                  BIOPESTICIDES REGISTRATION ACTION DOCUMENT

                                    Citral
                          3,7-Dimethyl-2,6-Octadienal
                               PC Code : 040510

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

                                 June 20, 2011

		TABLE OF CONTENTS
I.	EXECUTIVE SUMMARY:	5
II.	ACTIVE INGREDIENT OVERVIEW	7
III.   REGULATORY BACKGROUND	7
A.	Classification	7
B.	Food Clearances and Tolerances	7
IV.   RISK ASSESSMENT	8
A.	Active Ingredient Characterization	8
1.	Toxicology.............................................................................................8
2.	Dose Response Assessment	10
  3.	Drinking Water Exposure and Risk Characterization.....................................10
  4..	Occupational, Residential, School and Day Care Exposure and Risk Characterization	11
5.	Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation	11
6.	Cumulative Effects	11
7.     Risk Characterization	11
C.	ENVIRONMENTAL ASSESSMENT	11
1.	Ecological Hazards	11
2.	Environmental Fate and Ground Water Data	12
3.	Ecological Exposure and Risk Characterization............................................12
    4. 	Endangered Species Assessment................................................................12
D.	EFFICACY DATA	12
V.    Risk Management Decision	123
A.	Determination of Eligibility for Registration	13
B.	Regulatory Decision.................................................................................13

C.     Environmental Justice..............................................................................13
VI.	ACTIONS REQUIRED BY REGISTRANTS	13
A.	Reporting of Adverse Effects.....................................................................14
VII. Appendix A. DATA REQUIREMENTS (40 CFR PART 158)	14

VIII. APPENDIX B. Product Specific Information..................................................18
IX. Appendix C. References	18
BIOPESTICIDES REGISTRATION ACTION DOCUMENT (BRAD) TEAM

                  Office of Pesticide Programs:
      Biopesticides and Pollution Prevention Division
            Biochemical Pesticides Branch (BPB)

Branch Chief
Linda A. Hollis, M.S.

Health Effects/Nontarget Organisms
Russell S. Jones, Ph.D., Senior Biologist

Senior Regulatory Specialist
Leonard S. Cole, Jr. M.S.I.	EXECUTIVE SUMMARY:

Citral is a technical grade active ingredient/manufacturing use product to be used in end-use products that repel mosquitoes, biting flies, and biting midges.  Citral is either of, or a mixture of, a pair of terpenoids.  The two compounds are double bond isomers. The E-isomer is known as geraniol or citral A. The Z-isomer is known as neral or citral B.  Geraniol is a monoterpenoid C-10 (branched) alcohol found widely as a chief constituent in essential oils including ilang-ilang oil, palmarosa oil, geranium oil, orange flower oil, lemongrass oil, hops oil, and lavender oil. It is a clear to pale-yellow liquid with a boiling point of 230° C, is insoluble in water, soluble in alcohol, ether and most common organic solvents  It possesses a rose-like odor, and it is used in perfumes and flavoring.  Nerol is the cis-isomer of geraniol.  Geranial and neral are the corresponding aldehydes.  Citronellol is the dihydrogeraniol and citronellal is the corresponding aldehyde.   Citral is the major constituent of lemongrass oil, verbena oil, lemon oil, nikkel oil, lime oil, ginger oil, and other essential plant oils.  It is the main source of lemon odor.  Neral has a less intense, but sweeter odor.  Citral is also used in the production of retinol which is a form of vitamin A.
Geraniol is a pheromone of certain species of bees, being secreted by the scent glands of worker bees to signal the location of nectar-bearing flowers and the entrances to their hives. Geraniol is a known insect repellant or deterrant.
The Biopesticides and Pollution Prevention Division (BPPD) has determined that the data/information submitted for Product Chemistry and Tier I Acute Toxicity for Citral satisfy the current guideline requirements. BPPD granted waivers/exemptions from conducting Tier I Sub chronic, Developmental and Mutagenicity studies (OSCPP 870.3100 to 870.5375) due to the nature of the a.i. and its intended uses of potential new EP products. However, BPPD notes that should the intended end-use applications result in different anticipated exposures to humans, the data requirements may need to be addressed in future submissions. BPPD also granted waivers/exemptions from conducting the 90-Day Dermal-Rat study (OSCPP 870.3250) based on low acute dermal toxicity, minimal irritation, intended low application rates, and little human exposure when used in accordance with USEPA/OPP approved product labeling. As for Non-Target Organisms and Environmental Fate data requirements (OSCPP 850.2100 to 850.4450), the applicant satisfied these requirements either by submitting acceptable data or the data were waived because the guideline study was not applicable.  Based on this information, the Agency has determined that registered use of Citral as a technical grade active ingredient will have a provisional No Adverse Effects (NAE) on threatened and/or endangered species. A comprehensive Endangered Species Risk Assessment will be conducted upon submission of EP products containing this active ingredient.

