72994 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Rules and Regulations 

PART 214—POSTDECISIONAL 

ADMINISTRATIVE REVIEW PROCESS 

FOR OCCUPANCY OR USE OF 

NATIONAL FOREST SYSTEM LANDS 

AND RESOURCES 

■ 1. The authority citation for part 214 

continues to read as follows: 

Authority: 7 U.S.C. 1011(f); 16 U.S.C. 472, 

551. 

■ 2. Amend § 214.4(c) by adding 

paragraph (c)(6) to read as follows: 

§ 214.4 Decisions that are appealable. 

* * * * * 

(c) * * * 

(6) A decision of whether to 

temporarily reduce the annual land use 

fee for a recreation residence permit 

during a period of significantly 

restricted access to or occupancy of the 

recreation residence. 

* * * * * 

PART 251—LAND USES 

Subpart B—Special Uses 

■ 3. The authority citation for part 251, 

subpart B, continues to read as follows: 

Authority: 16 U.S.C. 460l–6a, 460l–6d, 

472, 497b, 497c, 551, 580d, 1134, 3210; 30 

U.S.C. 185; 43 U.S.C. 1740, 1761–1772. 

■ 4. Amend § 251.51 by adding in 

alphabetical order a definition for 

‘‘significantly restricted access to or 

occupancy of a recreation residence’’ to 

read as follows: 

§ 251.51 Definitions. 

* * * * * 

Significantly restricted access to or 

occupancy of a recreation residence— 

When access to or occupancy of a 

recreation residence is prohibited by 

law for a period of at least 30 

consecutive calendar days: 

(1) By an order issued under 36 CFR 

part 261, subpart B, closing an area 

including the National Forest System 

lands occupied by the recreation 

residence or closing a National Forest 

System road providing the sole access to 

the recreation residence to address 

public health or safety concerns, such as 

severe risk of fire or flooding, or 

(2) By a State or county department of 

transportation imposing a round-theclock closure of a State or county road 

providing the sole access to a recreation 

residence. 

* * * * * 

■ 5. Amend § 251.57 by adding 

paragraph (i) to read as follows: 

§ 251.57 Land use fees. 

* * * * * 

(i) The annual land use fee for a 

recreation residence permit shall be 

temporarily reduced during periods of 

significantly restricted access to or 

occupancy of the recreation residence. 

A temporary land use fee reduction for 

significantly restricted access to or 

occupancy of a recreation residence 

shall be calculated by dividing the 

annual land use fee for the recreation 

residence permit by 365 to determine 

the daily land use fee and then 

multiplying the daily land use fee by the 

number of days of significantly 

restricted access to or occupancy of the 

recreation residence. If significantly 

restricted access to or occupancy of the 

recreation residence includes part of 

one day, that day shall be counted as a 

whole day. A temporary land use fee 

reduction during significantly restricted 

access to or occupancy of a recreation 

residence shall be applied as a credit to 

the annual land use fee for the 

recreation residence permit for the 

following year. 

Homer Wilkes, 

Under Secretary, Natural Resources and 

Environment. 

[FR Doc. 2024–20239 Filed 9–6–24; 8:45 am] 

BILLING CODE 3411–15–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2023–0080; FRL–12040–01– 

OCSPP] 

Saflufenacil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

new tolerances for residues of 

saflufenacil in or on Mint, dried leaves 

and Mint, fresh leaves and crop group 

expansions for Fruit, citrus, group 10– 

10; Fruit, pome, group 11–10; Fruit, 

stone, group 12–12; and Nut, tree, group 

14–12. The Interregional Project 

Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 9, 2024. Objections and 

requests for hearings must be received 

on or before November 8, 2024, 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–2023–0080, is 

available at https://www.regulations.gov 

or in-person 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 and the OPP Docket is 

(202) 566–1744. For the latest status 

information on EPA/DC services, docket 

access, visit https://www.epa.gov/ 

dockets. 

FOR FURTHER INFORMATION CONTACT: 

Charles Smith, Director, Registration 

Division (7505T), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; main 

telephone number: (202) 566–1030; 

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 Office of the Federal Register’s eCFR site at https://www.ecfr.gov/ 

current/title-40/chapter-I/subchapter-E/ 

part-180. 

