[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)]
[Notices]
[Pages 6856-6858]
[FR Doc No: 2018-03137]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-2524]

Determination of Regulatory Review Period for Purposes of Patent
Extension; BRIDION

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for BRIDION and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
16, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 14, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 16, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.

     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-E-2524 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; BRIDION.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product BRIDION
(sugammadex sodium). BRIDION is indicated for the reversal of
neuromuscular blockade induced by rocuronium bromide and vecuronium
bromide in adults undergoing surgery. Subsequent to this approval, the
USPTO received a patent term restoration application for BRIDION (U.S.
Patent No. RE44733) from Merck Sharp & Dohme, B.V., and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated September 23, 2016, FDA
advised the USPTO that this human drug product had undergone a
regulatory review period and that the approval of BRIDION represented
the first permitted commercial marketing or use of the product.
Thereafter, the USPTO requested that FDA determine the product's
regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
BRIDION is 4,265 days. Of this time, 1,297 days occurred during the
testing phase of the regulatory review period, while 2,968 days
occurred during the approval phase. These periods of time were derived
from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
April 13, 2004. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on April
13, 2004.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: October 31,
2007. FDA has verified the applicant's claim that the new drug
application (NDA) for BRIDION (NDA 022225) was initially submitted on
October 31, 2007.
    3. The date the application was approved: December 15, 2015. FDA
has verified the applicant's claim that NDA 022225 was approved on
December 15, 2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,826 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21

CFR 60.30), any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period. To meet its burden, the petition
must comply with all the requirements of Sec.  60.30, including but not
limited to: must be timely (see DATES), must be filed in accordance
with Sec.  10.20, must contain sufficient facts to merit an FDA
investigation, and must certify that a true and complete copy of the
petition has been served upon the patent applicant. (See H. Rept. 857,
part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03137 Filed 2-14-18; 8:45 am]
BILLING CODE 4164-01-P


BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Carob Moth Pheromone Mimic

PC Code 128003

	U.S. Environmental Protection Agency

	Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

(Last updated May 8, 2013)

TABLE OF CONTENTS

  TOC \o "1-4" \h \z \u  I.	Executive Summary
………………………………………………………………
4

II. 	Active Ingredient OverView
…………………………………………………	5

  HYPERLINK \l "_Toc200350527"  III. 	REGULATORY BACKGROUND
…………………………………………………….	5

A.	Classification
………………………………………………………………
……………..	5

B.	Food Clearances and Tolerances
………………………………………………………..	5

  HYPERLINK \l "_Toc200350531"  IV. 	Risk Assessment
………………………………………………………………
…….	5

A.	Active Ingredient Characterization
……………………………………………………..	5

  HYPERLINK \l "_Toc200350534"  B. 	Human Health Assessment
………………………………………………………………
.	6

  HYPERLINK \l "_Toc200350535"  1. 	Toxicology
………………………………………………………………
………………	6

2.	Dose Response Assessment
…………………………………………………………….	7

3.	Food Quality Protection Act (FQPA) Consideration
………………………………	7

    4.	Occupational, Residential and School Exposure and Risk
Characterization ………..7

  HYPERLINK \l "_Toc200350557"  5	Cumulative Effects
………………………………………………………………
…8

  HYPERLINK \l "_Toc200350559"  6      Risk Characterization
………………………………………………………………
..8

  HYPERLINK \l "_Toc200350561"  C. 	ENVIRONMENTAL ASSESSMENT
……………………………..…………………	8

  HYPERLINK \l "_Toc200350562"  1. 	Ecological Hazards
………………………………………………………………
……..	8

2.	Environmental Fate and Ground Water Data
…………………………………….	8

3.	Ecological Exposure and Risk Characterization
…..………………………………….8

    4. 	Endangered Species Assessment
.………………………………………………….…...9

D.	EFFICACY DATA
………………………………………………………………
………	9

  HYPERLINK \l "_Toc200350570"  V.    Risk Management Decision
….…………………………………………………	9

  HYPERLINK \l "_Toc200350571"  A.		Determination of Eligibility for
Registration  ….……………………………………. ..	9

B.	Regulatory Decision
………………………………………………………………
……..9

C.	Environmental Justice
………………………………………………………………
….9

  HYPERLINK \l "_Toc200350573"  VI.	ACTIONS REQUIRED BY REGISTRANTS
…………….…………………………....  PAGEREF
_Toc200350573 \h  10

  HYPERLINK \l "_Toc200350574"  A.	Reporting Adverce Effects
………………………………………………………………
10