Based on the Acute Toxicity data for Citral, the active ingredient is toxicity category III. As stated above, Tier I Subchronic, Developmental and Mutagenicity data requirements are Not Applicable at this time due to the nature of the a.i. and intended uses of potential new EP products.  EPA has no concerns for any non-target organisms exposed to Citral when used in accordance with approved label directions.  EPA has not identified any toxic endpoints for non-target mammals, birds, plants, aquatic, or soil organisms. There are no concerns for any threatened and endangered species. Given that Citral very low toxicity and presents little if any risk to non-target organisms, EPA concludes that it is in the best interests of the public and the environment to issue the registration for Citral.

The Biopesticides and Pollution Prevention Division (BPPD) has reviewed the data/information in support of the requirements for granting registration under Section 3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). It was determined that the data/information submitted adequately satisfy current guideline requirements (please refer to 40 CFR 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 new policy, EPA intends to provide a public comment period prior to making a registration decision for, at minimum, 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 new policy of making registration actions more transparent, Citral is subject to a 30 day comment period as a "new active ingredient". While a final decision on registration is contingent upon review and consideration of public comments, EPA presently believes that based on the risk assessment and information submitted in support of the registration of Citral that it is in the best interests of the public and the environment to issue the registration for Citral. The basis for this preliminary decision can be found in the risk assessment for Citral, which is characterized in this BRAD.

II.		ACTIVE INGREDIENT OVERVIEW

   Common Name: 			Citral

      Chemical Names:            3,7-Dimethyl-2,6-Octadienal

   Trade & Other Names: 	Bedoukian Citral

      CAS Registry Number: 	5392-40-5

   OPP Chemical Code: 	040510

   Type of Pesticide:            Biochemical Pesticide (Repellent)

III.		REGULATORY BACKGROUND

On July 29, 2010, EPA received an application filed by Bedoukian Research, Inc., 21 Finance Drive, Danbury, CT  06810-4192 to register the product, Bedoukian Citral Technical, containing the new biochemical active ingredient, Citral, a mixture of a pair of terpenoids.  A notice of receipt of this application, allowing for a 30-day comment period, was published in the Federal Register of November 24, 2010 (75 FR 226). No comments were received following this publication.

A.	Classification

On September 26, 2008, the Biochemical Classification Committee determined that Citral can be classified as a biochemical pesticide due to its non-toxic mode of action, natural occurrence in the environment, and history of exposure to humans and the environment demonstrating minimal toxicity.

B.	Food Clearances/Tolerances

Currently, this active ingredient is not registered for use on food or feed commodities.  A tolerance or exemption from the requirement of a tolerance is not required.

IV.			RISK ASSESSMENT

A.	Active Ingredient Characterization

The new active ingredient Citral, a mixture of two terpenoids, will be formulated as an End-Use Product for repelling mosquitoes, biting flies, biting midgets and no-see-ums.  Citral, or 3,7-dimethyl-2,6-octadienal, is a mixture of a pair of terpenoids with the molecular formula C10H16O. The two compounds are double bond isomers. The E-isomer is known as geranial or citral A. The Z-isomer is known as neral or citral B. Geranial has a strong lemon odor. Neral's lemon odor is less intense, but sweeter.  Citral is therefore an aroma compound used in the perfume industry for its citrus effect.  Citral is also used as a flavor and for fortifying lemon oil. It also has strong antimicrobial qualities and some pheromonal effects in insects.  Citral is a simple compound that has low mammalian acute toxicity is likely to degrade rapidly in the environment.

Descriptions of the product formulation and production process, as well as the formation of impurities, were examined by BPPD and found to be acceptable in meeting current guideline standards.

All product chemistry data requirements for registration of Citral have been satisfied.

B.	Human Health Assessment

1.	Toxicology

For acute toxicity data requirements, toxicity categories are assigned based on the 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 lowest toxicity.