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– 


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Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Rules and Regulations 72995 

OPP–2023–0080, in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing and must be received 

by the Hearing Clerk on or before 

November 8, 2024. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

EPA’s Office of Administrative Law 

Judges (OALJ), in which the Hearing 

Clerk is housed, urges parties to file and 

serve documents by electronic means 

only, notwithstanding any other 

particular requirements set forth in 

other procedural rules governing those 

proceedings. See ‘‘Revised Order Urging 

Electronic Service and Filing’’, dated 

June 22, 2023, which can be found at 

https://www.epa.gov/system/files/ 

documents/2023-06/2023-06-22%20- 

%20revised%20order%20urging

%20electronic%20filing%20and

%20service.pdf. Although EPA’s 

regulations require submission via U.S. 

Mail or hand delivery, EPA intends to 

treat submissions filed via electronic 

means as properly filed submissions; 

therefore, EPA believes the preference 

for submission via electronic means will 

not be prejudicial. When submitting 

documents to the OALJ electronically, a 

person should utilize the OALJ e-filing 

system at https://yosemite.epa.gov/oa/ 

rhc/epaadmin.nsf. 

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– 

2023–0080, by one of the following 

methods: 

• Federal eRulemaking Portal: 

https://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 https://

www.epa.gov/dockets/where-sendcomments-epa-dockets. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at https:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of July 5, 2023 

(88 FR 42935) (FRL–10579–05–OCSPP), 

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 2E9045) by 

Interregional Project Number 4 (IR–4), 

North Carolina State University, 1730 

Varsity Drive, Venture IV, Suite 210, 

Raleigh, NC 27606. The petition 

requested that 40 CFR 180.649 be 

amended to establish tolerances for 

residues of the herbicide saflufenacil, 

including its metabolites and 

degradates, in or on Barley subgroup 

15–22B at 1 parts per million (ppm); 

Edible-podded bean subgroup 6–22A at 

0.03 ppm; Edible-podded pea subgroup 

6–22B at 0.03 ppm; Field corn subgroup 

15–22C at 0.03 ppm; Forage and hay of 

legumes vegetable group 7–22 (except 

pea, hay) at 0.1 ppm; Forage, hay, 

stover, and straw of cereal grains group 

16–22 (except barley and wheat and 

chia straw) at 0.1 ppm; Fruit, citrus 

group 10–10 at 0.03 ppm; Fruit, pome 

group 11–10 at 0.03 ppm; Fruit, stone 

group 12–12 at 0.03 ppm; Grain 

sorghum and millet subgroup 15–22E at 

0.03 ppm; Mint, dried leaves at 0.04 

ppm; Mint, fresh leaves at 0.04 ppm; 

Nut, tree, group 14–12 at 0.03 ppm; 

Pulses, dried shelled bean, except 

soybean, subgroup 6–22E at 0.3 ppm; 

Pulses, dried shelled pea subgroup 6– 

22F at 0.3 ppm; Rapeseed 20A at 0.6 

ppm; Rice subgroup 15–22F at 0.03 

ppm; Succulent shelled bean subgroup 

6–22C at 0.03 ppm; Succulent shelled 

pea subgroup 6–22D at 0.03 ppm; Sweet 

corn subgroup 15–22D at 0.03 ppm; and 

Wheat subgroup 15–22A at 0.7 ppm. 

Upon the establishment of the 

tolerances requested above, the 

petitioner requested that EPA amend 40 

CFR 180.649 by removing the tolerances 

for residues of saflufenacil in or on 

Barley, grain at 1.0 ppm; Chia, seed at 

0.6 ppm; Rapeseed subgroup 20A at 

0.45 ppm (identified in the July 5, 2023, 

Federal Register as ‘‘crop subgroup 

20A; rapeseed subgroup at 0.45 ppm); 

Fruit, citrus, group 10 at 0.03 ppm 

(identified in the July 5, 2023, Federal 

Register as ‘‘Fruit, pome, group 10 at 

0.03 ppm); Fruit, pome, group 11 at 0.03 

ppm; Fruit, stone, group 12 at 0.03 ppm; 

Grain, cereal, group 15 (except barley 

and wheat grain) at 0.03 ppm; Nut, tree, 

group 14 at 0.03 ppm; Pea and bean, 

dried shelled, except soybean, subgroup 

6C at 0.30 ppm; Pea and bean, succulent 

shelled, subgroup 6B at 0.03 ppm; 