  HYPERLINK \l "_Toc200350575"  B.	Reporting of Hypersensitivity
Incidents  ……………………………………………...
PAGEREF _Toc200350575 \h  10

VII. APPENDIX A. Data Requirements
……………………………………………………...10

VIII. APPENDIX B. Product Specific Information
………………………………………….13

  HYPERLINK \l "_Toc200350578"  IX. Appendix C. References
…………………………………………………………..	.13

BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM

Office of Pesticide Programs:

Biopesticides and Pollution Prevention Division

Biochemical Pesticides Branch (BPB)

Chris Pfeifer							Regulatory Action Leader

Linda Hollis							Branch Chief

Colin G. Walsh, M.S.					Biologist

Russell S. Jones, Ph.D.				Senior Biologist  I.	EXECUTIVE SUMMARY:

The new active ingredient Carob Moth Pheromone Mimic, also known as
7,9,11-Dodecatrien-1-ol, formate, (7Z,9E)-, is a technical grade
synthetic arthropod pheromone. This pheromone is structurally similar
to, and mimics, a naturally occurring pheromone produced by the female
carob moth (Ectomyelois ceratoniae) to attract males for mating. Carob
Moth Pheromone Mimic is intended for use in polymeric applications
applied to the bark of date palm trees in crop and non-crop areas to
disrupt the mating cycle of carob moths. Accordingly, EPA is considering
the approval of a registration for Carob Moth Pheromone Mimic under
Section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA).

The Biopesticides and Pollution Prevention Division (BPPD) has reviewed
the data required to support the registration of this biochemical active
ingredient, under Section 3(c)(5) of the Federal Insecticide, Fungicide
and Rodenticide Act (FIFRA). Product chemistry data requirements were
satisfied by acceptable guideline studies. Adequate mammalian toxicology
information was submitted to support registration of Carob Moth
Pheromone Mimic. Acceptable guideline studies were submitted for the
acute toxicity data requirements. Data waivers were granted by the
Agency for the remaining toxicity requirements based on the lack of
toxicity of the active ingredient. Ecological effects data requirements
for this arthropod pheromone were waived because of the use of this
pheromone in retrievable, polymeric applications (40 CFR § 158.2060).

Based on the data available to the Agency, it has been determined that
no unreasonable adverse effects to the U.S. population and the
environment will result from the use of this active ingredient when
label instructions are followed and good agricultural practices are
employed. Laboratory studies indicate that the active ingredient is not
toxic following oral, inhalation, or dermal exposure. Moreover, the
pesticidal usage of this biochemical in retrievable, polymeric
applications will not have any harmful environmental effects

Due to the negligible risk concerns when used as mating disrupter, Carob
Moth Pheromone Mimic meets the criteria as specified in §3(c)(5) of the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended,
and is thus eligible for unconditional registration. It was determined
that the data/information submitted adequately satisfy applicable data
requirements at 40 C.F.R. Subpart U §158.2000.

On October 1, 2009, EPA announced a new policy to provide a more
meaningful opportunity for the public to participate on major
registration decisions before they occur. According to this policy, EPA
provides a public comment period prior to making a registration decision
for the following types of applications: new active ingredients, first
food use, first outdoor use, first residential use; and any registration
decisions for which the Agency believes there may be substantial public
interest.

Consistent with the policy of making registration actions more
transparent, Carob Moth Pheromone Mimic is subject to a 15 day comment
period as a “new biochemical active ingredient.” The notice for this
comment period includes a draft of this Biopesticides Registration
Action Document (BRAD) and the draft product labels for ISCA EC-MP (EPA
File Symbol No. 80286-RO) and SPLAT EC-O (EPA File Symbol No. 80286-RI),
which contain this new active ingredient, Carob Moth Pheromone Mimic.
The docket identification (ID) number is EPA-HQ-OPP-2012-0787.
Altogether, the Agency believes that, based on the risk assessment and
information submitted in support of the registration of the pesticide
products containing Carob Moth Pheromone Mimic, it is in the best
interests of the public to issue the registrations for ISCA EC-MP and
SPLAT EC-O. The basis for this decision can be found in the risk
assessment for Carob Moth Pheromone Mimic, which is characterized in
this BRAD.