Adequate mammalian toxicology data/information is available to support registration of Citral.  All toxicology data requirements for Citral have been satisfied.

	a.	Acute Toxicity

Acute toxicity testing is required to 1) determine systemic toxicity from acute exposure via the dermal, inhalation and oral routes, 2) determine irritant effects from exposure to the eyes, and 3) determine the potential for skin sensitization (allergic contact dermatitis).

Tier I acute toxicity studies submitted and reviewed showed that Citral is a toxicity category III (slightly toxic) compound via acute dermal routes of exposure, based on testing at a limit dose of 2250 mg a.i./kg.  Citral falls in Toxicity Category IV (not toxic) for acute inhalation toxicity, primary dermal irritation, and primary eye irritation.  Citral is not an eye irritant, and definitive submitted information confirmed that Citral is a not a dermal sensitizer.

For more information regarding acute toxicity data requirements, refer to Table 3 in Appendix A.
 	b.	Subchronic Toxicity

 Subchronic data is required to determine a no-observed-effect-level (NOEL) and any toxic effects associated with repeated or continuous exposure to a test substance for a period of ninety days.

Waivers requested for the subchronic [90-day oral (OSCPP 870.3100), 90-day dermal (OSCPP 870.3250), and 90-day inhalation (OSCPP 870.3465)] were granted by BPPD, based on the product's toxicological and exposure profile below.

	i.	Low acute dermal toxicity (>2000 mg/kg; Tox Category III);
	ii.	Minimal dermal irritation (Toxicity Category IV);
	iii.	Intended low application rates;
	iv.	Products containing Citral as an active ingredient are not intended for purposeful application to human skin, and use of products containing Citral would not result in comparable prolonged human exposure when used in accordance with approved product labeling.

The two terpenoids comprising the active ingredient Citral, are double bond isomers containing 10 carbon atoms.  Citral is a mixture of two aldehydes that have the same molecular formula but different structures.   The aforementioned aldehydes are relatively simple compounds that have low mammalian acute toxicity and are likely to degrade rapidly in the environment.  For more information regarding the subchronic data requirements, refer to Table 3 in Appendix A.

      c.   Developmental Toxicity and Mutagenicity

BPPD granted waivers for Tier I Sub chronic, Developmental and Mutagenicity data
requirements (OSCPP 870.3100 to 870.5375) due to the nature of the a.i. and its intended uses in
potential new EP products (insect repellents).

	d.   Tier II/Tier III

The data requirements were not required due to the nature of the a.i. and its intended uses in
potential new EP products (insect repellents).

	e.	Effects on the Endocrine System

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a "naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." The EDSP employs a two-tiered approach to making the statutorily required determinations.  Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems.  Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data.  Tier 2 testing is designed to identify any adverse endocrine related effects caused by the substance, and establish a dose-response relationship between the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and nine inert ingredients.  This list of chemicals was selected based on the potential for human exposure through pathways such as food and water, residential activity, and certain post-application agricultural scenarios.  This list should not be construed as a list of known or likely endocrine disruptors.

Citral is not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP.  Under FFDCA section 408(p) the Agency must screen all pesticide chemicals.  Accordingly, EPA anticipates issuing future EDSP test orders/data call-ins for all pesticide active ingredients.

For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, please visit our website:  http://www.epa.gov/endo/.

2.	Dose Response Assessment

Because no toxicological endpoints were identified, a dose response assessment was not required.

3.	Drinking Water Exposure and Risk Characterization

No significant exposure via drinking water is expected when Citral is used according to the product label directions.  The active ingredient is not to be applied directly to water or to areas where surface water is present, and if used as labeled, is not likely to accumulate in drinking water.  In the unlikely event that exposure via drinking water did occur, the health risk would be expected to be minimal, based on the low acute oral toxicity of Citral.

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

	a.	Occupational Exposure and Risk Characterization

End-use products were not available for review.  Therefore, occupational exposure and risk cannot be assessed or characterized.  This assessment and characterization will be conducted upon receipt of an end-use product for review.

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

End-use products were not submitted for review.  Therefore, residential, school, and day-care exposure and risk cannot be assessed or characterized.  This assessment and characterization will be conducted upon receipt of an end-use product for review.