Pistachio at 0.03 ppm; Vegetable, foliage 

of legume, group 7 (except pea, hay) at 

0.10 ppm; Vegetable, legume, edible 

podded, subgroup 6A at 0.03 ppm; and 

Wheat, grain at 0.60 ppm. That 

document referenced a summary of the 

petition prepared by IR–4, the 

petitioner, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition and in 

accordance with its authority under 

FFDCA section 408(d)(4)(A)(i), EPA is 

establishing the tolerance for residues of 

saflufenacil in or on mint at a different 

level than requested by the petitioner. 

Additionally, EPA is not establishing 

some of the petitioned-for tolerances 

because the request was subsequently 

withdrawn by the petitioner. The 

reasons for these changes 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 saflufenacil 

including exposure resulting from the 

tolerance established by this action. 

EPA’s assessment of exposures and risks 

associated with saflufenacil follows. 

In an effort to streamline its 

publications in the Federal Register, 

EPA is not reprinting sections that 

repeat what has been previously 

published for tolerance rulemakings for 


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the same pesticide chemical. Where 

scientific information concerning a 

particular chemical remains unchanged, 

the content of those sections would not 

vary between tolerance rulemakings, 

and EPA considers referral back to those 

sections as sufficient to provide an 

explanation of the information EPA 

considered in making its safety 

determination of the new rulemaking. 

EPA has previously published a 

tolerance rulemaking in 2015, for 

saflufenacil in which EPA concluded, 

based on the available information, that 

there is a reasonable certainty that no 

harm would result from aggregate 

exposure to saflufenacil and established 

a tolerance for residues of that chemical. 

EPA is incorporating previously 

published sections from that rulemaking 

as described further in this rulemaking, 

as they remain unchanged. 

Toxicological profile. For a discussion 

of the toxicological profile for 

saflufenacil, see Unit III.A. of the 

saflufenacil tolerance rulemaking 

published in the Federal Register of 

November 25, 2015 (80 FR 73663) (FRL– 

9936–71). 

Toxicological points of departure/ 

Levels of concern. For a summary of the 

Toxicological Points of Departure/ 

Levels of Concern for saflufenacil used 

for human health risk assessment, see 

Unit III.B. of the November 25, 2015, 

rulemaking. 

Exposure assessment. Much of the 

exposure assessment remains 

unchanged from the November 2015, 

rulemaking, except as described below. 

The updates are discussed in this 

section; for a description of the rest of 

the EPA approach to and assumptions 

for the exposure assessment, see Unit 

III.C of the November 25, 2015, 

rulemaking. 

EPA’s dietary exposure assessments 

have been updated to include the 

additional exposures from the uses 

associated with the tolerances 

established since the November 25, 

2015, rulemaking and the additional 

exposure from the new use of 

saflufenacil on mint and the crop group 

conversions to fruit, citrus, group 10–10; 

fruit, pome, group 11–10; fruit, stone, 

group 12–12; and nut, tree, group 14–12. 

The dietary exposure assessments were 

conducted with Dietary Exposure 

Evaluation Model software using the 

Food Commodity Intake Database 

(DEEM–FCID), Version 4.02, which uses 

the 2005–2010 food consumption data 

from the United States Department of 

Agriculture (USDA) National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA). The 

assessment used the same assumptions 

as the November 25, 2015, final rule 

concerning tolerance-level residues, 

default processing factors for all 

processed commodities, and 100 

percent crop treated. 

Drinking water exposure. The 

drinking water numbers have not 

changed since the November 25, 2015, 

rulemaking. 

Non-occupational exposure. There are 

no residential (non-occupational) uses 

proposed or currently registered for 

saflufenacil. Therefore, a residential risk 

assessment was not conducted. 

Cumulative exposure. Section 

408(b)(2)(D)(v) of FFDCA requires that, 

when considering whether to establish, 

modify, or revoke a tolerance, the 

Agency consider ‘‘available 

information’’ concerning the cumulative 

effects of a particular pesticide’s 

residues and ‘‘other substances that 

have a common mechanism of toxicity.’’ 

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

saflufenacil and any other substances. 

