BIOPESTICIDES REGISTRATION ACTION DOCUMENT



# (Z,Z)

- 7,11

- Hexadecadienal

PC Code : 000712

U.S. Environmental Protection Agency Office of Pesticide Programs Biopesticides and Pollution Prevention Division

October 17 , 201 3(Z,Z)

- 7,11

- Hexadecadienal Page 2 of 16 Biopesticides Registration Action Document

TABLE OF CONTENTS

I. EXECUTIVE SUMMARY:

................................ ................................ ................................ 5

II. ACTIVE INGREDIENT OV ERVIEW

................................ ................................ .............. 7

II I. REGULATORY BACKGROUN D

................................ ................................ ...................... 7

A. Classification

................................ ................................ ................................ ........................ 7

B. Food Clearances/Tolerances

................................ ................................ ............................... 7

IV. RISK ASSESSMENT

................................ ................................ ................................ ......... 8

A. Active Ingredient Characterization

................................ ................................ .................... 8

B. Human Health Assessment

................................ ................................ ................................ .. 8

1. Toxicology

................................ ................................ ................................ ................................ ...................... 8
2. Dose Response Ass essment

................................ ................................ ................................ ........................... 8
3. Food Quality Protection Act (FQPA) Considerations

................................ ................................ ................ 9
4. Occupational, Residential, School and Day Care Exposure and Risk Characterization

........................ 9
5. Cumulative Effects

................................ ................................ ................................ ................................ ........ 9
6. Risk Characterization

................................ ................................ ................................ ................................ ... 9

C. Environmental Assessment

................................ ................................ ................................ . 9

1. Ecological Hazards

................................ ................................ ................................ ................................ ........ 9
2. Environme ntal Fate and Ground Water Data

................................ ................................ .......................... 10
3. Ecological Exposure and Risk Characterization

................................ ................................ ...................... 10
4. Endangered Species Assessment

................................ ................................ ................................ ................ 10

D. Efficacy Data

................................ ................................ ................................ ..................... 10

V. RISK MANAGEMENT DECI SION

................................ ................................ ................ 11

A. Determination of Eligibility for Registration

................................ ................................ .. 11

B. Regulatory Decision

................................ ................................ ................................ ........... 11

C. Environmental Justice

................................ ................................ ................................ ....... 12

VI. ACTIONS REQUIRED BY REGISTRANTS

................................ ................................ . 12

A. R eporting of Adverse Effects

................................ ................................ ............................ 12

B. Reporting of Hypersensitivity Incidents

................................ ................................ .......... 12

VII. APPENDIX A. DATA REQ UIREMENTS (40 CFR PA RT 158

- SUBPART U)

.......... 12(Z,Z)

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- Hexadecadienal Page 3 of 16 Biopesticides Registration Action Document

VIII. APPENDIX B.

................................ ................................ ................................ ................... 14

IX. APPENDIX C.

................................ ................................ ................................ ................... 15

X. GLOS SARY OF ACRONYMS AND ABBREVIATIONS

................................ ........... 15(Z,Z)

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- Hexadecadienal Page 4 of 16 Biopesticides Registration Action Document



### BIOPESTICIDES REGISTRATION ACTION DOCUMENT (BRAD) TEAM



## Branch Chief Linda A. Hollis, M.S.

Product Chemistry/ Human Health Effects/Nontarget Organisms Clara Fuentes, Ph.D., Entomologist

Regulatory Action Leader Colin G. Walsh, M.S., Biologist(Z,Z)

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- Hexadecadienal Page 5 of 16 Biopesticides Registration Action Document

I. EXECUTIVE SUMMARY:

(Z,Z)

- 7,11

- Hexadecadienal is a new technical grade synthetic Straight

- Chain Lepidopteran Pheromone (SCLP) biochemical pesticide active ingredient

. Th is synthetic SCLP pheromone is structurally similar to , and mimics , a naturally occurring pheromone produced by the female citrus leafminer, Phyllocnistis citrella Stai nton , to attract males for mating. Th is synthetic technical grade active ingredient (TGAI), (Z,Z)

- 7,11

- Hexadecadienal

, is intended to mitigate the
effects of the citrus leafminer by disrupting the normal mating cycle of this pest in citrus crops

. Currently , there is no proposed end

- use product associated with this SCLP active ingredient; however, the intended use of the TGAI is for use in the formulation of end

- use products either solely or in combination with insecticidal active ingredients.