5.	Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation

There is reasonable certainty that no harm to the U.S. population will result from aggregate exposure to Citral.  This includes all exposures for which there is reliable information.  The Agency arrived at this conclusion based on the pesticide's highly specific mode of action as a insect repellent, low toxicity to mammalian systems and the intended non-food use.  The risk from aggregate exposure (via oral, dermal and inhalation exposures) is negligible.

6.	Cumulative Effects

Based on the information available to the Agency, there is no indication that toxic effects associated with exposure to Citral are of toxicological concern.  Because of the active ingredient's low toxicity, cumulative effects with other substances that share a common mechanism of toxicity are not expected.

 7.   Risk Characterization

The Agency considered human exposure to Citral 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 Citral when label instructions are followed.

C.	ENVIRONMENTAL ASSESSMENT

1.	Ecological Hazards

Adequate non-target toxicology data/information are available to support registration of Citral.  All non-target toxicology data requirements for Citral have been satisfied.
Non-Target Organisms and Environmental Fate data requirements were waived.

2.	Environmental Fate and Ground Water Data

The need for environmental fate and groundwater data was not triggered because Citral acute toxicity studies did not trigger any additional Tier I studies.

3.	Ecological Exposure and Risk Characterization

Based on the information submitted in the data waiver requests for nontarget plants and data for nontarget insects, exposure and risk from the proposed use of Citral is not expected to occur for other nontarget organisms.

4.   Endangered Species Assessment

Based on the information discussed above, the Agency determined that registered use of Citral as an active ingredient will have No Adverse Effects (NAE) on threatened and/or endangered species.  When the product is used according to label use directions, there are no concerns for any nontarget organisms.

D.	PRODUCT PERFORMANCE DATA (EFFICACY)

Submission of product performance data (OSCPP 810.3000) is 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, i.e., ticks, mosquitoes, fleas, Mediterranean fruit flies, gypsy moths, Japanese beetles, etc.  For a list of organisms considered by the Agency as "public health pests", please refer to Pesticide Registration Notice 2002-1 (http://www.epa.gov/PR_Notices/pr2002-1.pdf).

No end-use products were available for review.  Therefore, product performance (efficacy) could not be evaluated.

V.	Risk Management Decision

A.	Determination of Eligibility for Registration

Section 3(c)(5) of FIFRA provides for the registration of new active ingredients if it is determined that: (A) its composition warrants proposed claims; (B) its labeling and other materials 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 supporting products containing Citral.  Such products are not expected to cause unreasonable adverse effects and are likely to provide protection as claimed when used according to label instructions. Therefore, Citral is eligible for registration for the labeled uses.

B.	Regulatory Decision

The data submitted fulfill the registration requirements of Citral for use as an insect repellent.  Refer to Appendix B for product-specific information.

      1.	Conditional/Unconditional Registration

All data requirements are fulfilled, and EPA has determined that unconditional registration of Citral 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 -- with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies. At this time, EPA does not believe that use of Citral pesticide products will cause harm or a disproportionate impact on at-risk communities.

For additional information regarding environmental justice issues, please visit EPA's website at http://www.epa.gov/compliance/environmentaljustice/index.html.

VI.		ACTIONS REQUIRED BY REGISTRANTS

EPA evaluated all data submitted in connection with the registration of the Citral pesticide products and determined that these data are sufficient to satisfy current registration data requirements. At this time, no additional data must be submitted to EPA for these particular products.  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 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

Pursuant to FIFRA section 6(a)(2), reports 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).

VII.	 Appendix A. Data Requirements (40 CFR Part 158-Subpart U)

*NOTE:  Master Record Identification (MRID) numbers listed in the following tables are representative of 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.

Structures and Chemical Data for Citral

                                    Citral

TABLE 1.  Physical and Chemical Properties for Bedoukian Citral Technical[a]

                       Guideline Reference No./Property

                             Description of Result

                                    Methods

830.6302	Color
                                  Pale-yellow
                               Visual inspection

830.6303	Physical State
                                    Liquid
                               Visual inspection

830.6304	Odor
                                 Strong, lemon
                             Olfactory inspection

830.6313	Stability
          Stable for 14 days at 54°C except in the presence of iron.
                              Gas chromatography

830.6314	Oxidation/Reduction:
        Chemical Incompatibility
                            Not required for TGAI.

830.6315	Flammability
                                    195°C
                           Pensky Martens closed cup

830.6316	Explodability
                            Not required for TGAI.
  Not applicable for MP, the product does not contain explosive ingredients.

