[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Rules and Regulations]
[Pages 49168-49171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20257]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0017; FRL-9930-16]


Lavandulyl Senecioate; 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 the arthropod pheromone, lavandulyl 
senecioate, in or on all raw agricultural commodities when applied or 
used in microbeads/dispensers at a rate not to exceed 150 grams active 
ingredient/acre/year in accordance with good agricultural practices. 
Suterra, 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 lavandulyl senecioate.

DATES: This regulation is effective August 17, 2015. Objections and 
requests for hearings must be received on or before October 16, 2015, 
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-2015-0017, 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 Printing Office's e-CFR site at http://

[[Page 49169]]

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-2015-0017 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 
October 16, 2015. 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-2015-0017, 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 and Statutory Findings

    In the Federal Register of March 4, 2015 (80 FR 11611) (FRL-9922-
68), 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 4F8292) by Suterra, LLC, 20950 NE Talus Place, Bend, OR 
97701. The petition requested that 40 CFR part 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of lavandulyl senecioate in or on all raw agricultural 
commodities when applied to growing crops at a rate not to exceed 150 
grams of active ingredient per acre per year. That document referenced 
a summary of the petition prepared by the petitioner Suterra, LLC, 
which is available in the docket via http://www.regulations.gov. No 
comments were received on 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.

A. Overview of Lavandulyl Senecioate

    Lavandulyl senecioate (5-methyl-2-(1-methylethenyl)-4-hexenyl 3-
methyl-2-butonate) is a technical grade synthetic arthropod pheromone. 
This arthropod pheromone is structurally similar to and mimics a 
naturally occurring pheromone produced by the female vine mealybug 
(Planococcus ficus) to attract males for mating. This pheromone is used 
to disrupt the normal mating cycle of the vine mealybug and has a non-
toxic mode of action.
    As an arthropod pheromone, lavandulyl senecioate is exempt from the 
requirement of a tolerance when used in retrievably sized polymeric 
matrix dispensers in or on all raw agricultural commodities when 
applied to growing crops only at a rate not to exceed 150 grams active 
ingredient/acre/year in accordance with good agricultural practices (40 
CFR 180.1124). The petitioner is requesting to apply this arthropod 
pheromone in an aqueous suspension of micro-bead/dispensers via normal 
spray equipment; therefore, the proposed new use of lavandulyl 
senecioate is not covered under the existing tolerance exemption listed 
in 40 CFR 180.1124. See the document entitled, ``Federal Food, Drug, 
and Cosmetic Act (FFDCA) Considerations for Lavandulyl Senecioate'' 
(June 30, 2015), available in the docket for this action.

B. Biochemical Pesticide Toxicology Data Requirements

    All applicable mammalian toxicology data requirements supporting 
the petition to exempt residues of the arthropod pheromone, lavandulyl 
senecioate, from the requirement of a tolerance in or on all raw 
agricultural commodities when applied or used in microbeads/dispensers 
at a rate not to exceed 150 grams active ingredient/acre/year have been 
fulfilled. No significant toxicological effects were observed in any of 
the acute toxicity studies. Three mutagenicity studies submitted 
indicate that lavandulyl senecioate is not a mutagen. There are no 
known effects on endocrine systems via oral, dermal, or inhalation 
routes of exposure.
    In the preamble to the final rule that exempted arthropod 
pheromones from the requirement of a tolerance when used in retrievably 
sized polymeric matrix dispensers, the Agency indicated that it did not 
have a toxicology

[[Page 49170]]

database for arthropod pheromones that addressed the potential risk of 
repeated, direct dietary exposure with sprayable formulations; 
therefore, at that time, the Agency limited the tolerance exemption to 
arthropod pheromones used in retrievably sized polymeric matrix 
dispensers with an annual rate limitation of 150 grams of active 
ingredient per acre. The Agency concluded that the limitations would 
not result in dietary exposure any greater than what may be found 
naturally as a result of heavy infestations of the pest arthropod. 
March 30, 1994 (59 FR 14757) (FRL-4761-9).
    To address the subchronic and prenatal developmental toxicity data 
requirements for this exemption from the requirement of a tolerance for 
this arthropod pheromone, lavandulyl senecioate, the petitioner 
submitted scientific rationales that demonstrate that it is highly 
unlikely that there will be significant repeated exposure, including 
dietary exposure and exposure to female humans, to this pheromone when 
used as proposed based on the extremely low application rate, low 
emission rate, rapid volatilization after emission from the microbeads, 
and rapid biodegradation. Taking into account the petitioner's 
rationale, EPA has concluded that there is unlikely to be exposure that 
could result in subchronic and developmental effects and so has waived 
the requirements for subchronic and prenatal developmental testing.
    For a full discussion of the data and rationale upon which EPA 
relied, and its human health risk assessment based on that data and 
rationale, please refer to the document entitled, ``Federal Food, Drug, 
and Cosmetic Act (FFDCA) Considerations for Lavandulyl Senecioate'' 
(June 30, 2015). This document, as well as other relevant information, 
is available in the docket for this action as described under 
ADDRESSES.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).