SCLPs have be en well characterized by the Agency since 1994 when the Agency issued a final rule establishing an exemption from the requirement of a tolerance for residues from the use of lepidopteran pheromones that are naturally occurring compounds, or identical or su bstantially similar synthetic compounds ( 40 CFR 180.1153 )

. In addition, EPA’s regulations at 40 CFR 158.2050(a)(2) and 158.2060(a)(2) exempt SCLP manufacturing

- use products from human health and environmental toxicology data requirements. These data were waived based on the criteria presented in the OECD publication

- Guidance for Registration Requirements for Pheromones and Other Semiochemicals Used for Pest Control ( OCED, 2002; http://www.epa.gov/pesticides/biopesticides/regtools/index.htm )

. No risks to human health are expected from the use of lepidopteran pheromones based on demonstrated low toxicity in animal testing and expected low exposure to humans. Further more, adverse effects to non

- target organisms are not expected because pheromones are released in very small quantities in the environment and act on a select group of insects. Thus, given that these compounds present both low hazard and low exposure, the Agency has determined that, when used as directed, they present low risk to both humans and non

- target organisms.

This Biopesticides Registration Action Document (BRAD) serves as an additional chapter to be added to the original SCLP BRAD issued by the Agency in 2001 (SCLP BRAD update in 2008) ( http://www.epa.gov/pesticides/chem_search/reg_actions/registration/decision_G

- 109_02

- Oct

08.pdf ) . This chapter is specific to (Z,Z)

- 7,11

- Hexadecadienal

, a synthetic SCLP of the female
citrus leafminer

, Phyllocnistis citrella Stainton

. Product chemistry data requireme nts for the manufacturing

- use product (MP)

, A.S. (Z,Z)

- 7,11

- Hexadeca d ienal

, were satisfied by acceptable guideline studies. Data waiver rationale submitted to address human health and environmental toxicology data requi rements for the MP is acceptable.

BPPD has reviewed the data and information in support of the requirements f or granting registration under Section 3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). BPPD has determined that the data and information submitted adequately satisfy

current data requirements (please refer to 40 CFR Subpart U § 1 58.2000)

.

On October 1, 2009, EPA announced a new policy to provide a more meaningful opportunity for the public to participate on major registrati on decisions before they occur. According to this policy, EPA provide s a public comment period prior to mak ing a registration decision for the following types of applications: new active ingredients, first food use, first outdoor use, first(Z,Z)

- 7,11

- Hexadecadienal Page 6 of 16 Biopesticides Registration Action Document

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, (Z,Z)

- 7,11

- Hexadecadienal is subject to a 15

- day comment period as a “new active ingredient

. ” EPA established a comment period of 15 days on the basis of (Z,Z)

- 7,11

- Hexadecadienal ’s minimal toxicity, the determination that (Z,Z)

- 7,11

- Hexadecadienal presents low risk of any adverse effects to human health and the environment, and critical need for this active ingredient. The notice for this comment period include d the draft BRAD and the draft product label for the M P, A.S. (Z,Z)

- 7,11

- Hexadeca d ienal , which contain s this new active ingredient, (Z,Z)

- 7,11

- Hexadecadienal

. The docket identification ( ID ) number is EPA

- HQ

- OPP

- 2013

- 0257

. The Agency did not receive any comments on the registration of (Z,Z)

- 7,11

- Hexadecadienal during
this 15

- day comment period. The Agency believes that based on the risk assessment and information submitted in support of the registration of the MP containing (Z,Z)

- 7,11

- Hexadecadienal , it is in the best interests of the public to issue the registration for A.S. (Z,Z)

- 7,11

- Hexadeca d ienal

. The basis for this decision can be found in the risk assessment for (Z,Z)