II.	ACTIVE INGREDIENT OVERVIEW

Common Name: 			Carob Moth Pheromone Mimic

Chemical Names: 		7,9,11-Dodecatrien-1-ol, formate, (7Z,9E)-

Trade & Other Names:	Carob Moth Pheromone Mimic

CAS Registry Number: 	146321-32-6

OPP Chemical Code: 	128003

Type of Pesticide: 		Mating disrupter for carob moths

Application rates and methods vary depending on the product.  For
specific information regarding the product(s) refer to Appendix B.

  REGULATORY BACKGROUND

On January 13, 2012, ISCA Technologies, Inc., submitted an application
for the registration of an end-use product (EP) SPLAT EC-O (80286-RI),
containing 2% Carob Moth Pheromone Mimic, and a manufacturing-use
product (MP) ISCA EC-MP (80286-RO), containing 90.8% Carob Moth
Pheromone Mimic. A notice of receipt of the application for registration
of Carob Moth Pheromone Mimic as a new active ingredient was published
in the Federal Register on November 7, 2012 (77 FR 216), with a 30-day
comment period. No comments were received following this publication.

A.	Classification

The Biochemical Classification Committee determined that Carob Moth
Pheromone Mimic is a biochemical pesticide because this pheromone has a
non toxic mode of action, and is structurally similar to and mimics a
naturally occurring pheromone produced by the carob moth.

B.	Food Clearances/Tolerances

Arthropod pheromones are exempt from the requirement of a tolerance in
or on raw agricultural commodities when used in retrievable, polymeric
matrix applications, and when the pheromone is applied to growing crops
at a rate not to exceed 150 grams active ingredient per acre per year in
accordance with good agricultural practices (40 CFR §180.1124). In
addition, the Agency has determined that the inert ingredients in the
dollop used in the EP that contain this new active ingredient can be
considered a retrievable polymeric application and can also be
considered under the tolerance exemption for retrievable polymeric
dispensers (40 CFR §180.1122).

IV.		RISK ASSESSMENT

A.	Active Ingredient Characterization

Carob Moth Pheromone Mimic is a synthetic compound that mimics a
naturally occurring pheromone produced by female carob moths. This
compound is a colorless liquid with a slightly fatty, waxy smell.

 The descriptions of the product formulation and production process, as
well as the formation of impurities, were examined by the Agency and
found to meet current standards. A preliminary analysis was conducted to
identify Carob Moth Pheromone Mimic in five batches of the product, and
the results were determined to be acceptable by the Agency. The
analytical method used to determine the content of the active ingredient
is also acceptable. Physical and chemical properties were submitted for
the active ingredient and are adequate.  Refer to Table 1 in Appendix A
for a summary of product chemistry data requirements. Refer to Table 2
in Appendix A for the summary of physical and chemical characteristics
for Carob Moth Pheromone Mimic. All product chemistry data requirements
for registration of Carob Moth Pheromone Mimic have been satisfied.

B.	Human Health Assessment

1.	Toxicology

Adequate mammalian toxicology data/information is available to support
registration of Carob Moth Pheromone Mimic. All toxicology data
requirements for Carob Moth Pheromone Mimic have been satisfied.

Carob Moth Pheromone Mimic is structurally and functionally similar to a
naturally occurring arthropod pheromone with a nontoxic mode of action.
Arthropod pheromones are generally effective at very low rates and are
used in point source applications such as retrievable polymeric
dispensers. The Agency recognizes the low toxicity, negligible expected
exposure, and lack of expected adverse effects on humans and non-target
organisms of arthropod pheromones when used in polymeric dispensers.
Moreover, published subchronic studies on compounds similar in structure
to arthropod pheromones have been submitted indicating these compounds
have no significant human health effects.

The applicant submitted Tier I human health toxicity information for the
active ingredient as a series of Guideline by Guideline rationales (MRID
48857302). The information submitted supports registration and
demonstrates that the new active ingredient, 7,9,11-Dodecatrien-1-ol,
formate, (7Z,9E)- (Carob Moth Pheromone Mimic), is sufficiently similar
to the naturally occurring  straight-chain Lepidopteran pheromone (SCLP)
to be evaluated as its equivalent. Specifically, the applicant showed
equivalency by making structural comparisons to the naturally occurring
carob moth pheromone (an SCLP) by the carbon chain length, terminal bond
positioning, and geometry. In addition, the applicant provided data
demonstrating that the electrophysiological properties and environmental
behavior of this mimic are indistinguishable from the naturally
occurring pheromone.

