 371.

0

2. In Sec. 180.679, amend paragraph (b) by:

0

1. Revising the introductory text; and

0

1. Adding in alphabetical order to the table the entries “Sugarcane,

cane” and “Sugarcane, molasses”.

The revision and additions read as follows:

Sec.  180.679  Flupyradifurone; tolerances for residues.

* * * * *

(b) Section 18 emergency exemptions. Time-limited tolerances are

established for residues of the insecticide flupyradifurone, including

its metabolites and degradates in or on the specified agricultural

commodities listed in table 2 to this paragraph (b), resulting from use

of the pesticide pursuant to a Federal Insecticide, Fungicide, and

Rodenticide Act (FFIFRA) section 18 emergency exemption. Compliance

with the tolerance levels specified in table 2 to this paragraph (b) is

to be determined by measuring only flupyradifurone, 4-[[(6-chloro-3-

pyridinyl)methyl](2,2-difluoroethyl)amino]-2(5H)-furanone. The

tolerances expire on the date specified in table 2 to this paragraph

(b).

 

[[Page 21948]]

 

 

 

Table 2 to Paragraph (b)

————————————————————————

Parts per      Expiration

Commodity                     million          date

————————————————————————

 

* * * * * * *

Sugarcane, cane…………………….               3      12/31/2023

Sugarcane, molasses…………………              90      12/31/2023

 

* * * * * * *

————————————————————————

 

* * * * *

[FR Doc. 2021-08598 Filed 4-23-21; 8:45 am]

BILLING CODE 6560-50-P

---

*Online at https://www.govinfo.gov/content/pkg/FR-2021-04-26/html/2021-08598.htm

---