- 7,11

- Hexadecadienal , which is characterized in this BRAD.(Z,Z)

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- Hexadecadienal Page 7 of 16 Biopesticides Registration Action Document

II. ACTIVE INGREDIENT OVERVIEW

Common Name: Z7Z11

- 16Ald

Chemical Names: (Z,Z)

- 7,11

- Hexadecadienal ; 7

- Z,11

- Hexadecadienal

Trade & Other Names: A.S. (Z,Z)

- 7,11

- Hexadeca d ienal

CAS Registry Number: 96883

- 53

- 3

OPP Chemical Code: 000712

Type of Pesticide: Straight

- Chain Lepidopteran Pheromone ( SCLP )

III. REGULATORY BACKGROUND

On February 1 , 20 13 , EPA received an application filed by Technology Sciences Group, Inc. (TSG)

, 1150 18 th Street, NW, Suite 1000, Washington, DC 20036

, on behalf of Alpha Scents, Inc., 1089 Willamette Falls Drive

, West Linn, OR 97068

, to register the product

, A.S. (Z,Z)

- 7,11

- Hexadeca d ienal (EPA File Symbol No. 85354

- E) co ntaining the new SCLP active ingredient, (Z,Z)

- 7,11

- Hexadeca d ienal . A notice of receipt (NOR) of this application, allowing
for a 30

- day comment period, was published in the Federal Register o n May 29 , 20 1 3 ( 78 FR
32246 )

. No comments were received following this publication

.

A. Classification

(Z,Z)

- 7,11

- Hexadeca d ienal is a synthetic Straight

- C hain Lepidoptera n Pheromone (SCLP) and is
classified as a biochemical pesticide.

B. F ood Clearances/Tolerances

SCLPs are exempt from the requirement of a tolerance in or on all raw agricultural commodities when applied to growing crops at a rate not to exceed 150 grams of active ingredient/acre/year
and in accordance with good agricultural use practices, and in indoor post

- harvest treatment in or
on all stored food commodities when a pplied/used at a rate not to exceed 3.5 grams active ingredient (AI)/1,000 square feet/year (equivalent of 150 grams AI/acre/year), in accordance with good agricultural use practices (40 CFR 180.1153). Pheromones are ubiquitous in the environment, and are not considered to be air pollutants. During the season when moths and/or butterflies appear, they normally emit pheromones and humans are naturally exposed to these pheromone s without knowledge and without any adverse reactions.(Z,Z)

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- Hexadecadienal Page 8 of 16 Biopesticides Registration Action Document

IV. RISK ASSESSMENT

A. Active Ingredient Characterization

(Z,Z)

- 7,11

- Hexadeca d ienal is a technical grade synthetic SCLP. This pheromone is structurally similar to, and mimic s , a naturally occurring pheromone produced by the female citrus leafminer, Phyllocnistis citrella Stainton, to attract males for mating. EPA reviewed the applicant’s data on the product formulation, production and packaging and determined that they all met current Agency standards. Acceptable results were provided regarding the preliminary an alysis of five batches of the product. All required physical and chemical characteristics were adequately presented.

All product chemistry data requirements for registration of (Z,Z)

- 7,11

- Hexadeca d ienal have been
satisfied.

For more information regard ing product chemistry data requirements, refer to Tables 1 and 2 in Appendix A

.

B. Human Health Assessment

1. Toxicology

Toxicology data for this TGAI/MP are not required for a SCLP as indicated in 40 CFR 158.2050(a)(2). Currently, there is no proposed end

- use product associated with this SCLP active ingredient; however, the intended use of the TGAI is for use in the formulation of end

- use products either solely or in combination with insecticidal active ingredients. Any proposed end

use product must have an application rate not to exceed 150 grams active ingredient/acre/year as indicated in the SCLP exempt ion from the requirement of a tolerance (40 CFR 180.1153)

.