Tier I acute toxicity data demonstrated that Carob Moth Pheromone Mimic
is a toxicity category III-IV (low toxicity) compound via acute oral,
acute dermal, eye irritation, primary dermal, and acute inhalation
routes of exposure, and that Carob Moth Pheromone Mimic is not an eye or
skin irritant.

Subchronic toxicity, developmental toxicity and mutagenicity data
requirements were all satisfied by information submitted in support of
waiver requests. Data showed structural and functional similarity
between the mimic and the naturally occurring carob moth pheromone,
which is regarded as nontoxic. Information on the compound’s
volatility demonstrated that any subchronic and developmental exposure
scenarios were highly unlikely. And data on scientifically acceptable
surrogates demonstrated that the mimic would not be subchronically or
developmentally toxic, and that it was not mutagenic.

For more information on the human toxicity data submitted, refer to
Table 3 in Appendix A.

2.	Dose Response Assessment

No meaningful toxicological endpoints were identified on Carob Moth
Pheromone Mimic when used as a pesticide; therefore, a dose response
assessment was not required.

3.  Food Quality Protection Act (FQPA) Consideration

a.  Dietary Exposure and Risk Characterization

In accordance with 40 CFR §180.1124, arthropod pheromones are exempt
from the requirement of a tolerance, and thus a dietary assessment is
not required.

Moreover, exposure to Carob Moth Pheromone Mimic is expected to be
minimal due to its use in point source dispensers, from which it is
released in very small quantities. Restricting the use of the Carob Moth
Pheromone Mimic to retrievably sized dollops will significantly limit
the possibility of dietary exposure to the pheromone.

b.  Drinking Water Exposure and Risk Characterization

No significant drinking water exposure or residues are expected to
result from the pesticidal usage of Carob Moth Pheromone Mimic. The
active ingredient is intended for use in retrievable dollops and is not
to be applied directly to water. If used in accordance with EPA-approved
labeling, it is not likely to accumulate in drinking water

As a result, dietary and drinking water exposure to residues of Carob
Moth Pheromone Mimic are expected to be minimal.

4.	Occupational, Residential, School and Day Care Exposure and Risk
Characterization

	a.	Occupational Exposure and Risk Characterization

Carob Moth Pheromone Mimic is a synthetic compound that is structurally
identical to, and mimics, the naturally occurring pheromone of the carob
moth, and acts via a nontoxic mode of action to specific target pests.
Low oral, dermal, and inhalation toxicity have been demonstrated by the
data summarized above. The end-use product will be applied via
polymeric-matrix applications to tree bark. The potential for dermal,
eye, and inhalation exposure to Carob Moth Pheromone Mimic for handlers
is minimal and will be mitigated as long as products are used according
to label directions. The Agency will require labels to include the
appropriate signal word, re-entry interval, and precautionary
statements.

	b.	Residential, School and Day Care Exposure and Risk Characterization

No indoor residential, school, or day care uses are currently approved
for products containing Carob Moth Pheromone Mimic. The Agency has
concluded that the potential for pheromone residues is not a dietary
hazard to the general population, including infants and children. This
decision was based on the following criteria: 1) low acute and
subchronic mammalian toxicity, 2) the known metabolism; and 3) the
history of safe use of similar arthropod pheromones. Also, for food uses
of pheromones, the toxicity and residue data support the conclusion that
an exemption from the requirement of a tolerance is appropriate and
adequate to protect human health, including that of infants and children
(40 CFR §180.1124).

5.	Cumulative Effects

EPA has considered the potential for cumulative effects of Carob Moth
Pheromone Mimic and other substances in relation to a common mechanism
of toxicity. Because of its low toxicity to mammalian systems, the
Agency does not expect any cumulative or incremental effects from
exposure to residues of Carob Moth Pheromone Mimic when applied/used as
directed on the label and in accordance with good agricultural
practices.

6.   Risk Characterization

The Agency considered human exposure to Carob Moth Pheromone Mimic in
light of the relevant safety factors in FQPA and FIFRA. A determination
has been made that no unreasonable adverse effects to the U.S.
population in general, and to infants and children in particular, will
result from the use of Carob Moth Pheromone Mimic when label
instructions are followed.

C.	ENVIRONMENTAL ASSESSMENT

1.	Ecological Hazards

According to 40 CFR §158.2060(a)(2), arthropod pheromones, when applied
at up to a maximum use rate of 150 grams active ingredient/acre/year,
and that are not expected to available to avian species, are not
required to provide non-target organism toxicity data. Carob Moth
Pheromone Mimic is a synthetic arthropod pheromone that is structurally
similar to, and mimics, the pheromone produced by the carob moth. This
compound acts on a select group of insects and has a nontoxic mode of
action. Carob Moth Pheromone Mimic will be used in retrievably sized
polymeric applications at a rate not exceeding 150 grams/acre/year.