For the purposes of this tolerance 

action, therefore, EPA has not assumed 

that saflufenacil has a common 

mechanism of toxicity with other 

substances. 

Safety factor for infants and children. 

EPA continues to conclude that there 

are reliable data to support the 

reduction of the Food Quality Protection 

Act (FQPA) safety factor from 10X to 

1X. See Unit III.D. of the November 25, 

2015, rulemaking for a discussion of the 

Agency’s rationale for that 

determination. 

Aggregate risks and Determination of 

safety. EPA determines whether acute 

and chronic dietary pesticide exposures 

are safe by comparing dietary exposure 

estimates to the acute populationadjusted dose (aPAD) and the chronic 

population-adjusted dose (cPAD).Short-, 

intermediate-, and chronic term 

aggregate risks are evaluated by 

comparing the estimated total food, 

water, and residential exposure to the 

appropriate points of departure to 

ensure that an adequate margin of 

exposure (MOE) exists. 

Acute dietary risks are below the 

Agency’s level of concern of 100% of 

the aPAD; they are less than 1% of the 

aPAD for all infants (less than 1 year 

old), the population subgroup with the 

highest exposure estimate. Chronic 

dietary risks are below the Agency’s 

level of concern of 100% of the cPAD; 

they are 26% of the cPAD for all infants 

(less than 1 year old), the population 

group with the highest exposure 

estimate. There is no short- or 

intermediate-term residential exposure 

expected since there are no proposed or 

previously registered residential uses of 

saflufenacil. Therefore, the acute and 

chronic aggregate risks consist only of 

the dietary risks from food and water, 

and as stated above, these are below the 

Agency’s level of concern. Based on the 

lack of evidence of carcinogenicity in 

two adequate rodent carcinogenicity 

studies, saflufenacil is not expected to 

pose a cancer risk to humans. 

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 saflufenacil residues, 

including its metabolites and 

degradates. More detailed information 

about the Agency’s analysis can be 

found at https://www.regulations.gov in 

the document titled ‘‘Saflufenacil. 

Section 3 Human Health Risk 

Assessment for Proposed New Uses on 

Mint (Peppermint and Spearmint) and 

Crop Group Conversions and 

Expansions’’ in docket ID number EPA– 

HQ–OPP–2023–0080. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

For a discussion of the available 

analytical enforcement method, see Unit 

IV.A. of the February 2, 2024, 

rulemaking (89 FR 7291) (FRL–11673– 

01–OCSPP). 

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, 

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. 

The Codex has not established an 

MRL for residues of saflufenacil in or on 

mint. The Codex has established MRLs 

for saflufenacil in or on Fruit, citrus, 

group 10–10 at 0.01 ppm; Fruit, pome, 

group 11–10 at 0.01 ppm; Fruit, stone, 


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group 12–12 at 0.01 ppm; and Nut, tree, 

group 14–12 at 0.01 ppm. The U.S. 

tolerance levels are not harmonized 

with these Codex commodity MRLs. 

Based on available residue data, use by 

U.S. growers consistent with approved 

label instructions would result in 

residues that exceed the Codex MRL. 

Harmonizing with these Codex MRLs 

could put U.S. growers at risk of 

violative residues despite legal use of 

saflufenacil according to the label. 

C. Revisions to Petitioned-For 

Tolerances 

EPA is establishing the tolerance for 

residues of saflufenacil in or on mint at 

0.03 ppm instead of the petitionerproposed 0.04 ppm. As discussed in the 

Human Health Risk Assessment, the 

petitioner’s proposed tolerance of 0.04 

ppm includes the parent compound and 

three metabolites. However, since EPA 

determined that the tolerance 

expression should only include the 

parent compound and two metabolites, 

the residue calculation was corrected to 

reflect these residues. 

EPA is not establishing some of the 

petitioned-for tolerances because the 

petitioner withdrew the requests for 

tolerances of residues of saflufenacil in 

or on Barley subgroup 15–22B; Ediblepodded bean subgroup 6–22A; Ediblepodded pea subgroup 6–22B; Field corn 

subgroup 15–22C; Forage and hay of 

legume vegetable group 7–22 (except 

pea, hay); Forage, hay, stover and straw 

of cereal grain group 6–22 (except 

barley, chia, and wheat straw); Grain 

sorghum and millet subgroup 15–22E; 

Pulses, dried shelled bean, except 

soybean, subgroup 6–22E; Pulses, dried 

shelled pea, subgroup 6–22F; Rapeseed 

subgroup 20A; Rice subgroup 15–22F; 

Succulent shelled pea subgroup 6–22C; 

Succulent shelled pea subgroup 6–22D; 

Sweet corn subgroup 15–22D and Wheat 

subgroup 15–22A. Therefore, EPA is not 

establishing these tolerances or 

removing the related tolerances as 

requested by IR–4. 