For acute toxicity data requirements, toxicity categories are assigned based on t he hazard(s) identified from studies and/or information on file with the Agency. The active ingredient is
classified into Toxicity Category I, II, III or IV where Toxicity Category I indicates the highest toxicity and Toxicity Category IV indicates the low est toxicity

. Based on historical mammalian toxicity data for arthropod pheromones, the toxicity categories for the MP are: 1) acute oral toxicity

– category IV, 2) acute dermal toxicity

– category III

- IV, 3) acute inhalation toxicity

– category III

- IV, 4) minimal eye irritation, and 5) minimal skin irritation.

Adequate information and scientific rationales to address all toxicity requirements for this product w ere submitted b y the applicant. All toxicology data requirements for (Z,Z)

- 7,11

- Hexadeca d ienal h ave been satisfied.

2. Dose Response Assessment

Because n o toxicolog ical endpoints were identified for this active ingredient

, a dose

- respon se assessment was not required.(Z,Z)

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- Hexadecadienal Page 9 of 16 Biopesticides Registration Action Document

3. Food Quality Protection Act (FQPA) Considerations

a. Dietary Exposure and Risk Characterization

Risk characterizations are not applicable for this TGAI/MP and are not required as indicated in 40 CFR 158.2050(a)(2). Future risk characterization for EPs containing this active ingredient, (Z,Z)

- 7,11

- Hexadeca d ienal , will follow the reduced toxicology data requirements as indicated in
40 CFR 158.2050.

b

. Drinking Water Exposure and Risk Characterization

Risk characterizations are not applicable for this TGAI/MP and are not required as indicated in
40 CFR 1 58.2050(a)(2). Risk characterization will depend on the information associated with the applications of EPs containing (Z,Z)

- 7,11

- Hexadeca d ienal

.

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

a. Occupational Exposure and Risk Characterization

Risk characterizations are not applicable for this TGAI/MP and are not required as indicated in 40 CFR 158.2050(a)(2). Risk characterization will depend on the information associated with the applications of EPs containing (Z,Z)

- 7,11

- Hexadeca d ienal

.

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

Risk characterizations are not applicable for this TGAI/MP and are not required as indicated in 40 CFR 158.2050(a)(2). Risk characterization will depend on the information associated with the applications of EPs containing (Z,Z)

- 7,11

- Hexadeca d ienal

.

5

. Cumulative Effects

Cumulative effects determinations are not applicable for this TGAI/MP and are not required as indicated in 40 CFR 158.2050(a)(2).

6

. Risk Characterization

Risk characterizations are not applicable for this TGAI/MP and are not required as indicated in 40 CFR 158.2050(a)( 2). Risk characterization will depend on the information associated with the applications of EPs containing (Z,Z)

- 7,11

- Hexadeca d ienal

.

C. E nvironmental Assessment

1. Ecological Hazards

Ecological toxicology data for this TGAI/MP are not required for a SCLP as indicated in 40 CFR 158.2060(a)(2). Accor ding to 40 CFR 158.2060(a) (2), SCLPs applied up to a maximum use rate(Z,Z)

- 7,11

- Hexadecadienal Page 10 of 16 Biopesticides Registration Action Document

of 150 gr ams active ingredient/acre/year, and that are not expected to be available to avian species , are not required to address non

- tar get toxicity data requirements. (Z,Z)

- 7,11

- Hexadeca d ienal is a synthetic pheromone subject to 180.2060(a)(2), which acts on a select group
of insects and has a non

- toxic mode of action. Future environmental assessments will be based
on information submitte d in conjunction with applications for EPs that contain (Z,Z)

- 7,11

- Hexadeca d ienal . The ecological data requirements can be found in 40 CFR 180.2060.

2. Environmental Fate and Ground Water Data

E nvironmental fate data are not required for this TGAI/MP and are not required for a SCLP as indicated in 40 CFR 158.2060(a)(2).

3. Ecological Exposure and Risk Characterization

Not applicable. The required Environmental Hazard statement for MPs is considered to be sufficient to mitigate any exposure relative to this manufacturing use.