Although not required, the applicant did provide Tier I TGAI non-target
organism toxicity information under MRID 48857303. The information is
summarized in Table 4 below.

2.	Environmental Fate and Ground Water Data

Environmental fate data are not required for this active ingredient
because it is an arthropod pheromone applied at a maximum use rate of
150 grams active ingredient/acre/year and is not expected to available
to avian species (40 CFR §158.2060).

3.	Ecological Exposure and Risk Characterization

Carob Moth Pheromone Mimic is a synthetic arthropod pheromone that
structurally and functionally mimics a naturally occurring pheromone
produced by the carob moth. It acts on a select group of insects and has
a nontoxic mode of action. Carob Moth Pheromone Mimic is intended for
use in retrievably sized polymeric dollops, which significantly limits
the possibility of adverse effects on non-target avian, aquatic, or
insect species. As a result, no toxicology or environmental fate and
effects data are necessary for registration.

4.   Endangered Species Assessment

Based on the fact that Carob Moth Pheromone Mimic is not toxic to
non-target organisms and on its use pattern in retrievable dispensers,
EPA has determined it will have "No Effect" on any currently listed
threatened or endangered species or any designated critical habitat.

D.	PRODUCT PERFORMANCE DATA (EFFICACY)

Submission of product performance data (OCSPP Guideline 810.3000) is
listed as a requirement for all pesticide products. Customarily, the
Agency requires efficacy data to be submitted for review only in
connection with the registration of products directly pertaining to the
mitigation of disease bearing human health organisms and certain
designated quarantine pests, e.g., ticks, mosquitoes, fleas,
Mediterranean fruit flies, gypsy moths, Japanese beetles. For a list of
organisms considered by the Agency as “public health pests”, please
refer to Pesticide Registration Notice 2002-1 (  HYPERLINK
"http://www.epa.gov/PR_Notices/pr2002-1.pdf"
http://www.epa.gov/PR_Notices/pr2002-1.pdf ).

V.	RISK MANAGEMENT DECISION

A.	DETERMINATION OF ELIGIBILITY FOR REGISTRATION

Section 3(c)(5) of FIFRA provides for the registration of a new active
ingredient if it is determined that (A) its composition is such as to
warrant the proposed claims for it; (B) its labeling and other materials
required to be submitted comply with the requirements of FIFRA; (C) it
will perform its intended function without unreasonable adverse effects
on the environment; and (D) when used in accordance with widespread and
commonly recognized practice, it will not generally cause unreasonable
adverse effects on the environment.

The four criteria of the Eligibility Determination for Pesticidal Active
Ingredients are satisfied by the science assessments evaluating the
subject registration application for products containing Carob Moth
Pheromone Mimic. Such products are not expected to cause unreasonable
adverse effects on the environment, and are likely to provide protection
as claimed when used according to label instructions. Therefore, Carob
Moth Pheromone Mimic is eligible for registration for the labeled uses.

B. REGULATORY DECISION

The data submitted fulfill the registration requirements of Carob Moth
Pheromone Mimic when used as an arthropod pheromone. Refer to Appendix B
for product-specific information.

	Conditional/Unconditional Registration

All data requirements are fulfilled, and EPA has determined that an
unconditional registration of Carob Moth Pheromone Mimic is appropriate.

C. ENVIRONMENTAL JUSTICE

EPA seeks to achieve environmental justice, the fair treatment and
meaningful involvement of all people, regardless of race, color,
national origin, or income, in the development, implementation, and
enforcement of environmental laws, regulations, and policies. To help
address potential environmental justice issues, the Agency seeks
information on any groups or segments of the population who, as a result
of their location, cultural practices, or other factors, may have
atypical, unusually high exposure to Carob Moth Pheromone Mimic,
compared to the general population. Please comment if you are aware of
any sub-populations that may have atypical, unusually high exposure
compared to the general population.

VI.   ACTIONS REQUIRED BY REGISTRANTS

The Agency evaluated all of the data submitted in connection with the
initial registration of Carob Moth Pheromone Mimic and determined that
these data are sufficient to satisfy current registration data
requirements. No additional data are required to be submitted to the
Agency at this time.  For new uses and/or changes to existing uses,
additional data may be required.