830.6317	Storage Stability
Estimated to be stable for one year at ambient temperatures. Based on 14 day tests at elevated temperatures.
                     One year storage stability required.

830.6319	Miscibility
Not required for TGAI.
Not applicable for MP, the product is not to be diluted with oil or nonpolar solvents.

830.6320	Corrosion Characteristics
Not required for TGAI
Not addressed for MP

830.6321	Dielectric Breakdown Voltage
Not required for TGAI/MP

830.7000	pH
Not applicable, the product is practically insoluble in water.

830.7100	Viscosity
2.44 CST at 25°C
                           ATSM D445 standard method

830.7200	Melting Range
-26.74°C
                     QSAR; Experimental data per EPISUITE

830.7220	Boiling Range
217.44°C
                        Experimental data per EPISuite

830.7300	Density/Relative Density/Bulk Density
0.885-0.891 at 25°C
                   Anton Parr Density meter, model DMA 4500

830.7370	Dissociation Constant in Water
Not applicable, the product is not pure active ingredient.

830.7550	Partition Coefficient
Log Pow 3.45
                                QSRA: EPISuite

830.7840	Water Solubility
1340 mg/L at 37°C
1101 mg/L at 25°C
                         QSAR: EPISuite (WSKOW v1.41)

830.7950	Vapor Pressure
0.0913 mm Hg at 25°C
                                QSAR: EPISuite

830.2240        Photolysis (water)
                                  1.14 years
                   Sunlight epsilon = 6.25x10[3] at 300 nm.

835.2120	Hydrolysis
pH 4   9.54  -  9.81 days
pH 7 106 - 230
pH 9   22.8  -  30.1 days

Table 3.0.  Toxicological Data  for Citral Technical (98% ai)
                               Data Requirement
                                     LD50
                               Toxicity Category
                                     MRIDs
Acute Oral Toxicity
OPPTS 870.1100

6,800 mg/kg
                                      IV
                              (Waiver Acceptable)

                                   48172502
Acute Dermal Toxicity
OPPTS 870.1200

2,250 mg/kg
                                      III
                              (Waiver Acceptable)

                                   48172502
Acute Inhalation Toxicity
OPPTS 870.1300

Used extensively as a fragrance.
                                      IV
                                  > 2 mg/L
                              (Waiver Acceptable)

                                   48172502
Primary Eye Irritation
OPPTS 870.2400
Citral was irritating to rabbit eyes

                              (Waiver Acceptable)

                                   48172502
Primary Dermal Irritation
OPPTS 870.2500

Irritating to rabbits

                              (Waiver Acceptable)

                                   48172502
Dermal Sensitization
OPPTS 870.2600

Dermal sensitizer

                              (Waiver Acceptable)

                                   48172502
90-Day Inhalation Subchronic
(870.3465)

Used extensively as a fragrance.
                                      IV
                                  > 2 mg/L
                              (Waiver Acceptable)

                                   48172502
Prenatal Development
(870.3700)
NOAEL = 200 mg/kg/day. No teratogenicity at 68 ppm.

                              (Waiver Acceptable)

                                   48172502
Mutagenicity
(870.5100, 870.5300, 870.5375)
10 mg/plate produced negative results with and without metabolic activation

                              (Waiver Acceptable)

                                   48172502
Reproduction
(870.3550)
Rats given 0, 40, 200, and 1000 mg/kg/day citral tech with no statistically significant effects.

                             NOAEL=1,000mg/kg/day

                                   48172502
                               MHW, Japan, 2000

Table 4.0.  Ecological Toxicological Data  for Citral Technical (98% ai)
                               Data Requirement
                                     LD50
                               Toxicity Category
                                     MRIDs
Acute Avian Oral Toxicity
OPPTS 850.2100; 850.2200
No oral exposure. Product is odorous repellent

                              (Waiver Acceptable)

                                   48172502
Acute Fish Toxicity
OPPTS 850.1075

LC50 4.6 -10 mg/L
                               Moderate toxicity
                              (Waiver Acceptable)

                                   48172502
Acute InvertebrateToxicity
OPPTS 850.1010

EC50 = 7  -  11 mg/L

                              (Waiver Acceptable)

                                   48172502
Daphnia Reproduction
OPPTS 850.1300
NOEC = 1mg/L
EC50 = 1.6 mg/L

                                    4817250
Seedling Emergence
OPPTS 850.4100
Odorous repellent no direct exposure to plants

                              (Waiver Acceptable)