4. Endangered Species Assessment

The Agency has not conducted a risk assessment that supports a complete endangered species determination. The ecological risk assessment planned during registration review will allow the Agency to determine whether the uses of (Z,Z)

- 7,11

- Hexadeca d ienal have “no effect” or “may effect” federally listed threatened or endangered species (listed species) or their designated
critical habitats. (Z,Z)

- 7,11

- Hexadeca d ienal is a synthetic SCLP and is stru cturally similar to,
and mimics

, a naturally occurring pheromone produced by the female citrus leafminer, Phyllocnistis citrella Stainton, to attract males for mating. It is not known to be toxic to any insect species or other non

- target organisms. Based o n this information, it is unlikely that (Z,Z)

- 7,11

- Hexadeca d ienal will affect listed species

.

Should an assessment conclude that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the Services), as appropriate.

D. Efficacy Data

Product performance data must be developed for all pesticides to ensure that pesticide products will perform as intended and that unnecessary pesticide exposure to the environment will not occur as a result of the use of ineffective products. The Agency reserves the right to require on a

case

- by

- case basis, submission of efficacy data for any pesticide product registered or proposed for registration that are intended to be used to control a pest of significance public health importance and a public health pest as defined in FIFRA section 28(d) and section 2(nn). For further guidance on product performance requirement, refer to Pestici de Registration Notice (PR)
Notices 96

- 7, 2002

- 1 and Explanation of Statutory Framework for Risk

- Benefit Balancing for
Public Health Pesticides ( http://www.epa.gov/PR _Notices/pr1996

- 7.pdf ) ( http://www.ea.gov/PR_Notices/pr2002

- 1.pdf ) and ( http://www.epa.gov/pesticides/health/risk

benefit.htm ).(Z,Z)

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- Hexadecadienal Page 11 of 16 Biopesticides Registration Action Document

The MP that contains this new ac tive ingredient

, (Z,Z)

- 7,11

- Hexadeca d ienal , is intended to be
used to formulate end

- use products and cannot itself be used to directly treat any pests; therefore, product performance (efficacy) was not evaluated.

V. R ISK 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 warrant s proposed claims; (B) its labeling and other materials comply with the r equirements 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
effe cts on the environment.

The four criteria of the Eligibility Determination for Pesticidal Active Ingredients are satisfied by
the science assessments supporting the MP containing this active ingredient

, (Z,Z)

- 7,11

- Hexadeca d ienal

. The product is not expected to cau se unreasonable adverse effects

. Therefore, (Z,Z)

- 7,11

- Hexadeca d ienal as a technical grade active ingredient is eligible for registration for
the labeled uses.

B. Regulatory Decision

The data submitted fulfill the registration requirements of (Z,Z)

- 7,11

- Hexadeca d ienal for use as synthetic SCLP pheromone that is structurally similar to , and mimics, a naturally occurring pheromone produced by the female citrus leafminer, Phyllocnistis citrella Stainton, to attract
males for matin g. Refer to Appendix B for product

- specific information.

Conditional/Unconditional Registration

All data requirements are fulfilled, and EPA determined that an unconditional registration of (Z,Z)

- 7,11

- Hexadeca d ienal is appropriate.

Consistent with the policy of making registration actions more transparent, (Z,Z)

- 7,11

- Hexadeca d ienal is subject to a 15

- day comment period as a “new active ingredient.” EPA has established a comment period of 15 days on the basis of (Z,Z)

- 7,11

- Hexadeca d ie nal ’s minimal toxicity, the determination that (Z,Z)

- 7,11

- Hexadeca d ienal presents low risk of any adverse effects to human health and the environment, and critical need for this active ingredient. The notice for this comment period include d the draft BRAD and draft product label for the MP, A.S. (Z,Z)

- 7,11

- Hexadeca d ienal

, which contain s this new active ingredient (Z,Z)

- 7,11

- Hexadeca d ienal . The docket identification (ID) number is EPA

- HQ

- OPP

- 2013

- 0257

. The Agency did not receive any comments on the registrat ion of (Z,Z)

- 7,11

- Hexadeca d ienal during
this 15

- day comment period. The Agency believes that based on the risk assessment and information submitted in support of the registration of the MP containing (Z,Z)

- 7,11

-(Z,Z)

- 7,11

- Hexadecadienal Page 12 of 16 Biopesticides Registration Action Document

Hexadeca d ienal , it is in the best interests o f the public to issue the registration for A.S. (Z,Z)

- 7,11

- Hexadeca d ienal . The basis for this decision can be found in the risk assessment for (Z,Z)

- 7,11

- Hexadeca d ienal , which is characterized in this BRAD.

