33890 Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations 

(b) Definitions. As used in this 

section— 

Captain of the Port (COTP) means the 

Commander, U.S. Coast Guard Sector 

Maryland—National Capital Region. 

Designated representative means any 

Coast Guard commissioned, warrant, or 

petty officer who has been authorized 

by the Captain of the Port Maryland— 

National Capital Region to assist in 

enforcing the safety zone described in 

paragraph (a) of this section. 

(c) Regulations. (1) Under the general 

safety zone regulations in subpart C of 

this part, you may not enter the safety 

zone described in paragraph (a) of this 

section unless authorized by the COTP 

or the COTP’s designated representative. 

(2) To seek permission to enter, 

contact the COTP or the COTP’s 

representative by telephone at 410–576– 

2693 or on Marine Band Radio VHF–FM 

channel 16 (156.8 MHz). The Coast 

Guard vessels enforcing this section can 

be contacted on Marine Band Radio 

VHF–FM channel 16 (156.8 MHz). 

(3) Those in the safety zone must 

comply with all lawful orders or 

directions given to them by the COTP or 

the COTP’s designated representative. 

(d) Enforcement officials. The U.S. 

Coast Guard may be assisted in the 

patrol and enforcement of the safety 

zone by Federal, State, and local 

agencies. 

(e) Enforcement period. This section 

will be enforced from 8 p.m. to 11 p.m. 

on July 4, 2021, or if necessary due to 

inclement weather on July 4, 2021, from 

8 p.m. to 11 p.m. on July 5, 2021. 

Dated: June 22, 2021. 

David E. O’Connell, 

Captain, U.S. Coast Guard, Captain of the 

Port Maryland—National Capital Region. 

[FR Doc. 2021–13727 Filed 6–25–21; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2019–0515; FRL–10021–90] 

1-Aminocyclopropane-1-Carboxylic 

Acid (1–ACC); Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the plant 

growth regulator 1-aminocyclopropane1-carboxylic acid (1–ACC) in or on 

apples and stone fruit when used in 

accordance with good agricultural 

practices. Valent BioSciences, LLC., 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an exemption from 

the requirement of a tolerance for 

residues of the plant growth regulator 1- 

aminocyclopropane-1-carboxylic acid 

(1–ACC) in or on apples and stone fruit 

when used in accordance with good 

agricultural practices. This regulation 

eliminates the need to establish a 

maximum permissible level for residues 

of 1-aminocyclopropane-1-carboxylic 

acid (1–ACC). 

DATES: This regulation is effective June 

28, 2021. Objections and requests for 

hearings must be received on or before 

August 27, 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–2019–0515, 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. 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: 

Charles Smith, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001; main telephone number: 

(703) 305–7090; email address: 

BPPDFRNotices@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 40 CFR part 180 

through the Government Publishing 

Office’s e-CFR site at http://

www.ecfr.gov/cgi-bin/textidx?&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–2019–0515 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 

August 27, 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– 

2019–0515, 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 


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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations 33891 

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. Background and Statutory Findings 

In the Federal Register of December 

23, 2020 (85 FR 83880) (FRL–10017–71), 

EPA issued a document pursuant to 

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

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

pesticide tolerance petition (PP 9F8781) 

by Valent BioSciences, LLC, 870 

Technology Way, Libertyville, IL 60048. 

The petition requested that 40 CFR part 

180 be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of the plant 

growth regulator 1-aminocyclopropane1-carboxylic Acid (1–ACC) in or on 

apple and stone fruit when used in 

accordance of good agricultural 

practices. That document referenced a 

summary of the petition prepared by the 

petitioner Valent BioSciences, LLC., 

which is available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

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

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(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. Pursuant to 

FFDCA section 408(c)(2)(B), in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

408(b)(2)(C), which require 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. . . .’’ Additionally, 

FFDCA section 408(b)(2)(D) requires 

that the Agency consider ‘‘available 

information concerning the cumulative 

effects of a particular pesticide’s 

residues’’ and ‘‘other substances that 

have a common mechanism of toxicity.’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

Consistent with FFDCA section 

408(b)(2)(D), EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability, and the 

relationship of this information 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. 

1–ACC is a naturally occurring nonprotein amino acid found in all plants. 

It acts as a plant growth regulator (PGR), 

precursing ethylene, a plant hormone 

regulating a wide variety of vegetative 

and developmental processes. The only 

conversion of 1–ACC for residues will 

most likely be into ethylene, which 

would not be measurable as ethylene is 

a quickly dissipating gas. Ethylene has 

been reviewed by EPA and is exempt 

from tolerance (40 CFR 180.1016). 

As a biochemical pesticide, 1–ACC is 

intended for use on apples and stone 

fruits for fruit thinning and enhanced 

return bloom and is foliarly applied 

with calibrated spray equipment (i.e. 

orchard air blast sprayer). 1–ACC’s 

mode of action is as a signaling 

molecule in plants to regulate fruit 

ripening, thinning, and enhanced return 

bloom. No direct application to food is 

expected as applications are made prefruiting, but it is possible that some 

trace amounts of the active ingredient 

may be taken up into the plant. 