                                   48172502
Vegetative Vigor
OPPTS 850.4150
Odorous repellent no direct exposure to plants

                              (Waiver Acceptable)

                                   48172502
Nontarget Insect
OPPTS 870.2600
Odorous repellent no direct contact to insects

                              (Waiver Acceptable)

                                   48172502

VIII. Appendix B.

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

IX.	Appendix C.

REFERENCES

                                     MRID
                                   Citation
                                 Receipt Date
42552800
Sun Deep, Inc. (1992) Submission of product chemistry data to support registration of Buzz Away. Transmittal of 1 study.
                                  09-Nov-1992
42552801
Gill, J. (1992) Product Chemistry: Buzz Away. Unpublished study prepared by Sun Deep, Inc. 13 p.
                                  09-Nov-1992
43272600
S.C. Johnson & Son Inc. (1994) Submittal of Product Chemistry Data in Support of Registration for Off! Moth Proofer 3. Transmittal of 1 study.
                                  13-Jun-1994
43272601
Schinkowitch, D.; Rudin, R. (1994) Off! Moth Proofer 3: Product Chemistry Data: Lab Project Number: 7867P100: 7867P100-C1. Unpublished study prepared by S. C. Johnson & Son Inc. 30 p.
                                  13-Jun-1994
43275600
S. C. Johnson & Son Inc. (1994) Submittal of Product Chemistry Data in Support of Registration of Off! Moth Proofer 4. Transmittal of 1 Study.
                                  13-Jun-1994
43275601
Schinkowitch, D.; Rudin, R. (1994) Product Chemistry Data: Off! Moth Proofer 4: Lab Project Number: 7867P101: 7867P101-C1. Unpublished study prepared by S. C. Johnson & Son Inc. 26 p.
                                  13-Jun-1994
43278600
L&F Products (1994) Submission of Product Chemistry Data for TRYSOL in Support of Registration. Transmittal of 1 study.
                                  22-Jun-1994
43278601
Herrity, M. (1994) Product Chemistry: TRYSOL: Lab Project Number: 93.0810. Unpublished study prepared by L&F Products, Research Development Lab. 56 p.
                                  22-Jun-1994
43941900
Avon Products, Inc. (1996) Submission of Product Chemistry Data in Support of the Application for Registration of Skin So Soft Moisturizing Outdoor Protection After Sun Spray. Transmittal of 1 Study.
                                  29-Feb-1996
43941901
Garey, J.; Garrison, M.; Luo, Q.; et al. (1996) 5 Batch Analysis of Skin So Soft Moisturizing Outdoor Protection After Sun Spray: Lab Project Number: 7222-24. Unpublished study prepared by Avon Products, Inc. 129 p.
                                  29-Feb-1996
48033000
E. I. du Pont de Nemours and Co., Inc. (2010) Submission of Product Chemistry and Toxicity Data in Support of Risk Assessment. Transmittal of 13 Studies.
                                  19-Feb-2010
48033013
Roncaglioni, A.; Piclin, N.; Pintore, M.; et al. (2008) Binary Classification Models for Endocrine Disrupter Effects Mediated Through the Estrogen Receptor. SAR and QSAR in Environmental Research 19(7-8): 679-733.
                                  19-Feb-2010
48172500
Bedoukian Research Inc. (2010) Submission of Product Chemistry and Toxicity Data In Support of the Application for Registration of Bedoukian Citral Technical. Transmittal of 2 Studies.
                                  02-Aug-2010
48172501
Maher, M. (2010) Application for Pesticide Registration: Bedoukian Citral Technical: Product Chemistry. Unpublished study prepared by Bedoukian Research, Inc. 116 p.
                                  02-Aug-2010
48172502
Maher, M. (2010) Application for Pesticide Registration: Bedoukian Citral Technical: Toxicity Testing. Unpublished study prepared by Bedoukian Research, Inc. 399 p.
                                  02-Aug-2010
48265800
Whitmire Micro-Gen Research Laboratories, Inc. (2010) Submission of Product Chemistry, Toxicity and Efficacy Data in Support of the Application for Registration of TC-314. Transmittal of 26 Studies.
                                  19-Oct-2010
48265813
Snell, E.; Smith, T.; Garrett, B. (2010) Efficacy of TC-314 (0.5% Chlorfenapyr), Phantom Pressurized Insecticide (0.5% Chlorfenapyr) and Mother Earth Exempt Contact Insecticide (6.0% geraniol, 0.5% Lemongrass Oil) When Applied as Direct Spray Applications to Carpenter Bees (Xylocopa virginica). Project Number: BASF/1653/1663, 2687, 1653. Unpublished study prepared by Snell Scientifics, LLC. 32 p.
                                  19-Oct-2010