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

— with respect to the development, implementation, and enforcement of environmental laws, regulations, and policie s. At this time

, EPA does not believe that use of the (Z,Z)

- 7,11

- Hexadeca d ienal pesticide product will cause harm or a disproportionate impact on at

- risk communities. For additional information regarding environmental justice issues, please visit EPA’s web site at http://www.epa.gov/compliance/environmentaljustice/index.html

.

V I

. ACTIONS REQUIRED BY REGISTRANTS

EPA evaluated all data submitted in connection with the registration of the (Z,Z)

- 7,11

- Hexadeca d ienal pesticide product and determined that these data are sufficient to satisfy current registration data requirements. At this time, n o additional data must be submi tted to EPA for th is particular product. For new uses and/or changes to existing uses, EPA may require additional
data.

Notwithstanding the information stated in the previous paragraph, it should be clearly understood that certain specific data are required to be reported to EPA as a requirement f or maintaining the Federal registration for a pesticide product. A brief summary of these types of data are listed
below.

A. R eporting of Adverse Effects

Pursuant to FIFRA section 6(a)(2), r eports of all incidents of adverse effects to the environment
must be submitted to EPA

.

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).

VI I

. A PPENDIX A. DATA REQUIREMENTS (40 CFR P ART 158

- S UBPART U)

*NOTE: Master Record Identification (MRID) numbers listed in the following tables are representative of supporting data/information 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.(Z,Z)

- 7,11

- Hexadecadienal Page 13 of 16 Biopesticides Registration Action Document

TABLE 1

. Product Chemistry Data Requirements for A.S. (Z,Z)

- 7,11

- Hexadecadienal ( 40 CFR § 158.2030 )

OCSPP Guideline Reference No./ Study Description of Result MRID

8 8 0. 1100 Product identity and composition The product identity and composition were adequately addressed. Confidential Business Information (CBI). 49015701

8 8 0. 1200 Description of starting materials, production, and formulation

process The description of the starting materials, production, and formulation process were adequately addressed. CBI. 49015701

8 8 0. 1400 Discussion of formation of impurities The discussion of formation of impurities was adequately addressed. CBI. 49015701
49173801

8 3 0. 1700 Preliminary analysis The preliminary analysis of the product was acceptable. CBI. 49015701

8 3 0. 1750 Certified limits The certified limits listed on the Confidential Statement of Formula ( CSF ) are acceptable. 49015701

8 3 0. 1800 Enforcement analytical method The enforcement analytical method was adequately addressed. CBI. 49015701(Z,Z)

- 7,11

- Hexadecadienal Page 14 of 16 Biopesticides Registration Action Document

TABLE 2 . Physical and Chemical Properties for A.S. (Z,Z)