Not withstanding the information stated in the previous paragraph, it
should be clearly understood that certain, specific, data are required
to be reported to the Agency as a requirement for maintaining the
Federal registration for a pesticide product. A brief summary of these
types of data are listed below.

A.  Reporting of Adverse Effects

Reports of all incidents of adverse effects to the environment must be
submitted to the Agency under the provisions stated in FIFRA, Section
6(a)(2).

B.	Reporting of Hypersensitivity Incidents

Additionally, all incidents of hypersensitivity (including both
suspected and confirmed incidents) must be reported to the Agency under
the provisions of 40 CFR Part 158.2050(d).

VII. APPENDIX A. DATA REQUIRMENTS (40 CFR Part 158-Subpart U)

*NOTE: MRIDs listed in the following tables provide supporting data for
the original registration of the product containing this active
ingredient. Subsequent to this registration, there may be additional
MRIDs that support registration of other products containing this active
ingredient.

TABLE 1.  Product Chemistry Data Requirements for Carob Moth Pheromone
Mimic (40 CFR § 158.2030)

OCSPP Guideline Reference No./Study

Description of Result

MRID

880.1100	Product identity and composition	The product identity and
composition were adequately addressed.	48857301

880.1200	Description of starting materials, production, and formulation
process	The description of the starting materials, production, and
formulation process were adequately addressed.	48857301

880.1400	Discussion of formation of impurities	The discussion of
formation of impurities was adequately addressed.	48857301

830.1700	Preliminary analysis	The preliminary analysis of the product
was acceptable.	48857301

830.1750	Certified limits	The certified limits listed on the CSF are
acceptable.	48857301

830.1800	Enforcement analytical method	The enforcement analytical method
was adequately addressed.	48857301

TABLE 2.  Physical and Chemical Properties for Carob Moth Pheromone
Mimic a (40 CFR § 158.2030)

Guideline Reference No./Property

Description of Result

Methods

830.6302	Color	Colorless	Visual inspection at room temperature

830.6303	Physical State	Liquid	Visual inspection at room temperature

830.6304	Odor	Waxy, fatty	Olfactory inspection at room temperature

830.6313	Stability to normal and elevated temperatures, metals and metal
ions	No decomposition detected when heated to 90°C for 48 hrs.
Incompatible with metal hydrides. Stored in glass containers, will not
come in contact with metal.

830.6315	Flammability	Flash point = 139.2 ± 12.7°C

Flame extension = 282.0 ± 54°Fb	Calculated using Advanced Chemistry
Development software v9.04 and the Scifinder Schoolar.

830.6317	Storage Stability	Ongoing

830.6319	Miscibility	Not miscible in water. Miscible in mineral oil,
hexane, toluene, acetone, and methyl alcohol.	Evaluated visually by
adding 2 mL of solvent to 50 mg of product in test tube, agitating, and
letting stand for 30 minute at 15°C.

830.6320	Corrosion Characteristics	Ongoing

830.7000	pH	Not applicable, the product is not soluble in water.

830.7050       UV/Visible light absorption	solvent	     λmax (nm)
Absorbance  SEQ CHAPTER \h \r 1

Ethanol		231	0.755	Analysis carried out on Agilent 8453 UV-Visible
spectrophotometer.

830.7100	Viscosity	0.00543 Pa/sec at 15°C

0.00356 Pa/sec at 30.1°C

0.00236 Pa/sec at 50.1°C	Controlled stress rheometer

830.7200	Melting Range	22 - 26°C	Calculated using Advanced Chemistry
Development software v9.04 and the Scifinder Schoolar.

830.7220	Boiling Range	305.8 ± 21.0°C	Calculated using Advanced
Chemistry Development software v9.04 and the Scifinder Schoolar.

830.7300	Density/Relative Density/Bulk Density	0.909 ±0.06 g/cm3 at
20°C	Calculated using Advanced Chemistry Development software v9.04 and
the Scifinder Schoolar.