 X.    GLOSSARY OF ACRONYMS AND ABBREVIATIONS

   a.i.	Active Ingredient
   BPPD	Biopesticides and Pollution Prevention Division
   BRAD	Biopesticide Registration Action Document
   CFR	Code of Federal Regulations

   cm[3] 	cubic centimeter
   CSF	Confidential Statement of Formula
   °C 	degrees Celsius
   EDSP	Endocrine Disruptor Screening Program
   EDSTAC	Endocrine Disruptor Screening and Testing Advisory Committee
   EPA	Environmental Protection Agency (the "Agency")
   FFDCA	Federal Food, Drug, and Cosmetic Act
   FIFRA	Federal Insecticide, Fungicide, and Rodenticide Act
   FQPA 	Food Quality Protection Act
   FR	Federal Register
   g 	gram
   kg	kilogram
   L                   liter
   LD50	median lethal dose. A statistically derived single dose that can be expected
   	to cause death in 50% of the test animals when administered by the route
   	indicated (oral, dermal, or inhalation). It is expressed as a weight of
   	substance per unit weight of animal (e.g., mg/kg).
   MRID No.	Master Record Identification Number
   mg	milligram
   mL	milliliter
   MP	manufacturing-use product
   MPCA	microbial pest control agent
   NE	"No Effect"
   NIOSH 	National Institute for Occupational Safety and Health
   OPP	Office of Pesticide Programs
   OPPTS 	Office of Prevention, Pesticides, and Toxic Substances
   PCR	polymerase chain reaction
   PPE 	personal protective equipment
       TGAI 	   technical grade of the active ingredient


[Federal Register Volume 78, Number 21 (Thursday, January 31, 2013)]
[Rules and Regulations]
[Pages 6730-6732]
[FR Doc No: 2013-02207]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2012-1013]
RIN 1625-AA00

Safety Zone; Woldenburg Park, Mississippi River, New Orleans, LA

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Captain of the Port New Orleans, under the authority of
the Ports and Waterways Safety Act, has established a temporary safety
zone on the Mississippi River in the vicinity of Woldenburg Park, mile
marker 94 to mile marker 96, extending out 300 feet from the East Bank
of the Mississippi River during Super Bowl 2013 celebratory events. The
Super Bowl is a large scale event that poses many public safety
concerns due to the number of people that will attend. This safety zone
has been established to protect the public from the hazards created by
congested river traffic.

DATES: This rule is effective from 6:00 a.m. on January 29, 2013
through 6:00 a.m. on February 4, 2013. The zone will be enforced
between the hours of 8:00 a.m. and 10:00 p.m. on each day of the
effective period described above.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2012-1013]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LCDR Kenneth Blair, Sector New Orleans, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If you have
questions on viewing or submitting material to the docket, call Renee
V. Wright, Program Manager, Docket Operations, telephone (202) 366-
9826.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard published a Notice of Proposed Rulemaking (NPRM)
for this Final Rule on December 19, 2012 (77 FR 75079). The comment
period for the NPRM expired on December 30, 2012. The Coast Guard
received no public comments and no requests to extend the comment
period.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. The Super Bowl events for which
this safety zone is intended to be effective begin the last week of
January 2013. Waiting 30 days after publication in the Federal Register
is contrary to public interest as that would delay the effective date
of this rule until after the Super Bowl events in this area have
completed.

B. Basis and Purpose

    The 2013 National Football League Super Bowl in New Orleans,
Louisiana will occur on February 3, 2013. This is a very high profile
event, with tens of thousands of people expected to attend events at
Woldenburg Park and other Mississippi River riverfront locations
before, during, and after the football game. Due to the unusually large
crowds expected along the riverfront, the consequences to the public of
an incident involving a vessel in the immediate area will greatly
increase. To address this concern, the Captain of the Port New Orleans
has established a temporary safety zone on the Mississippi River in the
vicinity of Woldenburg Park, mile marker 94 to mile marker 96,
extending out 300 feet from the East Bank of the Mississippi River.
This safety zone has been established to protect the public from the
potential hazards created by congested river traffic. All vessels are
prohibited from entering into or transiting through the safety zone
without prior approval of the Captain of the Port New Orleans.
    The legal basis and authorities for this rule are found in 33
U.S.C. 1231, 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33
CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Public Law 107-295, 116 Stat.
2064; and Department of Homeland Security Delegation No. 0170.1, which
collectively authorize the Coast Guard to propose, establish, and
define regulatory safety zones.