With regard to the overall 

toxicological profile of the active 

ingredient 1–ACC, the active ingredient 

is of minimal toxicity through the acute 

oral, acute dermal and acute inhalation 

routes of exposure. The active 

ingredient is only mildly irritating to the 

eye and the skin; and it is not a dermal 

sensitizer. With regard to the subchronic 

toxicity, developmental toxicity, 

reproductive toxicity and mutagenicity 

data requirements for the active 

ingredient 1–ACC, all data requirements 

were satisfied by guideline studies. 

There were no adverse subchronic 

effects for any oral or dermal routes of 

exposure. The active ingredient was 

determined to be non-mutagenic, and no 

adverse effects were identified relative 

to either developmental toxicity or 

reproductive toxicity. Based on this 

toxicological profile, EPA did not 

identify any toxicological endpoints of 

concern for assessing risk for this 

chemical. 

Additionally, humans have a history 

of safe natural exposure to 1–ACC as it 

is present in all fruits and vegetables 

and, therefore, is a regular part of the 

human diet. With specific regard to 

human oral toxicity, the Agency notes 

that the human digestive system has 

evolved to accommodate 1–ACC in its 

digestive processes. 

As part of its qualitative risk 

assessment for 1–ACC, the Agency also 

considered the potential for exposure to 

residues of 1–ACC, including dietary 

and non-occupational exposures. EPA 

concludes that dietary (food and 

drinking water) exposures are likely to 

be negligible, due to the short half-life 

and biodegradable nature of the 

pesticide. It is noted that dietary 

exposures to the residues of 1–ACC are 

not anticipated to exceed the naturally 

occurring background levels as 

exogenously applied 1–ACC is highly 

biodegradable. It has a half-life of less 

than 8.5 days on the plant and is even 

more biodegradable in aqueous soil 

conditions. No residential uses have 

been proposed. 

Based on 1–ACC’s low toxicity, 

anticipated minimal dietary exposure, 

and history of safe consumption in 

foods, no risks of concern have been 

identified from aggregate exposure to 1– 

ACC. Similarly, no risks of concern 

were identified for cumulative 

exposures to 1–ACC since no common 

mechanism of toxicity was identified for 

either 1–ACC or its metabolites. 

Therefore, based on the lack of toxicity 

and expected negligible exposures, EPA 

has determined that there is a 

reasonable certainty that no harm will 

result to the U.S. population, including 

infants and children, from aggregate 

exposure to 1–ACC. 

A full explanation of the data upon 

which EPA relied and its risk 

assessment based on those data can be 

found within the November 16, 2020, 

document entitled ‘‘Federal Food, Drug, 

and Cosmetic Act (FFDCA) 

Considerations for 1- 

aminocyclopropane-1-carboxylic acid 

(ACC).’’ This document, as well as other 

relevant information, is available in the 

docket for this action as described under 

ADDRESSES. 

IV. Determination of Safety for U.S. 

Population, Infants and Children 

Based on the Agency’s assessment, 

EPA concludes that there is reasonable 


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33892 Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations 

certainty that no harm will result to the 

U.S. population, including infants and 

children, from aggregate exposure to 

residues of 1–ACC. This includes all 

anticipated dietary exposures and all 

other exposures for which there is 

reliable information. Based on the 

reliable data indicating lack of toxicity, 

including threshold effects, that 

supports EPA’s determination to 

conduct a qualitative assessment, EPA 

has concluded that the additional 

margin of safety is not necessary to 

protect infants and children. 

V. Other Considerations 

Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

However, the analytical methods Ultra 

High-Performance Liquid 

Chromatography-Tandem Mass 

Spectrometry is available to EPA for the 

detection and measurement of the 

pesticide residues 

VI. Conclusions 

Therefore, an exemption is 

established for residues of 1- 

aminocyclopropane-1-carboxylic acid 

(1–ACC) in or on apple and stone fruit 

when used in accordance to good 

agricultural practices. 

VII. Statutory and Executive Order 

Reviews 

This action establishes an exemption 

from the requirement of 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), 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 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). 

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: May 26, 2021. 

Edward Messina, 

Acting Director, 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. Revise § 180.711 to read as follows: 

§ 180.711 1-Aminocyclopropane-1- 

carboxylic Acid (1–ACC); Exemption from 

the Requirement of a Tolerance. 

An exemption from the requirement 

of a tolerance is established for 1- 

aminocyclopropane-1-carboxylic acid 

(1–ACC) in or on apple and stone fruit 

when applied in accordance with good 

agricultural practices. 

[FR Doc. 2021–13681 Filed 6–25–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 257 

[EPA–HQ–OLEM–2020–0508; FRL–10024– 

75–OLEM] 

Texas: Approval of State Coal 

Combustion Residuals Permit Program 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final approval. 

SUMMARY: Pursuant to the Resource 

Conservation and Recovery Act (RCRA), 

the Environmental Protection Agency 

(EPA) is approving the Texas 

Commission on Environmental 

Quality’s partial State Coal Combustion 

Residuals (CCR) Permit Program, which 

will now operate in lieu of the Federal 

CCR program, with the exception of 

certain provisions for which the State 

did not seek approval. EPA has 

determined that the Texas partial CCR 

permit program meets the standard for 

approval under RCRA. Facilities 

operating under the State’s program 

requirements and resulting permit 

provisions are also subject to EPA’s 

information gathering and inspection 

and enforcement authorities under 

RCRA and other applicable statutory 

and regulatory provisions. 

DATES: The final approval of the Texas 

partial CCR Permit Program is effective 

on July 28, 2021. 


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