830.7520	Particle size, fiber length, and diameter distribution	N/A, is
a liquid.

830.7550	Partition Coefficient	Log P 4.244 + 0.297 at 25 oC	Guideline
acceptable datum

830.7840	Water Solubility	Not soluble in water

830.7950	Vapor Pressure	8.05 x 10-4 Torr at 25°C	Calculated using
Advanced Chemistry Development software v9.04 and the Scifinder Scholar.

aData from MRID 48857301

bData from CSF

Table 3: Mammalian Toxicology Data Requirements for Carob Moth Pheromone
Mimic (40 CFR § 158.2050)

Study/OCSPP Guideline No.	Results	Toxicity Category/Description	MRID

Acute oral toxicity (rat)

(870.1100)	Submitted information is sufficient to satisfy the data
requirement. Active ingredient is volatile and similar formates of about
10 carbon chain lengths (a.i. has 13) and one or more double bonds, such
as Geranyl formate (LD50 >6000 mg/kg) and Citronellyl formate (8400
mg/kg), are very low in acute oral toxicity. ACCEPTABLE.	Toxicity
Category III-IVa	48857302

Acute dermal toxicity (rat)

(870.1200)	Submitted information is sufficient to satisfy the data
requirement. Active ingredient is volatile and similar formates of about
10 carbon chain lengths (a.i. has 13) and one or more double bonds, such
as Geranyl formate (LD50 >6000 mg/kg) and Citronellyl formate (8400
mg/kg), are very low in acute oral toxicity. ACCEPTABLE.	Toxicity
Category III-IVa	48857302

Acute inhalation toxicity	 (rat)

(870.1300)	Submitted information is sufficient to satisfy the data
requirement. The Agency notes that the active ingredient is a volatile
substance, applied at extremely low rates (no more than 20 g
a.i./acre/application), that would be unlikely to result in acute
inhalation exposure. Also information provided on structurally
equivalent compounds demonstrated Threshold Limit Values (TLVs) far in
excess of where toxic effects can be observed. ACCEPTABLE.	Toxicity
Category III-IVa	48857302

Primary eye irritation (rabbit)

(870.2400)	Submitted information is sufficient to satisfy the data
requirement. Information on a surrogate demonstrated negligible eye
irritation. ACCEPTABLE.	Toxicity Category III-IVa	48857302

Primary dermal irritation (rabbit)

(870.2500)	Submitted information is sufficient to satisfy the data
requirement. Active ingredient is volatile and similar formates of about
10 carbon chain lengths (a.i. has 13) and one or more double bonds, such
as Geranyl formate (LD50 >6000 mg/kg) and Citronellyl formate (8400
mg/kg), are very low in acute oral toxicity. ACCEPTABLE.	Toxicity
Category III-IVa 	48857302

Dermal sensitization  (guinea pig)

(870.2600)	Submitted information is sufficient to satisfy the data
requirement. Information on a surrogate demonstrated negligible dermal
sensitivity. ACCEPTABLE.	Not a sensitizer	48857302

90-Day oral toxicity

(870.3100)	Submitted information is sufficient to satisfy the data
requirement. The active ingredient is a volatile substance with little
likelihood of oral exposure on either an acute or subchronic basis.
Naturally-occurring formates are ubiquitous in the environment, and
humans and the environment are regularly exposed to these formates.
Humans are also exposed to formates on a regular basis via their use as
cosmetics, fragrances, and food additives. Application rates are very
low relative to the likely ambient level of naturally-occurring formates
already present in the atmosphere. ACCEPTABLE.	Information submitted to
support waiver	48857302

90-Day dermal toxicity

(870.3250)	Submitted information is sufficient to satisfy the data
requirement. The active ingredient is a volatile substance with little
likelihood of dermal exposure on either an acute or subchronic basis.
Naturally-occurring formates are ubiquitous in the environment, and
humans and the environment are regularly exposed to these formates.
Humans are also exposed to formates on a regular basis via their use as
cosmetics, fragrances, and food additives. Application rates are very
low relative to the likely ambient level of naturally-occurring formates
already present in the atmosphere. ACCEPTABLE.	Information submitted to
support waiver	48857302

90-Day inhalation toxicity

(870.3465)	Submitted information is sufficient to satisfy the data
requirement. Information from the public literature demonstrates
negligible toxicity and minimal exposure. ACCEPTABLE.	Information
submitted to support waiver	48857302

Developmental toxicity

 (870.3700)	Submitted information is sufficient to satisfy the data
requirement. Information from the public literature on a surrogate
compound demonstrates that there is no developmental toxicity associated
with exposures to this compound. ACCEPTABLE.	Information submitted to
support waiver	48857302

Mutagenicity

(870.5100, 5300 and 5375)	Submitted information is sufficient to satisfy
the data requirements. Information from the public literature on a
surrogate compound demonstrates that there is no mutagenicity associated
with exposures to this compound. ACCEPTABLE.	Information submitted to
support waiver	48857302

aBased on historical mammalian toxicity data for arthropod pheromones,
the toxicity categories for the TGAI/MP are: 1) acute oral toxicity –
category III-IV, 2) acute dermal toxicity – category III-IV, and 3)
minimal skin irritation.