V. Conclusion 

Therefore, tolerances are established 

for residues of saflufenacil, including its 

metabolites and degradates, in or on 

Fruit, citrus, group 10–10 at 0.03 ppm; 

Fruit, pome, group 11–10 at 0.03 ppm; 

Fruit, stone, group 12–12 at 0.03 ppm; 

Mint, dried leaves at 0.03 ppm; Mint 

fresh leaves at 0.03 ppm; and Nut, tree, 

group 14–12 at 0.03 ppm. Upon the 

establishment of these tolerances, EPA 

is removing tolerances for residues of 

saflufenacil, including its metabolites 

and degradates, in or on fruit, citrus, 

group 10; fruit, pome, group 11; fruit, 

stone, group 12; nut, tree, group 14; and 

pistachio. 

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). 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. 

Dated: September 3, 2024. 

Charles Smith, 

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 § 180.649, amend the table in 

paragraph (a)(1) by: 

■ a. Removing the entry for ‘‘Fruit, 

citrus, group 10’’. 

■ b. Adding in alphabetical order the 

entry ‘‘Fruit, citrus, group 10–10’’. 

■ c. Removing the entry for ‘‘Fruit, 

pome, group 11’’. 

■ d. Adding in alphabetical order the 

entry ‘‘Fruit, pome, group 11–10’’. 

■ e. Removing the entry for ‘‘Fruit, 

stone, group 12’’. 

■ f. Adding in alphabetical order the 

entries ‘‘Fruit, stone, group 12–12’’, 

‘‘Mint, dried leaves’’, and ‘‘Mint, fresh 

leaves’’. 

■ g. Removing the entry for ‘‘Nut, tree, 

group 14’’. 

■ h. Adding in alphabetical order the 

entry ‘‘Nut, tree, group 14–12’’. 

■ i. Removing the entry for ‘‘Pistachio.’’ 


ddrumheller on DSK120RN23PROD with RULES1
72998 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Rules and Regulations 

The additions read as follows: 

§ 180.649 Saflufenacil; tolerances for 

residues. 

(a) * * * 

(1) * * * 

TABLE 1 TO PARAGRAPH (a)(1) 

Commodity Parts per 

million 

* * * * * 

Fruit, citrus, group 10–10 ........... 0.03 

Fruit, pome, group 11–10 ........... 0.03 

Fruit, stone, group 12–12 ........... 0.03 

* * * * * 

Mint, dried leaves ....................... 0.03 

Mint, fresh leaves ....................... 0.03 

Nut, tree, group 14–12 ............... 0.03 

* * * * * 

* * * * * 

[FR Doc. 2024–20256 Filed 9–6–24; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 423 

Office of the Secretary 

45 CFR Part 170 

[CMS–4205–CN] 

RINs 0938–AV24 and 0938–AU96 

Medicare Program; Medicare 

Prescription Drug Benefit Program; 

Health Information Technology 

Standards and Implementation 

Specifications; Correction 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Office of the 

National Coordinator for Health 

Information Technology (ONC), 

Department of Health and Human 

Services (HHS). 

ACTION: Final rule; correction. 

SUMMARY: This document corrects 

typographical and technical errors in 

the final rule that appeared in the June 

17, 2024, Federal Register, titled 

‘‘Medicare Program; Medicare 

Prescription Drug Benefit Program; 

Health Information Technology 

Standards and Implementation 

Specifications.’’ The effective date of the 

final rule was July 17, 2024. 

DATES: 

Effective date: This correction is 

effective September 9, 2024. 

Applicability date: This correcting 

document is applicable to the start of 

the transition period for use of the 

National Council for Prescription Drug 

Programs (NCPDP) SCRIPT standard 

and NCPDP Formulary and Benefit 

(F&B) standard versions beginning July 

17, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Maureen Connors, (410) 786–4132—Part 

D Standards for Electronic 

Prescribing. 

