[Federal Register Volume 84, Number 116 (Monday, June 17, 2019)]
[Rules and Regulations]
[Pages 27966-27968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12743]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0487; FRL-9993-15]


24-Epibrassinolide; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of 24-epibrassinolide in or on all food 
commodities when used in accordance with label directions and good 
agricultural practices. Suntton International Inc., submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
requesting an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of 24-epibrassinolide under FFDCA.

DATES: This regulation is effective June 17, 2019. Objections and 
requests for hearings must be received on or before August 16, 2019, 
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-2017-0487, 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 review the visitor instructions and 
additional information about the docket available at http://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 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(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-2017-0487 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 16, 2019. 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

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notice. Submit the non-CBI copy of your objection or hearing request, 
identified by docket ID number EPA-HQ-OPP-2017-0487, 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 December 15, 2017 (82 FR 59604) (FRL-
9970-50), 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 7F8599) by Suntton International Inc., 901 H St., Suite 
610, Sacramento, CA 95814. The petition requested that 40 CFR part 180 
be amended by establishing an exemption from the requirement of a 
tolerance for residues of 24-epibrassinolide in or on all food 
commodities. That document referenced a summary of the petition 
prepared by the petitioner Suntton International Inc., which is 
available in the docket via http://www.regulations.gov. There were no 
comments received in response to the notice of filing.

III. Final Rule

A. EPA's Safety Determination

    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 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 24-
epibrassinolide 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.
    24-epibrassinolide (24-Epi) is a naturally occurring 
brassinosteroid, which belongs to a class of plant steroid hormones. 
24-epibrassinolide has been recently found to regulate seed 
germination, seedling growth, root development, and photosynthesis, and 
to enhance immune response against biotic and abiotic stressors. Like 
other brassinosteroids, 24-epibrassinolide is ubiquitously distributed 
in the plant kingdom at low concentrations in a variety of plant 
organs, including pollens, anthers, seeds, leaves, stems, roots, 
flowers and grains, and as a result, humans are exposed to this 
substance.
    As a pesticide, 24-epibrassinolide is a synthetically produced 
brassinosteroid that is structurally similar to naturally occuring 
brassinsteroids and that is intended for use as a plant growth 
regulator (PGR) to improve crop quality and yield by promoting plant 
growth, defense, and development. Based on proposed label application 
rates, 24-epibrassinolide is applied at low concentrations, which is 
typical of a PGR.
    Based on the data submitted in support of this petition and the 
comprehensive risk assessment conducted by the Agency (included in the 
Docket for this action), EPA concludes that there is a reasonable 
certainty that no harm will result to the U.S. population, including 
infants and children, from aggregate exposures to 24-epibrassinolide, 
including dietary exposures from the consumption of food treated with 
this active ingredient in accordance with label directions and good 
agricultural practices, or food containing naturally occurring residues 
of 24-epibrassinolide, residues in drinking water, and other non-
occupational exposures. EPA has made this determination because 
available toxicology data indicate that the active ingredient is not 
acutely toxic and, based upon a weight of the evidence (WOE) approach, 
it has been determined not to be a developmental toxicant, a mutagen, 
or toxic via repeat oral exposure (i.e. not subchronically toxic via 
the oral route). As such the Agency has not identified any endpoints of 
concern for 24-epibrassinolide and has conducted a qualitative 
assessment of exposure. The Agency has determined that residues of 24-
epibrassinolide in drinking water are expected to be negligible since 
significant residues are not expected due to low application rates and 
currently proposed use patterns. Non-occupational exposures are 
anticipated because 24-epibrassinolide may be used in residential 
settings, such as turf, however, no toxicological endpoints have been 
identified. Therefore, a residential assessment was not conducted for 
24-epibrassinolide. An explanation of the data upon which EPA relied 
and its risk assessment based on those data can be found within the 
April 15, 2019, document entitled ``Federal Food, Drug, and Cosmetic 
Act (FFDCA) Safety Assessment for 24-epibrassinolide.'' 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 an exemption 
from the requirement of a tolerance for residues of 24-epibrassinolide.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes due 
to lack of concern for exposures, which supports the establishment of 
an exemption for residues of 24-epibrassinolide.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption 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

[[Page 27968]]

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 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 
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: June 4, 2019.
Richard Keigwin,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended 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.  180.1366 to subpart D to read as follows:


Sec.  180.1366  24-Epibrassinolide; exemption from the requirement of a 
tolerance.

    Residues of the plant growth regulator 24-epibrassinolide in or on 
all food commodities are exempt from the requirement of a tolerance, 
when used in accordance with label directions and good agricultural 
practices.

[FR Doc. 2019-12743 Filed 6-14-19; 8:45 am]
 BILLING CODE 6560-50-P