- 7,11

- Hexadecadienal a

Guideline Reference No./Property Description of Result MRID

830.6302 Color Clear 49015702

830.6303 Physical State Liquid 49015702

830.6304 Odor Waxy 49015702

830.6313 Stability N/A, not intended to come into
contact with metals or metal ions

. 1 49015702

830.6315 Flammability 110°C 49015702

830.6317 Storage Stability One

- year test is ongoing 49015702

830.6319 Miscibility N/A, the product is not to be emulsifiable liquid 49015702

830.6320 Corrosion Characteristics Not corrosive; one

- year test is ongoing 49015702

830.7000 pH N/A, the product is not dispersible
in water 49015702

830.7050 UV/Visible light absorption No absorption above 200 nm, in the visible portion of the spectrum. 49015702

830.7100 Viscosity 2.41 nN

. s/m 2 (2.41 centipoise) or
2.8cSt at 25°C 49015702

830.7200 Melting Range N/A, product is not a solid at room
temperature. 49015702

830.7220 Boiling Range 100°C 49015702

830.7300 Density/Relative Density/Bulk Density 0.861 g/cm 3 or 7.19 lbs/gal 49015702

830.7520 Particle size, fiber length/diameter N/A, product is water soluble at

10
- 6 g/L 49015702

830.7550 Partition Coefficient 6.28 49015702

830.7840 Water Solubility 0.122 mg/L at 25°C 49015702

830.7950 Vapor Pressure 4 .12x10
- 4 mm Hg at 25°C 49015702

1 Request to waive submission of Stability to Normal and Elevated Temperatures, Metal/Metal Ions data requirement for TGAIs (OPPTS 830.6313) is based on 40 CFR 158.2030 (e)(17) provision. The registrant states on pg. 6 of MRID 490157

- 01 that in accordance with 40 CFR 158.2030 (e)(17) provision, the test is not required because the TGAI will be stored in glass containers and it is not intended to come into contact with metals or metal ions during storage or usage , nor is it intended to be stored or used at elevated temperatures.

VIII. A PPENDIX B

.

For product specific information, please refer to http://www.epa.gov/pesticides/pestlabels

.(Z,Z)

- 7,11

- Hexadecadienal Page 15 of 16 Biopesticides Registration Action Document

IX

. APPENDIX C.

REFERENCES

OECD . 2002. Series on Pesticides No. 12: Guidance fo r Registration Requirements for
Pheromones and Other Semiochemicals Used for Arthropod Pest Control. Organization for Economic Cooperation and Development (OECD). Issued: 02/26/2002. http://www.epa.gov/pesticides/biopesticides/regtools/index.htm

EPA. 2008 . Biopesticides Registration Action Document (BRAD) for Straight Chain Lepidopteran Pheromones (SCLP)

. U.S. Environmental Protection Agency Office of Pesticide Programs. October 2, 2008. http://www.epa.gov/pesticides/chem_search/reg_actions/registr ation/decision_G

- 109_02

- Oct

- 08.pdf

REVIEWS AND OTHER REFERENCES

EPA. 201 3a . Memorandum from Clara Fuentes, Ph.D., to Gina Burnet t

. Science Review in Support of the Registration of new technical grade (TGAI) manufacturing use product (MP),
A.S. (Z,Z)

- 7,11

, - Hexadecatrienal , containing 82.93 % w/w of (Z,Z)

- 7,11,

- Hexadecatrienal as active ingredient. U.S. Environmental Protection Agency Office of Pesticide Programs. May 15,
2013

.

EPA. 2013b. Memorandum from Clara Fuentes, Ph.D., to Colin Walsh. Science Review of response to deficiencies in Support of the Registration of new technical grade (TGAI) manufacturing use product (MP), A.S. (Z,Z)

- 7,11,

- Hexadecatrienal , containing 82.93 % w/w of (Z,Z)

- 7,11,

- Hexadecatrienal as active ingredient. U.S. Envi ronmental Protection Agency Office of Pesticide Programs. September 5, 2013

.

X. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

a.i. a ctive i ngredient

BPPD Biopesticides and Pollution Prevention Division

BRAD Biopesticide Registration Action Document
CBI Confidential Business Information
CFR Code of Federal Regulations

cm centimeter
CSF Confidential Statement of Formula
cSt centistokes
°C degrees Celsius

EP end

- use product

EPA Environmental Protection Agency (the “Agency”)
FFDCA Federal Food, Drug, and C osmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FQPA Food Quality Protection Act(Z,Z)

- 7,11

- Hexadecadienal Page 16 of 16 Biopesticides Registration Action Document

FR Federal Register

g gram gal gallon kg kilogram
L liter
lbs pounds

m meter
MRID No. Master Record Identification Number

mg milligram

mL milliliter mm Hg millimeter in Mercury

MP manufacturing

- use product
N/A not applicable

NE “No Effect”

nm nanometer NOR notice of receipt
OPP Office of Pesticide Programs
O CSPP Office of Chemical Safety and Pollution Prevention
PR Notice Pesti cide Registration Notice

s second
TGAI technical grade of the active ingredient
TSG Technology Sciences Group, Inc.

UV ultra

- violet