Alexander Baker, (202) 260–2048— 

Health IT Standards. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In FR Doc. FR 2024–12842 of June 17, 

2024 (89 FR 51238), the final rule titled 

‘‘Medicare Program; Medicare 

Prescription Drug Benefit Program; 

Health Information Technology 

Standards and Implementation 

Specifications,’’ there were a few 

typographical and technical errors that 

are identified and corrected in this 

correction. The corrections are 

applicable to the start of the transition 

period for use of the National Council 

for Prescription Drug Programs (NCPDP) 

SCRIPT standard and NCPDP 

(Formulary and Benefit) F&B standard 

versions beginning July 17, 2024, as if 

they had been included in the document 

that appeared in the June 17, 2024 

Federal Register. 

II. Summary of Errors 

On page 51252, we made 

typographical errors in our discussion of 

the start dates for the transition periods 

for use of the NCPDP SCRIPT standard 

and NCPDP F&B standard versions, and 

in section IV of this document we 

correct these errors. 

On page 51255, we made errors in our 

discussion of how non-NCPDP members 

may review and inspect NCPDP 

standards that have been incorporated 

by reference, and in section IV of this 

document we correct this error. 

III. Waivers of Proposed Rulemaking 

and Delay in Effective Date 

Under 5 U.S.C. 553(b) of the 

Administrative Procedure Act (the 

APA), the agency is required to publish 

a notice of the proposed rule in the 

Federal Register before the provisions 

of a rule take effect. Specifically, 5 

U.S.C. 553 requires the agency to 

publish a notice of the proposed rule in 

the Federal Register that includes a 

reference to the legal authority under 

which the rule is proposed, and the 

terms and substance of the proposed 

rule or a description of the subjects and 

issues involved. Further, 5 U.S.C. 553 

requires the agency to give interested 

parties the opportunity to participate in 

the rulemaking through public comment 

on a proposed rule. Similarly, section 

1871(b)(1) of the Social Security Act 

(the Act) requires the Secretary to 

provide for notice of the proposed rule 

in the Federal Register and provide a 

period of not less than 60 days for 

public comment for rulemaking to carry 

out the administration of the Medicare 

program under title XVIII of the Act. In 

addition, section 553(d) of the APA and 

section 1871(e)(1)(B)(i) of the Act 

mandate a 30-day delay in effective date 

after issuance or publication of a rule. 

Sections 553(b)(B) and 553(d)(3) of the 

APA provide for exceptions from the 

APA notice and comment and delay in 

effective date requirements. In cases in 

which these exceptions apply, sections 

1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the 

Act provide exceptions from the notice, 

60-day comment period, and delay in 

effective date requirements of the Act as 

well. Section 553(b)(B) of the APA and 

section 1871(b)(2)(C) of the Act 

authorize an agency to dispense with 

normal notice and comment rulemaking 

procedures for good cause if the agency 

makes a finding that the notice and 

comment process is impracticable, 

unnecessary, or contrary to the public 

interest. In addition, both section 

553(d)(3) of the APA and section 

1871(e)(1)(B)(ii) of the Act allow the 

agency to avoid the 30-day delay in 

effective date where such delay is 

contrary to the public interest and the 

agency includes a statement of support. 

We believe that this correction does 

not constitute a rule that would be 

subject to the notice and comment or 

delayed effective date requirements of 

the APA or section 1871 of the Act. This 

document corrects typographical and 

technical errors in the preamble of the 

final rule but does not make substantive 

changes to the policies that were 

adopted in the final rule. As a result, 

this correction is intended to ensure that 

the information in the final rule 

accurately reflects the policies adopted 

in that final rule. 

In addition, even if this were a rule to 

which the notice and comment 

procedures and delayed effective date 

requirements applied, we find that there 

is good cause to waive such 

requirements. Undertaking further 

notice and comment procedures to 

incorporate the preamble corrections in 

this document into the final rule or 

delaying the effective date would be 

unnecessary, as we are not altering our 

policies or regulatory changes, but 

rather, we are simply implementing the 

policies and regulatory changes that we 

previously proposed, requested 

comment on, and subsequently 


ddrumheller on DSK120RN23PROD with RULES1