[Federal Register Volume 83, Number 44 (Tuesday, March 6, 2018)]
[Rules and Regulations]
[Pages 9440-9442]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04534]



40 CFR Part 180

[EPA-HQ-OPP-2017-0080; FRL-9973-39]

Lipochitooligosaccharide (LCO) SP104; 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 lipochitooligosaccharide (LCO) SP104 in or on all 
food commodities when used in accordance with label directions and good 
agricultural practices. Monsanto Company 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 LCO SP104 under FFDCA.

DATES: This regulation is effective March 6, 2018. Objections and 
requests for hearings must be received on or before May 7, 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-2017-0080, 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: 


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-2017-0080 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 
May 7, 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-2017-0080, 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 
     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

[[Page 9441]]

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 June 8, 2017 (82 FR 26641) (FRL-9961-
14), 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 6F8520) by Monsanto Company, 1300 I (Eye) St. NW, Suite 
450 East, Washington, DC 20005. The petition requested that 40 CFR 180 
be amended by establishing an exemption from the requirement of a 
tolerance for residues of the plant growth regulator LCO SP104 in or on 
raw agricultural commodities and processed foods. That document 
referenced a summary of the petition prepared by the petitioner, 
Monsanto Company, 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 Food Quality Protection Act Safety 
Factor (FQPA 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 
    EPA evaluated the available toxicity and exposure data on LCO SP104 
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.
    Lipochitooligosaccharides (LCOs) are signaling molecules produced 
by bacteria, which are involved in the initiation of plant-microbe 
endosymbiosis (the scenario when a microbe colonizes a plant) in an 
estimated 70-80% of terrestrial plants. As a pesticide, LCO SP104, a 
synthetically produced LCO, is intended for use as a plant growth 
regulator (PGR) to increase growth and decrease stress in growing 
crops. Typical of a PGR, LCO SP104 should be applied at low 
concentrations because use at high concentrations can result in 
detrimental effects to the plant. LCO SP104 is structurally similar to 
naturally occurring LCOs. Humans are exposed to naturally occurring 
LCOs as they are present in the roots of food crops and in the bacteria 
and fungi that are associated with the roots of these crops. Molecules 
identical to LCO breakdown products (such as chitin) are also present 
in insects, crustaceans, fungi, bacteria, and humans, and are regularly 
consumed by humans as part of a normal diet.
    Based on the data submitted in support of this petition (summarized 
in Unit II. B., below) and the comprehensive risk assessment conducted 
by the Agency (included in the Docket for this action), EPA concludes 
that there is a reasonable certainty of no harm from aggregate 
exposures to LCO SP104, 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 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 LC SP104 and has conducted a qualitative assessment of 
exposure. The Agency has determined that residues of LCO SP104 in 
drinking water are not expected when products are used according to 
label instructions. The active ingredient is applied at low 
concentrations, is very soluble in water, and will dissociate within 
minutes once applied. Non-occupational exposures are not expected since 
LCO SP104 is not intended for residential use. A full explanation of 
the data upon which EPA relied and its risk assessment based on those 
data can be found within the January 22, 2018, document entitled 
``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for 
Lipochitooligosaccharide (LCO) SP104.'' 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 LCO SP104 is of low 
acute toxicity and no toxicological endpoints have been identified for 
this compound. 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 LCO SP104. 
Therefore, EPA is establishing an exemption from the requirement of a 
tolerance for residues of LCO SP104.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes due 
to the lack of concern about safety for LCO SP104 at any exposure 

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

[[Page 9442]]

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 
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: February 23, 2018.
Richard Keigwin, Jr.,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:


1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

2. Add Sec.  180.1353 to subpart D to read as follows:

Sec.  180.1353  Lipochitooligosaccharide (LCO) SP104; exemption from 
the requirement of a tolerance.

    Residues of the biochemical pesticide Lipochitooligosaccharide 
(LCO) SP104 (which has been used in accordance with label directions 
and good agricultural practices) are exempt from the requirement of a 
tolerance in or on all food commodities.

[FR Doc. 2018-04534 Filed 3-5-18; 8:45 am]