[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Rules and Regulations]
[Pages 27711-27713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12809]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0565; FRL-9977-75]


Extract of Swinglea glutinosa; 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 Extract of Swinglea glutinosa in or on all food 
commodities when used in accordance with label directions and good 
agricultural practices. Gowan Company LLC 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 Extract of Swinglea glutinosa under FFDCA.

DATES: This regulation is effective June 14, 2018. Objections and 
requests for hearings must be received on or before August 13, 2018, 
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-2017-0565, 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: 
<a href="/cdn-cgi/l/email-protection#430113130705110d2c372a202630032633226d242c35"><span class="__cf_email__" data-cfemail="b8fae8e8fcfeeaf6d7ccd1dbddcbf8ddc8d996dfd7ce">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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-2017-0565 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 13, 2018. 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-2017-0565, by one of 
the following methods:
    <bullet> 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.
    <bullet> Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
    <bullet> 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 January 26, 2018 (83 FR 3658) (FRL-9971-
46), 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 6F8504) by Gowan Company LLC, P.O. Box 5569, Yuma, AZ 
85366-5569. The petition requested that 40 CFR 180 be amended by 
establishing an exemption from the

[[Page 27712]]

requirement of a tolerance for residues of the biochemical fungicide 
Extract of Swinglea glutinosa in or on all food commodities. That 
document referenced a summary of the petition prepared by the 
petitioner, Gowan Company LLC, 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.'' FFDCA 
section 408(b)(2)(C) provides that EPA shall apply an additional 
tenfold (10X) margin of safety for infants and children in the case of 
threshold effects to account for prenatal and postnatal toxicity and 
the completeness of the database on toxicity and exposure unless EPA 
determines based on reliable data that a different margin of safety 
will be safe for infants and children. This additional margin of safety 
is commonly referred to as the FQPA Safety Factor (SF). In applying 
this provision, EPA either retains the default value of 10X, or uses a 
different additional safety factor when reliable data available to EPA 
support the choice of a different factor.
    EPA evaluated the available toxicity and exposure data on Extract 
of Swinglea glutinosa and considered their 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.
    Extract of Swinglea glutinosa is extracted from the leaves of 
Swinglea glutinosa. Commonly known as Tabog, the plant is found in 
southeast Asian and South American countries and is also commercially 
cultivated for ornamental purposes. As a pesticidal active ingredient, 
Extract of Swinglea glutinosa is intended for use as a fungicide on 
growing crops and ornamentals in agricultural, greenhouse, turf, 
recreational, and commercial landscape use sites to control fungal 
diseases such as powdery mildew and sour rot. The antifungal mode of 
action (MOA) of Extract of Swinglea glutinosa is likely cell membrane 
disruption, attributable to the terpene constituents in the essential 
oil of the extract. This mode of action is similar to that observed in 
other essential oils that are considered biopesticides, such as tea 
tree oil, rosemary oil and thyme oil. The constituent compounds in 
Extract of Swinglea glutinosa are ubiquitous in fruits and vegetables 
and are regularly consumed by humans as part of a normal diet. The 
constituent compounds are also biodegradable; and the active ingredient 
is highly soluble in water and will degrade rapidly in aqueous 
environments.
    Based on the data submitted in support of this petition and the 
dietary risk assessment conducted by the Agency, EPA concludes that 
there is a reasonable certainty of no harm from aggregate exposures to 
Extract of Swinglea glutinosa, including the consumption of food 
treated with this active ingredient in accordance with label directions 
and good agricultural practices. EPA has made this determination 
because available toxicology data indicate that the active ingredient 
is not acutely toxic, subchronically toxic, mutagenic, or 
developmentally toxic via repeat oral exposure. As such, the Agency has 
not identified any endpoints of concern for Extract of Swinglea 
glutinosa and has conducted a qualitative assessment of exposure. The 
Agency has also determined that residues Extract of Swinglea glutinosa 
in drinking water are not expected to be significant when products are 
used according to label instructions. The active ingredient is applied 
at low concentrations, is very soluble in water, and degrades rapidly 
in aqueous solutions. Non-occupational exposures are not expected since 
Extract of Swinglea glutinosa is only intended for commercial 
agricultural and landscaping use. A full explanation of the data upon 
which EPA relied and its dietary risk assessment based on those data 
can be found within the April 10, 2018, document entitled ``Federal 
Food, Drug, and Cosmetic Act (FFDCA) Considerations for Extract of 
Swinglea glutinosa.'' This document, as well as other relevant 
information, is available in the docket for this action as described 
under ADDRESSES.
    Based upon its evaluation, EPA concludes that Extract of Swinglea 
glutinosa is not toxic. No toxic endpoints were established for oral 
toxicity, dermal toxicity or inhalation toxicity. Exposure to Extract 
of Swinglea glutinosa via pesticidal use is not expected to exceed any 
levels of concern. EPA also determined that retention of the Food 
Quality Protection Act (FQPA) safety factor was not necessary due to 
the lack of threshold effects.
    Therefore, EPA concludes that there is a reasonable certainty that 
no harm will result to the U.S. population, including infants and 
children, from aggregate exposure to residues of Extract of Swinglea 
glutinosa. Therefore, EPA is establishing an exemption from the 
requirement of a tolerance for residues of Extract of Swinglea 
glutinosa when applied pre-harvest in accordance with label directions 
and good agricultural practices.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes due 
to the lack of concern about safety for Extract of Swinglea glutinosa 
at any exposure level.

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 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

[[Page 27713]]

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 
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 29, 2018.
Richard P. Keigwin, Jr.,
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.  180.1356 to subpart D to read as follows:


Sec.  180.1356  Extract of Swinglea glutinosa; exemption from the 
requirement of a tolerance.

    Residues of the biochemical pesticide Extract of Swinglea glutinosa 
are exempt from the requirement of a tolerance in or on all food 
commodities when applied pre-harvest in accordance with label 
directions and good agricultural practices.

[FR Doc. 2018-12809 Filed 6-13-18; 8:45 am]
 BILLING CODE 6560-50-P


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