C. Discussion of Comments, Changes and the Final Rule

    The Coast Guard received no public comments on the proposed
temporary safety zone, therefore there are no changes to the regulatory
text in this final rule.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. The impacts on
navigation will be minimal due to the duration and location of the
safety zone, and the fact that vessels will be able to safely navigate
around this area on the Mississippi River. Additionally, vessels may
request permission from the Captain of the Port to enter into or
transit though the safety zone.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rule. The Coast Guard certifies under 5 U.S.C.
605(b) that this rule will not have a significant economic impact on a
substantial number of small entities.
    This final rule affects the following entities, some of which might
be small entities: the owners or operators of vessels intending to
transit on the Mississippi River in the Vicinity of Woldenburg Park,
New Orleans, Louisiana, mile marker 94 to mile marker 96, between 6:00
a.m. on January 29, 2013 through 6:00 a.m. on February 4, 2013.
    This safety zone will not have a significant economic impact on a
substantial number of small entities because most vessel traffic could
pass safely around the safety zone. Vessel traffic that cannot pass
safely around the safety zone would be allowed to pass through the zone
with the permission of the Captain of the Port New Orleans. Before the
activation of the safety zone, the Captain of the Port New Orleans
would issue maritime advisories widely available to users of the river.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INTFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not

consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule creates a temporary safety zone on the
Mississippi River in the vicinity of Woldenburg Park, mile marker 94 to
mile marker 96, extending out 300 feet from the East Bank of the
Mississippi River during Super Bowl 2013 celebratory events. The Super
Bowl is a large scale event that poses many public safety concerns due
to the number of people that will attend. This safety zone has been
established to protect the public from the hazards created by congested
river traffic. This rule is categorically excluded from further review
under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An
Environmental Analysis Checklist and a Categorical Exclusion
Determination are available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L,
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1

0
2. Add Sec.  165.T08-1013 to read as follows:

Sec.  165.T08-1013  Safety Zone; Woldenburg Park, Mississippi River,
New Orleans, LA.

    (a) Location. The following area is a safety zone: The waters on
the Mississippi River in the vicinity of Woldenburg Park, New Orleans,
Louisiana, mile marker 94 to mile marker 96, extending out
approximately 300 feet from the East Bank of the Mississippi River.
    (b) Effective Dates: This rule is effective from 6:00 a.m. on
January 29, 2013 through 6:00 a.m. on February 4, 2013.
    (c) Enforcement Periods: This safety zone will be enforced from
8:00 a.m. until 10:00 p.m. on each day of the effective dates described
in paragraph (b).
    (d) Regulations. (1) In accordance with the general regulation in
Sec.  165.23 of this part, vessels must not enter into, remain within,
or transit through this safety zone, unless authorized by the Captain
of the Port New Orleans.
    (2) Vessels requiring entry into or passage through the Safety Zone
must request permission from the Captain of the Port New Orleans, or a
designated representative. The Captain of the Port New Orleans, or a
designated representative, may be contacted on VHF-16, or by telephone
at<PHONE_NUMBER>.
    (3) All persons and vessels shall comply with the instructions of
the Captain of the Port New Orleans and designated personnel.
Designated personnel include commissioned, warrant, and petty officers
of the U.S. Coast Guard.

    Dated: January 23, 2013.
P.W. Gautier,
Captain, U.S. Coast Guard, Captain of the Port New Orleans.
[FR Doc. 2013-02207 Filed 1-30-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Notices]
[Page 68767]
[FR Doc No: 2012-27964]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER13-338-000]

Shiloh IV Lessee, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding,
of Shiloh IV Lessee, LLC's application for market-based rate authority,
with an accompanying rate schedule, noting that such application
includes a request for blanket authorization, under 18 CFR part 34, of
future issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability is November 29, 2012.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 9, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-27964 Filed 11-15-12; 8:45 am]
BILLING CODE 6717-01-P