A. Dietary Exposure

    In the preamble to the final rule, the Agency stated that limiting 
the exemption to applications of arthropod pheromones in retrievably 
sized dispensers would severely limit the possibility of direct dietary 
exposure. The Agency believed that restriction was necessary to protect 
public health due to a lack of data on repeat exposure but acknowledged 
that petitioners wanting to use other application methods or 
formulations could petition for an amendment by demonstrating that the 
new formulation did not increase the likely dietary exposure. For this 
tolerance exemption, based on the petitioner's submission concerning 
the proposed use, the Agency has determined that the proposed use 
(applying this arthropod pheromone in an aqueous suspension of 
microbead/dispensers via normal spray equipment with a limitation of 
150 grams active ingredient/acre/year) will not result in detectable 
residues in or on all food commodities. That use is unlikely to result 
in significant dietary exposure to lavandulyl senecioate based on the 
extremely low application rate, low emission rate, rapid volatilization 
after emission from the microbeads, and rapid biodegradation (see 
document entitled, ``Federal Food, Drug, and Cosmetic Act (FFDCA) 
Considerations for Lavandulyl Senecioate'' (June 30, 2015), available 
in the docket for this action). No significant exposure via drinking 
water is expected based on the previous information for dietary 
exposure and the fact that the arthropod pheromone is not to be applied 
directly to water. However, should any dietary and/or drinking water 
exposure occur, minimal to no risk is expected for the general 
population, including infants and children, due to the low toxicity of 
lavandulyl senecioate as demonstrated in the data submitted and 
evaluated by the Agency, as fully explained in the document entitled, 
``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for 
Lavandulyl Senecioate'' (June 30, 2015), available in the docket for 
this action.

B. Other Non-Occupational Exposure

    Other non-occupational exposure (other than dietary) is not 
expected because the arthropod pheromone, lavandulyl senecioate, is not 
approved for residential uses.

V. Cumulative Effects From Substances With a Common Mechanism of 
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance, 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 has not found lavandulyl senecioate to share a common mechanism 
of toxicity with any other substances, and lavandulyl senecioate does 
not appear to produce a toxic metabolite produced by other substances. 
For the purposes of this tolerance action, therefore, EPA has assumed 
that lavandulyl senecioate does not have a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see EPA's Web site 
at http://www.epa.gov/pesticides/cumulative.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C) provides that, in considering the 
establishment of a tolerance or tolerance exemption for a pesticide 
chemical residue, EPA shall assess the available information about 
consumption patterns among infants and children, special susceptibility 
of infants and children to pesticide chemical residues, and the 
cumulative effects on infants and children of the residues and other 
substances with a common mechanism of toxicity. In addition, 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 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. In applying this 
provision, EPA either retains the default value of 10X, or uses a 
different additional or no safety factor when reliable data are 
available to support a different additional or no safety factor.
    As part of its qualitative assessment, EPA evaluated the available 
toxicity and exposure data on lavandulyl senecioate and considered its 
validity, completeness, and reliability, as well as the relationship of 
this information to human risk. EPA considers the toxicity database to 
be complete and has identified no residual uncertainty with regard to 
prenatal and postnatal toxicity or exposure. No hazard was identified 
based on the available studies, as fully explained in the document 
entitled, ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations 
for Lavandulyl

[[Page 49171]]

Senecioate'' (June 30, 2015), available in the docket for this action. 
Based upon its evaluation, EPA concludes that there are no threshold 
effects of concern to infants or children when lavandulyl senecioate is 
applied or used in microbeads/dispensers in or on all raw agricultural 
commodities at a rate not to exceed 150 grams active ingredient/acre/
year. As a result, EPA concludes that no additional margin of exposure 
(safety) is necessary.
    Based on the available data, EPA determines that there is a 
reasonable certainty that no harm will result from aggregate exposure 
to lavandulyl senecioate to the general U.S. population, including 
infants and children when applied to growing crops using microbeads/
dispensers at a rate not to exceed 150 grams active ingredient/acre/
year. EPA concludes that an exemption from the requirement of a 
tolerance for residues of lavandulyl senecioate in or on raw 
agricultural commodities when applied to growing crops using 
microbeads/dispensers at a rate not to exceed 150 grams active 
ingredient/acre/year is safe.

VII. Other Considerations

A. 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.

VIII. Conclusions

    Therefore, an exemption is established for residues of the 
arthropod pheromone, lavandulyl senecioate, in or on all raw 
agricultural commodities when applied or used in microbeads/dispensers 
at a rate not to exceed 150 grams active ingredient/acre/year.

IX. 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). 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 exemption 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).

X. 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: July 31, 2015.
Robert McNally,
Director, Biopesticides and Pollution Prevention Division.

    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.  180.1332 to subpart D to read as follows:


Sec.  180.1332  Lavandulyl senecioate; exemption from the requirement 
of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the arthropod pheromone, lavandulyl senecioate (5-methyl-2-
(1-methylethenyl)-4-hexenyl 3-methyl-2-butonate), in or on all raw 
agricultural commodities when applied or used in microbeads/dispensers 
at a rate not to exceed 150 grams active ingredient/acre/year in 
accordance with good agricultural practices.

[FR Doc. 2015-20257 Filed 8-14-15; 8:45 am]
 BILLING CODE 6560-50-P