Table 4: Nontarget Organism Toxicity Data Requirements for Carob Moth
Pheromone Mimic (40 CFR § 158.2060)

Study/OCSPP Guideline No.	Results	MRID

Avian acute oral toxicity

(850.2100)	The a.i. is substantially-similar to an arthropod pheromone,
volatile (3.2 x 10-6 atm m3/mol), and is applied at a maximum
application rate of less than 150 g a.i./acre/year. EP testing (2% a.i.)
indicated that the LD50 > 2,000 mg/kg (practically nontoxic). Submitted
information is sufficient to satisfy the data requirement. ACCEPTABLE.
48857303

Avian dietary toxicity

(850.2200)	The a.i. is substantially-similar to an arthropod pheromone,
volatile (3.2 x 10-6 atm m3/mol), and is applied at a maximum
application rate of less than 150 g a.i./acre/year.

EP testing (2% a.i.) indicated that the LD50 > 5,000 ppm (practically
nontoxic). Submitted information is sufficient to satisfy the data
requirement. ACCEPTABLE.	48857303

Fish acute toxicity, freshwater

(850.1075)	The a.i. is substantially-similar to an arthropod pheromone,
volatile (3.2 x 10-6 atm m3/mol), and is applied at a maximum
application rate of less than 150 g a.i./acre/year.

Submitted information is sufficient to satisfy the data requirement.
ACCEPTABLE.	48857303

Aquatic invertebrate acute toxicity, freshwater

(850.1010)	The a.i. is substantially-similar to an arthropod pheromone,
volatile (3.2 x 10-6 atm m3/mol), and is applied at a maximum
application rate of less than 150 g a.i./acre/year.

Submitted information is sufficient to satisfy the data requirement.
ACCEPTABLE.	48857303

Nontarget plant testing

(850.4100 and 850.4150)	The a.i. is substantially-similar to an
arthropod pheromone, volatile (3.2 x 10-6 atm m3/mol), and is applied at
a maximum application rate of less than 150 g a.i./acre/year.

Submitted information is sufficient to satisfy the data requirement.
ACCEPTABLE.	48857303

Nontarget insect testing

(880.4350)	The a.i. is substantially-similar to an arthropod pheromone,
volatile (3.2 x 10-6 atm m3/mol), and is applied at a maximum
application rate of less than 150 g a.i./acre/year.

Submitted information is sufficient to satisfy the data requirement.
ACCEPTABLE.	48857303

VIII. APPENDIX B.

For product specific information, please refer to   HYPERLINK
"http://oaspub.epa.gov/pestlabl/ppls.home"
http://oaspub.epa.gov/pestlabl/ppls.home .

IX.	APPENDIX C.  REFERENCES

EPA. 2012. Memorandum from Colin G. Walsh to Chris Pfeifer. Science
Review in Support of the Registration of SPLAT EC-O, Containing 2.0% of
7,9,11-Dodecatrien-1-ol, formate, (7Z,9E)- As Its Active Ingredient
(A.I.).  U.S. Environmental Protection Agency Office of Pesticide
Programs. December 10, 2012.

EPA. 2012. Memorandum from Colin G. Walsh to J. Chris Pfeifer. Science
Review in Support of the Registration of ISCA MP-O), Containing 90.8% of
7,9,11-Dodecatrien-1-ol, formate, (7Z,9E)- As Its Active Ingredient
(A.I.).  U.S. Environmental Protection Agency Office of Pesticide
Programs. December 10, 2012.

EPA. 2012. Memorandum from Russell S. Jones to J. Chris Pfeifer. Science
Review in Support of the Registration of SPLAT EC MP, Containing 90.8%
of 7,9,11-Dodecatrien-1-ol, formate, (7Z,9E)- As Its Active Ingredient .
Response to Deficiencies.  U.S. Environmental Protection Agency Office
of Pesticide Programs. April 4, 2013.

EPA. 2012. Memorandum from Russell S. Jones to J. Chris Pfeifer. Science
Review in Support of the Registration of SPLAT EC-O, Containing 2.0% of
7,9,11-Dodecatrien-1-ol, formate, (7Z,9E)- As Its Active Ingredient .
Response to Deficiencies.  U.S. Environmental Protection Agency Office
of Pesticide Programs. April 8, 2013.

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