[Federal Register Volume 85, Number 129 (Monday, July 6, 2020)]
[Rules and Regulations]
[Pages 40126-40128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12143]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0367; FRL-10009-44]


1-Aminocyclopropane-1-carboxylic Acid (ACC); Temporary Exemption 
From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a temporary exemption from the 
requirement of a tolerance for residues of 1-aminocyclopropane-1-
carboxylic acid (ACC) in or on apples and stone fruits when used in 
accordance with the terms of the Experimental Use Permit (EUP) under 
EPA Number 73049-EUP-12. Valent BioSciences, LLC., submitted a petition 
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
requesting a temporary exemption from the requirement of a tolerance 
for the use of ACC for a period of three years. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of ACC resulting from use in accordance with the EUP No. 
73049-EUP-12 under FFDCA. The temporary exemption from the requirement 
of a tolerance expires on July 6, 2023.

DATES: This regulation is effective July 6, 2020. Objections and 
requests for hearings must be received on or before September 4, 2020 
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-2019-0367, 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.
    Please note that due to the public health emergency the EPA Docket 
Center (EPA/DC) and Reading Room was closed to public visitors on March 
31, 2020. Our EPA/DC staff will continue to provide customer service 
via email, phone, and webform. For further information on EPA/DC 
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, 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 Printing 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(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2019-0367 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 
September 4, 2020. 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-2019-0367, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

    In the Federal Register of August 2, 2019 (84 FR 37818) (FRL-9996-
78), 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 9F8760) by Valent BioSciences, LLC., 870 Technology Way, 
Libertyville, IL 60048. The petitioner requested that 40 CFR part 180 
be amended by establishing a temporary exemption from the requirement 
of a tolerance for three years for residues of the plant growth 
regulator 1-aminocyclopropane-1-carboxylic acid (ACC), in or on apples 
and stone fruits. That document referenced a summary of the petition 
prepared by the petitioner, Valent BioSciences, LLC., which is 
available in the docket via http://www.regulations.gov. Two comments 
were received. One approved of the action; one opposed using pesticides 
on apples. Although EPA recognizes that some do not want any pesticides 
in or on food, section 408 of the FFDCA authorizes EPA to set 
tolerances or establish exemptions for residues of pesticide chemicals 
when it determines that the tolerance or exemption meets the safety 
standard imposed by that statute. EPA has made that

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determination for the ACC exemption established by this final rule. The 
commenter provided no information supporting a conclusion that the 
tolerance exemption is not safe.

III. Final Rule

A. EPA's Safety Determination

    Section 408(r) of the FFDCA allows EPA to establish a temporary 
exemption from the requirement of a tolerance for uses covered by an 
experimental use permit. Under Section 408(c)(2)(A)(i), EPA may 
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) and (D), which require 
EPA to give special consideration to exposure of infants and children 
to the pesticide chemical residue in establishing a tolerance or 
tolerance exemption, 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 EPA consider 
``available information concerning the cumulative effects of a 
particular pesticide's residues and other substances that have a common 
mechanism of toxicity.''
    EPA evaluated the available toxicity and exposure data on 1-
aminocyclopropane-1-carboxylic acid (ACC) and considered its validity, 
completeness, and reliability, as well as the relationship of this 
information to human risk. EPA also considered available information 
concerning the variability of the sensitivities of major identifiable 
subgroups of consumers, including infants and children.
    ACC is a naturally occuring non-protein amino acid found in all 
plants. It acts as a plant growth regulator (PGR), pre-cursing 
ethylene, a plant hormone regulating a wide variety of vegetative and 
developmental processes. The only conversion of ACC for residues should 
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, ACC is intended for use on apples and 
stone fruits for fruit thinning and enhanced return bloom and is 
foliarly applied with an orchard air blast sprayer. 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.
    Overall, ACC is considered to be of low toxicity. Toxicological 
data demonstrate that ACC is of low toxicity relative to all routes of 
exposure. Additionally, humans have a history of safe natural exposure 
to ACC as it is present in all fruits and vegetables and 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 ACC in its digestive processes. Moreover, it is noted that 
dietary exposures to the residues of ACC are not anticipated to exceed 
the naturally occurring background levels as exogenously applied 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.
    With regard to the acute toxicological profile of the active 
ingredient ACC, the active ingredient is of low acute oral, dermal and 
inhalation toxicity; it 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 ACC, all data requirements were satisfied by guideline 
studies. There were no adverse subchronic effects for any route of 
exposure. The active ingredient was determined to be non-mutagenic. 
Finally, 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.
    As part of its qualitative risk assessment for ACC, the Agency also 
considered the potential for exposure to residues of ACC, including 
dietary and non-occupational exposures. EPA concludes that dietary 
exposures are likely to be negligible, due to the short half-life and 
biodegradable nature of the pesticide. Residential exposures are not 
expected under the conditions of the association EUP.
    Based on 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 ACC. Similarly, no risks of 
concern were identified for cumulative exposures to ACC since no common 
mechanism of toxicity was identified for either 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 ACC.
    A full explanation of the data upon which EPA relied and its risk 
assessment based on those data can be found within the April 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.
    Based on its safety determination, EPA is establishing a temporary 
exemption from the requirement of a tolerance for residues of the plant 
growth regulator 1-aminocyclopropane-1-carboxylic acid (ACC) in or on 
apples and stone fruits when used in accordance with the terms of the 
Experimental Use Permit (EUP) under EPA Number 73049-EUP-12. This 
temporary exemption from the requirement of a tolerance will expire on 
July 6, 2023.

B. Analytical Enforcement Methodology

    The analytical method for the residues of ACC can be evaluated by 
Ultra High-Performance Liquid Chromatography-Tandem Mass Spectrometry 
and is available to EPA for the detection and measurement of these 
pesticide residues.

IV. Statutory and Executive Order Reviews

    This action establishes a temporary exemption from the requirement 
of a tolerance under FFDCA section 408(d) in response to a petition 
submitted to EPA. 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

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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 temporary 
tolerance exemption in this action, 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. As a result, this 
action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 EPA's 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).

V. 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 28, 2020.
Robert McNally,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA amends 40 
CFR chapter I as follows:

PART 180--[AMENDED]

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. Add Sec.  180.711 to subpart C to read as follows:


Sec.  180.711  1-Aminocyclopropane-1-carboxylic acid (ACC); temporary 
exemption from the requirement of a tolerance for residues.

    A temporary exemption from the requirement of a tolerance is 
established for residues of the plant growth regulator, 1-
Aminocyclopropane-1-carboxylic acid (ACC) in or on apples and stone 
fruits when used in accordance with the terms of the Experimental Use 
Permit (EUP) under EPA Number 73049-EUP-12. This temporary exemption 
expires on July 6, 2023.

[FR Doc. 2020-12143 Filed 7-2-20; 8:45 am]
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