[Federal Register Volume 86, Number 121 (Monday, June 28, 2021)]
[Rules and Regulations]
[Pages 33890-33892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13681]


=======================================================================
-----------------------------------------------------------------------

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-
aminocyclopropane-1-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: 
[email protected].

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/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2019-0515 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

[[Page 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-
aminocyclopropane-1-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 non-protein 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 pre-
fruiting, 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

[[Page 33892]]

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

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. Revise Sec.  180.711 to read as follows:


Sec.  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